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United States · US · US:0143-9533_5f7a1da9-2b25-46d2-8b6b-fdb44a4e1fd7

Allopurinol sodium

In shortageOrange BookUNIISPLATC M04AA01

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

Identification

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

Packs · 1

  • ndc11
    0143953301
    1 VIAL in 1 BOX, UNIT-DOSE (0143-9533-01) / 25 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
428673RC2Z
ALLOPURINOL SODIUM
RxCUI 80566
Orange Book
A076870
AP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Allopurinol Tablet
Raw payload (JSON)
{
  "unii": {
    "unii": "428673RC2Z",
    "rxcui": "80566",
    "inchikey": "PTJRZVJXXNYNLN-UHFFFAOYSA-M",
    "display_name": "ALLOPURINOL SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "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": "0143-9533_5f7a1da9-2b25-46d2-8b6b-fdb44a4e1fd7",
  "productndc": "0143-9533",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "076870",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 500MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Aug 26, 2004"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ALLOPURINOL SODIUM",
  "shortage_reason": "Allopurinol Tablet",
  "shortage_status": "current",
  "proprietary_name": "Allopurinol sodium",
  "active_ingred_unit": "mg/25mL",
  "application_number": "ANDA076870",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Allopurinol sodium",
  "start_marketing_date": "20040901",
  "active_numerator_strength": "500"
}

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