| Product NDC: | 0054-0177 |
| Proprietary Name: | Buprenorphine HCl |
| Non Proprietary Name: | Buprenorphine HCl |
| Active Ingredient(s): | 8 mg/1 & nbsp; Buprenorphine HCl |
| Administration Route(s): | SUBLINGUAL |
| Dosage Form(s): | TABLET |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0054-0177 |
| Labeler Name: | Roxane Laboratories, Inc |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA078633 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20091008 |
| Package NDC: | 0054-0177-13 |
| Package Description: | 30 TABLET in 1 BOTTLE (0054-0177-13) |
| NDC Code | 0054-0177-13 |
| Proprietary Name | Buprenorphine HCl |
| Package Description | 30 TABLET in 1 BOTTLE (0054-0177-13) |
| Product NDC | 0054-0177 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Buprenorphine HCl |
| Dosage Form Name | TABLET |
| Route Name | SUBLINGUAL |
| Start Marketing Date | 20091008 |
| Marketing Category Name | ANDA |
| Labeler Name | Roxane Laboratories, Inc |
| Substance Name | BUPRENORPHINE HYDROCHLORIDE |
| Strength Number | 8 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] |