FDA.reportPublic FDA data

Xofluza

Product NDC
50242-617
11-digit product format
502420617
Labeler code
50242
Product ID
50242-617_c2da90f4-a11c-46d2-be18-53d286b084cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baloxavir Marboxil
Dosage form
GRANULE, FOR SUSPENSION
Route
ORAL
Labeler
Genentech, Inc.
Application
NDA214410
Marketing category
NDA
Marketing start
2025-05-30
Substance
BALOXAVIR MARBOXIL
Active strength
40 mg/1
Pharmacologic classes
Chelating Activity [MoA], Polymerase Acidic Endonuclease Inhibitor [EPC], Polymerase Acidic Endonuclease Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Xofluza
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BALOXAVIR MARBOXIL40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii505CXM6OHG
Rxcui2100008, 2100010, 2467537, 2467539, 2536740, 2536742, 2716798, 2716800

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e77882ec-c16a-4b71-b3f9-3d7ef83d1aedProduct name220260310

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50242-617-01Xofluza1 in 1 PACKETGRANULE, FOR SUSPENSION130
50242-617-01Xofluza1 in 1 CARTONGRANULE, FOR SUSPENSION130

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2716798baloxavir marboxil 30 MG Granules for Oral SuspensionPSNe49e1a61-1b7c-4be5-ac84-af6240b511e730
2467537baloxavir marboxil 40 MG Granules for Oral SuspensionPSNe49e1a61-1b7c-4be5-ac84-af6240b511e730
2100008baloxavir marboxil 40 MG Oral TabletPSNe49e1a61-1b7c-4be5-ac84-af6240b511e730
2536740baloxavir marboxil 80 MG Oral TabletPSNe49e1a61-1b7c-4be5-ac84-af6240b511e730
2716800Xofluza 30 MG Granules for Oral SuspensionPSNe49e1a61-1b7c-4be5-ac84-af6240b511e730
2467539Xofluza 40 MG Granules for Oral SuspensionPSNe49e1a61-1b7c-4be5-ac84-af6240b511e730
2100010Xofluza 40 MG Oral TabletPSNe49e1a61-1b7c-4be5-ac84-af6240b511e730
2536742Xofluza 80 MG Oral TabletPSNe49e1a61-1b7c-4be5-ac84-af6240b511e730
2716800baloxavir marboxil 30 MG Granules for Oral Suspension [Xofluza]SBDe49e1a61-1b7c-4be5-ac84-af6240b511e730
2467539baloxavir marboxil 40 MG Granules for Oral Suspension [Xofluza]SBDe49e1a61-1b7c-4be5-ac84-af6240b511e730
2100010baloxavir marboxil 40 MG Oral Tablet [Xofluza]SBDe49e1a61-1b7c-4be5-ac84-af6240b511e730
2536742baloxavir marboxil 80 MG Oral Tablet [Xofluza]SBDe49e1a61-1b7c-4be5-ac84-af6240b511e730
2716798baloxavir marboxil 30 MG Granules for Oral SuspensionSCDe49e1a61-1b7c-4be5-ac84-af6240b511e730
2467537baloxavir marboxil 40 MG Granules for Oral SuspensionSCDe49e1a61-1b7c-4be5-ac84-af6240b511e730
2100008baloxavir marboxil 40 MG Oral TabletSCDe49e1a61-1b7c-4be5-ac84-af6240b511e730
2536740baloxavir marboxil 80 MG Oral TabletSCDe49e1a61-1b7c-4be5-ac84-af6240b511e730
2716800Xofluza 30 MG Granules for Oral SuspensionSYe49e1a61-1b7c-4be5-ac84-af6240b511e730
2467539Xofluza 40 MG Granules for Oral SuspensionSYe49e1a61-1b7c-4be5-ac84-af6240b511e730
2100010Xofluza 40 MG Oral TabletSYe49e1a61-1b7c-4be5-ac84-af6240b511e730
2536742Xofluza 80 MG Oral TabletSYe49e1a61-1b7c-4be5-ac84-af6240b511e730

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50242-617-01502420617011 PACKET in 1 CARTON (50242-617-01) / 1 GRANULE, FOR SUSPENSION in 1 PACKET1 packet2025-05-30NoNoCurrent