Metaxalone

Product NDC: 55700-494
11-digit product format: 557000494
Labeler code: 55700
Product ID: 55700-494_f1dd5bd6-120d-44fd-8dc8-61f0e8569020
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metaxalone
Dosage form: TABLET
Route: ORAL
Labeler: Quality Care Products, LLC
Application: ANDA204770
Marketing category: ANDA
Marketing start: 2016-11-22
Marketing end: 2027-02-28
Substance: METAXALONE
Active strength: 800 mg/1
Pharmacologic classes: Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag: No
Current FDA listing: Yes

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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded package	package	55700-494	55700-494-21	D	Discontinued by firm	2026-10-05
excluded package	package	55700-494	55700-494-60	D	Discontinued by firm	2026-10-05
excluded package	package	55700-494	55700-494-90	D	Discontinued by firm	2026-10-05

Observed NDC auxiliary status history#

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

Historic NDC status page 1 of 1 · 21 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	55700-494-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	55700-494-21	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	55700-494-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	55700-494-21	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	55700-494-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	55700-494-21	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	55700-494-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	55700-494-21	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	55700-494-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	55700-494-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	55700-494-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	55700-494-21	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	55700-494-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	55700-494-21	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	55700-494-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	55700-494-21	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	55700-494-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	55700-494-21	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	55700-494-21	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	55700-494-21	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	55700-494-21	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A204770-001	METAXALONE	METAXALONE	800MG	TABLET / ORAL	AB		2016-11-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204770-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A204770-001	METAXALONE	800MG	TABLET / ORAL	AB	2016-11-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204770-001	METAXALONE	800MG	TABLET / ORAL	AB	2016-11-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204770-001	METAXALONE	800MG	TABLET / ORAL	AB	2016-11-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204770-001	METAXALONE	800MG	TABLET / ORAL	AB	2016-11-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204770-001	METAXALONE	800MG	TABLET / ORAL	AB	2016-11-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204770-001	METAXALONE	800MG	TABLET / ORAL	AB	2016-11-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204770-001	METAXALONE	800MG	TABLET / ORAL	AB	2016-11-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204770-001	METAXALONE	800MG	TABLET / ORAL	AB	2016-11-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204770-001	METAXALONE	800MG	TABLET / ORAL	AB	2016-11-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204770-001	METAXALONE	800MG	TABLET / ORAL	AB	2016-11-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204770-001	METAXALONE	800MG	TABLET / ORAL	AB	2016-11-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204770-001	METAXALONE	800MG	TABLET / ORAL	AB	2016-11-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204770-001	METAXALONE	800MG	TABLET / ORAL	AB	2016-11-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204770-001	METAXALONE	800MG	TABLET / ORAL	AB	2016-11-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204770-001	METAXALONE	800MG	TABLET / ORAL	AB	2016-11-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204770-001	METAXALONE	800MG	TABLET / ORAL	AB	2016-11-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204770-001	METAXALONE	800MG	TABLET / ORAL	AB	2016-11-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204770-001	METAXALONE	800MG	TABLET / ORAL	AB	2016-11-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204770-001	METAXALONE	800MG	TABLET / ORAL	AB	2016-11-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204770-001	METAXALONE	800MG	TABLET / ORAL	AB	2016-11-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204770-001	METAXALONE	800MG	TABLET / ORAL	AB	2016-11-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204770-001	METAXALONE	800MG	TABLET / ORAL	AB	2016-11-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204770-001	METAXALONE	800MG	TABLET / ORAL	AB	2016-11-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204770-001	METAXALONE	800MG	TABLET / ORAL	AB	2016-11-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204770-001	METAXALONE	800MG	TABLET / ORAL	AB	2016-11-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204770-001	METAXALONE	800MG	TABLET / ORAL	AB	2016-11-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204770-001	METAXALONE	800MG	TABLET / ORAL	AB	2016-11-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204770-001	METAXALONE	800MG	TABLET / ORAL	AB	2016-11-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204770-001	METAXALONE	800MG	TABLET / ORAL	AB	2016-11-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204770-001	METAXALONE	800MG	TABLET / ORAL	AB	2016-11-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204770-001	METAXALONE	800MG	TABLET / ORAL	AB	2016-11-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204770-001	METAXALONE	800MG	TABLET / ORAL	AB	2016-11-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204770-001	METAXALONE	800MG	TABLET / ORAL	AB	2016-11-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204770-001	METAXALONE	800MG	TABLET / ORAL	AB	2016-11-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204770-001	METAXALONE	800MG	TABLET / ORAL	AB	2016-11-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204770-001	METAXALONE	800MG	TABLET / ORAL	AB	2016-11-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204770-001	METAXALONE	800MG	TABLET / ORAL	AB	2016-11-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204770-001	METAXALONE	800MG	TABLET / ORAL	AB	2016-11-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204770-001	METAXALONE	800MG	TABLET / ORAL	AB	2016-11-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204770-001	METAXALONE	800MG	TABLET / ORAL	AB	2016-11-22	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A204770-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204770-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204770-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204770-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204770-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204770-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204770-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204770-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204770-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204770-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204770-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204770-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204770-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204770-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204770-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204770-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204770-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204770-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204770-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204770-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204770-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204770-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204770-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204770-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204770-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204770-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204770-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204770-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204770-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204770-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204770-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204770-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204770-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204770-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204770-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204770-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204770-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204770-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204770-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204770-001	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Metaxalone

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METAXALONE	800 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1NMA9J598Y	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
351254	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f05bb280-6736-4215-be5b-0e5f7991cd87	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
55700-494-21	Metaxalone	21 in 1 BOTTLE	TABLET	21	8
55700-494-30	Metaxalone	30 in 1 BOTTLE	TABLET	30	8
55700-494-60	Metaxalone	60 in 1 BOTTLE	TABLET	60	8
55700-494-90	Metaxalone	90 in 1 BOTTLE	TABLET	90	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55700-494-21	EA - Each	55700-494	6a7f8585-a255-4731-98f9-7b34b61e3b13	1	2017-12-14
55700-494-30	EA - Each	55700-494	3c53e5c7-58f1-40aa-97da-06a8c921314e	1	2017-03-06
55700-494-60	EA - Each	55700-494	365ed245-64a1-4c57-b379-697052a34a46	1	2017-03-06
55700-494-90	EA - Each	55700-494	ab71469c-d876-4919-ab35-b710e54ebb2b	1	2017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55700-494	METAXALONE TABLET [QUALITY CARE PRODUCTS, LLC]	8	Current NDC, Legacy NDC, 4 package rows	20241219_f05bb280-6736-4215-be5b-0e5f7991cd87.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 2 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metaxalone	METAXALONE	Doc Rx	4a558a2f-f9be-40d1-8d02-dd0c8c501ef6	2022-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204770 application number: ANDA204770

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	f05bb280-6736-4215-be5b-0e5f7991cd87	8
351254	metaxalone 800 MG Oral Tablet	SCD	f05bb280-6736-4215-be5b-0e5f7991cd87	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55700-494-21	55700049421	21 in 1 BOTTLE						Historical
55700-494-30	55700049430	30 TABLET in 1 BOTTLE (55700-494-30)	30 tablet	2017-02-10	2027-02-28	No	No	Current
55700-494-60	55700049460	60 TABLET in 1 BOTTLE (55700-494-60)	60 tablet	2017-02-10	0000-00-00	No	No	Current
55700-494-90	55700049490	90 TABLET in 1 BOTTLE (55700-494-90)	90 tablet	2017-02-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metaxalone Tablets, USP RX ONLY	Quality Care Products, LLC	2024-12-17	HUMAN PRESCRIPTION DRUG LABEL	8