Omega-3-acid ethyl esters

Product NDC
50090-3421
11-digit product format
500903421
Labeler code
50090
Product ID
50090-3421_2d56d8a2-7616-4591-b4e8-6773b74b95c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omega-3-acid ethyl esters
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090973
Marketing category
ANDA
Marketing start
2014-09-30
Marketing end
0000-00-00
Substance
OMEGA-3-ACID ETHYL ESTERS
Active strength
1 g/1
Pharmacologic classes
Fatty Acids, Omega-3 [CS],Omega-3 Fatty Acid [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
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
50090-3421-1Omega-3-acid ethyl esters120 in 1 BOTTLECAPSULE, LIQUID FILLED1201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3421-1EA - Each50090-3421c0a5b0be-4575-4145-adf6-e263969de70b12021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3421OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [A-S MEDICATION SOLUTIONS]1Legacy NDC, 1 package rows20210303_6735c25d-0f09-4959-b8ee-3650ef1b3a52.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577208omega-3 acid ethyl esters 1 GM Oral CapsulePSN6735c25d-0f09-4959-b8ee-3650ef1b3a521
577208omega-3 acid ethyl esters (USP) 1000 MG Oral CapsuleSCD6735c25d-0f09-4959-b8ee-3650ef1b3a521
577208omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral CapsuleSY6735c25d-0f09-4959-b8ee-3650ef1b3a521

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3421-150090342101120 CAPSULE, LIQUID FILLED in 1 BOTTLE (50090-3421-1) 2019-10-020000-00-00NoNoCurrent