FDA.reportPublic FDA data

careone esomeprazole magnesium

Product NDC
41520-727
11-digit product format
415200727
Labeler code
41520
Product ID
41520-727_96c2b7f1-ae2c-4b41-b58a-183b654a70ff
Type
HUMAN OTC DRUG
Nonproprietary name
Esomeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
American Sales Company
Application
ANDA207193
Marketing category
ANDA
Marketing start
2017-09-26
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
careone 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
41520-727-01careone esomeprazole magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE145
41520-727-01careone esomeprazole magnesium1 in 1 CARTONCAPSULE, DELAYED RELEASE15
41520-727-02careone esomeprazole magnesium2 in 1 CARTONCAPSULE, DELAYED RELEASE25
41520-727-02careone esomeprazole magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE145
41520-727-03careone esomeprazole magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE145
41520-727-03careone esomeprazole magnesium3 in 1 CARTONCAPSULE, DELAYED RELEASE35

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-727CAREONE ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE) CAPSULE, DELAYED RELEASE [AMERICAN SALES COMPANY]4Current NDC, Legacy NDC, 6 package rows20191220_3f9a2747-8afd-4898-bbfb-5f379293137e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN3f9a2747-8afd-4898-bbfb-5f379293137e5
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD3f9a2747-8afd-4898-bbfb-5f379293137e5
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY3f9a2747-8afd-4898-bbfb-5f379293137e5
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY3f9a2747-8afd-4898-bbfb-5f379293137e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-727-01415200727011 BOTTLE in 1 CARTON (41520-727-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2017-10-130000-00-00NoNoCurrent
41520-727-02415200727022 BOTTLE in 1 CARTON (41520-727-02) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE2 bottle2017-11-130000-00-00NoNoCurrent
41520-727-03415200727033 BOTTLE in 1 CARTON (41520-727-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2017-09-260000-00-00NoNoCurrent