XIGDUO

Boxed Warning 08/2026 Dosage and Administration 08/2026 Recommendations Regarding Missed Dose ( 2.7 ) Warnings and Precautions 08/2026 Lactic Acidosis ( 5.1 ) Genitourinary Infections, including Urosepsis, Pyelonephritis, Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene), and Genital Mycotic Infections ( 5.4 )

1 INDICATIONS AND USAGE XIGDUO XR is a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. Dapagliflozin, when used as a component of XIGDUO XR, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: • Sustained eGFR decline, end‐stage kidney disease, (CV) death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression. • CV death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure. • Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established CV disease or multiple CV risk factors. Limitations of Use • XIGDUO XR is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.2) ] . • Because of the metformin HCl component, the use of XIGDUO XR is limited to patients with type 2 diabetes mellitus for all indications. • XIGDUO XR is not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of immunosuppressive therapy for kidney disease. XIGDUO XR is not expected to be effective in these populations. XIGDUO XR is a combination of dapagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. ( 1 ) Dapagliflozin when used as a component of XIGDUO XR, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: • Sustained eGFR decline, end-stage kidney disease, cardiovascular (CV) death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression. ( 1 ) • CV death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure. ( 1 ) • Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established CV disease or multiple CV risk factors. ( 1 ) Limitations of use : • Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. ( 1 ) • Because of the metformin HCl component, the use of XIGDUO XR is limited to patients with type 2 diabetes mellitus for all indications. ( 1 ) • Not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of immunosuppressive therapy for the treatment of kidney disease. XIGDUO XR is not expected to be effective in these populations. ( 1 )

2 DOSAGE AND ADMINISTRATION • Assess renal function prior to initiating and then as clinically indicated. ( 2.1 ) • Assess volume status and correct volume depletion before initiating. ( 2.1 ) • Individualize the starting dosage based on the patient’s current treatment. ( 2.3 ) • Administer orally once daily in the morning with food. ( 2.2 ) • To improve glycemic control, for patients aged 10 years and older not already taking dapagliflozin, the recommended starting dosage for dapagliflozin is 5 mg once daily. ( 2.3 ) • For indications in adults related to heart failure and chronic kidney disease the recommended dosage of dapagliflozin is 10 mg once daily. ( 2.3 ) • Do not exceed a daily dosage of 10 mg dapagliflozin/2,000 mg metformin HCl extended-release. ( 2.3 ) • See Full Prescribing Information for dosage recommendations in patients with renal impairment. ( 2.4 ) • XIGDUO XR may need to be discontinued at time of, or prior to, iodinated contrast imaging procedures. ( 2.5 ) • Withhold XIGDUO XR for at least 3 days, if possible, prior to surgery or procedures associated with prolonged fasting. ( 2.6 ) 2.1 Testing Prior to Initiation of XIGDUO XR • Assess renal function prior to initiating XIGDUO XR and then as clinically indicated [see Warnings and Precautions (5.1 , 5.3) ] . • Assess volume status. In patients with volume depletion, correct this condition before initiating XIGDUO XR [see Warnings and Precautions (5.3) and Use in Specific Populations (8.5 , 8.6)]. 2.2 Recommended Administration • Take XIGDUO XR orally once daily in the morning with food. • Swallow XIGDUO XR tablets whole and never crush, cut, or chew. 2.3 Recommended Dosage • Individualize the starting dosage of XIGDUO XR based upon the patient’s current regimen. Patients taking an evening dosage of metformin HCl extended‐release should skip their last dose before starting XIGDUO XR. • To improve glycemic control in adults and pediatric patients aged 10 years and older not already taking: ∘ Dapagliflozin: the recommended starting dosage of dapagliflozin in XIGDUO XR is 5 mg orally once daily. ∘ Metformin HCl extended‐release: the recommended starting dosage of metformin HCl extended‐release in XIGDUO XR is 500 mg orally once daily. • For XIGDUO XR indications in adults related to heart failure and chronic kidney disease, the recommended dosage of dapagliflozin in XIGDUO XR is 10 mg orally once daily. • For all XIGDUO XR indications, the dosage may be adjusted based on effectiveness and tolerability. The maximum recommended daily dosage of dapagliflozin is 10 mg and 2,000 mg of metformin HCl extended‐release, with gradual dosage escalation to reduce gastrointestinal adverse reactions with metformin HCl [see Adverse Reactions (6.1) ] . 2.4 Recommended Dosage in Patients with Renal Impairment • The recommended dosage of XIGDUO XR in patients with an estimated glomerular filtration rate (eGFR) greater than or equal to 45 mL/min/1.73 m 2 is the same as the recommended dosage in patients with normal renal function. • Initiation of XIGDUO XR is not recommended in patients with an eGFR between 30 and 45 mL/min/1.73 m 2 . Assess the benefit and risk of continuing therapy if eGFR falls persistently below this level. ∘ Dapagliflozin is likely to be ineffective to improve glycemic control in patients with eGFR less than 45 mL/min/1.73 m 2 . ∘ Metformin HCl initiation is not recommended for patients with eGFR less than 45 mL/min/1.73 m 2 . • XIGDUO XR is contraindicated in patients with an eGFR below 30 mL/min/1.73 m2 and end‐stage renal disease due to the metformin HCl component [ see Contraindications (4) , Warnings and Precautions (5.1) , and Use in Specific Populations (8.6) ] . 2.5 Discontinuation for Iodinated Contrast Imaging Procedures Discontinue XIGDUO XR at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR less than 60 mL/min/1.73 m 2 , in patients with a history of liver disease, alcoholism or heart failure; or in pat …

3 DOSAGE FORMS AND STRENGTHS XIGDUO XR (dapagliflozin and metformin HCl) extended-release tablets are available as follows: Table 1: Dosage Forms and Strengths for XIGDUO XR Dapagliflozin Strength Metformin HCl Strength Color/Shape Tablet Markings 2.5 mg 1,000 mg light brown to brown, biconvex, oval-shaped, and film-coated tablet "1074" and "2.5/1000" debossed on one side and plain on the reverse side 5 mg 500 mg orange, biconvex, capsule-shaped, and film-coated tablet "1070" and "5/500" debossed on one side and plain on the reverse side 5 mg 1,000 mg pink to dark pink, biconvex, oval-shaped, and film-coated tablet "1071" and "5/1000" debossed on one side and plain on the reverse side 10 mg 500 mg pink, biconvex, capsule-shaped, and film-coated tablet "1072" and "10/500" debossed on one side and plain on the reverse side 10 mg 1,000 mg yellow to dark yellow, biconvex, oval-shaped, and film-coated tablet "1073" and "10/1000" debossed on one side and plain on the reverse side • 2.5 mg dapagliflozin/1,000 mg metformin HCl extended-release ( 3 ) • 5 mg dapagliflozin/500 mg metformin HCl extended-release ( 3 ) • 5 mg dapagliflozin/1,000 mg metformin HCl extended-release ( 3 ) • 10 mg dapagliflozin/500 mg metformin HCl extended-release ( 3 ) • 10 mg dapagliflozin/1,000 mg metformin HCl extended-release ( 3 )

4 CONTRAINDICATIONS XIGDUO XR is contraindicated in patients with: • Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ) or end-stage renal disease [see Warnings and Precautions (5.1) ] . • History of a serious hypersensitivity reaction to dapagliflozin, metformin HCl, or any of the excipients in XIGDUO XR. Serious hypersensitivity reactions, including anaphylaxis and angioedema have been reported with dapagliflozin [see Adverse Reactions (6.1) ] . • Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin [see Warnings and Precautions (5.1) and Warnings and Precautions (5.2) ] . • Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ) or end-stage renal disease. ( 4 ) • History of serious hypersensitivity to dapagliflozin, metformin HCl, or any of the excipients in XIGDUO XR. ( 4 ) • Metabolic acidosis, including diabetic ketoacidosis. ( 4 )

6 ADVERSE REACTIONS The following important adverse reactions are described below and elsewhere in the labeling: • Lactic Acidosis [see Boxed Warning and Warnings and Precautions (5.1) ] • Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis [see Warnings and Precautions (5.2) ] • Volume Depletion [see Warnings and Precautions (5.3) ] • Genitourinary Infections, including Urosepsis, Pyelonephritis, Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene), and Genital Mycotic Infections [see Warnings and Precautions (5.4 )] • Hypoglycemia with Concomitant Use with Insulin or Insulin Secretagogues [see Warnings and Precautions (5.5) ] • Vitamin B 12 Deficiency [see Warnings and Precautions (5.6) ] • Adverse reactions reported in >5% of patients treated with XIGDUO XR were female genital mycotic infection, nasopharyngitis, urinary tract infection, diarrhea, and headache. ( 6.1 ) • Adverse reactions reported in >5% of patients treated with metformin extended-release are: diarrhea and nausea/vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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 clinical practice. Clinical Trials with Metformin HCl Extended-Release in Adults with Type 2 Diabetes Mellitus In placebo-controlled monotherapy trials of metformin HCl extended-release, diarrhea and nausea/vomiting were reported in >5% of metformin-treated patients and more commonly than in placebo-treated patients (9.6% versus 2.6% for diarrhea and 6.5% versus 1.5% for nausea/vomiting). Diarrhea led to discontinuation of study medication in 0.6% of the patients treated with metformin HCl extended-release. Clinical Trials with Dapagliflozin in Adults Dapagliflozin Dapagliflozin has been evaluated in clinical trials in adult and pediatric patients 10 years of age and older with type 2 diabetes mellitus, in adult patients with heart failure, and in adult patients with chronic kidney disease. The overall safety profile of dapagliflozin was consistent across the studied indications. No new adverse reactions were identified in the DAPA-HF, DELIVER and DAPA-CKD trials. Pools of Placebo-Controlled Clinical Trials for Glycemic Control in Adults Pool of 8 Placebo-Controlled Adult Trials for Dapagliflozin and Metformin HCl for Glycemic Control Data from a prespecified pool of adult patients from 8 short-term, placebo-controlled trials of dapagliflozin coadministered with metformin HCl immediate- or extended-release was used to evaluate safety. This pool included several add-on trials (metformin HCl alone and in combination with a dipeptidyl peptidase-4 [DPP4] inhibitor and metformin HCl, or insulin and metformin HCl, 2 initial combination with metformin HCl trials, and 2 trials of patients with CVD and type 2 diabetes mellitus who received their usual treatment [with metformin HCl as background therapy]). For trials that included background therapy with and without metformin HCl, only patients who received metformin HCl were included in the 8-trial placebo-controlled pool. Across these 8 trials, 983 patients were treated once daily with dapagliflozin 10 mg and metformin HCl, and 1185 were treated with placebo and metformin HCl. These 8 trials provide a mean duration of exposure of 23 weeks. The mean age of the population was 57 years and 2% were older than 75 years. Fifty-four percent (54%) of the population was male; 88% White, 6% Asian, and 3% Black or African American. At baseline, the population had diabetes for an average of 8 years, mean hemoglobin A1c (HbA1c) was 8.4%, and renal function was normal or mildly impaired in 90% of patients and moderately impaired in 10% of patients. The overa …

7 DRUG INTERACTIONS Table 6: Clinically Relevant Interactions with XIGDUO XR Carbonic Anhydrase Inhibitors Clinical Impact Topiramate or other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide or dichlorphenamide) frequently causes a decrease in serum bicarbonate and induce non-anion gap, hyperchloremic metabolic acidosis. Concomitant use of these drugs with XIGDUO XR may increase the risk for lactic acidosis. Intervention Consider more frequent monitoring of these patients. Drugs that Reduce Metformin Clearance Clinical Impact Concomitant use of drugs that interfere with common renal tubular transport systems involved in the renal elimination of metformin (e.g., organic cationic transporter-2 [OCT2]/multidrug and toxin extrusion [MATE] inhibitors, such as ranolazine, vandetanib, dolutegravir, and cimetidine) could increase systemic exposure to metformin and may increase the risk for lactic acidosis [see Clinical Pharmacology (12.3) ] . Intervention Consider the benefits and risks of concomitant use. Alcohol Clinical Impact Alcohol is known to potentiate the effect of metformin on lactate metabolism. Intervention Warn patients against excessive alcohol intake while receiving XIGDUO XR. Insulin or Insulin Secretagogues Clinical Impact The risk of hypoglycemia may be increased when XIGDUO XR is used concomitantly with insulin or insulin secretagogues (e.g., sulfonylurea) [see Warnings and Precautions (5.5) ]. Intervention Concomitant use may require lower doses of insulin or the insulin secretagogue to reduce the risk of hypoglycemia. Drugs Affecting Glycemic Control Clinical Impact Certain drugs tend to produce hyperglycemia and may lead to loss of glycemic control. These medications include thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid. Intervention When such drugs are administered to a patient receiving XIGDUO XR, observe the patient closely for loss of blood glucose control. When such drugs are withdrawn from a patient receiving XIGDUO XR, observe the patient closely for hypoglycemia. Lithium Clinical Impact Concomitant use of an SGLT2 inhibitor with lithium may decrease serum lithium concentrations. Intervention Monitor serum lithium concentration more frequently during XIGDUO XR initiation and dosage changes. Positive Urine Glucose Test Clinical Impact SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose tests. Intervention Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control. Interference with 1,5-anhydroglucitol (1,5-AG) Assay Clinical Impact Measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors. Intervention Monitoring glycemic control with 1,5-AG assay is not recommended. Use alternative methods to monitor glycemic control. • Carbonic anhydrase inhibitors: May increase risk of lactic acidosis. Consider more frequent monitoring. (7) • Drugs that reduce metformin clearance: May increase risk of lactic acidosis. Consider benefits and risks of concomitant use. (7) • See full prescribing information for additional drug interactions and information on interference of XIGDUO XR with laboratory tests. ( 7 )

8 USE IN SPECIFIC POPULATIONS • Pregnancy: Advise females of the potential risk to a fetus, especially during the second and third trimesters. (8.1) • Lactation: Not recommended when breastfeeding. (8.2) • Females and Males of Reproductive Potential: Advise premenopausal females of the potential for an unintended pregnancy. (8.3) • Geriatrics: Higher incidence of adverse reactions related to hypotension. Assess renal function more frequently. ( 8.5 , 8.6 ) • Renal Impairment: Higher incidence of adverse reactions related to volume depletion. ( 8.6 ) • Hepatic Impairment: Avoid use in patients with hepatic impairment. (8.7) 8.1 Pregnancy Risk Summary Based on animal data showing adverse renal effects, XIGDUO XR is not recommended during the second and third trimesters of pregnancy. Limited data with XIGDUO XR or dapagliflozin in pregnant women are not sufficient to determine drug‐associated risk for major birth defects or miscarriage. Published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk (see Data) . There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations) . In animal studies, adverse renal pelvic and tubule dilatations, that were not fully reversible, were observed in rats when dapagliflozin was administered during a period of renal development corresponding to the late second and third trimesters of human pregnancy, at all doses tested; the lowest of which provided an exposure 15-times the 10 mg clinical dose (see Data) . The estimated background risk of major birth defects is 6 to 10% in women with pre-gestational diabetes with a HbA1c greater than 7% and has been reported to be as high as 20 to 25% in women with HbA1c greater than 10%. The estimated background risk of miscarriage for the indicated population is unknown. 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 Disease-associated maternal and/or embryofetal risk Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. Data Human Data Published data from post-marketing studies have not reported a clear association with metformin and major birth defects, miscarriage, or adverse maternal or fetal outcomes when metformin was used during pregnancy. However, these studies cannot definitely establish the absence of any metformin-associated risk because of methodological limitations, including small sample size and inconsistent comparator groups. Animal Data Dapagliflozin Dapagliflozin dosed directly to juvenile rats from postnatal day (PND) 21 until PND 90 at doses of 1, 15, or 75 mg/kg/day, increased kidney weights and increased the incidence of renal pelvic and tubular dilatations at all dose levels. Exposure at the lowest dose tested was 15-times the 10 mg clinical dose (based on AUC). The renal pelvic and tubular dilatations observed in juvenile animals did not fully reverse within a 1-month recovery period. In a prenatal and postnatal development study, dapagliflozin was administered to maternal rats from gestation day 6 through lactation day 21 at doses of 1, 15, or 75 mg/kg/day, and pups were indirectly exposed in utero and throughout lactation. Increased incidence or severity of renal pelvic dilatation was observed in 21-day-old pups offspring of treated dams at 75 mg/kg/day (maternal and pup dapagliflozin exposures were 1415-times and 137-times, respectively, the human values at the 10 mg clinical dose, based on AUC). Dose-related reductions in pup body weights were observed at greater or equal to 29-times the 10 m …

12.1 Mechanism of Action Dapagliflozin Sodium-glucose cotransporter 2 (SGLT2), expressed in the proximal renal tubules, is responsible for the majority of the reabsorption of filtered glucose from the tubular lumen. Dapagliflozin is an inhibitor of SGLT2. By inhibiting SGLT2, dapagliflozin reduces reabsorption of filtered glucose, and thereby promotes urinary glucose excretion. Dapagliflozin also reduces sodium reabsorption and increases the delivery of sodium to the distal tubule. This may influence several physiological functions including, but not restricted to, lowering both pre- and afterload of the heart and downregulation of sympathetic activity, and decreased intraglomerular pressure which is believed to be mediated by increased tubuloglomerular feedback. Metformin HCl Metformin is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes mellitus, lowering both basal and postprandial plasma glucose. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. With metformin therapy, insulin secretion remains unchanged while fasting insulin levels and day-long plasma insulin response may decrease.

11 DESCRIPTION XIGDUO XR tablets contain: dapagliflozin, a SGLT2 inhibitor, and metformin HCl, a biguanide. Dapagliflozin Dapagliflozin is described chemically as D-glucitol, 1,5-anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1S)-, compounded with (2S)-1,2-propanediol, hydrate (1:1:1). The empirical formula is C 21 H 25 ClO 6 •C 3 H 8 O 2 •H 2 O and the formula weight is 502.98. The structural formula is: Dapagliflozin chemical structure Metformin HCl Metformin HCl (N,N-dimethylimidodicarbonimidic diamide HCl) is a white to off-white crystalline compound with a molecular formula of C 4 H 11 N 5 •HCl and a molecular weight of 165.63. Metformin HCl is freely soluble in water, slightly soluble in alcohol, and is practically insoluble in acetone, ether, and chloroform. The pK a of metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. The structural formula is: Metformin hydrochloride chemical structure XIGDUO XR XIGDUO XR is available for oral administration as tablets containing the equivalent of 2.5 mg dapagliflozin as dapagliflozin propanediol and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (XIGDUO XR 2.5 mg/1,000 mg), 5 mg dapagliflozin as dapagliflozin propanediol and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (XIGDUO XR 5 mg/500 mg), the equivalent of 5 mg dapagliflozin as dapagliflozin propanediol and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (XIGDUO XR 5 mg/1,000 mg), the equivalent of 10 mg dapagliflozin as dapagliflozin propanediol and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (XIGDUO XR 10 mg/500 mg), or the equivalent of 10 mg dapagliflozin as dapagliflozin propanediol and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (XIGDUO XR 10 mg/1,000 mg). Each film-coated tablet of XIGDUO XR contains the following inactive ingredients: anhydrous lactose, carboxymethylcellulose sodium, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, and silicon dioxide. The film coatings contain the following inactive ingredients: polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Additionally, the film coating for the XIGDUO XR 5 mg/500 mg tablets contains FD&C Yellow No. 6/Sunset Yellow FCF aluminum lake. The film coating for the XIGDUO XR 2.5 mg/1,000 mg, 5 mg/1,000 mg, 10 mg/500 mg, and 10 mg/1,000 mg tablets contains iron oxides.

10 OVERDOSAGE Dapagliflozin In the event of an overdose, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations. The removal of dapagliflozin by hemodialysis has not been studied. Metformin HCl Overdose of metformin HCl has occurred, including ingestion of amounts >50 grams. Lactic acidosis has been reported in approximately 32% of metformin overdose cases [see Warnings and Precautions (5.1) ] . Metformin is dialyzable with a clearance of up to 170 mL/min under good hemodynamic conditions. Therefore, hemodialysis may be useful for removal of accumulated drug from patients in whom metformin overdosage is suspected.

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied XIGDUO ® XR (dapagliflozin and metformin HCl extended-release) tablets have markings on one side, are plain on the reverse side, and are available in the strengths and packages listed in Table 21. Table 21: XIGDUO XR Tablet Presentations Tablet Strength Film-Coated Tablet Color/Shape Tablet Markings Pack Size NDC Code 2.5 mg/ 1,000 mg Light brown to brown, biconvex, oval-shaped "1074" and "2.5/1000" debossed on one side and plain on the reverse side Bottle of 60 0310-6225-60 5 mg/ 500 mg orange, biconvex, capsule-shaped "1070" and "5/500" debossed on one side and plain on the reverse side Bottle of 30 0310-6250-30 5 mg/ 1,000 mg pink to dark pink, biconvex, oval-shaped "1071" and "5/1000" debossed on one side and plain on the reverse side Bottle of 60 0310-6260-60 10 mg/ 500 mg pink, biconvex, capsule-shaped "1072" and "10/500" debossed on one side and plain on the reverse side Bottle of 30 0310-6270-30 10 mg/ 1,000 mg yellow to dark yellow, biconvex, oval-shaped "1073" and "10/1000" debossed on one side and plain on the reverse side Bottle of 30 0310-6280-30 Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].