FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
62175-840
11-digit product format
621750840
Labeler code
62175
Product ID
62175-840_c7191b9f-a102-4242-91b3-209713bfecf3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA205563
Marketing category
ANDA
Marketing start
2017-09-01
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
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 MAGNESIUM40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR6DXU4WAY9
Rxcui606726, 606730

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62175-840-32Esomeprazole Magnesium30 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS3035
62175-840-43Esomeprazole Magnesium1000 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS100035
62175-840-46Esomeprazole Magnesium90 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS9035

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62175-840ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE PELLETS [LANNETT COMPANY, INC.]34Current NDC, Legacy NDC, 3 package rows20250406_eb8f8b81-d482-4b94-be87-c766f49e753f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNeb8f8b81-d482-4b94-be87-c766f49e753f35
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSNeb8f8b81-d482-4b94-be87-c766f49e753f35
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDeb8f8b81-d482-4b94-be87-c766f49e753f35
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCDeb8f8b81-d482-4b94-be87-c766f49e753f35
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYeb8f8b81-d482-4b94-be87-c766f49e753f35
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYeb8f8b81-d482-4b94-be87-c766f49e753f35
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSYeb8f8b81-d482-4b94-be87-c766f49e753f35
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSN3bad56bb-f949-4db5-8e7f-50778458e1cc3
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCD3bad56bb-f949-4db5-8e7f-50778458e1cc3
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSY3bad56bb-f949-4db5-8e7f-50778458e1cc3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62175-840-326217508403230 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (62175-840-32) 2017-09-010000-00-00NoNoCurrent
62175-840-43621750840431000 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (62175-840-43) 2017-09-010000-00-00NoNoCurrent
62175-840-466217508404690 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (62175-840-46) 2017-09-010000-00-00NoNoCurrent