FDA.reportPublic FDA data

ESOMEPRAZOLE MAGNESIUM

Product NDC
69618-073
11-digit product format
696180073
Labeler code
69618
Product ID
69618-073_7b9c7db0-8cc4-4e45-9715-69be0c208ca5
Type
HUMAN OTC DRUG
Nonproprietary name
ESOMEPRAZOLE MAGNESIUM
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Reliable 1 Laboratories LLC
Application
ANDA216349
Marketing category
ANDA
Marketing start
2023-04-14
Substance
ESOMEPRAZOLE MAGNESIUM
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 MAGNESIUM20 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
69618-073-42ESOMEPRAZOLE MAGNESIUM14 in 1 BOTTLECAPSULE, DELAYED RELEASE141
69618-073-42ESOMEPRAZOLE MAGNESIUM3 in 1 CARTONCAPSULE, DELAYED RELEASE31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69618-073-42EA - Each69618-073b15c8305-c84e-48df-b24c-bf6819cb0c4112024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69618-073ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [RELIABLE 1 LABORATORIES LLC]1Current NDC, 2 package rows20230416_15d2c4f7-5b20-4c7c-b2a6-9baed7bf39cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN15d2c4f7-5b20-4c7c-b2a6-9baed7bf39cf1
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD15d2c4f7-5b20-4c7c-b2a6-9baed7bf39cf1
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY15d2c4f7-5b20-4c7c-b2a6-9baed7bf39cf1
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY15d2c4f7-5b20-4c7c-b2a6-9baed7bf39cf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69618-073-42696180073423 BOTTLE in 1 CARTON (69618-073-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2023-04-14NoNoHistorical