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United States · US · US:0904-7495_b4dad9e0-98b3-4538-bc99-e390185bf642
OMEGA-3-ACID ETHYL ESTERS
Orange BookUNIISPLATC C10AX06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMajor Pharmaceuticals
CountryUS (United States)
ATC codeC10AX06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11090474950650 BLISTER PACK in 1 CARTON (0904-7495-06) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
D87YGH4Z0Q
OMEGA-3-ACID ETHYL ESTERS
RxCUI 484348
Orange Book
A215458
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": "0904-7495_b4dad9e0-98b3-4538-bc99-e390185bf642",
"productndc": "0904-7495",
"dosage_form": "CAPSULE, LIQUID FILLED",
"orange_book": {
"appl_no": "215458",
"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": "Nov 15, 2021"
}
],
"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": "ANDA215458",
"marketing_category": "ANDA",
"nonproprietary_name": "Omega-3-acid ethyl esters",
"start_marketing_date": "20241213",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code C10AX06.
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