Esomeprazole Magnesium

Product NDC
55315-010
11-digit product format
553150010
Labeler code
55315
Product ID
55315-010_c8242a71-0cd5-432d-9c87-cbda3d6fe678
Type
HUMAN OTC DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Fred's, 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
55315-010-04553150010043 BOTTLE in 1 CARTON (55315-010-04) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2017-10-160000-00-00NoNoCurrent
55315-010-74553150010741 BOTTLE in 1 CARTON (55315-010-74) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2017-10-160000-00-00NoNoCurrent