FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
43598-926
11-digit product format
435980926
Labeler code
43598
Product ID
43598-926_57f13c84-5f7b-444f-87e6-0ec18669cd08
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
2024-12-01
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
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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-926ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES INC]2Current NDC20241202_fab0b1fa-cf56-d97c-f026-1754cf5b792c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNfab0b1fa-cf56-d97c-f026-1754cf5b792c2
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDfab0b1fa-cf56-d97c-f026-1754cf5b792c2
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYfab0b1fa-cf56-d97c-f026-1754cf5b792c2
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYfab0b1fa-cf56-d97c-f026-1754cf5b792c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43598-926-28435980926282 BOTTLE in 1 CARTON (43598-926-28) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE2 bottle2024-12-01NoNoCurrent
43598-926-33435980926333 BOTTLE in 1 CARTON (43598-926-33) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2024-12-01NoNoCurrent
43598-926-52435980926521 BOTTLE in 1 CARTON (43598-926-52) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2024-12-01NoNoCurrent
43598-926-94435980926944000 CAPSULE, DELAYED RELEASE in 1 POUCH (43598-926-94)20-AUG-24Current