Esomeprazole Magnesium

Product NDC
55319-988
11-digit product format
553190988
Labeler code
55319
Product ID
55319-988_c18e4a94-deb0-48ba-adc1-19efedc6daae
Type
HUMAN OTC DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Family Dollar, Inc.
Application
ANDA209339
Marketing category
ANDA
Marketing start
2017-10-16
Marketing end
0000-00-00
Substance
ESOMEPRAZOLE MAGNESIUM DIHYDRATE
Active strength
20 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55319-988-05553190988051 BOTTLE in 1 CARTON (55319-988-05) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2017-10-160000-00-00NoNoCurrent
55319-988-60553190988603 BOTTLE in 1 CARTON (55319-988-60) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2017-10-160000-00-00NoNoCurrent