43386-570 : Methylphenidate Hydrochloride 2.5 mg Oral Tablet, Chewable

NDC:	43386-570
Labeler:	Gavis Pharmaceuticals, LLC
Product Type:	Human Prescription Drug
Drug Name:	Methylphenidate Hydrochloride
Dosage Form:	Oral Tablet, Chewable
Application #:	ANDA204115
Rev. Date:	Apr 6, 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:	NL;570
Shapes:	Round
Colors:	White
Size (mm):	7
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:

43386-570-01: 100 TABLET, CHEWABLE IN 1 BOTTLE (43386‑570‑01)

Active Ingredients:

Methylphenidate Hydrochloride

Dosage Strength:

2.5 mg

Inactive Ingredients:

Aspartame
Maltose
Cellulose, Microcrystalline
Phosphoric Acid
Starch, Corn
Stearic Acid

Pharmaceutical Classes:

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

NDC QR Code

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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.