| Product NDC: | 50383-801 |
| Proprietary Name: | Promethazine Hydrochloride |
| Non Proprietary Name: | Promethazine Hydrochloride |
| Active Ingredient(s): | 6.25 mg/5mL & nbsp; Promethazine Hydrochloride |
| Administration Route(s): | ORAL |
| Dosage Form(s): | SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 50383-801 |
| Labeler Name: | Hi-Tech Pharmacal Co., Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA040026 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 19980925 |
| Package NDC: | 50383-801-16 |
| Package Description: | 473 mL in 1 BOTTLE, GLASS (50383-801-16) |
| NDC Code | 50383-801-16 |
| Proprietary Name | Promethazine Hydrochloride |
| Package Description | 473 mL in 1 BOTTLE, GLASS (50383-801-16) |
| Product NDC | 50383-801 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Promethazine Hydrochloride |
| Dosage Form Name | SOLUTION |
| Route Name | ORAL |
| Start Marketing Date | 19980925 |
| Marketing Category Name | ANDA |
| Labeler Name | Hi-Tech Pharmacal Co., Inc. |
| Substance Name | PROMETHAZINE HYDROCHLORIDE |
| Strength Number | 6.25 |
| Strength Unit | mg/5mL |
| Pharmaceutical Classes | Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] |