Metaxalone

Product NDC
68788-7499
11-digit product format
687887499
Labeler code
68788
Product ID
68788-7499_f9b312f6-9bd2-43c9-b6ba-01e8cd61e1d3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA208774
Marketing category
ANDA
Marketing start
2018-09-24
Marketing end
0000-00-00
Substance
METAXALONE
Active strength
800 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7499-0EA - Each68788-7499c3648e43-7b0d-4ed3-b936-4f604db18fef12020-09-14
68788-7499-1EA - Each68788-7499b9497294-3738-4330-9695-23540db8b33812020-09-14
68788-7499-2EA - Each68788-7499cba31ab9-2647-462a-a5ae-f4cf452183b312020-09-14
68788-7499-3EA - Each68788-749940004926-9bb6-4363-b506-f09bcd67d73b12020-09-14
68788-7499-6EA - Each68788-7499d5b8bc50-10f3-43cc-876b-e2def5bbd7df12020-09-14
68788-7499-9EA - Each68788-7499b2ed91db-c7af-4d4e-bd40-ef390678710612020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7499METAXALONE TABLET [PREFERRED PHARMACEUTICALS, INC.]5Legacy NDC20240704_3f3a4ca6-999e-4d1d-8a3e-796bdc4ef2fa.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7499-06878874990015 TABLET in 1 BOTTLE (68788-7499-0) 15 tablet2019-12-270000-00-00NoNoCurrent
68788-7499-168788749901100 TABLET in 1 BOTTLE (68788-7499-1) 100 tablet2019-12-270000-00-00NoNoCurrent
68788-7499-26878874990220 TABLET in 1 BOTTLE (68788-7499-2) 20 tablet2019-12-270000-00-00NoNoCurrent
68788-7499-36878874990330 TABLET in 1 BOTTLE (68788-7499-3) 30 tablet2019-12-270000-00-00NoNoCurrent
68788-7499-66878874990660 TABLET in 1 BOTTLE (68788-7499-6) 60 tablet2019-12-270000-00-00NoNoCurrent
68788-7499-96878874990990 TABLET in 1 BOTTLE (68788-7499-9) 90 tablet2019-12-270000-00-00NoNoCurrent