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 Initial U.S. Approval: 2001
Approved
Approval ID
16fcf8c9-ef8a-4e93-9ee6-acfadd35a861
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 21, 2023
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 608775388
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-966
Application NumberANDA204217
Product Classification
M
Marketing Category
C73584
G
Generic Name
Zoledronic Acid
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 31, 2022
FDA Product Classification
INGREDIENTS (3)
ZOLEDRONIC ACIDActive
Quantity: 5 mg in 100 mL
Code: 6XC1PAD3KF
Classification: ACTIM
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT