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United States · US · US:69452-175_c1aebacc-8c18-3f0d-e053-2a95a90ab85a
Omega-3-Acid Ethyl Ester
Orange BookUNIISPLATC C10AX06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBionpharma Inc.
CountryUS (United States)
ATC codeC10AX06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11694521751760 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-175-17)
- ndc116945217522120 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-175-22)
Annotations
UNII (FDA Substance ID)
D87YGH4Z0Q
OMEGA-3-ACID ETHYL ESTERS
RxCUI 484348
Orange Book
A206455
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "D87YGH4Z0Q",
"rxcui": "484348",
"inchikey": null,
"display_name": "OMEGA-3-ACID ETHYL ESTERS",
"substance_type": "mixture",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"9499c40e-6665-4fbf-914d-1a9931b93562": {
"match": "brand_token",
"title": "OMEGA-3-ACID ETHYL ESTERS CAPSULE [STRIDES PHARMA SCIENCE LIMITED]",
"spl_version": "7",
"published_date": "2026-05-29"
}
},
"productid": "69452-175_c1aebacc-8c18-3f0d-e053-2a95a90ab85a",
"productndc": "69452-175",
"dosage_form": "CAPSULE, LIQUID FILLED",
"orange_book": {
"appl_no": "206455",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS",
"product_no": "001",
"approval_date": "Aug 7, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "OMEGA-3-ACID ETHYL ESTERS",
"proprietary_name": "Omega-3-Acid Ethyl Ester",
"active_ingred_unit": "mg/1",
"application_number": "ANDA206455",
"marketing_category": "ANDA",
"nonproprietary_name": "omega-3-acid ethyl esters",
"start_marketing_date": "20170115",
"active_numerator_strength": "900"
}Related drugs
Other records sharing ATC code C10AX06.
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