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United States · US · US:65162-321_0b4acd9a-d32e-4727-a9c3-3754a375840c
Niacin
Orange BookUNIISPLATC C10AD02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeC10AD02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11651623210330 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-321-03)
- ndc11651623210990 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-321-09)
- ndc116516232150500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-321-50)
Annotations
UNII (FDA Substance ID)
2679MF687A
NIACIN
RxCUI 7393
Orange Book
A203578
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "2679MF687A",
"rxcui": "7393",
"inchikey": "PVNIIMVLHYAWGP-UHFFFAOYSA-N",
"display_name": "NIACIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"8eff9205-84ac-e69d-e053-2995a90aad4b": {
"match": "brand_token",
"title": "NIACIN TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]",
"spl_version": "7",
"published_date": "2026-05-11"
}
},
"productid": "65162-321_0b4acd9a-d32e-4727-a9c3-3754a375840c",
"productndc": "65162-321",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "203578",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "001",
"approval_date": "Jul 24, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1GM",
"product_no": "002",
"approval_date": "Jul 24, 2015"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NIACIN",
"proprietary_name": "Niacin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA203578",
"marketing_category": "ANDA",
"nonproprietary_name": "Niacin",
"start_marketing_date": "20150727",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code C10AD02.
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