FDA.reportPublic FDA data

Pioglitazone

Product NDC
54458-865
11-digit product format
544580865
Labeler code
54458
Product ID
54458-865_a4eef739-cd4c-4e92-98f3-039301cf640b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pioglitazone
Dosage form
TABLET
Route
ORAL
Labeler
International Laboratories, LLC
Application
ANDA077210
Marketing category
ANDA
Marketing start
2015-05-01
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
E
Listing certified through
2018-12-31
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
54458-865-102020-01-31C16284748780-19d75b9d0-8c41-f424-e053-dadaa90a57ceThese 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
54458-865-10Pioglitazone30 in 1 BLISTER PACKTABLET304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54458-865-10EA - Each54458-865e12432e4-d707-43e9-a0d9-9c22be6cf51812015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PIOGLITAZONE HYDROCHLORIDEACTIVE INGREDIENTJQT35NPK6CPIOGLITAZONE TABLET [INTERNATIONAL LABS, INC.]1
PIOGLITAZONEACTIVE MOIETYX4OV71U42SPIOGLITAZONE TABLET [INTERNATIONAL LABS, INC.]1
CARBOXYMETHYLCELLULOSE CALCIUMINACTIVE INGREDIENTUTY7PDF93LPIOGLITAZONE TABLET [INTERNATIONAL LABS, INC.]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PPIOGLITAZONE TABLET [INTERNATIONAL LABS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PIOGLITAZONE TABLET [INTERNATIONAL LABS, INC.]1
MANNITOLINACTIVE INGREDIENT3OWL53L36APIOGLITAZONE TABLET [INTERNATIONAL LABS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54458-865PIOGLITAZONE TABLET [INTERNATIONAL LABORATORIES, LLC]4Legacy NDC, 1 package rows20170609_2f23c56c-2b13-4332-b945-96726deffbfe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317573pioglitazone 15 MG Oral TabletPSN2f23c56c-2b13-4332-b945-96726deffbfe4
312440pioglitazone 30 MG Oral TabletPSN2f23c56c-2b13-4332-b945-96726deffbfe4
312441pioglitazone 45 MG Oral TabletPSN2f23c56c-2b13-4332-b945-96726deffbfe4
317573pioglitazone 15 MG Oral TabletSCD2f23c56c-2b13-4332-b945-96726deffbfe4
312440pioglitazone 30 MG Oral TabletSCD2f23c56c-2b13-4332-b945-96726deffbfe4
312441pioglitazone 45 MG Oral TabletSCD2f23c56c-2b13-4332-b945-96726deffbfe4
312441pioglitazone (as pioglitazone HCl) 45 MG Oral TabletSY2f23c56c-2b13-4332-b945-96726deffbfe4
317573pioglitazone (as pioglitazone hydrochloride) 15 MG Oral TabletSY2f23c56c-2b13-4332-b945-96726deffbfe4
312440pioglitazone (as pioglitazone hydrochloride) 30 MG Oral TabletSY2f23c56c-2b13-4332-b945-96726deffbfe4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
54458-865-105445808651030 in 1 BLISTER PACKHistorical