OMEGA-3-ACID ETHYL ESTERS

Product NDC
70518-3040
11-digit product format
705183040
Labeler code
70518
Product ID
70518-3040_50747135-e049-04ff-e063-6394a90a1258
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OMEGA-3-ACID ETHYL ESTERS
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA210093
Marketing category
ANDA
Marketing start
2021-03-04
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
70518-3040-0OMEGA-3-ACID ETHYL ESTERS180 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1809
70518-3040-1OMEGA-3-ACID ETHYL ESTERS50 in 1 BOXCAPSULE, LIQUID FILLED509
70518-3040-2OMEGA-3-ACID ETHYL ESTERS1 in 1 POUCHCAPSULE, LIQUID FILLED19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3040OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID FILLED [REMEDYREPACK INC.]5Current NDC, Legacy NDC, 3 package rows20250417_c6b35b2d-5a65-4fc4-8a2c-af7b3aea3eee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3040-070518304000180 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (70518-3040-0) 2021-03-040000-00-00NoNoCurrent
70518-3040-17051830400150 POUCH in 1 BOX (70518-3040-1) / 1 CAPSULE, LIQUID FILLED in 1 POUCH (70518-3040-2) 50 pouch2026-04-25NoNoCurrent
70518-3040-2705183040021 in 1 POUCHHistorical