FDA.reportPublic FDA data

Metaxalone

Product NDC
85509-1435
11-digit product format
855091435
Labeler code
85509
Product ID
85509-1435_413b2fa9-d4bd-3aed-e063-6394a90a0835
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
PHOENIX RX LLC
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85509-1435-1Metaxalone120 in 1 BOTTLETABLET1201
85509-1435-3Metaxalone30 in 1 BOTTLETABLET301
85509-1435-6Metaxalone60 in 1 BOTTLETABLET601
85509-1435-9Metaxalone90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85509-1435-1EA - Each85509-1435e046fb8b-76ba-444c-b4d5-90b532b52a2c12025-12-16
85509-1435-3EA - Each85509-1435efe9e39e-defb-46b3-abc1-2f8444cd7d1c12025-12-16
85509-1435-6EA - Each85509-1435ad2bfdbd-119d-43cb-b84d-008711948bab12025-12-16
85509-1435-9EA - Each85509-14355b1248c7-a672-4fb4-a508-788fdaa93a4b12025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351254metaxalone 800 MG Oral TabletPSN413b300d-4163-afef-e063-6394a90a618f1
351254metaxalone 800 MG Oral TabletSCD413b300d-4163-afef-e063-6394a90a618f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85509-1435-185509143501120 TABLET in 1 BOTTLE (85509-1435-1) 120 tablet2025-10-16NoNoCurrent
85509-1435-38550914350330 TABLET in 1 BOTTLE (85509-1435-3) 30 tablet2025-10-16NoNoCurrent
85509-1435-68550914350660 TABLET in 1 BOTTLE (85509-1435-6) 60 tablet2025-10-16NoNoCurrent
85509-1435-98550914350990 TABLET in 1 BOTTLE (85509-1435-9) 90 tablet2025-10-16NoNoCurrent