Omega-3-Acid Ethyl Ester

Product NDC
63629-2451
11-digit product format
636292451
Labeler code
63629
Product ID
63629-2451_e3edad33-cb4d-4ab1-9e3b-27812ba558b1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
omega-3-acid ethyl esters
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA206455
Marketing category
ANDA
Marketing start
2017-01-15
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
63629-2451-1EA - Each63629-2451d028aaa2-d15a-45d8-af23-2d5751be18fb12021-05-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-2451-163629245101120 CAPSULE, LIQUID FILLED in 1 BOTTLE (63629-2451-1) 2017-01-150000-00-00NoNoCurrent