| NDC Code | 67296-2096-3 |
|---|
| Package Description | 30 FILM in 1 BOTTLE (67296-2096-3) |
|---|
| Product NDC | 67296-2096 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Buprenorphine And Naloxone |
|---|
| Non-Proprietary Name | Buprenorphine And Naloxone |
|---|
| Dosage Form | FILM |
|---|
| Usage | BUCCAL; SUBLINGUAL |
|---|
| Start Marketing Date | 20230829 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA212756 |
|---|
| Manufacturer | RedPharm Drug |
|---|
| Substance Name | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
|---|
| Strength | 12; 3 |
|---|
| Strength Unit | mg/1; mg/1 |
|---|
| Pharmacy Classes | Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA] |
|---|
| DEA Schedule | CIII |
|---|