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
7a5e8962-7c4b-40bb-ad69-0c3edb0338af
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 15, 2023
Manufacturers
FDA
Gland Pharma Limited
DUNS: 918601238
Products 2
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 Code68083-615
Application NumberANDA202930
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateNovember 15, 2023
Generic Namezoledronic acid
INGREDIENTS (4)
SODIUM CITRATEInactive
Quantity: 24 mg in 5 mL
Code: 1Q73Q2JULR
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MANNITOLInactive
Quantity: 220 mg in 5 mL
Code: 3OWL53L36A
Classification: IACT
ZOLEDRONIC ACIDActive
Quantity: 4 mg in 5 mL
Code: 6XC1PAD3KF
Classification: ACTIM
zoledronic acid
PRODUCT DETAILS
NDC Product Code68083-116
Application NumberANDA202930
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateNovember 15, 2023
Generic Namezoledronic acid
INGREDIENTS (4)
MANNITOLInactive
Quantity: 220 mg in 5 mL
Code: 3OWL53L36A
Classification: IACT
ZOLEDRONIC ACIDActive
Quantity: 4 mg in 5 mL
Code: 6XC1PAD3KF
Classification: ACTIM
SODIUM CITRATEInactive
Quantity: 24 mg in 5 mL
Code: 1Q73Q2JULR
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT