Sodium Bicarbonate

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 055750020

Effective Date

December 15, 2021

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

International Medication Systems, Limited

DUNS Number

055750020

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

NDC Product Code

76329-3352

Application Number

ANDA203449

Marketing Category

ANDA (C73584)

Route of Administration

INTRAVENOUS

Effective Date

September 25, 2017

Ingredients

Code: 8MDF5V39QOClass: ACTIBQuantity: 84 mg in 1 mL