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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
RedPharm Drug, Inc.
DUNS: 828374897
Effective Date
January 21, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Morphine(15 mg in 1 1)

Manufacturing Establishments1

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

EPM Packaging

RedPharm Drug, Inc.

079124340

Products1

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
67296-1753
Application Number
ANDA210610
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
January 21, 2022
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
MorphineActive
Code: X3P646A2J0Class: ACTIBQuantity: 15 mg in 1 1
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
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