Metaxalone

Product NDC: 53746-553
11-digit product format: 537460553
Labeler code: 53746
Product ID: 53746-553_b3ba9f93-52d6-4287-9e28-92059e0bf18b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metaxalone
Dosage form: TABLET
Route: ORAL
Labeler: Amneal Pharmaceuticals of New York LLC
Application: ANDA203399
Marketing category: ANDA
Marketing start: 2013-05-31
Substance: METAXALONE
Active strength: 800 mg/1
Pharmacologic classes: Centrally-mediated Muscle Relaxation [PE]
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
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…`

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
f06f2b96-3684-483c-89f7-6c9201fd4664	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
53746-553-01	Metaxalone	100 in 1 BOTTLE	TABLET	100	6
53746-553-05	Metaxalone	500 in 1 BOTTLE	TABLET	500	6
53746-553-30	Metaxalone	30 in 1 BOTTLE	TABLET	30	6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METAXALONE	ACTIVE INGREDIENT	1NMA9J598Y	METAXALONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	2
METAXALONE	ACTIVE MOIETY	1NMA9J598Y	METAXALONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	2
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	METAXALONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METAXALONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	METAXALONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	METAXALONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	METAXALONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	METAXALONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METAXALONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	METAXALONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	2
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	METAXALONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	2
METAXALONE	ACTIVE INGREDIENT	1NMA9J598Y	METAXALONE (METAXALONE) TABLET [AVKARE, INC.]	1
METAXALONE	ACTIVE MOIETY	1NMA9J598Y	METAXALONE (METAXALONE) TABLET [AVKARE, INC.]	1
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	METAXALONE (METAXALONE) TABLET [AVKARE, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METAXALONE (METAXALONE) TABLET [AVKARE, INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	METAXALONE (METAXALONE) TABLET [AVKARE, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	METAXALONE (METAXALONE) TABLET [AVKARE, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	METAXALONE (METAXALONE) TABLET [AVKARE, INC.]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	METAXALONE (METAXALONE) TABLET [AVKARE, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METAXALONE (METAXALONE) TABLET [AVKARE, INC.]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	METAXALONE (METAXALONE) TABLET [AVKARE, INC.]	1
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	METAXALONE (METAXALONE) TABLET [AVKARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53746-553	METAXALONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]	6	Current NDC, Legacy NDC, 3 package rows	20230112_f06f2b96-3684-483c-89f7-6c9201fd4664.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 ndc (product): 53746-553
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	f06f2b96-3684-483c-89f7-6c9201fd4664	6
351254	metaxalone 800 MG Oral Tablet	SCD	f06f2b96-3684-483c-89f7-6c9201fd4664	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53746-553-01	53746055301	100 TABLET in 1 BOTTLE (53746-553-01)	100 tablet	2013-05-31	0000-00-00	No	No	Current
53746-553-05	53746055305	500 TABLET in 1 BOTTLE (53746-553-05)	500 tablet	2013-05-31	0000-00-00	No	No	Current
53746-553-30	53746055330	30 TABLET in 1 BOTTLE (53746-553-30)	30 tablet	2013-05-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metaxalone Tablets, USP (800 mg) Rx Only	Amneal Pharmaceuticals of New York LLC \| Amneal Pharmaceuticals of New York, LLC	2023-01-11	HUMAN PRESCRIPTION DRUG LABEL	6
Metaxalone Tablets, USP (800 mg) Rx Only	AvKARE	2022-01-13	HUMAN PRESCRIPTION DRUG LABEL	10