50268-528 : Methylphenidate Hydrochloride 10 mg Oral Tablet

NDC:	50268-528
Labeler:	Avpak
Product Type:	Human Prescription Drug
Drug Name:	Methylphenidate Hydrochloride
Dosage Form:	Oral Tablet
Application #:	ANDA207416
Rev. Date:	Jul 10, 2020
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:	T;174
Shapes:	Round
Colors:	White
Size (mm):	7
Segments: ^*	2
^* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 2 indicates a scored pill which can be broken into 2 equal pieces.

NDC Package Codes:

50268-528-15: 50 BLISTER PACK IN 1 BOX (50268‑528‑15) > 1 TABLET IN 1 BLISTER PACK (50268‑528‑11)

Active Ingredients:

Methylphenidate Hydrochloride

Dosage Strength:

10 mg

Inactive Ingredients:

Silicon Dioxide
Sucrose
Lactose Monohydrate
Magnesium Stearate
Cellulose, Microcrystalline /

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.