| Product NDC: | 21695-515 |
| Proprietary Name: | Buprenorphine Hydrochloride |
| Non Proprietary Name: | Buprenorphine Hydrochloride |
| Active Ingredient(s): | .3 mg/mL & nbsp; Buprenorphine Hydrochloride |
| Administration Route(s): | INTRAMUSCULAR; INTRAVENOUS |
| Dosage Form(s): | INJECTION, SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 21695-515 |
| Labeler Name: | Rebel Distributors Corp |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA074137 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20100712 |
| Package NDC: | 21695-515-10 |
| Package Description: | 10 CARTRIDGE in 1 CARTON (21695-515-10) > 1 mL in 1 CARTRIDGE |
| NDC Code | 21695-515-10 |
| Proprietary Name | Buprenorphine Hydrochloride |
| Package Description | 10 CARTRIDGE in 1 CARTON (21695-515-10) > 1 mL in 1 CARTRIDGE |
| Product NDC | 21695-515 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Buprenorphine Hydrochloride |
| Dosage Form Name | INJECTION, SOLUTION |
| Route Name | INTRAMUSCULAR; INTRAVENOUS |
| Start Marketing Date | 20100712 |
| Marketing Category Name | ANDA |
| Labeler Name | Rebel Distributors Corp |
| Substance Name | BUPRENORPHINE HYDROCHLORIDE |
| Strength Number | .3 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] |