{
"NDC": [
{
"NDCCode": "50242-210-83",
"PackageDescription": "1 BOTTLE in 1 CARTON (50242-210-83) / 60 CAPSULE in 1 BOTTLE",
"NDC11Code": "50242-0210-83",
"ProductNDC": "50242-210",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gavreto",
"NonProprietaryName": "Pralsetinib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20210701",
"EndMarketingDate": "20260930",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213721",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "PRALSETINIB",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Rearranged during Transfection (RET) Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210701",
"EndMarketingDatePackage": "20260930",
"SamplePackage": "Y",
"IndicationAndUsage": "GAVRETO is a kinase inhibitor indicated for treatment of: 1 Adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer as detected by an FDA approved test (NSCLC). (1.1), 2 Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). (1.2).",
"Description": "Pralsetinib is an oral receptor tyrosine kinase inhibitor. The chemical name for pralsetinib is (cis)-N-((S)-1-(6-(4-fluoro-1H-pyrazol-1-yl)pyridin-3-yl)ethyl)-1-methoxy-4-(4-methyl-6-(5-methyl-1H-pyrazol-3-ylamino)pyrimidin-2-yl)cyclohexanecarboxamide. The molecular formula for pralsetinib is C27H32FN9O2, and the molecular weight is 533.61 g/mol. Pralsetinib has the following structure. The solubility of pralsetinib in aqueous media decreases over the range pH 1.99 to pH 7.64 from 0.880 mg/mL to < 0.001 mg/mL, indicating a decrease in solubility with increasing pH. GAVRETO (pralsetinib) is supplied for oral use as immediate release hydroxypropyl methylcellulose (HPMC) hard capsules containing 100 mg pralsetinib. The capsules also contain inactive ingredients. citric acid, hydroxypropyl methylcellulose (HPMC), magnesium stearate, microcrystalline cellulose (MCC), pregelatinized starch and sodium bicarbonate. The capsule shell consists of FD&C Blue #1 (Brilliant Blue FCF), hypromellose and titanium dioxide. The white printing ink contains butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, strong ammonia solution and titanium dioxide."
},
{
"NDCCode": "50242-214-83",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (50242-214-83) / .5 mL in 1 SYRINGE, GLASS",
"NDC11Code": "50242-0214-83",
"ProductNDC": "50242-214",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xolair Pfs",
"NonProprietaryName": "Omalizumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20180928",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103976",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "OMALIZUMAB",
"StrengthNumber": "75",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "Anti-IgE [EPC], Decreased IgE Activity [PE], IgE-directed Antibody Interactions [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230818",
"SamplePackage": "Y",
"IndicationAndUsage": "XOLAIR is an anti-IgE antibody indicated for: 1 Moderate to severe persistent asthma in adults and pediatric patients 6 years of age and older with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids (1.1), 2 Chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids, as add-on maintenance treatment (1.2), 3 IgE-mediated food allergy in adult and pediatric patients aged 1 year and older for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods. To be used in conjunction with food allergen avoidance (1.3), 4 Chronic spontaneous urticaria (CSU) in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment (1.4).",
"Description": "Omalizumab is a recombinant DNA-derived humanized IgG1κ monoclonal antibody that selectively binds to human immunoglobulin E (IgE). The antibody has a molecular weight of approximately 149 kiloDaltons. XOLAIR is produced by a Chinese hamster ovary cell suspension culture. XOLAIR (omalizumab) is administered as a subcutaneous (SC) injection and is available in prefilled syringe, autoinjector and in vials."
},
{
"NDCCode": "50242-215-83",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (50242-215-83) / 1 mL in 1 SYRINGE, GLASS",
"NDC11Code": "50242-0215-83",
"ProductNDC": "50242-215",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xolair Pfs",
"NonProprietaryName": "Omalizumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20180928",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103976",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "OMALIZUMAB",
"StrengthNumber": "150",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anti-IgE [EPC], Decreased IgE Activity [PE], IgE-directed Antibody Interactions [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230818",
"SamplePackage": "Y",
"IndicationAndUsage": "XOLAIR is an anti-IgE antibody indicated for: 1 Moderate to severe persistent asthma in adults and pediatric patients 6 years of age and older with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids (1.1), 2 Chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids, as add-on maintenance treatment (1.2), 3 IgE-mediated food allergy in adult and pediatric patients aged 1 year and older for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods. To be used in conjunction with food allergen avoidance (1.3), 4 Chronic spontaneous urticaria (CSU) in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment (1.4).",
"Description": "Omalizumab is a recombinant DNA-derived humanized IgG1κ monoclonal antibody that selectively binds to human immunoglobulin E (IgE). The antibody has a molecular weight of approximately 149 kiloDaltons. XOLAIR is produced by a Chinese hamster ovary cell suspension culture. XOLAIR (omalizumab) is administered as a subcutaneous (SC) injection and is available in prefilled syringe, autoinjector and in vials."
},
{
"NDCCode": "47682-210-83",
"PackageDescription": "15 PACKET in 1 BOX (47682-210-83) / 2 TABLET, CHEWABLE in 1 PACKET (47682-210-99) ",
"NDC11Code": "47682-0210-83",
"ProductNDC": "47682-210",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Medique Diotame",
"NonProprietaryName": "Bismuth Subsalicylate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20140401",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M008",
"LabelerName": "Unifirst First Aid Corporation",
"SubstanceName": "BISMUTH SUBSALICYLATE",
"StrengthNumber": "262",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140401",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. relieves: 1 traveler's diarrhea, 2 diarrhea, 3 upset stomach reliever due to overindulgence in food and drink, including: heartburn indigestion nausea gas belching fullness ."
},
{
"NDCCode": "57664-210-83",
"PackageDescription": "30 TABLET in 1 BOTTLE (57664-210-83) ",
"NDC11Code": "57664-0210-83",
"ProductNDC": "57664-210",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pramipexole",
"NonProprietaryName": "Pramipexole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130523",
"EndMarketingDate": "20181228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091683",
"LabelerName": "Caraco Pharmaceutical Laboratories, Ltd.",
"SubstanceName": "PRAMIPEXOLE DIHYDROCHLORIDE",
"StrengthNumber": ".75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130523",
"EndMarketingDatePackage": "20181228",
"SamplePackage": "N"
},
{
"NDCCode": "50242-210-12",
"PackageDescription": "1 BOTTLE in 1 CARTON (50242-210-12) / 120 CAPSULE in 1 BOTTLE",
"NDC11Code": "50242-0210-12",
"ProductNDC": "50242-210",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gavreto",
"NonProprietaryName": "Pralsetinib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20210701",
"EndMarketingDate": "20260930",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213721",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "PRALSETINIB",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Rearranged during Transfection (RET) Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220928",
"EndMarketingDatePackage": "20251231",
"SamplePackage": "N",
"IndicationAndUsage": "GAVRETO is a kinase inhibitor indicated for treatment of: 1 Adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer as detected by an FDA approved test (NSCLC). (1.1), 2 Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). (1.2).",
"Description": "Pralsetinib is an oral receptor tyrosine kinase inhibitor. The chemical name for pralsetinib is (cis)-N-((S)-1-(6-(4-fluoro-1H-pyrazol-1-yl)pyridin-3-yl)ethyl)-1-methoxy-4-(4-methyl-6-(5-methyl-1H-pyrazol-3-ylamino)pyrimidin-2-yl)cyclohexanecarboxamide. The molecular formula for pralsetinib is C27H32FN9O2, and the molecular weight is 533.61 g/mol. Pralsetinib has the following structure. The solubility of pralsetinib in aqueous media decreases over the range pH 1.99 to pH 7.64 from 0.880 mg/mL to < 0.001 mg/mL, indicating a decrease in solubility with increasing pH. GAVRETO (pralsetinib) is supplied for oral use as immediate release hydroxypropyl methylcellulose (HPMC) hard capsules containing 100 mg pralsetinib. The capsules also contain inactive ingredients. citric acid, hydroxypropyl methylcellulose (HPMC), magnesium stearate, microcrystalline cellulose (MCC), pregelatinized starch and sodium bicarbonate. The capsule shell consists of FD&C Blue #1 (Brilliant Blue FCF), hypromellose and titanium dioxide. The white printing ink contains butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, strong ammonia solution and titanium dioxide."
},
{
"NDCCode": "50242-210-60",
"PackageDescription": "1 BOTTLE in 1 CARTON (50242-210-60) / 60 CAPSULE in 1 BOTTLE",
"NDC11Code": "50242-0210-60",
"ProductNDC": "50242-210",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gavreto",
"NonProprietaryName": "Pralsetinib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20210701",
"EndMarketingDate": "20260930",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213721",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "PRALSETINIB",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Rearranged during Transfection (RET) Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210701",
"EndMarketingDatePackage": "20260930",
"SamplePackage": "N",
"IndicationAndUsage": "GAVRETO is a kinase inhibitor indicated for treatment of: 1 Adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer as detected by an FDA approved test (NSCLC). (1.1), 2 Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). (1.2).",
"Description": "Pralsetinib is an oral receptor tyrosine kinase inhibitor. The chemical name for pralsetinib is (cis)-N-((S)-1-(6-(4-fluoro-1H-pyrazol-1-yl)pyridin-3-yl)ethyl)-1-methoxy-4-(4-methyl-6-(5-methyl-1H-pyrazol-3-ylamino)pyrimidin-2-yl)cyclohexanecarboxamide. The molecular formula for pralsetinib is C27H32FN9O2, and the molecular weight is 533.61 g/mol. Pralsetinib has the following structure. The solubility of pralsetinib in aqueous media decreases over the range pH 1.99 to pH 7.64 from 0.880 mg/mL to < 0.001 mg/mL, indicating a decrease in solubility with increasing pH. GAVRETO (pralsetinib) is supplied for oral use as immediate release hydroxypropyl methylcellulose (HPMC) hard capsules containing 100 mg pralsetinib. The capsules also contain inactive ingredients. citric acid, hydroxypropyl methylcellulose (HPMC), magnesium stearate, microcrystalline cellulose (MCC), pregelatinized starch and sodium bicarbonate. The capsule shell consists of FD&C Blue #1 (Brilliant Blue FCF), hypromellose and titanium dioxide. The white printing ink contains butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, strong ammonia solution and titanium dioxide."
},
{
"NDCCode": "50242-210-86",
"PackageDescription": "1 BOTTLE in 1 CARTON (50242-210-86) > 120 CAPSULE in 1 BOTTLE",
"NDC11Code": "50242-0210-86",
"ProductNDC": "50242-210",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gavreto",
"NonProprietaryName": "Pralsetinib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200915",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213721",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "PRALSETINIB",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Rearranged during Transfection (RET) Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-02-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200915",
"SamplePackage": "Y"
},
{
"NDCCode": "50242-210-90",
"PackageDescription": "1 BOTTLE in 1 CARTON (50242-210-90) / 90 CAPSULE in 1 BOTTLE",
"NDC11Code": "50242-0210-90",
"ProductNDC": "50242-210",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gavreto",
"NonProprietaryName": "Pralsetinib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20210701",
"EndMarketingDate": "20260930",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213721",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "PRALSETINIB",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Rearranged during Transfection (RET) Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210701",
"EndMarketingDatePackage": "20260930",
"SamplePackage": "N",
"IndicationAndUsage": "GAVRETO is a kinase inhibitor indicated for treatment of: 1 Adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer as detected by an FDA approved test (NSCLC). (1.1), 2 Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). (1.2).",
"Description": "Pralsetinib is an oral receptor tyrosine kinase inhibitor. The chemical name for pralsetinib is (cis)-N-((S)-1-(6-(4-fluoro-1H-pyrazol-1-yl)pyridin-3-yl)ethyl)-1-methoxy-4-(4-methyl-6-(5-methyl-1H-pyrazol-3-ylamino)pyrimidin-2-yl)cyclohexanecarboxamide. The molecular formula for pralsetinib is C27H32FN9O2, and the molecular weight is 533.61 g/mol. Pralsetinib has the following structure. The solubility of pralsetinib in aqueous media decreases over the range pH 1.99 to pH 7.64 from 0.880 mg/mL to < 0.001 mg/mL, indicating a decrease in solubility with increasing pH. GAVRETO (pralsetinib) is supplied for oral use as immediate release hydroxypropyl methylcellulose (HPMC) hard capsules containing 100 mg pralsetinib. The capsules also contain inactive ingredients. citric acid, hydroxypropyl methylcellulose (HPMC), magnesium stearate, microcrystalline cellulose (MCC), pregelatinized starch and sodium bicarbonate. The capsule shell consists of FD&C Blue #1 (Brilliant Blue FCF), hypromellose and titanium dioxide. The white printing ink contains butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, strong ammonia solution and titanium dioxide."
},
{
"NDCCode": "10544-210-20",
"PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE (10544-210-20)",
"NDC11Code": "10544-0210-20",
"ProductNDC": "10544-210",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxyzine",
"NonProprietaryName": "Hydroxyzine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100517",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088618",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "HYDROXYZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antihistamine [EPC],Histamine Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus. As a sedative when used as a premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.",
"Description": "Hydroxyzine hydrochloride has the chemical name of 2-[2-[4-(p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride. C21H27ClN2O2 · 2HCl M. W. 447.83. Hydroxyzine hydrochloride occurs as a white, odorless powder which is very soluble in water. Each tablet for oral administration contains 10 mg, 25 mg or 50 mg hydroxyzine HCl. Inactive ingredients include anhydrous lactose, carnauba wax, colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium starch glycolate, titanium dioxide, and triacetin."
},
{
"NDCCode": "10544-210-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (10544-210-30)",
"NDC11Code": "10544-0210-30",
"ProductNDC": "10544-210",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxyzine",
"NonProprietaryName": "Hydroxyzine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100517",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088618",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "HYDROXYZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antihistamine [EPC],Histamine Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus. As a sedative when used as a premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.",
"Description": "Hydroxyzine hydrochloride has the chemical name of 2-[2-[4-(p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride. C21H27ClN2O2 · 2HCl M. W. 447.83. Hydroxyzine hydrochloride occurs as a white, odorless powder which is very soluble in water. Each tablet for oral administration contains 10 mg, 25 mg or 50 mg hydroxyzine HCl. Inactive ingredients include anhydrous lactose, carnauba wax, colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium starch glycolate, titanium dioxide, and triacetin."
},
{
"NDCCode": "43386-071-83",
"PackageDescription": "1 KIT in 1 KIT (43386-071-83) * 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (43386-010-61) * 2 L in 1 BOTTLE (43386-070-17) ",
"NDC11Code": "43386-0071-83",
"ProductNDC": "43386-071",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gavilyte-h And Bisacodyl",
"NonProprietaryName": "Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate, Potassium Chloride And Bisacodyl Delayed-release Tablet",
"DosageFormName": "KIT",
"RouteName": "ORAL",
"StartMarketingDate": "20150421",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202217",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"Status": "Active",
"LastUpdate": "2025-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150421",
"SamplePackage": "N",
"IndicationAndUsage": "GaviLyte - H and bisacodyl delayed-release tablet, USP is indicated for cleansing of the colon as a preparation for colonoscopy in adults.",
"Description": "GaviLyte - H and bisacodyl delayed-release tablet, USP consists of PEG-3350, an osmotic laxative and bisacodyl, a stimulant laxative. Each GaviLyte - H and 5 mg bisacodyl delayed-release tablet, USP (Polyethylene glycol (PEG) 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution and bisacodyl delayed-release tablet) consists of one 2 liter bottle of GaviLyte – H (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution) powder for reconstitution and one 5 mg bisacodyl, delayed-release tablet, USP. : 1 Bisacodyl delayed-release tablet, USP: Each pink, round, enteric coated bisacodyl delayed-release tablet, USP (debossed “N1”) contains 5 mg of bisacodyl, USP (C22H19NO4) with a molecular weight of 361.40. Inactive ingredients include lactose (anhydrous) NF, microcrystalline cellulose NF, croscarmellose sodium NF, magnesium stearate NF, methacrylic acid copolymer, talc, titanium dioxide, triethyl citrate, D&C red # 27/phloxine aluminum lake, colloidal anhydrous silica, sodium bicarbonate, sodium lauryl sulfate, FD&C blue # 2/indigo carmine aluminum lake and FD&C yellow # 6/sunset yellow FCF aluminum lake. The bisacodyl delayed-release tablet, USP is administered orally prior to drinking the GaviLyte - H [see Dosage and Administration ( 2)] ., 2 GaviLyte – H (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution): A white powder for reconstitution containing 210 grams of PEG-3350, 2.86 grams of sodium bicarbonate, 5.6 grams of sodium chloride, 0.74 grams of potassium chloride and 2 grams of flavoring ingredients (if applicable). Flavor Packs are available in Cherry (containing artificial cherry flavor powder, maltodextrin and sodium saccharin), Lemon (containing natural lemon flavor powder, maltodextrin and sodium saccharin), and Orange (containing natural and artificial orange flavor powder, maltodextrin and sodium saccharin). This preparation can be used without the addition of a Flavor Pack. When dissolved in water to a volume of 2 liters, the GaviLyte - H solution is isosmotic, clear, and colorless. The GaviLyte - H solution is administered orally after taking the one bisacodyl delayed-release tablet, USP [see Dosage and Administration ( 2)] ."
},
{
"NDCCode": "50419-171-00",
"PackageDescription": "210 BOTTLE in 1 BOX (50419-171-00) / 28 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "50419-0171-00",
"ProductNDC": "50419-171",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Stivarga",
"NonProprietaryName": "Regorafenib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120927",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA203085",
"LabelerName": "Bayer HealthCare Pharmaceuticals Inc.",
"SubstanceName": "REGORAFENIB",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Kinase Inhibitor [EPC], Kinase Inhibitors [MoA], UGT1A1 Inhibitors [MoA], UGT1A9 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120927",
"SamplePackage": "N",
"IndicationAndUsage": "STIVARGA is a kinase inhibitor indicated for the treatment of adult patients with: 1 Metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type, an anti-EGFR therapy. (1.1), 2 Locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate. (1.2), 3 Hepatocellular carcinoma (HCC) who have been previously treated with sorafenib (1.3) .",
"Description": "STIVARGA (regorafenib) is a multikinase inhibitor with the chemical name 4-[4-({[4-chloro-3-(trifluoromethyl) phenyl] carbamoyl} amino)-3-fluorophenoxy]-N-methylpyridine-2-carboxamide monohydrate. Regorafenib has the following structural formula. Regorafenib is a monohydrate and it has a molecular formula C21H15ClF4N4O3 H2O and a molecular weight of 500.83. Regorafenib is practically insoluble in water, slightly soluble in acetonitrile, methanol, ethanol, and ethyl acetate and sparingly soluble in acetone. STIVARGA tablets for oral administration are formulated as light pink, oval-shaped tablets debossed with \"BAYER\" on one side and \"40\" on the other. Each tablet contains 40 mg of regorafenib in the anhydrous state, which corresponds to 41.49 mg of regorafenib monohydrate, and the following inactive ingredients: cellulose microcrystalline, croscarmellose sodium, magnesium stearate, povidone, and colloidal silicon dioxide. The film-coating contains the following inactive ingredients: ferric oxide red, ferric oxide yellow, lecithin (soy), polyethylene glycol 3350, polyvinyl alcohol, talc, and titanium dioxide."
},
{
"NDCCode": "50633-210-11",
"PackageDescription": "1 VIAL in 1 CARTON (50633-210-11) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL",
"NDC11Code": "50633-0210-11",
"ProductNDC": "50633-210",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Voraxaze",
"NonProprietaryName": "Glucarpidase",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20120401",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125327",
"LabelerName": "BTG International Inc.",
"SubstanceName": "GLUCARPIDASE",
"StrengthNumber": "1000",
"StrengthUnit": "[USP'U]/1",
"Pharm_Classes": "Carboxypeptidase [EPC], Carboxypeptidases [CS]",
"Status": "Active",
"LastUpdate": "2024-11-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120401",
"SamplePackage": "N",
"IndicationAndUsage": "VORAXAZE is indicated to reduce toxic plasma methotrexate concentration (greater than 1 micromole per liter) in adult and pediatric patients with delayed methotrexate clearance (plasma methotrexate concentrations greater than 2 standard deviations of the mean methotrexate excretion curve specific for the dose of methotrexate administered) due to impaired renal function. Limitations of Use:VORAXAZE is not recommended for use in patients who exhibit the expected clearance and expected plasma methotrexate concentration. Reducing plasma methotrexate concentration in these patients may result in subtherapeutic exposure to methotrexate [see Clinical Studies ( 14)] .",
"Description": "Glucarpidase is a carboxypeptidase produced by recombinant DNA technology in genetically modified Escherichia coli.Glucarpidase is a 390-amino acid homodimer protein with a molecular weight of 83 kDa. Each potency Unit corresponds to the enzymatic cleavage of 1 µmol/L of methotrexate per minute at 37°C. VORAXAZE (glucarpidase) for injection, for intravenous use is supplied as a sterile, preservative-free, white lyophilized powder in single-dose vials. Each vial contains 1,000 Units of glucarpidase, lactose monohydrate (10 mg), Tris-HCl (0.6 mg) and zinc acetate dihydrate (0.002 mg)."
},
{
"NDCCode": "52667-012-83",
"PackageDescription": "83 mL in 1 TUBE (52667-012-83) ",
"NDC11Code": "52667-0012-83",
"ProductNDC": "52667-012",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "100% Pure",
"ProprietaryNameSuffix": "Green Tea Spf 30 Sunscreen",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210830",
"EndMarketingDate": "20250107",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Purity Cosmetics",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "210",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210830",
"EndMarketingDatePackage": "20250107",
"SamplePackage": "N"
},
{
"NDCCode": "85766-210-01",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (85766-210-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE",
"NDC11Code": "85766-0210-01",
"ProductNDC": "85766-210",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ceftriaxone Sodium",
"NonProprietaryName": "Ceftriaxone Sodium",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20050509",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065169",
"LabelerName": "Sportpharm LLC",
"SubstanceName": "CEFTRIAXONE SODIUM",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260723",
"SamplePackage": "N",
"IndicationAndUsage": "Before instituting treatment with ceftriaxone, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. Therapy may be instituted prior to obtaining results of susceptibility testing. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftriaxone for injection, USP and other antibacterial drugs, ceftriaxone for injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Ceftriaxone for injection, USP is indicated for the treatment of the following infections when caused by susceptible organisms.",
"Description": "Ceftriaxone for injection, USP is a sterile, semisynthetic, broad-spectrum cephalosporin antibiotic for intravenous or intramuscular administration. Ceftriaxone sodium is (6 R, 7 R)-7-[2-(2-Amino-4-thiazolyl) glyoxylamido]-8-oxo-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo- as-triazin-3-yl)thio]methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7 2-( Z)-( O-methyloxime), disodium salt, sesquaterhydrate. The chemical formula of ceftriaxone sodium is C 18H 16N 8Na 2O 7S 33.5H 2O. It has a calculated molecular weight of 661.60 and the following structural formula:. Ceftriaxone sodium is a white to yellowish crystalline powder which is readily soluble in water, sparingly soluble in methanol and very slightly soluble in ethanol. The pH of a 1% aqueous solution is approximately 6.7. The color of ceftriaxone sodium solutions ranges from light yellow to amber, depending on the length of storage, concentration and diluent used. Each vial contains ceftriaxone sodium equivalent to 250 mg, 500 mg, or 1 gram of ceftriaxone activity. Ceftriaxone sodium contains approximately 83 mg (3.6 mEq) of sodium per gram of ceftriaxone activity."
},
{
"NDCCode": "85766-210-10",
"PackageDescription": "10 VIAL, SINGLE-USE in 1 CARTON (85766-210-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE",
"NDC11Code": "85766-0210-10",
"ProductNDC": "85766-210",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ceftriaxone Sodium",
"NonProprietaryName": "Ceftriaxone Sodium",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20050509",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065169",
"LabelerName": "Sportpharm LLC",
"SubstanceName": "CEFTRIAXONE SODIUM",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260723",
"SamplePackage": "N",
"IndicationAndUsage": "Before instituting treatment with ceftriaxone, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. Therapy may be instituted prior to obtaining results of susceptibility testing. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftriaxone for injection, USP and other antibacterial drugs, ceftriaxone for injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Ceftriaxone for injection, USP is indicated for the treatment of the following infections when caused by susceptible organisms.",
"Description": "Ceftriaxone for injection, USP is a sterile, semisynthetic, broad-spectrum cephalosporin antibiotic for intravenous or intramuscular administration. Ceftriaxone sodium is (6 R, 7 R)-7-[2-(2-Amino-4-thiazolyl) glyoxylamido]-8-oxo-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo- as-triazin-3-yl)thio]methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7 2-( Z)-( O-methyloxime), disodium salt, sesquaterhydrate. The chemical formula of ceftriaxone sodium is C 18H 16N 8Na 2O 7S 33.5H 2O. It has a calculated molecular weight of 661.60 and the following structural formula:. Ceftriaxone sodium is a white to yellowish crystalline powder which is readily soluble in water, sparingly soluble in methanol and very slightly soluble in ethanol. The pH of a 1% aqueous solution is approximately 6.7. The color of ceftriaxone sodium solutions ranges from light yellow to amber, depending on the length of storage, concentration and diluent used. Each vial contains ceftriaxone sodium equivalent to 250 mg, 500 mg, or 1 gram of ceftriaxone activity. Ceftriaxone sodium contains approximately 83 mg (3.6 mEq) of sodium per gram of ceftriaxone activity."
},
{
"NDCCode": "50242-001-05",
"PackageDescription": "1 AMPULE in 1 CONTAINER (50242-001-05) > 5 mL in 1 AMPULE",
"NDC11Code": "50242-0001-05",
"ProductNDC": "50242-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sterile Water",
"NonProprietaryName": "Water",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20180505",
"MarketingCategoryName": "UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "WATER",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20180505",
"EndMarketingDatePackage": "20230119",
"SamplePackage": "N"
},
{
"NDCCode": "50242-005-01",
"PackageDescription": "1 SYRINGE, PLASTIC in 1 CARTON (50242-005-01) / 1.5 mL in 1 SYRINGE, PLASTIC",
"NDC11Code": "50242-0005-01",
"ProductNDC": "50242-005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enspryng",
"NonProprietaryName": "Satralizumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20261015",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761149",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "SATRALIZUMAB",
"StrengthNumber": "180",
"StrengthUnit": "mg/1.5mL",
"Status": "Active",
"LastUpdate": "2026-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261015",
"SamplePackage": "N",
"IndicationAndUsage": "ENSPRYNG is an interleukin-6 (IL-6) receptor antagonist indicated for: 1 the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. (1.1), 2 the treatment of thyroid eye disease (TED) regardless of TED activity or duration in adult patients. (1.2).",
"Description": "Satralizumab-mwge is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody based on a human IgG2 framework. Each light chain and heavy chain consists of 214 and 443 amino acids, respectively. Satralizumab-mwge is a glycoprotein with an approximate molecular weight of 143 kDa and is produced by recombinant DNA technology in Chinese hamster ovary cells. The binding of satralizumab-mwge to the IL-6 receptor is pH-sensitive. ENSPRYNG (satralizumab-mwge) injection for subcutaneous administration is supplied as a sterile, clear, colorless to slightly yellow solution with no preservative, and with an approximate pH of 6. ENSPRYNG is supplied in a single-dose 1 mL prefilled syringe with a needle safety device or a single-dose 1 mL or 1.5 mL autoinjector that contains a prefilled syringe. Each prefilled syringe delivers 1 mL of solution containing 120 mg satralizumab-mwge, L-arginine (26.1 mg), L-aspartic acid (pH adjustment), L-histidine (3.1 mg), poloxamer 188 (0.5 mg), and Water for Injection, USP. Each prefilled autoinjector delivers either: 1 1 mL of solution containing 120 mg satralizumab-mwge, L-arginine (26.1 mg), L-aspartic acid (pH adjustment), L-histidine (3.1 mg), poloxamer 188 (0.5 mg), and Water for Injection, USP., 2 1.5 mL of solution containing 180 mg satralizumab-mwge, L-arginine (39.2 mg), L-aspartic acid (pH adjustment), L-histidine (4.65 mg), poloxamer 188 (0.75 mg), and Water for Injection, USP."
},
{
"NDCCode": "50242-005-86",
"PackageDescription": "1 SYRINGE, PLASTIC in 1 CARTON (50242-005-86) / 1.5 mL in 1 SYRINGE, PLASTIC",
"NDC11Code": "50242-0005-86",
"ProductNDC": "50242-005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enspryng",
"NonProprietaryName": "Satralizumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20261015",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761149",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "SATRALIZUMAB",
"StrengthNumber": "180",
"StrengthUnit": "mg/1.5mL",
"Status": "Active",
"LastUpdate": "2026-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261015",
"SamplePackage": "Y",
"IndicationAndUsage": "ENSPRYNG is an interleukin-6 (IL-6) receptor antagonist indicated for: 1 the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. (1.1), 2 the treatment of thyroid eye disease (TED) regardless of TED activity or duration in adult patients. (1.2).",
"Description": "Satralizumab-mwge is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody based on a human IgG2 framework. Each light chain and heavy chain consists of 214 and 443 amino acids, respectively. Satralizumab-mwge is a glycoprotein with an approximate molecular weight of 143 kDa and is produced by recombinant DNA technology in Chinese hamster ovary cells. The binding of satralizumab-mwge to the IL-6 receptor is pH-sensitive. ENSPRYNG (satralizumab-mwge) injection for subcutaneous administration is supplied as a sterile, clear, colorless to slightly yellow solution with no preservative, and with an approximate pH of 6. ENSPRYNG is supplied in a single-dose 1 mL prefilled syringe with a needle safety device or a single-dose 1 mL or 1.5 mL autoinjector that contains a prefilled syringe. Each prefilled syringe delivers 1 mL of solution containing 120 mg satralizumab-mwge, L-arginine (26.1 mg), L-aspartic acid (pH adjustment), L-histidine (3.1 mg), poloxamer 188 (0.5 mg), and Water for Injection, USP. Each prefilled autoinjector delivers either: 1 1 mL of solution containing 120 mg satralizumab-mwge, L-arginine (26.1 mg), L-aspartic acid (pH adjustment), L-histidine (3.1 mg), poloxamer 188 (0.5 mg), and Water for Injection, USP., 2 1.5 mL of solution containing 180 mg satralizumab-mwge, L-arginine (39.2 mg), L-aspartic acid (pH adjustment), L-histidine (4.65 mg), poloxamer 188 (0.75 mg), and Water for Injection, USP."
},
{
"NDCCode": "50242-007-01",
"PackageDescription": "1 SYRINGE, PLASTIC in 1 CARTON (50242-007-01) / 1 mL in 1 SYRINGE, PLASTIC",
"NDC11Code": "50242-0007-01",
"ProductNDC": "50242-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enspryng",
"NonProprietaryName": "Satralizumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20200814",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761149",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "SATRALIZUMAB",
"StrengthNumber": "120",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200814",
"SamplePackage": "N",
"IndicationAndUsage": "ENSPRYNG is an interleukin-6 (IL-6) receptor antagonist indicated for: 1 the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. (1.1), 2 the treatment of thyroid eye disease (TED) regardless of TED activity or duration in adult patients. (1.2).",
"Description": "Satralizumab-mwge is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody based on a human IgG2 framework. Each light chain and heavy chain consists of 214 and 443 amino acids, respectively. Satralizumab-mwge is a glycoprotein with an approximate molecular weight of 143 kDa and is produced by recombinant DNA technology in Chinese hamster ovary cells. The binding of satralizumab-mwge to the IL-6 receptor is pH-sensitive. ENSPRYNG (satralizumab-mwge) injection for subcutaneous administration is supplied as a sterile, clear, colorless to slightly yellow solution with no preservative, and with an approximate pH of 6. ENSPRYNG is supplied in a single-dose 1 mL prefilled syringe with a needle safety device or a single-dose 1 mL or 1.5 mL autoinjector that contains a prefilled syringe. Each prefilled syringe delivers 1 mL of solution containing 120 mg satralizumab-mwge, L-arginine (26.1 mg), L-aspartic acid (pH adjustment), L-histidine (3.1 mg), poloxamer 188 (0.5 mg), and Water for Injection, USP. Each prefilled autoinjector delivers either: 1 1 mL of solution containing 120 mg satralizumab-mwge, L-arginine (26.1 mg), L-aspartic acid (pH adjustment), L-histidine (3.1 mg), poloxamer 188 (0.5 mg), and Water for Injection, USP., 2 1.5 mL of solution containing 180 mg satralizumab-mwge, L-arginine (39.2 mg), L-aspartic acid (pH adjustment), L-histidine (4.65 mg), poloxamer 188 (0.75 mg), and Water for Injection, USP."
},
{
"NDCCode": "50242-007-33",
"PackageDescription": "1 SYRINGE in 1 CARTON (50242-007-33) / 1 mL in 1 SYRINGE",
"NDC11Code": "50242-0007-33",
"ProductNDC": "50242-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enspryng",
"NonProprietaryName": "Satralizumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20200814",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761149",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "SATRALIZUMAB",
"StrengthNumber": "120",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260610",
"SamplePackage": "Y",
"IndicationAndUsage": "ENSPRYNG is an interleukin-6 (IL-6) receptor antagonist indicated for: 1 the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. (1.1), 2 the treatment of thyroid eye disease (TED) regardless of TED activity or duration in adult patients. (1.2).",
"Description": "Satralizumab-mwge is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody based on a human IgG2 framework. Each light chain and heavy chain consists of 214 and 443 amino acids, respectively. Satralizumab-mwge is a glycoprotein with an approximate molecular weight of 143 kDa and is produced by recombinant DNA technology in Chinese hamster ovary cells. The binding of satralizumab-mwge to the IL-6 receptor is pH-sensitive. ENSPRYNG (satralizumab-mwge) injection for subcutaneous administration is supplied as a sterile, clear, colorless to slightly yellow solution with no preservative, and with an approximate pH of 6. ENSPRYNG is supplied in a single-dose 1 mL prefilled syringe with a needle safety device or a single-dose 1 mL or 1.5 mL autoinjector that contains a prefilled syringe. Each prefilled syringe delivers 1 mL of solution containing 120 mg satralizumab-mwge, L-arginine (26.1 mg), L-aspartic acid (pH adjustment), L-histidine (3.1 mg), poloxamer 188 (0.5 mg), and Water for Injection, USP. Each prefilled autoinjector delivers either: 1 1 mL of solution containing 120 mg satralizumab-mwge, L-arginine (26.1 mg), L-aspartic acid (pH adjustment), L-histidine (3.1 mg), poloxamer 188 (0.5 mg), and Water for Injection, USP., 2 1.5 mL of solution containing 180 mg satralizumab-mwge, L-arginine (39.2 mg), L-aspartic acid (pH adjustment), L-histidine (4.65 mg), poloxamer 188 (0.75 mg), and Water for Injection, USP."
},
{
"NDCCode": "50242-007-55",
"PackageDescription": "1 SYRINGE, PLASTIC in 1 CARTON (50242-007-55) / 1 mL in 1 SYRINGE, PLASTIC",
"NDC11Code": "50242-0007-55",
"ProductNDC": "50242-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enspryng",
"NonProprietaryName": "Satralizumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20200814",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761149",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "SATRALIZUMAB",
"StrengthNumber": "120",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260610",
"SamplePackage": "N",
"IndicationAndUsage": "ENSPRYNG is an interleukin-6 (IL-6) receptor antagonist indicated for: 1 the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. (1.1), 2 the treatment of thyroid eye disease (TED) regardless of TED activity or duration in adult patients. (1.2).",
"Description": "Satralizumab-mwge is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody based on a human IgG2 framework. Each light chain and heavy chain consists of 214 and 443 amino acids, respectively. Satralizumab-mwge is a glycoprotein with an approximate molecular weight of 143 kDa and is produced by recombinant DNA technology in Chinese hamster ovary cells. The binding of satralizumab-mwge to the IL-6 receptor is pH-sensitive. ENSPRYNG (satralizumab-mwge) injection for subcutaneous administration is supplied as a sterile, clear, colorless to slightly yellow solution with no preservative, and with an approximate pH of 6. ENSPRYNG is supplied in a single-dose 1 mL prefilled syringe with a needle safety device or a single-dose 1 mL or 1.5 mL autoinjector that contains a prefilled syringe. Each prefilled syringe delivers 1 mL of solution containing 120 mg satralizumab-mwge, L-arginine (26.1 mg), L-aspartic acid (pH adjustment), L-histidine (3.1 mg), poloxamer 188 (0.5 mg), and Water for Injection, USP. Each prefilled autoinjector delivers either: 1 1 mL of solution containing 120 mg satralizumab-mwge, L-arginine (26.1 mg), L-aspartic acid (pH adjustment), L-histidine (3.1 mg), poloxamer 188 (0.5 mg), and Water for Injection, USP., 2 1.5 mL of solution containing 180 mg satralizumab-mwge, L-arginine (39.2 mg), L-aspartic acid (pH adjustment), L-histidine (4.65 mg), poloxamer 188 (0.75 mg), and Water for Injection, USP."
},
{
"NDCCode": "50242-007-86",
"PackageDescription": "1 SYRINGE, PLASTIC in 1 CARTON (50242-007-86) / 1 mL in 1 SYRINGE, PLASTIC",
"NDC11Code": "50242-0007-86",
"ProductNDC": "50242-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enspryng",
"NonProprietaryName": "Satralizumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20200814",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761149",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "SATRALIZUMAB",
"StrengthNumber": "120",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210813",
"SamplePackage": "Y",
"IndicationAndUsage": "ENSPRYNG is an interleukin-6 (IL-6) receptor antagonist indicated for: 1 the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. (1.1), 2 the treatment of thyroid eye disease (TED) regardless of TED activity or duration in adult patients. (1.2).",
"Description": "Satralizumab-mwge is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody based on a human IgG2 framework. Each light chain and heavy chain consists of 214 and 443 amino acids, respectively. Satralizumab-mwge is a glycoprotein with an approximate molecular weight of 143 kDa and is produced by recombinant DNA technology in Chinese hamster ovary cells. The binding of satralizumab-mwge to the IL-6 receptor is pH-sensitive. ENSPRYNG (satralizumab-mwge) injection for subcutaneous administration is supplied as a sterile, clear, colorless to slightly yellow solution with no preservative, and with an approximate pH of 6. ENSPRYNG is supplied in a single-dose 1 mL prefilled syringe with a needle safety device or a single-dose 1 mL or 1.5 mL autoinjector that contains a prefilled syringe. Each prefilled syringe delivers 1 mL of solution containing 120 mg satralizumab-mwge, L-arginine (26.1 mg), L-aspartic acid (pH adjustment), L-histidine (3.1 mg), poloxamer 188 (0.5 mg), and Water for Injection, USP. Each prefilled autoinjector delivers either: 1 1 mL of solution containing 120 mg satralizumab-mwge, L-arginine (26.1 mg), L-aspartic acid (pH adjustment), L-histidine (3.1 mg), poloxamer 188 (0.5 mg), and Water for Injection, USP., 2 1.5 mL of solution containing 180 mg satralizumab-mwge, L-arginine (39.2 mg), L-aspartic acid (pH adjustment), L-histidine (4.65 mg), poloxamer 188 (0.75 mg), and Water for Injection, USP."
},
{
"NDCCode": "50242-014-03",
"PackageDescription": "1 KIT in 1 CARTON (50242-014-03) * 1 VIAL, SINGLE-USE in 1 CARTON (50242-009-01) / 5 mL in 1 VIAL, SINGLE-USE * 1 VIAL, SINGLE-USE in 1 CARTON (50242-907-01) / 5.2 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "50242-0014-03",
"ProductNDC": "50242-014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tnkase",
"NonProprietaryName": "Tenecteplase",
"DosageFormName": "KIT",
"StartMarketingDate": "20250228",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103909",
"LabelerName": "Genentech, Inc.",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250228",
"SamplePackage": "N",
"IndicationAndUsage": "TNKase is a tissue plasminogen activator (tPA) indicated: 1 for the treatment of acute ischemic stroke (AIS) in adults. (1.1), 2 to reduce the risk of death associated with acute ST elevation myocardial infarction (STEMI) in adults. (1.2).",
"Description": "Tenecteplase is a tissue plasminogen activator (tPA) produced by recombinant DNA technology using a mammalian cell line (Chinese Hamster Ovary cells). Tenecteplase is a 527-amino acid glycoprotein developed by introducing the following modifications to the complementary DNA (cDNA) for natural human tPA: a substitution of threonine 103 with asparagine, and a substitution of asparagine 117 with glutamine, both within the kringle 1 domain, and a tetra-alanine substitution at amino acids 296–299 in the protease domain. It has a molecular weight of 58,742 daltons. Biological potency is determined by an in vitro clot lysis assay and is expressed in tenecteplase specific units. The specific activity of tenecteplase has been defined as 200 units/mg. TNKase (tenecteplase) for injection is a sterile, white to pale yellow, lyophilized powder for intravenous bolus administration after reconstitution with Sterile Water for Injection, USP. Each 25 mg single-dose vial of TNKase nominally contains 25 mg of tenecteplase, arginine (261 mg), phosphoric acid (approximately 80 mg), and polysorbate 20 (2.0 mg). Following reconstitution with the supplied 5.2 mL single-dose vial of Sterile Water for Injection, USP, the final concentration is 5 mg/mL with a pH of approximately 7.3. Each 50 mg single-dose vial of TNKase nominally contains 50 mg of tenecteplase, arginine (522 mg), phosphoric acid (approximately 160 mg), and polysorbate 20 (4.0 mg). Following reconstitution with the supplied 10 mL single-dose vial of Sterile Water for Injection, USP, the final concentration is 5 mg/mL with a pH of approximately 7.3."
},
{
"NDCCode": "50242-018-21",
"PackageDescription": "1 KIT in 1 CARTON (50242-018-21) * 10 mg in 1 VIAL * 10 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "50242-0018-21",
"ProductNDC": "50242-018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nutropin",
"NonProprietaryName": "Somatropin",
"DosageFormName": "KIT",
"StartMarketingDate": "19931117",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019676",
"LabelerName": "Genentech, Inc.",
"Status": "Deprecated",
"LastUpdate": "2015-12-04"
},
{
"NDCCode": "50242-038-61",
"PackageDescription": "1 KIT in 1 CARTON (50242-038-61) * 10 mL in 1 VIAL, SINGLE-USE * 10 mL in 1 VIAL, SINGLE-USE * 3 APPLICATOR in 1 PACKET > .7 mL in 1 APPLICATOR",
"NDC11Code": "50242-0038-61",
"ProductNDC": "50242-038",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tnkase",
"NonProprietaryName": "Tenecteplase",
"DosageFormName": "KIT",
"StartMarketingDate": "20000602",
"EndMarketingDate": "20140630",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103909",
"LabelerName": "Genentech, Inc.",
"Status": "Deprecated",
"LastUpdate": "2014-07-07"
},
{
"NDCCode": "50242-040-62",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (50242-040-62) / 1.2 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "50242-0040-62",
"ProductNDC": "50242-040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xolair",
"NonProprietaryName": "Omalizumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20030620",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103976",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "OMALIZUMAB",
"StrengthNumber": "150",
"StrengthUnit": "mg/1.2mL",
"Pharm_Classes": "Anti-IgE [EPC], Decreased IgE Activity [PE], IgE-directed Antibody Interactions [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20030620",
"SamplePackage": "N",
"IndicationAndUsage": "XOLAIR is an anti-IgE antibody indicated for: 1 Moderate to severe persistent asthma in adults and pediatric patients 6 years of age and older with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids (1.1), 2 Chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids, as add-on maintenance treatment (1.2), 3 IgE-mediated food allergy in adult and pediatric patients aged 1 year and older for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods. To be used in conjunction with food allergen avoidance (1.3), 4 Chronic spontaneous urticaria (CSU) in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment (1.4).",
"Description": "Omalizumab is a recombinant DNA-derived humanized IgG1κ monoclonal antibody that selectively binds to human immunoglobulin E (IgE). The antibody has a molecular weight of approximately 149 kiloDaltons. XOLAIR is produced by a Chinese hamster ovary cell suspension culture. XOLAIR (omalizumab) is administered as a subcutaneous (SC) injection and is available in prefilled syringe, autoinjector and in vials."
},
{
"NDCCode": "50242-040-86",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (50242-040-86) / 1.2 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "50242-0040-86",
"ProductNDC": "50242-040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xolair",
"NonProprietaryName": "Omalizumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20030620",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103976",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "OMALIZUMAB",
"StrengthNumber": "150",
"StrengthUnit": "mg/1.2mL",
"Pharm_Classes": "Anti-IgE [EPC], Decreased IgE Activity [PE], IgE-directed Antibody Interactions [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20131220",
"SamplePackage": "Y",
"IndicationAndUsage": "XOLAIR is an anti-IgE antibody indicated for: 1 Moderate to severe persistent asthma in adults and pediatric patients 6 years of age and older with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids (1.1), 2 Chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids, as add-on maintenance treatment (1.2), 3 IgE-mediated food allergy in adult and pediatric patients aged 1 year and older for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods. To be used in conjunction with food allergen avoidance (1.3), 4 Chronic spontaneous urticaria (CSU) in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment (1.4).",
"Description": "Omalizumab is a recombinant DNA-derived humanized IgG1κ monoclonal antibody that selectively binds to human immunoglobulin E (IgE). The antibody has a molecular weight of approximately 149 kiloDaltons. XOLAIR is produced by a Chinese hamster ovary cell suspension culture. XOLAIR (omalizumab) is administered as a subcutaneous (SC) injection and is available in prefilled syringe, autoinjector and in vials."
},
{
"NDCCode": "50242-041-10",
"PackageDescription": "10 VIAL in 1 CARTON (50242-041-10) / 2 mL in 1 VIAL",
"NDC11Code": "50242-0041-10",
"ProductNDC": "50242-041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cathflo Activase",
"NonProprietaryName": "Alteplase",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20010904",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103172",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "ALTEPLASE",
"StrengthNumber": "2.2",
"StrengthUnit": "mg/2mL",
"Status": "Active",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191014",
"SamplePackage": "N",
"IndicationAndUsage": "Cathflo® Activase® (Alteplase) is indicated for the restoration of function to central venous access devices as assessed by the ability to withdraw blood.",
"Description": "Cathflo® Activase® (Alteplase) is a tissue plasminogen activator (t‑PA) produced by recombinant DNA technology. It is a sterile, purified glycoprotein of 527 amino acids. It is synthesized using the complementary DNA (cDNA) for natural human tissue‑type plasminogen activator (t‑PA) obtained from an established human cell line. The manufacturing process involves secretion of the enzyme Alteplase into the culture medium by an established mammalian cell line (Chinese hamster ovary cells) into which the cDNA for Alteplase has been genetically inserted. Cathflo Activase (Alteplase) for injection is a sterile, white to pale yellow, lyophilized powder for intracatheter instillation for restoration of function to central venous access devices following reconstitution with Sterile Water for Injection, USP. Each vial of Cathflo Activase contains 2.2 mg of Alteplase (which includes a 10% overfill), 77 mg of L‑arginine, 0.2 mg of polysorbate 80, and phosphoric acid for pH adjustment. Each reconstituted vial will deliver 2 mg of Cathflo Activase, at a pH of approximately 7.3."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>50242-210-83</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (50242-210-83) / 60 CAPSULE in 1 BOTTLE</PackageDescription>
<NDC11Code>50242-0210-83</NDC11Code>
<ProductNDC>50242-210</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gavreto</ProprietaryName>
<NonProprietaryName>Pralsetinib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210701</StartMarketingDate>
<EndMarketingDate>20260930</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213721</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>PRALSETINIB</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC], Rearranged during Transfection (RET) Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210701</StartMarketingDatePackage>
<EndMarketingDatePackage>20260930</EndMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>GAVRETO is a kinase inhibitor indicated for treatment of: 1 Adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer as detected by an FDA approved test (NSCLC). (1.1), 2 Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). (1.2).</IndicationAndUsage>
<Description>Pralsetinib is an oral receptor tyrosine kinase inhibitor. The chemical name for pralsetinib is (cis)-N-((S)-1-(6-(4-fluoro-1H-pyrazol-1-yl)pyridin-3-yl)ethyl)-1-methoxy-4-(4-methyl-6-(5-methyl-1H-pyrazol-3-ylamino)pyrimidin-2-yl)cyclohexanecarboxamide. The molecular formula for pralsetinib is C27H32FN9O2, and the molecular weight is 533.61 g/mol. Pralsetinib has the following structure. The solubility of pralsetinib in aqueous media decreases over the range pH 1.99 to pH 7.64 from 0.880 mg/mL to < 0.001 mg/mL, indicating a decrease in solubility with increasing pH. GAVRETO (pralsetinib) is supplied for oral use as immediate release hydroxypropyl methylcellulose (HPMC) hard capsules containing 100 mg pralsetinib. The capsules also contain inactive ingredients. citric acid, hydroxypropyl methylcellulose (HPMC), magnesium stearate, microcrystalline cellulose (MCC), pregelatinized starch and sodium bicarbonate. The capsule shell consists of FD&C Blue #1 (Brilliant Blue FCF), hypromellose and titanium dioxide. The white printing ink contains butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, strong ammonia solution and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>50242-214-83</NDCCode>
<PackageDescription>1 SYRINGE, GLASS in 1 CARTON (50242-214-83) / .5 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>50242-0214-83</NDC11Code>
<ProductNDC>50242-214</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xolair Pfs</ProprietaryName>
<NonProprietaryName>Omalizumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20180928</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103976</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>OMALIZUMAB</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Pharm_Classes>Anti-IgE [EPC], Decreased IgE Activity [PE], IgE-directed Antibody Interactions [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230818</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>XOLAIR is an anti-IgE antibody indicated for: 1 Moderate to severe persistent asthma in adults and pediatric patients 6 years of age and older with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids (1.1), 2 Chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids, as add-on maintenance treatment (1.2), 3 IgE-mediated food allergy in adult and pediatric patients aged 1 year and older for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods. To be used in conjunction with food allergen avoidance (1.3), 4 Chronic spontaneous urticaria (CSU) in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment (1.4).</IndicationAndUsage>
<Description>Omalizumab is a recombinant DNA-derived humanized IgG1κ monoclonal antibody that selectively binds to human immunoglobulin E (IgE). The antibody has a molecular weight of approximately 149 kiloDaltons. XOLAIR is produced by a Chinese hamster ovary cell suspension culture. XOLAIR (omalizumab) is administered as a subcutaneous (SC) injection and is available in prefilled syringe, autoinjector and in vials.</Description>
</NDC>
<NDC>
<NDCCode>50242-215-83</NDCCode>
<PackageDescription>1 SYRINGE, GLASS in 1 CARTON (50242-215-83) / 1 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>50242-0215-83</NDC11Code>
<ProductNDC>50242-215</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xolair Pfs</ProprietaryName>
<NonProprietaryName>Omalizumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20180928</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103976</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>OMALIZUMAB</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anti-IgE [EPC], Decreased IgE Activity [PE], IgE-directed Antibody Interactions [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230818</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>XOLAIR is an anti-IgE antibody indicated for: 1 Moderate to severe persistent asthma in adults and pediatric patients 6 years of age and older with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids (1.1), 2 Chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids, as add-on maintenance treatment (1.2), 3 IgE-mediated food allergy in adult and pediatric patients aged 1 year and older for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods. To be used in conjunction with food allergen avoidance (1.3), 4 Chronic spontaneous urticaria (CSU) in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment (1.4).</IndicationAndUsage>
<Description>Omalizumab is a recombinant DNA-derived humanized IgG1κ monoclonal antibody that selectively binds to human immunoglobulin E (IgE). The antibody has a molecular weight of approximately 149 kiloDaltons. XOLAIR is produced by a Chinese hamster ovary cell suspension culture. XOLAIR (omalizumab) is administered as a subcutaneous (SC) injection and is available in prefilled syringe, autoinjector and in vials.</Description>
</NDC>
<NDC>
<NDCCode>47682-210-83</NDCCode>
<PackageDescription>15 PACKET in 1 BOX (47682-210-83) / 2 TABLET, CHEWABLE in 1 PACKET (47682-210-99) </PackageDescription>
<NDC11Code>47682-0210-83</NDC11Code>
<ProductNDC>47682-210</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Medique Diotame</ProprietaryName>
<NonProprietaryName>Bismuth Subsalicylate</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M008</ApplicationNumber>
<LabelerName>Unifirst First Aid Corporation</LabelerName>
<SubstanceName>BISMUTH SUBSALICYLATE</SubstanceName>
<StrengthNumber>262</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. relieves: 1 traveler's diarrhea, 2 diarrhea, 3 upset stomach reliever due to overindulgence in food and drink, including: heartburn indigestion nausea gas belching fullness .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57664-210-83</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (57664-210-83) </PackageDescription>
<NDC11Code>57664-0210-83</NDC11Code>
<ProductNDC>57664-210</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pramipexole</ProprietaryName>
<NonProprietaryName>Pramipexole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130523</StartMarketingDate>
<EndMarketingDate>20181228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091683</ApplicationNumber>
<LabelerName>Caraco Pharmaceutical Laboratories, Ltd.</LabelerName>
<SubstanceName>PRAMIPEXOLE DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>.75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130523</StartMarketingDatePackage>
<EndMarketingDatePackage>20181228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50242-210-12</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (50242-210-12) / 120 CAPSULE in 1 BOTTLE</PackageDescription>
<NDC11Code>50242-0210-12</NDC11Code>
<ProductNDC>50242-210</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gavreto</ProprietaryName>
<NonProprietaryName>Pralsetinib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210701</StartMarketingDate>
<EndMarketingDate>20260930</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213721</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>PRALSETINIB</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC], Rearranged during Transfection (RET) Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220928</StartMarketingDatePackage>
<EndMarketingDatePackage>20251231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GAVRETO is a kinase inhibitor indicated for treatment of: 1 Adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer as detected by an FDA approved test (NSCLC). (1.1), 2 Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). (1.2).</IndicationAndUsage>
<Description>Pralsetinib is an oral receptor tyrosine kinase inhibitor. The chemical name for pralsetinib is (cis)-N-((S)-1-(6-(4-fluoro-1H-pyrazol-1-yl)pyridin-3-yl)ethyl)-1-methoxy-4-(4-methyl-6-(5-methyl-1H-pyrazol-3-ylamino)pyrimidin-2-yl)cyclohexanecarboxamide. The molecular formula for pralsetinib is C27H32FN9O2, and the molecular weight is 533.61 g/mol. Pralsetinib has the following structure. The solubility of pralsetinib in aqueous media decreases over the range pH 1.99 to pH 7.64 from 0.880 mg/mL to < 0.001 mg/mL, indicating a decrease in solubility with increasing pH. GAVRETO (pralsetinib) is supplied for oral use as immediate release hydroxypropyl methylcellulose (HPMC) hard capsules containing 100 mg pralsetinib. The capsules also contain inactive ingredients. citric acid, hydroxypropyl methylcellulose (HPMC), magnesium stearate, microcrystalline cellulose (MCC), pregelatinized starch and sodium bicarbonate. The capsule shell consists of FD&C Blue #1 (Brilliant Blue FCF), hypromellose and titanium dioxide. The white printing ink contains butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, strong ammonia solution and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>50242-210-60</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (50242-210-60) / 60 CAPSULE in 1 BOTTLE</PackageDescription>
<NDC11Code>50242-0210-60</NDC11Code>
<ProductNDC>50242-210</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gavreto</ProprietaryName>
<NonProprietaryName>Pralsetinib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210701</StartMarketingDate>
<EndMarketingDate>20260930</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213721</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>PRALSETINIB</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC], Rearranged during Transfection (RET) Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210701</StartMarketingDatePackage>
<EndMarketingDatePackage>20260930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GAVRETO is a kinase inhibitor indicated for treatment of: 1 Adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer as detected by an FDA approved test (NSCLC). (1.1), 2 Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). (1.2).</IndicationAndUsage>
<Description>Pralsetinib is an oral receptor tyrosine kinase inhibitor. The chemical name for pralsetinib is (cis)-N-((S)-1-(6-(4-fluoro-1H-pyrazol-1-yl)pyridin-3-yl)ethyl)-1-methoxy-4-(4-methyl-6-(5-methyl-1H-pyrazol-3-ylamino)pyrimidin-2-yl)cyclohexanecarboxamide. The molecular formula for pralsetinib is C27H32FN9O2, and the molecular weight is 533.61 g/mol. Pralsetinib has the following structure. The solubility of pralsetinib in aqueous media decreases over the range pH 1.99 to pH 7.64 from 0.880 mg/mL to < 0.001 mg/mL, indicating a decrease in solubility with increasing pH. GAVRETO (pralsetinib) is supplied for oral use as immediate release hydroxypropyl methylcellulose (HPMC) hard capsules containing 100 mg pralsetinib. The capsules also contain inactive ingredients. citric acid, hydroxypropyl methylcellulose (HPMC), magnesium stearate, microcrystalline cellulose (MCC), pregelatinized starch and sodium bicarbonate. The capsule shell consists of FD&C Blue #1 (Brilliant Blue FCF), hypromellose and titanium dioxide. The white printing ink contains butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, strong ammonia solution and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>50242-210-86</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (50242-210-86) > 120 CAPSULE in 1 BOTTLE</PackageDescription>
<NDC11Code>50242-0210-86</NDC11Code>
<ProductNDC>50242-210</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gavreto</ProprietaryName>
<NonProprietaryName>Pralsetinib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200915</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213721</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>PRALSETINIB</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC], Rearranged during Transfection (RET) Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-02-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200915</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
</NDC>
<NDC>
<NDCCode>50242-210-90</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (50242-210-90) / 90 CAPSULE in 1 BOTTLE</PackageDescription>
<NDC11Code>50242-0210-90</NDC11Code>
<ProductNDC>50242-210</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gavreto</ProprietaryName>
<NonProprietaryName>Pralsetinib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210701</StartMarketingDate>
<EndMarketingDate>20260930</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213721</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>PRALSETINIB</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC], Rearranged during Transfection (RET) Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210701</StartMarketingDatePackage>
<EndMarketingDatePackage>20260930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GAVRETO is a kinase inhibitor indicated for treatment of: 1 Adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer as detected by an FDA approved test (NSCLC). (1.1), 2 Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). (1.2).</IndicationAndUsage>
<Description>Pralsetinib is an oral receptor tyrosine kinase inhibitor. The chemical name for pralsetinib is (cis)-N-((S)-1-(6-(4-fluoro-1H-pyrazol-1-yl)pyridin-3-yl)ethyl)-1-methoxy-4-(4-methyl-6-(5-methyl-1H-pyrazol-3-ylamino)pyrimidin-2-yl)cyclohexanecarboxamide. The molecular formula for pralsetinib is C27H32FN9O2, and the molecular weight is 533.61 g/mol. Pralsetinib has the following structure. The solubility of pralsetinib in aqueous media decreases over the range pH 1.99 to pH 7.64 from 0.880 mg/mL to < 0.001 mg/mL, indicating a decrease in solubility with increasing pH. GAVRETO (pralsetinib) is supplied for oral use as immediate release hydroxypropyl methylcellulose (HPMC) hard capsules containing 100 mg pralsetinib. The capsules also contain inactive ingredients. citric acid, hydroxypropyl methylcellulose (HPMC), magnesium stearate, microcrystalline cellulose (MCC), pregelatinized starch and sodium bicarbonate. The capsule shell consists of FD&C Blue #1 (Brilliant Blue FCF), hypromellose and titanium dioxide. The white printing ink contains butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, strong ammonia solution and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>10544-210-20</NDCCode>
<PackageDescription>20 TABLET, FILM COATED in 1 BOTTLE (10544-210-20)</PackageDescription>
<NDC11Code>10544-0210-20</NDC11Code>
<ProductNDC>10544-210</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxyzine</ProprietaryName>
<NonProprietaryName>Hydroxyzine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100517</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088618</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>HYDROXYZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC],Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus. As a sedative when used as a premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Hydroxyzine hydrochloride has the chemical name of 2-[2-[4-(p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride. C21H27ClN2O2 · 2HCl M. W. 447.83. Hydroxyzine hydrochloride occurs as a white, odorless powder which is very soluble in water. Each tablet for oral administration contains 10 mg, 25 mg or 50 mg hydroxyzine HCl. Inactive ingredients include anhydrous lactose, carnauba wax, colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium starch glycolate, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>10544-210-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (10544-210-30)</PackageDescription>
<NDC11Code>10544-0210-30</NDC11Code>
<ProductNDC>10544-210</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxyzine</ProprietaryName>
<NonProprietaryName>Hydroxyzine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100517</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088618</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>HYDROXYZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC],Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus. As a sedative when used as a premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Hydroxyzine hydrochloride has the chemical name of 2-[2-[4-(p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride. C21H27ClN2O2 · 2HCl M. W. 447.83. Hydroxyzine hydrochloride occurs as a white, odorless powder which is very soluble in water. Each tablet for oral administration contains 10 mg, 25 mg or 50 mg hydroxyzine HCl. Inactive ingredients include anhydrous lactose, carnauba wax, colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium starch glycolate, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>43386-071-83</NDCCode>
<PackageDescription>1 KIT in 1 KIT (43386-071-83) * 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (43386-010-61) * 2 L in 1 BOTTLE (43386-070-17) </PackageDescription>
<NDC11Code>43386-0071-83</NDC11Code>
<ProductNDC>43386-071</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gavilyte-h And Bisacodyl</ProprietaryName>
<NonProprietaryName>Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate, Potassium Chloride And Bisacodyl Delayed-release Tablet</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150421</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202217</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150421</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GaviLyte - H and bisacodyl delayed-release tablet, USP is indicated for cleansing of the colon as a preparation for colonoscopy in adults.</IndicationAndUsage>
<Description>GaviLyte - H and bisacodyl delayed-release tablet, USP consists of PEG-3350, an osmotic laxative and bisacodyl, a stimulant laxative. Each GaviLyte - H and 5 mg bisacodyl delayed-release tablet, USP (Polyethylene glycol (PEG) 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution and bisacodyl delayed-release tablet) consists of one 2 liter bottle of GaviLyte – H (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution) powder for reconstitution and one 5 mg bisacodyl, delayed-release tablet, USP. : 1 Bisacodyl delayed-release tablet, USP: Each pink, round, enteric coated bisacodyl delayed-release tablet, USP (debossed “N1”) contains 5 mg of bisacodyl, USP (C22H19NO4) with a molecular weight of 361.40. Inactive ingredients include lactose (anhydrous) NF, microcrystalline cellulose NF, croscarmellose sodium NF, magnesium stearate NF, methacrylic acid copolymer, talc, titanium dioxide, triethyl citrate, D&C red # 27/phloxine aluminum lake, colloidal anhydrous silica, sodium bicarbonate, sodium lauryl sulfate, FD&C blue # 2/indigo carmine aluminum lake and FD&C yellow # 6/sunset yellow FCF aluminum lake. The bisacodyl delayed-release tablet, USP is administered orally prior to drinking the GaviLyte - H [see Dosage and Administration ( 2)] ., 2 GaviLyte – H (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution): A white powder for reconstitution containing 210 grams of PEG-3350, 2.86 grams of sodium bicarbonate, 5.6 grams of sodium chloride, 0.74 grams of potassium chloride and 2 grams of flavoring ingredients (if applicable). Flavor Packs are available in Cherry (containing artificial cherry flavor powder, maltodextrin and sodium saccharin), Lemon (containing natural lemon flavor powder, maltodextrin and sodium saccharin), and Orange (containing natural and artificial orange flavor powder, maltodextrin and sodium saccharin). This preparation can be used without the addition of a Flavor Pack. When dissolved in water to a volume of 2 liters, the GaviLyte - H solution is isosmotic, clear, and colorless. The GaviLyte - H solution is administered orally after taking the one bisacodyl delayed-release tablet, USP [see Dosage and Administration ( 2)] .</Description>
</NDC>
<NDC>
<NDCCode>50419-171-00</NDCCode>
<PackageDescription>210 BOTTLE in 1 BOX (50419-171-00) / 28 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>50419-0171-00</NDC11Code>
<ProductNDC>50419-171</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Stivarga</ProprietaryName>
<NonProprietaryName>Regorafenib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120927</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA203085</ApplicationNumber>
<LabelerName>Bayer HealthCare Pharmaceuticals Inc.</LabelerName>
<SubstanceName>REGORAFENIB</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Kinase Inhibitor [EPC], Kinase Inhibitors [MoA], UGT1A1 Inhibitors [MoA], UGT1A9 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120927</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>STIVARGA is a kinase inhibitor indicated for the treatment of adult patients with: 1 Metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type, an anti-EGFR therapy. (1.1), 2 Locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate. (1.2), 3 Hepatocellular carcinoma (HCC) who have been previously treated with sorafenib (1.3) .</IndicationAndUsage>
<Description>STIVARGA (regorafenib) is a multikinase inhibitor with the chemical name 4-[4-({[4-chloro-3-(trifluoromethyl) phenyl] carbamoyl} amino)-3-fluorophenoxy]-N-methylpyridine-2-carboxamide monohydrate. Regorafenib has the following structural formula. Regorafenib is a monohydrate and it has a molecular formula C21H15ClF4N4O3 H2O and a molecular weight of 500.83. Regorafenib is practically insoluble in water, slightly soluble in acetonitrile, methanol, ethanol, and ethyl acetate and sparingly soluble in acetone. STIVARGA tablets for oral administration are formulated as light pink, oval-shaped tablets debossed with "BAYER" on one side and "40" on the other. Each tablet contains 40 mg of regorafenib in the anhydrous state, which corresponds to 41.49 mg of regorafenib monohydrate, and the following inactive ingredients: cellulose microcrystalline, croscarmellose sodium, magnesium stearate, povidone, and colloidal silicon dioxide. The film-coating contains the following inactive ingredients: ferric oxide red, ferric oxide yellow, lecithin (soy), polyethylene glycol 3350, polyvinyl alcohol, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>50633-210-11</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (50633-210-11) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL</PackageDescription>
<NDC11Code>50633-0210-11</NDC11Code>
<ProductNDC>50633-210</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Voraxaze</ProprietaryName>
<NonProprietaryName>Glucarpidase</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20120401</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125327</ApplicationNumber>
<LabelerName>BTG International Inc.</LabelerName>
<SubstanceName>GLUCARPIDASE</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>[USP'U]/1</StrengthUnit>
<Pharm_Classes>Carboxypeptidase [EPC], Carboxypeptidases [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VORAXAZE is indicated to reduce toxic plasma methotrexate concentration (greater than 1 micromole per liter) in adult and pediatric patients with delayed methotrexate clearance (plasma methotrexate concentrations greater than 2 standard deviations of the mean methotrexate excretion curve specific for the dose of methotrexate administered) due to impaired renal function. Limitations of Use:VORAXAZE is not recommended for use in patients who exhibit the expected clearance and expected plasma methotrexate concentration. Reducing plasma methotrexate concentration in these patients may result in subtherapeutic exposure to methotrexate [see Clinical Studies ( 14)] .</IndicationAndUsage>
<Description>Glucarpidase is a carboxypeptidase produced by recombinant DNA technology in genetically modified Escherichia coli.Glucarpidase is a 390-amino acid homodimer protein with a molecular weight of 83 kDa. Each potency Unit corresponds to the enzymatic cleavage of 1 µmol/L of methotrexate per minute at 37°C. VORAXAZE (glucarpidase) for injection, for intravenous use is supplied as a sterile, preservative-free, white lyophilized powder in single-dose vials. Each vial contains 1,000 Units of glucarpidase, lactose monohydrate (10 mg), Tris-HCl (0.6 mg) and zinc acetate dihydrate (0.002 mg).</Description>
</NDC>
<NDC>
<NDCCode>52667-012-83</NDCCode>
<PackageDescription>83 mL in 1 TUBE (52667-012-83) </PackageDescription>
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<EndMarketingDate>20250107</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
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<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210830</StartMarketingDatePackage>
<EndMarketingDatePackage>20250107</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (85766-210-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>85766-0210-01</NDC11Code>
<ProductNDC>85766-210</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ceftriaxone Sodium</ProprietaryName>
<NonProprietaryName>Ceftriaxone Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
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<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<StartMarketingDatePackage>20260723</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Before instituting treatment with ceftriaxone, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. Therapy may be instituted prior to obtaining results of susceptibility testing. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftriaxone for injection, USP and other antibacterial drugs, ceftriaxone for injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Ceftriaxone for injection, USP is indicated for the treatment of the following infections when caused by susceptible organisms.</IndicationAndUsage>
<Description>Ceftriaxone for injection, USP is a sterile, semisynthetic, broad-spectrum cephalosporin antibiotic for intravenous or intramuscular administration. Ceftriaxone sodium is (6 R, 7 R)-7-[2-(2-Amino-4-thiazolyl) glyoxylamido]-8-oxo-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo- as-triazin-3-yl)thio]methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7 2-( Z)-( O-methyloxime), disodium salt, sesquaterhydrate. The chemical formula of ceftriaxone sodium is C 18H 16N 8Na 2O 7S 33.5H 2O. It has a calculated molecular weight of 661.60 and the following structural formula:. Ceftriaxone sodium is a white to yellowish crystalline powder which is readily soluble in water, sparingly soluble in methanol and very slightly soluble in ethanol. The pH of a 1% aqueous solution is approximately 6.7. The color of ceftriaxone sodium solutions ranges from light yellow to amber, depending on the length of storage, concentration and diluent used. Each vial contains ceftriaxone sodium equivalent to 250 mg, 500 mg, or 1 gram of ceftriaxone activity. Ceftriaxone sodium contains approximately 83 mg (3.6 mEq) of sodium per gram of ceftriaxone activity.</Description>
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<StrengthUnit>g/1</StrengthUnit>
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<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260723</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Before instituting treatment with ceftriaxone, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. Therapy may be instituted prior to obtaining results of susceptibility testing. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftriaxone for injection, USP and other antibacterial drugs, ceftriaxone for injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Ceftriaxone for injection, USP is indicated for the treatment of the following infections when caused by susceptible organisms.</IndicationAndUsage>
<Description>Ceftriaxone for injection, USP is a sterile, semisynthetic, broad-spectrum cephalosporin antibiotic for intravenous or intramuscular administration. Ceftriaxone sodium is (6 R, 7 R)-7-[2-(2-Amino-4-thiazolyl) glyoxylamido]-8-oxo-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo- as-triazin-3-yl)thio]methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7 2-( Z)-( O-methyloxime), disodium salt, sesquaterhydrate. The chemical formula of ceftriaxone sodium is C 18H 16N 8Na 2O 7S 33.5H 2O. It has a calculated molecular weight of 661.60 and the following structural formula:. Ceftriaxone sodium is a white to yellowish crystalline powder which is readily soluble in water, sparingly soluble in methanol and very slightly soluble in ethanol. The pH of a 1% aqueous solution is approximately 6.7. The color of ceftriaxone sodium solutions ranges from light yellow to amber, depending on the length of storage, concentration and diluent used. Each vial contains ceftriaxone sodium equivalent to 250 mg, 500 mg, or 1 gram of ceftriaxone activity. Ceftriaxone sodium contains approximately 83 mg (3.6 mEq) of sodium per gram of ceftriaxone activity.</Description>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sterile Water</ProprietaryName>
<NonProprietaryName>Water</NonProprietaryName>
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<RouteName>SUBCUTANEOUS</RouteName>
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<LabelerName>Genentech, Inc.</LabelerName>
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<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<EndMarketingDatePackage>20230119</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
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<PackageDescription>1 SYRINGE, PLASTIC in 1 CARTON (50242-005-01) / 1.5 mL in 1 SYRINGE, PLASTIC</PackageDescription>
<NDC11Code>50242-0005-01</NDC11Code>
<ProductNDC>50242-005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Enspryng</ProprietaryName>
<NonProprietaryName>Satralizumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20261015</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761149</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>SATRALIZUMAB</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1.5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-10-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20261015</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ENSPRYNG is an interleukin-6 (IL-6) receptor antagonist indicated for: 1 the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. (1.1), 2 the treatment of thyroid eye disease (TED) regardless of TED activity or duration in adult patients. (1.2).</IndicationAndUsage>
<Description>Satralizumab-mwge is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody based on a human IgG2 framework. Each light chain and heavy chain consists of 214 and 443 amino acids, respectively. Satralizumab-mwge is a glycoprotein with an approximate molecular weight of 143 kDa and is produced by recombinant DNA technology in Chinese hamster ovary cells. The binding of satralizumab-mwge to the IL-6 receptor is pH-sensitive. ENSPRYNG (satralizumab-mwge) injection for subcutaneous administration is supplied as a sterile, clear, colorless to slightly yellow solution with no preservative, and with an approximate pH of 6. ENSPRYNG is supplied in a single-dose 1 mL prefilled syringe with a needle safety device or a single-dose 1 mL or 1.5 mL autoinjector that contains a prefilled syringe. Each prefilled syringe delivers 1 mL of solution containing 120 mg satralizumab-mwge, L-arginine (26.1 mg), L-aspartic acid (pH adjustment), L-histidine (3.1 mg), poloxamer 188 (0.5 mg), and Water for Injection, USP. Each prefilled autoinjector delivers either: 1 1 mL of solution containing 120 mg satralizumab-mwge, L-arginine (26.1 mg), L-aspartic acid (pH adjustment), L-histidine (3.1 mg), poloxamer 188 (0.5 mg), and Water for Injection, USP., 2 1.5 mL of solution containing 180 mg satralizumab-mwge, L-arginine (39.2 mg), L-aspartic acid (pH adjustment), L-histidine (4.65 mg), poloxamer 188 (0.75 mg), and Water for Injection, USP.</Description>
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<NDC>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<DosageFormName>INJECTION, SOLUTION</DosageFormName>
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<StartMarketingDate>20261015</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761149</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>SATRALIZUMAB</SubstanceName>
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<LastUpdate>2026-10-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20261015</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>ENSPRYNG is an interleukin-6 (IL-6) receptor antagonist indicated for: 1 the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. (1.1), 2 the treatment of thyroid eye disease (TED) regardless of TED activity or duration in adult patients. (1.2).</IndicationAndUsage>
<Description>Satralizumab-mwge is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody based on a human IgG2 framework. Each light chain and heavy chain consists of 214 and 443 amino acids, respectively. Satralizumab-mwge is a glycoprotein with an approximate molecular weight of 143 kDa and is produced by recombinant DNA technology in Chinese hamster ovary cells. The binding of satralizumab-mwge to the IL-6 receptor is pH-sensitive. ENSPRYNG (satralizumab-mwge) injection for subcutaneous administration is supplied as a sterile, clear, colorless to slightly yellow solution with no preservative, and with an approximate pH of 6. ENSPRYNG is supplied in a single-dose 1 mL prefilled syringe with a needle safety device or a single-dose 1 mL or 1.5 mL autoinjector that contains a prefilled syringe. Each prefilled syringe delivers 1 mL of solution containing 120 mg satralizumab-mwge, L-arginine (26.1 mg), L-aspartic acid (pH adjustment), L-histidine (3.1 mg), poloxamer 188 (0.5 mg), and Water for Injection, USP. Each prefilled autoinjector delivers either: 1 1 mL of solution containing 120 mg satralizumab-mwge, L-arginine (26.1 mg), L-aspartic acid (pH adjustment), L-histidine (3.1 mg), poloxamer 188 (0.5 mg), and Water for Injection, USP., 2 1.5 mL of solution containing 180 mg satralizumab-mwge, L-arginine (39.2 mg), L-aspartic acid (pH adjustment), L-histidine (4.65 mg), poloxamer 188 (0.75 mg), and Water for Injection, USP.</Description>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<DosageFormName>INJECTION, SOLUTION</DosageFormName>
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<ApplicationNumber>BLA761149</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>SATRALIZUMAB</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
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<LastUpdate>2026-10-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200814</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ENSPRYNG is an interleukin-6 (IL-6) receptor antagonist indicated for: 1 the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. (1.1), 2 the treatment of thyroid eye disease (TED) regardless of TED activity or duration in adult patients. (1.2).</IndicationAndUsage>
<Description>Satralizumab-mwge is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody based on a human IgG2 framework. Each light chain and heavy chain consists of 214 and 443 amino acids, respectively. Satralizumab-mwge is a glycoprotein with an approximate molecular weight of 143 kDa and is produced by recombinant DNA technology in Chinese hamster ovary cells. The binding of satralizumab-mwge to the IL-6 receptor is pH-sensitive. ENSPRYNG (satralizumab-mwge) injection for subcutaneous administration is supplied as a sterile, clear, colorless to slightly yellow solution with no preservative, and with an approximate pH of 6. ENSPRYNG is supplied in a single-dose 1 mL prefilled syringe with a needle safety device or a single-dose 1 mL or 1.5 mL autoinjector that contains a prefilled syringe. Each prefilled syringe delivers 1 mL of solution containing 120 mg satralizumab-mwge, L-arginine (26.1 mg), L-aspartic acid (pH adjustment), L-histidine (3.1 mg), poloxamer 188 (0.5 mg), and Water for Injection, USP. Each prefilled autoinjector delivers either: 1 1 mL of solution containing 120 mg satralizumab-mwge, L-arginine (26.1 mg), L-aspartic acid (pH adjustment), L-histidine (3.1 mg), poloxamer 188 (0.5 mg), and Water for Injection, USP., 2 1.5 mL of solution containing 180 mg satralizumab-mwge, L-arginine (39.2 mg), L-aspartic acid (pH adjustment), L-histidine (4.65 mg), poloxamer 188 (0.75 mg), and Water for Injection, USP.</Description>
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<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>ENSPRYNG is an interleukin-6 (IL-6) receptor antagonist indicated for: 1 the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. (1.1), 2 the treatment of thyroid eye disease (TED) regardless of TED activity or duration in adult patients. (1.2).</IndicationAndUsage>
<Description>Satralizumab-mwge is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody based on a human IgG2 framework. Each light chain and heavy chain consists of 214 and 443 amino acids, respectively. Satralizumab-mwge is a glycoprotein with an approximate molecular weight of 143 kDa and is produced by recombinant DNA technology in Chinese hamster ovary cells. The binding of satralizumab-mwge to the IL-6 receptor is pH-sensitive. ENSPRYNG (satralizumab-mwge) injection for subcutaneous administration is supplied as a sterile, clear, colorless to slightly yellow solution with no preservative, and with an approximate pH of 6. ENSPRYNG is supplied in a single-dose 1 mL prefilled syringe with a needle safety device or a single-dose 1 mL or 1.5 mL autoinjector that contains a prefilled syringe. Each prefilled syringe delivers 1 mL of solution containing 120 mg satralizumab-mwge, L-arginine (26.1 mg), L-aspartic acid (pH adjustment), L-histidine (3.1 mg), poloxamer 188 (0.5 mg), and Water for Injection, USP. Each prefilled autoinjector delivers either: 1 1 mL of solution containing 120 mg satralizumab-mwge, L-arginine (26.1 mg), L-aspartic acid (pH adjustment), L-histidine (3.1 mg), poloxamer 188 (0.5 mg), and Water for Injection, USP., 2 1.5 mL of solution containing 180 mg satralizumab-mwge, L-arginine (39.2 mg), L-aspartic acid (pH adjustment), L-histidine (4.65 mg), poloxamer 188 (0.75 mg), and Water for Injection, USP.</Description>
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<IndicationAndUsage>ENSPRYNG is an interleukin-6 (IL-6) receptor antagonist indicated for: 1 the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. (1.1), 2 the treatment of thyroid eye disease (TED) regardless of TED activity or duration in adult patients. (1.2).</IndicationAndUsage>
<Description>Satralizumab-mwge is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody based on a human IgG2 framework. Each light chain and heavy chain consists of 214 and 443 amino acids, respectively. Satralizumab-mwge is a glycoprotein with an approximate molecular weight of 143 kDa and is produced by recombinant DNA technology in Chinese hamster ovary cells. The binding of satralizumab-mwge to the IL-6 receptor is pH-sensitive. ENSPRYNG (satralizumab-mwge) injection for subcutaneous administration is supplied as a sterile, clear, colorless to slightly yellow solution with no preservative, and with an approximate pH of 6. ENSPRYNG is supplied in a single-dose 1 mL prefilled syringe with a needle safety device or a single-dose 1 mL or 1.5 mL autoinjector that contains a prefilled syringe. Each prefilled syringe delivers 1 mL of solution containing 120 mg satralizumab-mwge, L-arginine (26.1 mg), L-aspartic acid (pH adjustment), L-histidine (3.1 mg), poloxamer 188 (0.5 mg), and Water for Injection, USP. Each prefilled autoinjector delivers either: 1 1 mL of solution containing 120 mg satralizumab-mwge, L-arginine (26.1 mg), L-aspartic acid (pH adjustment), L-histidine (3.1 mg), poloxamer 188 (0.5 mg), and Water for Injection, USP., 2 1.5 mL of solution containing 180 mg satralizumab-mwge, L-arginine (39.2 mg), L-aspartic acid (pH adjustment), L-histidine (4.65 mg), poloxamer 188 (0.75 mg), and Water for Injection, USP.</Description>
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<ProductNDC>50242-007</ProductNDC>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>ENSPRYNG is an interleukin-6 (IL-6) receptor antagonist indicated for: 1 the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. (1.1), 2 the treatment of thyroid eye disease (TED) regardless of TED activity or duration in adult patients. (1.2).</IndicationAndUsage>
<Description>Satralizumab-mwge is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody based on a human IgG2 framework. Each light chain and heavy chain consists of 214 and 443 amino acids, respectively. Satralizumab-mwge is a glycoprotein with an approximate molecular weight of 143 kDa and is produced by recombinant DNA technology in Chinese hamster ovary cells. The binding of satralizumab-mwge to the IL-6 receptor is pH-sensitive. ENSPRYNG (satralizumab-mwge) injection for subcutaneous administration is supplied as a sterile, clear, colorless to slightly yellow solution with no preservative, and with an approximate pH of 6. ENSPRYNG is supplied in a single-dose 1 mL prefilled syringe with a needle safety device or a single-dose 1 mL or 1.5 mL autoinjector that contains a prefilled syringe. Each prefilled syringe delivers 1 mL of solution containing 120 mg satralizumab-mwge, L-arginine (26.1 mg), L-aspartic acid (pH adjustment), L-histidine (3.1 mg), poloxamer 188 (0.5 mg), and Water for Injection, USP. Each prefilled autoinjector delivers either: 1 1 mL of solution containing 120 mg satralizumab-mwge, L-arginine (26.1 mg), L-aspartic acid (pH adjustment), L-histidine (3.1 mg), poloxamer 188 (0.5 mg), and Water for Injection, USP., 2 1.5 mL of solution containing 180 mg satralizumab-mwge, L-arginine (39.2 mg), L-aspartic acid (pH adjustment), L-histidine (4.65 mg), poloxamer 188 (0.75 mg), and Water for Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>50242-014-03</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (50242-014-03) * 1 VIAL, SINGLE-USE in 1 CARTON (50242-009-01) / 5 mL in 1 VIAL, SINGLE-USE * 1 VIAL, SINGLE-USE in 1 CARTON (50242-907-01) / 5.2 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>50242-0014-03</NDC11Code>
<ProductNDC>50242-014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tnkase</ProprietaryName>
<NonProprietaryName>Tenecteplase</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20250228</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103909</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TNKase is a tissue plasminogen activator (tPA) indicated: 1 for the treatment of acute ischemic stroke (AIS) in adults. (1.1), 2 to reduce the risk of death associated with acute ST elevation myocardial infarction (STEMI) in adults. (1.2).</IndicationAndUsage>
<Description>Tenecteplase is a tissue plasminogen activator (tPA) produced by recombinant DNA technology using a mammalian cell line (Chinese Hamster Ovary cells). Tenecteplase is a 527-amino acid glycoprotein developed by introducing the following modifications to the complementary DNA (cDNA) for natural human tPA: a substitution of threonine 103 with asparagine, and a substitution of asparagine 117 with glutamine, both within the kringle 1 domain, and a tetra-alanine substitution at amino acids 296–299 in the protease domain. It has a molecular weight of 58,742 daltons. Biological potency is determined by an in vitro clot lysis assay and is expressed in tenecteplase specific units. The specific activity of tenecteplase has been defined as 200 units/mg. TNKase (tenecteplase) for injection is a sterile, white to pale yellow, lyophilized powder for intravenous bolus administration after reconstitution with Sterile Water for Injection, USP. Each 25 mg single-dose vial of TNKase nominally contains 25 mg of tenecteplase, arginine (261 mg), phosphoric acid (approximately 80 mg), and polysorbate 20 (2.0 mg). Following reconstitution with the supplied 5.2 mL single-dose vial of Sterile Water for Injection, USP, the final concentration is 5 mg/mL with a pH of approximately 7.3. Each 50 mg single-dose vial of TNKase nominally contains 50 mg of tenecteplase, arginine (522 mg), phosphoric acid (approximately 160 mg), and polysorbate 20 (4.0 mg). Following reconstitution with the supplied 10 mL single-dose vial of Sterile Water for Injection, USP, the final concentration is 5 mg/mL with a pH of approximately 7.3.</Description>
</NDC>
<NDC>
<NDCCode>50242-018-21</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (50242-018-21) * 10 mg in 1 VIAL * 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>50242-0018-21</NDC11Code>
<ProductNDC>50242-018</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nutropin</ProprietaryName>
<NonProprietaryName>Somatropin</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19931117</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019676</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2015-12-04</LastUpdate>
</NDC>
<NDC>
<NDCCode>50242-038-61</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (50242-038-61) * 10 mL in 1 VIAL, SINGLE-USE * 10 mL in 1 VIAL, SINGLE-USE * 3 APPLICATOR in 1 PACKET > .7 mL in 1 APPLICATOR</PackageDescription>
<NDC11Code>50242-0038-61</NDC11Code>
<ProductNDC>50242-038</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tnkase</ProprietaryName>
<NonProprietaryName>Tenecteplase</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20000602</StartMarketingDate>
<EndMarketingDate>20140630</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103909</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2014-07-07</LastUpdate>
</NDC>
<NDC>
<NDCCode>50242-040-62</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (50242-040-62) / 1.2 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>50242-0040-62</NDC11Code>
<ProductNDC>50242-040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xolair</ProprietaryName>
<NonProprietaryName>Omalizumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20030620</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103976</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>OMALIZUMAB</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1.2mL</StrengthUnit>
<Pharm_Classes>Anti-IgE [EPC], Decreased IgE Activity [PE], IgE-directed Antibody Interactions [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>XOLAIR is an anti-IgE antibody indicated for: 1 Moderate to severe persistent asthma in adults and pediatric patients 6 years of age and older with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids (1.1), 2 Chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids, as add-on maintenance treatment (1.2), 3 IgE-mediated food allergy in adult and pediatric patients aged 1 year and older for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods. To be used in conjunction with food allergen avoidance (1.3), 4 Chronic spontaneous urticaria (CSU) in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment (1.4).</IndicationAndUsage>
<Description>Omalizumab is a recombinant DNA-derived humanized IgG1κ monoclonal antibody that selectively binds to human immunoglobulin E (IgE). The antibody has a molecular weight of approximately 149 kiloDaltons. XOLAIR is produced by a Chinese hamster ovary cell suspension culture. XOLAIR (omalizumab) is administered as a subcutaneous (SC) injection and is available in prefilled syringe, autoinjector and in vials.</Description>
</NDC>
<NDC>
<NDCCode>50242-040-86</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (50242-040-86) / 1.2 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>50242-0040-86</NDC11Code>
<ProductNDC>50242-040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xolair</ProprietaryName>
<NonProprietaryName>Omalizumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20030620</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103976</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>OMALIZUMAB</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1.2mL</StrengthUnit>
<Pharm_Classes>Anti-IgE [EPC], Decreased IgE Activity [PE], IgE-directed Antibody Interactions [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131220</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>XOLAIR is an anti-IgE antibody indicated for: 1 Moderate to severe persistent asthma in adults and pediatric patients 6 years of age and older with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids (1.1), 2 Chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids, as add-on maintenance treatment (1.2), 3 IgE-mediated food allergy in adult and pediatric patients aged 1 year and older for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods. To be used in conjunction with food allergen avoidance (1.3), 4 Chronic spontaneous urticaria (CSU) in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment (1.4).</IndicationAndUsage>
<Description>Omalizumab is a recombinant DNA-derived humanized IgG1κ monoclonal antibody that selectively binds to human immunoglobulin E (IgE). The antibody has a molecular weight of approximately 149 kiloDaltons. XOLAIR is produced by a Chinese hamster ovary cell suspension culture. XOLAIR (omalizumab) is administered as a subcutaneous (SC) injection and is available in prefilled syringe, autoinjector and in vials.</Description>
</NDC>
<NDC>
<NDCCode>50242-041-10</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (50242-041-10) / 2 mL in 1 VIAL</PackageDescription>
<NDC11Code>50242-0041-10</NDC11Code>
<ProductNDC>50242-041</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cathflo Activase</ProprietaryName>
<NonProprietaryName>Alteplase</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20010904</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103172</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>ALTEPLASE</SubstanceName>
<StrengthNumber>2.2</StrengthNumber>
<StrengthUnit>mg/2mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191014</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cathflo® Activase® (Alteplase) is indicated for the restoration of function to central venous access devices as assessed by the ability to withdraw blood.</IndicationAndUsage>
<Description>Cathflo® Activase® (Alteplase) is a tissue plasminogen activator (t‑PA) produced by recombinant DNA technology. It is a sterile, purified glycoprotein of 527 amino acids. It is synthesized using the complementary DNA (cDNA) for natural human tissue‑type plasminogen activator (t‑PA) obtained from an established human cell line. The manufacturing process involves secretion of the enzyme Alteplase into the culture medium by an established mammalian cell line (Chinese hamster ovary cells) into which the cDNA for Alteplase has been genetically inserted. Cathflo Activase (Alteplase) for injection is a sterile, white to pale yellow, lyophilized powder for intracatheter instillation for restoration of function to central venous access devices following reconstitution with Sterile Water for Injection, USP. Each vial of Cathflo Activase contains 2.2 mg of Alteplase (which includes a 10% overfill), 77 mg of L‑arginine, 0.2 mg of polysorbate 80, and phosphoric acid for pH adjustment. Each reconstituted vial will deliver 2 mg of Cathflo Activase, at a pH of approximately 7.3.</Description>
</NDC>
</NDCList>