Metformin Hydrochloride (Page 7 of 7)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 500 mg (100 Tablets Bottle)

NDC 65862-008-01
Rx only
Metformin Hydrochloride Tablets, USP
500 mg AUROBINDO 100 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 500 mg (100 Tablets Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 850 mg (100 Tablets Bottle)

NDC 65862-009-01
Rx only
Metformin Hydrochloride
Tablets, USP
850 mg
AUROBINDO 100 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 850 mg (100 Tablets Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 1000 mg (100 Tablets Bottle)

NDC 65862-010-01
Rx only
Metformin Hydrochloride
Tablets, USP
1000 mg AUROBINDO 100 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 1000 mg (100 Tablets Bottle)
(click image for full-size original)
METFORMIN HYDROCHLORIDE metformin hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-008
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 K90
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (5 MPA.S)
POLYETHYLENE GLYCOL 400
POLYETHYLENE GLYCOL 6000
Product Characteristics
Color WHITE Score no score
Shape ROUND (Biconvex) Size 11mm
Flavor Imprint Code A;12
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-008-50 50 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65862-008-60 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65862-008-90 90 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:65862-008-01 100 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:65862-008-33 300 TABLET, FILM COATED in 1 BOTTLE None
6 NDC:65862-008-05 500 TABLET, FILM COATED in 1 BOTTLE None
7 NDC:65862-008-99 1000 TABLET, FILM COATED in 1 BOTTLE None
8 NDC:65862-008-45 4500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077095 01/14/2005
METFORMIN HYDROCHLORIDE metformin hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-009
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 K90
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (5 MPA.S)
POLYETHYLENE GLYCOL 400
POLYETHYLENE GLYCOL 6000
Product Characteristics
Color WHITE Score no score
Shape ROUND (Biconvex) Size 13mm
Flavor Imprint Code A;13
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-009-50 50 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65862-009-60 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65862-009-90 90 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:65862-009-01 100 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:65862-009-33 300 TABLET, FILM COATED in 1 BOTTLE None
6 NDC:65862-009-05 500 TABLET, FILM COATED in 1 BOTTLE None
7 NDC:65862-009-99 1000 TABLET, FILM COATED in 1 BOTTLE None
8 NDC:65862-009-44 2500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077095 01/14/2005
METFORMIN HYDROCHLORIDE metformin hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-010
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 K90
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (5 MPA.S)
POLYETHYLENE GLYCOL 400
POLYETHYLENE GLYCOL 6000
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL (Biconvex) Size 19mm
Flavor Imprint Code 1;4;A
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-010-50 50 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65862-010-60 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65862-010-90 90 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:65862-010-01 100 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:65862-010-33 300 TABLET, FILM COATED in 1 BOTTLE None
6 NDC:65862-010-05 500 TABLET, FILM COATED in 1 BOTTLE None
7 NDC:65862-010-99 1000 TABLET, FILM COATED in 1 BOTTLE None
8 NDC:65862-010-46 2000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077095 01/14/2005
Labeler — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 918917642 ANALYSIS (65862-008), ANALYSIS (65862-009), ANALYSIS (65862-010), MANUFACTURE (65862-008), MANUFACTURE (65862-009), MANUFACTURE (65862-010)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 650381903 ANALYSIS (65862-008), ANALYSIS (65862-009), ANALYSIS (65862-010), MANUFACTURE (65862-008), MANUFACTURE (65862-009), MANUFACTURE (65862-010)

Revised: 02/2020 Aurobindo Pharma Limited

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