Metaxalone

Manufacturer
Northwind Pharmaceuticals
Effective date
2014-06-03
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:18:51

Label at a glance#

ProductMetaxalone
Active ingredientMETAXALONE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 51655-163-20

MFG: 64720-321-10

Metaxalone 800mg

20 caplets

Rx only

Lot#:

Exp. date:

Each tablet contains 800 mg of metaxalone

Dosage: See package insert

Store between 59-86 degrees F.

Protect from moisture.

Store in a tight, light-resistant container (See USP).

Keep out of the reach of children.

Mfg. by: CorePharma, LLC Middlesex, NJ 08846

Repackaged by: Northwind Pharmaceuticals, Indianapolis, IN 46256

Metaxalone 51655-163Metaxalone 51655-163

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-163-202026-01-10C16284748780-19d75b9d0-d360-f424-e053-dadaa90a57ce4e5283d0-a1fb-467d-8832-4d833a1d43e4
51655-163-202020-01-31C16284748780-19d75b9d0-d360-f424-e053-dadaa90a57ce4e5283d0-a1fb-467d-8832-4d833a1d43e4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-163METAXALONE TABLET [NORTHWIND PHARMACEUTICALS]1Legacy NDC20140604_4e5283d0-a1fb-467d-8832-4d833a1d43e4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64720-321-10EA - Each64720-32174f9cb31-1f75-4fb0-8dcb-d81e89946cdb12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
METAXALONEACTIVE INGREDIENT1NMA9J598Y1
METAXALONEACTIVE MOIETY1NMA9J598Y1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 1 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51655-16351655-163-20
64720-321

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
METAXALONE1NMA9J598YACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N013217-001SKELAXINMETAXALONE400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982
N013217-003SKELAXINMETAXALONE800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2002-08-30

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N013217-00371225662026-02-06U-915

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N013217-001SKELAXIN400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 198284e616aacf4f…
2026-09-14 22:38:342026-08N013217-003SKELAXIN800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2002-08-3084e616aacf4f…
2026-08-18 06:07:402026-07N013217-001SKELAXIN400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N013217-003SKELAXIN800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2002-08-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N013217-001SKELAXIN400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N013217-003SKELAXIN800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2002-08-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N013217-001SKELAXIN400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N013217-003SKELAXIN800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2002-08-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N013217-001SKELAXIN400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N013217-003SKELAXIN800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2002-08-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N013217-001SKELAXIN400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N013217-003SKELAXIN800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2002-08-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N013217-001SKELAXIN400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N013217-003SKELAXIN800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2002-08-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N013217-001SKELAXIN400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N013217-003SKELAXIN800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2002-08-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N013217-001SKELAXIN400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N013217-003SKELAXIN800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2002-08-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N013217-001SKELAXIN400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N013217-003SKELAXIN800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2002-08-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N013217-001SKELAXIN400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N013217-003SKELAXIN800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2002-08-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N013217-001SKELAXIN400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N013217-003SKELAXIN800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2002-08-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N013217-001SKELAXIN400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N013217-003SKELAXIN800MGTABLET / ORALRLD2002-08-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N013217-001SKELAXIN400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N013217-003SKELAXIN800MGTABLET / ORALRLD2002-08-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N013217-001SKELAXIN400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N013217-003SKELAXIN800MGTABLET / ORALRLD2002-08-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05N013217-001SKELAXIN400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05N013217-003SKELAXIN800MGTABLET / ORALRLD2002-08-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N013217-001SKELAXIN400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N013217-003SKELAXIN800MGTABLET / ORALABRLD, RS2002-08-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N013217-001SKELAXIN400MGTABLET / ORALRLD, Approved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N013217-003SKELAXIN800MGTABLET / ORALABRLD, RS2002-08-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N013217-001SKELAXIN400MGTABLET / ORALRLD, Approved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N013217-003SKELAXIN800MGTABLET / ORALABRLD, RS2002-08-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N013217-001SKELAXIN400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET / ORALRLD, Approved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N013217-003SKELAXIN800MGTABLET / ORALABRLD, RS2002-08-3074a2ff9319b5…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N013217-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N013217-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N013217-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N013217-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N013217-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N013217-003AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N013217-003AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N013217-003AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N013217-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N013217-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N013217-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N013217-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N013217-003AB1ea99ee380514…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N013217-003AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N013217-003AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N013217-003AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N013217-003AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N013217-003AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N013217-003AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N013217-003AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N013217-003AB1cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 2 · 52 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N013217-00371225662026-02-06U-91584e616aacf4f…
2026-08-18 06:07:402026-07N013217-00371225662026-02-06U-915caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N013217-00371225662026-02-06U-915011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N013217-00371225662026-02-06U-91531067a03dcf5…
2025-08-23 18:47 UTC2025-08N013217-00371225662026-02-06U-9156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N013217-00371225662026-02-06U-915fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N013217-00371225662026-02-06U-915b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N013217-00371225662026-02-06U-91503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N013217-00371225662026-02-06U-9152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N013217-00371225662026-02-06U-9155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N013217-00371225662026-02-06U-915d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N013217-00371225662026-02-06U-915d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N013217-00371225662026-02-06U-91579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N013217-00371225662026-02-06U-915301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N013217-00371225662026-02-06U-9151e350fbaab3a…
2024-05-31 18:47 UTC2024-05N013217-00371225662026-02-06U-9158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N013217-00371225662026-02-06U-9155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N013217-00371225662026-02-06U-9155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N013217-00371225662026-02-06U-9154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N013217-00377140062021-12-03U-105074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N013217-00371225662026-02-06U-91574a2ff9319b5…
2022-03-09 01:35 UTC2022-03N013217-00371225662026-02-06U-915bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N013217-00377140062021-12-03U-1050782e0a99824c…
2021-12-28 21:50 UTC2021-12N013217-00371225662026-02-06U-915782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N013217-00377140062021-12-03U-105087673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N013217-00371225662026-02-06U-91587673890dc5c…
2021-03-12 10:30 UTC2021-03N013217-00377140062021-12-03U-10505aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N013217-00371225662026-02-06U-9155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N013217-00377140062021-12-03U-10508869cabd3fbd…
2020-12-22 03:56 UTC2020-12N013217-00371225662026-02-06U-9158869cabd3fbd…
2020-11-12 02:37 UTC2020-11N013217-00377140062021-12-03U-1050c0c555d07b60…
2020-11-12 02:37 UTC2020-11N013217-00371225662026-02-06U-915c0c555d07b60…
2019-12-14 00:12 UTC2019-12N013217-00377140062021-12-03U-10503f01610625f2…
2019-12-14 00:12 UTC2019-12N013217-00371225662026-02-06U-9153f01610625f2…
2019-09-15 20:21 UTC2019-09N013217-00377140062021-12-03U-1050b00525d2431f…
2019-09-15 20:21 UTC2019-09N013217-00371225662026-02-06U-915b00525d2431f…
2019-07-19 19:46 UTC2019-07N013217-00377140062021-12-03U-1050ea99ee380514…
2019-07-19 19:46 UTC2019-07N013217-00371225662026-02-06U-915ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N013217-00371225662026-02-06U-9156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N013217-00371225662026-02-06U-9151c564ffb4f44…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
47cdac6e-d72a-e43a-e063-6294a90a6f1f4e5283d0-a1fb-467d-8832-4d833a1d43e42026-01-07Exact identifier
spl set id: 4e5283d0-a1fb-467d-8832-4d833a1d43e4

Reported adverse events (FAERS/openFDA)#

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