FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
55111-493
11-digit product format
551110493
Labeler code
55111
Product ID
55111-493_be04a674-2f3c-368a-c3cf-0fb65f736cbc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Dr. Reddy's Laboratories Limited
Application
ANDA078279
Marketing category
ANDA
Marketing start
2015-09-25
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
No
Listing certified through
2019-12-31
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-493-30EA - Each55111-493aa60d775-7164-41db-86f1-9fef7b4c632412015-10-02

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 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