64850-900 : Phendimetrazine Tartrate 35 mg Oral Tablet

NDC:	64850-900
Labeler:	Elite Laboratories, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Phendimetrazine Tartrate
Dosage Form:	Oral Tablet
Application #:	ANDA203600
Rev. Date:	Jan 15, 2018
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:	EL;on;left;side;and;11;on;right;side;of;bisect
Shapes:	Round
Colors:	White
Size (mm):	6
Segments: *	2
* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 2 indicates a scored pill which can be broken into 2 equal pieces.

NDC Package Codes:

• 64850-900-01: 100 TABLET IN 1 BOTTLE (64850‑900‑01)
• 64850-900-10: 1000 TABLET IN 1 BOTTLE (64850‑900‑10)

Active Ingredients:

• Phendimetrazine Tartrate

Inactive Ingredients:

• Cellulose, Microcrystalline
• Croscarmellose Sodium
• Magnesium Stearate

Pharmaceutical Classes:

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

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