Esomeprazole Magnesium

Product NDC
46122-538
11-digit product format
461220538
Labeler code
46122
Product ID
46122-538_4516feac-4648-4b64-ba75-fc45bf554bb8
Type
HUMAN OTC DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Amerisource Bergen
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-538-03EA - Each46122-538efb7fe4e-44fd-4a07-a684-e0c6d323d28f12019-02-13
46122-538-04EA - Each46122-538d5747af4-abcd-4073-96d8-0ee2d3aaa5bc12019-02-13
46122-538-74EA - Each46122-53890fda73f-82fa-4c6e-af8f-5722e24f6a3012019-02-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46122-538-03461220538032 BOTTLE in 1 CARTON (46122-538-03) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE2 bottle2017-10-160000-00-00NoNoCurrent
46122-538-04461220538043 BOTTLE in 1 CARTON (46122-538-04) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2017-10-160000-00-00NoNoCurrent
46122-538-74461220538741 BOTTLE in 1 CARTON (46122-538-74) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2017-10-160000-00-00NoNoCurrent