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 Concentrate for Intravenous Infusion Initial U.S. Approval: 2001
Approved
Approval ID
634e9d4b-e940-4743-ad39-794dad28d79b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 5, 2023
Manufacturers
FDA
BPI Labs, LLC
DUNS: 078627620
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 Code54288-100
Application NumberANDA207341
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateOctober 5, 2023
Generic NameZOLEDRONIC ACID
INGREDIENTS (4)
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
ZOLEDRONIC ACIDActive
Quantity: 4 mg in 5 mL
Code: 6XC1PAD3KF
Classification: ACTIM