omega-3-acid ethyl esters

Generic: omega-3-acid ethyl esters

Labeler: amneal pharmaceuticals llc
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 amneal pharmaceuticals llc
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

omega-3-acid ethyl esters 1 g/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-034
Product ID 65162-034_605495d0-a1f3-490f-b32d-0ac015c034a0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204940
Marketing Start 2015-11-30
Marketing End 2026-07-01

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 65162034
Hyphenated Format 65162-034

Supplemental Identifiers

RxCUI
577208
UPC
0365162034066
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 ANDA204940 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 g/1
source: ndc
Packaging
  • 60 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-034-06)
  • 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-034-16)
  • 360 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-034-32)
source: ndc

Packages (3)

65162-034-06 60 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-034-06) 65162-034-16 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-034-16) 65162-034-32 360 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-034-32)

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": "605495d0-a1f3-490f-b32d-0ac015c034a0", "openfda": {"upc": ["0365162034066"], "unii": ["D87YGH4Z0Q"], "rxcui": ["577208"], "spl_set_id": ["530161f4-26a0-4cb0-8a01-a18cfd36d88c"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-034-06)", "package_ndc": "65162-034-06", "marketing_end_date": "20260701", "marketing_start_date": "20151130"}, {"sample": false, "description": "120 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-034-16)", "package_ndc": "65162-034-16", "marketing_end_date": "20260701", "marketing_start_date": "20151130"}, {"sample": false, "description": "360 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-034-32)", "package_ndc": "65162-034-32", "marketing_end_date": "20260701", "marketing_start_date": "20151130"}], "brand_name": "Omega-3-Acid Ethyl Esters", "product_id": "65162-034_605495d0-a1f3-490f-b32d-0ac015c034a0", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Fatty Acids", "Omega-3 [CS]", "Omega-3 Fatty Acid [EPC]"], "product_ndc": "65162-034", "generic_name": "Omega-3-Acid Ethyl Esters", "labeler_name": "Amneal Pharmaceuticals LLC", "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": "ANDA204940", "marketing_category": "ANDA", "marketing_end_date": "20260701", "marketing_start_date": "20151130"}