Source: FDA, National Drug Code (US)
MoviPrep consists of 4 separate pouches (2 of pouch A and 2 of pouch B) containing white to yellow powder for reconstitution. Each pouch A contains 100 grams of polyethylene glycol (PEG) 3350, NF, 7.5 grams of sodium sulfate, USP, 2.691 grams of sodium chloride, USP, and 1.015 grams of potassium chloride, USP, plus the following excipients: aspartame, NF (sweetener), acesulfame potassium, NF (sweetener), and lemon flavoring. Each pouch B contains 4.7 grams of ascorbic acid, USP and 5.9 grams of sodium ascorbate, USP. When 1 pouch A and 1 pouch B are dissolved together in water to a volume of 1 liter, MoviPrep (PEG 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid) is an oral solution having a lemon taste.
The entire, reconstituted, 2-liter MoviPrep colon preparation contains 200 grams of PEG 3350, 15 grams of sodium sulfate, 5.38 grams of sodium chloride, 2.03 grams of potassium chloride, 9.4 grams of ascorbic acid, and 11.8 grams of sodium ascorbate plus the following excipients: aspartame (sweetener), acesulfame potassium (sweetener), and lemon flavoring.
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MoviPrep is supplied in powdered form. MoviPrep is administered as an oral solution after reconstitution. MoviPrep is available in the following presentations: Carton: The MoviPrep carton contains a disposable container for reconstitution of MoviPrep and an inner carton containing 4 pouches (2 of pouch A and 2 of pouch B). Pouch A contains polyethylene glycol (PEG) 3350 100 grams, sodium sulfate 7.5 grams, sodium chloride 2.69 grams, and potassium chloride 1.015 grams. Pouch B contains ascorbic acid 4.7 grams and sodium ascorbate 5.9 grams. 1 pouch A and 1 pouch B should be dissolved together in 1 liter of lukewarm water. When reconstituted to 1 liter volume with water, the solution contains PEG-3350 29.6 mmol/L, sodium 181.6 mmol/L (of which not more than 56.2 mmol is absorbable), sulfate 52.8 mmol/L, chloride 59.8 mmol/L, potassium 14.2 mmol/L, and ascorbate 29.8 mmol/L. NDC 65649-201-75. Rx only. Manufactured by: Norgine B.V., Hogehilweg 7, 1101 CA Amsterdam Zuidoost, Netherlands For: Salix Pharmaceuticals, Inc., Morrisville, NC 27560 |
| Drug | Countries | |
|---|---|---|
| MOVIPREP | Austria, Canada, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Japan, Lithuania, Malta, Netherlands, New Zealand, Poland, Romania, United Kingdom, South Africa |
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