FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
0378-2351
11-digit product format
003782351
Labeler code
0378
Product ID
0378-2351_e0389e97-0278-4684-b6b7-d4c19a151f6f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA078936
Marketing category
ANDA
Marketing start
2015-08-03
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
0378-2351-77Esomeprazole Magnesium90 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE PELLETS9015
0378-2351-93Esomeprazole Magnesium30 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE PELLETS3015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-2351-10EA - Each0378-235199d0f652-3ec6-4493-bace-85fd8327fc7312015-09-10
0378-2351-77EA - Each0378-235143c11c39-1152-4bcc-a3a6-5266803cb73312016-01-13
0378-2351-93EA - Each0378-2351cb42b292-38d5-45dd-9a2c-80a559cc22ee12015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESOMEPRAZOLE MAGNESIUMACTIVE INGREDIENTR6DXU4WAY9ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]2
ESOMEPRAZOLEACTIVE MOIETYN3PA6559FTESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]2
GELATININACTIVE INGREDIENT2G86QN327LESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]2
SHELLACINACTIVE INGREDIENT46N107B71OESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]2
SUCROSEINACTIVE INGREDIENTC151H8M554ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-2351ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]15Current NDC, Legacy NDC, 2 package rows20240229_e04e7c84-59c8-4a1d-8dfc-d72588b97b59.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNe04e7c84-59c8-4a1d-8dfc-d72588b97b5915
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSNe04e7c84-59c8-4a1d-8dfc-d72588b97b5915
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDe04e7c84-59c8-4a1d-8dfc-d72588b97b5915
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCDe04e7c84-59c8-4a1d-8dfc-d72588b97b5915
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYe04e7c84-59c8-4a1d-8dfc-d72588b97b5915
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYe04e7c84-59c8-4a1d-8dfc-d72588b97b5915
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSYe04e7c84-59c8-4a1d-8dfc-d72588b97b5915

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-2351-770037823517790 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-2351-77) 2015-12-070000-00-00NoNoCurrent
0378-2351-930037823519330 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-2351-93) 2015-08-030000-00-00NoNoCurrent