FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
80425-0111
11-digit product format
804250111
Labeler code
80425
Product ID
80425-0111_2a99b1dd-becb-79f9-e063-6394a90a35f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA205606
Marketing category
ANDA
Marketing start
2016-04-21
Substance
ESOMEPRAZOLE MAGNESIUM DIHYDRATE
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
Brand name suffix
DR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESOMEPRAZOLE MAGNESIUM DIHYDRATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii36H71644EQ
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0111-1Esomeprazole MagnesiumDR30 in 1 BOTTLECAPSULE, DELAYED RELEASE307
80425-0111-2Esomeprazole MagnesiumDR60 in 1 BOTTLECAPSULE, DELAYED RELEASE607

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0111-1EA - Each80425-01113e6f84d4-e7ba-4e3a-bd57-e7977538a56712023-04-07
80425-0111-2EA - Each80425-0111757b17d7-2777-405b-bd39-e6ddf04789e812023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0111ESOMEPRAZOLE MAGNESIUM DR (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]7Current NDC, Legacy NDC, 2 package rows20250101_b4cd8ed1-d9d1-5b57-e053-2995a90a9f3c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNb4cd8ed1-d9d1-5b57-e053-2995a90a9f3c7
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDb4cd8ed1-d9d1-5b57-e053-2995a90a9f3c7
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYb4cd8ed1-d9d1-5b57-e053-2995a90a9f3c7
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYb4cd8ed1-d9d1-5b57-e053-2995a90a9f3c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80425-0111-18042501110130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0111-1) 2016-04-210000-00-00NoNoCurrent
80425-0111-28042501110260 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0111-2) 2016-04-210000-00-00NoNoCurrent