FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
68788-8511
11-digit product format
687888511
Labeler code
68788
Product ID
68788-8511_c4f694b1-fb3b-47b7-a6ef-cb788a6b67b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA078279
Marketing category
ANDA
Marketing start
2023-08-22
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Esomeprazole Magnesium
Listing expiration
2027-12-31

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
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
68788-8511-1Esomeprazole Magnesium100 in 1 BOTTLECAPSULE, DELAYED RELEASE1004
68788-8511-2Esomeprazole Magnesium20 in 1 BOTTLECAPSULE, DELAYED RELEASE204
68788-8511-3Esomeprazole Magnesium30 in 1 BOTTLECAPSULE, DELAYED RELEASE304
68788-8511-6Esomeprazole Magnesium60 in 1 BOTTLECAPSULE, DELAYED RELEASE604
68788-8511-9Esomeprazole Magnesium90 in 1 BOTTLECAPSULE, DELAYED RELEASE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8511-1EA - Each68788-8511ea1344ef-2895-42a8-a012-a47c0c6d403b12023-10-16
68788-8511-2EA - Each68788-8511071b8aa2-27d5-4916-b5e5-03b4a86e932d12023-10-16
68788-8511-3EA - Each68788-85111ebb91f4-c91a-4b6c-9cd2-08b88576cefc12023-10-16
68788-8511-6EA - Each68788-8511bdf6b294-2adc-4bc1-8a70-2c62bf610f8a12023-10-16
68788-8511-9EA - Each68788-8511deb4acf9-e2ae-4559-b576-b65aba1daf6d12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8511ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]3Current NDC, 5 package rows20250411_a9d05a38-08db-4710-b6f3-20c92ce885d5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNa9d05a38-08db-4710-b6f3-20c92ce885d54
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDa9d05a38-08db-4710-b6f3-20c92ce885d54
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYa9d05a38-08db-4710-b6f3-20c92ce885d54
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYa9d05a38-08db-4710-b6f3-20c92ce885d54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8511-168788851101100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8511-1) 2023-08-22NoNoHistorical
68788-8511-26878885110220 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8511-2) 2023-08-22NoNoHistorical
68788-8511-36878885110330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8511-3) 2023-08-22NoNoHistorical
68788-8511-66878885110660 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8511-6) 2023-08-22NoNoHistorical
68788-8511-96878885110990 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8511-9) 2023-08-22NoNoHistorical