🇺🇸
United States · US · US:63323-424_9f9520ae-2135-4731-8fb2-8a0a771c302b
Flumazenil
Orange BookUNIISPLATC V03AB25
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeV03AB25
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11633234240510 VIAL, MULTI-DOSE in 1 TRAY (63323-424-05) / 5 mL in 1 VIAL, MULTI-DOSE (63323-424-01)
- ndc1163323424101 VIAL, MULTI-DOSE in 1 CARTON (63323-424-10) / 10 mL in 1 VIAL, MULTI-DOSE
Annotations
UNII (FDA Substance ID)
40P7XK9392
FLUMAZENIL
RxCUI 4457
Orange Book
A076955
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": "63323-424_9f9520ae-2135-4731-8fb2-8a0a771c302b",
"productndc": "63323-424",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "076955",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "1MG/10ML (0.1MG/ML)",
"product_no": "001",
"approval_date": "Oct 12, 2004"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "0.5MG/5ML (0.1MG/ML)",
"product_no": "002",
"approval_date": "Oct 12, 2004"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FLUMAZENIL",
"proprietary_name": "Flumazenil",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA076955",
"marketing_category": "ANDA",
"nonproprietary_name": "FLUMAZENIL",
"start_marketing_date": "20050405",
"active_numerator_strength": ".1"
}Related drugs
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- BEAnexate 0.5 mg/5 mlCheplapharm Arzneimittel
- 🇪🇸ANEXATE 1 mg/10 ml SOLUCION INYECTABLECheplapharm Arzneimittel Gmbh
- IEAnexate 500 micrograms/5ml, solution for injection or infusionCheplapharm Arzneimittel GmbH
- GBAnexate 500micrograms/5ml solution for injection ampoulesRoche Products Ltd
- NLAnexate, 0,5 mg/5 ml en 1,0 mg/ 10 ml oplossing voor injectieCHEPLAPHARM Arzneimittel GmbH
- 🇺🇸FlumazenilProPharma Distribution
- 🇺🇸FlumazenilHikma Pharmaceuticals USA Inc.
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