69543-413 : Fendique ER 105 mg Oral Capsule, Extended Release

NDC:	69543-413
Labeler:	Virtus Pharmaceuticals, LLC
Product Type:	Human Prescription Drug
Drug Name:	Fendique ER
Dosage Form:	Oral Capsule, Extended Release
Application #:	NDA018074
Rev. Date:	Mar 18, 2020
CSA Schedule:	CIII (US) [1]

^[1] Schedule III / IIIN Controlled Substance: Has a potential for abuse less than substances in Schedules I or II and abuse may lead to moderate or low physical dependence or high psychological dependence. (i.e. Products containing not more than 90 milligrams of Codeine per dosage unit [such as Tylenol with Codeine], other narcotics such as Buprenorphine (Suboxone), and Schedule IIIN non-narcotics such as Didrex, Ketamine, Phendimetrazine, and Anabolic Steroids). More Details: US Dept of Justice Controlled Substance Schedules.

Appearance:

Markings:	E5254
Shapes:	Capsule
Colors:	Brown
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.

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:

• 69543-413-10: 100 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE (69543‑413‑10)
• 69543-413-11: 1000 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE (69543‑413‑11)
• 69543-413-30: 30 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE (69543‑413‑30)

Active Ingredients:

• Phendimetrazine Tartrate

Inactive Ingredients:

• Fd&c Blue No. 1
• Fd&c Red No. 40
• Gelatin, Unspecified
• Povidone, Unspecified
• Silicon Dioxide
• Sodium Lauryl Sulfate
• Starch, Corn
• Sucrose
• Talc
• Shellac /

Pharmaceutical Classes:

• Appetite Suppression [PE]
• Increased Sympathetic Activity [PE]
• Sympathomimetic Amine Anorectic [EPC]

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