FDA.reportPublic FDA data

Glipizide

Product NDC
50090-4008
11-digit product format
500904008
Labeler code
50090
Product ID
50090-4008_8e9785b7-4189-4c3e-8695-c00aa8b945a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glipizide
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA206928
Marketing category
ANDA
Marketing start
2017-05-12
Marketing end
0000-00-00
Substance
GLIPIZIDE
Active strength
10 mg/1
Pharmacologic classes
Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
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
50090-4008-02023-01-30C16284748780-1f386c64a-0394-0266-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
50090-4008-0Glipizide30 in 1 BOTTLETABLET, EXTENDED RELEASE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4008GLIPIZIDE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]2Legacy NDC, 1 package rows20190116_0af8dc45-9595-4fc8-8198-0ac59523279f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
315107glipiZIDE 10 MG 24HR Extended Release Oral TabletPSN0af8dc45-9595-4fc8-8198-0ac59523279f2
31510724 HR glipizide 10 MG Extended Release Oral TabletSCD0af8dc45-9595-4fc8-8198-0ac59523279f2
315107glipizide ER 10 MG 24 HR Extended Release Oral TabletSY0af8dc45-9595-4fc8-8198-0ac59523279f2
315107glipizide XL 10 MG 24 HR Extended Release Oral TabletSY0af8dc45-9595-4fc8-8198-0ac59523279f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4008-05009040080030 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-4008-0) 2018-12-280000-00-00NoNoCurrent