{
"NDC": [
{
"NDCCode": "54868-5808-0",
"PackageDescription": "10 CARTRIDGE in 1 BOX (54868-5808-0) > 1 mL in 1 CARTRIDGE",
"NDC11Code": "54868-5808-00",
"ProductNDC": "54868-5808",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Demerol",
"NonProprietaryName": "Meperidine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20070821",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021171",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "MEPERIDINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For the relief of moderate to severe pain. For preoperative medication. For support of anesthesia. For obstetrical analgesia.",
"Description": "Meperidine hydrochloride is ethyl 1-methyl-4-phenylisonipecotate hydrochloride, a white crystalline substance with a melting point of 186°C to 189°C. It is readily soluble in water and has a neutral reaction and a slightly bitter taste. The solution is not decomposed by a short period of boiling. DEMEROL injectable is supplied in Carpuject with luer lock of 2.5% (25 mg/1 mL), 5% (50 mg/1 mL), 7.5% (75 mg/1 mL), and 10% (100 mg/1 mL). Uni-Amp unit dose pak-ampuls of 5% solution (25 mg/0.5 mL), (50 mg/1 mL), (75 mg/1.5 mL), (100 mg/2 mL), and 10% solution (100 mg/1 mL). Multiple-dose vials of 5% and 10% solutions contain metacresol 0.1% as preservative. The pH of DEMEROL solutions is adjusted between 3.5 and 6 with sodium hydroxide or hydrochloric acid. DEMEROL, brand of meperidine hydrochloride, 5 percent solution has a specific gravity of 1.0086 at 20°C and 10 percent solution, a specific gravity of 1.0165 at 20°C."
},
{
"NDCCode": "50090-5808-0",
"PackageDescription": "60 TABLET in 1 BOTTLE (50090-5808-0) ",
"NDC11Code": "50090-5808-00",
"ProductNDC": "50090-5808",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gemfibrozil",
"NonProprietaryName": "Gemfibrozil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214603",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "GEMFIBROZIL",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "PPAR alpha [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211015",
"SamplePackage": "N",
"IndicationAndUsage": "Gemfibrozil Tablets are indicated as adjunctive therapy to diet for: 1 Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dL are unlikely to present a risk of pancreatitis. Gemfibrozil therapy may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. It is recognized that some Type IV patients with triglycerides under 1000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of gemfibrozil therapy on the risk of pancreatitis in such situations has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia., 2 Reducing the risk of developing coronary heart disease only in Type IIb patients without history of or symptoms of existing coronary heart disease who have had an inadequate response to weight loss, dietary therapy, exercise, and other pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to reduce LDL- and raise HDL-cholesterol) and who have the following triad of lipid abnormalities: low HDL-cholesterol levels in addition to elevated LDL-cholesterol and elevated triglycerides (see WARNINGS, PRECAUTIONS, and CLINICAL PHARMACOLOGY). The National Cholesterol Education Program has defined a serum HDL-cholesterol value that is consistently below 35 mg/dL as constituting an independent risk factor for coronary heart disease. Patients with significantly elevated triglycerides should be closely observed when treated with gemfibrozil. In some patients with high triglyceride levels, treatment with gemfibrozil is associated with a significant increase in LDL-cholesterol. BECAUSE OF POTENTIAL TOXICITY SUCH AS MALIGNANCY, GALLBLADDER DISEASE, ABDOMINAL PAIN LEADING TO APPENDECTOMY AND OTHER ABDOMINAL SURGERIES, AN INCREASED INCIDENCE IN NON-CORONARY MORTALITY, AND THE 44% RELATIVE INCREASE DURING THE TRIAL PERIOD IN AGE-ADJUSTED ALL-CAUSE MORTALITY SEEN WITH THE CHEMICALLY AND PHARMACOLOGICALLY RELATED DRUG, CLOFIBRATE, THE POTENTIAL BENEFIT OF GEMFIBROZIL IN TREATING TYPE IIA PATIENTS WITH ELEVATIONS OF LDL-CHOLESTEROL ONLY IS NOT LIKELY TO OUTWEIGH THE RISKS. GEMFIBROZIL IS ALSO NOT INDICATED FOR THE TREATMENT OF PATIENTS WITH LOW HDL-CHOLESTEROL AS THEIR ONLY LIPID ABNORMALITY.",
"Description": "Gemfibrozil, USP is a lipid regulating agent. It is available as tablets for oral administration. Each tablet contains 600 mg gemfibrozil. Each tablet also contains the following inactive ingredients: pregelatinized starch, microcrystalline cellulose, povidone, colloidal silicon dioxide, polysorbate, croscarmellose sodium, calcium stearate, hydroxypropyl cellulose, and talc. The chemical name is 5-(2,5-dimethylphenoxy)-2,2-dimethylpentanoic acid, with the following structural formula. The empirical formula is C15H22O3 and the molecular weight is 250.35; the solubility in water and acid is 0.0019% and in dilute base it is greater than 1%. The melting point is 58° – 61°C. Gemfibrozil is a white solid which is stable under ordinary conditions."
},
{
"NDCCode": "54868-3619-0",
"PackageDescription": "1 VIAL in 1 CARTON (54868-3619-0) > 10 mL in 1 VIAL",
"NDC11Code": "54868-3619-00",
"ProductNDC": "54868-3619",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Humulin R",
"NonProprietaryName": "Insulin Human",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "19950727",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018780",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "INSULIN HUMAN",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Humulin R U-100 is indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 1 and type 2 diabetes mellitus. Humulin R U-100 may be administered intravenously under proper medical supervision in a clinical setting for glycemic control (see DOSAGE AND ADMINISTRATION and Storage).",
"Description": "Humulin® R U-100 is a polypeptide hormone structurally identical to human insulin synthesized through rDNA technology in a special non-disease-producing laboratory strain of Escherichia coli bacteria. Humulin R U-100 has the empirical formula C257H383N65O77S6 and a molecular weight of 5808. Humulin R U-100 is a sterile, clear, aqueous, and colorless solution that contains human insulin (rDNA origin) 100 units/mL, glycerin 16 mg/mL and metacresol 2.5 mg/mL, endogenous zinc (approximately 0.015 mg/100 units) and water for injection. The pH is 7.0 to 7.8. Sodium hydroxide and/or hydrochloric acid may be added during manufacture to adjust the pH. Adequate insulin dosage permits patients with diabetes to effectively utilize carbohydrates, proteins and fats. Regardless of dose strength, insulin enables carbohydrate metabolism to occur and thus to prevent the production of ketone bodies by the liver. Some patients develop severe insulin resistance such that daily doses of several hundred units of insulin or more are required."
},
{
"NDCCode": "54868-4381-0",
"PackageDescription": "1 VIAL in 1 CARTON (54868-4381-0) > 10 mL in 1 VIAL",
"NDC11Code": "54868-4381-00",
"ProductNDC": "54868-4381",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Humalog",
"ProprietaryNameSuffix": "Mix75/25",
"NonProprietaryName": "Insulin Lispro",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20050222",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021017",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "INSULIN LISPRO",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin [Chemical/Ingredient],Insulin Analog [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Humalog Mix75/25, a mixture of 75% insulin lispro protamine suspension and 25% insulin lispro injection, (rDNA origin), is indicated in the treatment of patients with diabetes mellitus for the control of hyperglycemia. Humalog Mix75/25 has a more rapid onset of glucose–lowering activity compared with Humulin 70/30 while having a similar duration of action. This profile is achieved by combining the rapid onset of Humalog with the intermediate action of insulin lispro protamine suspension.",
"Description": "Humalog® Mix75/25 [75% insulin lispro protamine suspension and 25% insulin lispro injection, (rDNA origin)] is a mixture of insulin lispro solution, a rapid–acting blood glucose–lowering agent and insulin lispro protamine suspension, an intermediate–acting blood glucose–lowering agent. Chemically, insulin lispro is Lys(B28), Pro(B29) human insulin analog, created when the amino acids at positions 28 and 29 on the insulin B–chain are reversed. Insulin lispro is synthesized in a special non–pathogenic laboratory strain of Escherichia coli bacteria that has been genetically altered to produce insulin lispro. Insulin lispro protamine suspension (NPL component) is a suspension of crystals produced from combining insulin lispro and protamine sulfate under appropriate conditions for crystal formation. Insulin lispro has the following primary structure. Insulin lispro has the empirical formula C257H383N65O77S6 and a molecular weight of 5808, both identical to that of human insulin. Humalog Mix75/25 vials and Pens contain a sterile suspension of insulin lispro protamine suspension mixed with soluble insulin lispro for use as an injection. Each milliliter of Humalog Mix75/25 injection contains insulin lispro 100 units, 0.28 mg protamine sulfate, 16 mg glycerin, 3.78 mg dibasic sodium phosphate, 1.76 mg Metacresol, zinc oxide content adjusted to provide 0.025 mg zinc ion, 0.715 mg phenol, and Water for Injection. Humalog Mix75/25 has a pH of 7.0 to 7.8. Hydrochloric acid 10% and/or sodium hydroxide 10% may have been added to adjust pH."
},
{
"NDCCode": "54868-5108-0",
"PackageDescription": "1 VIAL in 1 CARTON (54868-5108-0) > 10 mL in 1 VIAL",
"NDC11Code": "54868-5108-00",
"ProductNDC": "54868-5108",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Humalog",
"NonProprietaryName": "Insulin Lispro",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20050502",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020563",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "INSULIN LISPRO",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin [Chemical/Ingredient],Insulin Analog [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "HUMALOG is an insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus.",
"Description": "HUMALOG® (insulin lispro injection, USP [rDNA origin]) is a rapid-acting human insulin analog used to lower blood glucose. Insulin lispro is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin lispro differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. Chemically, it is Lys(B28), Pro(B29) human insulin analog and has the empirical formula C257H383N65O77S6 and a molecular weight of 5808, both identical to that of human insulin. HUMALOG has the following primary structure:. HUMALOG is a sterile, aqueous, clear, and colorless solution. Each milliliter of HUMALOG contains insulin lispro 100 units, 16 mg glycerin, 1.88 mg dibasic sodium phosphate, 3.15 mg Metacresol, zinc oxide content adjusted to provide 0.0197 mg zinc ion, trace amounts of phenol, and Water for Injection. Insulin lispro has a pH of 7.0 to 7.8. The pH is adjusted by addition of aqueous solutions of hydrochloric acid 10% and/or sodium hydroxide 10%."
},
{
"NDCCode": "54868-5836-0",
"PackageDescription": "5 CARTRIDGE in 1 CARTON (54868-5836-0) > 3 mL in 1 CARTRIDGE",
"NDC11Code": "54868-5836-00",
"ProductNDC": "54868-5836",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Humalog",
"ProprietaryNameSuffix": "Cartridge",
"NonProprietaryName": "Insulin Lispro",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20071203",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020563",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "INSULIN LISPRO",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin [Chemical/Ingredient],Insulin Analog [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "HUMALOG is an insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus.",
"Description": "HUMALOG® (insulin lispro injection, USP [rDNA origin]) is a rapid-acting human insulin analog used to lower blood glucose. Insulin lispro is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin lispro differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. Chemically, it is Lys(B28), Pro(B29) human insulin analog and has the empirical formula C257H383N65O77S6 and a molecular weight of 5808, both identical to that of human insulin. HUMALOG has the following primary structure:. HUMALOG is a sterile, aqueous, clear, and colorless solution. Each milliliter of HUMALOG contains insulin lispro 100 units, 16 mg glycerin, 1.88 mg dibasic sodium phosphate, 3.15 mg Metacresol, zinc oxide content adjusted to provide 0.0197 mg zinc ion, trace amounts of phenol, and Water for Injection. Insulin lispro has a pH of 7.0 to 7.8. The pH is adjusted by addition of aqueous solutions of hydrochloric acid 10% and/or sodium hydroxide 10%."
},
{
"NDCCode": "54868-5899-0",
"PackageDescription": "5 SYRINGE in 1 CARTON (54868-5899-0) > 3 mL in 1 SYRINGE",
"NDC11Code": "54868-5899-00",
"ProductNDC": "54868-5899",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Humalog",
"ProprietaryNameSuffix": "Pen",
"NonProprietaryName": "Insulin Lispro",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20080512",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020563",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "INSULIN LISPRO",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin [Chemical/Ingredient],Insulin Analog [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "HUMALOG is an insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus.",
"Description": "HUMALOG® (insulin lispro injection, USP [rDNA origin]) is a rapid-acting human insulin analog used to lower blood glucose. Insulin lispro is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin lispro differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. Chemically, it is Lys(B28), Pro(B29) human insulin analog and has the empirical formula C257H383N65O77S6 and a molecular weight of 5808, both identical to that of human insulin. HUMALOG has the following primary structure:. HUMALOG is a sterile, aqueous, clear, and colorless solution. Each milliliter of HUMALOG contains insulin lispro 100 units, 16 mg glycerin, 1.88 mg dibasic sodium phosphate, 3.15 mg Metacresol, zinc oxide content adjusted to provide 0.0197 mg zinc ion, trace amounts of phenol, and Water for Injection. Insulin lispro has a pH of 7.0 to 7.8. The pH is adjusted by addition of aqueous solutions of hydrochloric acid 10% and/or sodium hydroxide 10%."
},
{
"NDCCode": "0002-7726-05",
"PackageDescription": "5 CARTRIDGE in 1 CARTON (0002-7726-05) / 3 mL in 1 CARTRIDGE (0002-7726-01) ",
"NDC11Code": "00002-7726-05",
"ProductNDC": "0002-7726",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lyumjev",
"NonProprietaryName": "Insulin Lispro-aabc",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20200615",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761109",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "INSULIN LISPRO",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [Chemical/Ingredient]",
"Status": "Active",
"LastUpdate": "2026-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200615",
"SamplePackage": "N",
"IndicationAndUsage": "LYUMJEV® is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.",
"Description": "Insulin lispro-aabc is a rapid-acting human insulin analog used to lower blood glucose. Insulin lispro-aabc is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin lispro-aabc differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. Chemically, it is Lys(B28), Pro(B29) human insulin analog and has the empirical formula C257H383N65O77S6 and a molecular weight of 5808 daltons, both identical to that of human insulin. Insulin lispro-aabc has the following primary structure:. LYUMJEV (insulin lispro-aabc) injection is a sterile, aqueous, clear, and colorless solution for subcutaneous or intravenous administration. Each mL of LYUMJEV U-100 contains 100 units of insulin lispro-aabc and the inactive ingredients: glycerol (12.1 mg), magnesium chloride hexahydrate (1.02 mg), metacresol (3.15 mg), sodium citrate dihydrate (4.41 mg), treprostinil sodium (1.06 mcg), zinc oxide (content adjusted to provide 39 mcg zinc ion), and Water for Injection, USP. Each mL of LYUMJEV U-200 contains 200 units of insulin lispro-aabc and the inactive ingredients: glycerol (12.1 mg), magnesium chloride hexahydrate (1.02 mg), metacresol (3.15 mg), sodium citrate dihydrate (4.41 mg), treprostinil sodium (1.06 mcg), zinc oxide (content adjusted to provide 52 mcg zinc ion), and Water for Injection, USP. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH. LYUMJEV has a pH of 7.0 to 7.8."
},
{
"NDCCode": "0002-7728-01",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (0002-7728-01) / 10 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00002-7728-01",
"ProductNDC": "0002-7728",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lyumjev",
"NonProprietaryName": "Insulin Lispro-aabc",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20200615",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761109",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "INSULIN LISPRO",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [Chemical/Ingredient]",
"Status": "Active",
"LastUpdate": "2026-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200615",
"SamplePackage": "N",
"IndicationAndUsage": "LYUMJEV® is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.",
"Description": "Insulin lispro-aabc is a rapid-acting human insulin analog used to lower blood glucose. Insulin lispro-aabc is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin lispro-aabc differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. Chemically, it is Lys(B28), Pro(B29) human insulin analog and has the empirical formula C257H383N65O77S6 and a molecular weight of 5808 daltons, both identical to that of human insulin. Insulin lispro-aabc has the following primary structure:. LYUMJEV (insulin lispro-aabc) injection is a sterile, aqueous, clear, and colorless solution for subcutaneous or intravenous administration. Each mL of LYUMJEV U-100 contains 100 units of insulin lispro-aabc and the inactive ingredients: glycerol (12.1 mg), magnesium chloride hexahydrate (1.02 mg), metacresol (3.15 mg), sodium citrate dihydrate (4.41 mg), treprostinil sodium (1.06 mcg), zinc oxide (content adjusted to provide 39 mcg zinc ion), and Water for Injection, USP. Each mL of LYUMJEV U-200 contains 200 units of insulin lispro-aabc and the inactive ingredients: glycerol (12.1 mg), magnesium chloride hexahydrate (1.02 mg), metacresol (3.15 mg), sodium citrate dihydrate (4.41 mg), treprostinil sodium (1.06 mcg), zinc oxide (content adjusted to provide 52 mcg zinc ion), and Water for Injection, USP. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH. LYUMJEV has a pH of 7.0 to 7.8."
},
{
"NDCCode": "0002-7728-99",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (0002-7728-99) / 10 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00002-7728-99",
"ProductNDC": "0002-7728",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lyumjev",
"NonProprietaryName": "Insulin Lispro-aabc",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20200615",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761109",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "INSULIN LISPRO",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2026-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200615",
"SamplePackage": "Y",
"IndicationAndUsage": "LYUMJEV® is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.",
"Description": "Insulin lispro-aabc is a rapid-acting human insulin analog used to lower blood glucose. Insulin lispro-aabc is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin lispro-aabc differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. Chemically, it is Lys(B28), Pro(B29) human insulin analog and has the empirical formula C257H383N65O77S6 and a molecular weight of 5808 daltons, both identical to that of human insulin. Insulin lispro-aabc has the following primary structure:. LYUMJEV (insulin lispro-aabc) injection is a sterile, aqueous, clear, and colorless solution for subcutaneous or intravenous administration. Each mL of LYUMJEV U-100 contains 100 units of insulin lispro-aabc and the inactive ingredients: glycerol (12.1 mg), magnesium chloride hexahydrate (1.02 mg), metacresol (3.15 mg), sodium citrate dihydrate (4.41 mg), treprostinil sodium (1.06 mcg), zinc oxide (content adjusted to provide 39 mcg zinc ion), and Water for Injection, USP. Each mL of LYUMJEV U-200 contains 200 units of insulin lispro-aabc and the inactive ingredients: glycerol (12.1 mg), magnesium chloride hexahydrate (1.02 mg), metacresol (3.15 mg), sodium citrate dihydrate (4.41 mg), treprostinil sodium (1.06 mcg), zinc oxide (content adjusted to provide 52 mcg zinc ion), and Water for Injection, USP. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH. LYUMJEV has a pH of 7.0 to 7.8."
},
{
"NDCCode": "0002-8207-05",
"PackageDescription": "5 SYRINGE in 1 CARTON (0002-8207-05) / 3 mL in 1 SYRINGE (0002-8207-01) ",
"NDC11Code": "00002-8207-05",
"ProductNDC": "0002-8207",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lyumjev",
"ProprietaryNameSuffix": "Kwikpen",
"NonProprietaryName": "Insulin Lispro-aabc",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20200615",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761109",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "INSULIN LISPRO",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [Chemical/Ingredient]",
"Status": "Active",
"LastUpdate": "2026-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200615",
"SamplePackage": "N",
"IndicationAndUsage": "LYUMJEV® is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.",
"Description": "Insulin lispro-aabc is a rapid-acting human insulin analog used to lower blood glucose. Insulin lispro-aabc is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin lispro-aabc differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. Chemically, it is Lys(B28), Pro(B29) human insulin analog and has the empirical formula C257H383N65O77S6 and a molecular weight of 5808 daltons, both identical to that of human insulin. Insulin lispro-aabc has the following primary structure:. LYUMJEV (insulin lispro-aabc) injection is a sterile, aqueous, clear, and colorless solution for subcutaneous or intravenous administration. Each mL of LYUMJEV U-100 contains 100 units of insulin lispro-aabc and the inactive ingredients: glycerol (12.1 mg), magnesium chloride hexahydrate (1.02 mg), metacresol (3.15 mg), sodium citrate dihydrate (4.41 mg), treprostinil sodium (1.06 mcg), zinc oxide (content adjusted to provide 39 mcg zinc ion), and Water for Injection, USP. Each mL of LYUMJEV U-200 contains 200 units of insulin lispro-aabc and the inactive ingredients: glycerol (12.1 mg), magnesium chloride hexahydrate (1.02 mg), metacresol (3.15 mg), sodium citrate dihydrate (4.41 mg), treprostinil sodium (1.06 mcg), zinc oxide (content adjusted to provide 52 mcg zinc ion), and Water for Injection, USP. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH. LYUMJEV has a pH of 7.0 to 7.8."
},
{
"NDCCode": "0002-8207-61",
"PackageDescription": "1 SYRINGE in 1 CARTON (0002-8207-61) / 3 mL in 1 SYRINGE",
"NDC11Code": "00002-8207-61",
"ProductNDC": "0002-8207",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lyumjev",
"ProprietaryNameSuffix": "Kwikpen",
"NonProprietaryName": "Insulin Lispro-aabc",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20200615",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761109",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "INSULIN LISPRO",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2026-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200615",
"SamplePackage": "Y",
"IndicationAndUsage": "LYUMJEV® is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.",
"Description": "Insulin lispro-aabc is a rapid-acting human insulin analog used to lower blood glucose. Insulin lispro-aabc is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin lispro-aabc differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. Chemically, it is Lys(B28), Pro(B29) human insulin analog and has the empirical formula C257H383N65O77S6 and a molecular weight of 5808 daltons, both identical to that of human insulin. Insulin lispro-aabc has the following primary structure:. LYUMJEV (insulin lispro-aabc) injection is a sterile, aqueous, clear, and colorless solution for subcutaneous or intravenous administration. Each mL of LYUMJEV U-100 contains 100 units of insulin lispro-aabc and the inactive ingredients: glycerol (12.1 mg), magnesium chloride hexahydrate (1.02 mg), metacresol (3.15 mg), sodium citrate dihydrate (4.41 mg), treprostinil sodium (1.06 mcg), zinc oxide (content adjusted to provide 39 mcg zinc ion), and Water for Injection, USP. Each mL of LYUMJEV U-200 contains 200 units of insulin lispro-aabc and the inactive ingredients: glycerol (12.1 mg), magnesium chloride hexahydrate (1.02 mg), metacresol (3.15 mg), sodium citrate dihydrate (4.41 mg), treprostinil sodium (1.06 mcg), zinc oxide (content adjusted to provide 52 mcg zinc ion), and Water for Injection, USP. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH. LYUMJEV has a pH of 7.0 to 7.8."
},
{
"NDCCode": "0002-8228-27",
"PackageDescription": "2 SYRINGE in 1 CARTON (0002-8228-27) / 3 mL in 1 SYRINGE (0002-8228-01) ",
"NDC11Code": "00002-8228-27",
"ProductNDC": "0002-8228",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lyumjev",
"ProprietaryNameSuffix": "Kwikpen",
"NonProprietaryName": "Insulin Lispro-aabc",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20200615",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761109",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "INSULIN LISPRO",
"StrengthNumber": "200",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [Chemical/Ingredient]",
"Status": "Active",
"LastUpdate": "2026-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200615",
"SamplePackage": "N",
"IndicationAndUsage": "LYUMJEV® is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.",
"Description": "Insulin lispro-aabc is a rapid-acting human insulin analog used to lower blood glucose. Insulin lispro-aabc is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin lispro-aabc differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. Chemically, it is Lys(B28), Pro(B29) human insulin analog and has the empirical formula C257H383N65O77S6 and a molecular weight of 5808 daltons, both identical to that of human insulin. Insulin lispro-aabc has the following primary structure:. LYUMJEV (insulin lispro-aabc) injection is a sterile, aqueous, clear, and colorless solution for subcutaneous or intravenous administration. Each mL of LYUMJEV U-100 contains 100 units of insulin lispro-aabc and the inactive ingredients: glycerol (12.1 mg), magnesium chloride hexahydrate (1.02 mg), metacresol (3.15 mg), sodium citrate dihydrate (4.41 mg), treprostinil sodium (1.06 mcg), zinc oxide (content adjusted to provide 39 mcg zinc ion), and Water for Injection, USP. Each mL of LYUMJEV U-200 contains 200 units of insulin lispro-aabc and the inactive ingredients: glycerol (12.1 mg), magnesium chloride hexahydrate (1.02 mg), metacresol (3.15 mg), sodium citrate dihydrate (4.41 mg), treprostinil sodium (1.06 mcg), zinc oxide (content adjusted to provide 52 mcg zinc ion), and Water for Injection, USP. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH. LYUMJEV has a pH of 7.0 to 7.8."
},
{
"NDCCode": "0002-8235-05",
"PackageDescription": "5 SYRINGE in 1 CARTON (0002-8235-05) / 3 mL in 1 SYRINGE (0002-8235-01) ",
"NDC11Code": "00002-8235-05",
"ProductNDC": "0002-8235",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lyumjev",
"ProprietaryNameSuffix": "Tempo Pen",
"NonProprietaryName": "Insulin Lispro-aabc",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20200615",
"EndMarketingDate": "20271106",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761109",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "INSULIN LISPRO",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [Chemical/Ingredient]",
"Status": "Active",
"LastUpdate": "2026-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220929",
"EndMarketingDatePackage": "20271106",
"SamplePackage": "N",
"IndicationAndUsage": "LYUMJEV® is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.",
"Description": "Insulin lispro-aabc is a rapid-acting human insulin analog used to lower blood glucose. Insulin lispro-aabc is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin lispro-aabc differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. Chemically, it is Lys(B28), Pro(B29) human insulin analog and has the empirical formula C257H383N65O77S6 and a molecular weight of 5808 daltons, both identical to that of human insulin. Insulin lispro-aabc has the following primary structure:. LYUMJEV (insulin lispro-aabc) injection is a sterile, aqueous, clear, and colorless solution for subcutaneous or intravenous administration. Each mL of LYUMJEV U-100 contains 100 units of insulin lispro-aabc and the inactive ingredients: glycerol (12.1 mg), magnesium chloride hexahydrate (1.02 mg), metacresol (3.15 mg), sodium citrate dihydrate (4.41 mg), treprostinil sodium (1.06 mcg), zinc oxide (content adjusted to provide 39 mcg zinc ion), and Water for Injection, USP. Each mL of LYUMJEV U-200 contains 200 units of insulin lispro-aabc and the inactive ingredients: glycerol (12.1 mg), magnesium chloride hexahydrate (1.02 mg), metacresol (3.15 mg), sodium citrate dihydrate (4.41 mg), treprostinil sodium (1.06 mcg), zinc oxide (content adjusted to provide 52 mcg zinc ion), and Water for Injection, USP. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH. LYUMJEV has a pH of 7.0 to 7.8."
},
{
"NDCCode": "0002-8235-99",
"PackageDescription": "1 SYRINGE in 1 CARTON (0002-8235-99) / 3 mL in 1 SYRINGE",
"NDC11Code": "00002-8235-99",
"ProductNDC": "0002-8235",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lyumjev",
"ProprietaryNameSuffix": "Tempo Pen",
"NonProprietaryName": "Insulin Lispro-aabc",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20200615",
"EndMarketingDate": "20271106",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761109",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "INSULIN LISPRO",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [Chemical/Ingredient]",
"Status": "Active",
"LastUpdate": "2026-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20240110",
"EndMarketingDatePackage": "20271106",
"SamplePackage": "Y",
"IndicationAndUsage": "LYUMJEV® is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.",
"Description": "Insulin lispro-aabc is a rapid-acting human insulin analog used to lower blood glucose. Insulin lispro-aabc is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin lispro-aabc differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. Chemically, it is Lys(B28), Pro(B29) human insulin analog and has the empirical formula C257H383N65O77S6 and a molecular weight of 5808 daltons, both identical to that of human insulin. Insulin lispro-aabc has the following primary structure:. LYUMJEV (insulin lispro-aabc) injection is a sterile, aqueous, clear, and colorless solution for subcutaneous or intravenous administration. Each mL of LYUMJEV U-100 contains 100 units of insulin lispro-aabc and the inactive ingredients: glycerol (12.1 mg), magnesium chloride hexahydrate (1.02 mg), metacresol (3.15 mg), sodium citrate dihydrate (4.41 mg), treprostinil sodium (1.06 mcg), zinc oxide (content adjusted to provide 39 mcg zinc ion), and Water for Injection, USP. Each mL of LYUMJEV U-200 contains 200 units of insulin lispro-aabc and the inactive ingredients: glycerol (12.1 mg), magnesium chloride hexahydrate (1.02 mg), metacresol (3.15 mg), sodium citrate dihydrate (4.41 mg), treprostinil sodium (1.06 mcg), zinc oxide (content adjusted to provide 52 mcg zinc ion), and Water for Injection, USP. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH. LYUMJEV has a pH of 7.0 to 7.8."
},
{
"NDCCode": "0002-8351-05",
"PackageDescription": "5 SYRINGE in 1 CARTON (0002-8351-05) / 3 mL in 1 SYRINGE (0002-8351-01) ",
"NDC11Code": "00002-8351-05",
"ProductNDC": "0002-8351",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lyumjev",
"ProprietaryNameSuffix": "Junior Kwikpen",
"NonProprietaryName": "Insulin Lispro-aabc",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20200615",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761109",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "INSULIN LISPRO",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [Chemical/Ingredient]",
"Status": "Active",
"LastUpdate": "2026-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200615",
"SamplePackage": "N",
"IndicationAndUsage": "LYUMJEV® is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.",
"Description": "Insulin lispro-aabc is a rapid-acting human insulin analog used to lower blood glucose. Insulin lispro-aabc is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin lispro-aabc differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. Chemically, it is Lys(B28), Pro(B29) human insulin analog and has the empirical formula C257H383N65O77S6 and a molecular weight of 5808 daltons, both identical to that of human insulin. Insulin lispro-aabc has the following primary structure:. LYUMJEV (insulin lispro-aabc) injection is a sterile, aqueous, clear, and colorless solution for subcutaneous or intravenous administration. Each mL of LYUMJEV U-100 contains 100 units of insulin lispro-aabc and the inactive ingredients: glycerol (12.1 mg), magnesium chloride hexahydrate (1.02 mg), metacresol (3.15 mg), sodium citrate dihydrate (4.41 mg), treprostinil sodium (1.06 mcg), zinc oxide (content adjusted to provide 39 mcg zinc ion), and Water for Injection, USP. Each mL of LYUMJEV U-200 contains 200 units of insulin lispro-aabc and the inactive ingredients: glycerol (12.1 mg), magnesium chloride hexahydrate (1.02 mg), metacresol (3.15 mg), sodium citrate dihydrate (4.41 mg), treprostinil sodium (1.06 mcg), zinc oxide (content adjusted to provide 52 mcg zinc ion), and Water for Injection, USP. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH. LYUMJEV has a pH of 7.0 to 7.8."
},
{
"NDCCode": "0024-5924-10",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (0024-5924-10) / 10 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00024-5924-10",
"ProductNDC": "0024-5924",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Admelog",
"NonProprietaryName": "Insulin Lispro",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20171211",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA209196",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "INSULIN LISPRO",
"StrengthNumber": "100",
"StrengthUnit": "U/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [Chemical/Ingredient]",
"Status": "Active",
"LastUpdate": "2025-06-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171211",
"SamplePackage": "N",
"IndicationAndUsage": "ADMELOG is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.",
"Description": "Insulin lispro is a rapid-acting human insulin analog produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin lispro differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. Insulin lispro has a molecular weight of 5808 Da, identical to that of human insulin. ADMELOG (insulin lispro) injection is a sterile, aqueous, clear, and colorless solution for subcutaneous or intravenous use. Each mL of ADMELOG contains 100 units of insulin lispro, and the inactive ingredients: dibasic sodium phosphate (1.88 mg), glycerin (16 mg), metacresol (3.15 mg), zinc oxide (content adjusted to provide 0.0197 mg zinc ion), and Water for Injection, USP. Insulin lispro has a pH of 7.0 to 7.8. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. ADMELOG is latex free."
},
{
"NDCCode": "0024-5925-00",
"PackageDescription": "1 SYRINGE in 1 CARTON (0024-5925-00) / 3 mL in 1 SYRINGE",
"NDC11Code": "00024-5925-00",
"ProductNDC": "0024-5925",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Admelog",
"NonProprietaryName": "Insulin Lispro",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20171211",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA209196",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "INSULIN LISPRO",
"StrengthNumber": "100",
"StrengthUnit": "U/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [Chemical/Ingredient]",
"Status": "Active",
"LastUpdate": "2025-06-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171211",
"SamplePackage": "Y",
"IndicationAndUsage": "ADMELOG is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.",
"Description": "Insulin lispro is a rapid-acting human insulin analog produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin lispro differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. Insulin lispro has a molecular weight of 5808 Da, identical to that of human insulin. ADMELOG (insulin lispro) injection is a sterile, aqueous, clear, and colorless solution for subcutaneous or intravenous use. Each mL of ADMELOG contains 100 units of insulin lispro, and the inactive ingredients: dibasic sodium phosphate (1.88 mg), glycerin (16 mg), metacresol (3.15 mg), zinc oxide (content adjusted to provide 0.0197 mg zinc ion), and Water for Injection, USP. Insulin lispro has a pH of 7.0 to 7.8. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. ADMELOG is latex free."
},
{
"NDCCode": "0024-5925-05",
"PackageDescription": "5 SYRINGE in 1 CARTON (0024-5925-05) / 3 mL in 1 SYRINGE (0024-5925-01) ",
"NDC11Code": "00024-5925-05",
"ProductNDC": "0024-5925",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Admelog",
"NonProprietaryName": "Insulin Lispro",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20171211",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA209196",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "INSULIN LISPRO",
"StrengthNumber": "100",
"StrengthUnit": "U/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [Chemical/Ingredient]",
"Status": "Active",
"LastUpdate": "2025-06-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171211",
"SamplePackage": "N",
"IndicationAndUsage": "ADMELOG is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.",
"Description": "Insulin lispro is a rapid-acting human insulin analog produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin lispro differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. Insulin lispro has a molecular weight of 5808 Da, identical to that of human insulin. ADMELOG (insulin lispro) injection is a sterile, aqueous, clear, and colorless solution for subcutaneous or intravenous use. Each mL of ADMELOG contains 100 units of insulin lispro, and the inactive ingredients: dibasic sodium phosphate (1.88 mg), glycerin (16 mg), metacresol (3.15 mg), zinc oxide (content adjusted to provide 0.0197 mg zinc ion), and Water for Injection, USP. Insulin lispro has a pH of 7.0 to 7.8. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. ADMELOG is latex free."
},
{
"NDCCode": "0024-5926-05",
"PackageDescription": "1 VIAL in 1 CARTON (0024-5926-05) / 3 mL in 1 VIAL",
"NDC11Code": "00024-5926-05",
"ProductNDC": "0024-5926",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Admelog",
"NonProprietaryName": "Insulin Lispro",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20181019",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA209196",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "INSULIN LISPRO",
"StrengthNumber": "100",
"StrengthUnit": "U/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [Chemical/Ingredient]",
"Status": "Active",
"LastUpdate": "2025-06-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181019",
"SamplePackage": "N",
"IndicationAndUsage": "ADMELOG is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.",
"Description": "Insulin lispro is a rapid-acting human insulin analog produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin lispro differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. Insulin lispro has a molecular weight of 5808 Da, identical to that of human insulin. ADMELOG (insulin lispro) injection is a sterile, aqueous, clear, and colorless solution for subcutaneous or intravenous use. Each mL of ADMELOG contains 100 units of insulin lispro, and the inactive ingredients: dibasic sodium phosphate (1.88 mg), glycerin (16 mg), metacresol (3.15 mg), zinc oxide (content adjusted to provide 0.0197 mg zinc ion), and Water for Injection, USP. Insulin lispro has a pH of 7.0 to 7.8. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. ADMELOG is latex free."
},
{
"NDCCode": "0169-1833-02",
"PackageDescription": "1 VIAL in 1 CARTON (0169-1833-02) > 10 mL in 1 VIAL",
"NDC11Code": "00169-1833-02",
"ProductNDC": "0169-1833",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Novolin",
"ProprietaryNameSuffix": "R",
"NonProprietaryName": "Human Insulin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "19910625",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA019938",
"LabelerName": "Novo Nordisk",
"SubstanceName": "INSULIN HUMAN",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin [CS], Insulin [EPC]",
"Status": "Active",
"LastUpdate": "2022-12-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19910625",
"SamplePackage": "N",
"IndicationAndUsage": "NOVOLIN R is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.",
"Description": "Insulin human is a short-acting human insulin produced by recombinant DNA technology, utilizing Saccharomyces cerevisiae (baker’s yeast) as the production organism and has the empirical formula C257H383N65O77S6 with a molecular weight of 5808 Da. Figure 1: Structural formula of NOVOLIN R. NOVOLIN R (insulin human) injection is a sterile, clear and colorless solution for subcutaneous or intravenous use. Each mililiter of NOVOLIN R contains 100 units of insulin human, and glycerin (16 mg), metacresol (3 mg), zinc (approximately 21 mcg/mL) and Water for Injection. Hydrochloric acid 2N and sodium hydroxide 2N may be added during manufacture to adjust pH. The pH is 7.0 to 7.8."
},
{
"NDCCode": "0169-1833-11",
"PackageDescription": "1 VIAL in 1 CARTON (0169-1833-11) > 10 mL in 1 VIAL",
"NDC11Code": "00169-1833-11",
"ProductNDC": "0169-1833",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Novolin",
"ProprietaryNameSuffix": "R",
"NonProprietaryName": "Human Insulin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "19910625",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA019938",
"LabelerName": "Novo Nordisk",
"SubstanceName": "INSULIN HUMAN",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin [CS], Insulin [EPC]",
"Status": "Active",
"LastUpdate": "2022-12-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19910625",
"SamplePackage": "N",
"IndicationAndUsage": "NOVOLIN R is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.",
"Description": "Insulin human is a short-acting human insulin produced by recombinant DNA technology, utilizing Saccharomyces cerevisiae (baker’s yeast) as the production organism and has the empirical formula C257H383N65O77S6 with a molecular weight of 5808 Da. Figure 1: Structural formula of NOVOLIN R. NOVOLIN R (insulin human) injection is a sterile, clear and colorless solution for subcutaneous or intravenous use. Each mililiter of NOVOLIN R contains 100 units of insulin human, and glycerin (16 mg), metacresol (3 mg), zinc (approximately 21 mcg/mL) and Water for Injection. Hydrochloric acid 2N and sodium hydroxide 2N may be added during manufacture to adjust pH. The pH is 7.0 to 7.8."
},
{
"NDCCode": "0169-1834-02",
"PackageDescription": "1 VIAL in 1 CARTON (0169-1834-02) > 10 mL in 1 VIAL",
"NDC11Code": "00169-1834-02",
"ProductNDC": "0169-1834",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Novolin",
"ProprietaryNameSuffix": "N",
"NonProprietaryName": "Human Insulin",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "19910701",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA019959",
"LabelerName": "Novo Nordisk",
"SubstanceName": "INSULIN HUMAN",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin [CS], Insulin [EPC]",
"Status": "Active",
"LastUpdate": "2022-12-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19910701",
"SamplePackage": "N",
"IndicationAndUsage": "NOVOLIN N is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.",
"Description": "Insulin isophane human is produced by recombinant DNA technology, utilizing Saccharomyces cerevisiae (baker’s yeast) as the production organism. Insulin isophane human is a suspension of crystals produced from combining human insulin and protamine sulfate under appropriate conditions for crystal formation. The amino acid sequence of insulin isophane human is identical to human insulin and has the empirical formula C257H383N65O77S6 and a molecular weight of 5808 Da. Figure 1: Structural formula of human insulin. NOVOLIN N (insulin isophane human) injectable suspension is an intermediate acting human insulin. It is a sterile, white and cloudy suspension that contains insulin isophane human suspension (NPH) for subcutaneous use. Each milliliter of Novolin N contains 100 units of insulin human, dibasic sodium phosphate (1.9 mg), glycerin (16 mg), metacresol (1.5 mg), phenol (0.65 mg), protamine sulfate (approximately 0.35 mg), zinc (33.5 mcg for the vial or 33.2 mcg for the FlexPen), and Water for Injection. Hydrochloric acid 2N and sodium hydroxide 2N may be added to adjust the pH. The pH is 7.1 to 7.5."
},
{
"NDCCode": "0169-1834-11",
"PackageDescription": "1 VIAL in 1 CARTON (0169-1834-11) > 10 mL in 1 VIAL",
"NDC11Code": "00169-1834-11",
"ProductNDC": "0169-1834",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Novolin",
"ProprietaryNameSuffix": "N",
"NonProprietaryName": "Human Insulin",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "19910701",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA019959",
"LabelerName": "Novo Nordisk",
"SubstanceName": "INSULIN HUMAN",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin [CS], Insulin [EPC]",
"Status": "Active",
"LastUpdate": "2022-12-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19910701",
"SamplePackage": "N",
"IndicationAndUsage": "NOVOLIN N is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.",
"Description": "Insulin isophane human is produced by recombinant DNA technology, utilizing Saccharomyces cerevisiae (baker’s yeast) as the production organism. Insulin isophane human is a suspension of crystals produced from combining human insulin and protamine sulfate under appropriate conditions for crystal formation. The amino acid sequence of insulin isophane human is identical to human insulin and has the empirical formula C257H383N65O77S6 and a molecular weight of 5808 Da. Figure 1: Structural formula of human insulin. NOVOLIN N (insulin isophane human) injectable suspension is an intermediate acting human insulin. It is a sterile, white and cloudy suspension that contains insulin isophane human suspension (NPH) for subcutaneous use. Each milliliter of Novolin N contains 100 units of insulin human, dibasic sodium phosphate (1.9 mg), glycerin (16 mg), metacresol (1.5 mg), phenol (0.65 mg), protamine sulfate (approximately 0.35 mg), zinc (33.5 mcg for the vial or 33.2 mcg for the FlexPen), and Water for Injection. Hydrochloric acid 2N and sodium hydroxide 2N may be added to adjust the pH. The pH is 7.1 to 7.5."
},
{
"NDCCode": "0169-1837-02",
"PackageDescription": "1 VIAL in 1 CARTON (0169-1837-02) > 10 mL in 1 VIAL",
"NDC11Code": "00169-1837-02",
"ProductNDC": "0169-1837",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Novolin",
"ProprietaryNameSuffix": "70/30",
"NonProprietaryName": "Human Insulin",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "19910625",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA019991",
"LabelerName": "Novo Nordisk",
"SubstanceName": "INSULIN HUMAN",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin [CS], Insulin [EPC]",
"Status": "Active",
"LastUpdate": "2022-12-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19910625",
"SamplePackage": "N",
"IndicationAndUsage": "NOVOLIN 70/30 is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. Limitations of Use. In NOVOLIN 70/30, the proportions of short-acting and intermediate-acting insulins are fixed and do not allow for basal versus prandial dose adjustments.",
"Description": "Insulin human is produced by recombinant DNA technology, utilizing Saccharomyces cerevisiae (baker’s yeast) as the production organism. The amino acid sequence of insulin human is identical to human insulin and has the empirical formula C257H383N65O77S6 and a molecular weight of 5808 Da. NOVOLIN 70/30 (insulin isophane human and insulin human) injectable suspension is a mixture of 70% of insulin isophane human, an intermediate-acting insulin, and 30% of insulin human, a short-acting insulin. NOVOLIN 70/30 is a suspension of crystals produced from combining insulin human and protamine sulfate under appropriate conditions for crystal formation and mixing with insulin human injection. Figure 1: Structural formula of human insulin. NOVOLIN 70/30 is a sterile, white and cloudy injectable suspension that contains insulin isophane human suspension (NPH) and insulin human injection (regular) for subcutaneous use. Each milliliter of NOVOLIN 70/30 contains 100 units of insulin human, dibasic sodium phosphate (1.9 mg), glycerin (16 mg), metacresol (1.5 mg), phenol (0.65 mg), protamine sulfate (approximately 0.25 mg), zinc (20.5 mcg/mL for the vial or 30.1 mcg for the FlexPen), and Water for Injection. Hydrochloric acid 2N and sodium hydroxide 2N may be added during manufacture to adjust the pH. The pH is 7.1-7.5."
},
{
"NDCCode": "0169-1837-11",
"PackageDescription": "1 VIAL in 1 CARTON (0169-1837-11) > 10 mL in 1 VIAL",
"NDC11Code": "00169-1837-11",
"ProductNDC": "0169-1837",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Novolin",
"ProprietaryNameSuffix": "70/30",
"NonProprietaryName": "Human Insulin",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "19910625",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA019991",
"LabelerName": "Novo Nordisk",
"SubstanceName": "INSULIN HUMAN",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin [CS], Insulin [EPC]",
"Status": "Active",
"LastUpdate": "2022-12-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19910625",
"SamplePackage": "N",
"IndicationAndUsage": "NOVOLIN 70/30 is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. Limitations of Use. In NOVOLIN 70/30, the proportions of short-acting and intermediate-acting insulins are fixed and do not allow for basal versus prandial dose adjustments.",
"Description": "Insulin human is produced by recombinant DNA technology, utilizing Saccharomyces cerevisiae (baker’s yeast) as the production organism. The amino acid sequence of insulin human is identical to human insulin and has the empirical formula C257H383N65O77S6 and a molecular weight of 5808 Da. NOVOLIN 70/30 (insulin isophane human and insulin human) injectable suspension is a mixture of 70% of insulin isophane human, an intermediate-acting insulin, and 30% of insulin human, a short-acting insulin. NOVOLIN 70/30 is a suspension of crystals produced from combining insulin human and protamine sulfate under appropriate conditions for crystal formation and mixing with insulin human injection. Figure 1: Structural formula of human insulin. NOVOLIN 70/30 is a sterile, white and cloudy injectable suspension that contains insulin isophane human suspension (NPH) and insulin human injection (regular) for subcutaneous use. Each milliliter of NOVOLIN 70/30 contains 100 units of insulin human, dibasic sodium phosphate (1.9 mg), glycerin (16 mg), metacresol (1.5 mg), phenol (0.65 mg), protamine sulfate (approximately 0.25 mg), zinc (20.5 mcg/mL for the vial or 30.1 mcg for the FlexPen), and Water for Injection. Hydrochloric acid 2N and sodium hydroxide 2N may be added during manufacture to adjust the pH. The pH is 7.1-7.5."
},
{
"NDCCode": "0169-3003-15",
"PackageDescription": "5 SYRINGE, PLASTIC in 1 CARTON (0169-3003-15) > 3 mL in 1 SYRINGE, PLASTIC (0169-3003-01) ",
"NDC11Code": "00169-3003-15",
"ProductNDC": "0169-3003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Novolin",
"ProprietaryNameSuffix": "R",
"NonProprietaryName": "Human Insulin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20190906",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA019938",
"LabelerName": "Novo Nordisk",
"SubstanceName": "INSULIN HUMAN",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin [CS], Insulin [EPC]",
"Status": "Active",
"LastUpdate": "2022-12-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190906",
"SamplePackage": "N",
"IndicationAndUsage": "NOVOLIN R is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.",
"Description": "Insulin human is a short-acting human insulin produced by recombinant DNA technology, utilizing Saccharomyces cerevisiae (baker’s yeast) as the production organism and has the empirical formula C257H383N65O77S6 with a molecular weight of 5808 Da. Figure 1: Structural formula of NOVOLIN R. NOVOLIN R (insulin human) injection is a sterile, clear and colorless solution for subcutaneous or intravenous use. Each mililiter of NOVOLIN R contains 100 units of insulin human, and glycerin (16 mg), metacresol (3 mg), zinc (approximately 21 mcg/mL) and Water for Injection. Hydrochloric acid 2N and sodium hydroxide 2N may be added during manufacture to adjust pH. The pH is 7.0 to 7.8."
},
{
"NDCCode": "0169-3003-25",
"PackageDescription": "5 SYRINGE, PLASTIC in 1 CARTON (0169-3003-25) > 3 mL in 1 SYRINGE, PLASTIC (0169-3003-12) ",
"NDC11Code": "00169-3003-25",
"ProductNDC": "0169-3003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Novolin",
"ProprietaryNameSuffix": "R",
"NonProprietaryName": "Human Insulin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20190906",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA019938",
"LabelerName": "Novo Nordisk",
"SubstanceName": "INSULIN HUMAN",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin [CS], Insulin [EPC]",
"Status": "Active",
"LastUpdate": "2022-12-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190906",
"SamplePackage": "N",
"IndicationAndUsage": "NOVOLIN R is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.",
"Description": "Insulin human is a short-acting human insulin produced by recombinant DNA technology, utilizing Saccharomyces cerevisiae (baker’s yeast) as the production organism and has the empirical formula C257H383N65O77S6 with a molecular weight of 5808 Da. Figure 1: Structural formula of NOVOLIN R. NOVOLIN R (insulin human) injection is a sterile, clear and colorless solution for subcutaneous or intravenous use. Each mililiter of NOVOLIN R contains 100 units of insulin human, and glycerin (16 mg), metacresol (3 mg), zinc (approximately 21 mcg/mL) and Water for Injection. Hydrochloric acid 2N and sodium hydroxide 2N may be added during manufacture to adjust pH. The pH is 7.0 to 7.8."
},
{
"NDCCode": "0169-3004-15",
"PackageDescription": "5 SYRINGE, PLASTIC in 1 CARTON (0169-3004-15) > 3 mL in 1 SYRINGE, PLASTIC (0169-3004-01) ",
"NDC11Code": "00169-3004-15",
"ProductNDC": "0169-3004",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Novolin",
"ProprietaryNameSuffix": "N",
"NonProprietaryName": "Human Insulin",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20190906",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA019959",
"LabelerName": "Novo Nordisk",
"SubstanceName": "INSULIN HUMAN",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin [CS], Insulin [EPC]",
"Status": "Active",
"LastUpdate": "2022-12-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190906",
"SamplePackage": "N",
"IndicationAndUsage": "NOVOLIN N is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.",
"Description": "Insulin isophane human is produced by recombinant DNA technology, utilizing Saccharomyces cerevisiae (baker’s yeast) as the production organism. Insulin isophane human is a suspension of crystals produced from combining human insulin and protamine sulfate under appropriate conditions for crystal formation. The amino acid sequence of insulin isophane human is identical to human insulin and has the empirical formula C257H383N65O77S6 and a molecular weight of 5808 Da. Figure 1: Structural formula of human insulin. NOVOLIN N (insulin isophane human) injectable suspension is an intermediate acting human insulin. It is a sterile, white and cloudy suspension that contains insulin isophane human suspension (NPH) for subcutaneous use. Each milliliter of Novolin N contains 100 units of insulin human, dibasic sodium phosphate (1.9 mg), glycerin (16 mg), metacresol (1.5 mg), phenol (0.65 mg), protamine sulfate (approximately 0.35 mg), zinc (33.5 mcg for the vial or 33.2 mcg for the FlexPen), and Water for Injection. Hydrochloric acid 2N and sodium hydroxide 2N may be added to adjust the pH. The pH is 7.1 to 7.5."
},
{
"NDCCode": "0169-3004-25",
"PackageDescription": "5 SYRINGE, PLASTIC in 1 CARTON (0169-3004-25) > 3 mL in 1 SYRINGE, PLASTIC (0169-3004-12) ",
"NDC11Code": "00169-3004-25",
"ProductNDC": "0169-3004",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Novolin",
"ProprietaryNameSuffix": "N",
"NonProprietaryName": "Human Insulin",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20190906",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA019959",
"LabelerName": "Novo Nordisk",
"SubstanceName": "INSULIN HUMAN",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin [CS], Insulin [EPC]",
"Status": "Active",
"LastUpdate": "2022-12-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190906",
"SamplePackage": "N",
"IndicationAndUsage": "NOVOLIN N is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.",
"Description": "Insulin isophane human is produced by recombinant DNA technology, utilizing Saccharomyces cerevisiae (baker’s yeast) as the production organism. Insulin isophane human is a suspension of crystals produced from combining human insulin and protamine sulfate under appropriate conditions for crystal formation. The amino acid sequence of insulin isophane human is identical to human insulin and has the empirical formula C257H383N65O77S6 and a molecular weight of 5808 Da. Figure 1: Structural formula of human insulin. NOVOLIN N (insulin isophane human) injectable suspension is an intermediate acting human insulin. It is a sterile, white and cloudy suspension that contains insulin isophane human suspension (NPH) for subcutaneous use. Each milliliter of Novolin N contains 100 units of insulin human, dibasic sodium phosphate (1.9 mg), glycerin (16 mg), metacresol (1.5 mg), phenol (0.65 mg), protamine sulfate (approximately 0.35 mg), zinc (33.5 mcg for the vial or 33.2 mcg for the FlexPen), and Water for Injection. Hydrochloric acid 2N and sodium hydroxide 2N may be added to adjust the pH. The pH is 7.1 to 7.5."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>54868-5808-0</NDCCode>
<PackageDescription>10 CARTRIDGE in 1 BOX (54868-5808-0) > 1 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>54868-5808-00</NDC11Code>
<ProductNDC>54868-5808</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Demerol</ProprietaryName>
<NonProprietaryName>Meperidine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20070821</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021171</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>MEPERIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For the relief of moderate to severe pain. For preoperative medication. For support of anesthesia. For obstetrical analgesia.</IndicationAndUsage>
<Description>Meperidine hydrochloride is ethyl 1-methyl-4-phenylisonipecotate hydrochloride, a white crystalline substance with a melting point of 186°C to 189°C. It is readily soluble in water and has a neutral reaction and a slightly bitter taste. The solution is not decomposed by a short period of boiling. DEMEROL injectable is supplied in Carpuject with luer lock of 2.5% (25 mg/1 mL), 5% (50 mg/1 mL), 7.5% (75 mg/1 mL), and 10% (100 mg/1 mL). Uni-Amp unit dose pak-ampuls of 5% solution (25 mg/0.5 mL), (50 mg/1 mL), (75 mg/1.5 mL), (100 mg/2 mL), and 10% solution (100 mg/1 mL). Multiple-dose vials of 5% and 10% solutions contain metacresol 0.1% as preservative. The pH of DEMEROL solutions is adjusted between 3.5 and 6 with sodium hydroxide or hydrochloric acid. DEMEROL, brand of meperidine hydrochloride, 5 percent solution has a specific gravity of 1.0086 at 20°C and 10 percent solution, a specific gravity of 1.0165 at 20°C.</Description>
</NDC>
<NDC>
<NDCCode>50090-5808-0</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (50090-5808-0) </PackageDescription>
<NDC11Code>50090-5808-00</NDC11Code>
<ProductNDC>50090-5808</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gemfibrozil</ProprietaryName>
<NonProprietaryName>Gemfibrozil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214603</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>GEMFIBROZIL</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>PPAR alpha [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211015</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gemfibrozil Tablets are indicated as adjunctive therapy to diet for: 1 Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dL are unlikely to present a risk of pancreatitis. Gemfibrozil therapy may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. It is recognized that some Type IV patients with triglycerides under 1000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of gemfibrozil therapy on the risk of pancreatitis in such situations has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia., 2 Reducing the risk of developing coronary heart disease only in Type IIb patients without history of or symptoms of existing coronary heart disease who have had an inadequate response to weight loss, dietary therapy, exercise, and other pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to reduce LDL- and raise HDL-cholesterol) and who have the following triad of lipid abnormalities: low HDL-cholesterol levels in addition to elevated LDL-cholesterol and elevated triglycerides (see WARNINGS, PRECAUTIONS, and CLINICAL PHARMACOLOGY). The National Cholesterol Education Program has defined a serum HDL-cholesterol value that is consistently below 35 mg/dL as constituting an independent risk factor for coronary heart disease. Patients with significantly elevated triglycerides should be closely observed when treated with gemfibrozil. In some patients with high triglyceride levels, treatment with gemfibrozil is associated with a significant increase in LDL-cholesterol. BECAUSE OF POTENTIAL TOXICITY SUCH AS MALIGNANCY, GALLBLADDER DISEASE, ABDOMINAL PAIN LEADING TO APPENDECTOMY AND OTHER ABDOMINAL SURGERIES, AN INCREASED INCIDENCE IN NON-CORONARY MORTALITY, AND THE 44% RELATIVE INCREASE DURING THE TRIAL PERIOD IN AGE-ADJUSTED ALL-CAUSE MORTALITY SEEN WITH THE CHEMICALLY AND PHARMACOLOGICALLY RELATED DRUG, CLOFIBRATE, THE POTENTIAL BENEFIT OF GEMFIBROZIL IN TREATING TYPE IIA PATIENTS WITH ELEVATIONS OF LDL-CHOLESTEROL ONLY IS NOT LIKELY TO OUTWEIGH THE RISKS. GEMFIBROZIL IS ALSO NOT INDICATED FOR THE TREATMENT OF PATIENTS WITH LOW HDL-CHOLESTEROL AS THEIR ONLY LIPID ABNORMALITY.</IndicationAndUsage>
<Description>Gemfibrozil, USP is a lipid regulating agent. It is available as tablets for oral administration. Each tablet contains 600 mg gemfibrozil. Each tablet also contains the following inactive ingredients: pregelatinized starch, microcrystalline cellulose, povidone, colloidal silicon dioxide, polysorbate, croscarmellose sodium, calcium stearate, hydroxypropyl cellulose, and talc. The chemical name is 5-(2,5-dimethylphenoxy)-2,2-dimethylpentanoic acid, with the following structural formula. The empirical formula is C15H22O3 and the molecular weight is 250.35; the solubility in water and acid is 0.0019% and in dilute base it is greater than 1%. The melting point is 58° – 61°C. Gemfibrozil is a white solid which is stable under ordinary conditions.</Description>
</NDC>
<NDC>
<NDCCode>54868-3619-0</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (54868-3619-0) > 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>54868-3619-00</NDC11Code>
<ProductNDC>54868-3619</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Humulin R</ProprietaryName>
<NonProprietaryName>Insulin Human</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>19950727</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018780</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>INSULIN HUMAN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Humulin R U-100 is indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 1 and type 2 diabetes mellitus. Humulin R U-100 may be administered intravenously under proper medical supervision in a clinical setting for glycemic control (see DOSAGE AND ADMINISTRATION and Storage).</IndicationAndUsage>
<Description>Humulin® R U-100 is a polypeptide hormone structurally identical to human insulin synthesized through rDNA technology in a special non-disease-producing laboratory strain of Escherichia coli bacteria. Humulin R U-100 has the empirical formula C257H383N65O77S6 and a molecular weight of 5808. Humulin R U-100 is a sterile, clear, aqueous, and colorless solution that contains human insulin (rDNA origin) 100 units/mL, glycerin 16 mg/mL and metacresol 2.5 mg/mL, endogenous zinc (approximately 0.015 mg/100 units) and water for injection. The pH is 7.0 to 7.8. Sodium hydroxide and/or hydrochloric acid may be added during manufacture to adjust the pH. Adequate insulin dosage permits patients with diabetes to effectively utilize carbohydrates, proteins and fats. Regardless of dose strength, insulin enables carbohydrate metabolism to occur and thus to prevent the production of ketone bodies by the liver. Some patients develop severe insulin resistance such that daily doses of several hundred units of insulin or more are required.</Description>
</NDC>
<NDC>
<NDCCode>54868-4381-0</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (54868-4381-0) > 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>54868-4381-00</NDC11Code>
<ProductNDC>54868-4381</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Humalog</ProprietaryName>
<ProprietaryNameSuffix>Mix75/25</ProprietaryNameSuffix>
<NonProprietaryName>Insulin Lispro</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20050222</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021017</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>INSULIN LISPRO</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin [Chemical/Ingredient],Insulin Analog [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Humalog Mix75/25, a mixture of 75% insulin lispro protamine suspension and 25% insulin lispro injection, (rDNA origin), is indicated in the treatment of patients with diabetes mellitus for the control of hyperglycemia. Humalog Mix75/25 has a more rapid onset of glucose–lowering activity compared with Humulin 70/30 while having a similar duration of action. This profile is achieved by combining the rapid onset of Humalog with the intermediate action of insulin lispro protamine suspension.</IndicationAndUsage>
<Description>Humalog® Mix75/25 [75% insulin lispro protamine suspension and 25% insulin lispro injection, (rDNA origin)] is a mixture of insulin lispro solution, a rapid–acting blood glucose–lowering agent and insulin lispro protamine suspension, an intermediate–acting blood glucose–lowering agent. Chemically, insulin lispro is Lys(B28), Pro(B29) human insulin analog, created when the amino acids at positions 28 and 29 on the insulin B–chain are reversed. Insulin lispro is synthesized in a special non–pathogenic laboratory strain of Escherichia coli bacteria that has been genetically altered to produce insulin lispro. Insulin lispro protamine suspension (NPL component) is a suspension of crystals produced from combining insulin lispro and protamine sulfate under appropriate conditions for crystal formation. Insulin lispro has the following primary structure. Insulin lispro has the empirical formula C257H383N65O77S6 and a molecular weight of 5808, both identical to that of human insulin. Humalog Mix75/25 vials and Pens contain a sterile suspension of insulin lispro protamine suspension mixed with soluble insulin lispro for use as an injection. Each milliliter of Humalog Mix75/25 injection contains insulin lispro 100 units, 0.28 mg protamine sulfate, 16 mg glycerin, 3.78 mg dibasic sodium phosphate, 1.76 mg Metacresol, zinc oxide content adjusted to provide 0.025 mg zinc ion, 0.715 mg phenol, and Water for Injection. Humalog Mix75/25 has a pH of 7.0 to 7.8. Hydrochloric acid 10% and/or sodium hydroxide 10% may have been added to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>54868-5108-0</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (54868-5108-0) > 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>54868-5108-00</NDC11Code>
<ProductNDC>54868-5108</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Humalog</ProprietaryName>
<NonProprietaryName>Insulin Lispro</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20050502</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020563</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>INSULIN LISPRO</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin [Chemical/Ingredient],Insulin Analog [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>HUMALOG is an insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus.</IndicationAndUsage>
<Description>HUMALOG® (insulin lispro injection, USP [rDNA origin]) is a rapid-acting human insulin analog used to lower blood glucose. Insulin lispro is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin lispro differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. Chemically, it is Lys(B28), Pro(B29) human insulin analog and has the empirical formula C257H383N65O77S6 and a molecular weight of 5808, both identical to that of human insulin. HUMALOG has the following primary structure:. HUMALOG is a sterile, aqueous, clear, and colorless solution. Each milliliter of HUMALOG contains insulin lispro 100 units, 16 mg glycerin, 1.88 mg dibasic sodium phosphate, 3.15 mg Metacresol, zinc oxide content adjusted to provide 0.0197 mg zinc ion, trace amounts of phenol, and Water for Injection. Insulin lispro has a pH of 7.0 to 7.8. The pH is adjusted by addition of aqueous solutions of hydrochloric acid 10% and/or sodium hydroxide 10%.</Description>
</NDC>
<NDC>
<NDCCode>54868-5836-0</NDCCode>
<PackageDescription>5 CARTRIDGE in 1 CARTON (54868-5836-0) > 3 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>54868-5836-00</NDC11Code>
<ProductNDC>54868-5836</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Humalog</ProprietaryName>
<ProprietaryNameSuffix>Cartridge</ProprietaryNameSuffix>
<NonProprietaryName>Insulin Lispro</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20071203</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020563</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>INSULIN LISPRO</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin [Chemical/Ingredient],Insulin Analog [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>HUMALOG is an insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus.</IndicationAndUsage>
<Description>HUMALOG® (insulin lispro injection, USP [rDNA origin]) is a rapid-acting human insulin analog used to lower blood glucose. Insulin lispro is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin lispro differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. Chemically, it is Lys(B28), Pro(B29) human insulin analog and has the empirical formula C257H383N65O77S6 and a molecular weight of 5808, both identical to that of human insulin. HUMALOG has the following primary structure:. HUMALOG is a sterile, aqueous, clear, and colorless solution. Each milliliter of HUMALOG contains insulin lispro 100 units, 16 mg glycerin, 1.88 mg dibasic sodium phosphate, 3.15 mg Metacresol, zinc oxide content adjusted to provide 0.0197 mg zinc ion, trace amounts of phenol, and Water for Injection. Insulin lispro has a pH of 7.0 to 7.8. The pH is adjusted by addition of aqueous solutions of hydrochloric acid 10% and/or sodium hydroxide 10%.</Description>
</NDC>
<NDC>
<NDCCode>54868-5899-0</NDCCode>
<PackageDescription>5 SYRINGE in 1 CARTON (54868-5899-0) > 3 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>54868-5899-00</NDC11Code>
<ProductNDC>54868-5899</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Humalog</ProprietaryName>
<ProprietaryNameSuffix>Pen</ProprietaryNameSuffix>
<NonProprietaryName>Insulin Lispro</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20080512</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020563</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>INSULIN LISPRO</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin [Chemical/Ingredient],Insulin Analog [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>HUMALOG is an insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus.</IndicationAndUsage>
<Description>HUMALOG® (insulin lispro injection, USP [rDNA origin]) is a rapid-acting human insulin analog used to lower blood glucose. Insulin lispro is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin lispro differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. Chemically, it is Lys(B28), Pro(B29) human insulin analog and has the empirical formula C257H383N65O77S6 and a molecular weight of 5808, both identical to that of human insulin. HUMALOG has the following primary structure:. HUMALOG is a sterile, aqueous, clear, and colorless solution. Each milliliter of HUMALOG contains insulin lispro 100 units, 16 mg glycerin, 1.88 mg dibasic sodium phosphate, 3.15 mg Metacresol, zinc oxide content adjusted to provide 0.0197 mg zinc ion, trace amounts of phenol, and Water for Injection. Insulin lispro has a pH of 7.0 to 7.8. The pH is adjusted by addition of aqueous solutions of hydrochloric acid 10% and/or sodium hydroxide 10%.</Description>
</NDC>
<NDC>
<NDCCode>0002-7726-05</NDCCode>
<PackageDescription>5 CARTRIDGE in 1 CARTON (0002-7726-05) / 3 mL in 1 CARTRIDGE (0002-7726-01) </PackageDescription>
<NDC11Code>00002-7726-05</NDC11Code>
<ProductNDC>0002-7726</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lyumjev</ProprietaryName>
<NonProprietaryName>Insulin Lispro-aabc</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20200615</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761109</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>INSULIN LISPRO</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [Chemical/Ingredient]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LYUMJEV® is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin lispro-aabc is a rapid-acting human insulin analog used to lower blood glucose. Insulin lispro-aabc is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin lispro-aabc differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. Chemically, it is Lys(B28), Pro(B29) human insulin analog and has the empirical formula C257H383N65O77S6 and a molecular weight of 5808 daltons, both identical to that of human insulin. Insulin lispro-aabc has the following primary structure:. LYUMJEV (insulin lispro-aabc) injection is a sterile, aqueous, clear, and colorless solution for subcutaneous or intravenous administration. Each mL of LYUMJEV U-100 contains 100 units of insulin lispro-aabc and the inactive ingredients: glycerol (12.1 mg), magnesium chloride hexahydrate (1.02 mg), metacresol (3.15 mg), sodium citrate dihydrate (4.41 mg), treprostinil sodium (1.06 mcg), zinc oxide (content adjusted to provide 39 mcg zinc ion), and Water for Injection, USP. Each mL of LYUMJEV U-200 contains 200 units of insulin lispro-aabc and the inactive ingredients: glycerol (12.1 mg), magnesium chloride hexahydrate (1.02 mg), metacresol (3.15 mg), sodium citrate dihydrate (4.41 mg), treprostinil sodium (1.06 mcg), zinc oxide (content adjusted to provide 52 mcg zinc ion), and Water for Injection, USP. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH. LYUMJEV has a pH of 7.0 to 7.8.</Description>
</NDC>
<NDC>
<NDCCode>0002-7728-01</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (0002-7728-01) / 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00002-7728-01</NDC11Code>
<ProductNDC>0002-7728</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lyumjev</ProprietaryName>
<NonProprietaryName>Insulin Lispro-aabc</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20200615</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761109</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>INSULIN LISPRO</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [Chemical/Ingredient]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LYUMJEV® is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin lispro-aabc is a rapid-acting human insulin analog used to lower blood glucose. Insulin lispro-aabc is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin lispro-aabc differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. Chemically, it is Lys(B28), Pro(B29) human insulin analog and has the empirical formula C257H383N65O77S6 and a molecular weight of 5808 daltons, both identical to that of human insulin. Insulin lispro-aabc has the following primary structure:. LYUMJEV (insulin lispro-aabc) injection is a sterile, aqueous, clear, and colorless solution for subcutaneous or intravenous administration. Each mL of LYUMJEV U-100 contains 100 units of insulin lispro-aabc and the inactive ingredients: glycerol (12.1 mg), magnesium chloride hexahydrate (1.02 mg), metacresol (3.15 mg), sodium citrate dihydrate (4.41 mg), treprostinil sodium (1.06 mcg), zinc oxide (content adjusted to provide 39 mcg zinc ion), and Water for Injection, USP. Each mL of LYUMJEV U-200 contains 200 units of insulin lispro-aabc and the inactive ingredients: glycerol (12.1 mg), magnesium chloride hexahydrate (1.02 mg), metacresol (3.15 mg), sodium citrate dihydrate (4.41 mg), treprostinil sodium (1.06 mcg), zinc oxide (content adjusted to provide 52 mcg zinc ion), and Water for Injection, USP. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH. LYUMJEV has a pH of 7.0 to 7.8.</Description>
</NDC>
<NDC>
<NDCCode>0002-7728-99</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (0002-7728-99) / 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00002-7728-99</NDC11Code>
<ProductNDC>0002-7728</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lyumjev</ProprietaryName>
<NonProprietaryName>Insulin Lispro-aabc</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20200615</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761109</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>INSULIN LISPRO</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200615</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>LYUMJEV® is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin lispro-aabc is a rapid-acting human insulin analog used to lower blood glucose. Insulin lispro-aabc is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin lispro-aabc differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. Chemically, it is Lys(B28), Pro(B29) human insulin analog and has the empirical formula C257H383N65O77S6 and a molecular weight of 5808 daltons, both identical to that of human insulin. Insulin lispro-aabc has the following primary structure:. LYUMJEV (insulin lispro-aabc) injection is a sterile, aqueous, clear, and colorless solution for subcutaneous or intravenous administration. Each mL of LYUMJEV U-100 contains 100 units of insulin lispro-aabc and the inactive ingredients: glycerol (12.1 mg), magnesium chloride hexahydrate (1.02 mg), metacresol (3.15 mg), sodium citrate dihydrate (4.41 mg), treprostinil sodium (1.06 mcg), zinc oxide (content adjusted to provide 39 mcg zinc ion), and Water for Injection, USP. Each mL of LYUMJEV U-200 contains 200 units of insulin lispro-aabc and the inactive ingredients: glycerol (12.1 mg), magnesium chloride hexahydrate (1.02 mg), metacresol (3.15 mg), sodium citrate dihydrate (4.41 mg), treprostinil sodium (1.06 mcg), zinc oxide (content adjusted to provide 52 mcg zinc ion), and Water for Injection, USP. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH. LYUMJEV has a pH of 7.0 to 7.8.</Description>
</NDC>
<NDC>
<NDCCode>0002-8207-05</NDCCode>
<PackageDescription>5 SYRINGE in 1 CARTON (0002-8207-05) / 3 mL in 1 SYRINGE (0002-8207-01) </PackageDescription>
<NDC11Code>00002-8207-05</NDC11Code>
<ProductNDC>0002-8207</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lyumjev</ProprietaryName>
<ProprietaryNameSuffix>Kwikpen</ProprietaryNameSuffix>
<NonProprietaryName>Insulin Lispro-aabc</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20200615</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761109</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>INSULIN LISPRO</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [Chemical/Ingredient]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LYUMJEV® is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin lispro-aabc is a rapid-acting human insulin analog used to lower blood glucose. Insulin lispro-aabc is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin lispro-aabc differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. Chemically, it is Lys(B28), Pro(B29) human insulin analog and has the empirical formula C257H383N65O77S6 and a molecular weight of 5808 daltons, both identical to that of human insulin. Insulin lispro-aabc has the following primary structure:. LYUMJEV (insulin lispro-aabc) injection is a sterile, aqueous, clear, and colorless solution for subcutaneous or intravenous administration. Each mL of LYUMJEV U-100 contains 100 units of insulin lispro-aabc and the inactive ingredients: glycerol (12.1 mg), magnesium chloride hexahydrate (1.02 mg), metacresol (3.15 mg), sodium citrate dihydrate (4.41 mg), treprostinil sodium (1.06 mcg), zinc oxide (content adjusted to provide 39 mcg zinc ion), and Water for Injection, USP. Each mL of LYUMJEV U-200 contains 200 units of insulin lispro-aabc and the inactive ingredients: glycerol (12.1 mg), magnesium chloride hexahydrate (1.02 mg), metacresol (3.15 mg), sodium citrate dihydrate (4.41 mg), treprostinil sodium (1.06 mcg), zinc oxide (content adjusted to provide 52 mcg zinc ion), and Water for Injection, USP. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH. LYUMJEV has a pH of 7.0 to 7.8.</Description>
</NDC>
<NDC>
<NDCCode>0002-8207-61</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (0002-8207-61) / 3 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>00002-8207-61</NDC11Code>
<ProductNDC>0002-8207</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lyumjev</ProprietaryName>
<ProprietaryNameSuffix>Kwikpen</ProprietaryNameSuffix>
<NonProprietaryName>Insulin Lispro-aabc</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20200615</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761109</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>INSULIN LISPRO</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200615</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>LYUMJEV® is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin lispro-aabc is a rapid-acting human insulin analog used to lower blood glucose. Insulin lispro-aabc is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin lispro-aabc differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. Chemically, it is Lys(B28), Pro(B29) human insulin analog and has the empirical formula C257H383N65O77S6 and a molecular weight of 5808 daltons, both identical to that of human insulin. Insulin lispro-aabc has the following primary structure:. LYUMJEV (insulin lispro-aabc) injection is a sterile, aqueous, clear, and colorless solution for subcutaneous or intravenous administration. Each mL of LYUMJEV U-100 contains 100 units of insulin lispro-aabc and the inactive ingredients: glycerol (12.1 mg), magnesium chloride hexahydrate (1.02 mg), metacresol (3.15 mg), sodium citrate dihydrate (4.41 mg), treprostinil sodium (1.06 mcg), zinc oxide (content adjusted to provide 39 mcg zinc ion), and Water for Injection, USP. Each mL of LYUMJEV U-200 contains 200 units of insulin lispro-aabc and the inactive ingredients: glycerol (12.1 mg), magnesium chloride hexahydrate (1.02 mg), metacresol (3.15 mg), sodium citrate dihydrate (4.41 mg), treprostinil sodium (1.06 mcg), zinc oxide (content adjusted to provide 52 mcg zinc ion), and Water for Injection, USP. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH. LYUMJEV has a pH of 7.0 to 7.8.</Description>
</NDC>
<NDC>
<NDCCode>0002-8228-27</NDCCode>
<PackageDescription>2 SYRINGE in 1 CARTON (0002-8228-27) / 3 mL in 1 SYRINGE (0002-8228-01) </PackageDescription>
<NDC11Code>00002-8228-27</NDC11Code>
<ProductNDC>0002-8228</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lyumjev</ProprietaryName>
<ProprietaryNameSuffix>Kwikpen</ProprietaryNameSuffix>
<NonProprietaryName>Insulin Lispro-aabc</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20200615</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761109</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>INSULIN LISPRO</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [Chemical/Ingredient]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LYUMJEV® is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin lispro-aabc is a rapid-acting human insulin analog used to lower blood glucose. Insulin lispro-aabc is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin lispro-aabc differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. Chemically, it is Lys(B28), Pro(B29) human insulin analog and has the empirical formula C257H383N65O77S6 and a molecular weight of 5808 daltons, both identical to that of human insulin. Insulin lispro-aabc has the following primary structure:. LYUMJEV (insulin lispro-aabc) injection is a sterile, aqueous, clear, and colorless solution for subcutaneous or intravenous administration. Each mL of LYUMJEV U-100 contains 100 units of insulin lispro-aabc and the inactive ingredients: glycerol (12.1 mg), magnesium chloride hexahydrate (1.02 mg), metacresol (3.15 mg), sodium citrate dihydrate (4.41 mg), treprostinil sodium (1.06 mcg), zinc oxide (content adjusted to provide 39 mcg zinc ion), and Water for Injection, USP. Each mL of LYUMJEV U-200 contains 200 units of insulin lispro-aabc and the inactive ingredients: glycerol (12.1 mg), magnesium chloride hexahydrate (1.02 mg), metacresol (3.15 mg), sodium citrate dihydrate (4.41 mg), treprostinil sodium (1.06 mcg), zinc oxide (content adjusted to provide 52 mcg zinc ion), and Water for Injection, USP. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH. LYUMJEV has a pH of 7.0 to 7.8.</Description>
</NDC>
<NDC>
<NDCCode>0002-8235-05</NDCCode>
<PackageDescription>5 SYRINGE in 1 CARTON (0002-8235-05) / 3 mL in 1 SYRINGE (0002-8235-01) </PackageDescription>
<NDC11Code>00002-8235-05</NDC11Code>
<ProductNDC>0002-8235</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lyumjev</ProprietaryName>
<ProprietaryNameSuffix>Tempo Pen</ProprietaryNameSuffix>
<NonProprietaryName>Insulin Lispro-aabc</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20200615</StartMarketingDate>
<EndMarketingDate>20271106</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761109</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>INSULIN LISPRO</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [Chemical/Ingredient]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220929</StartMarketingDatePackage>
<EndMarketingDatePackage>20271106</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LYUMJEV® is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin lispro-aabc is a rapid-acting human insulin analog used to lower blood glucose. Insulin lispro-aabc is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin lispro-aabc differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. Chemically, it is Lys(B28), Pro(B29) human insulin analog and has the empirical formula C257H383N65O77S6 and a molecular weight of 5808 daltons, both identical to that of human insulin. Insulin lispro-aabc has the following primary structure:. LYUMJEV (insulin lispro-aabc) injection is a sterile, aqueous, clear, and colorless solution for subcutaneous or intravenous administration. Each mL of LYUMJEV U-100 contains 100 units of insulin lispro-aabc and the inactive ingredients: glycerol (12.1 mg), magnesium chloride hexahydrate (1.02 mg), metacresol (3.15 mg), sodium citrate dihydrate (4.41 mg), treprostinil sodium (1.06 mcg), zinc oxide (content adjusted to provide 39 mcg zinc ion), and Water for Injection, USP. Each mL of LYUMJEV U-200 contains 200 units of insulin lispro-aabc and the inactive ingredients: glycerol (12.1 mg), magnesium chloride hexahydrate (1.02 mg), metacresol (3.15 mg), sodium citrate dihydrate (4.41 mg), treprostinil sodium (1.06 mcg), zinc oxide (content adjusted to provide 52 mcg zinc ion), and Water for Injection, USP. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH. LYUMJEV has a pH of 7.0 to 7.8.</Description>
</NDC>
<NDC>
<NDCCode>0002-8235-99</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (0002-8235-99) / 3 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>00002-8235-99</NDC11Code>
<ProductNDC>0002-8235</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lyumjev</ProprietaryName>
<ProprietaryNameSuffix>Tempo Pen</ProprietaryNameSuffix>
<NonProprietaryName>Insulin Lispro-aabc</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20200615</StartMarketingDate>
<EndMarketingDate>20271106</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761109</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>INSULIN LISPRO</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [Chemical/Ingredient]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20240110</StartMarketingDatePackage>
<EndMarketingDatePackage>20271106</EndMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>LYUMJEV® is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin lispro-aabc is a rapid-acting human insulin analog used to lower blood glucose. Insulin lispro-aabc is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin lispro-aabc differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. Chemically, it is Lys(B28), Pro(B29) human insulin analog and has the empirical formula C257H383N65O77S6 and a molecular weight of 5808 daltons, both identical to that of human insulin. Insulin lispro-aabc has the following primary structure:. LYUMJEV (insulin lispro-aabc) injection is a sterile, aqueous, clear, and colorless solution for subcutaneous or intravenous administration. Each mL of LYUMJEV U-100 contains 100 units of insulin lispro-aabc and the inactive ingredients: glycerol (12.1 mg), magnesium chloride hexahydrate (1.02 mg), metacresol (3.15 mg), sodium citrate dihydrate (4.41 mg), treprostinil sodium (1.06 mcg), zinc oxide (content adjusted to provide 39 mcg zinc ion), and Water for Injection, USP. Each mL of LYUMJEV U-200 contains 200 units of insulin lispro-aabc and the inactive ingredients: glycerol (12.1 mg), magnesium chloride hexahydrate (1.02 mg), metacresol (3.15 mg), sodium citrate dihydrate (4.41 mg), treprostinil sodium (1.06 mcg), zinc oxide (content adjusted to provide 52 mcg zinc ion), and Water for Injection, USP. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH. LYUMJEV has a pH of 7.0 to 7.8.</Description>
</NDC>
<NDC>
<NDCCode>0002-8351-05</NDCCode>
<PackageDescription>5 SYRINGE in 1 CARTON (0002-8351-05) / 3 mL in 1 SYRINGE (0002-8351-01) </PackageDescription>
<NDC11Code>00002-8351-05</NDC11Code>
<ProductNDC>0002-8351</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lyumjev</ProprietaryName>
<ProprietaryNameSuffix>Junior Kwikpen</ProprietaryNameSuffix>
<NonProprietaryName>Insulin Lispro-aabc</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20200615</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761109</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>INSULIN LISPRO</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [Chemical/Ingredient]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LYUMJEV® is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin lispro-aabc is a rapid-acting human insulin analog used to lower blood glucose. Insulin lispro-aabc is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin lispro-aabc differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. Chemically, it is Lys(B28), Pro(B29) human insulin analog and has the empirical formula C257H383N65O77S6 and a molecular weight of 5808 daltons, both identical to that of human insulin. Insulin lispro-aabc has the following primary structure:. LYUMJEV (insulin lispro-aabc) injection is a sterile, aqueous, clear, and colorless solution for subcutaneous or intravenous administration. Each mL of LYUMJEV U-100 contains 100 units of insulin lispro-aabc and the inactive ingredients: glycerol (12.1 mg), magnesium chloride hexahydrate (1.02 mg), metacresol (3.15 mg), sodium citrate dihydrate (4.41 mg), treprostinil sodium (1.06 mcg), zinc oxide (content adjusted to provide 39 mcg zinc ion), and Water for Injection, USP. Each mL of LYUMJEV U-200 contains 200 units of insulin lispro-aabc and the inactive ingredients: glycerol (12.1 mg), magnesium chloride hexahydrate (1.02 mg), metacresol (3.15 mg), sodium citrate dihydrate (4.41 mg), treprostinil sodium (1.06 mcg), zinc oxide (content adjusted to provide 52 mcg zinc ion), and Water for Injection, USP. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH. LYUMJEV has a pH of 7.0 to 7.8.</Description>
</NDC>
<NDC>
<NDCCode>0024-5924-10</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (0024-5924-10) / 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00024-5924-10</NDC11Code>
<ProductNDC>0024-5924</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Admelog</ProprietaryName>
<NonProprietaryName>Insulin Lispro</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20171211</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA209196</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>INSULIN LISPRO</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>U/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [Chemical/Ingredient]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ADMELOG is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin lispro is a rapid-acting human insulin analog produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin lispro differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. Insulin lispro has a molecular weight of 5808 Da, identical to that of human insulin. ADMELOG (insulin lispro) injection is a sterile, aqueous, clear, and colorless solution for subcutaneous or intravenous use. Each mL of ADMELOG contains 100 units of insulin lispro, and the inactive ingredients: dibasic sodium phosphate (1.88 mg), glycerin (16 mg), metacresol (3.15 mg), zinc oxide (content adjusted to provide 0.0197 mg zinc ion), and Water for Injection, USP. Insulin lispro has a pH of 7.0 to 7.8. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. ADMELOG is latex free.</Description>
</NDC>
<NDC>
<NDCCode>0024-5925-00</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (0024-5925-00) / 3 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>00024-5925-00</NDC11Code>
<ProductNDC>0024-5925</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Admelog</ProprietaryName>
<NonProprietaryName>Insulin Lispro</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20171211</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA209196</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>INSULIN LISPRO</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>U/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [Chemical/Ingredient]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171211</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>ADMELOG is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin lispro is a rapid-acting human insulin analog produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin lispro differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. Insulin lispro has a molecular weight of 5808 Da, identical to that of human insulin. ADMELOG (insulin lispro) injection is a sterile, aqueous, clear, and colorless solution for subcutaneous or intravenous use. Each mL of ADMELOG contains 100 units of insulin lispro, and the inactive ingredients: dibasic sodium phosphate (1.88 mg), glycerin (16 mg), metacresol (3.15 mg), zinc oxide (content adjusted to provide 0.0197 mg zinc ion), and Water for Injection, USP. Insulin lispro has a pH of 7.0 to 7.8. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. ADMELOG is latex free.</Description>
</NDC>
<NDC>
<NDCCode>0024-5925-05</NDCCode>
<PackageDescription>5 SYRINGE in 1 CARTON (0024-5925-05) / 3 mL in 1 SYRINGE (0024-5925-01) </PackageDescription>
<NDC11Code>00024-5925-05</NDC11Code>
<ProductNDC>0024-5925</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Admelog</ProprietaryName>
<NonProprietaryName>Insulin Lispro</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20171211</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA209196</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>INSULIN LISPRO</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>U/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [Chemical/Ingredient]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ADMELOG is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin lispro is a rapid-acting human insulin analog produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin lispro differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. Insulin lispro has a molecular weight of 5808 Da, identical to that of human insulin. ADMELOG (insulin lispro) injection is a sterile, aqueous, clear, and colorless solution for subcutaneous or intravenous use. Each mL of ADMELOG contains 100 units of insulin lispro, and the inactive ingredients: dibasic sodium phosphate (1.88 mg), glycerin (16 mg), metacresol (3.15 mg), zinc oxide (content adjusted to provide 0.0197 mg zinc ion), and Water for Injection, USP. Insulin lispro has a pH of 7.0 to 7.8. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. ADMELOG is latex free.</Description>
</NDC>
<NDC>
<NDCCode>0024-5926-05</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (0024-5926-05) / 3 mL in 1 VIAL</PackageDescription>
<NDC11Code>00024-5926-05</NDC11Code>
<ProductNDC>0024-5926</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Admelog</ProprietaryName>
<NonProprietaryName>Insulin Lispro</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20181019</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA209196</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>INSULIN LISPRO</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>U/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [Chemical/Ingredient]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181019</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ADMELOG is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin lispro is a rapid-acting human insulin analog produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin lispro differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. Insulin lispro has a molecular weight of 5808 Da, identical to that of human insulin. ADMELOG (insulin lispro) injection is a sterile, aqueous, clear, and colorless solution for subcutaneous or intravenous use. Each mL of ADMELOG contains 100 units of insulin lispro, and the inactive ingredients: dibasic sodium phosphate (1.88 mg), glycerin (16 mg), metacresol (3.15 mg), zinc oxide (content adjusted to provide 0.0197 mg zinc ion), and Water for Injection, USP. Insulin lispro has a pH of 7.0 to 7.8. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. ADMELOG is latex free.</Description>
</NDC>
<NDC>
<NDCCode>0169-1833-02</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (0169-1833-02) > 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>00169-1833-02</NDC11Code>
<ProductNDC>0169-1833</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Novolin</ProprietaryName>
<ProprietaryNameSuffix>R</ProprietaryNameSuffix>
<NonProprietaryName>Human Insulin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>19910625</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA019938</ApplicationNumber>
<LabelerName>Novo Nordisk</LabelerName>
<SubstanceName>INSULIN HUMAN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin [CS], Insulin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-12-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19910625</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NOVOLIN R is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin human is a short-acting human insulin produced by recombinant DNA technology, utilizing Saccharomyces cerevisiae (baker’s yeast) as the production organism and has the empirical formula C257H383N65O77S6 with a molecular weight of 5808 Da. Figure 1: Structural formula of NOVOLIN R. NOVOLIN R (insulin human) injection is a sterile, clear and colorless solution for subcutaneous or intravenous use. Each mililiter of NOVOLIN R contains 100 units of insulin human, and glycerin (16 mg), metacresol (3 mg), zinc (approximately 21 mcg/mL) and Water for Injection. Hydrochloric acid 2N and sodium hydroxide 2N may be added during manufacture to adjust pH. The pH is 7.0 to 7.8.</Description>
</NDC>
<NDC>
<NDCCode>0169-1833-11</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (0169-1833-11) > 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>00169-1833-11</NDC11Code>
<ProductNDC>0169-1833</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Novolin</ProprietaryName>
<ProprietaryNameSuffix>R</ProprietaryNameSuffix>
<NonProprietaryName>Human Insulin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>19910625</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA019938</ApplicationNumber>
<LabelerName>Novo Nordisk</LabelerName>
<SubstanceName>INSULIN HUMAN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin [CS], Insulin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-12-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19910625</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NOVOLIN R is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin human is a short-acting human insulin produced by recombinant DNA technology, utilizing Saccharomyces cerevisiae (baker’s yeast) as the production organism and has the empirical formula C257H383N65O77S6 with a molecular weight of 5808 Da. Figure 1: Structural formula of NOVOLIN R. NOVOLIN R (insulin human) injection is a sterile, clear and colorless solution for subcutaneous or intravenous use. Each mililiter of NOVOLIN R contains 100 units of insulin human, and glycerin (16 mg), metacresol (3 mg), zinc (approximately 21 mcg/mL) and Water for Injection. Hydrochloric acid 2N and sodium hydroxide 2N may be added during manufacture to adjust pH. The pH is 7.0 to 7.8.</Description>
</NDC>
<NDC>
<NDCCode>0169-1834-02</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (0169-1834-02) > 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>00169-1834-02</NDC11Code>
<ProductNDC>0169-1834</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Novolin</ProprietaryName>
<ProprietaryNameSuffix>N</ProprietaryNameSuffix>
<NonProprietaryName>Human Insulin</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>19910701</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA019959</ApplicationNumber>
<LabelerName>Novo Nordisk</LabelerName>
<SubstanceName>INSULIN HUMAN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin [CS], Insulin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-12-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19910701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NOVOLIN N is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin isophane human is produced by recombinant DNA technology, utilizing Saccharomyces cerevisiae (baker’s yeast) as the production organism. Insulin isophane human is a suspension of crystals produced from combining human insulin and protamine sulfate under appropriate conditions for crystal formation. The amino acid sequence of insulin isophane human is identical to human insulin and has the empirical formula C257H383N65O77S6 and a molecular weight of 5808 Da. Figure 1: Structural formula of human insulin. NOVOLIN N (insulin isophane human) injectable suspension is an intermediate acting human insulin. It is a sterile, white and cloudy suspension that contains insulin isophane human suspension (NPH) for subcutaneous use. Each milliliter of Novolin N contains 100 units of insulin human, dibasic sodium phosphate (1.9 mg), glycerin (16 mg), metacresol (1.5 mg), phenol (0.65 mg), protamine sulfate (approximately 0.35 mg), zinc (33.5 mcg for the vial or 33.2 mcg for the FlexPen), and Water for Injection. Hydrochloric acid 2N and sodium hydroxide 2N may be added to adjust the pH. The pH is 7.1 to 7.5.</Description>
</NDC>
<NDC>
<NDCCode>0169-1834-11</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (0169-1834-11) > 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>00169-1834-11</NDC11Code>
<ProductNDC>0169-1834</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Novolin</ProprietaryName>
<ProprietaryNameSuffix>N</ProprietaryNameSuffix>
<NonProprietaryName>Human Insulin</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>19910701</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA019959</ApplicationNumber>
<LabelerName>Novo Nordisk</LabelerName>
<SubstanceName>INSULIN HUMAN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin [CS], Insulin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-12-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19910701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NOVOLIN N is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin isophane human is produced by recombinant DNA technology, utilizing Saccharomyces cerevisiae (baker’s yeast) as the production organism. Insulin isophane human is a suspension of crystals produced from combining human insulin and protamine sulfate under appropriate conditions for crystal formation. The amino acid sequence of insulin isophane human is identical to human insulin and has the empirical formula C257H383N65O77S6 and a molecular weight of 5808 Da. Figure 1: Structural formula of human insulin. NOVOLIN N (insulin isophane human) injectable suspension is an intermediate acting human insulin. It is a sterile, white and cloudy suspension that contains insulin isophane human suspension (NPH) for subcutaneous use. Each milliliter of Novolin N contains 100 units of insulin human, dibasic sodium phosphate (1.9 mg), glycerin (16 mg), metacresol (1.5 mg), phenol (0.65 mg), protamine sulfate (approximately 0.35 mg), zinc (33.5 mcg for the vial or 33.2 mcg for the FlexPen), and Water for Injection. Hydrochloric acid 2N and sodium hydroxide 2N may be added to adjust the pH. The pH is 7.1 to 7.5.</Description>
</NDC>
<NDC>
<NDCCode>0169-1837-02</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (0169-1837-02) > 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>00169-1837-02</NDC11Code>
<ProductNDC>0169-1837</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Novolin</ProprietaryName>
<ProprietaryNameSuffix>70/30</ProprietaryNameSuffix>
<NonProprietaryName>Human Insulin</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>19910625</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA019991</ApplicationNumber>
<LabelerName>Novo Nordisk</LabelerName>
<SubstanceName>INSULIN HUMAN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin [CS], Insulin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-12-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19910625</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NOVOLIN 70/30 is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. Limitations of Use. In NOVOLIN 70/30, the proportions of short-acting and intermediate-acting insulins are fixed and do not allow for basal versus prandial dose adjustments.</IndicationAndUsage>
<Description>Insulin human is produced by recombinant DNA technology, utilizing Saccharomyces cerevisiae (baker’s yeast) as the production organism. The amino acid sequence of insulin human is identical to human insulin and has the empirical formula C257H383N65O77S6 and a molecular weight of 5808 Da. NOVOLIN 70/30 (insulin isophane human and insulin human) injectable suspension is a mixture of 70% of insulin isophane human, an intermediate-acting insulin, and 30% of insulin human, a short-acting insulin. NOVOLIN 70/30 is a suspension of crystals produced from combining insulin human and protamine sulfate under appropriate conditions for crystal formation and mixing with insulin human injection. Figure 1: Structural formula of human insulin. NOVOLIN 70/30 is a sterile, white and cloudy injectable suspension that contains insulin isophane human suspension (NPH) and insulin human injection (regular) for subcutaneous use. Each milliliter of NOVOLIN 70/30 contains 100 units of insulin human, dibasic sodium phosphate (1.9 mg), glycerin (16 mg), metacresol (1.5 mg), phenol (0.65 mg), protamine sulfate (approximately 0.25 mg), zinc (20.5 mcg/mL for the vial or 30.1 mcg for the FlexPen), and Water for Injection. Hydrochloric acid 2N and sodium hydroxide 2N may be added during manufacture to adjust the pH. The pH is 7.1-7.5.</Description>
</NDC>
<NDC>
<NDCCode>0169-1837-11</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (0169-1837-11) > 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>00169-1837-11</NDC11Code>
<ProductNDC>0169-1837</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Novolin</ProprietaryName>
<ProprietaryNameSuffix>70/30</ProprietaryNameSuffix>
<NonProprietaryName>Human Insulin</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>19910625</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA019991</ApplicationNumber>
<LabelerName>Novo Nordisk</LabelerName>
<SubstanceName>INSULIN HUMAN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin [CS], Insulin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-12-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19910625</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NOVOLIN 70/30 is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. Limitations of Use. In NOVOLIN 70/30, the proportions of short-acting and intermediate-acting insulins are fixed and do not allow for basal versus prandial dose adjustments.</IndicationAndUsage>
<Description>Insulin human is produced by recombinant DNA technology, utilizing Saccharomyces cerevisiae (baker’s yeast) as the production organism. The amino acid sequence of insulin human is identical to human insulin and has the empirical formula C257H383N65O77S6 and a molecular weight of 5808 Da. NOVOLIN 70/30 (insulin isophane human and insulin human) injectable suspension is a mixture of 70% of insulin isophane human, an intermediate-acting insulin, and 30% of insulin human, a short-acting insulin. NOVOLIN 70/30 is a suspension of crystals produced from combining insulin human and protamine sulfate under appropriate conditions for crystal formation and mixing with insulin human injection. Figure 1: Structural formula of human insulin. NOVOLIN 70/30 is a sterile, white and cloudy injectable suspension that contains insulin isophane human suspension (NPH) and insulin human injection (regular) for subcutaneous use. Each milliliter of NOVOLIN 70/30 contains 100 units of insulin human, dibasic sodium phosphate (1.9 mg), glycerin (16 mg), metacresol (1.5 mg), phenol (0.65 mg), protamine sulfate (approximately 0.25 mg), zinc (20.5 mcg/mL for the vial or 30.1 mcg for the FlexPen), and Water for Injection. Hydrochloric acid 2N and sodium hydroxide 2N may be added during manufacture to adjust the pH. The pH is 7.1-7.5.</Description>
</NDC>
<NDC>
<NDCCode>0169-3003-15</NDCCode>
<PackageDescription>5 SYRINGE, PLASTIC in 1 CARTON (0169-3003-15) > 3 mL in 1 SYRINGE, PLASTIC (0169-3003-01) </PackageDescription>
<NDC11Code>00169-3003-15</NDC11Code>
<ProductNDC>0169-3003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Novolin</ProprietaryName>
<ProprietaryNameSuffix>R</ProprietaryNameSuffix>
<NonProprietaryName>Human Insulin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190906</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA019938</ApplicationNumber>
<LabelerName>Novo Nordisk</LabelerName>
<SubstanceName>INSULIN HUMAN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin [CS], Insulin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-12-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190906</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NOVOLIN R is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin human is a short-acting human insulin produced by recombinant DNA technology, utilizing Saccharomyces cerevisiae (baker’s yeast) as the production organism and has the empirical formula C257H383N65O77S6 with a molecular weight of 5808 Da. Figure 1: Structural formula of NOVOLIN R. NOVOLIN R (insulin human) injection is a sterile, clear and colorless solution for subcutaneous or intravenous use. Each mililiter of NOVOLIN R contains 100 units of insulin human, and glycerin (16 mg), metacresol (3 mg), zinc (approximately 21 mcg/mL) and Water for Injection. Hydrochloric acid 2N and sodium hydroxide 2N may be added during manufacture to adjust pH. The pH is 7.0 to 7.8.</Description>
</NDC>
<NDC>
<NDCCode>0169-3003-25</NDCCode>
<PackageDescription>5 SYRINGE, PLASTIC in 1 CARTON (0169-3003-25) > 3 mL in 1 SYRINGE, PLASTIC (0169-3003-12) </PackageDescription>
<NDC11Code>00169-3003-25</NDC11Code>
<ProductNDC>0169-3003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Novolin</ProprietaryName>
<ProprietaryNameSuffix>R</ProprietaryNameSuffix>
<NonProprietaryName>Human Insulin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190906</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA019938</ApplicationNumber>
<LabelerName>Novo Nordisk</LabelerName>
<SubstanceName>INSULIN HUMAN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin [CS], Insulin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-12-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190906</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NOVOLIN R is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin human is a short-acting human insulin produced by recombinant DNA technology, utilizing Saccharomyces cerevisiae (baker’s yeast) as the production organism and has the empirical formula C257H383N65O77S6 with a molecular weight of 5808 Da. Figure 1: Structural formula of NOVOLIN R. NOVOLIN R (insulin human) injection is a sterile, clear and colorless solution for subcutaneous or intravenous use. Each mililiter of NOVOLIN R contains 100 units of insulin human, and glycerin (16 mg), metacresol (3 mg), zinc (approximately 21 mcg/mL) and Water for Injection. Hydrochloric acid 2N and sodium hydroxide 2N may be added during manufacture to adjust pH. The pH is 7.0 to 7.8.</Description>
</NDC>
<NDC>
<NDCCode>0169-3004-15</NDCCode>
<PackageDescription>5 SYRINGE, PLASTIC in 1 CARTON (0169-3004-15) > 3 mL in 1 SYRINGE, PLASTIC (0169-3004-01) </PackageDescription>
<NDC11Code>00169-3004-15</NDC11Code>
<ProductNDC>0169-3004</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Novolin</ProprietaryName>
<ProprietaryNameSuffix>N</ProprietaryNameSuffix>
<NonProprietaryName>Human Insulin</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190906</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA019959</ApplicationNumber>
<LabelerName>Novo Nordisk</LabelerName>
<SubstanceName>INSULIN HUMAN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin [CS], Insulin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-12-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190906</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NOVOLIN N is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin isophane human is produced by recombinant DNA technology, utilizing Saccharomyces cerevisiae (baker’s yeast) as the production organism. Insulin isophane human is a suspension of crystals produced from combining human insulin and protamine sulfate under appropriate conditions for crystal formation. The amino acid sequence of insulin isophane human is identical to human insulin and has the empirical formula C257H383N65O77S6 and a molecular weight of 5808 Da. Figure 1: Structural formula of human insulin. NOVOLIN N (insulin isophane human) injectable suspension is an intermediate acting human insulin. It is a sterile, white and cloudy suspension that contains insulin isophane human suspension (NPH) for subcutaneous use. Each milliliter of Novolin N contains 100 units of insulin human, dibasic sodium phosphate (1.9 mg), glycerin (16 mg), metacresol (1.5 mg), phenol (0.65 mg), protamine sulfate (approximately 0.35 mg), zinc (33.5 mcg for the vial or 33.2 mcg for the FlexPen), and Water for Injection. Hydrochloric acid 2N and sodium hydroxide 2N may be added to adjust the pH. The pH is 7.1 to 7.5.</Description>
</NDC>
<NDC>
<NDCCode>0169-3004-25</NDCCode>
<PackageDescription>5 SYRINGE, PLASTIC in 1 CARTON (0169-3004-25) > 3 mL in 1 SYRINGE, PLASTIC (0169-3004-12) </PackageDescription>
<NDC11Code>00169-3004-25</NDC11Code>
<ProductNDC>0169-3004</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Novolin</ProprietaryName>
<ProprietaryNameSuffix>N</ProprietaryNameSuffix>
<NonProprietaryName>Human Insulin</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190906</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA019959</ApplicationNumber>
<LabelerName>Novo Nordisk</LabelerName>
<SubstanceName>INSULIN HUMAN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin [CS], Insulin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-12-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190906</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NOVOLIN N is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin isophane human is produced by recombinant DNA technology, utilizing Saccharomyces cerevisiae (baker’s yeast) as the production organism. Insulin isophane human is a suspension of crystals produced from combining human insulin and protamine sulfate under appropriate conditions for crystal formation. The amino acid sequence of insulin isophane human is identical to human insulin and has the empirical formula C257H383N65O77S6 and a molecular weight of 5808 Da. Figure 1: Structural formula of human insulin. NOVOLIN N (insulin isophane human) injectable suspension is an intermediate acting human insulin. It is a sterile, white and cloudy suspension that contains insulin isophane human suspension (NPH) for subcutaneous use. Each milliliter of Novolin N contains 100 units of insulin human, dibasic sodium phosphate (1.9 mg), glycerin (16 mg), metacresol (1.5 mg), phenol (0.65 mg), protamine sulfate (approximately 0.35 mg), zinc (33.5 mcg for the vial or 33.2 mcg for the FlexPen), and Water for Injection. Hydrochloric acid 2N and sodium hydroxide 2N may be added to adjust the pH. The pH is 7.1 to 7.5.</Description>
</NDC>
</NDCList>