FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
68788-8812
11-digit product format
687888812
Labeler code
68788
Product ID
68788-8812_e264d9c8-5ba9-49c1-9b27-d6ff9a6a45ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA213859
Marketing category
ANDA
Marketing start
2025-01-20
Substance
ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
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 MAGNESIUM TRIHYDRATE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR6DXU4WAY9
Rxcui606730

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
68788-8812-1Esomeprazole Magnesium100 in 1 BOTTLECAPSULE, DELAYED RELEASE1001
68788-8812-2Esomeprazole Magnesium20 in 1 BOTTLECAPSULE, DELAYED RELEASE201
68788-8812-3Esomeprazole Magnesium30 in 1 BOTTLECAPSULE, DELAYED RELEASE301
68788-8812-6Esomeprazole Magnesium60 in 1 BOTTLECAPSULE, DELAYED RELEASE601
68788-8812-9Esomeprazole Magnesium90 in 1 BOTTLECAPSULE, DELAYED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8812-1EA - Each68788-8812a1af8164-42b6-4130-8ca2-047876a4f05412025-03-04
68788-8812-2EA - Each68788-8812db531a60-5f22-4c9b-81fe-7e774289ef3a12025-03-04
68788-8812-3EA - Each68788-8812673e4305-fa02-457d-a38d-74a6bdd2fa7112025-03-04
68788-8812-6EA - Each68788-881221810f7a-9f1f-44eb-a13c-8009dc8c5f5012025-03-04
68788-8812-9EA - Each68788-881228370ae7-de0a-4bef-b01c-2130e3fe9c8712025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8812ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 5 package rows20250122_e264d9c8-5ba9-49c1-9b27-d6ff9a6a45ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSNe264d9c8-5ba9-49c1-9b27-d6ff9a6a45ba1
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCDe264d9c8-5ba9-49c1-9b27-d6ff9a6a45ba1
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSYe264d9c8-5ba9-49c1-9b27-d6ff9a6a45ba1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8812-168788881201100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8812-1) 2025-01-20NoNoHistorical
68788-8812-26878888120220 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8812-2) 2025-01-20NoNoHistorical
68788-8812-36878888120330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8812-3) 2025-01-20NoNoHistorical
68788-8812-66878888120660 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8812-6) 2025-01-20NoNoHistorical
68788-8812-96878888120990 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8812-9) 2025-01-20NoNoHistorical