FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
63187-964
11-digit product format
631870964
Labeler code
63187
Product ID
63187-964_5d8ef640-33d7-451f-af54-2413337b92ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078279
Marketing category
ANDA
Marketing start
2015-12-10
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
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
63187-964-30Esomeprazole Magnesium30 in 1 BOTTLECAPSULE, DELAYED RELEASE306
63187-964-60Esomeprazole Magnesium60 in 1 BOTTLECAPSULE, DELAYED RELEASE606
63187-964-90Esomeprazole Magnesium90 in 1 BOTTLECAPSULE, DELAYED RELEASE906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-964-30EA - Each63187-964d2b1370d-1393-4c89-9cc5-cac33e00813412023-08-08
63187-964-60EA - Each63187-964d77e45bf-6a74-434b-8ca1-d34b1d6d5f6b12022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-964ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]6Current NDC, Legacy NDC, 3 package rows20230204_e5540d90-0b6e-4519-9272-c6e96730967b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNe5540d90-0b6e-4519-9272-c6e96730967b6
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDe5540d90-0b6e-4519-9272-c6e96730967b6
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYe5540d90-0b6e-4519-9272-c6e96730967b6
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYe5540d90-0b6e-4519-9272-c6e96730967b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-964-306318709643030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-964-30) 2018-01-010000-00-00NoNoCurrent
63187-964-606318709646060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-964-60) 2018-01-010000-00-00NoNoCurrent
63187-964-906318709649090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-964-90) 2018-01-010000-00-00NoNoCurrent