FDA.reportPublic FDA data

esomeprazole magnesium

Product NDC
68382-442
11-digit product format
683820442
Labeler code
68382
Product ID
68382-442_5d33bc3b-4750-4fd3-99b5-f70a1520c32c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
esomeprazole magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA206296
Marketing category
ANDA
Marketing start
2019-05-30
Substance
ESOMEPRAZOLE MAGNESIUM DIHYDRATE
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 MAGNESIUM DIHYDRATE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii36H71644EQ
Rxcui606726, 606730

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7006a36-e68d-42e2-8cd3-d725cb2e47b1Product name620251027
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
d71865e8-5c35-4d76-8ecd-a7adda982240Product name920180628
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
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
68382-442-06esomeprazole magnesium30 in 1 BOTTLECAPSULE, DELAYED RELEASE307
68382-442-10esomeprazole magnesium1000 in 1 BOTTLECAPSULE, DELAYED RELEASE10007
68382-442-16esomeprazole magnesium90 in 1 BOTTLECAPSULE, DELAYED RELEASE907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-442-06EA - Each68382-442fa425c67-84e5-41eb-b354-96c580dd537c12019-08-06
68382-442-10EA - Each68382-44236fd5518-8565-4cb1-a184-f608249db92d12019-08-06
68382-442-16EA - Each68382-442df2603a6-d8e6-469d-aea0-1e1956c58a5c12019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-442ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS USA INC.]7Current NDC, Legacy NDC, 3 package rows20241113_c4b0571e-7b09-441b-90be-bc653806812b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNc4b0571e-7b09-441b-90be-bc653806812b7
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSNc4b0571e-7b09-441b-90be-bc653806812b7
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDc4b0571e-7b09-441b-90be-bc653806812b7
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCDc4b0571e-7b09-441b-90be-bc653806812b7
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYc4b0571e-7b09-441b-90be-bc653806812b7
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYc4b0571e-7b09-441b-90be-bc653806812b7
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSYc4b0571e-7b09-441b-90be-bc653806812b7
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSN925cee78-83af-480f-838d-8ba97ac6b1e36
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCD925cee78-83af-480f-838d-8ba97ac6b1e36
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSY925cee78-83af-480f-838d-8ba97ac6b1e36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68382-442-066838204420630 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-442-06) 2019-05-300000-00-00NoNoCurrent
68382-442-10683820442101000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-442-10) 2019-05-300000-00-00NoNoCurrent
68382-442-166838204421690 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-442-16) 2019-05-300000-00-00NoNoCurrent