Boniva
These highlights do not include all the information needed to use BONIVA Tablets safely and effectively. See full prescribing information for BONIVA Tablets. BONIVA® (ibandronate sodium) Tablets Initial U.S. Approval: 2003
Approved
Approval ID
d6d7711f-541b-47d1-b937-2c6a021eb6c3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 2, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-5322
Application NumberNDA021455
Product Classification
M
Marketing Category
C73594
G
Generic Name
ibandronate sodium
Product Specifications
Route of AdministrationORAL
Effective DateDecember 2, 2010
FDA Product Classification
INGREDIENTS (12)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
IBANDRONATE SODIUMActive
Quantity: 150 mg in 1 1
Code: J12U072QL0
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT