Metaxalone

Product NDC: 33261-724
11-digit product format: 332610724
Labeler code: 33261
Product ID: 33261-724_56cf45ce-a692-486e-a961-3d53f18d418a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metaxalone
Dosage form: TABLET
Route: ORAL
Labeler: Aidarex Pharmaceuticals LLC
Application: ANDA203399
Marketing category: ANDA
Marketing start: 2013-05-31
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: 2019-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	33261-724		I	Inactivated by FDA	2026-08-17
excluded package	package	33261-724	33261-724-10	I	Inactivated by FDA	2026-08-17
excluded package	package	33261-724	33261-724-16	I	Inactivated by FDA	2026-08-17
excluded package	package	33261-724	33261-724-30	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 · 84 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	33261-724-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-724-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-724-16	`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	33261-724-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-724-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-724-16	`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	33261-724-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-724-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-724-16	`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	33261-724-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-724-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-724-16	`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	33261-724-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	33261-724-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	33261-724-16	`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	33261-724-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	33261-724-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	33261-724-16	`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	33261-724-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	33261-724-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	33261-724-16	`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	33261-724-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	33261-724-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	33261-724-16	`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	33261-724-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	33261-724-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	33261-724-16	`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	33261-724-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	33261-724-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	33261-724-16	`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	33261-724-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	33261-724-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	33261-724-16	`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	33261-724-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	33261-724-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	33261-724-16	`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	33261-724-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	33261-724-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	33261-724-16	`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	33261-724-10	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	33261-724-30	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	33261-724-16	`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	33261-724-10	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	33261-724-30	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	33261-724-16	`1332a3947898…`	`d4bfe170f9cd…`

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, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
33261-724-10	2020-01-31	C162847	48780-1	9d75b9cf-f1bb-f424-e053-dadaa90a57ce	Metaxalone Tablets
33261-724-16	2020-01-31	C162847	48780-1	9d75b9cf-f1bb-f424-e053-dadaa90a57ce	Metaxalone Tablets
33261-724-30	2020-01-31	C162847	48780-1	9d75b9cf-f1bb-f424-e053-dadaa90a57ce	Metaxalone Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
33261-724-10	Metaxalone	10 in 1 BOTTLE, PLASTIC	TABLET	10	1
33261-724-16	Metaxalone	16 in 1 BOTTLE, PLASTIC	TABLET	16	1
33261-724-30	Metaxalone	30 in 1 BOTTLE, PLASTIC	TABLET	30	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
33261-724-10	EA - Each	33261-724	26ddc84b-c706-40e9-b5d9-01068274ea14	1	2016-09-02
33261-724-16	EA - Each	33261-724	66106813-2150-45b5-8740-2073a4a9f6fa	1	2015-10-02
33261-724-30	EA - Each	33261-724	d6b8adcb-448b-4588-a424-00efbec1bacc	1	2015-10-02

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
33261-724	METAXALONE TABLET [AIDAREX PHARMACEUTICALS LLC]	1	Legacy NDC, 3 package rows	20140128_5311bdb3-37a7-48d8-a5bb-5765b3d43fbc.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	5311bdb3-37a7-48d8-a5bb-5765b3d43fbc	1
351254	metaxalone 800 MG Oral Tablet	SCD	5311bdb3-37a7-48d8-a5bb-5765b3d43fbc	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
33261-724-10	33261072410	10 in 1 BOTTLE, PLASTIC	Historical
33261-724-16	33261072416	16 in 1 BOTTLE, PLASTIC	Historical
33261-724-30	33261072430	30 in 1 BOTTLE, PLASTIC	Historical