FOSAMAX

{
  "unii": {
    "unii": "2UY4M2U3RA",
    "rxcui": "203152",
    "inchikey": "DCSBSVSZJRSITC-UHFFFAOYSA-M",
    "display_name": "ALENDRONATE SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "14e931fd-2c5f-4d90-b7db-5980706f4a56": {
      "match": "brand_token",
      "title": "FOSAMAX (ALENDRONATE SODIUM) TABLET [ORGANON LLC]",
      "spl_version": "10",
      "published_date": "2026-03-16"
    }
  },
  "productid": "78206-135_1013aa0b-071e-46c4-8bed-207bb10ac2fd",
  "productndc": "78206-135",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "020560",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Sep 29, 1995"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "002",
        "approval_date": "Sep 29, 1995"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "003",
        "approval_date": "Apr 25, 1997"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "004",
        "approval_date": "Oct 20, 2000"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 70MG BASE",
        "product_no": "005",
        "approval_date": "Oct 20, 2000"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ALENDRONATE SODIUM",
  "proprietary_name": "FOSAMAX",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020560",
  "marketing_category": "NDA",
  "nonproprietary_name": "alendronate sodium",
  "start_marketing_date": "20210601",
  "active_numerator_strength": "70"
}