Details for New Drug Application (NDA): 202981

NDA 202981 describes SODIUM BICARBONATE, which is a drug marketed by Exela Pharma, Hospira, Intl Medication Sys, Nivagen Pharms Inc, Omnivium Pharms, Steriscience, and Abbott, and is included in twelve NDAs. It is available from thirteen 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. Thirteen suppliers are listed for this compound. Additional details are available on the sodium bicarbonate profile page.

Summary for 202981

Tradename:	SODIUM BICARBONATE
Applicant:	Hospira
Ingredient:	sodium bicarbonate
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 202981

Mechanism of Action	Osmotic Activity Alkalinizing Activity
Physiological Effect	Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption

Suppliers and Packaging for NDA: 202981

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SODIUM BICARBONATE	sodium bicarbonate	INJECTABLE;INJECTION	202981	ANDA	Henry Schein, Inc.	0404-9951	0404-9951-05	1 VIAL, SINGLE-USE in 1 BAG (0404-9951-05) / 5 mL in 1 VIAL, SINGLE-USE
SODIUM BICARBONATE	sodium bicarbonate	INJECTABLE;INJECTION	202981	ANDA	Hospira, Inc.	0409-5555	0409-5555-02	25 VIAL, SINGLE-USE in 1 TRAY (0409-5555-02) / 5 mL in 1 VIAL, SINGLE-USE (0409-5555-12)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	0.5MEQ/ML
Approval Date:	Mar 4, 2016	TE:	AP	RLD:	No

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