{
"NDC": [
{
"NDCCode": "50242-007-55",
"PackageDescription": "1 SYRINGE, PLASTIC in 1 CARTON (50242-007-55) / 1 mL in 1 SYRINGE, PLASTIC",
"NDC11Code": "50242-0007-55",
"ProductNDC": "50242-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enspryng",
"NonProprietaryName": "Satralizumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20200814",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761149",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "SATRALIZUMAB",
"StrengthNumber": "120",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260610",
"SamplePackage": "N",
"IndicationAndUsage": "ENSPRYNG is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.",
"Description": "Satralizumab-mwge is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody based on a human IgG2 framework. Each light chain and heavy chain consists of 214 and 443 amino acids, respectively. Satralizumab-mwge is a glycoprotein with an approximate molecular weight of 143 kDa and is produced by recombinant DNA technology in Chinese hamster ovary cells. The binding of satralizumab-mwge to the IL-6 receptor is pH-sensitive. ENSPRYNG (satralizumab-mwge) injection for subcutaneous administration is supplied as a sterile, clear, colorless to slightly yellow solution with no preservative with an approximate pH of 6. ENSPRYNG is supplied in a single-dose 1.0 mL prefilled syringe with a needle safety device or a single-dose 1.0 mL autoinjector that contains a prefilled syringe. Each prefilled syringe or autoinjector delivers 1 mL of solution containing 120 mg satralizumab-mwge, L-arginine (26.1 mg), L-aspartic acid (pH adjustment), L-histidine (3.1 mg), poloxamer 188 (0.5 mg), and Water for Injection, USP."
},
{
"NDCCode": "50242-007-01",
"PackageDescription": "1 SYRINGE, PLASTIC in 1 CARTON (50242-007-01) / 1 mL in 1 SYRINGE, PLASTIC",
"NDC11Code": "50242-0007-01",
"ProductNDC": "50242-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enspryng",
"NonProprietaryName": "Satralizumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20200814",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761149",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "SATRALIZUMAB",
"StrengthNumber": "120",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200814",
"SamplePackage": "N",
"IndicationAndUsage": "ENSPRYNG is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.",
"Description": "Satralizumab-mwge is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody based on a human IgG2 framework. Each light chain and heavy chain consists of 214 and 443 amino acids, respectively. Satralizumab-mwge is a glycoprotein with an approximate molecular weight of 143 kDa and is produced by recombinant DNA technology in Chinese hamster ovary cells. The binding of satralizumab-mwge to the IL-6 receptor is pH-sensitive. ENSPRYNG (satralizumab-mwge) injection for subcutaneous administration is supplied as a sterile, clear, colorless to slightly yellow solution with no preservative with an approximate pH of 6. ENSPRYNG is supplied in a single-dose 1.0 mL prefilled syringe with a needle safety device or a single-dose 1.0 mL autoinjector that contains a prefilled syringe. Each prefilled syringe or autoinjector delivers 1 mL of solution containing 120 mg satralizumab-mwge, L-arginine (26.1 mg), L-aspartic acid (pH adjustment), L-histidine (3.1 mg), poloxamer 188 (0.5 mg), and Water for Injection, USP."
},
{
"NDCCode": "50242-007-33",
"PackageDescription": "1 SYRINGE in 1 CARTON (50242-007-33) / 1 mL in 1 SYRINGE",
"NDC11Code": "50242-0007-33",
"ProductNDC": "50242-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enspryng",
"NonProprietaryName": "Satralizumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20200814",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761149",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "SATRALIZUMAB",
"StrengthNumber": "120",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260610",
"SamplePackage": "Y",
"IndicationAndUsage": "ENSPRYNG is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.",
"Description": "Satralizumab-mwge is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody based on a human IgG2 framework. Each light chain and heavy chain consists of 214 and 443 amino acids, respectively. Satralizumab-mwge is a glycoprotein with an approximate molecular weight of 143 kDa and is produced by recombinant DNA technology in Chinese hamster ovary cells. The binding of satralizumab-mwge to the IL-6 receptor is pH-sensitive. ENSPRYNG (satralizumab-mwge) injection for subcutaneous administration is supplied as a sterile, clear, colorless to slightly yellow solution with no preservative with an approximate pH of 6. ENSPRYNG is supplied in a single-dose 1.0 mL prefilled syringe with a needle safety device or a single-dose 1.0 mL autoinjector that contains a prefilled syringe. Each prefilled syringe or autoinjector delivers 1 mL of solution containing 120 mg satralizumab-mwge, L-arginine (26.1 mg), L-aspartic acid (pH adjustment), L-histidine (3.1 mg), poloxamer 188 (0.5 mg), and Water for Injection, USP."
},
{
"NDCCode": "50242-007-86",
"PackageDescription": "1 SYRINGE, PLASTIC in 1 CARTON (50242-007-86) / 1 mL in 1 SYRINGE, PLASTIC",
"NDC11Code": "50242-0007-86",
"ProductNDC": "50242-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enspryng",
"NonProprietaryName": "Satralizumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20200814",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761149",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "SATRALIZUMAB",
"StrengthNumber": "120",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210813",
"SamplePackage": "Y",
"IndicationAndUsage": "ENSPRYNG is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.",
"Description": "Satralizumab-mwge is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody based on a human IgG2 framework. Each light chain and heavy chain consists of 214 and 443 amino acids, respectively. Satralizumab-mwge is a glycoprotein with an approximate molecular weight of 143 kDa and is produced by recombinant DNA technology in Chinese hamster ovary cells. The binding of satralizumab-mwge to the IL-6 receptor is pH-sensitive. ENSPRYNG (satralizumab-mwge) injection for subcutaneous administration is supplied as a sterile, clear, colorless to slightly yellow solution with no preservative with an approximate pH of 6. ENSPRYNG is supplied in a single-dose 1.0 mL prefilled syringe with a needle safety device or a single-dose 1.0 mL autoinjector that contains a prefilled syringe. Each prefilled syringe or autoinjector delivers 1 mL of solution containing 120 mg satralizumab-mwge, L-arginine (26.1 mg), L-aspartic acid (pH adjustment), L-histidine (3.1 mg), poloxamer 188 (0.5 mg), and Water for Injection, USP."
},
{
"NDCCode": "50242-078-55",
"PackageDescription": "1 VIAL in 1 CARTON (50242-078-55) / 1 mL in 1 VIAL",
"NDC11Code": "50242-0078-55",
"ProductNDC": "50242-078",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Susvimo",
"NonProprietaryName": "Ranibizumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVITREAL",
"StartMarketingDate": "20211022",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761197",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "RANIBIZUMAB",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211022",
"EndMarketingDatePackage": "20270930",
"SamplePackage": "N",
"IndicationAndUsage": "SUSVIMO (ranibizumab injection) is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with: : 1 Neovascular (wet) Age-related Macular Degeneration (AMD) who have previously responded to at least two intravitreal injections of a VEGF inhibitor (1.1)., 2 Diabetic Macular Edema (DME) who have previously responded to at least two intravitreal injections of a VEGF inhibitor (1.2)., 3 Diabetic Retinopathy (DR) who have previously responded to at least two intravitreal injections of a VEGF inhibitor (1.3).",
"Description": "Ranibizumab is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment for intraocular use. Ranibizumab binds to and inhibits the biologic activity of human vascular endothelial growth factor-A (VEGF-A). Ranibizumab, which lacks an Fc region, has a molecular weight of approximately 48 kilodaltons and is produced by an E. coli expression system in a nutrient medium containing the antibiotic tetracycline. Tetracycline is not detectable in the final product. SUSVIMO (ranibizumab injection) is supplied as a sterile, clear to slightly opalescent, colorless to slightly brownish solution for intravitreal use via the SUSVIMO implant. Each single-dose vial contains 10 mg of ranibizumab, histidine HCl (0.1 mg), polysorbate 20 (0.01 mg), sucrose (8.2 mg), and Water for Injection, in 0.1 mL of solution with a pH of 5.5. The SUSVIMO implant is designed to contain approximately 0.02 mL (2 mg) of ranibizumab solution when filled. SUSVIMO does not contain an antimicrobial preservative."
},
{
"NDCCode": "50242-214-55",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (50242-214-55) / .5 mL in 1 SYRINGE, GLASS",
"NDC11Code": "50242-0214-55",
"ProductNDC": "50242-214",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xolair Pfs",
"NonProprietaryName": "Omalizumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20180928",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103976",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "OMALIZUMAB",
"StrengthNumber": "75",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "Anti-IgE [EPC], Decreased IgE Activity [PE], IgE-directed Antibody Interactions [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230818",
"SamplePackage": "N",
"IndicationAndUsage": "XOLAIR is an anti-IgE antibody indicated for: 1 Moderate to severe persistent asthma in adults and pediatric patients 6 years of age and older with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids (1.1), 2 Chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids, as add-on maintenance treatment (1.2), 3 IgE-mediated food allergy in adult and pediatric patients aged 1 year and older for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods. To be used in conjunction with food allergen avoidance (1.3), 4 Chronic spontaneous urticaria (CSU) in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment (1.4).",
"Description": "Omalizumab is a recombinant DNA-derived humanized IgG1κ monoclonal antibody that selectively binds to human immunoglobulin E (IgE). The antibody has a molecular weight of approximately 149 kiloDaltons. XOLAIR is produced by a Chinese hamster ovary cell suspension culture. XOLAIR (omalizumab) is administered as a subcutaneous (SC) injection and is available in prefilled syringe, autoinjector and in vials."
},
{
"NDCCode": "50242-215-55",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (50242-215-55) / 1 mL in 1 SYRINGE, GLASS",
"NDC11Code": "50242-0215-55",
"ProductNDC": "50242-215",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xolair Pfs",
"NonProprietaryName": "Omalizumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20180928",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103976",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "OMALIZUMAB",
"StrengthNumber": "150",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anti-IgE [EPC], Decreased IgE Activity [PE], IgE-directed Antibody Interactions [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230818",
"SamplePackage": "N",
"IndicationAndUsage": "XOLAIR is an anti-IgE antibody indicated for: 1 Moderate to severe persistent asthma in adults and pediatric patients 6 years of age and older with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids (1.1), 2 Chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids, as add-on maintenance treatment (1.2), 3 IgE-mediated food allergy in adult and pediatric patients aged 1 year and older for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods. To be used in conjunction with food allergen avoidance (1.3), 4 Chronic spontaneous urticaria (CSU) in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment (1.4).",
"Description": "Omalizumab is a recombinant DNA-derived humanized IgG1κ monoclonal antibody that selectively binds to human immunoglobulin E (IgE). The antibody has a molecular weight of approximately 149 kiloDaltons. XOLAIR is produced by a Chinese hamster ovary cell suspension culture. XOLAIR (omalizumab) is administered as a subcutaneous (SC) injection and is available in prefilled syringe, autoinjector and in vials."
},
{
"NDCCode": "50242-227-55",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (50242-227-55) / 2 mL in 1 SYRINGE, GLASS",
"NDC11Code": "50242-0227-55",
"ProductNDC": "50242-227",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xolair",
"NonProprietaryName": "Omalizumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20230818",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103976",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "OMALIZUMAB",
"StrengthNumber": "300",
"StrengthUnit": "mg/2mL",
"Pharm_Classes": "Anti-IgE [EPC], Decreased IgE Activity [PE], IgE-directed Antibody Interactions [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230818",
"SamplePackage": "N",
"IndicationAndUsage": "XOLAIR is an anti-IgE antibody indicated for: 1 Moderate to severe persistent asthma in adults and pediatric patients 6 years of age and older with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids (1.1), 2 Chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids, as add-on maintenance treatment (1.2), 3 IgE-mediated food allergy in adult and pediatric patients aged 1 year and older for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods. To be used in conjunction with food allergen avoidance (1.3), 4 Chronic spontaneous urticaria (CSU) in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment (1.4).",
"Description": "Omalizumab is a recombinant DNA-derived humanized IgG1κ monoclonal antibody that selectively binds to human immunoglobulin E (IgE). The antibody has a molecular weight of approximately 149 kiloDaltons. XOLAIR is produced by a Chinese hamster ovary cell suspension culture. XOLAIR (omalizumab) is administered as a subcutaneous (SC) injection and is available in prefilled syringe, autoinjector and in vials."
},
{
"NDCCode": "43744-007-55",
"PackageDescription": "500 g in 1 DRUM (43744-007-55)",
"NDC11Code": "43744-0007-55",
"ProductNDC": "43744-007",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Acetazolamide",
"DosageFormName": "POWDER",
"StartMarketingDate": "20110224",
"EndMarketingDate": "20110225",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "CBSCHEM LIMITED",
"SubstanceName": "ACETAZOLAMIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20110225"
},
{
"NDCCode": "49836-007-21",
"PackageDescription": "1 KIT in 1 PACKAGE, COMBINATION (49836-007-21) * 5 mL in 1 VIAL, SINGLE-DOSE * 10 mL in 1 VIAL, SINGLE-DOSE * 10 mL in 1 VIAL, SINGLE-DOSE * 2 VIAL, SINGLE-DOSE in 1 CARTON > 1 mL in 1 VIAL, SINGLE-DOSE * .55 mL in 1 POUCH * 6.5 mL in 1 PACKET",
"NDC11Code": "49836-0007-21",
"ProductNDC": "49836-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "P-care K80mx",
"NonProprietaryName": "Triamcinolone Acetonide, Bupivacaine Hcl, Lidocaine Hcl, Sodium Chloride, Povidone Iodine, Isopropyl Alcohol",
"DosageFormName": "KIT",
"StartMarketingDate": "20170616",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA014901",
"LabelerName": "RX PHARMA-PACK, INC.",
"Status": "Deprecated",
"LastUpdate": "2020-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20170616",
"SamplePackage": "N"
},
{
"NDCCode": "63551-007-55",
"PackageDescription": "208200 mL in 1 DRUM (63551-007-55)",
"NDC11Code": "63551-0007-55",
"ProductNDC": "63551-007",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stat-foam",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080901",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Triad Group",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "for hand-washing to decrease bacteria on the skin. if hands are visibly soiled, use regular soap and water. recommended for repeated use."
},
{
"NDCCode": "71262-007-55",
"PackageDescription": "1 BOTTLE in 1 CARTON (71262-007-55) / 55 mL in 1 BOTTLE",
"NDC11Code": "71262-0007-55",
"ProductNDC": "71262-007",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vitastem Ultra",
"NonProprietaryName": "Bacitracin Zinc",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210601",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M004",
"LabelerName": "ViaDerma Distribution, Inc",
"SubstanceName": "BACITRACIN ZINC",
"StrengthNumber": "500",
"StrengthUnit": "U/mL",
"Pharm_Classes": "Decreased Cell Wall Synthesis & Repair [PE]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210601",
"SamplePackage": "N",
"IndicationAndUsage": "First aid to help prevent the risk of skin infection in minor cuts, scrapes, or burns."
},
{
"NDCCode": "73905-007-07",
"PackageDescription": "55 mL in 1 BOTTLE (73905-007-07) ",
"NDC11Code": "73905-0007-07",
"ProductNDC": "73905-007",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200320",
"EndMarketingDate": "20240423",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-04-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200320",
"EndMarketingDatePackage": "20240423",
"SamplePackage": "N"
},
{
"NDCCode": "74164-007-55",
"PackageDescription": "5000 mL in 1 BOTTLE, DISPENSING (74164-007-55) ",
"NDC11Code": "74164-0007-55",
"ProductNDC": "74164-007",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bubbly Suds Hand Sanitizer Gel",
"ProprietaryNameSuffix": "Lavender Dream",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200413",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "My Hao",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "73",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200413",
"SamplePackage": "N"
},
{
"NDCCode": "74519-007-55",
"PackageDescription": "208.175 L in 1 DRUM (74519-007-55)",
"NDC11Code": "74519-0007-55",
"ProductNDC": "74519-007",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"StartMarketingDate": "20201028",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Didion Ethanol, LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "100",
"StrengthUnit": "L/100L",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "75990-007-55",
"PackageDescription": "208200 mL in 1 DRUM (75990-007-55)",
"NDC11Code": "75990-0007-55",
"ProductNDC": "75990-007",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Celox Ultra",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110425",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Certus Medical, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "for hand-washing to decrease bacteria on the skin. if hands are visibly soiled, use regular soap and water. recommended for repeated use."
},
{
"NDCCode": "80948-007-55",
"PackageDescription": "4 BOTTLE in 1 PACKAGE (80948-007-55) / 350 mL in 1 BOTTLE",
"NDC11Code": "80948-0007-55",
"ProductNDC": "80948-007",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Puroma Foaming Hand Alcohol Free Fragrance Free",
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"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Plantar Fasciitis Pain Relief Gel-patch",
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{
"NDCCode": "50242-583-01",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (50242-583-01) / 20 mL in 1 BOTTLE, GLASS",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xofluza",
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"LabelerName": "Genentech, Inc.",
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"Pharm_Classes": "Chelating Activity [MoA], Polymerase Acidic Endonuclease Inhibitor [EPC], Polymerase Acidic Endonuclease Inhibitors [MoA]",
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"IndicationAndUsage": "XOFLUZA is an influenza virus polymerase acidic (PA) endonuclease inhibitor indicated for: 1 Treatment of acute uncomplicated influenza in patients 5 years of age and older who have been symptomatic for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications. (1.1), 2 Post-exposure prophylaxis of influenza in patients 5 years of age and older following contact with an individual who has influenza. (1.2).",
"Description": "Baloxavir marboxil is an influenza virus PA endonuclease inhibitor. The active component of XOFLUZA is baloxavir marboxil. The chemical name of baloxavir marboxil is ({(12aR)-12-[(11S)-7,8-Difluoro-6,11-dihydrodibenzo[b,e]thiepin-11-yl]-6,8-dioxo-3,4,6,8,12,12a-hexahydro-1H-[1,4]oxazino[3,4-c]pyrido[2,1-f][1,2,4]triazin-7-yl}oxy)methyl methyl carbonate. The empirical formula of baloxavir marboxil is C27H23F2N3O7S, and the chemical structure is shown below. Baloxavir marboxil has a molecular mass of 571.55 grams per mole and a partition coefficient (log P) of 2.26. It is freely soluble in dimethylsulfoxide, soluble in acetonitrile, slightly soluble in methanol and ethanol, and practically insoluble in water. XOFLUZA is supplied as tablets and for oral suspension (in packets and in bottles). XOFLUZA tablets are white to light yellow, film-coated for oral administration. The 40 mg film-coated tablet contains 40 mg of baloxavir marboxil, and the 80 mg film-coated tablet contains 80 mg of baloxavir marboxil. The inactive ingredients of XOFLUZA tablets are: croscarmellose sodium, hypromellose, lactose monohydrate, microcrystalline cellulose, povidone K25, sodium stearyl fumarate, talc, and titanium dioxide. XOFLUZA for oral suspension (packets) is supplied as white to light yellow granules in a packet. Each packet contains either 30 mg or 40 mg of baloxavir marboxil. The granules must be reconstituted in about 15 to 20 mL of room temperature drinking water. The inactive ingredients are: hypromellose, maltitol, mannitol, povidone K25, silicon dioxide, sodium chloride, strawberry flavor, sucralose, and talc. XOFLUZA for oral suspension (bottles) is supplied as white to light yellow granules in an amber glass bottle. Each bottle contains 40 mg (nominal) of baloxavir marboxil. The granules must be reconstituted with 20 mL of drinking water or sterile water to yield a 2 mg/mL greyish white, white to light yellow opaque suspension with strawberry flavor. The inactive ingredients are: hypromellose, maltitol, mannitol, povidone K25, silicon dioxide, sodium chloride, strawberry flavor, sucralose, and talc."
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{
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"PackageDescription": "1 PACKET in 1 CARTON (50242-599-01) / 1 GRANULE, FOR SUSPENSION in 1 PACKET",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "Genentech, Inc.",
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"IndicationAndUsage": "XOFLUZA is an influenza virus polymerase acidic (PA) endonuclease inhibitor indicated for: 1 Treatment of acute uncomplicated influenza in patients 5 years of age and older who have been symptomatic for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications. (1.1), 2 Post-exposure prophylaxis of influenza in patients 5 years of age and older following contact with an individual who has influenza. (1.2).",
"Description": "Baloxavir marboxil is an influenza virus PA endonuclease inhibitor. The active component of XOFLUZA is baloxavir marboxil. The chemical name of baloxavir marboxil is ({(12aR)-12-[(11S)-7,8-Difluoro-6,11-dihydrodibenzo[b,e]thiepin-11-yl]-6,8-dioxo-3,4,6,8,12,12a-hexahydro-1H-[1,4]oxazino[3,4-c]pyrido[2,1-f][1,2,4]triazin-7-yl}oxy)methyl methyl carbonate. The empirical formula of baloxavir marboxil is C27H23F2N3O7S, and the chemical structure is shown below. Baloxavir marboxil has a molecular mass of 571.55 grams per mole and a partition coefficient (log P) of 2.26. It is freely soluble in dimethylsulfoxide, soluble in acetonitrile, slightly soluble in methanol and ethanol, and practically insoluble in water. XOFLUZA is supplied as tablets and for oral suspension (in packets and in bottles). XOFLUZA tablets are white to light yellow, film-coated for oral administration. The 40 mg film-coated tablet contains 40 mg of baloxavir marboxil, and the 80 mg film-coated tablet contains 80 mg of baloxavir marboxil. The inactive ingredients of XOFLUZA tablets are: croscarmellose sodium, hypromellose, lactose monohydrate, microcrystalline cellulose, povidone K25, sodium stearyl fumarate, talc, and titanium dioxide. XOFLUZA for oral suspension (packets) is supplied as white to light yellow granules in a packet. Each packet contains either 30 mg or 40 mg of baloxavir marboxil. The granules must be reconstituted in about 15 to 20 mL of room temperature drinking water. The inactive ingredients are: hypromellose, maltitol, mannitol, povidone K25, silicon dioxide, sodium chloride, strawberry flavor, sucralose, and talc. XOFLUZA for oral suspension (bottles) is supplied as white to light yellow granules in an amber glass bottle. Each bottle contains 40 mg (nominal) of baloxavir marboxil. The granules must be reconstituted with 20 mL of drinking water or sterile water to yield a 2 mg/mL greyish white, white to light yellow opaque suspension with strawberry flavor. The inactive ingredients are: hypromellose, maltitol, mannitol, povidone K25, silicon dioxide, sodium chloride, strawberry flavor, sucralose, and talc."
},
{
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"PackageDescription": "1 PACKET in 1 CARTON (50242-617-01) / 1 GRANULE, FOR SUSPENSION in 1 PACKET",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"IndicationAndUsage": "XOFLUZA is an influenza virus polymerase acidic (PA) endonuclease inhibitor indicated for: 1 Treatment of acute uncomplicated influenza in patients 5 years of age and older who have been symptomatic for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications. (1.1), 2 Post-exposure prophylaxis of influenza in patients 5 years of age and older following contact with an individual who has influenza. (1.2).",
"Description": "Baloxavir marboxil is an influenza virus PA endonuclease inhibitor. The active component of XOFLUZA is baloxavir marboxil. The chemical name of baloxavir marboxil is ({(12aR)-12-[(11S)-7,8-Difluoro-6,11-dihydrodibenzo[b,e]thiepin-11-yl]-6,8-dioxo-3,4,6,8,12,12a-hexahydro-1H-[1,4]oxazino[3,4-c]pyrido[2,1-f][1,2,4]triazin-7-yl}oxy)methyl methyl carbonate. The empirical formula of baloxavir marboxil is C27H23F2N3O7S, and the chemical structure is shown below. Baloxavir marboxil has a molecular mass of 571.55 grams per mole and a partition coefficient (log P) of 2.26. It is freely soluble in dimethylsulfoxide, soluble in acetonitrile, slightly soluble in methanol and ethanol, and practically insoluble in water. XOFLUZA is supplied as tablets and for oral suspension (in packets and in bottles). XOFLUZA tablets are white to light yellow, film-coated for oral administration. The 40 mg film-coated tablet contains 40 mg of baloxavir marboxil, and the 80 mg film-coated tablet contains 80 mg of baloxavir marboxil. The inactive ingredients of XOFLUZA tablets are: croscarmellose sodium, hypromellose, lactose monohydrate, microcrystalline cellulose, povidone K25, sodium stearyl fumarate, talc, and titanium dioxide. XOFLUZA for oral suspension (packets) is supplied as white to light yellow granules in a packet. Each packet contains either 30 mg or 40 mg of baloxavir marboxil. The granules must be reconstituted in about 15 to 20 mL of room temperature drinking water. The inactive ingredients are: hypromellose, maltitol, mannitol, povidone K25, silicon dioxide, sodium chloride, strawberry flavor, sucralose, and talc. XOFLUZA for oral suspension (bottles) is supplied as white to light yellow granules in an amber glass bottle. Each bottle contains 40 mg (nominal) of baloxavir marboxil. The granules must be reconstituted with 20 mL of drinking water or sterile water to yield a 2 mg/mL greyish white, white to light yellow opaque suspension with strawberry flavor. The inactive ingredients are: hypromellose, maltitol, mannitol, povidone K25, silicon dioxide, sodium chloride, strawberry flavor, sucralose, and talc."
},
{
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"PackageDescription": "1 BLISTER PACK in 1 CARTON (50242-860-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "50242-0860-01",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"IndicationAndUsage": "XOFLUZA is an influenza virus polymerase acidic (PA) endonuclease inhibitor indicated for: 1 Treatment of acute uncomplicated influenza in patients 5 years of age and older who have been symptomatic for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications. (1.1), 2 Post-exposure prophylaxis of influenza in patients 5 years of age and older following contact with an individual who has influenza. (1.2).",
"Description": "Baloxavir marboxil is an influenza virus PA endonuclease inhibitor. The active component of XOFLUZA is baloxavir marboxil. The chemical name of baloxavir marboxil is ({(12aR)-12-[(11S)-7,8-Difluoro-6,11-dihydrodibenzo[b,e]thiepin-11-yl]-6,8-dioxo-3,4,6,8,12,12a-hexahydro-1H-[1,4]oxazino[3,4-c]pyrido[2,1-f][1,2,4]triazin-7-yl}oxy)methyl methyl carbonate. The empirical formula of baloxavir marboxil is C27H23F2N3O7S, and the chemical structure is shown below. Baloxavir marboxil has a molecular mass of 571.55 grams per mole and a partition coefficient (log P) of 2.26. It is freely soluble in dimethylsulfoxide, soluble in acetonitrile, slightly soluble in methanol and ethanol, and practically insoluble in water. XOFLUZA is supplied as tablets and for oral suspension (in packets and in bottles). XOFLUZA tablets are white to light yellow, film-coated for oral administration. The 40 mg film-coated tablet contains 40 mg of baloxavir marboxil, and the 80 mg film-coated tablet contains 80 mg of baloxavir marboxil. The inactive ingredients of XOFLUZA tablets are: croscarmellose sodium, hypromellose, lactose monohydrate, microcrystalline cellulose, povidone K25, sodium stearyl fumarate, talc, and titanium dioxide. XOFLUZA for oral suspension (packets) is supplied as white to light yellow granules in a packet. Each packet contains either 30 mg or 40 mg of baloxavir marboxil. The granules must be reconstituted in about 15 to 20 mL of room temperature drinking water. The inactive ingredients are: hypromellose, maltitol, mannitol, povidone K25, silicon dioxide, sodium chloride, strawberry flavor, sucralose, and talc. XOFLUZA for oral suspension (bottles) is supplied as white to light yellow granules in an amber glass bottle. Each bottle contains 40 mg (nominal) of baloxavir marboxil. The granules must be reconstituted with 20 mL of drinking water or sterile water to yield a 2 mg/mL greyish white, white to light yellow opaque suspension with strawberry flavor. The inactive ingredients are: hypromellose, maltitol, mannitol, povidone K25, silicon dioxide, sodium chloride, strawberry flavor, sucralose, and talc."
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{
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"NDC11Code": "50242-0860-86",
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"IndicationAndUsage": "XOFLUZA is an influenza virus polymerase acidic (PA) endonuclease inhibitor indicated for: 1 Treatment of acute uncomplicated influenza in patients 5 years of age and older who have been symptomatic for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications. (1.1), 2 Post-exposure prophylaxis of influenza in patients 5 years of age and older following contact with an individual who has influenza. (1.2).",
"Description": "Baloxavir marboxil is an influenza virus PA endonuclease inhibitor. The active component of XOFLUZA is baloxavir marboxil. The chemical name of baloxavir marboxil is ({(12aR)-12-[(11S)-7,8-Difluoro-6,11-dihydrodibenzo[b,e]thiepin-11-yl]-6,8-dioxo-3,4,6,8,12,12a-hexahydro-1H-[1,4]oxazino[3,4-c]pyrido[2,1-f][1,2,4]triazin-7-yl}oxy)methyl methyl carbonate. The empirical formula of baloxavir marboxil is C27H23F2N3O7S, and the chemical structure is shown below. Baloxavir marboxil has a molecular mass of 571.55 grams per mole and a partition coefficient (log P) of 2.26. It is freely soluble in dimethylsulfoxide, soluble in acetonitrile, slightly soluble in methanol and ethanol, and practically insoluble in water. XOFLUZA is supplied as tablets and for oral suspension (in packets and in bottles). XOFLUZA tablets are white to light yellow, film-coated for oral administration. The 40 mg film-coated tablet contains 40 mg of baloxavir marboxil, and the 80 mg film-coated tablet contains 80 mg of baloxavir marboxil. The inactive ingredients of XOFLUZA tablets are: croscarmellose sodium, hypromellose, lactose monohydrate, microcrystalline cellulose, povidone K25, sodium stearyl fumarate, talc, and titanium dioxide. XOFLUZA for oral suspension (packets) is supplied as white to light yellow granules in a packet. Each packet contains either 30 mg or 40 mg of baloxavir marboxil. The granules must be reconstituted in about 15 to 20 mL of room temperature drinking water. The inactive ingredients are: hypromellose, maltitol, mannitol, povidone K25, silicon dioxide, sodium chloride, strawberry flavor, sucralose, and talc. XOFLUZA for oral suspension (bottles) is supplied as white to light yellow granules in an amber glass bottle. Each bottle contains 40 mg (nominal) of baloxavir marboxil. The granules must be reconstituted with 20 mL of drinking water or sterile water to yield a 2 mg/mL greyish white, white to light yellow opaque suspension with strawberry flavor. The inactive ingredients are: hypromellose, maltitol, mannitol, povidone K25, silicon dioxide, sodium chloride, strawberry flavor, sucralose, and talc."
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{
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"Pharm_Classes": "Chelating Activity [MoA], Polymerase Acidic Endonuclease Inhibitor [EPC], Polymerase Acidic Endonuclease Inhibitors [MoA]",
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"IndicationAndUsage": "XOFLUZA is an influenza virus polymerase acidic (PA) endonuclease inhibitor indicated for: 1 Treatment of acute uncomplicated influenza in patients 5 years of age and older who have been symptomatic for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications. (1.1), 2 Post-exposure prophylaxis of influenza in patients 5 years of age and older following contact with an individual who has influenza. (1.2).",
"Description": "Baloxavir marboxil is an influenza virus PA endonuclease inhibitor. The active component of XOFLUZA is baloxavir marboxil. The chemical name of baloxavir marboxil is ({(12aR)-12-[(11S)-7,8-Difluoro-6,11-dihydrodibenzo[b,e]thiepin-11-yl]-6,8-dioxo-3,4,6,8,12,12a-hexahydro-1H-[1,4]oxazino[3,4-c]pyrido[2,1-f][1,2,4]triazin-7-yl}oxy)methyl methyl carbonate. The empirical formula of baloxavir marboxil is C27H23F2N3O7S, and the chemical structure is shown below. Baloxavir marboxil has a molecular mass of 571.55 grams per mole and a partition coefficient (log P) of 2.26. It is freely soluble in dimethylsulfoxide, soluble in acetonitrile, slightly soluble in methanol and ethanol, and practically insoluble in water. XOFLUZA is supplied as tablets and for oral suspension (in packets and in bottles). XOFLUZA tablets are white to light yellow, film-coated for oral administration. The 40 mg film-coated tablet contains 40 mg of baloxavir marboxil, and the 80 mg film-coated tablet contains 80 mg of baloxavir marboxil. The inactive ingredients of XOFLUZA tablets are: croscarmellose sodium, hypromellose, lactose monohydrate, microcrystalline cellulose, povidone K25, sodium stearyl fumarate, talc, and titanium dioxide. XOFLUZA for oral suspension (packets) is supplied as white to light yellow granules in a packet. Each packet contains either 30 mg or 40 mg of baloxavir marboxil. The granules must be reconstituted in about 15 to 20 mL of room temperature drinking water. The inactive ingredients are: hypromellose, maltitol, mannitol, povidone K25, silicon dioxide, sodium chloride, strawberry flavor, sucralose, and talc. XOFLUZA for oral suspension (bottles) is supplied as white to light yellow granules in an amber glass bottle. Each bottle contains 40 mg (nominal) of baloxavir marboxil. The granules must be reconstituted with 20 mL of drinking water or sterile water to yield a 2 mg/mL greyish white, white to light yellow opaque suspension with strawberry flavor. The inactive ingredients are: hypromellose, maltitol, mannitol, povidone K25, silicon dioxide, sodium chloride, strawberry flavor, sucralose, and talc."
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"IndicationAndUsage": "XOFLUZA is an influenza virus polymerase acidic (PA) endonuclease inhibitor indicated for: 1 Treatment of acute uncomplicated influenza in patients 5 years of age and older who have been symptomatic for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications. (1.1), 2 Post-exposure prophylaxis of influenza in patients 5 years of age and older following contact with an individual who has influenza. (1.2).",
"Description": "Baloxavir marboxil is an influenza virus PA endonuclease inhibitor. The active component of XOFLUZA is baloxavir marboxil. The chemical name of baloxavir marboxil is ({(12aR)-12-[(11S)-7,8-Difluoro-6,11-dihydrodibenzo[b,e]thiepin-11-yl]-6,8-dioxo-3,4,6,8,12,12a-hexahydro-1H-[1,4]oxazino[3,4-c]pyrido[2,1-f][1,2,4]triazin-7-yl}oxy)methyl methyl carbonate. The empirical formula of baloxavir marboxil is C27H23F2N3O7S, and the chemical structure is shown below. Baloxavir marboxil has a molecular mass of 571.55 grams per mole and a partition coefficient (log P) of 2.26. It is freely soluble in dimethylsulfoxide, soluble in acetonitrile, slightly soluble in methanol and ethanol, and practically insoluble in water. XOFLUZA is supplied as tablets and for oral suspension (in packets and in bottles). XOFLUZA tablets are white to light yellow, film-coated for oral administration. The 40 mg film-coated tablet contains 40 mg of baloxavir marboxil, and the 80 mg film-coated tablet contains 80 mg of baloxavir marboxil. The inactive ingredients of XOFLUZA tablets are: croscarmellose sodium, hypromellose, lactose monohydrate, microcrystalline cellulose, povidone K25, sodium stearyl fumarate, talc, and titanium dioxide. XOFLUZA for oral suspension (packets) is supplied as white to light yellow granules in a packet. Each packet contains either 30 mg or 40 mg of baloxavir marboxil. The granules must be reconstituted in about 15 to 20 mL of room temperature drinking water. The inactive ingredients are: hypromellose, maltitol, mannitol, povidone K25, silicon dioxide, sodium chloride, strawberry flavor, sucralose, and talc. XOFLUZA for oral suspension (bottles) is supplied as white to light yellow granules in an amber glass bottle. Each bottle contains 40 mg (nominal) of baloxavir marboxil. The granules must be reconstituted with 20 mL of drinking water or sterile water to yield a 2 mg/mL greyish white, white to light yellow opaque suspension with strawberry flavor. The inactive ingredients are: hypromellose, maltitol, mannitol, povidone K25, silicon dioxide, sodium chloride, strawberry flavor, sucralose, and talc."
},
{
"NDCCode": "25682-007-01",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (25682-007-01) / 10 mL in 1 VIAL, GLASS",
"NDC11Code": "25682-0007-01",
"ProductNDC": "25682-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kanuma",
"NonProprietaryName": "Sebelipase Alfa",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20151208",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125561",
"LabelerName": "Alexion Pharmaceuticals, Inc.",
"SubstanceName": "SEBELIPASE ALFA",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Hydrolytic Lysosomal Cholesteryl Ester-specific Enzyme [EPC], Hydrolytic Lysosomal Triacylglycerol-specific Enzyme [EPC], Sterol Esterase [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151208",
"SamplePackage": "N",
"IndicationAndUsage": "KANUMA® is indicated for the treatment of patients with a diagnosis of Lysosomal Acid Lipase (LAL) deficiency.",
"Description": "Sebelipase alfa is a recombinant human lysosomal acid lipase (rhLAL) that is a lysosomal glycoprotein enzyme produced by recombinant DNA technology in the egg white of eggs laid by genetically engineered chickens. Purified sebelipase alfa is a monomeric glycoprotein containing 6 N-linked glycosylation sites and has a molecular mass of approximately 55 kDa. The amino acid sequence for sebelipase alfa is the same as the amino acid sequence for human LAL. The specific activity of sebelipase alfa is 195 to 345 units/mg. One unit is the amount of enzyme activity that catalyzes the hydrolysis of 1 micromole of the synthetic substrate 4-methylumbelliferyl oleate per minute at 37°C under specified assay conditions. KANUMA (sebelipase alfa) injection is supplied as a sterile, preservative-free, non-pyrogenic clear to slightly opalescent, colorless to slightly colored aqueous solution in single-dose vials for intravenous infusion. Each vial contains sebelipase alfa 20 mg/10 mL. Each mL of solution contains sebelipase alfa (2 mg), citric acid monohydrate (1.57 mg), Human Serum Albumin (10 mg), and trisodium citrate dihydrate (13.7 mg) at pH 5.9."
},
{
"NDCCode": "69912-007-01",
"PackageDescription": "25 kg in 1 CONTAINER (69912-007-01) ",
"NDC11Code": "69912-0007-01",
"ProductNDC": "69912-007",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "LIQUID",
"StartMarketingDate": "20200327",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Nanomateriales, S.A. de C.V.",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": ".55",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "27-MAR-20"
},
{
"NDCCode": "82761-007-60",
"PackageDescription": "1 TUBE in 1 CARTON (82761-007-60) / 50 mL in 1 TUBE",
"NDC11Code": "82761-0007-60",
"ProductNDC": "82761-007",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Laura Mercier Tinted Moisturizer Light Revealer Natural Skin Illuminator Broad Spectrum Spf 25 Sunscreen 3n1 Sand",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, And Octocrylene",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220831",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Laura Mercier US Buyer LLC",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "1.53; 2.55; 2.55; 1.53",
"StrengthUnit": "g/50mL; g/50mL; g/50mL; g/50mL",
"Status": "Active",
"LastUpdate": "2023-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220831",
"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": "50242-001-05",
"PackageDescription": "1 AMPULE in 1 CONTAINER (50242-001-05) > 5 mL in 1 AMPULE",
"NDC11Code": "50242-0001-05",
"ProductNDC": "50242-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sterile Water",
"NonProprietaryName": "Water",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20180505",
"MarketingCategoryName": "UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "WATER",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20180505",
"EndMarketingDatePackage": "20230119",
"SamplePackage": "N"
},
{
"NDCCode": "50242-014-03",
"PackageDescription": "1 KIT in 1 CARTON (50242-014-03) * 1 VIAL, SINGLE-USE in 1 CARTON (50242-009-01) / 5 mL in 1 VIAL, SINGLE-USE * 1 VIAL, SINGLE-USE in 1 CARTON (50242-907-01) / 5.2 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "50242-0014-03",
"ProductNDC": "50242-014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tnkase",
"NonProprietaryName": "Tenecteplase",
"DosageFormName": "KIT",
"StartMarketingDate": "20250228",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103909",
"LabelerName": "Genentech, Inc.",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250228",
"SamplePackage": "N",
"IndicationAndUsage": "TNKase is a tissue plasminogen activator (tPA) indicated: 1 for the treatment of acute ischemic stroke (AIS) in adults. (1.1), 2 to reduce the risk of death associated with acute ST elevation myocardial infarction (STEMI) in adults. (1.2).",
"Description": "Tenecteplase is a tissue plasminogen activator (tPA) produced by recombinant DNA technology using a mammalian cell line (Chinese Hamster Ovary cells). Tenecteplase is a 527-amino acid glycoprotein developed by introducing the following modifications to the complementary DNA (cDNA) for natural human tPA: a substitution of threonine 103 with asparagine, and a substitution of asparagine 117 with glutamine, both within the kringle 1 domain, and a tetra-alanine substitution at amino acids 296–299 in the protease domain. It has a molecular weight of 58,742 daltons. Biological potency is determined by an in vitro clot lysis assay and is expressed in tenecteplase specific units. The specific activity of tenecteplase has been defined as 200 units/mg. TNKase (tenecteplase) for injection is a sterile, white to pale yellow, lyophilized powder for intravenous bolus administration after reconstitution with Sterile Water for Injection, USP. Each 25 mg single-dose vial of TNKase nominally contains 25 mg of tenecteplase, arginine (261 mg), phosphoric acid (approximately 80 mg), and polysorbate 20 (2.0 mg). Following reconstitution with the supplied 5.2 mL single-dose vial of Sterile Water for Injection, USP, the final concentration is 5 mg/mL with a pH of approximately 7.3. Each 50 mg single-dose vial of TNKase nominally contains 50 mg of tenecteplase, arginine (522 mg), phosphoric acid (approximately 160 mg), and polysorbate 20 (4.0 mg). Following reconstitution with the supplied 10 mL single-dose vial of Sterile Water for Injection, USP, the final concentration is 5 mg/mL with a pH of approximately 7.3."
}
]
}
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<NDCList>
<NDC>
<NDCCode>50242-007-55</NDCCode>
<PackageDescription>1 SYRINGE, PLASTIC in 1 CARTON (50242-007-55) / 1 mL in 1 SYRINGE, PLASTIC</PackageDescription>
<NDC11Code>50242-0007-55</NDC11Code>
<ProductNDC>50242-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Enspryng</ProprietaryName>
<NonProprietaryName>Satralizumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20200814</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761149</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>SATRALIZUMAB</SubstanceName>
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<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ENSPRYNG is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.</IndicationAndUsage>
<Description>Satralizumab-mwge is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody based on a human IgG2 framework. Each light chain and heavy chain consists of 214 and 443 amino acids, respectively. Satralizumab-mwge is a glycoprotein with an approximate molecular weight of 143 kDa and is produced by recombinant DNA technology in Chinese hamster ovary cells. The binding of satralizumab-mwge to the IL-6 receptor is pH-sensitive. ENSPRYNG (satralizumab-mwge) injection for subcutaneous administration is supplied as a sterile, clear, colorless to slightly yellow solution with no preservative with an approximate pH of 6. ENSPRYNG is supplied in a single-dose 1.0 mL prefilled syringe with a needle safety device or a single-dose 1.0 mL autoinjector that contains a prefilled syringe. Each prefilled syringe or autoinjector delivers 1 mL of solution containing 120 mg satralizumab-mwge, L-arginine (26.1 mg), L-aspartic acid (pH adjustment), L-histidine (3.1 mg), poloxamer 188 (0.5 mg), and Water for Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>50242-007-01</NDCCode>
<PackageDescription>1 SYRINGE, PLASTIC in 1 CARTON (50242-007-01) / 1 mL in 1 SYRINGE, PLASTIC</PackageDescription>
<NDC11Code>50242-0007-01</NDC11Code>
<ProductNDC>50242-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Enspryng</ProprietaryName>
<NonProprietaryName>Satralizumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
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<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761149</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>SATRALIZUMAB</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200814</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ENSPRYNG is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.</IndicationAndUsage>
<Description>Satralizumab-mwge is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody based on a human IgG2 framework. Each light chain and heavy chain consists of 214 and 443 amino acids, respectively. Satralizumab-mwge is a glycoprotein with an approximate molecular weight of 143 kDa and is produced by recombinant DNA technology in Chinese hamster ovary cells. The binding of satralizumab-mwge to the IL-6 receptor is pH-sensitive. ENSPRYNG (satralizumab-mwge) injection for subcutaneous administration is supplied as a sterile, clear, colorless to slightly yellow solution with no preservative with an approximate pH of 6. ENSPRYNG is supplied in a single-dose 1.0 mL prefilled syringe with a needle safety device or a single-dose 1.0 mL autoinjector that contains a prefilled syringe. Each prefilled syringe or autoinjector delivers 1 mL of solution containing 120 mg satralizumab-mwge, L-arginine (26.1 mg), L-aspartic acid (pH adjustment), L-histidine (3.1 mg), poloxamer 188 (0.5 mg), and Water for Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>50242-007-33</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (50242-007-33) / 1 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>50242-0007-33</NDC11Code>
<ProductNDC>50242-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Enspryng</ProprietaryName>
<NonProprietaryName>Satralizumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20200814</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761149</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>SATRALIZUMAB</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260610</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>ENSPRYNG is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.</IndicationAndUsage>
<Description>Satralizumab-mwge is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody based on a human IgG2 framework. Each light chain and heavy chain consists of 214 and 443 amino acids, respectively. Satralizumab-mwge is a glycoprotein with an approximate molecular weight of 143 kDa and is produced by recombinant DNA technology in Chinese hamster ovary cells. The binding of satralizumab-mwge to the IL-6 receptor is pH-sensitive. ENSPRYNG (satralizumab-mwge) injection for subcutaneous administration is supplied as a sterile, clear, colorless to slightly yellow solution with no preservative with an approximate pH of 6. ENSPRYNG is supplied in a single-dose 1.0 mL prefilled syringe with a needle safety device or a single-dose 1.0 mL autoinjector that contains a prefilled syringe. Each prefilled syringe or autoinjector delivers 1 mL of solution containing 120 mg satralizumab-mwge, L-arginine (26.1 mg), L-aspartic acid (pH adjustment), L-histidine (3.1 mg), poloxamer 188 (0.5 mg), and Water for Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>50242-007-86</NDCCode>
<PackageDescription>1 SYRINGE, PLASTIC in 1 CARTON (50242-007-86) / 1 mL in 1 SYRINGE, PLASTIC</PackageDescription>
<NDC11Code>50242-0007-86</NDC11Code>
<ProductNDC>50242-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Enspryng</ProprietaryName>
<NonProprietaryName>Satralizumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20200814</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761149</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>SATRALIZUMAB</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210813</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>ENSPRYNG is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.</IndicationAndUsage>
<Description>Satralizumab-mwge is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody based on a human IgG2 framework. Each light chain and heavy chain consists of 214 and 443 amino acids, respectively. Satralizumab-mwge is a glycoprotein with an approximate molecular weight of 143 kDa and is produced by recombinant DNA technology in Chinese hamster ovary cells. The binding of satralizumab-mwge to the IL-6 receptor is pH-sensitive. ENSPRYNG (satralizumab-mwge) injection for subcutaneous administration is supplied as a sterile, clear, colorless to slightly yellow solution with no preservative with an approximate pH of 6. ENSPRYNG is supplied in a single-dose 1.0 mL prefilled syringe with a needle safety device or a single-dose 1.0 mL autoinjector that contains a prefilled syringe. Each prefilled syringe or autoinjector delivers 1 mL of solution containing 120 mg satralizumab-mwge, L-arginine (26.1 mg), L-aspartic acid (pH adjustment), L-histidine (3.1 mg), poloxamer 188 (0.5 mg), and Water for Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>50242-078-55</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (50242-078-55) / 1 mL in 1 VIAL</PackageDescription>
<NDC11Code>50242-0078-55</NDC11Code>
<ProductNDC>50242-078</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Susvimo</ProprietaryName>
<NonProprietaryName>Ranibizumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVITREAL</RouteName>
<StartMarketingDate>20211022</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761197</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>RANIBIZUMAB</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211022</StartMarketingDatePackage>
<EndMarketingDatePackage>20270930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SUSVIMO (ranibizumab injection) is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with: : 1 Neovascular (wet) Age-related Macular Degeneration (AMD) who have previously responded to at least two intravitreal injections of a VEGF inhibitor (1.1)., 2 Diabetic Macular Edema (DME) who have previously responded to at least two intravitreal injections of a VEGF inhibitor (1.2)., 3 Diabetic Retinopathy (DR) who have previously responded to at least two intravitreal injections of a VEGF inhibitor (1.3).</IndicationAndUsage>
<Description>Ranibizumab is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment for intraocular use. Ranibizumab binds to and inhibits the biologic activity of human vascular endothelial growth factor-A (VEGF-A). Ranibizumab, which lacks an Fc region, has a molecular weight of approximately 48 kilodaltons and is produced by an E. coli expression system in a nutrient medium containing the antibiotic tetracycline. Tetracycline is not detectable in the final product. SUSVIMO (ranibizumab injection) is supplied as a sterile, clear to slightly opalescent, colorless to slightly brownish solution for intravitreal use via the SUSVIMO implant. Each single-dose vial contains 10 mg of ranibizumab, histidine HCl (0.1 mg), polysorbate 20 (0.01 mg), sucrose (8.2 mg), and Water for Injection, in 0.1 mL of solution with a pH of 5.5. The SUSVIMO implant is designed to contain approximately 0.02 mL (2 mg) of ranibizumab solution when filled. SUSVIMO does not contain an antimicrobial preservative.</Description>
</NDC>
<NDC>
<NDCCode>50242-214-55</NDCCode>
<PackageDescription>1 SYRINGE, GLASS in 1 CARTON (50242-214-55) / .5 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>50242-0214-55</NDC11Code>
<ProductNDC>50242-214</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xolair Pfs</ProprietaryName>
<NonProprietaryName>Omalizumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20180928</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103976</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>OMALIZUMAB</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Pharm_Classes>Anti-IgE [EPC], Decreased IgE Activity [PE], IgE-directed Antibody Interactions [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230818</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>XOLAIR is an anti-IgE antibody indicated for: 1 Moderate to severe persistent asthma in adults and pediatric patients 6 years of age and older with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids (1.1), 2 Chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids, as add-on maintenance treatment (1.2), 3 IgE-mediated food allergy in adult and pediatric patients aged 1 year and older for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods. To be used in conjunction with food allergen avoidance (1.3), 4 Chronic spontaneous urticaria (CSU) in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment (1.4).</IndicationAndUsage>
<Description>Omalizumab is a recombinant DNA-derived humanized IgG1κ monoclonal antibody that selectively binds to human immunoglobulin E (IgE). The antibody has a molecular weight of approximately 149 kiloDaltons. XOLAIR is produced by a Chinese hamster ovary cell suspension culture. XOLAIR (omalizumab) is administered as a subcutaneous (SC) injection and is available in prefilled syringe, autoinjector and in vials.</Description>
</NDC>
<NDC>
<NDCCode>50242-215-55</NDCCode>
<PackageDescription>1 SYRINGE, GLASS in 1 CARTON (50242-215-55) / 1 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>50242-0215-55</NDC11Code>
<ProductNDC>50242-215</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xolair Pfs</ProprietaryName>
<NonProprietaryName>Omalizumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20180928</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103976</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>OMALIZUMAB</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anti-IgE [EPC], Decreased IgE Activity [PE], IgE-directed Antibody Interactions [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230818</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>XOLAIR is an anti-IgE antibody indicated for: 1 Moderate to severe persistent asthma in adults and pediatric patients 6 years of age and older with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids (1.1), 2 Chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids, as add-on maintenance treatment (1.2), 3 IgE-mediated food allergy in adult and pediatric patients aged 1 year and older for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods. To be used in conjunction with food allergen avoidance (1.3), 4 Chronic spontaneous urticaria (CSU) in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment (1.4).</IndicationAndUsage>
<Description>Omalizumab is a recombinant DNA-derived humanized IgG1κ monoclonal antibody that selectively binds to human immunoglobulin E (IgE). The antibody has a molecular weight of approximately 149 kiloDaltons. XOLAIR is produced by a Chinese hamster ovary cell suspension culture. XOLAIR (omalizumab) is administered as a subcutaneous (SC) injection and is available in prefilled syringe, autoinjector and in vials.</Description>
</NDC>
<NDC>
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<PackageDescription>1 SYRINGE, GLASS in 1 CARTON (50242-227-55) / 2 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>50242-0227-55</NDC11Code>
<ProductNDC>50242-227</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xolair</ProprietaryName>
<NonProprietaryName>Omalizumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
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<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103976</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>OMALIZUMAB</SubstanceName>
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<StrengthUnit>mg/2mL</StrengthUnit>
<Pharm_Classes>Anti-IgE [EPC], Decreased IgE Activity [PE], IgE-directed Antibody Interactions [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>XOLAIR is an anti-IgE antibody indicated for: 1 Moderate to severe persistent asthma in adults and pediatric patients 6 years of age and older with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids (1.1), 2 Chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids, as add-on maintenance treatment (1.2), 3 IgE-mediated food allergy in adult and pediatric patients aged 1 year and older for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods. To be used in conjunction with food allergen avoidance (1.3), 4 Chronic spontaneous urticaria (CSU) in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment (1.4).</IndicationAndUsage>
<Description>Omalizumab is a recombinant DNA-derived humanized IgG1κ monoclonal antibody that selectively binds to human immunoglobulin E (IgE). The antibody has a molecular weight of approximately 149 kiloDaltons. XOLAIR is produced by a Chinese hamster ovary cell suspension culture. XOLAIR (omalizumab) is administered as a subcutaneous (SC) injection and is available in prefilled syringe, autoinjector and in vials.</Description>
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<NDC>
<NDCCode>43744-007-55</NDCCode>
<PackageDescription>500 g in 1 DRUM (43744-007-55)</PackageDescription>
<NDC11Code>43744-0007-55</NDC11Code>
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<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Acetazolamide</NonProprietaryName>
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<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>CBSCHEM LIMITED</LabelerName>
<SubstanceName>ACETAZOLAMIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20110225</ListingRecordCertifiedThrough>
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<NDC>
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<PackageDescription>1 KIT in 1 PACKAGE, COMBINATION (49836-007-21) * 5 mL in 1 VIAL, SINGLE-DOSE * 10 mL in 1 VIAL, SINGLE-DOSE * 10 mL in 1 VIAL, SINGLE-DOSE * 2 VIAL, SINGLE-DOSE in 1 CARTON > 1 mL in 1 VIAL, SINGLE-DOSE * .55 mL in 1 POUCH * 6.5 mL in 1 PACKET</PackageDescription>
<NDC11Code>49836-0007-21</NDC11Code>
<ProductNDC>49836-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>P-care K80mx</ProprietaryName>
<NonProprietaryName>Triamcinolone Acetonide, Bupivacaine Hcl, Lidocaine Hcl, Sodium Chloride, Povidone Iodine, Isopropyl Alcohol</NonProprietaryName>
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<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA014901</ApplicationNumber>
<LabelerName>RX PHARMA-PACK, INC.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2020-08-19</LastUpdate>
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<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<NDC11Code>63551-0007-55</NDC11Code>
<ProductNDC>63551-007</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stat-foam</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
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<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Triad Group</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
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<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>for hand-washing to decrease bacteria on the skin. if hands are visibly soiled, use regular soap and water. recommended for repeated use.</IndicationAndUsage>
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<NDC11Code>71262-0007-55</NDC11Code>
<ProductNDC>71262-007</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vitastem Ultra</ProprietaryName>
<NonProprietaryName>Bacitracin Zinc</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
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<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M004</ApplicationNumber>
<LabelerName>ViaDerma Distribution, Inc</LabelerName>
<SubstanceName>BACITRACIN ZINC</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>U/mL</StrengthUnit>
<Pharm_Classes>Decreased Cell Wall Synthesis & Repair [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>First aid to help prevent the risk of skin infection in minor cuts, scrapes, or burns.</IndicationAndUsage>
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<NDC>
<NDCCode>73905-007-07</NDCCode>
<PackageDescription>55 mL in 1 BOTTLE (73905-007-07) </PackageDescription>
<NDC11Code>73905-0007-07</NDC11Code>
<ProductNDC>73905-007</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
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<EndMarketingDate>20240423</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-04-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200320</StartMarketingDatePackage>
<EndMarketingDatePackage>20240423</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDCCode>74164-007-55</NDCCode>
<PackageDescription>5000 mL in 1 BOTTLE, DISPENSING (74164-007-55) </PackageDescription>
<NDC11Code>74164-0007-55</NDC11Code>
<ProductNDC>74164-007</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bubbly Suds Hand Sanitizer Gel</ProprietaryName>
<ProprietaryNameSuffix>Lavender Dream</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200413</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>My Hao</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>73</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200413</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>74519-007-55</NDCCode>
<PackageDescription>208.175 L in 1 DRUM (74519-007-55)</PackageDescription>
<NDC11Code>74519-0007-55</NDC11Code>
<ProductNDC>74519-007</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<StartMarketingDate>20201028</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Didion Ethanol, LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>75990-007-55</NDCCode>
<PackageDescription>208200 mL in 1 DRUM (75990-007-55)</PackageDescription>
<NDC11Code>75990-0007-55</NDC11Code>
<ProductNDC>75990-007</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Celox Ultra</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110425</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Certus Medical, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>for hand-washing to decrease bacteria on the skin. if hands are visibly soiled, use regular soap and water. recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>80948-007-55</NDCCode>
<PackageDescription>4 BOTTLE in 1 PACKAGE (80948-007-55) / 350 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>80948-0007-55</NDC11Code>
<ProductNDC>80948-007</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Puroma Foaming Hand Alcohol Free Fragrance Free</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210310</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>ZENITH MICRO CONTROL</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>130</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210310</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps eliminate bacteria on hands.</IndicationAndUsage>
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<NDC>
<NDCCode>84165-007-55</NDCCode>
<PackageDescription>55 BAG in 1 BOX (84165-007-55) / 6 g in 1 BAG (84165-007-01) </PackageDescription>
<NDC11Code>84165-0007-55</NDC11Code>
<ProductNDC>84165-007</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Plantar Fasciitis Pain Relief Gel-patch</ProprietaryName>
<NonProprietaryName>Lidocaine, Menthol</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250507</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Guangzhou Zhupuyou E-commerce Co., Ltd</LabelerName>
<SubstanceName>MENTHOL; LIDOCAINE</SubstanceName>
<StrengthNumber>1; 4</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250507</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves muscle soreness and minor jointpains in the wrist, knees, back, neck, hips, shoulders,elbows.</IndicationAndUsage>
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<NDC>
<NDCCode>50242-583-01</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (50242-583-01) / 20 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>50242-0583-01</NDC11Code>
<ProductNDC>50242-583</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xofluza</ProprietaryName>
<NonProprietaryName>Baloxavir Marboxil</NonProprietaryName>
<DosageFormName>GRANULE, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181024</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA214410</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>BALOXAVIR MARBOXIL</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/20mL</StrengthUnit>
<Pharm_Classes>Chelating Activity [MoA], Polymerase Acidic Endonuclease Inhibitor [EPC], Polymerase Acidic Endonuclease Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>XOFLUZA is an influenza virus polymerase acidic (PA) endonuclease inhibitor indicated for: 1 Treatment of acute uncomplicated influenza in patients 5 years of age and older who have been symptomatic for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications. (1.1), 2 Post-exposure prophylaxis of influenza in patients 5 years of age and older following contact with an individual who has influenza. (1.2).</IndicationAndUsage>
<Description>Baloxavir marboxil is an influenza virus PA endonuclease inhibitor. The active component of XOFLUZA is baloxavir marboxil. The chemical name of baloxavir marboxil is ({(12aR)-12-[(11S)-7,8-Difluoro-6,11-dihydrodibenzo[b,e]thiepin-11-yl]-6,8-dioxo-3,4,6,8,12,12a-hexahydro-1H-[1,4]oxazino[3,4-c]pyrido[2,1-f][1,2,4]triazin-7-yl}oxy)methyl methyl carbonate. The empirical formula of baloxavir marboxil is C27H23F2N3O7S, and the chemical structure is shown below. Baloxavir marboxil has a molecular mass of 571.55 grams per mole and a partition coefficient (log P) of 2.26. It is freely soluble in dimethylsulfoxide, soluble in acetonitrile, slightly soluble in methanol and ethanol, and practically insoluble in water. XOFLUZA is supplied as tablets and for oral suspension (in packets and in bottles). XOFLUZA tablets are white to light yellow, film-coated for oral administration. The 40 mg film-coated tablet contains 40 mg of baloxavir marboxil, and the 80 mg film-coated tablet contains 80 mg of baloxavir marboxil. The inactive ingredients of XOFLUZA tablets are: croscarmellose sodium, hypromellose, lactose monohydrate, microcrystalline cellulose, povidone K25, sodium stearyl fumarate, talc, and titanium dioxide. XOFLUZA for oral suspension (packets) is supplied as white to light yellow granules in a packet. Each packet contains either 30 mg or 40 mg of baloxavir marboxil. The granules must be reconstituted in about 15 to 20 mL of room temperature drinking water. The inactive ingredients are: hypromellose, maltitol, mannitol, povidone K25, silicon dioxide, sodium chloride, strawberry flavor, sucralose, and talc. XOFLUZA for oral suspension (bottles) is supplied as white to light yellow granules in an amber glass bottle. Each bottle contains 40 mg (nominal) of baloxavir marboxil. The granules must be reconstituted with 20 mL of drinking water or sterile water to yield a 2 mg/mL greyish white, white to light yellow opaque suspension with strawberry flavor. The inactive ingredients are: hypromellose, maltitol, mannitol, povidone K25, silicon dioxide, sodium chloride, strawberry flavor, sucralose, and talc.</Description>
</NDC>
<NDC>
<NDCCode>50242-599-01</NDCCode>
<PackageDescription>1 PACKET in 1 CARTON (50242-599-01) / 1 GRANULE, FOR SUSPENSION in 1 PACKET</PackageDescription>
<NDC11Code>50242-0599-01</NDC11Code>
<ProductNDC>50242-599</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xofluza</ProprietaryName>
<NonProprietaryName>Baloxavir Marboxil</NonProprietaryName>
<DosageFormName>GRANULE, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250530</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA214410</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>BALOXAVIR MARBOXIL</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Chelating Activity [MoA], Polymerase Acidic Endonuclease Inhibitor [EPC], Polymerase Acidic Endonuclease Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250530</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>XOFLUZA is an influenza virus polymerase acidic (PA) endonuclease inhibitor indicated for: 1 Treatment of acute uncomplicated influenza in patients 5 years of age and older who have been symptomatic for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications. (1.1), 2 Post-exposure prophylaxis of influenza in patients 5 years of age and older following contact with an individual who has influenza. (1.2).</IndicationAndUsage>
<Description>Baloxavir marboxil is an influenza virus PA endonuclease inhibitor. The active component of XOFLUZA is baloxavir marboxil. The chemical name of baloxavir marboxil is ({(12aR)-12-[(11S)-7,8-Difluoro-6,11-dihydrodibenzo[b,e]thiepin-11-yl]-6,8-dioxo-3,4,6,8,12,12a-hexahydro-1H-[1,4]oxazino[3,4-c]pyrido[2,1-f][1,2,4]triazin-7-yl}oxy)methyl methyl carbonate. The empirical formula of baloxavir marboxil is C27H23F2N3O7S, and the chemical structure is shown below. Baloxavir marboxil has a molecular mass of 571.55 grams per mole and a partition coefficient (log P) of 2.26. It is freely soluble in dimethylsulfoxide, soluble in acetonitrile, slightly soluble in methanol and ethanol, and practically insoluble in water. XOFLUZA is supplied as tablets and for oral suspension (in packets and in bottles). XOFLUZA tablets are white to light yellow, film-coated for oral administration. The 40 mg film-coated tablet contains 40 mg of baloxavir marboxil, and the 80 mg film-coated tablet contains 80 mg of baloxavir marboxil. The inactive ingredients of XOFLUZA tablets are: croscarmellose sodium, hypromellose, lactose monohydrate, microcrystalline cellulose, povidone K25, sodium stearyl fumarate, talc, and titanium dioxide. XOFLUZA for oral suspension (packets) is supplied as white to light yellow granules in a packet. Each packet contains either 30 mg or 40 mg of baloxavir marboxil. The granules must be reconstituted in about 15 to 20 mL of room temperature drinking water. The inactive ingredients are: hypromellose, maltitol, mannitol, povidone K25, silicon dioxide, sodium chloride, strawberry flavor, sucralose, and talc. XOFLUZA for oral suspension (bottles) is supplied as white to light yellow granules in an amber glass bottle. Each bottle contains 40 mg (nominal) of baloxavir marboxil. The granules must be reconstituted with 20 mL of drinking water or sterile water to yield a 2 mg/mL greyish white, white to light yellow opaque suspension with strawberry flavor. The inactive ingredients are: hypromellose, maltitol, mannitol, povidone K25, silicon dioxide, sodium chloride, strawberry flavor, sucralose, and talc.</Description>
</NDC>
<NDC>
<NDCCode>50242-617-01</NDCCode>
<PackageDescription>1 PACKET in 1 CARTON (50242-617-01) / 1 GRANULE, FOR SUSPENSION in 1 PACKET</PackageDescription>
<NDC11Code>50242-0617-01</NDC11Code>
<ProductNDC>50242-617</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xofluza</ProprietaryName>
<NonProprietaryName>Baloxavir Marboxil</NonProprietaryName>
<DosageFormName>GRANULE, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250530</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA214410</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>BALOXAVIR MARBOXIL</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Chelating Activity [MoA], Polymerase Acidic Endonuclease Inhibitor [EPC], Polymerase Acidic Endonuclease Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250530</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>XOFLUZA is an influenza virus polymerase acidic (PA) endonuclease inhibitor indicated for: 1 Treatment of acute uncomplicated influenza in patients 5 years of age and older who have been symptomatic for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications. (1.1), 2 Post-exposure prophylaxis of influenza in patients 5 years of age and older following contact with an individual who has influenza. (1.2).</IndicationAndUsage>
<Description>Baloxavir marboxil is an influenza virus PA endonuclease inhibitor. The active component of XOFLUZA is baloxavir marboxil. The chemical name of baloxavir marboxil is ({(12aR)-12-[(11S)-7,8-Difluoro-6,11-dihydrodibenzo[b,e]thiepin-11-yl]-6,8-dioxo-3,4,6,8,12,12a-hexahydro-1H-[1,4]oxazino[3,4-c]pyrido[2,1-f][1,2,4]triazin-7-yl}oxy)methyl methyl carbonate. The empirical formula of baloxavir marboxil is C27H23F2N3O7S, and the chemical structure is shown below. Baloxavir marboxil has a molecular mass of 571.55 grams per mole and a partition coefficient (log P) of 2.26. It is freely soluble in dimethylsulfoxide, soluble in acetonitrile, slightly soluble in methanol and ethanol, and practically insoluble in water. XOFLUZA is supplied as tablets and for oral suspension (in packets and in bottles). XOFLUZA tablets are white to light yellow, film-coated for oral administration. The 40 mg film-coated tablet contains 40 mg of baloxavir marboxil, and the 80 mg film-coated tablet contains 80 mg of baloxavir marboxil. The inactive ingredients of XOFLUZA tablets are: croscarmellose sodium, hypromellose, lactose monohydrate, microcrystalline cellulose, povidone K25, sodium stearyl fumarate, talc, and titanium dioxide. XOFLUZA for oral suspension (packets) is supplied as white to light yellow granules in a packet. Each packet contains either 30 mg or 40 mg of baloxavir marboxil. The granules must be reconstituted in about 15 to 20 mL of room temperature drinking water. The inactive ingredients are: hypromellose, maltitol, mannitol, povidone K25, silicon dioxide, sodium chloride, strawberry flavor, sucralose, and talc. XOFLUZA for oral suspension (bottles) is supplied as white to light yellow granules in an amber glass bottle. Each bottle contains 40 mg (nominal) of baloxavir marboxil. The granules must be reconstituted with 20 mL of drinking water or sterile water to yield a 2 mg/mL greyish white, white to light yellow opaque suspension with strawberry flavor. The inactive ingredients are: hypromellose, maltitol, mannitol, povidone K25, silicon dioxide, sodium chloride, strawberry flavor, sucralose, and talc.</Description>
</NDC>
<NDC>
<NDCCode>50242-860-01</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (50242-860-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>50242-0860-01</NDC11Code>
<ProductNDC>50242-860</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xofluza</ProprietaryName>
<NonProprietaryName>Baloxavir Marboxil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181024</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210854</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>BALOXAVIR MARBOXIL</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Chelating Activity [MoA], Polymerase Acidic Endonuclease Inhibitor [EPC], Polymerase Acidic Endonuclease Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210326</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>XOFLUZA is an influenza virus polymerase acidic (PA) endonuclease inhibitor indicated for: 1 Treatment of acute uncomplicated influenza in patients 5 years of age and older who have been symptomatic for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications. (1.1), 2 Post-exposure prophylaxis of influenza in patients 5 years of age and older following contact with an individual who has influenza. (1.2).</IndicationAndUsage>
<Description>Baloxavir marboxil is an influenza virus PA endonuclease inhibitor. The active component of XOFLUZA is baloxavir marboxil. The chemical name of baloxavir marboxil is ({(12aR)-12-[(11S)-7,8-Difluoro-6,11-dihydrodibenzo[b,e]thiepin-11-yl]-6,8-dioxo-3,4,6,8,12,12a-hexahydro-1H-[1,4]oxazino[3,4-c]pyrido[2,1-f][1,2,4]triazin-7-yl}oxy)methyl methyl carbonate. The empirical formula of baloxavir marboxil is C27H23F2N3O7S, and the chemical structure is shown below. Baloxavir marboxil has a molecular mass of 571.55 grams per mole and a partition coefficient (log P) of 2.26. It is freely soluble in dimethylsulfoxide, soluble in acetonitrile, slightly soluble in methanol and ethanol, and practically insoluble in water. XOFLUZA is supplied as tablets and for oral suspension (in packets and in bottles). XOFLUZA tablets are white to light yellow, film-coated for oral administration. The 40 mg film-coated tablet contains 40 mg of baloxavir marboxil, and the 80 mg film-coated tablet contains 80 mg of baloxavir marboxil. The inactive ingredients of XOFLUZA tablets are: croscarmellose sodium, hypromellose, lactose monohydrate, microcrystalline cellulose, povidone K25, sodium stearyl fumarate, talc, and titanium dioxide. XOFLUZA for oral suspension (packets) is supplied as white to light yellow granules in a packet. Each packet contains either 30 mg or 40 mg of baloxavir marboxil. The granules must be reconstituted in about 15 to 20 mL of room temperature drinking water. The inactive ingredients are: hypromellose, maltitol, mannitol, povidone K25, silicon dioxide, sodium chloride, strawberry flavor, sucralose, and talc. XOFLUZA for oral suspension (bottles) is supplied as white to light yellow granules in an amber glass bottle. Each bottle contains 40 mg (nominal) of baloxavir marboxil. The granules must be reconstituted with 20 mL of drinking water or sterile water to yield a 2 mg/mL greyish white, white to light yellow opaque suspension with strawberry flavor. The inactive ingredients are: hypromellose, maltitol, mannitol, povidone K25, silicon dioxide, sodium chloride, strawberry flavor, sucralose, and talc.</Description>
</NDC>
<NDC>
<NDCCode>50242-860-86</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (50242-860-86) / 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>50242-0860-86</NDC11Code>
<ProductNDC>50242-860</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xofluza</ProprietaryName>
<NonProprietaryName>Baloxavir Marboxil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181024</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210854</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>BALOXAVIR MARBOXIL</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Chelating Activity [MoA], Polymerase Acidic Endonuclease Inhibitor [EPC], Polymerase Acidic Endonuclease Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210831</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>XOFLUZA is an influenza virus polymerase acidic (PA) endonuclease inhibitor indicated for: 1 Treatment of acute uncomplicated influenza in patients 5 years of age and older who have been symptomatic for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications. (1.1), 2 Post-exposure prophylaxis of influenza in patients 5 years of age and older following contact with an individual who has influenza. (1.2).</IndicationAndUsage>
<Description>Baloxavir marboxil is an influenza virus PA endonuclease inhibitor. The active component of XOFLUZA is baloxavir marboxil. The chemical name of baloxavir marboxil is ({(12aR)-12-[(11S)-7,8-Difluoro-6,11-dihydrodibenzo[b,e]thiepin-11-yl]-6,8-dioxo-3,4,6,8,12,12a-hexahydro-1H-[1,4]oxazino[3,4-c]pyrido[2,1-f][1,2,4]triazin-7-yl}oxy)methyl methyl carbonate. The empirical formula of baloxavir marboxil is C27H23F2N3O7S, and the chemical structure is shown below. Baloxavir marboxil has a molecular mass of 571.55 grams per mole and a partition coefficient (log P) of 2.26. It is freely soluble in dimethylsulfoxide, soluble in acetonitrile, slightly soluble in methanol and ethanol, and practically insoluble in water. XOFLUZA is supplied as tablets and for oral suspension (in packets and in bottles). XOFLUZA tablets are white to light yellow, film-coated for oral administration. The 40 mg film-coated tablet contains 40 mg of baloxavir marboxil, and the 80 mg film-coated tablet contains 80 mg of baloxavir marboxil. The inactive ingredients of XOFLUZA tablets are: croscarmellose sodium, hypromellose, lactose monohydrate, microcrystalline cellulose, povidone K25, sodium stearyl fumarate, talc, and titanium dioxide. XOFLUZA for oral suspension (packets) is supplied as white to light yellow granules in a packet. Each packet contains either 30 mg or 40 mg of baloxavir marboxil. The granules must be reconstituted in about 15 to 20 mL of room temperature drinking water. The inactive ingredients are: hypromellose, maltitol, mannitol, povidone K25, silicon dioxide, sodium chloride, strawberry flavor, sucralose, and talc. XOFLUZA for oral suspension (bottles) is supplied as white to light yellow granules in an amber glass bottle. Each bottle contains 40 mg (nominal) of baloxavir marboxil. The granules must be reconstituted with 20 mL of drinking water or sterile water to yield a 2 mg/mL greyish white, white to light yellow opaque suspension with strawberry flavor. The inactive ingredients are: hypromellose, maltitol, mannitol, povidone K25, silicon dioxide, sodium chloride, strawberry flavor, sucralose, and talc.</Description>
</NDC>
<NDC>
<NDCCode>50242-877-01</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (50242-877-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>50242-0877-01</NDC11Code>
<ProductNDC>50242-877</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xofluza</ProprietaryName>
<NonProprietaryName>Baloxavir Marboxil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181024</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210854</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>BALOXAVIR MARBOXIL</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Chelating Activity [MoA], Polymerase Acidic Endonuclease Inhibitor [EPC], Polymerase Acidic Endonuclease Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210326</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>XOFLUZA is an influenza virus polymerase acidic (PA) endonuclease inhibitor indicated for: 1 Treatment of acute uncomplicated influenza in patients 5 years of age and older who have been symptomatic for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications. (1.1), 2 Post-exposure prophylaxis of influenza in patients 5 years of age and older following contact with an individual who has influenza. (1.2).</IndicationAndUsage>
<Description>Baloxavir marboxil is an influenza virus PA endonuclease inhibitor. The active component of XOFLUZA is baloxavir marboxil. The chemical name of baloxavir marboxil is ({(12aR)-12-[(11S)-7,8-Difluoro-6,11-dihydrodibenzo[b,e]thiepin-11-yl]-6,8-dioxo-3,4,6,8,12,12a-hexahydro-1H-[1,4]oxazino[3,4-c]pyrido[2,1-f][1,2,4]triazin-7-yl}oxy)methyl methyl carbonate. The empirical formula of baloxavir marboxil is C27H23F2N3O7S, and the chemical structure is shown below. Baloxavir marboxil has a molecular mass of 571.55 grams per mole and a partition coefficient (log P) of 2.26. It is freely soluble in dimethylsulfoxide, soluble in acetonitrile, slightly soluble in methanol and ethanol, and practically insoluble in water. XOFLUZA is supplied as tablets and for oral suspension (in packets and in bottles). XOFLUZA tablets are white to light yellow, film-coated for oral administration. The 40 mg film-coated tablet contains 40 mg of baloxavir marboxil, and the 80 mg film-coated tablet contains 80 mg of baloxavir marboxil. The inactive ingredients of XOFLUZA tablets are: croscarmellose sodium, hypromellose, lactose monohydrate, microcrystalline cellulose, povidone K25, sodium stearyl fumarate, talc, and titanium dioxide. XOFLUZA for oral suspension (packets) is supplied as white to light yellow granules in a packet. Each packet contains either 30 mg or 40 mg of baloxavir marboxil. The granules must be reconstituted in about 15 to 20 mL of room temperature drinking water. The inactive ingredients are: hypromellose, maltitol, mannitol, povidone K25, silicon dioxide, sodium chloride, strawberry flavor, sucralose, and talc. XOFLUZA for oral suspension (bottles) is supplied as white to light yellow granules in an amber glass bottle. Each bottle contains 40 mg (nominal) of baloxavir marboxil. The granules must be reconstituted with 20 mL of drinking water or sterile water to yield a 2 mg/mL greyish white, white to light yellow opaque suspension with strawberry flavor. The inactive ingredients are: hypromellose, maltitol, mannitol, povidone K25, silicon dioxide, sodium chloride, strawberry flavor, sucralose, and talc.</Description>
</NDC>
<NDC>
<NDCCode>50242-877-86</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (50242-877-86) / 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>50242-0877-86</NDC11Code>
<ProductNDC>50242-877</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xofluza</ProprietaryName>
<NonProprietaryName>Baloxavir Marboxil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181024</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210854</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>BALOXAVIR MARBOXIL</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Chelating Activity [MoA], Polymerase Acidic Endonuclease Inhibitor [EPC], Polymerase Acidic Endonuclease Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210831</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>XOFLUZA is an influenza virus polymerase acidic (PA) endonuclease inhibitor indicated for: 1 Treatment of acute uncomplicated influenza in patients 5 years of age and older who have been symptomatic for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications. (1.1), 2 Post-exposure prophylaxis of influenza in patients 5 years of age and older following contact with an individual who has influenza. (1.2).</IndicationAndUsage>
<Description>Baloxavir marboxil is an influenza virus PA endonuclease inhibitor. The active component of XOFLUZA is baloxavir marboxil. The chemical name of baloxavir marboxil is ({(12aR)-12-[(11S)-7,8-Difluoro-6,11-dihydrodibenzo[b,e]thiepin-11-yl]-6,8-dioxo-3,4,6,8,12,12a-hexahydro-1H-[1,4]oxazino[3,4-c]pyrido[2,1-f][1,2,4]triazin-7-yl}oxy)methyl methyl carbonate. The empirical formula of baloxavir marboxil is C27H23F2N3O7S, and the chemical structure is shown below. Baloxavir marboxil has a molecular mass of 571.55 grams per mole and a partition coefficient (log P) of 2.26. It is freely soluble in dimethylsulfoxide, soluble in acetonitrile, slightly soluble in methanol and ethanol, and practically insoluble in water. XOFLUZA is supplied as tablets and for oral suspension (in packets and in bottles). XOFLUZA tablets are white to light yellow, film-coated for oral administration. The 40 mg film-coated tablet contains 40 mg of baloxavir marboxil, and the 80 mg film-coated tablet contains 80 mg of baloxavir marboxil. The inactive ingredients of XOFLUZA tablets are: croscarmellose sodium, hypromellose, lactose monohydrate, microcrystalline cellulose, povidone K25, sodium stearyl fumarate, talc, and titanium dioxide. XOFLUZA for oral suspension (packets) is supplied as white to light yellow granules in a packet. Each packet contains either 30 mg or 40 mg of baloxavir marboxil. The granules must be reconstituted in about 15 to 20 mL of room temperature drinking water. The inactive ingredients are: hypromellose, maltitol, mannitol, povidone K25, silicon dioxide, sodium chloride, strawberry flavor, sucralose, and talc. XOFLUZA for oral suspension (bottles) is supplied as white to light yellow granules in an amber glass bottle. Each bottle contains 40 mg (nominal) of baloxavir marboxil. The granules must be reconstituted with 20 mL of drinking water or sterile water to yield a 2 mg/mL greyish white, white to light yellow opaque suspension with strawberry flavor. The inactive ingredients are: hypromellose, maltitol, mannitol, povidone K25, silicon dioxide, sodium chloride, strawberry flavor, sucralose, and talc.</Description>
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<NDC>
<NDCCode>25682-007-01</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (25682-007-01) / 10 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>25682-0007-01</NDC11Code>
<ProductNDC>25682-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kanuma</ProprietaryName>
<NonProprietaryName>Sebelipase Alfa</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20151208</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125561</ApplicationNumber>
<LabelerName>Alexion Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SEBELIPASE ALFA</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Hydrolytic Lysosomal Cholesteryl Ester-specific Enzyme [EPC], Hydrolytic Lysosomal Triacylglycerol-specific Enzyme [EPC], Sterol Esterase [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>KANUMA® is indicated for the treatment of patients with a diagnosis of Lysosomal Acid Lipase (LAL) deficiency.</IndicationAndUsage>
<Description>Sebelipase alfa is a recombinant human lysosomal acid lipase (rhLAL) that is a lysosomal glycoprotein enzyme produced by recombinant DNA technology in the egg white of eggs laid by genetically engineered chickens. Purified sebelipase alfa is a monomeric glycoprotein containing 6 N-linked glycosylation sites and has a molecular mass of approximately 55 kDa. The amino acid sequence for sebelipase alfa is the same as the amino acid sequence for human LAL. The specific activity of sebelipase alfa is 195 to 345 units/mg. One unit is the amount of enzyme activity that catalyzes the hydrolysis of 1 micromole of the synthetic substrate 4-methylumbelliferyl oleate per minute at 37°C under specified assay conditions. KANUMA (sebelipase alfa) injection is supplied as a sterile, preservative-free, non-pyrogenic clear to slightly opalescent, colorless to slightly colored aqueous solution in single-dose vials for intravenous infusion. Each vial contains sebelipase alfa 20 mg/10 mL. Each mL of solution contains sebelipase alfa (2 mg), citric acid monohydrate (1.57 mg), Human Serum Albumin (10 mg), and trisodium citrate dihydrate (13.7 mg) at pH 5.9.</Description>
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<NDC>
<NDCCode>69912-007-01</NDCCode>
<PackageDescription>25 kg in 1 CONTAINER (69912-007-01) </PackageDescription>
<NDC11Code>69912-0007-01</NDC11Code>
<ProductNDC>69912-007</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<StartMarketingDate>20200327</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Nanomateriales, S.A. de C.V.</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>.55</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>27-MAR-20</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>82761-007-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (82761-007-60) / 50 mL in 1 TUBE</PackageDescription>
<NDC11Code>82761-0007-60</NDC11Code>
<ProductNDC>82761-007</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Laura Mercier Tinted Moisturizer Light Revealer Natural Skin Illuminator Broad Spectrum Spf 25 Sunscreen 3n1 Sand</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, And Octocrylene</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220831</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Laura Mercier US Buyer LLC</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>1.53; 2.55; 2.55; 1.53</StrengthNumber>
<StrengthUnit>g/50mL; g/50mL; g/50mL; g/50mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220831</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>50242-001-05</NDCCode>
<PackageDescription>1 AMPULE in 1 CONTAINER (50242-001-05) > 5 mL in 1 AMPULE</PackageDescription>
<NDC11Code>50242-0001-05</NDC11Code>
<ProductNDC>50242-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sterile Water</ProprietaryName>
<NonProprietaryName>Water</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20180505</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE</MarketingCategoryName>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>WATER</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180505</StartMarketingDatePackage>
<EndMarketingDatePackage>20230119</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50242-014-03</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (50242-014-03) * 1 VIAL, SINGLE-USE in 1 CARTON (50242-009-01) / 5 mL in 1 VIAL, SINGLE-USE * 1 VIAL, SINGLE-USE in 1 CARTON (50242-907-01) / 5.2 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>50242-0014-03</NDC11Code>
<ProductNDC>50242-014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tnkase</ProprietaryName>
<NonProprietaryName>Tenecteplase</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20250228</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103909</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TNKase is a tissue plasminogen activator (tPA) indicated: 1 for the treatment of acute ischemic stroke (AIS) in adults. (1.1), 2 to reduce the risk of death associated with acute ST elevation myocardial infarction (STEMI) in adults. (1.2).</IndicationAndUsage>
<Description>Tenecteplase is a tissue plasminogen activator (tPA) produced by recombinant DNA technology using a mammalian cell line (Chinese Hamster Ovary cells). Tenecteplase is a 527-amino acid glycoprotein developed by introducing the following modifications to the complementary DNA (cDNA) for natural human tPA: a substitution of threonine 103 with asparagine, and a substitution of asparagine 117 with glutamine, both within the kringle 1 domain, and a tetra-alanine substitution at amino acids 296–299 in the protease domain. It has a molecular weight of 58,742 daltons. Biological potency is determined by an in vitro clot lysis assay and is expressed in tenecteplase specific units. The specific activity of tenecteplase has been defined as 200 units/mg. TNKase (tenecteplase) for injection is a sterile, white to pale yellow, lyophilized powder for intravenous bolus administration after reconstitution with Sterile Water for Injection, USP. Each 25 mg single-dose vial of TNKase nominally contains 25 mg of tenecteplase, arginine (261 mg), phosphoric acid (approximately 80 mg), and polysorbate 20 (2.0 mg). Following reconstitution with the supplied 5.2 mL single-dose vial of Sterile Water for Injection, USP, the final concentration is 5 mg/mL with a pH of approximately 7.3. Each 50 mg single-dose vial of TNKase nominally contains 50 mg of tenecteplase, arginine (522 mg), phosphoric acid (approximately 160 mg), and polysorbate 20 (4.0 mg). Following reconstitution with the supplied 10 mL single-dose vial of Sterile Water for Injection, USP, the final concentration is 5 mg/mL with a pH of approximately 7.3.</Description>
</NDC>
</NDCList>