FDA.reportPublic FDA data

Pioglitazone

Product NDC
50090-2401
11-digit product format
500902401
Labeler code
50090
Product ID
50090-2401_ba613f66-9127-4f58-b455-a93bb17efe60
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pioglitazone
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077210
Marketing category
ANDA
Marketing start
2015-05-22
Marketing end
0000-00-00
Substance
PIOGLITAZONE HYDROCHLORIDE
Active strength
45 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
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
50090-2401-02023-01-30C16284748780-1f386c64a-1007-0266-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
50090-2401-12023-01-30C16284748780-1f386c64a-1007-0266-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
50090-2401-0Pioglitazone30 in 1 BOTTLETABLET3020
50090-2401-1Pioglitazone90 in 1 BOTTLETABLET9020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2401-0EA - Each50090-240144ca16b6-c7b0-495d-bbdb-a049890701d412021-09-07
50090-2401-1EA - Each50090-240136ab0517-d862-4d39-a59c-588594031a5612021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2401PIOGLITAZONE TABLET [A-S MEDICATION SOLUTIONS]20Legacy NDC, 2 package rows20210818_a639e726-13ce-4d8e-b6c9-e3c4844d08d5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312440pioglitazone 30 MG Oral TabletPSNa639e726-13ce-4d8e-b6c9-e3c4844d08d520
312441pioglitazone 45 MG Oral TabletPSNa639e726-13ce-4d8e-b6c9-e3c4844d08d520
312440pioglitazone 30 MG Oral TabletSCDa639e726-13ce-4d8e-b6c9-e3c4844d08d520
312441pioglitazone 45 MG Oral TabletSCDa639e726-13ce-4d8e-b6c9-e3c4844d08d520
312441pioglitazone (as pioglitazone HCl) 45 MG Oral TabletSYa639e726-13ce-4d8e-b6c9-e3c4844d08d520
312440pioglitazone (as pioglitazone hydrochloride) 30 MG Oral TabletSYa639e726-13ce-4d8e-b6c9-e3c4844d08d520

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2401-05009024010030 TABLET in 1 BOTTLE (50090-2401-0) 30 tablet2016-05-160000-00-00NoNoCurrent
50090-2401-15009024010190 TABLET in 1 BOTTLE (50090-2401-1) 90 tablet2016-05-160000-00-00NoNoCurrent