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Requip-XL

Generic Name: ropinirole hydrochloride
Dosage Form: tablet, film coated, extended release

Medically reviewed on January 1, 2018

Principal Display Panel

NDC 0007-4885-13

REQUIP® XL®

(ropinirole extended-release tablets)

2 mg

Rx only

30 Tablets

Each tablet contains 2.28 mg ropinirole HCl equivalent to 2 mg ropinirole.

Dosage: See Prescribing Information for complete dosing instructions.

Do not use if safety seal under cap is broken or missing.

Store at 25oC (77oF); excursions permitted to 15-30oC (59-86oF) [see USP Controlled Room Temperature].

GlaxoSmithKline

Research Triangle Park, NC 27709

Made in Ireland

Rev. 3/13

10000000114273

Principal Display Panel

NDC 0007-4887-13

REQUIP® XL®

(ropinirole extended-release tablets)

4 mg

Rx only

30 Tablets

Each tablet contains 4.56 mg ropinirole HCl equivalent to 4 mg ropinirole.

Dosage: See Prescribing Information for complete dosing instructions.

Do not use if safety seal under cap is broken or missing.

Store at 25oC (77oF); excursions permitted to 15-30oC (59-86oF) [see USP Controlled Room Temperature].

GlaxoSmithKline

Research Triangle Park, NC 27709

Made in Ireland

Rev. 3/13

10000000114274

Principal Display Panel

NDC 0007-4883-13

REQUIP® XL®

(ropinirole extended-release tablets)

6 mg

Rx only

30 Tablets

Each tablet contains 6.84 mg ropinirole HCl equivalent to 6 mg ropinirole.

Dosage: See Prescribing Information for complete dosing instructions.

Do not use if safety seal under cap is broken or missing.

Store at 25oC (77oF); excursions permitted to 15-30oC (59-86oF) [see USP Controlled Room Temperature].

GlaxoSmithKline

Research Triangle Park, NC 27709

Made in Ireland

Rev. 3/13

10000000114275

Principal Display Panel

NDC 0007-4888-13

REQUIP® XL®

(ropinirole extended-release tablets)

8 mg

Rx only

30 Tablets

Each tablet contains 9.12 mg ropinirole HCl equivalent to 8 mg ropinirole.

Dosage: See Prescribing Information for complete dosing instructions.

Do not use if safety seal under cap is broken or missing.

Store at 25oC (77oF); excursions permitted to 15-30oC (59-86oF) [see USP Controlled Room Temperature].

GlaxoSmithKline

Research Triangle Park, NC 27709

Made in Ireland

Rev. 3/13

10000000114276

Principal Display Panel

NDC 0007-4882-13

REQUIP® XL®

(ropinirole extended-release tablets)

12 mg

Rx only

30 Tablets

Each tablet contains 13.68 mg ropinirole HCl equivalent to 12 mg ropinirole.

Dosage: See Prescribing Information for complete dosing instructions.

Do not use if safety seal under cap is broken or missing.

Store at 25oC (77oF); excursions permitted to 15-30oC (59-86oF) [see USP Controlled Room Temperature].

GlaxoSmithKline

Research Triangle Park, NC 27709

Made in Ireland

Rev. 3/13

10000000114272

REQUIP  XL
ropinirole hydrochloride tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:30256-014
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ROPINIROLE HYDROCHLORIDE (ROPINIROLE) ROPINIROLE 2 mg
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM  
SILICON DIOXIDE  
GLYCERYL DIBEHENATE  
HYDROGENATED CASTOR OIL  
HYPROMELLOSE, UNSPECIFIED  
LACTOSE MONOHYDRATE  
MAGNESIUM STEARATE  
MALTODEXTRIN  
MANNITOL  
POVIDONE, UNSPECIFIED  
Product Characteristics
Color PINK Score no score
Shape OVAL (capsule-shaped) Size 13mm
Flavor Imprint Code GS;3V2
Contains     
Packaging
# Item Code Package Description
1 NDC:30256-014-00 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
2 NDC:30256-014-01 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Approved Drug Product Manufactured Under Contract NDA022008 06/30/2008 03/31/2019
REQUIP  XL
ropinirole hydrochloride tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:30256-015
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ROPINIROLE HYDROCHLORIDE (ROPINIROLE) ROPINIROLE 4 mg
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM  
SILICON DIOXIDE  
GLYCERYL DIBEHENATE  
HYDROGENATED CASTOR OIL  
HYPROMELLOSE, UNSPECIFIED  
LACTOSE MONOHYDRATE  
MAGNESIUM STEARATE  
MALTODEXTRIN  
MANNITOL  
POVIDONE, UNSPECIFIED  
Product Characteristics
Color BROWN (light brown) Score no score
Shape OVAL (capsule-shaped) Size 13mm
Flavor Imprint Code GS;WXG
Contains     
Packaging
# Item Code Package Description
1 NDC:30256-015-00 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
2 NDC:30256-015-01 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Approved Drug Product Manufactured Under Contract NDA022008 06/30/2008 02/29/2020
REQUIP  XL
ropinirole hydrochloride tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:30256-016
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ROPINIROLE HYDROCHLORIDE (ROPINIROLE) ROPINIROLE 6 mg
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM  
SILICON DIOXIDE  
GLYCERYL DIBEHENATE  
HYDROGENATED CASTOR OIL  
HYPROMELLOSE, UNSPECIFIED  
LACTOSE MONOHYDRATE  
MAGNESIUM STEARATE  
MALTODEXTRIN  
MANNITOL  
POVIDONE, UNSPECIFIED  
Product Characteristics
Color WHITE Score no score
Shape OVAL (capsule-shaped) Size 13mm
Flavor Imprint Code GS;11F
Contains     
Packaging
# Item Code Package Description
1 NDC:30256-016-00 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Approved Drug Product Manufactured Under Contract NDA022008 08/03/2009 10/31/2020
REQUIP  XL
ropinirole hydrochloride tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:30256-017
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ROPINIROLE HYDROCHLORIDE (ROPINIROLE) ROPINIROLE 8 mg
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM  
SILICON DIOXIDE  
GLYCERYL DIBEHENATE  
HYDROGENATED CASTOR OIL  
HYPROMELLOSE, UNSPECIFIED  
LACTOSE MONOHYDRATE  
MAGNESIUM STEARATE  
MALTODEXTRIN  
MANNITOL  
POVIDONE, UNSPECIFIED  
Product Characteristics
Color RED Score no score
Shape OVAL (capsule-shaped) Size 13mm
Flavor Imprint Code GS;5CC
Contains     
Packaging
# Item Code Package Description
1 NDC:30256-017-00 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
2 NDC:30256-017-01 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Approved Drug Product Manufactured Under Contract NDA022008 06/30/2008 02/29/2020
REQUIP  XL
ropinirole hydrochloride tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:30256-018
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ROPINIROLE HYDROCHLORIDE (ROPINIROLE) ROPINIROLE 12 mg
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM  
SILICON DIOXIDE  
GLYCERYL DIBEHENATE  
HYDROGENATED CASTOR OIL  
HYPROMELLOSE, UNSPECIFIED  
LACTOSE MONOHYDRATE  
MAGNESIUM STEARATE  
MALTODEXTRIN  
MANNITOL  
POVIDONE, UNSPECIFIED  
Product Characteristics
Color GREEN Score no score
Shape OVAL (capsule-shaped) Size 13mm
Flavor Imprint Code GS;YX7
Contains     
Packaging
# Item Code Package Description
1 NDC:30256-018-00 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Approved Drug Product Manufactured Under Contract NDA022008 11/20/2008 10/31/2020
Labeler - Glaxo Wellcome SA (462027152)
 
Glaxo Wellcome SA
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