🇺🇸
United States · US · US:72865-139_b1d36d46-9e6f-4d12-abe1-d47abe02ad5e
Omega-3-acid ethyl esters
Orange BookUNIISPLATC C10AX06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerXLCare Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeC10AX06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc117286513905500 CAPSULE, LIQUID FILLED in 1 BOTTLE (72865-139-05)
- ndc117286513912120 CAPSULE, LIQUID FILLED in 1 BOTTLE (72865-139-12)
Annotations
UNII (FDA Substance ID)
D87YGH4Z0Q
OMEGA-3-ACID ETHYL ESTERS
RxCUI 484348
Orange Book
A207420
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": "72865-139_b1d36d46-9e6f-4d12-abe1-d47abe02ad5e",
"productndc": "72865-139",
"dosage_form": "CAPSULE, LIQUID FILLED",
"orange_book": {
"appl_no": "207420",
"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": "Feb 25, 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 esters",
"active_ingred_unit": "g/1",
"application_number": "ANDA207420",
"marketing_category": "ANDA",
"nonproprietary_name": "Omega-3-acid ethyl esters",
"start_marketing_date": "20200217",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code C10AX06.
Access this data programmatically
Query Omega-3-acid ethyl esters and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.