Alendronate

Orange BookUNIISPLATC M05BA04

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

Identification

ManufacturerMarlex Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeM05BA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
1013571912
3 BLISTER PACK in 1 CARTON (10135-719-12) / 4 TABLET in 1 BLISTER PACK
ndc11
1013571920
2 BLISTER PACK in 1 CARTON (10135-719-20) / 10 TABLET in 1 BLISTER PACK
ndc11
1013571944
1 BLISTER PACK in 1 CARTON (10135-719-44) / 4 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

2UY4M2U3RA

ALENDRONATE SODIUM

RxCUI 203152

Orange Book

A090258

ABABABAB

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": "10135-719_3e74abef-2742-2bbe-e063-6394a90a12cd",
  "productndc": "10135-719",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "090258",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "001",
        "approval_date": "Sep 24, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "002",
        "approval_date": "Sep 24, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 35MG BASE",
        "product_no": "003",
        "approval_date": "Sep 24, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 70MG BASE",
        "product_no": "004",
        "approval_date": "Sep 24, 2009"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ALENDRONATE SODIUM",
  "proprietary_name": "Alendronate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA090258",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Alendronate sodium tablet",
  "start_marketing_date": "20201201",
  "active_numerator_strength": "70"
}

Related drugs

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