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SODIUM BICARBONATE

Injection, USP FOR THE CORRECTION OF METABOLIC ACIDOSIS AND OTHER CONDITIONS REQUIRING SYSTEMIC ALKALINIZATION Glass VialRx only

Approved
Approval ID

da484a2f-154f-48b4-8467-7a86729204c3

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 14, 2023

Manufacturers
FDA

Henry Schein, Inc.

DUNS: 012430880

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

sodium bicarbonate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0404-9951
Application NumberANDA202981
Product Classification
M
Marketing Category
C73584
G
Generic Name
sodium bicarbonate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 14, 2023
FDA Product Classification

INGREDIENTS (2)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATEActive
Quantity: 42 mg in 1 mL
Code: 8MDF5V39QO
Classification: ACTIB

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SODIUM BICARBONATE - FDA Drug Approval Details