 
                        | Product NDC: | 54868-5413 | 
| Proprietary Name: | MORPHINE SULFATE | 
| Non Proprietary Name: | morphine sulfate | 
| Active Ingredient(s): | 10 mg/5mL & nbsp; morphine sulfate | 
| Administration Route(s): | ORAL | 
| Dosage Form(s): | SOLUTION | 
| Coding System: | National Drug Codes(NDC) | 
| Product NDC: | 54868-5413 | 
| Labeler Name: | Physicians Total Care, Inc. | 
| Product Type: | HUMAN PRESCRIPTION DRUG | 
| FDA Application Number: | NDA022195 | 
| Marketing Category: | NDA | 
| Start Marketing Date: | 20050912 | 
| Package NDC: | 54868-5413-0 | 
| Package Description: | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (54868-5413-0) > 500 mL in 1 BOTTLE, WITH APPLICATOR | 
| NDC Code | 54868-5413-0 | 
| Proprietary Name | MORPHINE SULFATE | 
| Package Description | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (54868-5413-0) > 500 mL in 1 BOTTLE, WITH APPLICATOR | 
| Product NDC | 54868-5413 | 
| Product Type Name | HUMAN PRESCRIPTION DRUG | 
| Non Proprietary Name | morphine sulfate | 
| Dosage Form Name | SOLUTION | 
| Route Name | ORAL | 
| Start Marketing Date | 20050912 | 
| Marketing Category Name | NDA | 
| Labeler Name | Physicians Total Care, Inc. | 
| Substance Name | MORPHINE SULFATE | 
| Strength Number | 10 | 
| Strength Unit | mg/5mL | 
| Pharmaceutical Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |