Heparin Sodium

Warnings and Precautions, Heparin-Induced Thrombocytopenia and Heparin-Induced Thrombocytopenia with Thrombosis ( 5.2) 11/2024 Warnings and Precautions, Unresponsiveness to Heparin with Concomitant Use with Andexanet Alfa ( 5.3 ) 11/2025 Warnings and Precautions, Heparin Resistance ( 5.5 ) 11/2024 Warnings and Precautions, Hypersensitivity Reactions ( 5.6 ) 11/2024 Warnings and Precautions, Elevations of Serum Aminotransferases ( 5.9 ) 11/2024

1 INDICATIONS AND USAGE Heparin Sodium Injection is indicated for: • Prophylaxis and treatment of venous thrombosis and pulmonary embolism; • Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease; • Atrial fibrillation with embolization; • Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation); • Prevention of clotting in arterial and cardiac surgery; • Prophylaxis and treatment of peripheral arterial embolism; • Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures. Heparin Sodium Injection is an anticoagulant indicated for ( 1 ): • Prophylaxis and treatment of venous thrombosis and pulmonary embolism • Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease • Atrial fibrillation with embolization • Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation) • Prevention of clotting in arterial and cardiac surgery • Prophylaxis and treatment of peripheral arterial embolism • Use as an anticoagulant in blood transfusions, extracorporeal circulation and dialysis procedures

2 DOSAGE AND ADMINISTRATION Recommended Adult Dosages: Therapeutic Anticoagulant Effect with Full-Dose Heparin Sodium † ( 2.4 ) † Based on 150 lb (68 kg) patient. Adjust dose based on laboratory monitoring. Deep Subcutaneous (Intrafat) Injection Use a different site for each injection Initial Dose 5,000 units by intravenous injection, followed by 10,000 to 20,000 units of a concentrated solution, subcutaneously Every 8 hours or Every 12 hours 8,000 to 10,000 units of a concentrated solution 15,000 to 20,000 units of a concentrated solution Intermittent Intravenous Injection Initial dose 10,000 units, either undiluted or in 50 to 100 mL of 0.9% Sodium Chloride Injection, USP Every 4 to 6 hours 5,000 to 10,000 units, either undiluted or in 50 to 100 mL of 0.9% Sodium Chloride Injection, USP Intravenous Infusion Initial dose 5,000 units by intravenous injection Continuous 20,000 to 40,000 units/24 hours in 1,000 mL of 0.9% Sodium Chloride Injection, USP (or in any compatible solution) for infusion 2.1 Preparation for Administration Confirm the choice of the correct heparin sodium injection syringe to ensure that the 1 mL syringe is not confused with a “catheter lock flush” syringe or other 1 mL syringe of incorrect strength [see Warnings and Precautions ( 5.1 )]. Confirm the selection of the correct formulation and strength prior to administration of the drug. To lessen this risk, the 1 mL syringe includes a red cautionary statement. Read the cautionary statement and confirm that you have selected the correct medication and strength. When heparin sodium injection is added to an infusion solution for continuous intravenous administration, invert the container repeatedly to ensure adequate mixing and prevent pooling of the heparin sodium in the solution. Inspect parenteral drug products visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Use only if solution is clear and the seal is intact. Do not use if solution is discolored or contains a precipitate. Administer heparin sodium injection by intermittent intravenous injection, intravenous infusion, or deep subcutaneous (intrafat, i.e., above the iliac crest or abdominal fat layer) injection. Do not administer heparin sodium injection by intramuscular injection because of the risk of hematoma at the injection site [see Adverse Reactions ( 6 )] . 2.2 Instructions for Use of Prefilled Syringe CAUTION: Certain glass syringes may malfunction, break or clog when connected to some Needleless Luer Access Devices (NLADs) and needles. This syringe has a larger internal syringe tip and an external collar (luer collar). The external collar must remain attached to the syringe. Data show that the syringe achieves acceptable connections with the BD EclipseTM Needle and the Terumo SurGuard2TM Safety Needle and with the following non-center post NLADs: Alaris SMARTSITETM, B-Braun ULTRASITETM, BD-Q SYTETM, Maximum MAX PLUSTM, and B-Braun SAFSITETM. The data also show acceptable connections are achieved to the center post ICU Medical CLAVETM. However, spontaneous disconnection of this glass syringe from needles and NLADs with leakage of drug product may occur. Assure that the needle or NLAD is securely attached before beginning the injection. Visually inspect the glass syringe-needle or glass syringe–NLAD connection before and during drug administration. Refer to Figure 1 for syringe diagram. Figure 1 Inspect the outer packaging (plastic tube) by verifying: -plastic tube integrity -drug name -drug strength -dose volume -route of administration -expiration date to be sure that the drug has not expired -sterile field applicability Do not use if package has been damaged. 2. Remove the plastic tube cap of the outer packaging to access the syringe. 3. Remove the syringe from the plastic tube. 4. Perform visual inspection on the syringe by verifying: -absence of syringe damage -absence of external particles -absence of internal particles -prope …

3 DOSAGE FORMS AND STRENGTHS Heparin Sodium Injection, USP is available as: Heparin Sodium Injection, USP, preservative free , is available as follows: • 2,000 USP units per 2 mL, single-dose vial • 5,000 USP units per 0.5 mL, single-dose vial Heparin Sodium Injection, USP contains benzyl alcohol and is available as follows: • 50,000 USP units per 10 mL, multiple-dose vial • 40,000 USP units per 4 mL, multiple-dose vial Heparin Sodium Injection, USP contains parabens and is available as follows: • 1,000 USP units per mL, multiple-dose vial • 10,000 USP units per 10 mL, multiple-dose vial • 30,000 USP units per 30 mL, multiple-dose vial • 5,000 USP units per mL, multiple-dose vial • 10,000 USP units per mL, multiple-dose vial • 50,000 USP units per 5 mL, multiple-dose vial • 20,000 USP units per mL, multiple-dose vial Heparin Sodium Injection, USP (porcine), preservative free Heparin Sodium Injection, USP (porcine) contains benzyl alcohol Heparin Sodium Injection, USP (porcine) contains parabens 2 mL single-dose vial contains 2,000 USP units 10 mL multiple-dose vial contains 50,000 USP units 1 mL multiple-dose vial contains 1,000 USP units 0.5 mL single-dose vial contains 5,000 USP units 4 mL multiple-dose vial contains 40,000 USP units 10 mL multiple-dose vial contains 10,000 USP units 30 mL multiple-dose vial contains 30,000 USP units 1 mL multiple-dose vial contains 5,000 USP units 1 mL multiple-dose vial contains 10,000 USP units 5 mL multiple-dose vial contains 50,000 USP units 1 mL multiple-dose vial contains 20,000 USP units

4 CONTRAINDICATIONS The use of Heparin Sodium Injection is contraindicated in patients with the following conditions: • History of heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis [see Warnings and Precautions (5.3) ] ; • Known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions) [see Adverse Reactions (6.2) ] ; • In whom suitable blood coagulation tests, e.g., the whole blood clotting time, partial thromboplastin time, etc., cannot be performed at appropriate intervals (this contraindication refers to full-dose heparin; there is usually no need to monitor coagulation parameters in patients receiving low-dose heparin); • An uncontrolled active bleeding state [see Warnings and Precautions (5.2) ] , except when this is due to disseminated intravascular coagulation. • Severe thrombocytopenia ( 4 ) • Known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions) ( 4 ) • When suitable blood coagulation tests, e.g., the whole blood clotting time, partial thromboplastin time, etc., cannot be performed at appropriate intervals ( 4 ) • An uncontrolled active bleeding state, except when this is due to disseminated intravascular coagulation ( 4 )

ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Hemorrhage Hemorrhage is the chief complication that may result from heparin therapy (see WARNINGS ). An overly prolonged clotting time or minor bleeding during therapy can usually be controlled by withdrawing the drug (see OVERDOSAGE ). It should be appreciated that gastrointestinal or urinary tract bleeding during anticoagulant therapy may indicate the presence of an underlying occult lesion. Bleeding can occur at any site but certain specific hemorrhagic complications may be difficult to detect: (a) Adrenal hemorrhage, with resultant acute adrenal insufficiency, has occurred during anticoagulant therapy. Therefore, such treatment should be discontinued in patients who develop signs and symptoms of acute adrenal hemorrhage and insufficiency. Initiation of corrective therapy should not depend on laboratory confirmation of the diagnosis, since any delay in an acute situation may result in the patient’s death. (b) Ovarian (corpus luteum) hemorrhage developed in a number of women of reproductive age receiving short- or long-term anticoagulant therapy. This complication, if unrecognized, may be fatal. (c) Retroperitoneal hemorrhage. Thrombocytopenia, Heparin-induced Thrombocytopenia (HIT) and Heparin-induced Thrombocytopenia and Thrombosis (HITT) and Delayed Onset of HIT and HITT See WARNINGS . Local Irritation Local irritation, erythema, mild pain, hematoma or ulceration may follow deep subcutaneous (intrafat) injection of heparin sodium. These complications are much more common after intramuscular use, and such use is not recommended. Hypersensitivity Generalized hypersensitivity reactions have been reported, with chills, fever and urticaria as the most usual manifestations, and asthma, rhinitis, lacrimation, headache, nausea and vomiting, and anaphylactoid reactions, including shock, occurring more rarely. Itching and burning, especially on the plantar side of the feet, may occur (see WARNINGS and PRECAUTIONS ). Certain episodes of painful, ischemic and cyanosed limbs have in the past been attributed to allergic vasospastic reactions. Whether these are in fact identical to the thrombocytopenia-associated complications, remains to be determined. Miscellaneous Osteoporosis following long-term administration of high doses of heparin, cutaneous necrosis after systemic administration, suppression of aldosterone synthesis, delayed transient alopecia, priapism, and rebound hyperlipemia on discontinuation of heparin sodium have also been reported. Significant elevations of aminotransferase (SGOT [S-AST] and SGPT [S-ALT]) levels have occurred in a high percentage of patients (and healthy subjects) who have received heparin.

Hemorrhage Hemorrhage is the chief complication that may result from heparin therapy (see WARNINGS ). An overly prolonged clotting time or minor bleeding during therapy can usually be controlled by withdrawing the drug (see OVERDOSAGE ). It should be appreciated that gastrointestinal or urinary tract bleeding during anticoagulant therapy may indicate the presence of an underlying occult lesion. Bleeding can occur at any site but certain specific hemorrhagic complications may be difficult to detect: (a) Adrenal hemorrhage, with resultant acute adrenal insufficiency, has occurred during anticoagulant therapy. Therefore, such treatment should be discontinued in patients who develop signs and symptoms of acute adrenal hemorrhage and insufficiency. Initiation of corrective therapy should not depend on laboratory confirmation of the diagnosis, since any delay in an acute situation may result in the patient’s death. (b) Ovarian (corpus luteum) hemorrhage developed in a number of women of reproductive age receiving short- or long-term anticoagulant therapy. This complication, if unrecognized, may be fatal. (c) Retroperitoneal hemorrhage.

Thrombocytopenia, Heparin-indu …

7 DRUG INTERACTIONS • Drugs that interfere with coagulation, platelet aggregation or drugs that counteract coagulation may induce bleeding ( 7 ) • Andexanet alfa may reduce the efficacy of heparin when used concomitantly ( 7.3 ) 7.1 Oral Anticoagulants Heparin sodium may prolong the one-stage prothrombin time. Therefore, when heparin sodium is given with dicumarol or warfarin sodium, a period of at least 5 hours after the last intravenous dose or 24 hours after the last subcutaneous dose should elapse before blood is drawn if a valid prothrombin time is to be obtained. 7.2 Platelet Inhibitors Drugs such as acetylsalicylic acid, dextran, phenylbutazone, ibuprofen, indomethacin, dipyridamole, hydroxychloroquine and others that interfere with platelet-aggregation reactions (the main hemostatic defense of heparinized patients) may induce bleeding and should be used with caution in patients receiving heparin sodium. 7.3 Unresponsiveness to Heparin With Concomitant Use With Andexanet Alfa Andexanet binds to heparin-bound antithrombin III (ATIII) and may reduce the anticoagulant effect of heparin. Unresponsiveness to unfractionated heparin may lead to serious and life-threatening thrombotic events. Use of andexanet alfa as an antidote for heparin has not been established. Avoid use of heparin after use of andexanet alfa for the reversal of direct Factor Xa inhibitors (apixaban and rivaroxaban). If anticoagulation is needed, use an alternative anticoagulant to heparin [see Warnings and Precautions (5.4) ] . 7.4 Other Interactions Digitalis, tetracyclines, nicotine, or antihistamines, or intravenous nitroglycerin may partially counteract the anticoagulant action of heparin sodium. Intravenous nitroglycerin administered to heparinized patients may result in a decrease of the partial thromboplastin time with subsequent rebound effect upon discontinuation of nitroglycerin. Careful monitoring of partial thromboplastin time and adjustment of heparin dosage are recommended during coadministration of heparin and intravenous nitroglycerin. 7.5 Drug/Laboratory Tests Interactions Prothrombin time – Heparin sodium may prolong the one-stage prothrombin time. Therefore, when heparin sodium is given with warfarin, allow a period of at least 5 hours after the last intravenous dose or 24 hours after the last subcutaneous dose of heparin to elapse before blood is drawn to obtain a valid prothrombin time. Hyperaminotransferasemia Significant elevations of aminotransferase AST (SGOT) and ALT (SGPT) levels have occurred in a high percentage of patients (and healthy subjects) who have received heparin. Since aminotransferase determinations are important in the differential diagnosis of myocardial infarction, liver disease and pulmonary emboli, rises that might be caused by drugs (like heparin) should be interpreted with caution.

8 USE IN SPECIFIC POPULATIONS Pregnancy: Preservative-free formulation recommended. Limited human data in pregnant women. ( 8.1 ) Lactation: Advise females not to breastfeed. ( 8.2 ) Pediatric Use: Use preservative-free formulation in neonates and infants. ( 8.4 ) Geriatric Use: A higher incidence of bleeding reported in patients, particularly women, over 60 years of age. ( 8.5 ) 8.1 Pregnancy Risk Summary There are no available data on heparin sodium injection use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. In published reports, heparin sodium exposure during pregnancy did not show evidence of an increased risk of adverse maternal or fetal outcomes in humans. No teratogenicity, but early embryo-fetal death was observed in animal reproduction studies with administration of heparin sodium to pregnant rats and rabbits during organogenesis at doses approximately 10 times the maximum recommended human dose (MRHD) of 45,000 units/day [see Data ] . Consider the benefits and risks of heparin sodium injection for the mother and possible risks to the fetus when prescribing heparin sodium injection to a pregnant woman. If available, preservative-free heparin sodium injection is recommended when heparin therapy is needed during pregnancy. There are no known adverse outcomes associated with fetal exposure to the preservative benzyl alcohol through maternal drug administration; however, the preservative benzyl alcohol can cause serious adverse events and death when administered intravenously to neonates and infants [see Warnings and Precautions ( 5.4 )]. The 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 2-4% and 15-20%, respectively. Data Human Data The maternal and fetal outcomes associated with uses of heparin sodium via various dosing methods and administration routes during pregnancy have been investigated in numerous studies. These studies generally reported normal deliveries with no maternal or fetal bleeding and no other complications. Animal Data In a published study conducted in rats and rabbits, pregnant animals received heparin sodium intravenously during organogenesis at a dose of 10,000 units/kg/day, approximately 10 times the maximum human daily dose based on body weight. The number of early resorptions increased in both species. There was no evidence of teratogenic effects. 8.2 Lactation Risk Summary If available, preservative-free heparin sodium injection is recommended when heparin therapy is needed during lactation. Benzyl alcohol present in maternal serum is likely to cross into human milk and may be orally absorbed by a nursing infant. There is no information regarding the presence of heparin sodium injection in human milk, the effects on the breastfed infant, or the effects on milk production. Due to its large molecular weight, heparin sodium is not likely to be excreted in human milk, and any heparin sodium in milk would not be orally absorbed by a nursing infant. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for heparin sodium injection and any potential adverse effects on the breastfed infant from heparin sodium injection or from the underlying maternal condition [see Use in Specific Populations ( 8.4 )] . 8.4 Pediatric Use There are no adequate and well controlled studies on heparin sodium use in pediatric patients. Pediatric dosing recommendations are based on clinical experience [see Dosage and Administration ( 2.5 )] . Carefully examine all heparin sodium injection syringes to confirm choice of the correct strength prior to administration of the drug. Pediatric patients, including neonates, have died as a result of medication errors in which heparin sodium injection vials have been confused with “catheter lock f …

12.1 Mechanism of Action Heparin inhibits reactions that lead to the clotting of blood and the formation of fibrin clots both in vitro and in vivo . Heparin acts at multiple sites in the normal coagulation system. Small amounts of heparin in combination with antithrombin III (heparin cofactor) can inhibit thrombosis by inactivating activated Factor X and inhibiting the conversion of prothrombin to thrombin. Once active thrombosis has developed, larger amounts of heparin can inhibit further coagulation by inactivating thrombin and preventing the conversion of fibrinogen to fibrin. Heparin also prevents the formation of a stable fibrin clot by inhibiting the activation of the fibrin stabilizing factor. Heparin does not have fibrinolytic activity; therefore, it will not lyse existing clots.

11 DESCRIPTION Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans, having anticoagulant properties. Although others may be present, the main sugars occurring in heparin are: (1) α-L-iduronic acid 2-sulfate, (2) 2-deoxy-2-sulfamino-α-D-glucose 6-sulfate, (3) β-D-glucuronic acid, (4) 2-acetamido-2-deoxy-α-D-glucose and (5) α-L-iduronic acid. These sugars are present in decreasing amounts, usually in the order (2)> (1)> (4)> (3)> (5), and are joined by glycosidic linkages, forming polymers of varying sizes. Heparin is strongly acidic because of its content of covalently linked sulfate and carboxylic acid groups. In heparin sodium, the acidic protons of the sulfate units are partially replaced by sodium ions. Heparin Sodium Injection, USP is a sterile solution of heparin sodium derived from porcine intestinal mucosa, standardized for anticoagulant activity, in water for injection. It is to be administered by intravenous or deep subcutaneous routes. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. Structure of Heparin Sodium (representative subunits): Structure of Heparin Sodium Heparin Sodium Injection, USP (porcine), preservative free, is available as follows: Each mL of the 1,000 units per mL preparation contains: 1,000 USP Heparin units (porcine); 9 mg sodium chloride; Water for Injection q.s. Made isotonic with sodium chloride. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment (5.0 to 7.5). Each 0.5 mL of the 5,000 units per 0.5 mL preparation contains: 5,000 USP Heparin units (porcine); Water for Injection q.s. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment (5.0 to 7.5). Heparin Sodium Injection, USP (porcine), preserved with benzyl alcohol, is available as follows: Each mL of the 5,000 units per mL preparation contains: 5,000 USP Heparin units (porcine); 6 mg sodium chloride; 15 mg benzyl alcohol (as a preservative); Water for Injection q.s. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment (5.0 to 7.5). Each mL of the 10,000 units per mL preparation contains: 10,000 USP Heparin units (porcine); 5 mg sodium chloride; 10.42 mg benzyl alcohol (as a preservative); Water for Injection q.s. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment (5.0 to 7.5). Heparin Sodium Injection, USP (porcine), preserved with parabens, is available as follows: Each mL of the 1,000 units per mL preparation contains: 1,000 USP Heparin units (porcine); 9 mg sodium chloride; 1.5 mg methylparaben; 0.15 mg propylparaben; Water for Injection q.s. Made isotonic with sodium chloride. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment (5.0 to 7.5). Each mL of the 5,000 units per mL preparation contains: 5,000 USP Heparin units (porcine); 5 mg sodium chloride; 1.5 mg methylparaben; 0.15 mg propylparaben; Water for Injection q.s. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment (5.0 to 7.5). Each mL of the 10,000 units per mL preparation contains: 10,000 USP Heparin units (porcine); 1.5 mg methylparaben; 0.15 mg propylparaben; Water for Injection q.s. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment (5.0 to 7.5). Each mL of the 20,000 units per mL preparation contains: 20,000 USP Heparin units (porcine); 1.5 mg methylparaben; 0.15 mg propylparaben; Water for Injection q.s. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment (5.0 to 7.5).

OVERDOSAGE Symptoms Bleeding is the chief sign of heparin overdosage. Nosebleeds, blood in urine or tarry stools may be noted as the first sign of bleeding. Easy bruising or petechial formations may precede frank bleeding. Treatment Neutralization of Heparin Effect —When clinical circumstances (bleeding) require reversal of heparinization, protamine sulfate (1% solution) by slow infusion will neutralize heparin sodium. No more than 50 mg should be administered, very slowly , in any 10 minute period. Each mg of protamine sulfate neutralizes approximately 100 USP heparin units. The amount of protamine required decreases over time as heparin is metabolized. Although the metabolism of heparin is complex, it may, for the purpose of choosing a protamine dose, be assumed to have a half-life of about 1/2 hour after intravenous injection. Administration of protamine sulfate can cause severe hypotensive and anaphylactoid reactions. Because fatal reactions often resembling anaphylaxis have been reported, the drug should be given only when resuscitation techniques and treatment of anaphylactoid shock are readily available. For additional information consult the labeling of Protamine Sulfate Injection, USP products.

Symptoms Bleeding is the chief sign of heparin overdosage. Nosebleeds, blood in urine or tarry stools may be noted as the first sign of bleeding. Easy bruising or petechial formations may precede frank bleeding.

Treatment Neutralization of Heparin Effect —When clinical circumstances (bleeding) require reversal of heparinization, protamine sulfate (1% solution) by slow infusion will neutralize heparin sodium. No more than 50 mg should be administered, very slowly , in any 10 minute period. Each mg of protamine sulfate neutralizes approximately 100 USP heparin units. The amount of protamine required decreases over time as heparin is metabolized. Although the metabolism of heparin is complex, it may, for the purpose of choosing a protamine dose, be assumed to have a half-life of about 1/2 hour after intravenous injection. Administration of protamine sulfate can cause severe hypotensive and anaphylactoid reactions. Because fatal reactions often resembling anaphylaxis have been reported, the drug should be given only when resuscitation techniques and treatment of anaphylactoid shock are readily available. For additional information consult the labeling of Protamine Sulfate Injection, USP products.

16 HOW SUPPLIED/STORAGE AND HANDLING Heparin Sodium Injection, USP (porcine), preservative free , is available as follows: Product Code Unit of Sale Strength Each 27602 NDC 63323-276-02 Unit of 25 2,000 USP units per 2 mL (1,000 USP units per mL) NDC 63323-276-01 2 mL single-dose, flip-top vial 504313 NDC 63323-543-13 Unit of 25 5,000 USP units per 0.5 mL NDC 63323-543-03 0.5 mL fill in a 2 mL single-dose, flip-top vial Use only if solution is clear and seal intact. Do not use if solution is discolored or contains a precipitate. This container closure is not made with natural rubber latex. Discard unused portion. Heparin Sodium Injection, USP (porcine) contains benzyl alcohol and is available as follows: Product Code Unit of Sale Strength Each 4710 NDC 63323-047-10 Unit of 25 50,000 USP units per 10 mL (5,000 USP units per mL) NDC 63323-047-01 10 mL multiple-dose, flip-top vial 504514 NDC 63323-459-14 Unit of 25 40,000 USP units per 4 mL (10,000 USP units per mL) NDC 63323-459-04 4 mL fill in a 5 mL multiple-dose, flip-top vial Use only if solution is clear and seal intact. Do not use if solution is discolored or contains a precipitate. This container closure is not made with natural rubber latex. Heparin Sodium Injection, USP (porcine) contains parabens and is available as follows: Product Code Unit of Sale Strength Each 504013 NDC 63323-540-13 Unit of 25 1,000 USP units per mL NDC 63323-540-03 1 mL fill in a 2 mL multiple-dose, flip-top vial 504015 NDC 63323-540-15 Unit of 25 10,000 USP units per 10 mL (1,000 USP units per mL) NDC 63323-540-05 10 mL multiple-dose, flip-top vial RF504015 NDC 65219-066-10 Unit of 25 10,000 USP units per 10 mL (1,000 USP units per mL) NDC 65219-066-01 10 mL multiple-dose, flip-top vial This product contains an RFID 504036 NDC 63323-540-36 Unit of 25 30,000 USP units per 30 mL (1,000 USP units per mL) NDC 63323-540-33 30 mL multiple-dose, flip-top vial 926206 NDC 63323-262-06 Unit of 25 5,000 USP units per mL NDC 63323-262-03 1 mL fill in a 2 mL multiple-dose, flip-top vial 504213 NDC 63323-542-13 Unit of 25 10,000 USP units per mL NDC 63323-542-09 1 mL fill in a 2 mL multiple-dose, flip-top vial 504214 NDC 63323-542-14 Unit of 25 50,000 USP units per 5 mL (10,000 USP units per mL) NDC 63323-542-04 5 mL fill in a 10 mL multiple-dose, flip-top vial 915513 NDC 63323-915-13 Unit of 25 20,000 USP units per mL NDC 63323-915-03 1 mL fill in a 2 mL multiple-dose, flip-top vial Use only if solution is clear and seal intact. Do not use if solution is discolored or contains a precipitate. This container closure is not made with natural rubber latex. STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].