47781-417 : Methylphenidate Hydrochloride 36 mg Oral Tablet, Extended Release

NDC:	47781-417
Labeler:	Alvogen Inc.
Product Type:	Human Prescription Drug
Drug Name:	Methylphenidate Hydrochloride
Dosage Form:	Oral Tablet, Extended Release
Application #:	ANDA210818
Rev. Date:	Nov 30, 2018
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:	AL
Shapes:	Round
Colors:	White
Size (mm):	10
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:

47781-417-01: 100 TABLET, EXTENDED RELEASE IN 1 BOTTLE (47781‑417‑01)

Active Ingredients:

Methylphenidate Hydrochloride

Dosage Strength:

36 mg

Inactive Ingredients:

Butylated Hydroxytoluene
Hypromellose, Unspecified
Lactose Monohydrate
Polyethylene Glycol, Unspecified
Povidone, Unspecified
Propylene Glycol
Sodium Chloride
Stearic Acid
Succinic Acid
Ferrosoferric Oxide
Titanium Dioxide
Triacetin
Cellulose Acetate
Anhydrous Citric Acid
Poloxamer 188
Ferric Oxide Yellow
Shellac
Butyl Alcohol
Ammonia
Isopropyl Alcohol
Polyethylene Oxide 7000000
Polyethylene Oxide 100000 /

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.