ropinirole hydrochloride
ROPINIROLE TABELTS
Approved
Approval ID
5525c364-3574-4029-89dc-1efc6d85c03c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 5, 2022
Manufacturers
FDA
Zydus Lifesciences Limited
DUNS: 918596198
Products 7
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ropinirole hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65841-718
Application NumberANDA090411
Product Classification
M
Marketing Category
C73584
G
Generic Name
ropinirole hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 5, 2022
FDA Product Classification
INGREDIENTS (9)
ROPINIROLE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: D7ZD41RZI9
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ropinirole hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65841-713
Application NumberANDA090411
Product Classification
M
Marketing Category
C73584
G
Generic Name
ropinirole hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 5, 2022
FDA Product Classification
INGREDIENTS (11)
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ROPINIROLE HYDROCHLORIDEActive
Quantity: 0.5 mg in 1 1
Code: D7ZD41RZI9
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ropinirole hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65841-712
Application NumberANDA090411
Product Classification
M
Marketing Category
C73584
G
Generic Name
ropinirole hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 5, 2022
FDA Product Classification
INGREDIENTS (8)
ROPINIROLE HYDROCHLORIDEActive
Quantity: 0.25 mg in 1 1
Code: D7ZD41RZI9
Classification: ACTIM
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ropinirole hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65841-715
Application NumberANDA090411
Product Classification
M
Marketing Category
C73584
G
Generic Name
ropinirole hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 5, 2022
FDA Product Classification
INGREDIENTS (10)
ROPINIROLE HYDROCHLORIDEActive
Quantity: 2 mg in 1 1
Code: D7ZD41RZI9
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ropinirole hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65841-714
Application NumberANDA090411
Product Classification
M
Marketing Category
C73584
G
Generic Name
ropinirole hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 5, 2022
FDA Product Classification
INGREDIENTS (10)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ROPINIROLE HYDROCHLORIDEActive
Quantity: 1 mg in 1 1
Code: D7ZD41RZI9
Classification: ACTIM
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ropinirole hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65841-717
Application NumberANDA090411
Product Classification
M
Marketing Category
C73584
G
Generic Name
ropinirole hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 5, 2022
FDA Product Classification
INGREDIENTS (11)
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
ROPINIROLE HYDROCHLORIDEActive
Quantity: 4 mg in 1 1
Code: D7ZD41RZI9
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
ropinirole hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65841-716
Application NumberANDA090411
Product Classification
M
Marketing Category
C73584
G
Generic Name
ropinirole hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 5, 2022
FDA Product Classification
INGREDIENTS (11)
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ROPINIROLE HYDROCHLORIDEActive
Quantity: 3 mg in 1 1
Code: D7ZD41RZI9
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CARMINIC ACIDInactive
Code: CID8Z8N95N
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 12/4/2017
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65841-712-01 in bottle of 100 tablets
Ropinirole Hydrochloride Tablets, 0.25 mg
100 tablets
NDC 65841-713-01 in bottle of 100 tablets
Ropinirole Hydrochloride Tablets, 0.5 mg
100 tablets
NDC 65841-714-01 in bottle of 100 tablets
Ropinirole Hydrochloride Tablets, 1 mg
100 tablets
NDC 65841-715-01in bottle of 100 tablets
Ropinirole Hydrochloride Tablets, 2 mg
100 tablets
NDC 65841-716-01 in bottle of 100 tablets
Ropinirole Hydrochloride Tablets, 3 mg
100 tablets
NDC 65841-717-01 in bottle of 100 tablets
Ropinirole Hydrochloride Tablets, 4 mg
100 tablets
NDC 65841-718-01 in bottle of 100 tablets
Ropinirole Hydrochloride Tablets, 5 mg
100 tablets
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 9/17/2020