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United States · US · US:0054-0176_e59c3c4f-a9cc-412b-b001-b9e430f537c5
Buprenorphine
Orange BookUNIISPLATC N07BC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeN07BC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11005401761330 TABLET in 1 BOTTLE (0054-0176-13)
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": "0054-0176_e59c3c4f-a9cc-412b-b001-b9e430f537c5",
"productndc": "0054-0176",
"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",
"active_ingred_unit": "mg/1",
"application_number": "ANDA078633",
"marketing_category": "ANDA",
"nonproprietary_name": "Buprenorphine",
"start_marketing_date": "20091008",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code N07BC01.
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