FDA.reportPublic FDA data

Duetact

Product NDC
64764-304
11-digit product format
647640304
Labeler code
64764
Product ID
64764-304_23f68487-5d22-4618-9ccc-417aeb9fd3a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pioglitazone and glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Takeda Pharmaceuticals America, Inc.
Application
NDA021925
Marketing category
NDA
Marketing start
2006-07-28
Substance
GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE
Active strength
4; 30 mg/1; 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], Sulfonylurea Compounds [CS], Sulfonylurea [EPC], 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
Duetact
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLIMEPIRIDE4 mg/1
PIOGLITAZONE HYDROCHLORIDE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJQT35NPK6C, 6KY687524K
Rxcui647237, 647239, 731457, 731463

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e11f0f31-8914-938f-521e-037b6de27c13Product name520210621
b890b964-2cf0-4439-aaf3-900c9e3e9e49Product name120160602
3e9b6ece-066b-2ac3-28f7-5e13060e5934Product name220151109
0d79b284-47e8-e90c-f249-892b9b251003Product name120140508
7611093e-8875-33d4-9e3c-f48c7e3af1e8Product name120140508
ac29cd77-922c-d25a-f8ad-66a8692935c5Product name120140508
d36d861f-8a90-80cc-8935-1e6be9b4c7ebProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64764-304-30Duetact30 in 1 BOTTLETABLET3023
64764-304-90Duetact90 in 1 BOTTLETABLET9023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64764-304-30EA - Each64764-3041c53ece5-2022-4666-979b-5f7b461d615412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
glimepirideACTIVE INGREDIENT6KY687524KDUETACT (PIOGLITAZONE AND GLIMEPIRIDE) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.]14
pioglitazone hydrochlorideACTIVE INGREDIENTJQT35NPK6CDUETACT (PIOGLITAZONE AND GLIMEPIRIDE) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.]14
glimepirideACTIVE MOIETY6KY687524KDUETACT (PIOGLITAZONE AND GLIMEPIRIDE) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.]14
pioglitazoneACTIVE MOIETYX4OV71U42SDUETACT (PIOGLITAZONE AND GLIMEPIRIDE) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.]14
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UDUETACT (PIOGLITAZONE AND GLIMEPIRIDE) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.]14
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48DUETACT (PIOGLITAZONE AND GLIMEPIRIDE) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.]14
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PDUETACT (PIOGLITAZONE AND GLIMEPIRIDE) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.]14
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XDUETACT (PIOGLITAZONE AND GLIMEPIRIDE) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.]14
magnesium stearateINACTIVE INGREDIENT70097M6I30DUETACT (PIOGLITAZONE AND GLIMEPIRIDE) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.]14
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HDUETACT (PIOGLITAZONE AND GLIMEPIRIDE) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.]14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64764-304DUETACT (PIOGLITAZONE AND GLIMEPIRIDE) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.]23Current NDC, Legacy NDC, 2 package rows20250409_f8b0c917-3fdd-4a28-a47d-6225b8195458.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
731463duetact 30 MG / 2 MG Oral TabletPSNf8b0c917-3fdd-4a28-a47d-6225b819545823
731457duetact 30 MG / 4 MG Oral TabletPSNf8b0c917-3fdd-4a28-a47d-6225b819545823
647237pioglitazone HCl 30 MG / glimepiride 2 MG Oral TabletPSNf8b0c917-3fdd-4a28-a47d-6225b819545823
647239pioglitazone HCl 30 MG / glimepiride 4 MG Oral TabletPSNf8b0c917-3fdd-4a28-a47d-6225b819545823
731463glimepiride 2 MG / pioglitazone 30 MG Oral Tablet [Duetact]SBDf8b0c917-3fdd-4a28-a47d-6225b819545823
731457glimepiride 4 MG / pioglitazone 30 MG Oral Tablet [Duetact]SBDf8b0c917-3fdd-4a28-a47d-6225b819545823
647237glimepiride 2 MG / pioglitazone 30 MG Oral TabletSCDf8b0c917-3fdd-4a28-a47d-6225b819545823
647239glimepiride 4 MG / pioglitazone 30 MG Oral TabletSCDf8b0c917-3fdd-4a28-a47d-6225b819545823
731463Duetact 30/2 (pioglitazone / glimepiride) Oral TabletSYf8b0c917-3fdd-4a28-a47d-6225b819545823
731463Duetact 30/2 MG Oral TabletSYf8b0c917-3fdd-4a28-a47d-6225b819545823
731457Duetact 30/4 (pioglitazone / glimepiride) Oral TabletSYf8b0c917-3fdd-4a28-a47d-6225b819545823
731457Duetact 30/4 MG Oral TabletSYf8b0c917-3fdd-4a28-a47d-6225b819545823
647237glimepiride 2 MG / pioglitazone (as pioglitazone hydrochloride) 30 MG Oral TabletSYf8b0c917-3fdd-4a28-a47d-6225b819545823
647239glimepiride 4 MG / pioglitazone (as pioglitazone hydrochloride) 30 MG Oral TabletSYf8b0c917-3fdd-4a28-a47d-6225b819545823

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64764-304-306476403043030 TABLET in 1 BOTTLE (64764-304-30) 30 tablet2006-07-280000-00-00NoNoCurrent
64764-304-906476403049090 TABLET in 1 BOTTLE (64764-304-90) 90 tablet2006-07-280000-00-00NoNoCurrent