Metformin Hydrochloride: Package Insert and Label Information (Page 4 of 4)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Metformin Hydrochloride Tablets, USP 500mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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Metformin Hydrochloride Tablets, USP 850mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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Metformin Hydrochloride Tablets, USP 1000mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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METFORMIN HYDROCHLORIDE metformin hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68645-582(NDC:70010-063)
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 K30
POVIDONE K90
STARCH, CORN
MAGNESIUM STEARATE
BLACKBERRY
POLYETHYLENE GLYCOL 400
HYPROMELLOSE 2910 (6 MPA.S)
TITANIUM DIOXIDE
Product Characteristics
Color white (white to off-white) Score no score
Shape ROUND (biconvex) Size 11mm
Flavor BLACKBERRY (Artificial) Imprint Code G;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68645-582-59 60 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090564 06/07/2019
METFORMIN HYDROCHLORIDE metformin hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68645-583(NDC:70010-064)
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 K30
POVIDONE K90
STARCH, CORN
MAGNESIUM STEARATE
BLACKBERRY
POLYETHYLENE GLYCOL 400
HYPROMELLOSE 2910 (6 MPA.S)
TITANIUM DIOXIDE
Product Characteristics
Color white (white to off-white) Score no score
Shape ROUND (biconvex) Size 13mm
Flavor BLACKBERRY (Artificial) Imprint Code G;11
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68645-583-59 60 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090564 06/07/2019
METFORMIN HYDROCHLORIDE metformin hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68645-584(NDC:70010-065)
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 K30
POVIDONE K90
STARCH, CORN
MAGNESIUM STEARATE
BLACKBERRY
POLYETHYLENE GLYCOL 400
HYPROMELLOSE 2910 (6 MPA.S)
TITANIUM DIOXIDE
Product Characteristics
Color white (white to off-white) Score no score
Shape OVAL (biconvex) Size 19mm
Flavor BLACKBERRY (Artificial) Imprint Code G;12
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68645-584-59 60 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090564 06/07/2019
Labeler — Legacy Pharmaceutical Packaging, LLC (143213275)

Revised: 05/2022 Legacy Pharmaceutical Packaging, LLC

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