Metaxalone

Product NDC
70934-160
11-digit product format
709340160
Labeler code
70934
Product ID
70934-160_b933cbc8-ce96-3188-e053-2995a90a00d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA203399
Marketing category
ANDA
Marketing start
2018-08-30
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
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70934-160-20EA - Each70934-1602dcb8dbe-bb40-449b-a479-189eeb7a4e8212018-11-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-160-207093401602020 TABLET in 1 BOTTLE, PLASTIC (70934-160-20) 20 tablet2018-08-300000-00-00NoNoCurrent