Ropinirole
rOPINIRole Tablets USP
Approved
Approval ID
4c88de4d-64b8-43e1-9dbe-c38eede024a8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 10, 2014
Manufacturers
FDA
Aphena Pharma Solutions - Tennessee, LLC
DUNS: 128385585
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
rOPINIRole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43353-912
Application NumberANDA077852
Product Classification
M
Marketing Category
C73584
G
Generic Name
rOPINIRole
Product Specifications
Route of AdministrationORAL
Effective DateJune 10, 2014
FDA Product Classification
INGREDIENTS (10)
ROPINIROLE HYDROCHLORIDEActive
Quantity: 1 mg in 1 1
Code: D7ZD41RZI9
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
rOPINIRole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43353-920
Application NumberANDA077852
Product Classification
M
Marketing Category
C73584
G
Generic Name
rOPINIRole
Product Specifications
Route of AdministrationORAL
Effective DateJune 10, 2014
FDA Product Classification
INGREDIENTS (10)
ROPINIROLE HYDROCHLORIDEActive
Quantity: 0.25 mg in 1 1
Code: D7ZD41RZI9
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
rOPINIRole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43353-911
Application NumberANDA077852
Product Classification
M
Marketing Category
C73584
G
Generic Name
rOPINIRole
Product Specifications
Route of AdministrationORAL
Effective DateJune 10, 2014
FDA Product Classification
INGREDIENTS (10)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ROPINIROLE HYDROCHLORIDEActive
Quantity: 2 mg in 1 1
Code: D7ZD41RZI9
Classification: ACTIM
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT