FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
71335-2040
11-digit product format
713352040
Labeler code
71335
Product ID
71335-2040_3688c82f-b564-4f5c-b916-617310c93f70
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA211977
Marketing category
ANDA
Marketing start
2020-06-02
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
71335-2040-1Esomeprazole Magnesium90 in 1 BOTTLECAPSULE, DELAYED RELEASE90105
71335-2040-2Esomeprazole Magnesium30 in 1 BOTTLECAPSULE, DELAYED RELEASE30105
71335-2040-3Esomeprazole Magnesium60 in 1 BOTTLECAPSULE, DELAYED RELEASE60105
71335-2040-4Esomeprazole Magnesium10 in 1 BOTTLECAPSULE, DELAYED RELEASE10105
71335-2040-5Esomeprazole Magnesium20 in 1 BOTTLECAPSULE, DELAYED RELEASE20105
71335-2040-6Esomeprazole Magnesium120 in 1 BOTTLECAPSULE, DELAYED RELEASE120105
71335-2040-7Esomeprazole Magnesium180 in 1 BOTTLECAPSULE, DELAYED RELEASE180105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2040-1EA - Each71335-204005b159ea-c9f2-49de-9b69-b6d9b1e27d6b12023-08-08
71335-2040-2EA - Each71335-204061a26b62-0c1a-46fc-ae2f-6599223978b212023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2040ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 7 package rows20240828_61cc0020-aab8-42a3-b0a6-93062f382c87.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSN61cc0020-aab8-42a3-b0a6-93062f382c87105
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCD61cc0020-aab8-42a3-b0a6-93062f382c87105
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSY61cc0020-aab8-42a3-b0a6-93062f382c87105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-2040-17133520400190 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2040-1) 2022-03-030000-00-00NoNoCurrent
71335-2040-27133520400230 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2040-2) 2022-04-200000-00-00NoNoCurrent
71335-2040-37133520400360 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2040-3) 2022-02-220000-00-00NoNoCurrent
71335-2040-47133520400410 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2040-4) 2024-08-120000-00-00NoNoCurrent
71335-2040-57133520400520 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2040-5) 2023-07-130000-00-00NoNoCurrent
71335-2040-671335204006120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2040-6) 2024-08-120000-00-00NoNoCurrent
71335-2040-771335204007180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2040-7) 2023-01-260000-00-00NoNoCurrent