FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
43598-510
11-digit product format
435980510
Labeler code
43598
Product ID
43598-510_bc23d230-ec98-ff25-5296-39e31fe9b775
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Dr. Reddy's Laboratories Inc
Application
ANDA078279
Marketing category
ANDA
Marketing start
2015-12-10
Substance
ESOMEPRAZOLE MAGNESIUM
Active strength
40 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 MAGNESIUM40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR6DXU4WAY9
Rxcui606726, 606730

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7006a36-e68d-42e2-8cd3-d725cb2e47b1Product name620251027
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
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
43598-510-10Esomeprazole Magnesium1000 in 1 BOTTLECAPSULE, DELAYED RELEASE100012
43598-510-30Esomeprazole Magnesium30 in 1 BOTTLECAPSULE, DELAYED RELEASE3012
43598-510-90Esomeprazole Magnesium90 in 1 BOTTLECAPSULE, DELAYED RELEASE9012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-510-10EA - Each43598-5108b4d2821-b37a-4d63-8b58-b4e981f5985c12016-06-14
43598-510-30EA - Each43598-5104656b450-5e43-4989-8c50-2d586bb494e912016-01-13
43598-510-90EA - Each43598-5105029951e-95dd-407b-991c-d97d72f6f53912016-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-510ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES INC]12Current NDC, Legacy NDC, 3 package rows20230906_15023261-51c8-2388-3439-48dace49ec02.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSNfdea1f5f-b717-4d49-8d70-0b373c959bf014
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCDfdea1f5f-b717-4d49-8d70-0b373c959bf014
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSYfdea1f5f-b717-4d49-8d70-0b373c959bf014
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN15023261-51c8-2388-3439-48dace49ec0212
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSN15023261-51c8-2388-3439-48dace49ec0212
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD15023261-51c8-2388-3439-48dace49ec0212
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCD15023261-51c8-2388-3439-48dace49ec0212
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY15023261-51c8-2388-3439-48dace49ec0212
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY15023261-51c8-2388-3439-48dace49ec0212
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSY15023261-51c8-2388-3439-48dace49ec0212
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSNba65c73d-fc7d-491e-aaaa-cf45a77833956
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCDba65c73d-fc7d-491e-aaaa-cf45a77833956
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSYba65c73d-fc7d-491e-aaaa-cf45a77833956
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSN9224142a-6e14-4ca3-9e72-506ff9fbd0e13
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCD9224142a-6e14-4ca3-9e72-506ff9fbd0e13
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSY9224142a-6e14-4ca3-9e72-506ff9fbd0e13
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSN4db9f4b8-b6df-f6e9-e063-6294a90a9f602
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCD4db9f4b8-b6df-f6e9-e063-6294a90a9f602
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSY4db9f4b8-b6df-f6e9-e063-6294a90a9f602
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSNf2f699d8-c770-c874-e053-2995a90ac6d01
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCDf2f699d8-c770-c874-e053-2995a90ac6d01
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSYf2f699d8-c770-c874-e053-2995a90ac6d01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43598-510-10435980510101000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43598-510-10) 2016-04-280000-00-00NoNoCurrent
43598-510-304359805103030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43598-510-30) 2015-12-100000-00-00NoNoCurrent
43598-510-904359805109090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43598-510-90) 2016-01-270000-00-00NoNoCurrent