BRIXADI

Orange BookUNIISPLATC N07BC01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerBraeburn Inc.

CountryUS (United States)

ATC codeN07BC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5828420801
1 SYRINGE, GLASS in 1 CARTON (58284-208-01) / .16 mL in 1 SYRINGE, GLASS

Annotations

UNII (FDA Substance ID)

40D3SCR4GZ

BUPRENORPHINE

RxCUI 1819

Orange Book

N210136

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "40D3SCR4GZ",
    "rxcui": "1819",
    "inchikey": "RMRJXGBAOAMLHD-IHFGGWKQSA-N",
    "display_name": "BUPRENORPHINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "5d8a8fd0-8619-422a-a664-d1d2e8970f48": {
      "match": "brand_token",
      "title": "BRIXADI (BUPRENORPHINE) INJECTION [BRAEBURN INC.]",
      "spl_version": "6",
      "published_date": "2026-01-06"
    }
  },
  "productid": "58284-208_4e1985eb-1302-42e0-ac79-10b0a492966a",
  "productndc": "58284-208",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "210136",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "8MG/0.16ML (50MG/ML)",
        "product_no": "001",
        "approval_date": "May 23, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "16MG/0.32ML (50MG/ML)",
        "product_no": "002",
        "approval_date": "May 23, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "24MG/0.48ML (50MG/ML)",
        "product_no": "003",
        "approval_date": "May 23, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "32MG/0.64ML (50MG/ML)",
        "product_no": "004",
        "approval_date": "May 23, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "64MG/0.18ML (356MG/ML)",
        "product_no": "005",
        "approval_date": "May 23, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "96MG/0.27ML (356MG/ML)",
        "product_no": "006",
        "approval_date": "May 23, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "128MG/0.36ML (356MG/ML)",
        "product_no": "007",
        "approval_date": "May 23, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CIII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BUPRENORPHINE",
  "proprietary_name": "BRIXADI",
  "active_ingred_unit": "mg/.16mL",
  "application_number": "NDA210136",
  "marketing_category": "NDA",
  "nonproprietary_name": "BUPRENORPHINE",
  "start_marketing_date": "20230606",
  "active_numerator_strength": "8"
}

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