69296-001 : Morphabond 100 mg Oral Tablet, Extended Release

NDC:	69296-001
Labeler:	Inspirion Delivery Technologies, LLC
Product Type:	Human Prescription Drug
Drug Name:	Morphabond
Dosage Form:	Oral Tablet, Extended Release
Application #:	NDA206544
Rev. Date:	Apr 2, 2016
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;M100
Shapes:	Round
Colors:	Gray
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:

• 69296-001-01: 100 TABLET, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (69296‑001‑01)

Active Ingredients:

• Morphine Sulfate

Inactive Ingredients:

• Hypromelloses
• Xanthan Gum
• Cellulose, Microcrystalline
• Sodium Alginate
• Alginic Acid
• Mannitol
• Silicon Dioxide
• Magnesium Stearate
• Ethyl Acrylate and Methyl Methacrylate Copolymer (2:1
• 750000 Mw)
• Ethyl Acrylate and Methyl Methacrylate Copolymer (2:1
• 600000 Mw)
• Lactose Monohydrate
• Polysorbate 80
• Titanium Dioxide
• Polyethylene Glycols
• Shellac
• Isopropyl Alcohol
• Ferrosoferric Oxide
• Butyl Alcohol
• Propylene Glycol
• Ammonia
• Fd&c Blue No. 2
• Fd&c Yellow No. 6
• Fd&c Red No. 40

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 69296-002 Morphabond 60 mg Oral Tablet, Extended Release by Inspirion Delivery Technologies, LLC
• 69296-003 Morphabond 30 mg Oral Tablet, Extended Release by Inspirion Delivery Technologies, LLC
• 69296-004 Morphabond 15 mg Oral Tablet, Extended Release by Inspirion Delivery Technologies, LLC
• 65597-301 Morphabond 15 mg Oral Tablet, Extended Release by Daiichi Sankyo Inc.
• 65597-302 Morphabond 30 mg Oral Tablet, Extended Release by Daiichi Sankyo Inc.
• 65597-303 Morphabond 60 mg Oral Tablet, Extended Release by Daiichi Sankyo Inc.
• 65597-304 Morphabond 100 mg Oral Tablet, Extended Release by Daiichi Sankyo Inc.

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