Metaxalone

Product NDC: 68258-7100
11-digit product format: 682587100
Labeler code: 68258
Product ID: 68258-7100_86de2f42-f64d-4801-98a8-b879a4779840
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metaxalone
Dosage form: TABLET
Route: ORAL
Labeler: Dispensing Solutions, Inc.
Application: NDA013217
Marketing category: NDA
Marketing start: 2007-11-01
Marketing end: 0000-00-00
Substance: METAXALONE
Active strength: 800 mg/1
Pharmacologic classes: Centrally-mediated Muscle Relaxation [PE]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68258-7100		I	Inactivated by FDA	2026-08-11
excluded package	package	68258-7100	68258-7100-1	I	Inactivated by FDA	2026-08-11
excluded package	package	68258-7100	68258-7100-2	I	Inactivated by FDA	2026-08-11
excluded package	package	68258-7100	68258-7100-3	I	Inactivated by FDA	2026-08-11
excluded package	package	68258-7100	68258-7100-6	I	Inactivated by FDA	2026-08-11
excluded package	package	68258-7100	68258-7100-9	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 3 · 132 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	68258-7100-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68258-7100-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68258-7100-9	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68258-7100-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68258-7100-3	`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	68258-7100-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68258-7100-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68258-7100-9	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68258-7100-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68258-7100-3	`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	68258-7100-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68258-7100-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68258-7100-9	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68258-7100-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68258-7100-3	`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	68258-7100-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68258-7100-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68258-7100-9	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68258-7100-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68258-7100-3	`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	68258-7100-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68258-7100-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68258-7100-9	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68258-7100-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68258-7100-3	`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	68258-7100-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68258-7100-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68258-7100-9	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68258-7100-6	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68258-7100-3	`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	68258-7100-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68258-7100-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68258-7100-9	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68258-7100-6	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68258-7100-3	`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	68258-7100-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68258-7100-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68258-7100-9	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68258-7100-6	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68258-7100-3	`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	68258-7100-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68258-7100-2	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68258-7100-9	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68258-7100-6	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68258-7100-3	`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	68258-7100-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68258-7100-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68258-7100-9	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68258-7100-6	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68258-7100-3	`ad56d346431e…`	`cc804d4bbf1e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N013217-001	SKELAXIN	METAXALONE	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982
N013217-003	SKELAXIN	METAXALONE	800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-08-30

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N013217-003	7122566	2026-02-06	U-915

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 · 82 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	N013217-001	SKELAXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N013217-003	SKELAXIN	800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-08-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N013217-001	SKELAXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N013217-003	SKELAXIN	800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-08-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N013217-001	SKELAXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N013217-003	SKELAXIN	800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-08-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N013217-001	SKELAXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N013217-003	SKELAXIN	800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-08-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N013217-001	SKELAXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N013217-003	SKELAXIN	800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-08-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N013217-001	SKELAXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N013217-003	SKELAXIN	800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-08-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N013217-001	SKELAXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N013217-003	SKELAXIN	800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-08-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N013217-001	SKELAXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N013217-003	SKELAXIN	800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-08-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N013217-001	SKELAXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N013217-003	SKELAXIN	800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-08-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N013217-001	SKELAXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N013217-003	SKELAXIN	800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-08-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N013217-001	SKELAXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N013217-003	SKELAXIN	800MG	TABLET / ORAL		RLD	2002-08-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N013217-001	SKELAXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N013217-003	SKELAXIN	800MG	TABLET / ORAL		RLD	2002-08-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N013217-001	SKELAXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N013217-003	SKELAXIN	800MG	TABLET / ORAL		RLD	2002-08-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N013217-001	SKELAXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N013217-003	SKELAXIN	800MG	TABLET / ORAL		RLD	2002-08-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N013217-001	SKELAXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N013217-003	SKELAXIN	800MG	TABLET / ORAL	AB	RLD, RS	2002-08-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N013217-001	SKELAXIN	400MG	TABLET / ORAL		RLD, Approved before 1982		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N013217-003	SKELAXIN	800MG	TABLET / ORAL	AB	RLD, RS	2002-08-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N013217-001	SKELAXIN	400MG	TABLET / ORAL		RLD, Approved before 1982		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N013217-003	SKELAXIN	800MG	TABLET / ORAL	AB	RLD, RS	2002-08-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N013217-001	SKELAXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		RLD, Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N013217-003	SKELAXIN	800MG	TABLET / ORAL	AB	RLD, RS	2002-08-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N013217-001	SKELAXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N013217-003	SKELAXIN	800MG	TABLET / ORAL	AB	RLD, RS	2002-08-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N013217-001	SKELAXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		RLD, Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N013217-003	SKELAXIN	800MG	TABLET / ORAL	AB	RLD, RS	2002-08-30	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N013217-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N013217-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N013217-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N013217-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N013217-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N013217-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N013217-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N013217-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N013217-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N013217-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N013217-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N013217-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N013217-003	AB	1	`ea99ee380514…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N013217-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N013217-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N013217-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N013217-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N013217-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N013217-003	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N013217-003	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N013217-003	AB	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 50 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N013217-003	7122566	2026-02-06	U-915	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N013217-003	7122566	2026-02-06	U-915	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N013217-003	7122566	2026-02-06	U-915	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N013217-003	7122566	2026-02-06	U-915	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N013217-003	7122566	2026-02-06	U-915	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N013217-003	7122566	2026-02-06	U-915	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N013217-003	7122566	2026-02-06	U-915	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N013217-003	7122566	2026-02-06	U-915	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N013217-003	7122566	2026-02-06	U-915	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N013217-003	7122566	2026-02-06	U-915	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N013217-003	7122566	2026-02-06	U-915	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N013217-003	7122566	2026-02-06	U-915	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N013217-003	7122566	2026-02-06	U-915	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N013217-003	7122566	2026-02-06	U-915	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N013217-003	7122566	2026-02-06	U-915	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N013217-003	7122566	2026-02-06	U-915	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N013217-003	7122566	2026-02-06	U-915	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N013217-003	7714006	2021-12-03	U-1050	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N013217-003	7122566	2026-02-06	U-915	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N013217-003	7122566	2026-02-06	U-915	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N013217-003	7714006	2021-12-03	U-1050	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N013217-003	7122566	2026-02-06	U-915	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N013217-003	7714006	2021-12-03	U-1050	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N013217-003	7122566	2026-02-06	U-915	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N013217-003	7714006	2021-12-03	U-1050	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N013217-003	7122566	2026-02-06	U-915	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N013217-003	7714006	2021-12-03	U-1050	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N013217-003	7122566	2026-02-06	U-915	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N013217-003	7714006	2021-12-03	U-1050	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N013217-003	7122566	2026-02-06	U-915	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N013217-003	7714006	2021-12-03	U-1050	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N013217-003	7122566	2026-02-06	U-915	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N013217-003	7714006	2021-12-03	U-1050	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N013217-003	7122566	2026-02-06	U-915	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N013217-003	7714006	2021-12-03	U-1050	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N013217-003	7122566	2026-02-06	U-915	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N013217-003	7122566	2026-02-06	U-915	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N013217-003	7122566	2026-02-06	U-915	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N013217-003	7122566	2026-02-06	U-915	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N013217-003	7122566	2026-02-06	U-915	`a72a2bbeb626…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4fe1c2a6-5488-f909-3872-734054eb745a	Product name	5	20181231
776ba7f6-e5b0-442b-bd42-1fdfdfd821a4	Product name	1	20150615
68c52498-c9cb-48ab-a792-a4876149361e	Product name	1	20150409

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
68258-7100-1	METAXALONE TABLETS 800 mg
68258-7100-2	METAXALONE TABLETS 800 mg
68258-7100-3	METAXALONE TABLETS 800 mg
68258-7100-6	METAXALONE TABLETS 800 mg
68258-7100-9	METAXALONE TABLETS 800 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68258-7100-1	Metaxalone	16 in 1 BOTTLE	TABLET	16	1
68258-7100-2	Metaxalone	20 in 1 BOTTLE	TABLET	20	1
68258-7100-3	Metaxalone	30 in 1 BOTTLE	TABLET	30	1
68258-7100-6	Metaxalone	60 in 1 BOTTLE	TABLET	60	1
68258-7100-9	Metaxalone	90 in 1 BOTTLE	TABLET	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68258-7100-3	EA - Each	68258-7100	fd11a8c7-fc94-4fe7-85b8-9cbb4e927e6b	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METAXALONE	ACTIVE INGREDIENT	1NMA9J598Y	METAXALONE TABLET [DISPENSING SOLUTIONS, INC.]	1
METAXALONE	ACTIVE MOIETY	1NMA9J598Y	METAXALONE TABLET [DISPENSING SOLUTIONS, INC.]	1
ALGINIC ACID	INACTIVE INGREDIENT	8C3Z4148WZ	METAXALONE TABLET [DISPENSING SOLUTIONS, INC.]	1
CALCIUM	INACTIVE INGREDIENT	SY7Q814VUP	METAXALONE TABLET [DISPENSING SOLUTIONS, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METAXALONE TABLET [DISPENSING SOLUTIONS, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	METAXALONE TABLET [DISPENSING SOLUTIONS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68258-7100	METAXALONE TABLET [DISPENSING SOLUTIONS, INC.]	1	Legacy NDC, 5 package rows	20110930_0755d115-dbf4-44ac-a02f-4d8a013902e3.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1NMA9J598Y	METAXALONE	1665-48-1	METAXALONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
351254	metaxalone 800 MG Oral Tablet	PSN	0755d115-dbf4-44ac-a02f-4d8a013902e3	1
351254	metaxalone 800 MG Oral Tablet	SCD	0755d115-dbf4-44ac-a02f-4d8a013902e3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68258-7100-1	68258710001	16 in 1 BOTTLE	Historical
68258-7100-2	68258710002	20 in 1 BOTTLE	Historical
68258-7100-3	68258710003	30 in 1 BOTTLE	Historical
68258-7100-6	68258710006	60 in 1 BOTTLE	Historical
68258-7100-9	68258710009	90 in 1 BOTTLE	Historical