FDA.reportPublic FDA data

Esomeprazole strontium

Product NDC
65162-955
11-digit product format
651620955
Labeler code
65162
Product ID
65162-955_cbbffeaf-54d6-4ec4-a7e9-fc6315cd527d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole strontium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
NDA202342
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2013-08-12
Marketing end
0000-00-00
Substance
ESOMEPRAZOLE STRONTIUM
Active strength
20 mg/1
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
65162-955-032023-07-28C16284748780-10191ceaa-620b-198a-e063-dbdaa90aec3eThese 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
65162-955-03Esomeprazole strontium30 in 1 BOTTLECAPSULE, DELAYED RELEASE3017

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESOMEPRAZOLE STRONTIUMACTIVE INGREDIENTC5N25H3803ESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]12
ESOMEPRAZOLEACTIVE MOIETYN3PA6559FTESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]12
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]12
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]12
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]12
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]12
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]12
GELATININACTIVE INGREDIENT2G86QN327LESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]12
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4ESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]12
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]12
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656ESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]12
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]12
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]12
SUCROSEINACTIVE INGREDIENTC151H8M554ESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]12
TALCINACTIVE INGREDIENT7SEV7J4R1UESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]12
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]12
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-955ESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS LLC]17Legacy NDC, 1 package rows20221226_61a5a84e-0194-4f11-91f8-83d7ac404932.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1810789esomeprazole strontium 24.65 MG Delayed Release Oral CapsulePSN61a5a84e-0194-4f11-91f8-83d7ac40493217
1810787esomeprazole strontium 49.3 MG Delayed Release Oral CapsulePSN61a5a84e-0194-4f11-91f8-83d7ac40493217
1810789esomeprazole strontium 24.65 MG Delayed Release Oral CapsuleSCD61a5a84e-0194-4f11-91f8-83d7ac40493217
1810787esomeprazole strontium 49.3 MG Delayed Release Oral CapsuleSCD61a5a84e-0194-4f11-91f8-83d7ac40493217

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65162-955-036516209550330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65162-955-03) 2013-08-120000-00-00NoNoCurrent