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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

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Zoledronic Acid - FDA Drug Approval Details