FDA.reportPublic FDA data

Esomeprazole magnesium

Product NDC
71335-9678
11-digit product format
713359678
Labeler code
71335
Product ID
71335-9678_e5116491-c738-4e54-9383-d8a4c7494fa0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole magnesium delayed release capsules
Dosage form
CAPSULE, COATED PELLETS
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210559
Marketing category
ANDA
Marketing start
2021-02-27
Substance
ESOMEPRAZOLE MAGNESIUM
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 magnesium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESOMEPRAZOLE MAGNESIUM20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR6DXU4WAY9
Rxcui606726

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
71335-9678-1Esomeprazole magnesium30 in 1 BOTTLECAPSULE, COATED PELLETS30103
71335-9678-2Esomeprazole magnesium10 in 1 BOTTLECAPSULE, COATED PELLETS10103
71335-9678-3Esomeprazole magnesium60 in 1 BOTTLECAPSULE, COATED PELLETS60103
71335-9678-4Esomeprazole magnesium90 in 1 BOTTLECAPSULE, COATED PELLETS90103
71335-9678-5Esomeprazole magnesium42 in 1 BOTTLECAPSULE, COATED PELLETS42103
71335-9678-6Esomeprazole magnesium120 in 1 BOTTLECAPSULE, COATED PELLETS120103
71335-9678-7Esomeprazole magnesium180 in 1 BOTTLECAPSULE, COATED PELLETS180103
71335-9678-8Esomeprazole magnesium20 in 1 BOTTLECAPSULE, COATED PELLETS20103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-9678-1EA - Each71335-96782812da93-96e1-4e5c-ada1-b19d093cf72a12024-09-09
71335-9678-3EA - Each71335-9678a1f2dc8c-4996-480f-a8c1-283c442697a612025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9678ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM DELAYED RELEASE CAPSULES) CAPSULE, COATED PELLETS [BRYANT RANCH PREPACK]103Current NDC, 8 package rows20240824_db8a346e-dba1-41bc-b122-a1de868ee91a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNdb8a346e-dba1-41bc-b122-a1de868ee91a103
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDdb8a346e-dba1-41bc-b122-a1de868ee91a103
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYdb8a346e-dba1-41bc-b122-a1de868ee91a103
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYdb8a346e-dba1-41bc-b122-a1de868ee91a103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-9678-17133596780130 CAPSULE, COATED PELLETS in 1 BOTTLE (71335-9678-1) 2023-05-17NoNoHistorical
71335-9678-27133596780210 CAPSULE, COATED PELLETS in 1 BOTTLE (71335-9678-2) 2024-05-30NoNoHistorical
71335-9678-37133596780360 CAPSULE, COATED PELLETS in 1 BOTTLE (71335-9678-3) 2023-03-23NoNoHistorical
71335-9678-47133596780490 CAPSULE, COATED PELLETS in 1 BOTTLE (71335-9678-4) 2024-05-30NoNoHistorical
71335-9678-57133596780542 CAPSULE, COATED PELLETS in 1 BOTTLE (71335-9678-5) 2024-05-30NoNoHistorical
71335-9678-671335967806120 CAPSULE, COATED PELLETS in 1 BOTTLE (71335-9678-6) 2024-05-30NoNoHistorical
71335-9678-771335967807180 CAPSULE, COATED PELLETS in 1 BOTTLE (71335-9678-7) 2024-05-30NoNoHistorical
71335-9678-87133596780820 CAPSULE, COATED PELLETS in 1 BOTTLE (71335-9678-8) 2024-05-30NoNoHistorical