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NDC 43386-0680-05 PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE .5; 50 mg/1; mg/1 Details
PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE .5; 50 mg/1; mg/1
PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Lupin Pharmaceuticals,Inc.. The primary component is NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Pentazocine is used to relieve moderate to severe pain. Pentazocine is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the brain and nervous system respond to pain.
Related Packages: 43386-0680-05Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pentazocine
Product Information
| NDC | 43386-0680 |
|---|---|
| Product ID | 43386-680_c20cf8d7-480d-4d2a-aa35-6465d1dafa2e |
| Associated GPIs | 65200040300310 |
| GCN Sequence Number | 004292 |
| GCN Sequence Number Description | pentazocine HCl/naloxone HCl TABLET 50MG-0.5MG ORAL |
| HIC3 | H3A |
| HIC3 Description | OPIOID ANALGESICS |
| GCN | 71060 |
| HICL Sequence Number | 001781 |
| HICL Sequence Number Description | PENTAZOCINE HCL/NALOXONE HCL |
| Brand/Generic | Generic |
| Proprietary Name | PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | pentazocine hydrochloride and naloxone hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | .5; 50 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE |
| Labeler Name | Lupin Pharmaceuticals,Inc. |
| Pharmaceutical Class | Competitive Opioid Antagonists [MoA], Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist/Antagonist [EPC], Partial Opioid Agonists [MoA] |
| DEA Schedule | CIV |
| Marketing Category | ANDA |
| Application Number | ANDA075735 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 43386-0680-05 (43386068005)
| NDC Package Code | 43386-680-05 |
|---|---|
| Billing NDC | 43386068005 |
| Package | 500 TABLET in 1 BOTTLE (43386-680-05) |
| Marketing Start Date | 2011-05-11 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |