omega-3-acid ethyl esters (62135-780)

Drug Facts

Product Profile

Brand Name omega-3-acid ethyl esters

Generic Name omega-3-acid ethyl esters

Labeler chartwell rx, llc

Dosage Form CAPSULE, LIQUID FILLED

Routes

ORAL

Active Ingredients

omega-3-acid ethyl esters 900 mg/1

Manufacturer

Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-780

Product ID 62135-780_46879b05-8040-8318-e063-6294a90ad8cc

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA211355

Listing Expiration 2026-12-31

Marketing Start 2020-02-19

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 62135780

Hyphenated Format 62135-780

Supplemental Identifiers

RxCUI

577208

UPC

0362135780128

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 ANDA211355 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

900 mg/1

source: ndc

Packaging

120 CAPSULE, LIQUID FILLED in 1 BOTTLE (62135-780-12)

source: ndc

Packages (1)

62135-780-12 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (62135-780-12)

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": "46879b05-8040-8318-e063-6294a90ad8cc", "openfda": {"upc": ["0362135780128"], "unii": ["D87YGH4Z0Q"], "rxcui": ["577208"], "spl_set_id": ["331d5d9d-58d8-4b4f-8114-b28efa7276d7"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 CAPSULE, LIQUID FILLED in 1 BOTTLE (62135-780-12)", "package_ndc": "62135-780-12", "marketing_start_date": "20231010"}], "brand_name": "omega-3-acid ethyl esters", "product_id": "62135-780_46879b05-8040-8318-e063-6294a90ad8cc", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Fatty Acids", "Omega-3 [CS]", "Omega-3 Fatty Acid [EPC]"], "product_ndc": "62135-780", "generic_name": "omega-3-acid ethyl esters", "labeler_name": "Chartwell RX, LLC", "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": "ANDA211355", "marketing_category": "ANDA", "marketing_start_date": "20200219", "listing_expiration_date": "20261231"}