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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
- ndc1123155170311 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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