Metformin Hydrochloride (Page 7 of 7)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

metf850
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metform1000
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metform500
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METFORMIN HYDROCHLORIDE
metformin hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67046-463(NDC:23155-102)
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
HYPROMELLOSE 2910 (6 MPA.S)
MAGNESIUM STEARATE
BLACKBERRY
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
Product Characteristics
Color white (white to off-white) Score no score
Shape ROUND (biconvex) Size 11mm
Flavor Imprint Code H;102
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67046-463-15 15 TABLET in 1 BLISTER PACK None
2 NDC:67046-463-14 14 TABLET in 1 BLISTER PACK None
3 NDC:67046-463-07 7 TABLET in 1 BLISTER PACK None
4 NDC:67046-463-60 60 TABLET in 1 BLISTER PACK None
5 NDC:67046-463-20 20 TABLET in 1 BLISTER PACK None
6 NDC:67046-463-21 21 TABLET in 1 BLISTER PACK None
7 NDC:67046-463-28 28 TABLET in 1 BLISTER PACK None
8 NDC:67046-463-30 30 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090564 09/20/2017
METFORMIN HYDROCHLORIDE
metformin hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67046-459(NDC:23155-103)
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
HYPROMELLOSE 2910 (6 MPA.S)
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 400
BLACKBERRY
TITANIUM DIOXIDE
Product Characteristics
Color white (white to off-white) Score no score
Shape ROUND (biconvex) Size 13mm
Flavor Imprint Code H;103
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67046-459-15 15 TABLET in 1 BLISTER PACK None
2 NDC:67046-459-28 28 TABLET in 1 BLISTER PACK None
3 NDC:67046-459-30 30 TABLET in 1 BLISTER PACK None
4 NDC:67046-459-60 60 TABLET in 1 BLISTER PACK None
5 NDC:67046-459-21 21 TABLET in 1 BLISTER PACK None
6 NDC:67046-459-07 7 TABLET in 1 BLISTER PACK None
7 NDC:67046-459-14 14 TABLET in 1 BLISTER PACK None
8 NDC:67046-459-20 20 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090564 09/20/2017
METFORMIN HYDROCHLORIDE
metformin hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67046-464(NDC:23155-104)
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
HYPROMELLOSE 2910 (6 MPA.S)
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 400
BLACKBERRY
TITANIUM DIOXIDE
Product Characteristics
Color white (white to off-white) Score 2 pieces
Shape OVAL (biconvex) Size 19mm
Flavor Imprint Code H;104
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67046-464-07 7 TABLET in 1 BLISTER PACK None
2 NDC:67046-464-14 14 TABLET in 1 BLISTER PACK None
3 NDC:67046-464-15 15 TABLET in 1 BLISTER PACK None
4 NDC:67046-464-20 20 TABLET in 1 BLISTER PACK None
5 NDC:67046-464-21 21 TABLET in 1 BLISTER PACK None
6 NDC:67046-464-28 28 TABLET in 1 BLISTER PACK None
7 NDC:67046-464-30 30 TABLET in 1 BLISTER PACK None
8 NDC:67046-464-60 60 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090564 09/20/2017
Labeler — Contract Pharmacy Services-PA (945429777)
Establishment
Name Address ID/FEI Operations
Coupler Enterprises 945429777 repack (67046-459), repack (67046-463), repack (67046-464)

Revised: 12/2018 Contract Pharmacy Services-PA

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