FDA.reportPublic FDA data

PIOGLITAZONE HYDROCHLORIDE

Product NDC
71610-497
11-digit product format
716100497
Labeler code
71610
Product ID
71610-497_d6c0b3a9-fe10-40ca-affa-b7c733200c61
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pioglitazone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA200268
Marketing category
ANDA
Marketing start
2013-02-13
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
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
71610-497-302023-01-30C16284748780-1f386c64a-287e-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
71610-497-602023-01-30C16284748780-1f386c64a-287e-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
71610-497-30PIOGLITAZONE HYDROCHLORIDE30 in 1 BOTTLETABLET302
71610-497-60PIOGLITAZONE HYDROCHLORIDE90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-497-30EA - Each71610-4976751d916-65e8-4c47-aff8-483cbb4aa35b12021-05-05
71610-497-60EA - Each71610-497fc43a612-901f-43da-91e0-4a92ccbe475912021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-497PIOGLITAZONE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC, 2 package rows20210428_08dc565a-32c8-4009-a37a-922a6a290142.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317573pioglitazone 15 MG Oral TabletPSN08dc565a-32c8-4009-a37a-922a6a2901422
317573pioglitazone 15 MG Oral TabletSCD08dc565a-32c8-4009-a37a-922a6a2901422
317573pioglitazone (as pioglitazone hydrochloride) 15 MG Oral TabletSY08dc565a-32c8-4009-a37a-922a6a2901422

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-497-307161004973030 TABLET in 1 BOTTLE (71610-497-30) 30 tablet2021-03-090000-00-00NoNoCurrent
71610-497-607161004976090 TABLET in 1 BOTTLE (71610-497-60) 90 tablet2020-11-190000-00-00NoNoCurrent