Glyburide and Metformin Hydrochloride (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-824-01 in bottles of 100 tablets

Glyburide and Metformin Hydrochloride Tablets USP, 1.25 mg/250 mg

100 Tablets

Rx only

Zydus

figure
(click image for full-size original)

NDC 65841-825-01 in bottles of 100 tablets

Glyburide and Metformin Hydrochloride Tablets USP, 2.5 mg/500 mg

100 Tablets

Rx only

Zydus

figure
(click image for full-size original)

NDC 65841-826-01 in bottles of 100 tablets

Glyburide and Metformin Hydrochloride Tablets USP, 5 mg/500 mg

100 Tablets

Rx only

Zydus

figure
(click image for full-size original)
GLYBURIDE AND METFORMIN HYDROCHLORIDE glyburide and metformin hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-824
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
CALCIUM CARBONATE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
HYPROMELLOSE 2910 (6 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 6000
POVIDONE K30
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape CAPSULE Size 13mm
Flavor Imprint Code 653
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-824-06 30 TABLET in 1 BOTTLE None
2 NDC:65841-824-16 90 TABLET in 1 BOTTLE None
3 NDC:65841-824-01 100 TABLET in 1 BOTTLE None
4 NDC:65841-824-05 500 TABLET in 1 BOTTLE None
5 NDC:65841-824-10 1000 TABLET in 1 BOTTLE None
6 NDC:65841-824-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (65841-824-30)
6 NDC:65841-824-30 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (65841-824-77)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206748 04/07/2016
GLYBURIDE AND METFORMIN HYDROCHLORIDE glyburide and metformin hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-825
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
CALCIUM CARBONATE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 2
FD&C YELLOW NO. 5
FD&C YELLOW NO. 6
HYPROMELLOSE 2910 (15 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 4000
POVIDONE K30
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW (tan to scarlet yellow) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code 654
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-825-06 30 TABLET in 1 BOTTLE None
2 NDC:65841-825-16 90 TABLET in 1 BOTTLE None
3 NDC:65841-825-01 100 TABLET in 1 BOTTLE None
4 NDC:65841-825-05 500 TABLET in 1 BOTTLE None
5 NDC:65841-825-10 1000 TABLET in 1 BOTTLE None
6 NDC:65841-825-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (65841-825-30)
6 NDC:65841-825-30 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (65841-825-77)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206748 04/07/2016
GLYBURIDE AND METFORMIN HYDROCHLORIDE glyburide and metformin hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-826
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
CALCIUM CARBONATE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
HYPROMELLOSE 2910 (15 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 4000
POVIDONE K30
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW (pale yellow) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code 655
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-826-06 30 TABLET in 1 BOTTLE None
2 NDC:65841-826-16 90 TABLET in 1 BOTTLE None
3 NDC:65841-826-01 100 TABLET in 1 BOTTLE None
4 NDC:65841-826-05 500 TABLET in 1 BOTTLE None
5 NDC:65841-826-10 1000 TABLET in 1 BOTTLE None
6 NDC:65841-826-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (65841-826-30)
6 NDC:65841-826-30 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (65841-826-77)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206748 04/07/2016
Labeler — Zydus Lifesciences Limited (918596198)
Registrant — Zydus Lifesciences Limited (918596198)
Establishment
Name Address ID/FEI Operations
Zydus Lifesciences Limited 677605858 ANALYSIS (65841-824), ANALYSIS (65841-825), ANALYSIS (65841-826), MANUFACTURE (65841-824), MANUFACTURE (65841-825), MANUFACTURE (65841-826)

Revised: 11/2022 Zydus Lifesciences Limited

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