Xofluza
These highlights do not include all the information needed to use XOFLUZA safely and effectively. See full prescribing information for XOFLUZA. XOFLUZA (baloxavir marboxil) tablets, for oral use XOFLUZA (baloxavir marboxil) for oral suspension Initial U.S. Approval: 2018
Approved
Approval ID
325b077a-8fe2-435c-be70-df9579862e13
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 16, 2021
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
BALOXAVIR MARBOXIL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-4104
Application NumberNDA210854
Product Classification
M
Marketing Category
C73594
G
Generic Name
BALOXAVIR MARBOXIL
Product Specifications
Route of AdministrationORAL
Effective DateJune 16, 2020
FDA Product Classification
INGREDIENTS (9)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
BALOXAVIR MARBOXILActive
Quantity: 40 mg in 1 1
Code: 505CXM6OHG
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
POVIDONE K25Inactive
Code: K0KQV10C35
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT