omega-3-acid ethyl esters

Generic: omega-3-acid ethyl esters

Labeler: kd pharma usa, 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 kd pharma usa, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

omega-3-acid ethyl esters 1 g/1

Manufacturer
KD Pharma USA, Inc.

Identifiers & Regulatory

Product NDC 72998-850
Product ID 72998-850_c51df0eb-53aa-40b8-974d-127c0c8a0be0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212504
Listing Expiration 2026-12-31
Marketing Start 2021-05-01

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 72998850
Hyphenated Format 72998-850

Supplemental Identifiers

RxCUI
577208
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 ANDA212504 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 g/1
source: ndc
Packaging
  • 120 CAPSULE in 1 BOTTLE, PLASTIC (72998-850-12)
source: ndc

Packages (1)

72998-850-12 120 CAPSULE in 1 BOTTLE, PLASTIC (72998-850-12)

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": "c51df0eb-53aa-40b8-974d-127c0c8a0be0", "openfda": {"unii": ["D87YGH4Z0Q"], "rxcui": ["577208"], "spl_set_id": ["5cf3091e-4a88-4799-a88a-d53a5bc1de57"], "manufacturer_name": ["KD Pharma USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 CAPSULE in 1 BOTTLE, PLASTIC (72998-850-12)", "package_ndc": "72998-850-12", "marketing_start_date": "20210501"}], "brand_name": "OMEGA-3-ACID ETHYL ESTERS", "product_id": "72998-850_c51df0eb-53aa-40b8-974d-127c0c8a0be0", "dosage_form": "CAPSULE", "pharm_class": ["Fatty Acids", "Omega-3 [CS]", "Omega-3 Fatty Acid [EPC]"], "product_ndc": "72998-850", "generic_name": "OMEGA-3-ACID ETHYL ESTERS", "labeler_name": "KD Pharma USA, 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": "ANDA212504", "marketing_category": "ANDA", "marketing_start_date": "20210501", "listing_expiration_date": "20261231"}