FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
0904-6581
11-digit product format
009046581
Labeler code
0904
Product ID
0904-6581_5488571a-b29b-4a7b-9589-0947411e2cfe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA078279
Marketing category
ANDA
Marketing start
2015-12-10
Substance
ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
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 MAGNESIUM TRIHYDRATE40 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
0904-6581-68Esomeprazole Magnesium1 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE16
0904-6581-68Esomeprazole Magnesium60 in 1 CARTONCAPSULE, DELAYED RELEASE606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6581-68EA - Each0904-658105b3937b-0a34-4258-b861-4d54f9249a7712017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6581ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]6Current NDC, Legacy NDC, 2 package rows20250110_ba65c73d-fc7d-491e-aaaa-cf45a7783395.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSNba65c73d-fc7d-491e-aaaa-cf45a77833956
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCDba65c73d-fc7d-491e-aaaa-cf45a77833956
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSYba65c73d-fc7d-491e-aaaa-cf45a77833956

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6581-680090465816860 BLISTER PACK in 1 CARTON (0904-6581-68) / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK60 blister pack2015-12-100000-00-00NoNoCurrent