FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
68462-391
11-digit product format
684620391
Labeler code
68462
Product ID
68462-391_5eef4592-c7ef-454c-88a9-62671fff9088
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA209495
Marketing category
ANDA
Marketing start
2021-11-01
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
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
68462-391-10Esomeprazole Magnesium1000 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE PELLETS10004
68462-391-30Esomeprazole Magnesium30 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE PELLETS304
68462-391-90Esomeprazole Magnesium90 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE PELLETS904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-391ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE PELLETS [GLENMARK PHARMACEUTICALS INC., USA]4Current NDC, Legacy NDC, 3 package rows20240612_a6430045-ae60-4a16-92b9-2975cb497629.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNa6430045-ae60-4a16-92b9-2975cb4976294
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSNa6430045-ae60-4a16-92b9-2975cb4976294
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDa6430045-ae60-4a16-92b9-2975cb4976294
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCDa6430045-ae60-4a16-92b9-2975cb4976294
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYa6430045-ae60-4a16-92b9-2975cb4976294
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYa6430045-ae60-4a16-92b9-2975cb4976294
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSYa6430045-ae60-4a16-92b9-2975cb4976294
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSNdef3f166-e740-41ed-82c0-9b03dd6432b13
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCDdef3f166-e740-41ed-82c0-9b03dd6432b13
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSYdef3f166-e740-41ed-82c0-9b03dd6432b13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68462-391-10684620391101000 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (68462-391-10) 2021-11-010000-00-00NoNoCurrent
68462-391-306846203913030 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (68462-391-30) 2021-11-010000-00-00NoNoCurrent
68462-391-906846203919090 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (68462-391-90) 2021-11-010000-00-00NoNoCurrent