0406-1820 : Methylphenidate Hydrochloride 20 mg Oral Capsule

NDC:	0406-1820
Labeler:	Mallinckrodt, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Methylphenidate Hydrochloride Extended-release
Dosage Form:	Oral Capsule
Application #:	ANDA203583
Rev. Date:	Sep 29, 2015
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:	20;MG;M;1820
Shapes:	Capsule
Colors:	White / Blue
Size (mm):	16
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:

• 0406-1820-01: 100 CAPSULE IN 1 BOTTLE, PLASTIC (0406‑1820‑01)

Active Ingredients:

• Methylphenidate Hydrochloride

Inactive Ingredients:

• Sucrose
• Starch, Corn
• Ethylcelluloses
• Oleic Acid
• Medium-chain Triglycerides
• Titanium Dioxide
• Gelatin
• Shellac
• Propylene Glycol
• Hypromelloses
• Polyethylene Glycols
• Ferrosoferric Oxide
• Fd&c Blue No. 2
• Sodium Hydroxide
• Povidones

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 0406-1810 Methylphenidate Hydrochloride 10 mg Oral Capsule by Mallinckrodt, Inc.
• 0406-1830 Methylphenidate Hydrochloride 30 mg Oral Capsule by Mallinckrodt, Inc.
• 0406-1840 Methylphenidate Hydrochloride 40 mg Oral Capsule by Mallinckrodt, Inc.
• 0406-1850 Methylphenidate Hydrochloride 50 mg Oral Capsule by Mallinckrodt, Inc.
• 0406-1860 Methylphenidate Hydrochloride 60 mg Oral Capsule by Mallinckrodt, Inc.
• 10702-075 Methylphenidate Hydrochloride Extended Release 10 mg Oral Tablet by Kvk-tech, Inc.
• 10702-076 Methylphenidate Hydrochloride Extended Release 20 mg Oral Tablet by Kvk-tech, Inc.

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