 
                        | Product NDC: | 0054-0404 | 
| Proprietary Name: | Morphine Sulfate | 
| Non Proprietary Name: | Morphine Sulfate | 
| Active Ingredient(s): | 100 mg/5mL & nbsp; Morphine Sulfate | 
| Administration Route(s): | ORAL | 
| Dosage Form(s): | SOLUTION | 
| Coding System: | National Drug Codes(NDC) | 
| Product NDC: | 0054-0404 | 
| Labeler Name: | Roxane Laboratories, Inc | 
| Product Type: | HUMAN PRESCRIPTION DRUG | 
| FDA Application Number: | NDA022195 | 
| Marketing Category: | NDA | 
| Start Marketing Date: | 20110125 | 
| Package NDC: | 0054-0404-44 | 
| Package Description: | 30 mL in 1 BOTTLE (0054-0404-44) | 
| NDC Code | 0054-0404-44 | 
| Proprietary Name | Morphine Sulfate | 
| Package Description | 30 mL in 1 BOTTLE (0054-0404-44) | 
| Product NDC | 0054-0404 | 
| Product Type Name | HUMAN PRESCRIPTION DRUG | 
| Non Proprietary Name | Morphine Sulfate | 
| Dosage Form Name | SOLUTION | 
| Route Name | ORAL | 
| Start Marketing Date | 20110125 | 
| Marketing Category Name | NDA | 
| Labeler Name | Roxane Laboratories, Inc | 
| Substance Name | MORPHINE SULFATE | 
| Strength Number | 100 | 
| Strength Unit | mg/5mL | 
| Pharmaceutical Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |