omega-3-acid ethyl esters

Generic: omega-3-acid ethyl esters

Labeler: lifestar pharma llc
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 lifestar pharma llc
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

omega-3-acid ethyl esters 1 g/1

Manufacturer
Lifestar Pharma LLC

Identifiers & Regulatory

Product NDC 70756-423
Product ID 70756-423_6576afc5-ca24-477d-b7ff-51ed56063309
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215458
Listing Expiration 2027-12-31
Marketing Start 2021-11-16

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 70756423
Hyphenated Format 70756-423

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 ANDA215458 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 g/1
source: ndc
Packaging
  • 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (70756-423-22)
source: ndc

Packages (1)

70756-423-22 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (70756-423-22)

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": "6576afc5-ca24-477d-b7ff-51ed56063309", "openfda": {"unii": ["D87YGH4Z0Q"], "rxcui": ["577208"], "spl_set_id": ["769ad170-5d70-4a54-995a-fef95ef503eb"], "manufacturer_name": ["Lifestar Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 CAPSULE, LIQUID FILLED in 1 BOTTLE (70756-423-22)", "package_ndc": "70756-423-22", "marketing_start_date": "20211116"}], "brand_name": "OMEGA-3-ACID ETHYL ESTERS", "product_id": "70756-423_6576afc5-ca24-477d-b7ff-51ed56063309", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Fatty Acids", "Omega-3 [CS]", "Omega-3 Fatty Acid [EPC]"], "product_ndc": "70756-423", "generic_name": "Omega-3-acid ethyl esters", "labeler_name": "Lifestar Pharma LLC", "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": "20211116", "listing_expiration_date": "20271231"}