FDA.reportPublic FDA data

Actos

Product NDC
64764-301
11-digit product format
647640301
Labeler code
64764
Product ID
64764-301_20e43dff-4bf2-4ae7-82a1-e7e895123f93
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pioglitazone
Dosage form
TABLET
Route
ORAL
Labeler
Takeda Pharmaceuticals America, Inc.
Application
NDA021073
Marketing category
NDA
Marketing start
1999-07-15
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
Actos
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PIOGLITAZONE HYDROCHLORIDE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJQT35NPK6C
Rxcui261266, 261267, 261268, 312440, 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
64764-301-02Actos6 in 1 TRAYTABLET620
64764-301-02Actos1 in 1 CARTONTABLET120
64764-301-14Actos30 in 1 BOTTLETABLET3020
64764-301-15Actos90 in 1 BOTTLETABLET9020
64764-301-16Actos500 in 1 BOTTLETABLET50020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64764-301-14EA - Each64764-3014e080239-d4a2-4a31-a98b-9ab7791996ec12012-07-24
64764-301-15EA - Each64764-3019304eeac-67e4-4f69-890a-42f9f67c6b8a12012-07-24
64764-301-16EA - Each64764-301ec2f61e1-b4cf-418f-8d69-63a8598fee0d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PIOGLITAZONE HYDROCHLORIDEACTIVE INGREDIENTJQT35NPK6CACTOS (PIOGLITAZONE) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.]12
pioglitazoneACTIVE MOIETYX4OV71U42SACTOS (PIOGLITAZONE) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.]12
carboxymethylcellulose calciumINACTIVE INGREDIENTUTY7PDF93LACTOS (PIOGLITAZONE) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.]12
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PACTOS (PIOGLITAZONE) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.]12
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XACTOS (PIOGLITAZONE) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.]12
magnesium stearateINACTIVE INGREDIENT70097M6I30ACTOS (PIOGLITAZONE) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.]12
pioglitazone hydrochlorideACTIVE INGREDIENTJQT35NPK6CACTOS (PIOGLITAZONE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]3
pioglitazoneACTIVE MOIETYX4OV71U42SACTOS (PIOGLITAZONE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]3
carboxymethylcellulose calciumINACTIVE INGREDIENTUTY7PDF93LACTOS (PIOGLITAZONE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]3
hydroxypropyl celluloseINACTIVE INGREDIENTRFW2ET671PACTOS (PIOGLITAZONE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]3
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XACTOS (PIOGLITAZONE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]3
magnesium stearateINACTIVE INGREDIENT70097M6I30ACTOS (PIOGLITAZONE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]3
pioglitazone hydrochlorideACTIVE INGREDIENTJQT35NPK6CACTOS (PIOGLITAZONE HYDROCHLORIDE) TABLET [DISPENSING SOLUTIONS, INC.]1
pioglitazoneACTIVE MOIETYX4OV71U42SACTOS (PIOGLITAZONE HYDROCHLORIDE) TABLET [DISPENSING SOLUTIONS, INC.]1
carboxymethylcellulose calciumINACTIVE INGREDIENTUTY7PDF93LACTOS (PIOGLITAZONE HYDROCHLORIDE) TABLET [DISPENSING SOLUTIONS, INC.]1
hydroxypropyl celluloseINACTIVE INGREDIENTRFW2ET671PACTOS (PIOGLITAZONE HYDROCHLORIDE) TABLET [DISPENSING SOLUTIONS, INC.]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XACTOS (PIOGLITAZONE HYDROCHLORIDE) TABLET [DISPENSING SOLUTIONS, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30ACTOS (PIOGLITAZONE HYDROCHLORIDE) TABLET [DISPENSING SOLUTIONS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64764-301ACTOS (PIOGLITAZONE) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.]20Current NDC, Legacy NDC, 5 package rows20250409_d2ddc491-88a9-4063-9150-443b4fa4330c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
261266Actos 15 MG Oral TabletPSNd2ddc491-88a9-4063-9150-443b4fa4330c20
261267Actos 30 MG Oral TabletPSNd2ddc491-88a9-4063-9150-443b4fa4330c20
261268Actos 45 MG Oral TabletPSNd2ddc491-88a9-4063-9150-443b4fa4330c20
317573pioglitazone 15 MG Oral TabletPSNd2ddc491-88a9-4063-9150-443b4fa4330c20
312440pioglitazone 30 MG Oral TabletPSNd2ddc491-88a9-4063-9150-443b4fa4330c20
312441pioglitazone 45 MG Oral TabletPSNd2ddc491-88a9-4063-9150-443b4fa4330c20
261266pioglitazone 15 MG Oral Tablet [Actos]SBDd2ddc491-88a9-4063-9150-443b4fa4330c20
261267pioglitazone 30 MG Oral Tablet [Actos]SBDd2ddc491-88a9-4063-9150-443b4fa4330c20
261268pioglitazone 45 MG Oral Tablet [Actos]SBDd2ddc491-88a9-4063-9150-443b4fa4330c20
317573pioglitazone 15 MG Oral TabletSCDd2ddc491-88a9-4063-9150-443b4fa4330c20
312440pioglitazone 30 MG Oral TabletSCDd2ddc491-88a9-4063-9150-443b4fa4330c20
312441pioglitazone 45 MG Oral TabletSCDd2ddc491-88a9-4063-9150-443b4fa4330c20
261266Actos (as pioglitazone hydrochloride) 15 MG Oral TabletSYd2ddc491-88a9-4063-9150-443b4fa4330c20
261267Actos (as pioglitazone hydrochloride) 30 MG Oral TabletSYd2ddc491-88a9-4063-9150-443b4fa4330c20
261268Actos (as pioglitazone hydrochloride) 45 MG Oral TabletSYd2ddc491-88a9-4063-9150-443b4fa4330c20
261266Actos 15 MG Oral TabletSYd2ddc491-88a9-4063-9150-443b4fa4330c20
261267Actos 30 MG Oral TabletSYd2ddc491-88a9-4063-9150-443b4fa4330c20
261268Actos 45 MG Oral TabletSYd2ddc491-88a9-4063-9150-443b4fa4330c20
312441pioglitazone (as pioglitazone HCl) 45 MG Oral TabletSYd2ddc491-88a9-4063-9150-443b4fa4330c20
317573pioglitazone (as pioglitazone hydrochloride) 15 MG Oral TabletSYd2ddc491-88a9-4063-9150-443b4fa4330c20
312440pioglitazone (as pioglitazone hydrochloride) 30 MG Oral TabletSYd2ddc491-88a9-4063-9150-443b4fa4330c20
261266Actos 15 MG Oral TabletPSN2a97ef74-b338-4655-a60b-923f867201793
261267Actos 30 MG Oral TabletPSN2a97ef74-b338-4655-a60b-923f867201793
261268Actos 45 MG Oral TabletPSN2a97ef74-b338-4655-a60b-923f867201793
317573pioglitazone 15 MG Oral TabletPSN2a97ef74-b338-4655-a60b-923f867201793
312440pioglitazone 30 MG Oral TabletPSN2a97ef74-b338-4655-a60b-923f867201793
312441pioglitazone 45 MG Oral TabletPSN2a97ef74-b338-4655-a60b-923f867201793
261266pioglitazone 15 MG Oral Tablet [Actos]SBD2a97ef74-b338-4655-a60b-923f867201793
261267pioglitazone 30 MG Oral Tablet [Actos]SBD2a97ef74-b338-4655-a60b-923f867201793
261268pioglitazone 45 MG Oral Tablet [Actos]SBD2a97ef74-b338-4655-a60b-923f867201793
317573pioglitazone 15 MG Oral TabletSCD2a97ef74-b338-4655-a60b-923f867201793
312440pioglitazone 30 MG Oral TabletSCD2a97ef74-b338-4655-a60b-923f867201793
312441pioglitazone 45 MG Oral TabletSCD2a97ef74-b338-4655-a60b-923f867201793
261266Actos (as pioglitazone hydrochloride) 15 MG Oral TabletSY2a97ef74-b338-4655-a60b-923f867201793
261267Actos (as pioglitazone hydrochloride) 30 MG Oral TabletSY2a97ef74-b338-4655-a60b-923f867201793
261268Actos (as pioglitazone hydrochloride) 45 MG Oral TabletSY2a97ef74-b338-4655-a60b-923f867201793
261266Actos 15 MG Oral TabletSY2a97ef74-b338-4655-a60b-923f867201793
261267Actos 30 MG Oral TabletSY2a97ef74-b338-4655-a60b-923f867201793
261268Actos 45 MG Oral TabletSY2a97ef74-b338-4655-a60b-923f867201793
312441pioglitazone (as pioglitazone HCl) 45 MG Oral TabletSY2a97ef74-b338-4655-a60b-923f867201793
317573pioglitazone (as pioglitazone hydrochloride) 15 MG Oral TabletSY2a97ef74-b338-4655-a60b-923f867201793
312440pioglitazone (as pioglitazone hydrochloride) 30 MG Oral TabletSY2a97ef74-b338-4655-a60b-923f867201793

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64764-301-02647640301026 CARTON in 1 TRAY (64764-301-02) / 1 BLISTER PACK in 1 CARTON / 7 TABLET in 1 BLISTER PACK6 carton1999-07-150000-00-00NoNoCurrent
64764-301-146476403011430 TABLET in 1 BOTTLE (64764-301-14) 30 tablet1999-07-150000-00-00NoNoCurrent
64764-301-156476403011590 TABLET in 1 BOTTLE (64764-301-15) 90 tablet1999-07-150000-00-00NoNoCurrent
64764-301-1664764030116500 TABLET in 1 BOTTLE (64764-301-16) 500 tablet1999-07-150000-00-00NoNoCurrent