| NDC Code | 50383-801-04 |
| Package Description | 118 mL in 1 BOTTLE (50383-801-04) |
| Product NDC | 50383-801 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Promethazine Hydrochloride |
| Non-Proprietary Name | Promethazine Hydrochloride |
| Dosage Form | SOLUTION |
| Usage | ORAL |
| Start Marketing Date | 19980925 |
| Marketing Category Name | ANDA |
| Application Number | ANDA040026 |
| Manufacturer | Hi-Tech Pharmacal Co., Inc. |
| Substance Name | PROMETHAZINE HYDROCHLORIDE |
| Strength | 6.25 |
| Strength Unit | mg/5mL |
| Pharmacy Classes | Phenothiazine [EPC], Phenothiazines [CS] |