Prescription Drug Information: Metformin Hydrochloride (Page 6 of 6)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Metformin Hydrochloride Tablets USP, 500 mg 30′s Container pack

met-30-500mg
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Metformin Hydrochloride Tablets USP, 500 mg1000′s Container pack

met-500-500mg
(click image for full-size original)

Metformin Hydrochloride Tablets USP, 850 mg30′s Container pack

met-30s-850mg
(click image for full-size original)

Metformin Hydrochloride Tablets USP, 850 mg500′s Container pack

met-500s-850mg
(click image for full-size original)

Metformin Hydrochloride Tablets USP, 1000 mg30′s Container pack

met-30s-1000mg
(click image for full-size original)

Metformin Hydrochloride Tablets USP, 1000 mg500′s Container pack

met-500s-100mg
(click image for full-size original)
METFORMIN HYDROCHLORIDE metformin hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:25000-134
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
POVIDONE, UNSPECIFIED
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
POLYVINYL ALCOHOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL, UNSPECIFIED
Product Characteristics
Color WHITE (White to off white) Score no score
Shape ROUND Size 12mm
Flavor Imprint Code 134
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:25000-134-03 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:25000-134-14 1000 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:25000-134-51 2600 TABLET, FILM COATED in 1 BAG None
4 NDC:25000-134-98 1 BAG in 1 BOX contains a BAG
4 16455 TABLET, FILM COATED in 1 BAG This package is contained within the BOX (25000-134-98)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090888 06/01/2012
METFORMIN HYDROCHLORIDE metformin hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:25000-131
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METFORMIN HYDROCHLORIDE (METFORMIN) METFORMIN HYDROCHLORIDE 850 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE, UNSPECIFIED
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND Size 13mm
Flavor Imprint Code 131
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:25000-131-03 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:25000-131-12 500 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:25000-131-52 1800 TABLET, FILM COATED in 1 BAG None
4 NDC:25000-131-98 1 BAG in 1 BOX contains a BAG
4 9680 TABLET, FILM COATED in 1 BAG This package is contained within the BOX (25000-131-98)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090888 06/01/2012
METFORMIN HYDROCHLORIDE metformin hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:25000-132
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
POVIDONE, UNSPECIFIED
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (white to off-white) Score 2 pieces
Shape OVAL Size 19mm
Flavor Imprint Code 132
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:25000-132-03 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:25000-132-12 500 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:25000-132-53 1500 TABLET, FILM COATED in 1 BAG None
4 NDC:25000-132-98 1 BAG in 1 BOX contains a BAG
4 8225 TABLET, FILM COATED in 1 BAG This package is contained within the BOX (25000-132-98)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090888 06/01/2012
Labeler — MARKSANS PHARMA LIMITED (925822975)
Establishment
Name Address ID/FEI Operations
MARKSANS PHARMA LIMITED 925822975 MANUFACTURE (25000-131), MANUFACTURE (25000-132), MANUFACTURE (25000-134)

Revised: 11/2019 MARKSANS PHARMA LIMITED

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