FDA.reportPublic FDA data

Pioglitazone

Product NDC
71335-1137
11-digit product format
713351137
Labeler code
71335
Product ID
71335-1137_95b1666b-7f41-4b65-8995-a485afb2bd98
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pioglitazone
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077210
Marketing category
ANDA
Marketing start
2015-02-04
Marketing end
0000-00-00
Substance
PIOGLITAZONE HYDROCHLORIDE
Active strength
15 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
71335-1137-12024-01-30C16284748780-11030e365-4951-111a-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
71335-1137-22024-01-30C16284748780-11030e365-4951-111a-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
71335-1137-32024-01-30C16284748780-11030e365-4951-111a-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
71335-1137-42024-01-30C16284748780-11030e365-4951-111a-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
71335-1137-1Pioglitazone30 in 1 BOTTLETABLET308
71335-1137-2Pioglitazone90 in 1 BOTTLETABLET908
71335-1137-3Pioglitazone60 in 1 BOTTLETABLET608
71335-1137-4Pioglitazone120 in 1 BOTTLETABLET1208

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1137PIOGLITAZONE TABLET [BRYANT RANCH PREPACK]8Legacy NDC, 4 package rows20220204_95b1666b-7f41-4b65-8995-a485afb2bd98.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317573pioglitazone 15 MG Oral TabletPSN95b1666b-7f41-4b65-8995-a485afb2bd988
317573pioglitazone 15 MG Oral TabletSCD95b1666b-7f41-4b65-8995-a485afb2bd988
317573pioglitazone (as pioglitazone hydrochloride) 15 MG Oral TabletSY95b1666b-7f41-4b65-8995-a485afb2bd988

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1137-17133511370130 TABLET in 1 BOTTLE (71335-1137-1) 30 tablet2019-09-110000-00-00NoNoCurrent
71335-1137-27133511370290 TABLET in 1 BOTTLE (71335-1137-2) 90 tablet2019-03-040000-00-00NoNoCurrent
71335-1137-37133511370360 TABLET in 1 BOTTLE (71335-1137-3) 60 tablet2021-12-280000-00-00NoNoCurrent
71335-1137-471335113704120 TABLET in 1 BOTTLE (71335-1137-4) 120 tablet2021-12-280000-00-00NoNoCurrent