NDC Code | 12634-907-16 |
Package Description | 473 mL in 1 BOTTLE (12634-907-16) |
Product NDC | 12634-907 |
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 | 20100317 |
Marketing Category Name | ANDA |
Application Number | ANDA090180 |
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 |