Is there a generic for Sodium bicarbonate?

Yes. The FDA Orange Book lists 15 approved generic (ANDA) applications for Sodium bicarbonate, referencing the brand SODIUM BICARBONATE IN PLASTIC CONTAINER. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Sodium bicarbonate?

SODIUM BICARBONATE IN PLASTIC CONTAINER (NDA 019443, ABBOTT) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Sodium bicarbonate are approved?

Sodium bicarbonate is approved in the following dosage form: solution.

FDA Orange Book · active-ingredient family

Sodium bicarbonate

Sodium bicarbonate is approved as 1 brand and 15 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:SODIUM BICARBONATE IN PLASTIC CONTAINER · NDA 019443

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · solution

Product	Applicant	Application	TE	Approved
SODIUM BICARBONATE IN PLASTIC CONTAINERRLD×2	ABBOTT	NDA 019443	—	Jun 03, 1986

Generic (ANDA) products (15)

Product	Applicant	Application	TE	Approved
SODIUM BICARBONATE×3	ASPIRO	ANDA 220788	AP	Apr 15, 2026
SODIUM BICARBONATE	AMNEAL	ANDA 217523	AP	Jan 13, 2026
SODIUM BICARBONATE×2	FRESENIUS KABI USA	ANDA 206688	AP	Aug 25, 2025
SODIUM BICARBONATE	ANTHEA PHARMA	ANDA 219701	AP	Jun 26, 2025
SODIUM BICARBONATE	LONG GROVE PHARMS	ANDA 216042	AP	Feb 27, 2024
SODIUM BICARBONATE	STERISCIENCE	ANDA 217594	AP	Jun 28, 2023
SODIUM BICARBONATE	OMNIVIUM PHARMS	ANDA 216364	AP	Jun 15, 2023
SODIUM BICARBONATE×4	EXELA PHARMA	ANDA 211091	AP	Jun 20, 2019
SODIUM BICARBONATE	HOSPIRA	ANDA 202432	AP	Sep 26, 2017
SODIUM BICARBONATE	INTL MEDICATION SYS	ANDA 203449	AP	Sep 19, 2017
SODIUM BICARBONATE	HOSPIRA	ANDA 202679	AP	Mar 07, 2017
SODIUM BICARBONATE	HOSPIRA	ANDA 202495	AP	Mar 06, 2017
SODIUM BICARBONATE×2	HOSPIRA	ANDA 202494	AP	Mar 06, 2017
SODIUM BICARBONATE	HOSPIRA	ANDA 202981	AP	Mar 04, 2016
SODIUM BICARBONATE×2	HOSPIRA	ANDA 077394	—	Nov 09, 2005

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Sodium bicarbonate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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