omega-3-acid ethyl esters

Generic: omega-3-acid ethyl esters

Labeler: xlcare pharmaceuticals, inc.
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 xlcare pharmaceuticals, inc.
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

omega-3-acid ethyl esters 1 g/1

Manufacturer
XLCare Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72865-139
Product ID 72865-139_74f8b700-c6a0-406f-ade2-14615adefab5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207420
Listing Expiration 2026-12-31
Marketing Start 2020-02-17

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 72865139
Hyphenated Format 72865-139

Supplemental Identifiers

RxCUI
577208
UPC
0372865139127
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 ANDA207420 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 g/1
source: ndc
Packaging
  • 500 CAPSULE, LIQUID FILLED in 1 BOTTLE (72865-139-05)
  • 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (72865-139-12)
source: ndc

Packages (2)

72865-139-05 500 CAPSULE, LIQUID FILLED in 1 BOTTLE (72865-139-05) 72865-139-12 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (72865-139-12)

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": "74f8b700-c6a0-406f-ade2-14615adefab5", "openfda": {"upc": ["0372865139127"], "unii": ["D87YGH4Z0Q"], "rxcui": ["577208"], "spl_set_id": ["18947318-31b4-42fb-83be-8f1bfe732e95"], "manufacturer_name": ["XLCare Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 CAPSULE, LIQUID FILLED in 1 BOTTLE (72865-139-05)", "package_ndc": "72865-139-05", "marketing_start_date": "20200217"}, {"sample": false, "description": "120 CAPSULE, LIQUID FILLED in 1 BOTTLE (72865-139-12)", "package_ndc": "72865-139-12", "marketing_start_date": "20200217"}], "brand_name": "Omega-3-acid ethyl esters", "product_id": "72865-139_74f8b700-c6a0-406f-ade2-14615adefab5", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Fatty Acids", "Omega-3 [CS]", "Omega-3 Fatty Acid [EPC]"], "product_ndc": "72865-139", "generic_name": "Omega-3-acid ethyl esters", "labeler_name": "XLCare Pharmaceuticals, Inc.", "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": "ANDA207420", "marketing_category": "ANDA", "marketing_start_date": "20200217", "listing_expiration_date": "20261231"}