Details for New Drug Application (NDA): 218475

NDA 218475 describes EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE, which is a drug marketed by Baxter Hlthcare Corp and is included in one NDA. It is available from one supplier. Additional details are available on the EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE profile page.

The generic ingredient in EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE is epinephrine bitartrate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the epinephrine bitartrate profile page.

Summary for 218475

Tradename:	EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE
Applicant:	Baxter Hlthcare Corp
Ingredient:	epinephrine bitartrate
Patents:	0

Pharmacology for NDA: 218475

Mechanism of Action

Adrenergic alpha-Agonists Adrenergic beta-Agonists

Suppliers and Packaging for NDA: 218475

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	epinephrine bitartrate	SOLUTION;INTRAVENOUS	218475	NDA	Baxter Healthcare Corporation	0338-0006	0338-0006-20	20 BAG in 1 CARTON (0338-0006-20) / 250 mL in 1 BAG
EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	epinephrine bitartrate	SOLUTION;INTRAVENOUS	218475	NDA	Baxter Healthcare Corporation	0338-0024	0338-0024-20	20 BAG in 1 CARTON (0338-0024-20) / 250 mL in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAVENOUS			Strength	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)
Approval Date:	Feb 28, 2025	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)
Approval Date:	Mar 16, 2026	TE:		RLD:	Yes

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