Metformin Hydrochloride (Page 7 of 7)

PRINCIPAL DISPLAY PANEL

610-01
(click image for full-size original)

610-18
610-36
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610-90
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611-01
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611-18
611-50
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METFORMIN HYDROCHLORIDE
metformin hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-610(NDC:53746-178)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METFORMIN HYDROCHLORIDE (METFORMIN) METFORMIN HYDROCHLORIDE 500 mg
Product Characteristics
Color white Score no score
Shape CAPSULE (Biconvex) Size 19mm
Flavor Imprint Code IP;178
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42291-610-18 180 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:42291-610-36 360 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:42291-610-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None
4 NDC:42291-610-10 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE None
5 NDC:42291-610-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078596 10/04/2010
METFORMIN HYDROCHLORIDE
metformin hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-611(NDC:53746-179)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METFORMIN HYDROCHLORIDE (METFORMIN) METFORMIN HYDROCHLORIDE 750 mg
Product Characteristics
Color white Score no score
Shape CAPSULE (Biconvex) Size 19mm
Flavor Imprint Code IP;179
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42291-611-18 180 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:42291-611-27 270 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:42291-611-50 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None
4 NDC:42291-611-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None
5 NDC:42291-611-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078596 10/04/2010
Labeler — AvKARE (796560394)

Revised: 10/2021 AvKARE

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