FDA.reportPublic FDA data

Acid Reducer

Product NDC
59726-056
11-digit product format
597260056
Labeler code
59726
Product ID
59726-056_03fda90d-5e9e-4340-899b-0e3734510a66
Type
HUMAN OTC DRUG
Nonproprietary name
Esomeprazole magnesium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
P & L Development, LLC
Application
ANDA212088
Marketing category
ANDA
Marketing start
2020-12-31
Marketing end
2026-06-30
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
59726-056-14Acid Reducer14 in 1 BOTTLETABLET, DELAYED RELEASE144
59726-056-14Acid Reducer1 in 1 CARTONTABLET, DELAYED RELEASE14
59726-056-42Acid Reducer3 in 1 CARTONTABLET, DELAYED RELEASE34
59726-056-42Acid Reducer14 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE144

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59726-056ACID REDUCER (ESOMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [P & L DEVELOPMENT, LLC]4Current NDC, Legacy NDC, 4 package rows20241103_08f09939-10d1-4380-81bb-826856444674.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
433733esomeprazole magnesium 20 MG Delayed Release Oral TabletPSN08f09939-10d1-4380-81bb-8268564446744
433733esomeprazole 20 MG Delayed Release Oral TabletSCD08f09939-10d1-4380-81bb-8268564446744
433733esomeprazole 20 MG (as esomeprazole magnesium 22.3 MG) Delayed Release Oral TabletSY08f09939-10d1-4380-81bb-8268564446744

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59726-056-14597260056141 BOTTLE in 1 CARTON (59726-056-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2020-12-312026-06-30NoNoCurrent
59726-056-42597260056423 BOTTLE, PLASTIC in 1 CARTON (59726-056-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2020-12-312026-06-30NoNoCurrent