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
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
54868-4973Application Number
NDA022207Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
January 11, 2012SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MorphineActive
Code: X3P646A2J0Class: ACTIBQuantity: 30 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
Morphine Sulfate
Product Details
NDC Product Code
54868-3191Application Number
NDA022207Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
January 11, 2012STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MorphineActive
Code: X3P646A2J0Class: ACTIBQuantity: 15 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT