Product NDC: | 63629-2959 |
Proprietary Name: | PROMETHAZINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE AND CODEINE PHOSPHATE |
Non Proprietary Name: | PROMETHAZINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE AND CODEINE PHOSPHATE |
Active Ingredient(s): | 10; 5; 6.25 mg/5mL; mg/5mL; mg/5mL & nbsp; PROMETHAZINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE AND CODEINE PHOSPHATE |
Administration Route(s): | ORAL |
Dosage Form(s): | SYRUP |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 63629-2959 |
Labeler Name: | Bryant Ranch Prepack |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA088764 |
Marketing Category: | ANDA |
Start Marketing Date: | 20111219 |
Package NDC: | 63629-2959-1 |
Package Description: | 120 mL in 1 BOTTLE (63629-2959-1) |
NDC Code | 63629-2959-1 |
Proprietary Name | PROMETHAZINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE AND CODEINE PHOSPHATE |
Package Description | 120 mL in 1 BOTTLE (63629-2959-1) |
Product NDC | 63629-2959 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | PROMETHAZINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE AND CODEINE PHOSPHATE |
Dosage Form Name | SYRUP |
Route Name | ORAL |
Start Marketing Date | 20111219 |
Marketing Category Name | ANDA |
Labeler Name | Bryant Ranch Prepack |
Substance Name | CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE |
Strength Number | 10; 5; 6.25 |
Strength Unit | mg/5mL; mg/5mL; mg/5mL |
Pharmaceutical Classes | Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] |