50458-861 : 12 Hr Nucynta 100 mg Extended Release Tablet

NDC:	50458-861
Labeler:	Janssen Pharmaceuticals, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Nucynta ER
Dosage Form:	Oral Tablet, Film Coated, Extended Release
Application #:	NDA200533
Rev. Date:	Aug 25, 2011
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:	OMJ;100
Shapes:	Oval
Colors:	Blue
Size (mm):	17
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:

• 50458-861-01: 60 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (50458‑861‑01)
• 50458-861-02: 10 BLISTER PACK IN 1 BOX, UNIT‑DOSE (50458‑861‑02) > 10 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BLISTER PACK

Active Ingredients:

• Tapentadol Hydrochloride

Inactive Ingredients:

• Polyethylene Glycols
• Hypromelloses
• .alpha.-tocopherol
• Polyvinyl Alcohol
• Titanium Dioxide
• Talc
• Shellac
• Propylene Glycol
• Ferrosoferric Oxide
• Fd&c Blue No. 2
• Aluminum Oxide

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

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