Esomeprazole Magnesium

Product NDC
50090-6943
11-digit product format
500906943
Labeler code
50090
Product ID
50090-6943_85769778-437b-4822-a079-e02753ce91f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078279
Marketing category
ANDA
Marketing start
2019-09-17
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
50090-6943-0Esomeprazole Magnesium90 in 1 BOTTLECAPSULE, DELAYED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6943-0EA - Each50090-694391d01eee-3a5e-4f02-9dac-b475bb5c9e3a12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6943ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]1Current NDC, 1 package rows20231228_99fceec8-59a2-485f-a7f3-7c5afd98401d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSN99fceec8-59a2-485f-a7f3-7c5afd98401d1
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCD99fceec8-59a2-485f-a7f3-7c5afd98401d1
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSY99fceec8-59a2-485f-a7f3-7c5afd98401d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6943-05009069430090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-6943-0) 2023-12-15NoNoCurrent