Metaxalone

Product NDC: 74157-018
11-digit product format: 741570018
Labeler code: 74157
Product ID: 74157-018_4a02d857-976b-b4c7-e063-6294a90a655b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metaxalone
Dosage form: TABLET
Route: ORAL
Labeler: INA Pharmaceutics Inc
Application: NDA022503
Marketing category: NDA
Marketing start: 2025-02-10
Substance: METAXALONE
Active strength: 640 mg/1
Pharmacologic classes: Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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
N022503-001	METAXALONE	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, RS	2015-06-01

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022503-001	11918559	2039-07-29		Drug product	2024-03-13
N022503-001	12485111	2043-05-14	U-4453	Drug product	2026-04-10

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, RS	2015-06-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, RS	2015-06-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, RS	2015-06-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2015-06-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2015-06-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2015-06-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2015-06-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2015-06-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2015-06-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2015-06-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2015-06-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2015-06-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2015-06-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2015-06-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2015-06-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2015-06-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022503-001	METAXALONE	640MG	TABLET / ORAL	RLD	2015-06-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022503-001	METAXALONE	640MG	TABLET / ORAL	RLD	2015-06-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2015-06-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2015-06-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2015-06-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2015-06-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2015-06-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2015-06-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2015-06-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2015-06-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2015-06-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2015-06-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2015-06-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2015-06-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2015-06-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2015-06-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2015-06-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2015-06-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, RS	2015-06-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, RS	2015-06-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2015-06-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2015-06-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2015-06-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2015-06-01	`e64feba35796…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022503-001	11918559	2039-07-29		Drug product	2024-03-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022503-001	12485111	2043-05-14	U-4453	Drug product	2026-04-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022503-001	11918559	2039-07-29		Drug product	2024-03-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022503-001	11918559	2039-07-29		Drug product	2024-03-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022503-001	11918559	2039-07-29		Drug product	2024-03-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022503-001	11918559	2039-07-29		Drug product	2024-03-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022503-001	11918559	2039-07-29		Drug product	2024-03-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022503-001	11918559	2039-07-29		Drug product	2024-03-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022503-001	11918559	2039-07-29		Drug product	2024-03-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022503-001	11918559	2039-07-29		Drug product	2024-03-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022503-001	11918559	2039-07-29		Drug product	2024-03-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022503-001	11918559	2039-07-29		Drug product	2024-03-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022503-001	11918559	2039-07-29		Drug product	2024-03-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022503-001	11918559	2039-07-29		Drug product	2024-03-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022503-001	11918559	2039-07-29		Drug product	2024-03-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022503-001	11918559	2039-07-29		Drug product	2024-03-13	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022503-001	11918559	2039-07-29		Drug product	2024-03-13	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022503-001	12485111	2043-05-14	U-4453	Drug product	2026-04-10	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Metaxalone
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METAXALONE	640 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
2627781	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
fc6de1a6-26aa-47ac-a5d2-bf127a6ca563	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	Strength	SPL version
74157-018-60	Metaxalone	60 in 1 BOTTLE	TABLET	60		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
74157-018-60	EA - Each	74157-018	d5aeac52-5d15-4264-bfab-57b32d106f2a	1	2025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
74157-018	METAXALONE TABLET [INA PHARMACEUTICS INC]	2	Current NDC, 1 package rows	20250515_fc6de1a6-26aa-47ac-a5d2-bf127a6ca563.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	INA Pharmaceutics Inc	fc6de1a6-26aa-47ac-a5d2-bf127a6ca563	2026-02-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022503 application number: NDA022503 ndc (product): 74157-018

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
2627781	metaxalone 640 MG Oral Tablet	PSN	fc6de1a6-26aa-47ac-a5d2-bf127a6ca563	4
2627781	metaxalone 640 MG Oral Tablet	SCD	fc6de1a6-26aa-47ac-a5d2-bf127a6ca563	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
74157-018-60	74157001860	60 TABLET in 1 BOTTLE (74157-018-60)	60 tablet	2025-02-10	No	No	Current