FDA.reportPublic FDA data

esomeprazole magnesium

Product NDC
82804-078
11-digit product format
828040078
Labeler code
82804
Product ID
82804-078_7b92ac4f-50c9-4061-b4a7-535a58cea8f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
esomeprazole magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA213486
Marketing category
ANDA
Marketing start
2021-03-19
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
Rxcui606730

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
82804-078-30esomeprazole magnesium30 in 1 BOTTLECAPSULE, DELAYED RELEASE301
82804-078-60esomeprazole magnesium60 in 1 BOTTLECAPSULE, DELAYED RELEASE601
82804-078-90esomeprazole magnesium90 in 1 BOTTLECAPSULE, DELAYED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-078-30EA - Each82804-07816b55fea-4023-4ff5-b62c-73f21f04e8fd12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-078ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1Current NDC, 3 package rows20240310_7b92ac4f-50c9-4061-b4a7-535a58cea8f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSN7b92ac4f-50c9-4061-b4a7-535a58cea8f61
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCD7b92ac4f-50c9-4061-b4a7-535a58cea8f61
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSY7b92ac4f-50c9-4061-b4a7-535a58cea8f61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82804-078-308280400783030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82804-078-30) 2024-02-28NoNoCurrent
82804-078-608280400786060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82804-078-60) 2024-02-28NoNoCurrent
82804-078-908280400789090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82804-078-90) 2024-02-28NoNoCurrent