MedPath
FDA Approval

ropinirole hydrochloride

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
SOLCO HEALTHCARE US, LLC
DUNS: 828343017
Effective Date
January 20, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Ropinirole(4 mg in 1 1)

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
43547-600
Application Number
ANDA078110
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
August 31, 2020
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
RopiniroleActive
Code: D7ZD41RZI9Class: ACTIMQuantity: 4 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT

ropinirole hydrochloride

Product Details

NDC Product Code
43547-597
Application Number
ANDA078110
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
August 31, 2020
RopiniroleActive
Code: D7ZD41RZI9Class: ACTIMQuantity: 1 mg in 1 1
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT

ropinirole hydrochloride

Product Details

NDC Product Code
43547-598
Application Number
ANDA078110
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
August 31, 2020
RopiniroleActive
Code: D7ZD41RZI9Class: ACTIMQuantity: 2 mg in 1 1
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62Class: IACT

ropinirole hydrochloride

Product Details

NDC Product Code
43547-599
Application Number
ANDA078110
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
August 31, 2020
RopiniroleActive
Code: D7ZD41RZI9Class: ACTIMQuantity: 3 mg in 1 1
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
COCHINEALInactive
Code: TZ8Z31B35MClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT

ropinirole hydrochloride

Product Details

NDC Product Code
43547-596
Application Number
ANDA078110
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
August 31, 2020
RopiniroleActive
Code: D7ZD41RZI9Class: ACTIMQuantity: 0.5 mg in 1 1
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT

ropinirole hydrochloride

Product Details

NDC Product Code
43547-601
Application Number
ANDA078110
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
August 31, 2020
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
RopiniroleActive
Code: D7ZD41RZI9Class: ACTIMQuantity: 5 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62Class: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT

ropinirole hydrochloride

Product Details

NDC Product Code
43547-595
Application Number
ANDA078110
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
August 31, 2020
RopiniroleActive
Code: D7ZD41RZI9Class: ACTIMQuantity: 0.25 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy