Details for New Drug Application (NDA): 206688

NDA 206688 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 206688

Tradename:	SODIUM BICARBONATE
Applicant:	Fresenius Kabi Usa
Ingredient:	sodium bicarbonate
Patents:	0

Pharmacology for NDA: 206688

Mechanism of Action

Alkalinizing Activity

Suppliers and Packaging for NDA: 206688

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SODIUM BICARBONATE	sodium bicarbonate	INJECTABLE;INJECTION	206688	ANDA	Fresenius Kabi USA, LLC	63323-083	63323-083-05	25 VIAL, SINGLE-DOSE in 1 TRAY (63323-083-05) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-083-03)
SODIUM BICARBONATE	sodium bicarbonate	INJECTABLE;INJECTION	206688	ANDA	Fresenius Kabi USA, LLC	63323-089	63323-089-50	25 VIAL, SINGLE-DOSE in 1 TRAY (63323-089-50) / 50 mL in 1 VIAL, SINGLE-DOSE (63323-089-25)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	0.5MEQ/ML
Approval Date:	Aug 25, 2025	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	1MEQ/ML
Approval Date:	Aug 25, 2025	TE:	AP	RLD:	No

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