omega-3-acid ethyl esters

Generic: omega-3-acid ethyl esters

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

omega-3-acid ethyl esters 1 g/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3040
Product ID 70518-3040_4b1b4772-93eb-034c-e063-6294a90aaf24
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210093
Listing Expiration 2027-12-31
Marketing Start 2021-03-04

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 705183040
Hyphenated Format 70518-3040

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 (source: ndc)
Application Number ANDA210093 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 g/1
source: ndc
Packaging
  • 180 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (70518-3040-0)
source: ndc

Packages (1)

70518-3040-0 180 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (70518-3040-0)

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": "4b1b4772-93eb-034c-e063-6294a90aaf24", "openfda": {"unii": ["D87YGH4Z0Q"], "rxcui": ["577208"], "spl_set_id": ["c6b35b2d-5a65-4fc4-8a2c-af7b3aea3eee"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "180 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (70518-3040-0)", "package_ndc": "70518-3040-0", "marketing_start_date": "20210304"}], "brand_name": "OMEGA-3-ACID ETHYL ESTERS", "product_id": "70518-3040_4b1b4772-93eb-034c-e063-6294a90aaf24", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Fatty Acids", "Omega-3 [CS]", "Omega-3 Fatty Acid [EPC]"], "product_ndc": "70518-3040", "generic_name": "OMEGA-3-ACID ETHYL ESTERS", "labeler_name": "REMEDYREPACK 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": "ANDA210093", "marketing_category": "ANDA", "marketing_start_date": "20210304", "listing_expiration_date": "20271231"}