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United States · US · US:65862-237_ac6119dd-ca9a-4a6e-9a3b-4ddb60924abe

Ibandronate Sodium

Orange BookUNIISPLATC M05BA06

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeM05BA06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6586223703
    1 BLISTER PACK in 1 CARTON (65862-237-03) / 3 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
J12U072QL0
IBANDRONATE SODIUM
RxCUI 236916
Orange Book
A204502
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "J12U072QL0",
    "rxcui": "236916",
    "inchikey": "VBDRTGFACFYFCT-UHFFFAOYSA-M",
    "display_name": "IBANDRONATE SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "86c0b4ae-5e38-4efe-88af-50ac560e294f": {
      "match": "brand_token",
      "title": "IBANDRONATE SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]",
      "spl_version": "12",
      "published_date": "2026-03-26"
    }
  },
  "productid": "65862-237_ac6119dd-ca9a-4a6e-9a3b-4ddb60924abe",
  "productndc": "65862-237",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "204502",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 150MG BASE",
        "product_no": "001",
        "approval_date": "Mar 11, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IBANDRONATE SODIUM",
  "proprietary_name": "Ibandronate Sodium",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA204502",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ibandronate Sodium",
  "start_marketing_date": "20160311",
  "active_numerator_strength": "150"
}

Related drugs

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