FDA.reportPublic FDA data

Pioglitazone

Product NDC
54458-884
11-digit product format
544580884
Labeler code
54458
Product ID
54458-884_05ae0b63-253a-4685-8952-3122b0818661
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pioglitazone
Dosage form
TABLET
Route
ORAL
Labeler
International Laboratories, LLC
Application
NDA021073
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2013-12-08
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
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
54458-884-102020-01-31C16284748780-19d75b9cf-ff3b-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
54458-884-10Pioglitazone30 in 1 BLISTER PACKTABLET305

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PIOGLITAZONE HYDROCHLORIDEACTIVE INGREDIENTJQT35NPK6CPIOGLITAZONE TABLET [INTERNATIONAL LABS, INC.]3
PIOGLITAZONEACTIVE MOIETYX4OV71U42SPIOGLITAZONE TABLET [INTERNATIONAL LABS, INC.]3
CARBOXYMETHYLCELLULOSE CALCIUMINACTIVE INGREDIENTUTY7PDF93LPIOGLITAZONE TABLET [INTERNATIONAL LABS, INC.]3
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PPIOGLITAZONE TABLET [INTERNATIONAL LABS, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPIOGLITAZONE TABLET [INTERNATIONAL LABS, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PIOGLITAZONE TABLET [INTERNATIONAL LABS, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54458-884PIOGLITAZONE TABLET [INTERNATIONAL LABORATORIES, LLC]5Legacy NDC, 1 package rows20170525_fb49b7d6-8071-44c7-a10c-e8116d7d5b42.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317573pioglitazone 15 MG Oral TabletPSNfb49b7d6-8071-44c7-a10c-e8116d7d5b425
312440pioglitazone 30 MG Oral TabletPSNfb49b7d6-8071-44c7-a10c-e8116d7d5b425
312441pioglitazone 45 MG Oral TabletPSNfb49b7d6-8071-44c7-a10c-e8116d7d5b425
317573pioglitazone 15 MG Oral TabletSCDfb49b7d6-8071-44c7-a10c-e8116d7d5b425
312440pioglitazone 30 MG Oral TabletSCDfb49b7d6-8071-44c7-a10c-e8116d7d5b425
312441pioglitazone 45 MG Oral TabletSCDfb49b7d6-8071-44c7-a10c-e8116d7d5b425
312441pioglitazone (as pioglitazone HCl) 45 MG Oral TabletSYfb49b7d6-8071-44c7-a10c-e8116d7d5b425
317573pioglitazone (as pioglitazone hydrochloride) 15 MG Oral TabletSYfb49b7d6-8071-44c7-a10c-e8116d7d5b425
312440pioglitazone (as pioglitazone hydrochloride) 30 MG Oral TabletSYfb49b7d6-8071-44c7-a10c-e8116d7d5b425

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
54458-884-105445808841030 in 1 BLISTER PACKHistorical