FDA.reportPublic FDA data

Esomeprazole strontium

Product NDC
69336-129
11-digit product format
693360129
Labeler code
69336
Product ID
69336-129_efe4b937-3708-4288-a6ae-8cb189ab0055
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole strontium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Sterling-Knight Pharmaceuticals, LLC
Application
NDA202342
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2020-06-25
Marketing end
0000-00-00
Substance
ESOMEPRAZOLE STRONTIUM
Active strength
49 mg/1
Pharmacologic classes
Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
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
69336-129-302022-01-28C16284748780-1d6a99b39-7626-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use ESOMEPRAZOLE STRONTIUM safely and effectively. See full prescribing information for ESOMEPRAZOLE STRONTIUM.ESOMEPRAZOLE STRONTIUM delayed-release capsules, for oral use Initial U.S. Approval: 1989 (omeprazole)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69336-129-30Esomeprazole strontium30 in 1 BOTTLECAPSULE, DELAYED RELEASE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69336-129-30EA - Each69336-1292ae77368-37a8-4665-b36e-ae8028f01f7312020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69336-129ESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [STERLING-KNIGHT PHARMACEUTICALS, LLC]1Legacy NDC, 1 package rows20200627_7e30823f-c435-4abf-8f2f-5e6d6fa4ab86.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1810787esomeprazole strontium 49.3 MG Delayed Release Oral CapsulePSN7e30823f-c435-4abf-8f2f-5e6d6fa4ab861
1810787esomeprazole strontium 49.3 MG Delayed Release Oral CapsuleSCD7e30823f-c435-4abf-8f2f-5e6d6fa4ab861

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69336-129-306933601293030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69336-129-30) 2020-06-250000-00-00NoNoCurrent