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United States · US · US:0143-9642_c3a41c1b-a9b0-4ad4-83b8-25e56e2c95fe
Zoledronic Acid
Orange BookUNIISPLATC M05BA08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeM05BA08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1101439642015 mL in 1 VIAL (0143-9642-01)
Annotations
UNII (FDA Substance ID)
6XC1PAD3KF
ZOLEDRONIC ACID
RxCUI 77655
Orange Book
A202182
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": "0143-9642_c3a41c1b-a9b0-4ad4-83b8-25e56e2c95fe",
"productndc": "0143-9642",
"dosage_form": "INJECTION, SOLUTION, CONCENTRATE",
"orange_book": {
"appl_no": "202182",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 4MG BASE/5ML",
"product_no": "001",
"approval_date": "Jun 3, 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": "ANDA202182",
"marketing_category": "ANDA",
"nonproprietary_name": "zoledronic acid",
"start_marketing_date": "20130603",
"active_numerator_strength": "4"
}Related drugs
Other records sharing ATC code M05BA08.
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