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 use Initial U.S. Approval: 2001
Approved
Approval ID
1738a682-5903-b675-3a7a-61d299a6f248
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 30, 2023
Manufacturers
FDA
Dr. Reddy's Laboratories Limited
DUNS: 650562841
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 Code55111-685
Application NumberANDA091186
Product Classification
M
Marketing Category
C73584
G
Generic Name
Zoledronic Acid
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 25, 2019
FDA Product Classification
INGREDIENTS (4)
Zoledronic AcidActive
Quantity: 4 mg in 5 mL
Code: 6XC1PAD3KF
Classification: ACTIM
MannitolInactive
Quantity: 220 mg in 5 mL
Code: 3OWL53L36A
Classification: IACT
Sodium CitrateInactive
Quantity: 24 mg in 5 mL
Code: 1Q73Q2JULR
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT