16590-885 : Kadian 200 mg Extended Release Capsule

NDC:	16590-885
Labeler:	Stat Rx USA LLC
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;200;mg
Shapes:	Capsule
Colors:	Brown
Size (mm):	22
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:

• 16590-885-30: 30 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE (16590‑885‑30)
• 16590-885-60: 60 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE (16590‑885‑60)
• 16590-885-90: 90 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE (16590‑885‑90)

Active Ingredients:

• Morphine Sulfate

Inactive Ingredients:

• Hypromelloses
• Ethylcelluloses
• Methacrylic Acid - Methyl Methacrylate Copolymer (1:1)
• Polyethylene Glycol
• Diethyl Phthalate
• Talc
• Starch, Corn
• Sucrose
• Gelatin
• Silicon Dioxide
• Sodium Lauryl Sulfate
• Titanium Dioxide
• Ferric Oxide Red
• Ferric Oxide Yellow
• Ferrosoferric Oxide

Pharmaceutical Classes:

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

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Based on records with the same trade name.

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• 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.
• 0023-6017 Kadian 80 mg Oral Capsule, Extended Release by Allergan, Inc.
• 0023-6018 Kadian 100 mg Oral Capsule, Extended Release by Allergan, Inc.
• 0023-6019 Kadian 200 mg Oral Capsule, Extended Release by Allergan, Inc.
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• 35356-048 Kadian 20 mg Extended Release Capsule by Lake Erie Medical Dba Quality Care Products LLC
• 35356-049 Kadian 30 mg Extended Release Capsule by Lake Erie Medical Dba Quality Care Products LLC
• 35356-050 Kadian 50 mg Extended Release Capsule by Lake Erie Medical Dba Quality Care Products LLC
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