Omega-3-acid ethyl esters

Product NDC
50090-5800
11-digit product format
500905800
Labeler code
50090
Product ID
50090-5800_77a00a66-49f3-48d7-9c1b-beb40127ee15
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omega-3-acid ethyl esters
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA207420
Marketing category
ANDA
Marketing start
2019-02-25
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
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
D87YGH4Z0QOMEGA-3-ACID ETHYL ESTERS308081-97-2OMEGA-3-ACID ETHYL ESTERS

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-5800-2500905800021440 CAPSULE, LIQUID FILLED in 1 BOTTLE (50090-5800-2) 2022-01-25NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Omega-3-acid ethyl estersA-S Medication Solutions2024-02-18HUMAN PRESCRIPTION DRUG LABEL2