Glyburide and Metformin Hydrochloride (Page 7 of 7)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 1.25 mg/250 mg (100 Tablets Bottle)

NDC 65862-080-01
Rx only
Glyburide and Metformin
Hydrochloride Tablets, USP
1.25 mg/250 mg
AUROBINDO 100 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 1.25 mg/250 mg (100 Tablets Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 2.5 mg/500 mg (100 Tablets Bottle)

NDC 65862-081-01
Rx only
Glyburide and Metformin
Hydrochloride Tablets, USP
2.5 mg/500 mg AUROBINDO 100 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 2.5 mg/500 mg (100 Tablets Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 5 mg/500 mg (100 Tablets Bottle)

NDC 65862-082-01
Rx only
Glyburide and Metformin
Hydrochloride Tablets, USP
5 mg/500 mg

AUROBINDO 100 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 5 mg/500 mg (100 Tablets Bottle)
(click image for full-size original)

GLYBURIDE AND METFORMIN HYDROCHLORIDE glyburide and metformin hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-080
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYBURIDE (GLYBURIDE) GLYBURIDE 1.25 mg
METFORMIN HYDROCHLORIDE (METFORMIN) METFORMIN HYDROCHLORIDE 250 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
POVIDONE K90
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
PROPYLENE GLYCOL
POLYSORBATE 80
TALC
TITANIUM DIOXIDE
FD&C YELLOW NO. 6
D&C YELLOW NO. 10
Product Characteristics
Color YELLOW Score no score
Shape CAPSULE (Biconvex) Size 13mm
Flavor Imprint Code A;46
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-080-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65862-080-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65862-080-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077870 11/14/2007
GLYBURIDE AND METFORMIN HYDROCHLORIDE glyburide and metformin hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-081
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYBURIDE (GLYBURIDE) GLYBURIDE 2.5 mg
METFORMIN HYDROCHLORIDE (METFORMIN) METFORMIN HYDROCHLORIDE 500 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
POVIDONE K90
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
PROPYLENE GLYCOL
POLYSORBATE 80
TALC
TITANIUM DIOXIDE
FD&C YELLOW NO. 6
FD&C RED NO. 40
Product Characteristics
Color PINK (Light Pink) Score no score
Shape CAPSULE (Biconvex) Size 17mm
Flavor Imprint Code A;47
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-081-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65862-081-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65862-081-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077870 11/14/2007
GLYBURIDE AND METFORMIN HYDROCHLORIDE glyburide and metformin hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-082
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYBURIDE (GLYBURIDE) GLYBURIDE 5 mg
METFORMIN HYDROCHLORIDE (METFORMIN) METFORMIN HYDROCHLORIDE 500 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
POVIDONE K90
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
PROPYLENE GLYCOL
POLYSORBATE 80
TALC
TITANIUM DIOXIDE
FD&C YELLOW NO. 6
D&C YELLOW NO. 10
Product Characteristics
Color YELLOW Score no score
Shape CAPSULE (Biconvex) Size 17mm
Flavor Imprint Code A;48
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-082-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65862-082-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65862-082-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077870 11/14/2007
Labeler — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 918917642 ANALYSIS (65862-080), ANALYSIS (65862-081), ANALYSIS (65862-082), MANUFACTURE (65862-080), MANUFACTURE (65862-081), MANUFACTURE (65862-082)

Revised: 03/2022 Aurobindo Pharma Limited

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