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United States · US · US:16571-884_5cd32f4f-2795-4776-ad00-f33f91bda391

Allopurinol

In shortageOrange BookUNIISPLATC M04AA01

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

Identification

ManufacturerRising Pharma Holdings, Inc.
CountryUS (United States)
ATC codeM04AA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    1657188401
    100 TABLET in 1 BOTTLE (16571-884-01)
  • ndc11
    1657188409
    90 TABLET in 1 BOTTLE (16571-884-09)
  • ndc11
    1657188410
    1000 TABLET in 1 BOTTLE (16571-884-10)
  • ndc11
    1657188450
    500 TABLET in 1 BOTTLE (16571-884-50)

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": "16571-884_5cd32f4f-2795-4776-ad00-f33f91bda391",
  "productndc": "16571-884",
  "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": "20230921",
  "active_numerator_strength": "200"
}

Related drugs

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