Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Takeda GmbH
Takeda Pharmaceuticals America, Inc.
313270015
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Duetact
Product Details
NDC Product Code
64764-304Application Number
NDA021925Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
June 1, 2020PioglitazoneActive
Code: JQT35NPK6CClass: ACTIMQuantity: 30 mg in 1 1
GlimepirideActive
Code: 6KY687524KClass: ACTIBQuantity: 4 mg in 1 1
croscarmellose sodiumInactive
Code: M28OL1HH48Class: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5XClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT
microcrystalline celluloseInactive
Code: OP1R32D61UClass: IACT
Duetact
Product Details
NDC Product Code
64764-302Application Number
NDA021925Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
June 1, 2020magnesium stearateInactive
Code: 70097M6I30Class: IACT
PioglitazoneActive
Code: JQT35NPK6CClass: ACTIMQuantity: 30 mg in 1 1
croscarmellose sodiumInactive
Code: M28OL1HH48Class: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT
GlimepirideActive
Code: 6KY687524KClass: ACTIBQuantity: 2 mg in 1 1
lactose monohydrateInactive
Code: EWQ57Q8I5XClass: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
microcrystalline celluloseInactive
Code: OP1R32D61UClass: IACT