Products7
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ropinirole
Product Details
NDC Product Code
10135-676Application Number
ANDA079165Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 15, 2023CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3BClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
RopiniroleActive
Code: D7ZD41RZI9Class: ACTIMQuantity: 2 mg in 1 1
Ropinirole
Product Details
NDC Product Code
10135-675Application Number
ANDA079165Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 15, 2023MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
RopiniroleActive
Code: D7ZD41RZI9Class: ACTIMQuantity: 1 mg in 1 1
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3BClass: IACT
Ropinirole
Product Details
NDC Product Code
10135-673Application Number
ANDA079165Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 15, 2023CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3BClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
RopiniroleActive
Code: D7ZD41RZI9Class: ACTIMQuantity: 0.25 mg in 1 1
Ropinirole
Product Details
NDC Product Code
10135-679Application Number
ANDA079165Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 15, 2023HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3BClass: IACT
RopiniroleActive
Code: D7ZD41RZI9Class: ACTIMQuantity: 5 mg in 1 1
Ropinirole
Product Details
NDC Product Code
10135-674Application Number
ANDA079165Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 15, 2023CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3BClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
RopiniroleActive
Code: D7ZD41RZI9Class: ACTIMQuantity: 0.5 mg in 1 1
Ropinirole
Product Details
NDC Product Code
10135-677Application Number
ANDA079165Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 15, 2023TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3BClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
RopiniroleActive
Code: D7ZD41RZI9Class: ACTIMQuantity: 3 mg in 1 1
Ropinirole
Product Details
NDC Product Code
10135-678Application Number
ANDA079165Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 15, 2023HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3BClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
RopiniroleActive
Code: D7ZD41RZI9Class: ACTIMQuantity: 4 mg in 1 1