Details for New Drug Application (NDA): 218469

NDA 218469 describes SODIUM ACETATE, which is a drug marketed by Amneal, Fresenius Kabi Usa, Hikma, Hospira, Milla Pharms, and Somerset Theraps Llc, and is included in six NDAs. It is available from six suppliers. Additional details are available on the SODIUM ACETATE profile page.

The generic ingredient in SODIUM ACETATE is sodium acetate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the sodium acetate profile page.

Summary for 218469

Tradename:	SODIUM ACETATE
Applicant:	Amneal
Ingredient:	sodium acetate
Patents:	0

Suppliers and Packaging for NDA: 218469

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SODIUM ACETATE	sodium acetate	SOLUTION;INTRAVENOUS	218469	ANDA	Amneal Pharmaceuticals Private Limited	80830-2436	80830-2436-2	25 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (80830-2436-2) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE (80830-2436-1)
SODIUM ACETATE	sodium acetate	SOLUTION;INTRAVENOUS	218469	ANDA	Amneal Pharmaceuticals Private Limited	80830-2437	80830-2437-2	10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (80830-2437-2) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (80830-2437-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	100MEQ/50ML (2MEQ/ML)
Approval Date:	Aug 8, 2025	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	200MEQ/100ML (2MEQ/ML)
Approval Date:	Aug 8, 2025	TE:	AP	RLD:	No

Complete Access Available with Subscription