Omega-3-Acid Ethyl Esters

Product NDC
50090-3956
11-digit product format
500903956
Labeler code
50090
Product ID
50090-3956_7852b44c-7fb0-431a-9a35-2a9ca6341187
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
omega-3-acid ethyl esters
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA091018
Marketing category
ANDA
Marketing start
2014-06-30
Marketing end
0000-00-00
Substance
OMEGA-3-ACID ETHYL ESTERS
Active strength
900 mg/1
Pharmacologic classes
Fatty Acids, Omega-3 [CS],Omega-3 Fatty Acid [EPC]
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
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
50090-3956-0Omega-3-Acid Ethyl Esters120 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3956OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID FILLED [A-S MEDICATION SOLUTIONS]3Legacy NDC, 1 package rows20200122_c20f373a-8938-4430-ac6f-e3cd1269fc8d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577208omega-3 acid ethyl esters 1 GM Oral CapsulePSNc20f373a-8938-4430-ac6f-e3cd1269fc8d3
577208omega-3 acid ethyl esters (USP) 1000 MG Oral CapsuleSCDc20f373a-8938-4430-ac6f-e3cd1269fc8d3
577208omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral CapsuleSYc20f373a-8938-4430-ac6f-e3cd1269fc8d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3956-050090395600120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (50090-3956-0) 2018-12-110000-00-00NoNoCurrent