Product NDC: | 0517-0725 |
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, SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0517-0725 |
Labeler Name: | American Regent, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA078331 |
Marketing Category: | ANDA |
Start Marketing Date: | 20100813 |
Package NDC: | 0517-0725-05 |
Package Description: | 5 VIAL in 1 CARTON (0517-0725-05) > 1 mL in 1 VIAL (0517-0725-01) |
NDC Code | 0517-0725-05 |
Proprietary Name | Buprenorphine Hydrochloride |
Package Description | 5 VIAL in 1 CARTON (0517-0725-05) > 1 mL in 1 VIAL (0517-0725-01) |
Product NDC | 0517-0725 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Buprenorphine Hydrochloride |
Dosage Form Name | INJECTION, SOLUTION |
Route Name | INTRAMUSCULAR; INTRAVENOUS |
Start Marketing Date | 20100813 |
Marketing Category Name | ANDA |
Labeler Name | American Regent, Inc. |
Substance Name | BUPRENORPHINE HYDROCHLORIDE |
Strength Number | .324 |
Strength Unit | mg/mL |
Pharmaceutical Classes | Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] |