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
acbc54fc-4248-416f-849c-2cd3bed0a843
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 1, 2022
Manufacturers
FDA
Alvogen Inc.
DUNS: 008057330
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 Code47781-103
Application NumberANDA078998
Product Classification
M
Marketing Category
C73584
G
Generic Name
IBANDRONATE SODIUM
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 1, 2017
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
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT