FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
31722-665
11-digit product format
317220665
Labeler code
31722
Product ID
31722-665_1d0ba185-85a8-988b-e063-6394a90a5fff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA211977
Marketing category
ANDA
Marketing start
2020-06-02
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
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
31722-665-10Esomeprazole Magnesium1000 in 1 BOTTLECAPSULE, DELAYED RELEASE10006
31722-665-30Esomeprazole Magnesium30 in 1 BOTTLECAPSULE, DELAYED RELEASE306
31722-665-90Esomeprazole Magnesium90 in 1 BOTTLECAPSULE, DELAYED RELEASE906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-665-10EA - Each31722-665399ae3c3-b657-4ae9-9ed3-41b27c171e6112021-09-07
31722-665-30EA - Each31722-665f10dd460-fddd-4590-8df4-d8f04070edea12021-09-07
31722-665-90EA - Each31722-6654f7afe71-c4bd-46af-9610-de1978105a7312021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-665ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [CAMBER PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 3 package rows20240713_c18067ba-26ba-40b4-a328-3011710be216.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSN61cc0020-aab8-42a3-b0a6-93062f382c87105
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCD61cc0020-aab8-42a3-b0a6-93062f382c87105
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSY61cc0020-aab8-42a3-b0a6-93062f382c87105
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSN27e7f7f0-7403-4425-8baa-d12ae93213649
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCD27e7f7f0-7403-4425-8baa-d12ae93213649
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSY27e7f7f0-7403-4425-8baa-d12ae93213649
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNc18067ba-26ba-40b4-a328-3011710be2166
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSNc18067ba-26ba-40b4-a328-3011710be2166
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDc18067ba-26ba-40b4-a328-3011710be2166
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCDc18067ba-26ba-40b4-a328-3011710be2166
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYc18067ba-26ba-40b4-a328-3011710be2166
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYc18067ba-26ba-40b4-a328-3011710be2166
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSYc18067ba-26ba-40b4-a328-3011710be2166
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSN42b8d3f5-d919-48dd-92e4-ed49488dd6645
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCD42b8d3f5-d919-48dd-92e4-ed49488dd6645
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSY42b8d3f5-d919-48dd-92e4-ed49488dd6645
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSNd5f56bd4-3a59-6857-e053-2995a90a6e004
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCDd5f56bd4-3a59-6857-e053-2995a90a6e004
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSYd5f56bd4-3a59-6857-e053-2995a90a6e004
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSNfab87a2d-79c8-6045-e053-6394a90a23682
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCDfab87a2d-79c8-6045-e053-6394a90a23682
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSYfab87a2d-79c8-6045-e053-6394a90a23682
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN2690dbe7-e559-4de8-9582-79b627af19641
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSNab3d31c8-cab1-4c44-bacd-5e5c67dd13841
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSN2690dbe7-e559-4de8-9582-79b627af19641
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSNd92c29bf-6f84-0c4d-e053-2995a90abc3b1
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSNe327a639-68a4-920a-e053-2995a90aa5771
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD2690dbe7-e559-4de8-9582-79b627af19641
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCDab3d31c8-cab1-4c44-bacd-5e5c67dd13841
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCD2690dbe7-e559-4de8-9582-79b627af19641
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCDd92c29bf-6f84-0c4d-e053-2995a90abc3b1
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCDe327a639-68a4-920a-e053-2995a90aa5771
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY2690dbe7-e559-4de8-9582-79b627af19641
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY2690dbe7-e559-4de8-9582-79b627af19641
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSY2690dbe7-e559-4de8-9582-79b627af19641
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSYe327a639-68a4-920a-e053-2995a90aa5771
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSYd92c29bf-6f84-0c4d-e053-2995a90abc3b1
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSYab3d31c8-cab1-4c44-bacd-5e5c67dd13841

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-665-10317220665101000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-665-10) 2020-06-020000-00-00NoNoCurrent
31722-665-303172206653030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-665-30) 2020-06-020000-00-00NoNoCurrent
31722-665-903172206659090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-665-90) 2020-06-020000-00-00NoNoCurrent