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Promethazine Hydrochloride and Codeine Phosphate
Promethazine Hydrochloride and Codeine Phosphate - 50383-804-16 - (Promethazine Hydrochloride and Codeine Phosphate)
Drug Information of Promethazine Hydrochloride and Codeine Phosphate
| Product NDC: | 50383-804 |
| Proprietary Name: | Promethazine Hydrochloride and Codeine Phosphate |
| Non Proprietary Name: | Promethazine Hydrochloride and Codeine Phosphate |
| Active Ingredient(s): | 10; 6.25 mg/5mL; mg/5mL & nbsp; Promethazine Hydrochloride and Codeine Phosphate |
| Administration Route(s): | ORAL |
| Dosage Form(s): | SYRUP |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of Promethazine Hydrochloride and Codeine Phosphate
| Product NDC: | 50383-804 |
| Labeler Name: | Hi-Tech Pharmacal Co., Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA040151 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 19970826 |
Package Information of Promethazine Hydrochloride and Codeine Phosphate
| Package NDC: | 50383-804-16 |
| Package Description: | 473 mL in 1 BOTTLE (50383-804-16) |
NDC Information of Promethazine Hydrochloride and Codeine Phosphate
| NDC Code | 50383-804-16 |
| Proprietary Name | Promethazine Hydrochloride and Codeine Phosphate |
| Package Description | 473 mL in 1 BOTTLE (50383-804-16) |
| Product NDC | 50383-804 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Promethazine Hydrochloride and Codeine Phosphate |
| Dosage Form Name | SYRUP |
| Route Name | ORAL |
| Start Marketing Date | 19970826 |
| Marketing Category Name | ANDA |
| Labeler Name | Hi-Tech Pharmacal Co., Inc. |
| Substance Name | CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE |
| Strength Number | 10; 6.25 |
| Strength Unit | mg/5mL; mg/5mL |
| Pharmaceutical Classes | Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] |
