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United States · US · US:55150-220_944b269c-d810-411d-9ed4-8edd9d0ac1b7

Eptifibatide

Orange BookUNIISPLATC B01AC16

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

Identification

ManufacturerEugia US LLC
CountryUS (United States)
ATC codeB01AC16
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5515022099
    1 VIAL, SINGLE-DOSE in 1 CARTON (55150-220-99) / 100 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
NA8320J834
EPTIFIBATIDE
RxCUI 75635
Orange Book
A206127
APAP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "NA8320J834",
    "rxcui": "75635",
    "inchikey": "CZKPOZZJODAYPZ-LROMGURASA-N",
    "display_name": "EPTIFIBATIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "5f46b76b-5c83-49b9-ada8-4ad5cf81a38c": {
      "match": "brand_token",
      "title": "EPTIFIBATIDE INJECTION [BAXTER HEALTHCARE COMPANY]",
      "spl_version": "13",
      "published_date": "2026-05-21"
    }
  },
  "productid": "55150-220_944b269c-d810-411d-9ed4-8edd9d0ac1b7",
  "productndc": "55150-220",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "206127",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "2MG/ML",
        "product_no": "001",
        "approval_date": "Dec 8, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "75MG/100ML",
        "product_no": "002",
        "approval_date": "Dec 8, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EPTIFIBATIDE",
  "proprietary_name": "Eptifibatide",
  "active_ingred_unit": "mg/100mL",
  "application_number": "ANDA206127",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Eptifibatide",
  "start_marketing_date": "20151208",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code B01AC16.

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