{
"NDC": [
{
"NDCCode": "79887-114-54",
"PackageDescription": "500 mL in 1 BOTTLE (79887-114-54) ",
"NDC11Code": "79887-0114-54",
"ProductNDC": "79887-114",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neutralizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200814",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "AWSM Marcin Szakola",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "80",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200814",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "79887-114-24",
"PackageDescription": "200 mL in 1 BOTTLE (79887-114-24) ",
"NDC11Code": "79887-0114-24",
"ProductNDC": "79887-114",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neutralizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200814",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "AWSM Marcin Szakola",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "80",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200814",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "43479-114-54",
"PackageDescription": "1 TUBE in 1 BOX (43479-114-54) / 120 mL in 1 TUBE (43479-114-14) ",
"NDC11Code": "43479-0114-54",
"ProductNDC": "43479-114",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Eradikate Clarifying Acne",
"ProprietaryNameSuffix": "Cleanser",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210401",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M006",
"LabelerName": "KATE SOMERVILLE SKINCARE, LLC",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "1",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2025-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210401",
"SamplePackage": "N",
"IndicationAndUsage": "FOR THE TREATMENT OF ACNE. HELPS KEEP SKIN CLEAR OF NEW ACNE BLEMISHES."
},
{
"NDCCode": "52347-111-01",
"PackageDescription": "116 g in 1 TUBE (52347-111-01)",
"NDC11Code": "52347-0111-01",
"ProductNDC": "52347-111",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Skin Care Prescription",
"NonProprietaryName": "Avobenzone,octocrylene,oxybenzone,homosalate,octisalate",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100623",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Skin Care Physicians, Inc.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OXYBENZONE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "3.4; 17.01; .06; .05; 4.54",
"StrengthUnit": "g/114.4g; g/113.4g; g/113.4g; g/113.4g; g/113.4g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "78206-114-01",
"PackageDescription": "1 POUCH in 1 CARTON (78206-114-01) / 1 INHALER in 1 POUCH / 120 INHALANT in 1 INHALER",
"NDC11Code": "78206-0114-01",
"ProductNDC": "78206-114",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Asmanex",
"NonProprietaryName": "Mometasone Furoate",
"DosageFormName": "INHALANT",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20210601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021067",
"LabelerName": "Organon LLC",
"SubstanceName": "MOMETASONE FUROATE",
"StrengthNumber": "220",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210601",
"SamplePackage": "N",
"IndicationAndUsage": "ASMANEX® TWISTHALER® is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 4 years of age and older. Limitations of Use. ASMANEX TWISTHALER is not indicated for the relief of acute bronchospasm. ASMANEX TWISTHALER is not indicated in children less than 4 years of age.",
"Description": "Mometasone furoate, the active component of the ASMANEX TWISTHALER product, is a corticosteroid with the chemical name 9,21-dichloro-11(Beta),17-dihydroxy-16(alpha)-methylpregna-1,4-diene-3,20-dione 17-(2-furoate) and the following chemical structure. Mometasone furoate is a white powder with an empirical formula of C27H30Cl2O6, and molecular weight of 521.44 Daltons. The ASMANEX TWISTHALER 110 mcg and 220 mcg products are cap-activated, inhalation-driven, multidose dry powder inhalers containing mometasone furoate and anhydrous lactose (which contains trace amounts of milk proteins). Each actuation of the ASMANEX TWISTHALER 110 mcg or 220 mcg inhaler provides a measured dose of approximately 0.75 or 1.5 mg mometasone furoate inhalation powder, containing 110 or 220 mcg of mometasone furoate, respectively. This results in delivery of 100 or 200 mcg mometasone furoate from the mouthpiece, respectively, based on in vitro testing at flow rates of 30 L/min and 60 L/min with constant volume of 2 L. The amount of mometasone furoate emitted from the inhaler in vitro does not differ significantly for flow rates ranging from 28.3 L/min to 70 L/min at a constant volume of 2 L. However, the amount of drug delivered to the lung will depend on patient factors such as inspiratory flow and peak inspiratory flow through the device. In adult and adolescent patients (aged ≥12 years) with varied asthma severity, mean peak inspiratory flow rate through the device was 69 L/min (range: 54–77 L/min). In pediatric patients (aged 5-12 years) diagnosed with asthma, mean peak inspiratory flow rate in the 5- to 8-year-old subgroup was >50 L/min (minimum of 46 L/min) and for the 9- to 12-year-old subgroup was >60 L/min (minimum of 48 L/min)."
},
{
"NDCCode": "78206-114-02",
"PackageDescription": "1 POUCH in 1 CARTON (78206-114-02) / 1 INHALER in 1 POUCH / 60 INHALANT in 1 INHALER",
"NDC11Code": "78206-0114-02",
"ProductNDC": "78206-114",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Asmanex",
"NonProprietaryName": "Mometasone Furoate",
"DosageFormName": "INHALANT",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20210601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021067",
"LabelerName": "Organon LLC",
"SubstanceName": "MOMETASONE FUROATE",
"StrengthNumber": "220",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210601",
"SamplePackage": "N",
"IndicationAndUsage": "ASMANEX® TWISTHALER® is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 4 years of age and older. Limitations of Use. ASMANEX TWISTHALER is not indicated for the relief of acute bronchospasm. ASMANEX TWISTHALER is not indicated in children less than 4 years of age.",
"Description": "Mometasone furoate, the active component of the ASMANEX TWISTHALER product, is a corticosteroid with the chemical name 9,21-dichloro-11(Beta),17-dihydroxy-16(alpha)-methylpregna-1,4-diene-3,20-dione 17-(2-furoate) and the following chemical structure. Mometasone furoate is a white powder with an empirical formula of C27H30Cl2O6, and molecular weight of 521.44 Daltons. The ASMANEX TWISTHALER 110 mcg and 220 mcg products are cap-activated, inhalation-driven, multidose dry powder inhalers containing mometasone furoate and anhydrous lactose (which contains trace amounts of milk proteins). Each actuation of the ASMANEX TWISTHALER 110 mcg or 220 mcg inhaler provides a measured dose of approximately 0.75 or 1.5 mg mometasone furoate inhalation powder, containing 110 or 220 mcg of mometasone furoate, respectively. This results in delivery of 100 or 200 mcg mometasone furoate from the mouthpiece, respectively, based on in vitro testing at flow rates of 30 L/min and 60 L/min with constant volume of 2 L. The amount of mometasone furoate emitted from the inhaler in vitro does not differ significantly for flow rates ranging from 28.3 L/min to 70 L/min at a constant volume of 2 L. However, the amount of drug delivered to the lung will depend on patient factors such as inspiratory flow and peak inspiratory flow through the device. In adult and adolescent patients (aged ≥12 years) with varied asthma severity, mean peak inspiratory flow rate through the device was 69 L/min (range: 54–77 L/min). In pediatric patients (aged 5-12 years) diagnosed with asthma, mean peak inspiratory flow rate in the 5- to 8-year-old subgroup was >50 L/min (minimum of 46 L/min) and for the 9- to 12-year-old subgroup was >60 L/min (minimum of 48 L/min)."
},
{
"NDCCode": "78206-114-03",
"PackageDescription": "1 POUCH in 1 CARTON (78206-114-03) / 1 INHALER in 1 POUCH / 14 INHALANT in 1 INHALER",
"NDC11Code": "78206-0114-03",
"ProductNDC": "78206-114",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Asmanex",
"NonProprietaryName": "Mometasone Furoate",
"DosageFormName": "INHALANT",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20210601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021067",
"LabelerName": "Organon LLC",
"SubstanceName": "MOMETASONE FUROATE",
"StrengthNumber": "220",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210601",
"SamplePackage": "N",
"IndicationAndUsage": "ASMANEX® TWISTHALER® is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 4 years of age and older. Limitations of Use. ASMANEX TWISTHALER is not indicated for the relief of acute bronchospasm. ASMANEX TWISTHALER is not indicated in children less than 4 years of age.",
"Description": "Mometasone furoate, the active component of the ASMANEX TWISTHALER product, is a corticosteroid with the chemical name 9,21-dichloro-11(Beta),17-dihydroxy-16(alpha)-methylpregna-1,4-diene-3,20-dione 17-(2-furoate) and the following chemical structure. Mometasone furoate is a white powder with an empirical formula of C27H30Cl2O6, and molecular weight of 521.44 Daltons. The ASMANEX TWISTHALER 110 mcg and 220 mcg products are cap-activated, inhalation-driven, multidose dry powder inhalers containing mometasone furoate and anhydrous lactose (which contains trace amounts of milk proteins). Each actuation of the ASMANEX TWISTHALER 110 mcg or 220 mcg inhaler provides a measured dose of approximately 0.75 or 1.5 mg mometasone furoate inhalation powder, containing 110 or 220 mcg of mometasone furoate, respectively. This results in delivery of 100 or 200 mcg mometasone furoate from the mouthpiece, respectively, based on in vitro testing at flow rates of 30 L/min and 60 L/min with constant volume of 2 L. The amount of mometasone furoate emitted from the inhaler in vitro does not differ significantly for flow rates ranging from 28.3 L/min to 70 L/min at a constant volume of 2 L. However, the amount of drug delivered to the lung will depend on patient factors such as inspiratory flow and peak inspiratory flow through the device. In adult and adolescent patients (aged ≥12 years) with varied asthma severity, mean peak inspiratory flow rate through the device was 69 L/min (range: 54–77 L/min). In pediatric patients (aged 5-12 years) diagnosed with asthma, mean peak inspiratory flow rate in the 5- to 8-year-old subgroup was >50 L/min (minimum of 46 L/min) and for the 9- to 12-year-old subgroup was >60 L/min (minimum of 48 L/min)."
},
{
"NDCCode": "78206-114-04",
"PackageDescription": "1 POUCH in 1 CARTON (78206-114-04) / 1 INHALER in 1 POUCH / 30 INHALANT in 1 INHALER",
"NDC11Code": "78206-0114-04",
"ProductNDC": "78206-114",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Asmanex",
"NonProprietaryName": "Mometasone Furoate",
"DosageFormName": "INHALANT",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20210601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021067",
"LabelerName": "Organon LLC",
"SubstanceName": "MOMETASONE FUROATE",
"StrengthNumber": "220",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210601",
"SamplePackage": "N",
"IndicationAndUsage": "ASMANEX® TWISTHALER® is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 4 years of age and older. Limitations of Use. ASMANEX TWISTHALER is not indicated for the relief of acute bronchospasm. ASMANEX TWISTHALER is not indicated in children less than 4 years of age.",
"Description": "Mometasone furoate, the active component of the ASMANEX TWISTHALER product, is a corticosteroid with the chemical name 9,21-dichloro-11(Beta),17-dihydroxy-16(alpha)-methylpregna-1,4-diene-3,20-dione 17-(2-furoate) and the following chemical structure. Mometasone furoate is a white powder with an empirical formula of C27H30Cl2O6, and molecular weight of 521.44 Daltons. The ASMANEX TWISTHALER 110 mcg and 220 mcg products are cap-activated, inhalation-driven, multidose dry powder inhalers containing mometasone furoate and anhydrous lactose (which contains trace amounts of milk proteins). Each actuation of the ASMANEX TWISTHALER 110 mcg or 220 mcg inhaler provides a measured dose of approximately 0.75 or 1.5 mg mometasone furoate inhalation powder, containing 110 or 220 mcg of mometasone furoate, respectively. This results in delivery of 100 or 200 mcg mometasone furoate from the mouthpiece, respectively, based on in vitro testing at flow rates of 30 L/min and 60 L/min with constant volume of 2 L. The amount of mometasone furoate emitted from the inhaler in vitro does not differ significantly for flow rates ranging from 28.3 L/min to 70 L/min at a constant volume of 2 L. However, the amount of drug delivered to the lung will depend on patient factors such as inspiratory flow and peak inspiratory flow through the device. In adult and adolescent patients (aged ≥12 years) with varied asthma severity, mean peak inspiratory flow rate through the device was 69 L/min (range: 54–77 L/min). In pediatric patients (aged 5-12 years) diagnosed with asthma, mean peak inspiratory flow rate in the 5- to 8-year-old subgroup was >50 L/min (minimum of 46 L/min) and for the 9- to 12-year-old subgroup was >60 L/min (minimum of 48 L/min)."
},
{
"NDCCode": "78206-114-59",
"PackageDescription": "1 POUCH in 1 CARTON (78206-114-59) / 1 INHALER in 1 POUCH / 14 INHALANT in 1 INHALER",
"NDC11Code": "78206-0114-59",
"ProductNDC": "78206-114",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Asmanex",
"NonProprietaryName": "Mometasone Furoate",
"DosageFormName": "INHALANT",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20210601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021067",
"LabelerName": "Organon LLC",
"SubstanceName": "MOMETASONE FUROATE",
"StrengthNumber": "220",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210601",
"SamplePackage": "N",
"IndicationAndUsage": "ASMANEX® TWISTHALER® is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 4 years of age and older. Limitations of Use. ASMANEX TWISTHALER is not indicated for the relief of acute bronchospasm. ASMANEX TWISTHALER is not indicated in children less than 4 years of age.",
"Description": "Mometasone furoate, the active component of the ASMANEX TWISTHALER product, is a corticosteroid with the chemical name 9,21-dichloro-11(Beta),17-dihydroxy-16(alpha)-methylpregna-1,4-diene-3,20-dione 17-(2-furoate) and the following chemical structure. Mometasone furoate is a white powder with an empirical formula of C27H30Cl2O6, and molecular weight of 521.44 Daltons. The ASMANEX TWISTHALER 110 mcg and 220 mcg products are cap-activated, inhalation-driven, multidose dry powder inhalers containing mometasone furoate and anhydrous lactose (which contains trace amounts of milk proteins). Each actuation of the ASMANEX TWISTHALER 110 mcg or 220 mcg inhaler provides a measured dose of approximately 0.75 or 1.5 mg mometasone furoate inhalation powder, containing 110 or 220 mcg of mometasone furoate, respectively. This results in delivery of 100 or 200 mcg mometasone furoate from the mouthpiece, respectively, based on in vitro testing at flow rates of 30 L/min and 60 L/min with constant volume of 2 L. The amount of mometasone furoate emitted from the inhaler in vitro does not differ significantly for flow rates ranging from 28.3 L/min to 70 L/min at a constant volume of 2 L. However, the amount of drug delivered to the lung will depend on patient factors such as inspiratory flow and peak inspiratory flow through the device. In adult and adolescent patients (aged ≥12 years) with varied asthma severity, mean peak inspiratory flow rate through the device was 69 L/min (range: 54–77 L/min). In pediatric patients (aged 5-12 years) diagnosed with asthma, mean peak inspiratory flow rate in the 5- to 8-year-old subgroup was >50 L/min (minimum of 46 L/min) and for the 9- to 12-year-old subgroup was >60 L/min (minimum of 48 L/min)."
},
{
"NDCCode": "81481-803-01",
"PackageDescription": "1 VIAL, GLASS in 1 BOX (81481-803-01) / .4 mL in 1 VIAL, GLASS",
"NDC11Code": "81481-0803-01",
"ProductNDC": "81481-803",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Anktiva",
"NonProprietaryName": "Nogapendekin Alfa Inbakicept-pmln",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVESICAL",
"StartMarketingDate": "20240506",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761336",
"LabelerName": "Altor BioScience, LLC, an indirect wholly-owned subsidiary of ImmunityBio, Inc.",
"SubstanceName": "NOGAPENDEKIN ALFA INBAKICEPT-PMLN",
"StrengthNumber": "400",
"StrengthUnit": "ug/.4mL",
"Pharm_Classes": "Interleukin-15 Receptor Agonist [EPC], Interleukin-15 Receptor Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240506",
"SamplePackage": "N",
"IndicationAndUsage": "ANKTIVA in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.",
"Description": "Nogapendekin alfa inbakicept-pmln is an interleukin-15 (IL-15) receptor agonist. It is a soluble complex consisting of (a) nogapendekin alfa (a human IL-15N72D variant, 114 amino acids) bound to (b) inbakicept [a dimeric human IL-15Rα sushi domain (65 amino acids)/human IgG1 Fc fusion protein (232 amino acids)]. Each fully assembled nogapendekin alfa inbakicept-pmln complex consists of a single inbakicept and two nogapendekin alfa components. Each IL-15N72D component is bound to one of the IL-15Rα sushi domains. The recombinant protein complex is produced by a recombinant cell line that was created by transfecting a Chinese hamster ovary (CHO-K1) cell line with plasmids carrying genes for the IL-15N72D and IL-15RαSu/IgG1 Fc proteins. Purification of the product is achieved by conventional chromatography. The molecular weight of the deglycosylated nogapendekin alfa inbakicept-pmln complex is 92,106.5 Da. The molecular weights of the individual deglycosylated sub-units are 66565.6 Da (dimer) and 12,770.45 Da for the IL-15RαSu/IgG1 Fc domain and the IL-15N72D domain, respectively. ANKTIVA (nogapendekin alfa inbakicept-pmln) solution is a clear to slightly opalescent, colorless to slightly yellow solution provided in a single-dose vial containing 400 mcg in 0.4 mL for intravesical administration upon dilution [see Dosage and Administration ( 2)] . Each vial also contains dibasic sodium phosphate (0.57 mg), monobasic potassium phosphate (0.54 mg), sodium chloride (3.27 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide is added to adjust the pH to 7.4."
},
{
"NDCCode": "83634-114-20",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (83634-114-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (83634-114-41) ",
"NDC11Code": "83634-0114-20",
"ProductNDC": "83634-114",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS; ORAL",
"StartMarketingDate": "20260815",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210274",
"LabelerName": "Avenacy, LLC",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Active",
"LastUpdate": "2026-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260815",
"SamplePackage": "N",
"IndicationAndUsage": "Vancomycin Hydrochloride for Injection is a glycopeptide antibacterial indicated in adult and pediatric patients less than 18 years of age as follows: : 1 Vancomycin Hydrochloride for Injection administered intravenously is indicated for the treatment of:Septicemia (1.1) Infective Endocarditis (1.2) Skin and Skin Structure Infections (1.3) Bone Infections (1.4) Lower Respiratory Tract Infections (1.5) , 2 Vancomycin Hydrochloride for Injection administered orally is indicated for the treatment of:Clostridioides difficile-associated diarrhea (1.6) Enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) (1.7) .",
"Description": "Vancomycin Hydrochloride for Injection contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibacterial derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is (Sa)-(3S,6R,7R,22R,23S, 26S,36R,38aR)-44-[[2-O-(3-Amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino)valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[1,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24 HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula:. Vancomycin Hydrochloride for Injection is a sterile, preservative-free, white, almost white to tan to brown, spray-dried powder, for preparing intravenous (IV) infusions, in single-dose vials each containing the equivalent of 500 mg, 750 mg, 1 gram, 1.25 grams or 1.5 grams vancomycin base. Each 500 mg vial contains 500 mg vancomycin (equivalent to 513 mg vancomycin hydrochloride), 125 mg trehalose, 0.05 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 750 mg vial contains 750 mg vancomycin (equivalent to 769 mg vancomycin hydrochloride), 187.5 mg trehalose, 0.075 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1 gram vial contains 1 gram vancomycin (equivalent to 1.025 grams vancomycin hydrochloride), 250 mg trehalose, 0.1 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1.25 gram vial contains 1.25 grams vancomycin (equivalent to 1.28 grams vancomycin hydrochloride), 312.5 mg trehalose, 0.125 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1.5 gram vial contains 1.5 grams vancomycin (equivalent to 1.54 grams vancomycin hydrochloride), 375 mg trehalose, 0.15 mg polysorbate 80, and hydrochloric acid used to adjust the pH. The spray-dried powder is reconstituted with Sterile Water for Injection which forms a clear solution and subsequently diluted prior to intravenous or oral administration [see Dosage and Administration (2.5, 2.8)]. Vancomycin Hydrochloride for Injection may also be diluted with a sweetening agent for oral administration [see Dosage and Administration (2.8)]."
},
{
"NDCCode": "79887-111-21",
"PackageDescription": "200 mL in 1 BOTTLE (79887-111-21) ",
"NDC11Code": "79887-0111-21",
"ProductNDC": "79887-111",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Boosietizer",
"NonProprietaryName": "Hand Sanitizer",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200801",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "AWSM Marcin Szakola",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200801",
"SamplePackage": "N"
},
{
"NDCCode": "79887-111-51",
"PackageDescription": "500 mL in 1 BOTTLE (79887-111-51) ",
"NDC11Code": "79887-0111-51",
"ProductNDC": "79887-111",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Boosietizer",
"NonProprietaryName": "Hand Sanitizer",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200801",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "AWSM Marcin Szakola",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200801",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "79887-112-23",
"PackageDescription": "200 mL in 1 BOTTLE (79887-112-23) ",
"NDC11Code": "79887-0112-23",
"ProductNDC": "79887-112",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Boosietizer Peach Scent",
"NonProprietaryName": "Hand Sanitizer",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200803",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "AWSM Marcin Szakola",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "80",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200803",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "79887-112-53",
"PackageDescription": "500 mL in 1 BOTTLE (79887-112-53) ",
"NDC11Code": "79887-0112-53",
"ProductNDC": "79887-112",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Boosietizer Peach Scent",
"NonProprietaryName": "Hand Sanitizer",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200803",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "AWSM Marcin Szakola",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "80",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200803",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "79887-113-22",
"PackageDescription": "200 mL in 1 BOTTLE (79887-113-22) ",
"NDC11Code": "79887-0113-22",
"ProductNDC": "79887-113",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Issactizer",
"NonProprietaryName": "Hand Sanitizer",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200803",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "AWSM Marcin Szakola",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "80",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200803",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "79887-113-52",
"PackageDescription": "500 mL in 1 BOTTLE (79887-113-52) ",
"NDC11Code": "79887-0113-52",
"ProductNDC": "79887-113",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Issactizer",
"NonProprietaryName": "Hand Sanitizer",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200803",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "AWSM Marcin Szakola",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "80",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200803",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "0002-3227-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0002-3227-30) ",
"NDC11Code": "00002-3227-30",
"ProductNDC": "0002-3227",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Strattera",
"NonProprietaryName": "Atomoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20021126",
"EndMarketingDate": "20270731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021411",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20030110",
"EndMarketingDatePackage": "20270731",
"SamplePackage": "N",
"IndicationAndUsage": "STRATTERA is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. STRATTERA is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.",
"Description": "Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is:. Atomoxetine hydrochloride is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. STRATTERA (atomoxetine) capsules are for oral administration only. Each STRATTERA capsule contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.4 mg, 20.6 mg, 28.6 mg, 45.7 mg, 68.6 mg, 91.4 mg and 114.3 mg of atomoxetine hydrochloride, respectively). The capsules also contain pregelatinized starch and dimethicone. The capsule shells contain gelatin, sodium lauryl sulfate, and one or more of the following inactive ingredients:. FD&C Blue No. 2, synthetic yellow iron oxide, titanium dioxide, red iron oxide. The capsules are imprinted with edible black ink."
},
{
"NDCCode": "0002-3228-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0002-3228-30) ",
"NDC11Code": "00002-3228-30",
"ProductNDC": "0002-3228",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Strattera",
"NonProprietaryName": "Atomoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20021126",
"EndMarketingDate": "20270731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021411",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20030110",
"EndMarketingDatePackage": "20270731",
"SamplePackage": "N",
"IndicationAndUsage": "STRATTERA is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. STRATTERA is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.",
"Description": "Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is:. Atomoxetine hydrochloride is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. STRATTERA (atomoxetine) capsules are for oral administration only. Each STRATTERA capsule contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.4 mg, 20.6 mg, 28.6 mg, 45.7 mg, 68.6 mg, 91.4 mg and 114.3 mg of atomoxetine hydrochloride, respectively). The capsules also contain pregelatinized starch and dimethicone. The capsule shells contain gelatin, sodium lauryl sulfate, and one or more of the following inactive ingredients:. FD&C Blue No. 2, synthetic yellow iron oxide, titanium dioxide, red iron oxide. The capsules are imprinted with edible black ink."
},
{
"NDCCode": "0002-3229-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0002-3229-30) ",
"NDC11Code": "00002-3229-30",
"ProductNDC": "0002-3229",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Strattera",
"NonProprietaryName": "Atomoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20021126",
"EndMarketingDate": "20270731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021411",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20030110",
"EndMarketingDatePackage": "20270731",
"SamplePackage": "N",
"IndicationAndUsage": "STRATTERA is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. STRATTERA is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.",
"Description": "Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is:. Atomoxetine hydrochloride is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. STRATTERA (atomoxetine) capsules are for oral administration only. Each STRATTERA capsule contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.4 mg, 20.6 mg, 28.6 mg, 45.7 mg, 68.6 mg, 91.4 mg and 114.3 mg of atomoxetine hydrochloride, respectively). The capsules also contain pregelatinized starch and dimethicone. The capsule shells contain gelatin, sodium lauryl sulfate, and one or more of the following inactive ingredients:. FD&C Blue No. 2, synthetic yellow iron oxide, titanium dioxide, red iron oxide. The capsules are imprinted with edible black ink."
},
{
"NDCCode": "0002-3238-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0002-3238-30) ",
"NDC11Code": "00002-3238-30",
"ProductNDC": "0002-3238",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Strattera",
"NonProprietaryName": "Atomoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20021126",
"EndMarketingDate": "20270731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021411",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "18",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20030110",
"EndMarketingDatePackage": "20270731",
"SamplePackage": "N",
"IndicationAndUsage": "STRATTERA is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. STRATTERA is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.",
"Description": "Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is:. Atomoxetine hydrochloride is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. STRATTERA (atomoxetine) capsules are for oral administration only. Each STRATTERA capsule contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.4 mg, 20.6 mg, 28.6 mg, 45.7 mg, 68.6 mg, 91.4 mg and 114.3 mg of atomoxetine hydrochloride, respectively). The capsules also contain pregelatinized starch and dimethicone. The capsule shells contain gelatin, sodium lauryl sulfate, and one or more of the following inactive ingredients:. FD&C Blue No. 2, synthetic yellow iron oxide, titanium dioxide, red iron oxide. The capsules are imprinted with edible black ink."
},
{
"NDCCode": "0002-3239-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0002-3239-30) ",
"NDC11Code": "00002-3239-30",
"ProductNDC": "0002-3239",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Strattera",
"NonProprietaryName": "Atomoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20021126",
"EndMarketingDate": "20270731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021411",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20030110",
"EndMarketingDatePackage": "20270731",
"SamplePackage": "N",
"IndicationAndUsage": "STRATTERA is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. STRATTERA is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.",
"Description": "Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is:. Atomoxetine hydrochloride is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. STRATTERA (atomoxetine) capsules are for oral administration only. Each STRATTERA capsule contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.4 mg, 20.6 mg, 28.6 mg, 45.7 mg, 68.6 mg, 91.4 mg and 114.3 mg of atomoxetine hydrochloride, respectively). The capsules also contain pregelatinized starch and dimethicone. The capsule shells contain gelatin, sodium lauryl sulfate, and one or more of the following inactive ingredients:. FD&C Blue No. 2, synthetic yellow iron oxide, titanium dioxide, red iron oxide. The capsules are imprinted with edible black ink."
},
{
"NDCCode": "0002-3250-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0002-3250-30) ",
"NDC11Code": "00002-3250-30",
"ProductNDC": "0002-3250",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Strattera",
"NonProprietaryName": "Atomoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20050214",
"EndMarketingDate": "20270731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021411",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20050824",
"EndMarketingDatePackage": "20270731",
"SamplePackage": "N",
"IndicationAndUsage": "STRATTERA is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. STRATTERA is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.",
"Description": "Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is:. Atomoxetine hydrochloride is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. STRATTERA (atomoxetine) capsules are for oral administration only. Each STRATTERA capsule contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.4 mg, 20.6 mg, 28.6 mg, 45.7 mg, 68.6 mg, 91.4 mg and 114.3 mg of atomoxetine hydrochloride, respectively). The capsules also contain pregelatinized starch and dimethicone. The capsule shells contain gelatin, sodium lauryl sulfate, and one or more of the following inactive ingredients:. FD&C Blue No. 2, synthetic yellow iron oxide, titanium dioxide, red iron oxide. The capsules are imprinted with edible black ink."
},
{
"NDCCode": "0002-3251-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0002-3251-30) ",
"NDC11Code": "00002-3251-30",
"ProductNDC": "0002-3251",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Strattera",
"NonProprietaryName": "Atomoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20050214",
"EndMarketingDate": "20270731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021411",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20050824",
"EndMarketingDatePackage": "20270731",
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"IndicationAndUsage": "STRATTERA is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. STRATTERA is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.",
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"Description": "JIVI [antihemophilic factor (recombinant), PEGylated-aucl] is a sterile, nonpyrogenic, preservative-free, white to slightly yellow lyophilized powder for reconstitution with sterile Water for Injection (sWFI) as diluent for intravenous (IV) administration. The product is supplied in single-dose vials containing dosage strengths of 500, 1000, 2000 and 3000 IU in 2.5 mL fill size and 4000 IU in 5 mL fill size. For each dosage strength, the actual assayed potency is directly printed on each vial label. The container closure system consists of a 10 mL, Type I glass vial sealed with a bromobutyl grey stopper and an aluminum crimp seal with plastic flip-off cap plus vial adapter. The vial adapter was designed to connect with the sWFI, prefilled diluent syringe. The 500, 1000, 2000, and 3000 IU vials of JIVI are formulated with the following excipients: 59 mg glycine, 27 mg sucrose, 8.4 mg histidine, 4.7 mg sodium chloride, 0.7 mg calcium chloride, and 0.216 mg polysorbate 80. The 4000 IU vial of Jivi is formulated with the following quantities of these excipients: 114 mg glycine, 52 mg sucrose, 16.1 mg histidine, 9.1 mg sodium chloride, 1.9 mg calcium chloride, and 0.416 mg polysorbate 80. The pH of the reconstituted product is 6.6 to 7.0. The specific activity of JIVI is approximately 10,000 IU/mg protein. The active protein (or starting molecule), prior to conjugation is a recombinant B-domain deleted human coagulation Factor VIII (BDD-rFVIII) produced by recombinant DNA technology in Baby Hamster Kidney (BHK) cells. JIVI is produced by site-specific conjugation of the BDD-rFVIII variant K1804C at the cysteine amino acid position 1804 (within the A3 domain) with a single maleimide-derivatized, 60 kilodalton (kDa) branched PEG (two 30 kDa PEG) moiety. The A3 domain was selected for conjugation to provide both a consistent coagulation activity and high PEGylation efficiency. The molecular weight of JIVI is approximately 234 kDa based on the calculated average molecular weight of the BDD-rFVIII variant of 165 kDa, plus glycosylation (~4 kDa), and the average molecular weight of the PEG-maleimide of approximately 60 kDa. Functional characterization of JIVI shows comparable mechanism of action to that of rFVIII product with an extended plasma half-life [see Clinical Pharmacology (12.1)]. The manufacturing process of JIVI involves propagation of the recombinant production cell line with the harvest isolation process consisting of continuous filtration of tissue culture fluid and anion exchange chromatography on a membrane adsorber capsule. The process intermediate is purified from process- and product-related impurities using a series of chromatography and filtration steps, including 20 nm viral filtration, prior to conjugation to the 60 kDa maleimide PEG moiety. The mono-PEGylated JIVI active molecule is separated from product-related species by chromatography and then formulated by ultrafiltration. The cell culture, PEGylation, purification process and formulation used in the manufacture of JIVI do not use any additives of human or animal origins."
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"Description": "JIVI [antihemophilic factor (recombinant), PEGylated-aucl] is a sterile, nonpyrogenic, preservative-free, white to slightly yellow lyophilized powder for reconstitution with sterile Water for Injection (sWFI) as diluent for intravenous (IV) administration. The product is supplied in single-dose vials containing dosage strengths of 500, 1000, 2000 and 3000 IU in 2.5 mL fill size and 4000 IU in 5 mL fill size. For each dosage strength, the actual assayed potency is directly printed on each vial label. The container closure system consists of a 10 mL, Type I glass vial sealed with a bromobutyl grey stopper and an aluminum crimp seal with plastic flip-off cap plus vial adapter. The vial adapter was designed to connect with the sWFI, prefilled diluent syringe. The 500, 1000, 2000, and 3000 IU vials of JIVI are formulated with the following excipients: 59 mg glycine, 27 mg sucrose, 8.4 mg histidine, 4.7 mg sodium chloride, 0.7 mg calcium chloride, and 0.216 mg polysorbate 80. The 4000 IU vial of Jivi is formulated with the following quantities of these excipients: 114 mg glycine, 52 mg sucrose, 16.1 mg histidine, 9.1 mg sodium chloride, 1.9 mg calcium chloride, and 0.416 mg polysorbate 80. The pH of the reconstituted product is 6.6 to 7.0. The specific activity of JIVI is approximately 10,000 IU/mg protein. The active protein (or starting molecule), prior to conjugation is a recombinant B-domain deleted human coagulation Factor VIII (BDD-rFVIII) produced by recombinant DNA technology in Baby Hamster Kidney (BHK) cells. JIVI is produced by site-specific conjugation of the BDD-rFVIII variant K1804C at the cysteine amino acid position 1804 (within the A3 domain) with a single maleimide-derivatized, 60 kilodalton (kDa) branched PEG (two 30 kDa PEG) moiety. The A3 domain was selected for conjugation to provide both a consistent coagulation activity and high PEGylation efficiency. The molecular weight of JIVI is approximately 234 kDa based on the calculated average molecular weight of the BDD-rFVIII variant of 165 kDa, plus glycosylation (~4 kDa), and the average molecular weight of the PEG-maleimide of approximately 60 kDa. Functional characterization of JIVI shows comparable mechanism of action to that of rFVIII product with an extended plasma half-life [see Clinical Pharmacology (12.1)]. The manufacturing process of JIVI involves propagation of the recombinant production cell line with the harvest isolation process consisting of continuous filtration of tissue culture fluid and anion exchange chromatography on a membrane adsorber capsule. The process intermediate is purified from process- and product-related impurities using a series of chromatography and filtration steps, including 20 nm viral filtration, prior to conjugation to the 60 kDa maleimide PEG moiety. The mono-PEGylated JIVI active molecule is separated from product-related species by chromatography and then formulated by ultrafiltration. The cell culture, PEGylation, purification process and formulation used in the manufacture of JIVI do not use any additives of human or animal origins."
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"Description": "JIVI [antihemophilic factor (recombinant), PEGylated-aucl] is a sterile, nonpyrogenic, preservative-free, white to slightly yellow lyophilized powder for reconstitution with sterile Water for Injection (sWFI) as diluent for intravenous (IV) administration. The product is supplied in single-dose vials containing dosage strengths of 500, 1000, 2000 and 3000 IU in 2.5 mL fill size and 4000 IU in 5 mL fill size. For each dosage strength, the actual assayed potency is directly printed on each vial label. The container closure system consists of a 10 mL, Type I glass vial sealed with a bromobutyl grey stopper and an aluminum crimp seal with plastic flip-off cap plus vial adapter. The vial adapter was designed to connect with the sWFI, prefilled diluent syringe. The 500, 1000, 2000, and 3000 IU vials of JIVI are formulated with the following excipients: 59 mg glycine, 27 mg sucrose, 8.4 mg histidine, 4.7 mg sodium chloride, 0.7 mg calcium chloride, and 0.216 mg polysorbate 80. The 4000 IU vial of Jivi is formulated with the following quantities of these excipients: 114 mg glycine, 52 mg sucrose, 16.1 mg histidine, 9.1 mg sodium chloride, 1.9 mg calcium chloride, and 0.416 mg polysorbate 80. The pH of the reconstituted product is 6.6 to 7.0. The specific activity of JIVI is approximately 10,000 IU/mg protein. The active protein (or starting molecule), prior to conjugation is a recombinant B-domain deleted human coagulation Factor VIII (BDD-rFVIII) produced by recombinant DNA technology in Baby Hamster Kidney (BHK) cells. JIVI is produced by site-specific conjugation of the BDD-rFVIII variant K1804C at the cysteine amino acid position 1804 (within the A3 domain) with a single maleimide-derivatized, 60 kilodalton (kDa) branched PEG (two 30 kDa PEG) moiety. The A3 domain was selected for conjugation to provide both a consistent coagulation activity and high PEGylation efficiency. The molecular weight of JIVI is approximately 234 kDa based on the calculated average molecular weight of the BDD-rFVIII variant of 165 kDa, plus glycosylation (~4 kDa), and the average molecular weight of the PEG-maleimide of approximately 60 kDa. Functional characterization of JIVI shows comparable mechanism of action to that of rFVIII product with an extended plasma half-life [see Clinical Pharmacology (12.1)]. The manufacturing process of JIVI involves propagation of the recombinant production cell line with the harvest isolation process consisting of continuous filtration of tissue culture fluid and anion exchange chromatography on a membrane adsorber capsule. The process intermediate is purified from process- and product-related impurities using a series of chromatography and filtration steps, including 20 nm viral filtration, prior to conjugation to the 60 kDa maleimide PEG moiety. The mono-PEGylated JIVI active molecule is separated from product-related species by chromatography and then formulated by ultrafiltration. The cell culture, PEGylation, purification process and formulation used in the manufacture of JIVI do not use any additives of human or animal origins."
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<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M006</ApplicationNumber>
<LabelerName>KATE SOMERVILLE SKINCARE, LLC</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FOR THE TREATMENT OF ACNE. HELPS KEEP SKIN CLEAR OF NEW ACNE BLEMISHES.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>52347-111-01</NDCCode>
<PackageDescription>116 g in 1 TUBE (52347-111-01)</PackageDescription>
<NDC11Code>52347-0111-01</NDC11Code>
<ProductNDC>52347-111</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Skin Care Prescription</ProprietaryName>
<NonProprietaryName>Avobenzone,octocrylene,oxybenzone,homosalate,octisalate</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100623</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Skin Care Physicians, Inc.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OXYBENZONE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>3.4; 17.01; .06; .05; 4.54</StrengthNumber>
<StrengthUnit>g/114.4g; g/113.4g; g/113.4g; g/113.4g; g/113.4g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>78206-114-01</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (78206-114-01) / 1 INHALER in 1 POUCH / 120 INHALANT in 1 INHALER</PackageDescription>
<NDC11Code>78206-0114-01</NDC11Code>
<ProductNDC>78206-114</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Asmanex</ProprietaryName>
<NonProprietaryName>Mometasone Furoate</NonProprietaryName>
<DosageFormName>INHALANT</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20210601</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021067</ApplicationNumber>
<LabelerName>Organon LLC</LabelerName>
<SubstanceName>MOMETASONE FUROATE</SubstanceName>
<StrengthNumber>220</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ASMANEX® TWISTHALER® is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 4 years of age and older. Limitations of Use. ASMANEX TWISTHALER is not indicated for the relief of acute bronchospasm. ASMANEX TWISTHALER is not indicated in children less than 4 years of age.</IndicationAndUsage>
<Description>Mometasone furoate, the active component of the ASMANEX TWISTHALER product, is a corticosteroid with the chemical name 9,21-dichloro-11(Beta),17-dihydroxy-16(alpha)-methylpregna-1,4-diene-3,20-dione 17-(2-furoate) and the following chemical structure. Mometasone furoate is a white powder with an empirical formula of C27H30Cl2O6, and molecular weight of 521.44 Daltons. The ASMANEX TWISTHALER 110 mcg and 220 mcg products are cap-activated, inhalation-driven, multidose dry powder inhalers containing mometasone furoate and anhydrous lactose (which contains trace amounts of milk proteins). Each actuation of the ASMANEX TWISTHALER 110 mcg or 220 mcg inhaler provides a measured dose of approximately 0.75 or 1.5 mg mometasone furoate inhalation powder, containing 110 or 220 mcg of mometasone furoate, respectively. This results in delivery of 100 or 200 mcg mometasone furoate from the mouthpiece, respectively, based on in vitro testing at flow rates of 30 L/min and 60 L/min with constant volume of 2 L. The amount of mometasone furoate emitted from the inhaler in vitro does not differ significantly for flow rates ranging from 28.3 L/min to 70 L/min at a constant volume of 2 L. However, the amount of drug delivered to the lung will depend on patient factors such as inspiratory flow and peak inspiratory flow through the device. In adult and adolescent patients (aged ≥12 years) with varied asthma severity, mean peak inspiratory flow rate through the device was 69 L/min (range: 54–77 L/min). In pediatric patients (aged 5-12 years) diagnosed with asthma, mean peak inspiratory flow rate in the 5- to 8-year-old subgroup was >50 L/min (minimum of 46 L/min) and for the 9- to 12-year-old subgroup was >60 L/min (minimum of 48 L/min).</Description>
</NDC>
<NDC>
<NDCCode>78206-114-02</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (78206-114-02) / 1 INHALER in 1 POUCH / 60 INHALANT in 1 INHALER</PackageDescription>
<NDC11Code>78206-0114-02</NDC11Code>
<ProductNDC>78206-114</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Asmanex</ProprietaryName>
<NonProprietaryName>Mometasone Furoate</NonProprietaryName>
<DosageFormName>INHALANT</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20210601</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021067</ApplicationNumber>
<LabelerName>Organon LLC</LabelerName>
<SubstanceName>MOMETASONE FUROATE</SubstanceName>
<StrengthNumber>220</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ASMANEX® TWISTHALER® is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 4 years of age and older. Limitations of Use. ASMANEX TWISTHALER is not indicated for the relief of acute bronchospasm. ASMANEX TWISTHALER is not indicated in children less than 4 years of age.</IndicationAndUsage>
<Description>Mometasone furoate, the active component of the ASMANEX TWISTHALER product, is a corticosteroid with the chemical name 9,21-dichloro-11(Beta),17-dihydroxy-16(alpha)-methylpregna-1,4-diene-3,20-dione 17-(2-furoate) and the following chemical structure. Mometasone furoate is a white powder with an empirical formula of C27H30Cl2O6, and molecular weight of 521.44 Daltons. The ASMANEX TWISTHALER 110 mcg and 220 mcg products are cap-activated, inhalation-driven, multidose dry powder inhalers containing mometasone furoate and anhydrous lactose (which contains trace amounts of milk proteins). Each actuation of the ASMANEX TWISTHALER 110 mcg or 220 mcg inhaler provides a measured dose of approximately 0.75 or 1.5 mg mometasone furoate inhalation powder, containing 110 or 220 mcg of mometasone furoate, respectively. This results in delivery of 100 or 200 mcg mometasone furoate from the mouthpiece, respectively, based on in vitro testing at flow rates of 30 L/min and 60 L/min with constant volume of 2 L. The amount of mometasone furoate emitted from the inhaler in vitro does not differ significantly for flow rates ranging from 28.3 L/min to 70 L/min at a constant volume of 2 L. However, the amount of drug delivered to the lung will depend on patient factors such as inspiratory flow and peak inspiratory flow through the device. In adult and adolescent patients (aged ≥12 years) with varied asthma severity, mean peak inspiratory flow rate through the device was 69 L/min (range: 54–77 L/min). In pediatric patients (aged 5-12 years) diagnosed with asthma, mean peak inspiratory flow rate in the 5- to 8-year-old subgroup was >50 L/min (minimum of 46 L/min) and for the 9- to 12-year-old subgroup was >60 L/min (minimum of 48 L/min).</Description>
</NDC>
<NDC>
<NDCCode>78206-114-03</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (78206-114-03) / 1 INHALER in 1 POUCH / 14 INHALANT in 1 INHALER</PackageDescription>
<NDC11Code>78206-0114-03</NDC11Code>
<ProductNDC>78206-114</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Asmanex</ProprietaryName>
<NonProprietaryName>Mometasone Furoate</NonProprietaryName>
<DosageFormName>INHALANT</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20210601</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021067</ApplicationNumber>
<LabelerName>Organon LLC</LabelerName>
<SubstanceName>MOMETASONE FUROATE</SubstanceName>
<StrengthNumber>220</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ASMANEX® TWISTHALER® is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 4 years of age and older. Limitations of Use. ASMANEX TWISTHALER is not indicated for the relief of acute bronchospasm. ASMANEX TWISTHALER is not indicated in children less than 4 years of age.</IndicationAndUsage>
<Description>Mometasone furoate, the active component of the ASMANEX TWISTHALER product, is a corticosteroid with the chemical name 9,21-dichloro-11(Beta),17-dihydroxy-16(alpha)-methylpregna-1,4-diene-3,20-dione 17-(2-furoate) and the following chemical structure. Mometasone furoate is a white powder with an empirical formula of C27H30Cl2O6, and molecular weight of 521.44 Daltons. The ASMANEX TWISTHALER 110 mcg and 220 mcg products are cap-activated, inhalation-driven, multidose dry powder inhalers containing mometasone furoate and anhydrous lactose (which contains trace amounts of milk proteins). Each actuation of the ASMANEX TWISTHALER 110 mcg or 220 mcg inhaler provides a measured dose of approximately 0.75 or 1.5 mg mometasone furoate inhalation powder, containing 110 or 220 mcg of mometasone furoate, respectively. This results in delivery of 100 or 200 mcg mometasone furoate from the mouthpiece, respectively, based on in vitro testing at flow rates of 30 L/min and 60 L/min with constant volume of 2 L. The amount of mometasone furoate emitted from the inhaler in vitro does not differ significantly for flow rates ranging from 28.3 L/min to 70 L/min at a constant volume of 2 L. However, the amount of drug delivered to the lung will depend on patient factors such as inspiratory flow and peak inspiratory flow through the device. In adult and adolescent patients (aged ≥12 years) with varied asthma severity, mean peak inspiratory flow rate through the device was 69 L/min (range: 54–77 L/min). In pediatric patients (aged 5-12 years) diagnosed with asthma, mean peak inspiratory flow rate in the 5- to 8-year-old subgroup was >50 L/min (minimum of 46 L/min) and for the 9- to 12-year-old subgroup was >60 L/min (minimum of 48 L/min).</Description>
</NDC>
<NDC>
<NDCCode>78206-114-04</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (78206-114-04) / 1 INHALER in 1 POUCH / 30 INHALANT in 1 INHALER</PackageDescription>
<NDC11Code>78206-0114-04</NDC11Code>
<ProductNDC>78206-114</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Asmanex</ProprietaryName>
<NonProprietaryName>Mometasone Furoate</NonProprietaryName>
<DosageFormName>INHALANT</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20210601</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021067</ApplicationNumber>
<LabelerName>Organon LLC</LabelerName>
<SubstanceName>MOMETASONE FUROATE</SubstanceName>
<StrengthNumber>220</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ASMANEX® TWISTHALER® is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 4 years of age and older. Limitations of Use. ASMANEX TWISTHALER is not indicated for the relief of acute bronchospasm. ASMANEX TWISTHALER is not indicated in children less than 4 years of age.</IndicationAndUsage>
<Description>Mometasone furoate, the active component of the ASMANEX TWISTHALER product, is a corticosteroid with the chemical name 9,21-dichloro-11(Beta),17-dihydroxy-16(alpha)-methylpregna-1,4-diene-3,20-dione 17-(2-furoate) and the following chemical structure. Mometasone furoate is a white powder with an empirical formula of C27H30Cl2O6, and molecular weight of 521.44 Daltons. The ASMANEX TWISTHALER 110 mcg and 220 mcg products are cap-activated, inhalation-driven, multidose dry powder inhalers containing mometasone furoate and anhydrous lactose (which contains trace amounts of milk proteins). Each actuation of the ASMANEX TWISTHALER 110 mcg or 220 mcg inhaler provides a measured dose of approximately 0.75 or 1.5 mg mometasone furoate inhalation powder, containing 110 or 220 mcg of mometasone furoate, respectively. This results in delivery of 100 or 200 mcg mometasone furoate from the mouthpiece, respectively, based on in vitro testing at flow rates of 30 L/min and 60 L/min with constant volume of 2 L. The amount of mometasone furoate emitted from the inhaler in vitro does not differ significantly for flow rates ranging from 28.3 L/min to 70 L/min at a constant volume of 2 L. However, the amount of drug delivered to the lung will depend on patient factors such as inspiratory flow and peak inspiratory flow through the device. In adult and adolescent patients (aged ≥12 years) with varied asthma severity, mean peak inspiratory flow rate through the device was 69 L/min (range: 54–77 L/min). In pediatric patients (aged 5-12 years) diagnosed with asthma, mean peak inspiratory flow rate in the 5- to 8-year-old subgroup was >50 L/min (minimum of 46 L/min) and for the 9- to 12-year-old subgroup was >60 L/min (minimum of 48 L/min).</Description>
</NDC>
<NDC>
<NDCCode>78206-114-59</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (78206-114-59) / 1 INHALER in 1 POUCH / 14 INHALANT in 1 INHALER</PackageDescription>
<NDC11Code>78206-0114-59</NDC11Code>
<ProductNDC>78206-114</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Asmanex</ProprietaryName>
<NonProprietaryName>Mometasone Furoate</NonProprietaryName>
<DosageFormName>INHALANT</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20210601</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021067</ApplicationNumber>
<LabelerName>Organon LLC</LabelerName>
<SubstanceName>MOMETASONE FUROATE</SubstanceName>
<StrengthNumber>220</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ASMANEX® TWISTHALER® is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 4 years of age and older. Limitations of Use. ASMANEX TWISTHALER is not indicated for the relief of acute bronchospasm. ASMANEX TWISTHALER is not indicated in children less than 4 years of age.</IndicationAndUsage>
<Description>Mometasone furoate, the active component of the ASMANEX TWISTHALER product, is a corticosteroid with the chemical name 9,21-dichloro-11(Beta),17-dihydroxy-16(alpha)-methylpregna-1,4-diene-3,20-dione 17-(2-furoate) and the following chemical structure. Mometasone furoate is a white powder with an empirical formula of C27H30Cl2O6, and molecular weight of 521.44 Daltons. The ASMANEX TWISTHALER 110 mcg and 220 mcg products are cap-activated, inhalation-driven, multidose dry powder inhalers containing mometasone furoate and anhydrous lactose (which contains trace amounts of milk proteins). Each actuation of the ASMANEX TWISTHALER 110 mcg or 220 mcg inhaler provides a measured dose of approximately 0.75 or 1.5 mg mometasone furoate inhalation powder, containing 110 or 220 mcg of mometasone furoate, respectively. This results in delivery of 100 or 200 mcg mometasone furoate from the mouthpiece, respectively, based on in vitro testing at flow rates of 30 L/min and 60 L/min with constant volume of 2 L. The amount of mometasone furoate emitted from the inhaler in vitro does not differ significantly for flow rates ranging from 28.3 L/min to 70 L/min at a constant volume of 2 L. However, the amount of drug delivered to the lung will depend on patient factors such as inspiratory flow and peak inspiratory flow through the device. In adult and adolescent patients (aged ≥12 years) with varied asthma severity, mean peak inspiratory flow rate through the device was 69 L/min (range: 54–77 L/min). In pediatric patients (aged 5-12 years) diagnosed with asthma, mean peak inspiratory flow rate in the 5- to 8-year-old subgroup was >50 L/min (minimum of 46 L/min) and for the 9- to 12-year-old subgroup was >60 L/min (minimum of 48 L/min).</Description>
</NDC>
<NDC>
<NDCCode>81481-803-01</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 BOX (81481-803-01) / .4 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>81481-0803-01</NDC11Code>
<ProductNDC>81481-803</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Anktiva</ProprietaryName>
<NonProprietaryName>Nogapendekin Alfa Inbakicept-pmln</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVESICAL</RouteName>
<StartMarketingDate>20240506</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761336</ApplicationNumber>
<LabelerName>Altor BioScience, LLC, an indirect wholly-owned subsidiary of ImmunityBio, Inc.</LabelerName>
<SubstanceName>NOGAPENDEKIN ALFA INBAKICEPT-PMLN</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>ug/.4mL</StrengthUnit>
<Pharm_Classes>Interleukin-15 Receptor Agonist [EPC], Interleukin-15 Receptor Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ANKTIVA in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.</IndicationAndUsage>
<Description>Nogapendekin alfa inbakicept-pmln is an interleukin-15 (IL-15) receptor agonist. It is a soluble complex consisting of (a) nogapendekin alfa (a human IL-15N72D variant, 114 amino acids) bound to (b) inbakicept [a dimeric human IL-15Rα sushi domain (65 amino acids)/human IgG1 Fc fusion protein (232 amino acids)]. Each fully assembled nogapendekin alfa inbakicept-pmln complex consists of a single inbakicept and two nogapendekin alfa components. Each IL-15N72D component is bound to one of the IL-15Rα sushi domains. The recombinant protein complex is produced by a recombinant cell line that was created by transfecting a Chinese hamster ovary (CHO-K1) cell line with plasmids carrying genes for the IL-15N72D and IL-15RαSu/IgG1 Fc proteins. Purification of the product is achieved by conventional chromatography. The molecular weight of the deglycosylated nogapendekin alfa inbakicept-pmln complex is 92,106.5 Da. The molecular weights of the individual deglycosylated sub-units are 66565.6 Da (dimer) and 12,770.45 Da for the IL-15RαSu/IgG1 Fc domain and the IL-15N72D domain, respectively. ANKTIVA (nogapendekin alfa inbakicept-pmln) solution is a clear to slightly opalescent, colorless to slightly yellow solution provided in a single-dose vial containing 400 mcg in 0.4 mL for intravesical administration upon dilution [see Dosage and Administration ( 2)] . Each vial also contains dibasic sodium phosphate (0.57 mg), monobasic potassium phosphate (0.54 mg), sodium chloride (3.27 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide is added to adjust the pH to 7.4.</Description>
</NDC>
<NDC>
<NDCCode>83634-114-20</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (83634-114-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (83634-114-41) </PackageDescription>
<NDC11Code>83634-0114-20</NDC11Code>
<ProductNDC>83634-114</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; ORAL</RouteName>
<StartMarketingDate>20260815</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210274</ApplicationNumber>
<LabelerName>Avenacy, LLC</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vancomycin Hydrochloride for Injection is a glycopeptide antibacterial indicated in adult and pediatric patients less than 18 years of age as follows: : 1 Vancomycin Hydrochloride for Injection administered intravenously is indicated for the treatment of:Septicemia (1.1) Infective Endocarditis (1.2) Skin and Skin Structure Infections (1.3) Bone Infections (1.4) Lower Respiratory Tract Infections (1.5) , 2 Vancomycin Hydrochloride for Injection administered orally is indicated for the treatment of:Clostridioides difficile-associated diarrhea (1.6) Enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) (1.7) .</IndicationAndUsage>
<Description>Vancomycin Hydrochloride for Injection contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibacterial derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is (Sa)-(3S,6R,7R,22R,23S, 26S,36R,38aR)-44-[[2-O-(3-Amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino)valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[1,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24 HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula:. Vancomycin Hydrochloride for Injection is a sterile, preservative-free, white, almost white to tan to brown, spray-dried powder, for preparing intravenous (IV) infusions, in single-dose vials each containing the equivalent of 500 mg, 750 mg, 1 gram, 1.25 grams or 1.5 grams vancomycin base. Each 500 mg vial contains 500 mg vancomycin (equivalent to 513 mg vancomycin hydrochloride), 125 mg trehalose, 0.05 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 750 mg vial contains 750 mg vancomycin (equivalent to 769 mg vancomycin hydrochloride), 187.5 mg trehalose, 0.075 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1 gram vial contains 1 gram vancomycin (equivalent to 1.025 grams vancomycin hydrochloride), 250 mg trehalose, 0.1 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1.25 gram vial contains 1.25 grams vancomycin (equivalent to 1.28 grams vancomycin hydrochloride), 312.5 mg trehalose, 0.125 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1.5 gram vial contains 1.5 grams vancomycin (equivalent to 1.54 grams vancomycin hydrochloride), 375 mg trehalose, 0.15 mg polysorbate 80, and hydrochloric acid used to adjust the pH. The spray-dried powder is reconstituted with Sterile Water for Injection which forms a clear solution and subsequently diluted prior to intravenous or oral administration [see Dosage and Administration (2.5, 2.8)]. Vancomycin Hydrochloride for Injection may also be diluted with a sweetening agent for oral administration [see Dosage and Administration (2.8)].</Description>
</NDC>
<NDC>
<NDCCode>79887-111-21</NDCCode>
<PackageDescription>200 mL in 1 BOTTLE (79887-111-21) </PackageDescription>
<NDC11Code>79887-0111-21</NDC11Code>
<ProductNDC>79887-111</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Boosietizer</ProprietaryName>
<NonProprietaryName>Hand Sanitizer</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200801</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>AWSM Marcin Szakola</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>79887-111-51</NDCCode>
<PackageDescription>500 mL in 1 BOTTLE (79887-111-51) </PackageDescription>
<NDC11Code>79887-0111-51</NDC11Code>
<ProductNDC>79887-111</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Boosietizer</ProprietaryName>
<NonProprietaryName>Hand Sanitizer</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200801</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>AWSM Marcin Szakola</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>79887-112-23</NDCCode>
<PackageDescription>200 mL in 1 BOTTLE (79887-112-23) </PackageDescription>
<NDC11Code>79887-0112-23</NDC11Code>
<ProductNDC>79887-112</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Boosietizer Peach Scent</ProprietaryName>
<NonProprietaryName>Hand Sanitizer</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200803</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>AWSM Marcin Szakola</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200803</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>79887-112-53</NDCCode>
<PackageDescription>500 mL in 1 BOTTLE (79887-112-53) </PackageDescription>
<NDC11Code>79887-0112-53</NDC11Code>
<ProductNDC>79887-112</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Boosietizer Peach Scent</ProprietaryName>
<NonProprietaryName>Hand Sanitizer</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200803</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>AWSM Marcin Szakola</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200803</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>79887-113-22</NDCCode>
<PackageDescription>200 mL in 1 BOTTLE (79887-113-22) </PackageDescription>
<NDC11Code>79887-0113-22</NDC11Code>
<ProductNDC>79887-113</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Issactizer</ProprietaryName>
<NonProprietaryName>Hand Sanitizer</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200803</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>AWSM Marcin Szakola</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200803</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>79887-113-52</NDCCode>
<PackageDescription>500 mL in 1 BOTTLE (79887-113-52) </PackageDescription>
<NDC11Code>79887-0113-52</NDC11Code>
<ProductNDC>79887-113</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Issactizer</ProprietaryName>
<NonProprietaryName>Hand Sanitizer</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200803</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>AWSM Marcin Szakola</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200803</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0002-3227-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0002-3227-30) </PackageDescription>
<NDC11Code>00002-3227-30</NDC11Code>
<ProductNDC>0002-3227</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Strattera</ProprietaryName>
<NonProprietaryName>Atomoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20021126</StartMarketingDate>
<EndMarketingDate>20270731</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021411</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20030110</StartMarketingDatePackage>
<EndMarketingDatePackage>20270731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>STRATTERA is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. STRATTERA is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.</IndicationAndUsage>
<Description>Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is:. Atomoxetine hydrochloride is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. STRATTERA (atomoxetine) capsules are for oral administration only. Each STRATTERA capsule contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.4 mg, 20.6 mg, 28.6 mg, 45.7 mg, 68.6 mg, 91.4 mg and 114.3 mg of atomoxetine hydrochloride, respectively). The capsules also contain pregelatinized starch and dimethicone. The capsule shells contain gelatin, sodium lauryl sulfate, and one or more of the following inactive ingredients:. FD&C Blue No. 2, synthetic yellow iron oxide, titanium dioxide, red iron oxide. The capsules are imprinted with edible black ink.</Description>
</NDC>
<NDC>
<NDCCode>0002-3228-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0002-3228-30) </PackageDescription>
<NDC11Code>00002-3228-30</NDC11Code>
<ProductNDC>0002-3228</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Strattera</ProprietaryName>
<NonProprietaryName>Atomoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20021126</StartMarketingDate>
<EndMarketingDate>20270731</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021411</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20030110</StartMarketingDatePackage>
<EndMarketingDatePackage>20270731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>STRATTERA is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. STRATTERA is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.</IndicationAndUsage>
<Description>Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is:. Atomoxetine hydrochloride is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. STRATTERA (atomoxetine) capsules are for oral administration only. Each STRATTERA capsule contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.4 mg, 20.6 mg, 28.6 mg, 45.7 mg, 68.6 mg, 91.4 mg and 114.3 mg of atomoxetine hydrochloride, respectively). The capsules also contain pregelatinized starch and dimethicone. The capsule shells contain gelatin, sodium lauryl sulfate, and one or more of the following inactive ingredients:. FD&C Blue No. 2, synthetic yellow iron oxide, titanium dioxide, red iron oxide. The capsules are imprinted with edible black ink.</Description>
</NDC>
<NDC>
<NDCCode>0002-3229-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0002-3229-30) </PackageDescription>
<NDC11Code>00002-3229-30</NDC11Code>
<ProductNDC>0002-3229</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Strattera</ProprietaryName>
<NonProprietaryName>Atomoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20021126</StartMarketingDate>
<EndMarketingDate>20270731</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021411</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20030110</StartMarketingDatePackage>
<EndMarketingDatePackage>20270731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>STRATTERA is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. STRATTERA is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.</IndicationAndUsage>
<Description>Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is:. Atomoxetine hydrochloride is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. STRATTERA (atomoxetine) capsules are for oral administration only. Each STRATTERA capsule contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.4 mg, 20.6 mg, 28.6 mg, 45.7 mg, 68.6 mg, 91.4 mg and 114.3 mg of atomoxetine hydrochloride, respectively). The capsules also contain pregelatinized starch and dimethicone. The capsule shells contain gelatin, sodium lauryl sulfate, and one or more of the following inactive ingredients:. FD&C Blue No. 2, synthetic yellow iron oxide, titanium dioxide, red iron oxide. The capsules are imprinted with edible black ink.</Description>
</NDC>
<NDC>
<NDCCode>0002-3238-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0002-3238-30) </PackageDescription>
<NDC11Code>00002-3238-30</NDC11Code>
<ProductNDC>0002-3238</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Strattera</ProprietaryName>
<NonProprietaryName>Atomoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20021126</StartMarketingDate>
<EndMarketingDate>20270731</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021411</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>18</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20030110</StartMarketingDatePackage>
<EndMarketingDatePackage>20270731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>STRATTERA is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. STRATTERA is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.</IndicationAndUsage>
<Description>Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is:. Atomoxetine hydrochloride is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. STRATTERA (atomoxetine) capsules are for oral administration only. Each STRATTERA capsule contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.4 mg, 20.6 mg, 28.6 mg, 45.7 mg, 68.6 mg, 91.4 mg and 114.3 mg of atomoxetine hydrochloride, respectively). The capsules also contain pregelatinized starch and dimethicone. The capsule shells contain gelatin, sodium lauryl sulfate, and one or more of the following inactive ingredients:. FD&C Blue No. 2, synthetic yellow iron oxide, titanium dioxide, red iron oxide. The capsules are imprinted with edible black ink.</Description>
</NDC>
<NDC>
<NDCCode>0002-3239-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0002-3239-30) </PackageDescription>
<NDC11Code>00002-3239-30</NDC11Code>
<ProductNDC>0002-3239</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Strattera</ProprietaryName>
<NonProprietaryName>Atomoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20021126</StartMarketingDate>
<EndMarketingDate>20270731</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021411</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20030110</StartMarketingDatePackage>
<EndMarketingDatePackage>20270731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>STRATTERA is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. STRATTERA is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.</IndicationAndUsage>
<Description>Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is:. Atomoxetine hydrochloride is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. STRATTERA (atomoxetine) capsules are for oral administration only. Each STRATTERA capsule contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.4 mg, 20.6 mg, 28.6 mg, 45.7 mg, 68.6 mg, 91.4 mg and 114.3 mg of atomoxetine hydrochloride, respectively). The capsules also contain pregelatinized starch and dimethicone. The capsule shells contain gelatin, sodium lauryl sulfate, and one or more of the following inactive ingredients:. FD&C Blue No. 2, synthetic yellow iron oxide, titanium dioxide, red iron oxide. The capsules are imprinted with edible black ink.</Description>
</NDC>
<NDC>
<NDCCode>0002-3250-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0002-3250-30) </PackageDescription>
<NDC11Code>00002-3250-30</NDC11Code>
<ProductNDC>0002-3250</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Strattera</ProprietaryName>
<NonProprietaryName>Atomoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050214</StartMarketingDate>
<EndMarketingDate>20270731</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021411</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
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<Description>Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is:. Atomoxetine hydrochloride is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. STRATTERA (atomoxetine) capsules are for oral administration only. Each STRATTERA capsule contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.4 mg, 20.6 mg, 28.6 mg, 45.7 mg, 68.6 mg, 91.4 mg and 114.3 mg of atomoxetine hydrochloride, respectively). The capsules also contain pregelatinized starch and dimethicone. The capsule shells contain gelatin, sodium lauryl sulfate, and one or more of the following inactive ingredients:. FD&C Blue No. 2, synthetic yellow iron oxide, titanium dioxide, red iron oxide. The capsules are imprinted with edible black ink.</Description>
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<Description>JIVI [antihemophilic factor (recombinant), PEGylated-aucl] is a sterile, nonpyrogenic, preservative-free, white to slightly yellow lyophilized powder for reconstitution with sterile Water for Injection (sWFI) as diluent for intravenous (IV) administration. The product is supplied in single-dose vials containing dosage strengths of 500, 1000, 2000 and 3000 IU in 2.5 mL fill size and 4000 IU in 5 mL fill size. For each dosage strength, the actual assayed potency is directly printed on each vial label. The container closure system consists of a 10 mL, Type I glass vial sealed with a bromobutyl grey stopper and an aluminum crimp seal with plastic flip-off cap plus vial adapter. The vial adapter was designed to connect with the sWFI, prefilled diluent syringe. The 500, 1000, 2000, and 3000 IU vials of JIVI are formulated with the following excipients: 59 mg glycine, 27 mg sucrose, 8.4 mg histidine, 4.7 mg sodium chloride, 0.7 mg calcium chloride, and 0.216 mg polysorbate 80. The 4000 IU vial of Jivi is formulated with the following quantities of these excipients: 114 mg glycine, 52 mg sucrose, 16.1 mg histidine, 9.1 mg sodium chloride, 1.9 mg calcium chloride, and 0.416 mg polysorbate 80. The pH of the reconstituted product is 6.6 to 7.0. The specific activity of JIVI is approximately 10,000 IU/mg protein. The active protein (or starting molecule), prior to conjugation is a recombinant B-domain deleted human coagulation Factor VIII (BDD-rFVIII) produced by recombinant DNA technology in Baby Hamster Kidney (BHK) cells. JIVI is produced by site-specific conjugation of the BDD-rFVIII variant K1804C at the cysteine amino acid position 1804 (within the A3 domain) with a single maleimide-derivatized, 60 kilodalton (kDa) branched PEG (two 30 kDa PEG) moiety. The A3 domain was selected for conjugation to provide both a consistent coagulation activity and high PEGylation efficiency. The molecular weight of JIVI is approximately 234 kDa based on the calculated average molecular weight of the BDD-rFVIII variant of 165 kDa, plus glycosylation (~4 kDa), and the average molecular weight of the PEG-maleimide of approximately 60 kDa. Functional characterization of JIVI shows comparable mechanism of action to that of rFVIII product with an extended plasma half-life [see Clinical Pharmacology (12.1)]. The manufacturing process of JIVI involves propagation of the recombinant production cell line with the harvest isolation process consisting of continuous filtration of tissue culture fluid and anion exchange chromatography on a membrane adsorber capsule. The process intermediate is purified from process- and product-related impurities using a series of chromatography and filtration steps, including 20 nm viral filtration, prior to conjugation to the 60 kDa maleimide PEG moiety. The mono-PEGylated JIVI active molecule is separated from product-related species by chromatography and then formulated by ultrafiltration. The cell culture, PEGylation, purification process and formulation used in the manufacture of JIVI do not use any additives of human or animal origins.</Description>
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<IndicationAndUsage>JIVI, is indicated for use in previously treated adults and pediatric patients 7 years of age and older with hemophilia A (congenital Factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes, 2 Perioperative management of bleeding, 3 Routine prophylaxis to reduce the frequency of bleeding episodes .</IndicationAndUsage>
<Description>JIVI [antihemophilic factor (recombinant), PEGylated-aucl] is a sterile, nonpyrogenic, preservative-free, white to slightly yellow lyophilized powder for reconstitution with sterile Water for Injection (sWFI) as diluent for intravenous (IV) administration. The product is supplied in single-dose vials containing dosage strengths of 500, 1000, 2000 and 3000 IU in 2.5 mL fill size and 4000 IU in 5 mL fill size. For each dosage strength, the actual assayed potency is directly printed on each vial label. The container closure system consists of a 10 mL, Type I glass vial sealed with a bromobutyl grey stopper and an aluminum crimp seal with plastic flip-off cap plus vial adapter. The vial adapter was designed to connect with the sWFI, prefilled diluent syringe. The 500, 1000, 2000, and 3000 IU vials of JIVI are formulated with the following excipients: 59 mg glycine, 27 mg sucrose, 8.4 mg histidine, 4.7 mg sodium chloride, 0.7 mg calcium chloride, and 0.216 mg polysorbate 80. The 4000 IU vial of Jivi is formulated with the following quantities of these excipients: 114 mg glycine, 52 mg sucrose, 16.1 mg histidine, 9.1 mg sodium chloride, 1.9 mg calcium chloride, and 0.416 mg polysorbate 80. The pH of the reconstituted product is 6.6 to 7.0. The specific activity of JIVI is approximately 10,000 IU/mg protein. The active protein (or starting molecule), prior to conjugation is a recombinant B-domain deleted human coagulation Factor VIII (BDD-rFVIII) produced by recombinant DNA technology in Baby Hamster Kidney (BHK) cells. JIVI is produced by site-specific conjugation of the BDD-rFVIII variant K1804C at the cysteine amino acid position 1804 (within the A3 domain) with a single maleimide-derivatized, 60 kilodalton (kDa) branched PEG (two 30 kDa PEG) moiety. The A3 domain was selected for conjugation to provide both a consistent coagulation activity and high PEGylation efficiency. The molecular weight of JIVI is approximately 234 kDa based on the calculated average molecular weight of the BDD-rFVIII variant of 165 kDa, plus glycosylation (~4 kDa), and the average molecular weight of the PEG-maleimide of approximately 60 kDa. Functional characterization of JIVI shows comparable mechanism of action to that of rFVIII product with an extended plasma half-life [see Clinical Pharmacology (12.1)]. The manufacturing process of JIVI involves propagation of the recombinant production cell line with the harvest isolation process consisting of continuous filtration of tissue culture fluid and anion exchange chromatography on a membrane adsorber capsule. The process intermediate is purified from process- and product-related impurities using a series of chromatography and filtration steps, including 20 nm viral filtration, prior to conjugation to the 60 kDa maleimide PEG moiety. The mono-PEGylated JIVI active molecule is separated from product-related species by chromatography and then formulated by ultrafiltration. The cell culture, PEGylation, purification process and formulation used in the manufacture of JIVI do not use any additives of human or animal origins.</Description>
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<Description>JIVI [antihemophilic factor (recombinant), PEGylated-aucl] is a sterile, nonpyrogenic, preservative-free, white to slightly yellow lyophilized powder for reconstitution with sterile Water for Injection (sWFI) as diluent for intravenous (IV) administration. The product is supplied in single-dose vials containing dosage strengths of 500, 1000, 2000 and 3000 IU in 2.5 mL fill size and 4000 IU in 5 mL fill size. For each dosage strength, the actual assayed potency is directly printed on each vial label. The container closure system consists of a 10 mL, Type I glass vial sealed with a bromobutyl grey stopper and an aluminum crimp seal with plastic flip-off cap plus vial adapter. The vial adapter was designed to connect with the sWFI, prefilled diluent syringe. The 500, 1000, 2000, and 3000 IU vials of JIVI are formulated with the following excipients: 59 mg glycine, 27 mg sucrose, 8.4 mg histidine, 4.7 mg sodium chloride, 0.7 mg calcium chloride, and 0.216 mg polysorbate 80. The 4000 IU vial of Jivi is formulated with the following quantities of these excipients: 114 mg glycine, 52 mg sucrose, 16.1 mg histidine, 9.1 mg sodium chloride, 1.9 mg calcium chloride, and 0.416 mg polysorbate 80. The pH of the reconstituted product is 6.6 to 7.0. The specific activity of JIVI is approximately 10,000 IU/mg protein. The active protein (or starting molecule), prior to conjugation is a recombinant B-domain deleted human coagulation Factor VIII (BDD-rFVIII) produced by recombinant DNA technology in Baby Hamster Kidney (BHK) cells. JIVI is produced by site-specific conjugation of the BDD-rFVIII variant K1804C at the cysteine amino acid position 1804 (within the A3 domain) with a single maleimide-derivatized, 60 kilodalton (kDa) branched PEG (two 30 kDa PEG) moiety. The A3 domain was selected for conjugation to provide both a consistent coagulation activity and high PEGylation efficiency. The molecular weight of JIVI is approximately 234 kDa based on the calculated average molecular weight of the BDD-rFVIII variant of 165 kDa, plus glycosylation (~4 kDa), and the average molecular weight of the PEG-maleimide of approximately 60 kDa. Functional characterization of JIVI shows comparable mechanism of action to that of rFVIII product with an extended plasma half-life [see Clinical Pharmacology (12.1)]. The manufacturing process of JIVI involves propagation of the recombinant production cell line with the harvest isolation process consisting of continuous filtration of tissue culture fluid and anion exchange chromatography on a membrane adsorber capsule. The process intermediate is purified from process- and product-related impurities using a series of chromatography and filtration steps, including 20 nm viral filtration, prior to conjugation to the 60 kDa maleimide PEG moiety. The mono-PEGylated JIVI active molecule is separated from product-related species by chromatography and then formulated by ultrafiltration. The cell culture, PEGylation, purification process and formulation used in the manufacture of JIVI do not use any additives of human or animal origins.</Description>
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<Description>JIVI [antihemophilic factor (recombinant), PEGylated-aucl] is a sterile, nonpyrogenic, preservative-free, white to slightly yellow lyophilized powder for reconstitution with sterile Water for Injection (sWFI) as diluent for intravenous (IV) administration. The product is supplied in single-dose vials containing dosage strengths of 500, 1000, 2000 and 3000 IU in 2.5 mL fill size and 4000 IU in 5 mL fill size. For each dosage strength, the actual assayed potency is directly printed on each vial label. The container closure system consists of a 10 mL, Type I glass vial sealed with a bromobutyl grey stopper and an aluminum crimp seal with plastic flip-off cap plus vial adapter. The vial adapter was designed to connect with the sWFI, prefilled diluent syringe. The 500, 1000, 2000, and 3000 IU vials of JIVI are formulated with the following excipients: 59 mg glycine, 27 mg sucrose, 8.4 mg histidine, 4.7 mg sodium chloride, 0.7 mg calcium chloride, and 0.216 mg polysorbate 80. The 4000 IU vial of Jivi is formulated with the following quantities of these excipients: 114 mg glycine, 52 mg sucrose, 16.1 mg histidine, 9.1 mg sodium chloride, 1.9 mg calcium chloride, and 0.416 mg polysorbate 80. The pH of the reconstituted product is 6.6 to 7.0. The specific activity of JIVI is approximately 10,000 IU/mg protein. The active protein (or starting molecule), prior to conjugation is a recombinant B-domain deleted human coagulation Factor VIII (BDD-rFVIII) produced by recombinant DNA technology in Baby Hamster Kidney (BHK) cells. JIVI is produced by site-specific conjugation of the BDD-rFVIII variant K1804C at the cysteine amino acid position 1804 (within the A3 domain) with a single maleimide-derivatized, 60 kilodalton (kDa) branched PEG (two 30 kDa PEG) moiety. The A3 domain was selected for conjugation to provide both a consistent coagulation activity and high PEGylation efficiency. The molecular weight of JIVI is approximately 234 kDa based on the calculated average molecular weight of the BDD-rFVIII variant of 165 kDa, plus glycosylation (~4 kDa), and the average molecular weight of the PEG-maleimide of approximately 60 kDa. Functional characterization of JIVI shows comparable mechanism of action to that of rFVIII product with an extended plasma half-life [see Clinical Pharmacology (12.1)]. The manufacturing process of JIVI involves propagation of the recombinant production cell line with the harvest isolation process consisting of continuous filtration of tissue culture fluid and anion exchange chromatography on a membrane adsorber capsule. The process intermediate is purified from process- and product-related impurities using a series of chromatography and filtration steps, including 20 nm viral filtration, prior to conjugation to the 60 kDa maleimide PEG moiety. The mono-PEGylated JIVI active molecule is separated from product-related species by chromatography and then formulated by ultrafiltration. The cell culture, PEGylation, purification process and formulation used in the manufacture of JIVI do not use any additives of human or animal origins.</Description>
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<Description>JIVI [antihemophilic factor (recombinant), PEGylated-aucl] is a sterile, nonpyrogenic, preservative-free, white to slightly yellow lyophilized powder for reconstitution with sterile Water for Injection (sWFI) as diluent for intravenous (IV) administration. The product is supplied in single-dose vials containing dosage strengths of 500, 1000, 2000 and 3000 IU in 2.5 mL fill size and 4000 IU in 5 mL fill size. For each dosage strength, the actual assayed potency is directly printed on each vial label. The container closure system consists of a 10 mL, Type I glass vial sealed with a bromobutyl grey stopper and an aluminum crimp seal with plastic flip-off cap plus vial adapter. The vial adapter was designed to connect with the sWFI, prefilled diluent syringe. The 500, 1000, 2000, and 3000 IU vials of JIVI are formulated with the following excipients: 59 mg glycine, 27 mg sucrose, 8.4 mg histidine, 4.7 mg sodium chloride, 0.7 mg calcium chloride, and 0.216 mg polysorbate 80. The 4000 IU vial of Jivi is formulated with the following quantities of these excipients: 114 mg glycine, 52 mg sucrose, 16.1 mg histidine, 9.1 mg sodium chloride, 1.9 mg calcium chloride, and 0.416 mg polysorbate 80. The pH of the reconstituted product is 6.6 to 7.0. The specific activity of JIVI is approximately 10,000 IU/mg protein. The active protein (or starting molecule), prior to conjugation is a recombinant B-domain deleted human coagulation Factor VIII (BDD-rFVIII) produced by recombinant DNA technology in Baby Hamster Kidney (BHK) cells. JIVI is produced by site-specific conjugation of the BDD-rFVIII variant K1804C at the cysteine amino acid position 1804 (within the A3 domain) with a single maleimide-derivatized, 60 kilodalton (kDa) branched PEG (two 30 kDa PEG) moiety. The A3 domain was selected for conjugation to provide both a consistent coagulation activity and high PEGylation efficiency. The molecular weight of JIVI is approximately 234 kDa based on the calculated average molecular weight of the BDD-rFVIII variant of 165 kDa, plus glycosylation (~4 kDa), and the average molecular weight of the PEG-maleimide of approximately 60 kDa. Functional characterization of JIVI shows comparable mechanism of action to that of rFVIII product with an extended plasma half-life [see Clinical Pharmacology (12.1)]. The manufacturing process of JIVI involves propagation of the recombinant production cell line with the harvest isolation process consisting of continuous filtration of tissue culture fluid and anion exchange chromatography on a membrane adsorber capsule. The process intermediate is purified from process- and product-related impurities using a series of chromatography and filtration steps, including 20 nm viral filtration, prior to conjugation to the 60 kDa maleimide PEG moiety. The mono-PEGylated JIVI active molecule is separated from product-related species by chromatography and then formulated by ultrafiltration. The cell culture, PEGylation, purification process and formulation used in the manufacture of JIVI do not use any additives of human or animal origins.</Description>
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<IndicationAndUsage>JIVI, is indicated for use in previously treated adults and pediatric patients 7 years of age and older with hemophilia A (congenital Factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes, 2 Perioperative management of bleeding, 3 Routine prophylaxis to reduce the frequency of bleeding episodes .</IndicationAndUsage>
<Description>JIVI [antihemophilic factor (recombinant), PEGylated-aucl] is a sterile, nonpyrogenic, preservative-free, white to slightly yellow lyophilized powder for reconstitution with sterile Water for Injection (sWFI) as diluent for intravenous (IV) administration. The product is supplied in single-dose vials containing dosage strengths of 500, 1000, 2000 and 3000 IU in 2.5 mL fill size and 4000 IU in 5 mL fill size. For each dosage strength, the actual assayed potency is directly printed on each vial label. The container closure system consists of a 10 mL, Type I glass vial sealed with a bromobutyl grey stopper and an aluminum crimp seal with plastic flip-off cap plus vial adapter. The vial adapter was designed to connect with the sWFI, prefilled diluent syringe. The 500, 1000, 2000, and 3000 IU vials of JIVI are formulated with the following excipients: 59 mg glycine, 27 mg sucrose, 8.4 mg histidine, 4.7 mg sodium chloride, 0.7 mg calcium chloride, and 0.216 mg polysorbate 80. The 4000 IU vial of Jivi is formulated with the following quantities of these excipients: 114 mg glycine, 52 mg sucrose, 16.1 mg histidine, 9.1 mg sodium chloride, 1.9 mg calcium chloride, and 0.416 mg polysorbate 80. The pH of the reconstituted product is 6.6 to 7.0. The specific activity of JIVI is approximately 10,000 IU/mg protein. The active protein (or starting molecule), prior to conjugation is a recombinant B-domain deleted human coagulation Factor VIII (BDD-rFVIII) produced by recombinant DNA technology in Baby Hamster Kidney (BHK) cells. JIVI is produced by site-specific conjugation of the BDD-rFVIII variant K1804C at the cysteine amino acid position 1804 (within the A3 domain) with a single maleimide-derivatized, 60 kilodalton (kDa) branched PEG (two 30 kDa PEG) moiety. The A3 domain was selected for conjugation to provide both a consistent coagulation activity and high PEGylation efficiency. The molecular weight of JIVI is approximately 234 kDa based on the calculated average molecular weight of the BDD-rFVIII variant of 165 kDa, plus glycosylation (~4 kDa), and the average molecular weight of the PEG-maleimide of approximately 60 kDa. Functional characterization of JIVI shows comparable mechanism of action to that of rFVIII product with an extended plasma half-life [see Clinical Pharmacology (12.1)]. The manufacturing process of JIVI involves propagation of the recombinant production cell line with the harvest isolation process consisting of continuous filtration of tissue culture fluid and anion exchange chromatography on a membrane adsorber capsule. The process intermediate is purified from process- and product-related impurities using a series of chromatography and filtration steps, including 20 nm viral filtration, prior to conjugation to the 60 kDa maleimide PEG moiety. The mono-PEGylated JIVI active molecule is separated from product-related species by chromatography and then formulated by ultrafiltration. The cell culture, PEGylation, purification process and formulation used in the manufacture of JIVI do not use any additives of human or animal origins.</Description>
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