Metaxalone

Product NDC
60760-093
11-digit product format
607600093
Labeler code
60760
Product ID
60760-093_50c7d5bf-ab64-ef1f-e063-6294a90a9e97
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
St. Mary's Medical Park Pharmacy
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
2027-12-31
Current FDA listing
Yes

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage60760-09360760-093-06DDiscontinued by firm2026-08-11
excluded packagepackage60760-09360760-093-60DDiscontinued by firm2026-08-11

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 · 18 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0560760-093-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0560760-093-90d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2660760-093-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2660760-093-90f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3160760-093-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3160760-093-902ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2860760-093-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2860760-093-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2160760-093-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2160760-093-90cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1060760-093-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1060760-093-90cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3160760-093-60302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3160760-093-90302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2060760-093-60ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2060760-093-90ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1060760-093-600efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1060760-093-900efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203695-001METAXALONE800MGTABLET / ORALAB2017-06-15cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203695-001AB1cb3db0bc1861…

Additional Listing Data#

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

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
5de36266-3964-5aca-e053-2991aa0a2205Available 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
60760-093-06Metaxalone6 in 1 BOTTLE, PLASTICTABLET611
60760-093-20Metaxalone20 in 1 BOTTLE, PLASTICTABLET2011
60760-093-30Metaxalone30 in 1 BOTTLE, PLASTICTABLET3011
60760-093-60Metaxalone60 in 1 BOTTLE, PLASTICTABLET6011
60760-093-90Metaxalone90 in 1 BOTTLE, PLASTICTABLET9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-093-06EA - Each60760-093b52c04f5-0840-4771-903b-b1f3c5f2c6a812018-06-11
60760-093-20EA - Each60760-093fcaf7cad-6b7b-43f2-9280-2bfcc90c159112017-12-14
60760-093-30EA - Each60760-093932d0fad-1c2b-440b-9ddd-ab4ee1db479912018-02-20
60760-093-60EA - Each60760-093e5e60652-fbf5-488d-828f-b15a72fc22bc12018-08-13
60760-093-90EA - Each60760-0932e940d9b-b806-4fd6-8d92-23933912011112018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-093METAXALONE TABLET [ST. MARY'S MEDICAL PARK PHARMACY]7Current NDC, Legacy NDC, 5 package rows20241215_5de36266-3964-5aca-e053-2991aa0a2205.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
ndc (product): 60760-093
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
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 TabletPSN5de36266-3964-5aca-e053-2991aa0a220511
351254metaxalone 800 MG Oral TabletSCD5de36266-3964-5aca-e053-2991aa0a220511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60760-093-06607600093066 TABLET in 1 BOTTLE, PLASTIC (60760-093-06) 6 tablet2018-04-240000-00-00NoNoCurrent
60760-093-206076000932020 TABLET in 1 BOTTLE, PLASTIC (60760-093-20) 20 tablet2017-11-100000-00-00NoNoCurrent
60760-093-306076000933030 TABLET in 1 BOTTLE, PLASTIC (60760-093-30) 30 tablet2017-11-100000-00-00NoNoCurrent
60760-093-606076000936060 TABLET in 1 BOTTLE, PLASTIC (60760-093-60) 60 tablet2018-06-280000-00-00NoNoCurrent
60760-093-906076000939090 TABLET in 1 BOTTLE, PLASTIC (60760-093-90) 90 tablet2026-03-250000-00-00NoNoCurrent