OMEGA-3-ACID ETHYL ESTERS

Product NDC
71335-2024
11-digit product format
713352024
Labeler code
71335
Product ID
71335-2024_05917de9-e724-43c9-9cd6-2ba4753592ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OMEGA-3-ACID ETHYL ESTERS
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Bryant Ranch Prepack
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
71335-2024-1OMEGA-3-ACID ETHYL ESTERS90 in 1 BOTTLECAPSULE, LIQUID FILLED90103
71335-2024-2OMEGA-3-ACID ETHYL ESTERS28 in 1 BOTTLECAPSULE, LIQUID FILLED28103
71335-2024-3OMEGA-3-ACID ETHYL ESTERS60 in 1 BOTTLECAPSULE, LIQUID FILLED60103
71335-2024-4OMEGA-3-ACID ETHYL ESTERS120 in 1 BOTTLECAPSULE, LIQUID FILLED120103
71335-2024-5OMEGA-3-ACID ETHYL ESTERS100 in 1 BOTTLECAPSULE, LIQUID FILLED100103
71335-2024-6OMEGA-3-ACID ETHYL ESTERS30 in 1 BOTTLECAPSULE, LIQUID FILLED30103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2024OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID FILLED [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 6 package rows20240809_c8dc6c4a-ed19-4727-ba5a-35075f1ddddf.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-2024-17133520240190 CAPSULE, LIQUID FILLED in 1 BOTTLE (71335-2024-1) 2022-01-100000-00-00NoNoCurrent
71335-2024-27133520240228 CAPSULE, LIQUID FILLED in 1 BOTTLE (71335-2024-2) 2022-01-100000-00-00NoNoCurrent
71335-2024-37133520240360 CAPSULE, LIQUID FILLED in 1 BOTTLE (71335-2024-3) 2022-01-100000-00-00NoNoCurrent
71335-2024-471335202404120 CAPSULE, LIQUID FILLED in 1 BOTTLE (71335-2024-4) 2022-01-100000-00-00NoNoCurrent
71335-2024-571335202405100 CAPSULE, LIQUID FILLED in 1 BOTTLE (71335-2024-5) 2022-01-100000-00-00NoNoCurrent
71335-2024-67133520240630 CAPSULE, LIQUID FILLED in 1 BOTTLE (71335-2024-6) 2022-01-100000-00-00NoNoCurrent