 
                        | Product NDC: | 0603-9013 | 
| Proprietary Name: | Acetaminophen And Codeine | 
| Non Proprietary Name: | Acetaminophen and Codeine Phosphate | 
| Active Ingredient(s): | 120; 12 mg/5mL; mg/5mL & nbsp; Acetaminophen and Codeine Phosphate | 
| Administration Route(s): | ORAL | 
| Dosage Form(s): | SOLUTION | 
| Coding System: | National Drug Codes(NDC) | 
| Product NDC: | 0603-9013 | 
| Labeler Name: | Qualitest Pharmaceuticals | 
| Product Type: | HUMAN PRESCRIPTION DRUG | 
| FDA Application Number: | ANDA091238 | 
| Marketing Category: | ANDA | 
| Start Marketing Date: | 20111110 | 
| Package NDC: | 0603-9013-54 | 
| Package Description: | 120 mL in 1 BOTTLE (0603-9013-54) | 
| NDC Code | 0603-9013-54 | 
| Proprietary Name | Acetaminophen And Codeine | 
| Package Description | 120 mL in 1 BOTTLE (0603-9013-54) | 
| Product NDC | 0603-9013 | 
| Product Type Name | HUMAN PRESCRIPTION DRUG | 
| Non Proprietary Name | Acetaminophen and Codeine Phosphate | 
| Dosage Form Name | SOLUTION | 
| Route Name | ORAL | 
| Start Marketing Date | 20111110 | 
| Marketing Category Name | ANDA | 
| Labeler Name | Qualitest Pharmaceuticals | 
| Substance Name | ACETAMINOPHEN; CODEINE PHOSPHATE | 
| Strength Number | 120; 12 | 
| Strength Unit | mg/5mL; mg/5mL | 
| Pharmaceutical Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |