Source: FDA, National Drug Code (US) Revision Year: 2021
NAPROSYN (naproxen) tablets, EC-NAPROSYN (naproxen) delayed-release tablets and ANAPROX DS (naproxen sodium) tablets are nonsteroidal anti-inflammatory drugs available as follows:
NAPROSYN tablets are available as yellow tablets containing 500 mg of naproxen for oral administration.
EC-NAPROSYN delayed-release tablets are available as enteric-coated white tablets containing 375 mg of naproxen or 500 mg of naproxen for oral administration.
ANAPROX DS tablets are available as dark blue tablets containing 550 mg of naproxen sodium for oral administration.
Naproxen is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen and naproxen sodium are (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid and (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen sodium has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. Naproxen and naproxen sodium have the following structures, respectively:
Naproxen is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. Naproxen sodium is a white to creamy white, crystalline solid, freely soluble in water at neutral pH.
The inactive ingredients in NAPROSYN tablets include: croscarmellose sodium, iron oxides, povidone and magnesium stearate.
The inactive ingredients in EC-NAPROSYN delayed release tablets include: croscarmellose sodium, povidone and magnesium stearate. The enteric coating dispersion contains methacrylic acid copolymer, talc, triethyl citrate, sodium hydroxide and purified water. The imprinting on the tablets is black ink. The dissolution of this enteric-coated naproxen tablet is pH dependent with rapid dissolution above pH 6. There is no dissolution below pH 4.
The inactive ingredients in ANAPROX DS tablets include: magnesium stearate, microcrystalline cellulose, povidone and talc. The coating suspension may contain hydroxypropyl methylcellulose 2910, Opaspray K-1-4227, polyethylene glycol 8000 or Opadry YS-1-4216.
| Dosage Forms and Strengths |
|---|
|
NAPROSYN (naproxen) tablets: 500 mg: yellow, capsule-shaped, engraved with NPR LE 500 on one side and scored on the other. EC-NAPROSYN (naproxen) delayed-release tablets: 375 mg: white, oval biconvex coated tablets imprinted with NPR EC 375 on one side. EC-NAPROSYN (naproxen) delayed-release tablets: 500 mg: white, oblong coated tablets imprinted with NPR EC 500 on one side. ANAPROX DS (naproxen sodium) tablets: 550 mg: dark blue, oblong-shaped, engraved with NPS 550 on one side and scored on both sides. |
| How Supplied |
|---|
|
NAPROSYN (naproxen) tablets 500 mg: yellow, capsule-shaped tablets, engraved with NPR LE 500 on one side and scored on the other. Packaged in light-resistant bottles of 100. Store at 15°C to 30°C (59°F to 86°F) in well-closed containers; dispense in light-resistant containers. EC-NAPROSYN (naproxen) delayed-release tablets: 375 mg: white, oval biconvex coated tablets imprinted with NPR EC 375 on one side. Packaged in light-resistant bottles of 100. 500 mg: white, oblong coated tablets imprinted with NPR EC 500 on one side. Packaged in light-resistant bottles of 100. Store at 15°C to 30°C (59°F to 86°F) in well-closed containers; dispense in light-resistant containers. ANAPROX DS (naproxen sodium) Tablets 550 mg: dark blue, oblong-shaped tablets, engraved with NPS 550 on one side and scored on both sides. Packaged in bottles of 100. Manufactured For: Atnahs Pharma US Limited, Miles Gray Road, Basildon, Essex, SS14 3FR, United Kingdom Distributed by: Canton Laboratories, LLC., Alpharetta, GA 30004-5945, United States |
| Drug | Countries | |
|---|---|---|
| EC-NAPROSYN | United Kingdom, United States |
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