FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
80425-0419
11-digit product format
804250419
Labeler code
80425
Product ID
80425-0419_1d8bcbd7-393e-9c1d-e063-6394a90a823c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA211977
Marketing category
ANDA
Marketing start
2024-07-18
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
80425-0419-1Esomeprazole Magnesium30 in 1 BOTTLECAPSULE, DELAYED RELEASE301
80425-0419-2Esomeprazole Magnesium60 in 1 BOTTLECAPSULE, DELAYED RELEASE601
80425-0419-3Esomeprazole Magnesium90 in 1 BOTTLECAPSULE, DELAYED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0419-1EA - Each80425-04199a1cab5a-53b4-4037-be97-f21e1c02675712024-09-09
80425-0419-2EA - Each80425-041977768fca-52c9-4d42-b047-552fd494d39c12024-09-09
80425-0419-3EA - Each80425-041925dd950e-374d-46f6-b7ba-03ec98bc3d1212024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0419ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [ADVANCED RX OF TENNESSEE, LLC]1Current NDC, 3 package rows20240802_1d8bd104-66d4-8c19-e063-6394a90a3cb6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN1d8bd104-66d4-8c19-e063-6394a90a3cb61
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD1d8bd104-66d4-8c19-e063-6394a90a3cb61
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY1d8bd104-66d4-8c19-e063-6394a90a3cb61
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY1d8bd104-66d4-8c19-e063-6394a90a3cb61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80425-0419-18042504190130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0419-1) 2024-07-18NoNoHistorical
80425-0419-28042504190260 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0419-2) 2024-07-18NoNoHistorical
80425-0419-38042504190390 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0419-3) 2024-07-18NoNoHistorical