43063-531 : Xartemis Oral Tablet, Coated

NDC:	43063-531
Labeler:	Pd-rx Pharmaceuticals, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Xartemis XR
Dosage Form:	Oral Tablet, Coated
Application #:	NDA204031
Rev. Date:	Apr 30, 2013
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:	M;115
Shapes:	Oval
Colors:	Blue
Size (mm):	19
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:

• 43063-531-60: 60 TABLET, COATED IN 1 BOTTLE, PLASTIC (43063‑531‑60)

Active Ingredients:

• Oxycodone Hydrochloride
• Acetaminophen

Inactive Ingredients:

• Polyethylene Glycol 900000
• Cellulose, Microcrystalline
• Hydroxypropyl Cellulose (Type H)
• Croscarmellose Sodium
• Magnesium Stearate
• Silicon Dioxide
• Starch, Corn
• Anhydrous Citric Acid
• Edetate Disodium
• Polyvinyl Alcohol
• Titanium Dioxide
• Polyethylene Glycol 3350
• Talc
• Fd&c Blue No. 2
• Aluminum Oxide

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 23635-115 Xartemis Oral Tablet, Coated by Mallinckrodt, Inc

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