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
fd0324d8-b9bd-fd4c-e053-6394a90a5465
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 7, 2023
Manufacturers
FDA
FOSUN PHARMA USA INC
DUNS: 080920998
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 Code72266-152
Application NumberANDA209578
Product Classification
M
Marketing Category
C73584
G
Generic Name
Zoledronic acid
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 7, 2023
FDA Product Classification
INGREDIENTS (4)
MANNITOLInactive
Quantity: 4950 mg in 100 mL
Code: 3OWL53L36A
Classification: IACT
ZOLEDRONIC ACIDActive
Quantity: 5 mg in 100 mL
Code: 6XC1PAD3KF
Classification: ACTIM
SODIUM CITRATEInactive
Quantity: 30 mg in 100 mL
Code: 1Q73Q2JULR
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT