FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
43598-407
11-digit product format
435980407
Labeler code
43598
Product ID
43598-407_1f7dc391-028d-a98f-7cc6-887f293caf06
Type
HUMAN OTC DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Dr. Reddy's Laboratories Inc
Application
ANDA207673
Marketing category
ANDA
Marketing start
2018-05-16
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
d71865e8-5c35-4d76-8ecd-a7adda982240Product name920180628
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
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
43598-407-27Esomeprazole Magnesium2 in 1 CARTONCAPSULE, DELAYED RELEASE29
43598-407-27Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE149
43598-407-33Esomeprazole Magnesium3 in 1 CARTONCAPSULE, DELAYED RELEASE39
43598-407-33Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE149
43598-407-52Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE149
43598-407-52Esomeprazole Magnesium1 in 1 CARTONCAPSULE, DELAYED RELEASE19
43598-407-70Esomeprazole Magnesium7 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE79
43598-407-74Esomeprazole Magnesium2 in 1 CARTONCAPSULE, DELAYED RELEASE29

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-407-27EA - Each43598-4079265f067-fb45-43ff-b759-271012fed97f12019-11-12
43598-407-33EA - Each43598-407640b1d30-ce63-4ac0-aef0-2ecd0170378f12019-07-02
43598-407-52EA - Each43598-4075369eaf8-6d29-47f8-9d1a-1e2ed4859f0012019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-407ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES INC]9Current NDC, Legacy NDC, 8 package rows20221014_cb8297ad-ce1b-aa31-2488-5a38b2dbc774.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNf97f8604-9f00-6ed5-ae25-fedc8cf36a5d11
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDf97f8604-9f00-6ed5-ae25-fedc8cf36a5d11
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYf97f8604-9f00-6ed5-ae25-fedc8cf36a5d11
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYf97f8604-9f00-6ed5-ae25-fedc8cf36a5d11
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNcb8297ad-ce1b-aa31-2488-5a38b2dbc7749
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDcb8297ad-ce1b-aa31-2488-5a38b2dbc7749
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYcb8297ad-ce1b-aa31-2488-5a38b2dbc7749
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYcb8297ad-ce1b-aa31-2488-5a38b2dbc7749
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNb4cdf878-61d3-01bd-48c9-4d6f4fbc71df6
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNf95053ab-d6c5-ee92-58d1-6f203873f79c6
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDf95053ab-d6c5-ee92-58d1-6f203873f79c6
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDb4cdf878-61d3-01bd-48c9-4d6f4fbc71df6
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYb4cdf878-61d3-01bd-48c9-4d6f4fbc71df6
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYf95053ab-d6c5-ee92-58d1-6f203873f79c6
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYb4cdf878-61d3-01bd-48c9-4d6f4fbc71df6
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYf95053ab-d6c5-ee92-58d1-6f203873f79c6
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN945beb4b-8a31-d904-8881-1cf8396043474
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNe3747f1e-01e7-f3cf-499e-c7c3f6d06a304
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDe3747f1e-01e7-f3cf-499e-c7c3f6d06a304
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD945beb4b-8a31-d904-8881-1cf8396043474
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYe3747f1e-01e7-f3cf-499e-c7c3f6d06a304
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY945beb4b-8a31-d904-8881-1cf8396043474
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY945beb4b-8a31-d904-8881-1cf8396043474
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYe3747f1e-01e7-f3cf-499e-c7c3f6d06a304
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN0d6e66c5-ca6d-5cda-72d7-9350dbd1eba02
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD0d6e66c5-ca6d-5cda-72d7-9350dbd1eba02
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY0d6e66c5-ca6d-5cda-72d7-9350dbd1eba02
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY0d6e66c5-ca6d-5cda-72d7-9350dbd1eba02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-407-27435980407272 BOTTLE in 1 CARTON (43598-407-27) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE2 bottle2018-05-160000-00-00NoNoCurrent
43598-407-33435980407333 BOTTLE in 1 CARTON (43598-407-33) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2018-05-160000-00-00NoNoCurrent
43598-407-52435980407521 BOTTLE in 1 CARTON (43598-407-52) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2018-05-160000-00-00NoNoCurrent
43598-407-70435980407707 in 1 BLISTER PACKHistorical
43598-407-74435980407742 BLISTER PACK in 1 CARTON (43598-407-74) / 7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (43598-407-70) 2 blister pack2018-05-160000-00-00NoNoCurrent