59011-276 : Hysingla ER 100 mg Oral Tablet, Extended Release

NDC:	59011-276
Labeler:	Purdue Pharma Lp
Product Type:	Human Prescription Drug
Drug Name:	Hysingla ER
Dosage Form:	Oral Tablet, Extended Release
Application #:	NDA206627
Rev. Date:	Jan 15, 2015
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:	HYD;100
Shapes:	Round
Colors:	Blue
Size (mm):	12
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:

• 59011-276-60: 60 TABLET, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (59011‑276‑60)

Active Ingredients:

• Hydrocodone Bitartrate

Inactive Ingredients:

• Hydroxypropyl Cellulose (Type H)
• Polyethylene Glycol 3350
• Cellulose, Microcrystalline
• Polysorbate 80
• Polyvinyl Alcohol
• Talc
• Titanium Dioxide
• Fd&c Blue No. 2
• Aluminum Oxide
• Magnesium Stearate
• Polyethylene Glycols
• Butylated Hydroxytoluene

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 59011-271 Hysingla ER 20 mg Oral Tablet, Extended Release by Purdue Pharma Lp
• 59011-272 Hysingla ER 30 mg Oral Tablet, Extended Release by Purdue Pharma Lp
• 59011-273 Hysingla ER 40 mg Oral Tablet, Extended Release by Purdue Pharma Lp
• 59011-274 Hysingla ER 60 mg Oral Tablet, Extended Release by Purdue Pharma Lp
• 59011-275 Hysingla ER 80 mg Oral Tablet, Extended Release by Purdue Pharma Lp
• 59011-277 Hysingla ER 120 mg Oral Tablet, Extended Release by Purdue Pharma Lp

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