| 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] |