54569-5195 : Phendimetrazine Tartrate 35 mg Oral Tablet

NDC:	54569-5195
Labeler:	A-s Medication Solutions LLC
Product Type:	Human Prescription Drug
Drug Name:	Phendimetrazine Tartrate
Dosage Form:	Oral Tablet
Application #:	ANDA091042
Rev. Date:	Sep 15, 2010
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:	K;77
Shapes:	Round
Colors:	Yellow
Size (mm):	7
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:

• 54569-5195-0: 30 TABLET IN 1 BOTTLE (54569‑5195‑0)
• 54569-5195-1: 60 TABLET IN 1 BOTTLE (54569‑5195‑1)
• 54569-5195-2: 90 TABLET IN 1 BOTTLE (54569‑5195‑2)
• 54569-5195-3: 180 TABLET IN 1 BOTTLE (54569‑5195‑3)
• 54569-5195-4: 42 TABLET IN 1 BOTTLE (54569‑5195‑4)
• 54569-5195-5: 168 TABLET IN 1 BOTTLE (54569‑5195‑5)
• 54569-5195-6: 28 TABLET IN 1 BOTTLE (54569‑5195‑6)
• 54569-5195-7: 84 TABLET IN 1 BOTTLE (54569‑5195‑7)
• 54569-5195-8: 56 TABLET IN 1 BOTTLE (54569‑5195‑8)
• 54569-5195-9: 112 TABLET IN 1 BOTTLE (54569‑5195‑9)

Active Ingredients:

• Phendimetrazine Tartrate

Inactive Ingredients:

• Silicon Dioxide
• Fd&c Yellow No. 5
• Lactose Monohydrate
• Magnesium Stearate
• Cellulose, Microcrystalline
• Sodium Starch Glycolate Type a Potato

Pharmaceutical Classes:

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

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