FDA.reportPublic FDA data

Metaxalone

Product NDC
69306-100
11-digit product format
693060100
Labeler code
69306
Product ID
69306-100_cd0929e3-c3b2-c89a-e053-2a95a90a7b2a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
Doc Rx
Application
ANDA203695
Marketing category
ANDA
Marketing start
2019-04-01
Substance
METAXALONE
Active strength
800 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE]
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
69306-100-01Metaxalone100 in 1 BOTTLETABLET1009
69306-100-02Metaxalone20 in 1 BOTTLETABLET209
69306-100-03Metaxalone30 in 1 BOTTLETABLET309
69306-100-06Metaxalone60 in 1 BOTTLETABLET609
69306-100-09Metaxalone90 in 1 BOTTLETABLET909
69306-100-15Metaxalone15 in 1 BOTTLETABLET159

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69306-100-01EA - Each69306-100715ee2b3-60ae-4e89-9afb-1de15e53fb3c12021-10-08
69306-100-02EA - Each69306-1007ea2e9b0-e7d3-4d21-a060-57cea1fc45c412021-10-08
69306-100-03EA - Each69306-100621f79da-66a4-4eda-80ff-3a44a2400c7a12021-10-08
69306-100-06EA - Each69306-100a5aefca2-5360-4a9f-a057-cf462cf2b30e12021-10-08
69306-100-09EA - Each69306-100f7220d1b-3cb3-49fe-aac1-f97ad1f6c12012021-10-08
69306-100-15EA - Each69306-100e61e1c1b-a223-40ee-ad37-253fe3eef05512021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69306-100METAXALONE TABLET [DOC RX]9Current NDC, Legacy NDC, 6 package rows20210930_87518046-c959-d5f3-e053-2a95a90a5f7e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351254metaxalone 800 MG Oral TabletPSN87518046-c959-d5f3-e053-2a95a90a5f7e9
351254metaxalone 800 MG Oral TabletSCD87518046-c959-d5f3-e053-2a95a90a5f7e9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69306-100-0169306010001100 TABLET in 1 BOTTLE (69306-100-01) 100 tablet2019-04-010000-00-00NoNoCurrent
69306-100-026930601000220 TABLET in 1 BOTTLE (69306-100-02) 20 tablet2020-01-010000-00-00NoNoCurrent
69306-100-036930601000330 TABLET in 1 BOTTLE (69306-100-03) 30 tablet2019-12-130000-00-00NoNoCurrent
69306-100-066930601000660 TABLET in 1 BOTTLE (69306-100-06) 60 tablet2019-12-130000-00-00NoNoCurrent
69306-100-096930601000990 TABLET in 1 BOTTLE (69306-100-09) 90 tablet2019-12-130000-00-00NoNoCurrent
69306-100-156930601001515 TABLET in 1 BOTTLE (69306-100-15) 15 tablet2020-01-010000-00-00NoNoCurrent