Alendronate Sodium

Orange BookUNIISPLATC M05BA04

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

Identification

ManufacturerAmneal Pharmaceuticals of New York LLC

CountryUS (United States)

ATC codeM05BA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0115168008
30 TABLET in 1 BOTTLE (0115-1680-08)

Annotations

UNII (FDA Substance ID)

2UY4M2U3RA

ALENDRONATE SODIUM

RxCUI 203152

Orange Book

A075710

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": {
    "815a87c4-e489-4eb9-9a2e-fb7a16642f01": {
      "match": "brand_token",
      "title": "ALENDRONATE SODIUM TABLET [AUROBINDO PHARMA LIMITED]",
      "spl_version": "27",
      "published_date": "2026-05-26"
    }
  },
  "productid": "0115-1680_0bb7b70c-72e0-4bb8-9d3a-0fc8e4762dd1",
  "productndc": "0115-1680",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "075710",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 5MG BASE",
        "product_no": "001",
        "approval_date": "Feb 6, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 10MG BASE",
        "product_no": "002",
        "approval_date": "Feb 6, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 35MG BASE",
        "product_no": "003",
        "approval_date": "Feb 6, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 40MG BASE",
        "product_no": "004",
        "approval_date": "Feb 6, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 70MG BASE",
        "product_no": "005",
        "approval_date": "Feb 6, 2008"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ALENDRONATE SODIUM",
  "proprietary_name": "Alendronate Sodium",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075710",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Alendronate Sodium",
  "start_marketing_date": "20080206",
  "active_numerator_strength": "40"
}

Related drugs

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