FDA.reportPublic FDA data

Esomeprazole magnesium

Product NDC
50090-5777
11-digit product format
500905777
Labeler code
50090
Product ID
50090-5777_cddbb6a7-49a9-46ac-9757-448cb4be8d4d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole magnesium delayed release capsules
Dosage form
CAPSULE, COATED PELLETS
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA210559
Marketing category
ANDA
Marketing start
2021-02-27
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
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
50090-5777-12025-01-30C16284748780-1f386c649-eadb-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)
50090-5777-12023-02-06C16284748780-1f386c649-eadb-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)
50090-5777-12023-01-30C16284748780-1f386c649-eadb-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
50090-5777-1Esomeprazole magnesium90 in 1 BOTTLECAPSULE, COATED PELLETS904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5777-1EA - Each50090-5777b3744353-fdb7-494e-8503-72bb3c3515ba12023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5777ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM DELAYED RELEASE CAPSULES) CAPSULE, COATED PELLETS [A-S MEDICATION SOLUTIONS]4Legacy NDC, 1 package rows20230219_eb6819fd-d00e-4172-b02d-ef259f9ec805.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSNeb6819fd-d00e-4172-b02d-ef259f9ec8054
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCDeb6819fd-d00e-4172-b02d-ef259f9ec8054
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSYeb6819fd-d00e-4172-b02d-ef259f9ec8054

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5777-15009057770190 CAPSULE, COATED PELLETS in 1 BOTTLE (50090-5777-1) 2021-10-070000-00-00NoNoCurrent