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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 219684

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NDA 219684 describes KETAMINE HYDROCHLORIDE, which is a drug marketed by Caplin, Eugia Pharma, Fresenius Kabi Usa, Gland, Hikma, Hospira, and Baxter Hlthcare Corp, and is included in seven NDAs. It is available from ten suppliers. Additional details are available on the KETAMINE HYDROCHLORIDE profile page.

The generic ingredient in KETAMINE HYDROCHLORIDE is ketamine hydrochloride. There are eight drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the ketamine hydrochloride profile page.

Summary for 219684

Tradename:	KETAMINE HYDROCHLORIDE
Applicant:	Baxter Hlthcare Corp
Ingredient:	ketamine hydrochloride
Patents:	0

Pharmacology for NDA: 219684

Physiological Effect	General Anesthesia

Medical Subject Heading (MeSH) Categories for 219684

Analgesics
Anesthetics, Dissociative
Excitatory Amino Acid Antagonists

Suppliers and Packaging for NDA: 219684

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
KETAMINE HYDROCHLORIDE	ketamine hydrochloride	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	219684	ANDA	Baxter Healthcare Corporation	43066-177	43066-177-05	5 CARTON in 1 CARTON (43066-177-05) / 1 SYRINGE, PLASTIC in 1 CARTON (43066-177-01) / 10 mL in 1 SYRINGE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAMUSCULAR, INTRAVENOUS			Strength	EQ 100MG BASE/10ML (EQ 10MG BASE/ML)
Approval Date:	Sep 17, 2025	TE:		RLD:	No

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