FDA.reportPublic FDA data

Omega-3-acid ethyl esters

Product NDC
50090-5799
11-digit product format
500905799
Labeler code
50090
Product ID
50090-5799_5bb41a86-8975-42d4-a657-94bf7910916b
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

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
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5799-02023-02-07C16284748780-1f386c649-a0d0-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use OMEGA-3-ACID ETHYL ESTERS CAPSULES safely and effectively. See full prescribing information for OMEGA-3-ACID ETHYL ESTERS CAPSULES. OMEGA-3-ACID ETHYL ESTERS Capsules, for oral use Initial U.S. Approval: 2004
50090-5799-02023-01-30C16284748780-1f386c649-a0d0-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use OMEGA-3-ACID ETHYL ESTERS CAPSULES safely and effectively. See full prescribing information for OMEGA-3-ACID ETHYL ESTERS CAPSULES. OMEGA-3-ACID ETHYL ESTERS Capsules, for oral use Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5799-0Omega-3-acid ethyl esters120 in 1 BOTTLECAPSULE, LIQUID FILLED1206

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5799-0EA - Each50090-5799afb72313-2a66-4653-9845-342bcb7d8c5512023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5799OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [A-S MEDICATION SOLUTIONS]6Current NDC, Legacy NDC, 1 package rows20230524_990a3e8a-8642-43d7-ace3-0dd7c48ff3e9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577208omega-3 acid ethyl esters 1 GM Oral CapsulePSN990a3e8a-8642-43d7-ace3-0dd7c48ff3e96
577208omega-3 acid ethyl esters (USP) 1000 MG Oral CapsuleSCD990a3e8a-8642-43d7-ace3-0dd7c48ff3e96
577208omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral CapsuleSY990a3e8a-8642-43d7-ace3-0dd7c48ff3e96

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5799-050090579900120 CAPSULE, LIQUID FILLED in 1 BOTTLE (50090-5799-0) 2021-10-140000-00-00NoNoCurrent