FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
46122-736
11-digit product format
461220736
Labeler code
46122
Product ID
46122-736_90b0b01d-01cc-40a8-b352-5e1e568cadde
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
2023-07-19
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
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
46122-736-03Esomeprazole Magnesium2 in 1 CARTONCAPSULE, DELAYED RELEASE22
46122-736-03Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE142
46122-736-04Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE142
46122-736-04Esomeprazole Magnesium3 in 1 CARTONCAPSULE, DELAYED RELEASE32
46122-736-74Esomeprazole Magnesium1 in 1 CARTONCAPSULE, DELAYED RELEASE12
46122-736-74Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE142

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-736-03EA - Each46122-7364e51cacb-c204-4f2a-9a90-06a3c08d847412023-10-16
46122-736-04EA - Each46122-736d7f63a73-bcca-45fa-8823-1eda20e563be12023-10-16
46122-736-74EA - Each46122-736cdd99833-c636-4109-8ba5-d29d497bea5712023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-736ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [AMERISOURCE BERGEN]2Current NDC, 6 package rows20240404_c94eb997-07d4-4d2e-b213-9a0d51db41c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNc94eb997-07d4-4d2e-b213-9a0d51db41c02
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDc94eb997-07d4-4d2e-b213-9a0d51db41c02
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYc94eb997-07d4-4d2e-b213-9a0d51db41c02
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYc94eb997-07d4-4d2e-b213-9a0d51db41c02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
46122-736-03461220736032 BOTTLE in 1 CARTON (46122-736-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE2 bottle2023-07-19NoNoCurrent
46122-736-04461220736043 BOTTLE in 1 CARTON (46122-736-04) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2023-07-20NoNoCurrent
46122-736-74461220736741 BOTTLE in 1 CARTON (46122-736-74) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2023-08-04NoNoCurrent