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United States · US · US:55111-575_eeeb1802-6fe6-ebb0-2df8-98b42385b89f

Ibandronate sodium

Orange BookUNIISPLATC M05BA06

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

Identification

ManufacturerDr. Reddy's Laboratories Limited
CountryUS (United States)
ATC codeM05BA06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5511157503
    3 BLISTER PACK in 1 CARTON (55111-575-03) / 1 TABLET in 1 BLISTER PACK (55111-575-11)
  • ndc11
    5511157543
    1 BLISTER PACK in 1 CARTON (55111-575-43) / 3 TABLET in 1 BLISTER PACK (55111-575-13)

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": "55111-575_eeeb1802-6fe6-ebb0-2df8-98b42385b89f",
  "productndc": "55111-575",
  "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

Other records sharing ATC code M05BA06.

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