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"Description": "Bimekizumab-bkzx, an interleukin-17 A and F antagonist, is a recombinant humanized immunoglobulin G1 (IgG1) monoclonal antibody. Bimekizumab-bkzx is produced by recombinant DNA technology in Chinese Hamster Ovary cells, and has an approximate molecular weight of 150 kDa. BIMZELX (bimekizumab-bkzx) injection is a sterile, preservative-free, clear to slightly opalescent, and colorless to pale brownish-yellow solution for subcutaneous use. Each BIMZELX 1 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 1 mL containing 160 mg bimekizumab-bkzx, glacial acetic acid (1.23 mg), glycine (16.5 mg), polysorbate 80 (0.4 mg), sodium acetate (2.83 mg), and Water for Injection, USP at pH 5.1. Each BIMZELX 2 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 2 mL containing 320 mg bimekizumab-bkzx, glacial acetic acid (2.46 mg), glycine (33.0 mg), polysorbate 80 (0.8 mg), sodium acetate (5.65 mg), and Water for Injection, USP at pH 5.1."
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"Description": "Bimekizumab-bkzx, an interleukin-17 A and F antagonist, is a recombinant humanized immunoglobulin G1 (IgG1) monoclonal antibody. Bimekizumab-bkzx is produced by recombinant DNA technology in Chinese Hamster Ovary cells, and has an approximate molecular weight of 150 kDa. BIMZELX (bimekizumab-bkzx) injection is a sterile, preservative-free, clear to slightly opalescent, and colorless to pale brownish-yellow solution for subcutaneous use. Each BIMZELX 1 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 1 mL containing 160 mg bimekizumab-bkzx, glacial acetic acid (1.23 mg), glycine (16.5 mg), polysorbate 80 (0.4 mg), sodium acetate (2.83 mg), and Water for Injection, USP at pH 5.1. Each BIMZELX 2 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 2 mL containing 320 mg bimekizumab-bkzx, glacial acetic acid (2.46 mg), glycine (33.0 mg), polysorbate 80 (0.8 mg), sodium acetate (5.65 mg), and Water for Injection, USP at pH 5.1."
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"IndicationAndUsage": "BIMZELX is a humanized interleukin-17A and F antagonist indicated for the treatment of: 1 Moderate to severe plaque psoriasis (PSO)in adults who are candidates for systemic therapy or phototherapy. ( 1.1) , 2 Adults with active psoriatic arthritis (PsA). ( 1.2) , 3 Adults with active non-radiographic axial spondyloarthritis( nr-axSpA) with objective signs of inflammation. ( 1.3) , 4 Adults with active ankylosing spondylitis( AS). ( 1.4) , 5 Adults with moderate to severe hidradenitis suppurativa (HS). ( 1.5) .",
"Description": "Bimekizumab-bkzx, an interleukin-17 A and F antagonist, is a recombinant humanized immunoglobulin G1 (IgG1) monoclonal antibody. Bimekizumab-bkzx is produced by recombinant DNA technology in Chinese Hamster Ovary cells, and has an approximate molecular weight of 150 kDa. BIMZELX (bimekizumab-bkzx) injection is a sterile, preservative-free, clear to slightly opalescent, and colorless to pale brownish-yellow solution for subcutaneous use. Each BIMZELX 1 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 1 mL containing 160 mg bimekizumab-bkzx, glacial acetic acid (1.23 mg), glycine (16.5 mg), polysorbate 80 (0.4 mg), sodium acetate (2.83 mg), and Water for Injection, USP at pH 5.1. Each BIMZELX 2 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 2 mL containing 320 mg bimekizumab-bkzx, glacial acetic acid (2.46 mg), glycine (33.0 mg), polysorbate 80 (0.8 mg), sodium acetate (5.65 mg), and Water for Injection, USP at pH 5.1."
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"Description": "Bimekizumab-bkzx, an interleukin-17 A and F antagonist, is a recombinant humanized immunoglobulin G1 (IgG1) monoclonal antibody. Bimekizumab-bkzx is produced by recombinant DNA technology in Chinese Hamster Ovary cells, and has an approximate molecular weight of 150 kDa. BIMZELX (bimekizumab-bkzx) injection is a sterile, preservative-free, clear to slightly opalescent, and colorless to pale brownish-yellow solution for subcutaneous use. Each BIMZELX 1 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 1 mL containing 160 mg bimekizumab-bkzx, glacial acetic acid (1.23 mg), glycine (16.5 mg), polysorbate 80 (0.4 mg), sodium acetate (2.83 mg), and Water for Injection, USP at pH 5.1. Each BIMZELX 2 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 2 mL containing 320 mg bimekizumab-bkzx, glacial acetic acid (2.46 mg), glycine (33.0 mg), polysorbate 80 (0.8 mg), sodium acetate (5.65 mg), and Water for Injection, USP at pH 5.1."
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"IndicationAndUsage": "BIMZELX is a humanized interleukin-17A and F antagonist indicated for the treatment of: 1 Moderate to severe plaque psoriasis (PSO)in adults who are candidates for systemic therapy or phototherapy. ( 1.1) , 2 Adults with active psoriatic arthritis (PsA). ( 1.2) , 3 Adults with active non-radiographic axial spondyloarthritis( nr-axSpA) with objective signs of inflammation. ( 1.3) , 4 Adults with active ankylosing spondylitis( AS). ( 1.4) , 5 Adults with moderate to severe hidradenitis suppurativa (HS). ( 1.5) .",
"Description": "Bimekizumab-bkzx, an interleukin-17 A and F antagonist, is a recombinant humanized immunoglobulin G1 (IgG1) monoclonal antibody. Bimekizumab-bkzx is produced by recombinant DNA technology in Chinese Hamster Ovary cells, and has an approximate molecular weight of 150 kDa. BIMZELX (bimekizumab-bkzx) injection is a sterile, preservative-free, clear to slightly opalescent, and colorless to pale brownish-yellow solution for subcutaneous use. Each BIMZELX 1 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 1 mL containing 160 mg bimekizumab-bkzx, glacial acetic acid (1.23 mg), glycine (16.5 mg), polysorbate 80 (0.4 mg), sodium acetate (2.83 mg), and Water for Injection, USP at pH 5.1. Each BIMZELX 2 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 2 mL containing 320 mg bimekizumab-bkzx, glacial acetic acid (2.46 mg), glycine (33.0 mg), polysorbate 80 (0.8 mg), sodium acetate (5.65 mg), and Water for Injection, USP at pH 5.1."
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"Description": "Bimekizumab-bkzx, an interleukin-17 A and F antagonist, is a recombinant humanized immunoglobulin G1 (IgG1) monoclonal antibody. Bimekizumab-bkzx is produced by recombinant DNA technology in Chinese Hamster Ovary cells, and has an approximate molecular weight of 150 kDa. BIMZELX (bimekizumab-bkzx) injection is a sterile, preservative-free, clear to slightly opalescent, and colorless to pale brownish-yellow solution for subcutaneous use. Each BIMZELX 1 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 1 mL containing 160 mg bimekizumab-bkzx, glacial acetic acid (1.23 mg), glycine (16.5 mg), polysorbate 80 (0.4 mg), sodium acetate (2.83 mg), and Water for Injection, USP at pH 5.1. Each BIMZELX 2 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 2 mL containing 320 mg bimekizumab-bkzx, glacial acetic acid (2.46 mg), glycine (33.0 mg), polysorbate 80 (0.8 mg), sodium acetate (5.65 mg), and Water for Injection, USP at pH 5.1."
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"Description": "Bimekizumab-bkzx, an interleukin-17 A and F antagonist, is a recombinant humanized immunoglobulin G1 (IgG1) monoclonal antibody. Bimekizumab-bkzx is produced by recombinant DNA technology in Chinese Hamster Ovary cells, and has an approximate molecular weight of 150 kDa. BIMZELX (bimekizumab-bkzx) injection is a sterile, preservative-free, clear to slightly opalescent, and colorless to pale brownish-yellow solution for subcutaneous use. Each BIMZELX 1 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 1 mL containing 160 mg bimekizumab-bkzx, glacial acetic acid (1.23 mg), glycine (16.5 mg), polysorbate 80 (0.4 mg), sodium acetate (2.83 mg), and Water for Injection, USP at pH 5.1. Each BIMZELX 2 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 2 mL containing 320 mg bimekizumab-bkzx, glacial acetic acid (2.46 mg), glycine (33.0 mg), polysorbate 80 (0.8 mg), sodium acetate (5.65 mg), and Water for Injection, USP at pH 5.1."
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"IndicationAndUsage": "BIMZELX is a humanized interleukin-17A and F antagonist indicated for the treatment of: 1 Moderate to severe plaque psoriasis (PSO)in adults who are candidates for systemic therapy or phototherapy. ( 1.1) , 2 Adults with active psoriatic arthritis (PsA). ( 1.2) , 3 Adults with active non-radiographic axial spondyloarthritis( nr-axSpA) with objective signs of inflammation. ( 1.3) , 4 Adults with active ankylosing spondylitis( AS). ( 1.4) , 5 Adults with moderate to severe hidradenitis suppurativa (HS). ( 1.5) .",
"Description": "Bimekizumab-bkzx, an interleukin-17 A and F antagonist, is a recombinant humanized immunoglobulin G1 (IgG1) monoclonal antibody. Bimekizumab-bkzx is produced by recombinant DNA technology in Chinese Hamster Ovary cells, and has an approximate molecular weight of 150 kDa. BIMZELX (bimekizumab-bkzx) injection is a sterile, preservative-free, clear to slightly opalescent, and colorless to pale brownish-yellow solution for subcutaneous use. Each BIMZELX 1 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 1 mL containing 160 mg bimekizumab-bkzx, glacial acetic acid (1.23 mg), glycine (16.5 mg), polysorbate 80 (0.4 mg), sodium acetate (2.83 mg), and Water for Injection, USP at pH 5.1. Each BIMZELX 2 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 2 mL containing 320 mg bimekizumab-bkzx, glacial acetic acid (2.46 mg), glycine (33.0 mg), polysorbate 80 (0.8 mg), sodium acetate (5.65 mg), and Water for Injection, USP at pH 5.1."
},
{
"NDCCode": "50474-783-78",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (50474-783-78) / 2 mL in 1 SYRINGE, GLASS",
"NDC11Code": "50474-0783-78",
"ProductNDC": "50474-783",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bimzelx",
"NonProprietaryName": "Bimekizumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20241205",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761151",
"LabelerName": "UCB, Inc.",
"SubstanceName": "BIMEKIZUMAB",
"StrengthNumber": "320",
"StrengthUnit": "mg/2mL",
"Status": "Active",
"LastUpdate": "2025-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241205",
"SamplePackage": "N",
"IndicationAndUsage": "BIMZELX is a humanized interleukin-17A and F antagonist indicated for the treatment of: 1 Moderate to severe plaque psoriasis (PSO)in adults who are candidates for systemic therapy or phototherapy. ( 1.1) , 2 Adults with active psoriatic arthritis (PsA). ( 1.2) , 3 Adults with active non-radiographic axial spondyloarthritis( nr-axSpA) with objective signs of inflammation. ( 1.3) , 4 Adults with active ankylosing spondylitis( AS). ( 1.4) , 5 Adults with moderate to severe hidradenitis suppurativa (HS). ( 1.5) .",
"Description": "Bimekizumab-bkzx, an interleukin-17 A and F antagonist, is a recombinant humanized immunoglobulin G1 (IgG1) monoclonal antibody. Bimekizumab-bkzx is produced by recombinant DNA technology in Chinese Hamster Ovary cells, and has an approximate molecular weight of 150 kDa. BIMZELX (bimekizumab-bkzx) injection is a sterile, preservative-free, clear to slightly opalescent, and colorless to pale brownish-yellow solution for subcutaneous use. Each BIMZELX 1 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 1 mL containing 160 mg bimekizumab-bkzx, glacial acetic acid (1.23 mg), glycine (16.5 mg), polysorbate 80 (0.4 mg), sodium acetate (2.83 mg), and Water for Injection, USP at pH 5.1. Each BIMZELX 2 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 2 mL containing 320 mg bimekizumab-bkzx, glacial acetic acid (2.46 mg), glycine (33.0 mg), polysorbate 80 (0.8 mg), sodium acetate (5.65 mg), and Water for Injection, USP at pH 5.1."
},
{
"NDCCode": "0078-0734-61",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (0078-0734-61) / 1 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "00078-0734-61",
"ProductNDC": "0078-0734",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ilaris",
"NonProprietaryName": "Canakinumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20161222",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125319",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "CANAKINUMAB",
"StrengthNumber": "150",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20161222",
"SamplePackage": "N",
"IndicationAndUsage": "ILARIS is an interleukin-1β blocker indicated for the treatment of. Periodic Fever Syndromes (1.1):. -Cryopyrin-Associated Periodic Syndromes (CAPS), in adults and children 4 years of age and older, including:. ◾Familial Cold Auto-inflammatory Syndrome (FCAS). ◾Muckle-Wells Syndrome (MWS). -Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS) in adult and pediatric patients. -Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD) in adult and pediatric patients. -Familial Mediterranean Fever (FMF) in adult and pediatric patients. Active Still’s Disease, including Adult-Onset Still’s Disease (AOSD) and Systemic Juvenile Idiopathic Arthritis (SJIA) in patients 2 years of age and older (1.2). Gout flares in adults in whom non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine are contraindicated, are not tolerated, or do not provide an adequate response, and in whom repeated courses of corticosteroids are not appropriate (1.3).",
"Description": "Canakinumab is a recombinant, human anti-human-IL-1β monoclonal antibody that belongs to the IgG1/κ isotype subclass. It is expressed in a murine Sp2/0-Ag14 cell line and comprised of two 447- (or 448-) residue heavy chains and two 214-residue light chains, with a molecular mass of 145157 Daltons when deglycosylated. Both heavy chains of canakinumab contain oligosaccharide chains linked to the protein backbone at asparagine 298 (Asn 298). The biological activity of canakinumab is measured by comparing its inhibition of IL-1β-dependent expression of the reporter gene luciferase to that of a canakinumab internal reference standard, using a stably transfected cell line. ILARIS Injection. ILARIS (canakinumab) Injection is supplied as a sterile, preservative-free, clear to opalescent, colorless to slightly brownish-yellow solution for subcutaneous injection in a single-dose, glass vial with coated stopper and aluminum flip-off cap. Each vial delivers 1 mL containing 150 mg canakinumab, L-histidine (2.1 mg), L-histidine HCl monohydrate (1.3 mg), mannitol (49.2 mg), polysorbate 80 (0.4 mg), and Sterile Water for Injection."
},
{
"NDCCode": "0172-4357-49",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (0172-4357-49) ",
"NDC11Code": "00172-4357-49",
"ProductNDC": "0172-4357",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ranitidine",
"NonProprietaryName": "Ranitidine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19970912",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075165",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "RANITIDINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "19970912",
"SamplePackage": "N"
},
{
"NDCCode": "0407-2222-19",
"PackageDescription": "10 BOTTLE, PLASTIC in 1 BOX (0407-2222-19) / 150 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "00407-2222-19",
"ProductNDC": "0407-2222",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Visipaque",
"NonProprietaryName": "Iodixanol",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVASCULAR",
"StartMarketingDate": "20021213",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020351",
"LabelerName": "GE Healthcare Inc.",
"SubstanceName": "IODIXANOL",
"StrengthNumber": "270",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20021213",
"SamplePackage": "N",
"IndicationAndUsage": "VISIPAQUE is indicated for.",
"Description": "VISIPAQUE (iodixanol) injection is a dimeric, iso-osmolar, nonionic, water-soluble, radiographic contrast medium for intravascular (intravenous and intra-arterial) use. It is provided as a ready-to-use sterile, pyrogen-free, and preservative free, colorless to pale yellow solution. The chemical formula is 5,5´-[(2-hydroxy-1,3-propanediyl) bis(acetylimino)] bis[N,N´-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3- benzenedicarboxamide] with a molecular weight of 1550.20 (iodine content 49.1%). VISIPAQUE (C35H44I6N6O15) has the following structural formula. VISIPAQUE is available in two strengths: 1 VISIPAQUE 270 mg Iodine/mL (550 mg Iodixanol/mL), 0.074 mg calcium chloride dihydrate, 1.87 mg sodium chloride, 1.2 mg tromethamine, and 0.1 mg edetate calcium disodium., 2 VISIPAQUE 320 mg Iodine/mL (652 mg Iodixanol/mL), 0.044 mg calcium chloride dihydrate, 1.11 mg sodium chloride, 1.2 mg tromethamine and 0.1 mg edetate calcium disodium."
},
{
"NDCCode": "0407-2223-19",
"PackageDescription": "10 BOTTLE, PLASTIC in 1 BOX (0407-2223-19) / 150 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "00407-2223-19",
"ProductNDC": "0407-2223",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Visipaque",
"NonProprietaryName": "Iodixanol",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVASCULAR",
"StartMarketingDate": "20030909",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020351",
"LabelerName": "GE Healthcare Inc.",
"SubstanceName": "IODIXANOL",
"StrengthNumber": "320",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20030909",
"SamplePackage": "N",
"IndicationAndUsage": "VISIPAQUE is indicated for.",
"Description": "VISIPAQUE (iodixanol) injection is a dimeric, iso-osmolar, nonionic, water-soluble, radiographic contrast medium for intravascular (intravenous and intra-arterial) use. It is provided as a ready-to-use sterile, pyrogen-free, and preservative free, colorless to pale yellow solution. The chemical formula is 5,5´-[(2-hydroxy-1,3-propanediyl) bis(acetylimino)] bis[N,N´-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3- benzenedicarboxamide] with a molecular weight of 1550.20 (iodine content 49.1%). VISIPAQUE (C35H44I6N6O15) has the following structural formula. VISIPAQUE is available in two strengths: 1 VISIPAQUE 270 mg Iodine/mL (550 mg Iodixanol/mL), 0.074 mg calcium chloride dihydrate, 1.87 mg sodium chloride, 1.2 mg tromethamine, and 0.1 mg edetate calcium disodium., 2 VISIPAQUE 320 mg Iodine/mL (652 mg Iodixanol/mL), 0.044 mg calcium chloride dihydrate, 1.11 mg sodium chloride, 1.2 mg tromethamine and 0.1 mg edetate calcium disodium."
},
{
"NDCCode": "0407-2223-66",
"PackageDescription": "10 BOTTLE, PLASTIC in 1 BOX (0407-2223-66) / 150 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "00407-2223-66",
"ProductNDC": "0407-2223",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Visipaque",
"NonProprietaryName": "Iodixanol",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVASCULAR",
"StartMarketingDate": "20100601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020808",
"LabelerName": "GE Healthcare Inc.",
"SubstanceName": "IODIXANOL",
"StrengthNumber": "320",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20100601",
"EndMarketingDatePackage": "20241109",
"SamplePackage": "N",
"IndicationAndUsage": "VISIPAQUE is indicated in for.",
"Description": "VISIPAQUE (iodixanol) injection is a dimeric, iso-osmolar, nonionic, water-soluble, radiographic contrast medium for intravascular (intravenous and intra-arterial) use. It is provided as a ready-to-use sterile, pyrogen-free, and preservative free, colorless to pale yellow solution. The chemical formula is 5,5´-[(2-hydroxy-1,3-propanediyl) bis(acetylimino)] bis[N,N´-bis(2,3-dihydroxypropyl)-2,4,6-triiodo- 1,3- benzenedicarboxamide] with a molecular weight of 1550.20 (iodine content 49.1%). VISIPAQUE (C 35H 44I 6N 6O 15) has the following structural formula:. VISIPAQUE is available in two strengths: 1 VISIPAQUE 270 mg Iodine/mL(550 mg Iodixanol/mL), 0.074 mg calcium chloride dehydrate, 1.87 mg sodium chloride, 1.2 mg tromethamine, and 0.1 mg edetate calcium disodium. , 2 VISIPAQUE 320 mg Iodine/mL(652 mg Iodixanol/mL), 0.044 mg calcium chloride dehydrate, 1.11 mg sodium chloride, 1.2 mg tromethamine and 0.1 mg edetate calcium disodium. ."
},
{
"NDCCode": "0703-3213-01",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (0703-3213-01) / 5 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00703-3213-01",
"ProductNDC": "0703-3213",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paclitaxel",
"NonProprietaryName": "Paclitaxel",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200707",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075184",
"LabelerName": "Teva Parenteral Medicines, Inc.",
"SubstanceName": "PACLITAXEL",
"StrengthNumber": "6",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200707",
"SamplePackage": "N",
"IndicationAndUsage": "Paclitaxel Injection USP is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, paclitaxel injection is indicated in combination with cisplatin. Paclitaxel Injection USP is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone receptor-negative tumors (see CLINICAL STUDIES, Breast Carcinoma). Paclitaxel Injection USP is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. Paclitaxel Injection USP, in combination with cisplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy. Paclitaxel Injection USP is indicated for the second-line treatment of AIDS-related Kaposi’s sarcoma.",
"Description": "Paclitaxel Injection USP is a clear, colorless to slightly yellow viscous solution. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Paclitaxel Injection USP is available in 30 mg (5 mL), 100 mg (16.7 mL), 150 mg (25 mL), and 300 mg (50 mL) multidose vials. Each mL of sterile nonpyrogenic solution contains 6 mg paclitaxel, USP, 527 mg of polyoxyl 35 castor oil, 2 mg of anhydrous citric acid, and 49.7% (v/v) and 39.6% (w/v) dehydrated alcohol. Paclitaxel, USP is a semi-synthetic product with antitumor activity. Paclitaxel, USP is obtained from Taxus species. The chemical name for paclitaxel, USP is 5β,20-Epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine. Paclitaxel, USP has the following structural formula. C47H51NO14 M.W. 853.9. Paclitaxel, USP is a white to off-white crystalline powder. It is highly lipophilic, insoluble in water, and melts at around 216 to 217° C."
},
{
"NDCCode": "0703-3216-01",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (0703-3216-01) / 16.7 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00703-3216-01",
"ProductNDC": "0703-3216",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paclitaxel",
"NonProprietaryName": "Paclitaxel",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200325",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075184",
"LabelerName": "Teva Parenteral Medicines, Inc.",
"SubstanceName": "PACLITAXEL",
"StrengthNumber": "6",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200325",
"SamplePackage": "N",
"IndicationAndUsage": "Paclitaxel Injection USP is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, paclitaxel injection is indicated in combination with cisplatin. Paclitaxel Injection USP is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone receptor-negative tumors (see CLINICAL STUDIES, Breast Carcinoma). Paclitaxel Injection USP is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. Paclitaxel Injection USP, in combination with cisplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy. Paclitaxel Injection USP is indicated for the second-line treatment of AIDS-related Kaposi’s sarcoma.",
"Description": "Paclitaxel Injection USP is a clear, colorless to slightly yellow viscous solution. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Paclitaxel Injection USP is available in 30 mg (5 mL), 100 mg (16.7 mL), 150 mg (25 mL), and 300 mg (50 mL) multidose vials. Each mL of sterile nonpyrogenic solution contains 6 mg paclitaxel, USP, 527 mg of polyoxyl 35 castor oil, 2 mg of anhydrous citric acid, and 49.7% (v/v) and 39.6% (w/v) dehydrated alcohol. Paclitaxel, USP is a semi-synthetic product with antitumor activity. Paclitaxel, USP is obtained from Taxus species. The chemical name for paclitaxel, USP is 5β,20-Epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine. Paclitaxel, USP has the following structural formula. C47H51NO14 M.W. 853.9. Paclitaxel, USP is a white to off-white crystalline powder. It is highly lipophilic, insoluble in water, and melts at around 216 to 217° C."
},
{
"NDCCode": "0703-3217-01",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (0703-3217-01) / 25 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00703-3217-01",
"ProductNDC": "0703-3217",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paclitaxel",
"NonProprietaryName": "Paclitaxel",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200305",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075184",
"LabelerName": "Teva Parenteral Medicines, Inc.",
"SubstanceName": "PACLITAXEL",
"StrengthNumber": "6",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200305",
"SamplePackage": "N",
"IndicationAndUsage": "Paclitaxel Injection USP is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, paclitaxel injection is indicated in combination with cisplatin. Paclitaxel Injection USP is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone receptor-negative tumors (see CLINICAL STUDIES, Breast Carcinoma). Paclitaxel Injection USP is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. Paclitaxel Injection USP, in combination with cisplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy. Paclitaxel Injection USP is indicated for the second-line treatment of AIDS-related Kaposi’s sarcoma.",
"Description": "Paclitaxel Injection USP is a clear, colorless to slightly yellow viscous solution. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Paclitaxel Injection USP is available in 30 mg (5 mL), 100 mg (16.7 mL), 150 mg (25 mL), and 300 mg (50 mL) multidose vials. Each mL of sterile nonpyrogenic solution contains 6 mg paclitaxel, USP, 527 mg of polyoxyl 35 castor oil, 2 mg of anhydrous citric acid, and 49.7% (v/v) and 39.6% (w/v) dehydrated alcohol. Paclitaxel, USP is a semi-synthetic product with antitumor activity. Paclitaxel, USP is obtained from Taxus species. The chemical name for paclitaxel, USP is 5β,20-Epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine. Paclitaxel, USP has the following structural formula. C47H51NO14 M.W. 853.9. Paclitaxel, USP is a white to off-white crystalline powder. It is highly lipophilic, insoluble in water, and melts at around 216 to 217° C."
},
{
"NDCCode": "0703-3218-01",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (0703-3218-01) / 50 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00703-3218-01",
"ProductNDC": "0703-3218",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paclitaxel",
"NonProprietaryName": "Paclitaxel",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200305",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075184",
"LabelerName": "Teva Parenteral Medicines, Inc.",
"SubstanceName": "PACLITAXEL",
"StrengthNumber": "6",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200305",
"SamplePackage": "N",
"IndicationAndUsage": "Paclitaxel Injection USP is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, paclitaxel injection is indicated in combination with cisplatin. Paclitaxel Injection USP is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone receptor-negative tumors (see CLINICAL STUDIES, Breast Carcinoma). Paclitaxel Injection USP is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. Paclitaxel Injection USP, in combination with cisplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy. Paclitaxel Injection USP is indicated for the second-line treatment of AIDS-related Kaposi’s sarcoma.",
"Description": "Paclitaxel Injection USP is a clear, colorless to slightly yellow viscous solution. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Paclitaxel Injection USP is available in 30 mg (5 mL), 100 mg (16.7 mL), 150 mg (25 mL), and 300 mg (50 mL) multidose vials. Each mL of sterile nonpyrogenic solution contains 6 mg paclitaxel, USP, 527 mg of polyoxyl 35 castor oil, 2 mg of anhydrous citric acid, and 49.7% (v/v) and 39.6% (w/v) dehydrated alcohol. Paclitaxel, USP is a semi-synthetic product with antitumor activity. Paclitaxel, USP is obtained from Taxus species. The chemical name for paclitaxel, USP is 5β,20-Epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine. Paclitaxel, USP has the following structural formula. C47H51NO14 M.W. 853.9. Paclitaxel, USP is a white to off-white crystalline powder. It is highly lipophilic, insoluble in water, and melts at around 216 to 217° C."
},
{
"NDCCode": "47783-644-01",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (47783-644-01) / 5 mL in 1 VIAL, GLASS",
"NDC11Code": "47783-0644-01",
"ProductNDC": "47783-644",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Takhzyro",
"NonProprietaryName": "Lanadelumab-flyo",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20180824",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761090",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": "LANADELUMAB",
"StrengthNumber": "300",
"StrengthUnit": "mg/2mL",
"Pharm_Classes": "Kallikrein Inhibitors [MoA], Plasma Kallikrein Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180824",
"SamplePackage": "N",
"IndicationAndUsage": "TAKHZYRO® is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 2 years and older.",
"Description": "Lanadelumab-flyo, a plasma kallikrein inhibitor, is a non-plasma derived, recombinant, fully human, monoclonal antibody (IgG1/κ-light chain) produced in Chinese Hamster Ovary (CHO) cells. Based on the amino acid sequence, the molecular weight of the non-glycosylated lanadelumab-flyo is 146 kDa. The calculated molecular mass of the fully reduced light chain is 23 kDa. The calculated molecular mass of the fully reduced and non-glycosylated heavy chain is 49 kDa. TAKHZYRO (lanadelumab-flyo) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous use. Each mL of ready-to-use TAKHZYRO solution contains 150 mg of lanadelumab-flyo, citric acid monohydrate (4.1 mg), L-histidine (7.8 mg), polysorbate 80 (0.1 mg), sodium chloride (5.3 mg), sodium phosphate dibasic dihydrate (5.3 mg), and Water for Injection, USP. The solution has a pH of approximately 6.0."
},
{
"NDCCode": "47783-645-01",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (47783-645-01) / 1 mL in 1 SYRINGE, GLASS",
"NDC11Code": "47783-0645-01",
"ProductNDC": "47783-645",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Takhzyro",
"NonProprietaryName": "Lanadelumab-flyo",
"DosageFormName": "SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20230203",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761090",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": "LANADELUMAB",
"StrengthNumber": "150",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Kallikrein Inhibitors [MoA], Plasma Kallikrein Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230203",
"SamplePackage": "N",
"IndicationAndUsage": "TAKHZYRO® is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 2 years and older.",
"Description": "Lanadelumab-flyo, a plasma kallikrein inhibitor, is a non-plasma derived, recombinant, fully human, monoclonal antibody (IgG1/κ-light chain) produced in Chinese Hamster Ovary (CHO) cells. Based on the amino acid sequence, the molecular weight of the non-glycosylated lanadelumab-flyo is 146 kDa. The calculated molecular mass of the fully reduced light chain is 23 kDa. The calculated molecular mass of the fully reduced and non-glycosylated heavy chain is 49 kDa. TAKHZYRO (lanadelumab-flyo) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous use. Each mL of ready-to-use TAKHZYRO solution contains 150 mg of lanadelumab-flyo, citric acid monohydrate (4.1 mg), L-histidine (7.8 mg), polysorbate 80 (0.1 mg), sodium chloride (5.3 mg), sodium phosphate dibasic dihydrate (5.3 mg), and Water for Injection, USP. The solution has a pH of approximately 6.0."
},
{
"NDCCode": "47783-646-01",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (47783-646-01) / 2 mL in 1 SYRINGE, GLASS",
"NDC11Code": "47783-0646-01",
"ProductNDC": "47783-646",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Takhzyro",
"NonProprietaryName": "Lanadelumab-flyo",
"DosageFormName": "SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20220208",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761090",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": "LANADELUMAB",
"StrengthNumber": "300",
"StrengthUnit": "mg/2mL",
"Pharm_Classes": "Kallikrein Inhibitors [MoA], Plasma Kallikrein Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220208",
"SamplePackage": "N",
"IndicationAndUsage": "TAKHZYRO® is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 2 years and older.",
"Description": "Lanadelumab-flyo, a plasma kallikrein inhibitor, is a non-plasma derived, recombinant, fully human, monoclonal antibody (IgG1/κ-light chain) produced in Chinese Hamster Ovary (CHO) cells. Based on the amino acid sequence, the molecular weight of the non-glycosylated lanadelumab-flyo is 146 kDa. The calculated molecular mass of the fully reduced light chain is 23 kDa. The calculated molecular mass of the fully reduced and non-glycosylated heavy chain is 49 kDa. TAKHZYRO (lanadelumab-flyo) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous use. Each mL of ready-to-use TAKHZYRO solution contains 150 mg of lanadelumab-flyo, citric acid monohydrate (4.1 mg), L-histidine (7.8 mg), polysorbate 80 (0.1 mg), sodium chloride (5.3 mg), sodium phosphate dibasic dihydrate (5.3 mg), and Water for Injection, USP. The solution has a pH of approximately 6.0."
},
{
"NDCCode": "49035-566-49",
"PackageDescription": "44.4 mL in 1 BOTTLE (49035-566-49) ",
"NDC11Code": "49035-0566-49",
"ProductNDC": "49035-566",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sunscreen Ultra Broad Spectrum",
"ProprietaryNameSuffix": "Equate",
"NonProprietaryName": "Avobenzone Homosalate Octisalate Octocrylene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190221",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "WAL-MART STORES INC.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "30; 150; 50; 70",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2024-10-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201006",
"SamplePackage": "N",
"IndicationAndUsage": " helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "50881-012-10",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (50881-012-10) / 1 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "50881-0012-10",
"ProductNDC": "50881-012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Niktimvo",
"NonProprietaryName": "Axatilimab-csfr",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240814",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761411",
"LabelerName": "Incyte Corporation",
"SubstanceName": "AXATILIMAB",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Colony Stimulating Factor Receptor Type 1 (CSF-1R) Inhibitors [MoA], Colony Stimulating Factor-1 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240814",
"SamplePackage": "N",
"IndicationAndUsage": "NIKTIMVO is indicated for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg.",
"Description": "Axatilimab-csfr is a CSF-1R–blocking antibody. Axatilimab-csfr is a humanized IgG4 (kappa light chain) monoclonal antibody produced in Chinese hamster ovary cells. Axatilimab-csfr has an approximate molecular weight of 150 kDa. NIKTIMVO (axatilimab-csfr) injection is a sterile, preservative-free, slightly opalescent, pale brownish yellow solution for intravenous use. The solution is free from visible particles. Each single-dose vial contains 9 mg or 22 mg of axatilimab-csfr at a concentration of 10 mg/mL or 50 mg/mL. Each mL of solution contains citric acid monohydrate (3.6 mg), glycine (9.38 mg), polysorbate 80 (0.5 mg), sodium citrate (8.49 mg), sucrose (42.79 mg) and Water for Injection, USP. The pH is 5.0."
},
{
"NDCCode": "50881-023-11",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (50881-023-11) / .44 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "50881-0023-11",
"ProductNDC": "50881-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Niktimvo",
"NonProprietaryName": "Axatilimab-csfr",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761411",
"LabelerName": "Incyte Corporation",
"SubstanceName": "AXATILIMAB",
"StrengthNumber": "22",
"StrengthUnit": "mg/.44mL",
"Pharm_Classes": "Colony Stimulating Factor Receptor Type 1 (CSF-1R) Inhibitors [MoA], Colony Stimulating Factor-1 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250115",
"SamplePackage": "N",
"IndicationAndUsage": "NIKTIMVO is indicated for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg.",
"Description": "Axatilimab-csfr is a CSF-1R–blocking antibody. Axatilimab-csfr is a humanized IgG4 (kappa light chain) monoclonal antibody produced in Chinese hamster ovary cells. Axatilimab-csfr has an approximate molecular weight of 150 kDa. NIKTIMVO (axatilimab-csfr) injection is a sterile, preservative-free, slightly opalescent, pale brownish yellow solution for intravenous use. The solution is free from visible particles. Each single-dose vial contains 9 mg or 22 mg of axatilimab-csfr at a concentration of 10 mg/mL or 50 mg/mL. Each mL of solution contains citric acid monohydrate (3.6 mg), glycine (9.38 mg), polysorbate 80 (0.5 mg), sodium citrate (8.49 mg), sucrose (42.79 mg) and Water for Injection, USP. The pH is 5.0."
},
{
"NDCCode": "50881-034-12",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (50881-034-12) / .18 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "50881-0034-12",
"ProductNDC": "50881-034",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Niktimvo",
"NonProprietaryName": "Axatilimab-csfr",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761411",
"LabelerName": "Incyte Corporation",
"SubstanceName": "AXATILIMAB",
"StrengthNumber": "9",
"StrengthUnit": "mg/.18mL",
"Pharm_Classes": "Colony Stimulating Factor Receptor Type 1 (CSF-1R) Inhibitors [MoA], Colony Stimulating Factor-1 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250115",
"SamplePackage": "N",
"IndicationAndUsage": "NIKTIMVO is indicated for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg.",
"Description": "Axatilimab-csfr is a CSF-1R–blocking antibody. Axatilimab-csfr is a humanized IgG4 (kappa light chain) monoclonal antibody produced in Chinese hamster ovary cells. Axatilimab-csfr has an approximate molecular weight of 150 kDa. NIKTIMVO (axatilimab-csfr) injection is a sterile, preservative-free, slightly opalescent, pale brownish yellow solution for intravenous use. The solution is free from visible particles. Each single-dose vial contains 9 mg or 22 mg of axatilimab-csfr at a concentration of 10 mg/mL or 50 mg/mL. Each mL of solution contains citric acid monohydrate (3.6 mg), glycine (9.38 mg), polysorbate 80 (0.5 mg), sodium citrate (8.49 mg), sucrose (42.79 mg) and Water for Injection, USP. The pH is 5.0."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>50474-150-49</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (50474-150-49) > 115 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>50474-0150-49</NDC11Code>
<ProductNDC>50474-150</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tussionex Pennkinetic</ProprietaryName>
<NonProprietaryName>Hydrocodone And Chlorpheniramine</NonProprietaryName>
<DosageFormName>SUSPENSION, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19871231</StartMarketingDate>
<EndMarketingDate>20190630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019111</ApplicationNumber>
<LabelerName>UCB Inc.</LabelerName>
<SubstanceName>HYDROCODONE; CHLORPHENIRAMINE</SubstanceName>
<StrengthNumber>10; 8</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19871231</StartMarketingDatePackage>
<EndMarketingDatePackage>20190630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0407-1412-49</NDCCode>
<PackageDescription>10 BOTTLE, GLASS in 1 BOX (0407-1412-49) > 150 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>00407-1412-49</NDC11Code>
<ProductNDC>0407-1412</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omnipaque</ProprietaryName>
<NonProprietaryName>Iohexol</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19851226</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018956</ApplicationNumber>
<LabelerName>GE Healthcare Inc.</LabelerName>
<SubstanceName>IOHEXOL</SubstanceName>
<StrengthNumber>240</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-08-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19851226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42195-150-49</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (42195-150-49) > 49 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>42195-0150-49</NDC11Code>
<ProductNDC>42195-150</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zodex</ProprietaryName>
<NonProprietaryName>Dexamethasone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170816</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088237</ApplicationNumber>
<LabelerName>Xspire Pharma, Llc</LabelerName>
<SubstanceName>DEXAMETHASONE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-06-21</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>49035-260-03</NDCCode>
<PackageDescription>2 BOTTLE in 1 PACKAGE (49035-260-03) > 150 TABLET in 1 BOTTLE (49035-260-49) </PackageDescription>
<NDC11Code>49035-0260-03</NDC11Code>
<ProductNDC>49035-260</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Loratadine</ProprietaryName>
<NonProprietaryName>Loratadine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160630</StartMarketingDate>
<EndMarketingDate>20200331</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075209</ApplicationNumber>
<LabelerName>Wal-Mart</LabelerName>
<SubstanceName>LORATADINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160630</StartMarketingDatePackage>
<EndMarketingDatePackage>20200331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>78505-002-49</NDCCode>
<PackageDescription>150 POUCH in 1 BOTTLE (78505-002-49) > 3.5 g in 1 POUCH</PackageDescription>
<NDC11Code>78505-0002-49</NDC11Code>
<ProductNDC>78505-002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Disinfectant Wipes</ProprietaryName>
<NonProprietaryName>Disinfectant Wipes</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200529</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>JINHUA CHANG GONG CLEANING UTENSILS CO.,LTD</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For Hand Sanitizing.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50474-780-78</NDCCode>
<PackageDescription>1 SYRINGE, GLASS in 1 CARTON (50474-780-78) / 1 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>50474-0780-78</NDC11Code>
<ProductNDC>50474-780</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bimzelx</ProprietaryName>
<NonProprietaryName>Bimekizumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20231017</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761151</ApplicationNumber>
<LabelerName>UCB, Inc.</LabelerName>
<SubstanceName>BIMEKIZUMAB</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241001</StartMarketingDatePackage>
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<IndicationAndUsage>ILARIS is an interleukin-1β blocker indicated for the treatment of. Periodic Fever Syndromes (1.1):. -Cryopyrin-Associated Periodic Syndromes (CAPS), in adults and children 4 years of age and older, including:. ◾Familial Cold Auto-inflammatory Syndrome (FCAS). ◾Muckle-Wells Syndrome (MWS). -Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS) in adult and pediatric patients. -Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD) in adult and pediatric patients. -Familial Mediterranean Fever (FMF) in adult and pediatric patients. Active Still’s Disease, including Adult-Onset Still’s Disease (AOSD) and Systemic Juvenile Idiopathic Arthritis (SJIA) in patients 2 years of age and older (1.2). Gout flares in adults in whom non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine are contraindicated, are not tolerated, or do not provide an adequate response, and in whom repeated courses of corticosteroids are not appropriate (1.3).</IndicationAndUsage>
<Description>Canakinumab is a recombinant, human anti-human-IL-1β monoclonal antibody that belongs to the IgG1/κ isotype subclass. It is expressed in a murine Sp2/0-Ag14 cell line and comprised of two 447- (or 448-) residue heavy chains and two 214-residue light chains, with a molecular mass of 145157 Daltons when deglycosylated. Both heavy chains of canakinumab contain oligosaccharide chains linked to the protein backbone at asparagine 298 (Asn 298). The biological activity of canakinumab is measured by comparing its inhibition of IL-1β-dependent expression of the reporter gene luciferase to that of a canakinumab internal reference standard, using a stably transfected cell line. ILARIS Injection. ILARIS (canakinumab) Injection is supplied as a sterile, preservative-free, clear to opalescent, colorless to slightly brownish-yellow solution for subcutaneous injection in a single-dose, glass vial with coated stopper and aluminum flip-off cap. Each vial delivers 1 mL containing 150 mg canakinumab, L-histidine (2.1 mg), L-histidine HCl monohydrate (1.3 mg), mannitol (49.2 mg), polysorbate 80 (0.4 mg), and Sterile Water for Injection.</Description>
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<NDCCode>0172-4357-49</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (0172-4357-49) </PackageDescription>
<NDC11Code>00172-4357-49</NDC11Code>
<ProductNDC>0172-4357</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ranitidine</ProprietaryName>
<NonProprietaryName>Ranitidine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970912</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075165</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19970912</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0407-2222-19</NDCCode>
<PackageDescription>10 BOTTLE, PLASTIC in 1 BOX (0407-2222-19) / 150 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00407-2222-19</NDC11Code>
<ProductNDC>0407-2222</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Visipaque</ProprietaryName>
<NonProprietaryName>Iodixanol</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVASCULAR</RouteName>
<StartMarketingDate>20021213</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020351</ApplicationNumber>
<LabelerName>GE Healthcare Inc.</LabelerName>
<SubstanceName>IODIXANOL</SubstanceName>
<StrengthNumber>270</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20021213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VISIPAQUE is indicated for.</IndicationAndUsage>
<Description>VISIPAQUE (iodixanol) injection is a dimeric, iso-osmolar, nonionic, water-soluble, radiographic contrast medium for intravascular (intravenous and intra-arterial) use. It is provided as a ready-to-use sterile, pyrogen-free, and preservative free, colorless to pale yellow solution. The chemical formula is 5,5´-[(2-hydroxy-1,3-propanediyl) bis(acetylimino)] bis[N,N´-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3- benzenedicarboxamide] with a molecular weight of 1550.20 (iodine content 49.1%). VISIPAQUE (C35H44I6N6O15) has the following structural formula. VISIPAQUE is available in two strengths: 1 VISIPAQUE 270 mg Iodine/mL (550 mg Iodixanol/mL), 0.074 mg calcium chloride dihydrate, 1.87 mg sodium chloride, 1.2 mg tromethamine, and 0.1 mg edetate calcium disodium., 2 VISIPAQUE 320 mg Iodine/mL (652 mg Iodixanol/mL), 0.044 mg calcium chloride dihydrate, 1.11 mg sodium chloride, 1.2 mg tromethamine and 0.1 mg edetate calcium disodium.</Description>
</NDC>
<NDC>
<NDCCode>0407-2223-19</NDCCode>
<PackageDescription>10 BOTTLE, PLASTIC in 1 BOX (0407-2223-19) / 150 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00407-2223-19</NDC11Code>
<ProductNDC>0407-2223</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Visipaque</ProprietaryName>
<NonProprietaryName>Iodixanol</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVASCULAR</RouteName>
<StartMarketingDate>20030909</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020351</ApplicationNumber>
<LabelerName>GE Healthcare Inc.</LabelerName>
<SubstanceName>IODIXANOL</SubstanceName>
<StrengthNumber>320</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030909</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VISIPAQUE is indicated for.</IndicationAndUsage>
<Description>VISIPAQUE (iodixanol) injection is a dimeric, iso-osmolar, nonionic, water-soluble, radiographic contrast medium for intravascular (intravenous and intra-arterial) use. It is provided as a ready-to-use sterile, pyrogen-free, and preservative free, colorless to pale yellow solution. The chemical formula is 5,5´-[(2-hydroxy-1,3-propanediyl) bis(acetylimino)] bis[N,N´-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3- benzenedicarboxamide] with a molecular weight of 1550.20 (iodine content 49.1%). VISIPAQUE (C35H44I6N6O15) has the following structural formula. VISIPAQUE is available in two strengths: 1 VISIPAQUE 270 mg Iodine/mL (550 mg Iodixanol/mL), 0.074 mg calcium chloride dihydrate, 1.87 mg sodium chloride, 1.2 mg tromethamine, and 0.1 mg edetate calcium disodium., 2 VISIPAQUE 320 mg Iodine/mL (652 mg Iodixanol/mL), 0.044 mg calcium chloride dihydrate, 1.11 mg sodium chloride, 1.2 mg tromethamine and 0.1 mg edetate calcium disodium.</Description>
</NDC>
<NDC>
<NDCCode>0407-2223-66</NDCCode>
<PackageDescription>10 BOTTLE, PLASTIC in 1 BOX (0407-2223-66) / 150 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00407-2223-66</NDC11Code>
<ProductNDC>0407-2223</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Visipaque</ProprietaryName>
<NonProprietaryName>Iodixanol</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVASCULAR</RouteName>
<StartMarketingDate>20100601</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020808</ApplicationNumber>
<LabelerName>GE Healthcare Inc.</LabelerName>
<SubstanceName>IODIXANOL</SubstanceName>
<StrengthNumber>320</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-11-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100601</StartMarketingDatePackage>
<EndMarketingDatePackage>20241109</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VISIPAQUE is indicated in for.</IndicationAndUsage>
<Description>VISIPAQUE (iodixanol) injection is a dimeric, iso-osmolar, nonionic, water-soluble, radiographic contrast medium for intravascular (intravenous and intra-arterial) use. It is provided as a ready-to-use sterile, pyrogen-free, and preservative free, colorless to pale yellow solution. The chemical formula is 5,5´-[(2-hydroxy-1,3-propanediyl) bis(acetylimino)] bis[N,N´-bis(2,3-dihydroxypropyl)-2,4,6-triiodo- 1,3- benzenedicarboxamide] with a molecular weight of 1550.20 (iodine content 49.1%). VISIPAQUE (C 35H 44I 6N 6O 15) has the following structural formula:. VISIPAQUE is available in two strengths: 1 VISIPAQUE 270 mg Iodine/mL(550 mg Iodixanol/mL), 0.074 mg calcium chloride dehydrate, 1.87 mg sodium chloride, 1.2 mg tromethamine, and 0.1 mg edetate calcium disodium. , 2 VISIPAQUE 320 mg Iodine/mL(652 mg Iodixanol/mL), 0.044 mg calcium chloride dehydrate, 1.11 mg sodium chloride, 1.2 mg tromethamine and 0.1 mg edetate calcium disodium. .</Description>
</NDC>
<NDC>
<NDCCode>0703-3213-01</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (0703-3213-01) / 5 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00703-3213-01</NDC11Code>
<ProductNDC>0703-3213</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paclitaxel</ProprietaryName>
<NonProprietaryName>Paclitaxel</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200707</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075184</ApplicationNumber>
<LabelerName>Teva Parenteral Medicines, Inc.</LabelerName>
<SubstanceName>PACLITAXEL</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200707</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paclitaxel Injection USP is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, paclitaxel injection is indicated in combination with cisplatin. Paclitaxel Injection USP is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone receptor-negative tumors (see CLINICAL STUDIES, Breast Carcinoma). Paclitaxel Injection USP is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. Paclitaxel Injection USP, in combination with cisplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy. Paclitaxel Injection USP is indicated for the second-line treatment of AIDS-related Kaposi’s sarcoma.</IndicationAndUsage>
<Description>Paclitaxel Injection USP is a clear, colorless to slightly yellow viscous solution. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Paclitaxel Injection USP is available in 30 mg (5 mL), 100 mg (16.7 mL), 150 mg (25 mL), and 300 mg (50 mL) multidose vials. Each mL of sterile nonpyrogenic solution contains 6 mg paclitaxel, USP, 527 mg of polyoxyl 35 castor oil, 2 mg of anhydrous citric acid, and 49.7% (v/v) and 39.6% (w/v) dehydrated alcohol. Paclitaxel, USP is a semi-synthetic product with antitumor activity. Paclitaxel, USP is obtained from Taxus species. The chemical name for paclitaxel, USP is 5β,20-Epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine. Paclitaxel, USP has the following structural formula. C47H51NO14 M.W. 853.9. Paclitaxel, USP is a white to off-white crystalline powder. It is highly lipophilic, insoluble in water, and melts at around 216 to 217° C.</Description>
</NDC>
<NDC>
<NDCCode>0703-3216-01</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (0703-3216-01) / 16.7 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00703-3216-01</NDC11Code>
<ProductNDC>0703-3216</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paclitaxel</ProprietaryName>
<NonProprietaryName>Paclitaxel</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200325</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075184</ApplicationNumber>
<LabelerName>Teva Parenteral Medicines, Inc.</LabelerName>
<SubstanceName>PACLITAXEL</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200325</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paclitaxel Injection USP is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, paclitaxel injection is indicated in combination with cisplatin. Paclitaxel Injection USP is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone receptor-negative tumors (see CLINICAL STUDIES, Breast Carcinoma). Paclitaxel Injection USP is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. Paclitaxel Injection USP, in combination with cisplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy. Paclitaxel Injection USP is indicated for the second-line treatment of AIDS-related Kaposi’s sarcoma.</IndicationAndUsage>
<Description>Paclitaxel Injection USP is a clear, colorless to slightly yellow viscous solution. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Paclitaxel Injection USP is available in 30 mg (5 mL), 100 mg (16.7 mL), 150 mg (25 mL), and 300 mg (50 mL) multidose vials. Each mL of sterile nonpyrogenic solution contains 6 mg paclitaxel, USP, 527 mg of polyoxyl 35 castor oil, 2 mg of anhydrous citric acid, and 49.7% (v/v) and 39.6% (w/v) dehydrated alcohol. Paclitaxel, USP is a semi-synthetic product with antitumor activity. Paclitaxel, USP is obtained from Taxus species. The chemical name for paclitaxel, USP is 5β,20-Epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine. Paclitaxel, USP has the following structural formula. C47H51NO14 M.W. 853.9. Paclitaxel, USP is a white to off-white crystalline powder. It is highly lipophilic, insoluble in water, and melts at around 216 to 217° C.</Description>
</NDC>
<NDC>
<NDCCode>0703-3217-01</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (0703-3217-01) / 25 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00703-3217-01</NDC11Code>
<ProductNDC>0703-3217</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paclitaxel</ProprietaryName>
<NonProprietaryName>Paclitaxel</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200305</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075184</ApplicationNumber>
<LabelerName>Teva Parenteral Medicines, Inc.</LabelerName>
<SubstanceName>PACLITAXEL</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200305</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paclitaxel Injection USP is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, paclitaxel injection is indicated in combination with cisplatin. Paclitaxel Injection USP is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone receptor-negative tumors (see CLINICAL STUDIES, Breast Carcinoma). Paclitaxel Injection USP is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. Paclitaxel Injection USP, in combination with cisplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy. Paclitaxel Injection USP is indicated for the second-line treatment of AIDS-related Kaposi’s sarcoma.</IndicationAndUsage>
<Description>Paclitaxel Injection USP is a clear, colorless to slightly yellow viscous solution. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Paclitaxel Injection USP is available in 30 mg (5 mL), 100 mg (16.7 mL), 150 mg (25 mL), and 300 mg (50 mL) multidose vials. Each mL of sterile nonpyrogenic solution contains 6 mg paclitaxel, USP, 527 mg of polyoxyl 35 castor oil, 2 mg of anhydrous citric acid, and 49.7% (v/v) and 39.6% (w/v) dehydrated alcohol. Paclitaxel, USP is a semi-synthetic product with antitumor activity. Paclitaxel, USP is obtained from Taxus species. The chemical name for paclitaxel, USP is 5β,20-Epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine. Paclitaxel, USP has the following structural formula. C47H51NO14 M.W. 853.9. Paclitaxel, USP is a white to off-white crystalline powder. It is highly lipophilic, insoluble in water, and melts at around 216 to 217° C.</Description>
</NDC>
<NDC>
<NDCCode>0703-3218-01</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (0703-3218-01) / 50 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00703-3218-01</NDC11Code>
<ProductNDC>0703-3218</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paclitaxel</ProprietaryName>
<NonProprietaryName>Paclitaxel</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200305</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075184</ApplicationNumber>
<LabelerName>Teva Parenteral Medicines, Inc.</LabelerName>
<SubstanceName>PACLITAXEL</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200305</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paclitaxel Injection USP is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, paclitaxel injection is indicated in combination with cisplatin. Paclitaxel Injection USP is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone receptor-negative tumors (see CLINICAL STUDIES, Breast Carcinoma). Paclitaxel Injection USP is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. Paclitaxel Injection USP, in combination with cisplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy. Paclitaxel Injection USP is indicated for the second-line treatment of AIDS-related Kaposi’s sarcoma.</IndicationAndUsage>
<Description>Paclitaxel Injection USP is a clear, colorless to slightly yellow viscous solution. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Paclitaxel Injection USP is available in 30 mg (5 mL), 100 mg (16.7 mL), 150 mg (25 mL), and 300 mg (50 mL) multidose vials. Each mL of sterile nonpyrogenic solution contains 6 mg paclitaxel, USP, 527 mg of polyoxyl 35 castor oil, 2 mg of anhydrous citric acid, and 49.7% (v/v) and 39.6% (w/v) dehydrated alcohol. Paclitaxel, USP is a semi-synthetic product with antitumor activity. Paclitaxel, USP is obtained from Taxus species. The chemical name for paclitaxel, USP is 5β,20-Epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine. Paclitaxel, USP has the following structural formula. C47H51NO14 M.W. 853.9. Paclitaxel, USP is a white to off-white crystalline powder. It is highly lipophilic, insoluble in water, and melts at around 216 to 217° C.</Description>
</NDC>
<NDC>
<NDCCode>47783-644-01</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (47783-644-01) / 5 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>47783-0644-01</NDC11Code>
<ProductNDC>47783-644</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Takhzyro</ProprietaryName>
<NonProprietaryName>Lanadelumab-flyo</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20180824</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761090</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<SubstanceName>LANADELUMAB</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/2mL</StrengthUnit>
<Pharm_Classes>Kallikrein Inhibitors [MoA], Plasma Kallikrein Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180824</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TAKHZYRO® is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 2 years and older.</IndicationAndUsage>
<Description>Lanadelumab-flyo, a plasma kallikrein inhibitor, is a non-plasma derived, recombinant, fully human, monoclonal antibody (IgG1/κ-light chain) produced in Chinese Hamster Ovary (CHO) cells. Based on the amino acid sequence, the molecular weight of the non-glycosylated lanadelumab-flyo is 146 kDa. The calculated molecular mass of the fully reduced light chain is 23 kDa. The calculated molecular mass of the fully reduced and non-glycosylated heavy chain is 49 kDa. TAKHZYRO (lanadelumab-flyo) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous use. Each mL of ready-to-use TAKHZYRO solution contains 150 mg of lanadelumab-flyo, citric acid monohydrate (4.1 mg), L-histidine (7.8 mg), polysorbate 80 (0.1 mg), sodium chloride (5.3 mg), sodium phosphate dibasic dihydrate (5.3 mg), and Water for Injection, USP. The solution has a pH of approximately 6.0.</Description>
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<PackageDescription>1 SYRINGE, GLASS in 1 CARTON (47783-645-01) / 1 mL in 1 SYRINGE, GLASS</PackageDescription>
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<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20230203</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761090</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<SubstanceName>LANADELUMAB</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
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<LastUpdate>2026-09-22</LastUpdate>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TAKHZYRO® is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 2 years and older.</IndicationAndUsage>
<Description>Lanadelumab-flyo, a plasma kallikrein inhibitor, is a non-plasma derived, recombinant, fully human, monoclonal antibody (IgG1/κ-light chain) produced in Chinese Hamster Ovary (CHO) cells. Based on the amino acid sequence, the molecular weight of the non-glycosylated lanadelumab-flyo is 146 kDa. The calculated molecular mass of the fully reduced light chain is 23 kDa. The calculated molecular mass of the fully reduced and non-glycosylated heavy chain is 49 kDa. TAKHZYRO (lanadelumab-flyo) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous use. Each mL of ready-to-use TAKHZYRO solution contains 150 mg of lanadelumab-flyo, citric acid monohydrate (4.1 mg), L-histidine (7.8 mg), polysorbate 80 (0.1 mg), sodium chloride (5.3 mg), sodium phosphate dibasic dihydrate (5.3 mg), and Water for Injection, USP. The solution has a pH of approximately 6.0.</Description>
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<ProprietaryName>Takhzyro</ProprietaryName>
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<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20220208</StartMarketingDate>
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<ApplicationNumber>BLA761090</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<SubstanceName>LANADELUMAB</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/2mL</StrengthUnit>
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<Status>Active</Status>
<LastUpdate>2026-09-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TAKHZYRO® is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 2 years and older.</IndicationAndUsage>
<Description>Lanadelumab-flyo, a plasma kallikrein inhibitor, is a non-plasma derived, recombinant, fully human, monoclonal antibody (IgG1/κ-light chain) produced in Chinese Hamster Ovary (CHO) cells. Based on the amino acid sequence, the molecular weight of the non-glycosylated lanadelumab-flyo is 146 kDa. The calculated molecular mass of the fully reduced light chain is 23 kDa. The calculated molecular mass of the fully reduced and non-glycosylated heavy chain is 49 kDa. TAKHZYRO (lanadelumab-flyo) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous use. Each mL of ready-to-use TAKHZYRO solution contains 150 mg of lanadelumab-flyo, citric acid monohydrate (4.1 mg), L-histidine (7.8 mg), polysorbate 80 (0.1 mg), sodium chloride (5.3 mg), sodium phosphate dibasic dihydrate (5.3 mg), and Water for Injection, USP. The solution has a pH of approximately 6.0.</Description>
</NDC>
<NDC>
<NDCCode>49035-566-49</NDCCode>
<PackageDescription>44.4 mL in 1 BOTTLE (49035-566-49) </PackageDescription>
<NDC11Code>49035-0566-49</NDC11Code>
<ProductNDC>49035-566</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sunscreen Ultra Broad Spectrum</ProprietaryName>
<ProprietaryNameSuffix>Equate</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone Homosalate Octisalate Octocrylene</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190221</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>WAL-MART STORES INC.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>30; 150; 50; 70</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-10-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201006</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50881-012-10</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (50881-012-10) / 1 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>50881-0012-10</NDC11Code>
<ProductNDC>50881-012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Niktimvo</ProprietaryName>
<NonProprietaryName>Axatilimab-csfr</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20240814</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761411</ApplicationNumber>
<LabelerName>Incyte Corporation</LabelerName>
<SubstanceName>AXATILIMAB</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Colony Stimulating Factor Receptor Type 1 (CSF-1R) Inhibitors [MoA], Colony Stimulating Factor-1 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240814</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NIKTIMVO is indicated for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg.</IndicationAndUsage>
<Description>Axatilimab-csfr is a CSF-1R–blocking antibody. Axatilimab-csfr is a humanized IgG4 (kappa light chain) monoclonal antibody produced in Chinese hamster ovary cells. Axatilimab-csfr has an approximate molecular weight of 150 kDa. NIKTIMVO (axatilimab-csfr) injection is a sterile, preservative-free, slightly opalescent, pale brownish yellow solution for intravenous use. The solution is free from visible particles. Each single-dose vial contains 9 mg or 22 mg of axatilimab-csfr at a concentration of 10 mg/mL or 50 mg/mL. Each mL of solution contains citric acid monohydrate (3.6 mg), glycine (9.38 mg), polysorbate 80 (0.5 mg), sodium citrate (8.49 mg), sucrose (42.79 mg) and Water for Injection, USP. The pH is 5.0.</Description>
</NDC>
<NDC>
<NDCCode>50881-023-11</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (50881-023-11) / .44 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>50881-0023-11</NDC11Code>
<ProductNDC>50881-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Niktimvo</ProprietaryName>
<NonProprietaryName>Axatilimab-csfr</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761411</ApplicationNumber>
<LabelerName>Incyte Corporation</LabelerName>
<SubstanceName>AXATILIMAB</SubstanceName>
<StrengthNumber>22</StrengthNumber>
<StrengthUnit>mg/.44mL</StrengthUnit>
<Pharm_Classes>Colony Stimulating Factor Receptor Type 1 (CSF-1R) Inhibitors [MoA], Colony Stimulating Factor-1 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NIKTIMVO is indicated for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg.</IndicationAndUsage>
<Description>Axatilimab-csfr is a CSF-1R–blocking antibody. Axatilimab-csfr is a humanized IgG4 (kappa light chain) monoclonal antibody produced in Chinese hamster ovary cells. Axatilimab-csfr has an approximate molecular weight of 150 kDa. NIKTIMVO (axatilimab-csfr) injection is a sterile, preservative-free, slightly opalescent, pale brownish yellow solution for intravenous use. The solution is free from visible particles. Each single-dose vial contains 9 mg or 22 mg of axatilimab-csfr at a concentration of 10 mg/mL or 50 mg/mL. Each mL of solution contains citric acid monohydrate (3.6 mg), glycine (9.38 mg), polysorbate 80 (0.5 mg), sodium citrate (8.49 mg), sucrose (42.79 mg) and Water for Injection, USP. The pH is 5.0.</Description>
</NDC>
<NDC>
<NDCCode>50881-034-12</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (50881-034-12) / .18 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>50881-0034-12</NDC11Code>
<ProductNDC>50881-034</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Niktimvo</ProprietaryName>
<NonProprietaryName>Axatilimab-csfr</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761411</ApplicationNumber>
<LabelerName>Incyte Corporation</LabelerName>
<SubstanceName>AXATILIMAB</SubstanceName>
<StrengthNumber>9</StrengthNumber>
<StrengthUnit>mg/.18mL</StrengthUnit>
<Pharm_Classes>Colony Stimulating Factor Receptor Type 1 (CSF-1R) Inhibitors [MoA], Colony Stimulating Factor-1 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NIKTIMVO is indicated for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg.</IndicationAndUsage>
<Description>Axatilimab-csfr is a CSF-1R–blocking antibody. Axatilimab-csfr is a humanized IgG4 (kappa light chain) monoclonal antibody produced in Chinese hamster ovary cells. Axatilimab-csfr has an approximate molecular weight of 150 kDa. NIKTIMVO (axatilimab-csfr) injection is a sterile, preservative-free, slightly opalescent, pale brownish yellow solution for intravenous use. The solution is free from visible particles. Each single-dose vial contains 9 mg or 22 mg of axatilimab-csfr at a concentration of 10 mg/mL or 50 mg/mL. Each mL of solution contains citric acid monohydrate (3.6 mg), glycine (9.38 mg), polysorbate 80 (0.5 mg), sodium citrate (8.49 mg), sucrose (42.79 mg) and Water for Injection, USP. The pH is 5.0.</Description>
</NDC>
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