OMEGA-3-ACID ETHYL ESTERS

Product NDC
24658-350
11-digit product format
246580350
Labeler code
24658
Product ID
24658-350_2b366b82-0c22-bba8-e063-6294a90a9a6a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OMEGA-3-ACID ETHYL ESTERS
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS
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
24658-350-12OMEGA-3-ACID ETHYL ESTERS120 in 1 BOTTLECAPSULE, LIQUID FILLED1202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24658-350-12EA - Each24658-350bcb79afd-3bdb-4593-87f8-afd0e845416812023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24658-350OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID FILLED [PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS]2Current NDC, 1 package rows20250110_52d4fc86-227a-4a74-9f42-50fd184714d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577208omega-3 acid ethyl esters 1 GM Oral CapsulePSN52d4fc86-227a-4a74-9f42-50fd184714d82
577208omega-3 acid ethyl esters (USP) 1000 MG Oral CapsuleSCD52d4fc86-227a-4a74-9f42-50fd184714d82
577208omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral CapsuleSY52d4fc86-227a-4a74-9f42-50fd184714d82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
24658-350-1224658035012120 CAPSULE, LIQUID FILLED in 1 BOTTLE (24658-350-12) 2023-08-22NoNoHistorical