Metaxalone

Product NDC
70518-0818
11-digit product format
705180818
Labeler code
70518
Product ID
70518-0818_e26e42f7-e241-9df0-e053-2995a90ae019
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA203695
Marketing category
ANDA
Marketing start
2017-11-02
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
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-0818-07051808180090 TABLET in 1 BOTTLE, PLASTIC (70518-0818-0) 90 tablet2017-11-020000-00-00NoNoCurrent
70518-0818-17051808180160 TABLET in 1 BOTTLE, PLASTIC (70518-0818-1) 60 tablet2021-07-120000-00-00NoNoCurrent
70518-0818-27051808180230 TABLET in 1 BOTTLE, PLASTIC (70518-0818-2) 30 tablet2021-10-150000-00-00NoNoCurrent