FDA.reportPublic FDA data

Xofluza

Product NDC
50090-4102
11-digit product format
500904102
Labeler code
50090
Product ID
50090-4102_d1793e75-d47c-48b6-a799-17e2f6603be2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BALOXAVIR MARBOXIL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA210854
Marketing category
NDA
Marketing start
2018-10-24
Marketing end
0000-00-00
Substance
BALOXAVIR MARBOXIL
Active strength
20 mg/1
Pharmacologic classes
Polymerase Acidic Endonuclease Inhibitor [EPC],Polymerase Acidic Endonuclease Inhibitors [MoA],Chelating Activity [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4102-02023-01-30C16284748780-1f386c64a-406b-0266-e053-dadaa90a7c1aThese 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4102-0Xofluza1 in 1 CARTONTABLET, FILM COATED15
50090-4102-0Xofluza2 in 1 BLISTER PACKTABLET, FILM COATED25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4102-0EA - Each50090-410285299486-b841-4d15-af29-5f72967e378b12022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4102XOFLUZA (BALOXAVIR MARBOXIL) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]5Legacy NDC, 2 package rows20210418_e9e6990a-66d3-4e13-b823-ff04d2d65886.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2100099{2 (baloxavir marboxil 20 MG Oral Tablet [Xofluza]) } Pack [Xofluza 40 MG Dose Pack (2 x 20 MG Tablets)]BPCKe9e6990a-66d3-4e13-b823-ff04d2d658865
2100024{2 (baloxavir marboxil 20 MG Oral Tablet) } PackGPCKe9e6990a-66d3-4e13-b823-ff04d2d658865
2100000baloxavir marboxil 20 MG Oral TabletPSNe9e6990a-66d3-4e13-b823-ff04d2d658865
2100024baloxavir marboxil 40 MG Dose Pack (2 x 20 MG Tablets)PSNe9e6990a-66d3-4e13-b823-ff04d2d658865
2100006Xofluza 20 MG Oral TabletPSNe9e6990a-66d3-4e13-b823-ff04d2d658865
2100099Xofluza 40 MG Dose Pack (2 x 20 MG Tablets)PSNe9e6990a-66d3-4e13-b823-ff04d2d658865
2100006baloxavir marboxil 20 MG Oral Tablet [Xofluza]SBDe9e6990a-66d3-4e13-b823-ff04d2d658865
2100000baloxavir marboxil 20 MG Oral TabletSCDe9e6990a-66d3-4e13-b823-ff04d2d658865
2100024baloxavir marboxil 40 MG Dose Pack (2 x 20 MG Tablets)SYe9e6990a-66d3-4e13-b823-ff04d2d658865
2100006Xofluza 20 MG Oral TabletSYe9e6990a-66d3-4e13-b823-ff04d2d658865
2100099Xofluza 40 MG Dose Pack (2 x 20 MG Tablets)SYe9e6990a-66d3-4e13-b823-ff04d2d658865

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4102-0500904102001 BLISTER PACK in 1 CARTON (50090-4102-0) > 2 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2019-01-290000-00-00NoNoCurrent