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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 216042

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NDA 216042 describes SODIUM BICARBONATE, which is a drug marketed by Exela Pharma, Fresenius Kabi Usa, Hospira, Intl Medication Sys, Long Grove Pharms, Neocubes Pharma, Omnivium Pharms, Steriscience, and Abbott, and is included in fourteen NDAs. It is available from nineteen suppliers. Additional details are available on the SODIUM BICARBONATE profile page.

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

Summary for 216042

Tradename:	SODIUM BICARBONATE
Applicant:	Long Grove Pharms
Ingredient:	sodium bicarbonate
Patents:	0

Pharmacology for NDA: 216042

Mechanism of Action	Alkalinizing Activity

Suppliers and Packaging for NDA: 216042

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SODIUM BICARBONATE	sodium bicarbonate	INJECTABLE;INJECTION	216042	ANDA	Long Grove Pharmaceuticals, LLC	81298-7620	81298-7620-3	20 VIAL in 1 CARTON (81298-7620-3) / 50 mL in 1 VIAL (81298-7620-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	1MEQ/ML
Approval Date:	Feb 27, 2024	TE:	AP	RLD:	No

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