0591-3574 : Fentanyl 600 Mcg Buccal Tablet

NDC:	0591-3574
Labeler:	Watson Laboratories, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Fentanyl Buccal
Dosage Form:	Buccal; Oral; Transmucosal Tablet
Application #:	ANDA079075
Rev. Date:	Jan 1, 2013
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:	WPI;3574
Shapes:	Round
Colors:	White
Size (mm):	8
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:

• 0591-3574-96: 7 BLISTER PACK IN 1 CARTON (0591‑3574‑96) > 4 TABLET IN 1 BLISTER PACK (0591‑3574‑04)

Active Ingredients:

• Fentanyl Citrate

Inactive Ingredients:

• Mannitol
• Sodium Starch Glycolate Type a Potato
• Potassium Bicarbonate
• Magnesium Stearate

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 0591-3571 Fentanyl (As Fentanyl Citrate) 100 Mcg Buccal Tablet by Watson Laboratories, Inc.
• 0591-3572 Fentanyl (As Fentanyl Citrate) 200 Mcg Buccal Tablet by Watson Laboratories, Inc.
• 0591-3573 Fentanyl 400 Mcg Buccal Tablet by Watson Laboratories, Inc.
• 0591-3575 Fentanyl 800 Mcg Buccal Tablet by Watson Laboratories, Inc.
• 51862-634 Fentanyl Buccal 100 ug/1 Buccal; Sublingual Tablet by Mayne Pharma
• 51862-635 Fentanyl Buccal 200 ug/1 Buccal; Sublingual Tablet by Mayne Pharma
• 51862-636 Fentanyl Buccal 400 ug/1 Buccal; Sublingual Tablet by Mayne Pharma
• 51862-637 Fentanyl Buccal 600 ug/1 Buccal; Sublingual Tablet by Mayne Pharma
• 51862-638 Fentanyl Buccal 800 ug/1 Buccal; Sublingual Tablet by Mayne Pharma

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