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NDC 12496-0757-05 Buprenex 0.3 mg/mL Details
Buprenex 0.3 mg/mL
Buprenex is a INTRAMUSCULAR; INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Indivior Inc.. The primary component is BUPRENORPHINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Buprenorphine extended-release injection is used to treat opioid dependence (addiction to opioid drugs, including heroin and narcotic painkillers) in people who have received buccal or sublingual buprenorphine for at least 7 days. Buprenorphine extended-release injection is in a class of medications called opiate partial agonists. It works to prevent withdrawal symptoms when someone stops taking opioid drugs by producing similar effects to these drugs.
Related Packages: 12496-0757-05Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Buprenorphine Injection
Product Information
| NDC | 12496-0757 |
|---|---|
| Product ID | 12496-0757_9925737b-3031-4372-a2cf-8c4ed05ebdbf |
| Associated GPIs | 65200010102005 |
| GCN Sequence Number | 004262 |
| GCN Sequence Number Description | buprenorphine HCl AMPUL 0.3 MG/ML INJECTION |
| HIC3 | H3A |
| HIC3 Description | OPIOID ANALGESICS |
| GCN | 27500 |
| HICL Sequence Number | 001762 |
| HICL Sequence Number Description | BUPRENORPHINE HCL |
| Brand/Generic | Brand |
| Proprietary Name | Buprenex |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | buprenorphine hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION |
| Route | INTRAMUSCULAR; INTRAVENOUS |
| Active Ingredient Strength | 0.3 |
| Active Ingredient Units | mg/mL |
| Substance Name | BUPRENORPHINE HYDROCHLORIDE |
| Labeler Name | Indivior Inc. |
| Pharmaceutical Class | Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA] |
| DEA Schedule | CIII |
| Marketing Category | NDA |
| Application Number | NDA018401 |
| Listing Certified Through | 2023-12-31 |
Package
NDC 12496-0757-05 (12496075705)
| NDC Package Code | 12496-0757-5 |
|---|---|
| Billing NDC | 12496075705 |
| Package | 5 AMPULE in 1 CARTON (12496-0757-5) / 1 mL in 1 AMPULE (12496-0757-1) |
| Marketing Start Date | 1985-06-30 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |