Omega-3-acid ethyl esters

Product NDC
50090-6822
11-digit product format
500906822
Labeler code
50090
Product ID
50090-6822_ec2d058f-65d9-4c46-83ed-ceebca1d6360
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6822-0Omega-3-acid ethyl esters120 in 1 BOTTLECAPSULE, LIQUID FILLED1201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6822-0EA - Each50090-6822768546a6-ee69-4f8c-8be8-5544ceae6e7e12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6822OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [A-S MEDICATION SOLUTIONS]1Current NDC, 1 package rows20240123_b11807f8-4301-4f91-8a7a-53226f945c49.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577208omega-3 acid ethyl esters 1 GM Oral CapsulePSNb11807f8-4301-4f91-8a7a-53226f945c491
577208omega-3 acid ethyl esters (USP) 1000 MG Oral CapsuleSCDb11807f8-4301-4f91-8a7a-53226f945c491
577208omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral CapsuleSYb11807f8-4301-4f91-8a7a-53226f945c491

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6822-050090682200120 CAPSULE, LIQUID FILLED in 1 BOTTLE (50090-6822-0) 2024-01-04NoNoCurrent