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Last Updated: December 14, 2025

Details for New Drug Application (NDA): 203619

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NDA 203619 describes PENTOBARBITAL SODIUM, which is a drug marketed by Lannett, Vitarine, Whiteworth Town Plsn, Bpi Labs, Elkins Sinn, Hikma, and Sagent Pharms Inc, and is included in nine NDAs. It is available from two suppliers. Additional details are available on the PENTOBARBITAL SODIUM profile page.

The generic ingredient in PENTOBARBITAL SODIUM is pentobarbital sodium. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the pentobarbital sodium profile page.

Summary for 203619

Tradename:	PENTOBARBITAL SODIUM
Applicant:	Hikma
Ingredient:	pentobarbital sodium
Patents:	0

Suppliers and Packaging for NDA: 203619

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PENTOBARBITAL SODIUM	pentobarbital sodium	INJECTABLE;INJECTION	203619	ANDA	Hikma Pharmaceuticals USA Inc. (dba Leucadia Pharmaceuticals)	24201-010	24201-010-20	1 VIAL in 1 CARTON (24201-010-20) / 20 mL in 1 VIAL
PENTOBARBITAL SODIUM	pentobarbital sodium	INJECTABLE;INJECTION	203619	ANDA	Hikma Pharmaceuticals USA Inc. (dba Leucadia Pharmaceuticals)	24201-010	24201-010-50	1 VIAL in 1 CARTON (24201-010-50) / 50 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	50MG/ML
Approval Date:	Nov 13, 2017	TE:	AP	RLD:	No

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