FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
43598-327
11-digit product format
435980327
Labeler code
43598
Product ID
43598-327_80664ea4-4cd2-43cd-2055-2bd69dec3768
Type
HUMAN OTC DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Dr. Reddy's Laboratories Inc
Application
ANDA207198
Marketing category
ANDA
Marketing start
2025-03-01
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
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
43598-327-27Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE148
43598-327-27Esomeprazole Magnesium2 in 1 CARTONCAPSULE, DELAYED RELEASE28
43598-327-33Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE148
43598-327-33Esomeprazole Magnesium3 in 1 CARTONCAPSULE, DELAYED RELEASE38
43598-327-52Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE148
43598-327-52Esomeprazole Magnesium1 in 1 CARTONCAPSULE, DELAYED RELEASE18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-327ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES INC]8Current NDC, 6 package rows20250302_fca35363-7d27-b8b3-14c0-56f603652053.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNfca35363-7d27-b8b3-14c0-56f6036520538
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDfca35363-7d27-b8b3-14c0-56f6036520538
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYfca35363-7d27-b8b3-14c0-56f6036520538
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYfca35363-7d27-b8b3-14c0-56f6036520538
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN1edcb0be-7af2-c08c-dab2-0be03364a1403
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNa5a6f614-2920-d74c-1ddc-9a07a0ec6e053
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD1edcb0be-7af2-c08c-dab2-0be03364a1403
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDa5a6f614-2920-d74c-1ddc-9a07a0ec6e053
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY1edcb0be-7af2-c08c-dab2-0be03364a1403
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYa5a6f614-2920-d74c-1ddc-9a07a0ec6e053
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYa5a6f614-2920-d74c-1ddc-9a07a0ec6e053
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY1edcb0be-7af2-c08c-dab2-0be03364a1403
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN993f86d0-c18b-a843-6adf-e8a967da37452
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNd001e9c2-1c70-7ff6-ad72-c431a46d17712
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD993f86d0-c18b-a843-6adf-e8a967da37452
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDd001e9c2-1c70-7ff6-ad72-c431a46d17712
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY993f86d0-c18b-a843-6adf-e8a967da37452
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYd001e9c2-1c70-7ff6-ad72-c431a46d17712
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY993f86d0-c18b-a843-6adf-e8a967da37452
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYd001e9c2-1c70-7ff6-ad72-c431a46d17712
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN144fcd6b-2b40-f84b-c559-07a847b276381
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD144fcd6b-2b40-f84b-c559-07a847b276381
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY144fcd6b-2b40-f84b-c559-07a847b276381
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY144fcd6b-2b40-f84b-c559-07a847b276381

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43598-327-27435980327272 BOTTLE in 1 CARTON (43598-327-27) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE2 bottle2025-03-01NoNoHistorical
43598-327-33435980327333 BOTTLE in 1 CARTON (43598-327-33) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2025-03-01NoNoHistorical
43598-327-52435980327521 BOTTLE in 1 CARTON (43598-327-52) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2025-03-01NoNoHistorical