ALENDRONATE SODIUM

Orange BookUNIISPLATC M05BA04

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

Identification

ManufacturerA-S Medication Solutions

CountryUS (United States)

ATC codeM05BA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5009046920
1 BLISTER PACK in 1 CARTON (50090-4692-0) / 4 TABLET in 1 BLISTER PACK
ndc11
5009046921
3 BLISTER PACK in 1 CARTON (50090-4692-1) / 4 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

2UY4M2U3RA

ALENDRONATE SODIUM

RxCUI 203152

Orange Book

A076768

ABABABABAB

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": "50090-4692_789fd89e-ccc6-4b79-9611-c35fa3061ba7",
  "productndc": "50090-4692",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "076768",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "001",
        "approval_date": "Aug 4, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "002",
        "approval_date": "Aug 4, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 35MG BASE",
        "product_no": "003",
        "approval_date": "Aug 4, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "004",
        "approval_date": "Aug 4, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 70MG BASE",
        "product_no": "005",
        "approval_date": "Aug 4, 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": "ANDA076768",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Alendronate sodium",
  "start_marketing_date": "20080804",
  "active_numerator_strength": "70"
}

Related drugs

Other records sharing ATC code M05BA04.

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