omega-3-acid ethyl esters (0615-8550)

Drug Facts

Product Profile

Brand Name omega-3-acid ethyl esters

Generic Name omega-3-acid ethyl esters

Labeler ncs healthcare of ky, llc dba vangard labs

Dosage Form CAPSULE, LIQUID FILLED

Routes

ORAL

Active Ingredients

omega-3-acid ethyl esters 1 g/1

Manufacturer

NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-8550

Product ID 0615-8550_57a3c56b-8da3-4ec0-a45c-cd15f8173f43

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA210093

Listing Expiration 2026-12-31

Marketing Start 2020-07-02

Pharmacologic Class

Classes

fatty acids omega-3 [cs] omega-3 fatty acid [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06158550

Hyphenated Format 0615-8550

Supplemental Identifiers

RxCUI

577208

UNII

D87YGH4Z0Q

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name omega-3-acid ethyl esters (source: ndc)

Generic Name omega-3-acid ethyl esters (source: ndc)

Application Number ANDA210093 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

1 g/1

source: ndc

Packaging

30 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0615-8550-39)

source: ndc

Packages (1)

0615-8550-39 30 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0615-8550-39)

Ingredients (1)

omega-3-acid ethyl esters (1 g/1)

Linked Drug Pages (1)

OMEGA-3-ACID ETHYL ESTERS ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "57a3c56b-8da3-4ec0-a45c-cd15f8173f43", "openfda": {"unii": ["D87YGH4Z0Q"], "rxcui": ["577208"], "spl_set_id": ["c293de7f-b4b6-461b-a0eb-470e5b84618d"], "manufacturer_name": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0615-8550-39)", "package_ndc": "0615-8550-39", "marketing_start_date": "20241015"}], "brand_name": "OMEGA-3-ACID ETHYL ESTERS", "product_id": "0615-8550_57a3c56b-8da3-4ec0-a45c-cd15f8173f43", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Fatty Acids", "Omega-3 [CS]", "Omega-3 Fatty Acid [EPC]"], "product_ndc": "0615-8550", "generic_name": "OMEGA-3-ACID ETHYL ESTERS", "labeler_name": "NCS HealthCare of KY, LLC dba Vangard Labs", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OMEGA-3-ACID ETHYL ESTERS", "active_ingredients": [{"name": "OMEGA-3-ACID ETHYL ESTERS", "strength": "1 g/1"}], "application_number": "ANDA210093", "marketing_category": "ANDA", "marketing_start_date": "20200702", "listing_expiration_date": "20261231"}