Actoplus Met (Page 11 of 11)

PRINCIPAL DISPLAY PANEL 15 mg / 500 mg 60 Tablet Bottle

60 Tablets

actoplus met®

pioglitazone HCl 15 mg and
metformin HCl 500 mg tablets

Each film-coated tablet contains
pioglitazone hydrochloride
equivalent to 15 mg pioglitazone
and 500 mg metformin HCl.

Dispense with Medication Guide
available in package insert or at www.actoplusmet.com

Rx Only

PRINCIPAL DISPLAY PANEL 15 mg / 500 mg 60 Tablet Bottle
(click image for full-size original)

PRINCIPAL DISPLAY PANEL 15 mg / 850 mg 60 Tablet Bottle

60 Tablets

actoplus met®

pioglitazone HCl 15 mg and
metformin HCl 850 mg tablets

Each film-coated tablet contains
pioglitazone hydrochloride
equivalent to 15 mg pioglitazone
and 850 mg metformin HCl.

Dispense with Medication Guide
available in package insert or at www.actoplusmet.com

Rx Only

PRINCIPAL DISPLAY PANEL 15 mg / 850 mg 60 Tablet Bottle
(click image for full-size original)
ACTOPLUS MET pioglitazone hydrochloride and metformin hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5500(NDC:64764-155)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PIOGLITAZONE HYDROCHLORIDE (PIOGLITAZONE) PIOGLITAZONE HYDROCHLORIDE 15 mg
METFORMIN HYDROCHLORIDE (METFORMIN) METFORMIN HYDROCHLORIDE 500 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 8000
TITANIUM DIOXIDE
TALC
Product Characteristics
Color white (white to off-white) Score no score
Shape OVAL (oblong) Size 14mm
Flavor Imprint Code 4833M;15;500
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5500-0 90 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:54868-5500-1 60 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC None
3 NDC:54868-5500-2 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021842 01/04/2006
ACTOPLUS MET pioglitazone hydrochloride and metformin hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5553(NDC:64764-158)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PIOGLITAZONE HYDROCHLORIDE (PIOGLITAZONE) PIOGLITAZONE HYDROCHLORIDE 15 mg
METFORMIN HYDROCHLORIDE (METFORMIN) METFORMIN HYDROCHLORIDE 850 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 8000
TITANIUM DIOXIDE
TALC
Product Characteristics
Color white (white to off-white) Score no score
Shape OVAL (oblong) Size 18mm
Flavor Imprint Code 4833M;15;850
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5553-0 60 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:54868-5553-1 90 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC None
3 NDC:54868-5553-2 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021842 03/21/2006
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel, repack

Revised: 02/2010 Physicians Total Care, Inc.

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