FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
68071-2782
11-digit product format
680712782
Labeler code
68071
Product ID
68071-2782_e327a639-68a5-920a-e053-2995a90aa577
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA211977
Marketing category
ANDA
Marketing start
2020-06-02
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2782-42025-01-30C16284748780-12cef2736-abbe-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES. ESOMEPRAZOLE magnesium delayed-release capsules, for oral use Initial U.S. Approval: 1989 (omeprazole)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2782-4Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2782ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 1 package rows20220707_e327a639-68a4-920a-e053-2995a90aa577.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSNe327a639-68a4-920a-e053-2995a90aa5771
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCDe327a639-68a4-920a-e053-2995a90aa5771
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSYe327a639-68a4-920a-e053-2995a90aa5771

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2782-46807127820414 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-2782-4) 2022-07-060000-00-00NoNoCurrent