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United States · US · US:0121-2038_2c22b6ad-acee-4045-b5c5-025afe061b79
buprenorphine hydrochloride
Orange BookUNIISPLATC N07BC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma
CountryUS (United States)
ATC codeN07BC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11012120383030 TABLET in 1 BOTTLE (0121-2038-30)
Annotations
UNII (FDA Substance ID)
56W8MW3EN1
BUPRENORPHINE HYDROCHLORIDE
RxCUI 203841
Orange Book
A090622
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": "0121-2038_2c22b6ad-acee-4045-b5c5-025afe061b79",
"productndc": "0121-2038",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "090622",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 2MG BASE",
"product_no": "001",
"approval_date": "Sep 24, 2010"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 8MG BASE",
"product_no": "002",
"approval_date": "Sep 24, 2010"
}
],
"appl_type": "A"
},
"dea_schedule": "CIII",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BUPRENORPHINE HYDROCHLORIDE",
"proprietary_name": "buprenorphine hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA090622",
"marketing_category": "ANDA",
"nonproprietary_name": "buprenorphine hydrochloride",
"start_marketing_date": "20231012",
"active_numerator_strength": "8"
}Related drugs
Other records sharing ATC code N07BC01.
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