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Focalin
Focalin - 0078-0609-05 - (dexmethylphenidate hydrochloride)
Drug Information of Focalin
| Product NDC: | 0078-0609 |
| Proprietary Name: | Focalin |
| Non Proprietary Name: | dexmethylphenidate hydrochloride |
| Active Ingredient(s): | 35 mg/1 & nbsp; dexmethylphenidate hydrochloride |
| Administration Route(s): | ORAL |
| Dosage Form(s): | CAPSULE, EXTENDED RELEASE |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of Focalin
| Product NDC: | 0078-0609 |
| Labeler Name: | Novartis Pharmaceuticals Corporation |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021802 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20050531 |
Package Information of Focalin
| Package NDC: | 0078-0609-05 |
| Package Description: | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0609-05) |
NDC Information of Focalin
| NDC Code | 0078-0609-05 |
| Proprietary Name | Focalin |
| Package Description | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0609-05) |
| Product NDC | 0078-0609 |
| 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 | 35 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] |
