Allopurinol

In shortageOrange BookUNIISPLATC M04AA01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerCoupler LLC

CountryUS (United States)

ATC codeM04AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6704616583
30 TABLET in 1 BLISTER PACK (67046-1658-3)

Annotations

UNII (FDA Substance ID)

63CZ7GJN5I

ALLOPURINOL

RxCUI 519

Orange Book

A204467

ABABAB

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Allopurinol Tablet

Raw payload (JSON)

{
  "unii": {
    "unii": "63CZ7GJN5I",
    "rxcui": "519",
    "inchikey": "OFCNXPDARWKPPY-UHFFFAOYSA-N",
    "display_name": "ALLOPURINOL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "211e47c6-85b9-43e8-9e07-6cc4b8f708a0": {
      "match": "brand_token",
      "title": "ALLOPURINOL TABLET [PD-RX PHARMACEUTICALS, INC.]",
      "spl_version": "17",
      "published_date": "2026-06-01"
    }
  },
  "productid": "67046-1658_4af14e76-f131-6a06-e063-6394a90abeb0",
  "productndc": "67046-1658",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "204467",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Jul 28, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "Jul 28, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "003",
        "approval_date": "May 22, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ALLOPURINOL",
  "shortage_reason": "Allopurinol Tablet",
  "shortage_status": "current",
  "proprietary_name": "Allopurinol",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA204467",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Allopurinol",
  "start_marketing_date": "20260204",
  "active_numerator_strength": "300"
}

Related drugs

Other records sharing ATC code M04AA01.

Access this data programmatically

Query Allopurinol and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs