mistries, vital signs, plasma carnitine concentrations and overall clinical condition.
How is Levocarnitine Tablet Supplied
Levocarnitine Tablets, USP are supplied as white, round compressed tablets debossed “cor” over “160” on one side and other side is plain.
They are supplied as follows:
Blister pack of 10 tablets, packaged in boxes of 90 tablets (NDC 64980-130-09)
Store at 20o to 25oC (68o to 77oF). [See USP Controlled Room Temperature].
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
Manufactured by:
CorePharma, LLC
Middlesex, NJ 08846
Distributed by:
Rising Pharmaceuticals, Inc.
Allendale,NJ 07401
390-02
Rev. October, 2011
REFERENCES
1. Bohmer, T., Rydning, A. and Solberg, H.E. 1974. Carnitine levels in human serum in health and disease Clin. Chim. Acta 57:55-61.
2. Brooks, H., Goldberg, L. Holland, R. et al. 1977. Carnitine-induced effects on cardiac and peripheral hemodynamics. J. Clin. Pharmacol. 17:561-568
3. Christiansen, R., Bremer, J. 1976. Active transport of butyrobetaine and carnitine into isolated liver cells. Biochim, Biophys. Acta 448:562-577.
4. Lindstedt, S. and Lindstedt, G. 1961. Distribution and excretion of carnitine in the rat. Acta Chem. Scand. 15:701-702
5. Rebouche, C.J. and Engel, A.G. 1983. Carnitine metabolism and deficiency syndromes. Mayo Clin. Proc. 58: 533-540.
6. Rebouche, C.J. and Paulson, D.J. 1986. Carnitine metabolism and function in humans. Ann. Rev. Nutr. 6:41-66.
7. Scriver, C.R., Beaudet, A.L., Sly, W.S. and Valle, D. 1989. The Metabolic Basis of Inherited Disease. New York:McGraw-Hill.
8. Schaub, J., Van Hoof, F. and Vis, H.L. 1991. Inborn Errors of Metabolism. New York:Raven Press.
9. Marzo, A., Arrigoni Martelli, E., Mancinelli, A., Cardace, G., Corbelletta, C., Bassani, E. and Solbiati, M. 1991. Protein binding of L-carnitine family components. Eur. J. Drug Met. Pharmacokin., Special Issue III: 364-368.
10. Rebouche, C.J. 1991. Quantitative estimation of absorption and degradation of a carnitine supplement by human adults. Metabolism 40:1305-1310.
Principal Display Panel
LEVOCARNITINE
Levocarnitine Tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:64980-130
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOCARNITINE (LEVOCARNITINE) LEVOCARNITINE 330 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
POVIDONE
Product Characteristics
Color WHITE (White) Score no score
Shape ROUND (round) Size 12mm
Flavor Imprint Code cor;160
Contains
Packaging
Item Code Package Description
1 NDC:64980-130-09 9 BLISTER PACK (9 BLISTER PACK) in 1 BOX
1 10 TABLET (10 TABLET) in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076858 09/20/2004
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