Ibandronate Sodium
These highlights do not include all the information needed to use IBANDRONATE SODIUM INJECTION safely and effectively. See full prescribing information for IBANDRONATE SODIUM INJECTION. IBANDRONATE SODIUM injection, for intravenous use Initial U.S. Approval: 2003
Approved
Approval ID
e81f2c5b-bead-48ac-be3e-016cf963d7ed
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 28, 2022
Manufacturers
FDA
AuroMedics Pharma LLC
DUNS: 968961354
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ibandronate Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55150-191
Application NumberANDA205332
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ibandronate Sodium
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 5, 2022
FDA Product Classification
INGREDIENTS (5)
IBANDRONATE SODIUMActive
Quantity: 3 mg in 3 mL
Code: J12U072QL0
Classification: ACTIM
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT