Celecoxib

Boxed Warning 5/2016 Warnings and Precautions, Cardiovascular Thrombotic Events ( 5.1 ) 5/2016 Warnings and Precautions, Heart Failure and Edema ( 5.5 ) 5/2016

1 INDICATIONS AND USAGE Celecoxib Capsule is a non-steroidal 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 ) Carefully consider the potential benefits and risks of Celecoxib Capsules and other treatment options before deciding to use Celecoxib Capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions ( 5 )] 1.1 Osteoarthritis (OA) Celecoxib Capsules is indicated for relief of the signs and symptoms of OA [see Clinical Studies ( 14.1 )] 1.2 Rheumatoid Arthritis (RA) Celecoxib Capsules is indicated for relief of the signs and symptoms of RA [see Clinical Studies ( 14.2 )] 1.3 Juvenile Rheumatoid Arthritis (JRA) Celecoxib Capsules is indicated for relief of the signs and symptoms of JRA in patients 2 years and older [see Clinical Studies ( 14.3 )] 1.4 Ankylosing Spondylitis (AS) Celecoxib Capsules is indicated for the relief of signs and symptoms of AS [see Clinical Studies ( 14.4 )] 1.5 Acute Pain (AP) Celecoxib Capsules is indicated for the management of AP in adults [see Clinical Studies ( 14.5 )] 1.6 Primary Dysmenorrhea (PD) Celecoxib Capsules is indicated for the treatment of PD [see Clinical Studies ( 14.5 )]

2. DOSAGE AND ADMINISTRATION • Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals. ( Error! Hyperlink reference not valid. ) • OA: 200 mg once daily or 100 mg twice daily. ( Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. ) • RA: 100 mg to 200 mg twice daily. ( Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. ) • JRA: 50 mg twice daily in patients 10 kg to 25 kg. 100 mg twice daily in patients more than 25 kg. ( Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. ) • AS: 200 mg once daily single dose or 100 mg twice daily. If no effect is observed after 6 weeks, a trial of 400 mg (single or divided doses) may be of benefit. ( Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. ) • AP and PD: 400 mg initially, followed by 200 mg dose if needed on first day. On subsequent days, 200 mg twice daily as needed. ( Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. ) Hepatic Impairment: Reduce daily dose by 50% in patients with moderate hepatic impairment (Child-Pugh Class B). ( Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. ) Poor Metabolizers of CYP2C9 Substrates: Consider a dose reduction by 50% (or alternative management for JRA) in patients who are known or suspected to be CYP2C9 poor metabolizers. ( Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. ) 2.1 General Dosing Instructions Carefully consider the potential benefits and risks of celecoxib and other treatment options before deciding to use celecoxib. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [ see Error! Hyperlink reference not valid. ]. These doses can be given without regard to timing of meals. 2.2 Osteoarthritis For OA, the dosage is 200 mg per day administered as a single dose or as 100 mg twice daily. 2.3 Rheumatoid Arthritis For RA, the dosage is 100 mg to 200 mg twice daily. 2.4 Juvenile Rheumatoid Arthritis For JRA, the dosage for pediatric patients (age 2 years and older) is based on weight. For patients ≥ 10 kg to ≤ 25 kg the recommended dose is 50 mg twice daily. For patients > 25 kg the recommended dose is 100 mg twice daily. For patients who have difficulty swallowing capsules, the contents of a celecoxib capsule can be added to applesauce. The entire capsule contents are carefully emptied onto a level teaspoon of cool or room temperature applesauce and ingested immediately with water. The sprinkled capsule contents on applesauce are stable for up to 6 hours under refrigerated conditions (2°C to 8°C/ 35°F to 45°F). 2.5 Ankylosing Spondylitis For AS, the dosage of celecoxib is 200 mg daily in single (once per day) or divided (twice per day) doses. If no effect is observed after 6 weeks, a trial of 400 mg daily may be worthwhile. If no effect is observed after 6 weeks on 400 mg daily, a response is not likely and consideration should be given to alternate treatment options. 2.6 Management of Acute Pain and Treatment of Primary Dysmenorrhea For management of Acute Pain and Treatment of Primary Dysmenorrhea, the dosage is 400 mg initially, followed by an additional 200 mg dose if needed on the first day. On subsequent days, the recommended dose is 200 mg twice daily as needed. 2.7 Special Populations Hepatic Impairment In patients with moderate hepatic impairment (Child-Pugh Class B), reduce the dose by 50%. The use of celecoxib in patients with severe hepatic impairment is not recommended [ see Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. , and Error! Hyperlink reference not valid. ]. Poor Metabolizers of CYP2C9 Substrates In adult patients who are known or suspected to be poor CYP2C9 metabolizers based on genotype or previous history/exper …

3 DOSAGE FORMS AND STRENGTHS Celecoxib capsules: • 50 mg are opaque white/opaque white hard gelatin capsules size “5” having imprinting “134” on body with red ink and “A” on cap with red ink filled with white to off-white colored granular powder. • 100 mg are opaque white/opaque white hard gelatin capsules size “3” having imprinting “135” on body with blue ink and “A” on cap with blue ink filled with white to off-white colored granular powder. • 200 mg are opaque white/opaque white hard gelatin capsules size “1” having imprinting “136” on body with golden yellow ink and “A” on cap with golden yellow ink filled with white to off-white colored granular powder. • 400 mg are opaque white/opaque white hard gelatin capsules size “00” having imprinting “137” on body with green ink and “A” on cap with green ink filled with white to off-white colored granular powder. Celecoxib capsules: 50 mg, 100 mg, 200 mg, and 400 mg ( 3 )

4. CONTRAINDICATIONS Celecoxib is contraindicated in the following patients: • Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to celecoxib, any components of the drug product [ see Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. ]. • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs, have been reported in such patients [ see Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. ]. • In the setting of CABG surgery [ see Error! Hyperlink reference not valid. ]. • In patients who have demonstrated allergic-type reactions to sulfonamides [ see Error! Hyperlink reference not valid. ]. • Known hypersensitivity to celecoxib, or any components of the drug product or sulfonamides. ( 4 ) • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. ( 4 ) • In the setting of CABG surgery. ( 4 )

6. Adverse Reactions The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events [ see WARNINGS AND PRECAUTIONS (5.1)] GI Bleeding, Ulceration and Perforation [ see WARNINGS AND PRECAUTIONS (5.2)] Hepatotoxicity [ see WARNINGS AND PRECAUTIONS (5.3)] Hypertension [ see WARNINGS AND PRECAUTIONS (5.4)] Heart Failure and Edema [ see WARNINGS AND PRECAUTIONS (5.5)] Renal Toxicity and Hyperkalemia [ see WARNINGS AND PRECAUTIONS (5.6)] Anaphylactic Reactions [ see WARNINGS AND PRECAUTIONS (5.7)] Serious Skin Reactions [ see WARNINGS AND PRECAUTIONS (5.9)] Hematologic Toxicity [ see WARNINGS AND PRECAUTIONS (5.12)] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. Of the celecoxib-treated patients in the pre-marketing controlled clinical trials, approximately 4,250 were patients with OA, approximately 2,100 were patients with RA, and approximately 1,050 were patients with post-surgical pain. More than 8,500 patients received a total daily dose of celecoxib of 200 mg (100 mg twice daily or 200 mg once daily) or more, including more than 400 treated at 800 mg (400 mg twice daily). Approximately 3,900 patients received celecoxib at these doses for 6 months or more; approximately 2,300 of these have received it for 1 year or more and 124 of these have received it for 2 years or more. Pre-marketing Controlled Arthritis Trials Table 1 lists all adverse events, regardless of causality, occurring in ≥ 2% of patients receiving celecoxib from 12 controlled studies conducted in patients with OA or RA that included a placebo and/or a positive control group. Since these 12 trials were of different durations, and patients in the trials may not have been exposed for the same duration of time, these percentages do not capture cumulative rates of occurrence. Table 1: Adverse Events Occurring in ≥2% of Celecoxib Patients from Pre-marketing Controlled Arthritis Trials CBX N=4146 Placebo N=1864 NAP N=1366 DCF N=387 IBU N=345 Gastrointestinal Abdominal Pain 4.1% 2.8% 7.7% 9.0% 9.0% Diarrhea 5.6% 3.8% 5.3% 9.3% 5.8% Dyspepsia 8.8% 6.2% 12.2% 10.9% 12.8% Flatulence 2.2% 1.0% 3.6% 4.1% 3.5% Nausea 3.5% 4.2% 6.0% 3.4% 6.7% Body as a whole Back Pain 2.8% 3.6% 2.2% 2.6% 0.9% Peripheral Edema 2.1% 1.1% 2.1% 1.0% 3.5% Injury-Accidental 2.9% 2.3% 3.0% 2.6% 3.2% Central, Peripheral Nervous system Dizziness 2.0% 1.7% 2.6% 1.3% 2.3% Headache 15.8% 20.2% 14.5% 15.5% 15.4% Psychiatric Insomnia 2.3% 2.3% 2.9% 1.3% 1.4% Respiratory Pharyngitis 2.3% 1.1% 1.7% 1.6% 2.6% Rhinitis 2.0% 1.3% 2.4% 2.3% 0.6% Sinusitis 5.0% 4.3% 4.0% 5.4% 5.8% Upper Respiratory Infection 8.1% 6.7% 9.9% 9.8% 9.9% Skin Rash 2.2% 2.1% 2.1% 1.3% 1.2% CBX = Celecoxib capsule 100 mg to 200 mg twice daily or 200 mg once daily; NAP = Naproxen 500 mg twice daily; DCF = Diclofenac 75 mg twice daily; IBU = Ibuprofen 800 mg three times daily. In placebo- or active-controlled clinical trials, the discontinuation rate due to adverse events was 7.1% for patients receiving celecoxib and 6.1% for patients receiving placebo. Among the most common reasons for discontinuation due to adverse events in the celecoxib treatment groups were dyspepsia and abdominal pain (cited as reasons for discontinuation in 0.8% and 0.7% of celecoxib patients, respectively). Among patients receiving placebo, 0.6% discontinued due to dyspepsia and 0.6% withdrew due to abdominal pain. The following adverse reactions occurred in 0.1% to 1.9% of patients treated with celecoxib capsule (100 mg to 200 mg twice daily or 200 mg once daily): Gastroi …

7. DRUG INTERACTIONS See Table 3 for clinically significant drug interactions with celecoxib. Table 3: Clinically Significant Drug Interactions with Celecoxib Drugs That Interfere with Hemostasis Clinical Impact: • Celecoxib and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of celecoxib and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone. • Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone. Intervention: Monitor patients with concomitant use of celecoxib with anticoagulants (e.g., warfarin), antiplatelet drugs (e.g., aspirin), SSRIs, and SNRIs for signs of bleeding [ see Error! Hyperlink reference not valid. ]. Aspirin Clinical Impact: Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone. In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone [ see Error! Hyperlink reference not valid. ]. In two studies in healthy volunteers, and in patients with osteoarthritis and established heart disease respectively, celecoxib (200 mg to 400 mg daily) has demonstrated a lack of interference with the cardioprotective antiplatelet effect of aspirin (100 mg to 325 mg). Intervention: Concomitant use of celecoxib and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding [ see Error! Hyperlink reference not valid. ]. Celecoxib is not a substitute for low dose aspirin for cardiovascular protection. ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers Clinical Impact: • NSAIDs may diminish the antihypertensive effect of ACE inhibitors, ARBs, or beta-blockers (including propranolol). • In patients who are elderly, volume-depleted (including those on diuretic therapy), or have renal impairment, co-administration of an NSAID with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Intervention: • During concomitant use of celecoxib and ACE inhibitors, ARBs, or beta-blockers, monitor blood pressure to ensure that the desired blood pressure is obtained. • During concomitant use of celecoxib and ACE inhibitors or ARBs in patients who are elderly, volume-depleted, or have impaired renal function, monitor for signs of worsening renal function [ see Error! Hyperlink reference not valid. ]. • When these drugs are administered concomitantly, patients should be adequately hydrated. Assess renal function at the beginning of the concomitant treatment and periodically thereafter. Diuretics Clinical Impact: Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis. Intervention: During concomitant use of celecoxib with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects [ see Error! Hyperlink reference not valid. ]. Digoxin Clinical Impact: The concomitant use of celecoxib with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin. Intervention: During concomitant use of celecoxib and digoxin, monitor serum digoxin levels. Lithium Clinical Impact: NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the rena …

8. Use in Specific Populations 8.1 Pregnancy Risk Summary Use of NSAIDs, including celecoxib, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, limit dose and duration of celecoxib use between about 20 and 30 weeks of gestation and avoid celecoxib use at about 30 weeks of gestation and later in pregnancy ( see Clinical Considerations, Data). Premature Closure of Fetal Ductus Arteriosus Use of NSAIDs, including celecoxib, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Oligohydramnios/Neonatal Renal Impairment Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. Data from observational studies regarding other potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. In animal reproduction studies, embryo-fetal deaths and an increase in diaphragmatic hernias were observed in rats administered celecoxib daily during the period of organogenesis at oral doses approximately 6 times the maximum recommended human dose (MRHD) of 200 mg twice daily. In addition, structural abnormalities (e.g., septal defects, ribs fused, sternebrae fused and sternebrae misshapen) were observed in rabbits given daily oral doses of celecoxib during the period of organogenesis at approximately 2 times the MRHD ( see Data). Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, administration of prostaglandin synthesis inhibitors such as celecoxib, resulted in increased pre- and post- implantation loss. Prostaglandins also have been shown to have an important role in fetal kidney development. In published animal studies, prostaglandin synthesis inhibitors have been reported to impair kidney development when administered at clinically relevant doses. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Premature closure of Fetal Ductus Arteriosus: Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy, because NSAIDs, including celecoxib, can cause premature closure of the fetal ductus arteriosus ( see Data). Oligohydramnios/Neonatal Renal Impairment: If an NSAID is necessary at about 20 weeks gestation or later in pregnancy, limit the use to the lowest effective dose and shortest duration possible. If celecoxib treatment extends beyond 48 hours, consider monitoring with ultrasound for oligohydramnios. If oligohydramnios occurs, discontinue celecoxib and follow up according to clinical practice ( see Data). Labor or Delivery There are no studies on the effects of celecoxib during labor or delivery. In animal studies, NSAIDs, including celecoxib, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth. Data Human Data The available data do not establish the presence or absence of developmental toxicity related to the use of celecoxib. Premature Closure of Fetal Ductus Arteriosus: Published literature reports that the use of NSAIDs at about 30 weeks of gestation and later in pregnancy may cause premature closure of the fetal ductus arteriosus. Oligohydramnios/Neonatal Renal Impairment: Published studies and postmarketing reports describe maternal NSAID use at about 20 weeks gestation or lat …

12.1 Mechanism of Action CELECOXIB has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of celecoxib capsules are believed to be due to inhibition of prostaglandin synthesis, primarily via inhibition of cyclooxygenase-2 (COX-2). Celecoxib is a potent inhibitor of prostaglandin synthesis in vitro. Celecoxib concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation. Since celecoxib is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.

11 DESCRIPTION Celecoxib is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib USP 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 C 17 H 14 F 3 N 3 O 2 S, and it has the following chemical structure: Celecoxib USP is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib USP is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: gelatin, lactose monohydrate, magnesium stearate, povidone, sodium lauryl sulfate, hydroxypropyl cellulose, crospovidone and titanium dioxide. The imprinting ink of capsule shell of the 50 mg capsule contains the following inactive ingredients: shellac, propylene glycol, sodium hydroxide, titanium dioxide, povidone and FD&C Red#40 Aluminum Lake- E129. The imprinting ink of capsule shell of the 100 mg capsule contains the following inactive ingredients: shellac, propylene glycol, strong ammonia solution and FD&C Blue#2 Aluminum Lake-E132. The imprinting ink of capsule shell of the 200 mg capsule contains the following inactive ingredients: shellac, propylene glycol, strong ammonia solution and yellow iron oxide. The imprinting ink of capsule shell of the 400 mg capsule contains the following inactive ingredients: shellac, propylene glycol, sodium hydroxide, povidone, titanium dioxide, FD&C Blue#1 Aluminum Lake- E133 and FD&C Yellow#5 Aluminum Lake-E102. structure

10. OVERDOSAGE Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression, and coma have occurred, but were rare [ see Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. ]. No overdoses of celecoxib were reported during clinical trials. Doses up to 2,400 mg/day for up to 10 days in 12 patients did not result in serious toxicity. No information is available regarding the removal of celecoxib by hemodialysis, but based on its high degree of plasma protein binding (> 97%) dialysis is unlikely to be useful in overdose. Manage patients with symptomatic and supportive care following an NSAID overdosage. There are no specific antidotes. Consider emesis and/or activated charcoal (60 to 100 grams in adults, 1 to 2 grams per kg of body weight in pediatric patients) and/or osmotic cathartic in symptomatic patients seen within four hours of ingestion or in patients with a large overdosage (5 to 10 times the recommended dosage). Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding. For additional information about overdosage treatment contact a poison control center (1-800-222-1222).

16. HOW SUPPLIED/STORAGE AND HANDLING Celecoxib capsules, 50 mg are white, with reverse printed white on red band with markings SG on cap and 156 on body, supplied as: NDC 76420-842-01 Bottle of 01 (repackaged from NDC 50228-156-XX) NDC 76420-842-07 Bottle of 07 (repackaged from NDC 50228-156-XX) NDC 76420-842-14 Bottle of 14 (repackaged from NDC 50228-156-XX) NDC 76420-842-20 Bottle of 20 (repackaged from NDC 50228-156-XX) NDC 76420-842-30 Bottle of 30 (relabeled from NDC 50228-156-30) NDC 76420-842-60 Bottle of 60 (relabeled from NDC 50228-156-60) NDC 76420-842-90 Bottle of 90 (repackaged from NDC 50228-156-XX) NDC 76420-842-00 Bottle of 1,000 (relabeled from NDC 50228-156-10) Celecoxib capsules, 100 mg are white, with reverse printed white on blue band with markings SG on cap and 157 on body, supplied as: NDC 76420-843-01 Bottle of 01 (repackaged from NDC 50228-157-XX) NDC 76420-843-07 Bottle of 07 (repackaged from NDC 50228-157-XX) NDC 76420-843-14 Bottle of 14 (repackaged from NDC 50228-157-XX) NDC 76420-843-20 Bottle of 20 (repackaged from NDC 50228-157-XX) NDC 76420-843-30 Bottle of 30 (relabeled from NDC 50228-157-30) NDC 76420-843-60 Bottle of 60 (repackaged from NDC 50228-157-XX) NDC 76420-843-90 Bottle of 90 (repackaged from NDC 50228-157-XX) NDC 76420-843-01 Bottle of 100 (relabeled from NDC 50228-157-01) NDC 76420-843-05 Bottle of 500 (relabeled from NDC 50228-157-05) NDC 76420-843-00 Bottle of 1,000 (relabeled from NDC 50228-157-10) Celecoxib capsules, 200 mg are white, with reverse printed white on gold band with markings SG on cap and 158 on body, supplied as: NDC 76420-844-01 Bottle of 01 (repackaged from NDC 50228-158-XX) NDC 76420-844-07 Bottle of 07 (repackaged from NDC 50228-158-XX) NDC 76420-844-14 Bottle of 14 (repackaged from NDC 50228-158-XX) NDC 76420-844-20 Bottle of 20 (repackaged from NDC 50228-158-XX) NDC 76420-844-30 Bottle of 30 (relabeled/repackaged from NDC 50228-158-30/50228-158-XX) NDC 76420-844-60 Bottle of 60 (repackaged from NDC 50228-158-XX) NDC 76420-844-90 Bottle of 90 (repackaged from NDC 50228-158-XX) NDC 76420-844-01 Bottle of 100 (relabeled from NDC 50228-158-01) NDC 76420-844-12 Bottle of 120 (repackaged from NDC 50228-158-XX) NDC 76420-844-05 Bottle of 500 (relabeled from NDC 50228-158-05) NDC 76420-844-00 Bottle of 1,000 (relabeled from NDC 50228-158-10) Celecoxib capsules, 400 mg are white, with reverse printed white on green band with markings SG on cap and 159 on body, supplied as: NDC 76420-845-01 Bottle of 01 (repackaged from NDC 50228-159-XX) NDC 76420-845-07 Bottle of 07 (repackaged from NDC 50228-159-XX) NDC 76420-845-14 Bottle of 14 (repackaged from NDC 50228-159-XX) NDC 76420-845-20 Bottle of 20 (repackaged from NDC 50228-159-XX) NDC 76420-845-30 Bottle of 30 (relabeled from NDC 50228-159-30) NDC 76420-845-60 Bottle of 60 (relabeled from NDC 50228-159-60) NDC 76420-845-90 Bottle of 90 (repackaged from NDC 50228-159-XX) NDC 76420-845-05 Bottle of 500 (relabeled from NDC 50228-159-05) Storage: Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].