omega-3-acid ethyl esters

Product NDC
50268-676
11-digit product format
502680676
Labeler code
50268
Product ID
50268-676_d5651e19-0067-fc36-e053-2995a90a7de6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
omega-3-acid ethyl esters
Dosage form
CAPSULE
Route
ORAL
Labeler
AvPAK
Application
ANDA203893
Marketing category
ANDA
Marketing start
2021-03-08
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-676-11EA - Each50268-67627b281a6-0921-410a-86be-5ea97356419f12021-04-08
50268-676-12EA - Each50268-6760219d35c-8339-444d-bc8d-376e1971977612021-04-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-676-125026806761220 BLISTER PACK in 1 BOX (50268-676-12) > 1 CAPSULE in 1 BLISTER PACK (50268-676-11) 20 blister pack2021-03-080000-00-00NoNoCurrent