Ropinirole

These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . ROPINIROLE extended-release tablets, Initial U.S. Approval: 1997

Approved

Approval ID

ec0612a1-ccb1-bb51-8881-04faf491e093

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 28, 2023

Manufacturers

FDA

Dr. Reddys Laboratories Limited

DUNS: 650562841

Products 5

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Ropinirole

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code55111-659

Application NumberANDA201576

Product Classification

Marketing Category

C73584

Generic Name

Ropinirole

Product Specifications

Route of AdministrationORAL

Effective DateFebruary 28, 2023

FDA Product Classification

INGREDIENTS (12)

ETHYLCELLULOSESInactive

Code: 7Z8S9VYZ4B

Classification: IACT

Ropinirole HydrochlorideActive

Quantity: 2 mg in 1 1

Code: D7ZD41RZI9

Classification: ACTIM

anhydrous lactoseInactive

Code: 3SY5LH9PMK

Classification: IACT

carboxymethylcellulose sodiumInactive

Code: K679OBS311

Classification: IACT

silicon dioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

Hypromellose, UnspecifiedInactive

Code: 3NXW29V3WO

Classification: IACT

magnesium stearateInactive

Code: 70097M6I30

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

povidoneInactive

Code: FZ989GH94E

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

triethyl citrateInactive

Code: 8Z96QXD6UM

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

Ropinirole

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code55111-727

Application NumberANDA201576

Product Classification

Marketing Category

C73584

Generic Name

Ropinirole

Product Specifications

Route of AdministrationORAL

Effective DateFebruary 28, 2023

FDA Product Classification

INGREDIENTS (11)

silicon dioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

Ropinirole HydrochlorideActive

Quantity: 6 mg in 1 1

Code: D7ZD41RZI9

Classification: ACTIM

carboxymethylcellulose sodiumInactive

Code: K679OBS311

Classification: IACT

anhydrous lactoseInactive

Code: 3SY5LH9PMK

Classification: IACT

Hypromellose, UnspecifiedInactive

Code: 3NXW29V3WO

Classification: IACT

magnesium stearateInactive

Code: 70097M6I30

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

povidoneInactive

Code: FZ989GH94E

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

ETHYLCELLULOSESInactive

Code: 7Z8S9VYZ4B

Classification: IACT

triethyl citrateInactive

Code: 8Z96QXD6UM

Classification: IACT

Ropinirole

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code55111-661

Application NumberANDA201576

Product Classification

Marketing Category

C73584

Generic Name

Ropinirole

Product Specifications

Route of AdministrationORAL

Effective DateFebruary 28, 2023

FDA Product Classification

INGREDIENTS (13)

povidoneInactive

Code: FZ989GH94E

Classification: IACT

anhydrous lactoseInactive

Code: 3SY5LH9PMK

Classification: IACT

carboxymethylcellulose sodiumInactive

Code: K679OBS311

Classification: IACT

magnesium stearateInactive

Code: 70097M6I30

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

triethyl citrateInactive

Code: 8Z96QXD6UM

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

ETHYLCELLULOSESInactive

Code: 7Z8S9VYZ4B

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

silicon dioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

Ropinirole HydrochlorideActive

Quantity: 4 mg in 1 1

Code: D7ZD41RZI9

Classification: ACTIM

Hypromellose, UnspecifiedInactive

Code: 3NXW29V3WO

Classification: IACT

Ropinirole

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code55111-662

Application NumberANDA201576

Product Classification

Marketing Category

C73584

Generic Name

Ropinirole

Product Specifications

Route of AdministrationORAL

Effective DateFebruary 28, 2023

FDA Product Classification

INGREDIENTS (14)

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

triethyl citrateInactive

Code: 8Z96QXD6UM

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

ETHYLCELLULOSESInactive

Code: 7Z8S9VYZ4B

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

Ropinirole HydrochlorideActive

Quantity: 8 mg in 1 1

Code: D7ZD41RZI9

Classification: ACTIM

anhydrous lactoseInactive

Code: 3SY5LH9PMK

Classification: IACT

carboxymethylcellulose sodiumInactive

Code: K679OBS311

Classification: IACT

silicon dioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

Hypromellose, UnspecifiedInactive

Code: 3NXW29V3WO

Classification: IACT

magnesium stearateInactive

Code: 70097M6I30

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

povidoneInactive

Code: FZ989GH94E

Classification: IACT

Ropinirole

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code55111-728

Application NumberANDA201576

Product Classification

Marketing Category

C73584

Generic Name

Ropinirole

Product Specifications

Route of AdministrationORAL

Effective DateFebruary 28, 2023

FDA Product Classification

INGREDIENTS (13)

Ropinirole HydrochlorideActive

Quantity: 12 mg in 1 1

Code: D7ZD41RZI9

Classification: ACTIM

anhydrous lactoseInactive

Code: 3SY5LH9PMK

Classification: IACT

carboxymethylcellulose sodiumInactive

Code: K679OBS311

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

povidoneInactive

Code: FZ989GH94E

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

triethyl citrateInactive

Code: 8Z96QXD6UM

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

ETHYLCELLULOSESInactive

Code: 7Z8S9VYZ4B

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

silicon dioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

Hypromellose, UnspecifiedInactive

Code: 3NXW29V3WO

Classification: IACT

magnesium stearateInactive

Code: 70097M6I30

Classification: IACT

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Ropinirole

Products 5

Ropinirole

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (12)

Ropinirole

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (11)

Ropinirole

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

Ropinirole

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

Ropinirole

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

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