OMEGA-3-ACID ETHYL ESTERS

Product NDC
69837-170
11-digit product format
698370170
Labeler code
69837
Product ID
69837-170_6fe820c3-0ed6-4fc9-a64e-35f6e0c85fce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OMEGA-3-ACID ETHYL ESTERS
Dosage form
CAPSULE
Route
ORAL
Labeler
International Brand Management Inc
Application
ANDA090973
Marketing category
ANDA
Marketing start
2016-04-09
Marketing end
0000-00-00
Substance
OMEGA-3-ACID ETHYL ESTERS
Active strength
1 g/g
Pharmacologic classes
Fatty Acids, Omega-3 [CS],Omega-3 Fatty Acid [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69837-170-02OMEGA-3-ACID ETHYL ESTERS1 g in 1 CAPSULECAPSULE15
69837-170-03OMEGA-3-ACID ETHYL ESTERS30 in 1 BOTTLECAPSULE305
69837-170-05OMEGA-3-ACID ETHYL ESTERS120 in 1 BOTTLECAPSULE1205
69837-170-30OMEGA-3-ACID ETHYL ESTERS30 in 1 BOTTLECAPSULE305
69837-170-31OMEGA-3-ACID ETHYL ESTERS1 g in 1 CAPSULECAPSULE15
69837-170-03Sure Result O3D3 System30 g in 1 BOTTLECAPSULE1 g1 g in 1g1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69837-170OMEGA-3-ACID ETHYL ESTERS CAPSULE [INTERNATIONAL BRAND MANAGEMENT INC]5Legacy NDC, 5 package rows20160506_ba854570-ad04-4960-b326-30a6beda89a8.zip
69837-170SURE RESULT O3D3 SYSTEM (OMEGA-3-ACID ETHYL ESTERS) KIT [INTERNATIONAL BRAND MANAGEMENT, LLC]1Legacy NDC20160418_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 CapsulePSNba854570-ad04-4960-b326-30a6beda89a85
577208omega-3 acid ethyl esters (USP) 1000 MG Oral CapsuleSCDba854570-ad04-4960-b326-30a6beda89a85
577208omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral CapsuleSYba854570-ad04-4960-b326-30a6beda89a85
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
69837-170-02698370170021 g in 1 CAPSULE1 gHistorical
69837-170-036983701700330 in 1 BOTTLEHistorical
69837-170-0569837017005120 in 1 BOTTLEHistorical
69837-170-306983701703030 in 1 BOTTLEHistorical
69837-170-31698370170311 g in 1 CAPSULE1 gHistorical