| NDC Code | 0121-1008-12 |
|---|
| Package Description | 12.5 mL in 1 CUP, UNIT-DOSE (0121-1008-12) |
|---|
| Product NDC | 0121-1008 |
|---|
| 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 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA087508 |
|---|
| Manufacturer | PAI Holdings, LLC dba PAI Pharma |
|---|
| Substance Name | ACETAMINOPHEN; CODEINE PHOSPHATE |
|---|
| Strength | 300; 30 |
|---|
| Strength Unit | mg/12.5mL; mg/12.5mL |
|---|
| Pharmacy Classes | Full Opioid Agonists [MoA], Opioid Agonist [EPC] |
|---|
| DEA Schedule | CV |
|---|