| NDC Code | 0115-1682-01 |
|---|
| Package Description | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0115-1682-01) |
|---|
| Product NDC | 0115-1682 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Dexmethylphenidate Hydrochloride |
|---|
| Non-Proprietary Name | Dexmethylphenidate Hydrochloride |
|---|
| Dosage Form | CAPSULE, EXTENDED RELEASE |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20150806 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA079108 |
|---|
| Manufacturer | Amneal Pharmaceuticals of New York LLC |
|---|
| Substance Name | DEXMETHYLPHENIDATE HYDROCHLORIDE |
|---|
| Strength | 5 |
|---|
| Strength Unit | mg/1 |
|---|
| Pharmacy Classes | Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE] |
|---|
| DEA Schedule | CII |
|---|