🇺🇸
United States · US · US:25021-408_7e4a3720-9c2e-4fb7-b703-f896f7fd0686
eptifibatide
Orange BookUNIISPLATC B01AC16
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSagent Pharmaceuticals
CountryUS (United States)
ATC codeB01AC16
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1125021408511 VIAL in 1 CARTON (25021-408-51) / 100 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
NA8320J834
EPTIFIBATIDE
RxCUI 75635
Orange Book
A204693
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": "25021-408_7e4a3720-9c2e-4fb7-b703-f896f7fd0686",
"productndc": "25021-408",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "204693",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "2MG/ML",
"product_no": "001",
"approval_date": "Mar 7, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "75MG/100ML",
"product_no": "002",
"approval_date": "Mar 7, 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": "ANDA204693",
"marketing_category": "ANDA",
"nonproprietary_name": "eptifibatide",
"start_marketing_date": "20180715",
"active_numerator_strength": ".75"
}Related drugs
Other records sharing ATC code B01AC16.
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- 🇪🇸EPTIFIBATIDA ACCORD 2 MG/ML SOLUCION INYECTABLE EFGAccord Healthcare S.L.U.
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- 🇺🇸EptifibatideHainan Shuangcheng Pharmaceuticals Co., Ltd.
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