Product NDC: | 0078-0433 |
Proprietary Name: | Focalin |
Non Proprietary Name: | dexmethylphenidate hydrochloride |
Active Ingredient(s): | 30 mg/1 & nbsp; dexmethylphenidate hydrochloride |
Administration Route(s): | ORAL |
Dosage Form(s): | CAPSULE, EXTENDED RELEASE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0078-0433 |
Labeler Name: | Novartis Pharmaceuticals Corporation |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA021802 |
Marketing Category: | NDA |
Start Marketing Date: | 20050531 |
Package NDC: | 0078-0433-05 |
Package Description: | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0433-05) |
NDC Code | 0078-0433-05 |
Proprietary Name | Focalin |
Package Description | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0433-05) |
Product NDC | 0078-0433 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | dexmethylphenidate hydrochloride |
Dosage Form Name | CAPSULE, EXTENDED RELEASE |
Route Name | ORAL |
Start Marketing Date | 20050531 |
Marketing Category Name | NDA |
Labeler Name | Novartis Pharmaceuticals Corporation |
Substance Name | DEXMETHYLPHENIDATE HYDROCHLORIDE |
Strength Number | 30 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] |