Back to search
🇺🇸

United States · US · US:50090-1337_23609fa7-bb15-4ec9-8c7b-27cb56e883cd

Flumazenil

Orange BookUNIISPLATC V03AB25

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeV03AB25
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5009013370
    1 VIAL, MULTI-DOSE in 1 BOX (50090-1337-0) / 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": "50090-1337_23609fa7-bb15-4ec9-8c7b-27cb56e883cd",
  "productndc": "50090-1337",
  "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

Other records sharing ATC code V03AB25.

Access this data programmatically

Query Flumazenil and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.