FDA.reportPublic FDA data

Glipizide

Product NDC
53002-4460
11-digit product format
530024460
Labeler code
53002
Product ID
53002-4460_76a0cb91-c019-4ca5-8b00-d9929462020d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
glipizide
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA074550
Marketing category
ANDA
Marketing start
2011-07-18
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
53002-4460-02025-01-30C16284748780-19d75b9d0-c745-f424-e053-dadaa90a57ceGLIPIZIDE TABLETS, USP
53002-4460-32025-01-30C16284748780-19d75b9d0-c745-f424-e053-dadaa90a57ceGLIPIZIDE TABLETS, USP
53002-4460-62025-01-30C16284748780-19d75b9d0-c745-f424-e053-dadaa90a57ceGLIPIZIDE TABLETS, USP
53002-4460-02023-06-07C16284748780-19d75b9d0-c745-f424-e053-dadaa90a57ceGLIPIZIDE TABLETS, USP
53002-4460-32023-06-07C16284748780-19d75b9d0-c745-f424-e053-dadaa90a57ceGLIPIZIDE TABLETS, USP
53002-4460-62023-06-07C16284748780-19d75b9d0-c745-f424-e053-dadaa90a57ceGLIPIZIDE TABLETS, USP
53002-4460-02023-01-30C16284748780-19d75b9d0-c745-f424-e053-dadaa90a57ceGLIPIZIDE TABLETS, USP
53002-4460-32023-01-30C16284748780-19d75b9d0-c745-f424-e053-dadaa90a57ceGLIPIZIDE TABLETS, USP
53002-4460-62023-01-30C16284748780-19d75b9d0-c745-f424-e053-dadaa90a57ceGLIPIZIDE TABLETS, USP
53002-4460-02020-12-16C16284748780-19d75b9d0-c745-f424-e053-dadaa90a57ceGLIPIZIDE TABLETS, USP
53002-4460-32020-12-16C16284748780-19d75b9d0-c745-f424-e053-dadaa90a57ceGLIPIZIDE TABLETS, USP
53002-4460-62020-12-16C16284748780-19d75b9d0-c745-f424-e053-dadaa90a57ceGLIPIZIDE TABLETS, USP
53002-4460-02020-01-31C16284748780-19d75b9d0-c745-f424-e053-dadaa90a57ceGLIPIZIDE TABLETS, USP
53002-4460-32020-01-31C16284748780-19d75b9d0-c745-f424-e053-dadaa90a57ceGLIPIZIDE TABLETS, USP
53002-4460-62020-01-31C16284748780-19d75b9d0-c745-f424-e053-dadaa90a57ceGLIPIZIDE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-4460-0Glipizide100 in 1 BOTTLETABLET1007
53002-4460-3Glipizide30 in 1 BOTTLETABLET307
53002-4460-6Glipizide60 in 1 BOTTLETABLET607

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-4460GLIPIZIDE TABLET [RPK PHARMACEUTICALS, INC.]7Legacy NDC, 3 package rows20230609_a98b2568-0ce3-4c80-a1aa-a0bf5884564a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310488glipiZIDE 10 MG Oral TabletPSNa98b2568-0ce3-4c80-a1aa-a0bf5884564a7
310490glipiZIDE 5 MG Oral TabletPSNa98b2568-0ce3-4c80-a1aa-a0bf5884564a7
310488glipizide 10 MG Oral TabletSCDa98b2568-0ce3-4c80-a1aa-a0bf5884564a7
310490glipizide 5 MG Oral TabletSCDa98b2568-0ce3-4c80-a1aa-a0bf5884564a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-4460-053002446000100 TABLET in 1 BOTTLE (53002-4460-0) 100 tablet2017-10-010000-00-00NoNoCurrent
53002-4460-35300244600330 TABLET in 1 BOTTLE (53002-4460-3) 30 tablet2017-10-010000-00-00NoNoCurrent
53002-4460-65300244600660 TABLET in 1 BOTTLE (53002-4460-6) 60 tablet2017-10-010000-00-00NoNoCurrent