MedPath

Sodium Bicarbonate

8.4% Sodium Bicarbonate 1 mEq/mL Injection, USP 10 mL Abboject Syringe

Approved
Approval ID

f85cc1e7-fa1f-4e19-a43f-ae1b60302c85

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 Code0404-9950
Application NumberANDA202495
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sodium Bicarbonate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 14, 2023
FDA Product Classification

INGREDIENTS (1)

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

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Sodium Bicarbonate - FDA Drug Approval Details