24510-075 : Nucynta 75 mg Oral Tablet, Film Coated

NDC:	24510-075
Labeler:	Collegium Pharmaceutical, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Nucynta
Dosage Form:	Oral Tablet, Film Coated
Application #:	NDA022304
Rev. Date:	Apr 1, 2019
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;75
Shapes:	Round
Colors:	Yellow / Orange
Size (mm):	8
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:

• 24510-075-01: 10 BLISTER PACK IN 1 CARTON (24510‑075‑01) > 10 TABLET, FILM COATED IN 1 BLISTER PACK
• 24510-075-10: 100 TABLET, FILM COATED IN 1 BOTTLE (24510‑075‑10)

Active Ingredients:

• Tapentadol Hydrochloride

Inactive Ingredients:

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

Pharmaceutical Classes:

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

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