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United States · US · US:65162-034_605495d0-a1f3-490f-b32d-0ac015c034a0
Omega-3-Acid Ethyl Esters
Orange BookUNIISPLATC C10AX06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeC10AX06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11651620340660 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-034-06)
- ndc116516203416120 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-034-16)
- ndc116516203432360 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-034-32)
Annotations
UNII (FDA Substance ID)
D87YGH4Z0Q
OMEGA-3-ACID ETHYL ESTERS
RxCUI 484348
Orange Book
A204940
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": "65162-034_605495d0-a1f3-490f-b32d-0ac015c034a0",
"productndc": "65162-034",
"dosage_form": "CAPSULE, LIQUID FILLED",
"orange_book": {
"appl_no": "204940",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS",
"product_no": "001",
"approval_date": "Nov 27, 2015"
}
],
"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": "ANDA204940",
"marketing_category": "ANDA",
"nonproprietary_name": "Omega-3-Acid Ethyl Esters",
"start_marketing_date": "20151130",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code C10AX06.
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