| NDC Code | 43598-581-30 |
|---|
| Package Description | 30 POUCH in 1 CARTON (43598-581-30) / 1 FILM, SOLUBLE in 1 POUCH (43598-581-01) |
|---|
| Product NDC | 43598-581 |
|---|
| 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 | 20180614 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA205806 |
|---|
| Manufacturer | Dr.Reddys Laboratories Inc |
|---|
| Substance Name | BUPRENORPHINE HYDROCHLORIDE; NALOXONE |
|---|
| 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 |
|---|