FDA.reportPublic FDA data

ESOMEPRAZOLE MAGNESIUM

Product NDC
61919-834
11-digit product format
619190834
Labeler code
61919
Product ID
61919-834_267916e4-c6ac-43b5-9d81-be20ff1b15d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESOMEPRAZOLE MAGNESIUM
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
DirectRX
Application
ANDA078279
Marketing category
ANDA
Marketing start
2015-01-01
Marketing end
0000-00-00
Substance
ESOMEPRAZOLE MAGNESIUM
Active strength
40 mg/1
Pharmacologic classes
Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-834-302020-01-31C16284748780-19d75b9d0-2287-f424-e053-dadaa90a57ceESOMEPRAZOLE MAGNESIUM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-834-30ESOMEPRAZOLE MAGNESIUMD/R30 in 1 BOTTLECAPSULE, DELAYED RELEASE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-834-30EA - Each61919-834cea7d494-f590-4bce-9ea3-b9838c6e3f4212016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Esomeprazole MagnesiumACTIVE INGREDIENTR6DXU4WAY9ESOMEPRAZOLE MAGNESIUM D/R (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [DIRECTRX]1
ESOMEPRAZOLEACTIVE MOIETYN3PA6559FTESOMEPRAZOLE MAGNESIUM D/R (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [DIRECTRX]1
AlcoholINACTIVE INGREDIENT3K9958V90MESOMEPRAZOLE MAGNESIUM D/R (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [DIRECTRX]1
AmmoniaINACTIVE INGREDIENT5138Q19F1XESOMEPRAZOLE MAGNESIUM D/R (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [DIRECTRX]1
Butyl AlcoholINACTIVE INGREDIENT8PJ61P6TS3ESOMEPRAZOLE MAGNESIUM D/R (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [DIRECTRX]1
D&C Red No. 28INACTIVE INGREDIENT767IP0Y5NHESOMEPRAZOLE MAGNESIUM D/R (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [DIRECTRX]1
Fd&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDESOMEPRAZOLE MAGNESIUM D/R (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [DIRECTRX]1
Ferrosoferric OxideINACTIVE INGREDIENTXM0M87F357ESOMEPRAZOLE MAGNESIUM D/R (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [DIRECTRX]1
GelatinINACTIVE INGREDIENT2G86QN327LESOMEPRAZOLE MAGNESIUM D/R (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [DIRECTRX]1
Glyceryl MonostearateINACTIVE INGREDIENT230OU9XXE4ESOMEPRAZOLE MAGNESIUM D/R (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [DIRECTRX]1
Hydroxypropyl Cellulose (Type H)INACTIVE INGREDIENTRFW2ET671PESOMEPRAZOLE MAGNESIUM D/R (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [DIRECTRX]1
HypromellosesINACTIVE INGREDIENT3NXW29V3WOESOMEPRAZOLE MAGNESIUM D/R (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [DIRECTRX]1
Isopropyl AlcoholINACTIVE INGREDIENTND2M416302ESOMEPRAZOLE MAGNESIUM D/R (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [DIRECTRX]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30ESOMEPRAZOLE MAGNESIUM D/R (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [DIRECTRX]1
Methacrylic AcidINACTIVE INGREDIENT1CS02G8656ESOMEPRAZOLE MAGNESIUM D/R (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [DIRECTRX]1
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HESOMEPRAZOLE MAGNESIUM D/R (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [DIRECTRX]1
Potassium HydroxideINACTIVE INGREDIENTWZH3C48M4TESOMEPRAZOLE MAGNESIUM D/R (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [DIRECTRX]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3ESOMEPRAZOLE MAGNESIUM D/R (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [DIRECTRX]1
ShellacINACTIVE INGREDIENT46N107B71OESOMEPRAZOLE MAGNESIUM D/R (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [DIRECTRX]1
TalcINACTIVE INGREDIENT7SEV7J4R1UESOMEPRAZOLE MAGNESIUM D/R (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [DIRECTRX]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPESOMEPRAZOLE MAGNESIUM D/R (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [DIRECTRX]1
Triethyl CitrateINACTIVE INGREDIENT8Z96QXD6UMESOMEPRAZOLE MAGNESIUM D/R (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [DIRECTRX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-834ESOMEPRAZOLE MAGNESIUM D/R (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [DIRECTRX]1Legacy NDC, 1 package rows20151021_d3679d70-faa3-41e0-93a5-3f4cb7b6a1ad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSNd3679d70-faa3-41e0-93a5-3f4cb7b6a1ad1
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCDd3679d70-faa3-41e0-93a5-3f4cb7b6a1ad1
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSYd3679d70-faa3-41e0-93a5-3f4cb7b6a1ad1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-834-306191908343030 in 1 BOTTLEHistorical