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United States · US · US:16729-135_40820fd2-3759-d43f-e063-6394a90a7c93

Allopurinol

In shortageOrange BookUNIISPLATC M04AA01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAccord Healthcare Inc.
CountryUS (United States)
ATC codeM04AA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    1672913501
    100 TABLET in 1 BOTTLE (16729-135-01)
  • ndc11
    1672913516
    500 TABLET in 1 BOTTLE (16729-135-16)

Annotations

UNII (FDA Substance ID)
63CZ7GJN5I
ALLOPURINOL
RxCUI 519
Orange Book
A203154
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": "16729-135_40820fd2-3759-d43f-e063-6394a90a7c93",
  "productndc": "16729-135",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "203154",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "May 6, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "May 6, 2013"
      }
    ],
    "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": "ANDA203154",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ALLOPURINOL",
  "start_marketing_date": "20150429",
  "active_numerator_strength": "300"
}

Related drugs

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