52544-063 : Kadian 60 mg Oral Capsule, Extended Release

NDC:	52544-063
Labeler:	Actavis Pharma, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Kadian
Dosage Form:	Oral Capsule, Extended Release
Application #:	NDA020616
Rev. Date:	Apr 7, 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:	Kadian;60;mg
Shapes:	Capsule
Colors:	Pink
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:

• 52544-063-60: 60 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE (52544‑063‑60)

Active Ingredients:

• Morphine Sulfate

Inactive Ingredients:

• Hypromelloses
• Ethylcelluloses
• Methacrylic Acid - Methyl Methacrylate Copolymer (1:1)
• Polyethylene Glycols
• Diethyl Phthalate
• Talc
• Starch, Corn
• Sucrose
• Gelatin
• Silicon Dioxide
• Sodium Lauryl Sulfate
• Titanium Dioxide
• Fd&c Red No. 40
• Fd&c Blue No. 1
• D&c Red No. 28
• Shellac
• Propylene Glycol
• Potassium Hydroxide
• Ferrosoferric Oxide

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

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• 0023-6013 Kadian 30 mg Oral Capsule, Extended Release by Allergan, Inc.
• 0023-6014 Kadian 40 mg Oral Capsule, Extended Release by Allergan, Inc.
• 0023-6015 Kadian 50 mg Oral Capsule, Extended Release by Allergan, Inc.
• 0023-6016 Kadian 60 mg Oral Capsule, Extended Release by Allergan, Inc.
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• 16590-598 Kadian 60 mg Extended Release Capsule by Stat Rx USA LLC
• 16590-606 Kadian 50 mg Extended Release Capsule by Stat Rx USA LLC
• 16590-660 Kadian 30 mg Extended Release Capsule by Stat Rx USA LLC
• More related products ...

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