Description (Naproxen 500mg 1)
Naproxen
Product Images NDC 53217-405
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Product Visual Gallery
This gallery contains 4 technical images submitted to the FDA as part of the official labeling for Naproxen (NDC 53217-405). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Aidarex Pharmaceuticals Llc, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.
Clinical Pahrmacology (Naproxen 500mg 2)
This text provides information on the pharmacokinetics of two different forms of naproxen tablets. The first form is delayed-release and administered at a dose of 500 mg twice daily. The Cmax (maximum concentration) achieved after administration was 94.9 μg/mL with 18% variability, and Tmax (time to reach maximum concentration) was 4 hours with 39% variability. The AUC0-12 (area under the curve) was 845 μg-hr/mL with 20% variability. The second form is standard naproxen tablets also administered at a dose of 500 mg twice daily. The Cmax achieved was 97.4 μg/mL with 13% variability, and Tmax was 1.9 hours with 61% variability. The AUC0-12 was 767 μg-hr/mL with 15% variability. This text provides mean values and coefficients of variation for these pharmacokinetic parameters.*
Dosage And Administration (Naproxen 500mg 3)
Naproxen is a medication available in the form of delayed-release tablets of 375mg or 500mg dosage. The recommended frequency of the medication is twice daily.*
53217-0405_naproxen-dr_500mg (Naproxen 500mg 4)
This is a description of a medication called "Naproxen DR, USP". It is a generic for "Naprosyn DR". It is a 500mg tablet that is enteric-coated and comes in a package of 30 tablets. It is manufactured by Invagen Pharmaceuticals, Inc., and is packaged in Hauppauge, NY. The NDC is 53217-0405-30, and the lot number is 60420. The patient is advised to take the medication every few hours, as needed. There are various RX numbers and other codes listed on the packaging, as well.*
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.
