| NDC Code | 0527-8108-37 |
|---|
| Package Description | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0527-8108-37) |
|---|
| Product NDC | 0527-8108 |
|---|
| 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 | 20181009 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA210279 |
|---|
| Manufacturer | Lannett Company, 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 |
|---|