FDA.reportPublic FDA data

Esomeprazole magnesium

Product NDC
67877-478
11-digit product format
678770478
Labeler code
67877
Product ID
67877-478_c6b5c112-5f5b-453a-836f-54bac8c7dca9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA208333
Marketing category
ANDA
Marketing start
2017-10-20
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
67877-478-05Esomeprazole magnesium500 in 1 BOTTLECAPSULE, DELAYED RELEASE50019
67877-478-10Esomeprazole magnesium1000 in 1 BOTTLECAPSULE, DELAYED RELEASE100019
67877-478-30Esomeprazole magnesium30 in 1 BOTTLECAPSULE, DELAYED RELEASE3019
67877-478-38Esomeprazole magnesium10 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE1019
67877-478-38Esomeprazole magnesium10 in 1 CARTONCAPSULE, DELAYED RELEASE1019
67877-478-90Esomeprazole magnesium90 in 1 BOTTLECAPSULE, DELAYED RELEASE9019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-478-10EA - Each67877-478026c966f-0195-4a84-82e0-b67f2b96c5aa12018-09-05
67877-478-30EA - Each67877-478169b16fe-fcd7-406b-8a7d-a574997ea42012018-09-05
67877-478-90EA - Each67877-478ac39fee5-05ba-46d5-ac14-997f62d44a1d12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-478ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]19Current NDC, Legacy NDC, 6 package rows20240312_f3d4a0d7-77fd-496e-8dfa-2b2dbace4bac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNf3d4a0d7-77fd-496e-8dfa-2b2dbace4bac19
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSNf3d4a0d7-77fd-496e-8dfa-2b2dbace4bac19
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDf3d4a0d7-77fd-496e-8dfa-2b2dbace4bac19
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCDf3d4a0d7-77fd-496e-8dfa-2b2dbace4bac19
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYf3d4a0d7-77fd-496e-8dfa-2b2dbace4bac19
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYf3d4a0d7-77fd-496e-8dfa-2b2dbace4bac19
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSYf3d4a0d7-77fd-496e-8dfa-2b2dbace4bac19
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN8504300f-a584-29ed-e053-2a91aa0ad26c2
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD8504300f-a584-29ed-e053-2a91aa0ad26c2
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY8504300f-a584-29ed-e053-2a91aa0ad26c2
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY8504300f-a584-29ed-e053-2a91aa0ad26c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-478-0567877047805500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-478-05) 2017-10-200000-00-00NoNoCurrent
67877-478-10678770478101000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-478-10) 2017-10-200000-00-00NoNoCurrent
67877-478-306787704783030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-478-30) 2017-10-200000-00-00NoNoCurrent
67877-478-386787704783810 BLISTER PACK in 1 CARTON (67877-478-38) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK10 blister pack2017-10-200000-00-00NoNoCurrent
67877-478-906787704789090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-478-90) 2017-10-200000-00-00NoNoCurrent