FDA.reportPublic FDA data

Pioglitazone

Product NDC
0093-7271
11-digit product format
000937271
Labeler code
0093
Product ID
0093-7271_4552ad10-d451-4a09-8640-bf7a5d9cc5d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pioglitazone
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA077210
Marketing category
ANDA
Marketing start
2015-02-04
Substance
PIOGLITAZONE HYDROCHLORIDE
Active strength
15 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PIOGLITAZONE HYDROCHLORIDE15 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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-7271-05Pioglitazone500 in 1 BOTTLETABLET50015
0093-7271-56Pioglitazone30 in 1 BOTTLETABLET3015
0093-7271-98Pioglitazone90 in 1 BOTTLETABLET9015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-7271-05EA - Each0093-72712143970b-04db-493a-9b03-85503121e98d12015-03-03
0093-7271-56EA - Each0093-7271cdedd270-f5a4-4161-a14f-8df0a789f8e612015-06-09
0093-7271-98EA - Each0093-72717ae6507f-4b77-4652-8a7a-6919270d95e512015-06-09

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-7271PIOGLITAZONE TABLET [TEVA PHARMACEUTICALS USA, INC.]15Current NDC, Legacy NDC, 3 package rows20250321_c5c81c67-90cf-4e64-acb5-58b0358fa742.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317573pioglitazone 15 MG Oral TabletPSNc5c81c67-90cf-4e64-acb5-58b0358fa74215
312440pioglitazone 30 MG Oral TabletPSNc5c81c67-90cf-4e64-acb5-58b0358fa74215
312441pioglitazone 45 MG Oral TabletPSNc5c81c67-90cf-4e64-acb5-58b0358fa74215
317573pioglitazone 15 MG Oral TabletSCDc5c81c67-90cf-4e64-acb5-58b0358fa74215
312440pioglitazone 30 MG Oral TabletSCDc5c81c67-90cf-4e64-acb5-58b0358fa74215
312441pioglitazone 45 MG Oral TabletSCDc5c81c67-90cf-4e64-acb5-58b0358fa74215
312441pioglitazone (as pioglitazone HCl) 45 MG Oral TabletSYc5c81c67-90cf-4e64-acb5-58b0358fa74215
317573pioglitazone (as pioglitazone hydrochloride) 15 MG Oral TabletSYc5c81c67-90cf-4e64-acb5-58b0358fa74215
312440pioglitazone (as pioglitazone hydrochloride) 30 MG Oral TabletSYc5c81c67-90cf-4e64-acb5-58b0358fa74215
317573pioglitazone 15 MG Oral TabletPSN95b1666b-7f41-4b65-8995-a485afb2bd988
317573pioglitazone 15 MG Oral TabletSCD95b1666b-7f41-4b65-8995-a485afb2bd988
317573pioglitazone (as pioglitazone hydrochloride) 15 MG Oral TabletSY95b1666b-7f41-4b65-8995-a485afb2bd988
317573pioglitazone 15 MG Oral TabletPSNf3a2222d-5156-4533-bb4b-74652c8eb9c76
312440pioglitazone 30 MG Oral TabletPSNf3a2222d-5156-4533-bb4b-74652c8eb9c76
317573pioglitazone 15 MG Oral TabletSCDf3a2222d-5156-4533-bb4b-74652c8eb9c76
312440pioglitazone 30 MG Oral TabletSCDf3a2222d-5156-4533-bb4b-74652c8eb9c76
317573pioglitazone (as pioglitazone hydrochloride) 15 MG Oral TabletSYf3a2222d-5156-4533-bb4b-74652c8eb9c76
312440pioglitazone (as pioglitazone hydrochloride) 30 MG Oral TabletSYf3a2222d-5156-4533-bb4b-74652c8eb9c76
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
317573pioglitazone 15 MG Oral TabletPSN3817b214-0541-4dd7-82e9-9b95ed7b00fe3
317573pioglitazone 15 MG Oral TabletPSNba52f865-5768-4035-8505-53049e1effd83
317573pioglitazone 15 MG Oral TabletPSNa4751cb4-0700-dd22-e053-2995a90adfdb3
317573pioglitazone 15 MG Oral TabletSCDa4751cb4-0700-dd22-e053-2995a90adfdb3
317573pioglitazone 15 MG Oral TabletSCD3817b214-0541-4dd7-82e9-9b95ed7b00fe3
317573pioglitazone 15 MG Oral TabletSCDba52f865-5768-4035-8505-53049e1effd83
317573pioglitazone (as pioglitazone hydrochloride) 15 MG Oral TabletSYa4751cb4-0700-dd22-e053-2995a90adfdb3
317573pioglitazone (as pioglitazone hydrochloride) 15 MG Oral TabletSYba52f865-5768-4035-8505-53049e1effd83
317573pioglitazone (as pioglitazone hydrochloride) 15 MG Oral TabletSY3817b214-0541-4dd7-82e9-9b95ed7b00fe3
317573pioglitazone 15 MG Oral TabletPSN22569835-bc9f-7787-e063-6394a90a62322
312440pioglitazone 30 MG Oral TabletPSN22569835-bc9f-7787-e063-6394a90a62322
312441pioglitazone 45 MG Oral TabletPSN22569835-bc9f-7787-e063-6394a90a62322
317573pioglitazone 15 MG Oral TabletSCD22569835-bc9f-7787-e063-6394a90a62322
312440pioglitazone 30 MG Oral TabletSCD22569835-bc9f-7787-e063-6394a90a62322
312441pioglitazone 45 MG Oral TabletSCD22569835-bc9f-7787-e063-6394a90a62322
312441pioglitazone (as pioglitazone HCl) 45 MG Oral TabletSY22569835-bc9f-7787-e063-6394a90a62322
317573pioglitazone (as pioglitazone hydrochloride) 15 MG Oral TabletSY22569835-bc9f-7787-e063-6394a90a62322
312440pioglitazone (as pioglitazone hydrochloride) 30 MG Oral TabletSY22569835-bc9f-7787-e063-6394a90a62322
317573pioglitazone 15 MG Oral TabletPSNacaed3b3-4278-6175-e053-2a95a90a0b1f1
317573pioglitazone 15 MG Oral TabletSCDacaed3b3-4278-6175-e053-2a95a90a0b1f1
317573pioglitazone (as pioglitazone hydrochloride) 15 MG Oral TabletSYacaed3b3-4278-6175-e053-2a95a90a0b1f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-7271-0500093727105500 TABLET in 1 BOTTLE (0093-7271-05) 500 tablet2015-02-040000-00-00NoNoCurrent
0093-7271-560009372715630 TABLET in 1 BOTTLE (0093-7271-56) 30 tablet2015-06-030000-00-00NoNoCurrent
0093-7271-980009372719890 TABLET in 1 BOTTLE (0093-7271-98) 90 tablet2015-05-130000-00-00NoNoCurrent