OMEGA-3-ACID ETHYL ESTERS

Product NDC
50090-6691
11-digit product format
500906691
Labeler code
50090
Product ID
50090-6691_4668b3c6-f2a0-42b6-a956-221d58e7b31d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OMEGA-3-ACID ETHYL ESTERS
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA210093
Marketing category
ANDA
Marketing start
2020-07-02
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
OMEGA-3-ACID ETHYL ESTERS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEGA-3-ACID ETHYL ESTERS1 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD87YGH4Z0Q
Rxcui577208

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6691-0OMEGA-3-ACID ETHYL ESTERS120 in 1 BOTTLECAPSULE, LIQUID FILLED1203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6691OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID FILLED [A-S MEDICATION SOLUTIONS]1Current NDC, 1 package rows20241020_6fea8860-3c63-435f-a5b0-4281364ebd09.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577208omega-3 acid ethyl esters 1 GM Oral CapsulePSN6fea8860-3c63-435f-a5b0-4281364ebd093
577208omega-3 acid ethyl esters (USP) 1000 MG Oral CapsuleSCD6fea8860-3c63-435f-a5b0-4281364ebd093
577208omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral CapsuleSY6fea8860-3c63-435f-a5b0-4281364ebd093

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6691-050090669100120 CAPSULE, LIQUID FILLED in 1 BOTTLE (50090-6691-0) 2023-09-18NoNoCurrent