SPL Set ID: 67815abd-5e97-4ccb-ac9b-28c2ef6123e7
1 drug(s) with this SPL Set ID
Naproxen delayed-release tablets, USP are nonsteroidal anti-inflammatory drug available as follows: Naproxen delayed-release tablets, USP are available as enteric-coated white to off-white tablets containing 375 mg of naproxen, USP or 500 mg of naproxen, USP for oral administration. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen is (+)-6-Methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . It has the following structural formula: Naproxen, USP is a practically odorless, white to off-white crystalline powder. It is soluble in chloroform, in dehydrated alcohol, and in alcohol, sparingly soluble in ether, practically insoluble in water. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. The inactive ingredients in naproxen delayed-release tablets include: black iron oxide, croscarmellose sodium, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, povidone, polyethylene glycol, propylene glycol, shellac glaze, simethicone emulsion, sodium hydroxide, talc and titanium dioxide. The dissolution of this enteric-coated naproxen tablet is pH dependent with rapid dissolution above pH 6. There is no dissolution below pH 4. FDA approved dissolution test specifications differ from USP. Chemical Structure