Metformin Hydrochloride (Page 6 of 6)

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Label 500 mg
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Label 1000 mg
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METFORMIN HYDROCHLORIDE metformin hydrochloride tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-2719
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METFORMIN HYDROCHLORIDE (METFORMIN) METFORMIN HYDROCHLORIDE 500 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE ACETATE
HYPROMELLOSES
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 400
POLYETHYLENE GLYCOL 8000
POLYSORBATE 80
POVIDONE
SODIUM LAURYL SULFATE
CANDELILLA WAX
FERROSOFERRIC OXIDE
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 12mm
Flavor Imprint Code 574
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0591-2719-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA021574 04/18/2012
METFORMIN HYDROCHLORIDE metformin hydrochloride tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-2720
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METFORMIN HYDROCHLORIDE (METFORMIN) METFORMIN HYDROCHLORIDE 1000 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE ACETATE
HYPROMELLOSES
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 400
POLYETHYLENE GLYCOL 8000
POLYSORBATE 80
POVIDONE
SODIUM LAURYL SULFATE
CANDELILLA WAX
FERROSOFERRIC OXIDE
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 13mm
Flavor Imprint Code 575
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0591-2720-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA021574 04/18/2012
Labeler — Actavis Pharma, Inc. (119723554)
Establishment
Name Address ID/FEI Operations
Actavis Laboratories FL, Inc. 020778751 MANUFACTURE (0591-2719), MANUFACTURE (0591-2720)
Establishment
Name Address ID/FEI Operations
Actavis Laboratories FL, Inc. 014759176 LABEL (0591-2719), LABEL (0591-2720), PACK (0591-2719), PACK (0591-2720)

Revised: 11/2018 Actavis Pharma, Inc.

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