omega-3-acid ethyl esters

Generic: omega-3-acid ethyl esters

Labeler: par pharmaceutical inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name omega-3-acid ethyl esters
Generic Name omega-3-acid ethyl esters
Labeler par pharmaceutical inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

omega-3-acid ethyl esters 900 mg/1

Manufacturer
Par Pharmaceutical Inc.

Identifiers & Regulatory

Product NDC 0254-3010
Product ID 0254-3010_9b349968-03b7-4a4f-ab40-976570f5e398
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203893
Listing Expiration 2026-12-31
Marketing Start 2017-09-19

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 02543010
Hyphenated Format 0254-3010

Supplemental Identifiers

RxCUI
577208
UNII
D87YGH4Z0Q

Packaging Origin

Original Packager
true

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 ANDA203893 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 900 mg/1
source: ndc
Packaging
  • 120 CAPSULE in 1 BOTTLE (0254-3010-08)
source: ndc

Packages (1)

0254-3010-08 120 CAPSULE in 1 BOTTLE (0254-3010-08)

Ingredients (1)

omega-3-acid ethyl esters (900 mg/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": "9b349968-03b7-4a4f-ab40-976570f5e398", "openfda": {"unii": ["D87YGH4Z0Q"], "rxcui": ["577208"], "spl_set_id": ["b53f1c14-43da-4e05-8c80-a0a455dd41cf"], "manufacturer_name": ["Par Pharmaceutical Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 CAPSULE in 1 BOTTLE (0254-3010-08)", "package_ndc": "0254-3010-08", "marketing_start_date": "20170919"}], "brand_name": "Omega-3-acid ethyl esters", "product_id": "0254-3010_9b349968-03b7-4a4f-ab40-976570f5e398", "dosage_form": "CAPSULE", "pharm_class": ["Fatty Acids", "Omega-3 [CS]", "Omega-3 Fatty Acid [EPC]"], "product_ndc": "0254-3010", "generic_name": "Omega-3-acid ethyl esters", "labeler_name": "Par Pharmaceutical Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Omega-3-acid ethyl esters", "active_ingredients": [{"name": "OMEGA-3-ACID ETHYL ESTERS", "strength": "900 mg/1"}], "application_number": "ANDA203893", "marketing_category": "ANDA", "marketing_start_date": "20170919", "listing_expiration_date": "20261231"}