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United States · US · US:58118-0177_0e76c642-8fc8-c0b6-e063-6394a90a413e
Buprenorphine HCl
Orange BookUNIISPLATC N07BC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerClinical Solutions Wholesale, LLC
CountryUS (United States)
ATC codeN07BC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11581180177830 TABLET in 1 BLISTER PACK (58118-0177-8)
Annotations
UNII (FDA Substance ID)
56W8MW3EN1
BUPRENORPHINE HYDROCHLORIDE
RxCUI 203841
Orange Book
A078633
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "56W8MW3EN1",
"rxcui": "203841",
"inchikey": "UAIXRPCCYXNJMQ-RZIPZOSSSA-N",
"display_name": "BUPRENORPHINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "SUBLINGUAL",
"spl_meta": {
"2738feae-316e-426f-971c-5f142ac01b60": {
"match": "brand_token",
"title": "BUPRENORPHINE PATCH [RHODES PHARMACEUTICALS LLC]",
"spl_version": "17",
"published_date": "2026-06-01"
}
},
"productid": "58118-0177_0e76c642-8fc8-c0b6-e063-6394a90a413e",
"productndc": "58118-0177",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "078633",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 2MG BASE",
"product_no": "001",
"approval_date": "Oct 8, 2009"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "EQ 8MG BASE",
"product_no": "002",
"approval_date": "Oct 8, 2009"
}
],
"appl_type": "A"
},
"dea_schedule": "CIII",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BUPRENORPHINE HYDROCHLORIDE",
"proprietary_name": "Buprenorphine HCl",
"active_ingred_unit": "mg/1",
"application_number": "ANDA078633",
"marketing_category": "ANDA",
"nonproprietary_name": "Buprenorphine HCl",
"start_marketing_date": "20091008",
"active_numerator_strength": "8"
}Related drugs
Other records sharing ATC code N07BC01.
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