FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
16714-979
11-digit product format
167140979
Labeler code
16714
Product ID
16714-979_0db3d40a-29ae-8151-d2cb-2a75c0573a1b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA078279
Marketing category
ANDA
Marketing start
2019-09-17
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
16714-979-01Esomeprazole Magnesium30 in 1 BOTTLECAPSULE, DELAYED RELEASE305
16714-979-02Esomeprazole Magnesium90 in 1 BOTTLECAPSULE, DELAYED RELEASE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-979-01EA - Each16714-979aeef371e-ab2f-4859-9974-c8be4d8c28f812020-02-13
16714-979-02EA - Each16714-979347d8a61-3ed0-4eb2-a30f-1bfde6075a0612020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-979ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [NORTHSTAR RX LLC]5Current NDC, Legacy NDC, 2 package rows20231020_380da8db-bfa3-8c0c-f8f3-573675fed981.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN380da8db-bfa3-8c0c-f8f3-573675fed9815
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSN380da8db-bfa3-8c0c-f8f3-573675fed9815
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD380da8db-bfa3-8c0c-f8f3-573675fed9815
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCD380da8db-bfa3-8c0c-f8f3-573675fed9815
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY380da8db-bfa3-8c0c-f8f3-573675fed9815
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY380da8db-bfa3-8c0c-f8f3-573675fed9815
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSY380da8db-bfa3-8c0c-f8f3-573675fed9815
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN2879c79f-bf2a-0bc9-e063-6394a90a98ae2
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD2879c79f-bf2a-0bc9-e063-6394a90a98ae2
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY2879c79f-bf2a-0bc9-e063-6394a90a98ae2
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY2879c79f-bf2a-0bc9-e063-6394a90a98ae2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-979-011671409790130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-979-01) 2019-09-170000-00-00NoNoCurrent
16714-979-021671409790290 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-979-02) 2019-09-170000-00-00NoNoCurrent