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United States · US · US:82381-2174_057c1420-60f7-4a86-922c-44b37df317f6

BRENZAVVY

Orange BookUNIISPLATC A10BK08

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

Identification

ManufacturerTheracosBio, LLC
CountryUS (United States)
ATC codeA10BK08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    8238121741
    30 TABLET in 1 BOTTLE (82381-2174-1)
  • ndc11
    8238121742
    90 TABLET in 1 BOTTLE (82381-2174-2)

Annotations

UNII (FDA Substance ID)
EY00JF42FV
BEXAGLIFLOZIN
Orange Book
N214373
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "EY00JF42FV",
    "rxcui": null,
    "inchikey": "BTCRKOKVYTVOLU-SJSRKZJXSA-N",
    "display_name": "BEXAGLIFLOZIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "3cdf28fc-4194-4ad6-aa03-c9eaa68da83e": {
      "match": "brand_token",
      "title": "BRENZAVVY (BEXAGLIFLOZIN) TABLET [THERACOSBIO, LLC]",
      "spl_version": "8",
      "published_date": "2025-11-20"
    }
  },
  "productid": "82381-2174_057c1420-60f7-4a86-922c-44b37df317f6",
  "productndc": "82381-2174",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "214373",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Jan 20, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BEXAGLIFLOZIN",
  "proprietary_name": "BRENZAVVY",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA214373",
  "marketing_category": "NDA",
  "nonproprietary_name": "Bexagliflozin",
  "start_marketing_date": "20230713",
  "active_numerator_strength": "20"
}

Related drugs

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