Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Physicians Total Care, Inc.
Physicians Total Care, Inc.
194123980
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
54868-5413Application Number
NDA022195Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
April 6, 2011MorphineActive
Code: X3P646A2J0Class: ACTIBQuantity: 10 mg in 5 mL
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1SClass: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT