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
6704615143
30 TABLET in 1 BLISTER PACK (67046-1514-3)

Annotations

UNII (FDA Substance ID)

63CZ7GJN5I

ALLOPURINOL

RxCUI 519

Orange Book

N016084

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": "67046-1514_2d6cdaf0-8651-d103-e063-6394a90a9352",
  "productndc": "67046-1514",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "016084",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "003",
        "approval_date": "Aug 4, 2022"
      }
    ],
    "appl_type": "N"
  },
  "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": "NDA016084",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "allopurinol",
  "start_marketing_date": "20250205",
  "active_numerator_strength": "300"
}

Related drugs

Other records sharing ATC code M04AA01.

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