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United States · US · US:71288-413_a15dafa6-7923-4999-8938-28e580304e57

Eptifibatide

Orange BookUNIISPLATC B01AC16

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

Identification

ManufacturerMeitheal Pharmaceuticals Inc.
CountryUS (United States)
ATC codeB01AC16
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7128841351
    1 VIAL, SINGLE-DOSE in 1 CARTON (71288-413-51) / 100 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
NA8320J834
EPTIFIBATIDE
RxCUI 75635
Orange Book
A213599
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": "71288-413_a15dafa6-7923-4999-8938-28e580304e57",
  "productndc": "71288-413",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "213599",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "2MG/ML",
        "product_no": "001",
        "approval_date": "May 9, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "75MG/100ML",
        "product_no": "002",
        "approval_date": "May 9, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EPTIFIBATIDE",
  "proprietary_name": "Eptifibatide",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA213599",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Eptifibatide",
  "start_marketing_date": "20240509",
  "active_numerator_strength": ".75"
}

Related drugs

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