FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
63868-425
11-digit product format
638680425
Labeler code
63868
Product ID
63868-425_241fe5f8-399c-5ac9-fc77-f078e69ecb65
Type
HUMAN OTC DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
CHAIN DRUG MARKETING ASSOCIATION INC
Application
ANDA207673
Marketing category
ANDA
Marketing start
2018-07-06
Substance
ESOMEPRAZOLE MAGNESIUM
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
Esomeprazole Magnesium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESOMEPRAZOLE MAGNESIUM20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR6DXU4WAY9
Rxcui606726

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7006a36-e68d-42e2-8cd3-d725cb2e47b1Product name620251027
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
d71865e8-5c35-4d76-8ecd-a7adda982240Product name920180628
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d71865e8-5c35-4d76-8ecd-a7adda982240Product name820171212
094c6751-235c-4d12-acee-2baf94f676f4Product name120151116
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-425-14EA - Each63868-42543f5212f-e653-4e8a-bd47-b817bd6f7d4312020-05-08
63868-425-42EA - Each63868-425a41920e2-cb36-4560-8d09-5b2081efa18812022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-425ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION INC]5Current NDC, Legacy NDC20241020_f95053ab-d6c5-ee92-58d1-6f203873f79c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNf95053ab-d6c5-ee92-58d1-6f203873f79c6
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDf95053ab-d6c5-ee92-58d1-6f203873f79c6
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYf95053ab-d6c5-ee92-58d1-6f203873f79c6
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYf95053ab-d6c5-ee92-58d1-6f203873f79c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-425-14638680425141 BOTTLE in 1 CARTON (63868-425-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2018-07-060000-00-00NoNoCurrent
63868-425-28638680425282 BOTTLE in 1 CARTON (63868-425-28) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE2 bottle2019-03-150000-00-00NoNoCurrent
63868-425-42638680425423 BOTTLE in 1 CARTON (63868-425-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2018-07-060000-00-00NoNoCurrent