Back to search
🇺🇸

United States · US · US:33342-150_29367df4-fac5-4117-963c-3e40ed998461

IBANDRONATE SODIUM

Orange BookUNIISPLATC M05BA06

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

Identification

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

Packs · 2

  • ndc11
    3334215052
    1 BLISTER PACK in 1 CARTON (33342-150-52) / 3 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    3334215053
    3 CARTON in 1 BOX (33342-150-53) / 1 BLISTER PACK in 1 CARTON (33342-150-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
J12U072QL0
IBANDRONATE SODIUM
RxCUI 236916
Orange Book
A206887
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": "33342-150_29367df4-fac5-4117-963c-3e40ed998461",
  "productndc": "33342-150",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "206887",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 150MG BASE",
        "product_no": "001",
        "approval_date": "Oct 31, 2017"
      }
    ],
    "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": "ANDA206887",
  "marketing_category": "ANDA",
  "nonproprietary_name": "IBANDRONATE SODIUM",
  "start_marketing_date": "20180613",
  "active_numerator_strength": "150"
}

Related drugs

Other records sharing ATC code M05BA06.

Access this data programmatically

Query IBANDRONATE SODIUM and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.