Metaxalone

Product NDC
60687-663
11-digit product format
606870663
Labeler code
60687
Product ID
60687-663_20d59b85-e39f-06bb-e063-6394a90a2d96
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA207466
Marketing category
ANDA
Marketing start
2023-01-06
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
60687-663-216068706632130 BLISTER PACK in 1 CARTON (60687-663-21) / 1 TABLET in 1 BLISTER PACK (60687-663-11) 30 blister pack2023-01-06NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Metaxalone Tablets, USP Rx Only 8466321/1022FAmerican Health Packaging2024-08-29HUMAN PRESCRIPTION DRUG LABEL3