Omega-3-acid ethyl esters
These highlights do not include all the information needed to use OMEGA-3-ACID ethyl esters capsules, USP safely and effectively. See full prescribing information for OMEGA-3-ACID ethyl esters capsules, USP. OMEGA-3-ACID ethyl esters capsules, USP for oral use. Initial U.S. Approval: 2004
Approved
Approval ID
b53f1c14-43da-4e05-8c80-a0a455dd41cf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 25, 2017
Manufacturers
FDA
Par Pharmaceutical Inc.
DUNS: 092733690
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Omega-3-acid ethyl esters
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0254-3010
Application NumberANDA203893
Product Classification
M
Marketing Category
C73584
G
Generic Name
Omega-3-acid ethyl esters
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 25, 2017
FDA Product Classification
INGREDIENTS (9)
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
OMEGA-3-ACID ETHYL ESTERSActive
Quantity: 900 mg in 1 1
Code: D87YGH4Z0Q
Classification: ACTIB
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT