Metaxalone

Product NDC: 64980-472
11-digit product format: 649800472
Labeler code: 64980
Product ID: 64980-472_f256e874-703a-48a8-bae8-77c0b46a2968
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metaxalone
Dosage form: TABLET
Route: ORAL
Labeler: Rising Pharmaceuticals, Inc.
Application: ANDA208774
Marketing category: ANDA
Marketing start: 2018-09-24
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	64980-472		D	Discontinued by firm	2026-08-17
excluded package	package	64980-472	64980-472-01	D	Discontinued by firm	2026-08-17
excluded package	package	64980-472	64980-472-50	D	Discontinued by firm	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 · 21 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64980-472-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64980-472-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64980-472-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64980-472-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64980-472-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64980-472-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64980-472-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64980-472-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64980-472-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64980-472-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64980-472-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64980-472-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64980-472-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64980-472-50	`302b2466d912…`	`e7b80fea0513…`

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
A208774-001	METAXALONE	METAXALONE	800MG	TABLET / ORAL			2018-09-24

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	A208774-001	METAXALONE	800MG	TABLET / ORAL		2018-09-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208774-001	METAXALONE	800MG	TABLET / ORAL		2018-09-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208774-001	METAXALONE	800MG	TABLET / ORAL		2018-09-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208774-001	METAXALONE	800MG	TABLET / ORAL		2018-09-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208774-001	METAXALONE	800MG	TABLET / ORAL		2018-09-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208774-001	METAXALONE	800MG	TABLET / ORAL		2018-09-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208774-001	METAXALONE	800MG	TABLET / ORAL		2018-09-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208774-001	METAXALONE	800MG	TABLET / ORAL		2018-09-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208774-001	METAXALONE	800MG	TABLET / ORAL	BX	2018-09-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208774-001	METAXALONE	800MG	TABLET / ORAL	BX	2018-09-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208774-001	METAXALONE	800MG	TABLET / ORAL	BX	2018-09-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208774-001	METAXALONE	800MG	TABLET / ORAL	BX	2018-09-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208774-001	METAXALONE	800MG	TABLET / ORAL	BX	2018-09-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208774-001	METAXALONE	800MG	TABLET / ORAL	BX	2018-09-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208774-001	METAXALONE	800MG	TABLET / ORAL	BX	2018-09-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208774-001	METAXALONE	800MG	TABLET / ORAL	BX	2018-09-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208774-001	METAXALONE	800MG	TABLET / ORAL	BX	2018-09-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208774-001	METAXALONE	800MG	TABLET / ORAL	BX	2018-09-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208774-001	METAXALONE	800MG	TABLET / ORAL	AB	2018-09-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208774-001	METAXALONE	800MG	TABLET / ORAL	BX	2018-09-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208774-001	METAXALONE	800MG	TABLET / ORAL	BX	2018-09-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208774-001	METAXALONE	800MG	TABLET / ORAL	AB	2018-09-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208774-001	METAXALONE	800MG	TABLET / ORAL	AB	2018-09-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208774-001	METAXALONE	800MG	TABLET / ORAL	AB	2018-09-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208774-001	METAXALONE	800MG	TABLET / ORAL	AB	2018-09-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208774-001	METAXALONE	800MG	TABLET / ORAL	AB	2018-09-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208774-001	METAXALONE	800MG	TABLET / ORAL	AB	2018-09-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208774-001	METAXALONE	800MG	TABLET / ORAL	AB	2018-09-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208774-001	METAXALONE	800MG	TABLET / ORAL	BX	2018-09-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208774-001	METAXALONE	800MG	TABLET / ORAL	BX	2018-09-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208774-001	METAXALONE	800MG	TABLET / ORAL	BX	2018-09-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208774-001	METAXALONE	800MG	TABLET / ORAL	BX	2018-09-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208774-001	METAXALONE	800MG	TABLET / ORAL	BX	2018-09-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208774-001	METAXALONE	800MG	TABLET / ORAL	BX	2018-09-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208774-001	METAXALONE	800MG	TABLET / ORAL	BX	2018-09-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208774-001	METAXALONE	800MG	TABLET / ORAL	BX	2018-09-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208774-001	METAXALONE	800MG	TABLET / ORAL	BX	2018-09-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208774-001	METAXALONE	800MG	TABLET / ORAL	BX	2018-09-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208774-001	METAXALONE	800MG	TABLET / ORAL	BX	2018-09-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208774-001	METAXALONE	800MG	TABLET / ORAL	BX	2018-09-24	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208774-001	BX	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208774-001	BX	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208774-001	BX	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208774-001	BX	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208774-001	BX	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208774-001	BX	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208774-001	BX	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208774-001	BX	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208774-001	BX	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208774-001	BX	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208774-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208774-001	BX	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208774-001	BX	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208774-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208774-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208774-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208774-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208774-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208774-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208774-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208774-001	BX	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208774-001	BX	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208774-001	BX	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208774-001	BX	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208774-001	BX	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208774-001	BX	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208774-001	BX	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208774-001	BX	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208774-001	BX	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208774-001	BX	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208774-001	BX	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208774-001	BX	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208774-001	BX	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
4fe1c2a6-5488-f909-3872-734054eb745a	Product name	5	20181231
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
776ba7f6-e5b0-442b-bd42-1fdfdfd821a4	Product name	1	20150615
68c52498-c9cb-48ab-a792-a4876149361e	Product name	1	20150409

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64980-472-01	EA - Each	64980-472	2d489cfe-3404-446a-9e1b-19c520fe8828	1	2019-03-12

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	a37094c9-6941-da34-e053-2995a90a9c25	3
351254	metaxalone 800 MG Oral Tablet	SCD	a37094c9-6941-da34-e053-2995a90a9c25	3
351254	metaxalone 800 MG Oral Tablet	PSN	7cd2c31c-adf9-459f-9c52-7bbc5639767f	2
351254	metaxalone 800 MG Oral Tablet	SCD	7cd2c31c-adf9-459f-9c52-7bbc5639767f	2
351254	metaxalone 800 MG Oral Tablet	PSN	124f3ef7-17a4-b9a9-e063-6394a90afe15	1
351254	metaxalone 800 MG Oral Tablet	PSN	bc2cec64-f842-532c-e053-2995a90a554d	1
351254	metaxalone 800 MG Oral Tablet	SCD	124f3ef7-17a4-b9a9-e063-6394a90afe15	1
351254	metaxalone 800 MG Oral Tablet	SCD	bc2cec64-f842-532c-e053-2995a90a554d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64980-472-01	64980047201	100 TABLET in 1 BOTTLE (64980-472-01)	100 tablet	2018-09-24	0000-00-00	No	No	Current
64980-472-50	64980047250	500 TABLET in 1 BOTTLE (64980-472-50)	500 tablet	2018-09-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
METAXALONE TABLETS, USP	PD-Rx Pharmaceuticals, Inc.	2024-10-08	HUMAN PRESCRIPTION DRUG LABEL	6
METAXALONE 800mg	RedPharm Drug, Inc.	2024-07-25	HUMAN PRESCRIPTION DRUG LABEL	3
METAXALONE TABLETS, USP	Preferred Pharmaceuticals, Inc.	2024-07-03	HUMAN PRESCRIPTION DRUG LABEL	5
METAXALONE TABLETS, USP	Proficient Rx LP	2024-05-01	HUMAN PRESCRIPTION DRUG LABEL	3
METAXALONE TABLETS, USP	Medsource Pharmaceuticals \| APPCO PHARMA LLC	2024-02-26	HUMAN PRESCRIPTION DRUG LABEL	1
METAXALONE TABLETS, USP	Bryant Ranch Prepack	2023-12-08	HUMAN PRESCRIPTION DRUG LABEL	102
METAXALONE TABLETS, USP	Bryant Ranch Prepack	2023-11-15	Human Prescription Drug Label	2
METAXALONE TABLETS, USP	Bryant Ranch Prepack	2023-10-06	HUMAN PRESCRIPTION DRUG LABEL	100
METAXALONE TABLETS, USP	REMEDYREPACK INC.	2023-03-09	HUMAN PRESCRIPTION DRUG LABEL	5
METAXALONE TABLETS, USP	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2023-02-01	HUMAN PRESCRIPTION DRUG LABEL	4
METAXALONE TABLETS, USP	Northwind Pharmaceuticals	2023-01-01	HUMAN PRESCRIPTION DRUG LABEL	1
Metaxalone - Central Packaging \| Central Packaging, LLC	Central Packaging \| Central Packaging, LLC	2021-02-25	HUMAN PRESCRIPTION DRUG LABEL	1
METAXALONE TABLETS, USP	Proficient Rx LP	2020-08-01	HUMAN PRESCRIPTION DRUG LABEL	1
METAXALONE TABLETS, USP	Rising Pharmaceuticals, Inc. \| APPCO PHARMA LLC	2018-10-04	Human Prescription Drug Label	1