🇺🇸
United States · US · US:12496-0300_a5971cb4-0e84-4bc6-a2ff-bbd668f2dbec
SUBLOCADE
Orange BookUNIISPLATC N07BC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerIndivior Inc.
CountryUS (United States)
ATC codeN07BC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1112496030011 POUCH in 1 CARTON (12496-0300-1) / 1 SYRINGE in 1 POUCH (12496-0300-2) / 1 SOLUTION in 1 SYRINGE (12496-0300-5)
Annotations
UNII (FDA Substance ID)
40D3SCR4GZ
BUPRENORPHINE
RxCUI 1819
Orange Book
N209819
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "40D3SCR4GZ",
"rxcui": "1819",
"inchikey": "RMRJXGBAOAMLHD-IHFGGWKQSA-N",
"display_name": "BUPRENORPHINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "SUBCUTANEOUS",
"spl_meta": {
"6189fb21-9432-45f8-8481-0bfaf3ccde95": {
"match": "brand_token",
"title": "SUBLOCADE (BUPRENORPHINE) SOLUTION [INDIVIOR INC.]",
"spl_version": "42",
"published_date": "2026-02-16"
}
},
"productid": "12496-0300_a5971cb4-0e84-4bc6-a2ff-bbd668f2dbec",
"productndc": "12496-0300",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "209819",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "100MG/0.5ML (100MG/0.5ML)",
"product_no": "001",
"approval_date": "Nov 30, 2017"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "300MG/1.5ML (200MG/ML)",
"product_no": "002",
"approval_date": "Nov 30, 2017"
}
],
"appl_type": "N"
},
"dea_schedule": "CIII",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BUPRENORPHINE",
"proprietary_name": "SUBLOCADE",
"active_ingred_unit": "mg/1",
"application_number": "NDA209819",
"marketing_category": "NDA",
"nonproprietary_name": "buprenorphine",
"start_marketing_date": "20180226",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code N07BC01.
Access this data programmatically
Query SUBLOCADE and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.