Fortamet (Page 7 of 7)

PRINCIPAL DISPLAY PANEL

FORTAMET® (metformin hydrochloride) Extended-Release Tablets

500 mg

image of 500 mg package label
(click image for full-size original)

1000 mg

image of 1000 mg package label
(click image for full-size original)
FORTAMET metformin hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5558(NDC:59630-574)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METFORMIN HYDROCHLORIDE (METFORMIN) METFORMIN 500 mg
Inactive Ingredients
Ingredient Name Strength
CANDELILLA WAX
CELLULOSE ACETATE
HYPROMELLOSE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL
POLYSORBATE 80
POVIDONE
SODIUM LAURYL SULFATE
FERROSOFERRIC OXIDE
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color white (white) Score no score
Shape ROUND (round) Size 12mm
Flavor Imprint Code 574
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5558-0 60 TABLET, EXTENDED RELEASE (TABLET) in 1 BOTTLE None
2 NDC:54868-5558-1 90 TABLET, EXTENDED RELEASE (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021574 03/24/2006
FORTAMET metformin hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-2894(NDC:59630-575)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METFORMIN HYDROCHLORIDE (METFORMIN) METFORMIN 1000 mg
Inactive Ingredients
Ingredient Name Strength
CANDELILLA WAX
CELLULOSE ACETATE
HYPROMELLOSE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL
POLYSORBATE 80
SODIUM LAURYL SULFATE
FERROSOFERRIC OXIDE
TITANIUM DIOXIDE
TRIACETIN
POVIDONE
Product Characteristics
Color white (white) Score no score
Shape ROUND (round) Size 13mm
Flavor Imprint Code 575
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-2894-0 30 TABLET, EXTENDED RELEASE (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021574 02/18/2010
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel, repack

Revised: 03/2010 Physicians Total Care, Inc.

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