FDA.reportPublic FDA data

Esomeprazole magnesium

Product NDC
68788-7483
11-digit product format
687887483
Labeler code
68788
Product ID
68788-7483_49db3431-5f96-4436-8acf-b0f0877e1d0e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA208333
Marketing category
ANDA
Marketing start
2020-03-02
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
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7006a36-e68d-42e2-8cd3-d725cb2e47b1Product name620251027
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
68788-7483-12022-01-28C16284748780-1d6a99b39-bba8-a426-e053-dadaa90af4c2These 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)
68788-7483-22022-01-28C16284748780-1d6a99b39-bba8-a426-e053-dadaa90af4c2These 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)
68788-7483-32022-01-28C16284748780-1d6a99b39-bba8-a426-e053-dadaa90af4c2These 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)
68788-7483-62022-01-28C16284748780-1d6a99b39-bba8-a426-e053-dadaa90af4c2These 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)
68788-7483-92022-01-28C16284748780-1d6a99b39-bba8-a426-e053-dadaa90af4c2These 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
68788-7483-1Esomeprazole magnesium100 in 1 BOTTLECAPSULE, DELAYED RELEASE1001
68788-7483-2Esomeprazole magnesium20 in 1 BOTTLECAPSULE, DELAYED RELEASE201
68788-7483-3Esomeprazole magnesium30 in 1 BOTTLECAPSULE, DELAYED RELEASE301
68788-7483-6Esomeprazole magnesium60 in 1 BOTTLECAPSULE, DELAYED RELEASE601
68788-7483-9Esomeprazole magnesium90 in 1 BOTTLECAPSULE, DELAYED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7483-1EA - Each68788-74836b6c6b59-3558-4717-9837-e7f7c0ec454a12020-04-20
68788-7483-2EA - Each68788-74830790fab2-7d3e-4604-bd70-e8b6e915b43712020-04-20
68788-7483-3EA - Each68788-748395eac859-0b1f-4490-84aa-af96aa7499de12020-04-20
68788-7483-6EA - Each68788-748325332697-fc69-41da-9b6a-34d157449ceb12020-04-20
68788-7483-9EA - Each68788-748367ad03b8-5b48-4196-8dbb-6df06fd4aba212020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7483ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]1Legacy NDC, 5 package rows20200304_49db3431-5f96-4436-8acf-b0f0877e1d0e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSN49db3431-5f96-4436-8acf-b0f0877e1d0e1
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCD49db3431-5f96-4436-8acf-b0f0877e1d0e1
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSY49db3431-5f96-4436-8acf-b0f0877e1d0e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7483-168788748301100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7483-1) 2020-03-020000-00-00NoNoCurrent
68788-7483-26878874830220 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7483-2) 2020-03-020000-00-00NoNoCurrent
68788-7483-36878874830330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7483-3) 2020-03-020000-00-00NoNoCurrent
68788-7483-66878874830660 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7483-6) 2020-03-020000-00-00NoNoCurrent
68788-7483-96878874830990 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7483-9) 2020-03-020000-00-00NoNoCurrent