FDA.reportPublic FDA data

Esomeprazole magnesium

Product NDC
43547-002
11-digit product format
435470002
Labeler code
43547
Product ID
43547-002_3d2a1a0f-c770-4f46-851e-0697e4f5de4c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Solco Healthcare US LLC
Application
ANDA214920
Marketing category
ANDA
Marketing start
2023-03-28
Substance
ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
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 MAGNESIUM TRIHYDRATE40 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
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
43547-002-03Esomeprazole magnesium30 in 1 BOTTLECAPSULE, DELAYED RELEASE304
43547-002-09Esomeprazole magnesium90 in 1 BOTTLECAPSULE, DELAYED RELEASE904
43547-002-11Esomeprazole magnesium1000 in 1 BOTTLECAPSULE, DELAYED RELEASE10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-002ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [SOLCO HEALTHCARE US LLC]2Current NDC, 3 package rows20240402_3cd80c04-43a2-4be3-b831-ebccc273a0d2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN3cd80c04-43a2-4be3-b831-ebccc273a0d24
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSN3cd80c04-43a2-4be3-b831-ebccc273a0d24
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD3cd80c04-43a2-4be3-b831-ebccc273a0d24
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCD3cd80c04-43a2-4be3-b831-ebccc273a0d24
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY3cd80c04-43a2-4be3-b831-ebccc273a0d24
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY3cd80c04-43a2-4be3-b831-ebccc273a0d24
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSY3cd80c04-43a2-4be3-b831-ebccc273a0d24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
43547-002-034354700020330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-002-03) 2023-03-28NoNoCurrent
43547-002-094354700020990 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-002-09) 2023-03-28NoNoCurrent
43547-002-11435470002111000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-002-11) 2023-03-28NoNoCurrent