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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 218149

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NDA 218149 describes METHIMAZOLE, which is a drug marketed by Aiping Pharm Inc, Bionpharma, Chartwell Rx, Discovery Therap, Heritage Pharma, Macleods Pharms Ltd, Mylan, Rising, Square Pharms Plc, and Sun Pharm Inds Inc, and is included in ten NDAs. It is available from twenty suppliers. Additional details are available on the METHIMAZOLE profile page.

The generic ingredient in METHIMAZOLE is methimazole. There are three drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the methimazole profile page.

Summary for 218149

Tradename:	METHIMAZOLE
Applicant:	Bionpharma
Ingredient:	methimazole
Patents:	0

Pharmacology for NDA: 218149

Mechanism of Action	Thyroid Hormone Synthesis Inhibitors

Medical Subject Heading (MeSH) Categories for 218149

Antithyroid Agents

Suppliers and Packaging for NDA: 218149

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METHIMAZOLE	methimazole	TABLET;ORAL	218149	ANDA	AvPAK	50268-495	50268-495-15	50 BLISTER PACK in 1 BOX (50268-495-15) / 1 TABLET in 1 BLISTER PACK (50268-495-11)
METHIMAZOLE	methimazole	TABLET;ORAL	218149	ANDA	AvPAK	50268-496	50268-496-15	50 BLISTER PACK in 1 BOX (50268-496-15) / 1 TABLET in 1 BLISTER PACK (50268-496-11)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Sep 25, 2023	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Sep 25, 2023	TE:	AB	RLD:	No

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