omega-3-acid ethyl ester

Generic: omega-3-acid ethyl esters

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

Drug Facts

Product Profile

Brand Name omega-3-acid ethyl ester
Generic Name omega-3-acid ethyl esters
Labeler bionpharma inc.
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

omega-3-acid ethyl esters 900 mg/1

Manufacturer
Bionpharma Inc.

Identifiers & Regulatory

Product NDC 69452-175
Product ID 69452-175_c1aebacc-8c18-3f0d-e053-2a95a90ab85a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206455
Listing Expiration 2026-12-31
Marketing Start 2017-01-15

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 69452175
Hyphenated Format 69452-175

Supplemental Identifiers

RxCUI
577208
UPC
0369452175224
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 ester (source: ndc)
Generic Name omega-3-acid ethyl esters (source: ndc)
Application Number ANDA206455 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 900 mg/1
source: ndc
Packaging
  • 60 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-175-17)
  • 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-175-22)
source: ndc

Packages (2)

69452-175-17 60 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-175-17) 69452-175-22 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-175-22)

Ingredients (1)

omega-3-acid ethyl esters (900 mg/1)

Linked Drug Pages (1)

Omega-3-Acid Ethyl Ester ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c1aebacc-8c18-3f0d-e053-2a95a90ab85a", "openfda": {"upc": ["0369452175224"], "unii": ["D87YGH4Z0Q"], "rxcui": ["577208"], "spl_set_id": ["91ef2e89-e816-4494-9558-2f647b7452f8"], "manufacturer_name": ["Bionpharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-175-17)", "package_ndc": "69452-175-17", "marketing_start_date": "20170115"}, {"sample": false, "description": "120 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-175-22)", "package_ndc": "69452-175-22", "marketing_start_date": "20170115"}], "brand_name": "Omega-3-Acid Ethyl Ester", "product_id": "69452-175_c1aebacc-8c18-3f0d-e053-2a95a90ab85a", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Fatty Acids", "Omega-3 [CS]", "Omega-3 Fatty Acid [EPC]"], "product_ndc": "69452-175", "generic_name": "omega-3-acid ethyl esters", "labeler_name": "Bionpharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Omega-3-Acid Ethyl Ester", "active_ingredients": [{"name": "OMEGA-3-ACID ETHYL ESTERS", "strength": "900 mg/1"}], "application_number": "ANDA206455", "marketing_category": "ANDA", "marketing_start_date": "20170115", "listing_expiration_date": "20261231"}