KAZANO
These highlights do not include all the information needed to use KAZANO safely and effectively. See full prescribing information for KAZANO. KAZANO (alogliptin and metformin hydrochloride) tablets, for oral use Initial U.S. Approval: 2013
Approved
Approval ID
83cb7914-a683-47bb-a713-f2bc6a596bd2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 7, 2023
Manufacturers
FDA
Takeda Pharmaceuticals America, Inc.
DUNS: 039997266
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
alogliptin and metformin hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64764-335
Application NumberNDA203414
Product Classification
M
Marketing Category
C73594
G
Generic Name
alogliptin and metformin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 31, 2023
FDA Product Classification
INGREDIENTS (11)
ALOGLIPTIN BENZOATEActive
Quantity: 12.5 mg in 1 1
Code: EEN99869SC
Classification: ACTIM
Metformin hydrochlorideActive
Quantity: 500 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
ferric oxide yellowInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
alogliptin and metformin hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64764-337
Application NumberNDA203414
Product Classification
M
Marketing Category
C73594
G
Generic Name
alogliptin and metformin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 31, 2023
FDA Product Classification
INGREDIENTS (11)
ALOGLIPTIN BENZOATEActive
Quantity: 12.5 mg in 1 1
Code: EEN99869SC
Classification: ACTIM
Metformin hydrochlorideActive
Quantity: 1000 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
ferric oxide yellowInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT