Raltegravir labels and packages
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]
==Labels and Packages== [1]
PRINCIPAL DISPLAY PANEL - 400 mg Bottle Label
NDC 0006-0227-61
Isentress® (raltegravir) tablets
400 mg
Each tablet contains 434.4 mg raltegravir potassium, equivalent to 400 mg raltegravir.
USUAL DOSAGE: See Package Insert.
Rx only
60 Tablets
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PRINCIPAL DISPLAY PANEL - 100 mg Bottle Label
NDC 0006-0477-61
Isentress® (raltegravir) CHEWABLE Tablets
100 mg
For Pediatric Patients 2 to less than 12 Years of Age
Phenylketonurics: contains phenylalanine (a component of aspartame) 0.10 mg per 100 mg chewable tablet.
Rx only
60 Tablets
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PRINCIPAL DISPLAY PANEL - 25 mg Bottle Label
NDC 0006-0473-61
Isentress® (raltegravir) CHEWABLE Tablets
25 mg
For Pediatric Patients 2 to less than 12 Years of Age
Phenylketonurics: contains phenylalanine (a component of aspartame) 0.05 mg per 25 mg chewable tablet.
Rx only
60 Tablets
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References
Adapted from the FDA Package Insert.