FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
51316-220
11-digit product format
513160220
Labeler code
51316
Product ID
51316-220_e2f6fd0a-b44f-472c-aa41-bc46d5551495
Type
HUMAN OTC DRUG
Nonproprietary name
esomeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Application
ANDA207193
Marketing category
ANDA
Marketing start
2024-03-13
Substance
ESOMEPRAZOLE
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
ESOMEPRAZOLE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN3PA6559FT
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
51316-220-01Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE142
51316-220-01Esomeprazole Magnesium1 in 1 CARTONCAPSULE, DELAYED RELEASE12
51316-220-03Esomeprazole Magnesium3 in 1 CARTONCAPSULE, DELAYED RELEASE32
51316-220-03Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-220ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE) CAPSULE, DELAYED RELEASE [CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED]2Current NDC, 4 package rows20240316_19fa87e4-8225-4969-9857-1bf43db4427b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN19fa87e4-8225-4969-9857-1bf43db4427b2
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD19fa87e4-8225-4969-9857-1bf43db4427b2
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY19fa87e4-8225-4969-9857-1bf43db4427b2
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY19fa87e4-8225-4969-9857-1bf43db4427b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-220-01513160220011 BOTTLE in 1 CARTON (51316-220-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2024-03-13NoNoCurrent
51316-220-03513160220033 BOTTLE in 1 CARTON (51316-220-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2024-03-13NoNoCurrent