Glyburide (Page 4 of 4)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-832-01 in bottles of 100 tablets

Glyburide Tablets USP, 1.25 mg

100 Tablets

Zydus

Rx only

figure
(click image for full-size original)

NDC 65841-833-01 in bottles of 100 tablets

Glyburide Tablets USP, 2.5 mg

100 Tablets

Zydus

Rx only

figure
(click image for full-size original)

NDC 65841-834-01 in bottles of 100 tablets

Glyburide Tablets USP, 5 mg

100 Tablets

Zydus

Rx only

figure
(click image for full-size original)
GLYBURIDE
glyburide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-832
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYBURIDE (GLYBURIDE) GLYBURIDE 1.25 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE
CELLULOSE, MICROCRYSTALLINE
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
MAGNESIUM STEARATE
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
Product Characteristics
Color WHITE (white to off-white) Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code 656
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-832-06 30 TABLET in 1 BOTTLE None
2 NDC:65841-832-16 90 TABLET in 1 BOTTLE None
3 NDC:65841-832-01 100 TABLET in 1 BOTTLE None
4 NDC:65841-832-05 500 TABLET in 1 BOTTLE None
5 NDC:65841-832-10 1000 TABLET in 1 BOTTLE None
6 NDC:65841-832-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (65841-832-30)
6 NDC:65841-832-30 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (65841-832-77)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206749 06/02/2016
GLYBURIDE
glyburide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-833
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYBURIDE (GLYBURIDE) GLYBURIDE 2.5 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE
CELLULOSE, MICROCRYSTALLINE
D&C YELLOW NO. 10
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
FD&C YELLOW NO. 6
MAGNESIUM STEARATE
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
Product Characteristics
Color YELLOW (light yellow to yellow) Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code 657
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-833-06 30 TABLET in 1 BOTTLE None
2 NDC:65841-833-16 90 TABLET in 1 BOTTLE None
3 NDC:65841-833-01 100 TABLET in 1 BOTTLE None
4 NDC:65841-833-05 500 TABLET in 1 BOTTLE None
5 NDC:65841-833-10 1000 TABLET in 1 BOTTLE None
6 NDC:65841-833-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (65841-833-30)
6 NDC:65841-833-30 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (65841-833-77)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206749 06/02/2016
GLYBURIDE
glyburide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-834
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYBURIDE (GLYBURIDE) GLYBURIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE
CELLULOSE, MICROCRYSTALLINE
D&C YELLOW NO. 10
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
FD&C BLUE NO. 1
MAGNESIUM STEARATE
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
Product Characteristics
Color GREEN (light green) Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code 658
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-834-06 30 TABLET in 1 BOTTLE None
2 NDC:65841-834-16 90 TABLET in 1 BOTTLE None
3 NDC:65841-834-01 100 TABLET in 1 BOTTLE None
4 NDC:65841-834-05 500 TABLET in 1 BOTTLE None
5 NDC:65841-834-10 1000 TABLET in 1 BOTTLE None
6 NDC:65841-834-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (65841-834-30)
6 NDC:65841-834-30 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (65841-834-77)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206749 06/02/2016
Labeler — Zydus Lifesciences Limited (918596198)
Registrant — Zydus Lifesciences Limited (677605858)
Establishment
Name Address ID/FEI Operations
Zydus Lifesciences Limited 677605858 ANALYSIS (65841-832), ANALYSIS (65841-833), ANALYSIS (65841-834), MANUFACTURE (65841-832), MANUFACTURE (65841-833), MANUFACTURE (65841-834)

Revised: 11/2022 Zydus Lifesciences Limited

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