FOSAMAX PLUS D

Orange BookUNIISPLATC M05BA

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerOrganon LLC

CountryUS (United States)

ATC codeM05BA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7820613601
4 TABLET in 1 BLISTER PACK (78206-136-01)

Annotations

UNII (FDA Substance ID)

2UY4M2U3RA

ALENDRONATE SODIUM

RxCUI 203152

Orange Book

N021762

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "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": "78206-136_10aeb309-f6e1-49c6-ac6f-ad743db28527",
  "productndc": "78206-136",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "021762",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 70MG BASE;2,800 IU",
        "product_no": "001",
        "approval_date": "Apr 7, 2005"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 70MG BASE;5,600 IU",
        "product_no": "002",
        "approval_date": "Apr 26, 2007"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ALENDRONATE SODIUM; CHOLECALCIFEROL",
  "proprietary_name": "FOSAMAX PLUS D",
  "active_ingred_unit": "mg/1; [iU]/1",
  "application_number": "NDA021762",
  "marketing_category": "NDA",
  "nonproprietary_name": "ALENDRONATE SODIUM and CHOLECALCIFEROL",
  "start_marketing_date": "20210601",
  "active_numerator_strength": "70; 5600"
}

Related drugs

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