| NDC Code | 72912-545-10 |
|---|
| Package Description | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72912-545-10) |
|---|
| Product NDC | 72912-545 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Adhansia Xr |
|---|
| Non-Proprietary Name | Methylphenidate Hydrochloride |
|---|
| Dosage Form | CAPSULE, EXTENDED RELEASE |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20190701 |
|---|
| Marketing Category Name | NDA |
|---|
| Application Number | NDA212038 |
|---|
| Manufacturer | Adlon Therapeutics L.P. |
|---|
| Substance Name | METHYLPHENIDATE HYDROCHLORIDE |
|---|
| Strength | 45 |
|---|
| Strength Unit | mg/1 |
|---|
| Pharmacy Classes | Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] |
|---|
| DEA Schedule | CII |
|---|