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United States · US · US:71872-7038_fd01fac1-36c1-8788-e053-6294a90aed8d

Flumazenil

Orange BookUNIISPLATC V03AB25

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

Identification

ManufacturerMedical Purchasing Solutions, LLC
CountryUS (United States)
ATC codeV03AB25
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7187270381
    1 VIAL, MULTI-DOSE in 1 BAG (71872-7038-1) / 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": "71872-7038_fd01fac1-36c1-8788-e053-6294a90aed8d",
  "productndc": "71872-7038",
  "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"
}

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