Metaxalone

Product NDC: 68788-4168
11-digit product format: 687884168
Labeler code: 68788
Product ID: 68788-4168_01199953-8124-4ace-947f-7b11989b44c3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metaxalone
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA207466
Marketing category: ANDA
Marketing start: 2026-07-24
Substance: METAXALONE
Active strength: 800 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 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207466-001	METAXALONE	METAXALONE	800MG	TABLET / ORAL	AB		2017-08-31
A207466-002	METAXALONE	METAXALONE	400MG	TABLET / ORAL	AB		2020-03-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A207466-001	AB
A207466-002	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 3 · 82 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
2026-09-14 22:38:34	2026-08	A207466-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-08-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207466-002	METAXALONE	400MG	TABLET / ORAL	AB	2020-03-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207466-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-08-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207466-002	METAXALONE	400MG	TABLET / ORAL	AB	2020-03-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207466-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207466-002	METAXALONE	400MG	TABLET / ORAL	AB	2020-03-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207466-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-08-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207466-002	METAXALONE	400MG	TABLET / ORAL	AB	2020-03-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207466-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-08-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207466-002	METAXALONE	400MG	TABLET / ORAL	AB	2020-03-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207466-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-08-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207466-002	METAXALONE	400MG	TABLET / ORAL	AB	2020-03-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207466-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-08-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207466-002	METAXALONE	400MG	TABLET / ORAL	AB	2020-03-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207466-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-08-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207466-002	METAXALONE	400MG	TABLET / ORAL	AB	2020-03-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207466-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-08-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207466-002	METAXALONE	400MG	TABLET / ORAL	AB	2020-03-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207466-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-08-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207466-002	METAXALONE	400MG	TABLET / ORAL	AB	2020-03-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207466-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-08-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207466-002	METAXALONE	400MG	TABLET / ORAL	AB	2020-03-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207466-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-08-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207466-002	METAXALONE	400MG	TABLET / ORAL	AB	2020-03-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207466-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-08-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207466-002	METAXALONE	400MG	TABLET / ORAL	AB	2020-03-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207466-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-08-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207466-002	METAXALONE	400MG	TABLET / ORAL	AB	2020-03-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207466-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-08-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207466-002	METAXALONE	400MG	TABLET / ORAL	AB	2020-03-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207466-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-08-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207466-002	METAXALONE	400MG	TABLET / ORAL	AB	2020-03-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207466-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-08-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207466-002	METAXALONE	400MG	TABLET / ORAL	AB	2020-03-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207466-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-08-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207466-002	METAXALONE	400MG	TABLET / ORAL	AB	2020-03-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207466-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-08-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207466-002	METAXALONE	400MG	TABLET / ORAL	AB	2020-03-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207466-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-08-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207466-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-08-31	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A207466-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207466-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207466-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207466-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207466-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207466-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207466-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207466-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207466-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207466-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207466-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207466-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207466-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207466-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207466-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207466-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207466-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207466-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207466-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207466-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207466-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207466-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207466-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207466-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207466-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207466-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207466-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207466-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207466-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207466-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207466-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207466-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207466-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207466-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207466-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207466-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207466-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207466-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207466-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207466-001	AB	1	`bb7c543d1eb4…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

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
01199953-8124-4ace-947f-7b11989b44c3	Available on FDA.report

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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metaxalone	METAXALONE	PD-Rx Pharmaceuticals, Inc.	98713a2b-6666-44ea-9966-54e78041d27a	2026-09-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207466 application number: ANDA207466
Metaxalone	METAXALONE	REMEDYREPACK INC.	fe82b33b-2a24-4477-91ca-b23e59156675	2026-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207466 application number: ANDA207466
Metaxalone	METAXALONE	Preferred Pharmaceuticals Inc.	01199953-8124-4ace-947f-7b11989b44c3	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207466 application number: ANDA207466 ndc (product): 68788-4168
Metaxalone	METAXALONE	Preferred Pharmaceuticals Inc.	8aa84e64-0075-4f22-a576-da085f32d56c	2026-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207466 application number: ANDA207466
Metaxalone	METAXALONE	Highmark Pharma LLC	834be129-cfb5-4420-b660-025833376b3e	2026-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207466 application number: ANDA207466
Metaxalone	METAXALONE	Advanced Rx of Tennessee, LLC	4facde6f-1828-9138-e063-6294a90a1ec1	2026-04-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207466 application number: ANDA207466
Metaxalone	METAXALONE	Northwind Health Company, LLC	f2b46d69-1c20-5ae9-e053-2a95a90a60a9	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207466 application number: ANDA207466
Metaxalone	METAXALONE	BluePoint Laboratories	c91c0fb0-0b61-4e45-8bea-d0bf57ca7068	2025-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207466 application number: ANDA207466
Metaxalone	METAXALONE	Advanced Rx of Tennessee, LLC	36c1d263-48ce-831b-e063-6394a90a0a2b	2025-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207466 application number: ANDA207466
Metaxalone	METAXALONE	Major Pharmaceuticals	8c1e10fe-0330-4bf8-a94d-aeed80f6aef1	2025-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207466 application number: ANDA207466
Metaxalone	METAXALONE	PD-Rx Pharmaceuticals, Inc.	edc6ba8d-2d45-4833-8dc7-e2d4e5d72856	2025-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207466 application number: ANDA207466
Metaxalone	METAXALONE	Dr. Reddys Laboratories Limited	02eb5938-cd59-4a81-853d-a4148d813a94	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207466 application number: ANDA207466
Metaxalone	METAXALONE	American Health Packaging	b6afb4d3-eb3e-4e9f-9aa9-a44cfacb959c	2024-08-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207466 application number: ANDA207466
Metaxalone	METAXALONE	ScieGen Pharmaceuticals, Inc.	1cef46bb-e590-4a58-82e0-7cf1fc3836a5	2024-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207466 application number: ANDA207466
Metaxalone	METAXALONE	Proficient Rx LP	9c7d0cd4-625a-485e-9d13-ce854630148c	2024-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207466 application number: ANDA207466
Metaxalone	METAXALONE	Misemer Pharmaceuticals, Inc.	d0276e7b-a1c9-61f3-e053-2a95a90ae3aa	2024-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207466 application number: ANDA207466
Metaxalone	METAXALONE	CIPLA USA INC.	c1f49112-e8ce-43a9-bdb8-1a3db4fb6bc4	2023-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207466 application number: ANDA207466

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1NMA9J598Y	METAXALONE	1665-48-1	METAXALONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68788-4168-1	68788416801	100 TABLET in 1 BOTTLE (68788-4168-1)	100 tablet	2026-07-24	No	No	Current
68788-4168-3	68788416803	30 TABLET in 1 BOTTLE (68788-4168-3)	30 tablet	2026-07-24	No	No	Current
68788-4168-6	68788416806	60 TABLET in 1 BOTTLE (68788-4168-6)	60 tablet	2026-07-24	No	No	Current
68788-4168-8	68788416808	120 TABLET in 1 BOTTLE (68788-4168-8)	120 tablet	2026-07-24	No	No	Current
68788-4168-9	68788416809	90 TABLET in 1 BOTTLE (68788-4168-9)	90 tablet	2026-07-24	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
METAXALONE TABLETS, USP	Preferred Pharmaceuticals Inc.	2026-07-24	HUMAN PRESCRIPTION DRUG LABEL	1