Metaxalone

Product NDC
70934-429
11-digit product format
709340429
Labeler code
70934
Product ID
70934-429_ad27b2c8-d03c-6193-e053-2a95a90a056d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA208774
Marketing category
ANDA
Marketing start
2019-08-13
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
2021-12-31
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
70934-429-30EA - Each70934-4298767e637-0869-4ad8-bec0-d268d7fe96a212022-12-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-429-107093404291010 TABLET in 1 BOTTLE, PLASTIC (70934-429-10) 10 tablet2019-08-130000-00-00NoNoCurrent
70934-429-307093404293030 TABLET in 1 BOTTLE, PLASTIC (70934-429-30) 30 tablet2020-02-260000-00-00NoNoCurrent