FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
50090-6198
11-digit product format
500906198
Labeler code
50090
Product ID
50090-6198_3505b03c-9233-4994-a556-19ce321f036b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA211977
Marketing category
ANDA
Marketing start
2020-06-02
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
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 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
50090-6198-0Esomeprazole Magnesium30 in 1 BOTTLECAPSULE, DELAYED RELEASE306
50090-6198-1Esomeprazole Magnesium90 in 1 BOTTLECAPSULE, DELAYED RELEASE906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6198-0EA - Each50090-61988537b542-5387-49cd-9b14-2a524540e0ff12022-12-07
50090-6198-1EA - Each50090-6198294e61ff-24f5-4016-adb0-79748faa13a112022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6198ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]4Current NDC, Legacy NDC, 2 package rows20240119_00aa81c2-73c7-4bf8-94e9-f644381b631f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN00aa81c2-73c7-4bf8-94e9-f644381b631f6
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD00aa81c2-73c7-4bf8-94e9-f644381b631f6
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY00aa81c2-73c7-4bf8-94e9-f644381b631f6
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY00aa81c2-73c7-4bf8-94e9-f644381b631f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-6198-05009061980030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-6198-0) 2022-11-010000-00-00NoNoCurrent
50090-6198-15009061980190 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-6198-1) 2022-11-010000-00-00NoNoCurrent