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United States · US · US:0228-3153_eb9e7c72-45fb-4455-a405-027cf06caac6
Buprenorphine
Orange BookUNIISPLATC N07BC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerActavis Pharma, Inc.
CountryUS (United States)
ATC codeN07BC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11022831530330 TABLET in 1 BOTTLE (0228-3153-03)
Annotations
UNII (FDA Substance ID)
56W8MW3EN1
BUPRENORPHINE HYDROCHLORIDE
RxCUI 203841
Orange Book
A090819
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": "0228-3153_eb9e7c72-45fb-4455-a405-027cf06caac6",
"productndc": "0228-3153",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "090819",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 2MG BASE",
"product_no": "001",
"approval_date": "Feb 19, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 8MG BASE",
"product_no": "002",
"approval_date": "Feb 19, 2015"
}
],
"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": "ANDA090819",
"marketing_category": "ANDA",
"nonproprietary_name": "Buprenorphine",
"start_marketing_date": "20150219",
"active_numerator_strength": "8"
}Related drugs
Other records sharing ATC code N07BC01.
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