FDA.reportPublic FDA data

Pioglitazone

Product NDC
71335-1385
11-digit product format
713351385
Labeler code
71335
Product ID
71335-1385_d622c545-bf07-4c39-95b5-d15221bd66b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pioglitazone
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077210
Marketing category
ANDA
Marketing start
2015-05-22
Marketing end
0000-00-00
Substance
PIOGLITAZONE HYDROCHLORIDE
Active strength
45 mg/1
Pharmacologic classes
PPAR alpha [CS], PPAR gamma [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor Activity [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e11f0f31-8914-938f-521e-037b6de27c13Product name520210621
3e9b6ece-066b-2ac3-28f7-5e13060e5934Product name220151109
0d79b284-47e8-e90c-f249-892b9b251003Product name120140508
7611093e-8875-33d4-9e3c-f48c7e3af1e8Product name120140508
ac29cd77-922c-d25a-f8ad-66a8692935c5Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-1385-12024-01-30C16284748780-11030e365-5575-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use PIOGLITAZONE TABLETS safely and effectively. See full prescribing information for PIOGLITAZONE TABLETS. PIOGLITAZONE tablets, for oral use Initial U.S. Approval: 1999
71335-1385-22024-01-30C16284748780-11030e365-5575-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use PIOGLITAZONE TABLETS safely and effectively. See full prescribing information for PIOGLITAZONE TABLETS. PIOGLITAZONE tablets, for oral use Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1385-1Pioglitazone30 in 1 BOTTLETABLET30100
71335-1385-2Pioglitazone90 in 1 BOTTLETABLET90100

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1385PIOGLITAZONE TABLET [BRYANT RANCH PREPACK]100Legacy NDC, 2 package rows20220225_8997f51c-e55c-4f54-97f8-59fbffa71028.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312441pioglitazone 45 MG Oral TabletPSN8997f51c-e55c-4f54-97f8-59fbffa71028100
312441pioglitazone 45 MG Oral TabletSCD8997f51c-e55c-4f54-97f8-59fbffa71028100
312441pioglitazone (as pioglitazone HCl) 45 MG Oral TabletSY8997f51c-e55c-4f54-97f8-59fbffa71028100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1385-17133513850130 TABLET in 1 BOTTLE (71335-1385-1) 30 tablet2019-11-190000-00-00NoNoCurrent
71335-1385-27133513850290 TABLET in 1 BOTTLE (71335-1385-2) 90 tablet2019-11-190000-00-00NoNoCurrent