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United States · US · US:12496-1212_ad5a289a-6285-4b2d-b7ad-e4812169dd58
Suboxone
Orange BookUNIISPLATC N02AE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerINDIVIOR INC.
CountryUS (United States)
ATC codeN02AE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11124961212330 POUCH in 1 CARTON (12496-1212-3) / 1 FILM, SOLUBLE in 1 POUCH (12496-1212-1)
Annotations
UNII (FDA Substance ID)
56W8MW3EN1
BUPRENORPHINE HYDROCHLORIDE
RxCUI 203841
Orange Book
N022410
ABABABAB
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": "BUCCAL; SUBLINGUAL",
"spl_meta": {
"8a5edcf9-828c-4f97-b671-268ab13a8ecd": {
"match": "brand_token",
"title": "SUBOXONE (BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE) FILM, SOLUBLE [INDIVIOR INC.]",
"spl_version": "37",
"published_date": "2026-02-11"
}
},
"productid": "12496-1212_ad5a289a-6285-4b2d-b7ad-e4812169dd58",
"productndc": "12496-1212",
"dosage_form": "FILM, SOLUBLE",
"orange_book": {
"appl_no": "022410",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 2MG BASE;EQ 0.5MG BASE",
"product_no": "001",
"approval_date": "Aug 30, 2010"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 8MG BASE;EQ 2MG BASE",
"product_no": "002",
"approval_date": "Aug 30, 2010"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 4MG BASE;EQ 1MG BASE",
"product_no": "003",
"approval_date": "Aug 10, 2012"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "EQ 12MG BASE;EQ 3MG BASE",
"product_no": "004",
"approval_date": "Aug 10, 2012"
}
],
"appl_type": "N"
},
"dea_schedule": "CIII",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE",
"proprietary_name": "Suboxone",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "NDA022410",
"marketing_category": "NDA",
"nonproprietary_name": "buprenorphine hydrochloride, naloxone hydrochloride",
"start_marketing_date": "20120824",
"active_numerator_strength": "12; 3"
}Related drugs
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