Ropinirole Hydrochloride

Ropinirole Hydrochloride Tablets

Approved

Approval ID

6f7fc849-8a38-47a1-bc39-54801a86416c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 14, 2011

Manufacturers

FDA

Zhejiang Huahai Pharmaceutical Co., Ltd.

DUNS: 530732460

Products 7

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 Code64220-426

Application NumberANDA078110

Product Classification

Marketing Category

C73584

Generic Name

Ropinirole Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateAugust 10, 2011

FDA Product Classification

INGREDIENTS (18)

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

ROPINIROLE HYDROCHLORIDEActive

Quantity: 5 mg in 1 1

Code: D7ZD41RZI9

Classification: ACTIB

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

D&C RED NO. 27Inactive

Code: 2LRS185U6K

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

D&C Yellow No. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

LECITHIN, SOYBEANInactive

Code: 1DI56QDM62

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

HYDROXYPROPYL CELLULOSEInactive

Code: RFW2ET671P

Classification: IACT

POLYETHYLENE GLYCOLInactive

Code: 3WJQ0SDW1A

Classification: IACT

POLYVINYL ALCOHOLInactive

Code: 532B59J990

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

Ropinirole Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code64220-422

Application NumberANDA078110

Product Classification

Marketing Category

C73584

Generic Name

Ropinirole Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateAugust 10, 2011

FDA Product Classification

INGREDIENTS (18)

ROPINIROLE HYDROCHLORIDEActive

Quantity: 1 mg in 1 1

Code: D7ZD41RZI9

Classification: ACTIB

HYDROXYPROPYL CELLULOSEInactive

Code: RFW2ET671P

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

D&C Yellow No. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

D&C RED NO. 27Inactive

Code: 2LRS185U6K

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

LECITHIN, SOYBEANInactive

Code: 1DI56QDM62

Classification: IACT

POLYETHYLENE GLYCOLInactive

Code: 3WJQ0SDW1A

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

POLYVINYL ALCOHOLInactive

Code: 532B59J990

Classification: IACT

Ropinirole Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code64220-425

Application NumberANDA078110

Product Classification

Marketing Category

C73584

Generic Name

Ropinirole Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateAugust 10, 2011

FDA Product Classification

INGREDIENTS (18)

ROPINIROLE HYDROCHLORIDEActive

Quantity: 4 mg in 1 1

Code: D7ZD41RZI9

Classification: ACTIB

HYDROXYPROPYL CELLULOSEInactive

Code: RFW2ET671P

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

D&C Yellow No. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

D&C RED NO. 27Inactive

Code: 2LRS185U6K

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

LECITHIN, SOYBEANInactive

Code: 1DI56QDM62

Classification: IACT

POLYETHYLENE GLYCOLInactive

Code: 3WJQ0SDW1A

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

POLYVINYL ALCOHOLInactive

Code: 532B59J990

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

Ropinirole Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code64220-424

Application NumberANDA078110

Product Classification

Marketing Category

C73584

Generic Name

Ropinirole Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateAugust 10, 2011

FDA Product Classification

INGREDIENTS (18)

ROPINIROLE HYDROCHLORIDEActive

Quantity: 3 mg in 1 1

Code: D7ZD41RZI9

Classification: ACTIB

HYDROXYPROPYL CELLULOSEInactive

Code: RFW2ET671P

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

D&C Yellow No. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

D&C RED NO. 27Inactive

Code: 2LRS185U6K

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

LECITHIN, SOYBEANInactive

Code: 1DI56QDM62

Classification: IACT

POLYETHYLENE GLYCOLInactive

Code: 3WJQ0SDW1A

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

POLYVINYL ALCOHOLInactive

Code: 532B59J990

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

Ropinirole Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code64220-421

Application NumberANDA078110

Product Classification

Marketing Category

C73584

Generic Name

Ropinirole Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateAugust 10, 2011

FDA Product Classification

INGREDIENTS (18)

HYDROXYPROPYL CELLULOSEInactive

Code: RFW2ET671P

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

ROPINIROLE HYDROCHLORIDEActive

Quantity: 0.5 mg in 1 1

Code: D7ZD41RZI9

Classification: ACTIB

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

D&C Yellow No. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

POLYVINYL ALCOHOLInactive

Code: 532B59J990

Classification: IACT

LECITHIN, SOYBEANInactive

Code: 1DI56QDM62

Classification: IACT

POLYETHYLENE GLYCOLInactive

Code: 3WJQ0SDW1A

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

D&C RED NO. 27Inactive

Code: 2LRS185U6K

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

Ropinirole Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code64220-423

Application NumberANDA078110

Product Classification

Marketing Category

C73584

Generic Name

Ropinirole Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateAugust 10, 2011

FDA Product Classification

INGREDIENTS (18)

ROPINIROLE HYDROCHLORIDEActive

Quantity: 2 mg in 1 1

Code: D7ZD41RZI9

Classification: ACTIB

HYDROXYPROPYL CELLULOSEInactive

Code: RFW2ET671P

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

D&C Yellow No. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

D&C RED NO. 27Inactive

Code: 2LRS185U6K

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

POLYETHYLENE GLYCOLInactive

Code: 3WJQ0SDW1A

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

LECITHIN, SOYBEANInactive

Code: 1DI56QDM62

Classification: IACT

POLYVINYL ALCOHOLInactive

Code: 532B59J990

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

Ropinirole Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code64220-420

Application NumberANDA078110

Product Classification

Marketing Category

C73584

Generic Name

Ropinirole Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateAugust 10, 2011

FDA Product Classification

INGREDIENTS (18)

ROPINIROLE HYDROCHLORIDEActive

Quantity: 0.25 mg in 1 1

Code: D7ZD41RZI9

Classification: ACTIB

HYDROXYPROPYL CELLULOSEInactive

Code: RFW2ET671P

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

D&C RED NO. 27Inactive

Code: 2LRS185U6K

Classification: IACT

D&C Yellow No. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

LECITHIN, SOYBEANInactive

Code: 1DI56QDM62

Classification: IACT

POLYETHYLENE GLYCOLInactive

Code: 3WJQ0SDW1A

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

POLYVINYL ALCOHOLInactive

Code: 532B59J990

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

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Ropinirole Hydrochloride

Products 7

Ropinirole Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (18)

Ropinirole Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (18)

Ropinirole Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (18)

Ropinirole Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (18)

Ropinirole Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (18)

Ropinirole Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (18)

Ropinirole Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (18)

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