| NDC Code | 55289-048-15 |
|---|
| Package Description | 15 TABLET in 1 BOTTLE, PLASTIC (55289-048-15) |
|---|
| Product NDC | 55289-048 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Tylenol With Codeine |
|---|
| Non-Proprietary Name | Acetaminophen And Codeine Phosphate |
|---|
| Dosage Form | TABLET |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 19770817 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA085055 |
|---|
| Manufacturer | PD-Rx Pharmaceuticals, Inc. |
|---|
| Substance Name | ACETAMINOPHEN; CODEINE PHOSPHATE |
|---|
| Strength | 300; 30 |
|---|
| Strength Unit | mg/1; mg/1 |
|---|
| Pharmacy Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |
|---|
| DEA Schedule | CIII |
|---|