Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Alembic Pharmaceuticals Limited
Alembic Pharmaceuticals Inc.
650574671
Products7
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ROPINIROLE HYDROCHLORIDE
Product Details
NDC Product Code
62332-030Application Number
ANDA090429Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 10, 2021CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
RopiniroleActive
Code: D7ZD41RZI9Class: ACTIMQuantity: 0.25 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
ROPINIROLE HYDROCHLORIDE
Product Details
NDC Product Code
62332-036Application Number
ANDA090429Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 10, 2021RopiniroleActive
Code: D7ZD41RZI9Class: ACTIMQuantity: 5 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933Class: IACT
ROPINIROLE HYDROCHLORIDE
Product Details
NDC Product Code
62332-033Application Number
ANDA090429Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 10, 2021MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
RopiniroleActive
Code: D7ZD41RZI9Class: ACTIMQuantity: 2 mg in 1 1
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
ROPINIROLE HYDROCHLORIDE
Product Details
NDC Product Code
62332-035Application Number
ANDA090429Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 10, 2021CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
RopiniroleActive
Code: D7ZD41RZI9Class: ACTIMQuantity: 4 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
ROPINIROLE HYDROCHLORIDE
Product Details
NDC Product Code
62332-031Application Number
ANDA090429Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 10, 2021MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
RopiniroleActive
Code: D7ZD41RZI9Class: ACTIMQuantity: 0.5 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
ROPINIROLE HYDROCHLORIDE
Product Details
NDC Product Code
62332-032Application Number
ANDA090429Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 10, 2021RopiniroleActive
Code: D7ZD41RZI9Class: ACTIMQuantity: 1 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
ROPINIROLE HYDROCHLORIDE
Product Details
NDC Product Code
62332-034Application Number
ANDA090429Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 10, 2021RopiniroleActive
Code: D7ZD41RZI9Class: ACTIMQuantity: 3 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933Class: IACT