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United States · US · US:69315-291_227ef709-80a3-45e9-807a-2db8abee3a50
Allopurinol
In shortageOrange BookUNIISPLATC M04AA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLeading Pharma, LLC
CountryUS (United States)
ATC codeM04AA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc116931529101100 TABLET in 1 BOTTLE (69315-291-01)
- ndc116931529105500 TABLET in 1 BOTTLE (69315-291-05)
- ndc1169315291101000 TABLET in 1 BOTTLE (69315-291-10)
Annotations
UNII (FDA Substance ID)
63CZ7GJN5I
ALLOPURINOL
RxCUI 519
Orange Book
A214443
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": "69315-291_227ef709-80a3-45e9-807a-2db8abee3a50",
"productndc": "69315-291",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "214443",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "001",
"approval_date": "Mar 7, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "300MG",
"product_no": "002",
"approval_date": "Mar 7, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG",
"product_no": "003",
"approval_date": "Jun 17, 2024"
}
],
"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": "ANDA214443",
"marketing_category": "ANDA",
"nonproprietary_name": "Allopurinol",
"start_marketing_date": "20240501",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code M04AA01.
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