NDC Code | 0121-0504-16 |
Package Description | 473 mL in 1 BOTTLE (0121-0504-16) |
Product NDC | 0121-0504 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Acetaminophen And Codeine Phosphate |
Non-Proprietary Name | Acetaminophen And Codeine Phosphate |
Dosage Form | SOLUTION |
Usage | ORAL |
Start Marketing Date | 19810821 |
End Marketing Date | 20250430 |
Marketing Category Name | ANDA |
Application Number | ANDA087508 |
Manufacturer | PAI Holdings, LLC dba PAI Pharma |
Substance Name | ACETAMINOPHEN; CODEINE PHOSPHATE |
Strength | 120; 12 |
Strength Unit | mg/5mL; mg/5mL |
Pharmacy Classes | Full Opioid Agonists [MoA], Opioid Agonist [EPC] |
DEA Schedule | CV |