NDC Code | 0527-8106-37 |
Package Description | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0527-8106-37) |
Product NDC | 0527-8106 |
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 | 5 |
Strength Unit | mg/1 |
Pharmacy Classes | Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE] |
DEA Schedule | CII |