niacin

Generic: niacin

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name niacin
Generic Name niacin
Labeler aurobindo pharma limited
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

niacin 750 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-019
Product ID 59651-019_8539231f-47da-402e-b05d-16c45cc3670c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209236
Listing Expiration 2026-12-31
Marketing Start 2018-02-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651019
Hyphenated Format 59651-019

Supplemental Identifiers

RxCUI
1098134 1098141 1098143
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 ANDA209236 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 750 mg/1
source: ndc
Packaging
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-019-05)
  • 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-019-18)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-019-90)
source: ndc

Packages (3)

59651-019-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-019-05) 59651-019-18 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-019-18) 59651-019-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-019-90)

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": "8539231f-47da-402e-b05d-16c45cc3670c", "openfda": {"nui": ["N0000175594", "M0014839"], "unii": ["2679MF687A"], "rxcui": ["1098134", "1098141", "1098143"], "spl_set_id": ["43233a21-3f90-4c69-bbeb-f50d5f2d35ae"], "pharm_class_cs": ["Nicotinic Acids [CS]"], "pharm_class_epc": ["Nicotinic Acid [EPC]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-019-05)", "package_ndc": "59651-019-05", "marketing_start_date": "20180201"}, {"sample": false, "description": "180 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-019-18)", "package_ndc": "59651-019-18", "marketing_start_date": "20180201"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-019-90)", "package_ndc": "59651-019-90", "marketing_start_date": "20180201"}], "brand_name": "Niacin", "product_id": "59651-019_8539231f-47da-402e-b05d-16c45cc3670c", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Nicotinic Acid [EPC]", "Nicotinic Acids [CS]"], "product_ndc": "59651-019", "generic_name": "Niacin", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Niacin", "active_ingredients": [{"name": "NIACIN", "strength": "750 mg/1"}], "application_number": "ANDA209236", "marketing_category": "ANDA", "marketing_start_date": "20180201", "listing_expiration_date": "20261231"}