NDC Code | 52125-587-01 |
Package Description | 473 mL in 1 BOTTLE (52125-587-01) |
Product NDC | 52125-587 |
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 | 20130604 |
Marketing Category Name | ANDA |
Application Number | ANDA040151 |
Manufacturer | REMEDYREPACK 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 [Chemical/Ingredient] |