Last Updated: November 8, 2026

Details for New Drug Application (NDA): 217523

« Back to Dashboard

NDA 217523 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 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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.