niacin

Generic: niacin

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name niacin
Generic Name niacin
Labeler amneal pharmaceuticals llc
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

niacin 750 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-322
Product ID 65162-322_b75c66ae-a08b-439c-b526-7897a38bc3a8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204178
Listing Expiration 2026-12-31
Marketing Start 2015-12-11

Pharmacologic Class

Established (EPC)
nicotinic acid [epc]
Chemical Structure
nicotinic acids [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65162322
Hyphenated Format 65162-322

Supplemental Identifiers

RxCUI
1098143
UPC
0365162322095
UNII
2679MF687A
NUI
N0000175594 M0014839

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name niacin (source: ndc)
Generic Name niacin (source: ndc)
Application Number ANDA204178 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 750 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65162-322-03)
  • 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65162-322-09)
  • 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65162-322-50)
source: ndc

Packages (3)

65162-322-03 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65162-322-03) 65162-322-09 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65162-322-09) 65162-322-50 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65162-322-50)

Ingredients (1)

niacin (750 mg/1)

Linked Drug Pages (1)

Niacin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b75c66ae-a08b-439c-b526-7897a38bc3a8", "openfda": {"nui": ["N0000175594", "M0014839"], "upc": ["0365162322095"], "unii": ["2679MF687A"], "rxcui": ["1098143"], "spl_set_id": ["7250313b-b2ef-4736-bd25-2f29c2ac0eb9"], "pharm_class_cs": ["Nicotinic Acids [CS]"], "pharm_class_epc": ["Nicotinic Acid [EPC]"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65162-322-03)", "package_ndc": "65162-322-03", "marketing_start_date": "20151211"}, {"sample": false, "description": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65162-322-09)", "package_ndc": "65162-322-09", "marketing_start_date": "20151211"}, {"sample": false, "description": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65162-322-50)", "package_ndc": "65162-322-50", "marketing_start_date": "20151211"}], "brand_name": "Niacin", "product_id": "65162-322_b75c66ae-a08b-439c-b526-7897a38bc3a8", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Nicotinic Acid [EPC]", "Nicotinic Acids [CS]"], "product_ndc": "65162-322", "generic_name": "Niacin", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Niacin", "active_ingredients": [{"name": "NIACIN", "strength": "750 mg/1"}], "application_number": "ANDA204178", "marketing_category": "ANDA", "marketing_start_date": "20151211", "listing_expiration_date": "20261231"}