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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 078400

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NDA 078400 describes BUTORPHANOL TARTRATE, which is a drug marketed by Baxter Hlthcare Corp, Hikma, Hikma Farmaceutica, Hospira, Apotex, and Rising, and is included in fourteen NDAs. It is available from four suppliers. Additional details are available on the BUTORPHANOL TARTRATE profile page.

The generic ingredient in BUTORPHANOL TARTRATE is butorphanol tartrate. There are eight drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the butorphanol tartrate profile page.

Summary for 078400

Tradename:	BUTORPHANOL TARTRATE
Applicant:	Hikma Farmaceutica
Ingredient:	butorphanol tartrate
Patents:	0

Pharmacology for NDA: 078400

Mechanism of Action	Competitive Opioid Antagonists Partial Opioid Agonists

Medical Subject Heading (MeSH) Categories for 078400

Analgesics, Opioid
Antitussive Agents
Narcotic Antagonists
Narcotics

Suppliers and Packaging for NDA: 078400

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BUTORPHANOL TARTRATE	butorphanol tartrate	INJECTABLE;INJECTION	078400	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9864	0143-9864-10	1 mL in 1 VIAL, SINGLE-DOSE (0143-9864-10)
BUTORPHANOL TARTRATE	butorphanol tartrate	INJECTABLE;INJECTION	078400	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9867	0143-9867-10	1 mL in 1 VIAL, SINGLE-DOSE (0143-9867-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	1MG/ML
Approval Date:	May 1, 2009	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	2MG/ML
Approval Date:	May 1, 2009	TE:	AP	RLD:	No

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