NDC Code | 0078-0430-05 |
Package Description | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0430-05) |
Product NDC | 0078-0430 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Focalin |
Proprietary Name Suffix | Xr |
Non-Proprietary Name | Dexmethylphenidate Hydrochloride |
Dosage Form | CAPSULE, EXTENDED RELEASE |
Usage | ORAL |
Start Marketing Date | 20050531 |
Marketing Category Name | NDA |
Application Number | NDA021802 |
Manufacturer | Novartis Pharmaceuticals Corporation |
Substance Name | DEXMETHYLPHENIDATE HYDROCHLORIDE |
Strength | 5 |
Strength Unit | mg/1 |
Pharmacy Classes | Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE] |
DEA Schedule | CII |