42043-161 : Modafinil 200 mg Oral Tablet

NDC:	42043-161
Labeler:	Orchidpharma Inc
Product Type:	Human Prescription Drug
Drug Name:	Modafinil
Dosage Form:	Oral Tablet
Application #:	ANDA078963
Rev. Date:	Aug 1, 2013
CSA Schedule:	CIV (US) [1]

^[1] Schedule IV Controlled Substance: Low potential for abuse relative to substances in Schedule III. Examples include Alprazolam (Xanax), Diazepam (Valium), Carisoprodol (Soma), Clonazepam (Klonopin), Lorazepam (Ativan), Clorazepate (Tranxene), Midazolam (Versed), Temazepam (Restoril), and Triazolam (Halcion).. More Details: US Dept of Justice Controlled Substance Schedules.

Appearance:

Markings:	ORCHID;200;MG
Shapes:	Capsule
Colors:	White
Size (mm):	17
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:

• 42043-161-01: 100 TABLET IN 1 BOTTLE, PLASTIC (42043‑161‑01)
• 42043-161-03: 1 BOTTLE, PLASTIC IN 1 CARTON (42043‑161‑03) > 30 TABLET IN 1 BOTTLE, PLASTIC
• 42043-161-90: 1 BOTTLE, PLASTIC IN 1 CARTON (42043‑161‑90) > 90 TABLET IN 1 BOTTLE, PLASTIC

Active Ingredients:

• Modafinil

Inactive Ingredients:

• Crospovidone
• Starch, Corn
• Cellulose, Microcrystalline
• Povidone
• Lactose Monohydrate
• Silicon Dioxide
• Talc
• Magnesium Stearate

Pharmaceutical Classes:

• Central Nervous System Stimulation [PE]
• Increased Sympathetic Activity [PE]
• Sympathomimetic-like Agent [EPC]

Related Products:

Based on records with the same trade name.

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