| NDC Code | 0378-2661-05 |
|---|
| Package Description | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-2661-05) |
|---|
| Product NDC | 0378-2661 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Morphine Sulfate |
|---|
| Non-Proprietary Name | Morphine Sulfate |
|---|
| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20130319 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA200824 |
|---|
| Manufacturer | Mylan Pharmaceuticals Inc. |
|---|
| Substance Name | MORPHINE SULFATE |
|---|
| Strength | 100 |
|---|
| Strength Unit | mg/1 |
|---|
| Pharmacy Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |
|---|
| DEA Schedule | CII |
|---|