NDC Code | 0378-4082-01 |
Package Description | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4082-01) |
Product NDC | 0378-4082 |
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 | 15 |
Strength Unit | mg/1 |
Pharmacy Classes | Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] |
DEA Schedule | CII |