Metaxalone

Product NDC
55700-911
11-digit product format
557000911
Labeler code
55700
Product ID
55700-911_0e6eda0b-8dd0-4f70-a549-234678a9212d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA203695
Marketing category
ANDA
Marketing start
2021-08-17
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-911-30EA - Each55700-9111052c174-5a18-4bd6-9f06-a1edd797455012022-12-07
55700-911-90EA - Each55700-9111018a448-f2d3-4619-b164-f6bc1fe06edc12021-09-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-911-305570009113030 TABLET in 1 BOTTLE (55700-911-30) 30 tablet2021-08-170000-00-00NoNoCurrent
55700-911-905570009119090 TABLET in 1 BOTTLE (55700-911-90) 90 tablet2021-08-170000-00-00NoNoCurrent