FDA.reportPublic FDA data

Glipizide

Product NDC
0591-0900
11-digit product format
005910900
Labeler code
0591
Product ID
0591-0900_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
2006-04-03
Marketing end
0000-00-00
Substance
GLIPIZIDE
Active strength
3 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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
0591-0900-30EA - Each0591-09004c0e0947-6466-4bce-81f6-30ccfffbb7b512012-07-24

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 [REBEL DISTRIBUTORS CORP]1
GLIPIZIDEACTIVE MOIETYX7WDT95N5CGLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
ACETYLTRIBUTYL CITRATEINACTIVE INGREDIENT0ZBX0N59RZGLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XGLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)INACTIVE INGREDIENTS38J6RZN16GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PGLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AGLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
SHELLACINACTIVE INGREDIENT46N107B71OGLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-0900GLIPIZIDE 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
310489glipiZIDE 2.5 MG 24HR Extended Release Oral TabletPSN8b38ed9c-1f9c-4059-9ee2-6a56cb0fcaa34
31048924 HR glipizide 2.5 MG Extended Release Oral TabletSCD8b38ed9c-1f9c-4059-9ee2-6a56cb0fcaa34
310489glipizide ER 2.5 MG 24 HR Extended Release Oral TabletSY8b38ed9c-1f9c-4059-9ee2-6a56cb0fcaa34
310489glipizide XL 2.5 MG 24 HR Extended Release Oral TabletSY8b38ed9c-1f9c-4059-9ee2-6a56cb0fcaa34
310489glipiZIDE 2.5 MG 24HR Extended Release Oral TabletPSN289bda32-6198-4072-a9f3-283438bda7071
31048924 HR glipizide 2.5 MG Extended Release Oral TabletSCD289bda32-6198-4072-a9f3-283438bda7071
310489glipizide ER 2.5 MG 24 HR Extended Release Oral TabletSY289bda32-6198-4072-a9f3-283438bda7071
310489glipizide XL 2.5 MG 24 HR Extended Release Oral TabletSY289bda32-6198-4072-a9f3-283438bda7071

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0591-0900-300059109003030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-0900-30) 2006-04-030000-00-00NoNoCurrent