69296-005 : Roxybond 5 mg Oral Tablet, Coated

NDC:	69296-005
Labeler:	Inspirion Delivery Sciences LLC
Product Type:	Human Prescription Drug
Drug Name:	Roxybond
Dosage Form:	Oral Tablet, Coated
Application #:	NDA209777
Rev. Date:	Oct 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:	IDT;O5
Shapes:	Round
Colors:	White
Size (mm):	11
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:

• 69296-005-01: 100 TABLET, COATED IN 1 BOTTLE (69296‑005‑01)

Active Ingredients:

• Oxycodone Hydrochloride

Inactive Ingredients:

• Alginic Acid
• Ammonia
• Silicon Dioxide
• Dibutyl Sebacate
• Dimethylaminoethyl Methacrylate - Butyl Methacrylate - Methyl Methacrylate Copolymer
• Ethyl Acrylate and Methyl Methacrylate Copolymer (2:1
• 750000 Mw)
• Ethylcellulose, Unspecified
• Hypromellose, Unspecified
• Ferrosoferric Oxide
• Isopropyl Alcohol
• Lactose Monohydrate
• Magnesium Stearate
• Mannitol
• Microcrystalline Cellulose
• Butyl Alcohol
• Polyethylene Glycol, Unspecified
• Polysorbate 80
• Polyvinyl Alcohol, Unspecified
• Propylene Glycol
• Shellac
• Sodium Alginate
• Talc
• Titanium Dioxide
• Xanthan Gum

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 69296-006 Roxybond 15 mg Oral Tablet, Coated by Inspirion Delivery Sciences LLC
• 69296-007 Roxybond 30 mg Oral Tablet, Coated by Inspirion Delivery Sciences LLC
• 65597-501 Roxybond 5 mg Oral Tablet, Coated by Daiichi Sankyo Inc.
• 65597-502 Roxybond 15 mg Oral Tablet, Coated by Daiichi Sankyo Inc.
• 65597-503 Roxybond 30 mg Oral Tablet, Coated by Daiichi Sankyo Inc.
• 81140-101 Roxybond 5 mg Oral Tablet, Coated by Protega Pharmaceuticals LLC
• 81140-102 Roxybond 15 mg Oral Tablet, Coated by Protega Pharmaceuticals LLC
• 81140-103 Roxybond 30 mg Oral Tablet, Coated by Protega Pharmaceuticals LLC
• 81140-104 Roxybond 10 mg Oral Tablet, Coated by Protega Pharmaceuticals Inc

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