Alogliptin and Pioglitazone (Page 11 of 11)

PRINCIPAL DISPLAY PANEL — 12.5 mg/15 mg Tablet Bottle Label

Rx Only

NDC 45802-238 -65

Alogliptin
and Pioglitazone
Tablets
12.5 mg/15 mg

Dispense with
Medication Guide

30 Tablets Perrigo®

PRINCIPAL DISPLAY PANEL -- 12.5 mg/15 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 12.5 mg/30 mg Tablet Bottle Label

Rx Only

NDC 45802-260 -65

Alogliptin
and Pioglitazone
Tablets
12.5 mg/30 mg

Dispense with
Medication Guide

30 Tablets Perrigo®

PRINCIPAL DISPLAY PANEL -- 12.5 mg/30 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 12.5 mg/45 mg Tablet Bottle Label

Rx Only

NDC 45802-304 -65

Alogliptin
and Pioglitazone
Tablets
12.5 mg/45 mg

Dispense with
Medication Guide

30 Tablets Perrigo®

PRINCIPAL DISPLAY PANEL -- 12.5 mg/45 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 25 mg/15 mg Tablet Bottle Label

Rx Only

NDC 45802-351 -65

Alogliptin
and Pioglitazone
Tablets
25 mg/15 mg

Dispense with
Medication Guide

30 Tablets Perrigo®

PRINCIPAL DISPLAY PANEL -- 25 mg/15 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 25 mg/30 mg Tablet Bottle Label

Rx Only

NDC 45802-402 -65

Alogliptin
and Pioglitazone
Tablets
25 mg/30 mg

Dispense with
Medication Guide

30 Tablets Perrigo®

PRINCIPAL DISPLAY PANEL -- 25 mg/30 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 25 mg/45 mg Tablet Bottle Label

Rx Only

NDC 45802-499 -65

Alogliptin
and Pioglitazone
Tablets
25 mg/45 mg

Dispense with
Medication Guide

30 Tablets Perrigo®

PRINCIPAL DISPLAY PANEL -- 25 mg/45 mg Tablet Bottle Label
(click image for full-size original)
ALOGLIPTIN AND PIOGLITAZONE alogliptin benzoate and pioglitazone hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45802-238
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Alogliptin Benzoate (Alogliptin) Alogliptin 12.5 mg
Pioglitazone hydrochloride (Pioglitazone) Pioglitazone 15 mg
Inactive Ingredients
Ingredient Name Strength
Mannitol
HYDROXYPROPYL CELLULOSE (90000 WAMW)
Microcrystalline Cellulose
Croscarmellose sodium
Magnesium stearate
Hypromellose 2910 (6 MPA.S)
Titanium dioxide
Polyethylene Glycol 8000
Talc
Lactose Monohydrate
Ferric oxide yellow
Ferric oxide Red
Carnauba wax
Polyglyceryl-10 oleate
Butyl Alcohol
Alcohol
Shellac
Product Characteristics
Color YELLOW (Pale yellow) Score no score
Shape ROUND (biconvex) Size 9mm
Flavor Imprint Code AP;12;5;15
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45802-238-65 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA022426 04/08/2016
ALOGLIPTIN AND PIOGLITAZONE alogliptin benzoate and pioglitazone hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45802-260
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Alogliptin Benzoate (Alogliptin) Alogliptin 12.5 mg
Pioglitazone hydrochloride (Pioglitazone) Pioglitazone 30 mg
Inactive Ingredients
Ingredient Name Strength
Mannitol
HYDROXYPROPYL CELLULOSE (90000 WAMW)
Microcrystalline Cellulose
Croscarmellose sodium
Magnesium stearate
Hypromellose 2910 (6 MPA.S)
Titanium dioxide
Polyethylene Glycol 8000
Talc
Lactose Monohydrate
Ferric oxide yellow
Ferric oxide Red
Carnauba wax
Polyglyceryl-10 oleate
Butyl Alcohol
Alcohol
Shellac
Product Characteristics
Color ORANGE (Pale peach) Score no score
Shape ROUND (biconvex) Size 9mm
Flavor Imprint Code AP;12;5;30
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45802-260-65 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA022426 04/08/2016
ALOGLIPTIN AND PIOGLITAZONE alogliptin benzoate and pioglitazone hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45802-304
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Alogliptin Benzoate (Alogliptin) Alogliptin 12.5 mg
Pioglitazone hydrochloride (Pioglitazone) Pioglitazone 45 mg
Inactive Ingredients
Ingredient Name Strength
Mannitol
HYDROXYPROPYL CELLULOSE (90000 WAMW)
Microcrystalline Cellulose
Croscarmellose sodium
Magnesium stearate
Hypromellose 2910 (6 MPA.S)
Titanium dioxide
Polyethylene Glycol 8000
Talc
Lactose Monohydrate
Ferric oxide Red
Carnauba wax
Polyglyceryl-10 oleate
Butyl Alcohol
Alcohol
Shellac
Product Characteristics
Color RED (Pale red) Score no score
Shape ROUND (biconvex) Size 9mm
Flavor Imprint Code AP;12;5;45
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45802-304-65 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA022426 04/08/2016
ALOGLIPTIN AND PIOGLITAZONE alogliptin benzoate and pioglitazone hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45802-351
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Alogliptin Benzoate (Alogliptin) Alogliptin 25 mg
Pioglitazone hydrochloride (Pioglitazone) Pioglitazone 15 mg
Inactive Ingredients
Ingredient Name Strength
Mannitol
HYDROXYPROPYL CELLULOSE (90000 WAMW)
Microcrystalline Cellulose
Croscarmellose sodium
Magnesium stearate
Hypromellose 2910 (6 MPA.S)
Titanium dioxide
Polyethylene Glycol 8000
Talc
Lactose Monohydrate
Ferric oxide yellow
Ferrosoferric oxide
Shellac
Butyl Alcohol
Alcohol
Product Characteristics
Color YELLOW Score no score
Shape ROUND (biconvex) Size 9mm
Flavor Imprint Code AP;25;15
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45802-351-65 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA022426 04/08/2016
ALOGLIPTIN AND PIOGLITAZONE alogliptin benzoate and pioglitazone hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45802-499
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Alogliptin Benzoate (Alogliptin) Alogliptin 25 mg
Pioglitazone hydrochloride (Pioglitazone) Pioglitazone 45 mg
Inactive Ingredients
Ingredient Name Strength
Mannitol
HYDROXYPROPYL CELLULOSE (90000 WAMW)
Microcrystalline Cellulose
Croscarmellose sodium
Magnesium stearate
Hypromellose 2910 (6 MPA.S)
Titanium dioxide
Polyethylene Glycol 8000
Talc
Lactose Monohydrate
Ferrosoferric oxide
Ferric oxide Red
Butyl Alcohol
Alcohol
Shellac
Product Characteristics
Color RED Score no score
Shape ROUND (biconvex) Size 9mm
Flavor Imprint Code AP;25;45
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45802-499-65 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA022426 04/08/2016
ALOGLIPTIN AND PIOGLITAZONE alogliptin benzoate and pioglitazone hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45802-402
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Alogliptin Benzoate (Alogliptin) Alogliptin 25 mg
Pioglitazone hydrochloride (Pioglitazone) Pioglitazone 30 mg
Inactive Ingredients
Ingredient Name Strength
Mannitol
HYDROXYPROPYL CELLULOSE (90000 WAMW)
Microcrystalline Cellulose
Croscarmellose sodium
Magnesium stearate
Hypromellose 2910 (6 MPA.S)
Titanium dioxide
Polyethylene Glycol 8000
Talc
Lactose Monohydrate
Ferric oxide yellow
Ferric oxide Red
Ferrosoferric oxide
Butyl Alcohol
Alcohol
Shellac
Product Characteristics
Color ORANGE (peach) Score no score
Shape ROUND (biconvex) Size 9mm
Flavor Imprint Code AP;25;30
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45802-402-65 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA022426 04/08/2016
Labeler — Perrigo New York Inc (078846912)

Revised: 11/2019 Perrigo New York Inc

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