🇺🇸
United States · US · US:55150-219_944b269c-d810-411d-9ed4-8edd9d0ac1b7
Eptifibatide
Orange BookUNIISPLATC B01AC16
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEugia US LLC
CountryUS (United States)
ATC codeB01AC16
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1155150219101 VIAL, SINGLE-DOSE in 1 CARTON (55150-219-10) / 10 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
NA8320J834
EPTIFIBATIDE
RxCUI 75635
Orange Book
A206127
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": "55150-219_944b269c-d810-411d-9ed4-8edd9d0ac1b7",
"productndc": "55150-219",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "206127",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "2MG/ML",
"product_no": "001",
"approval_date": "Dec 8, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "75MG/100ML",
"product_no": "002",
"approval_date": "Dec 8, 2015"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "EPTIFIBATIDE",
"proprietary_name": "Eptifibatide",
"active_ingred_unit": "mg/10mL",
"application_number": "ANDA206127",
"marketing_category": "ANDA",
"nonproprietary_name": "Eptifibatide",
"start_marketing_date": "20151208",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code B01AC16.
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- 🇺🇸EptifibatideMylan Institutional LLC
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- 🇺🇸EptifibatideSlate Run Pharmaceuticals, LLC
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