63459-541 : Fentora 0.1 mg Buccal Tablet

NDC:	63459-541
Labeler:	Cephalon, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Fentora
Dosage Form:	Buccal; Oral; Transmucosal Tablet
Application #:	NDA021947
Rev. Date:	Oct 2, 2006
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:	1;C
Shapes:	Round
Colors:	White
Size (mm):	6
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.

The above image is provided by the U.S. National Library of Medicine (NLM) and is not part of the official label.

NDC Package Codes:

• 63459-541-28: 7 BLISTER PACK IN 1 CARTON (63459‑541‑28) > 4 TABLET IN 1 BLISTER PACK (63459‑541‑04)

Active Ingredients:

• Fentanyl Citrate

Inactive Ingredients:

• Mannitol
• Sodium Bicarbonate
• Magnesium Stearate
• Sodium Carbonate
• Sodium Starch Glycolate Type a Potato
• Citric Acid Monohydrate

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 63459-542 Fentora 0.2 mg Buccal Tablet by Cephalon, Inc.
• 63459-544 Fentora 0.4 mg Buccal Tablet by Cephalon, Inc.
• 63459-546 Fentora 0.6 mg Buccal Tablet by Cephalon, Inc.
• 63459-548 Fentora 0.8 mg Buccal Tablet by Cephalon, Inc.

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