Metaxalone

Product NDC: 68387-108
11-digit product format: 683870108
Labeler code: 68387
Product ID: 68387-108_654dcfdc-4012-426e-bcd3-eb21b8e3ce2a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metaxalone
Dosage form: TABLET
Route: ORAL
Labeler: Keltman Pharmaceuticals Inc.
Application: ANDA040486
Marketing category: ANDA
Marketing start: 2008-06-25
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68387-108		I	Inactivated by FDA	2026-08-10
excluded package	package	68387-108	68387-108-30	I	Inactivated by FDA	2026-08-10
excluded package	package	68387-108	68387-108-60	I	Inactivated by FDA	2026-08-10
excluded package	package	68387-108	68387-108-90	I	Inactivated by FDA	2026-08-10

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 · 88 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	68387-108-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68387-108-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68387-108-60	`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	68387-108-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68387-108-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68387-108-60	`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	68387-108-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68387-108-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68387-108-60	`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	68387-108-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68387-108-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68387-108-60	`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	68387-108-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68387-108-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68387-108-60	`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	68387-108-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68387-108-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68387-108-60	`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	68387-108-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68387-108-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68387-108-60	`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	68387-108-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68387-108-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68387-108-60	`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	68387-108-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68387-108-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68387-108-60	`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	68387-108-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68387-108-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68387-108-60	`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	68387-108-90	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68387-108-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68387-108-60	`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	68387-108-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68387-108-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68387-108-60	`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	68387-108-90	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68387-108-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68387-108-60	`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	68387-108-90	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68387-108-30	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68387-108-60	`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	68387-108-90	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68387-108-30	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68387-108-60	`1332a3947898…`	`d4bfe170f9cd…`

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

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
A040486-001	METAXALONE	METAXALONE	400MG	TABLET / ORAL	AB		2015-02-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040486-001	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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040486-001	METAXALONE	400MG	TABLET / ORAL	AB	2015-02-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040486-001	METAXALONE	400MG	TABLET / ORAL	AB	2015-02-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040486-001	METAXALONE	400MG	TABLET / ORAL	AB	2015-02-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040486-001	METAXALONE	400MG	TABLET / ORAL	AB	2015-02-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040486-001	METAXALONE	400MG	TABLET / ORAL	AB	2015-02-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040486-001	METAXALONE	400MG	TABLET / ORAL	AB	2015-02-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040486-001	METAXALONE	400MG	TABLET / ORAL	AB	2015-02-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040486-001	METAXALONE	400MG	TABLET / ORAL	AB	2015-02-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040486-001	METAXALONE	400MG	TABLET / ORAL	AB	2015-02-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040486-001	METAXALONE	400MG	TABLET / ORAL	AB	2015-02-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040486-001	METAXALONE	400MG	TABLET / ORAL	AB	2015-02-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040486-001	METAXALONE	400MG	TABLET / ORAL	AB	2015-02-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040486-001	METAXALONE	400MG	TABLET / ORAL	AB	2015-02-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040486-001	METAXALONE	400MG	TABLET / ORAL	AB	2015-02-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040486-001	METAXALONE	400MG	TABLET / ORAL	AB	2015-02-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040486-001	METAXALONE	400MG	TABLET / ORAL	AB	2015-02-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040486-001	METAXALONE	400MG	TABLET / ORAL	AB	2015-02-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040486-001	METAXALONE	400MG	TABLET / ORAL		2015-02-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040486-001	METAXALONE	400MG	TABLET / ORAL	AB	2015-02-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040486-001	METAXALONE	400MG	TABLET / ORAL	AB	2015-02-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040486-001	METAXALONE	400MG	TABLET / ORAL	AB	2015-02-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040486-001	METAXALONE	400MG	TABLET / ORAL	AB	2015-02-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040486-001	METAXALONE	400MG	TABLET / ORAL	AB	2015-02-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040486-001	METAXALONE	400MG	TABLET / ORAL	AB	2015-02-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040486-001	METAXALONE	400MG	TABLET / ORAL		2015-02-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040486-001	METAXALONE	400MG	TABLET / ORAL		2015-02-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040486-001	METAXALONE	400MG	TABLET / ORAL		2015-02-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040486-001	METAXALONE	400MG	TABLET / ORAL	AB	2015-02-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040486-001	METAXALONE	400MG	TABLET / ORAL	AB	2015-02-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040486-001	METAXALONE	400MG	TABLET / ORAL	AB	2015-02-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040486-001	METAXALONE	400MG	TABLET / ORAL	AB	2015-02-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040486-001	METAXALONE	400MG	TABLET / ORAL	AB	2015-02-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040486-001	METAXALONE	400MG	TABLET / ORAL	AB	2015-02-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040486-001	METAXALONE	400MG	TABLET / ORAL	AB	2015-02-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040486-001	METAXALONE	400MG	TABLET / ORAL	AB	2015-02-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040486-001	METAXALONE	400MG	TABLET / ORAL	AB	2015-02-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040486-001	METAXALONE	400MG	TABLET / ORAL	AB	2015-02-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040486-001	METAXALONE	400MG	TABLET / ORAL	AB	2015-02-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040486-001	METAXALONE	400MG	TABLET / ORAL	AB	2015-02-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040486-001	METAXALONE	400MG	TABLET / ORAL	AB	2015-02-27	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040486-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040486-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040486-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040486-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040486-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040486-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040486-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040486-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040486-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040486-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040486-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040486-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040486-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040486-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040486-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040486-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040486-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A040486-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040486-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040486-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040486-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040486-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040486-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040486-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040486-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040486-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040486-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040486-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040486-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040486-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040486-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040486-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040486-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040486-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040486-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040486-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A040486-001	AB	1	`a50c72e98297…`

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
68387-108-30	2019-10-21	C162847	48780-1	956f9ecf-cf90-621f-e053-dbdaa90a74ad	Metaxalone Tablets, 800 mg
68387-108-60	2019-10-21	C162847	48780-1	956f9ecf-cf90-621f-e053-dbdaa90a74ad	Metaxalone Tablets, 800 mg
68387-108-90	2019-10-21	C162847	48780-1	956f9ecf-cf90-621f-e053-dbdaa90a74ad	Metaxalone Tablets, 800 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68387-108-30	Metaxalone	30 in 1 BOTTLE, PLASTIC	TABLET	30	1
68387-108-60	Metaxalone	60 in 1 BOTTLE, PLASTIC	TABLET	60	1
68387-108-90	Metaxalone	90 in 1 BOTTLE, PLASTIC	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
68387-108-30	EA - Each	68387-108	a15ea018-601b-47d6-8ee6-5b303988d302	1	2012-07-24
68387-108-60	EA - Each	68387-108	f02c1b6e-b7e0-493f-9cf2-e9dfd2504c7f	1	2012-07-24
68387-108-90	EA - Each	68387-108	91faf83e-6dbe-4508-af49-8d3a62f1d7d8	1	2012-07-24

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68387-108	METAXALONE TABLET [KELTMAN PHARMACEUTICALS INC.]	1	Legacy NDC, 3 package rows	20100929_83cfbe48-4b69-445a-9c13-742ea345830e.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metaxalone	METAXALONE	Amneal Pharmaceuticals of New York LLC	de3448df-4ca1-44ec-bad1-486549cddf64	2024-08-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040486 application number: ANDA040486

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	83cfbe48-4b69-445a-9c13-742ea345830e	1
351254	metaxalone 800 MG Oral Tablet	SCD	83cfbe48-4b69-445a-9c13-742ea345830e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68387-108-30	68387010830	30 in 1 BOTTLE, PLASTIC	Historical
68387-108-60	68387010860	60 in 1 BOTTLE, PLASTIC	Historical
68387-108-90	68387010890	90 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metaxalone Tablets, 800 mg	Keltman Pharmaceuticals Inc. \| Sandhills Packaging	2010-09-27	HUMAN PRESCRIPTION DRUG LABEL	1