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United States · US · US:71390-011_4da618a9-2e04-4d75-922b-173d22b4e84c

BYFAVO

Orange BookUNIISPLATC N05CD14

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

Identification

ManufacturerAcacia Pharma, Ltd.
CountryUS (United States)
ATC codeN05CD14
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7139001111
    10 VIAL in 1 CARTON (71390-011-11) / 8 mL in 1 VIAL (71390-011-00)

Annotations

UNII (FDA Substance ID)
280XQ6482H
REMIMAZOLAM BESYLATE
RxCUI 2383942
Orange Book
N212295
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "280XQ6482H",
    "rxcui": "2383942",
    "inchikey": "QMTKNJZIWGTNTE-LMOVPXPDSA-N",
    "display_name": "REMIMAZOLAM BESYLATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "4e1838f2-b999-41a7-a761-d94f09aa531f": {
      "match": "brand_token",
      "title": "BYFAVO (REMIMAZOLAM BESYLATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACACIA PHARMA, LTD.]",
      "spl_version": "9",
      "published_date": "2025-02-28"
    }
  },
  "productid": "71390-011_4da618a9-2e04-4d75-922b-173d22b4e84c",
  "productndc": "71390-011",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "212295",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 20MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Oct 6, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "REMIMAZOLAM BESYLATE",
  "proprietary_name": "BYFAVO",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA212295",
  "marketing_category": "NDA",
  "nonproprietary_name": "remimazolam besylate",
  "start_marketing_date": "20201006",
  "active_numerator_strength": "2.5"
}

Related drugs

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