| Product NDC: | 54868-1029 |
| Proprietary Name: | Promethazine with Codeine |
| 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) |
| Product NDC: | 54868-1029 |
| Labeler Name: | Physicians Total Care, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA040650 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20010213 |
| Package NDC: | 54868-1029-0 |
| Package Description: | 237 mL in 1 BOTTLE (54868-1029-0) |
| NDC Code | 54868-1029-0 |
| Proprietary Name | Promethazine with Codeine |
| Package Description | 237 mL in 1 BOTTLE (54868-1029-0) |
| Product NDC | 54868-1029 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Promethazine Hydrochloride and Codeine Phosphate |
| Dosage Form Name | SYRUP |
| Route Name | ORAL |
| Start Marketing Date | 20010213 |
| Marketing Category Name | ANDA |
| Labeler Name | Physicians Total Care, 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] |