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
824eaeee-6b3d-4d62-b268-77f8bd8e7f10
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 8, 2020
Manufacturers
FDA
Gland Pharma Limited
DUNS: 918601238
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 Code68083-135
Application NumberANDA204217
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateAugust 8, 2020
Generic NameZoledronic Acid
INGREDIENTS (3)
MannitolInactive
Code: 3OWL53L36A
Classification: IACT
Zoledronic AcidActive
Quantity: 5 mg in 100 mL
Code: 6XC1PAD3KF
Classification: ACTIM
Sodium CitrateInactive
Code: 1Q73Q2JULR
Classification: IACT