PIOGLITAZONEHYDROCHLORIDE (Page 9 of 9)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pioglitazone Tablets 15mg

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pioglitazone Tablets 30mg

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pioglitazone Tablets 45mg

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PIOGLITAZONEHYDROCHLORIDE pioglitazonehydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-140
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PIOGLITAZONE HYDROCHLORIDE (PIOGLITAZONE) PIOGLITAZONE 15 mg
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE CALCIUM
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
Product Characteristics
Color white (white to off-white) Score no score
Shape ROUND Size 5mm
Flavor Imprint Code 140;15
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-140-30 30 TABLET in 1 BOTTLE None
2 NDC:13668-140-53 9000 TABLET in 1 BOTTLE None
3 NDC:13668-140-74 100 TABLET in 1 CARTON None
4 NDC:13668-140-05 500 TABLET in 1 BOTTLE None
5 NDC:13668-140-90 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091298 02/13/2013
PIOGLITAZONEHYDROCHLORIDE pioglitazonehydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-119
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PIOGLITAZONE HYDROCHLORIDE (PIOGLITAZONE) PIOGLITAZONE 30 mg
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE CALCIUM
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
Product Characteristics
Color white (white to off-white) Score no score
Shape ROUND Size 7mm
Flavor Imprint Code 1119
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-119-74 100 TABLET in 1 CARTON None
2 NDC:13668-119-52 7000 TABLET in 1 BOTTLE None
3 NDC:13668-119-05 500 TABLET in 1 BOTTLE None
4 NDC:13668-119-90 90 TABLET in 1 BOTTLE None
5 NDC:13668-119-30 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091298 02/13/2013
PIOGLITAZONEHYDROCHLORIDE pioglitazonehydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-120
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PIOGLITAZONE HYDROCHLORIDE (PIOGLITAZONE) PIOGLITAZONE 45 mg
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE CALCIUM
HYDROXYMETHYL CELLULOSE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
Product Characteristics
Color white (white to off-white) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code 1120
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-120-30 30 TABLET in 1 BOTTLE None
2 NDC:13668-120-74 100 TABLET in 1 CARTON None
3 NDC:13668-120-51 5000 TABLET in 1 BOTTLE None
4 NDC:13668-120-05 500 TABLET in 1 BOTTLE None
5 NDC:13668-120-90 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091298 02/13/2013
Labeler — TORRENT PHARMACEUTICALS LIMITED (916488547)
Registrant — Torrent Pharma, Inc. (790033935)
Establishment
Name Address ID/FEI Operations
TORRENT PHARMACEUTICALS LIMITED 916488547 manufacture (13668-140), manufacture (13668-119), manufacture (13668-120)

Revised: 12/2018 TORRENT PHARMACEUTICALS LIMITED

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