🇺🇸
United States · US · US:43598-331_d89899a3-8ada-0438-07b9-2164c640995a
Zoledronic Acid
Orange BookUNIISPLATC M05BA08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDr.Reddy's Laboratories Inc
CountryUS (United States)
ATC codeM05BA08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc114359833111100 mL in 1 BOTTLE, GLASS (43598-331-11)
Annotations
UNII (FDA Substance ID)
6XC1PAD3KF
ZOLEDRONIC ACID
RxCUI 77655
Orange Book
A091363
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": "43598-331_d89899a3-8ada-0438-07b9-2164c640995a",
"productndc": "43598-331",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "091363",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 5MG BASE/100ML",
"product_no": "001",
"approval_date": "Mar 29, 2013"
}
],
"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": "ANDA091363",
"marketing_category": "ANDA",
"nonproprietary_name": "Zoledronic Acid",
"start_marketing_date": "20130819",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code M05BA08.
Access this data programmatically
Query Zoledronic Acid and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.