Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Nesher Pharmaceuticals (USA) LLC
969028351
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Nesher Pharmaceuticals (USA) LLC
Zydus Pharmaceuticals (USA) Inc.
Nesher Pharmaceuticals (USA) LLC
969028351
Products5
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
68382-905Application Number
ANDA076720Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 17, 2021CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MorphineActive
Code: X3P646A2J0Class: ACTIBQuantity: 60 mg in 1 1
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
MORPHINE SULFATE
Product Details
NDC Product Code
68382-906Application Number
ANDA077855Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 17, 2021LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
MorphineActive
Code: X3P646A2J0Class: ACTIBQuantity: 100 mg in 1 1
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
MORPHINE SULFATE
Product Details
NDC Product Code
68382-904Application Number
ANDA076720Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 17, 2021D&C RED NO. 27Inactive
Code: 2LRS185U6KClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
MorphineActive
Code: X3P646A2J0Class: ACTIBQuantity: 30 mg in 1 1
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
MORPHINE SULFATE
Product Details
NDC Product Code
68382-907Application Number
ANDA077855Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 17, 2021MorphineActive
Code: X3P646A2J0Class: ACTIBQuantity: 200 mg in 1 1
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
MORPHINE SULFATE
Product Details
NDC Product Code
68382-903Application Number
ANDA076733Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 17, 2021MorphineActive
Code: X3P646A2J0Class: ACTIBQuantity: 15 mg in 1 1
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT