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United States · US · US:0406-7012_12e82887-be89-46cd-a55a-46e9e2ef2cba
Buprenorphine HCl
Orange BookUNIISPLATC N07BC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSpecGx LLC
CountryUS (United States)
ATC codeN07BC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11040670120330 TABLET in 1 BOTTLE (0406-7012-03)
Annotations
UNII (FDA Substance ID)
56W8MW3EN1
BUPRENORPHINE HYDROCHLORIDE
RxCUI 203841
Orange Book
A218473
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": "0406-7012_12e82887-be89-46cd-a55a-46e9e2ef2cba",
"productndc": "0406-7012",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "218473",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 2MG BASE",
"product_no": "001",
"approval_date": "Dec 10, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 8MG BASE",
"product_no": "002",
"approval_date": "Dec 10, 2025"
}
],
"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": "ANDA218473",
"marketing_category": "ANDA",
"nonproprietary_name": "Buprenorphine HCl",
"start_marketing_date": "20260119",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code N07BC01.
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