| Product NDC: | 55390-100 |
| Proprietary Name: | Buprenorphine Hydrochloride |
| Non Proprietary Name: | Buprenorphine Hydrochloride |
| Active Ingredient(s): | .324 mg/mL & nbsp; Buprenorphine Hydrochloride |
| Administration Route(s): | INTRAMUSCULAR; INTRAVENOUS |
| Dosage Form(s): | INJECTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 55390-100 |
| Labeler Name: | Bedford Laboratories |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA076931 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20050525 |
| Package NDC: | 55390-100-10 |
| Package Description: | 10 VIAL in 1 BOX (55390-100-10) > 1 mL in 1 VIAL |
| NDC Code | 55390-100-10 |
| Proprietary Name | Buprenorphine Hydrochloride |
| Package Description | 10 VIAL in 1 BOX (55390-100-10) > 1 mL in 1 VIAL |
| Product NDC | 55390-100 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Buprenorphine Hydrochloride |
| Dosage Form Name | INJECTION |
| Route Name | INTRAMUSCULAR; INTRAVENOUS |
| Start Marketing Date | 20050525 |
| Marketing Category Name | ANDA |
| Labeler Name | Bedford Laboratories |
| Substance Name | BUPRENORPHINE HYDROCHLORIDE |
| Strength Number | .324 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] |