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Requip

Generic Name: ropinirole
Dosage Form: tablet, film coated

Medically reviewed on Jan 1, 2018

Principal Display Panel

NDC 0007-4890-20

See also: Gocovri

Requip®

(rOPINIRole tablets)

0.25 mg

100 Tablets

Rx only

Each tablet contains 0.29 mg ropinirole HCl equivalent to 0.25 mg ropinirole.

Store at controlled room temperature 20o to 25oC (68o to 77oF) [see USP].

Protect from light and moisture. Close container tightly after each use.

Dosage: See Prescribing Information for complete dosing instructions.

GlaxoSmithKline

Research Triangle Park,

NC 27709

Made in Ireland

Rev. 9/11

10000000099522

Principal Display Panel

NDC 0007-4891-20

Requip®

(rOPINIRole tablets)

0.5 mg

100 Tablets

Rx only

Each tablet contains 0.57 mg ropinirole HCl equivalent to 0.5 mg ropinirole.

Store at controlled room temperature 20o to 25oC (68o to 77oF) [see USP].

Protect from light and moisture. Close container tightly after each use.

Dosage: See Prescribing Information for complete dosing instructions.

GlaxoSmithKline

Research Triangle Park,

NC 27709

Made in Ireland

Rev. 9/11

10000000099523

Principal Display Panel

NDC 0007-4892-20

Requip®

(rOPINIRole tablets)

1 mg

100 Tablets

Rx only

Each tablet contains 1.14 mg ropinirole HCl equivalent to 1 mg ropinirole.

Store at controlled room temperature 20o to 25oC (68o to 77oF) [see USP].

Protect from light and moisture. Close container tightly after each use.

Dosage: See Prescribing Information for complete dosing instructions.

GlaxoSmithKline

Research Triangle Park,

NC 27709

Made in Ireland

Rev. 9/11

10000000099524

Principal Display Panel

NDC 0007-4893-20

Requip®

(rOPINIRole tablets)

2 mg

100 Tablets

Rx only

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

Store at controlled room temperature 20o to 25oC (68o to 77oF) [see USP].

Protect from light and moisture. Close container tightly after each use.

Dosage: See Prescribing Information for complete dosing instructions.

GlaxoSmithKline

Research Triangle Park,

NC 27709

Made in Ireland

Rev. 9/11

10000000099525

Principal Display Panel

NDC 0007-4895-20

Requip®

(rOPINIRole tablets)

3 mg

100 Tablets

Rx only

Each tablet contains 3.42 mg ropinirole HCl equivalent to 3 mg ropinirole.

Store at controlled room temperature 20o to 25oC (68o to 77oF) [see USP].

Protect from light and moisture. Close container tightly after each use.

Dosage: See Prescribing Information for complete dosing instructions.

GlaxoSmithKline

Research Triangle Park,

NC 27709

Made in Ireland

Rev. 9/11

10000000099526

Principal Display Panel

NDC 0007-4896-20

Requip®

(rOPINIRole tablets)

4 mg

100 Tablets

Rx only

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

Store at controlled room temperature 20o to 25oC (68o to 77oF) [see USP].

Protect from light and moisture. Close container tightly after each use.

Dosage: See Prescribing Information for complete dosing instructions.

GlaxoSmithKline

Research Triangle Park,

NC 27709

Made in Ireland

Rev. 9/11

10000000099527

Principal Display Panel

NDC 0007-4894-20

Requip®

(rOPINIRole tablets)

5 mg

100 Tablets

Rx only

Each tablet contains 5.70 mg ropinirole HCl equivalent to 5 mg ropinirole.

Store at controlled room temperature 20o to 25oC (68o to 77oF) [see USP].

Protect from light and moisture. Close container tightly after each use.

Dosage: See Prescribing Information for complete dosing instructions.

GlaxoSmithKline

Research Triangle Park,

NC 27709

Made in Ireland

Rev. 9/11

10000000099528

Requip 
ropinirole tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:30256-007
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ROPINIROLE HYDROCHLORIDE (ROPINIROLE) ROPINIROLE 0.25 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM  
LACTOSE MONOHYDRATE  
MAGNESIUM STEARATE  
MICROCRYSTALLINE CELLULOSE  
HYPROMELLOSE 2910 (3 MPA.S)  
POLYETHYLENE GLYCOL 400  
POLYSORBATE 80  
TITANIUM DIOXIDE  
HYPROMELLOSE 2910 (6 MPA.S)  
Product Characteristics
Color WHITE Score no score
Shape FREEFORM (pentagonal (5 sided)) Size 8mm
Flavor Imprint Code SB;4890
Contains     
Packaging
# Item Code Package Description
1 NDC:30256-007-00 100 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Approved Drug Product Manufactured Under Contract NDA020658 10/10/1997 01/31/2019
Requip 
ropinirole tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:30256-008
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ROPINIROLE HYDROCHLORIDE (ROPINIROLE) ROPINIROLE 0.5 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM  
LACTOSE MONOHYDRATE  
MAGNESIUM STEARATE  
MICROCRYSTALLINE CELLULOSE  
HYPROMELLOSE 2910 (6 MPA.S)  
POLYETHYLENE GLYCOL 400  
TITANIUM DIOXIDE  
FERRIC OXIDE YELLOW  
FERRIC OXIDE RED  
INDIGOTINDISULFONATE SODIUM  
FD&C BLUE NO. 2  
ALUMINUM OXIDE  
Product Characteristics
Color YELLOW Score no score
Shape FREEFORM (pentagonal (5 sided)) Size 8mm
Flavor Imprint Code SB;4891
Contains     
Packaging
# Item Code Package Description
1 NDC:30256-008-00 100 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Approved Drug Product Manufactured Under Contract NDA020658 10/10/1997 07/31/2019
Requip 
ropinirole tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:30256-009
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ROPINIROLE HYDROCHLORIDE (ROPINIROLE) ROPINIROLE 1 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM  
LACTOSE MONOHYDRATE  
MAGNESIUM STEARATE  
MICROCRYSTALLINE CELLULOSE  
HYPROMELLOSE 2910 (6 MPA.S)  
POLYETHYLENE GLYCOL 400  
TITANIUM DIOXIDE  
FERRIC OXIDE YELLOW  
FD&C BLUE NO. 2  
ALUMINUM OXIDE  
Product Characteristics
Color GREEN Score no score
Shape FREEFORM (pentagonal (5 sided)) Size 8mm
Flavor Imprint Code SB;4892
Contains     
Packaging
# Item Code Package Description
1 NDC:30256-009-00 100 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Approved Drug Product Manufactured Under Contract NDA020658 10/01/1997 07/31/2019
Requip 
ropinirole tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:30256-010
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
CROSCARMELLOSE SODIUM  
LACTOSE MONOHYDRATE  
MAGNESIUM STEARATE  
MICROCRYSTALLINE CELLULOSE  
HYPROMELLOSE 2910 (6 MPA.S)  
POLYETHYLENE GLYCOL 400  
TITANIUM DIOXIDE  
FERRIC OXIDE YELLOW  
FERRIC OXIDE RED  
Product Characteristics
Color YELLOW (pale yellowish-pink) Score no score
Shape FREEFORM (pentagonal (5 sided)) Size 8mm
Flavor Imprint Code SB;4893
Contains     
Packaging
# Item Code Package Description
1 NDC:30256-010-00 100 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Approved Drug Product Manufactured Under Contract NDA020658 10/03/1997 02/28/2019
Requip 
ropinirole tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:30256-011
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ROPINIROLE HYDROCHLORIDE (ROPINIROLE) ROPINIROLE 3 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM  
LACTOSE MONOHYDRATE  
MAGNESIUM STEARATE  
MICROCRYSTALLINE CELLULOSE  
HYPROMELLOSE 2910 (6 MPA.S)  
POLYETHYLENE GLYCOL 400  
TITANIUM DIOXIDE  
ALUMINUM OXIDE  
COCHINEAL  
FD&C YELLOW NO. 6  
FD&C BLUE NO. 2  
INDIGOTINDISULFONATE SODIUM  
Product Characteristics
Color RED (moderate reddish-purple) Score no score
Shape FREEFORM (pentagonal (5 sided)) Size 8mm
Flavor Imprint Code SB;4895
Contains     
Packaging
# Item Code Package Description
1 NDC:30256-011-00 100 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Approved Drug Product Manufactured Under Contract NDA020658 06/19/2001 10/31/2018
Requip 
ropinirole tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:30256-012
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
CROSCARMELLOSE SODIUM  
LACTOSE MONOHYDRATE  
MAGNESIUM STEARATE  
MICROCRYSTALLINE CELLULOSE  
HYPROMELLOSE 2910 (6 MPA.S)  
POLYETHYLENE GLYCOL 400  
TITANIUM DIOXIDE  
FD&C YELLOW NO. 6  
FD&C BLUE NO. 2  
INDIGOTINDISULFONATE SODIUM  
ALUMINUM OXIDE  
Product Characteristics
Color BROWN (pale brown) Score no score
Shape FREEFORM (pentagonal (5 sided)) Size 8mm
Flavor Imprint Code SB;4896
Contains     
Packaging
# Item Code Package Description
1 NDC:30256-012-00 100 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Approved Drug Product Manufactured Under Contract NDA020658 09/21/1999 07/31/2019
Requip 
ropinirole tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:30256-013
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ROPINIROLE HYDROCHLORIDE (ROPINIROLE) ROPINIROLE 5 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM  
LACTOSE MONOHYDRATE  
MAGNESIUM STEARATE  
MICROCRYSTALLINE CELLULOSE  
HYPROMELLOSE 2910 (3 MPA.S)  
HYPROMELLOSE 2910 (6 MPA.S)  
POLYETHYLENE GLYCOL 400  
TITANIUM DIOXIDE  
INDIGOTINDISULFONATE SODIUM  
FD&C BLUE NO. 2  
ALUMINUM OXIDE  
Product Characteristics
Color BLUE Score no score
Shape FREEFORM (pentagonal (5 sided)) Size 8mm
Flavor Imprint Code SB;4894
Contains     
Packaging
# Item Code Package Description
1 NDC:30256-013-00 100 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Approved Drug Product Manufactured Under Contract NDA020658 10/10/1997 03/31/2019
Labeler - Glaxo Wellcome SA (462027152)
 
Glaxo Wellcome SA
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