FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
71335-1170
11-digit product format
713351170
Labeler code
71335
Product ID
71335-1170_e83812c6-e48e-4f50-93cf-a3777695c51a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA205563
Marketing category
ANDA
Marketing start
2017-09-01
Substance
ESOMEPRAZOLE MAGNESIUM
Active strength
20 mg/1
Pharmacologic classes
Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Esomeprazole Magnesium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESOMEPRAZOLE MAGNESIUM20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR6DXU4WAY9
Rxcui606726

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
71335-1170-12024-05-20C16284748780-11030e365-073a-111a-e063-dadaa90a10e2These 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 USP, for oral use Initial U.S. Approval: 1989 (omeprazole)
71335-1170-22024-05-20C16284748780-11030e365-073a-111a-e063-dadaa90a10e2These 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 USP, for oral use Initial U.S. Approval: 1989 (omeprazole)
71335-1170-32024-05-20C16284748780-11030e365-073a-111a-e063-dadaa90a10e2These 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 USP, for oral use Initial U.S. Approval: 1989 (omeprazole)
71335-1170-42024-05-20C16284748780-11030e365-073a-111a-e063-dadaa90a10e2These 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 USP, for oral use Initial U.S. Approval: 1989 (omeprazole)
71335-1170-52024-05-20C16284748780-11030e365-073a-111a-e063-dadaa90a10e2These 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 USP, for oral use Initial U.S. Approval: 1989 (omeprazole)
71335-1170-62024-05-20C16284748780-11030e365-073a-111a-e063-dadaa90a10e2These 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 USP, for oral use Initial U.S. Approval: 1989 (omeprazole)
71335-1170-72024-05-20C16284748780-11030e365-073a-111a-e063-dadaa90a10e2These 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 USP, for oral use Initial U.S. Approval: 1989 (omeprazole)
71335-1170-82024-05-20C16284748780-11030e365-073a-111a-e063-dadaa90a10e2These 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 USP, for oral use Initial U.S. Approval: 1989 (omeprazole)
71335-1170-12024-01-30C16284748780-11030e365-073a-111a-e063-dadaa90a10e2These 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 USP, for oral use Initial U.S. Approval: 1989 (omeprazole)
71335-1170-22024-01-30C16284748780-11030e365-073a-111a-e063-dadaa90a10e2These 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 USP, for oral use Initial U.S. Approval: 1989 (omeprazole)
71335-1170-32024-01-30C16284748780-11030e365-073a-111a-e063-dadaa90a10e2These 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 USP, for oral use Initial U.S. Approval: 1989 (omeprazole)
71335-1170-42024-01-30C16284748780-11030e365-073a-111a-e063-dadaa90a10e2These 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 USP, for oral use Initial U.S. Approval: 1989 (omeprazole)
71335-1170-52024-01-30C16284748780-11030e365-073a-111a-e063-dadaa90a10e2These 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 USP, for oral use Initial U.S. Approval: 1989 (omeprazole)
71335-1170-62024-01-30C16284748780-11030e365-073a-111a-e063-dadaa90a10e2These 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 USP, for oral use Initial U.S. Approval: 1989 (omeprazole)
71335-1170-72024-01-30C16284748780-11030e365-073a-111a-e063-dadaa90a10e2These 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 USP, for oral use Initial U.S. Approval: 1989 (omeprazole)
71335-1170-82024-01-30C16284748780-11030e365-073a-111a-e063-dadaa90a10e2These 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 USP, for oral use Initial U.S. Approval: 1989 (omeprazole)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1170-1Esomeprazole Magnesium30 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS307
71335-1170-2Esomeprazole Magnesium10 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS107
71335-1170-3Esomeprazole Magnesium60 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS607
71335-1170-4Esomeprazole Magnesium90 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS907
71335-1170-5Esomeprazole Magnesium42 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS427
71335-1170-6Esomeprazole Magnesium120 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS1207
71335-1170-7Esomeprazole Magnesium180 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS1807
71335-1170-8Esomeprazole Magnesium20 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS207

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1170ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]7Current NDC, Legacy NDC, 8 package rows20240522_fed0e554-7d61-4957-9b91-356f3abc0777.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNfed0e554-7d61-4957-9b91-356f3abc07777
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDfed0e554-7d61-4957-9b91-356f3abc07777
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYfed0e554-7d61-4957-9b91-356f3abc07777
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYfed0e554-7d61-4957-9b91-356f3abc07777

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1170-17133511700130 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-1170-1) 2019-03-250000-00-00NoNoCurrent
71335-1170-27133511700210 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-1170-2) 2019-07-010000-00-00NoNoCurrent
71335-1170-37133511700360 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-1170-3) 2019-05-070000-00-00NoNoCurrent
71335-1170-47133511700490 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-1170-4) 2019-06-100000-00-00NoNoCurrent
71335-1170-57133511700542 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-1170-5) 2024-05-170000-00-00NoNoCurrent
71335-1170-671335117006120 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-1170-6) 2024-05-170000-00-00NoNoCurrent
71335-1170-771335117007180 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-1170-7) 2024-05-170000-00-00NoNoCurrent
71335-1170-87133511700820 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-1170-8) 2019-09-040000-00-00NoNoCurrent