CELEBREX Capsule Ref.[10546] Active ingredients: Celecoxib

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

Product description

CELEBREX (celecoxib) capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)3(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole.

The molecular weight is 381.38. Its molecular formula is C17H14F3N3O2S, and it has the following chemical structure:

Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range.

The inactive ingredients in CELEBREX include: croscarmellose sodium, edible inks, gelatin, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate.

Dosage Forms and Strengths

CELEBREX (celecoxib) capsules:

50 mg white, with reverse printed white on red band of body and cap with markings of 7767 on the cap and 50 on the body.

100 mg white, with reverse printed white on blue band of body and cap with markings of 7767 on the cap and 100 on the body.

200 mg white, with reverse printed white on gold band with markings of 7767 on the cap and 200 on the body.

400 mg white, with reverse printed white on green band with markings of 7767 on the cap and 400 on the body.

How Supplied

CELEBREX (celecoxib) 50 mg capsules are white, with reverse printed white on red band of body and cap with markings of 7767 on the cap and 50 on the body, supplied as:

NDC Number Size
0025-1515-01 bottle of 60

CELEBREX (celecoxib) 100 mg capsules are white, with reverse printed white on blue band of body and cap with markings of 7767 on the cap and 100 on the body, supplied as:

NDC Number Size
0025-1520-31 bottle of 100
0025-1520-51 bottle of 500
0025-1520-34 carton of 100 unit dose

CELEBREX (celecoxib) 200 mg capsules are white, with reverse printed white on gold band with markings of 7767 on the cap and 200 on the body, supplied as:

NDC Number Size
0025-1525-31 bottle of 100
0025-1525-51 bottle of 500
0025-1525-34 carton of 100 unit dose

CELEBREX (celecoxib) 400 mg capsules are white, with reverse printed white on green band with markings of 7767 on the cap and 400 on the body, supplied as:

NDC Number Size
0025-1530-02 bottle of 60
0025-1530-01 carton of 100 unit dose

Drugs

Drug Countries
CELEBREX Austria, Australia, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, France, Hong Kong, Ireland, Italy, Lithuania, Malta, Mexico, Nigeria, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

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