| Product NDC: | 50383-079 |
| Proprietary Name: | Acetaminophen and Codeine Phosphate |
| 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: | 50383-079 |
| Labeler Name: | Hi-Tech Pharmacal Co., Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA040119 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 19960426 |
| Package NDC: | 50383-079-16 |
| Package Description: | 473 mL in 1 BOTTLE (50383-079-16) |
| NDC Code | 50383-079-16 |
| Proprietary Name | Acetaminophen and Codeine Phosphate |
| Package Description | 473 mL in 1 BOTTLE (50383-079-16) |
| Product NDC | 50383-079 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Acetaminophen and Codeine Phosphate |
| Dosage Form Name | SOLUTION |
| Route Name | ORAL |
| Start Marketing Date | 19960426 |
| Marketing Category Name | ANDA |
| Labeler Name | Hi-Tech Pharmacal Co., Inc. |
| Substance Name | ACETAMINOPHEN; CODEINE PHOSPHATE |
| Strength Number | 120; 12 |
| Strength Unit | mg/5mL; mg/5mL |
| Pharmaceutical Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |