esomeprazole magnesium

Product NDC
48792-7842
11-digit product format
487927842
Labeler code
48792
Product ID
48792-7842_6d69256f-9caf-3958-e053-2991aa0a7a3b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Sunshine Lake Pharma Co., Ltd.
Application
ANDA207265
Marketing category
ANDA
Marketing start
2018-05-18
Marketing end
0000-00-00
Substance
ESOMEPRAZOLE MAGNESIUM
Active strength
40 mg/1
Pharmacologic classes
Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
48792-7842-14879278420160 CAPSULE, DELAYED RELEASE in 1 BOTTLE (48792-7842-1) 2018-05-180000-00-00NoNoCurrent