69344-311 : Arymo 60 mg Oral Tablet, Film Coated, Extended Release

NDC:	69344-311
Labeler:	Egalet Us Inc.
Product Type:	Human Prescription Drug
Drug Name:	Arymo ER
Dosage Form:	Oral Tablet, Film Coated, Extended Release
Application #:	NDA208603
Rev. Date:	Feb 1, 2017
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:	EGLT;60
Shapes:	Capsule
Colors:	Orange
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:

• 69344-311-11: 100 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (69344‑311‑11)

Active Ingredients:

• Morphine Sulfate

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 69344-111 Arymo 15 mg Oral Tablet, Film Coated, Extended Release by Egalet Us Inc.
• 69344-211 Arymo 30 mg Oral Tablet, Film Coated, Extended Release by Egalet Us Inc.

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