Omega-3-Acid Ethyl Esters

Product NDC
72998-851
11-digit product format
729980851
Labeler code
72998
Product ID
72998-851_1ef0517f-68e3-4a99-97ff-b367aad55ff3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omega-3-Acid Ethyl Esters
Dosage form
CAPSULE
Route
ORAL
Labeler
KD Pharma USA, Inc.
Application
ANDA091028
Marketing category
ANDA
Marketing start
2024-02-01
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
72998-851-12Omega-3-Acid Ethyl Esters120 in 1 BOTTLE, PLASTICCAPSULE1202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72998-851OMEGA-3-ACID ETHYL ESTERS CAPSULE [KD PHARMA USA, INC.]2Current NDC, 1 package rows20250213_d1fd2a28-befb-4a09-b516-0c01bc4c8c6c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577208omega-3 acid ethyl esters 1 GM Oral CapsulePSN11d744aa-cc06-1206-e063-6294a90a49c93
577208omega-3 acid ethyl esters (USP) 1000 MG Oral CapsuleSCD11d744aa-cc06-1206-e063-6294a90a49c93
577208omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral CapsuleSY11d744aa-cc06-1206-e063-6294a90a49c93
577208omega-3 acid ethyl esters 1 GM Oral CapsulePSNd1fd2a28-befb-4a09-b516-0c01bc4c8c6c2
577208omega-3 acid ethyl esters (USP) 1000 MG Oral CapsuleSCDd1fd2a28-befb-4a09-b516-0c01bc4c8c6c2
577208omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral CapsuleSYd1fd2a28-befb-4a09-b516-0c01bc4c8c6c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72998-851-1272998085112120 CAPSULE in 1 BOTTLE, PLASTIC (72998-851-12) 120 capsule2024-02-01NoNoCurrent