| NDC Code | 12634-909-16 |
|---|
| Package Description | 473 mL in 1 BOTTLE (12634-909-16) |
|---|
| Product NDC | 12634-909 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Promethazine Hydrochloride And Codeine Phosphate |
|---|
| Non-Proprietary Name | Promethazine Hydrochloride And Codeine Phosphate |
|---|
| Dosage Form | SYRUP |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 19970826 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA040151 |
|---|
| Manufacturer | Apotheca Inc |
|---|
| 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 |
|---|