METAXALONE

Product NDC: 61919-262
11-digit product format: 619190262
Labeler code: 61919
Product ID: 61919-262_948f5317-b39f-5d57-e053-2995a90ac991
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: metaxalone tablet
Dosage form: TABLET
Route: ORAL
Labeler: Direct RX
Application: ANDA203399
Marketing category: ANDA
Marketing start: 2015-01-01
Marketing end: 0000-00-00
Substance: METAXALONE
Active strength: 800 mg/1
Pharmacologic classes: Centrally-mediated Muscle Relaxation [PE]
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61919-262		I	Inactivated by FDA	2026-08-17
excluded package	package	61919-262	61919-262-20	I	Inactivated by FDA	2026-08-17
excluded package	package	61919-262	61919-262-30	I	Inactivated by FDA	2026-08-17
excluded package	package	61919-262	61919-262-60	I	Inactivated by FDA	2026-08-17
excluded package	package	61919-262	61919-262-71	I	Inactivated by FDA	2026-08-17

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 2 · 75 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	61919-262-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-262-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-262-71	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-262-20	`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	61919-262-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-262-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-262-71	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-262-20	`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	61919-262-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-262-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-262-71	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-262-20	`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	61919-262-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-262-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-262-71	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-262-20	`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	61919-262-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-262-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-262-71	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-262-20	`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	61919-262-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-262-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-262-71	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-262-20	`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	61919-262-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-262-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-262-71	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-262-20	`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	61919-262-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-262-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-262-71	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-262-20	`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	61919-262-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-262-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-262-71	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-262-20	`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	61919-262-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61919-262-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61919-262-71	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61919-262-20	`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	61919-262-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61919-262-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61919-262-71	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61919-262-20	`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	61919-262-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61919-262-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61919-262-71	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61919-262-20	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203399-001	METAXALONE	METAXALONE	800MG	TABLET / ORAL	AB	RS	2013-06-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A203399-001	AB

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 · 42 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
2026-08-18 06:07:40	2026-07	A203399-001	METAXALONE	800MG	TABLET / ORAL	AB	RS	2013-06-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203399-001	METAXALONE	800MG	TABLET / ORAL	AB	RS	2013-06-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203399-001	METAXALONE	800MG	TABLET / ORAL	AB	RS	2013-06-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203399-001	METAXALONE	800MG	TABLET / ORAL	AB	RS	2013-06-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203399-001	METAXALONE	800MG	TABLET / ORAL	AB	RS	2013-06-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203399-001	METAXALONE	800MG	TABLET / ORAL	AB	RS	2013-06-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203399-001	METAXALONE	800MG	TABLET / ORAL	AB	RS	2013-06-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203399-001	METAXALONE	800MG	TABLET / ORAL	AB	RS	2013-06-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203399-001	METAXALONE	800MG	TABLET / ORAL	AB	RS	2013-06-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203399-001	METAXALONE	800MG	TABLET / ORAL	AB	RS	2013-06-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203399-001	METAXALONE	800MG	TABLET / ORAL	AB	RS	2013-06-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203399-001	METAXALONE	800MG	TABLET / ORAL	AB	RS	2013-06-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203399-001	METAXALONE	800MG	TABLET / ORAL	AB	RS	2013-06-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203399-001	METAXALONE	800MG	TABLET / ORAL	AB	RS	2013-06-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203399-001	METAXALONE	800MG	TABLET / ORAL	AB	RS	2013-06-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203399-001	METAXALONE	800MG	TABLET / ORAL	AB		2013-06-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203399-001	METAXALONE	800MG	TABLET / ORAL	AB		2013-06-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203399-001	METAXALONE	800MG	TABLET / ORAL	AB		2013-06-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203399-001	METAXALONE	800MG	TABLET / ORAL	AB		2013-06-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203399-001	METAXALONE	800MG	TABLET / ORAL	AB		2013-06-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203399-001	METAXALONE	800MG	TABLET / ORAL	AB		2013-06-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203399-001	METAXALONE	800MG	TABLET / ORAL	AB		2013-06-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203399-001	METAXALONE	800MG	TABLET / ORAL	AB		2013-06-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203399-001	METAXALONE	800MG	TABLET / ORAL	AB		2013-06-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203399-001	METAXALONE	800MG	TABLET / ORAL	AB		2013-06-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203399-001	METAXALONE	800MG	TABLET / ORAL	AB		2013-06-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203399-001	METAXALONE	800MG	TABLET / ORAL	AB		2013-06-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203399-001	METAXALONE	800MG	TABLET / ORAL	AB		2013-06-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203399-001	METAXALONE	800MG	TABLET / ORAL	AB	RS	2013-06-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203399-001	METAXALONE	800MG	TABLET / ORAL	AB	RS	2013-06-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203399-001	METAXALONE	800MG	TABLET / ORAL	AB	RS	2013-06-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203399-001	METAXALONE	800MG	TABLET / ORAL	AB	RS	2013-06-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203399-001	METAXALONE	800MG	TABLET / ORAL	AB	RS	2013-06-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203399-001	METAXALONE	800MG	TABLET / ORAL	AB		2013-06-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203399-001	METAXALONE	800MG	TABLET / ORAL	AB		2013-06-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203399-001	METAXALONE	800MG	TABLET / ORAL	AB		2013-06-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203399-001	METAXALONE	800MG	TABLET / ORAL	AB		2013-06-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203399-001	METAXALONE	800MG	TABLET / ORAL	AB		2013-06-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203399-001	METAXALONE	800MG	TABLET / ORAL	AB		2013-06-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203399-001	METAXALONE	800MG	TABLET / ORAL	AB		2013-06-21	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A203399-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203399-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203399-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203399-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203399-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203399-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203399-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203399-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203399-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203399-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203399-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203399-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203399-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203399-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203399-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203399-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203399-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203399-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203399-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203399-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203399-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203399-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203399-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203399-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203399-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203399-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203399-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203399-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203399-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203399-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203399-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203399-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203399-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203399-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203399-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203399-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203399-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203399-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203399-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203399-001	AB	1	`e64feba35796…`

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
61919-262-20	METAXALONE- metaxalone tablet
61919-262-30	METAXALONE- metaxalone tablet
61919-262-60	METAXALONE- metaxalone tablet
61919-262-71	METAXALONE- metaxalone tablet

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61919-262-20	METAXALONE	20 in 1 BOTTLE	TABLET	20	2
61919-262-30	METAXALONE	30 in 1 BOTTLE	TABLET	30	2
61919-262-60	METAXALONE	60 in 1 BOTTLE	TABLET	60	2
61919-262-71	METAXALONE	100 in 1 BOTTLE	TABLET	100	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-262-30	EA - Each	61919-262	f484630a-d65c-4fc9-96ba-ab89bae3afc7	1	2016-09-02
61919-262-60	EA - Each	61919-262	2f90c9dc-2330-4a21-a70d-35ff78a1e6d7	1	2016-09-02
61919-262-71	EA - Each	61919-262	aac01e25-9af2-4eeb-bcfd-37cd64c12758	1	2019-12-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METAXALONE	ACTIVE INGREDIENT	1NMA9J598Y	METAXALONE (METAXALONE TABLET) TABLET [DIRECT RX]	1
METAXALONE	ACTIVE MOIETY	1NMA9J598Y	METAXALONE (METAXALONE TABLET) TABLET [DIRECT RX]	1
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	METAXALONE (METAXALONE TABLET) TABLET [DIRECT RX]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METAXALONE (METAXALONE TABLET) TABLET [DIRECT RX]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	METAXALONE (METAXALONE TABLET) TABLET [DIRECT RX]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	METAXALONE (METAXALONE TABLET) TABLET [DIRECT RX]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	METAXALONE (METAXALONE TABLET) TABLET [DIRECT RX]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	METAXALONE (METAXALONE TABLET) TABLET [DIRECT RX]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METAXALONE (METAXALONE TABLET) TABLET [DIRECT RX]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	METAXALONE (METAXALONE TABLET) TABLET [DIRECT RX]	1
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	METAXALONE (METAXALONE TABLET) TABLET [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-262	METAXALONE (METAXALONE TABLET) TABLET [DIRECT RX]	2	Legacy NDC, 4 package rows	20191126_e8643c67-c531-4a4f-931d-0e3c91cfc0c8.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metaxalone	METAXALONE	AvKARE	4c3b2aa4-fe65-507c-e063-6394a90a7b00	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203399 application number: ANDA203399
Metaxalone	METAXALONE	AvKARE	4c3ae824-48a9-fd91-e063-6394a90a9a54	2026-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203399 application number: ANDA203399
Metaxalone	METAXALONE	AvPAK	9b21a974-6a5a-9efb-e9de-470363217126	2025-11-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203399 application number: ANDA203399
Metaxalone	METAXALONE	Amneal Pharmaceuticals LLC	3aa9dba9-29b0-4520-a0f7-66d19d52c6bc	2025-03-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203399 application number: ANDA203399
Metaxalone	METAXALONE	Advanced Rx of Tennessee, LLC	b3279496-293e-7e1f-e053-2a95a90ab506	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203399 application number: ANDA203399
Metaxalone	METAXALONE	Amneal Pharmaceuticals of New York LLC	f06f2b96-3684-483c-89f7-6c9201fd4664	2023-01-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203399 application number: ANDA203399
Metaxalone	METAXALONE	Proficient Rx LP	fba1601d-3ac4-41cf-9548-35ec4994a95e	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203399 application number: ANDA203399

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	e8643c67-c531-4a4f-931d-0e3c91cfc0c8	2
351254	metaxalone 800 MG Oral Tablet	SCD	e8643c67-c531-4a4f-931d-0e3c91cfc0c8	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-262-20	61919026220	20 TABLET in 1 BOTTLE (61919-262-20)	20 tablet	2015-01-01	0000-00-00	No	No	Current
61919-262-30	61919026230	30 TABLET in 1 BOTTLE (61919-262-30)	30 tablet	2015-01-01	0000-00-00	No	No	Current
61919-262-60	61919026260	60 TABLET in 1 BOTTLE (61919-262-60)	60 tablet	2015-01-01	0000-00-00	No	No	Current
61919-262-71	61919026271	100 TABLET in 1 BOTTLE (61919-262-71)	100 tablet	2015-01-01	0000-00-00	No	No	Current