Xofluza

Product NDC: 50090-4104
11-digit product format: 500904104
Labeler code: 50090
Product ID: 50090-4104_dd56a138-b947-4413-8098-c65e5a6de200
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: 40 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50090-4104		I	Inactivated by FDA		2026-08-11
excluded package	package	50090-4104	50090-4104-0	I	Inactivated by FDA		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-4104-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-4104-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-4104-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-4104-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-4104-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-4104-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-4104-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-4104-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-4104-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50090-4104-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-4104-0	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-4104-0	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50090-4104-0	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50090-4104-0	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50090-4104-0	`1332a3947898…`	`d4bfe170f9cd…`

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.

Application-product, TE code table
Application-product	TE code
N210854-002	AB
N210854-003	AB

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	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N210854-001	M-187	2027-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210854-002	M-187	2027-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210854-003	M-187	2027-12-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210854-001	M-187	2027-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210854-002	M-187	2027-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210854-003	M-187	2027-12-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210854-001	M-187	2027-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210854-002	M-187	2027-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210854-003	M-187	2027-12-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210854-001	M-187	2027-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210854-002	M-187	2027-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210854-003	M-187	2027-12-19	`fd3edfee7708…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210854-001	I-811	2022-10-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210854-001	NCE	2023-10-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210854-002	I-811	2022-10-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210854-002	NCE	2023-10-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210854-003	I-811	2022-10-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210854-003	NCE	2023-10-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210854-001	I-811	2022-10-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N210854-001	NCE	2023-10-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N210854-002	I-811	2022-10-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N210854-002	NCE	2023-10-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N210854-003	I-811	2022-10-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N210854-003	NCE	2023-10-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210854-001	I-811	2022-10-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N210854-001	NCE	2023-10-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N210854-002	I-811	2022-10-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N210854-002	NCE	2023-10-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N210854-003	I-811	2022-10-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N210854-003	NCE	2023-10-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210854-001	I-811	2022-10-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N210854-001	NCE	2023-10-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N210854-002	I-811	2022-10-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N210854-002	NCE	2023-10-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210854-001	I-811	2022-10-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N210854-001	NCE	2023-10-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N210854-002	I-811	2022-10-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N210854-002	NCE	2023-10-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N210854-003	I-811	2022-10-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N210854-003	NCE	2023-10-24	`bb7c543d1eb4…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e77882ec-c16a-4b71-b3f9-3d7ef83d1aed	Product name	2	20260310

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-4104-0	2023-01-30	C162847	48780-1	f386c64a-2011-0266-e053-dadaa90a7c1a	These 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 NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-4104-0	Xofluza	2 in 1 BLISTER PACK	TABLET, FILM COATED	2		5
50090-4104-0	Xofluza	1 in 1 CARTON	TABLET, FILM COATED	1		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-4104	XOFLUZA (BALOXAVIR MARBOXIL) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]	5	Legacy NDC, 2 package rows	20210418_325b077a-8fe2-435c-be70-df9579862e13.zip

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Xofluza	BALOXAVIR MARBOXIL	Sportpharm LLC	b58b2899-4d22-41e1-8f0c-bdead8917694	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210854 application number: NDA210854
Xofluza	BALOXAVIR MARBOXIL	Genentech, Inc.	e49e1a61-1b7c-4be5-ac84-af6240b511e7	2025-12-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210854 application number: NDA210854

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
505CXM6OHG	BALOXAVIR MARBOXIL	1985606-14-1	BALOXAVIR MARBOXIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2100100	{2 (baloxavir marboxil 40 MG Oral Tablet [Xofluza]) } Pack [Xofluza 80 MG Dose Pack (2 x 40 MG Tablets)]	BPCK	325b077a-8fe2-435c-be70-df9579862e13	5
2100026	{2 (baloxavir marboxil 40 MG Oral Tablet) } Pack	GPCK	325b077a-8fe2-435c-be70-df9579862e13	5
2100008	baloxavir marboxil 40 MG Oral Tablet	PSN	325b077a-8fe2-435c-be70-df9579862e13	5
2100026	baloxavir marboxil 80 MG Dose Pack (2 x 40 MG Tablets)	PSN	325b077a-8fe2-435c-be70-df9579862e13	5
2100010	Xofluza 40 MG Oral Tablet	PSN	325b077a-8fe2-435c-be70-df9579862e13	5
2100100	Xofluza 80 MG Dose Pack (2 x 40 MG Tablets)	PSN	325b077a-8fe2-435c-be70-df9579862e13	5
2100010	baloxavir marboxil 40 MG Oral Tablet [Xofluza]	SBD	325b077a-8fe2-435c-be70-df9579862e13	5
2100008	baloxavir marboxil 40 MG Oral Tablet	SCD	325b077a-8fe2-435c-be70-df9579862e13	5
2100026	baloxavir marboxil 80 MG Dose Pack (2 x 40 MG Tablets)	SY	325b077a-8fe2-435c-be70-df9579862e13	5
2100010	Xofluza 40 MG Oral Tablet	SY	325b077a-8fe2-435c-be70-df9579862e13	5
2100100	Xofluza 80 MG Dose Pack (2 x 40 MG Tablets)	SY	325b077a-8fe2-435c-be70-df9579862e13	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-4104-0	50090410400	1 BLISTER PACK in 1 CARTON (50090-4104-0) > 2 TABLET, FILM COATED in 1 BLISTER PACK	1 blister pack	2019-01-29	0000-00-00	No	No	Current