FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
45865-163
11-digit product format
458650163
Labeler code
45865
Product ID
45865-163_1278c4e8-89c4-94b5-e063-6294a90a7d73
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA078279
Marketing category
ANDA
Marketing start
2015-12-10
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
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
45865-163-30Esomeprazole Magnesium30 in 1 BOTTLECAPSULE, DELAYED RELEASE301
45865-163-60Esomeprazole Magnesium60 in 1 BOTTLECAPSULE, DELAYED RELEASE601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-163ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]1Current NDC, 2 package rows20240301_1278cf6f-cc7a-462b-e063-6394a90a34e5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN1278cf6f-cc7a-462b-e063-6394a90a34e51
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD1278cf6f-cc7a-462b-e063-6394a90a34e51
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY1278cf6f-cc7a-462b-e063-6394a90a34e51
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY1278cf6f-cc7a-462b-e063-6394a90a34e51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
45865-163-304586501633030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (45865-163-30) 2022-07-28NoNoHistorical
45865-163-604586501636060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (45865-163-60) 2020-12-28NoNoHistorical