FDA.reportPublic FDA data

Esomeprazole magnesium

Product NDC
80425-0440
11-digit product format
804250440
Labeler code
80425
Product ID
80425-0440_25a48082-ca9a-42a4-e063-6394a90ae559
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA217427
Marketing category
ANDA
Marketing start
2024-10-29
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
Rxcui606730

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0440-1Esomeprazole magnesium30 in 1 BOTTLECAPSULE, DELAYED RELEASE301
80425-0440-2Esomeprazole magnesium60 in 1 BOTTLECAPSULE, DELAYED RELEASE601
80425-0440-3Esomeprazole magnesium90 in 1 BOTTLECAPSULE, DELAYED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0440-1EA - Each80425-0440e8f2489e-d41f-4ed0-9f5c-2ce0d982f99012024-12-10
80425-0440-2EA - Each80425-04403749e29b-2c71-4139-add9-e696d7c67ddf12024-12-10
80425-0440-3EA - Each80425-0440ac9afcff-ea35-4085-813e-63fb9ab38c2812024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0440ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [ADVANCED RX OF TENNESSEE, LLC]1Current NDC, 3 package rows20241031_25a48082-ca99-42a4-e063-6394a90ae559.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSN25a48082-ca99-42a4-e063-6394a90ae5591
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCD25a48082-ca99-42a4-e063-6394a90ae5591
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSY25a48082-ca99-42a4-e063-6394a90ae5591

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80425-0440-18042504400130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0440-1) 2024-10-29NoNoHistorical
80425-0440-28042504400260 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0440-2) 2024-10-29NoNoHistorical
80425-0440-38042504400390 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0440-3) 2024-10-29NoNoHistorical