ROPINIROLE HYDROCHLORIDE
Approved
Approval ID
a543b4fb-186a-40f4-8c88-861b7db2b3e9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 23, 2011
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
Products 2
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 Code16590-643
Application NumberANDA078881
Product Classification
M
Marketing Category
C73584
G
Generic Name
ROPINIROLE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateJune 23, 2011
FDA Product Classification
INGREDIENTS (8)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
ROPINIROLE HYDROCHLORIDEActive
Quantity: 1 mg in 1 1
Code: D7ZD41RZI9
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ROPINIROLE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-734
Application NumberANDA078881
Product Classification
M
Marketing Category
C73584
G
Generic Name
ROPINIROLE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateJune 23, 2011
FDA Product Classification
INGREDIENTS (9)
ROPINIROLE HYDROCHLORIDEActive
Quantity: 2 mg in 1 1
Code: D7ZD41RZI9
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
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