Naproxen CR Tablets

Naproxen sodium extended-release tablets are available as follows:

375 mg: white, round tablet imprinted with “Andrx 825”, in bottles of 100, NDC 62037-825-01. Each tablet contains 412.5 mg naproxen sodium equivalent to 375 mg naproxen.

500 mg: white, capsule-shaped tablet imprinted with “Andrx 826”; in bottles of 75, NDC 62037-826-75. Each tablet contains 550 mg naproxen sodium equivalent to 500 mg naproxen.

750 mg: white, capsule-shaped, film-coated tablets printed with “A750” on one side and plain on the other side, in bottles of 30, NDC 62037-827-30, bottles of 60, NDC 62037-827-60, bottles of 90, NDC 62037-827-19, and bottles of 500, NDC 62037-827-05. Each tablet contains 825 mg naproxen sodium equivalent to 750 mg naproxen.

Naproxen sodium extended-release tablets are a nonsteroidal anti-inflammatory drug, available as extended-release tablets in 375 mg, 500 mg, and 750 mg strengths for oral administration. The chemical name is 2-naphthaleneacetic acid, 6-methoxy-α-methyl-sodium salt, (S)-. The molecular weight is 252.24. Its molecular formula is C14H13NaO3, and it has the following chemical structure.

Naproxen sodium is an odorless crystalline powder, white to creamy in color. It is soluble in methanol and water. Naproxen sodium extended-release tablets contain 412.5 mg, 550 mg, or 825 mg of naproxen sodium, equivalent to 375 mg, 500 mg, and 750 mg of naproxen, and 37.5 mg, 50 mg, and 75 mg sodium respectively. Each naproxen sodium extended-release tablet also contains the following inactive ingredients: black iron oxide, colloidal silicon dioxide, ethyl acrylate/methyl methacrylate copolymer, fumaric acid, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, and propylene glycol. The tablet coating contains hypromellose, polyethylene glycol, polysorbate 80, and titanium dioxide.

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

A two year study was performed in rats to evaluate the carcinogenic potential of naproxen at doses of 8 mg/kg/day, 16 mg/kg/day, and 24 mg/kg/day (0.05, 0.1, and 0.16 times the maximum recommended human daily dose of 1500 mg/day based on a body surface area comparison). No evidence of tumorigenicity was found.

Mutagenesis

Studies to evaluate the mutagenic potential of Naprosyn Suspension have not been completed.

Impairment of Fertility

Studies to evaluate the impact of naproxen on male or female fertility have not been completed.

Naproxen sodium extended-release tablets are available as follows:

375 mg: white, round tablet imprinted with “Andrx 825”, in bottles of 100, NDC 62037-825-01. Each tablet contains 412.5 mg naproxen sodium equivalent to 375 mg naproxen.

500 mg: white, capsule-shaped tablet imprinted with “Andrx 826”; in bottles of 75, NDC 62037-826-75. Each tablet contains 550 mg naproxen sodium equivalent to 500 mg naproxen.

750 mg: white, capsule-shaped, film-coated tablets printed with “A750” on one side and plain on the other side, in bottles of 30, NDC 62037-827-30, bottles of 60, NDC 62037-827-60, bottles of 90, NDC 62037-827-19, and bottles of 500, NDC 62037-827-05. Each tablet contains 825 mg naproxen sodium equivalent to 750 mg naproxen.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

PHARMACIST: Dispense in a well-closed container.

NDC 62037-825-01
Naproxen
Sodium
Extended-Release Tablets
375 mg
100 Tablets
Rx Only

NDC 62037-827-30
Naproxen
Sodium
Extended-Release Tablets
750 mg
30 Tablets
Rx Only