NDC Code | 60846-970-03 |
Package Description | 30 TABLET in 1 BOTTLE (60846-970-03) |
Product NDC | 60846-970 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Buprenorphine And Naloxone |
Non-Proprietary Name | Buprenorphine And Naloxone |
Dosage Form | TABLET |
Usage | SUBLINGUAL |
Start Marketing Date | 20130222 |
Marketing Category Name | ANDA |
Application Number | ANDA203136 |
Manufacturer | Gemini Laboratories, LLC |
Substance Name | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE |
Strength | 2; .5 |
Strength Unit | mg/1; mg/1 |
Pharmacy Classes | Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC],Opioid Antagonist [EPC],Opioid Antagonists [MoA] |
DEA Schedule | CIII |