FDA.reportPublic FDA data

ESOMEPRAZOLE MAGNESIUM

Product NDC
82009-033
11-digit product format
820090033
Labeler code
82009
Product ID
82009-033_af9a0697-ca95-405e-8b81-ec8b38a034f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESOMEPRAZOLE MAGNESIUM
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Quallent Pharmaceuticals Health LLC
Application
ANDA213486
Marketing category
ANDA
Marketing start
2022-12-01
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, 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
82009-033-10ESOMEPRAZOLE MAGNESIUM1000 in 1 BOTTLECAPSULE, DELAYED RELEASE10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82009-033-10EA - Each82009-033bc1e4b0d-d2f8-460f-9e22-b3c411fbc0cf12023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82009-033ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [QUALLENT PHARMACEUTICALS HEALTH LLC]3Current NDC, Legacy NDC, 1 package rows20250302_7362f930-0879-451e-8de9-8bb8565bfb7e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN7362f930-0879-451e-8de9-8bb8565bfb7e3
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSN7362f930-0879-451e-8de9-8bb8565bfb7e3
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD7362f930-0879-451e-8de9-8bb8565bfb7e3
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCD7362f930-0879-451e-8de9-8bb8565bfb7e3
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY7362f930-0879-451e-8de9-8bb8565bfb7e3
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY7362f930-0879-451e-8de9-8bb8565bfb7e3
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSY7362f930-0879-451e-8de9-8bb8565bfb7e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
82009-033-10820090033101000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82009-033-10) 2022-12-010000-00-00NoNoCurrent