🇺🇸
United States · US · US:84549-783_3f7a30b5-2727-0c82-e063-6394a90a92dd
Flumazenil
Orange BookUNIISPLATC V03AB25
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProPharma Distribution
CountryUS (United States)
ATC codeV03AB25
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11845497831010 mL in 1 VIAL, MULTI-DOSE (84549-783-10)
Annotations
UNII (FDA Substance ID)
40P7XK9392
FLUMAZENIL
RxCUI 4457
Orange Book
A078527
APAP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "40P7XK9392",
"rxcui": "4457",
"inchikey": "OFBIFZUFASYYRE-UHFFFAOYSA-N",
"display_name": "FLUMAZENIL",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"3eefb01b-3d6a-a3eb-e063-6394a90a4829": {
"match": "brand_token",
"title": "FLUMAZENIL INJECTION, SOLUTION [PROPHARMA DISTRIBUTION]",
"spl_version": "2",
"published_date": "2025-12-19"
}
},
"productid": "84549-783_3f7a30b5-2727-0c82-e063-6394a90a92dd",
"productndc": "84549-783",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "078527",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "0.5MG/5ML (0.1MG/ML)",
"product_no": "001",
"approval_date": "Mar 23, 2009"
},
{
"rs": true,
"rld": false,
"te_code": "AP",
"strength": "1MG/10ML (0.1MG/ML)",
"product_no": "002",
"approval_date": "Mar 23, 2009"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FLUMAZENIL",
"proprietary_name": "Flumazenil",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA078527",
"marketing_category": "ANDA",
"nonproprietary_name": "flumazenil",
"start_marketing_date": "20070101",
"active_numerator_strength": ".1"
}Related drugs
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- IEAnexate 500 micrograms/5ml, solution for injection or infusionCheplapharm Arzneimittel GmbH
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- 🇺🇸FlumazenilMedical Purchasing Solutions, LLC
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