Esomeprazole Magnesium

Product NDC
50090-7949
11-digit product format
500907949
Labeler code
50090
Product ID
50090-7949_cfef4d2e-ff61-404d-9cd4-537ab63e47b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA213859
Marketing category
ANDA
Marketing start
2023-08-15
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Esomeprazole Magnesium
Listing expiration
2027-12-31

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
d71865e8-5c35-4d76-8ecd-a7adda982240Product name920180628
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
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
50090-7949-0Esomeprazole Magnesium90 in 1 BOTTLECAPSULE, DELAYED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7949-0EA - Each50090-79494ebfef62-299a-4ed4-8492-fb927416600912026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSNb58bfbdb-939e-456e-827d-068e9d8088401
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCDb58bfbdb-939e-456e-827d-068e9d8088401
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSYb58bfbdb-939e-456e-827d-068e9d8088401

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7949-05009079490090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-7949-0) 2026-04-07NoNoHistorical