FDA.reportPublic FDA data

Esomeprazole sodium

Product NDC
14335-060
11-digit product format
143350060
Labeler code
14335
Product ID
14335-060_d8054c01-c776-3c25-e053-2a95a90a0998
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole sodium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Hainan Poly Pharm. Co., Ltd.
Application
ANDA215732
Marketing category
ANDA
Marketing start
2021-01-31
Marketing end
0000-00-00
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
2023-12-31
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
14335-060-012026-01-29C16284748780-149896155-ac18-586f-e063-e6dba90add90These highlights do not include all the information needed to use ESOMEPRAZOLE SODIUM FOR INJECTION safely and effectively. See full prescribing information for ESOMEPRAZOLE SODIUM FOR INJECTION ESOMEPRAZOLE SODIUM for Injection, for intravenous use Initial U.S. Approval: 2005

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14335-060-01Esomeprazole sodium10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,101
14335-060-01Esomeprazole sodium5 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14335-060ESOMEPRAZOLE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HAINAN POLY PHARM. CO., LTD.]1Legacy NDC, 2 package rows20220215_d6635546-be95-4df0-b311-c6d74a4258e7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
486501esomeprazole 40 MG InjectionPSNd6635546-be95-4df0-b311-c6d74a4258e71
486501esomeprazole 40 MG InjectionSCDd6635546-be95-4df0-b311-c6d74a4258e71
486501esomeprazole 40 MG (as esomeprazole sodium 42.5 MG) InjectionSYd6635546-be95-4df0-b311-c6d74a4258e71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
14335-060-011433500600110 VIAL in 1 CARTON (14335-060-01) > 5 mL in 1 VIAL10 vial2021-01-310000-00-00NoNoCurrent