Sodium Bicarbonate

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

FDA Approval Summary

Company

Civica

DUNS: 081373942

Effective Date

January 9, 2024

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Sodium bicarbonate(84 mg in 1 mL)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Exela Pharma Sciences, LLC

DUNS Number

831274399

Manufacturing Establishments1

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

Exela Pharma Sciences, LLC

Labeler

Civica

Registrant

Exela Pharma Sciences, LLC

DUNS Number

831274399

Products1

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