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United States · US · US:72189-582_248524c6-4c8c-a450-e063-6394a90a81ef
Buprenorphine Sublingual C-III
Orange BookUNIISPLATC N07BC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDirect_Rx
CountryUS (United States)
ATC codeN07BC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11721895826060 TABLET in 1 BOTTLE (72189-582-60)
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": "72189-582_248524c6-4c8c-a450-e063-6394a90a81ef",
"productndc": "72189-582",
"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 Sublingual C-III",
"active_ingred_unit": "mg/1",
"application_number": "ANDA078633",
"marketing_category": "ANDA",
"nonproprietary_name": "Buprenorphine Sublingual C-III",
"start_marketing_date": "20241015",
"active_numerator_strength": "8"
}Related drugs
Other records sharing ATC code N07BC01.
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