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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
- ndc11713900111110 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
Other records sharing ATC code N05CD14.
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