Omega-3-acid ethyl esters

Product NDC
70518-1636
11-digit product format
705181636
Labeler code
70518
Product ID
70518-1636_bc80acd5-f0cf-3bbf-e053-2995a90a6df2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omega-3-acid ethyl esters
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090973
Marketing category
ANDA
Marketing start
2018-11-06
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
2022-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1636-170518163601180 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (70518-1636-1) 2019-02-060000-00-00NoNoCurrent
70518-1636-37051816360330 POUCH in 1 BOX (70518-1636-3) > 1 CAPSULE, LIQUID FILLED in 1 POUCH (70518-1636-4) 30 pouch2021-03-010000-00-00NoNoCurrent