Metaxalone

Product NDC: 45865-985
Requested package NDC: 45865-985-30
11-digit product format: 458650985
Labeler code: 45865
Product ID: 45865-985_9af18dc9-fcef-fde1-e053-2995a90a4087
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metaxalone
Dosage form: TABLET
Route: ORAL
Labeler: medsource pharmaceuticals
Application: ANDA203695
Marketing category: ANDA
Marketing start: 2017-06-19
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	45865-985	45865-985-30	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 1 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
A203695-001	METAXALONE	METAXALONE	800MG	TABLET / ORAL	AB		2017-06-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203695-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A203695-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-06-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203695-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-06-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203695-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-06-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203695-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-06-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203695-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-06-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203695-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-06-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203695-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-06-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203695-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-06-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203695-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-06-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203695-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-06-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203695-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-06-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203695-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-06-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203695-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-06-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203695-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-06-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203695-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-06-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203695-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-06-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203695-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-06-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203695-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-06-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203695-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-06-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203695-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-06-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203695-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-06-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203695-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-06-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203695-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-06-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203695-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-06-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203695-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-06-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203695-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-06-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203695-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-06-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203695-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-06-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203695-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-06-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203695-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-06-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203695-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-06-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203695-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-06-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203695-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-06-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203695-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-06-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203695-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-06-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203695-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-06-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203695-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-06-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203695-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-06-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203695-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-06-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203695-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-06-15	`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	A203695-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203695-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203695-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203695-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203695-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203695-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203695-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203695-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203695-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203695-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203695-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203695-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203695-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203695-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203695-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203695-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203695-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203695-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203695-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203695-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203695-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203695-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203695-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203695-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203695-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203695-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203695-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203695-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203695-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203695-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203695-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203695-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203695-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203695-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203695-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203695-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203695-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203695-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203695-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203695-001	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
45865-985-30	2025-01-30	C162847	48780-1	2cef2736-701b-d83d-e063-dadaa90ab31f	Metaxalone Tablets
45865-985-90	2025-01-30	C162847	48780-1	2cef2736-701b-d83d-e063-dadaa90ab31f	Metaxalone Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45865-985-30	Metaxalone	30 in 1 BOTTLE	TABLET	30		1
45865-985-90	Metaxalone	90 in 1 BOTTLE	TABLET	90		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45865-985	METAXALONE TABLET [MEDSOURCE PHARMACEUTICALS]	1	Legacy NDC, 2 package rows	20191231_9af17dc7-04cd-de48-e053-2995a90a8709.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metaxalone	METAXALONE	St. Mary's Medical Park Pharmacy	5de36266-3964-5aca-e053-2991aa0a2205	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203695 application number: ANDA203695
Metaxalone	METAXALONE	Asclemed USA, Inc.	f4a0e910-2b20-46d4-b49e-21fb15925b58	2026-04-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203695 application number: ANDA203695
Metaxalone	METAXALONE	Sportpharm LLC	5bcdc9d3-8827-4d05-8783-4519f1b284a3	2026-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203695 application number: ANDA203695
Metaxalone	METAXALONE	Direct_Rx	45726fbc-3450-63f7-e063-6394a90a671a	2026-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203695 application number: ANDA203695
Metaxalone	METAXALONE	PHOENIX RX LLC	3a7c8b4d-7add-cb31-e063-6294a90a37f8	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203695 application number: ANDA203695
Metaxalone	METAXALONE	Actavis Pharma, Inc.	b3a4f6bc-abd4-4b8e-970f-59b3aa6f17a0	2025-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203695 application number: ANDA203695
Metaxalone	METAXALONE	Advanced Rx Pharmacy of Tennessee, LLC	bd1c9022-aadc-af1f-e053-2995a90a0b42	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203695 application number: ANDA203695
Metaxalone	METAXALONE	Bryant Ranch Prepack	c2dd7071-cba3-410c-ade5-9d7e5af42038	2024-09-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203695 application number: ANDA203695
Metaxalone	METAXALONE	Bryant Ranch Prepack	07ccff59-e335-40be-9e40-fd2d08197617	2024-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203695 application number: ANDA203695
Metaxalone	METAXALONE	Proficient Rx LP	c796d4a1-fad4-4a0c-a459-8ae3b5b52fb6	2024-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203695 application number: ANDA203695
Metaxalone	METAXALONE	Doc Rx	87518046-c959-d5f3-e053-2a95a90a5f7e	2021-09-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203695 application number: ANDA203695

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	9af17dc7-04cd-de48-e053-2995a90a8709	1
351254	metaxalone 800 MG Oral Tablet	SCD	9af17dc7-04cd-de48-e053-2995a90a8709	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45865-985-30	45865098530	30 TABLET in 1 BOTTLE (45865-985-30)	30 tablet	2019-12-11	0000-00-00	No	No	Current