Alendronate Sodium

Orange BookUNIISPLATC M05BA04

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeM05BA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0054028259
4 BOTTLE, UNIT-DOSE in 1 CARTON (0054-0282-59) / 75 mL in 1 BOTTLE, UNIT-DOSE

Annotations

UNII (FDA Substance ID)

2UY4M2U3RA

ALENDRONATE SODIUM

RxCUI 203152

Orange Book

A090520

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": "0054-0282_56e063a8-8c3d-4445-91fd-0c8806c2b127",
  "productndc": "0054-0282",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "090520",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "EQ 70MG BASE/75ML",
        "product_no": "001",
        "approval_date": "Feb 25, 2013"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ALENDRONATE SODIUM",
  "proprietary_name": "Alendronate Sodium",
  "active_ingred_unit": "mg/75mL",
  "application_number": "ANDA090520",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Alendronate Sodium",
  "start_marketing_date": "20201030",
  "active_numerator_strength": "70"
}

Related drugs

Other records sharing ATC code M05BA04.

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