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
2b84257d-d8b3-56fe-e054-00144ff88e88
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2024
Manufacturers
FDA
Accord Healthcare Inc.
DUNS: 604222237
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 Code16729-274
Application NumberANDA206058
Product Classification
M
Marketing Category
C73584
G
Generic Name
ibandronate sodium
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 9, 2024
FDA Product Classification
INGREDIENTS (5)
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
IBANDRONATE SODIUMActive
Quantity: 3 mg in 3 mL
Code: J12U072QL0
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT