Ropinirole Hydrochloride
Ropinirole Tablets, USP
Approved
Approval ID
414cd6c4-4926-4dfc-93c4-f04f4b7eeac3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 5, 2013
Manufacturers
FDA
Wockhardt Limited
DUNS: 650069115
Products 1
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 Code55648-177
Application NumberANDA079050
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ropinirole Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 5, 2013
FDA Product Classification
INGREDIENTS (9)
ROPINIROLE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: D7ZD41RZI9
Classification: ACTIM
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT