Product NDC: | 54868-5684 |
Proprietary Name: | FocalinXR |
Non Proprietary Name: | dexmethylphenidate hydrochloride |
Active Ingredient(s): | 20 mg/1 & nbsp; dexmethylphenidate hydrochloride |
Administration Route(s): | ORAL |
Dosage Form(s): | CAPSULE, EXTENDED RELEASE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 54868-5684 |
Labeler Name: | Physicians Total Care, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA021802 |
Marketing Category: | NDA |
Start Marketing Date: | 20061011 |
Package NDC: | 54868-5684-1 |
Package Description: | 10 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (54868-5684-1) |
NDC Code | 54868-5684-1 |
Proprietary Name | FocalinXR |
Package Description | 10 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (54868-5684-1) |
Product NDC | 54868-5684 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | dexmethylphenidate hydrochloride |
Dosage Form Name | CAPSULE, EXTENDED RELEASE |
Route Name | ORAL |
Start Marketing Date | 20061011 |
Marketing Category Name | NDA |
Labeler Name | Physicians Total Care, Inc. |
Substance Name | DEXMETHYLPHENIDATE HYDROCHLORIDE |
Strength Number | 20 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] |