FDA.reportPublic FDA data

Pioglitazone

Product NDC
33342-055
11-digit product format
333420055
Labeler code
33342
Product ID
33342-055_7d118937-d5b2-402f-8e24-f70a48c1d432
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pioglitazone
Dosage form
TABLET
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA202467
Marketing category
ANDA
Marketing start
2013-02-14
Substance
PIOGLITAZONE HYDROCHLORIDE
Active strength
30 mg/1
Pharmacologic classes
PPAR alpha [CS], PPAR gamma [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor Activity [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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PIOGLITAZONE HYDROCHLORIDE30 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
33342-055-07Pioglitazone30 in 1 BOTTLETABLET307
33342-055-10Pioglitazone90 in 1 BOTTLETABLET907
33342-055-12Pioglitazone100 in 1 BOX, UNIT-DOSETABLET1007
33342-055-15Pioglitazone500 in 1 BOTTLETABLET5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-055-07EA - Each33342-0550531fe48-b630-43c4-8271-1b95d4451bae12014-06-03
33342-055-10EA - Each33342-05592bbbadd-6b1d-4dbf-95e7-8223471a836b12014-06-03
33342-055-15EA - Each33342-0554440b4c9-f0cc-436d-998b-8f45bcd70fca12014-06-03

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-055PIOGLITAZONE TABLET [MACLEODS PHARMACEUTICALS LIMITED]7Current NDC, Legacy NDC, 4 package rows20230101_482cef76-0623-4b4f-a0ea-f008c97b2281.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317573pioglitazone 15 MG Oral TabletPSN482cef76-0623-4b4f-a0ea-f008c97b22817
312440pioglitazone 30 MG Oral TabletPSN482cef76-0623-4b4f-a0ea-f008c97b22817
312441pioglitazone 45 MG Oral TabletPSN482cef76-0623-4b4f-a0ea-f008c97b22817
317573pioglitazone 15 MG Oral TabletSCD482cef76-0623-4b4f-a0ea-f008c97b22817
312440pioglitazone 30 MG Oral TabletSCD482cef76-0623-4b4f-a0ea-f008c97b22817
312441pioglitazone 45 MG Oral TabletSCD482cef76-0623-4b4f-a0ea-f008c97b22817
312441pioglitazone (as pioglitazone HCl) 45 MG Oral TabletSY482cef76-0623-4b4f-a0ea-f008c97b22817
317573pioglitazone (as pioglitazone hydrochloride) 15 MG Oral TabletSY482cef76-0623-4b4f-a0ea-f008c97b22817
312440pioglitazone (as pioglitazone hydrochloride) 30 MG Oral TabletSY482cef76-0623-4b4f-a0ea-f008c97b22817
312440pioglitazone 30 MG Oral TabletPSNaf863b9e-9646-3b1e-e053-2995a90ab93a3
312440pioglitazone 30 MG Oral TabletSCDaf863b9e-9646-3b1e-e053-2995a90ab93a3
312440pioglitazone (as pioglitazone hydrochloride) 30 MG Oral TabletSYaf863b9e-9646-3b1e-e053-2995a90ab93a3
312440pioglitazone 30 MG Oral TabletPSN266c81ff-e877-6b00-e063-6394a90a50ac1
312440pioglitazone 30 MG Oral TabletSCD266c81ff-e877-6b00-e063-6394a90a50ac1
312440pioglitazone (as pioglitazone hydrochloride) 30 MG Oral TabletSY266c81ff-e877-6b00-e063-6394a90a50ac1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33342-055-073334200550730 TABLET in 1 BOTTLE (33342-055-07) 30 tablet2013-02-140000-00-00NoNoCurrent
33342-055-103334200551090 TABLET in 1 BOTTLE (33342-055-10) 90 tablet2013-02-140000-00-00NoNoCurrent
33342-055-1233342005512100 TABLET in 1 BOX, UNIT-DOSE (33342-055-12) 100 tablet2013-02-140000-00-00NoNoCurrent
33342-055-1533342005515500 TABLET in 1 BOTTLE (33342-055-15) 500 tablet2013-02-140000-00-00NoNoCurrent