65224-340 : Zohydro ER 40 mg Oral Capsule, Extended Release

NDC:	65224-340
Labeler:	Pernix Therapeutics
Product Type:	Human Prescription Drug
Drug Name:	Zohydro ER
Dosage Form:	Oral Capsule, Extended Release
Application #:	NDA202880
Rev. Date:	Oct 25, 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:	Z340;40mg
Shapes:	Capsule
Colors:	Brown / White
Size (mm):	16
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:

• 65224-340-60: 60 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE (65224‑340‑60)

Active Ingredients:

• Hydrocodone Bitartrate

Inactive Ingredients:

• Sucrose
• Hypromelloses
• Ammonio Methacrylate Copolymer Type B
• Silicon Dioxide
• Talc
• Polyethylene Glycols
• Povidones
• Titanium Dioxide
• Fd&c Blue No. 1
• Fd&c Red No. 40
• Ferric Oxide Yellow
• Fd&c Red No. 3
• Ferrosoferric Oxide
• Ferric Oxide Red
• Gelatin

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 65224-310 Zohydro ER 10 mg Oral Capsule, Extended Release by Pernix Therapeutics
• 65224-315 Zohydro ER 15 mg Oral Capsule, Extended Release by Pernix Therapeutics
• 65224-320 Zohydro ER 20 mg Oral Capsule, Extended Release by Pernix Therapeutics
• 65224-330 Zohydro ER 30 mg Oral Capsule, Extended Release by Pernix Therapeutics
• 65224-350 Zohydro ER 50 mg Oral Capsule, Extended Release by Pernix Therapeutics

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