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.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

https://medlibrary.org/lib/rx/meds/glipizide-er-15/page/5/

Clinical Trials

MedLibrary.org

Medication Sections

RSS Feeds

About

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.