Glipizide (Page 5 of 5)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 2.5 mg (30 Tablet Container)

NDC 59651-268-30
glipiZIDE
Extended-Release Tablets
2.5 mg
Rx only 30 Tablets AUROBINDO

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 2.5 mg (30 Tablet Container)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 5 mg (30 Tablet Container)

NDC 59651-269-30
glipiZIDE
Extended-Release Tablets
5 mg
Rx only 30 Tablets
AUROBINDO

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 5 mg (30 Tablet Container)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 10 mg (30 Tablet Container)

NDC 59651-270-30
glipiZIDE
Extended-Release Tablets
10 mg
Rx only 30 Tablets
AUROBINDO

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 10 mg (30 Tablet Container)
(click image for full-size original)

GLIPIZIDE glipizide tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59651-268
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLIPIZIDE (GLIPIZIDE) GLIPIZIDE 2.5 mg
Inactive Ingredients
Ingredient Name Strength
ACETYLTRIBUTYL CITRATE
AMMONIA
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)
HYDROXYPROPYL CELLULOSE (90000 WAMW)
FERROSOFERRIC OXIDE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:1)
POLYETHYLENE GLYCOL 400
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color WHITE (White to Off-white) Score no score
Shape ROUND (Biconvex) Size 6mm
Flavor Imprint Code A
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59651-268-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206928 05/12/2017
GLIPIZIDE glipizide tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59651-269
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLIPIZIDE (GLIPIZIDE) GLIPIZIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
ACETYLTRIBUTYL CITRATE
AMMONIA
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)
HYDROXYPROPYL CELLULOSE (90000 WAMW)
FERROSOFERRIC OXIDE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:1)
POLYETHYLENE GLYCOL 400
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color WHITE (White to Off-white) Score no score
Shape ROUND (Biconvex) Size 6mm
Flavor Imprint Code B
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59651-269-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:59651-269-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:59651-269-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206928 05/12/2017
GLIPIZIDE glipizide tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59651-270
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLIPIZIDE (GLIPIZIDE) GLIPIZIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
ACETYLTRIBUTYL CITRATE
AMMONIA
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)
HYDROXYPROPYL CELLULOSE (90000 WAMW)
FERROSOFERRIC OXIDE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:1)
POLYETHYLENE GLYCOL 400
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color WHITE (White to off-white) Score no score
Shape ROUND (Biconvex) Size 6mm
Flavor Imprint Code C
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59651-270-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:59651-270-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:59651-270-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None
4 NDC:59651-270-99 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206928 05/12/2017
Labeler — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 650381903 ANALYSIS (59651-268), ANALYSIS (59651-269), ANALYSIS (59651-270), MANUFACTURE (59651-268), MANUFACTURE (59651-269), MANUFACTURE (59651-270)

Revised: 12/2019 Aurobindo Pharma Limited

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