| Product NDC: | 50383-930 |
| Proprietary Name: | buprenorphine hydrochloride |
| Non Proprietary Name: | buprenorphine hydrochloride |
| Active Ingredient(s): | 8 mg/1 & nbsp; buprenorphine hydrochloride |
| Administration Route(s): | SUBLINGUAL |
| Dosage Form(s): | TABLET |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 50383-930 |
| Labeler Name: | Hi-Tech Pharmacal Co., Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA090622 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20100924 |
| Package NDC: | 50383-930-93 |
| Package Description: | 30 TABLET in 1 BOTTLE (50383-930-93) |
| NDC Code | 50383-930-93 |
| Proprietary Name | buprenorphine hydrochloride |
| Package Description | 30 TABLET in 1 BOTTLE (50383-930-93) |
| Product NDC | 50383-930 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | buprenorphine hydrochloride |
| Dosage Form Name | TABLET |
| Route Name | SUBLINGUAL |
| Start Marketing Date | 20100924 |
| Marketing Category Name | ANDA |
| Labeler Name | Hi-Tech Pharmacal Co., Inc. |
| Substance Name | BUPRENORPHINE HYDROCHLORIDE |
| Strength Number | 8 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] |