FDA.reportPublic FDA data

Glipizide

Product NDC
0591-0844
11-digit product format
005910844
Labeler code
0591
Product ID
0591-0844_84db3537-cb18-4bb5-8cd9-05a9da26ec90
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glipizide
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA076467
Marketing category
ANDA
Marketing start
2003-11-19
Marketing end
0000-00-00
Substance
GLIPIZIDE
Active strength
5 mg/1
Pharmacologic classes
Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ec4adfb0-aabc-95b9-ad07-5cb8f8533a09Product name220250625
b1de1ca9-d9db-4f4b-2103-09e2014d30d5Product name520180912
2dee091b-3b8c-d27a-b1ba-fcb0d32e776aProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-0844-01EA - Each0591-08441f9e6074-62b7-49a8-8e0c-01152c39892812012-07-24
0591-0844-10EA - Each0591-0844b7c66e99-6404-467b-9a54-b27db04dc2b112012-07-24
0591-0844-15EA - Each0591-08447290d774-516c-44cc-8891-d37d5dc7f90212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLIPIZIDEACTIVE INGREDIENTX7WDT95N5CGLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.]13
GLIPIZIDEACTIVE MOIETYX7WDT95N5CGLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.]13
ACETYLTRIBUTYL CITRATEINACTIVE INGREDIENT0ZBX0N59RZGLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.]13
AMMONIAINACTIVE INGREDIENT5138Q19F1XGLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.]13
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.]13
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.]13
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.]13
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)INACTIVE INGREDIENTS38J6RZN16GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.]13
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PGLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.]13
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.]13
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.]13
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.]13
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.]13
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.]13
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.]13
SHELLACINACTIVE INGREDIENT46N107B71OGLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.]13
GLIPIZIDEACTIVE INGREDIENTX7WDT95N5CGLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]4
GLIPIZIDEACTIVE MOIETYX7WDT95N5CGLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]4
ACETYLTRIBUTYL CITRATEINACTIVE INGREDIENT0ZBX0N59RZGLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]4
AMMONIAINACTIVE INGREDIENT5138Q19F1XGLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]4
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]4
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)INACTIVE INGREDIENTS38J6RZN16GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]4
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PGLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]4
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]4
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]4
POLYETHYLENE GLYCOLsINACTIVE INGREDIENT3WJQ0SDW1AGLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]4
SHELLACINACTIVE INGREDIENT46N107B71OGLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]4
GLIPIZIDEACTIVE INGREDIENTX7WDT95N5CGLIPIZIDEER ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
GLIPIZIDEACTIVE MOIETYX7WDT95N5CGLIPIZIDEER ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
ACETYLTRIBUTYL CITRATEINACTIVE INGREDIENT0ZBX0N59RZGLIPIZIDEER ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XGLIPIZIDEER ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3GLIPIZIDEER ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8GLIPIZIDEER ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357GLIPIZIDEER ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)INACTIVE INGREDIENTS38J6RZN16GLIPIZIDEER ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PGLIPIZIDEER ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302GLIPIZIDEER ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGLIPIZIDEER ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLIPIZIDEER ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13GLIPIZIDEER ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGLIPIZIDEER ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GLIPIZIDEER ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
SHELLACINACTIVE INGREDIENT46N107B71OGLIPIZIDEER ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-0844GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]22Legacy NDC20250406_a430577c-f233-40a7-bfd8-3d2bc6f98aa2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314006glipiZIDE 5 MG 24HR Extended Release Oral TabletPSNe8b4e73b-20ce-4d57-8214-04ad370b339021
31400624 HR glipizide 5 MG Extended Release Oral TabletSCDe8b4e73b-20ce-4d57-8214-04ad370b339021
314006glipizide ER 5 MG 24 HR Extended Release Oral TabletSYe8b4e73b-20ce-4d57-8214-04ad370b339021
314006glipizide XL 5 MG 24 HR Extended Release Oral TabletSYe8b4e73b-20ce-4d57-8214-04ad370b339021
315107glipiZIDE 10 MG 24HR Extended Release Oral TabletPSN6c92a536-508d-4e94-89af-453e3eb2a5601
314006glipiZIDE 5 MG 24HR Extended Release Oral TabletPSN6c92a536-508d-4e94-89af-453e3eb2a5601
31510724 HR glipizide 10 MG Extended Release Oral TabletSCD6c92a536-508d-4e94-89af-453e3eb2a5601
31400624 HR glipizide 5 MG Extended Release Oral TabletSCD6c92a536-508d-4e94-89af-453e3eb2a5601
315107glipizide ER 10 MG 24 HR Extended Release Oral TabletSY6c92a536-508d-4e94-89af-453e3eb2a5601
314006glipizide ER 5 MG 24 HR Extended Release Oral TabletSY6c92a536-508d-4e94-89af-453e3eb2a5601
315107glipizide XL 10 MG 24 HR Extended Release Oral TabletSY6c92a536-508d-4e94-89af-453e3eb2a5601
314006glipizide XL 5 MG 24 HR Extended Release Oral TabletSY6c92a536-508d-4e94-89af-453e3eb2a5601

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0591-0844-0100591084401100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-0844-01) 2003-11-190000-00-00NoNoCurrent
0591-0844-10005910844101000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-0844-10) 2003-11-190000-00-00NoNoCurrent