FDA.reportPublic FDA data

basic care esomeprazole magnesium

Product NDC
72288-700
11-digit product format
722880700
Labeler code
72288
Product ID
72288-700_4df7a0fa-f656-49a8-85fb-2ad2ee20bf28
Type
HUMAN OTC DRUG
Nonproprietary name
esomeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Amazon.com Services LLC
Application
ANDA207193
Marketing category
ANDA
Marketing start
2020-06-15
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
basic care 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
72288-700-01basic care esomeprazole magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE142
72288-700-03basic care esomeprazole magnesium3 in 1 CARTONCAPSULE, DELAYED RELEASE32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-700BASIC CARE ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE) CAPSULE, DELAYED RELEASE [AMAZON.COM SERVICES LLC]2Current NDC, Legacy NDC, 2 package rows20240806_0b115351-318c-4bd9-935c-704a09bcdf52.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN0b115351-318c-4bd9-935c-704a09bcdf522
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD0b115351-318c-4bd9-935c-704a09bcdf522
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY0b115351-318c-4bd9-935c-704a09bcdf522
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY0b115351-318c-4bd9-935c-704a09bcdf522

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72288-700-017228807000114 in 1 BOTTLEHistorical
72288-700-03722880700033 BOTTLE in 1 CARTON (72288-700-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (72288-700-01) 3 bottle2020-06-150000-00-00NoNoCurrent