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NDC 00054-0188-13 buprenorphine hydrochloride and naloxone hydrochloride dihydrate 2; .5 mg/1; mg/1 Details
buprenorphine hydrochloride and naloxone hydrochloride dihydrate 2; .5 mg/1; mg/1
buprenorphine hydrochloride and naloxone hydrochloride dihydrate is a SUBLINGUAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Hikma Pharmaceuticals USA 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: 00054-0188-13Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Buprenorphine Sublingual and Buccal (opioid dependence)
Product Information
| NDC | 00054-0188 |
|---|---|
| Product ID | 0054-0188_1055d41b-9222-44ec-b732-024497a6269c |
| Associated GPIs | 65200010200720 |
| GCN Sequence Number | 051640 |
| GCN Sequence Number Description | buprenorphine HCl/naloxone HCl TAB SUBL 2 MG-0.5MG SUBLINGUAL |
| HIC3 | H3W |
| HIC3 Description | OPIOID WITHDRAWAL THERAPY AGENTS, OPIOID-TYPE |
| GCN | 18973 |
| HICL Sequence Number | 024846 |
| HICL Sequence Number Description | BUPRENORPHINE HCL/NALOXONE HCL |
| Brand/Generic | Generic |
| Proprietary Name | buprenorphine hydrochloride and naloxone hydrochloride dihydrate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | buprenorphine hydrochloride and naloxone hydrochloride dihydrate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | SUBLINGUAL |
| Active Ingredient Strength | 2; .5 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE |
| Labeler Name | Hikma Pharmaceuticals USA 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 | ANDA203326 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00054-0188-13 (00054018813)
| NDC Package Code | 0054-0188-13 |
|---|---|
| Billing NDC | 00054018813 |
| Package | 30 TABLET in 1 BOTTLE (0054-0188-13) |
| Marketing Start Date | 2014-06-27 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.53821 |
| Pricing Unit | EA |
| Effective Date | 2024-02-21 |
| NDC Description | BUPRENORPHINE-NALOXONE 2-0.5 MG SL TABLET |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |