Zoledronic Acid
These highlights do not include all the information needed to use ZOLEDRONIC ACID INJECTION safely and effectively. See full prescribing information for ZOLEDRONIC ACID INJECTION. ZOLEDRONIC ACID injection, for intravenous infusion Initial U.S. Approval: 2001
Approved
Approval ID
bf5f96d4-f87c-4968-bed0-a4b5e77f4162
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 2, 2023
Manufacturers
FDA
Eugia US LLC
DUNS: 968961354
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Zoledronic Acid
PRODUCT DETAILS
NDC Product Code55150-283
Application NumberANDA209125
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateMarch 18, 2023
Generic NameZoledronic Acid
INGREDIENTS (4)
ZOLEDRONIC ACIDActive
Quantity: 5 mg in 100 mL
Code: 6XC1PAD3KF
Classification: ACTIM
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT