FDA.reportPublic FDA data

good sense esomeprazole magnesium

Product NDC
0113-0651
11-digit product format
001130651
Labeler code
0113
Product ID
0113-0651_d4793305-cd87-49cc-b1b1-7c891c986d88
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
2020-04-05
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
0113-0651-01good sense esomeprazole magnesium1 in 1 CARTONCAPSULE, DELAYED RELEASE12
0113-0651-01good sense esomeprazole magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE142
0113-0651-02good sense esomeprazole magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE142
0113-0651-02good sense esomeprazole magnesium2 in 1 CARTONCAPSULE, DELAYED RELEASE22
0113-0651-03good sense esomeprazole magnesium3 in 1 CARTONCAPSULE, DELAYED RELEASE32
0113-0651-03good sense esomeprazole magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE142

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0651-02EA - Each0113-065189b8c07e-578b-4e58-8341-8c83b3b1a2bc12024-02-14
0113-0651-03EA - Each0113-0651a4efca6f-cbd2-4f57-ab2b-51055a17562212024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0651GOOD SENSE ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE) CAPSULE, DELAYED RELEASE [L. PERRIGO COMPANY]2Current NDC, Legacy NDC, 6 package rows20240808_e54f2cc9-1d5f-4f0a-8bcf-bd5b917d98ec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNe54f2cc9-1d5f-4f0a-8bcf-bd5b917d98ec2
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDe54f2cc9-1d5f-4f0a-8bcf-bd5b917d98ec2
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYe54f2cc9-1d5f-4f0a-8bcf-bd5b917d98ec2
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYe54f2cc9-1d5f-4f0a-8bcf-bd5b917d98ec2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0651-01001130651011 BOTTLE in 1 CARTON (0113-0651-01) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2020-04-050000-00-00NoNoCurrent
0113-0651-02001130651022 BOTTLE in 1 CARTON (0113-0651-02) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE2 bottle2020-04-050000-00-00NoNoCurrent
0113-0651-03001130651033 BOTTLE in 1 CARTON (0113-0651-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2020-04-050000-00-00NoNoCurrent