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Xofluza

Baloxavir Marboxil · Granule, for Suspension

Prescription NDA RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Xofluza
Generic name
Baloxavir Marboxil
Dosage form
Granule, for Suspension
Route
Oral
Marketing category
NDA · NDA
Labeler
Genentech, Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
2
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Baloxavir Marboxil 30 mg/1 2536740 View
Baloxavir Marboxil 40 mg/1 2536740 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Granule, for Suspension
Route of administration
Oral
Presentations
4

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Chelating Activity [MoA] MoA 3 members — no class page
Polymerase Acidic Endonuclease Inhibitor [EPC] EPC 2 members — no class page
Polymerase Acidic Endonuclease Inhibitors [MoA] MoA 2 members — no class page

Regulatory status

Source: Drugs@FDANDC Directory
Application number
214410
Application type
NDA · New Drug Application
Approval date
November 23, 2020
Sponsor
GENENTECH INC
Products on application
3
Submissions recorded
7
Products approved under application 214410.
Product Trade name Form Strength Ingredient Status TE Flags
214410-001 XOFLUZA FOR SUSPENSION BALOXAVIR MARBOXIL Prescription — RLD RS
214410-002 XOFLUZA FOR SUSPENSION BALOXAVIR MARBOXIL Prescription — RLD
214410-003 XOFLUZA FOR SUSPENSION BALOXAVIR MARBOXIL Prescription — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
9815835 June 14, 2030 001 No December 17, 2020
9815835 June 14, 2030 002 No June 26, 2025
9815835 June 14, 2030 003 No June 26, 2025
8927710 May 5, 2031 001 No December 17, 2020
8927710 May 5, 2031 002 No June 26, 2025
8927710 May 5, 2031 003 No June 26, 2025
8987441 October 24, 2032 001 Yes December 17, 2020
8987441 October 24, 2032 002 Yes June 26, 2025
8987441 October 24, 2032 003 Yes June 26, 2025
10633397 April 27, 2036 001 No U-2816 December 17, 2020
10633397 April 27, 2036 001 No U-3000 December 17, 2020
10392406 April 27, 2036 001 Yes December 17, 2020
10633397 April 27, 2036 002 No U-3000 June 26, 2025
10633397 April 27, 2036 002 No U-2816 June 26, 2025
10392406 April 27, 2036 002 Yes June 26, 2025
10633397 April 27, 2036 003 No U-3000 June 26, 2025
10633397 April 27, 2036 003 No U-2816 June 26, 2025
10392406 April 27, 2036 003 Yes June 26, 2025
11306106 August 9, 2037 001 No U-2816 May 17, 2022
11306106 August 9, 2037 001 No U-3000 May 17, 2022
10759814 August 9, 2037 001 Yes December 17, 2020
11306106 August 9, 2037 002 No U-3000 June 26, 2025
11306106 August 9, 2037 002 No U-2816 June 26, 2025
10759814 August 9, 2037 002 Yes June 26, 2025
11306106 August 9, 2037 003 No U-2816 June 26, 2025
11306106 August 9, 2037 003 No U-3000 June 26, 2025
10759814 August 9, 2037 003 Yes June 26, 2025
11261198 September 25, 2038 001 No April 4, 2022
11261198 September 25, 2038 002 No June 26, 2025
11261198 September 25, 2038 003 No June 26, 2025
11925648 April 21, 2041 001 No March 28, 2024
11925648 April 21, 2041 002 No June 26, 2025
11925648 April 21, 2041 003 No June 26, 2025
Regulatory exclusivity periods.
Code Expires Product
M-187 December 19, 2027 001
M-187 December 19, 2027 002
M-187 December 19, 2027 003

Approval history

Source: Drugs@FDA
Most recent submissions on application 214410.
Type No. Action Status Date Review
Supplement 8 Efficacy Approved May 30, 2025 Standard
Supplement 7 Efficacy Approved December 19, 2024 Standard
Supplement 6 Efficacy Approved March 1, 2024 Standard
Supplement 5 Labeling Approved June 15, 2023 Standard
Original application 2 Efficacy Approved August 11, 2022 Standard
Supplement 1 Labeling Approved September 27, 2021 Standard
Original application 1 Type 3 - New Dosage Form Approved November 23, 2020 Standard

Review documents

  • 0 · Supplement · April 27, 2026
  • 0 · Supplement · June 2, 2025
  • 0 · Supplement · December 23, 2024
  • 0 · Supplement · December 20, 2024
  • 0 · Supplement · March 4, 2024
  • 0 · Supplement · March 4, 2024
  • 0 · Supplement · June 16, 2023
  • 0 · Supplement · June 16, 2023
  • 0 · Original application · October 3, 2022
  • 0 · Original application · August 12, 2022
  • 0 · Original application · August 11, 2022
  • 0 · Supplement · September 28, 2021
  • 0 · Original application · February 3, 2021
  • 0 · Original application · December 21, 2020
  • 0 · Original application · November 25, 2020

Adverse event reports

Source: openFDA FAERS
2,301
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: BALOXAVIR MARBOXIL. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
50242-599-01 50242-599 Genentech, Inc. 1 PACKET in 1 CARTON (50242-599-01) / 1 GRANULE, FOR SUSPENSION in 1 PACKET May 30, 2025
50242-617-01 50242-617 Genentech, Inc. 1 PACKET in 1 CARTON (50242-617-01) / 1 GRANULE, FOR SUSPENSION in 1 PACKET May 30, 2025
50242-599 50242-599 Genentech, Inc. — May 30, 2025
50242-617 50242-617 Genentech, Inc. — May 30, 2025

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 12 sections on this page.