🇺🇸
United States · US · US:52958-040_6f3dec26-ea9b-4e6e-8e5b-0fa6fb430598
Eptifibatide
Orange BookUNIISPLATC B01AC16
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHainan Shuangcheng Pharmaceuticals Co., Ltd.
CountryUS (United States)
ATC codeB01AC16
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1152958040011 VIAL, SINGLE-DOSE in 1 CARTON (52958-040-01) / 100 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
NA8320J834
EPTIFIBATIDE
RxCUI 75635
Orange Book
A213081
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": "52958-040_6f3dec26-ea9b-4e6e-8e5b-0fa6fb430598",
"productndc": "52958-040",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "213081",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "2MG/ML",
"product_no": "001",
"approval_date": "Sep 7, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "75MG/100ML",
"product_no": "002",
"approval_date": "Apr 20, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "EPTIFIBATIDE",
"proprietary_name": "Eptifibatide",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA213081",
"marketing_category": "ANDA",
"nonproprietary_name": "Eptifibatide",
"start_marketing_date": "20220421",
"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
- 🇺🇸EptifibatideHainan Shuangcheng Pharmaceuticals Co., Ltd.
- 🇺🇸EptifibatideAvenacy Inc.
- 🇺🇸EptifibatideEugia US LLC
- 🇺🇸EptifibatideMylan Institutional LLC
- 🇺🇸EptifibatideSlate Run Pharmaceuticals, LLC
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