Esomeprazole Magnesium

Product NDC
71205-143
11-digit product format
712050143
Labeler code
71205
Product ID
71205-143_a1a1941e-0c5f-486e-84d0-321d53061b34
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078279
Marketing category
ANDA
Marketing start
2015-12-10
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
71205-143-30Esomeprazole Magnesium30 in 1 BOTTLECAPSULE, DELAYED RELEASE303
71205-143-60Esomeprazole Magnesium60 in 1 BOTTLECAPSULE, DELAYED RELEASE603
71205-143-90Esomeprazole Magnesium90 in 1 BOTTLECAPSULE, DELAYED RELEASE903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-143ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]3Current NDC, Legacy NDC, 3 package rows20220710_9224142a-6e14-4ca3-9e72-506ff9fbd0e1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSN9224142a-6e14-4ca3-9e72-506ff9fbd0e13
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCD9224142a-6e14-4ca3-9e72-506ff9fbd0e13
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSY9224142a-6e14-4ca3-9e72-506ff9fbd0e13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-143-307120501433030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-143-30) 2018-12-100000-00-00NoNoCurrent
71205-143-607120501436060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-143-60) 2018-12-100000-00-00NoNoCurrent
71205-143-907120501439090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-143-90) 2018-12-110000-00-00NoNoCurrent