Last Updated: September 24, 2026

Details for New Drug Application (NDA): 217523

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NDA 217523 describes SODIUM BICARBONATE, which is a drug marketed by Amneal, Anthea Pharma, Aspiro, Exela Pharma, Fresenius Kabi Usa, Hospira, Intl Medication Sys, Long Grove Pharms, Milla Pharms, Omnivium Pharms, Steriscience, and Abbott, and is included in eighteen NDAs. It is available from twenty-two suppliers. Additional details are available on the SODIUM BICARBONATE profile page.

The generic ingredient in SODIUM BICARBONATE is sodium bicarbonate. There is one drug master file entry for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the sodium bicarbonate profile page.

Summary for 217523

Tradename:	SODIUM BICARBONATE
Applicant:	Amneal
Ingredient:	sodium bicarbonate
Patents:	0

Pharmacology for NDA: 217523

Mechanism of Action	Alkalinizing Activity

Suppliers and Packaging for NDA: 217523

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SODIUM BICARBONATE	sodium bicarbonate	SOLUTION;INTRAVENOUS	217523	ANDA	Amneal Pharmaceuticals Private Limited	80830-2305	80830-2305-2	25 VIAL, SINGLE-DOSE in 1 CARTON (80830-2305-2) / 50 mL in 1 VIAL, SINGLE-DOSE (80830-2305-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	50MEQ/50ML (1MEQ/ML)
Approval Date:	Jan 13, 2026	TE:	AP	RLD:	No

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