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NDC 12496-0300-01 SUBLOCADE 300 mg/1 Details
SUBLOCADE 300 mg/1
SUBLOCADE is a SUBCUTANEOUS SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Indivior Inc.. The primary component is BUPRENORPHINE.
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: 12496-0300-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Buprenorphine Injection
Product Information
| NDC | 12496-0300 |
|---|---|
| Product ID | 12496-0300_73ae82ca-2145-481f-9787-eef712d1b4cc |
| Associated GPIs | 6520001000E530 |
| GCN Sequence Number | 077999 |
| GCN Sequence Number Description | buprenorphine SOLER SYR 300 MG/1.5 SUBCUT |
| HIC3 | H3W |
| HIC3 Description | OPIOID WITHDRAWAL THERAPY AGENTS, OPIOID-TYPE |
| GCN | 44186 |
| HICL Sequence Number | 023438 |
| HICL Sequence Number Description | BUPRENORPHINE |
| Brand/Generic | Brand |
| Proprietary Name | SUBLOCADE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | buprenorphine |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | SUBCUTANEOUS |
| Active Ingredient Strength | 300 |
| Active Ingredient Units | mg/1 |
| Substance Name | BUPRENORPHINE |
| Labeler Name | Indivior Inc. |
| Pharmaceutical Class | Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA] |
| DEA Schedule | CIII |
| Marketing Category | NDA |
| Application Number | NDA209819 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 12496-0300-01 (12496030001)
| NDC Package Code | 12496-0300-1 |
|---|---|
| Billing NDC | 12496030001 |
| Package | 1 POUCH in 1 CARTON (12496-0300-1) / 1 SYRINGE in 1 POUCH (12496-0300-2) / 1 SOLUTION in 1 SYRINGE (12496-0300-5) |
| Marketing Start Date | 2018-02-26 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |