Omega-3-acid ethyl esters

Product NDC
0904-6706
11-digit product format
009046706
Labeler code
0904
Product ID
0904-6706_df45a33c-6079-47f4-bed9-f0cfdc65ab86
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omega-3-acid ethyl esters
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Major Pharmaceuticals
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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6706OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS]4Legacy NDC20240619_11eb53a4-b473-4610-983f-14e7b4e38e39.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6706-060090467060650 BLISTER PACK in 1 CARTON (0904-6706-06) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK50 blister pack2014-09-300000-00-00NoNoCurrent