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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 080172

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NDA 080172 describes PROPYLTHIOURACIL, which is a drug marketed by Abbott, Actavis Elizabeth, Anabolic, Ani Pharms, Chartwell Molecular, Chartwell Rx, Endo Operations, Halsey, Impax Labs, Lilly, Macleods Pharms Ltd, Quagen, Sun Pharm Industries, Tablicaps, and Watson Labs, and is included in sixteen NDAs. It is available from eight suppliers. Additional details are available on the PROPYLTHIOURACIL profile page.

The generic ingredient in PROPYLTHIOURACIL is propylthiouracil. There are four drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the propylthiouracil profile page.

Summary for 080172

Tradename:	PROPYLTHIOURACIL
Applicant:	Actavis Elizabeth
Ingredient:	propylthiouracil
Patents:	0

Pharmacology for NDA: 080172

Mechanism of Action	Thyroid Hormone Synthesis Inhibitors

Medical Subject Heading (MeSH) Categories for 080172

Antimetabolites
Antithyroid Agents

Suppliers and Packaging for NDA: 080172

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PROPYLTHIOURACIL	propylthiouracil	TABLET;ORAL	080172	ANDA	Actavis Pharma, Inc.	0228-2348	0228-2348-10	100 TABLET in 1 BOTTLE (0228-2348-10)
PROPYLTHIOURACIL	propylthiouracil	TABLET;ORAL	080172	ANDA	Teva Pharmaceuticals, Inc.	0480-9242	0480-9242-01	100 TABLET in 1 BOTTLE (0480-9242-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	BD	RLD:	No

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