FDA.reportPublic FDA data

Esomeprazole strontium

Product NDC
53746-957
11-digit product format
537460957
Labeler code
53746
Product ID
53746-957_5252b611-d9ae-4d79-a11a-c17cbc053dec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole strontium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
NDA202342
Marketing category
NDA
Marketing start
2013-08-12
Marketing end
0000-00-00
Substance
ESOMEPRAZOLE STRONTIUM
Active strength
40 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
53746-957-032023-07-28C16284748780-1ba0f9c33-2b66-a910-e053-dadaa90a0b85These 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)
53746-957-032022-11-18C16284748780-1ba0f9c33-2b66-a910-e053-dadaa90a0b85These 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)
53746-957-032021-01-29C16284748780-1ba0f9c33-2b66-a910-e053-dadaa90a0b85These 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
53746-957-03Esomeprazole strontium30 in 1 BOTTLECAPSULE, DELAYED RELEASE309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53746-957-03EA - Each53746-95759bfd13a-2179-4f5d-b4b3-c9d017dca75412013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESOMEPRAZOLE STRONTIUMACTIVE INGREDIENTC5N25H3803ESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS, LLC]7
ESOMEPRAZOLEACTIVE MOIETYN3PA6559FTESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS, LLC]7
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS, LLC]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS, LLC]7
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS, LLC]7
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS, LLC]7
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS, LLC]7
GELATININACTIVE INGREDIENT2G86QN327LESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS, LLC]7
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4ESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS, LLC]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS, LLC]7
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656ESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS, LLC]7
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS, LLC]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS, LLC]7
SUCROSEINACTIVE INGREDIENTC151H8M554ESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS, LLC]7
TALCINACTIVE INGREDIENT7SEV7J4R1UESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS, LLC]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS, LLC]7
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS, LLC]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53746-957ESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]9Legacy NDC, 1 package rows20221119_e2e18e10-6f02-4ccc-842d-1962a3838b74.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1810789esomeprazole strontium 24.65 MG Delayed Release Oral CapsulePSNe2e18e10-6f02-4ccc-842d-1962a3838b749
1810787esomeprazole strontium 49.3 MG Delayed Release Oral CapsulePSNe2e18e10-6f02-4ccc-842d-1962a3838b749
1810789esomeprazole strontium 24.65 MG Delayed Release Oral CapsuleSCDe2e18e10-6f02-4ccc-842d-1962a3838b749
1810787esomeprazole strontium 49.3 MG Delayed Release Oral CapsuleSCDe2e18e10-6f02-4ccc-842d-1962a3838b749

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53746-957-035374609570330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (53746-957-03) 2013-08-120000-00-00NoNoCurrent