Metaxalone

Product NDC
63629-2097
11-digit product format
636292097
Labeler code
63629
Product ID
63629-2097_e15c407c-e85f-4520-9b53-6926513f3c19
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

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
63629-2097-1Metaxalone100 in 1 BOTTLETABLET100104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2097-1EA - Each63629-20970adba32e-1071-4906-ba93-50bc67b1bb5912021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2097METAXALONE TABLET [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 1 package rows20240816_c86862a4-f6ff-4268-bec6-35dedbe4cd4a.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2097-163629209701100 TABLET in 1 BOTTLE (63629-2097-1) 100 tablet2016-11-220000-00-00NoNoCurrent