Omega-3-Acid Ethyl Esters

Product NDC
62559-410
11-digit product format
625590410
Labeler code
62559
Product ID
62559-410_e1966d70-7378-43bb-915d-fd9b44389846
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omega-3-Acid Ethyl Esters
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA211355
Marketing category
ANDA
Marketing start
2020-02-19
Marketing end
2022-11-30
Substance
OMEGA-3-ACID ETHYL ESTERS
Active strength
900 mg/1
Pharmacologic classes
Fatty Acids, Omega-3 [CS],Omega-3 Fatty Acid [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-410-12EA - Each62559-410001fdf1d-7a30-4052-be18-501badefcbe112020-05-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62559-410-12625590410121 BOTTLE in 1 CARTON (62559-410-12) > 120 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2020-02-190000-00-00NoNoCurrent