GLIPIZIDE ER

Product NDC
61919-725
11-digit product format
619190725
Labeler code
61919
Product ID
61919-725_f5b4d391-8b0c-4e7e-a8e8-e2855c1ed8ff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GLIPIZIDE ER
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
DirectRX
Application
ANDA076467
Marketing category
ANDA
Marketing start
2015-01-01
Marketing end
0000-00-00
Substance
GLIPIZIDE
Active strength
10 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
b1de1ca9-d9db-4f4b-2103-09e2014d30d5Product name520180912
2dee091b-3b8c-d27a-b1ba-fcb0d32e776aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-725-902020-01-31C16284748780-19d75b9d1-0381-f424-e053-dadaa90a57ceGLIPIZIDE ER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-725-90GLIPIZIDE ER90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE901

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLIPIZIDEACTIVE INGREDIENTX7WDT95N5CGLIPIZIDE ER TABLET, FILM COATED, EXTENDED RELEASE [DIRECTRX]1
GLIPIZIDEACTIVE MOIETYX7WDT95N5CGLIPIZIDE ER TABLET, FILM COATED, EXTENDED RELEASE [DIRECTRX]1
ACETYLTRIBUTYL CITRATEINACTIVE INGREDIENT0ZBX0N59RZGLIPIZIDE ER TABLET, FILM COATED, EXTENDED RELEASE [DIRECTRX]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XGLIPIZIDE ER TABLET, FILM COATED, EXTENDED RELEASE [DIRECTRX]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3GLIPIZIDE ER TABLET, FILM COATED, EXTENDED RELEASE [DIRECTRX]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357GLIPIZIDE ER TABLET, FILM COATED, EXTENDED RELEASE [DIRECTRX]1
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)INACTIVE INGREDIENTS38J6RZN16GLIPIZIDE ER TABLET, FILM COATED, EXTENDED RELEASE [DIRECTRX]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PGLIPIZIDE ER TABLET, FILM COATED, EXTENDED RELEASE [DIRECTRX]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302GLIPIZIDE ER TABLET, FILM COATED, EXTENDED RELEASE [DIRECTRX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGLIPIZIDE ER TABLET, FILM COATED, EXTENDED RELEASE [DIRECTRX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLIPIZIDE ER TABLET, FILM COATED, EXTENDED RELEASE [DIRECTRX]1
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13GLIPIZIDE ER TABLET, FILM COATED, EXTENDED RELEASE [DIRECTRX]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGLIPIZIDE ER TABLET, FILM COATED, EXTENDED RELEASE [DIRECTRX]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GLIPIZIDE ER TABLET, FILM COATED, EXTENDED RELEASE [DIRECTRX]1
SHELLACINACTIVE INGREDIENT46N107B71OGLIPIZIDE ER TABLET, FILM COATED, EXTENDED RELEASE [DIRECTRX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-725GLIPIZIDE ER TABLET, FILM COATED, EXTENDED RELEASE [DIRECTRX]1Legacy NDC, 1 package rows20151110_a06d4e6f-d14a-43f8-8e6f-4c381f8eeb62.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
315107glipiZIDE 10 MG 24HR Extended Release Oral TabletPSNa06d4e6f-d14a-43f8-8e6f-4c381f8eeb621
31510724 HR glipizide 10 MG Extended Release Oral TabletSCDa06d4e6f-d14a-43f8-8e6f-4c381f8eeb621
315107glipizide ER 10 MG 24 HR Extended Release Oral TabletSYa06d4e6f-d14a-43f8-8e6f-4c381f8eeb621
315107glipizide XL 10 MG 24 HR Extended Release Oral TabletSYa06d4e6f-d14a-43f8-8e6f-4c381f8eeb621

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-725-906191907259090 in 1 BOTTLEHistorical