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Active ingredient

Niacin

24 finished FDA listings contain Niacin as their only active ingredient; 41 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
NIACIN
Dosage forms
Tablet, Tablet, Extended Release, Tablet, Film Coated, Extended Release
Routes
Oral
Manufacturers / labelers
13
Strengths listed
1000 mg/1 · 500 mg/1 · 750 mg/1
Brand names in FDA listings
Niacor

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 7393

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
ANDA 040378AVONDALE PHARMS2000-05-033
ANDA 090892CHARTWELL RX2014-03-201
ANDA 201273SUN PHARM2014-04-231
ANDA 200484SUN PHARM2014-04-232
ANDA 203578AMNEAL PHARMS2015-07-243
ANDA 204178AMNEAL PHARMS2015-12-111
ANDA 203899QUAGEN2017-06-168
ANDA 209236AUROBINDO PHARMA LTD2018-02-013
ANDA 204934MACLEODS PHARMS2022-03-032

Official labeling on DailyMed

Showing the 12 most recent of 13 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.