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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

  • ndc11
    6476433501
    4 CARTON in 1 TRAY (64764-335-01) / 1 BLISTER PACK in 1 CARTON / 14 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    6476433560
    60 TABLET, FILM COATED in 1 BOTTLE (64764-335-60)
  • ndc11
    6476433577
    500 TABLET, FILM COATED in 1 BOTTLE (64764-335-77)
  • ndc11
    6476433580
    180 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

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