Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Dr. Reddys Laboratories Limited
Dr. Reddys Laboratories Limited
918608162
Products5
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
55111-659Application Number
ANDA201576Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 28, 2023ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4BClass: IACT
RopiniroleActive
Code: D7ZD41RZI9Class: ACTIMQuantity: 2 mg in 1 1
anhydrous lactoseInactive
Code: 3SY5LH9PMKClass: IACT
carboxymethylcellulose sodiumInactive
Code: K679OBS311Class: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4Class: IACT
Hypromellose, UnspecifiedInactive
Code: 3NXW29V3WOClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
povidoneInactive
Code: FZ989GH94EClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
triethyl citrateInactive
Code: 8Z96QXD6UMClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
Ropinirole
Product Details
NDC Product Code
55111-727Application Number
ANDA201576Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 28, 2023silicon dioxideInactive
Code: ETJ7Z6XBU4Class: IACT
RopiniroleActive
Code: D7ZD41RZI9Class: ACTIMQuantity: 6 mg in 1 1
carboxymethylcellulose sodiumInactive
Code: K679OBS311Class: IACT
anhydrous lactoseInactive
Code: 3SY5LH9PMKClass: IACT
Hypromellose, UnspecifiedInactive
Code: 3NXW29V3WOClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
povidoneInactive
Code: FZ989GH94EClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4BClass: IACT
triethyl citrateInactive
Code: 8Z96QXD6UMClass: IACT
Ropinirole
Product Details
NDC Product Code
55111-661Application Number
ANDA201576Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 28, 2023povidoneInactive
Code: FZ989GH94EClass: IACT
anhydrous lactoseInactive
Code: 3SY5LH9PMKClass: IACT
carboxymethylcellulose sodiumInactive
Code: K679OBS311Class: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
triethyl citrateInactive
Code: 8Z96QXD6UMClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4BClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4Class: IACT
RopiniroleActive
Code: D7ZD41RZI9Class: ACTIMQuantity: 4 mg in 1 1
Hypromellose, UnspecifiedInactive
Code: 3NXW29V3WOClass: IACT
Ropinirole
Product Details
NDC Product Code
55111-662Application Number
ANDA201576Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 28, 2023TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
triethyl citrateInactive
Code: 8Z96QXD6UMClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4BClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
RopiniroleActive
Code: D7ZD41RZI9Class: ACTIMQuantity: 8 mg in 1 1
anhydrous lactoseInactive
Code: 3SY5LH9PMKClass: IACT
carboxymethylcellulose sodiumInactive
Code: K679OBS311Class: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4Class: IACT
Hypromellose, UnspecifiedInactive
Code: 3NXW29V3WOClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
povidoneInactive
Code: FZ989GH94EClass: IACT
Ropinirole
Product Details
NDC Product Code
55111-728Application Number
ANDA201576Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 28, 2023RopiniroleActive
Code: D7ZD41RZI9Class: ACTIMQuantity: 12 mg in 1 1
anhydrous lactoseInactive
Code: 3SY5LH9PMKClass: IACT
carboxymethylcellulose sodiumInactive
Code: K679OBS311Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
povidoneInactive
Code: FZ989GH94EClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
triethyl citrateInactive
Code: 8Z96QXD6UMClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4BClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4Class: IACT
Hypromellose, UnspecifiedInactive
Code: 3NXW29V3WOClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT