FDA.reportPublic FDA data

equate esomeprazole magnesium

Product NDC
49035-921
11-digit product format
490350921
Labeler code
49035
Product ID
49035-921_d4a545cc-a934-4205-97e0-ceb4550d86d1
Type
HUMAN OTC DRUG
Nonproprietary name
Esomeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Wal-Mart Stores Inc
Application
ANDA207193
Marketing category
ANDA
Marketing start
2017-10-05
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
equate esomeprazole magnesium
Listing expiration
2027-12-31

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
49035-921-01equate esomeprazole magnesium1 in 1 CARTONCAPSULE, DELAYED RELEASE14
49035-921-01equate esomeprazole magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE144
49035-921-02equate esomeprazole magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE144
49035-921-02equate esomeprazole magnesium2 in 1 CARTONCAPSULE, DELAYED RELEASE24
49035-921-03equate esomeprazole magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE144
49035-921-03equate esomeprazole magnesium3 in 1 CARTONCAPSULE, DELAYED RELEASE34
49035-921-14equate esomeprazole magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE144
49035-921-14equate esomeprazole magnesium1 in 1 CARTONCAPSULE, DELAYED RELEASE14
49035-921-28equate esomeprazole magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE144
49035-921-28equate esomeprazole magnesium2 in 1 CARTONCAPSULE, DELAYED RELEASE24
49035-921-42equate esomeprazole magnesium3 in 1 CARTONCAPSULE, DELAYED RELEASE34
49035-921-42equate esomeprazole magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE144

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNaaafc536-f846-4019-a629-b52b3f36e6824
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDaaafc536-f846-4019-a629-b52b3f36e6824
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYaaafc536-f846-4019-a629-b52b3f36e6824
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYaaafc536-f846-4019-a629-b52b3f36e6824

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
49035-921-01490350921011 in 1 CARTONHistorical
49035-921-024903509210214 in 1 BOTTLEHistorical
49035-921-034903509210314 in 1 BOTTLEHistorical
49035-921-14490350921141 BOTTLE in 1 CARTON (49035-921-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2025-12-17NoNoCurrent
49035-921-28490350921282 BOTTLE in 1 CARTON (49035-921-28) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE2 bottle2025-12-17NoNoCurrent
49035-921-42490350921423 BOTTLE in 1 CARTON (49035-921-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2026-01-07NoNoCurrent