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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
Precision Dose, Inc.
DUNS: 035886746
Effective Date
July 20, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Morphine(100 mg in 5 mL)

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
68094-256
Application Number
NDA022195
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
June 30, 2023
MorphineActive
Code: X3P646A2J0Class: ACTIBQuantity: 100 mg in 5 mL
citric acid monohydrateInactive
Code: 2968PHW8QPClass: IACT
edetate disodiumInactive
Code: 7FLD91C86KClass: IACT
sodium benzoateInactive
Code: OJ245FE5EUClass: IACT
glycerinInactive
Code: PDC6A3C0OXClass: IACT
sorbitolInactive
Code: 506T60A25RClass: IACT
waterInactive
Code: 059QF0KO0RClass: IACT
D&C Red No. 33Inactive
Code: 9DBA0SBB0LClass: IACT
SucraloseInactive
Code: 96K6UQ3ZD4Class: IACT
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