FDA.reportPublic FDA data

Metaxalone

Product NDC
0527-1435
11-digit product format
005271435
Labeler code
0527
Product ID
0527-1435_2fd9917f-213e-4c83-9319-5551cabd5c91
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
Lannett Company, Inc.
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

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 Identifiers#

Field, Values table
FieldValues
Unii1NMA9J598Y
Rxcui351254

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
0527-1435-012024-01-30C16284748780-11030e365-25d5-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use METAXALONE safely and effectively. See full prescribing information for METAXALONE. METAXALONE tablets, USP, for oral use Initial U.S. Approval: 1962
0527-1435-052024-01-30C16284748780-11030e365-25d5-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use METAXALONE safely and effectively. See full prescribing information for METAXALONE. METAXALONE tablets, USP, for oral use Initial U.S. Approval: 1962

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0527-1435-01Metaxalone100 in 1 BOTTLETABLET10021
0527-1435-05Metaxalone500 in 1 BOTTLETABLET50021

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0527-1435METAXALONE TABLET [LANNETT COMPANY, INC.]21Current NDC, Legacy NDC, 2 package rows20240712_8294bb3c-c8eb-474c-b567-e53cf81249e9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351254metaxalone 800 MG Oral TabletPSNc86862a4-f6ff-4268-bec6-35dedbe4cd4a104
351254metaxalone 800 MG Oral TabletSCDc86862a4-f6ff-4268-bec6-35dedbe4cd4a104
351254metaxalone 800 MG Oral TabletPSNa662fd07-2896-4cbb-bafc-aa5ab179a148103
351254metaxalone 800 MG Oral TabletSCDa662fd07-2896-4cbb-bafc-aa5ab179a148103
351254metaxalone 800 MG Oral TabletPSNa12304b7-6477-4518-8db5-898879c62caf100
351254metaxalone 800 MG Oral TabletSCDa12304b7-6477-4518-8db5-898879c62caf100
351254metaxalone 800 MG Oral TabletPSN8294bb3c-c8eb-474c-b567-e53cf81249e921
351254metaxalone 800 MG Oral TabletSCD8294bb3c-c8eb-474c-b567-e53cf81249e921
351254metaxalone 800 MG Oral TabletPSNd4caa7c6-afb5-43a2-ba38-cf30106b1d6219
351254metaxalone 800 MG Oral TabletSCDd4caa7c6-afb5-43a2-ba38-cf30106b1d6219
351254metaxalone 800 MG Oral TabletPSNe9e45029-b1a4-435f-b9ca-cdfa01051bc817
351254metaxalone 800 MG Oral TabletSCDe9e45029-b1a4-435f-b9ca-cdfa01051bc817
351254metaxalone 800 MG Oral TabletPSNf05bb280-6736-4215-be5b-0e5f7991cd878
351254metaxalone 800 MG Oral TabletSCDf05bb280-6736-4215-be5b-0e5f7991cd878
351254metaxalone 800 MG Oral TabletPSN7f758053-2367-4c5f-9bbd-ce8ce263a6157
351254metaxalone 800 MG Oral TabletPSNb713a0f2-d47a-0ae7-e053-2995a90a5b857
351254metaxalone 800 MG Oral TabletSCD7f758053-2367-4c5f-9bbd-ce8ce263a6157
351254metaxalone 800 MG Oral TabletSCDb713a0f2-d47a-0ae7-e053-2995a90a5b857
351254metaxalone 800 MG Oral TabletPSNef47682d-ea41-465e-aa21-cc773d45a6f06
351254metaxalone 800 MG Oral TabletSCDef47682d-ea41-465e-aa21-cc773d45a6f06
351254metaxalone 800 MG Oral TabletPSN1541da6a-7681-40bc-b67e-28e02a950d725
351254metaxalone 800 MG Oral TabletPSNa23ca660-b066-1396-e053-2a95a90a30b25
351254metaxalone 800 MG Oral TabletSCD1541da6a-7681-40bc-b67e-28e02a950d725
351254metaxalone 800 MG Oral TabletSCDa23ca660-b066-1396-e053-2a95a90a30b25
351254metaxalone 800 MG Oral TabletPSN49250bbf-fbfe-07cd-e054-00144ff88e884
351254metaxalone 800 MG Oral TabletPSNd9cefc55-7643-ce9b-e053-2a95a90aff124
351254metaxalone 800 MG Oral TabletSCD49250bbf-fbfe-07cd-e054-00144ff88e884
351254metaxalone 800 MG Oral TabletSCDd9cefc55-7643-ce9b-e053-2a95a90aff124
351254metaxalone 800 MG Oral TabletPSNee86f52c-fbf4-4882-bb7d-50220736fbb33
351254metaxalone 800 MG Oral TabletPSN3e7efad7-2752-4f7d-ba30-40f17d13e4c33
351254metaxalone 800 MG Oral TabletPSN9b7b4fc3-3f38-db66-e053-2995a90aaadb3
351254metaxalone 800 MG Oral TabletSCD9b7b4fc3-3f38-db66-e053-2995a90aaadb3
351254metaxalone 800 MG Oral TabletSCDee86f52c-fbf4-4882-bb7d-50220736fbb33
351254metaxalone 800 MG Oral TabletSCD3e7efad7-2752-4f7d-ba30-40f17d13e4c33
351254metaxalone 800 MG Oral TabletPSN8c3bc0a2-5c93-e1d6-e053-2995a90a0b832
351254metaxalone 800 MG Oral TabletPSN91432cd0-8404-8029-e053-2a95a90adc1b2
351254metaxalone 800 MG Oral TabletSCD8c3bc0a2-5c93-e1d6-e053-2995a90a0b832
351254metaxalone 800 MG Oral TabletSCD91432cd0-8404-8029-e053-2a95a90adc1b2
351254metaxalone 800 MG Oral TabletPSN02c42f72-5d78-436d-8105-8c0f8d4c0d911
351254metaxalone 800 MG Oral TabletPSNeaeedfd0-03dd-c924-e053-2a95a90a99951
351254metaxalone 800 MG Oral TabletPSN413b300d-4163-afef-e063-6394a90a618f1
351254metaxalone 800 MG Oral TabletPSN4a558a2f-f9be-40d1-8d02-dd0c8c501ef61
351254metaxalone 800 MG Oral TabletPSN9add116a-cf29-7138-e053-2995a90a976e1
351254metaxalone 800 MG Oral TabletSCD413b300d-4163-afef-e063-6394a90a618f1
351254metaxalone 800 MG Oral TabletSCDeaeedfd0-03dd-c924-e053-2a95a90a99951
351254metaxalone 800 MG Oral TabletSCD4a558a2f-f9be-40d1-8d02-dd0c8c501ef61
351254metaxalone 800 MG Oral TabletSCD02c42f72-5d78-436d-8105-8c0f8d4c0d911
351254metaxalone 800 MG Oral TabletSCD9add116a-cf29-7138-e053-2995a90a976e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0527-1435-0100527143501100 TABLET in 1 BOTTLE (0527-1435-01) 100 tablet2016-11-220000-00-00NoNoCurrent
0527-1435-0500527143505500 TABLET in 1 BOTTLE (0527-1435-05) 500 tablet2016-11-220000-00-00NoNoCurrent