NDC Code(s) : 60951-933-92, 60951-934-92, 60951-935-92, 60951-936-92, 60951-937-92
Packager : Par Pharmaceutical

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Pramipexole Dihydrochloride Pramipexole Dihydrochloride Tablets TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60951-933
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAMIPEXOLE DIHYDROCHLORIDE(UNII: 3D867NP06J)
(PRAMIPEXOLE - UNII:83619PEU5T) 		PRAMIPEXOLE DIHYDROCHLORIDE0.125 mg
Inactive Ingredients
Ingredient Name Strength
BETADEX(UNII: JV039JZZ3A)
STARCH, CORN(UNII: O8232NY3SJ)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
POVIDONE(UNII: FZ989GH94E)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
Product Characteristics
Color WHITE (White to off-white) Score no score
Shape ROUND (Circular) Size 6 mm
Flavor Imprint Code E;33
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60951-933-9290 in 1 BOTTLE Type 0: Not a Combination Product09/10/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078894 10/09/2010 07/31/2012
Pramipexole Dihydrochloride Pramipexole Dihydrochloride Tablets TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60951-934
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAMIPEXOLE DIHYDROCHLORIDE(UNII: 3D867NP06J)
(PRAMIPEXOLE - UNII:83619PEU5T) 		PRAMIPEXOLE DIHYDROCHLORIDE0.25 mg
Inactive Ingredients
Ingredient Name Strength
BETADEX(UNII: JV039JZZ3A)
STARCH, CORN(UNII: O8232NY3SJ)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
POVIDONE(UNII: FZ989GH94E)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
Product Characteristics
Color WHITE (White to off-white) Score 2 pieces
Shape OVAL Size 8 mm
Flavor Imprint Code E;E;34;34
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60951-934-9290 in 1 BOTTLE Type 0: Not a Combination Product09/10/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078894 10/09/2010 07/31/2012
Pramipexole Dihydrochloride Pramipexole Dihydrochloride Tablets TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60951-935
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAMIPEXOLE DIHYDROCHLORIDE(UNII: 3D867NP06J)
(PRAMIPEXOLE - UNII:83619PEU5T) 		PRAMIPEXOLE DIHYDROCHLORIDE0.5 mg
Inactive Ingredients
Ingredient Name Strength
BETADEX(UNII: JV039JZZ3A)
STARCH, CORN(UNII: O8232NY3SJ)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
POVIDONE(UNII: FZ989GH94E)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
Product Characteristics
Color WHITE (White to off-white) Score 2 pieces
Shape OVAL Size 10 mm
Flavor Imprint Code E;E;35;35
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60951-935-9290 in 1 BOTTLE Type 0: Not a Combination Product09/10/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078894 10/09/2010 07/31/2012
Pramipexole Dihydrochloride Pramipexole Dihydrochloride Tablets TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60951-936
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAMIPEXOLE DIHYDROCHLORIDE(UNII: 3D867NP06J)
(PRAMIPEXOLE - UNII:83619PEU5T) 		PRAMIPEXOLE DIHYDROCHLORIDE1 mg
Inactive Ingredients
Ingredient Name Strength
BETADEX(UNII: JV039JZZ3A)
STARCH, CORN(UNII: O8232NY3SJ)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
POVIDONE(UNII: FZ989GH94E)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
Product Characteristics
Color WHITE (White to off-white) Score 2 pieces
Shape ROUND (Circular) Size 9 mm
Flavor Imprint Code E;E;36;36
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60951-936-9290 in 1 BOTTLE Type 0: Not a Combination Product09/10/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078894 10/09/2010 07/31/2012
Pramipexole Dihydrochloride Pramipexole Dihydrochloride Tablets TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60951-937
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAMIPEXOLE DIHYDROCHLORIDE(UNII: 3D867NP06J)
(PRAMIPEXOLE - UNII:83619PEU5T) 		PRAMIPEXOLE DIHYDROCHLORIDE1.5 mg
Inactive Ingredients
Ingredient Name Strength
BETADEX(UNII: JV039JZZ3A)
STARCH, CORN(UNII: O8232NY3SJ)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
POVIDONE(UNII: FZ989GH94E)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
Product Characteristics
Color WHITE (White to off-white) Score 2 pieces
Shape ROUND (Circular) Size 11 mm
Flavor Imprint Code E;E;37;37
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60951-937-9290 in 1 BOTTLE Type 0: Not a Combination Product09/10/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078894 10/09/2010 07/31/2012

PRINCIPAL DISPLAY PANEL


Pramipexole Dihydrochloride Tablets 0.125 mg (90 Tablets in 1 Bottle)
Each uncoated tablet contains : Pramipexole dihydrochloride monohydrate USP 0.125 mg
NDC 60951-933-92



0.125 mg 90

PRINCIPAL DISPLAY PANEL

Pramipexole Dihydrochloride Tablets 0.25 mg (90 Tablets in 1 Bottle)
Each uncoated tablet contains : Pramipexole dihydrochloride monohydrate USP  0.25 mg
NDC 60951-934-92


0.25 mg 90

PRINCIPAL DISPLAY PANEL

Pramipexole Dihydrochloride Tablets 0.5 mg (90 Tablets in 1 Bottle)
Each uncoated tablet contains : Pramipexole dihydrochloride monohydrate USP 0.5 mg
NDC 60951-935-92


0.5 mg 90

PRINCIPAL DISPLAY PANEL

Pramipexole Dihydrochloride Tablets 1 mg (90 Tablets in 1 Bottle)
Each uncoated tablet contains : Pramipexole dihydrochloride monohydrate USP 1 mg
NDC 60951-936-92


1 mg 90

PRINCIPAL DISPLAY PANEL

Pramipexole Dihydrochloride Tablets 1.5 mg (90 Tablets in 1 Bottle)
Each uncoated tablet contains : Pramipexole dihydrochloride monohydrate USP  1.5 mg
NDC 60951-937-92


1.5 mg 90