Metaxalone

Product NDC
67296-0993
11-digit product format
672960993
Labeler code
67296
Product ID
67296-0993_d60f98e1-7bc1-717f-e053-2995a90ae8d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA203399
Marketing category
ANDA
Marketing start
2013-05-31
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
2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67296-0993IInactivated by FDA2026-08-17
excluded packagepackage67296-099367296-0993-1IInactivated by FDA2026-08-17

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 · 32 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67296-0993-1IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67296-0993-1IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67296-0993-1IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67296-0993-1IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67296-0993-1IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67296-0993-1IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67296-0993-1IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67296-0993-1IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67296-0993-1IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67296-0993-1IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67296-0993-1IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67296-0993-1IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67296-0993-1IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67296-0993-1IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67296-0993-1IInactivated by FDA1332a3947898…d4bfe170f9cd…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage67296-0993-1EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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
A203399-001METAXALONEMETAXALONE800MGTABLET / ORALABRS2013-06-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203399-001AB

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 06:07:402026-07A203399-001METAXALONE800MGTABLET / ORALABRS2013-06-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203399-001METAXALONE800MGTABLET / ORALABRS2013-06-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203399-001METAXALONE800MGTABLET / ORALABRS2013-06-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203399-001METAXALONE800MGTABLET / ORALABRS2013-06-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203399-001METAXALONE800MGTABLET / ORALABRS2013-06-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203399-001METAXALONE800MGTABLET / ORALABRS2013-06-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203399-001METAXALONE800MGTABLET / ORALABRS2013-06-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203399-001METAXALONE800MGTABLET / ORALABRS2013-06-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203399-001METAXALONE800MGTABLET / ORALABRS2013-06-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203399-001METAXALONE800MGTABLET / ORALABRS2013-06-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203399-001METAXALONE800MGTABLET / ORALABRS2013-06-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203399-001METAXALONE800MGTABLET / ORALABRS2013-06-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203399-001METAXALONE800MGTABLET / ORALABRS2013-06-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203399-001METAXALONE800MGTABLET / ORALABRS2013-06-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203399-001METAXALONE800MGTABLET / ORALABRS2013-06-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203399-001METAXALONE800MGTABLET / ORALAB2013-06-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203399-001METAXALONE800MGTABLET / ORALAB2013-06-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203399-001METAXALONE800MGTABLET / ORALAB2013-06-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203399-001METAXALONE800MGTABLET / ORALAB2013-06-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203399-001METAXALONE800MGTABLET / ORALAB2013-06-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203399-001METAXALONE800MGTABLET / ORALAB2013-06-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203399-001METAXALONE800MGTABLET / ORALAB2013-06-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A203399-001METAXALONE800MGTABLET / ORALAB2013-06-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203399-001METAXALONE800MGTABLET / ORALAB2013-06-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203399-001METAXALONE800MGTABLET / ORALAB2013-06-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203399-001METAXALONE800MGTABLET / ORALAB2013-06-213f01610625f2…
2019-09-15 20:21 UTC2019-09A203399-001METAXALONE800MGTABLET / ORALAB2013-06-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A203399-001METAXALONE800MGTABLET / ORALAB2013-06-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203399-001METAXALONE800MGTABLET / ORALABRS2013-06-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203399-001METAXALONE800MGTABLET / ORALABRS2013-06-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203399-001METAXALONE800MGTABLET / ORALABRS2013-06-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203399-001METAXALONE800MGTABLET / ORALABRS2013-06-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203399-001METAXALONE800MGTABLET / ORALABRS2013-06-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203399-001METAXALONE800MGTABLET / ORALAB2013-06-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203399-001METAXALONE800MGTABLET / ORALAB2013-06-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A203399-001METAXALONE800MGTABLET / ORALAB2013-06-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A203399-001METAXALONE800MGTABLET / ORALAB2013-06-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203399-001METAXALONE800MGTABLET / ORALAB2013-06-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203399-001METAXALONE800MGTABLET / ORALAB2013-06-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203399-001METAXALONE800MGTABLET / ORALAB2013-06-21e64feba35796…

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 06:07:402026-07A203399-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203399-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203399-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203399-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203399-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203399-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203399-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203399-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203399-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203399-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203399-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203399-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203399-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203399-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203399-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203399-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203399-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203399-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203399-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203399-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203399-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203399-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A203399-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203399-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203399-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203399-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A203399-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A203399-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203399-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203399-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203399-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203399-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203399-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203399-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203399-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A203399-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A203399-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203399-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203399-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203399-001AB1e64feba35796…

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
67296-0993-12024-01-30C16284748780-11030e365-5dec-111a-e063-dadaa90a10e24dee3f39-f735-329c-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-0993-1Metaxalone15 in 1 BOTTLETABLET154

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0993METAXALONE TABLET [REDPHARM DRUG, INC.]4Legacy NDC, 1 package rows20220121_4dee3f39-f735-329c-e054-00144ff8d46c.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MetaxaloneMETAXALONEAvKARE4c3b2aa4-fe65-507c-e063-6394a90a7b002026-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203399
application number: ANDA203399
MetaxaloneMETAXALONEAvKARE4c3ae824-48a9-fd91-e063-6394a90a9a542026-03-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203399
application number: ANDA203399
MetaxaloneMETAXALONEAvPAK9b21a974-6a5a-9efb-e9de-4703632171262025-11-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203399
application number: ANDA203399
MetaxaloneMETAXALONEAmneal Pharmaceuticals LLC3aa9dba9-29b0-4520-a0f7-66d19d52c6bc2025-03-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203399
application number: ANDA203399
MetaxaloneMETAXALONEAdvanced Rx of Tennessee, LLCb3279496-293e-7e1f-e053-2a95a90ab5062024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203399
application number: ANDA203399
MetaxaloneMETAXALONEAmneal Pharmaceuticals of New York LLCf06f2b96-3684-483c-89f7-6c9201fd46642023-01-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203399
application number: ANDA203399
MetaxaloneMETAXALONEProficient Rx LPfba1601d-3ac4-41cf-9548-35ec4994a95e2022-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203399
application number: ANDA203399

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351254metaxalone 800 MG Oral TabletPSN4dee3f39-f735-329c-e054-00144ff8d46c4
351254metaxalone 800 MG Oral TabletSCD4dee3f39-f735-329c-e054-00144ff8d46c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-0993-16729609930115 TABLET in 1 BOTTLE (67296-0993-1) 15 tablet2013-05-310000-00-00NoNoCurrent