60687-554 : Methylphenidate Hydrochloride 36 mg Oral Tablet, Extended Release

NDC:	60687-554
Labeler:	American Health Packaging
Product Type:	Human Prescription Drug
Drug Name:	Methylphenidate Hydrochloride
Dosage Form:	Oral Tablet, Extended Release
Application #:	ANDA211009
Rev. Date:	Sep 22, 2024
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:	214
Shapes:	Round
Colors:	White
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:

60687-554-21: 30 BLISTER PACK IN 1 BOX, UNIT‑DOSE (60687‑554‑21) > 1 TABLET, EXTENDED RELEASE IN 1 BLISTER PACK (60687‑554‑11)

Active Ingredients:

Methylphenidate Hydrochloride

Dosage Strength:

36 mg

Inactive Ingredients:

Butylated Hydroxytoluene
Cellulose Acetate
Hypromellose, Unspecified
Phosphoric Acid
Polyethylene Glycol, Unspecified
Povidone, Unspecified
Propylene Glycol
Sodium Chloride
Stearic Acid
Succinic Acid
Ferric Oxide Yellow
Fd&c Red No. 40
Titanium Dioxide
Talc
Ferrosoferric Oxide /

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.