🇺🇸
United States · US · US:72078-026_7af20acf-ba9f-4387-9729-85d3c137f41e
Eptifibatide
Orange BookUNIISPLATC B01AC16
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Institutional LLC
CountryUS (United States)
ATC codeB01AC16
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1172078026101 VIAL in 1 CARTON (72078-026-10) / 100 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
NA8320J834
EPTIFIBATIDE
RxCUI 75635
Orange Book
A203258
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": "72078-026_7af20acf-ba9f-4387-9729-85d3c137f41e",
"productndc": "72078-026",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "203258",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AP",
"strength": "2MG/ML",
"product_no": "001",
"approval_date": "Jul 20, 2018"
},
{
"rs": true,
"rld": false,
"te_code": "AP",
"strength": "75MG/100ML",
"product_no": "002",
"approval_date": "Jul 20, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "EPTIFIBATIDE",
"proprietary_name": "Eptifibatide",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA203258",
"marketing_category": "ANDA",
"nonproprietary_name": "eptifibatide",
"start_marketing_date": "20201120",
"active_numerator_strength": ".75"
}Related drugs
Other records sharing ATC code B01AC16.
- 🇪🇸EPTIFIBATIDA ACCORD 0,75 MG/ML SOLUCION PARA PERFUSION EFGAccord Healthcare S.L.U.
- 🇪🇸EPTIFIBATIDA ACCORD 2 MG/ML SOLUCION INYECTABLE EFGAccord Healthcare S.L.U.
- 🇺🇸eptifibatideSagent Pharmaceuticals
- 🇺🇸EptifibatideMylan Institutional LLC
- 🇺🇸EptifibatideAvenacy Inc.
- 🇺🇸EptifibatideEugia US LLC
- 🇺🇸EptifibatideMylan Institutional LLC
- 🇺🇸EptifibatideSlate Run Pharmaceuticals, LLC
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