Product NDC: | 68788-9895 |
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: | 68788-9895 |
Labeler Name: | Preferred Pharmaceuticals, Inc |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA040650 |
Marketing Category: | ANDA |
Start Marketing Date: | 20120214 |
Package NDC: | 68788-9895-1 |
Package Description: | 118 mL in 1 BOTTLE (68788-9895-1) |
NDC Code | 68788-9895-1 |
Proprietary Name | Promethazine with Codeine |
Package Description | 118 mL in 1 BOTTLE (68788-9895-1) |
Product NDC | 68788-9895 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Promethazine Hydrochloride and Codeine Phosphate |
Dosage Form Name | SYRUP |
Route Name | ORAL |
Start Marketing Date | 20120214 |
Marketing Category Name | ANDA |
Labeler Name | Preferred Pharmaceuticals, 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] |