Metaxalone

Product NDC: 80425-0122
11-digit product format: 804250122
Labeler code: 80425
Product ID: 80425-0122_2a99aae5-c903-7940-e063-6294a90a4146
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metaxalone
Dosage form: TABLET
Route: ORAL
Labeler: Advanced Rx Pharmacy of Tennessee, LLC
Application: ANDA204770
Marketing category: ANDA
Marketing start: 2016-11-22
Substance: METAXALONE
Active strength: 800 mg/1
Pharmacologic classes: Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
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 · 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	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…`
2022-09-29 23:25 UTC	2022-09	A204770-001	METAXALONE	800MG	TABLET / ORAL	AB	2016-11-22	`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	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…`
2022-09-29 23:25 UTC	2022-09	A204770-001	AB	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Metaxalone
Listing expiration: 2026-12-31

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
b713a0f2-d47a-0ae7-e053-2995a90a5b85	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
80425-0122-1	Metaxalone	30 in 1 BOTTLE	TABLET	30	7
80425-0122-2	Metaxalone	60 in 1 BOTTLE	TABLET	60	7
80425-0122-3	Metaxalone	90 in 1 BOTTLE	TABLET	90	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0122-1	EA - Each	80425-0122	fd38f6a3-d0da-4a2d-829e-ddf6685746bc	1	2023-04-07
80425-0122-2	EA - Each	80425-0122	3cf8b25b-f836-48b3-85c5-8dbc14a522b9	1	2023-04-07
80425-0122-3	EA - Each	80425-0122	90c8319a-268f-420c-8409-a3357118e5c4	1	2023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0122	METAXALONE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]	7	Current NDC, Legacy NDC, 3 package rows	20250101_b713a0f2-d47a-0ae7-e053-2995a90a5b85.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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metaxalone	METAXALONE	REMEDYREPACK INC.	e9e45029-b1a4-435f-b9ca-cdfa01051bc8	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204770 application number: ANDA204770
Metaxalone	METAXALONE	Preferred Pharmaceuticals, Inc.	1541da6a-7681-40bc-b67e-28e02a950d72	2026-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204770 application number: ANDA204770
Metaxalone	METAXALONE	Direct_Rx	8c3bc0a2-5c93-e1d6-e053-2995a90a0b83	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204770 application number: ANDA204770
METAXALONE	METAXALONE	DIRECT RX	9b7b4fc3-3f38-db66-e053-2995a90aaadb	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204770 application number: ANDA204770
Metaxalone	METAXALONE	Direct_Rx	91432cd0-8404-8029-e053-2a95a90adc1b	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204770 application number: ANDA204770
Metaxalone	METAXALONE	St. Mary's Medical Park Pharmacy	a23ca660-b066-1396-e053-2a95a90a30b2	2026-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204770 application number: ANDA204770
Metaxalone	METAXALONE	Sportpharm LLC	3e7efad7-2752-4f7d-ba30-40f17d13e4c3	2026-04-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204770 application number: ANDA204770
METAXALONE	METAXALONE	DIRECT RX	49250bbf-fbfe-07cd-e054-00144ff88e88	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204770 application number: ANDA204770
Metaxalone	METAXALONE	Northwind Health Company, LLC	d9cefc55-7643-ce9b-e053-2a95a90aff12	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204770 application number: ANDA204770
Metaxalone	METAXALONE	A-S Medication Solutions	d4caa7c6-afb5-43a2-ba38-cf30106b1d62	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204770 application number: ANDA204770
Metaxalone	METAXALONE	PHOENIX RX LLC	413b300d-4163-afef-e063-6394a90a618f	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204770 application number: ANDA204770
Metaxalone	METAXALONE	Advanced Rx Pharmacy of Tennessee, LLC	b713a0f2-d47a-0ae7-e053-2995a90a5b85	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204770 application number: ANDA204770 ndc (product): 80425-0122
Metaxalone	METAXALONE	Quality Care Products, LLC	f05bb280-6736-4215-be5b-0e5f7991cd87	2024-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204770 application number: ANDA204770
Metaxalone	METAXALONE	Bryant Ranch Prepack	a12304b7-6477-4518-8db5-898879c62caf	2024-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204770 application number: ANDA204770
Metaxalone	METAXALONE	Bryant Ranch Prepack	a662fd07-2896-4cbb-bafc-aa5ab179a148	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204770 application number: ANDA204770
Metaxalone	METAXALONE	Bryant Ranch Prepack	7f758053-2367-4c5f-9bbd-ce8ce263a615	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204770 application number: ANDA204770
Metaxalone	METAXALONE	Bryant Ranch Prepack	c86862a4-f6ff-4268-bec6-35dedbe4cd4a	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204770 application number: ANDA204770
Metaxalone	METAXALONE	Lannett Company, Inc.	8294bb3c-c8eb-474c-b567-e53cf81249e9	2024-06-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204770 application number: ANDA204770
Metaxalone	METAXALONE	A-S Medication Solutions	ef47682d-ea41-465e-aa21-cc773d45a6f0	2023-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204770 application number: ANDA204770
Metaxalone	METAXALONE	Asclemed USA, Inc.	02c42f72-5d78-436d-8105-8c0f8d4c0d91	2022-07-25	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	b713a0f2-d47a-0ae7-e053-2995a90a5b85	7
351254	metaxalone 800 MG Oral Tablet	SCD	b713a0f2-d47a-0ae7-e053-2995a90a5b85	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
80425-0122-1	80425012201	30 TABLET in 1 BOTTLE (80425-0122-1)	30 tablet	2016-11-22		No	No	Current
80425-0122-2	80425012202	60 TABLET in 1 BOTTLE (80425-0122-2)	60 tablet	2016-11-22	0000-00-00	No	No	Current
80425-0122-3	80425012203	90 TABLET in 1 BOTTLE (80425-0122-3)	90 tablet	2016-11-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metaxalone Tablets	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	7