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United States · US · US:54288-100_fd8bf083-6f6b-44db-bc6d-5368522b83d1
Zoledronic Acid
Orange BookUNIISPLATC M05BA08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBPI Labs LLC
CountryUS (United States)
ATC codeM05BA08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1154288100011 VIAL in 1 CARTON (54288-100-01) / 5 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
6XC1PAD3KF
ZOLEDRONIC ACID
RxCUI 77655
Orange Book
A207341
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": "54288-100_fd8bf083-6f6b-44db-bc6d-5368522b83d1",
"productndc": "54288-100",
"dosage_form": "INJECTION, SOLUTION, CONCENTRATE",
"orange_book": {
"appl_no": "207341",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 4MG BASE/5ML",
"product_no": "001",
"approval_date": "Dec 29, 2017"
}
],
"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": "ANDA207341",
"marketing_category": "ANDA",
"nonproprietary_name": "zoledronic acid",
"start_marketing_date": "20180402",
"active_numerator_strength": "4"
}Related drugs
Other records sharing ATC code M05BA08.
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