Pramipexole Dihydrochloride (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

Unvarnished Area Consists of: 2D Barcode, Lot Number, Expiry Date and Serial Number

Container Label 0.375 mg — 30’s count:

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Container Label 0.75 mg — 30’s count:

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Container Label 1.5 mg — 30’s count:

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Container Label 3 mg — 30’s count:

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Container Label 4.5 mg — 30’s count:

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PRAMIPEXOLE DIHYDROCHLORIDE
pramipexole dihydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55111-611
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE) PRAMIPEXOLE DIHYDROCHLORIDE 0.375 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, PREGELATINIZED CORN
CARBOMER HOMOPOLYMER TYPE A
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 9mm
Flavor Imprint Code RDY;611
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55111-611-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203354 08/14/2015
PRAMIPEXOLE DIHYDROCHLORIDE
pramipexole dihydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55111-612
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
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
CARBOMER HOMOPOLYMER TYPE A
STARCH, PREGELATINIZED CORN
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code RDY;612
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55111-612-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203354 08/14/2015
PRAMIPEXOLE DIHYDROCHLORIDE
pramipexole dihydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55111-613
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
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
CARBOMER HOMOPOLYMER TYPE A
STARCH, PREGELATINIZED CORN
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 14mm
Flavor Imprint Code RDY;613
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55111-613-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203354 08/14/2015
PRAMIPEXOLE DIHYDROCHLORIDE
pramipexole dihydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55111-614
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE) PRAMIPEXOLE DIHYDROCHLORIDE 3 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, PREGELATINIZED CORN
CARBOMER HOMOPOLYMER TYPE A
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 15mm
Flavor Imprint Code RDY;614
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55111-614-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203354 08/14/2015
PRAMIPEXOLE DIHYDROCHLORIDE
pramipexole dihydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55111-615
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE) PRAMIPEXOLE DIHYDROCHLORIDE 4.5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
CARBOMER HOMOPOLYMER TYPE A
STARCH, PREGELATINIZED CORN
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 16mm
Flavor Imprint Code RDY;615
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55111-615-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203354 08/14/2015
Labeler — Dr. Reddy’s Laboratories Limited (650562841)
Registrant — Dr. Reddy’s Laboratories Limited (FTO-III) (918608162)
Establishment
Name Address ID/FEI Operations
Dr. Reddy’s Laboratories Limited (FTO-III) 918608162 analysis (55111-611), analysis (55111-612), analysis (55111-613), analysis (55111-614), analysis (55111-615), manufacture (55111-611), manufacture (55111-612), manufacture (55111-613), manufacture (55111-614), manufacture (55111-615)

Revised: 08/2021 Dr. Reddy’s Laboratories Limited

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