Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Carilion Materials Management
Carilion Materials Management
079239644
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ropinirole
Product Details
NDC Product Code
68151-4073Application Number
ANDA077852Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 25, 2013CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
RopiniroleActive
Code: D7ZD41RZI9Class: ACTIMQuantity: 1 mg in 1 1
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
LACTOSEInactive
Code: J2B2A4N98GClass: IACT