FDA.reportPublic FDA data

Acid Reducer

Product NDC
0363-9977
11-digit product format
003639977
Labeler code
0363
Product ID
0363-9977_c57a9831-809a-487c-97fe-2edfdf904c85
Type
HUMAN OTC DRUG
Nonproprietary name
Esomeprazole magnesium
Dosage form
TABLET
Route
ORAL
Labeler
Walgreens
Application
ANDA212088
Marketing category
ANDA
Marketing start
2022-11-04
Marketing end
2026-11-28
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Acid Reducer

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESOMEPRAZOLE MAGNESIUM20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR6DXU4WAY9
Rxcui433733

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
0363-9977-14Acid Reducer1 in 1 CARTONTABLET14
0363-9977-14Acid Reducer14 in 1 BOTTLETABLET144
0363-9977-42Acid Reducer14 in 1 BOTTLE, PLASTICTABLET144
0363-9977-42Acid Reducer3 in 1 CARTONTABLET34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9977ACID REDUCER (ESOMEPRAZOLE MAGNESIUM) TABLET [WALGREENS]2Current NDC, Legacy NDC, 4 package rows20230811_4f3c1d76-e1ba-4f85-9384-ed8f35fa6bc6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
433733esomeprazole magnesium 20 MG Delayed Release Oral TabletPSN4f3c1d76-e1ba-4f85-9384-ed8f35fa6bc64
433733esomeprazole 20 MG Delayed Release Oral TabletSCD4f3c1d76-e1ba-4f85-9384-ed8f35fa6bc64
433733esomeprazole 20 MG (as esomeprazole magnesium 22.3 MG) Delayed Release Oral TabletSY4f3c1d76-e1ba-4f85-9384-ed8f35fa6bc64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-9977-14003639977141 BOTTLE in 1 CARTON (0363-9977-14) / 14 TABLET in 1 BOTTLE1 bottle2022-11-042026-11-28NoNoCurrent
0363-9977-42003639977423 BOTTLE, PLASTIC in 1 CARTON (0363-9977-42) / 14 TABLET in 1 BOTTLE, PLASTIC2022-11-042026-11-28NoNoCurrent