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United States · US · US:65162-322_b75c66ae-a08b-439c-b526-7897a38bc3a8
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
- ndc11651623220330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65162-322-03)
- ndc11651623220990 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65162-322-09)
- ndc116516232250500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65162-322-50)
Annotations
UNII (FDA Substance ID)
2679MF687A
NIACIN
RxCUI 7393
Orange Book
A204178
AB
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": "65162-322_b75c66ae-a08b-439c-b526-7897a38bc3a8",
"productndc": "65162-322",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "204178",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "750MG",
"product_no": "001",
"approval_date": "Dec 11, 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": "ANDA204178",
"marketing_category": "ANDA",
"nonproprietary_name": "Niacin",
"start_marketing_date": "20151211",
"active_numerator_strength": "750"
}Related drugs
Other records sharing ATC code C10AD02.
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