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 useInitial U.S. Approval: 2003
Approved
Approval ID
6ca94cce-a2bb-421f-bd8f-6b14bc2bd985
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 23, 2023
Manufacturers
FDA
Bionpharma Inc.
DUNS: 079637826
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 Code69452-378
Application NumberANDA078998
Product Classification
M
Marketing Category
C73584
G
Generic Name
IBANDRONATE SODIUM
Product Specifications
Route of AdministrationORAL
Effective DateMay 23, 2023
FDA Product Classification
INGREDIENTS (12)
IBANDRONATE SODIUMActive
Quantity: 150 mg in 1 1
Code: J12U072QL0
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: CNTM
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT