| Product NDC: | 60977-016 | 
| Proprietary Name: | Duramorph | 
| Non Proprietary Name: | morphine sulfate | 
| Active Ingredient(s): | .5 mg/mL & nbsp; morphine sulfate | 
| Administration Route(s): | EPIDURAL; INTRATHECAL; INTRAVENOUS | 
| Dosage Form(s): | INJECTION, SOLUTION | 
| Coding System: | National Drug Codes(NDC) | 
| Product NDC: | 60977-016 | 
| Labeler Name: | Baxter Healthcare Corporation | 
| Product Type: | HUMAN PRESCRIPTION DRUG | 
| FDA Application Number: | NDA018565 | 
| Marketing Category: | NDA | 
| Start Marketing Date: | 20100531 | 
| Package NDC: | 60977-016-02 | 
| Package Description: | 10 AMPULE in 1 PACKAGE (60977-016-02) > 10 mL in 1 AMPULE (60977-016-73) | 
| NDC Code | 60977-016-02 | 
| Proprietary Name | Duramorph | 
| Package Description | 10 AMPULE in 1 PACKAGE (60977-016-02) > 10 mL in 1 AMPULE (60977-016-73) | 
| Product NDC | 60977-016 | 
| Product Type Name | HUMAN PRESCRIPTION DRUG | 
| Non Proprietary Name | morphine sulfate | 
| Dosage Form Name | INJECTION, SOLUTION | 
| Route Name | EPIDURAL; INTRATHECAL; INTRAVENOUS | 
| Start Marketing Date | 20100531 | 
| Marketing Category Name | NDA | 
| Labeler Name | Baxter Healthcare Corporation | 
| Substance Name | MORPHINE SULFATE | 
| Strength Number | .5 | 
| Strength Unit | mg/mL | 
| Pharmaceutical Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |