Warfarin Sodium

Dosage and Administration, Renal Impairment (2.5) 5/2017 Dosage and Administration, Intravenous Route of Administration (2.7) Removed 8/2017 Warnings and Precautions, Calciphylaxis (5.3) 9/2016 Warnings and Precautions, Acute kidney injury (5.4) 5/2017 Dosage and Administration, Renal Impairment (2.5) 5/2017 Dosage and Administration, Intravenous Route of Administration (2.7) Removed 8/2017 Warnings and Precautions, Calciphylaxis (5.3) 9/2016 Warnings and Precautions, Acute kidney injury (5.4) 5/2017

1 INDICATIONS AND USAGE Warfarin sodium tablets are indicated for: • Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE). • Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement. • Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction. Limitations of Use Warfarin sodium tablets have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. Once a thrombus has occurred, however, the goals of anticoagulant treatment are to prevent further extension of the formed clot and to prevent secondary thromboembolic complications that may result in serious and possibly fatal sequelae. Warfarin sodium tablets are a vitamin K antagonist indicated for: • Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism ( 1 ) • Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement ( 1 ) • Reduction in the risk of death, recurrent myocardial infarction, and thromboembolic events such as stroke or systemic embolization after myocardial infarction ( 1 ) Limitations of Use Warfarin sodium tablets have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. ( 1 )

2 DOSAGE AND ADMINISTRATION • Individualize dosing regimen for each patient, and adjust based on INR response. ( 2.1 , 2.2 ) • Knowledge of genotype can inform initial dose selection. ( 2.3 ) • Monitoring: Obtain daily INR determinations upon initiation until stable in the therapeutic range. Obtain subsequent INR determinations every 1 to 4 weeks. ( 2.4 ) • Review conversion instructions from other anticoagulants. ( 2.8 ) 2.1 Individualized Dosing The dosage and administration of warfarin sodium tablets must be individualized for each patient according to the patient’s INR response to the drug. Adjust the dose based on the patient’s INR and the condition being treated. Consult the latest evidence-based clinical practice guidelines regarding the duration and intensity of anticoagulation for the indicated conditions. 2.2 Recommended Target INR Ranges and Durations for Individual Indications An INR of greater than 4 appears to provide no additional therapeutic benefit in most patients and is associated with a higher risk of bleeding. Venous Thromboembolism (including deep venous thrombosis [DVT] and PE) Adjust the warfarin dose to maintain a target INR of 2.5 (INR range, 2 to 3) for all treatment durations. The duration of treatment is based on the indication as follows: • For patients with a DVT or PE secondary to a transient (reversible) risk factor, treatment with warfarin for 3 months is recommended. • For patients with an unprovoked DVT or PE, treatment with warfarin is recommended for at least 3 months. After 3 months of therapy, evaluate the risk-benefit ratio of long-term treatment for the individual patient. • For patients with two episodes of unprovoked DVT or PE, long-term treatment with warfarin is recommended. For a patient receiving long-term anticoagulant treatment, periodically reassess the risk-benefit ratio of continuing such treatment in the individual patient. Atrial Fibrillation In patients with non-valvular AF, anticoagulate with warfarin to target INR of 2.5 (range, 2 to 3). • In patients with non-valvular AF that is persistent or paroxysmal and at high risk of stroke (i.e., having any of the following features: prior ischemic stroke, transient ischemic attack, or systemic embolism, or 2 of the following risk factors: age greater than 75 years, moderately or severely impaired left ventricular systolic function and/or heart failure, history of hypertension, or diabetes mellitus), long-term anticoagulation with warfarin is recommended. • In patients with non-valvular AF that is persistent or paroxysmal and at an intermediate risk of ischemic stroke (i.e., having 1 of the following risk factors: age greater than 75 years, moderately or severely impaired left ventricular systolic function and/or heart failure, history of hypertension, or diabetes mellitus), long-term anticoagulation with warfarin is recommended. • For patients with AF and mitral stenosis, long-term anticoagulation with warfarin is recommended. • For patients with AF and prosthetic heart valves, long-term anticoagulation with warfarin is recommended; the target INR may be increased and aspirin added depending on valve type and position, and on patient factors. Mechanical and Bioprosthetic Heart Valves • For patients with a bileaflet mechanical valve or a Medtronic Hall (Minneapolis, MN) tilting disk valve in the aortic position who are in sinus rhythm and without left atrial enlargement, therapy with warfarin to a target INR of 2.5 (range, 2 to 3) is recommended. • For patients with tilting disk valves and bileaflet mechanical valves in the mitral position, therapy with warfarin to a target INR of 3 (range, 2.5 to 3.5) is recommended. • For patients with caged ball or caged disk valves, therapy with warfarin to a target INR of 3 (range, 2.5 to 3.5) is recommended. • For patients with a bioprosthetic valve in the mitral position, therapy with warfarin to a target INR of 2.5 (range, 2 to 3) for the first 3 months after valve insertion is recommend …

3 DOSAGE FORMS AND STRENGTHS Warfarin Sodium Tablets USP, 1 mg are supplied as pink to light pink, oval shaped uncoated scored tablets with debossing ‘761’ and ‘1’ on either side of the breakline on one side and ‘AN’ on the other side. Warfarin Sodium Tablets USP, 2 mg are supplied as lavender to light lavender, oval shaped uncoated scored tablets with debossing ‘762’ and ‘2’ on either side of the breakline on one side and ‘AN’ on the other side. Warfarin Sodium Tablets USP, 21⁄2mg are supplied as green to light green, oval shaped uncoated scored tablets with debossing ‘763’ and ‘21⁄2’ on either side of the breakline on one side and ‘AN’ on the other side. Warfarin Sodium Tablets USP, 3 mg are supplied as tan to light tan, oval shaped uncoated scored tablets with debossing ‘764’ and ‘3’ on either side of the breakline on one side and ‘AN’ on the other side. Warfarin Sodium Tablets USP, 4 mg are supplied as blue to light blue, oval shaped uncoated scored tablets with debossing ‘765’ and ‘4’ on either side of the breakline on one side and ‘AN’ on the other side. Warfarin Sodium Tablets USP, 5 mg are supplied as peach to light peach, oval shaped uncoated scored tablets with debossing ‘766’ and ‘5’ on either side of the breakline on one side and ‘AN’ on the other side. Warfarin Sodium Tablets USP, 6 mg are supplied as teal to light teal, oval shaped uncoated scored tablets with debossing ‘767’ and ‘6’ on either side of the breakline on one side and ‘AN’ on the other side. Warfarin Sodium Tablets USP, 71⁄2 mg are supplied as yellow to light yellow, oval shaped uncoated scored tablets with debossing ‘768’ and ‘71⁄2’ on either side of the breakline on one side and ‘AN’ on the other side. Warfarin Sodium Tablets USP, 10 mg are supplied as white to off white, oval shaped uncoated scored tablets with debossing ‘769’ and ‘10’ on either side of the breakline on one side and ‘AN’ on the other side. • Scored tablets: 1, 2, 2-1/2, 3, 4, 5, 6, 7-1/2, or 10 mg (3)

4 CONTRAINDICATIONS Warfarin sodium is contraindicated in: • Pregnancy Warfarin sodium is contraindicated in women who are pregnant except in pregnant women with mechanical heart valves, who are at high risk of thromboembolism [ see Warnings and Precautions ( 5.5 ) and Use in Specific Populations ( 8.1 ) ]. Warfarin sodium can cause fetal harm when administered to a pregnant woman. Warfarin sodium exposure during pregnancy causes a recognized pattern of major congenital malformations (warfarin embryopathy and fetotoxicity), fatal fetal hemorrhage, and an increased risk of spontaneous abortion and fetal mortality. If warfarin sodium is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [ see Warnings and Precautions ( 5.6 ) and Use in Specific Populations ( 8.1 ) ]. Warfarin sodium is contraindicated in patients with: • Hemorrhagic tendencies or blood dyscrasias • Recent or contemplated surgery of the central nervous system or eye, or traumatic surgery resulting in large open surfaces [ see Warnings and Precautions ( 5.7 ) ] • Bleeding tendencies associated with: − Active ulceration or overt bleeding of the gastrointestinal, genitourinary, or respiratory tract − Central nervous system hemorrhage − Cerebral aneurysms, dissecting aorta − Pericarditis and pericardial effusions − Bacterial endocarditis • Threatened abortion, eclampsia, and preeclampsia • Unsupervised patients with conditions associated with potential high level of non-compliance • Spinal puncture and other diagnostic or therapeutic procedures with potential for uncontrollable bleeding • Hypersensitivity to warfarin or to any other components of this product (e.g., anaphylaxis) [ see Adverse Reactions ( 6 ) ] • Major regional or lumbar block anesthesia • Malignant hypertension • Pregnancy, except in women with mechanical heart valves ( 4 , 5.5 , 8.1 ) • Hemorrhagic tendencies or blood dyscrasias ( 4 ) • Recent or contemplated surgery of the central nervous system (CNS) or eye, or traumatic surgery resulting in large open surfaces ( 4 , 5.7 ) • Bleeding tendencies associated with certain conditions ( 4 ) • Threatened abortion, eclampsia, and preeclampsia ( 4 ) • Unsupervised patients with potential high levels of non-compliance ( 4 ) • Spinal puncture and other diagnostic or therapeutic procedures with potential for uncontrollable bleeding ( 4 ) • Hypersensitivity to warfarin or any component of the product ( 4 ) • Major regional or lumbar block anesthesia ( 4 ) • Malignant hypertension ( 4 )

6 ADVERSE REACTIONS The following serious adverse reactions to warfarin sodium are discussed in greater detail in other sections of the labeling: • Hemorrhage [see Boxed Warning , Warnings and Precautions (5.1) , and Overdosage (10) ] • Tissue Necrosis [see Warnings and Precautions (5.2) ] • Calciphylaxis [see Warnings and Precautions (5.3) ] • Acute Kidney Injury [see Warnings and Precautions (5.4) ] • Systemic Atheroemboli and Cholesterol Microemboli [see Warnings and Precautions (5.5) ] • Limb Ischemia, Necrosis, and Gangrene in Patients with HIT and HITTS [see Warnings and Precautions (5.6) ] • Other Clinical Settings with Increased Risks [see Warnings and Precautions (5.8) ] Other adverse reactions to warfarin sodium include: • Immune system disorders: hypersensitivity/allergic reactions (including urticaria and anaphylactic reactions) • Vascular disorders: vasculitis • Hepatobiliary disorders: hepatitis, elevated liver enzymes. Cholestatic hepatitis has been associated with concomitant administration of warfarin sodium and ticlopidine. • Gastrointestinal disorders: nausea, vomiting, diarrhea, taste perversion, abdominal pain, flatulence, bloating • Skin disorders: rash, dermatitis (including bullous eruptions), pruritus, alopecia • Respiratory disorders: tracheal or tracheobronchial calcification • General disorders: chills Most common adverse reactions to warfarin sodium are fatal and nonfatal hemorrhage from any tissue or organ. (6) To report SUSPECTED ADVERSE REACTIONS, contact Taro Pharmaceuticals U.S.A., Inc., at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

7 DRUG INTERACTIONS • Concomitant use of drugs that increase bleeding risk, antibiotics, antifungals, botanical (herbal) products, and inhibitors and inducers of CYP2C9, 1A2, or 3A4. ( 7 ) • Consult labeling of all concurrently used drugs for complete information about interactions with warfarin sodium or increased risks for bleeding. (7) 7.1 General Information Drugs may interact with warfarin sodium through pharmacodynamic or pharmacokinetic mechanisms. Pharmacodynamic mechanisms for drug interactions with warfarin sodium are synergism (impaired hemostasis, reduced clotting factor synthesis), competitive antagonism (vitamin K), and alteration of the physiologic control loop for vitamin K metabolism (hereditary resistance). Pharmacokinetic mechanisms for drug interactions with warfarin sodium are mainly enzyme induction, enzyme inhibition, and reduced plasma protein binding. It is important to note that some drugs may interact by more than one mechanism. More frequent INR monitoring should be performed when starting or stopping other drugs, including botanicals, or when changing dosages of other drugs, including drugs intended for short-term use (e.g., antibiotics, antifungals, corticosteroids) [see Boxed Warning ] . Consult the labeling of all concurrently used drugs to obtain further information about interactions with warfarin sodium or adverse reactions pertaining to bleeding. 7.2 CYP450 Interactions CYP450 isozymes involved in the metabolism of warfarin include CYP2C9, 2C19, 2C8, 2C18, 1A2, and 3A4. The more potent warfarin S -enantiomer is metabolized by CYP2C9 while the R -enantiomer is metabolized by CYP1A2 and 3A4. • Inhibitors of CYP2C9, 1A2, and/or 3A4 have the potential to increase the effect (increase INR) of warfarin by increasing the exposure of warfarin. • Inducers of CYP2C9, 1A2, and/or 3A4 have the potential to decrease the effect (decrease INR) of warfarin by decreasing the exposure of warfarin. Examples of inhibitors and inducers of CYP2C9, 1A2, and 3A4 are below in Table 2; however, this list should not be considered all-inclusive. Consult the labeling of all concurrently used drugs to obtain further information about CYP450 interaction potential. The CYP450 inhibition and induction potential should be considered when starting, stopping, or changing dose of concomitant medications. Closely monitor INR if a concomitant drug is a CYP2C9, 1A2, and/or 3A4 inhibitor or inducer. Table 2: Examples of CYP450 Interactions with Warfarin Enzyme Inhibitors Inducers CYP2C9 amiodarone, capecitabine, cotrimoxazole, etravirine, fluconazole, fluvastatin, fluvoxamine, metronidazole, miconazole, oxandrolone, sulfinpyrazone, tigecycline, voriconazole, zafirlukast aprepitant, bosentan, carbamazepine, phenobarbital, rifampin CYP1A2 acyclovir, allopurinol, caffeine, cimetidine, ciprofloxacin, disulfiram, enoxacin, famotidine, fluvoxamine, methoxsalen, mexiletine, norfloxacin, oral contraceptives, phenylpropanolamine, propafenone, propranolol, terbinafine, thiabendazole, ticlopidine, verapamil, zileuton montelukast, moricizine, omeprazole, phenobarbital, phenytoin, cigarette smoking CYP3A4 alprazolam, amiodarone, amlodipine, amprenavir, aprepitant, atorvastatin, atazanavir, bicalutamide, cilostazol, cimetidine, ciprofloxacin, clarithromycin, conivaptan, cyclosporine, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fluoxetine, fluvoxamine, fosamprenavir, imatinib, indinavir, isoniazid, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, nilotinib, oral contraceptives, posaconazole, ranitidine, ranolazine, ritonavir, saquinavir, telithromycin, tipranavir, voriconazole, zileuton armodafinil, amprenavir, aprepitant, bosentan, carbamazepine, efavirenz, etravirine, modafinil, nafcillin, phenytoin, pioglitazone, prednisone, rifampin, rufinamide 7.3 Drugs that Increase Bleeding Risk Examples of drugs known to increase the risk of bleeding are presented in Table 3. Because bleeding risk is increased when t …

8 USE IN SPECIFIC POPULATIONS Pregnant women with mechanical heart valves: Warfarin sodium may cause fetal harm; however, the benefits may outweigh the risks. ( 8.1 ) Lactation: Monitor breastfeeding infants for bruising or bleeding. ( 8.2 ) Renal Impairment: Instruct patients with renal impairment to frequently monitor their INR. ( 8.6 ) 8.1 Pregnancy Risk Summary Warfarin sodium tablets, USP are contraindicated in women who are pregnant except in pregnant women with mechanical heart valves, who are at high risk of thromboembolism, and for whom the benefits of warfarin sodium may outweigh the risks [see Warnings and Precautions (5.7) ]. Warfarin sodium can cause fetal harm. Exposure to warfarin during the first trimester of pregnancy caused a pattern of congenital malformations in about 5% of exposed offspring. Because these data were not collected in adequate and well-controlled studies, this incidence of major birth defects is not an adequate basis for comparison to the estimated incidences in the control group or the U.S. general population and may not reflect the incidences observed in practice. Consider the benefits and risks of warfarin sodium and possible risks to the fetus when prescribing warfarin sodium to a pregnant woman. Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. The estimated background risk of major birth defects and 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 Fetal/Neonatal Adverse Reactions In humans, warfarin crosses the placenta, and concentrations in fetal plasma approach the maternal values. Exposure to warfarin during the first trimester of pregnancy caused a pattern of congenital malformations in about 5% of exposed offspring. Warfarin embryopathy is characterized by nasal hypoplasia with or without stippled epiphyses (chondrodysplasia punctata) and growth retardation (including low birth weight). Central nervous system and eye abnormalities have also been reported, including dorsal midline dysplasia characterized by agenesis of the corpus callosum, Dandy-Walker malformation, midline cerebellar atrophy, and ventral midline dysplasia characterized by optic atrophy. Mental retardation, blindness, schizencephaly, microcephaly, hydrocephalus, and other adverse pregnancy outcomes have been reported following warfarin exposure during the second and third trimesters of pregnancy [see Contraindications (4) ]. 8.2 Lactation Risk Summary Warfarin was not present in human milk from mothers treated with warfarin from a limited published study. Because of the potential for serious adverse reactions, including bleeding in a breastfed infant, consider the developmental and health benefits of breastfeeding along with the mother's clinical need for warfarin sodium and any potential adverse effects on the breastfed infant from warfarin sodium or from the underlying maternal condition before prescribing warfarin sodium to a lactating woman. Clinical Considerations Monitor breastfeeding infants for bruising or bleeding. Data Human Data Based on published data in 15 nursing mothers, warfarin was not detected in human milk. Among the 15 full-term newborns, 6 nursing infants had documented prothrombin times within the expected range. Prothrombin times were not obtained for the other 9 nursing infants. Effects in premature infants have not been evaluated. 8.3 Females and Males of Reproductive Potential Pregnancy Testing Warfarin sodium can cause fetal harm [see Use in Specific Populations (8.1) ]. Verify the pregnancy status of females of reproductive potential prior to initiating warfarin sodium therapy. Contraception Females Advise females of reproductive potential to use effective contraception during treatment and for at least 1 month after the final dose …

12.1 Mechanism of Action Warfarin acts by inhibiting the synthesis of vitamin K-dependent clotting factors, which include Factors II, VII, IX, and X, and the anticoagulant proteins C and S. Vitamin K is an essential cofactor for the post ribosomal synthesis of the vitamin K-dependent clotting factors. Vitamin K promotes the biosynthesis of γ-carboxyglutamic acid residues in the proteins that are essential for biological activity. Warfarin is thought to interfere with clotting factor synthesis by inhibition of the C1 subunit of vitamin K epoxide reductase (VKORC1) enzyme complex, thereby reducing the regeneration of vitamin K 1 epoxide [ see Clinical Pharmacology ( 12.5 ) ].

11 DESCRIPTION Warfarin sodium tablets USP contain warfarin sodium, an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. The chemical name of warfarin sodium is 3-(α-acetonylbenzyl)-4-hydroxycoumarin sodium salt, which is a racemic mixture of the R - and S -enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its structural formula may be represented as follows: C 19 H 15 NaO 4 M.W. 330.31 Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each tablet, for oral administration, contains 1 mg, 2 mg, 2.5 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7.5 mg or 10 mg warfarin sodium, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The 1 mg also contains FD&C red no. 40. The 2 mg also contains FD&C blue no. 2 aluminum lake and FD&C red no. 40 aluminum lake. The 2.5 mg also contains D&C yellow no. 10 aluminum lake and FD&C blue no. 1 aluminum lake. The 3 mg also contains FD&C yellow no. 6 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, and D&C yellow no. 10 aluminum lake. The 4 mg also contains FD&C blue no. 1 aluminum lake and FD&C blue no. 2 aluminum lake. The 5 mg also contains FD&C yellow no. 6 aluminum lake, FD&C red no. 40 aluminum lake and D&C yellow no. 10 aluminum lake. The 6 mg also contains D&C yellow no. 10 aluminum lake and FD&C blue no. 1 aluminum lake. The 7.5 mg also contains FD&C yellow no. 5 (tartrazine) aluminum lake and FD&C red no. 40 aluminum lake. Warfarin Structural Formula

10. OVERDOSAGE 10.1 Signs and Symptoms Bleeding (e.g., appearance of blood in stools or urine, hematuria, excessive menstrual bleeding, melena, petechiae, excessive bruising or persistent oozing from superficial injuries, unexplained fall in hemoglobin) is a manifestation of excessive anticoagulation. 10.2 Treatment The treatment of excessive anticoagulation is based on the level of the INR, the presence or absence of bleeding, and clinical circumstances. Reversal of warfarin sodium anticoagulation may be obtained by discontinuing warfarin sodium therapy and, if necessary, by administration of oral or parenteral vitamin K 1 . The use of vitamin K 1 reduces response to subsequent warfarin sodium therapy and patients may return to a pretreatment thrombotic status following the rapid reversal of a prolonged INR. Resumption of warfarin sodium administration reverses the effect of vitamin K, and a therapeutic INR can again be obtained by careful dosage adjustment. If rapid re-anticoagulation is indicated, heparin may be preferable for initial therapy. Prothrombin complex concentrate (PCC), fresh frozen plasma, or activated Factor VII treatment may be considered if the requirement to reverse the effects of warfarin sodium is urgent. A risk of hepatitis and other viral diseases is associated with the use of blood products; PCC and activated Factor VII are also associated with an increased risk of thrombosis. Therefore, these preparations should be used only in exceptional or life-threatening bleeding episodes secondary to warfarin sodium overdosage.

16 HOW SUPPLIED/STORAGE AND HANDLING Tablets Warfarin Sodium Tablets USP, 1 mg are supplied as pink to light pink, oval shaped uncoated scored tablets with debossing ‘761’ and ‘1’ on either side of the breakline on one side and ‘AN’ on the other side. They are available as follows: Bottle of 100 Tablets: NDC 65162-761-10 Bottle of 500 Tablets: NDC 65162-761-50 Bottle of 1000 Tablets: NDC 65162-761-11 Warfarin Sodium Tablets USP, 2 mg are supplied as lavender to light lavender, oval shaped uncoated scored tablets with debossing ‘762’ and ‘2’ on either side of the breakline on one side and ‘AN’ on the other side. They are available as follows: Bottle of 100 Tablets: NDC 65162-762-10 Bottle of 500 Tablets: NDC 65162-762-50 Bottle of 1000 Tablets: NDC 65162-762-11 Warfarin Sodium Tablets USP, 21⁄2 mg are supplied as green to light green, oval shaped uncoated scored tablets with debossing ‘763’ and ‘21⁄2’ on either side of the breakline on one side and ‘AN’ on the other side. They are available as follows: Bottle of 100 Tablets: NDC 65162-763-10 Bottle of 500 Tablets: NDC 65162-763-50 Bottle of 1000 Tablets: NDC 65162-763-11 Warfarin Sodium Tablets USP, 3 mg are supplied as tan to light tan, oval shaped uncoated scored tablets with debossing ‘764’ and ‘3’ on either side of the breakline on one side and ‘AN’ on the other side. They are available as follows: Bottle of 100 Tablets: NDC 65162-764-10 Bottle of 500 Tablets: NDC 65162-764-50 Bottle of 1000 Tablets: NDC 65162-764-11 Warfarin Sodium Tablets USP, 4 mg are supplied as blue to light blue, oval shaped uncoated scored tablets with debossing ‘765’ and ‘4’ on either side of the breakline on one side and ‘AN’ on the other side. They are available as follows: Bottle of 100 Tablets: NDC 65162-765-10 Bottle of 500 Tablets: NDC 65162-765-50 Bottle of 1000 Tablets: NDC 65162-765-11 Warfarin Sodium Tablets USP, 5 mg are supplied as peach to light peach, oval shaped uncoated scored tablets with debossing ‘766’ and ‘5’ on either side of the breakline on one side and ‘AN’ on the other side. They are available as follows: Bottle of 100 Tablets: NDC 65162-766-10 Bottle of 500 Tablets: NDC 65162-766-50 Bottle of 1000 Tablets: NDC 65162-766-11 Warfarin Sodium Tablets USP, 6 mg are supplied as teal to light teal, oval shaped uncoated scored tablets with debossing ‘767’ and ‘6’ on either side of the breakline on one side and ‘AN’ on the other side. They are available as follows: Bottle of 100 Tablets: NDC 65162-767-10 Bottle of 500 Tablets: NDC 65162-767-50 Bottle of 1000 Tablets: NDC 65162-767-11 Warfarin Sodium Tablets USP, 71⁄2 mg are supplied as yellow to light yellow, oval shaped uncoated scored tablets with debossing ‘768’ and ‘71⁄2’ on either side of the breakline on one side and ‘AN’ on the other side. They are available as follows: Bottle of 100 Tablets: NDC 65162-768-10 Bottle of 500 Tablets: NDC 65162-768-50 Bottle of 1000 Tablets: NDC 65162-768-11 Warfarin Sodium Tablets USP, 10 mg are supplied as white to off white, oval shaped uncoated scored tablets with debossing ‘769’ and ‘10’ on either side of the breakline on one side and ‘AN’ on the other side. They are available as follows: Bottle of 100 Tablets: NDC 65162-769-10 Bottle of 500 Tablets: NDC 65162-769-50 Bottle of 1000 Tablets: NDC 65162-769-11 Protect from light and moisture. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. Special Handling Procedures for proper handling and disposal of potentially hazardous drugs should be considered. Guidelines on this subject have been published [see References (15) ]. Pharmacy and clinical personnel who are pregnant should avoid exposure to crushed or broken tablets [see Use in Specific Populations (8.1) ].