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FDA Approval

Sodium Bicarbonate

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

FDA Approval Summary

Company
Hospira, Inc.
DUNS: 141588017
Effective Date
November 23, 2020
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Sodium bicarbonate(84 mg in 1 mL)

Manufacturing Establishments1

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

Hospira, Inc.

Hospira, Inc.

827731089

Products2

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

Sodium Bicarbonate

Product Details

NDC Product Code
0409-6637
Application Number
ANDA202494
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
November 23, 2020
Code: 8MDF5V39QOClass: ACTIBQuantity: 84 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT

Sodium Bicarbonate

Product Details

NDC Product Code
0409-4916
Application Number
ANDA202494
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
November 23, 2020
Code: 8MDF5V39QOClass: ACTIBQuantity: 75 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
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