ropinirole hydrochloride
Ropinirole Hydrochloride Tablets
Approved
Approval ID
88c5b939-a658-4972-b849-e5c00a447b53
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 30, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code21695-793
Application NumberANDA090429
Product Classification
M
Marketing Category
C73584
G
Generic Name
ropinirole hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 2, 2011
FDA Product Classification
INGREDIENTS (12)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
ROPINIROLE HYDROCHLORIDEActive
Quantity: 0.5 mg in 1 1
Code: D7ZD41RZI9
Classification: ACTIM
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT