celecoxib capsule
1 INDICATIONS AND USAGE Celecoxib is a nonsteroidal anti-inflammatory drug indicated for: Osteoarthritis (OA) ( 1.1 ) Rheumatoid Arthritis (RA) ( 1.2 ) Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older ( 1.3 ) Ankylosing Spondylitis (AS) ( 1.4 ) Acute Pain (AP) (1.5) Primary Dysmenorrhea (PD) ( 1.6 ) Celecoxib capsules are indicated 1.1 Osteoarthritis (OA) For the management of the signs and symptoms of OA [see Clinical Studies ( 14.1 )]. 1.2 Rheumatoid Arthritis (RA) For the management of the signs and symptoms of RA [see Clinical Studies ( 14.2 )]. 1.3 Juvenile Rheumatoid Arthritis (JRA) For the management of the signs and symptoms of JRA in patients 2 years and older [see Clinical Studies (14.3)]. 1.4 Ankylosing Spondylitis (AS) For the management of the signs and symptoms of AS [see Clinical Studies ( 14.4 )]. 1.5 Acute Pain For the management of acute pain in adults [see Clinical Studies ( 14.5 )]. 1.6 Primary Dysmenorrhea For the management of primary dysmenorrhea [see Clinical Studies ( 14.5 )].
lupin pharmaceuticals, inc.
CAPSULE YELLOW LU N43
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celecoxib 100 mg
Lupin Pharmaceuticals, Inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING
CELECOXIB capsules, 50 mg are available as size "3" capsules having red opaque cap, imprinted with 'LU' in black ink and white opaque body imprinted with 'N41' in black ink, containing white to off-white powder. They are supplied as follows: NDC Number Size NDC 68180-395-07 bottle of 60
CELECOXIB capsules, 100 mg are available as size "3" capsules having blue opaque cap, imprinted with 'LU' in black ink and white opaque body imprinted with 'N42' in black ink, containing white to off-white powder. They are supplied as follows: NDC Number Size NDC 68180-396-01 bottle of 100 NDC 68180-396-02 bottle of 500 NDC 68180-396-03 bottle of 1000
CELECOXIB capsules, 200 mg are size "1" capsules having gold opaque cap, imprinted with 'LU' in black ink and white opaque body imprinted with 'N43' in black ink, containing white to off-white powder. NDC Number Size NDC 68180-399-01 bottle of 100 NDC 68180-399-02 bottle of 500
CELECOXIB capsules, 400 mg are size "00EL" capsules having green opaque cap, imprinted with 'LU' in black ink and white opaque body imprinted with 'N44' in black ink, containing white to off-white powder. NDC Number Size NDC 68180-398-07 bottle of 60 NDC 68180-398-01 bottle of 100 Storage Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].
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