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Active ingredient

Methimazole

54 finished FDA listings contain Methimazole as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
METHIMAZOLE
Dosage forms
Tablet
Routes
Oral
Manufacturers / labelers
21
Strengths listed
10 mg/1 · 5 mg/1

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 6835

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 040350MYLAN2000-03-2915
ANDA 040411CHARTWELL RX2001-03-272
ANDA 040547AIPING PHARM INC2005-02-186
ANDA 040734HERITAGE PHARMA2007-12-1414
ANDA 202068RISING2012-03-075
ANDA 209827MACLEODS PHARMS2023-05-242
ANDA 218149BIONPHARMA2023-09-254
ANDA 218830SQUARE PHARMS PLC2025-02-056

Official labeling on DailyMed

Showing the 12 most recent of 39 labels.

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