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United States · US · US:23155-170_f4991976-8a87-4a00-839f-3f62c561c230

Zoledronic acid

Orange BookUNIISPLATC M05BA08

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

Identification

ManufacturerHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
CountryUS (United States)
ATC codeM05BA08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    2315517031
    1 VIAL, GLASS in 1 CARTON (23155-170-31) / 5 mL in 1 VIAL, GLASS

Annotations

UNII (FDA Substance ID)
6XC1PAD3KF
ZOLEDRONIC ACID
RxCUI 77655
Orange Book
A201783
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "6XC1PAD3KF",
    "rxcui": "77655",
    "inchikey": "FUXFIVRTGHOMSO-UHFFFAOYSA-N",
    "display_name": "ZOLEDRONIC ACID",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "1977d713-4cc7-405e-b4c1-a9a91635eff6": {
      "match": "brand_token",
      "title": "ZOLEDRONIC ACID INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]",
      "spl_version": "6",
      "published_date": "2026-05-28"
    }
  },
  "productid": "23155-170_f4991976-8a87-4a00-839f-3f62c561c230",
  "productndc": "23155-170",
  "dosage_form": "INJECTION, SOLUTION, CONCENTRATE",
  "orange_book": {
    "appl_no": "201783",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 4MG BASE/5ML",
        "product_no": "001",
        "approval_date": "Mar 12, 2013"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ZOLEDRONIC ACID",
  "proprietary_name": "Zoledronic acid",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA201783",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Zoledronic acid",
  "start_marketing_date": "20230831",
  "active_numerator_strength": "4"
}

Related drugs

Other records sharing ATC code M05BA08.

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