Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Takeda Pharmaceuticals America, Inc.
830134016
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Takeda GmbH
Prasco Laboratories
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.
pioglitazone and glimepiride
Product Details
NDC Product Code
66993-821Application Number
NDA021925Marketing Category
NDA authorized generic (C73605)Route of Administration
ORALEffective Date
December 29, 2017croscarmellose sodiumInactive
Code: M28OL1HH48Class: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5XClass: IACT
hydroxypropyl cellulose (1600000 wamw)Inactive
Code: RFW2ET671PClass: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT
microcrystalline celluloseInactive
Code: OP1R32D61UClass: IACT
PioglitazoneActive
Code: JQT35NPK6CClass: ACTIMQuantity: 30 mg in 1 1
GlimepirideActive
Code: 6KY687524KClass: ACTIBQuantity: 2 mg in 1 1
pioglitazone and glimepiride
Product Details
NDC Product Code
66993-822Application Number
NDA021925Marketing Category
NDA authorized generic (C73605)Route of Administration
ORALEffective Date
December 29, 2017magnesium stearateInactive
Code: 70097M6I30Class: IACT
microcrystalline celluloseInactive
Code: OP1R32D61UClass: IACT
PioglitazoneActive
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
hydroxypropyl cellulose (1600000 wamw)Inactive
Code: RFW2ET671PClass: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT