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United States · US · US:70518-4404_4a142f8c-ee72-cae7-e063-6294a90ad762

ALLOPURINOL

In shortageOrange BookUNIISPLATC M04AA01

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

Identification

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

Packs · 2

  • ndc11
    7051844040
    30 TABLET in 1 BLISTER PACK (70518-4404-0)
  • ndc11
    7051844041
    100 TABLET in 1 BOTTLE, PLASTIC (70518-4404-1)

Annotations

UNII (FDA Substance ID)
63CZ7GJN5I
ALLOPURINOL
RxCUI 519
Orange Book
A217748
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": "70518-4404_4a142f8c-ee72-cae7-e063-6294a90ad762",
  "productndc": "70518-4404",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "217748",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Aug 3, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "Aug 3, 2023"
      }
    ],
    "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": "ANDA217748",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ALLOPURINOL",
  "start_marketing_date": "20250726",
  "active_numerator_strength": "300"
}

Related drugs

Other records sharing ATC code M04AA01.

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