FDA.reportPublic FDA data

Pioglitazone

Product NDC
0093-7272
11-digit product format
000937272
Labeler code
0093
Product ID
0093-7272_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
30 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 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
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
0093-7272-05Pioglitazone500 in 1 BOTTLETABLET50015
0093-7272-56Pioglitazone30 in 1 BOTTLETABLET3015
0093-7272-98Pioglitazone90 in 1 BOTTLETABLET9015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-7272-05EA - Each0093-7272b3981de2-3c92-42e7-97a1-9dbc06a26fac12015-03-03
0093-7272-56EA - Each0093-7272ad5c218c-b8e2-4e66-ad37-a0bd44446f3412015-05-05
0093-7272-98EA - Each0093-72726c8886f3-78f2-4a25-87a0-cf2eb63933cb12015-06-09

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
0093-7272PIOGLITAZONE 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
312440pioglitazone 30 MG Oral TabletPSNfbdaaa34-06c4-49af-85b4-91a85922b30b101
312440pioglitazone 30 MG Oral TabletSCDfbdaaa34-06c4-49af-85b4-91a85922b30b101
312440pioglitazone (as pioglitazone hydrochloride) 30 MG Oral TabletSYfbdaaa34-06c4-49af-85b4-91a85922b30b101
312440pioglitazone 30 MG Oral TabletPSNa639e726-13ce-4d8e-b6c9-e3c4844d08d520
312441pioglitazone 45 MG Oral TabletPSNa639e726-13ce-4d8e-b6c9-e3c4844d08d520
312440pioglitazone 30 MG Oral TabletSCDa639e726-13ce-4d8e-b6c9-e3c4844d08d520
312441pioglitazone 45 MG Oral TabletSCDa639e726-13ce-4d8e-b6c9-e3c4844d08d520
312441pioglitazone (as pioglitazone HCl) 45 MG Oral TabletSYa639e726-13ce-4d8e-b6c9-e3c4844d08d520
312440pioglitazone (as pioglitazone hydrochloride) 30 MG Oral TabletSYa639e726-13ce-4d8e-b6c9-e3c4844d08d520
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 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
312440pioglitazone 30 MG Oral TabletPSN0b1e935f-742a-4879-8a2c-a11e75f7071e3
312440pioglitazone 30 MG Oral TabletSCD0b1e935f-742a-4879-8a2c-a11e75f7071e3
312440pioglitazone (as pioglitazone hydrochloride) 30 MG Oral TabletSY0b1e935f-742a-4879-8a2c-a11e75f7071e3
317573pioglitazone 15 MG Oral TabletPSN22569835-bc9f-7787-e063-6394a90a62322
312440pioglitazone 30 MG Oral TabletPSN22569835-bc9f-7787-e063-6394a90a62322
312440pioglitazone 30 MG Oral TabletPSNbde7fa79-aafc-3ba0-e053-2a95a90aa4d22
312441pioglitazone 45 MG Oral TabletPSN22569835-bc9f-7787-e063-6394a90a62322
317573pioglitazone 15 MG Oral TabletSCD22569835-bc9f-7787-e063-6394a90a62322
312440pioglitazone 30 MG Oral TabletSCDbde7fa79-aafc-3ba0-e053-2a95a90aa4d22
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 TabletSYbde7fa79-aafc-3ba0-e053-2a95a90aa4d22
312440pioglitazone (as pioglitazone hydrochloride) 30 MG Oral TabletSY22569835-bc9f-7787-e063-6394a90a62322
312440pioglitazone 30 MG Oral TabletPSNc3e3d8ea-c4f6-6707-e053-2995a90a1b0e1
312440pioglitazone 30 MG Oral TabletSCDc3e3d8ea-c4f6-6707-e053-2995a90a1b0e1
312440pioglitazone (as pioglitazone hydrochloride) 30 MG Oral TabletSYc3e3d8ea-c4f6-6707-e053-2995a90a1b0e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-7272-0500093727205500 TABLET in 1 BOTTLE (0093-7272-05) 500 tablet2015-02-040000-00-00NoNoCurrent
0093-7272-560009372725630 TABLET in 1 BOTTLE (0093-7272-56) 30 tablet2015-04-220000-00-00NoNoCurrent
0093-7272-980009372729890 TABLET in 1 BOTTLE (0093-7272-98) 90 tablet2015-06-030000-00-00NoNoCurrent