FDA.reportPublic FDA data

Esomeprazole Sodium

Product NDC
68083-452
11-digit product format
680830452
Labeler code
68083
Product ID
68083-452_e8d62781-b9de-4d02-b5d2-02b024895c95
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole Sodium
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Gland Pharma Limited
Application
ANDA203349
Marketing category
ANDA
Marketing start
2020-04-01
Substance
ESOMEPRAZOLE SODIUM
Active strength
40 mg/5mL
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 Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESOMEPRAZOLE SODIUM40 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL2C9GWQ43H
Rxcui486499, 486501

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
68083-452-01Esomeprazole Sodium5 mL in 1 VIALINJECTION57
68083-452-10Esomeprazole Sodium10 in 1 CARTONINJECTION107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-452ESOMEPRAZOLE SODIUM INJECTION [GLAND PHARMA LIMITED]7Current NDC, Legacy NDC, 2 package rows20230801_9354958c-e997-41c8-8605-23f0a58993c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
486499esomeprazole 20 MG InjectionPSN9354958c-e997-41c8-8605-23f0a58993c07
486501esomeprazole 40 MG InjectionPSN9354958c-e997-41c8-8605-23f0a58993c07
486499esomeprazole 20 MG InjectionSCD9354958c-e997-41c8-8605-23f0a58993c07
486501esomeprazole 40 MG InjectionSCD9354958c-e997-41c8-8605-23f0a58993c07
486499esomeprazole 20 MG (as esomeprazole sodium 21.3 MG) InjectionSY9354958c-e997-41c8-8605-23f0a58993c07
486501esomeprazole 40 MG (as esomeprazole sodium 42.5 MG) InjectionSY9354958c-e997-41c8-8605-23f0a58993c07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68083-452-01680830452015 mL in 1 VIAL5 mlHistorical
68083-452-106808304521010 VIAL in 1 CARTON (68083-452-10) / 5 mL in 1 VIAL (68083-452-01) 10 vial2020-04-010000-00-00NoNoCurrent