Home NDC 85766-058 Xofluza
Product NDC 85766-058
11-digit product format 857660058
Labeler code 85766
Product ID 85766-058_502f0591-7637-2e7b-e063-6294a90a6e98
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name BALOXAVIR MARBOXIL
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sportpharm LLC
Application NDA210854
Marketing category NDA
Marketing start 2018-10-24
Substance BALOXAVIR MARBOXIL
Active strength 80 mg/1
Pharmacologic classes Chelating Activity [MoA], Polymerase Acidic Endonuclease Inhibitor [EPC], Polymerase Acidic Endonuclease Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N210854-001 XOFLUZA BALOXAVIR MARBOXIL 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2018-10-24 N210854-002 XOFLUZA BALOXAVIR MARBOXIL 40MG TABLET / ORAL AB RLD 2018-10-24 N210854-003 XOFLUZA BALOXAVIR MARBOXIL 80MG TABLET / ORAL AB RLD, RS 2021-03-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 33 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N210854-001 9815835 2030-06-14 Drug product 2018-11-16 N210854-001 8927710 2031-05-05 Drug product 2018-11-16 N210854-001 8987441 2032-10-24 Drug substance, Drug product 2018-11-16 N210854-001 10392406 2036-04-27 Drug substance 2019-09-20 N210854-001 10633397 2036-04-27 U-2816 2020-05-26 N210854-001 10633397 2036-04-27 U-3000 2020-05-26 N210854-001 10759814 2037-08-09 Drug substance, Drug product 2020-12-17 N210854-001 11306106 2037-08-09 U-2816 2022-05-17 N210854-001 11306106 2037-08-09 U-3000 2022-05-17 N210854-001 11261198 2038-09-25 Drug product 2022-04-04 N210854-001 12064438 2039-10-09 Drug product 2024-09-16 N210854-002 9815835 2030-06-14 Drug product 2018-11-16 N210854-002 8927710 2031-05-05 Drug product 2018-11-16 N210854-002 8987441 2032-10-24 Drug substance, Drug product 2018-11-16 N210854-002 10392406 2036-04-27 Drug substance 2019-09-20 N210854-002 10633397 2036-04-27 U-2816 2020-05-26 N210854-002 10633397 2036-04-27 U-3000 2020-05-26 N210854-002 10759814 2037-08-09 Drug substance, Drug product 2020-12-17 N210854-002 11306106 2037-08-09 U-2816 2022-05-17 N210854-002 11306106 2037-08-09 U-3000 2022-05-17 N210854-002 11261198 2038-09-25 Drug product 2022-04-04 N210854-002 12064438 2039-10-09 Drug product 2024-09-16 N210854-003 9815835 2030-06-14 Drug product 2021-08-11 N210854-003 8927710 2031-05-05 Drug product 2021-08-11 N210854-003 8987441 2032-10-24 Drug substance, Drug product 2021-08-11 N210854-003 10392406 2036-04-27 Drug substance 2021-08-11 N210854-003 10633397 2036-04-27 U-2816 2021-08-11 N210854-003 10633397 2036-04-27 U-3000 2021-08-11 N210854-003 10759814 2037-08-09 Drug substance, Drug product 2021-08-11 N210854-003 11306106 2037-08-09 U-2816 2022-05-17 N210854-003 11306106 2037-08-09 U-3000 2022-05-17 N210854-003 11261198 2038-09-25 Drug product 2022-04-04 N210854-003 12064438 2039-10-09 Drug product 2024-09-16
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 3 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N210854-001 M-187 2027-12-19 N210854-002 M-187 2027-12-19 N210854-003 M-187 2027-12-19
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 116 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N210854-001 XOFLUZA 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2018-10-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210854-002 XOFLUZA 40MG TABLET / ORAL RLD 2018-10-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210854-003 XOFLUZA 80MG TABLET / ORAL RLD, RS 2021-03-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210854-001 XOFLUZA 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2018-10-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210854-002 XOFLUZA 40MG TABLET / ORAL RLD 2018-10-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210854-003 XOFLUZA 80MG TABLET / ORAL RLD, RS 2021-03-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210854-001 XOFLUZA 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2018-10-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210854-002 XOFLUZA 40MG TABLET / ORAL RLD 2018-10-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210854-003 XOFLUZA 80MG TABLET / ORAL RLD, RS 2021-03-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210854-001 XOFLUZA 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2018-10-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210854-002 XOFLUZA 40MG TABLET / ORAL RLD 2018-10-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210854-003 XOFLUZA 80MG TABLET / ORAL RLD, RS 2021-03-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210854-001 XOFLUZA 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2018-10-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210854-002 XOFLUZA 40MG TABLET / ORAL RLD 2018-10-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210854-003 XOFLUZA 80MG TABLET / ORAL RLD, RS 2021-03-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210854-001 XOFLUZA 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2018-10-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210854-002 XOFLUZA 40MG TABLET / ORAL RLD 2018-10-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210854-003 XOFLUZA 80MG TABLET / ORAL RLD, RS 2021-03-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210854-001 XOFLUZA 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2018-10-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210854-002 XOFLUZA 40MG TABLET / ORAL RLD 2018-10-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210854-003 XOFLUZA 80MG TABLET / ORAL RLD, RS 2021-03-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210854-001 XOFLUZA 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2018-10-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210854-002 XOFLUZA 40MG TABLET / ORAL RLD 2018-10-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210854-003 XOFLUZA 80MG TABLET / ORAL RLD, RS 2021-03-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210854-001 XOFLUZA 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2018-10-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210854-002 XOFLUZA 40MG TABLET / ORAL RLD 2018-10-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210854-003 XOFLUZA 80MG TABLET / ORAL RLD, RS 2021-03-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210854-001 XOFLUZA 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2018-10-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N210854-002 XOFLUZA 40MG TABLET / ORAL RLD 2018-10-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N210854-003 XOFLUZA 80MG TABLET / ORAL RLD, RS 2021-03-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210854-001 XOFLUZA 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2018-10-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210854-002 XOFLUZA 40MG TABLET / ORAL RLD 2018-10-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210854-003 XOFLUZA 80MG TABLET / ORAL RLD, RS 2021-03-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210854-001 XOFLUZA 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2018-10-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210854-002 XOFLUZA 40MG TABLET / ORAL RLD 2018-10-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210854-003 XOFLUZA 80MG TABLET / ORAL RLD, RS 2021-03-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210854-001 XOFLUZA 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2018-10-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210854-002 XOFLUZA 40MG TABLET / ORAL RLD 2018-10-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210854-003 XOFLUZA 80MG TABLET / ORAL RLD, RS 2021-03-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210854-001 XOFLUZA 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2018-10-24 8072bd15b7f6…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N210854-002 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N210854-003 AB 1 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 27 · 1,063 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N210854-001 9815835 2030-06-14 Drug product 2018-11-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210854-001 8927710 2031-05-05 Drug product 2018-11-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210854-001 8987441 2032-10-24 Drug substance, Drug product 2018-11-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210854-001 10392406 2036-04-27 Drug substance 2019-09-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210854-001 10633397 2036-04-27 U-2816 2020-05-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210854-001 10633397 2036-04-27 U-3000 2020-05-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210854-001 10759814 2037-08-09 Drug substance, Drug product 2020-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210854-001 11306106 2037-08-09 U-2816 2022-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210854-001 11306106 2037-08-09 U-3000 2022-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210854-001 11261198 2038-09-25 Drug product 2022-04-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210854-001 12064438 2039-10-09 Drug product 2024-09-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210854-002 9815835 2030-06-14 Drug product 2018-11-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210854-002 8927710 2031-05-05 Drug product 2018-11-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210854-002 8987441 2032-10-24 Drug substance, Drug product 2018-11-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210854-002 10392406 2036-04-27 Drug substance 2019-09-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210854-002 10633397 2036-04-27 U-2816 2020-05-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210854-002 10633397 2036-04-27 U-3000 2020-05-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210854-002 10759814 2037-08-09 Drug substance, Drug product 2020-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210854-002 11306106 2037-08-09 U-2816 2022-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210854-002 11306106 2037-08-09 U-3000 2022-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210854-002 11261198 2038-09-25 Drug product 2022-04-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210854-002 12064438 2039-10-09 Drug product 2024-09-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210854-003 9815835 2030-06-14 Drug product 2021-08-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210854-003 8927710 2031-05-05 Drug product 2021-08-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210854-003 8987441 2032-10-24 Drug substance, Drug product 2021-08-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210854-003 10392406 2036-04-27 Drug substance 2021-08-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210854-003 10633397 2036-04-27 U-3000 2021-08-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210854-003 10633397 2036-04-27 U-2816 2021-08-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210854-003 10759814 2037-08-09 Drug substance, Drug product 2021-08-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210854-003 11306106 2037-08-09 U-2816 2022-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210854-003 11306106 2037-08-09 U-3000 2022-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210854-003 11261198 2038-09-25 Drug product 2022-04-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210854-003 12064438 2039-10-09 Drug product 2024-09-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210854-001 9815835 2030-06-14 Drug product 2018-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210854-001 8927710 2031-05-05 Drug product 2018-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210854-001 8987441 2031-09-21 Drug substance, Drug product 2018-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210854-001 10392406 2036-04-27 Drug substance 2019-09-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210854-001 10633397 2036-04-27 U-2816 2020-05-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210854-001 10633397 2036-04-27 U-3000 2020-05-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210854-001 10759814 2037-08-09 Drug substance, Drug product 2020-12-17 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 123 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Xofluza
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BALOXAVIR MARBOXIL 80 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 505CXM6OHG Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2536740 Internal RxNorm lookup 2536742 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85766-058-01 Xofluza 1 in 1 BLISTER PACK TABLET, FILM COATED 1 2 85766-058-01 Xofluza 1 in 1 CARTON TABLET, FILM COATED 1 2
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85766-058-01 85766005801 1 BLISTER PACK in 1 CARTON (85766-058-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2025-08-22 No No Current