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Sodium Bicarbonate

Sodium Bicarbonate Injection, USP

Approved
Approval ID

77698221-a01d-4568-a7bc-d3d4e982875d

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 15, 2021

Manufacturers
FDA

International Medication Systems, Limited

DUNS: 055750020

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 Code76329-3352
Application NumberANDA203449
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sodium Bicarbonate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 25, 2017
FDA Product Classification

INGREDIENTS (1)

Sodium BicarbonateActive
Quantity: 84 mg in 1 mL
Code: 8MDF5V39QO
Classification: ACTIB

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Sodium Bicarbonate - FDA Drug Approval Details