Butrans

Orange BookUNIISPLATC N07BC01

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

Identification

ManufacturerKnoa Pharma LLC

CountryUS (United States)

ATC codeN07BC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5901175204
4 POUCH in 1 CARTON (59011-752-04) / 1 PATCH in 1 POUCH / 168 h in 1 PATCH

Annotations

UNII (FDA Substance ID)

40D3SCR4GZ

BUPRENORPHINE

RxCUI 1819

Orange Book

N021306

ABABABABAB

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": "TRANSDERMAL",
  "spl_meta": {
    "794aa355-66de-41b8-aedf-f2c40f6bc664": {
      "match": "brand_token",
      "title": "BUTRANS (BUPRENORPHINE) PATCH, EXTENDED RELEASE [KNOA PHARMA LLC]",
      "spl_version": "32",
      "published_date": "2026-05-13"
    }
  },
  "productid": "59011-752_cf5d162f-a313-4f27-a292-3ecf640fbea7",
  "productndc": "59011-752",
  "dosage_form": "PATCH, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "021306",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "5MCG/HR",
        "product_no": "001",
        "approval_date": "Jun 30, 2010"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "10MCG/HR",
        "product_no": "002",
        "approval_date": "Jun 30, 2010"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "20MCG/HR",
        "product_no": "003",
        "approval_date": "Jun 30, 2010"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "15MCG/HR",
        "product_no": "004",
        "approval_date": "Jul 25, 2013"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "7.5MCG/HR",
        "product_no": "005",
        "approval_date": "Jun 30, 2014"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CIII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BUPRENORPHINE",
  "proprietary_name": "Butrans",
  "active_ingred_unit": "ug/h",
  "application_number": "NDA021306",
  "marketing_category": "NDA",
  "nonproprietary_name": "buprenorphine",
  "start_marketing_date": "20110214",
  "active_numerator_strength": "20"
}

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