FDA.reportPublic FDA data

PIOGLITAZONE HYDROCHLORIDE

Product NDC
65862-514
11-digit product format
658620514
Labeler code
65862
Product ID
65862-514_75b48749-1268-4752-8a50-83382f05c951
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pioglitazone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA200268
Marketing category
ANDA
Marketing start
2013-02-13
Substance
PIOGLITAZONE HYDROCHLORIDE
Active strength
45 mg/1
Pharmacologic classes
Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA], Peroxisome Proliferator-activated Receptor gamma Agonists [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PIOGLITAZONE HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PIOGLITAZONE HYDROCHLORIDE45 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJQT35NPK6C
Rxcui312440, 312441, 317573

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-514-05PIOGLITAZONE HYDROCHLORIDE500 in 1 BOTTLETABLET50011
65862-514-10PIOGLITAZONE HYDROCHLORIDE10 in 1 BLISTER PACKTABLET1011
65862-514-10PIOGLITAZONE HYDROCHLORIDE3 in 1 CARTONTABLET311
65862-514-30PIOGLITAZONE HYDROCHLORIDE30 in 1 BOTTLETABLET3011
65862-514-90PIOGLITAZONE HYDROCHLORIDE90 in 1 BOTTLETABLET9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-514-05EA - Each65862-514122152a2-f85d-48ff-a0a1-5b5c521cd82b12019-10-07
65862-514-30EA - Each65862-514f1c2641a-8bc8-435a-85f5-2eac296a036512013-03-03
65862-514-90EA - Each65862-51470a32da2-7056-45a3-b584-0c5fefad288512023-07-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PIOGLITAZONE HYDROCHLORIDEACTIVE INGREDIENTJQT35NPK6CPIOGLITAZONE HYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]4
PIOGLITAZONEACTIVE MOIETYX4OV71U42SPIOGLITAZONE HYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]4
CARBOXYMETHYLCELLULOSE CALCIUMINACTIVE INGREDIENTUTY7PDF93LPIOGLITAZONE HYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]4
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PPIOGLITAZONE HYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPIOGLITAZONE HYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PIOGLITAZONE HYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-514PIOGLITAZONE HYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]11Current NDC, Legacy NDC, 5 package rows20250523_1f259863-21fd-4d62-b094-4eff845944df.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317573pioglitazone 15 MG Oral TabletPSN1f259863-21fd-4d62-b094-4eff845944df11
312440pioglitazone 30 MG Oral TabletPSN1f259863-21fd-4d62-b094-4eff845944df11
312441pioglitazone 45 MG Oral TabletPSN1f259863-21fd-4d62-b094-4eff845944df11
317573pioglitazone 15 MG Oral TabletSCD1f259863-21fd-4d62-b094-4eff845944df11
312440pioglitazone 30 MG Oral TabletSCD1f259863-21fd-4d62-b094-4eff845944df11
312441pioglitazone 45 MG Oral TabletSCD1f259863-21fd-4d62-b094-4eff845944df11
312441pioglitazone (as pioglitazone HCl) 45 MG Oral TabletSY1f259863-21fd-4d62-b094-4eff845944df11
317573pioglitazone (as pioglitazone hydrochloride) 15 MG Oral TabletSY1f259863-21fd-4d62-b094-4eff845944df11
312440pioglitazone (as pioglitazone hydrochloride) 30 MG Oral TabletSY1f259863-21fd-4d62-b094-4eff845944df11
312441pioglitazone 45 MG Oral TabletPSNe64b46e5-3c94-4635-908e-cdc2263bd3d44
312441pioglitazone 45 MG Oral TabletSCDe64b46e5-3c94-4635-908e-cdc2263bd3d44
312441pioglitazone (as pioglitazone HCl) 45 MG Oral TabletSYe64b46e5-3c94-4635-908e-cdc2263bd3d44
312441pioglitazone 45 MG Oral TabletPSN04577c39-a9c0-4c66-a775-4c79e2c3dea51
312441pioglitazone 45 MG Oral TabletSCD04577c39-a9c0-4c66-a775-4c79e2c3dea51
312441pioglitazone (as pioglitazone HCl) 45 MG Oral TabletSY04577c39-a9c0-4c66-a775-4c79e2c3dea51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-514-0565862051405500 TABLET in 1 BOTTLE (65862-514-05) 500 tablet2013-02-130000-00-00NoNoCurrent
65862-514-10658620514103 BLISTER PACK in 1 CARTON (65862-514-10) / 10 TABLET in 1 BLISTER PACK3 blister pack2013-02-130000-00-00NoNoCurrent
65862-514-306586205143030 TABLET in 1 BOTTLE (65862-514-30) 30 tablet2013-02-130000-00-00NoNoCurrent
65862-514-906586205149090 TABLET in 1 BOTTLE (65862-514-90) 90 tablet2013-02-130000-00-00NoNoCurrent