FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
31722-664
11-digit product format
317220664
Labeler code
31722
Product ID
31722-664_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
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
31722-664-10Esomeprazole Magnesium1000 in 1 BOTTLECAPSULE, DELAYED RELEASE10006
31722-664-30Esomeprazole Magnesium30 in 1 BOTTLECAPSULE, DELAYED RELEASE306
31722-664-90Esomeprazole Magnesium90 in 1 BOTTLECAPSULE, DELAYED RELEASE906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-664-10EA - Each31722-664727a4641-47b6-47c4-9787-de38d450bccc12021-09-07
31722-664-30EA - Each31722-664238e4029-9f43-4250-85ae-fece4440549b12021-09-07
31722-664-90EA - Each31722-664a98d60c3-3dfd-498e-b43e-544db331abbc12021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-664ESOMEPRAZOLE 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
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN7778bf7c-52f7-44b3-ac2c-e5a25f6967b7103
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD7778bf7c-52f7-44b3-ac2c-e5a25f6967b7103
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY7778bf7c-52f7-44b3-ac2c-e5a25f6967b7103
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY7778bf7c-52f7-44b3-ac2c-e5a25f6967b7103
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN00aa81c2-73c7-4bf8-94e9-f644381b631f6
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 CapsuleSCD00aa81c2-73c7-4bf8-94e9-f644381b631f6
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 CapsuleSY00aa81c2-73c7-4bf8-94e9-f644381b631f6
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
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY00aa81c2-73c7-4bf8-94e9-f644381b631f6
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSYc18067ba-26ba-40b4-a328-3011710be2166
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNe8937778-8baf-05f5-e053-2995a90a3a983
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDe8937778-8baf-05f5-e053-2995a90a3a983
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYe8937778-8baf-05f5-e053-2995a90a3a983
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYe8937778-8baf-05f5-e053-2995a90a3a983
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNd28006cc-c759-93e5-e053-2a95a90ac4732
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDd28006cc-c759-93e5-e053-2a95a90ac4732
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYd28006cc-c759-93e5-e053-2a95a90ac4732
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYd28006cc-c759-93e5-e053-2a95a90ac4732
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN2690dbe7-e559-4de8-9582-79b627af19641
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN1d8bd104-66d4-8c19-e063-6394a90a3cb61
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN1e92676a-6c59-796d-e063-6294a90aaab41
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN9a3df29e-dc44-4dfe-a26f-4bbbf18e31eb1
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSN2690dbe7-e559-4de8-9582-79b627af19641
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD1d8bd104-66d4-8c19-e063-6394a90a3cb61
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD9a3df29e-dc44-4dfe-a26f-4bbbf18e31eb1
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD2690dbe7-e559-4de8-9582-79b627af19641
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD1e92676a-6c59-796d-e063-6294a90aaab41
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCD2690dbe7-e559-4de8-9582-79b627af19641
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY9a3df29e-dc44-4dfe-a26f-4bbbf18e31eb1
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY2690dbe7-e559-4de8-9582-79b627af19641
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY1e92676a-6c59-796d-e063-6294a90aaab41
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY1d8bd104-66d4-8c19-e063-6394a90a3cb61
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY9a3df29e-dc44-4dfe-a26f-4bbbf18e31eb1
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY1d8bd104-66d4-8c19-e063-6394a90a3cb61
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY2690dbe7-e559-4de8-9582-79b627af19641
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY1e92676a-6c59-796d-e063-6294a90aaab41
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSY2690dbe7-e559-4de8-9582-79b627af19641

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-664-10317220664101000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-664-10) 2020-06-020000-00-00NoNoCurrent
31722-664-303172206643030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-664-30) 2020-06-020000-00-00NoNoCurrent
31722-664-903172206649090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-664-90) 2020-06-020000-00-00NoNoCurrent