FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
46122-821
11-digit product format
461220821
Labeler code
46122
Product ID
46122-821_3c6c2fd5-1a0f-44f7-8d02-c9bc26b8db46
Type
HUMAN OTC DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Amerisource Bergen
Application
ANDA209339
Marketing category
ANDA
Marketing start
2025-08-30
Substance
ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
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 TRIHYDRATE20 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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
d71865e8-5c35-4d76-8ecd-a7adda982240Product name920180628
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
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
46122-821-59Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE141
46122-821-59Esomeprazole Magnesium3 in 1 CARTONCAPSULE, DELAYED RELEASE31
46122-821-61Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE141
46122-821-61Esomeprazole Magnesium1 in 1 CARTONCAPSULE, DELAYED RELEASE11
46122-821-62Esomeprazole Magnesium2 in 1 CARTONCAPSULE, DELAYED RELEASE21
46122-821-62Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE141

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN3c6c2fd5-1a0f-44f7-8d02-c9bc26b8db461
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD3c6c2fd5-1a0f-44f7-8d02-c9bc26b8db461
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY3c6c2fd5-1a0f-44f7-8d02-c9bc26b8db461
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY3c6c2fd5-1a0f-44f7-8d02-c9bc26b8db461

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
46122-821-59461220821593 BOTTLE in 1 CARTON (46122-821-59) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2025-08-30NoNoHistorical
46122-821-61461220821611 BOTTLE in 1 CARTON (46122-821-61) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2025-08-30NoNoHistorical
46122-821-62461220821622 BOTTLE in 1 CARTON (46122-821-62) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE2 bottle2025-08-30NoNoHistorical