Home NDC 50242-617 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 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 N214410-001 XOFLUZA BALOXAVIR MARBOXIL 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 N214410-002 XOFLUZA BALOXAVIR MARBOXIL 30MG/PACKET FOR SUSPENSION / ORAL RLD 2025-05-30 N214410-003 XOFLUZA BALOXAVIR MARBOXIL 40MG/PACKET FOR SUSPENSION / ORAL RLD, RS 2025-05-30
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 N214410-001 9815835 2030-06-14 Drug product 2020-12-17 N214410-001 8927710 2031-05-05 Drug product 2020-12-17 N214410-001 8987441 2032-10-24 Drug substance, Drug product 2020-12-17 N214410-001 10392406 2036-04-27 Drug substance 2020-12-17 N214410-001 10633397 2036-04-27 U-2816 2020-12-17 N214410-001 10633397 2036-04-27 U-3000 2020-12-17 N214410-001 10759814 2037-08-09 Drug substance, Drug product 2020-12-17 N214410-001 11306106 2037-08-09 U-2816 2022-05-17 N214410-001 11306106 2037-08-09 U-3000 2022-05-17 N214410-001 11261198 2038-09-25 Drug product 2022-04-04 N214410-001 11925648 2041-04-21 Drug product 2024-03-28 N214410-002 9815835 2030-06-14 Drug product 2025-06-26 N214410-002 8927710 2031-05-05 Drug product 2025-06-26 N214410-002 8987441 2032-10-24 Drug substance, Drug product 2025-06-26 N214410-002 10392406 2036-04-27 Drug substance 2025-06-26 N214410-002 10633397 2036-04-27 U-2816 2025-06-26 N214410-002 10633397 2036-04-27 U-3000 2025-06-26 N214410-002 10759814 2037-08-09 Drug substance, Drug product 2025-06-26 N214410-002 11306106 2037-08-09 U-2816 2025-06-26 N214410-002 11306106 2037-08-09 U-3000 2025-06-26 N214410-002 11261198 2038-09-25 Drug product 2025-06-26 N214410-002 11925648 2041-04-21 Drug product 2025-06-26 N214410-003 9815835 2030-06-14 Drug product 2025-06-26 N214410-003 8927710 2031-05-05 Drug product 2025-06-26 N214410-003 8987441 2032-10-24 Drug substance, Drug product 2025-06-26 N214410-003 10392406 2036-04-27 Drug substance 2025-06-26 N214410-003 10633397 2036-04-27 U-2816 2025-06-26 N214410-003 10633397 2036-04-27 U-3000 2025-06-26 N214410-003 10759814 2037-08-09 Drug substance, Drug product 2025-06-26 N214410-003 11306106 2037-08-09 U-2816 2025-06-26 N214410-003 11306106 2037-08-09 U-3000 2025-06-26 N214410-003 11261198 2038-09-25 Drug product 2025-06-26 N214410-003 11925648 2041-04-21 Drug product 2025-06-26
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 3 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N214410-001 M-187 2027-12-19 N214410-002 M-187 2027-12-19 N214410-003 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 2 · 44 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 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-002 XOFLUZA 30MG/PACKET FOR SUSPENSION / ORAL RLD 2025-05-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-003 XOFLUZA 40MG/PACKET FOR SUSPENSION / ORAL RLD, RS 2025-05-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214410-002 XOFLUZA 30MG/PACKET FOR SUSPENSION / ORAL RLD 2025-05-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214410-003 XOFLUZA 40MG/PACKET FOR SUSPENSION / ORAL RLD, RS 2025-05-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214410-002 XOFLUZA 30MG/PACKET FOR SUSPENSION / ORAL RLD 2025-05-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214410-003 XOFLUZA 40MG/PACKET FOR SUSPENSION / ORAL RLD, RS 2025-05-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 8869cabd3fbd…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 11 · 436 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 N214410-001 9815835 2030-06-14 Drug product 2020-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-001 8927710 2031-05-05 Drug product 2020-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-001 8987441 2032-10-24 Drug substance, Drug product 2020-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-001 10392406 2036-04-27 Drug substance 2020-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-001 10633397 2036-04-27 U-2816 2020-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-001 10633397 2036-04-27 U-3000 2020-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-001 10759814 2037-08-09 Drug substance, Drug product 2020-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-001 11306106 2037-08-09 U-2816 2022-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-001 11306106 2037-08-09 U-3000 2022-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-001 11261198 2038-09-25 Drug product 2022-04-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-001 11925648 2041-04-21 Drug product 2024-03-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-002 9815835 2030-06-14 Drug product 2025-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-002 8927710 2031-05-05 Drug product 2025-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-002 8987441 2032-10-24 Drug substance, Drug product 2025-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-002 10392406 2036-04-27 Drug substance 2025-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-002 10633397 2036-04-27 U-3000 2025-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-002 10633397 2036-04-27 U-2816 2025-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-002 10759814 2037-08-09 Drug substance, Drug product 2025-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-002 11306106 2037-08-09 U-3000 2025-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-002 11306106 2037-08-09 U-2816 2025-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-002 11261198 2038-09-25 Drug product 2025-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-002 11925648 2041-04-21 Drug product 2025-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-003 9815835 2030-06-14 Drug product 2025-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-003 8927710 2031-05-05 Drug product 2025-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-003 8987441 2032-10-24 Drug substance, Drug product 2025-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-003 10392406 2036-04-27 Drug substance 2025-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-003 10633397 2036-04-27 U-3000 2025-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-003 10633397 2036-04-27 U-2816 2025-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-003 10759814 2037-08-09 Drug substance, Drug product 2025-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-003 11306106 2037-08-09 U-2816 2025-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-003 11306106 2037-08-09 U-3000 2025-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-003 11261198 2038-09-25 Drug product 2025-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-003 11925648 2041-04-21 Drug product 2025-06-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214410-001 9815835 2030-06-14 Drug product 2020-12-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214410-001 8927710 2031-05-05 Drug product 2020-12-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214410-001 8987441 2031-09-21 Drug substance, Drug product 2020-12-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214410-001 10392406 2036-04-27 Drug substance 2020-12-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214410-001 10633397 2036-04-27 U-2816 2020-12-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214410-001 10633397 2036-04-27 U-3000 2020-12-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214410-001 10759814 2037-08-09 Drug substance, Drug product 2020-12-17 31067a03dcf5…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Xofluza
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BALOXAVIR MARBOXIL 40 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 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2100008 Internal RxNorm lookup 2100010 Internal RxNorm lookup 2467537 Internal RxNorm lookup 2467539 Internal RxNorm lookup 2536740 Internal RxNorm lookup 2536742 Internal RxNorm lookup 2716798 Internal RxNorm lookup 2716800 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 50242-617-01 Xofluza 1 in 1 PACKET GRANULE, FOR SUSPENSION 1 30 50242-617-01 Xofluza 1 in 1 CARTON GRANULE, FOR SUSPENSION 1 30
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 · 1 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 50242-617-01 50242061701 1 PACKET in 1 CARTON (50242-617-01) / 1 GRANULE, FOR SUSPENSION in 1 PACKET 1 packet 2025-05-30 No No Current