Product NDC: | 57664-185 |
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) |
Product NDC: | 57664-185 |
Labeler Name: | Caraco Pharmaceutical Laboratories, Ltd. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA090180 |
Marketing Category: | ANDA |
Start Marketing Date: | 20100317 |
Package NDC: | 57664-185-34 |
Package Description: | 473 mL in 1 BOTTLE (57664-185-34) |
NDC Code | 57664-185-34 |
Proprietary Name | promethazine hydrochloride and codeine phosphate |
Package Description | 473 mL in 1 BOTTLE (57664-185-34) |
Product NDC | 57664-185 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | promethazine hydrochloride and codeine phosphate |
Dosage Form Name | SYRUP |
Route Name | ORAL |
Start Marketing Date | 20100317 |
Marketing Category Name | ANDA |
Labeler Name | Caraco Pharmaceutical Laboratories, Ltd. |
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] |