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
a5741ef6-0599-4657-8cda-2902ded4f680
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 2, 2022
Manufacturers
FDA
Macleods Pharmaceuticals Limited
DUNS: 862128535
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 Code33342-150
Application NumberANDA206887
Product Classification
M
Marketing Category
C73584
G
Generic Name
IBANDRONATE SODIUM
Product Specifications
Route of AdministrationORAL
Effective DateJuly 2, 2022
FDA Product Classification
INGREDIENTS (11)
IBANDRONATE SODIUMActive
Quantity: 150 mg in 1 1
Code: J12U072QL0
Classification: ACTIM
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
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 GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT