Details for New Drug Application (NDA): 216042

NDA 216042 describes SODIUM BICARBONATE, which is a drug marketed by Amneal, Anthea Pharma, Aspiro, Exela Pharma, Fresenius Kabi Usa, Hospira, Intl Medication Sys, Long Grove Pharms, Milla Pharms, Omnivium Pharms, Steriscience, and Abbott, and is included in eighteen NDAs. It is available from twenty-two 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-two 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	SOLUTION;INTRAVENOUS	216042	ANDA	Civica, Inc.	72572-200	72572-200-20	20 CARTON in 1 BOX (72572-200-20) / 1 VIAL, SINGLE-DOSE in 1 CARTON (72572-200-01) / 50 mL in 1 VIAL, SINGLE-DOSE
SODIUM BICARBONATE	sodium bicarbonate	SOLUTION;INTRAVENOUS	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:	SOLUTION;INTRAVENOUS			Strength	50MEQ/50ML (1MEQ/ML)
Approval Date:	Feb 27, 2024	TE:	AP	RLD:	No

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