FDA.reportPublic FDA data

Metaxalone

Product NDC
60687-663
11-digit product format
606870663
Labeler code
60687
Product ID
60687-663_20d59b85-e39f-06bb-e063-6394a90a2d96
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA207466
Marketing category
ANDA
Marketing start
2023-01-06
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-663-11Metaxalone1 in 1 BLISTER PACKTABLET13
60687-663-21Metaxalone30 in 1 CARTONTABLET303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-663-11EA - Each60687-6630098c9e4-ba94-448c-8418-885160f4ad2412022-12-07
60687-663-21EA - Each60687-663b5a136e2-b7f4-4fb9-a9ee-22a1e26523a112022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-663METAXALONE TABLET [AMERICAN HEALTH PACKAGING]3Current NDC, Legacy NDC, 2 package rows20240906_b6afb4d3-eb3e-4e9f-9aa9-a44cfacb959c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351254metaxalone 800 MG Oral TabletPSNb6afb4d3-eb3e-4e9f-9aa9-a44cfacb959c3
351254metaxalone 800 MG Oral TabletSCDb6afb4d3-eb3e-4e9f-9aa9-a44cfacb959c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-663-11606870663111 in 1 BLISTER PACKHistorical
60687-663-216068706632130 BLISTER PACK in 1 CARTON (60687-663-21) / 1 TABLET in 1 BLISTER PACK (60687-663-11) 30 blister pack2023-01-060000-00-00NoNoCurrent