ESOMEPRAZOLE MAGNESIUM

Product NDC
76519-1173
11-digit product format
765191173
Labeler code
76519
Product ID
76519-1173_9ab66178-9c73-65ef-e053-2995a90aee2d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESOMEPRAZOLE MAGNESIUM
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA078279
Marketing category
ANDA
Marketing start
2019-03-25
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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76519-1173-32022-01-28C16284748780-1d6a99b39-36d1-a426-e053-dadaa90af4c21173 ESOMEPRAZOLE MG DR 40MG

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76519-1173-3ESOMEPRAZOLE MAGNESIUM30 in 1 BOTTLECAPSULE, DELAYED RELEASE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76519-1173ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 1 package rows20200106_874e4e49-ff3b-0e1b-e053-2a95a90af2ec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSN874e4e49-ff3b-0e1b-e053-2a95a90af2ec2
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCD874e4e49-ff3b-0e1b-e053-2a95a90af2ec2
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSY874e4e49-ff3b-0e1b-e053-2a95a90af2ec2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76519-1173-37651911730330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76519-1173-3) 2019-03-250000-00-00NoNoCurrent