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United States · US · US:68788-8458_92bc61cd-b263-4e1a-8387-f82b295df68b
Allopurinol
In shortageOrange BookUNIISPLATC M04AA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeM04AA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc116878884581100 TABLET in 1 BOTTLE, PLASTIC (68788-8458-1)
- ndc11687888458330 TABLET in 1 BOTTLE, PLASTIC (68788-8458-3)
- ndc11687888458660 TABLET in 1 BOTTLE, PLASTIC (68788-8458-6)
- ndc11687888458990 TABLET in 1 BOTTLE, PLASTIC (68788-8458-9)
Annotations
UNII (FDA Substance ID)
63CZ7GJN5I
ALLOPURINOL
RxCUI 519
Orange Book
A211820
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": "68788-8458_92bc61cd-b263-4e1a-8387-f82b295df68b",
"productndc": "68788-8458",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "211820",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "001",
"approval_date": "Mar 12, 2019"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "300MG",
"product_no": "002",
"approval_date": "Mar 12, 2019"
}
],
"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": "ANDA211820",
"marketing_category": "ANDA",
"nonproprietary_name": "Allopurinol",
"start_marketing_date": "20230614",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code M04AA01.
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