FDA.reportPublic FDA data

good sense esomeprazole magnesium

Product NDC
0113-2022
11-digit product format
001132022
Labeler code
0113
Product ID
0113-2022_674a7792-7ba0-4a78-acd3-0dfcde8128d5
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
2024-04-24
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
good sense esomeprazole magnesium
Listing expiration
2027-12-31

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
0113-2022-01good sense esomeprazole magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE143
0113-2022-02good sense esomeprazole magnesium2 in 1 CARTONCAPSULE, DELAYED RELEASE23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-2022GOOD SENSE ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE) CAPSULE, DELAYED RELEASE [L. PERRIGO COMPANY]2Current NDC, 2 package rows20240511_f13088de-6841-453e-acb0-08bbdf9529d1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNf13088de-6841-453e-acb0-08bbdf9529d13
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDf13088de-6841-453e-acb0-08bbdf9529d13
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYf13088de-6841-453e-acb0-08bbdf9529d13
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYf13088de-6841-453e-acb0-08bbdf9529d13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0113-2022-010011320220114 in 1 BOTTLEHistorical
0113-2022-02001132022022 BOTTLE in 1 CARTON (0113-2022-02) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0113-2022-01) 2 bottle2024-04-24NoNoHistorical