Glipizide

Product NDC
21695-967
11-digit product format
216950967
Labeler code
21695
Product ID
21695-967_289bda32-6198-4072-a9f3-283438bda707
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glipizide
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA076467
Marketing category
ANDA
Marketing start
2006-04-01
Marketing end
0000-00-00
Substance
GLIPIZIDE
Active strength
3 mg/1
Pharmacologic classes
Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-967-302019-09-24C16284748780-1934fe258-489f-48b1-e053-8cdaa90a720aGlipizide Extended-Release Tablets Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-967-30GlipizideER30 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-967-30EA - Each21695-967879ecbbe-9229-40ff-8485-57237db671b912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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
21695-967GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110914_289bda32-6198-4072-a9f3-283438bda707.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 formatDescriptionStatus
21695-967-302169509673030 in 1 BOTTLE, PLASTICHistorical