FDA.reportPublic FDA data

Esomeprazole magnesium

Product NDC
71335-2011
11-digit product format
713352011
Labeler code
71335
Product ID
71335-2011_6ee83d0e-6566-4cb0-a9bd-8a11a149d78f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7006a36-e68d-42e2-8cd3-d725cb2e47b1Product name620251027
d71865e8-5c35-4d76-8ecd-a7adda982240Product name920180628
d71865e8-5c35-4d76-8ecd-a7adda982240Product name820171212
094c6751-235c-4d12-acee-2baf94f676f4Product name120151116
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2011-1Esomeprazole magnesium90 in 1 BOTTLECAPSULE, DELAYED RELEASE90103
71335-2011-2Esomeprazole magnesium30 in 1 BOTTLECAPSULE, DELAYED RELEASE30103
71335-2011-3Esomeprazole magnesium60 in 1 BOTTLECAPSULE, DELAYED RELEASE60103
71335-2011-4Esomeprazole magnesium10 in 1 BOTTLECAPSULE, DELAYED RELEASE10103
71335-2011-5Esomeprazole magnesium20 in 1 BOTTLECAPSULE, DELAYED RELEASE20103
71335-2011-6Esomeprazole magnesium120 in 1 BOTTLECAPSULE, DELAYED RELEASE120103
71335-2011-7Esomeprazole magnesium180 in 1 BOTTLECAPSULE, DELAYED RELEASE180103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2011ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]103Legacy NDC, 7 package rows20240525_6ee83d0e-6566-4cb0-a9bd-8a11a149d78f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSN6ee83d0e-6566-4cb0-a9bd-8a11a149d78f103
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCD6ee83d0e-6566-4cb0-a9bd-8a11a149d78f103
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSY6ee83d0e-6566-4cb0-a9bd-8a11a149d78f103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-2011-17133520110190 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2011-1) 2022-01-210000-00-00NoNoCurrent
71335-2011-27133520110230 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2011-2) 2021-12-010000-00-00NoNoCurrent
71335-2011-37133520110360 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2011-3) 2021-12-170000-00-00NoNoCurrent
71335-2011-47133520110410 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2011-4) 2022-05-030000-00-00NoNoCurrent
71335-2011-57133520110520 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2011-5) 2022-05-030000-00-00NoNoCurrent
71335-2011-671335201106120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2011-6) 2022-05-030000-00-00NoNoCurrent
71335-2011-771335201107180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2011-7) 2022-05-030000-00-00NoNoCurrent