FDA.reportPublic FDA data

Metaxalone

Product NDC
85509-2341
11-digit product format
855092341
Labeler code
85509
Product ID
85509-2341_41ae7309-4967-b721-e063-6294a90abf2c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
PHOENIX RX LLC
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
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
85509-2341-1Metaxalone100 in 1 BOTTLETABLET1002
85509-2341-2Metaxalone120 in 1 BOTTLETABLET1202
85509-2341-3Metaxalone30 in 1 BOTTLETABLET302
85509-2341-6Metaxalone60 in 1 BOTTLETABLET602
85509-2341-9Metaxalone90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85509-2341-1EA - Each85509-23418203ce30-10c1-4650-93a0-fc4cfd0ea8e912025-09-12
85509-2341-2EA - Each85509-2341c2516acc-737f-4ec4-8224-3799d445936812025-12-16
85509-2341-3EA - Each85509-23415c0cf6ef-64d6-4632-8d85-b9801be97a5712025-09-12
85509-2341-6EA - Each85509-2341c22db59f-a6a2-497b-b1c3-234e4491c1c212025-09-12
85509-2341-9EA - Each85509-2341ff1680f7-321b-4057-ade9-bf0e65b72f7c12025-09-12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351254metaxalone 800 MG Oral TabletPSN3a7c8b4d-7add-cb31-e063-6294a90a37f82
351254metaxalone 800 MG Oral TabletSCD3a7c8b4d-7add-cb31-e063-6294a90a37f82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85509-2341-185509234101100 TABLET in 1 BOTTLE (85509-2341-1) 100 tablet2025-07-31NoNoHistorical
85509-2341-285509234102120 TABLET in 1 BOTTLE (85509-2341-2) 120 tablet2025-07-31NoNoHistorical
85509-2341-38550923410330 TABLET in 1 BOTTLE (85509-2341-3) 30 tablet2025-07-31NoNoHistorical
85509-2341-68550923410660 TABLET in 1 BOTTLE (85509-2341-6) 60 tablet2025-07-31NoNoHistorical
85509-2341-98550923410990 TABLET in 1 BOTTLE (85509-2341-9) 90 tablet2025-07-31NoNoHistorical