FDA.reportPublic FDA data

Pioglitazone

Product NDC
50090-4780
11-digit product format
500904780
Labeler code
50090
Product ID
50090-4780_be85c821-d443-47c5-857a-9afa6410c5ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pioglitazone
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
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
Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [CS],PPAR gamma [CS],Thiazolidinedione [EPC],Thiazolidinediones [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e11f0f31-8914-938f-521e-037b6de27c13Product name520210621
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
3e9b6ece-066b-2ac3-28f7-5e13060e5934Product name220151109
0d79b284-47e8-e90c-f249-892b9b251003Product name120140508
7611093e-8875-33d4-9e3c-f48c7e3af1e8Product name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
ac29cd77-922c-d25a-f8ad-66a8692935c5Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4780-02023-01-30C16284748780-1f386c649-acfc-0266-e053-dadaa90a7c1aThese 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
50090-4780-12023-01-30C16284748780-1f386c649-acfc-0266-e053-dadaa90a7c1aThese 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
50090-4780-0Pioglitazone30 in 1 BOTTLETABLET303
50090-4780-1Pioglitazone90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4780PIOGLITAZONE TABLET [A-S MEDICATION SOLUTIONS]3Legacy NDC, 2 package rows20210416_3817b214-0541-4dd7-82e9-9b95ed7b00fe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317573pioglitazone 15 MG Oral TabletPSN3817b214-0541-4dd7-82e9-9b95ed7b00fe3
317573pioglitazone 15 MG Oral TabletSCD3817b214-0541-4dd7-82e9-9b95ed7b00fe3
317573pioglitazone (as pioglitazone hydrochloride) 15 MG Oral TabletSY3817b214-0541-4dd7-82e9-9b95ed7b00fe3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4780-05009047800030 TABLET in 1 BOTTLE (50090-4780-0) 30 tablet2019-12-050000-00-00NoNoCurrent
50090-4780-15009047800190 TABLET in 1 BOTTLE (50090-4780-1) 90 tablet2019-12-050000-00-00NoNoCurrent