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United States · US · US:50268-129_47e239f0-069e-a3e1-e063-6294a90a7bf1
Buprenorphine
Orange BookUNIISPLATC N07BC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAvPAK
CountryUS (United States)
ATC codeN07BC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11502681291550 BLISTER PACK in 1 BOX (50268-129-15) / 1 TABLET in 1 BLISTER PACK (50268-129-11)
Annotations
UNII (FDA Substance ID)
56W8MW3EN1
BUPRENORPHINE HYDROCHLORIDE
RxCUI 203841
Orange Book
A201760
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": "50268-129_47e239f0-069e-a3e1-e063-6294a90a7bf1",
"productndc": "50268-129",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "201760",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 2MG BASE",
"product_no": "001",
"approval_date": "Jan 29, 2016"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 8MG BASE",
"product_no": "002",
"approval_date": "Jan 29, 2016"
}
],
"appl_type": "A"
},
"dea_schedule": "CIII",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BUPRENORPHINE HYDROCHLORIDE",
"proprietary_name": "Buprenorphine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA201760",
"marketing_category": "ANDA",
"nonproprietary_name": "Buprenorphine",
"start_marketing_date": "20240319",
"active_numerator_strength": "8"
}Related drugs
Other records sharing ATC code N07BC01.
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