Glipizide ER (Page 5 of 5)

PRINCIPAL DISPLAY PANEL

NDC 0591-0900-30
GlipiZIDE
Extended-Release
Tablets
2.5 mg
Rx only30 Tablets

Label 2.5 mg, 30 Tablets
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0591-0844-01
GlipiZIDE
Extended-Release
Tablets
5 mg
Rx only
100 Tablets

Label 5 mg, 100 Tablets
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0591-0845-01
GlipiZIDE
Extended-Release
Tablets
10 mg
Rx only
100 Tablets

Label 10 mg, 100 Tablets
(click image for full-size original)
GLIPIZIDE ER glipizide tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-0844
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
BUTYL ALCOHOL
FERROSOFERRIC OXIDE
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
ISOPROPYL ALCOHOL
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:1)
POLYETHYLENE GLYCOL 400
PROPYLENE GLYCOL
SHELLAC
FD&C YELLOW NO. 6
Product Characteristics
Color orange Score no score
Shape ROUND Size 6mm
Flavor Imprint Code WPI;844
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0591-0844-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
2 NDC:0591-0844-10 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076467 11/19/2003
GLIPIZIDE ER glipizide tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-0845
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
BUTYL ALCOHOL
FERROSOFERRIC OXIDE
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
ISOPROPYL ALCOHOL
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 Size 6mm
Flavor Imprint Code WPI;845
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0591-0845-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
2 NDC:0591-0845-10 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076467 11/19/2003
GLIPIZIDE ER glipizide tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-0900
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
BUTYL ALCOHOL
FERROSOFERRIC OXIDE
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
ISOPROPYL ALCOHOL
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:1)
POLYETHYLENE GLYCOL 400
PROPYLENE GLYCOL
SHELLAC
FD&C YELLOW NO. 6
Product Characteristics
Color orange (light orange) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code WPI;900
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0591-0900-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076467 04/03/2006
Labeler — Actavis Pharma, Inc. (119723554)

Revised: 12/2020 Actavis Pharma, Inc.

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