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United States · US · US:62756-218_61378ee8-cc2f-4f55-954b-4eb55e975f5c

IBANDRONATE SODIUM

Orange BookUNIISPLATC M05BA06

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeM05BA06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6275621840
    1 VIAL, SINGLE-DOSE in 1 CARTON (62756-218-40) / 3 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
J12U072QL0
IBANDRONATE SODIUM
RxCUI 236916
Orange Book
A090853
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": "INTRAVENOUS",
  "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": "62756-218_61378ee8-cc2f-4f55-954b-4eb55e975f5c",
  "productndc": "62756-218",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "090853",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 3MG BASE/3ML",
        "product_no": "001",
        "approval_date": "Feb 14, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IBANDRONATE SODIUM",
  "proprietary_name": "IBANDRONATE SODIUM",
  "active_ingred_unit": "mg/3mL",
  "application_number": "ANDA090853",
  "marketing_category": "ANDA",
  "nonproprietary_name": "IBANDRONATE SODIUM",
  "start_marketing_date": "20140215",
  "active_numerator_strength": "3"
}

Related drugs

Other records sharing ATC code M05BA06.

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