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United States · US · US:71288-806_a4589df5-8c10-4040-ba54-637c518a0e11
Zoledronic Acid
Orange BookUNIISPLATC M05BA08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMeitheal Pharmaceuticals Inc.
CountryUS (United States)
ATC codeM05BA08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1171288806511 BOTTLE, GLASS in 1 CARTON (71288-806-51) / 100 mL in 1 BOTTLE, GLASS
Annotations
UNII (FDA Substance ID)
6XC1PAD3KF
ZOLEDRONIC ACID
RxCUI 77655
Orange Book
A213371
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": "71288-806_a4589df5-8c10-4040-ba54-637c518a0e11",
"productndc": "71288-806",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "213371",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 5MG BASE/100ML",
"product_no": "001",
"approval_date": "Jun 5, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ZOLEDRONIC ACID",
"proprietary_name": "Zoledronic Acid",
"active_ingred_unit": "mg/100mL",
"application_number": "ANDA213371",
"marketing_category": "ANDA",
"nonproprietary_name": "Zoledronic Acid",
"start_marketing_date": "20230605",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code M05BA08.
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