Sure Result O3D3 System

Product NDC
69837-700
11-digit product format
698370700
Labeler code
69837
Product ID
69837-700_8dc0e6fb-fd78-4e95-adb1-91e64de5a3da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OMEGA-3-ACID ETHYL ESTERS
Dosage form
KIT
Labeler
International Brand Management, LLC
Application
ANDA090973
Marketing category
ANDA
Marketing start
2016-03-05
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ef9a935e-31b7-402c-a66c-716cdfe4f126Product name920241218
115c5bd2-98e1-4a98-8292-90803ca7e851Product name120220127

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69837-700-072020-01-31C16284748780-19d75b9d1-2715-f424-e053-dadaa90a57cefa9a1060-5d12-4d8e-9d39-5bf6fddc25b9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69837-170-03Sure Result O3D3 System30 g in 1 BOTTLECAPSULE1 g1 g in 1g1
69837-700-07Sure Result O3D3 System1 in 1 KITKIT11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69837-700-07EA - Each69837-700d5864b61-d1ca-4990-9ae6-6958287e4c1e12016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69837-700SURE RESULT O3D3 SYSTEM (OMEGA-3-ACID ETHYL ESTERS) KIT [INTERNATIONAL BRAND MANAGEMENT, LLC]1Legacy NDC, 2 package rows20160418_fa9a1060-5d12-4d8e-9d39-5bf6fddc25b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577208omega-3 acid ethyl esters 1 GM Oral CapsulePSNfa9a1060-5d12-4d8e-9d39-5bf6fddc25b91
245500vitamin D3 25 MCG (1000 UNT) Oral CapsulePSNfa9a1060-5d12-4d8e-9d39-5bf6fddc25b91
245500cholecalciferol 0.025 MG Oral CapsuleSCDfa9a1060-5d12-4d8e-9d39-5bf6fddc25b91
577208omega-3 acid ethyl esters (USP) 1000 MG Oral CapsuleSCDfa9a1060-5d12-4d8e-9d39-5bf6fddc25b91
577208omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral CapsuleSYfa9a1060-5d12-4d8e-9d39-5bf6fddc25b91
245500vitamin D3 1000 UNT Oral CapsuleSYfa9a1060-5d12-4d8e-9d39-5bf6fddc25b91
245500vitamin D3 25 MCG Oral CapsuleSYfa9a1060-5d12-4d8e-9d39-5bf6fddc25b91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
69837-170-036983701700330 g in 1 BOTTLE30 gHistorical
69837-700-07698370700071 in 1 KITHistorical