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NDC 00378-8768-93 Buprenorphine and Naloxone 12; 3 mg/1; mg/1 Details
Buprenorphine and Naloxone 12; 3 mg/1; mg/1
Buprenorphine and Naloxone is a BUCCAL; SUBLINGUAL FILM in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE.
MedlinePlus Drug Summary
Buprenorphine and the combination of buprenorphine and naloxone are used to treat opioid dependence (addiction to opioid drugs, including heroin and narcotic painkillers). Buprenorphine is in a class of medications called opioid partial agonist-antagonists and naloxone is in a class of medications called opioid antagonists. Buprenorphine alone and the combination of buprenorphine and naloxone work to prevent withdrawal symptoms when someone stops taking opioid drugs by producing similar effects to these drugs.
Related Packages: 00378-8768-93Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Buprenorphine Sublingual and Buccal (opioid dependence)
Product Information
| NDC | 00378-8768 |
|---|---|
| Product ID | 0378-8768_c7243e18-0425-4883-ae65-48d90b31c4fa |
| Associated GPIs | 65200010208250 |
| GCN Sequence Number | 070262 |
| GCN Sequence Number Description | buprenorphine HCl/naloxone HCl FILM 12 MG-3 MG SUBLINGUAL |
| HIC3 | H3W |
| HIC3 Description | OPIOID WITHDRAWAL THERAPY AGENTS, OPIOID-TYPE |
| GCN | 33744 |
| HICL Sequence Number | 024846 |
| HICL Sequence Number Description | BUPRENORPHINE HCL/NALOXONE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Buprenorphine and Naloxone |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Buprenorphine and Naloxone |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | FILM |
| Route | BUCCAL; SUBLINGUAL |
| Active Ingredient Strength | 12; 3 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE |
| Labeler Name | Mylan Pharmaceuticals Inc. |
| Pharmaceutical Class | Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA] |
| DEA Schedule | CIII |
| Marketing Category | ANDA |
| Application Number | ANDA207607 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00378-8768-93 (00378876893)
| NDC Package Code | 0378-8768-93 |
|---|---|
| Billing NDC | 00378876893 |
| Package | 30 POUCH in 1 CARTON (0378-8768-93) / 1 FILM in 1 POUCH (0378-8768-16) |
| Marketing Start Date | 2019-02-20 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 5.88029 |
| Pricing Unit | EA |
| Effective Date | 2024-02-21 |
| NDC Description | BUPRENORPHINE-NALOXONE 12-3 MG SL FILM |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |