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United States · US · US:72998-850_c51df0eb-53aa-40b8-974d-127c0c8a0be0

OMEGA-3-ACID ETHYL ESTERS

Orange BookUNIISPLATC C10AX06

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerKD Pharma USA, Inc.
CountryUS (United States)
ATC codeC10AX06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7299885012
    120 CAPSULE in 1 BOTTLE, PLASTIC (72998-850-12)

Annotations

UNII (FDA Substance ID)
D87YGH4Z0Q
OMEGA-3-ACID ETHYL ESTERS
RxCUI 484348
Orange Book
A212504
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": "72998-850_c51df0eb-53aa-40b8-974d-127c0c8a0be0",
  "productndc": "72998-850",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "212504",
    "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 19, 2020"
      }
    ],
    "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": "ANDA212504",
  "marketing_category": "ANDA",
  "nonproprietary_name": "OMEGA-3-ACID ETHYL ESTERS",
  "start_marketing_date": "20210501",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code C10AX06.

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