NDC Code | 64380-447-02 |
Package Description | 500 TABLET in 1 BOTTLE (64380-447-02) |
Product NDC | 64380-447 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Acetaminophen And Codeine Phosphate |
Non-Proprietary Name | Acetaminophen And Codeine Phosphate |
Dosage Form | TABLET |
Usage | ORAL |
Start Marketing Date | 20240520 |
Marketing Category Name | ANDA |
Application Number | ANDA089828 |
Manufacturer | Strides Pharma Science Limited |
Substance Name | ACETAMINOPHEN; CODEINE PHOSPHATE |
Strength | 300; 60 |
Strength Unit | mg/1; mg/1 |
Pharmacy Classes | Full Opioid Agonists [MoA], Opioid Agonist [EPC] |
DEA Schedule | CIII |