35356-611 : Nucynta 100 mg Oral Tablet

NDC:	35356-611
Labeler:	Lake Erie Medical Dba Quality Care Products LLC
Product Type:	Human Prescription Drug
Drug Name:	Nucynta
Dosage Form:	Oral Tablet, Film Coated
Application #:	NDA022304
Rev. Date:	Jun 1, 2009
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:	O;M;100
Shapes:	Round
Colors:	Orange
Size (mm):	9
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:

• 35356-611-30: 30 TABLET, FILM COATED IN 1 BOTTLE (35356‑611‑30)
• 35356-611-60: 60 TABLET, FILM COATED IN 1 BOTTLE (35356‑611‑60)
• 35356-611-90: 90 TABLET, FILM COATED IN 1 BOTTLE (35356‑611‑90)

Active Ingredients:

• Tapentadol Hydrochloride

Inactive Ingredients:

• Cellulose, Microcrystalline
• Lactose Monohydrate
• Croscarmellose Sodium
• Povidone
• Magnesium Stearate
• Polyvinyl Alcohol
• Titanium Dioxide
• Polyethylene Glycols
• Talc
• Aluminum Oxide

Pharmaceutical Classes:

• Opioid Agonist [EPC]
• Opioid Agonists [MoA]

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