kazano

Generic: alogliptin and metformin hydrochloride

Labeler: takeda pharmaceuticals america, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name kazano
Generic Name alogliptin and metformin hydrochloride
Labeler takeda pharmaceuticals america, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

alogliptin benzoate 12.5 mg/1, metformin hydrochloride 1000 mg/1

Manufacturer
Takeda Pharmaceuticals America, Inc.

Identifiers & Regulatory

Product NDC 64764-337
Product ID 64764-337_2179e953-e16e-4bfe-a36e-fce2da468f33
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA203414
Listing Expiration 2026-12-31
Marketing Start 2013-01-25

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs] dipeptidyl peptidase 4 inhibitor [epc] dipeptidyl peptidase 4 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64764337
Hyphenated Format 64764-337

Supplemental Identifiers

RxCUI
1368385 1368391 1368392 1368398
UPC
0364764335601
UNII
EEN99869SC 786Z46389E

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name kazano (source: ndc)
Generic Name alogliptin and metformin hydrochloride (source: ndc)
Application Number NDA203414 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
  • 1000 mg/1
source: ndc
Packaging
  • 4 CARTON in 1 TRAY (64764-337-01) / 1 BLISTER PACK in 1 CARTON / 14 TABLET, FILM COATED in 1 BLISTER PACK
  • 60 TABLET, FILM COATED in 1 BOTTLE (64764-337-60)
  • 500 TABLET, FILM COATED in 1 BOTTLE (64764-337-77)
  • 180 TABLET, FILM COATED in 1 BOTTLE (64764-337-80)
source: ndc

Packages (4)

64764-337-01 4 CARTON in 1 TRAY (64764-337-01) / 1 BLISTER PACK in 1 CARTON / 14 TABLET, FILM COATED in 1 BLISTER PACK 64764-337-60 60 TABLET, FILM COATED in 1 BOTTLE (64764-337-60) 64764-337-77 500 TABLET, FILM COATED in 1 BOTTLE (64764-337-77) 64764-337-80 180 TABLET, FILM COATED in 1 BOTTLE (64764-337-80)

Ingredients (2)

alogliptin benzoate (12.5 mg/1) metformin hydrochloride (1000 mg/1)

Linked Drug Pages (1)

KAZANO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2179e953-e16e-4bfe-a36e-fce2da468f33", "openfda": {"upc": ["0364764335601"], "unii": ["EEN99869SC", "786Z46389E"], "rxcui": ["1368385", "1368391", "1368392", "1368398"], "spl_set_id": ["83cb7914-a683-47bb-a713-f2bc6a596bd2"], "manufacturer_name": ["Takeda Pharmaceuticals America, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 CARTON in 1 TRAY (64764-337-01)  / 1 BLISTER PACK in 1 CARTON / 14 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "64764-337-01", "marketing_start_date": "20130125"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (64764-337-60)", "package_ndc": "64764-337-60", "marketing_start_date": "20130125"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (64764-337-77)", "package_ndc": "64764-337-77", "marketing_start_date": "20130125"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (64764-337-80)", "package_ndc": "64764-337-80", "marketing_start_date": "20130125"}], "brand_name": "KAZANO", "product_id": "64764-337_2179e953-e16e-4bfe-a36e-fce2da468f33", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]", "Dipeptidyl Peptidase 4 Inhibitor [EPC]", "Dipeptidyl Peptidase 4 Inhibitors [MoA]"], "product_ndc": "64764-337", "generic_name": "alogliptin and metformin hydrochloride", "labeler_name": "Takeda Pharmaceuticals America, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "KAZANO", "active_ingredients": [{"name": "ALOGLIPTIN BENZOATE", "strength": "12.5 mg/1"}, {"name": "METFORMIN HYDROCHLORIDE", "strength": "1000 mg/1"}], "application_number": "NDA203414", "marketing_category": "NDA", "marketing_start_date": "20130125", "listing_expiration_date": "20261231"}