| NDC Code | 0121-0928-16 |
|---|
| Package Description | 473 mL in 1 BOTTLE (0121-0928-16) |
|---|
| Product NDC | 0121-0928 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Promethazine With Codeine |
|---|
| Non-Proprietary Name | Promethazine Hydrochloride And Codeine Phosphate |
|---|
| Dosage Form | SOLUTION |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20200918 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA040650 |
|---|
| Manufacturer | PAI Holdings, LLC |
|---|
| Substance Name | CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE |
|---|
| Strength | 10; 6.25 |
|---|
| Strength Unit | mg/5mL; mg/5mL |
|---|
| Pharmacy Classes | Full Opioid Agonists [MoA], Opioid Agonist [EPC], Phenothiazine [EPC], Phenothiazines [CS] |
|---|
| DEA Schedule | CV |
|---|