🇺🇸
United States · US · US:70436-162_4a614df8-4e1d-d610-e063-6294a90a7d7c
Eptifibatide
Orange BookUNIISPLATC B01AC16
Last synced from FDA National Drug Code directory (United States) on
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
- ndc11704361628010 mL in 1 VIAL (70436-162-80)
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": "70436-162_4a614df8-4e1d-d610-e063-6294a90a7d7c",
"productndc": "70436-162",
"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": "2"
}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.
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- 🇺🇸EptifibatideAvenacy Inc.
- 🇺🇸EptifibatideEugia US LLC
- 🇺🇸EptifibatideMylan Institutional LLC
- 🇺🇸EptifibatideHainan Shuangcheng Pharmaceuticals Co., Ltd.
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