Ibandronate Sodium
These highlights do not include all the information needed to use IBANDRONATE safely and effectively. See full prescribing information for IBANDRONATE . IBANDRONATE sodium injection, for intravenous use Initial U.S. Approval: 2003
Approved
Approval ID
9fad4982-95af-d711-f50a-867311835143
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 14, 2023
Manufacturers
FDA
Apotex Corp.
DUNS: 845263701
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 Code60505-6097
Application NumberANDA204222
Product Classification
M
Marketing Category
C73584
G
Generic Name
ibandronate sodium
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 14, 2023
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