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United States · US · US:65219-380_2d2f4a09-b8bd-47ff-87db-a615efc34c4c
Allopurinol
In shortageOrange BookUNIISPLATC M04AA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeM04AA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1165219380301 VIAL, GLASS in 1 CARTON (65219-380-30) / 25 mL in 1 VIAL, GLASS
Annotations
UNII (FDA Substance ID)
428673RC2Z
ALLOPURINOL SODIUM
RxCUI 80566
Orange Book
A212363
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": "65219-380_2d2f4a09-b8bd-47ff-87db-a615efc34c4c",
"productndc": "65219-380",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "212363",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 500MG BASE/VIAL",
"product_no": "001",
"approval_date": "Jan 26, 2022"
}
],
"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",
"active_ingred_unit": "mg/25mL",
"application_number": "ANDA212363",
"marketing_category": "ANDA",
"nonproprietary_name": "Allopurinol",
"start_marketing_date": "20220314",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code M04AA01.
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