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Active ingredient

Isoniazid

27 finished FDA listings contain Isoniazid as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
ISONIAZID
Dosage forms
Injection, Solution, Solution, Tablet
Routes
Intramuscular, Oral
Manufacturers / labelers
14
Strengths listed
100 mg/1 · 100 mg/ml · 300 mg/1 · 50 mg/5ml

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 6038

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 080936GENUS LIFESCIENCES1972-08-244
ANDA 080937GENUS LIFESCIENCES1972-08-2410
ANDA 088235CMP PHARMA INC1983-11-101
ANDA 089776CHARTWELL MOLECULAR1988-06-131
ANDA 040090OMNIVIUM PHARMS1997-06-269
ANDA 081118CHARTWELL RX1997-07-211
ANDA 040648SANDOZ2005-07-051

Official labeling on DailyMed

Showing the 12 most recent of 23 labels.

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