FDA.reportPublic FDA data

Esomeprazole magnesium

Product NDC
67877-571
11-digit product format
678770571
Labeler code
67877
Product ID
67877-571_27b22eed-c148-41cd-bdd7-434610f98b70
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole magnesium delayed release capsules
Dosage form
CAPSULE, COATED PELLETS
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA210559
Marketing category
ANDA
Marketing start
2021-02-27
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
67877-571-05Esomeprazole magnesium500 in 1 BOTTLECAPSULE, COATED PELLETS50012
67877-571-10Esomeprazole magnesium1000 in 1 BOTTLECAPSULE, COATED PELLETS100012
67877-571-30Esomeprazole magnesium30 in 1 BOTTLECAPSULE, COATED PELLETS3012
67877-571-38Esomeprazole magnesium10 in 1 CARTONCAPSULE, COATED PELLETS1012
67877-571-38Esomeprazole magnesium10 in 1 BLISTER PACKCAPSULE, COATED PELLETS1012
67877-571-90Esomeprazole magnesium90 in 1 BOTTLECAPSULE, COATED PELLETS9012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-571-30EA - Each67877-571df09a8a2-a805-4a34-8528-89891f70e85612021-05-05
67877-571-90EA - Each67877-5714decd937-f587-4f6c-83d3-620879efcd7912021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-571ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM DELAYED RELEASE CAPSULES) CAPSULE, COATED PELLETS [ASCEND LABORATORIES, LLC]11Current NDC, Legacy NDC, 6 package rows20240420_277ce748-2809-4be0-81e7-6a4d604f2c6f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNdb8a346e-dba1-41bc-b122-a1de868ee91a103
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDdb8a346e-dba1-41bc-b122-a1de868ee91a103
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYdb8a346e-dba1-41bc-b122-a1de868ee91a103
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYdb8a346e-dba1-41bc-b122-a1de868ee91a103
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN277ce748-2809-4be0-81e7-6a4d604f2c6f12
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSN277ce748-2809-4be0-81e7-6a4d604f2c6f12
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD277ce748-2809-4be0-81e7-6a4d604f2c6f12
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCD277ce748-2809-4be0-81e7-6a4d604f2c6f12
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY277ce748-2809-4be0-81e7-6a4d604f2c6f12
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY277ce748-2809-4be0-81e7-6a4d604f2c6f12
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSY277ce748-2809-4be0-81e7-6a4d604f2c6f12
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN85a963c1-9c13-4eb7-826b-08d5a991fe282
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNad05cdde-a9e9-4442-80c4-1b02f5ebf6b42
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSN85a963c1-9c13-4eb7-826b-08d5a991fe282
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD85a963c1-9c13-4eb7-826b-08d5a991fe282
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDad05cdde-a9e9-4442-80c4-1b02f5ebf6b42
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCD85a963c1-9c13-4eb7-826b-08d5a991fe282
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYad05cdde-a9e9-4442-80c4-1b02f5ebf6b42
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY85a963c1-9c13-4eb7-826b-08d5a991fe282
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYad05cdde-a9e9-4442-80c4-1b02f5ebf6b42
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY85a963c1-9c13-4eb7-826b-08d5a991fe282
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSY85a963c1-9c13-4eb7-826b-08d5a991fe282
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNf31e5472-7fcb-0f42-e053-2995a90a19b31
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDf31e5472-7fcb-0f42-e053-2995a90a19b31
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYf31e5472-7fcb-0f42-e053-2995a90a19b31
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYf31e5472-7fcb-0f42-e053-2995a90a19b31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-571-0567877057105500 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-571-05) 2021-02-270000-00-00NoNoCurrent
67877-571-10678770571101000 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-571-10) 2021-02-270000-00-00NoNoCurrent
67877-571-306787705713030 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-571-30) 2021-02-270000-00-00NoNoCurrent
67877-571-386787705713810 BLISTER PACK in 1 CARTON (67877-571-38) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK10 blister pack2021-02-270000-00-00NoNoCurrent
67877-571-906787705719090 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-571-90) 2021-02-270000-00-00NoNoCurrent