63304-400 : Oxycodone Hydrochloride 10 mg 12 Hr Extended Release Tablet

NDC:	63304-400
Labeler:	Ranbaxy Pharmaceuticals Inc
Product Type:	Human Prescription Drug
Drug Name:	Oxycodone Hcl Controlled-release
Dosage Form:	Oral Tablet
Application #:	NDA020553
Rev. Date:	Feb 1, 2010
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:	OC;10
Shapes:	Round
Colors:	White
Size (mm):	7
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:

• 63304-400-01: 100 TABLET IN 1 BOTTLE (63304‑400‑01)

Active Ingredients:

• Oxycodone Hydrochloride

Inactive Ingredients:

• Hypromellose
• Lactose
• Magnesium Stearate
• Polyethylene Glycol 400
• Povidone
• Sodium Hydroxide
• Sorbic Acid
• Stearyl Alcohol
• Talc
• Titanium Dioxide
• Triacetin
• Hydroxypropyl Cellulose
• Eudragit Rs 30

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 63304-401 Oxycodone Hydrochloride 20 mg 12 Hr Extended Release Tablet by Ranbaxy Pharmaceuticals Inc

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