FDA.reportPublic FDA data

Esomeprazole magnesium

Product NDC
76420-227
11-digit product format
764200227
Labeler code
76420
Product ID
76420-227_23b36bd4-0dbd-366a-e063-6294a90a1565
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole magnesium delayed release capsules
Dosage form
CAPSULE, COATED PELLETS
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA210559
Marketing category
ANDA
Marketing start
2021-02-27
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
76420-227-30Esomeprazole magnesium30 in 1 BOTTLECAPSULE, COATED PELLETS302
76420-227-60Esomeprazole magnesium60 in 1 BOTTLECAPSULE, COATED PELLETS602
76420-227-90Esomeprazole magnesium90 in 1 BOTTLECAPSULE, COATED PELLETS902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-227-30EA - Each76420-227f8b8a87f-ef98-4b76-88eb-38e2cfba4c3e12022-09-12
76420-227-60EA - Each76420-227ec312bb9-2b42-4389-8a62-06d68394067912022-09-12
76420-227-90EA - Each76420-227e6a9158a-2d1f-43b8-b23a-68c133e75ff512022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-227ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM DELAYED RELEASE CAPSULES) CAPSULE, COATED PELLETS [ASCLEMED USA, INC.]2Current NDC, Legacy NDC, 3 package rows20241008_85a963c1-9c13-4eb7-826b-08d5a991fe28.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN85a963c1-9c13-4eb7-826b-08d5a991fe282
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSN85a963c1-9c13-4eb7-826b-08d5a991fe282
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD85a963c1-9c13-4eb7-826b-08d5a991fe282
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCD85a963c1-9c13-4eb7-826b-08d5a991fe282
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 CapsuleSY85a963c1-9c13-4eb7-826b-08d5a991fe282
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSY85a963c1-9c13-4eb7-826b-08d5a991fe282

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76420-227-307642002273030 CAPSULE, COATED PELLETS in 1 BOTTLE (76420-227-30) 2022-07-270000-00-00NoNoCurrent
76420-227-607642002276060 CAPSULE, COATED PELLETS in 1 BOTTLE (76420-227-60) 2022-07-270000-00-00NoNoCurrent
76420-227-907642002279090 CAPSULE, COATED PELLETS in 1 BOTTLE (76420-227-90) 2022-07-270000-00-00NoNoCurrent