omega-3-acid ethyl esters

Generic: omega-3-acid ethyl esters capsules

Labeler: major pharmaceuticals
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 capsules
Labeler major pharmaceuticals
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

omega-3-acid ethyl esters 1 g/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7495
Product ID 0904-7495_aafd4810-3468-4b20-9d96-df37cc74a524
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215458
Listing Expiration 2027-12-31
Marketing Start 2024-12-13

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 09047495
Hyphenated Format 0904-7495

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 capsules (source: ndc)
Application Number ANDA215458 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 g/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 CARTON (0904-7495-06) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
source: ndc

Packages (1)

0904-7495-06 50 BLISTER PACK in 1 CARTON (0904-7495-06) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

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": "aafd4810-3468-4b20-9d96-df37cc74a524", "openfda": {"unii": ["D87YGH4Z0Q"], "rxcui": ["577208"], "spl_set_id": ["e40d55f2-db9f-4a48-8639-9aa7491e4de5"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 CARTON (0904-7495-06)  / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "0904-7495-06", "marketing_start_date": "20241213"}], "brand_name": "OMEGA-3-ACID ETHYL ESTERS", "product_id": "0904-7495_aafd4810-3468-4b20-9d96-df37cc74a524", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Fatty Acids", "Omega-3 [CS]", "Omega-3 Fatty Acid [EPC]"], "product_ndc": "0904-7495", "generic_name": "Omega-3-acid ethyl esters capsules", "labeler_name": "Major Pharmaceuticals", "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": "ANDA215458", "marketing_category": "ANDA", "marketing_start_date": "20241213", "listing_expiration_date": "20271231"}