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United States · US · US:59011-757_cf5d162f-a313-4f27-a292-3ecf640fbea7
Butrans
Orange BookUNIISPLATC N07BC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerKnoa Pharma LLC
CountryUS (United States)
ATC codeN07BC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1159011757044 POUCH in 1 CARTON (59011-757-04) / 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": "59011-757_cf5d162f-a313-4f27-a292-3ecf640fbea7",
"productndc": "59011-757",
"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": "7.5"
}Related drugs
Other records sharing ATC code N07BC01.
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