Metaxalone

Product NDC

43063-581

11-digit product format

430630581

Labeler code

43063

Product ID

43063-581_800f5fac-f2d5-358f-e053-2a91aa0ad6a6

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Metaxalone

Dosage form

TABLET

Route

ORAL

Labeler

PD-Rx Pharmaceuticals, Inc.

Application

NDA013217

Marketing category

NDA

Marketing start

2007-11-01

Marketing end

2020-04-01

Substance

METAXALONE

Active strength

800 mg/1

Pharmacologic classes

Centrally-mediated Muscle Relaxation [PE]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record