{
"NDC": [
{
"NDCCode": "0169-4060-97",
"PackageDescription": "1 SYRINGE, PLASTIC in 1 CARTON (0169-4060-97) > 3 mL in 1 SYRINGE, PLASTIC",
"NDC11Code": "00169-4060-97",
"ProductNDC": "0169-4060",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Victoza",
"NonProprietaryName": "Liraglutide (rdna Origin) Injection",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20100125",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022341",
"LabelerName": "Novo Nordisk",
"SubstanceName": "LIRAGLUTIDE",
"StrengthNumber": "6",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "GLP-1 Receptor Agonist [EPC],Glucagon-Like Peptide 1 [Chemical/Ingredient],Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2015-04-03"
},
{
"NDCCode": "0169-4060-12",
"PackageDescription": "2 SYRINGE, PLASTIC in 1 CARTON (0169-4060-12) / 3 mL in 1 SYRINGE, PLASTIC",
"NDC11Code": "00169-4060-12",
"ProductNDC": "0169-4060",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Victoza",
"NonProprietaryName": "Liraglutide",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20100125",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022341",
"LabelerName": "Novo Nordisk",
"SubstanceName": "LIRAGLUTIDE",
"StrengthNumber": "6",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100125",
"SamplePackage": "N",
"IndicationAndUsage": "VICTOZA is indicated: 1 as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus,, 2 to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease. .",
"Description": "VICTOZA contains liraglutide, an analog of human GLP-1 and acts as a GLP-1 receptor agonist. The peptide precursor of liraglutide, produced by a process that includes expression of recombinant DNA in Saccharomyces cerevisiae, has been engineered to be 97% homologous to native human GLP-1 by substituting arginine for lysine at position 34. Liraglutide is made by attaching a C-16 fatty acid (palmitic acid) with a glutamic acid spacer on the remaining lysine residue at position 26 of the peptide precursor. The molecular formula of liraglutide is C172H265N43O51 and the molecular weight is 3751.2 Daltons. The structural formula (Figure 1) is. Figure 1. Structural Formula of liraglutide. VICTOZA injection is a sterile, aqueous, clear, colorless or almost colorless solution for subcutaneous use. Each 1 mL of VICTOZA solution contains 6 mg of liraglutide and the following inactive ingredients: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection. VICTOZA has a pH of approximately 8.15, hydrochloric acid or sodium hydroxide may be added to adjust pH. Each prefilled pen contains a 3 mL solution of VICTOZA equivalent to 18 mg liraglutide (free-base, anhydrous)."
},
{
"NDCCode": "0169-4060-13",
"PackageDescription": "3 SYRINGE, PLASTIC in 1 CARTON (0169-4060-13) / 3 mL in 1 SYRINGE, PLASTIC",
"NDC11Code": "00169-4060-13",
"ProductNDC": "0169-4060",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Victoza",
"NonProprietaryName": "Liraglutide",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20100125",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022341",
"LabelerName": "Novo Nordisk",
"SubstanceName": "LIRAGLUTIDE",
"StrengthNumber": "6",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100125",
"SamplePackage": "N",
"IndicationAndUsage": "VICTOZA is indicated: 1 as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus,, 2 to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease. .",
"Description": "VICTOZA contains liraglutide, an analog of human GLP-1 and acts as a GLP-1 receptor agonist. The peptide precursor of liraglutide, produced by a process that includes expression of recombinant DNA in Saccharomyces cerevisiae, has been engineered to be 97% homologous to native human GLP-1 by substituting arginine for lysine at position 34. Liraglutide is made by attaching a C-16 fatty acid (palmitic acid) with a glutamic acid spacer on the remaining lysine residue at position 26 of the peptide precursor. The molecular formula of liraglutide is C172H265N43O51 and the molecular weight is 3751.2 Daltons. The structural formula (Figure 1) is. Figure 1. Structural Formula of liraglutide. VICTOZA injection is a sterile, aqueous, clear, colorless or almost colorless solution for subcutaneous use. Each 1 mL of VICTOZA solution contains 6 mg of liraglutide and the following inactive ingredients: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection. VICTOZA has a pH of approximately 8.15, hydrochloric acid or sodium hydroxide may be added to adjust pH. Each prefilled pen contains a 3 mL solution of VICTOZA equivalent to 18 mg liraglutide (free-base, anhydrous)."
},
{
"NDCCode": "0169-4060-90",
"PackageDescription": "1 SYRINGE, PLASTIC in 1 CARTON (0169-4060-90) / 3 mL in 1 SYRINGE, PLASTIC",
"NDC11Code": "00169-4060-90",
"ProductNDC": "0169-4060",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Victoza",
"NonProprietaryName": "Liraglutide",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20100125",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022341",
"LabelerName": "Novo Nordisk",
"SubstanceName": "LIRAGLUTIDE",
"StrengthNumber": "6",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100125",
"SamplePackage": "Y",
"IndicationAndUsage": "VICTOZA is indicated: 1 as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus,, 2 to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease. .",
"Description": "VICTOZA contains liraglutide, an analog of human GLP-1 and acts as a GLP-1 receptor agonist. The peptide precursor of liraglutide, produced by a process that includes expression of recombinant DNA in Saccharomyces cerevisiae, has been engineered to be 97% homologous to native human GLP-1 by substituting arginine for lysine at position 34. Liraglutide is made by attaching a C-16 fatty acid (palmitic acid) with a glutamic acid spacer on the remaining lysine residue at position 26 of the peptide precursor. The molecular formula of liraglutide is C172H265N43O51 and the molecular weight is 3751.2 Daltons. The structural formula (Figure 1) is. Figure 1. Structural Formula of liraglutide. VICTOZA injection is a sterile, aqueous, clear, colorless or almost colorless solution for subcutaneous use. Each 1 mL of VICTOZA solution contains 6 mg of liraglutide and the following inactive ingredients: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection. VICTOZA has a pH of approximately 8.15, hydrochloric acid or sodium hydroxide may be added to adjust pH. Each prefilled pen contains a 3 mL solution of VICTOZA equivalent to 18 mg liraglutide (free-base, anhydrous)."
},
{
"NDCCode": "0169-4060-98",
"PackageDescription": "1 SYRINGE, PLASTIC in 1 CARTON (0169-4060-98) > 3 mL in 1 SYRINGE, PLASTIC",
"NDC11Code": "00169-4060-98",
"ProductNDC": "0169-4060",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Victoza",
"NonProprietaryName": "Liraglutide (rdna Origin) Injection",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20100125",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022341",
"LabelerName": "Novo Nordisk",
"SubstanceName": "LIRAGLUTIDE",
"StrengthNumber": "6",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "GLP-1 Receptor Agonist [EPC],Glucagon-Like Peptide 1 [Chemical/Ingredient],Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "0169-4060-99",
"PackageDescription": "1 SYRINGE, PLASTIC in 1 CARTON (0169-4060-99) / 3 mL in 1 SYRINGE, PLASTIC",
"NDC11Code": "00169-4060-99",
"ProductNDC": "0169-4060",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Victoza",
"NonProprietaryName": "Liraglutide",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20100125",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022341",
"LabelerName": "Novo Nordisk",
"SubstanceName": "LIRAGLUTIDE",
"StrengthNumber": "6",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150213",
"SamplePackage": "Y",
"IndicationAndUsage": "VICTOZA is indicated: 1 as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus,, 2 to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease. .",
"Description": "VICTOZA contains liraglutide, an analog of human GLP-1 and acts as a GLP-1 receptor agonist. The peptide precursor of liraglutide, produced by a process that includes expression of recombinant DNA in Saccharomyces cerevisiae, has been engineered to be 97% homologous to native human GLP-1 by substituting arginine for lysine at position 34. Liraglutide is made by attaching a C-16 fatty acid (palmitic acid) with a glutamic acid spacer on the remaining lysine residue at position 26 of the peptide precursor. The molecular formula of liraglutide is C172H265N43O51 and the molecular weight is 3751.2 Daltons. The structural formula (Figure 1) is. Figure 1. Structural Formula of liraglutide. VICTOZA injection is a sterile, aqueous, clear, colorless or almost colorless solution for subcutaneous use. Each 1 mL of VICTOZA solution contains 6 mg of liraglutide and the following inactive ingredients: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection. VICTOZA has a pH of approximately 8.15, hydrochloric acid or sodium hydroxide may be added to adjust pH. Each prefilled pen contains a 3 mL solution of VICTOZA equivalent to 18 mg liraglutide (free-base, anhydrous)."
},
{
"NDCCode": "0169-2550-97",
"PackageDescription": "1 SYRINGE, PLASTIC in 1 CARTON (0169-2550-97) > 3 mL in 1 SYRINGE, PLASTIC (0169-2550-90) ",
"NDC11Code": "00169-2550-97",
"ProductNDC": "0169-2550",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tresiba",
"NonProprietaryName": "Insulin Degludec",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20150925",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA203314",
"LabelerName": "Novo Nordisk",
"SubstanceName": "INSULIN DEGLUDEC",
"StrengthNumber": "200",
"StrengthUnit": "U/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [CS]",
"Status": "Active",
"LastUpdate": "2022-07-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150925",
"SamplePackage": "N",
"IndicationAndUsage": "TRESIBA is indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus. Limitations of Use: 1 Not recommended for the treatment of diabetic ketoacidosis.",
"Description": "Insulin degludec is a long-acting basal human insulin analog for subcutaneous injection produced by a process that includes expression of recombinant DNA in Saccharomyces cerevisiae followed by chemical modification. Insulin degludec differs from human insulin in that the amino acid threonine in position B30 has been omitted and a side-chain consisting of glutamic acid and a C16 fatty acid has been attached (chemical name: LysB29(Nε-hexadecandioyl-γ-Glu) des(B30) human insulin). Insulin degludec has a molecular formula of C274H411N65O81S6 and a molecular weight of 6.104 kDa. It has the following structure. Figure 1: Structural Formula of Insulin Degludec. TRESIBA (insulin degludec) injection is a sterile, aqueous, clear, and colorless solution available as 100 units/mL (U-100) or 200 units/mL (U-200) for subcutaneous use. For the 100 units/mL solution, each mL contains 100 units of insulin degludec and glycerin (19.6 mg), metacresol (1.72 mg), phenol (1.5 mg), zinc (32.7 mcg), and Water for Injection, USP. For the 200 units/mL solution, each mL contains 200 units of insulin degludec and glycerin (19.6 mg), metacresol (1.72 mg), phenol (1.5 mg), zinc (71.9 mcg), and Water for Injection, USP. TRESIBA has a pH of approximately 7.6. Hydrochloric acid or sodium hydroxide may be added to adjust pH."
},
{
"NDCCode": "0169-2660-97",
"PackageDescription": "1 SYRINGE, PLASTIC in 1 CARTON (0169-2660-97) > 3 mL in 1 SYRINGE, PLASTIC (0169-2660-90) ",
"NDC11Code": "00169-2660-97",
"ProductNDC": "0169-2660",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tresiba",
"NonProprietaryName": "Insulin Degludec",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20150925",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA203314",
"LabelerName": "Novo Nordisk",
"SubstanceName": "INSULIN DEGLUDEC",
"StrengthNumber": "100",
"StrengthUnit": "U/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [CS]",
"Status": "Active",
"LastUpdate": "2022-07-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150925",
"SamplePackage": "N",
"IndicationAndUsage": "TRESIBA is indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus. Limitations of Use: 1 Not recommended for the treatment of diabetic ketoacidosis.",
"Description": "Insulin degludec is a long-acting basal human insulin analog for subcutaneous injection produced by a process that includes expression of recombinant DNA in Saccharomyces cerevisiae followed by chemical modification. Insulin degludec differs from human insulin in that the amino acid threonine in position B30 has been omitted and a side-chain consisting of glutamic acid and a C16 fatty acid has been attached (chemical name: LysB29(Nε-hexadecandioyl-γ-Glu) des(B30) human insulin). Insulin degludec has a molecular formula of C274H411N65O81S6 and a molecular weight of 6.104 kDa. It has the following structure. Figure 1: Structural Formula of Insulin Degludec. TRESIBA (insulin degludec) injection is a sterile, aqueous, clear, and colorless solution available as 100 units/mL (U-100) or 200 units/mL (U-200) for subcutaneous use. For the 100 units/mL solution, each mL contains 100 units of insulin degludec and glycerin (19.6 mg), metacresol (1.72 mg), phenol (1.5 mg), zinc (32.7 mcg), and Water for Injection, USP. For the 200 units/mL solution, each mL contains 200 units of insulin degludec and glycerin (19.6 mg), metacresol (1.72 mg), phenol (1.5 mg), zinc (71.9 mcg), and Water for Injection, USP. TRESIBA has a pH of approximately 7.6. Hydrochloric acid or sodium hydroxide may be added to adjust pH."
},
{
"NDCCode": "0169-2770-97",
"PackageDescription": "1 SYRINGE in 1 CARTON (0169-2770-97) > 3 mL in 1 SYRINGE",
"NDC11Code": "00169-2770-97",
"ProductNDC": "0169-2770",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ryzodeg 70/30",
"NonProprietaryName": "Insulin Degludec And Insulin Aspart Injection",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20180101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA203313",
"LabelerName": "Novo Nordisk",
"SubstanceName": "INSULIN DEGLUDEC; INSULIN ASPART",
"StrengthNumber": "70; 30",
"StrengthUnit": "U/mL; U/mL",
"Pharm_Classes": "Insulin [Chemical/Ingredient],Insulin Analog [EPC],Insulin [Chemical/Ingredient],Insulin Analog [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-01-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N"
},
{
"NDCCode": "0169-2800-97",
"PackageDescription": "1 SYRINGE, PLASTIC in 1 CARTON (0169-2800-97) / 3 mL in 1 SYRINGE, PLASTIC",
"NDC11Code": "00169-2800-97",
"ProductNDC": "0169-2800",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Saxenda",
"NonProprietaryName": "Liraglutide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20141231",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206321",
"LabelerName": "Novo Nordisk Pharmaceutical Industries, LP",
"SubstanceName": "LIRAGLUTIDE",
"StrengthNumber": "6",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150119",
"SamplePackage": "N",
"IndicationAndUsage": "SAXENDA is indicated in combination with a reduced calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in: 1 Adults and pediatric patients aged 12 years and older with body weight greater than 60 kg and obesity., 2 Adults with overweight in the presence of at least one weight-related comorbid condition.",
"Description": "SAXENDA contains liraglutide, an analog of human GLP-1 and acts as a GLP-1 receptor agonist. The peptide precursor of liraglutide, produced by a process that includes expression of recombinant DNA in Saccharomyces cerevisiae, has been engineered to be 97% homologous to native human GLP-1 by substituting arginine for lysine at position 34. Liraglutide is made by attaching a C-16 fatty acid (palmitic acid) with a glutamic acid spacer on the remaining lysine residue at position 26 of the peptide precursor. The molecular formula of liraglutide is C172H265N43O51 and the molecular weight is 3751.2 Daltons. The structural formula (Figure 1) is. Figure 1. Structural Formula of liraglutide. SAXENDA injection is a sterile, aqueous, clear, colorless or almost colorless solution for subcutaneous use. Each 1 mL of SAXENDA solution contains 6 mg of liraglutide and the following inactive ingredients: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection. SAXENDA has a pH of approximately 8.15, hydrochloric acid or sodium hydroxide may be added to adjust pH. Each prefilled pen contains a 3 mL solution of SAXENDA equivalent to 18 mg liraglutide (free-base, anhydrous)."
},
{
"NDCCode": "0169-2911-97",
"PackageDescription": "1 SYRINGE, PLASTIC in 1 CARTON (0169-2911-97) > 3 mL in 1 SYRINGE, PLASTIC (0169-2911-90) ",
"NDC11Code": "00169-2911-97",
"ProductNDC": "0169-2911",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xultophy 100/3.6",
"NonProprietaryName": "(insulin Degludec And Liraglutide)",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20161121",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA208583",
"LabelerName": "Novo Nordisk",
"SubstanceName": "INSULIN DEGLUDEC; LIRAGLUTIDE",
"StrengthNumber": "100; 3.6",
"StrengthUnit": "[iU]/mL; mg/mL",
"Pharm_Classes": "GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], Insulin Analog [EPC], Insulin [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-06-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20161121",
"SamplePackage": "N"
},
{
"NDCCode": "0169-3170-97",
"PackageDescription": "1 SYRINGE in 1 CARTON (0169-3170-97) / 1 mL in 1 SYRINGE (0169-3170-90) ",
"NDC11Code": "00169-3170-97",
"ProductNDC": "0169-3170",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Awiqli",
"NonProprietaryName": "Insulin Icodec-abae",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20260811",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761326",
"LabelerName": "Novo Nordisk Pharmaceutical Industries, LP",
"SubstanceName": "INSULIN ICODEC",
"StrengthNumber": "700",
"StrengthUnit": "U/mL",
"Status": "Active",
"LastUpdate": "2026-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260811",
"SamplePackage": "Y"
},
{
"NDCCode": "0169-3204-97",
"PackageDescription": "1 SYRINGE, PLASTIC in 1 CARTON (0169-3204-97) / 3 mL in 1 SYRINGE, PLASTIC (0169-3204-90) ",
"NDC11Code": "00169-3204-97",
"ProductNDC": "0169-3204",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fiasp",
"NonProprietaryName": "Insulin Aspart Injection",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20171020",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA208751",
"LabelerName": "Novo Nordisk",
"SubstanceName": "INSULIN ASPART",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [CS]",
"Status": "Active",
"LastUpdate": "2023-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171020",
"SamplePackage": "Y",
"IndicationAndUsage": "FIASP is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.",
"Description": "Insulin aspart is a rapid-acting insulin analog for subcutaneous or intravenous administration. Insulin aspart is homologous with regular human insulin with the exception of a single substitution of the amino acid proline by aspartic acid in position B28, and is produced by recombinant DNA technology utilizing Saccharomyces cerevisiae. Insulin aspart has the empirical formula C256H381N65079S6 and a molecular weight of 5825.8 daltons. FIASP (insulin aspart) injection is an aqueous, sterile, clear and colorless solution. Each mL contains 100 units of insulin aspart and the inactive ingredients: arginine (as L-arginine hydrochloride), USP (3.48 mg); dibasic sodium phosphate, USP (0.42 mg); glycerin, USP (3.3 mg); metacresol, USP (1.72 mg); niacinamide, USP (20.8 mg); phenol, USP (1.50 mg); zinc (as zinc acetate), USP (19.6 mcg) and Water for Injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH to 7.1."
},
{
"NDCCode": "0169-3696-97",
"PackageDescription": "1 SYRINGE, PLASTIC in 1 CARTON (0169-3696-97) > 3 mL in 1 SYRINGE, PLASTIC",
"NDC11Code": "00169-3696-97",
"ProductNDC": "0169-3696",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Novolog Mix 70/30",
"NonProprietaryName": "Insulin Aspart",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20020911",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021172",
"LabelerName": "Novo Nordisk",
"SubstanceName": "INSULIN ASPART",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin [Chemical/Ingredient],Insulin Analog [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-05-23"
},
{
"NDCCode": "0169-4132-97",
"PackageDescription": "1 SYRINGE, PLASTIC in 1 CARTON (0169-4132-97) / 1.5 mL in 1 SYRINGE, PLASTIC (0169-4132-90) ",
"NDC11Code": "00169-4132-97",
"ProductNDC": "0169-4132",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ozempic",
"NonProprietaryName": "Semaglutide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20171206",
"EndMarketingDate": "20250930",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209637",
"LabelerName": "Novo Nordisk",
"SubstanceName": "SEMAGLUTIDE",
"StrengthNumber": "1.34",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20171206",
"EndMarketingDatePackage": "20250531",
"SamplePackage": "Y",
"IndicationAndUsage": "OZEMPIC is indicated: 1 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus., 2 to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease., 3 to reduce the risk of sustained eGFR decline, end-stage kidney disease, and cardiovascular death in adults with type 2 diabetes mellitus and chronic kidney disease.",
"Description": "OZEMPIC (semaglutide) injection, for subcutaneous use, contains semaglutide, a human GLP-1 receptor agonist (or GLP-1 analog). The peptide backbone is produced by yeast fermentation. The main protraction mechanism of semaglutide is albumin binding, facilitated by modification of position 26 lysine with a hydrophilic spacer and a C18 fatty di-acid. Furthermore, semaglutide is modified in position 8 to provide stabilization against degradation by the enzyme dipeptidyl-peptidase 4 (DPP-4). A minor modification was made in position 34 to ensure the attachment of only one fatty di-acid. The molecular formula is C187H291N45O59 and the molecular weight is 4113.58 g/mol. Structural formula. OZEMPIC is a sterile, aqueous, clear, colorless solution. Each 3 mL prefilled single-patient use pen contains semaglutide 2 mg (0.68 mg/mL), 4 mg (1.34 mg/mL), or 8 mg (2.68 mg/mL). Each 1 mL of OZEMPIC solution also contains the following inactive ingredients: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injections. OZEMPIC has a pH of approximately 7.4. Hydrochloric acid or sodium hydroxide may be added to adjust pH. The 2 mg/1.5 mL (1.34 mg/mL) strength is not currently marketed by Novo Nordisk Inc."
},
{
"NDCCode": "0169-4181-97",
"PackageDescription": "1 SYRINGE, PLASTIC in 1 CARTON (0169-4181-97) / 3 mL in 1 SYRINGE, PLASTIC (0169-4181-90) ",
"NDC11Code": "00169-4181-97",
"ProductNDC": "0169-4181",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ozempic",
"NonProprietaryName": "Semaglutide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20221007",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209637",
"LabelerName": "Novo Nordisk Pharmaceutical Industries, LP",
"SubstanceName": "SEMAGLUTIDE",
"StrengthNumber": ".68",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221007",
"SamplePackage": "Y"
},
{
"NDCCode": "0169-4772-97",
"PackageDescription": "1 SYRINGE, PLASTIC in 1 CARTON (0169-4772-97) / 3 mL in 1 SYRINGE, PLASTIC (0169-4772-90) ",
"NDC11Code": "00169-4772-97",
"ProductNDC": "0169-4772",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ozempic",
"NonProprietaryName": "Semaglutide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20220425",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209637",
"LabelerName": "Novo Nordisk Pharmaceutical Industries, LP",
"SubstanceName": "SEMAGLUTIDE",
"StrengthNumber": "2.68",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220425",
"SamplePackage": "Y"
},
{
"NDCCode": "0169-6338-97",
"PackageDescription": "1 SYRINGE, PLASTIC in 1 CARTON (0169-6338-97) > 3 mL in 1 SYRINGE, PLASTIC (0169-6338-90)",
"NDC11Code": "00169-6338-97",
"ProductNDC": "0169-6338",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Novolog",
"NonProprietaryName": "Insulin Aspart",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20131031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020986",
"LabelerName": "Novo Nordisk",
"SubstanceName": "INSULIN ASPART",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin [Chemical/Ingredient],Insulin Analog [EPC]",
"Status": "Deprecated",
"LastUpdate": "2015-02-13"
},
{
"NDCCode": "0169-6339-97",
"PackageDescription": "1 SYRINGE, PLASTIC in 1 CARTON (0169-6339-97) > 3 mL in 1 SYRINGE, PLASTIC (0169-6339-90)",
"NDC11Code": "00169-6339-97",
"ProductNDC": "0169-6339",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Novolog",
"NonProprietaryName": "Insulin Aspart",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20030122",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020986",
"LabelerName": "Novo Nordisk",
"SubstanceName": "INSULIN ASPART",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin [Chemical/Ingredient],Insulin Analog [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-09-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0169-6438-97",
"PackageDescription": "1 SYRINGE, PLASTIC in 1 CARTON (0169-6438-97) > 3 mL in 1 SYRINGE, PLASTIC (0169-6438-90)",
"NDC11Code": "00169-6438-97",
"ProductNDC": "0169-6438",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levemir",
"NonProprietaryName": "Insulin Detemir",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20131031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021536",
"LabelerName": "Novo Nordisk",
"SubstanceName": "INSULIN DETEMIR",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin [Chemical/Ingredient],Insulin Analog [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-04-11"
},
{
"NDCCode": "0169-6439-97",
"PackageDescription": "1 SYRINGE, PLASTIC in 1 CARTON (0169-6439-97) > 3 mL in 1 SYRINGE, PLASTIC (0169-6439-90)",
"NDC11Code": "00169-6439-97",
"ProductNDC": "0169-6439",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levemir",
"NonProprietaryName": "Insulin Detemir",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20060327",
"EndMarketingDate": "20161130",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021536",
"LabelerName": "Novo Nordisk",
"SubstanceName": "INSULIN DETEMIR",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin [Chemical/Ingredient],Insulin Analog [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "0169-7901-97",
"PackageDescription": "1 KIT in 1 KIT (0169-7901-97) * 4 mL in 1 VIAL, GLASS (0169-7911-90) * 4 mL in 1 SYRINGE, GLASS (0169-7009-98) * 4 mL in 1 VIAL, GLASS (0169-7911-11) ",
"NDC11Code": "00169-7901-97",
"ProductNDC": "0169-7901",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rebinyn",
"NonProprietaryName": "Coagulation Factor Ix Recombinant, Glycopegylated",
"DosageFormName": "KIT",
"StartMarketingDate": "20171201",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125611",
"LabelerName": "Novo Nordisk",
"Status": "Active",
"LastUpdate": "2024-08-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220505",
"SamplePackage": "Y",
"IndicationAndUsage": "REBINYN, Coagulation Factor IX (Recombinant), GlycoPEGylated, is a recombinant DNA-derived coagulation Factor IX concentrate indicated for use in adults and children with hemophilia B (congenital Factor IX deficiency) for: 1 On-demand treatment and control of bleeding episodes, 2 Perioperative management of bleeding, 3 Routine prophylaxis to reduce the frequency of bleeding episodes.",
"Description": "REBINYN is a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution with the provided histidine diluent for intravenous infusion. After reconstitution, the solution appears as a clear and colorless to slightly yellow liquid, free from visible particles and contains the following excipients per mL: sodium chloride, 2.34 mg; histidine, 3.10 mg; sucrose, 10 mg; mannitol, 25 mg; polysorbate 80, 0.05 mg. REBINYN is available in single-dose vials containing the labeled amount of Factor IX activity, expressed in IU. Each vial contains nominally 500 IU, 1000 IU, 2000, or 3000 IU. REBINYN potency is assigned using an in vitro, activated partial thromboplastin time (aPTT)-based, one-stage clotting assay calibrated against the World Health Organization (WHO) international standard for Factor IX concentrates. REBINYN contains no preservatives. REBINYN is a purified recombinant human Factor IX (rFIX) with a 40 kilodalton (kDa) polyethylene-glycol (PEG) conjugated to the protein. The 40 kDa PEG group is selectively attached to specific -N-linked glycans in the rFIX activation peptide, with mono-PEGylated rFIX as the predominant form of REBINYN. The rFIX protein in REBINYN consists of a gamma-carboxylated (Gla) domain, two EGF-like (epidermal growth factor) domains, an activation peptide (which is cleaved off upon activation), and a protease domain. Once activated, the resulting rFIX has structural and functional properties similar to those of endogenous activated Factor IX. The primary amino acid sequence in REBINYN is identical to the Thr148 allelic form of human plasma-derived Factor IX and consists of 415 amino acids. The average molecular weight of REBINYN is approximately 98 kDa and the molecular weight of the protein moiety alone is 56 kDa. The nominal specific activity of REBINYN is 144 IU/mg protein. REBINYN is produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells. No additives of human or animal origin are used in the cell culture, purification, conjugation, or formulation of REBINYN. The rFIX protein is purified by a series of chromatographic steps, including an affinity chromatography step using a monoclonal antibody (produced in CHO cells), to selectively isolate rFIX from the cell culture medium. The production process includes two dedicated viral clearance steps, namely a detergent treatment step for inactivation and a 20 nm filtration step for removal of viruses. The conjugation of the PEG-group is done by an enzymatic reaction during the purification process, followed by final purification of REBINYN."
},
{
"NDCCode": "0169-7902-97",
"PackageDescription": "1 KIT in 1 KIT (0169-7902-97) * 4 mL in 1 VIAL, GLASS (0169-7922-90) * 4 mL in 1 SYRINGE, GLASS (0169-7009-98) * 4 mL in 1 VIAL, GLASS (0169-7922-11) ",
"NDC11Code": "00169-7902-97",
"ProductNDC": "0169-7902",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rebinyn",
"NonProprietaryName": "Coagulation Factor Ix Recombinant, Glycopegylated",
"DosageFormName": "KIT",
"StartMarketingDate": "20171201",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125611",
"LabelerName": "Novo Nordisk",
"Status": "Active",
"LastUpdate": "2024-08-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220505",
"SamplePackage": "Y",
"IndicationAndUsage": "REBINYN, Coagulation Factor IX (Recombinant), GlycoPEGylated, is a recombinant DNA-derived coagulation Factor IX concentrate indicated for use in adults and children with hemophilia B (congenital Factor IX deficiency) for: 1 On-demand treatment and control of bleeding episodes, 2 Perioperative management of bleeding, 3 Routine prophylaxis to reduce the frequency of bleeding episodes.",
"Description": "REBINYN is a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution with the provided histidine diluent for intravenous infusion. After reconstitution, the solution appears as a clear and colorless to slightly yellow liquid, free from visible particles and contains the following excipients per mL: sodium chloride, 2.34 mg; histidine, 3.10 mg; sucrose, 10 mg; mannitol, 25 mg; polysorbate 80, 0.05 mg. REBINYN is available in single-dose vials containing the labeled amount of Factor IX activity, expressed in IU. Each vial contains nominally 500 IU, 1000 IU, 2000, or 3000 IU. REBINYN potency is assigned using an in vitro, activated partial thromboplastin time (aPTT)-based, one-stage clotting assay calibrated against the World Health Organization (WHO) international standard for Factor IX concentrates. REBINYN contains no preservatives. REBINYN is a purified recombinant human Factor IX (rFIX) with a 40 kilodalton (kDa) polyethylene-glycol (PEG) conjugated to the protein. The 40 kDa PEG group is selectively attached to specific -N-linked glycans in the rFIX activation peptide, with mono-PEGylated rFIX as the predominant form of REBINYN. The rFIX protein in REBINYN consists of a gamma-carboxylated (Gla) domain, two EGF-like (epidermal growth factor) domains, an activation peptide (which is cleaved off upon activation), and a protease domain. Once activated, the resulting rFIX has structural and functional properties similar to those of endogenous activated Factor IX. The primary amino acid sequence in REBINYN is identical to the Thr148 allelic form of human plasma-derived Factor IX and consists of 415 amino acids. The average molecular weight of REBINYN is approximately 98 kDa and the molecular weight of the protein moiety alone is 56 kDa. The nominal specific activity of REBINYN is 144 IU/mg protein. REBINYN is produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells. No additives of human or animal origin are used in the cell culture, purification, conjugation, or formulation of REBINYN. The rFIX protein is purified by a series of chromatographic steps, including an affinity chromatography step using a monoclonal antibody (produced in CHO cells), to selectively isolate rFIX from the cell culture medium. The production process includes two dedicated viral clearance steps, namely a detergent treatment step for inactivation and a 20 nm filtration step for removal of viruses. The conjugation of the PEG-group is done by an enzymatic reaction during the purification process, followed by final purification of REBINYN."
},
{
"NDCCode": "0169-7905-97",
"PackageDescription": "1 KIT in 1 KIT (0169-7905-97) * 4 mL in 1 VIAL, GLASS (0169-7955-90) * 4 mL in 1 SYRINGE, GLASS (0169-7009-98) * 4 mL in 1 VIAL, GLASS (0169-7955-11) ",
"NDC11Code": "00169-7905-97",
"ProductNDC": "0169-7905",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rebinyn",
"NonProprietaryName": "Coagulation Factor Ix Recombinant, Glycopegylated",
"DosageFormName": "KIT",
"StartMarketingDate": "20171201",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125611",
"LabelerName": "Novo Nordisk",
"Status": "Active",
"LastUpdate": "2024-08-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220505",
"SamplePackage": "Y",
"IndicationAndUsage": "REBINYN, Coagulation Factor IX (Recombinant), GlycoPEGylated, is a recombinant DNA-derived coagulation Factor IX concentrate indicated for use in adults and children with hemophilia B (congenital Factor IX deficiency) for: 1 On-demand treatment and control of bleeding episodes, 2 Perioperative management of bleeding, 3 Routine prophylaxis to reduce the frequency of bleeding episodes.",
"Description": "REBINYN is a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution with the provided histidine diluent for intravenous infusion. After reconstitution, the solution appears as a clear and colorless to slightly yellow liquid, free from visible particles and contains the following excipients per mL: sodium chloride, 2.34 mg; histidine, 3.10 mg; sucrose, 10 mg; mannitol, 25 mg; polysorbate 80, 0.05 mg. REBINYN is available in single-dose vials containing the labeled amount of Factor IX activity, expressed in IU. Each vial contains nominally 500 IU, 1000 IU, 2000, or 3000 IU. REBINYN potency is assigned using an in vitro, activated partial thromboplastin time (aPTT)-based, one-stage clotting assay calibrated against the World Health Organization (WHO) international standard for Factor IX concentrates. REBINYN contains no preservatives. REBINYN is a purified recombinant human Factor IX (rFIX) with a 40 kilodalton (kDa) polyethylene-glycol (PEG) conjugated to the protein. The 40 kDa PEG group is selectively attached to specific -N-linked glycans in the rFIX activation peptide, with mono-PEGylated rFIX as the predominant form of REBINYN. The rFIX protein in REBINYN consists of a gamma-carboxylated (Gla) domain, two EGF-like (epidermal growth factor) domains, an activation peptide (which is cleaved off upon activation), and a protease domain. Once activated, the resulting rFIX has structural and functional properties similar to those of endogenous activated Factor IX. The primary amino acid sequence in REBINYN is identical to the Thr148 allelic form of human plasma-derived Factor IX and consists of 415 amino acids. The average molecular weight of REBINYN is approximately 98 kDa and the molecular weight of the protein moiety alone is 56 kDa. The nominal specific activity of REBINYN is 144 IU/mg protein. REBINYN is produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells. No additives of human or animal origin are used in the cell culture, purification, conjugation, or formulation of REBINYN. The rFIX protein is purified by a series of chromatographic steps, including an affinity chromatography step using a monoclonal antibody (produced in CHO cells), to selectively isolate rFIX from the cell culture medium. The production process includes two dedicated viral clearance steps, namely a detergent treatment step for inactivation and a 20 nm filtration step for removal of viruses. The conjugation of the PEG-group is done by an enzymatic reaction during the purification process, followed by final purification of REBINYN."
},
{
"NDCCode": "12634-169-97",
"PackageDescription": "7 CAPSULE in 1 BOTTLE (12634-169-97)",
"NDC11Code": "12634-0169-97",
"ProductNDC": "12634-169",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19840911",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062500",
"LabelerName": "Apotheca Inc.",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC],Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Capsules and other antibacterial drugs, Doxycycline Hyclate Capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as Doxycycline Hyclate Capsules and Tablets for oral administration. The structural formula of doxycycline monohydrate is. with a molecular formula of C 22H 24N 2O 8∙H 2O and a molecular weight of 462.46. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a- pentahydroxy-6-methyl- 1,11-dioxo-2-naphthacenecarboxamide monohydrate. The molecular formula for doxycycline hydrochloride hemiethanolate hemihydrate is (C 22H 24N 2O 8∙HCl) 2∙C 2H 6O∙H 2O and the molecular weight is 1025.89. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate is soluble in water, while doxycycline monohydrate is very slightly soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each capsule for oral administration contains doxycycline hyclate equivalent to 50 mg or 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Lactose Anhydrous, Magnesium Stearate, Methylcellulose, Microcrystalline Cellulose, Polyethylene Glycol, Sodium Starch Glycolate, and Stearic Acid. 50 mg gelatin capsule shell contains: FD&C Blue #1, D&C Yellow #10, and other inert ingredients. 100 mg gelatin capsule shell contains: FD&C Blue #1 and other inert ingredients."
},
{
"NDCCode": "70370-4060-1",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (70370-4060-1) ",
"NDC11Code": "70370-4060-01",
"ProductNDC": "70370-4060",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ingrezza Sprinkle",
"NonProprietaryName": "Valbenazine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA218390",
"LabelerName": "Neurocrine Biosciences, Inc.",
"SubstanceName": "VALBENAZINE TOSYLATE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Vesicular Monoamine Transporter 2 Inhibitor [EPC], Vesicular Monoamine Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240430",
"SamplePackage": "N",
"IndicationAndUsage": "INGREZZA and INGREZZA SPRINKLE are indicated for the treatment of adults with. - tardive dyskinesia [see Clinical Studies (14.1)]. - chorea associated with Huntington’s disease [see Clinical Studies (14.2)].",
"Description": "INGREZZA and INGREZZA SPRINKLE contains valbenazine, a vesicular monoamine transporter 2 (VMAT2) inhibitor, present as valbenazine tosylate salt, with the chemical name, L-Valine, (2R,3R,11bR)-1,3,4,6,7,11b-hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-yl ester, 4-methylbenzenesulfonate (1:2). Valbenazine tosylate is slightly soluble in water. Its molecular formula is C38H54N2O10S2, and its molecular weight is 762.97 g/mol (ditosylate salt) with the following structure. The molecular formula of valbenazine free base is C24H38N2O4 and its molecular weight is 418.57. INGREZZA is intended for oral administration only. Each capsule contains 73 mg, 109 mg or 146 mg of valbenazine tosylate equivalent to 40 mg, 60 mg or 80 mg of valbenazine free base, respectively. The capsules contain the following inactive ingredients: hypromellose, isomalt, magnesium stearate, pregelatinized starch, and silicified microcrystalline cellulose. The capsule shells contain candurin silver fine, FD&C Blue#1, FD&C Red#40, and gelatin. INGREZZA SPRINKLE is intended for oral administration. Each capsule contains granules consisting of 73 mg, 109 mg or 146 mg of valbenazine tosylate equivalent to 40 mg, 60 mg or 80 mg of valbenazine free base, respectively. The oral granules contain the following inactive ingredients: silicified microcrystalline cellulose, isomalt, pregelatinized maize starch, hypromellose, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc in hard gelatin capsules (contains gelatin and candurin silver fine)."
},
{
"NDCCode": "60687-169-01",
"PackageDescription": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-169-01) / 1 TABLET in 1 BLISTER PACK (60687-169-11) ",
"NDC11Code": "60687-0169-01",
"ProductNDC": "60687-169",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pravastatin Sodium",
"NonProprietaryName": "Pravastatin Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161201",
"EndMarketingDate": "20260430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077987",
"LabelerName": "American Health Packaging",
"SubstanceName": "PRAVASTATIN SODIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20161201",
"EndMarketingDatePackage": "20260430",
"SamplePackage": "N",
"IndicationAndUsage": "Pravastatin sodium tablets are indicated: 1 To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD)., 2 To reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient ischemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident CHD., 3 As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia., 4 As an adjunct to diet to reduce LDL-C in pediatric patients ages 8 years and older with heterozygous familial hypercholesterolemia (HeFH)., 5 As an adjunct to diet for the treatment of adults with:, 6 Primary dysbetalipoproteinemia., 7 Hypertriglyceridemia.",
"Description": "Pravastatin Sodium Tablets, USP is a statin, an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Pravastatin sodium, USP is designated chemically as 1-Naphthaleneheptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1S-[1α(βS*,δS*),2α,6α,8β(R*),8aα]]-. Structural formula. Pravastatin sodium, USP is an odorless, white to off-white, fine or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7.0. It is soluble in methanol and water (>300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Pravastatin Sodium Tablets, USP for oral use contain 10 mg, 20 mg, 40 mg, and 80 mg pravastatin sodium, which is equivalent to 9.48 mg, 18.97 mg, 37.94 mg and 75.88 mg of pravastatin, respectively. Inactive ingredients include: colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, mannitol, meglumine, microcrystalline cellulose and starch. The 10 mg, 20 mg and 80 mg tablets also contain D&C yellow no. 10 aluminum lake and the 40 mg tablet also contains D&C yellow no. 10 aluminum lake and FD&C blue no. 1 aluminum lake."
},
{
"NDCCode": "0220-4060-41",
"PackageDescription": "9 [hp_C] in 1 TUBE (0220-4060-41) ",
"NDC11Code": "00220-4060-41",
"ProductNDC": "0220-4060",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pilocarpus",
"NonProprietaryName": "Pilocarpus Jaborandii Leaf",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "19830303",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Boiron",
"SubstanceName": "PILOCARPUS JABORANDII LEAF",
"StrengthNumber": "9",
"StrengthUnit": "[hp_C]/9[hp_C]",
"Status": "Active",
"LastUpdate": "2023-11-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19830303",
"SamplePackage": "N",
"IndicationAndUsage": "Hypersalivation*."
},
{
"NDCCode": "0363-4200-08",
"PackageDescription": "1 KIT in 1 KIT (0363-4200-08) * 118 mL in 1 BOTTLE, PLASTIC (0363-4070-04) * 118 mL in 1 BOTTLE, PLASTIC (0363-4060-04) ",
"NDC11Code": "00363-4200-08",
"ProductNDC": "0363-4200",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Daytime Nighttime Multi Symptom Cold",
"ProprietaryNameSuffix": "Childrens",
"NonProprietaryName": "Dextromethorphan Hbr,guaifenesin,phenylephrine Hcl,acetaminophen,diphenhydramine Hcl, Phenylephrine Hcl",
"DosageFormName": "KIT",
"StartMarketingDate": "20141231",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Walgreens",
"Status": "Active",
"LastUpdate": "2026-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20141231",
"SamplePackage": "N",
"IndicationAndUsage": "Daytime: 1 helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive, 2 temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritantsthe intensity of coughingthe impulse to cough to help your child get to sleepnasal congestion due to a coldstuffy nose."
},
{
"NDCCode": "0404-9904-02",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 BAG (0404-9904-02) / 2 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00404-9904-02",
"ProductNDC": "0404-9904",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Magnesium Sulfate",
"NonProprietaryName": "Magnesium Sulfate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20220118",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019316",
"LabelerName": "Henry Schein, Inc.",
"SubstanceName": "MAGNESIUM SULFATE HEPTAHYDRATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2025-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220118",
"SamplePackage": "N",
"IndicationAndUsage": "Magnesium Sulfate Injection, USP is suitable for replacement therapy in magnesium deficiency, especially in acute hypomagnesemia accompanied by signs of tetany similar to those observed in hypocalcemia. In such cases, the serum magnesium level is usually below the lower limit of normal (1.5 to 2.5 mEq/L) and the serum calcium level is normal (4.3 to 5.2 mEq/L) or elevated. In total parental nutrition (TPN), magnesium sulfate may be added to the nutriend admixture to correct or prevent hypomagnesemia which can arise during the course of therapy. Magnesium sulfate injection is also indicated for the prevention and control of seizures in pre-eclampsia and eclampsia, respectively.",
"Description": "Magnesium Sulfate Injection, USP 50% is a sterile, nonpyrogenic, concentrated solution of magnesium sulfate heptahydrate in Water for Injection. It is administered by the intravenous (IV) or intramuscular (IM) routes as an electrolyte replenisher or anticonvulsant. Must be diluted before IV use. Each mL contains: Magnesium sulfate heptahydrate 500 mg; Water for Injection q.s. Sulfuric acid and/or sodium hydroxide may have been added for pH adjustment. The pH of a 5% solution is between 5.5 and 7.0. (Osmolarity: 4060 mOsmol/L (calc.); 2.03 mM/mL magnesium sulfate anhydrous; 4.06 mEq/mL magnesium sulfate anhydrous). The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended only for use as a single dose injection. When smaller doses are required the unused portion should be discarded with the entire unit. Magnesium sulfate heptahydrate is chemically designated MgSO 47H 2O, with a molecular weight of 246.47 and occurs as colorless crystals or white powder freely soluble in water."
}
]
}
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<NDCList>
<NDC>
<NDCCode>0169-4060-97</NDCCode>
<PackageDescription>1 SYRINGE, PLASTIC in 1 CARTON (0169-4060-97) > 3 mL in 1 SYRINGE, PLASTIC</PackageDescription>
<NDC11Code>00169-4060-97</NDC11Code>
<ProductNDC>0169-4060</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Victoza</ProprietaryName>
<NonProprietaryName>Liraglutide (rdna Origin) Injection</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20100125</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022341</ApplicationNumber>
<LabelerName>Novo Nordisk</LabelerName>
<SubstanceName>LIRAGLUTIDE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>GLP-1 Receptor Agonist [EPC],Glucagon-Like Peptide 1 [Chemical/Ingredient],Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-04-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>0169-4060-12</NDCCode>
<PackageDescription>2 SYRINGE, PLASTIC in 1 CARTON (0169-4060-12) / 3 mL in 1 SYRINGE, PLASTIC</PackageDescription>
<NDC11Code>00169-4060-12</NDC11Code>
<ProductNDC>0169-4060</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Victoza</ProprietaryName>
<NonProprietaryName>Liraglutide</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20100125</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022341</ApplicationNumber>
<LabelerName>Novo Nordisk</LabelerName>
<SubstanceName>LIRAGLUTIDE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VICTOZA is indicated: 1 as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus,, 2 to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease. .</IndicationAndUsage>
<Description>VICTOZA contains liraglutide, an analog of human GLP-1 and acts as a GLP-1 receptor agonist. The peptide precursor of liraglutide, produced by a process that includes expression of recombinant DNA in Saccharomyces cerevisiae, has been engineered to be 97% homologous to native human GLP-1 by substituting arginine for lysine at position 34. Liraglutide is made by attaching a C-16 fatty acid (palmitic acid) with a glutamic acid spacer on the remaining lysine residue at position 26 of the peptide precursor. The molecular formula of liraglutide is C172H265N43O51 and the molecular weight is 3751.2 Daltons. The structural formula (Figure 1) is. Figure 1. Structural Formula of liraglutide. VICTOZA injection is a sterile, aqueous, clear, colorless or almost colorless solution for subcutaneous use. Each 1 mL of VICTOZA solution contains 6 mg of liraglutide and the following inactive ingredients: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection. VICTOZA has a pH of approximately 8.15, hydrochloric acid or sodium hydroxide may be added to adjust pH. Each prefilled pen contains a 3 mL solution of VICTOZA equivalent to 18 mg liraglutide (free-base, anhydrous).</Description>
</NDC>
<NDC>
<NDCCode>0169-4060-13</NDCCode>
<PackageDescription>3 SYRINGE, PLASTIC in 1 CARTON (0169-4060-13) / 3 mL in 1 SYRINGE, PLASTIC</PackageDescription>
<NDC11Code>00169-4060-13</NDC11Code>
<ProductNDC>0169-4060</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Victoza</ProprietaryName>
<NonProprietaryName>Liraglutide</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20100125</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022341</ApplicationNumber>
<LabelerName>Novo Nordisk</LabelerName>
<SubstanceName>LIRAGLUTIDE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VICTOZA is indicated: 1 as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus,, 2 to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease. .</IndicationAndUsage>
<Description>VICTOZA contains liraglutide, an analog of human GLP-1 and acts as a GLP-1 receptor agonist. The peptide precursor of liraglutide, produced by a process that includes expression of recombinant DNA in Saccharomyces cerevisiae, has been engineered to be 97% homologous to native human GLP-1 by substituting arginine for lysine at position 34. Liraglutide is made by attaching a C-16 fatty acid (palmitic acid) with a glutamic acid spacer on the remaining lysine residue at position 26 of the peptide precursor. The molecular formula of liraglutide is C172H265N43O51 and the molecular weight is 3751.2 Daltons. The structural formula (Figure 1) is. Figure 1. Structural Formula of liraglutide. VICTOZA injection is a sterile, aqueous, clear, colorless or almost colorless solution for subcutaneous use. Each 1 mL of VICTOZA solution contains 6 mg of liraglutide and the following inactive ingredients: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection. VICTOZA has a pH of approximately 8.15, hydrochloric acid or sodium hydroxide may be added to adjust pH. Each prefilled pen contains a 3 mL solution of VICTOZA equivalent to 18 mg liraglutide (free-base, anhydrous).</Description>
</NDC>
<NDC>
<NDCCode>0169-4060-90</NDCCode>
<PackageDescription>1 SYRINGE, PLASTIC in 1 CARTON (0169-4060-90) / 3 mL in 1 SYRINGE, PLASTIC</PackageDescription>
<NDC11Code>00169-4060-90</NDC11Code>
<ProductNDC>0169-4060</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Victoza</ProprietaryName>
<NonProprietaryName>Liraglutide</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20100125</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022341</ApplicationNumber>
<LabelerName>Novo Nordisk</LabelerName>
<SubstanceName>LIRAGLUTIDE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100125</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>VICTOZA is indicated: 1 as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus,, 2 to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease. .</IndicationAndUsage>
<Description>VICTOZA contains liraglutide, an analog of human GLP-1 and acts as a GLP-1 receptor agonist. The peptide precursor of liraglutide, produced by a process that includes expression of recombinant DNA in Saccharomyces cerevisiae, has been engineered to be 97% homologous to native human GLP-1 by substituting arginine for lysine at position 34. Liraglutide is made by attaching a C-16 fatty acid (palmitic acid) with a glutamic acid spacer on the remaining lysine residue at position 26 of the peptide precursor. The molecular formula of liraglutide is C172H265N43O51 and the molecular weight is 3751.2 Daltons. The structural formula (Figure 1) is. Figure 1. Structural Formula of liraglutide. VICTOZA injection is a sterile, aqueous, clear, colorless or almost colorless solution for subcutaneous use. Each 1 mL of VICTOZA solution contains 6 mg of liraglutide and the following inactive ingredients: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection. VICTOZA has a pH of approximately 8.15, hydrochloric acid or sodium hydroxide may be added to adjust pH. Each prefilled pen contains a 3 mL solution of VICTOZA equivalent to 18 mg liraglutide (free-base, anhydrous).</Description>
</NDC>
<NDC>
<NDCCode>0169-4060-98</NDCCode>
<PackageDescription>1 SYRINGE, PLASTIC in 1 CARTON (0169-4060-98) > 3 mL in 1 SYRINGE, PLASTIC</PackageDescription>
<NDC11Code>00169-4060-98</NDC11Code>
<ProductNDC>0169-4060</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Victoza</ProprietaryName>
<NonProprietaryName>Liraglutide (rdna Origin) Injection</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20100125</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022341</ApplicationNumber>
<LabelerName>Novo Nordisk</LabelerName>
<SubstanceName>LIRAGLUTIDE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>GLP-1 Receptor Agonist [EPC],Glucagon-Like Peptide 1 [Chemical/Ingredient],Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>0169-4060-99</NDCCode>
<PackageDescription>1 SYRINGE, PLASTIC in 1 CARTON (0169-4060-99) / 3 mL in 1 SYRINGE, PLASTIC</PackageDescription>
<NDC11Code>00169-4060-99</NDC11Code>
<ProductNDC>0169-4060</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Victoza</ProprietaryName>
<NonProprietaryName>Liraglutide</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20100125</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022341</ApplicationNumber>
<LabelerName>Novo Nordisk</LabelerName>
<SubstanceName>LIRAGLUTIDE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150213</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>VICTOZA is indicated: 1 as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus,, 2 to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease. .</IndicationAndUsage>
<Description>VICTOZA contains liraglutide, an analog of human GLP-1 and acts as a GLP-1 receptor agonist. The peptide precursor of liraglutide, produced by a process that includes expression of recombinant DNA in Saccharomyces cerevisiae, has been engineered to be 97% homologous to native human GLP-1 by substituting arginine for lysine at position 34. Liraglutide is made by attaching a C-16 fatty acid (palmitic acid) with a glutamic acid spacer on the remaining lysine residue at position 26 of the peptide precursor. The molecular formula of liraglutide is C172H265N43O51 and the molecular weight is 3751.2 Daltons. The structural formula (Figure 1) is. Figure 1. Structural Formula of liraglutide. VICTOZA injection is a sterile, aqueous, clear, colorless or almost colorless solution for subcutaneous use. Each 1 mL of VICTOZA solution contains 6 mg of liraglutide and the following inactive ingredients: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection. VICTOZA has a pH of approximately 8.15, hydrochloric acid or sodium hydroxide may be added to adjust pH. Each prefilled pen contains a 3 mL solution of VICTOZA equivalent to 18 mg liraglutide (free-base, anhydrous).</Description>
</NDC>
<NDC>
<NDCCode>0169-2550-97</NDCCode>
<PackageDescription>1 SYRINGE, PLASTIC in 1 CARTON (0169-2550-97) > 3 mL in 1 SYRINGE, PLASTIC (0169-2550-90) </PackageDescription>
<NDC11Code>00169-2550-97</NDC11Code>
<ProductNDC>0169-2550</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tresiba</ProprietaryName>
<NonProprietaryName>Insulin Degludec</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20150925</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA203314</ApplicationNumber>
<LabelerName>Novo Nordisk</LabelerName>
<SubstanceName>INSULIN DEGLUDEC</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>U/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-07-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150925</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TRESIBA is indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus. Limitations of Use: 1 Not recommended for the treatment of diabetic ketoacidosis.</IndicationAndUsage>
<Description>Insulin degludec is a long-acting basal human insulin analog for subcutaneous injection produced by a process that includes expression of recombinant DNA in Saccharomyces cerevisiae followed by chemical modification. Insulin degludec differs from human insulin in that the amino acid threonine in position B30 has been omitted and a side-chain consisting of glutamic acid and a C16 fatty acid has been attached (chemical name: LysB29(Nε-hexadecandioyl-γ-Glu) des(B30) human insulin). Insulin degludec has a molecular formula of C274H411N65O81S6 and a molecular weight of 6.104 kDa. It has the following structure. Figure 1: Structural Formula of Insulin Degludec. TRESIBA (insulin degludec) injection is a sterile, aqueous, clear, and colorless solution available as 100 units/mL (U-100) or 200 units/mL (U-200) for subcutaneous use. For the 100 units/mL solution, each mL contains 100 units of insulin degludec and glycerin (19.6 mg), metacresol (1.72 mg), phenol (1.5 mg), zinc (32.7 mcg), and Water for Injection, USP. For the 200 units/mL solution, each mL contains 200 units of insulin degludec and glycerin (19.6 mg), metacresol (1.72 mg), phenol (1.5 mg), zinc (71.9 mcg), and Water for Injection, USP. TRESIBA has a pH of approximately 7.6. Hydrochloric acid or sodium hydroxide may be added to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>0169-2660-97</NDCCode>
<PackageDescription>1 SYRINGE, PLASTIC in 1 CARTON (0169-2660-97) > 3 mL in 1 SYRINGE, PLASTIC (0169-2660-90) </PackageDescription>
<NDC11Code>00169-2660-97</NDC11Code>
<ProductNDC>0169-2660</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tresiba</ProprietaryName>
<NonProprietaryName>Insulin Degludec</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20150925</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA203314</ApplicationNumber>
<LabelerName>Novo Nordisk</LabelerName>
<SubstanceName>INSULIN DEGLUDEC</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>U/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-07-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150925</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TRESIBA is indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus. Limitations of Use: 1 Not recommended for the treatment of diabetic ketoacidosis.</IndicationAndUsage>
<Description>Insulin degludec is a long-acting basal human insulin analog for subcutaneous injection produced by a process that includes expression of recombinant DNA in Saccharomyces cerevisiae followed by chemical modification. Insulin degludec differs from human insulin in that the amino acid threonine in position B30 has been omitted and a side-chain consisting of glutamic acid and a C16 fatty acid has been attached (chemical name: LysB29(Nε-hexadecandioyl-γ-Glu) des(B30) human insulin). Insulin degludec has a molecular formula of C274H411N65O81S6 and a molecular weight of 6.104 kDa. It has the following structure. Figure 1: Structural Formula of Insulin Degludec. TRESIBA (insulin degludec) injection is a sterile, aqueous, clear, and colorless solution available as 100 units/mL (U-100) or 200 units/mL (U-200) for subcutaneous use. For the 100 units/mL solution, each mL contains 100 units of insulin degludec and glycerin (19.6 mg), metacresol (1.72 mg), phenol (1.5 mg), zinc (32.7 mcg), and Water for Injection, USP. For the 200 units/mL solution, each mL contains 200 units of insulin degludec and glycerin (19.6 mg), metacresol (1.72 mg), phenol (1.5 mg), zinc (71.9 mcg), and Water for Injection, USP. TRESIBA has a pH of approximately 7.6. Hydrochloric acid or sodium hydroxide may be added to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>0169-2770-97</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (0169-2770-97) > 3 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>00169-2770-97</NDC11Code>
<ProductNDC>0169-2770</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ryzodeg 70/30</ProprietaryName>
<NonProprietaryName>Insulin Degludec And Insulin Aspart Injection</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20180101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA203313</ApplicationNumber>
<LabelerName>Novo Nordisk</LabelerName>
<SubstanceName>INSULIN DEGLUDEC; INSULIN ASPART</SubstanceName>
<StrengthNumber>70; 30</StrengthNumber>
<StrengthUnit>U/mL; U/mL</StrengthUnit>
<Pharm_Classes>Insulin [Chemical/Ingredient],Insulin Analog [EPC],Insulin [Chemical/Ingredient],Insulin Analog [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-01-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0169-2800-97</NDCCode>
<PackageDescription>1 SYRINGE, PLASTIC in 1 CARTON (0169-2800-97) / 3 mL in 1 SYRINGE, PLASTIC</PackageDescription>
<NDC11Code>00169-2800-97</NDC11Code>
<ProductNDC>0169-2800</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Saxenda</ProprietaryName>
<NonProprietaryName>Liraglutide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20141231</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206321</ApplicationNumber>
<LabelerName>Novo Nordisk Pharmaceutical Industries, LP</LabelerName>
<SubstanceName>LIRAGLUTIDE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SAXENDA is indicated in combination with a reduced calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in: 1 Adults and pediatric patients aged 12 years and older with body weight greater than 60 kg and obesity., 2 Adults with overweight in the presence of at least one weight-related comorbid condition.</IndicationAndUsage>
<Description>SAXENDA contains liraglutide, an analog of human GLP-1 and acts as a GLP-1 receptor agonist. The peptide precursor of liraglutide, produced by a process that includes expression of recombinant DNA in Saccharomyces cerevisiae, has been engineered to be 97% homologous to native human GLP-1 by substituting arginine for lysine at position 34. Liraglutide is made by attaching a C-16 fatty acid (palmitic acid) with a glutamic acid spacer on the remaining lysine residue at position 26 of the peptide precursor. The molecular formula of liraglutide is C172H265N43O51 and the molecular weight is 3751.2 Daltons. The structural formula (Figure 1) is. Figure 1. Structural Formula of liraglutide. SAXENDA injection is a sterile, aqueous, clear, colorless or almost colorless solution for subcutaneous use. Each 1 mL of SAXENDA solution contains 6 mg of liraglutide and the following inactive ingredients: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection. SAXENDA has a pH of approximately 8.15, hydrochloric acid or sodium hydroxide may be added to adjust pH. Each prefilled pen contains a 3 mL solution of SAXENDA equivalent to 18 mg liraglutide (free-base, anhydrous).</Description>
</NDC>
<NDC>
<NDCCode>0169-2911-97</NDCCode>
<PackageDescription>1 SYRINGE, PLASTIC in 1 CARTON (0169-2911-97) > 3 mL in 1 SYRINGE, PLASTIC (0169-2911-90) </PackageDescription>
<NDC11Code>00169-2911-97</NDC11Code>
<ProductNDC>0169-2911</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xultophy 100/3.6</ProprietaryName>
<NonProprietaryName>(insulin Degludec And Liraglutide)</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20161121</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA208583</ApplicationNumber>
<LabelerName>Novo Nordisk</LabelerName>
<SubstanceName>INSULIN DEGLUDEC; LIRAGLUTIDE</SubstanceName>
<StrengthNumber>100; 3.6</StrengthNumber>
<StrengthUnit>[iU]/mL; mg/mL</StrengthUnit>
<Pharm_Classes>GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], Insulin Analog [EPC], Insulin [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-06-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0169-3170-97</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (0169-3170-97) / 1 mL in 1 SYRINGE (0169-3170-90) </PackageDescription>
<NDC11Code>00169-3170-97</NDC11Code>
<ProductNDC>0169-3170</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Awiqli</ProprietaryName>
<NonProprietaryName>Insulin Icodec-abae</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20260811</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761326</ApplicationNumber>
<LabelerName>Novo Nordisk Pharmaceutical Industries, LP</LabelerName>
<SubstanceName>INSULIN ICODEC</SubstanceName>
<StrengthNumber>700</StrengthNumber>
<StrengthUnit>U/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-08-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260811</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
</NDC>
<NDC>
<NDCCode>0169-3204-97</NDCCode>
<PackageDescription>1 SYRINGE, PLASTIC in 1 CARTON (0169-3204-97) / 3 mL in 1 SYRINGE, PLASTIC (0169-3204-90) </PackageDescription>
<NDC11Code>00169-3204-97</NDC11Code>
<ProductNDC>0169-3204</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fiasp</ProprietaryName>
<NonProprietaryName>Insulin Aspart Injection</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20171020</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA208751</ApplicationNumber>
<LabelerName>Novo Nordisk</LabelerName>
<SubstanceName>INSULIN ASPART</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171020</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>FIASP is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin aspart is a rapid-acting insulin analog for subcutaneous or intravenous administration. Insulin aspart is homologous with regular human insulin with the exception of a single substitution of the amino acid proline by aspartic acid in position B28, and is produced by recombinant DNA technology utilizing Saccharomyces cerevisiae. Insulin aspart has the empirical formula C256H381N65079S6 and a molecular weight of 5825.8 daltons. FIASP (insulin aspart) injection is an aqueous, sterile, clear and colorless solution. Each mL contains 100 units of insulin aspart and the inactive ingredients: arginine (as L-arginine hydrochloride), USP (3.48 mg); dibasic sodium phosphate, USP (0.42 mg); glycerin, USP (3.3 mg); metacresol, USP (1.72 mg); niacinamide, USP (20.8 mg); phenol, USP (1.50 mg); zinc (as zinc acetate), USP (19.6 mcg) and Water for Injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH to 7.1.</Description>
</NDC>
<NDC>
<NDCCode>0169-3696-97</NDCCode>
<PackageDescription>1 SYRINGE, PLASTIC in 1 CARTON (0169-3696-97) > 3 mL in 1 SYRINGE, PLASTIC</PackageDescription>
<NDC11Code>00169-3696-97</NDC11Code>
<ProductNDC>0169-3696</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Novolog Mix 70/30</ProprietaryName>
<NonProprietaryName>Insulin Aspart</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20020911</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021172</ApplicationNumber>
<LabelerName>Novo Nordisk</LabelerName>
<SubstanceName>INSULIN ASPART</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin [Chemical/Ingredient],Insulin Analog [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-05-23</LastUpdate>
</NDC>
<NDC>
<NDCCode>0169-4132-97</NDCCode>
<PackageDescription>1 SYRINGE, PLASTIC in 1 CARTON (0169-4132-97) / 1.5 mL in 1 SYRINGE, PLASTIC (0169-4132-90) </PackageDescription>
<NDC11Code>00169-4132-97</NDC11Code>
<ProductNDC>0169-4132</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ozempic</ProprietaryName>
<NonProprietaryName>Semaglutide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20171206</StartMarketingDate>
<EndMarketingDate>20250930</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA209637</ApplicationNumber>
<LabelerName>Novo Nordisk</LabelerName>
<SubstanceName>SEMAGLUTIDE</SubstanceName>
<StrengthNumber>1.34</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20171206</StartMarketingDatePackage>
<EndMarketingDatePackage>20250531</EndMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>OZEMPIC is indicated: 1 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus., 2 to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease., 3 to reduce the risk of sustained eGFR decline, end-stage kidney disease, and cardiovascular death in adults with type 2 diabetes mellitus and chronic kidney disease.</IndicationAndUsage>
<Description>OZEMPIC (semaglutide) injection, for subcutaneous use, contains semaglutide, a human GLP-1 receptor agonist (or GLP-1 analog). The peptide backbone is produced by yeast fermentation. The main protraction mechanism of semaglutide is albumin binding, facilitated by modification of position 26 lysine with a hydrophilic spacer and a C18 fatty di-acid. Furthermore, semaglutide is modified in position 8 to provide stabilization against degradation by the enzyme dipeptidyl-peptidase 4 (DPP-4). A minor modification was made in position 34 to ensure the attachment of only one fatty di-acid. The molecular formula is C187H291N45O59 and the molecular weight is 4113.58 g/mol. Structural formula. OZEMPIC is a sterile, aqueous, clear, colorless solution. Each 3 mL prefilled single-patient use pen contains semaglutide 2 mg (0.68 mg/mL), 4 mg (1.34 mg/mL), or 8 mg (2.68 mg/mL). Each 1 mL of OZEMPIC solution also contains the following inactive ingredients: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injections. OZEMPIC has a pH of approximately 7.4. Hydrochloric acid or sodium hydroxide may be added to adjust pH. The 2 mg/1.5 mL (1.34 mg/mL) strength is not currently marketed by Novo Nordisk Inc.</Description>
</NDC>
<NDC>
<NDCCode>0169-4181-97</NDCCode>
<PackageDescription>1 SYRINGE, PLASTIC in 1 CARTON (0169-4181-97) / 3 mL in 1 SYRINGE, PLASTIC (0169-4181-90) </PackageDescription>
<NDC11Code>00169-4181-97</NDC11Code>
<ProductNDC>0169-4181</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ozempic</ProprietaryName>
<NonProprietaryName>Semaglutide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20221007</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA209637</ApplicationNumber>
<LabelerName>Novo Nordisk Pharmaceutical Industries, LP</LabelerName>
<SubstanceName>SEMAGLUTIDE</SubstanceName>
<StrengthNumber>.68</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221007</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
</NDC>
<NDC>
<NDCCode>0169-4772-97</NDCCode>
<PackageDescription>1 SYRINGE, PLASTIC in 1 CARTON (0169-4772-97) / 3 mL in 1 SYRINGE, PLASTIC (0169-4772-90) </PackageDescription>
<NDC11Code>00169-4772-97</NDC11Code>
<ProductNDC>0169-4772</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ozempic</ProprietaryName>
<NonProprietaryName>Semaglutide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20220425</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA209637</ApplicationNumber>
<LabelerName>Novo Nordisk Pharmaceutical Industries, LP</LabelerName>
<SubstanceName>SEMAGLUTIDE</SubstanceName>
<StrengthNumber>2.68</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220425</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
</NDC>
<NDC>
<NDCCode>0169-6338-97</NDCCode>
<PackageDescription>1 SYRINGE, PLASTIC in 1 CARTON (0169-6338-97) > 3 mL in 1 SYRINGE, PLASTIC (0169-6338-90)</PackageDescription>
<NDC11Code>00169-6338-97</NDC11Code>
<ProductNDC>0169-6338</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Novolog</ProprietaryName>
<NonProprietaryName>Insulin Aspart</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20131031</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020986</ApplicationNumber>
<LabelerName>Novo Nordisk</LabelerName>
<SubstanceName>INSULIN ASPART</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin [Chemical/Ingredient],Insulin Analog [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-02-13</LastUpdate>
</NDC>
<NDC>
<NDCCode>0169-6339-97</NDCCode>
<PackageDescription>1 SYRINGE, PLASTIC in 1 CARTON (0169-6339-97) > 3 mL in 1 SYRINGE, PLASTIC (0169-6339-90)</PackageDescription>
<NDC11Code>00169-6339-97</NDC11Code>
<ProductNDC>0169-6339</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Novolog</ProprietaryName>
<NonProprietaryName>Insulin Aspart</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20030122</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020986</ApplicationNumber>
<LabelerName>Novo Nordisk</LabelerName>
<SubstanceName>INSULIN ASPART</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin [Chemical/Ingredient],Insulin Analog [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-09-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0169-6438-97</NDCCode>
<PackageDescription>1 SYRINGE, PLASTIC in 1 CARTON (0169-6438-97) > 3 mL in 1 SYRINGE, PLASTIC (0169-6438-90)</PackageDescription>
<NDC11Code>00169-6438-97</NDC11Code>
<ProductNDC>0169-6438</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levemir</ProprietaryName>
<NonProprietaryName>Insulin Detemir</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20131031</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021536</ApplicationNumber>
<LabelerName>Novo Nordisk</LabelerName>
<SubstanceName>INSULIN DETEMIR</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin [Chemical/Ingredient],Insulin Analog [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-04-11</LastUpdate>
</NDC>
<NDC>
<NDCCode>0169-6439-97</NDCCode>
<PackageDescription>1 SYRINGE, PLASTIC in 1 CARTON (0169-6439-97) > 3 mL in 1 SYRINGE, PLASTIC (0169-6439-90)</PackageDescription>
<NDC11Code>00169-6439-97</NDC11Code>
<ProductNDC>0169-6439</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levemir</ProprietaryName>
<NonProprietaryName>Insulin Detemir</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20060327</StartMarketingDate>
<EndMarketingDate>20161130</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021536</ApplicationNumber>
<LabelerName>Novo Nordisk</LabelerName>
<SubstanceName>INSULIN DETEMIR</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin [Chemical/Ingredient],Insulin Analog [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>0169-7901-97</NDCCode>
<PackageDescription>1 KIT in 1 KIT (0169-7901-97) * 4 mL in 1 VIAL, GLASS (0169-7911-90) * 4 mL in 1 SYRINGE, GLASS (0169-7009-98) * 4 mL in 1 VIAL, GLASS (0169-7911-11) </PackageDescription>
<NDC11Code>00169-7901-97</NDC11Code>
<ProductNDC>0169-7901</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rebinyn</ProprietaryName>
<NonProprietaryName>Coagulation Factor Ix Recombinant, Glycopegylated</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20171201</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125611</ApplicationNumber>
<LabelerName>Novo Nordisk</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-08-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220505</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>REBINYN, Coagulation Factor IX (Recombinant), GlycoPEGylated, is a recombinant DNA-derived coagulation Factor IX concentrate indicated for use in adults and children with hemophilia B (congenital Factor IX deficiency) for: 1 On-demand treatment and control of bleeding episodes, 2 Perioperative management of bleeding, 3 Routine prophylaxis to reduce the frequency of bleeding episodes.</IndicationAndUsage>
<Description>REBINYN is a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution with the provided histidine diluent for intravenous infusion. After reconstitution, the solution appears as a clear and colorless to slightly yellow liquid, free from visible particles and contains the following excipients per mL: sodium chloride, 2.34 mg; histidine, 3.10 mg; sucrose, 10 mg; mannitol, 25 mg; polysorbate 80, 0.05 mg. REBINYN is available in single-dose vials containing the labeled amount of Factor IX activity, expressed in IU. Each vial contains nominally 500 IU, 1000 IU, 2000, or 3000 IU. REBINYN potency is assigned using an in vitro, activated partial thromboplastin time (aPTT)-based, one-stage clotting assay calibrated against the World Health Organization (WHO) international standard for Factor IX concentrates. REBINYN contains no preservatives. REBINYN is a purified recombinant human Factor IX (rFIX) with a 40 kilodalton (kDa) polyethylene-glycol (PEG) conjugated to the protein. The 40 kDa PEG group is selectively attached to specific -N-linked glycans in the rFIX activation peptide, with mono-PEGylated rFIX as the predominant form of REBINYN. The rFIX protein in REBINYN consists of a gamma-carboxylated (Gla) domain, two EGF-like (epidermal growth factor) domains, an activation peptide (which is cleaved off upon activation), and a protease domain. Once activated, the resulting rFIX has structural and functional properties similar to those of endogenous activated Factor IX. The primary amino acid sequence in REBINYN is identical to the Thr148 allelic form of human plasma-derived Factor IX and consists of 415 amino acids. The average molecular weight of REBINYN is approximately 98 kDa and the molecular weight of the protein moiety alone is 56 kDa. The nominal specific activity of REBINYN is 144 IU/mg protein. REBINYN is produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells. No additives of human or animal origin are used in the cell culture, purification, conjugation, or formulation of REBINYN. The rFIX protein is purified by a series of chromatographic steps, including an affinity chromatography step using a monoclonal antibody (produced in CHO cells), to selectively isolate rFIX from the cell culture medium. The production process includes two dedicated viral clearance steps, namely a detergent treatment step for inactivation and a 20 nm filtration step for removal of viruses. The conjugation of the PEG-group is done by an enzymatic reaction during the purification process, followed by final purification of REBINYN.</Description>
</NDC>
<NDC>
<NDCCode>0169-7902-97</NDCCode>
<PackageDescription>1 KIT in 1 KIT (0169-7902-97) * 4 mL in 1 VIAL, GLASS (0169-7922-90) * 4 mL in 1 SYRINGE, GLASS (0169-7009-98) * 4 mL in 1 VIAL, GLASS (0169-7922-11) </PackageDescription>
<NDC11Code>00169-7902-97</NDC11Code>
<ProductNDC>0169-7902</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rebinyn</ProprietaryName>
<NonProprietaryName>Coagulation Factor Ix Recombinant, Glycopegylated</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20171201</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125611</ApplicationNumber>
<LabelerName>Novo Nordisk</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-08-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220505</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>REBINYN, Coagulation Factor IX (Recombinant), GlycoPEGylated, is a recombinant DNA-derived coagulation Factor IX concentrate indicated for use in adults and children with hemophilia B (congenital Factor IX deficiency) for: 1 On-demand treatment and control of bleeding episodes, 2 Perioperative management of bleeding, 3 Routine prophylaxis to reduce the frequency of bleeding episodes.</IndicationAndUsage>
<Description>REBINYN is a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution with the provided histidine diluent for intravenous infusion. After reconstitution, the solution appears as a clear and colorless to slightly yellow liquid, free from visible particles and contains the following excipients per mL: sodium chloride, 2.34 mg; histidine, 3.10 mg; sucrose, 10 mg; mannitol, 25 mg; polysorbate 80, 0.05 mg. REBINYN is available in single-dose vials containing the labeled amount of Factor IX activity, expressed in IU. Each vial contains nominally 500 IU, 1000 IU, 2000, or 3000 IU. REBINYN potency is assigned using an in vitro, activated partial thromboplastin time (aPTT)-based, one-stage clotting assay calibrated against the World Health Organization (WHO) international standard for Factor IX concentrates. REBINYN contains no preservatives. REBINYN is a purified recombinant human Factor IX (rFIX) with a 40 kilodalton (kDa) polyethylene-glycol (PEG) conjugated to the protein. The 40 kDa PEG group is selectively attached to specific -N-linked glycans in the rFIX activation peptide, with mono-PEGylated rFIX as the predominant form of REBINYN. The rFIX protein in REBINYN consists of a gamma-carboxylated (Gla) domain, two EGF-like (epidermal growth factor) domains, an activation peptide (which is cleaved off upon activation), and a protease domain. Once activated, the resulting rFIX has structural and functional properties similar to those of endogenous activated Factor IX. The primary amino acid sequence in REBINYN is identical to the Thr148 allelic form of human plasma-derived Factor IX and consists of 415 amino acids. The average molecular weight of REBINYN is approximately 98 kDa and the molecular weight of the protein moiety alone is 56 kDa. The nominal specific activity of REBINYN is 144 IU/mg protein. REBINYN is produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells. No additives of human or animal origin are used in the cell culture, purification, conjugation, or formulation of REBINYN. The rFIX protein is purified by a series of chromatographic steps, including an affinity chromatography step using a monoclonal antibody (produced in CHO cells), to selectively isolate rFIX from the cell culture medium. The production process includes two dedicated viral clearance steps, namely a detergent treatment step for inactivation and a 20 nm filtration step for removal of viruses. The conjugation of the PEG-group is done by an enzymatic reaction during the purification process, followed by final purification of REBINYN.</Description>
</NDC>
<NDC>
<NDCCode>0169-7905-97</NDCCode>
<PackageDescription>1 KIT in 1 KIT (0169-7905-97) * 4 mL in 1 VIAL, GLASS (0169-7955-90) * 4 mL in 1 SYRINGE, GLASS (0169-7009-98) * 4 mL in 1 VIAL, GLASS (0169-7955-11) </PackageDescription>
<NDC11Code>00169-7905-97</NDC11Code>
<ProductNDC>0169-7905</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rebinyn</ProprietaryName>
<NonProprietaryName>Coagulation Factor Ix Recombinant, Glycopegylated</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20171201</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125611</ApplicationNumber>
<LabelerName>Novo Nordisk</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-08-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220505</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>REBINYN, Coagulation Factor IX (Recombinant), GlycoPEGylated, is a recombinant DNA-derived coagulation Factor IX concentrate indicated for use in adults and children with hemophilia B (congenital Factor IX deficiency) for: 1 On-demand treatment and control of bleeding episodes, 2 Perioperative management of bleeding, 3 Routine prophylaxis to reduce the frequency of bleeding episodes.</IndicationAndUsage>
<Description>REBINYN is a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution with the provided histidine diluent for intravenous infusion. After reconstitution, the solution appears as a clear and colorless to slightly yellow liquid, free from visible particles and contains the following excipients per mL: sodium chloride, 2.34 mg; histidine, 3.10 mg; sucrose, 10 mg; mannitol, 25 mg; polysorbate 80, 0.05 mg. REBINYN is available in single-dose vials containing the labeled amount of Factor IX activity, expressed in IU. Each vial contains nominally 500 IU, 1000 IU, 2000, or 3000 IU. REBINYN potency is assigned using an in vitro, activated partial thromboplastin time (aPTT)-based, one-stage clotting assay calibrated against the World Health Organization (WHO) international standard for Factor IX concentrates. REBINYN contains no preservatives. REBINYN is a purified recombinant human Factor IX (rFIX) with a 40 kilodalton (kDa) polyethylene-glycol (PEG) conjugated to the protein. The 40 kDa PEG group is selectively attached to specific -N-linked glycans in the rFIX activation peptide, with mono-PEGylated rFIX as the predominant form of REBINYN. The rFIX protein in REBINYN consists of a gamma-carboxylated (Gla) domain, two EGF-like (epidermal growth factor) domains, an activation peptide (which is cleaved off upon activation), and a protease domain. Once activated, the resulting rFIX has structural and functional properties similar to those of endogenous activated Factor IX. The primary amino acid sequence in REBINYN is identical to the Thr148 allelic form of human plasma-derived Factor IX and consists of 415 amino acids. The average molecular weight of REBINYN is approximately 98 kDa and the molecular weight of the protein moiety alone is 56 kDa. The nominal specific activity of REBINYN is 144 IU/mg protein. REBINYN is produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells. No additives of human or animal origin are used in the cell culture, purification, conjugation, or formulation of REBINYN. The rFIX protein is purified by a series of chromatographic steps, including an affinity chromatography step using a monoclonal antibody (produced in CHO cells), to selectively isolate rFIX from the cell culture medium. The production process includes two dedicated viral clearance steps, namely a detergent treatment step for inactivation and a 20 nm filtration step for removal of viruses. The conjugation of the PEG-group is done by an enzymatic reaction during the purification process, followed by final purification of REBINYN.</Description>
</NDC>
<NDC>
<NDCCode>12634-169-97</NDCCode>
<PackageDescription>7 CAPSULE in 1 BOTTLE (12634-169-97)</PackageDescription>
<NDC11Code>12634-0169-97</NDC11Code>
<ProductNDC>12634-169</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840911</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062500</ApplicationNumber>
<LabelerName>Apotheca Inc.</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC],Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Capsules and other antibacterial drugs, Doxycycline Hyclate Capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as Doxycycline Hyclate Capsules and Tablets for oral administration. The structural formula of doxycycline monohydrate is. with a molecular formula of C 22H 24N 2O 8∙H 2O and a molecular weight of 462.46. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a- pentahydroxy-6-methyl- 1,11-dioxo-2-naphthacenecarboxamide monohydrate. The molecular formula for doxycycline hydrochloride hemiethanolate hemihydrate is (C 22H 24N 2O 8∙HCl) 2∙C 2H 6O∙H 2O and the molecular weight is 1025.89. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate is soluble in water, while doxycycline monohydrate is very slightly soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each capsule for oral administration contains doxycycline hyclate equivalent to 50 mg or 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Lactose Anhydrous, Magnesium Stearate, Methylcellulose, Microcrystalline Cellulose, Polyethylene Glycol, Sodium Starch Glycolate, and Stearic Acid. 50 mg gelatin capsule shell contains: FD&C Blue #1, D&C Yellow #10, and other inert ingredients. 100 mg gelatin capsule shell contains: FD&C Blue #1 and other inert ingredients.</Description>
</NDC>
<NDC>
<NDCCode>70370-4060-1</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (70370-4060-1) </PackageDescription>
<NDC11Code>70370-4060-01</NDC11Code>
<ProductNDC>70370-4060</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ingrezza Sprinkle</ProprietaryName>
<NonProprietaryName>Valbenazine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240430</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA218390</ApplicationNumber>
<LabelerName>Neurocrine Biosciences, Inc.</LabelerName>
<SubstanceName>VALBENAZINE TOSYLATE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Vesicular Monoamine Transporter 2 Inhibitor [EPC], Vesicular Monoamine Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INGREZZA and INGREZZA SPRINKLE are indicated for the treatment of adults with. - tardive dyskinesia [see Clinical Studies (14.1)]. - chorea associated with Huntington’s disease [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>INGREZZA and INGREZZA SPRINKLE contains valbenazine, a vesicular monoamine transporter 2 (VMAT2) inhibitor, present as valbenazine tosylate salt, with the chemical name, L-Valine, (2R,3R,11bR)-1,3,4,6,7,11b-hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-yl ester, 4-methylbenzenesulfonate (1:2). Valbenazine tosylate is slightly soluble in water. Its molecular formula is C38H54N2O10S2, and its molecular weight is 762.97 g/mol (ditosylate salt) with the following structure. The molecular formula of valbenazine free base is C24H38N2O4 and its molecular weight is 418.57. INGREZZA is intended for oral administration only. Each capsule contains 73 mg, 109 mg or 146 mg of valbenazine tosylate equivalent to 40 mg, 60 mg or 80 mg of valbenazine free base, respectively. The capsules contain the following inactive ingredients: hypromellose, isomalt, magnesium stearate, pregelatinized starch, and silicified microcrystalline cellulose. The capsule shells contain candurin silver fine, FD&C Blue#1, FD&C Red#40, and gelatin. INGREZZA SPRINKLE is intended for oral administration. Each capsule contains granules consisting of 73 mg, 109 mg or 146 mg of valbenazine tosylate equivalent to 40 mg, 60 mg or 80 mg of valbenazine free base, respectively. The oral granules contain the following inactive ingredients: silicified microcrystalline cellulose, isomalt, pregelatinized maize starch, hypromellose, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc in hard gelatin capsules (contains gelatin and candurin silver fine).</Description>
</NDC>
<NDC>
<NDCCode>60687-169-01</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-169-01) / 1 TABLET in 1 BLISTER PACK (60687-169-11) </PackageDescription>
<NDC11Code>60687-0169-01</NDC11Code>
<ProductNDC>60687-169</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pravastatin Sodium</ProprietaryName>
<NonProprietaryName>Pravastatin Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161201</StartMarketingDate>
<EndMarketingDate>20260430</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077987</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>PRAVASTATIN SODIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20161201</StartMarketingDatePackage>
<EndMarketingDatePackage>20260430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pravastatin sodium tablets are indicated: 1 To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD)., 2 To reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient ischemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident CHD., 3 As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia., 4 As an adjunct to diet to reduce LDL-C in pediatric patients ages 8 years and older with heterozygous familial hypercholesterolemia (HeFH)., 5 As an adjunct to diet for the treatment of adults with:, 6 Primary dysbetalipoproteinemia., 7 Hypertriglyceridemia.</IndicationAndUsage>
<Description>Pravastatin Sodium Tablets, USP is a statin, an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Pravastatin sodium, USP is designated chemically as 1-Naphthaleneheptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1S-[1α(βS*,δS*),2α,6α,8β(R*),8aα]]-. Structural formula. Pravastatin sodium, USP is an odorless, white to off-white, fine or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7.0. It is soluble in methanol and water (>300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Pravastatin Sodium Tablets, USP for oral use contain 10 mg, 20 mg, 40 mg, and 80 mg pravastatin sodium, which is equivalent to 9.48 mg, 18.97 mg, 37.94 mg and 75.88 mg of pravastatin, respectively. Inactive ingredients include: colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, mannitol, meglumine, microcrystalline cellulose and starch. The 10 mg, 20 mg and 80 mg tablets also contain D&C yellow no. 10 aluminum lake and the 40 mg tablet also contains D&C yellow no. 10 aluminum lake and FD&C blue no. 1 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>0220-4060-41</NDCCode>
<PackageDescription>9 [hp_C] in 1 TUBE (0220-4060-41) </PackageDescription>
<NDC11Code>00220-4060-41</NDC11Code>
<ProductNDC>0220-4060</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pilocarpus</ProprietaryName>
<NonProprietaryName>Pilocarpus Jaborandii Leaf</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19830303</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Boiron</LabelerName>
<SubstanceName>PILOCARPUS JABORANDII LEAF</SubstanceName>
<StrengthNumber>9</StrengthNumber>
<StrengthUnit>[hp_C]/9[hp_C]</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-11-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19830303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypersalivation*.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0363-4200-08</NDCCode>
<PackageDescription>1 KIT in 1 KIT (0363-4200-08) * 118 mL in 1 BOTTLE, PLASTIC (0363-4070-04) * 118 mL in 1 BOTTLE, PLASTIC (0363-4060-04) </PackageDescription>
<NDC11Code>00363-4200-08</NDC11Code>
<ProductNDC>0363-4200</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Daytime Nighttime Multi Symptom Cold</ProprietaryName>
<ProprietaryNameSuffix>Childrens</ProprietaryNameSuffix>
<NonProprietaryName>Dextromethorphan Hbr,guaifenesin,phenylephrine Hcl,acetaminophen,diphenhydramine Hcl, Phenylephrine Hcl</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20141231</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Walgreens</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141231</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Daytime: 1 helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive, 2 temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritantsthe intensity of coughingthe impulse to cough to help your child get to sleepnasal congestion due to a coldstuffy nose.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0404-9904-02</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 BAG (0404-9904-02) / 2 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00404-9904-02</NDC11Code>
<ProductNDC>0404-9904</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Magnesium Sulfate</ProprietaryName>
<NonProprietaryName>Magnesium Sulfate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20220118</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019316</ApplicationNumber>
<LabelerName>Henry Schein, Inc.</LabelerName>
<SubstanceName>MAGNESIUM SULFATE HEPTAHYDRATE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220118</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Magnesium Sulfate Injection, USP is suitable for replacement therapy in magnesium deficiency, especially in acute hypomagnesemia accompanied by signs of tetany similar to those observed in hypocalcemia. In such cases, the serum magnesium level is usually below the lower limit of normal (1.5 to 2.5 mEq/L) and the serum calcium level is normal (4.3 to 5.2 mEq/L) or elevated. In total parental nutrition (TPN), magnesium sulfate may be added to the nutriend admixture to correct or prevent hypomagnesemia which can arise during the course of therapy. Magnesium sulfate injection is also indicated for the prevention and control of seizures in pre-eclampsia and eclampsia, respectively.</IndicationAndUsage>
<Description>Magnesium Sulfate Injection, USP 50% is a sterile, nonpyrogenic, concentrated solution of magnesium sulfate heptahydrate in Water for Injection. It is administered by the intravenous (IV) or intramuscular (IM) routes as an electrolyte replenisher or anticonvulsant. Must be diluted before IV use. Each mL contains: Magnesium sulfate heptahydrate 500 mg; Water for Injection q.s. Sulfuric acid and/or sodium hydroxide may have been added for pH adjustment. The pH of a 5% solution is between 5.5 and 7.0. (Osmolarity: 4060 mOsmol/L (calc.); 2.03 mM/mL magnesium sulfate anhydrous; 4.06 mEq/mL magnesium sulfate anhydrous). The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended only for use as a single dose injection. When smaller doses are required the unused portion should be discarded with the entire unit. Magnesium sulfate heptahydrate is chemically designated MgSO 47H 2O, with a molecular weight of 246.47 and occurs as colorless crystals or white powder freely soluble in water.</Description>
</NDC>
</NDCList>