| Product NDC: | 49999-152 | 
| 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: | 49999-152 | 
| Labeler Name: | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC | 
| Product Type: | HUMAN PRESCRIPTION DRUG | 
| FDA Application Number: | ANDA040650 | 
| Marketing Category: | ANDA | 
| Start Marketing Date: | 20120321 | 
| Package NDC: | 49999-152-04 | 
| Package Description: | 118 mL in 1 BOTTLE (49999-152-04) | 
| NDC Code | 49999-152-04 | 
| Proprietary Name | Promethazine with Codeine | 
| Package Description | 118 mL in 1 BOTTLE (49999-152-04) | 
| Product NDC | 49999-152 | 
| Product Type Name | HUMAN PRESCRIPTION DRUG | 
| Non Proprietary Name | Promethazine Hydrochloride and Codeine Phosphate | 
| Dosage Form Name | SYRUP | 
| Route Name | ORAL | 
| Start Marketing Date | 20120321 | 
| Marketing Category Name | ANDA | 
| Labeler Name | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC | 
| Substance Name | CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE | 
| Strength Number | 10; 6.25 | 
| Strength Unit | mg/5mL; mg/5mL | 
| Pharmaceutical Classes | Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] |