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United States · US · US:64764-335_2179e953-e16e-4bfe-a36e-fce2da468f33
KAZANO
Orange BookUNIISPLATC A10BH
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTakeda Pharmaceuticals America, Inc.
CountryUS (United States)
ATC codeA10BH
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc1164764335014 CARTON in 1 TRAY (64764-335-01) / 1 BLISTER PACK in 1 CARTON / 14 TABLET, FILM COATED in 1 BLISTER PACK
- ndc11647643356060 TABLET, FILM COATED in 1 BOTTLE (64764-335-60)
- ndc116476433577500 TABLET, FILM COATED in 1 BOTTLE (64764-335-77)
- ndc116476433580180 TABLET, FILM COATED in 1 BOTTLE (64764-335-80)
Annotations
UNII (FDA Substance ID)
EEN99869SC
ALOGLIPTIN BENZOATE
RxCUI 1368000
Orange Book
N203414
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "EEN99869SC",
"rxcui": "1368000",
"inchikey": "KEJICOXJTRHYAK-XFULWGLBSA-N",
"display_name": "ALOGLIPTIN BENZOATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"83cb7914-a683-47bb-a713-f2bc6a596bd2": {
"match": "brand_token",
"title": "KAZANO (ALOGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]",
"spl_version": "21",
"published_date": "2025-06-04"
}
},
"productid": "64764-335_2179e953-e16e-4bfe-a36e-fce2da468f33",
"productndc": "64764-335",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "203414",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 12.5MG BASE;500MG",
"product_no": "001",
"approval_date": "Jan 25, 2013"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 12.5MG BASE;1GM",
"product_no": "002",
"approval_date": "Jan 25, 2013"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE",
"proprietary_name": "KAZANO",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "NDA203414",
"marketing_category": "NDA",
"nonproprietary_name": "alogliptin and metformin hydrochloride",
"start_marketing_date": "20130125",
"active_numerator_strength": "12.5; 500"
}Related drugs
Other records sharing ATC code A10BH.
- GBAlogliptin 12.5mg / Metformin 1g tabletsJ M McGill Ltd
- GBAlogliptin 12.5mg / Metformin 1g tabletsNiche Pharma Ltd
- GBAlogliptin 12.5mg / Metformin 1g tabletsTakeda UK Ltd
- GBAlogliptin 12.5mg / Metformin 1g tabletsColorama Pharmaceuticals Ltd
- GBAlogliptin 12.5mg / Metformin 1g tabletsEnnogen Healthcare Ltd
- 🇺🇸alogliptin and metformin hydrochlorideA-S Medication Solutions
- 🇺🇸alogliptin and metformin hydrochloridePadagis Israel Pharmaceuticals Ltd
- 🇺🇸alogliptin and metformin hydrochloridePadagis Israel Pharmaceuticals Ltd
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