FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
70771-1391
11-digit product format
707711391
Labeler code
70771
Product ID
70771-1391_983313a8-2120-4c76-8412-0c0c6a159465
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
GRANULE, DELAYED RELEASE
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA206055
Marketing category
ANDA
Marketing start
2023-06-30
Substance
ESOMEPRAZOLE MAGNESIUM DIHYDRATE
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 MAGNESIUM DIHYDRATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii36H71644EQ
Rxcui692576, 692578

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7006a36-e68d-42e2-8cd3-d725cb2e47b1Product name620251027
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
d71865e8-5c35-4d76-8ecd-a7adda982240Product name920180628
d71865e8-5c35-4d76-8ecd-a7adda982240Product name820171212
094c6751-235c-4d12-acee-2baf94f676f4Product name120151116
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1391-3Esomeprazole Magnesium30 in 1 CARTONGRANULE, DELAYED RELEASE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1391ESOMEPRAZOLE MAGNESIUM GRANULE, DELAYED RELEASE [ZYDUS LIFESCIENCES LIMITED]2Current NDC, 1 package rows20241201_4cd9e802-c519-4593-bc38-947ad7f9b567.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
692576esomeprazole 20 MG Granules for Delayed Release Oral SuspensionPSN4cd9e802-c519-4593-bc38-947ad7f9b5672
692578esomeprazole 40 MG Granules for Delayed Release Oral SuspensionPSN4cd9e802-c519-4593-bc38-947ad7f9b5672
692576esomeprazole 20 MG Granules for Oral SuspensionSCD4cd9e802-c519-4593-bc38-947ad7f9b5672
692578esomeprazole 40 MG Granules for Oral SuspensionSCD4cd9e802-c519-4593-bc38-947ad7f9b5672
692576esomeprazole (as esomeprazole magnesium) 20 MG Granules for Delayed Release Oral SuspensionSY4cd9e802-c519-4593-bc38-947ad7f9b5672
692576esomeprazole 20 MG Granules for Delayed Release Oral SuspensionSY4cd9e802-c519-4593-bc38-947ad7f9b5672
692578esomeprazole 40 MG (equivalent to esomeprazole magnesium 44.5 MG) Granules for Delayed Release Oral SuspensionSY4cd9e802-c519-4593-bc38-947ad7f9b5672
692578esomeprazole 40 MG Granules for Delayed Release Oral SuspensionSY4cd9e802-c519-4593-bc38-947ad7f9b5672

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70771-1391-37077113910330 GRANULE, DELAYED RELEASE in 1 CARTON (70771-1391-3) 2023-06-30NoNoHistorical