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:

Container Label 0.75 mg — 30’s count:

Container Label 1.5 mg — 30’s count:

Container Label 3 mg — 30’s count:

Container Label 4.5 mg — 30’s count:

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