Omega-3-Acid Ethyl Esters

Product NDC
0093-5401
11-digit product format
000935401
Labeler code
0093
Product ID
0093-5401_2af84228-edce-4e1e-8b19-26fa1b35548f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omega-3-Acid Ethyl Esters
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA091028
Marketing category
ANDA
Marketing start
2014-04-07
Marketing end
2021-11-30
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
0093-5401-89EA - Each0093-5401b4cf0c2a-55c0-4c90-94b4-2d15ffb2cd0812014-05-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0093-5401-8900093540189120 CAPSULE, LIQUID FILLED in 1 BOTTLE (0093-5401-89) 2014-04-072021-11-30NoNoCurrent