OSENI

{
  "unii": {
    "unii": "EEN99869SC",
    "rxcui": "1368000",
    "inchikey": "KEJICOXJTRHYAK-XFULWGLBSA-N",
    "display_name": "ALOGLIPTIN BENZOATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "4c619ed9-fe3e-4158-9938-80c6c3493d55": {
      "match": "brand_token",
      "title": "OSENI (ALOGLIPTIN AND PIOGLITAZONE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]",
      "spl_version": "23",
      "published_date": "2025-03-24"
    }
  },
  "productid": "64764-253_2346b7f5-b2c1-45f0-9f8f-5cbb4b202857",
  "productndc": "64764-253",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "022426",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 25MG BASE;EQ 15MG BASE",
        "product_no": "001",
        "approval_date": "Jan 25, 2013"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 25MG BASE;EQ 30MG BASE",
        "product_no": "002",
        "approval_date": "Jan 25, 2013"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 25MG BASE;EQ 45MG BASE",
        "product_no": "003",
        "approval_date": "Jan 25, 2013"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 12.5MG BASE;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "004",
        "approval_date": "Jan 25, 2013"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 12.5MG BASE;EQ 30MG BASE",
        "product_no": "005",
        "approval_date": "Jan 25, 2013"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 12.5MG BASE;EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "006",
        "approval_date": "Jan 25, 2013"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE",
  "proprietary_name": "OSENI",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA022426",
  "marketing_category": "NDA",
  "nonproprietary_name": "alogliptin and pioglitazone",
  "start_marketing_date": "20130125",
  "active_numerator_strength": "25; 30"
}