FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
68071-2590
11-digit product format
680712590
Labeler code
68071
Product ID
68071-2590_d2800765-612c-63a1-e053-2995a90a3b8e
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
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
2022-12-31
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
68071-2590-62025-01-30C16284748780-1f386c649-ae0e-0266-e053-dadaa90a7c1aThese 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)
68071-2590-62023-10-16C16284748780-1f386c649-ae0e-0266-e053-dadaa90a7c1aThese 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)
68071-2590-62023-01-30C16284748780-1f386c649-ae0e-0266-e053-dadaa90a7c1aThese 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
68071-2590-6Esomeprazole Magnesium60 in 1 BOTTLECAPSULE, DELAYED RELEASE602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2590ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [NUCARE PHARMACEUTICALS,INC.]2Legacy NDC, 1 package rows20231017_d28006cc-c759-93e5-e053-2a95a90ac473.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNd28006cc-c759-93e5-e053-2a95a90ac4732
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDd28006cc-c759-93e5-e053-2a95a90ac4732
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYd28006cc-c759-93e5-e053-2a95a90ac4732
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYd28006cc-c759-93e5-e053-2a95a90ac4732

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2590-66807125900660 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-2590-6) 2021-12-060000-00-00NoNoCurrent