omega-3-acid ethyl ester

Generic: omega-3-acid ethyl esters

Labeler: bryant ranch prepack
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 bryant ranch prepack
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

omega-3-acid ethyl esters 900 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-2448
Product ID 63629-2448_1f7ec163-5055-457e-b725-1c1af6aa7d9d
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 636292448
Hyphenated Format 63629-2448

Supplemental Identifiers

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 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
  • 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (63629-2448-1)
source: ndc

Packages (1)

63629-2448-1 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (63629-2448-1)

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": "1f7ec163-5055-457e-b725-1c1af6aa7d9d", "openfda": {"unii": ["D87YGH4Z0Q"], "spl_set_id": ["09ce03c0-1c22-4c60-a532-f781949f3172"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "120 CAPSULE, LIQUID FILLED in 1 BOTTLE (63629-2448-1)", "package_ndc": "63629-2448-1", "marketing_start_date": "20211110"}], "brand_name": "Omega-3-Acid Ethyl Ester", "product_id": "63629-2448_1f7ec163-5055-457e-b725-1c1af6aa7d9d", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Fatty Acids", "Omega-3 [CS]", "Omega-3 Fatty Acid [EPC]"], "product_ndc": "63629-2448", "generic_name": "omega-3-acid ethyl esters", "labeler_name": "Bryant Ranch Prepack", "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"}