omega-3-acid ethyl esters

Generic: omega-3-acid ethyl esters

Labeler: strides pharma science limited
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 strides pharma science limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

omega-3-acid ethyl esters 900 mg/1

Manufacturer
Strides Pharma Science Limited

Identifiers & Regulatory

Product NDC 64380-761
Product ID 64380-761_8d39d714-db8f-4d90-90c7-ee249eb17de9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203893
Listing Expiration 2026-12-31
Marketing Start 2019-01-18

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 64380761
Hyphenated Format 64380-761

Supplemental Identifiers

RxCUI
577208
UPC
0364380761112
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 ANDA203893 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 900 mg/1
source: ndc
Packaging
  • 5 BLISTER PACK in 1 CARTON (64380-761-02) / 10 CAPSULE in 1 BLISTER PACK (64380-761-01)
  • 120 CAPSULE in 1 BOTTLE (64380-761-11)
source: ndc

Packages (2)

64380-761-02 5 BLISTER PACK in 1 CARTON (64380-761-02) / 10 CAPSULE in 1 BLISTER PACK (64380-761-01) 64380-761-11 120 CAPSULE in 1 BOTTLE (64380-761-11)

Ingredients (1)

omega-3-acid ethyl esters (900 mg/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": "8d39d714-db8f-4d90-90c7-ee249eb17de9", "openfda": {"upc": ["0364380761112"], "unii": ["D87YGH4Z0Q"], "rxcui": ["577208"], "spl_set_id": ["9499c40e-6665-4fbf-914d-1a9931b93562"], "manufacturer_name": ["Strides Pharma Science Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 BLISTER PACK in 1 CARTON (64380-761-02)  / 10 CAPSULE in 1 BLISTER PACK (64380-761-01)", "package_ndc": "64380-761-02", "marketing_start_date": "20211130"}, {"sample": false, "description": "120 CAPSULE in 1 BOTTLE (64380-761-11)", "package_ndc": "64380-761-11", "marketing_start_date": "20190118"}], "brand_name": "omega-3-acid ethyl esters", "product_id": "64380-761_8d39d714-db8f-4d90-90c7-ee249eb17de9", "dosage_form": "CAPSULE", "pharm_class": ["Fatty Acids", "Omega-3 [CS]", "Omega-3 Fatty Acid [EPC]"], "product_ndc": "64380-761", "generic_name": "omega-3-acid ethyl esters", "labeler_name": "Strides Pharma Science Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "omega-3-acid ethyl esters", "active_ingredients": [{"name": "OMEGA-3-ACID ETHYL ESTERS", "strength": "900 mg/1"}], "application_number": "ANDA203893", "marketing_category": "ANDA", "marketing_start_date": "20190118", "listing_expiration_date": "20261231"}