| NDC Code | 0378-4085-05 |
|---|
| Package Description | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4085-05) |
|---|
| Product NDC | 0378-4085 |
|---|
| 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 | 20150826 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA204266 |
|---|
| Manufacturer | Mylan Pharmaceuticals Inc. |
|---|
| Substance Name | DEXMETHYLPHENIDATE HYDROCHLORIDE |
|---|
| Strength | 40 |
|---|
| Strength Unit | mg/1 |
|---|
| Pharmacy Classes | Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] |
|---|
| DEA Schedule | CII |
|---|