# FDA Orange Book Scraper (`parseforge/fda-orange-book-scraper`) Actor

Scrape the FDA Orange Book of approved drug products with therapeutic equivalence evaluations. Get NDA, ingredient, dosage form, strength, route, applicant, marketing status, TE code, RLD/RS flags, exclusivity and patent data. Perfect for pharma research, payers, and generics intelligence.

- **URL**: https://apify.com/parseforge/fda-orange-book-scraper.md
- **Developed by:** [ParseForge](https://apify.com/parseforge) (community)
- **Categories:** Automation, Other
- **Stats:** 2 total users, 1 monthly users, 100.0% runs succeeded, NaN bookmarks
- **User rating**: No ratings yet

## Pricing

Pay per usage

This Actor is paid per platform usage. The Actor is free to use, and you only pay for the Apify platform usage, which gets cheaper the higher subscription plan you have.

Learn more: https://docs.apify.com/platform/actors/running/actors-in-store#pay-per-usage

## What's an Apify Actor?

Actors are a software tools running on the Apify platform, for all kinds of web data extraction and automation use cases.
In Batch mode, an Actor accepts a well-defined JSON input, performs an action which can take anything from a few seconds to a few hours,
and optionally produces a well-defined JSON output, datasets with results, or files in key-value store.
In Standby mode, an Actor provides a web server which can be used as a website, API, or an MCP server.
Actors are written with capital "A".

## How to integrate an Actor?

If asked about integration, you help developers integrate Actors into their projects.
You adapt to their stack and deliver integrations that are safe, well-documented, and production-ready.
The best way to integrate Actors is as follows.

In JavaScript/TypeScript projects, use official [JavaScript/TypeScript client](https://docs.apify.com/api/client/js.md):

```bash
npm install apify-client
```

In Python projects, use official [Python client library](https://docs.apify.com/api/client/python.md):

```bash
pip install apify-client
```

In shell scripts, use [Apify CLI](https://docs.apify.com/cli/docs.md):

````bash
# MacOS / Linux
curl -fsSL https://apify.com/install-cli.sh | bash
# Windows
irm https://apify.com/install-cli.ps1 | iex
```bash

In AI frameworks, you might use the [Apify MCP server](https://docs.apify.com/platform/integrations/mcp.md).

If your project is in a different language, use the [REST API](https://docs.apify.com/api/v2.md).

For usage examples, see the [API](#api) section below.

For more details, see Apify documentation as [Markdown index](https://docs.apify.com/llms.txt) and [Markdown full-text](https://docs.apify.com/llms-full.txt).


# README

![ParseForge Banner](https://github.com/ParseForge/apify-assets/blob/ad35ccc13ddd068b9d6cba33f323962e39aed5b2/banner.jpg?raw=true)

## 💊 FDA Orange Book Scraper

> 🚀 **Export FDA Orange Book approved drugs with TE codes and ingredients in seconds.**

> 🕒 **Last updated:** 2026-05-26 · **📊 12 fields** per record · **29,000+ products · 200+ TE codes · 12 fields per drug product**

The FDA Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) lists every approved prescription, OTC, and biologic product in the United States. This Actor uses the official openFDA Drugs@FDA API to pull one row per product and 12 structured fields covering application, sponsor, ingredient, dosage, route, marketing status, and TE code.

| 🎯 Target Audience | 💡 Primary Use Cases |
|---|---|
| Pharma teams | Map generics to RLDs |
| Compliance & legal | Verify TE equivalence claims |
| Pricing & market access | Build payer formularies |
| Researchers | Study approval-trend datasets |

### 📋 What the FDA Orange Book Scraper does

- Queries the public FDA Orange Book source and structures the response
- Returns one record per item with 12 normalized fields
- Supports pagination and optional filters
- Outputs to CSV, Excel, JSON, XML via Apify dataset
- Auto-limits to 10 items on the free plan; up to 1,000,000 on paid

> 💡 **Why it matters:** FDA Orange Book data is public record. This Actor makes it usable.

### 🎬 Full Demo (_🚧 Coming soon_)

### ⚙️ Input

<table>
<thead><tr><th>Field</th><th>Type</th><th>Description</th></tr></thead>
<tbody><tr><td>maxItems</td><td>integer</td><td>Cap on rows (free: 10)</td></tr><tr><td>search</td><td>string</td><td>Optional openFDA search expression (e.g. sponsor_name:PFIZER)</td></tr></tbody>
</table>

```json
{ "maxItems": 100 }
````

```json
{ "maxItems": 500, "search": "sponsor_name:PFIZER" }
```

> ⚠️ **Good to Know:** openFDA refreshes the Orange Book monthly. Some discontinued products retain historical TE codes.

### 📊 Output

| Field | Type | Description |
|---|---|---|
| 🔹 applicationNumber | string | FDA application number (NDA/ANDA/BLA) |
| 🔹 sponsor | string | Sponsor / applicant company |
| 🔹 brandName | string | Product brand name |
| 🔹 activeIngredient | string | Active ingredient(s) + strength |
| 🔹 dosageForm | string | Dosage form (TABLET, INJECTION...) |
| 🔹 route | string | Route of administration (ORAL, IV...) |
| 🔹 marketingStatus | string | Prescription / OTC / Discontinued |
| 🔹 teCode | string | Therapeutic equivalence code |
| 🔹 referenceDrug | boolean | Whether this is the reference listed drug |
| 🔹 referenceStandard | boolean | Whether this is the reference standard |
| 🔹 latestSubmissionStatus | string | AP, RV, etc. |
| 🔹 latestSubmissionDate | string | YYYYMMDD of latest submission status |
| 🕒 scrapedAt | string | ISO timestamp of when the record was collected |
| ❌ error | string | null | Error message if extraction failed |

### ✨ Why choose this Actor

- Direct FDA Orange Book source, no third-party caching
- Real-time data, never stale
- Pay-per-result pricing; only charged for what you keep
- Works with Make, Zapier, n8n, Airbyte, GitHub Actions, Google Sheets

### 📈 How it compares to alternatives

| Approach | Cost | Maintenance | Coverage |
|---|---|---|---|
| Manual Orange Book PDF download | Free | Medium | Static snapshot |
| Pharma DBs (IQVIA, Cortellis) | $$$$ | None | Curated, paywalled |
| This actor | Pay per result | None | Live openFDA feed |

### 🚀 How to use

1. [Create a free account w/ $5 credit](https://console.apify.com/sign-up?fpr=vmoqkp)
2. Open the Actor page
3. Set `maxItems` and any optional filters
4. Run
5. Download dataset as CSV, Excel, JSON, or XML

### 💼 Business use cases

#### Competitor & market intelligence

Track FDA Orange Book entries relevant to your sector.

#### Compliance monitoring

Spot regulatory or enforcement signals in your industry feed.

#### Lead generation

Use FDA Orange Book entries as a clean prospect list.

#### Risk & due diligence

Vet counterparties or candidates against the official record.

### 🔌 Automating FDA Orange Book Scraper

Connects with Make, Zapier, n8n, Slack, Airbyte, GitHub Actions, and Google Drive via Apify's standard integrations.

### 🌟 Beyond business use cases

#### Research

Academic studies on regulation, public policy, and enforcement trends.

#### Personal

Citizens following developments in their communities.

#### Non-profit

Watchdog organizations and civic-tech projects auditing the record.

#### Experimentation

Train models on labeled regulatory data.

### 🤖 Ask an AI assistant about this scraper

ChatGPT, Claude, Perplexity, or Copilot can explain inputs, sample outputs, and integration patterns.

### ❓ Frequently Asked Questions

**Q: What is a TE code?** A: A two- or three-letter code rating therapeutic equivalence (AB, BX, etc.).
**Q: Are biologics included?** A: Yes, via BLA application numbers.
**Q: Can I filter by sponsor?** A: Yes via the search input: sponsor\_name:PFIZER.
**Q: Are discontinued products included?** A: Yes. Their marketing status reflects that.
**Q: How fresh is the data?** A: openFDA updates the dataset monthly; we pull it live.
**Q: Is this affiliated with the FDA?** A: No. Independent tool using the public openFDA API.
**Q: How are duplicates handled?** A: Each product row is unique by application + product number.
**Q: What is the reference listed drug?** A: The branded innovator a generic is compared against.
**Q: Can I get patent data?** A: Patents are in a separate openFDA endpoint.
**Q: Are OTCs included?** A: Yes. The marketingStatus field will say OTC.

### 🔌 Integrate with any app

Make, Zapier, n8n, Slack, Airbyte, GitHub Actions, Google Sheets, Webhooks, REST API.

### 🔗 Recommended Actors

| Actor | Description |
|---|---|
| [FDA Warning Letters Scraper](https://apify.com/parseforge/fda-warning-letters-scraper) | FDA warning letters |
| [SEC Litigation Releases Scraper](https://apify.com/parseforge/sec-litigation-releases-scraper) | SEC enforcement actions |
| [FTC Actions Scraper](https://apify.com/parseforge/ftc-actions-scraper) | FTC enforcement actions |

> 💡 **Pro Tip:** browse the complete [ParseForge collection](https://apify.com/parseforge).

**🆘 Need Help?** [Open our contact form](https://tally.so/r/BzdKgA)

> **⚠️ Disclaimer:** independent tool, not affiliated with the FDA Orange Book source agency or any government. Only publicly available data collected.

# Actor input Schema

## `maxItems` (type: `integer`):

Free users: Limited to 10 items (preview). Paid users: Optional, max 1,000,000

## `search` (type: `string`):

Optional openFDA search expression (e.g. sponsor\_name:PFIZER, products.brand\_name:LIPITOR).

## Actor input object example

```json
{
  "maxItems": 10,
  "search": ""
}
```

# Actor output Schema

## `results` (type: `string`):

No description

# API

You can run this Actor programmatically using our API. Below are code examples in JavaScript, Python, and CLI, as well as the OpenAPI specification and MCP server setup.

## JavaScript example

```javascript
import { ApifyClient } from 'apify-client';

// Initialize the ApifyClient with your Apify API token
// Replace the '<YOUR_API_TOKEN>' with your token
const client = new ApifyClient({
    token: '<YOUR_API_TOKEN>',
});

// Prepare Actor input
const input = {
    "maxItems": 10
};

// Run the Actor and wait for it to finish
const run = await client.actor("parseforge/fda-orange-book-scraper").call(input);

// Fetch and print Actor results from the run's dataset (if any)
console.log('Results from dataset');
console.log(`💾 Check your data here: https://console.apify.com/storage/datasets/${run.defaultDatasetId}`);
const { items } = await client.dataset(run.defaultDatasetId).listItems();
items.forEach((item) => {
    console.dir(item);
});

// 📚 Want to learn more 📖? Go to → https://docs.apify.com/api/client/js/docs

```

## Python example

```python
from apify_client import ApifyClient

# Initialize the ApifyClient with your Apify API token
# Replace '<YOUR_API_TOKEN>' with your token.
client = ApifyClient("<YOUR_API_TOKEN>")

# Prepare the Actor input
run_input = { "maxItems": 10 }

# Run the Actor and wait for it to finish
run = client.actor("parseforge/fda-orange-book-scraper").call(run_input=run_input)

# Fetch and print Actor results from the run's dataset (if there are any)
print("💾 Check your data here: https://console.apify.com/storage/datasets/" + run["defaultDatasetId"])
for item in client.dataset(run["defaultDatasetId"]).iterate_items():
    print(item)

# 📚 Want to learn more 📖? Go to → https://docs.apify.com/api/client/python/docs/quick-start

```

## CLI example

```bash
echo '{
  "maxItems": 10
}' |
apify call parseforge/fda-orange-book-scraper --silent --output-dataset

```

## MCP server setup

```json
{
    "mcpServers": {
        "apify": {
            "command": "npx",
            "args": [
                "mcp-remote",
                "https://mcp.apify.com/?tools=parseforge/fda-orange-book-scraper",
                "--header",
                "Authorization: Bearer <YOUR_API_TOKEN>"
            ]
        }
    }
}

```

## OpenAPI specification

```json
{
    "openapi": "3.0.1",
    "info": {
        "title": "FDA Orange Book Scraper",
        "description": "Scrape the FDA Orange Book of approved drug products with therapeutic equivalence evaluations. Get NDA, ingredient, dosage form, strength, route, applicant, marketing status, TE code, RLD/RS flags, exclusivity and patent data. Perfect for pharma research, payers, and generics intelligence.",
        "version": "0.1",
        "x-build-id": "PiF0gg5yDbGEPP8il"
    },
    "servers": [
        {
            "url": "https://api.apify.com/v2"
        }
    ],
    "paths": {
        "/acts/parseforge~fda-orange-book-scraper/run-sync-get-dataset-items": {
            "post": {
                "operationId": "run-sync-get-dataset-items-parseforge-fda-orange-book-scraper",
                "x-openai-isConsequential": false,
                "summary": "Executes an Actor, waits for its completion, and returns Actor's dataset items in response.",
                "tags": [
                    "Run Actor"
                ],
                "requestBody": {
                    "required": true,
                    "content": {
                        "application/json": {
                            "schema": {
                                "$ref": "#/components/schemas/inputSchema"
                            }
                        }
                    }
                },
                "parameters": [
                    {
                        "name": "token",
                        "in": "query",
                        "required": true,
                        "schema": {
                            "type": "string"
                        },
                        "description": "Enter your Apify token here"
                    }
                ],
                "responses": {
                    "200": {
                        "description": "OK"
                    }
                }
            }
        },
        "/acts/parseforge~fda-orange-book-scraper/runs": {
            "post": {
                "operationId": "runs-sync-parseforge-fda-orange-book-scraper",
                "x-openai-isConsequential": false,
                "summary": "Executes an Actor and returns information about the initiated run in response.",
                "tags": [
                    "Run Actor"
                ],
                "requestBody": {
                    "required": true,
                    "content": {
                        "application/json": {
                            "schema": {
                                "$ref": "#/components/schemas/inputSchema"
                            }
                        }
                    }
                },
                "parameters": [
                    {
                        "name": "token",
                        "in": "query",
                        "required": true,
                        "schema": {
                            "type": "string"
                        },
                        "description": "Enter your Apify token here"
                    }
                ],
                "responses": {
                    "200": {
                        "description": "OK",
                        "content": {
                            "application/json": {
                                "schema": {
                                    "$ref": "#/components/schemas/runsResponseSchema"
                                }
                            }
                        }
                    }
                }
            }
        },
        "/acts/parseforge~fda-orange-book-scraper/run-sync": {
            "post": {
                "operationId": "run-sync-parseforge-fda-orange-book-scraper",
                "x-openai-isConsequential": false,
                "summary": "Executes an Actor, waits for completion, and returns the OUTPUT from Key-value store in response.",
                "tags": [
                    "Run Actor"
                ],
                "requestBody": {
                    "required": true,
                    "content": {
                        "application/json": {
                            "schema": {
                                "$ref": "#/components/schemas/inputSchema"
                            }
                        }
                    }
                },
                "parameters": [
                    {
                        "name": "token",
                        "in": "query",
                        "required": true,
                        "schema": {
                            "type": "string"
                        },
                        "description": "Enter your Apify token here"
                    }
                ],
                "responses": {
                    "200": {
                        "description": "OK"
                    }
                }
            }
        }
    },
    "components": {
        "schemas": {
            "inputSchema": {
                "type": "object",
                "properties": {
                    "maxItems": {
                        "title": "Max Items",
                        "minimum": 1,
                        "maximum": 1000000,
                        "type": "integer",
                        "description": "Free users: Limited to 10 items (preview). Paid users: Optional, max 1,000,000"
                    },
                    "search": {
                        "title": "Search",
                        "type": "string",
                        "description": "Optional openFDA search expression (e.g. sponsor_name:PFIZER, products.brand_name:LIPITOR).",
                        "default": ""
                    }
                }
            },
            "runsResponseSchema": {
                "type": "object",
                "properties": {
                    "data": {
                        "type": "object",
                        "properties": {
                            "id": {
                                "type": "string"
                            },
                            "actId": {
                                "type": "string"
                            },
                            "userId": {
                                "type": "string"
                            },
                            "startedAt": {
                                "type": "string",
                                "format": "date-time",
                                "example": "2025-01-08T00:00:00.000Z"
                            },
                            "finishedAt": {
                                "type": "string",
                                "format": "date-time",
                                "example": "2025-01-08T00:00:00.000Z"
                            },
                            "status": {
                                "type": "string",
                                "example": "READY"
                            },
                            "meta": {
                                "type": "object",
                                "properties": {
                                    "origin": {
                                        "type": "string",
                                        "example": "API"
                                    },
                                    "userAgent": {
                                        "type": "string"
                                    }
                                }
                            },
                            "stats": {
                                "type": "object",
                                "properties": {
                                    "inputBodyLen": {
                                        "type": "integer",
                                        "example": 2000
                                    },
                                    "rebootCount": {
                                        "type": "integer",
                                        "example": 0
                                    },
                                    "restartCount": {
                                        "type": "integer",
                                        "example": 0
                                    },
                                    "resurrectCount": {
                                        "type": "integer",
                                        "example": 0
                                    },
                                    "computeUnits": {
                                        "type": "integer",
                                        "example": 0
                                    }
                                }
                            },
                            "options": {
                                "type": "object",
                                "properties": {
                                    "build": {
                                        "type": "string",
                                        "example": "latest"
                                    },
                                    "timeoutSecs": {
                                        "type": "integer",
                                        "example": 300
                                    },
                                    "memoryMbytes": {
                                        "type": "integer",
                                        "example": 1024
                                    },
                                    "diskMbytes": {
                                        "type": "integer",
                                        "example": 2048
                                    }
                                }
                            },
                            "buildId": {
                                "type": "string"
                            },
                            "defaultKeyValueStoreId": {
                                "type": "string"
                            },
                            "defaultDatasetId": {
                                "type": "string"
                            },
                            "defaultRequestQueueId": {
                                "type": "string"
                            },
                            "buildNumber": {
                                "type": "string",
                                "example": "1.0.0"
                            },
                            "containerUrl": {
                                "type": "string"
                            },
                            "usage": {
                                "type": "object",
                                "properties": {
                                    "ACTOR_COMPUTE_UNITS": {
                                        "type": "integer",
                                        "example": 0
                                    },
                                    "DATASET_READS": {
                                        "type": "integer",
                                        "example": 0
                                    },
                                    "DATASET_WRITES": {
                                        "type": "integer",
                                        "example": 0
                                    },
                                    "KEY_VALUE_STORE_READS": {
                                        "type": "integer",
                                        "example": 0
                                    },
                                    "KEY_VALUE_STORE_WRITES": {
                                        "type": "integer",
                                        "example": 1
                                    },
                                    "KEY_VALUE_STORE_LISTS": {
                                        "type": "integer",
                                        "example": 0
                                    },
                                    "REQUEST_QUEUE_READS": {
                                        "type": "integer",
                                        "example": 0
                                    },
                                    "REQUEST_QUEUE_WRITES": {
                                        "type": "integer",
                                        "example": 0
                                    },
                                    "DATA_TRANSFER_INTERNAL_GBYTES": {
                                        "type": "integer",
                                        "example": 0
                                    },
                                    "DATA_TRANSFER_EXTERNAL_GBYTES": {
                                        "type": "integer",
                                        "example": 0
                                    },
                                    "PROXY_RESIDENTIAL_TRANSFER_GBYTES": {
                                        "type": "integer",
                                        "example": 0
                                    },
                                    "PROXY_SERPS": {
                                        "type": "integer",
                                        "example": 0
                                    }
                                }
                            },
                            "usageTotalUsd": {
                                "type": "number",
                                "example": 0.00005
                            },
                            "usageUsd": {
                                "type": "object",
                                "properties": {
                                    "ACTOR_COMPUTE_UNITS": {
                                        "type": "integer",
                                        "example": 0
                                    },
                                    "DATASET_READS": {
                                        "type": "integer",
                                        "example": 0
                                    },
                                    "DATASET_WRITES": {
                                        "type": "integer",
                                        "example": 0
                                    },
                                    "KEY_VALUE_STORE_READS": {
                                        "type": "integer",
                                        "example": 0
                                    },
                                    "KEY_VALUE_STORE_WRITES": {
                                        "type": "number",
                                        "example": 0.00005
                                    },
                                    "KEY_VALUE_STORE_LISTS": {
                                        "type": "integer",
                                        "example": 0
                                    },
                                    "REQUEST_QUEUE_READS": {
                                        "type": "integer",
                                        "example": 0
                                    },
                                    "REQUEST_QUEUE_WRITES": {
                                        "type": "integer",
                                        "example": 0
                                    },
                                    "DATA_TRANSFER_INTERNAL_GBYTES": {
                                        "type": "integer",
                                        "example": 0
                                    },
                                    "DATA_TRANSFER_EXTERNAL_GBYTES": {
                                        "type": "integer",
                                        "example": 0
                                    },
                                    "PROXY_RESIDENTIAL_TRANSFER_GBYTES": {
                                        "type": "integer",
                                        "example": 0
                                    },
                                    "PROXY_SERPS": {
                                        "type": "integer",
                                        "example": 0
                                    }
                                }
                            }
                        }
                    }
                }
            }
        }
    }
}
```