NALFON Capsule Ref.[10055] Active ingredients: Fenoprofen

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

NALFON (fenoprofen calcium, USP) capsules is a nonsteroidal, anti-inflammatory drug available in 200 mg and 400 mg capsule form for oral administration.

The 200 mg capsule is opaque yellow No. 97 cap and opaque white body, imprinted with “RX681” on the cap and body.

The 400 mg capsule is opaque green cap and opaque blue body, imprinted with “NALFON 400 mg” on the cap and “EP 123” on the body.

The chemical name is Benzenaecetic acid, α-methyl-3-phenoxy-, calcium salt dihydrate, (±)-. The molecular weight is 558.65. Its molecular formula is C30H26CaO6•2H2O, and it has the following chemical structure.

Benzeneacetic acid, α-methyl-3-phenoxy-, calcium salt (2:1)(±), dihydrate

Fenoprofen Calcium is an arylacetic acid derivative. It is a white crystalline powder. At 25°C, it dissolves to a 15 mg/mL solution in alcohol (95%). It is slightly soluble in water and insoluble in benzene.The pKa of fenoprofen calcium is 4.5 at 25°C.

Nalfon capsules contain fenoprofen calcium as the dihydrate in an amount equivalent to 200 mg (0.826 mmol) or 400 mg (1.65 mmol) of fenoprofen.

Inactive ingredients in Nalfon capsules are crospovidone, magnesium stearate, sodium lauryl sulfate, and talc. In addition, the 200 mg capsules contain gelatin, titanium dioxide, yellow iron oxide, and red iron oxide, and the 400 mg capsules contain gelatin, D&C Yellow #10, FD&C Blue #1, FD&C Red #40, FD&C Yellow #6, and titanium dioxide.

Dosage Forms and Strengths

Nalfon (fenoprofen calcium) capsules:

  • The 200 mg capsule is opaque yellow No. 97 cap and opaque white body, imprinted with “RX681” on the cap and body.
  • The 400 mg capsule is opaque green cap and opaque blue body, imprinted with “NALFON 400 mg” on the cap and “EP 123” on the body.
How Supplied

Product: 71335-0805

NDC: 71335-0805-1 30 CAPSULE in a BOTTLE
NDC: 71335-0805-2 60 CAPSULE in a BOTTLE
NDC: 71335-0805-3 90 CAPSULE in a BOTTLE
NDC: 71335-0805-4 120 CAPSULE in a BOTTLE
NDC: 71335-0805-5 28 CAPSULE in a BOTTLE

Drugs

Drug Countries
NALFON United States

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