FDA.reportPublic FDA data

esomeprazole

Product NDC
33342-306
11-digit product format
333420306
Labeler code
33342
Product ID
33342-306_d68c9247-91c7-4e0f-adc4-2cfa7446580f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
esomeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA208511
Marketing category
ANDA
Marketing start
2024-10-23
Substance
ESOMEPRAZOLE
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESOMEPRAZOLE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN3PA6559FT
Rxcui606726, 606730

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
33342-306-07esomeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE301
33342-306-10esomeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-306ESOMEPRAZOLE CAPSULE, DELAYED RELEASE [MACLEODS PHARMACEUTICALS LIMITED]1Current NDC, 2 package rows20241201_d68c9247-91c7-4e0f-adc4-2cfa7446580f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNd68c9247-91c7-4e0f-adc4-2cfa7446580f1
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSNd68c9247-91c7-4e0f-adc4-2cfa7446580f1
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDd68c9247-91c7-4e0f-adc4-2cfa7446580f1
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCDd68c9247-91c7-4e0f-adc4-2cfa7446580f1
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYd68c9247-91c7-4e0f-adc4-2cfa7446580f1
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYd68c9247-91c7-4e0f-adc4-2cfa7446580f1
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSYd68c9247-91c7-4e0f-adc4-2cfa7446580f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
33342-306-073334203060730 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-306-07) 2024-10-23NoNoCurrent
33342-306-103334203061090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-306-10) 2024-10-23NoNoCurrent