Ibandronate sodium
These highlights do not include all the information needed to use IBANDRONATE SODIUM TABLETS safely and effectively. See full prescribing information for IBANDRONATE SODIUM TABLETS. IBANDRONATE SODIUM tablets, for oral use Initial U.S. Approval: 2003
Approved
Approval ID
f94d9c49-245a-8081-42c4-785113fce498
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 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.
Ibandronate sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55111-575
Application NumberANDA078997
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ibandronate sodium
Product Specifications
Route of AdministrationORAL
Effective DateApril 30, 2023
FDA Product Classification
INGREDIENTS (15)
ibandronate sodiumActive
Quantity: 150 mg in 1 1
Code: J12U072QL0
Classification: ACTIM
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
sodium stearyl fumarateInactive
Code: 7CV7WJK4UI
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
polyethylene glycol 400Inactive
Code: B697894SGQ
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
shellacInactive
Code: 46N107B71O
Classification: IACT