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Buprenorphine HCl and Naloxone HCl
Buprenorphine HCl and Naloxone HCl - 65162-416-09 - (Buprenorphine and Naloxone)
Drug Information of Buprenorphine HCl and Naloxone HCl
| Product NDC: | 65162-416 |
| Proprietary Name: | Buprenorphine HCl and Naloxone HCl |
| Non Proprietary Name: | Buprenorphine and Naloxone |
| Active Ingredient(s): | 2; .5 mg/1; mg/1 & nbsp; Buprenorphine and Naloxone |
| Administration Route(s): | SUBLINGUAL |
| Dosage Form(s): | TABLET |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of Buprenorphine HCl and Naloxone HCl
| Product NDC: | 65162-416 |
| Labeler Name: | Amneal Pharmaceuticals, LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA203136 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20130222 |
Package Information of Buprenorphine HCl and Naloxone HCl
| Package NDC: | 65162-416-09 |
| Package Description: | 90 TABLET in 1 BOTTLE (65162-416-09) |
NDC Information of Buprenorphine HCl and Naloxone HCl
| NDC Code | 65162-416-09 |
| Proprietary Name | Buprenorphine HCl and Naloxone HCl |
| Package Description | 90 TABLET in 1 BOTTLE (65162-416-09) |
| Product NDC | 65162-416 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Buprenorphine and Naloxone |
| Dosage Form Name | TABLET |
| Route Name | SUBLINGUAL |
| Start Marketing Date | 20130222 |
| Marketing Category Name | ANDA |
| Labeler Name | Amneal Pharmaceuticals, LLC |
| Substance Name | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE |
| Strength Number | 2; .5 |
| Strength Unit | mg/1; mg/1 |
| Pharmaceutical Classes | Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] |
