TYLENOL with Codeine - acetaminophen and codeine phosphate
Navigation: NDC > Supplier starting with: J > JANSSEN PHARMACEUTICALS, INC.| Field | Value |
|---|---|
| NDC Code: | 50458-515 |
| Proprietary Name: | TYLENOL with Codeine |
| Suffix: | |
| Non-Proprietary Name: | acetaminophen and codeine phosphate |
| Dosage Form: | TABLET |
| Method: | ORAL |
| Original Marketing Date: | 17-08-1977 |
| Category Name: | ANDA |
| Application Number: | ANDA085055 |
| Labeler: | JANSSEN PHARMACEUTICALS, INC. |
| Substance Name: | ACETAMINOPHEN; CODEINE PHOSPHATE |
| Active Numerator Strength: | 300; 60 |
| Active Ingredient Unit: | mg/1; mg/1 |
| Pharm Classes: | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |
| DEA Schedule: | CIII |