ESOMEPRAZOLE MAGNESIUM

Product NDC
61919-789
11-digit product format
619190789
Labeler code
61919
Product ID
61919-789_94e342b2-7844-4e39-e053-2a95a90a203d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESOMEPRAZOLE MAGNESIUM
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
DirectRX
Application
ANDA208333
Marketing category
ANDA
Marketing start
2019-03-26
Marketing end
0000-00-00
Substance
ESOMEPRAZOLE MAGNESIUM
Active strength
20 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
61919-789-302023-01-30C16284748780-1f386c64a-0899-0266-e053-dadaa90a7c1aESOMEPRAZOLE MAGNESIUM DR
61919-789-602023-01-30C16284748780-1f386c64a-0899-0266-e053-dadaa90a7c1aESOMEPRAZOLE MAGNESIUM DR

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-789-30ESOMEPRAZOLE MAGNESIUMDR30 in 1 BOTTLECAPSULE, DELAYED RELEASE302
61919-789-60ESOMEPRAZOLE MAGNESIUMDR60 in 1 BOTTLECAPSULE, DELAYED RELEASE602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-789-30EA - Each61919-78991c16048-796b-4696-a8e6-a62184a0c95612019-11-12
61919-789-60EA - Each61919-7899a795afe-8a97-4a7b-9673-d2355dd307c912019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-789ESOMEPRAZOLE MAGNESIUM DR (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [DIRECTRX]2Legacy NDC, 2 package rows20191015_8504300f-a584-29ed-e053-2a91aa0ad26c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN8504300f-a584-29ed-e053-2a91aa0ad26c2
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD8504300f-a584-29ed-e053-2a91aa0ad26c2
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY8504300f-a584-29ed-e053-2a91aa0ad26c2
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY8504300f-a584-29ed-e053-2a91aa0ad26c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-789-306191907893030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (61919-789-30) 2019-03-260000-00-00NoNoCurrent
61919-789-606191907896060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (61919-789-60) 2019-03-260000-00-00NoNoCurrent