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United States · US · US:50090-7654_1b55f284-94ab-46b3-bb1b-0ef5746bb901

Ibandronate sodium

Orange BookUNIISPLATC M05BA06

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeM05BA06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5009076540
    1 BLISTER PACK in 1 CARTON (50090-7654-0) / 3 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
J12U072QL0
IBANDRONATE SODIUM
RxCUI 236916
Orange Book
A078997
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": "50090-7654_1b55f284-94ab-46b3-bb1b-0ef5746bb901",
  "productndc": "50090-7654",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "078997",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 150MG BASE",
        "product_no": "001",
        "approval_date": "Apr 30, 2012"
      }
    ],
    "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": "ANDA078997",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ibandronate sodium",
  "start_marketing_date": "20120621",
  "active_numerator_strength": "150"
}

Related drugs

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