FDA.reportPublic FDA data

Glipizide

Product NDC
68788-7230
11-digit product format
687887230
Labeler code
68788
Product ID
68788-7230_c1f5da75-6f55-41a6-a59b-77dbdbb1ed52
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glipizide
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA076159
Marketing category
ANDA
Marketing start
2018-08-06
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
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
b1de1ca9-d9db-4f4b-2103-09e2014d30d5Product name520180912
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
2dee091b-3b8c-d27a-b1ba-fcb0d32e776aProduct name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68788-7230-12022-01-28C16284748780-1d6a99b39-3f63-a426-e053-dadaa90af4c2These 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
68788-7230-32022-01-28C16284748780-1d6a99b39-3f63-a426-e053-dadaa90af4c2These 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
68788-7230-62022-01-28C16284748780-1d6a99b39-3f63-a426-e053-dadaa90af4c2These 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
68788-7230-92022-01-28C16284748780-1d6a99b39-3f63-a426-e053-dadaa90af4c2These 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
68788-7230-1Glipizide100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1003
68788-7230-3Glipizide30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE303
68788-7230-6Glipizide60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE603
68788-7230-9Glipizide90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7230GLIPIZIDE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS INC.]3Legacy NDC, 4 package rows20200607_0fa9b09f-27d1-4092-87d7-32ec37451847.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
315107glipiZIDE 10 MG 24HR Extended Release Oral TabletPSN0fa9b09f-27d1-4092-87d7-32ec374518473
31510724 HR glipizide 10 MG Extended Release Oral TabletSCD0fa9b09f-27d1-4092-87d7-32ec374518473
315107glipizide ER 10 MG 24 HR Extended Release Oral TabletSY0fa9b09f-27d1-4092-87d7-32ec374518473
315107glipizide XL 10 MG 24 HR Extended Release Oral TabletSY0fa9b09f-27d1-4092-87d7-32ec374518473

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7230-168788723001100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-7230-1) 2018-08-060000-00-00NoNoCurrent
68788-7230-36878872300330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-7230-3) 2018-08-060000-00-00NoNoCurrent
68788-7230-66878872300660 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-7230-6) 2018-08-060000-00-00NoNoCurrent
68788-7230-96878872300990 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-7230-9) 2018-08-060000-00-00NoNoCurrent