FDA.reportPublic FDA data

PIOGLITAZONEHYDROCHLORIDE

Product NDC
53002-1757
11-digit product format
530021757
Labeler code
53002
Product ID
53002-1757_050b9b36-78ef-4b7a-a938-acfa7b12ce09
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PIOGLITAZONEHYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA091298
Marketing category
ANDA
Marketing start
2013-02-13
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
53002-1757-32023-01-30C16284748780-1f386c649-c752-0266-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
53002-1757-92023-01-30C16284748780-1f386c649-c752-0266-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
53002-1757-3PIOGLITAZONEHYDROCHLORIDE30 in 1 BOTTLETABLET304
53002-1757-9PIOGLITAZONEHYDROCHLORIDE90 in 1 BOTTLETABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-1757PIOGLITAZONEHYDROCHLORIDE TABLET [RPK PHARMACEUTICALS, INC.]4Legacy NDC, 2 package rows20210106_38011100-3203-4626-ba3b-81acd3a0f0f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317573pioglitazone 15 MG Oral TabletPSN38011100-3203-4626-ba3b-81acd3a0f0f14
312441pioglitazone 45 MG Oral TabletPSN38011100-3203-4626-ba3b-81acd3a0f0f14
317573pioglitazone 15 MG Oral TabletSCD38011100-3203-4626-ba3b-81acd3a0f0f14
312441pioglitazone 45 MG Oral TabletSCD38011100-3203-4626-ba3b-81acd3a0f0f14
312441pioglitazone (as pioglitazone HCl) 45 MG Oral TabletSY38011100-3203-4626-ba3b-81acd3a0f0f14
317573pioglitazone (as pioglitazone hydrochloride) 15 MG Oral TabletSY38011100-3203-4626-ba3b-81acd3a0f0f14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-1757-35300217570330 TABLET in 1 BOTTLE (53002-1757-3) 30 tablet2018-10-010000-00-00NoNoCurrent
53002-1757-95300217570990 TABLET in 1 BOTTLE (53002-1757-9) 90 tablet2018-10-010000-00-00NoNoCurrent