FDA.reportPublic FDA data

PIOGLITAZONE

Product NDC
68071-2495
11-digit product format
680712495
Labeler code
68071
Product ID
68071-2495_c8e602e4-31dd-0969-e053-2995a90a5919
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PIOGLITAZONE
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA200044
Marketing category
ANDA
Marketing start
2013-02-13
Marketing end
0000-00-00
Substance
PIOGLITAZONE HYDROCHLORIDE
Active strength
30 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
68071-2495-12023-01-30C16284748780-1f386c649-9ad7-0266-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
68071-2495-92023-01-30C16284748780-1f386c649-9ad7-0266-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
68071-2495-1PIOGLITAZONE120 in 1 BOTTLETABLET1201
68071-2495-9PIOGLITAZONE90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2495PIOGLITAZONE TABLET [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 2 package rows20210808_c8e60817-8a8c-7402-e053-2a95a90a11c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312440pioglitazone 30 MG Oral TabletPSNc8e60817-8a8c-7402-e053-2a95a90a11c91
312440pioglitazone 30 MG Oral TabletSCDc8e60817-8a8c-7402-e053-2a95a90a11c91
312440pioglitazone (as pioglitazone hydrochloride) 30 MG Oral TabletSYc8e60817-8a8c-7402-e053-2a95a90a11c91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2495-168071249501120 TABLET in 1 BOTTLE (68071-2495-1) 120 tablet2021-08-060000-00-00NoNoCurrent
68071-2495-96807124950990 TABLET in 1 BOTTLE (68071-2495-9) 90 tablet2021-08-060000-00-00NoNoCurrent