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FDA Approval

Morphine Sulfate

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

FDA Approval Summary

Company
Hospira, Inc.
DUNS: 141588017
Effective Date
October 13, 2021
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Morphine(25 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.

Morphine Sulfate

Product Details

NDC Product Code
0409-1135
Route of Administration
INTRAVENOUS
Effective Date
October 13, 2021
MorphineActive
Code: X3P646A2J0Class: ACTIBQuantity: 25 mg in 1 mL

Morphine Sulfate

Product Details

NDC Product Code
0409-1134
Route of Administration
INTRAVENOUS
Effective Date
October 13, 2021
MorphineActive
Code: X3P646A2J0Class: ACTIBQuantity: 50 mg in 1 mL
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