Last Updated: November 13, 2026

Details for New Drug Application (NDA): 220788

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NDA 220788 describes SODIUM BICARBONATE, which is a drug marketed by Adaptis, Amneal, Aspiro, Baxter Hlthcare Corp, Exela Pharma, Fresenius Kabi Usa, Hospira, Intl Medication Sys, Long Grove Pharms, Milla Pharms, Omnivium Pharms, Steriscience, and Abbott, and is included in nineteen NDAs. It is available from twenty-three 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-three suppliers are listed for this compound. Additional details are available on the sodium bicarbonate profile page.

Summary for 220788

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	5MEQ/10ML (0.5MEQ/ML)
Approval Date:	Apr 15, 2026	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	10MEQ/10ML (1MEQ/ML)
Approval Date:	Apr 15, 2026	TE:	AP	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	50MEQ/50ML (1MEQ/ML)
Approval Date:	Apr 15, 2026	TE:	AP	RLD:	No

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