| NDC Code | 54868-5683-0 |
|---|
| Package Description | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (54868-5683-0) |
|---|
| Product NDC | 54868-5683 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Focalinxr |
|---|
| Non-Proprietary Name | Dexmethylphenidate Hydrochloride |
|---|
| Dosage Form | CAPSULE, EXTENDED RELEASE |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20061011 |
|---|
| Marketing Category Name | NDA |
|---|
| Application Number | NDA021802 |
|---|
| Manufacturer | Physicians Total Care, Inc. |
|---|
| Substance Name | DEXMETHYLPHENIDATE HYDROCHLORIDE |
|---|
| Strength | 15 |
|---|
| Strength Unit | mg/1 |
|---|
| Pharmacy Classes | Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] |
|---|
| DEA Schedule | CII |
|---|