| NDC Code | 33342-270-11 |
| Package Description | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (33342-270-11) |
| Product NDC | 33342-270 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Tramadol Hydrochloride |
| Non-Proprietary Name | Tramadol Hydrochloride |
| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
| Usage | ORAL |
| Start Marketing Date | 20250131 |
| Marketing Category Name | ANDA |
| Application Number | ANDA209404 |
| Manufacturer | Macleods Pharmaceuticals Limited |
| Substance Name | TRAMADOL HYDROCHLORIDE |
| Strength | 200 |
| Strength Unit | mg/1 |
| Pharmacy Classes | Full Opioid Agonists [MoA], Opioid Agonist [EPC] |
| DEA Schedule | CIV |