FDA.reportPublic FDA data

Esomeprazole

Product NDC
51660-027
11-digit product format
516600027
Labeler code
51660
Product ID
51660-027_df9b1217-4941-448a-9225-7c0684c141ff
Type
HUMAN OTC DRUG
Nonproprietary name
esomeprazole magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Ohm Laboratories Inc.
Application
ANDA212866
Marketing category
ANDA
Marketing start
2020-08-14
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
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
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
51660-027-14Esomeprazole1 in 1 CARTONCAPSULE, DELAYED RELEASE13
51660-027-14Esomeprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE143
51660-027-27Esomeprazole2 in 1 CARTONCAPSULE, DELAYED RELEASE23
51660-027-27Esomeprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE143
51660-027-44Esomeprazole3 in 1 CARTONCAPSULE, DELAYED RELEASE33
51660-027-44Esomeprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE143

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51660-027-27EA - Each51660-0271a86b131-aa50-47bd-bcf9-62e35706d23612021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51660-027ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [OHM LABORATORIES INC.]3Current NDC, Legacy NDC, 6 package rows20221004_e6d19b0a-44a8-42fe-8a6c-717ecb3ac1c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNe6d19b0a-44a8-42fe-8a6c-717ecb3ac1c43
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDe6d19b0a-44a8-42fe-8a6c-717ecb3ac1c43
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYe6d19b0a-44a8-42fe-8a6c-717ecb3ac1c43
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYe6d19b0a-44a8-42fe-8a6c-717ecb3ac1c43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51660-027-14516600027141 BOTTLE in 1 CARTON (51660-027-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2020-08-140000-00-00NoNoCurrent
51660-027-27516600027272 BOTTLE in 1 CARTON (51660-027-27) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE2 bottle2020-08-140000-00-00NoNoCurrent
51660-027-44516600027443 BOTTLE in 1 CARTON (51660-027-44) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2020-08-140000-00-00NoNoCurrent