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, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

niacin 500 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-321
Product ID 65162-321_0b4acd9a-d32e-4727-a9c3-3754a375840c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203578
Listing Expiration 2027-12-31
Marketing Start 2015-07-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65162321
Hyphenated Format 65162-321

Supplemental Identifiers

RxCUI
1098134 1098141
UPC
0365162323030 0365162321036
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 ANDA203578 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-321-03)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-321-09)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-321-50)
source: ndc

Packages (3)

65162-321-03 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-321-03) 65162-321-09 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-321-09) 65162-321-50 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-321-50)

Ingredients (1)

niacin (500 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": "0b4acd9a-d32e-4727-a9c3-3754a375840c", "openfda": {"nui": ["N0000175594", "M0014839"], "upc": ["0365162323030", "0365162321036"], "unii": ["2679MF687A"], "rxcui": ["1098134", "1098141"], "spl_set_id": ["6e604319-e164-4056-ab80-b78b98c519c7"], "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, EXTENDED RELEASE in 1 BOTTLE (65162-321-03)", "package_ndc": "65162-321-03", "marketing_start_date": "20150727"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-321-09)", "package_ndc": "65162-321-09", "marketing_start_date": "20150727"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-321-50)", "package_ndc": "65162-321-50", "marketing_start_date": "20150727"}], "brand_name": "Niacin", "product_id": "65162-321_0b4acd9a-d32e-4727-a9c3-3754a375840c", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Nicotinic Acid [EPC]", "Nicotinic Acids [CS]"], "product_ndc": "65162-321", "generic_name": "Niacin", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Niacin", "active_ingredients": [{"name": "NIACIN", "strength": "500 mg/1"}], "application_number": "ANDA203578", "marketing_category": "ANDA", "marketing_start_date": "20150727", "listing_expiration_date": "20271231"}