Eptifibatide

Orange BookUNIISPLATC B01AC16

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerSlate Run Pharmaceuticals, LLC

CountryUS (United States)

ATC codeB01AC16

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7043616380
100 mL in 1 VIAL (70436-163-80)

Annotations

UNII (FDA Substance ID)

NA8320J834

EPTIFIBATIDE

RxCUI 75635

Orange Book

A209864

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": "70436-163_4a614df8-4e1d-d610-e063-6294a90a7d7c",
  "productndc": "70436-163",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "209864",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "2MG/ML",
        "product_no": "001",
        "approval_date": "Jan 25, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "75MG/100ML",
        "product_no": "002",
        "approval_date": "Jan 25, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EPTIFIBATIDE",
  "proprietary_name": "Eptifibatide",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA209864",
  "marketing_category": "ANDA",
  "nonproprietary_name": "eptifibatide",
  "start_marketing_date": "20190601",
  "active_numerator_strength": ".75"
}

Related drugs

Other records sharing ATC code B01AC16.

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