FDA.reportPublic FDA data

Glipizide

Product NDC
50090-3069
11-digit product format
500903069
Labeler code
50090
Product ID
50090-3069_53cc167c-3ad0-4afe-96a4-cbf6994184a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glipizide
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA076159
Marketing category
ANDA
Marketing start
2016-12-21
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
2021-12-31
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
50090-3069-02023-01-30C16284748780-1f386c649-dab0-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use GLIPIZIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GLIPIZIDE EXTENDED-RELEASE TABLETS. GlipiZIDE Extended-Release Tablets, for oral use Initial U.S. Approval: 1994
50090-3069-22023-01-30C16284748780-1f386c649-dab0-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use GLIPIZIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GLIPIZIDE EXTENDED-RELEASE TABLETS. GlipiZIDE Extended-Release Tablets, for oral use Initial U.S. Approval: 1994

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3069-0Glipizide30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3010
50090-3069-2Glipizide90 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3069-0EA - Each50090-306915b07696-5027-43ff-8837-8797225d399c12019-02-13
50090-3069-2EA - Each50090-3069f8cc4257-a3a1-46f8-8347-c7e42ceef9a112019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3069GLIPIZIDE TABLET, FILM COATED, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]10Legacy NDC, 2 package rows20200219_98591ff5-b735-47b0-9bd2-1e9118d261e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
315107glipiZIDE 10 MG 24HR Extended Release Oral TabletPSN98591ff5-b735-47b0-9bd2-1e9118d261e610
314006glipiZIDE 5 MG 24HR Extended Release Oral TabletPSN98591ff5-b735-47b0-9bd2-1e9118d261e610
31510724 HR glipizide 10 MG Extended Release Oral TabletSCD98591ff5-b735-47b0-9bd2-1e9118d261e610
31400624 HR glipizide 5 MG Extended Release Oral TabletSCD98591ff5-b735-47b0-9bd2-1e9118d261e610
315107glipizide ER 10 MG 24 HR Extended Release Oral TabletSY98591ff5-b735-47b0-9bd2-1e9118d261e610
314006glipizide ER 5 MG 24 HR Extended Release Oral TabletSY98591ff5-b735-47b0-9bd2-1e9118d261e610
315107glipizide XL 10 MG 24 HR Extended Release Oral TabletSY98591ff5-b735-47b0-9bd2-1e9118d261e610
314006glipizide XL 5 MG 24 HR Extended Release Oral TabletSY98591ff5-b735-47b0-9bd2-1e9118d261e610

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3069-05009030690030 in 1 BOTTLEHistorical
50090-3069-25009030690290 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50090-3069-2) 2016-12-210000-00-00NoNoCurrent