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United States · US · US:47335-539_bc18daa3-5321-43bd-9d00-dabd9adac571
NIACIN
Orange BookUNIISPLATC C10AD02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeC10AD02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc114733553908100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-539-08)
- ndc1147335539181000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-539-18)
- ndc11473355398190 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-539-81)
- ndc11473355398330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-539-83)
- ndc114733553988100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-539-88)
Annotations
UNII (FDA Substance ID)
2679MF687A
NIACIN
RxCUI 7393
Orange Book
A200484
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": "47335-539_bc18daa3-5321-43bd-9d00-dabd9adac571",
"productndc": "47335-539",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "200484",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "001",
"approval_date": "Apr 23, 2014"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "1GM",
"product_no": "002",
"approval_date": "Apr 23, 2014"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NIACIN",
"proprietary_name": "NIACIN",
"active_ingred_unit": "mg/1",
"application_number": "ANDA200484",
"marketing_category": "ANDA",
"nonproprietary_name": "NIACIN",
"start_marketing_date": "20140627",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code C10AD02.
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