| NDC Code | 0115-1042-02 |
| Package Description | 500 TABLET in 1 BOTTLE (0115-1042-02) |
| Product NDC | 0115-1042 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Promethazine Hydrochloride |
| Non-Proprietary Name | Promethazine Hydrochloride |
| Dosage Form | TABLET |
| Usage | ORAL |
| Start Marketing Date | 20080520 |
| Marketing Category Name | ANDA |
| Application Number | ANDA040791 |
| Manufacturer | Global Pharmaceuticals, Division of Impax Laboratories Inc. |
| Substance Name | PROMETHAZINE HYDROCHLORIDE |
| Strength | 50 |
| Strength Unit | mg/1 |
| Pharmacy Classes | Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] |