FDA.reportPublic FDA data

Good Sense Esomeprazole Magnesium

Product NDC
0113-0898
11-digit product format
001130898
Labeler code
0113
Product ID
0113-0898_34b0e9f8-27ec-49a8-a373-2a43ce42861d
Type
HUMAN OTC DRUG
Nonproprietary name
Esomeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA207193
Marketing category
ANDA
Marketing start
2017-09-22
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
Good Sense 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
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
0113-0898-01Good Sense Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE145
0113-0898-01Good Sense Esomeprazole Magnesium1 in 1 CARTONCAPSULE, DELAYED RELEASE15
0113-0898-02Good Sense Esomeprazole Magnesium2 in 1 CARTONCAPSULE, DELAYED RELEASE25
0113-0898-02Good Sense Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE145
0113-0898-03Good Sense Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE145
0113-0898-03Good Sense Esomeprazole Magnesium3 in 1 CARTONCAPSULE, DELAYED RELEASE35

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0898-01EA - Each0113-08980fbd987a-55be-4f5a-be8a-4c865b5f7ee512018-03-08
0113-0898-02EA - Each0113-089810b69061-c7da-477e-b3ea-1c6d66c1242a12018-03-08
0113-0898-03EA - Each0113-08988055d30f-933e-4bc6-b8d8-370e9e72243f12018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0898GOOD SENSE ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE) CAPSULE, DELAYED RELEASE [L. PERRIGO COMPANY]5Current NDC, Legacy NDC, 6 package rows20240829_4a89b4b5-5c42-44ee-98a9-e26a237aaef7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN4a89b4b5-5c42-44ee-98a9-e26a237aaef75
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD4a89b4b5-5c42-44ee-98a9-e26a237aaef75
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY4a89b4b5-5c42-44ee-98a9-e26a237aaef75
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY4a89b4b5-5c42-44ee-98a9-e26a237aaef75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0898-01001130898011 BOTTLE in 1 CARTON (0113-0898-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2017-09-220000-00-00NoNoCurrent
0113-0898-02001130898022 BOTTLE in 1 CARTON (0113-0898-02) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE2 bottle2017-09-220000-00-00NoNoCurrent
0113-0898-03001130898033 BOTTLE in 1 CARTON (0113-0898-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2017-09-220000-00-00NoNoCurrent