50458-587 : Concerta 54 mg 24 Hr Extended Release Tablet

NDC:	50458-587
Labeler:	Janssen Pharmaceuticals, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Concerta
Dosage Form:	Oral Tablet, Extended Release
Application #:	NDA021121
Rev. Date:	Aug 1, 2000
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:	alza;54
Shapes:	Oval
Colors:	Red
Size (mm):	15
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:

• 50458-587-01: 100 TABLET, EXTENDED RELEASE IN 1 BOTTLE (50458‑587‑01)

Active Ingredients:

• Methylphenidate Hydrochloride

Inactive Ingredients:

• Butylated Hydroxytoluene
• Carnauba Wax
• Hypromelloses
• Lactose
• Phosphoric Acid
• Polyethylene Glycols
• Povidones
• Propylene Glycol
• Sodium Chloride
• Stearic Acid
• Succinic Acid
• Ferrosoferric Oxide
• Titanium Dioxide
• Triacetin
• Cellulose Acetate

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 50458-585 24 Hr Concerta 18 mg Extended Release Tablet by Janssen Pharmaceuticals, Inc.
• 50458-586 Concerta 36 mg 24 Hr Extended Release Tablet by Janssen Pharmaceuticals, Inc.
• 50458-588 Concerta 27 mg 24 Hr Extended Release Tablet by Janssen Pharmaceuticals, Inc.
• 54868-4489 24 Hr Concerta 18 mg Extended Release Tablet by Physicians Total Care, Inc.
• 54868-4759 Concerta 36 mg 24 Hr Extended Release Tablet by Physicians Total Care, Inc.
• 54868-4789 Concerta 54 mg 24 Hr Extended Release Tablet by Physicians Total Care, Inc.
• 54868-4957 Concerta 27 mg 24 Hr Extended Release Tablet by Physicians Total Care, Inc.

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