Allopurinol

In shortageOrange BookUNIISPLATC M04AA01

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

Identification

ManufacturerMajor Pharmaceuticals

CountryUS (United States)

ATC codeM04AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0904657261
100 BLISTER PACK in 1 CARTON (0904-6572-61) / 1 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

63CZ7GJN5I

ALLOPURINOL

RxCUI 519

Orange Book

A075798

ABAB

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": "0904-6572_e8995c18-7672-418d-8e39-bffe2ad7c7fb",
  "productndc": "0904-6572",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "075798",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Jun 27, 2003"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "Jun 27, 2003"
      }
    ],
    "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": "ANDA075798",
  "marketing_category": "ANDA",
  "nonproprietary_name": "allopurinol",
  "start_marketing_date": "20030627",
  "active_numerator_strength": "300"
}

Related drugs

Other records sharing ATC code M04AA01.

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