Metformin ER 500 Mg: Package Insert and Label Information (Page 4 of 4)

17.2 FDA-Approved Patient

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SPL PATIENT PACKAGE INSERT SECTION

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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METFORMIN ER 500 MG metformin er 500 mg tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62207-491
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
HYPROMELLOSES
MAGNESIUM STEARATE
Product Characteristics
Color white (white to off-white) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code G7
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62207-491-54 30 TABLET in 1 BOTTLE None
2 NDC:62207-491-49 1000 TABLET in 1 BOTTLE None
3 NDC:62207-491-43 100 TABLET in 1 BOTTLE None
4 NDC:62207-491-47 500 TABLET in 1 BOTTLE None
5 NDC:62207-491-31 5000 TABLET in 1 POUCH None
6 NDC:62207-491-35 25000 TABLET in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209313 06/28/2018
METFORMIN ER 750 MG metformin er 750 mg tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62207-492
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METFORMIN HYDROCHLORIDE (METFORMIN) METFORMIN HYDROCHLORIDE 750 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES
MAGNESIUM STEARATE
POVIDONE
Product Characteristics
Color white (white to off-white) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code G8
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62207-492-54 30 TABLET in 1 BOTTLE None
2 NDC:62207-492-49 1000 TABLET in 1 BOTTLE None
3 NDC:62207-492-43 100 TABLET in 1 BOTTLE None
4 NDC:62207-492-47 500 TABLET in 1 BOTTLE None
5 NDC:62207-492-40 3500 TABLET in 1 POUCH None
6 NDC:62207-492-74 25000 TABLET in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209313 06/28/2018
Labeler — Granules India Ltd (915000087)
Establishment
Name Address ID/FEI Operations
Granules India Ltd 918609236 analysis (62207-491), analysis (62207-492), label (62207-491), label (62207-492), manufacture (62207-491), manufacture (62207-492), pack (62207-491), pack (62207-492)

Revised: 10/2020 Granules India Ltd

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