Esomeprazole Magnesium

Product NDC
42292-010
11-digit product format
422920010
Labeler code
42292
Product ID
42292-010_d3d2f0c2-9f4f-6c36-e053-2995a90a00c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA078936
Marketing category
ANDA
Marketing start
2016-05-31
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
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
42292-010-01EA - Each42292-0105f536e8c-952f-4b72-b4a2-aede13db31eb12016-07-19
42292-010-16EA - Each42292-010eada2f62-7915-42bb-afbc-b3c5a364f5b412016-07-19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42292-010-164229200101660 BLISTER PACK in 1 CARTON (42292-010-16) > 1 CAPSULE, DELAYED RELEASE PELLETS in 1 BLISTER PACK (42292-010-01) 60 blister pack2016-05-310000-00-00NoNoCurrent