🇺🇸
United States · US · US:51662-1254_100d725a-9db5-5dd8-e063-6294a90a0797
FLUMAZENIL
Orange BookUNIISPLATC V03AB25
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHF Acquisition Co. LLC, DBA HealthFirst
CountryUS (United States)
ATC codeV03AB25
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1151662125415 mL in 1 VIAL, MULTI-DOSE (51662-1254-1)
- ndc11516621254310 POUCH in 1 CASE (51662-1254-3) / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1254-2) / 5 mL in 1 VIAL, MULTI-DOSE
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": "51662-1254_100d725a-9db5-5dd8-e063-6294a90a0797",
"productndc": "51662-1254",
"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": "20180901",
"active_numerator_strength": ".1"
}Related drugs
Other records sharing ATC code V03AB25.
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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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