| NDC Code | 31722-480-30 |
|---|
| Package Description | 30 POUCH in 1 CARTON (31722-480-30) / 1 FILM, SOLUBLE in 1 POUCH (31722-480-31) |
|---|
| Product NDC | 31722-480 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Buprenorphine And Naloxone |
|---|
| Non-Proprietary Name | Buprenorphine And Naloxone |
|---|
| Dosage Form | FILM, SOLUBLE |
|---|
| Usage | BUCCAL; SUBLINGUAL |
|---|
| Start Marketing Date | 20260501 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA219850 |
|---|
| Manufacturer | Camber Pharmaceuticals, Inc. |
|---|
| Substance Name | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
|---|
| Strength | 4; 1 |
|---|
| 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 |
|---|