Suboxone is a Buccal; Sublingual Film, Soluble in the Human Prescription Drug category. It is labeled and distributed by Indivior Inc.. The primary component is Buprenorphine Hydrochloride; Naloxone Hydrochloride.
Product ID | 12496-1202_1e2afa2f-2bc7-481c-a1f6-97632642199f |
NDC | 12496-1202 |
Product Type | Human Prescription Drug |
Proprietary Name | Suboxone |
Generic Name | Buprenorphine Hydrochloride, Naloxone Hydrochloride |
Dosage Form | Film, Soluble |
Route of Administration | BUCCAL; SUBLINGUAL |
Marketing Start Date | 2010-09-13 |
Marketing Category | NDA / NDA |
Application Number | NDA022410 |
Labeler Name | Indivior Inc. |
Substance Name | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
Active Ingredient Strength | 2 mg/1; mg/1 |
Pharm Classes | Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA] |
DEA Schedule | CIII |
NDC Exclude Flag | N |
Listing Certified Through | 2023-12-31 |
Marketing Start Date | 2010-09-13 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | NDA |
Application Number | NDA022410 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2010-09-13 |
Marketing Category | NDA |
Application Number | NDA022410 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2010-09-13 |
Ingredient | Strength |
---|---|
BUPRENORPHINE HYDROCHLORIDE | 2 mg/1 |
SPL SET ID: | 8a5edcf9-828c-4f97-b671-268ab13a8ecd |
Manufacturer | |
UNII | |
RxNorm Concept Unique ID - RxCUI | |
UPC Code |
NDC | Brand Name | Generic Name |
---|---|---|
12496-1202 | Suboxone | buprenorphine hydrochloride, naloxone hydrochloride |
12496-1204 | Suboxone | buprenorphine hydrochloride, naloxone hydrochloride |
12496-1212 | Suboxone | Suboxone |
12496-1208 | Suboxone | Suboxone |
53217-328 | Suboxone | Suboxone |
55700-147 | Suboxone | Suboxone |
63629-4028 | Suboxone | Suboxone |
0781-7216 | BUPRENORPHINE AND NALOXONE | buprenorphine hydrochloride, naloxone hydrochloride |
0781-7227 | BUPRENORPHINE AND NALOXONE | buprenorphine hydrochloride, naloxone hydrochloride |
0781-7238 | BUPRENORPHINE AND NALOXONE | buprenorphine hydrochloride, naloxone hydrochloride |
0781-7249 | BUPRENORPHINE AND NALOXONE | buprenorphine hydrochloride, naloxone hydrochloride |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SUBOXONE 78303449 2917297 Dead/Cancelled |
Reckitt Benckiser Healthcare (UK) Limited 2003-09-22 |
SUBOXONE 77727995 3917631 Live/Registered |
INDIVIOR UK LIMITED 2009-05-04 |
SUBOXONE 75226449 2169133 Live/Registered |
INDIVIOR UK LIMITED 1997-01-16 |