| NDC Code | 0781-2688-01 |
|---|
| Package Description | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2688-01) |
|---|
| Product NDC | 0781-2688 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Dexmethylphenidate Hydrochloride |
|---|
| Proprietary Name Suffix | Extended-release |
|---|
| Non-Proprietary Name | Dexmethylphenidate Hydrochloride |
|---|
| Dosage Form | CAPSULE, EXTENDED RELEASE |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20170105 |
|---|
| Marketing Category Name | NDA AUTHORIZED GENERIC |
|---|
| Application Number | NDA021802 |
|---|
| Manufacturer | Sandoz Inc |
|---|
| Substance Name | DEXMETHYLPHENIDATE HYDROCHLORIDE |
|---|
| Strength | 35 |
|---|
| Strength Unit | mg/1 |
|---|
| Pharmacy Classes | Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE] |
|---|
| DEA Schedule | CII |
|---|