43376-320 : Zohydro 20 mg Oral Capsule, Extended Release

NDC:	43376-320
Labeler:	Zogenix, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Zohydro
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:	ZGNX;20mg
Shapes:	Capsule
Colors:	Green
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:

• 43376-320-60: 60 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE (43376‑320‑60)

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.

• 43376-210 Zohydro (Hydrocodone Bitartrate 10 mg) by Zogenix, Inc.
• 43376-215 Zohydro (Hydrocodone Bitartrate 15 mg) by Zogenix, Inc.
• 43376-220 Zohydro (Hydrocodone Bitartrate 20 mg) by Zogenix, Inc.
• 43376-230 Zohydro (Hydrocodone Bitartrate 30 mg) by Zogenix, Inc.
• 43376-240 Zohydro (Hydrocodone Bitartrate 40 mg) by Zogenix, Inc.
• 43376-250 Zohydro (Hydrocodone Bitartrate 50 mg) by Zogenix, Inc.
• 43376-310 Zohydro 10 mg Oral Capsule, Extended Release by Zogenix, Inc.
• 43376-315 Zohydro 15 mg Oral Capsule, Extended Release by Zogenix, Inc.
• 43376-330 Zohydro 30 mg Oral Capsule, Extended Release by Zogenix, Inc.
• 43376-340 Zohydro 40 mg Oral Capsule, Extended Release by Zogenix, Inc.
• 43376-350 Zohydro 50 mg Oral Capsule, Extended Release by Zogenix, Inc.

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