FDA.reportPublic FDA data

Omega-3-acid ethyl esters

Product NDC
60505-3170
11-digit product format
605053170
Labeler code
60505
Product ID
60505-3170_b6e21953-3718-143a-4134-31b2d4f19e9c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omega-3-acid ethyl esters
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA090973
Marketing category
ANDA
Marketing start
2014-09-30
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
16a2c1cd-ae95-d910-f03d-7e06b11dd243Product name520260202
86fffa7b-d382-4771-a253-25cccb64b590Product name320251124
c599c4a0-705d-4ebb-ab1f-977af038f96aProduct name120251124
653485de-0601-41e4-82db-7a60bb223e27Product name120251024
95250459-30e4-45c1-b08a-993044f49109Product name220250805
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
ef9a935e-31b7-402c-a66c-716cdfe4f126Product name920241218
23fb3cda-2b50-f3d3-ebde-f542350bd77bProduct name420240828
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
081b54f0-4545-48b6-b854-03e1401f09eaProduct name120230112
115c5bd2-98e1-4a98-8292-90803ca7e851Product name120220127
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
e2dae634-14ed-febf-08ee-93196433b5b7Product name920190614
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
aead65a2-216e-4ff8-a178-44aab77c24edProduct name120180531
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
d394f843-7479-dc48-dbd3-232266c5548cProduct name120140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-3170-7Omega-3 Well Pack120 in 1 BOTTLECAPSULE, LIQUID FILLED11 g2
60505-3170-7Omega-3 Well Pack1 in 1 BOTTLECAPSULE, LIQUID FILLED11 g1
60505-3170-7Omega-3 Rx Complete1 in 1 BOTTLECAPSULE, LIQUID FILLED11 g1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-3170-7EA - Each60505-3170d2fb1b7a-3ac8-4d8e-9bb4-bfb8124fac7812015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OMEGA-3-ACID ETHYL ESTERSACTIVE INGREDIENTD87YGH4Z0QOMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [APOTEX CORP.]2
OMEGA-3 FATTY ACIDSACTIVE MOIETY71M78END5SOMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [APOTEX CORP.]2
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [APOTEX CORP.]2
AmmoniaINACTIVE INGREDIENT5138Q19F1XOMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [APOTEX CORP.]2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OOMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [APOTEX CORP.]2
GELATININACTIVE INGREDIENT2G86QN327LOMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [APOTEX CORP.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXOMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [APOTEX CORP.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [APOTEX CORP.]2
SHELLACINACTIVE INGREDIENT46N107B71OOMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [APOTEX CORP.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [APOTEX CORP.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [APOTEX CORP.]2
WATERINACTIVE INGREDIENT059QF0KO0ROMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [APOTEX CORP.]2
OMEGA-3-ACID ETHYL ESTERSACTIVE INGREDIENTD87YGH4Z0QOMEGA-3 WELL PACK KIT [TMIG, INC.]1
VITAMIN DACTIVE INGREDIENT9VU1KI44GPOMEGA-3 WELL PACK KIT [TMIG, INC.]1
OMEGA-3 FATTY ACIDSACTIVE MOIETY71M78END5SOMEGA-3 WELL PACK KIT [TMIG, INC.]1
VITAMIN DACTIVE MOIETY9VU1KI44GPOMEGA-3 WELL PACK KIT [TMIG, INC.]1
ALPHA-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1OMEGA-3 WELL PACK KIT [TMIG, INC.]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XOMEGA-3 WELL PACK KIT [TMIG, INC.]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OOMEGA-3 WELL PACK KIT [TMIG, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LOMEGA-3 WELL PACK KIT [TMIG, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXOMEGA-3 WELL PACK KIT [TMIG, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OMEGA-3 WELL PACK KIT [TMIG, INC.]1
SHELLACINACTIVE INGREDIENT46N107B71OOMEGA-3 WELL PACK KIT [TMIG, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OMEGA-3 WELL PACK KIT [TMIG, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOMEGA-3 WELL PACK KIT [TMIG, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0ROMEGA-3 WELL PACK KIT [TMIG, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-3170OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [APOTEX CORP.]15Legacy NDC20250523_1dd5cda1-6077-f8bc-69f3-e8685a49f39d.zip
60505-3170OMEGA-3 WELL PACK KIT [CLOVERLEAF PHARMA LLC]2Legacy NDC20200122_9caa9c29-b439-4a5c-e053-2a95a90af7fd.zip
60505-3170OMEGA-3 RX COMPLETE KIT [TMIG, INC.]1Legacy NDC20190121_ff4a8e34-360b-4a9d-b8d2-d3cf447b6338.zip
60505-3170OMEGA-3 WELL PACK KIT [TMIG, INC.]1Legacy NDC20150902_1eb20ef6-7a56-5b3e-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577208omega-3 acid ethyl esters 1 GM Oral CapsulePSNe57f57fe-1af6-468a-9e72-d3144d63aecf100
577208omega-3 acid ethyl esters (USP) 1000 MG Oral CapsuleSCDe57f57fe-1af6-468a-9e72-d3144d63aecf100
577208omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral CapsuleSYe57f57fe-1af6-468a-9e72-d3144d63aecf100
577208omega-3 acid ethyl esters 1 GM Oral CapsulePSN2bfadd2a-79e8-4fda-ae2c-134106c0feba6
577208omega-3 acid ethyl esters (USP) 1000 MG Oral CapsuleSCD2bfadd2a-79e8-4fda-ae2c-134106c0feba6
577208omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral CapsuleSY2bfadd2a-79e8-4fda-ae2c-134106c0feba6
577208omega-3 acid ethyl esters 1 GM Oral CapsulePSN9caa9c29-b439-4a5c-e053-2a95a90af7fd2
577208omega-3 acid ethyl esters (USP) 1000 MG Oral CapsuleSCD9caa9c29-b439-4a5c-e053-2a95a90af7fd2
577208omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral CapsuleSY9caa9c29-b439-4a5c-e053-2a95a90af7fd2
577208omega-3 acid ethyl esters 1 GM Oral CapsulePSN1eb20ef6-7a56-5b3e-e054-00144ff88e881
577208omega-3 acid ethyl esters 1 GM Oral CapsulePSNff4a8e34-360b-4a9d-b8d2-d3cf447b63381
577208omega-3 acid ethyl esters 1 GM Oral CapsulePSN6735c25d-0f09-4959-b8ee-3650ef1b3a521
577208omega-3 acid ethyl esters 1 GM Oral CapsulePSN8f274c0a-3072-8233-e053-2a95a90aa0bc1
577208omega-3 acid ethyl esters 1 GM Oral CapsulePSN8f2795af-acfb-24e5-e053-2995a90a58d11
577208omega-3 acid ethyl esters 1 GM Oral CapsulePSN8f2833dc-a3fe-ca8e-e053-2995a90ad88e1
577208omega-3 acid ethyl esters (USP) 1000 MG Oral CapsuleSCDff4a8e34-360b-4a9d-b8d2-d3cf447b63381
577208omega-3 acid ethyl esters (USP) 1000 MG Oral CapsuleSCD8f2833dc-a3fe-ca8e-e053-2995a90ad88e1
577208omega-3 acid ethyl esters (USP) 1000 MG Oral CapsuleSCD8f2795af-acfb-24e5-e053-2995a90a58d11
577208omega-3 acid ethyl esters (USP) 1000 MG Oral CapsuleSCD8f274c0a-3072-8233-e053-2a95a90aa0bc1
577208omega-3 acid ethyl esters (USP) 1000 MG Oral CapsuleSCD6735c25d-0f09-4959-b8ee-3650ef1b3a521
577208omega-3 acid ethyl esters (USP) 1000 MG Oral CapsuleSCD1eb20ef6-7a56-5b3e-e054-00144ff88e881
577208omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral CapsuleSY8f2833dc-a3fe-ca8e-e053-2995a90ad88e1
577208omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral CapsuleSY8f2795af-acfb-24e5-e053-2995a90a58d11
577208omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral CapsuleSY8f274c0a-3072-8233-e053-2a95a90aa0bc1
577208omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral CapsuleSY6735c25d-0f09-4959-b8ee-3650ef1b3a521
577208omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral CapsuleSYff4a8e34-360b-4a9d-b8d2-d3cf447b63381
577208omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral CapsuleSY1eb20ef6-7a56-5b3e-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-3170-36050531700330 CAPSULE, LIQUID FILLED in 1 BOTTLE (60505-3170-3) 2014-09-300000-00-00NoNoCurrent
60505-3170-66050531700660 CAPSULE, LIQUID FILLED in 1 BOTTLE (60505-3170-6) 2014-09-300000-00-00NoNoCurrent
60505-3170-760505317007120 CAPSULE, LIQUID FILLED in 1 BOTTLE (60505-3170-7) 2014-09-300000-00-00NoNoCurrent