FDA.reportPublic FDA data

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210093-001OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2020-06-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A210093-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A210093-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2020-06-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A210093-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERSREMEDYREPACK INC.c6b35b2d-5a65-4fc4-8a2c-af7b3aea3eee2026-04-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210093
application number: ANDA210093
OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERSA-S Medication Solutions6fea8860-3c63-435f-a5b0-4281364ebd092026-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210093
application number: ANDA210093
OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERSA-S Medication Solutions4eef8b47-8185-4d93-9b2a-1200b953a6e32026-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210093
application number: ANDA210093
OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERSPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS52d4fc86-227a-4a74-9f42-50fd184714d82025-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210093
application number: ANDA210093
ndc (product): 24658-350
OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERSEPIC PHARMA, LLC787f9929-ef31-42a7-a305-8ba343e396722025-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210093
application number: ANDA210093
OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERSNCS HealthCare of KY, LLC dba Vangard Labsc293de7f-b4b6-461b-a0eb-470e5b84618d2024-10-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210093
application number: ANDA210093
OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERSBryant Ranch Prepackc8dc6c4a-ed19-4727-ba5a-35075f1ddddf2024-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210093
application number: ANDA210093

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
D87YGH4Z0QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
577208Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
52d4fc86-227a-4a74-9f42-50fd184714d8Available on FDA.report

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) 2023-08-22NoNoCurrent