OMEGA-3-ACID ETHYL ESTERS

Product NDC
72189-024
11-digit product format
721890024
Labeler code
72189
Product ID
72189-024_8f274c0a-3073-8233-e053-2a95a90aa0bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OMEGA-3-ACID ETHYL ESTERS
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Direct_Rx
Application
ANDA090973
Marketing category
ANDA
Marketing start
2019-08-02
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ef9a935e-31b7-402c-a66c-716cdfe4f126Product name920241218
115c5bd2-98e1-4a98-8292-90803ca7e851Product name120220127

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72189-024-302023-01-30C16284748780-1f386c649-d420-0266-e053-dadaa90a7c1aOMEGA-3-ACID ETHYL ESTERS
72189-024-602023-01-30C16284748780-1f386c649-cc32-0266-e053-dadaa90a7c1aOMEGA-3-ACID ETHYL ESTERS
72189-024-902023-01-30C16284748780-1f386c64a-001c-0266-e053-dadaa90a7c1aOMEGA-3-ACID ETHYL ESTERS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-024-30OMEGA-3-ACID ETHYL ESTERS30 in 1 BOTTLECAPSULE, LIQUID FILLED301
72189-024-60OMEGA-3-ACID ETHYL ESTERS60 in 1 BOTTLECAPSULE, LIQUID FILLED601
72189-024-90OMEGA-3-ACID ETHYL ESTERS90 in 1 BOTTLECAPSULE, LIQUID FILLED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-024-30EA - Each72189-024cd46a0d0-5793-4f62-b0b5-5943ca40713212019-09-05
72189-024-60EA - Each72189-024c28d8986-f3b0-4c19-9817-52c0229d70be12019-09-05
72189-024-90EA - Each72189-0241744c0bc-7c0e-4816-80c7-8d7e6afee85012019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-024OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID FILLED [DIRECT_RX]1Legacy NDC, 1 package rows20190803_8f2833dc-a3fe-ca8e-e053-2995a90ad88e.zip
72189-024OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID FILLED [DIRECT_RX]1Legacy NDC, 1 package rows20190803_8f274c0a-3072-8233-e053-2a95a90aa0bc.zip
72189-024OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID FILLED [DIRECT_RX]1Legacy NDC, 1 package rows20190803_8f2795af-acfb-24e5-e053-2995a90a58d1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 CapsuleSCD8f274c0a-3072-8233-e053-2a95a90aa0bc1
577208omega-3 acid ethyl esters (USP) 1000 MG Oral CapsuleSCD8f2795af-acfb-24e5-e053-2995a90a58d11
577208omega-3 acid ethyl esters (USP) 1000 MG Oral CapsuleSCD8f2833dc-a3fe-ca8e-e053-2995a90ad88e1
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 CapsuleSY8f2795af-acfb-24e5-e053-2995a90a58d11
577208omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral CapsuleSY8f2833dc-a3fe-ca8e-e053-2995a90ad88e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-024-307218900243030 CAPSULE, LIQUID FILLED in 1 BOTTLE (72189-024-30) 2019-08-020000-00-00NoNoCurrent
72189-024-607218900246060 CAPSULE, LIQUID FILLED in 1 BOTTLE (72189-024-60) 2019-08-020000-00-00NoNoCurrent
72189-024-907218900249090 CAPSULE, LIQUID FILLED in 1 BOTTLE (72189-024-90) 2019-08-020000-00-00NoNoCurrent