Pramipexole Dihydrochloride (Page 8 of 8)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 0.125 mg (90 Tablet Bottle)

90 Tablets
NDC 57237-180-90
Pramipexole
Dihydrochloride Tablets
0.125 mg
Rx only
Citron Pharma

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 0.125 mg (90 Tablet Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 0.25 mg (90 Tablet Bottle)

90 Tablets
NDC 57237-181 -90
Pramipexole
Dihydrochloride Tablets
0.25 mg
Rx only
Citron Pharma

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 0.25 mg (90 Tablet Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 0.5 mg (90 Tablet Bottle)

90 Tablets
NDC 57237-182 -90
Pramipexole
Dihydrochloride Tablets
0.5 mg
Rx only
Citron Pharma

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 0.5 mg (90 Tablet Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 0.75 mg (90 Tablet Bottle)

90 Tablets
NDC 57237-183 -90
Pramipexole
Dihydrochloride
Tablets
0.75 mg
Rx only
Citron Pharma

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 0.75 mg (90 Tablet Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 1 mg (90 Tablet Bottle)

90 Tablets
NDC 57237-184 -90
Pramipexole
Dihydrochloride
Tablets
1 mg
Rx only
Citron Pharma

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 1 mg (90 Tablet Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 1.5 mg (90 Tablet Bottle)

90 Tablets
NDC 57237-185 -90
Pramipexole
Dihydrochloride
Tablets
1.5 mg
Rx only
Citron Pharma

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 1.5 mg (90 Tablet Bottle)
(click image for full-size original)

PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57237-180
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE) PRAMIPEXOLE DIHYDROCHLORIDE 0.125 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
STARCH, CORN
MAGNESIUM STEARATE
MANNITOL
POVIDONE K30
POVIDONE K90
Product Characteristics
Color WHITE (White to Off-white) Score no score
Shape ROUND (Flat, Beveled Edge) Size 6mm
Flavor Imprint Code Y;41
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57237-180-90 90 TABLET in 1 BOTTLE None
2 NDC:57237-180-99 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202633 10/26/2012
PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57237-181
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE) PRAMIPEXOLE DIHYDROCHLORIDE 0.25 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
STARCH, CORN
MAGNESIUM STEARATE
MANNITOL
POVIDONE K30
POVIDONE K90
Product Characteristics
Color WHITE (White to Off-white) Score 2 pieces
Shape OVAL (Biconcave, Beveled Edge) Size 7mm
Flavor Imprint Code Y;42
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57237-181-90 90 TABLET in 1 BOTTLE None
2 NDC:57237-181-99 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202633 10/26/2012
PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57237-182
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE) PRAMIPEXOLE DIHYDROCHLORIDE 0.5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
STARCH, CORN
MAGNESIUM STEARATE
MANNITOL
POVIDONE K30
POVIDONE K90
Product Characteristics
Color WHITE (White to Off-white) Score 2 pieces
Shape OVAL (Biconcave, Beveled Edge) Size 8mm
Flavor Imprint Code Y;43
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57237-182-90 90 TABLET in 1 BOTTLE None
2 NDC:57237-182-99 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202633 10/26/2012
PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57237-183
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE) PRAMIPEXOLE DIHYDROCHLORIDE 0.75 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
STARCH, CORN
MAGNESIUM STEARATE
MANNITOL
POVIDONE K30
POVIDONE K90
Product Characteristics
Color WHITE (White to Off-white) Score no score
Shape OVAL (Biconcave, Beveled Edge) Size 11mm
Flavor Imprint Code Y;44
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57237-183-90 90 TABLET in 1 BOTTLE None
2 NDC:57237-183-99 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202633 10/26/2012
PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57237-184
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE) PRAMIPEXOLE DIHYDROCHLORIDE 1 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
STARCH, CORN
MAGNESIUM STEARATE
MANNITOL
POVIDONE K30
POVIDONE K90
Product Characteristics
Color WHITE (White to Off-white) Score 2 pieces
Shape ROUND (Flat, Beveled Edge) Size 9mm
Flavor Imprint Code Y;45
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57237-184-90 90 TABLET in 1 BOTTLE None
2 NDC:57237-184-99 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202633 10/26/2012
PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57237-185
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE) PRAMIPEXOLE DIHYDROCHLORIDE 1.5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
STARCH, CORN
MAGNESIUM STEARATE
MANNITOL
POVIDONE K30
POVIDONE K90
Product Characteristics
Color WHITE (White to Off-white) Score 2 pieces
Shape ROUND (Flat, Beveled Edge) Size 11mm
Flavor Imprint Code Y;46
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57237-185-90 90 TABLET in 1 BOTTLE None
2 NDC:57237-185-99 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202633 10/26/2012
Labeler — Citron Pharma LLC (078731527)

Revised: 03/2016 Citron Pharma LLC

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