0078-0609 : 24 Hr Focalin 35 mg Extended Release Capsule

NDC:	0078-0609
Labeler:	Novartis Pharmaceuticals Corporation
Product Type:	Human Prescription Drug
Drug Name:	Focalin XR
Dosage Form:	Oral Capsule, Extended Release
Application #:	NDA021802
Rev. Date:	May 31, 2005
CSA Schedule:	CII (US) ^[1]

^[1] Schedule II / IIN Controlled Substance: High potential for abuse which may lead to severe psychological or physical dependence. (i.e. Narcotics such as Dilaudid, Methadone, Demerol, Oxycodone, Percocet, Fentanyl, Morphine, Opium, Codeine, and Hydrocodone ... Schedule IIN stimulants include non-narcotic Amphetamines such as Dexedrine, Adderall, Desoxyn, Methylphenidate (Ritalin) ... Other Schedule II substances include Amobarbital, Glutethimide, and Pentobarbital. More Details: US Dept of Justice Controlled Substance Schedules.

Appearance:

Markings:	NVR;D35
Shapes:	Capsule
Colors:	Blue
Size (mm):	19
Segments: ^*	1
^* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

0078-0609-05: 100 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE (0078‑0609‑05)

Active Ingredients:

Dexmethylphenidate Hydrochloride

Dosage Strength:

35 mg

Inactive Ingredients:

Ferric Oxide Yellow
Gelatin
Polyethylene Glycols
Dextrose
Talc
Titanium Dioxide
Triethyl Citrate

Pharmaceutical Classes:

Central Nervous System Stimulant [EPC]
Central Nervous System Stimulation [PE]

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.