Metaxalone

Product NDC
68001-485
11-digit product format
680010485
Labeler code
68001
Product ID
68001-485_38efd774-a6de-1f8c-e063-6394a90a93fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA207466
Marketing category
ANDA
Marketing start
2021-05-31
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
1NMA9J598YMETAXALONE1665-48-1METAXALONE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68001-485-0068001048500100 TABLET in 1 BOTTLE (68001-485-00) 100 tablet2021-05-31NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
MetaxaloneBluePoint Laboratories | ScieGen Pharmaceuticals, Inc.2025-07-07HUMAN PRESCRIPTION DRUG LABEL4
Metaxalone Tablets, USP Rx Only 8466321/1022FAmerican Health Packaging2024-08-29HUMAN PRESCRIPTION DRUG LABEL3