FDA.reportPublic FDA data

Xofluza

Product NDC
50242-583
11-digit product format
502420583
Labeler code
50242
Product ID
50242-583_c2da90f4-a11c-46d2-be18-53d286b084cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BALOXAVIR MARBOXIL
Dosage form
GRANULE, FOR SOLUTION
Route
ORAL
Labeler
Genentech, Inc.
Application
NDA214410
Marketing category
NDA
Marketing start
2018-10-24
Substance
BALOXAVIR MARBOXIL
Active strength
40 mg/20mL
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/20mL

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
50242-583-01Xofluza1 in 1 CARTONGRANULE, FOR SOLUTION130
50242-583-01Xofluza20 mL in 1 BOTTLE, GLASSGRANULE, FOR SOLUTION2030

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50242-583-01ML - Milliliter50242-58393758549-2f63-4d92-b5d1-c01cad64e11712022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50242-583XOFLUZA (BALOXAVIR MARBOXIL) TABLET, FILM COATED XOFLUZA (BALOXAVIR MARBOXIL) GRANULE, FOR SOLUTION [GENENTECH, INC.]27Current NDC, Legacy NDC, 2 package rows20250326_e49e1a61-1b7c-4be5-ac84-af6240b511e7.zip

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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50242-583-01502420583011 BOTTLE, GLASS in 1 CARTON (50242-583-01) / 20 mL in 1 BOTTLE, GLASS2020-11-230000-00-00NoNoCurrent