Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
American Health Packaging
American Health Packaging
929561009
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Morphine Sulfate Extended Release
Product Details
NDC Product Code
68084-157Application Number
ANDA074862Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 24, 2022CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1SClass: IACT
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)Inactive
Code: 8136Y38GY5Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
MorphineActive
Code: X3P646A2J0Class: ACTIBQuantity: 15 mg in 1 1
Morphine Sulfate Extended Release
Product Details
NDC Product Code
68084-158Application Number
ANDA074862Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 24, 2022CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1SClass: IACT
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)Inactive
Code: 8136Y38GY5Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
MorphineActive
Code: X3P646A2J0Class: ACTIBQuantity: 30 mg in 1 1
D&C RED NO. 7Inactive
Code: ECW0LZ41X8Class: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT