Esomeprazole Magnesium

Product NDC
80425-0183
11-digit product format
804250183
Labeler code
80425
Product ID
80425-0183_edade565-8416-3f4f-e053-2995a90ac91c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA209735
Marketing category
ANDA
Marketing start
2018-05-31
Marketing end
0000-00-00
Substance
ESOMEPRAZOLE MAGNESIUM
Active strength
40 mg/1
Pharmacologic classes
Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80425-0183-18042501830130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0183-1) 2018-05-310000-00-00NoNoCurrent