Metaxalone

Product NDC
71335-0958
11-digit product format
713350958
Labeler code
71335
Product ID
71335-0958_d884568c-4c86-428f-958a-16367089c4ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204770
Marketing category
ANDA
Marketing start
2016-11-22
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

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
A204770-001METAXALONEMETAXALONE800MGTABLET / ORALAB2016-11-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204770-001AB

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 06:07:402026-07A204770-001METAXALONE800MGTABLET / ORALAB2016-11-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204770-001METAXALONE800MGTABLET / ORALAB2016-11-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204770-001METAXALONE800MGTABLET / ORALAB2016-11-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A204770-001METAXALONE800MGTABLET / ORALAB2016-11-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204770-001METAXALONE800MGTABLET / ORALAB2016-11-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204770-001METAXALONE800MGTABLET / ORALAB2016-11-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204770-001METAXALONE800MGTABLET / ORALAB2016-11-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204770-001METAXALONE800MGTABLET / ORALAB2016-11-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204770-001METAXALONE800MGTABLET / ORALAB2016-11-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204770-001METAXALONE800MGTABLET / ORALAB2016-11-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204770-001METAXALONE800MGTABLET / ORALAB2016-11-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204770-001METAXALONE800MGTABLET / ORALAB2016-11-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204770-001METAXALONE800MGTABLET / ORALAB2016-11-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204770-001METAXALONE800MGTABLET / ORALAB2016-11-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204770-001METAXALONE800MGTABLET / ORALAB2016-11-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204770-001METAXALONE800MGTABLET / ORALAB2016-11-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204770-001METAXALONE800MGTABLET / ORALAB2016-11-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204770-001METAXALONE800MGTABLET / ORALAB2016-11-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204770-001METAXALONE800MGTABLET / ORALAB2016-11-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204770-001METAXALONE800MGTABLET / ORALAB2016-11-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204770-001METAXALONE800MGTABLET / ORALAB2016-11-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204770-001METAXALONE800MGTABLET / ORALAB2016-11-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A204770-001METAXALONE800MGTABLET / ORALAB2016-11-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204770-001METAXALONE800MGTABLET / ORALAB2016-11-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204770-001METAXALONE800MGTABLET / ORALAB2016-11-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12A204770-001METAXALONE800MGTABLET / ORALAB2016-11-223f01610625f2…
2019-09-15 20:21 UTC2019-09A204770-001METAXALONE800MGTABLET / ORALAB2016-11-22b00525d2431f…
2019-07-19 19:46 UTC2019-07A204770-001METAXALONE800MGTABLET / ORALAB2016-11-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204770-001METAXALONE800MGTABLET / ORALAB2016-11-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A204770-001METAXALONE800MGTABLET / ORALAB2016-11-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A204770-001METAXALONE800MGTABLET / ORALAB2016-11-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A204770-001METAXALONE800MGTABLET / ORALAB2016-11-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A204770-001METAXALONE800MGTABLET / ORALAB2016-11-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A204770-001METAXALONE800MGTABLET / ORALAB2016-11-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A204770-001METAXALONE800MGTABLET / ORALAB2016-11-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A204770-001METAXALONE800MGTABLET / ORALAB2016-11-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A204770-001METAXALONE800MGTABLET / ORALAB2016-11-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A204770-001METAXALONE800MGTABLET / ORALAB2016-11-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A204770-001METAXALONE800MGTABLET / ORALAB2016-11-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A204770-001METAXALONE800MGTABLET / ORALAB2016-11-22e64feba35796…

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 06:07:402026-07A204770-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204770-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204770-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204770-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204770-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204770-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204770-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204770-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204770-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204770-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204770-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204770-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204770-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204770-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204770-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204770-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204770-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204770-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204770-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204770-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204770-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204770-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A204770-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204770-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204770-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A204770-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A204770-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A204770-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204770-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A204770-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A204770-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A204770-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A204770-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A204770-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A204770-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A204770-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A204770-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A204770-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A204770-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A204770-001AB1e64feba35796…

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
7f758053-2367-4c5f-9bbd-ce8ce263a615Available 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
71335-0958-0Metaxalone100 in 1 BOTTLETABLET1007
71335-0958-1Metaxalone30 in 1 BOTTLETABLET307
71335-0958-2Metaxalone20 in 1 BOTTLETABLET207
71335-0958-3Metaxalone90 in 1 BOTTLETABLET907
71335-0958-4Metaxalone120 in 1 BOTTLETABLET1207
71335-0958-5Metaxalone15 in 1 BOTTLETABLET157
71335-0958-6Metaxalone10 in 1 BOTTLETABLET107
71335-0958-7Metaxalone60 in 1 BOTTLETABLET607
71335-0958-8Metaxalone16 in 1 BOTTLETABLET167
71335-0958-9Metaxalone84 in 1 BOTTLETABLET847

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0958-1EA - Each71335-09584930a31a-2410-4788-bab3-bf5ac84ff56712020-09-14
71335-0958-3EA - Each71335-0958e81c0402-7ca6-4447-aee0-d44918d399e112021-12-08
71335-0958-4EA - Each71335-09585405787c-b90f-4e1d-9cd0-26f664fb852812023-06-06
71335-0958-7EA - Each71335-095835ed3c6f-f54a-4364-a0d3-33d2de36692112020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0958METAXALONE TABLET [BRYANT RANCH PREPACK]7Current NDC, Legacy NDC, 10 package rows20240809_7f758053-2367-4c5f-9bbd-ce8ce263a615.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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MetaxaloneMETAXALONEREMEDYREPACK INC.e9e45029-b1a4-435f-b9ca-cdfa01051bc82026-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204770
application number: ANDA204770
MetaxaloneMETAXALONEPreferred Pharmaceuticals, Inc.1541da6a-7681-40bc-b67e-28e02a950d722026-06-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204770
application number: ANDA204770
MetaxaloneMETAXALONEDirect_Rx8c3bc0a2-5c93-e1d6-e053-2995a90a0b832026-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204770
application number: ANDA204770
METAXALONEMETAXALONEDIRECT RX9b7b4fc3-3f38-db66-e053-2995a90aaadb2026-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204770
application number: ANDA204770
MetaxaloneMETAXALONEDirect_Rx91432cd0-8404-8029-e053-2a95a90adc1b2026-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204770
application number: ANDA204770
MetaxaloneMETAXALONESt. Mary's Medical Park Pharmacya23ca660-b066-1396-e053-2a95a90a30b22026-05-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204770
application number: ANDA204770
MetaxaloneMETAXALONESportpharm LLC3e7efad7-2752-4f7d-ba30-40f17d13e4c32026-04-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204770
application number: ANDA204770
METAXALONEMETAXALONEDIRECT RX49250bbf-fbfe-07cd-e054-00144ff88e882026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204770
application number: ANDA204770
MetaxaloneMETAXALONENorthwind Health Company, LLCd9cefc55-7643-ce9b-e053-2a95a90aff122026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204770
application number: ANDA204770
MetaxaloneMETAXALONEA-S Medication Solutionsd4caa7c6-afb5-43a2-ba38-cf30106b1d622025-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204770
application number: ANDA204770
MetaxaloneMETAXALONEPHOENIX RX LLC413b300d-4163-afef-e063-6394a90a618f2025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204770
application number: ANDA204770
MetaxaloneMETAXALONEAdvanced Rx Pharmacy of Tennessee, LLCb713a0f2-d47a-0ae7-e053-2995a90a5b852024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204770
application number: ANDA204770
MetaxaloneMETAXALONEQuality Care Products, LLCf05bb280-6736-4215-be5b-0e5f7991cd872024-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204770
application number: ANDA204770
MetaxaloneMETAXALONEBryant Ranch Prepacka12304b7-6477-4518-8db5-898879c62caf2024-11-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204770
application number: ANDA204770
MetaxaloneMETAXALONEBryant Ranch Prepacka662fd07-2896-4cbb-bafc-aa5ab179a1482024-08-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204770
application number: ANDA204770
MetaxaloneMETAXALONEBryant Ranch Prepack7f758053-2367-4c5f-9bbd-ce8ce263a6152024-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204770
application number: ANDA204770
ndc (product): 71335-0958
MetaxaloneMETAXALONEBryant Ranch Prepackc86862a4-f6ff-4268-bec6-35dedbe4cd4a2024-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204770
application number: ANDA204770
MetaxaloneMETAXALONELannett Company, Inc.8294bb3c-c8eb-474c-b567-e53cf81249e92024-06-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204770
application number: ANDA204770
MetaxaloneMETAXALONEA-S Medication Solutionsef47682d-ea41-465e-aa21-cc773d45a6f02023-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204770
application number: ANDA204770
MetaxaloneMETAXALONEAsclemed USA, Inc.02c42f72-5d78-436d-8105-8c0f8d4c0d912022-07-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204770
application number: ANDA204770

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351254metaxalone 800 MG Oral TabletPSN7f758053-2367-4c5f-9bbd-ce8ce263a6157
351254metaxalone 800 MG Oral TabletSCD7f758053-2367-4c5f-9bbd-ce8ce263a6157

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0958-071335095800100 TABLET in 1 BOTTLE (71335-0958-0) 100 tablet2020-05-080000-00-00NoNoCurrent
71335-0958-17133509580130 TABLET in 1 BOTTLE (71335-0958-1) 30 tablet2018-09-270000-00-00NoNoCurrent
71335-0958-27133509580220 TABLET in 1 BOTTLE (71335-0958-2) 20 tablet2019-06-110000-00-00NoNoCurrent
71335-0958-37133509580390 TABLET in 1 BOTTLE (71335-0958-3) 90 tablet2019-03-210000-00-00NoNoCurrent
71335-0958-471335095804120 TABLET in 1 BOTTLE (71335-0958-4) 120 tablet2019-04-010000-00-00NoNoCurrent
71335-0958-57133509580515 TABLET in 1 BOTTLE (71335-0958-5) 15 tablet2021-07-290000-00-00NoNoCurrent
71335-0958-67133509580610 TABLET in 1 BOTTLE (71335-0958-6) 10 tablet2021-01-250000-00-00NoNoCurrent
71335-0958-77133509580760 TABLET in 1 BOTTLE (71335-0958-7) 60 tablet2019-03-120000-00-00NoNoCurrent
71335-0958-87133509580816 TABLET in 1 BOTTLE (71335-0958-8) 16 tablet2021-12-280000-00-00NoNoCurrent
71335-0958-97133509580984 TABLET in 1 BOTTLE (71335-0958-9) 84 tablet2021-12-280000-00-00NoNoCurrent