FDA.reportPublic FDA data

OMEGA-3-ACID ETHYL ESTERS

Product NDC
42806-552
11-digit product format
428060552
Labeler code
42806
Product ID
42806-552_2b206d7a-b677-757e-e063-6294a90a9c0d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OMEGA-3-ACID ETHYL ESTERS
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
EPIC PHARMA, LLC
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
OMEGA-3-ACID ETHYL ESTERS
Listing expiration
2026-12-31

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
42806-552-12OMEGA-3-ACID ETHYL ESTERS120 in 1 BOTTLECAPSULE, LIQUID FILLED1203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-552-12EA - Each42806-5527435e0bd-fd26-4759-bfb4-829f058b995d12020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-552OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID FILLED [EPIC PHARMA, LLC]3Current NDC, Legacy NDC, 1 package rows20250109_787f9929-ef31-42a7-a305-8ba343e39672.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577208omega-3 acid ethyl esters 1 GM Oral CapsulePSNc8dc6c4a-ed19-4727-ba5a-35075f1ddddf103
577208omega-3 acid ethyl esters (USP) 1000 MG Oral CapsuleSCDc8dc6c4a-ed19-4727-ba5a-35075f1ddddf103
577208omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral CapsuleSYc8dc6c4a-ed19-4727-ba5a-35075f1ddddf103
577208omega-3 acid ethyl esters 1 GM Oral CapsulePSNc6b35b2d-5a65-4fc4-8a2c-af7b3aea3eee9
577208omega-3 acid ethyl esters (USP) 1000 MG Oral CapsuleSCDc6b35b2d-5a65-4fc4-8a2c-af7b3aea3eee9
577208omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral CapsuleSYc6b35b2d-5a65-4fc4-8a2c-af7b3aea3eee9
577208omega-3 acid ethyl esters 1 GM Oral CapsulePSN4eef8b47-8185-4d93-9b2a-1200b953a6e33
577208omega-3 acid ethyl esters 1 GM Oral CapsulePSN787f9929-ef31-42a7-a305-8ba343e396723
577208omega-3 acid ethyl esters 1 GM Oral CapsulePSN6fea8860-3c63-435f-a5b0-4281364ebd093
577208omega-3 acid ethyl esters (USP) 1000 MG Oral CapsuleSCD787f9929-ef31-42a7-a305-8ba343e396723
577208omega-3 acid ethyl esters (USP) 1000 MG Oral CapsuleSCD6fea8860-3c63-435f-a5b0-4281364ebd093
577208omega-3 acid ethyl esters (USP) 1000 MG Oral CapsuleSCD4eef8b47-8185-4d93-9b2a-1200b953a6e33
577208omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral CapsuleSY787f9929-ef31-42a7-a305-8ba343e396723
577208omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral CapsuleSY6fea8860-3c63-435f-a5b0-4281364ebd093
577208omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral CapsuleSY4eef8b47-8185-4d93-9b2a-1200b953a6e33
577208omega-3 acid ethyl esters 1 GM Oral CapsulePSNc293de7f-b4b6-461b-a0eb-470e5b84618d1
577208omega-3 acid ethyl esters (USP) 1000 MG Oral CapsuleSCDc293de7f-b4b6-461b-a0eb-470e5b84618d1
577208omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral CapsuleSYc293de7f-b4b6-461b-a0eb-470e5b84618d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42806-552-1242806055212120 CAPSULE, LIQUID FILLED in 1 BOTTLE (42806-552-12) 2020-07-020000-00-00NoNoCurrent