Metaxalone

Product NDC
0591-2341
11-digit product format
005912341
Labeler code
0591
Product ID
0591-2341_ca4c1e06-87e3-4f44-aeac-3da9d4b901d3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA203695
Marketing category
ANDA
Marketing start
2017-06-19
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

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0591-23410591-2341-05DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203695-001METAXALONEMETAXALONE800MGTABLET / ORALAB2017-06-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203695-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A203695-001METAXALONE800MGTABLET / ORALAB2017-06-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203695-001METAXALONE800MGTABLET / ORALAB2017-06-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203695-001METAXALONE800MGTABLET / ORALAB2017-06-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A203695-001METAXALONE800MGTABLET / ORALAB2017-06-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203695-001METAXALONE800MGTABLET / ORALAB2017-06-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203695-001METAXALONE800MGTABLET / ORALAB2017-06-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203695-001METAXALONE800MGTABLET / ORALAB2017-06-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203695-001METAXALONE800MGTABLET / ORALAB2017-06-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203695-001METAXALONE800MGTABLET / ORALAB2017-06-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203695-001METAXALONE800MGTABLET / ORALAB2017-06-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203695-001METAXALONE800MGTABLET / ORALAB2017-06-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203695-001METAXALONE800MGTABLET / ORALAB2017-06-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203695-001METAXALONE800MGTABLET / ORALAB2017-06-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203695-001METAXALONE800MGTABLET / ORALAB2017-06-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203695-001METAXALONE800MGTABLET / ORALAB2017-06-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203695-001METAXALONE800MGTABLET / ORALAB2017-06-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203695-001METAXALONE800MGTABLET / ORALAB2017-06-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203695-001METAXALONE800MGTABLET / ORALAB2017-06-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203695-001METAXALONE800MGTABLET / ORALAB2017-06-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203695-001METAXALONE800MGTABLET / ORALAB2017-06-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203695-001METAXALONE800MGTABLET / ORALAB2017-06-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203695-001METAXALONE800MGTABLET / ORALAB2017-06-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A203695-001METAXALONE800MGTABLET / ORALAB2017-06-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203695-001METAXALONE800MGTABLET / ORALAB2017-06-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203695-001METAXALONE800MGTABLET / ORALAB2017-06-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203695-001METAXALONE800MGTABLET / ORALAB2017-06-153f01610625f2…
2019-09-15 20:21 UTC2019-09A203695-001METAXALONE800MGTABLET / ORALAB2017-06-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A203695-001METAXALONE800MGTABLET / ORALAB2017-06-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203695-001METAXALONE800MGTABLET / ORALAB2017-06-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203695-001METAXALONE800MGTABLET / ORALAB2017-06-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203695-001METAXALONE800MGTABLET / ORALAB2017-06-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203695-001METAXALONE800MGTABLET / ORALAB2017-06-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203695-001METAXALONE800MGTABLET / ORALAB2017-06-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203695-001METAXALONE800MGTABLET / ORALAB2017-06-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203695-001METAXALONE800MGTABLET / ORALAB2017-06-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A203695-001METAXALONE800MGTABLET / ORALAB2017-06-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A203695-001METAXALONE800MGTABLET / ORALAB2017-06-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203695-001METAXALONE800MGTABLET / ORALAB2017-06-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203695-001METAXALONE800MGTABLET / ORALAB2017-06-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203695-001METAXALONE800MGTABLET / ORALAB2017-06-15e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A203695-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203695-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203695-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203695-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203695-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203695-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203695-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203695-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203695-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203695-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203695-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203695-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203695-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203695-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203695-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203695-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203695-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203695-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203695-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203695-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203695-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203695-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A203695-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203695-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203695-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203695-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A203695-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A203695-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203695-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203695-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203695-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203695-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203695-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203695-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203695-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A203695-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A203695-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203695-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203695-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203695-001AB1e64feba35796…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METAXALONE800 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1NMA9J598YInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
351254Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b3a4f6bc-abd4-4b8e-970f-59b3aa6f17a0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe1c2a6-5488-f909-3872-734054eb745aProduct name520181231
776ba7f6-e5b0-442b-bd42-1fdfdfd821a4Product name120150615
68c52498-c9cb-48ab-a792-a4876149361eProduct name120150409

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-2341-01Metaxalone100 in 1 BOTTLETABLET1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-2341-01EA - Each0591-2341b23f73cd-9ecd-4aa7-9398-dfb30b06fa1a12017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-2341METAXALONE TABLET [ACTAVIS PHARMA, INC.]8Current NDC, Legacy NDC, 1 package rows20240801_b3a4f6bc-abd4-4b8e-970f-59b3aa6f17a0.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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MetaxaloneMETAXALONESt. Mary's Medical Park Pharmacy5de36266-3964-5aca-e053-2991aa0a22052026-06-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203695
application number: ANDA203695
MetaxaloneMETAXALONEAsclemed USA, Inc.f4a0e910-2b20-46d4-b49e-21fb15925b582026-04-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203695
application number: ANDA203695
MetaxaloneMETAXALONESportpharm LLC5bcdc9d3-8827-4d05-8783-4519f1b284a32026-02-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203695
application number: ANDA203695
MetaxaloneMETAXALONEDirect_Rx45726fbc-3450-63f7-e063-6394a90a671a2026-01-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203695
application number: ANDA203695
MetaxaloneMETAXALONEPHOENIX RX LLC3a7c8b4d-7add-cb31-e063-6294a90a37f82025-10-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203695
application number: ANDA203695
MetaxaloneMETAXALONEActavis Pharma, Inc.b3a4f6bc-abd4-4b8e-970f-59b3aa6f17a02025-07-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203695
application number: ANDA203695
ndc (product): 0591-2341
MetaxaloneMETAXALONEAdvanced Rx Pharmacy of Tennessee, LLCbd1c9022-aadc-af1f-e053-2995a90a0b422024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203695
application number: ANDA203695
MetaxaloneMETAXALONEBryant Ranch Prepackc2dd7071-cba3-410c-ade5-9d7e5af420382024-09-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203695
application number: ANDA203695
MetaxaloneMETAXALONEBryant Ranch Prepack07ccff59-e335-40be-9e40-fd2d081976172024-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203695
application number: ANDA203695
MetaxaloneMETAXALONEProficient Rx LPc796d4a1-fad4-4a0c-a459-8ae3b5b52fb62024-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203695
application number: ANDA203695
MetaxaloneMETAXALONEDoc Rx87518046-c959-d5f3-e053-2a95a90a5f7e2021-09-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203695
application number: ANDA203695

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351254metaxalone 800 MG Oral TabletPSNc2dd7071-cba3-410c-ade5-9d7e5af4203811
351254metaxalone 800 MG Oral TabletPSN5de36266-3964-5aca-e053-2991aa0a220511
351254metaxalone 800 MG Oral TabletSCDc2dd7071-cba3-410c-ade5-9d7e5af4203811
351254metaxalone 800 MG Oral TabletSCD5de36266-3964-5aca-e053-2991aa0a220511
351254metaxalone 800 MG Oral TabletPSN07ccff59-e335-40be-9e40-fd2d0819761710
351254metaxalone 800 MG Oral TabletSCD07ccff59-e335-40be-9e40-fd2d0819761710
351254metaxalone 800 MG Oral TabletPSNc0882edb-e2ad-470e-b26d-3c83b657abf99
351254metaxalone 800 MG Oral TabletPSNb3a4f6bc-abd4-4b8e-970f-59b3aa6f17a09
351254metaxalone 800 MG Oral TabletPSN87518046-c959-d5f3-e053-2a95a90a5f7e9
351254metaxalone 800 MG Oral TabletSCDc0882edb-e2ad-470e-b26d-3c83b657abf99
351254metaxalone 800 MG Oral TabletSCDb3a4f6bc-abd4-4b8e-970f-59b3aa6f17a09
351254metaxalone 800 MG Oral TabletSCD87518046-c959-d5f3-e053-2a95a90a5f7e9
351254metaxalone 800 MG Oral TabletPSNbd1c9022-aadc-af1f-e053-2995a90a0b426
351254metaxalone 800 MG Oral TabletSCDbd1c9022-aadc-af1f-e053-2995a90a0b426
351254metaxalone 800 MG Oral TabletPSNc796d4a1-fad4-4a0c-a459-8ae3b5b52fb65
351254metaxalone 800 MG Oral TabletSCDc796d4a1-fad4-4a0c-a459-8ae3b5b52fb65
351254metaxalone 800 MG Oral TabletPSN5bcdc9d3-8827-4d05-8783-4519f1b284a33
351254metaxalone 800 MG Oral TabletPSNdbede7cf-c326-4e8c-a17d-2136f61c8c973
351254metaxalone 800 MG Oral TabletPSN45726fbc-3450-63f7-e063-6394a90a671a3
351254metaxalone 800 MG Oral TabletPSNf4a0e910-2b20-46d4-b49e-21fb15925b583
351254metaxalone 800 MG Oral TabletSCDdbede7cf-c326-4e8c-a17d-2136f61c8c973
351254metaxalone 800 MG Oral TabletSCDf4a0e910-2b20-46d4-b49e-21fb15925b583
351254metaxalone 800 MG Oral TabletSCD5bcdc9d3-8827-4d05-8783-4519f1b284a33
351254metaxalone 800 MG Oral TabletSCD45726fbc-3450-63f7-e063-6394a90a671a3
351254metaxalone 800 MG Oral TabletPSN6869a255-cc41-4127-a629-97f8d78e880c2
351254metaxalone 800 MG Oral TabletPSN3a7c8b4d-7add-cb31-e063-6294a90a37f82
351254metaxalone 800 MG Oral TabletSCD6869a255-cc41-4127-a629-97f8d78e880c2
351254metaxalone 800 MG Oral TabletSCD3a7c8b4d-7add-cb31-e063-6294a90a37f82
351254metaxalone 800 MG Oral TabletPSN9af17dc7-04cd-de48-e053-2995a90a87091
351254metaxalone 800 MG Oral TabletSCD9af17dc7-04cd-de48-e053-2995a90a87091

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-2341-0100591234101100 TABLET in 1 BOTTLE (0591-2341-01) 100 tablet2017-06-190000-00-00NoNoCurrent