RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "59651-261-48",
      "PackageDescription": "8 BLISTER PACK in 1 CARTON (59651-261-48)  / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
      "NDC11Code": "59651-0261-48",
      "ProductNDC": "59651-261",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clozapine",
      "NonProprietaryName": "Clozapine",
      "DosageFormName": "TABLET, ORALLY DISINTEGRATING",
      "RouteName": "ORAL",
      "StartMarketingDate": "20241212",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212923",
      "LabelerName": "Aurobindo Pharma Limited",
      "SubstanceName": "CLOZAPINE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-06-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20241212",
      "SamplePackage": "N",
      "IndicationAndUsage": "Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: 1 Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment (1.1), 2 Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior (1.2).",
      "Description": "Clozapine, an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine. The structural formula is. Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) are yellow to pale yellow, and are for oral administration. Each orally disintegrating tablet contains clozapine, USP, equivalent to 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg. The inactive ingredients include aspartame, crospovidone, magnesium stearate, mannitol, polyvinyl acetate, povidone, powdarome peppermint premium, silicified microcrystalline cellulose, sodium lauryl sulfate, sodium stearyl fumarate and yellow iron oxide. Clozapine ODT contains aspartame [see Warnings and Precautions (5.18)]. Phenylalanine is a component of aspartame. Each 12.5 mg, orally disintegrating tablet contains 1.25 mg aspartame, thus, 0.70 mg phenylalanine. Each 25 mg, orally disintegrating tablet contains 2.5 mg aspartame, thus, 1.40 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 10 mg aspartame, thus, 5.61 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 15 mg aspartame, thus, 8.42 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 20 mg aspartame, thus, 11.23 mg phenylalanine."
    },
    {
      "NDCCode": "59651-261-01",
      "PackageDescription": "100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (59651-261-01) ",
      "NDC11Code": "59651-0261-01",
      "ProductNDC": "59651-261",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clozapine",
      "NonProprietaryName": "Clozapine",
      "DosageFormName": "TABLET, ORALLY DISINTEGRATING",
      "RouteName": "ORAL",
      "StartMarketingDate": "20241212",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212923",
      "LabelerName": "Aurobindo Pharma Limited",
      "SubstanceName": "CLOZAPINE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-06-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20241212",
      "SamplePackage": "N",
      "IndicationAndUsage": "Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: 1 Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment (1.1), 2 Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior (1.2).",
      "Description": "Clozapine, an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine. The structural formula is. Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) are yellow to pale yellow, and are for oral administration. Each orally disintegrating tablet contains clozapine, USP, equivalent to 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg. The inactive ingredients include aspartame, crospovidone, magnesium stearate, mannitol, polyvinyl acetate, povidone, powdarome peppermint premium, silicified microcrystalline cellulose, sodium lauryl sulfate, sodium stearyl fumarate and yellow iron oxide. Clozapine ODT contains aspartame [see Warnings and Precautions (5.18)]. Phenylalanine is a component of aspartame. Each 12.5 mg, orally disintegrating tablet contains 1.25 mg aspartame, thus, 0.70 mg phenylalanine. Each 25 mg, orally disintegrating tablet contains 2.5 mg aspartame, thus, 1.40 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 10 mg aspartame, thus, 5.61 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 15 mg aspartame, thus, 8.42 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 20 mg aspartame, thus, 11.23 mg phenylalanine."
    },
    {
      "NDCCode": "59651-262-48",
      "PackageDescription": "8 BLISTER PACK in 1 CARTON (59651-262-48)  / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
      "NDC11Code": "59651-0262-48",
      "ProductNDC": "59651-262",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clozapine",
      "NonProprietaryName": "Clozapine",
      "DosageFormName": "TABLET, ORALLY DISINTEGRATING",
      "RouteName": "ORAL",
      "StartMarketingDate": "20241212",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212923",
      "LabelerName": "Aurobindo Pharma Limited",
      "SubstanceName": "CLOZAPINE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-06-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20241212",
      "SamplePackage": "N",
      "IndicationAndUsage": "Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: 1 Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment (1.1), 2 Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior (1.2).",
      "Description": "Clozapine, an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine. The structural formula is. Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) are yellow to pale yellow, and are for oral administration. Each orally disintegrating tablet contains clozapine, USP, equivalent to 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg. The inactive ingredients include aspartame, crospovidone, magnesium stearate, mannitol, polyvinyl acetate, povidone, powdarome peppermint premium, silicified microcrystalline cellulose, sodium lauryl sulfate, sodium stearyl fumarate and yellow iron oxide. Clozapine ODT contains aspartame [see Warnings and Precautions (5.18)]. Phenylalanine is a component of aspartame. Each 12.5 mg, orally disintegrating tablet contains 1.25 mg aspartame, thus, 0.70 mg phenylalanine. Each 25 mg, orally disintegrating tablet contains 2.5 mg aspartame, thus, 1.40 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 10 mg aspartame, thus, 5.61 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 15 mg aspartame, thus, 8.42 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 20 mg aspartame, thus, 11.23 mg phenylalanine."
    },
    {
      "NDCCode": "59651-263-48",
      "PackageDescription": "8 BLISTER PACK in 1 CARTON (59651-263-48)  / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
      "NDC11Code": "59651-0263-48",
      "ProductNDC": "59651-263",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clozapine",
      "NonProprietaryName": "Clozapine",
      "DosageFormName": "TABLET, ORALLY DISINTEGRATING",
      "RouteName": "ORAL",
      "StartMarketingDate": "20241212",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212923",
      "LabelerName": "Aurobindo Pharma Limited",
      "SubstanceName": "CLOZAPINE",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-06-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20241212",
      "SamplePackage": "N",
      "IndicationAndUsage": "Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: 1 Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment (1.1), 2 Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior (1.2).",
      "Description": "Clozapine, an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine. The structural formula is. Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) are yellow to pale yellow, and are for oral administration. Each orally disintegrating tablet contains clozapine, USP, equivalent to 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg. The inactive ingredients include aspartame, crospovidone, magnesium stearate, mannitol, polyvinyl acetate, povidone, powdarome peppermint premium, silicified microcrystalline cellulose, sodium lauryl sulfate, sodium stearyl fumarate and yellow iron oxide. Clozapine ODT contains aspartame [see Warnings and Precautions (5.18)]. Phenylalanine is a component of aspartame. Each 12.5 mg, orally disintegrating tablet contains 1.25 mg aspartame, thus, 0.70 mg phenylalanine. Each 25 mg, orally disintegrating tablet contains 2.5 mg aspartame, thus, 1.40 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 10 mg aspartame, thus, 5.61 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 15 mg aspartame, thus, 8.42 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 20 mg aspartame, thus, 11.23 mg phenylalanine."
    },
    {
      "NDCCode": "59651-264-48",
      "PackageDescription": "8 BLISTER PACK in 1 CARTON (59651-264-48)  / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
      "NDC11Code": "59651-0264-48",
      "ProductNDC": "59651-264",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clozapine",
      "NonProprietaryName": "Clozapine",
      "DosageFormName": "TABLET, ORALLY DISINTEGRATING",
      "RouteName": "ORAL",
      "StartMarketingDate": "20241212",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212923",
      "LabelerName": "Aurobindo Pharma Limited",
      "SubstanceName": "CLOZAPINE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-06-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20241212",
      "SamplePackage": "N",
      "IndicationAndUsage": "Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: 1 Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment (1.1), 2 Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior (1.2).",
      "Description": "Clozapine, an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine. The structural formula is. Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) are yellow to pale yellow, and are for oral administration. Each orally disintegrating tablet contains clozapine, USP, equivalent to 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg. The inactive ingredients include aspartame, crospovidone, magnesium stearate, mannitol, polyvinyl acetate, povidone, powdarome peppermint premium, silicified microcrystalline cellulose, sodium lauryl sulfate, sodium stearyl fumarate and yellow iron oxide. Clozapine ODT contains aspartame [see Warnings and Precautions (5.18)]. Phenylalanine is a component of aspartame. Each 12.5 mg, orally disintegrating tablet contains 1.25 mg aspartame, thus, 0.70 mg phenylalanine. Each 25 mg, orally disintegrating tablet contains 2.5 mg aspartame, thus, 1.40 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 10 mg aspartame, thus, 5.61 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 15 mg aspartame, thus, 8.42 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 20 mg aspartame, thus, 11.23 mg phenylalanine."
    },
    {
      "NDCCode": "51407-261-30",
      "PackageDescription": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (51407-261-30) ",
      "NDC11Code": "51407-0261-30",
      "ProductNDC": "51407-261",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olanzapine",
      "NonProprietaryName": "Olanzapine",
      "DosageFormName": "TABLET, ORALLY DISINTEGRATING",
      "RouteName": "ORAL",
      "StartMarketingDate": "20111024",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091265",
      "LabelerName": "Golden State Medical Supply, Inc.",
      "SubstanceName": "OLANZAPINE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-04-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20191016",
      "SamplePackage": "N",
      "IndicationAndUsage": "Olanzapine orally disintegrating tablets are an atypical antipsychotic indicated. As oral formulation for the: 1 Treatment of schizophrenia. ( 1.1) Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. ( 14.1) Adolescents (ages 13 to 17): Efficacy was established in one 6­-week trial in patients with schizophrenia ( 14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.1) , 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. ( 1.2) Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. ( 14.2) Adolescents (ages 13 to 17): Efficacy was established in one 3­-week trial in patients with manic or mixed episodes associated with bipolar I disorder ( 14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.2) , 3 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. ( 1.3) , 4 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. ( 1.2) Efficacy was established in two 6-week clinical trials in adults ( 14.2). Maintenance efficacy has not been systematically evaluated. .",
      "Description": "Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10 H-thieno[2,3- b][1,5]benzodiazepine. The molecular formula is C 17H 20N 4S, which corresponds to a molecular weight of 312.43 g/mol. The chemical structure is:. Olanzapine is a yellow powder. Olanzapine orally disintegrating tablets, USP are intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 mcmol), 10 mg (32 mcmol), 15 mg (48 mcmol) or 20 mg (64 mcmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets also contain the following inactive ingredients: carboxymethylcellulose calcium, colloidal silicon dioxide, magnesium stearate, mannitol, microcrystalline cellulose and sucralose. Meets USP Disintegration Test 2."
    },
    {
      "NDCCode": "59651-104-69",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (59651-104-69)  / 6 TABLET, FILM COATED in 1 BLISTER PACK (59651-104-06) ",
      "NDC11Code": "59651-0104-69",
      "ProductNDC": "59651-104",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Eletriptan Hydrobromide",
      "NonProprietaryName": "Eletriptan Hydrobromide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190115",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210708",
      "LabelerName": "Aurobindo Pharma Limited",
      "SubstanceName": "ELETRIPTAN HYDROBROMIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-06-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190115",
      "SamplePackage": "N",
      "IndicationAndUsage": "Eletriptan hydrobromide tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use.",
      "Description": "Eletriptan hydrobromide tablets contain eletriptan hydrobromide, which is a selective 5-hydroxytryptamine 1B/1D (5-HT1B/1D) receptor agonist. Eletriptan hydrobromide is chemically designated as (R)-3-[(1-Methyl-2-pyrrolidinyl)methyl]-5-[2-(phenylsulfonyl)ethyl]-1H-indole monohydrobromide, and it has the following chemical structure. The molecular formula is C22H26N2O2S . HBr, representing a molecular weight of 463.43. Eletriptan hydrobromide is an off-white to brown color powder that is freely soluble in methanol and very slightly soluble in water. Each eletriptan hydrobromide tablet for oral administration contains 24.23 or 48.46 mg of eletriptan hydrobromide equivalent to 20 mg or 40 mg of eletriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, FD&C yellow 6 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin."
    },
    {
      "NDCCode": "59651-105-69",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (59651-105-69)  / 6 TABLET, FILM COATED in 1 BLISTER PACK (59651-105-06) ",
      "NDC11Code": "59651-0105-69",
      "ProductNDC": "59651-105",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Eletriptan Hydrobromide",
      "NonProprietaryName": "Eletriptan Hydrobromide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180216",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210708",
      "LabelerName": "Aurobindo Pharma Limited",
      "SubstanceName": "ELETRIPTAN HYDROBROMIDE",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-06-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190115",
      "SamplePackage": "N",
      "IndicationAndUsage": "Eletriptan hydrobromide tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use.",
      "Description": "Eletriptan hydrobromide tablets contain eletriptan hydrobromide, which is a selective 5-hydroxytryptamine 1B/1D (5-HT1B/1D) receptor agonist. Eletriptan hydrobromide is chemically designated as (R)-3-[(1-Methyl-2-pyrrolidinyl)methyl]-5-[2-(phenylsulfonyl)ethyl]-1H-indole monohydrobromide, and it has the following chemical structure. The molecular formula is C22H26N2O2S . HBr, representing a molecular weight of 463.43. Eletriptan hydrobromide is an off-white to brown color powder that is freely soluble in methanol and very slightly soluble in water. Each eletriptan hydrobromide tablet for oral administration contains 24.23 or 48.46 mg of eletriptan hydrobromide equivalent to 20 mg or 40 mg of eletriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, FD&C yellow 6 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin."
    },
    {
      "NDCCode": "59651-105-93",
      "PackageDescription": "2 BLISTER PACK in 1 CARTON (59651-105-93)  / 6 TABLET, FILM COATED in 1 BLISTER PACK",
      "NDC11Code": "59651-0105-93",
      "ProductNDC": "59651-105",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Eletriptan Hydrobromide",
      "NonProprietaryName": "Eletriptan Hydrobromide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180216",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210708",
      "LabelerName": "Aurobindo Pharma Limited",
      "SubstanceName": "ELETRIPTAN HYDROBROMIDE",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-06-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190115",
      "SamplePackage": "N",
      "IndicationAndUsage": "Eletriptan hydrobromide tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use.",
      "Description": "Eletriptan hydrobromide tablets contain eletriptan hydrobromide, which is a selective 5-hydroxytryptamine 1B/1D (5-HT1B/1D) receptor agonist. Eletriptan hydrobromide is chemically designated as (R)-3-[(1-Methyl-2-pyrrolidinyl)methyl]-5-[2-(phenylsulfonyl)ethyl]-1H-indole monohydrobromide, and it has the following chemical structure. The molecular formula is C22H26N2O2S . HBr, representing a molecular weight of 463.43. Eletriptan hydrobromide is an off-white to brown color powder that is freely soluble in methanol and very slightly soluble in water. Each eletriptan hydrobromide tablet for oral administration contains 24.23 or 48.46 mg of eletriptan hydrobromide equivalent to 20 mg or 40 mg of eletriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, FD&C yellow 6 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin."
    },
    {
      "NDCCode": "59651-597-60",
      "PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (59651-597-60)  / 60 mL in 1 BOTTLE, GLASS",
      "NDC11Code": "59651-0597-60",
      "ProductNDC": "59651-597",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oseltamivir Phosphate",
      "NonProprietaryName": "Oseltamivir Phosphate",
      "DosageFormName": "POWDER, FOR SUSPENSION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240510",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA218131",
      "LabelerName": "Aurobindo Pharma Limited",
      "SubstanceName": "OSELTAMIVIR PHOSPHATE",
      "StrengthNumber": "6",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Neuraminidase Inhibitor [EPC], Neuraminidase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-08-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240510",
      "SamplePackage": "N",
      "IndicationAndUsage": "Oseltamivir phosphate for oral suspension is an influenza neuraminidase inhibitor (NAI) indicated for: 1 Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours.  (1.1) , 2 Prophylaxis of influenza A and B in patients 1 year and older. (1.2) .",
      "Description": "Oseltamivir phosphate USP, an influenza neuraminidase inhibitor (NAI), is available as:. In addition to the active ingredient, the powder for oral suspension contains monosodium citrate, saccharin sodium, silicon dioxide, sodium benzoate, sorbitol, titanium dioxide, tutti frutti flavor (contains artificial flavors, benzyl alcohol, dl-alpha-tocopherol, maltodextrin, propylene glycol), and xanthan gum. Each 12.5 mL of oseltamivir phosphate for oral suspension contains 7.44 mg of phosphorus and 16 mg of sodium. Oseltamivir phosphate USP is a white to off-white powder with the chemical name (3R,4R,5S)-4-acetylamino-5-amino-3(1­-ethylpropoxy)-1-cyclohexene-1-carboxylic acid, ethyl ester, phosphate (1:1). The chemical formula is C16H28N2O4 (free base). The molecular weight is 312.4 for oseltamivir free base and 410.4 for oseltamivir phosphate salt. The structural formula is as follows."
    },
    {
      "NDCCode": "0115-2134-01",
      "PackageDescription": "21 TABLET in 1 BOTTLE (0115-2134-01) ",
      "NDC11Code": "00115-2134-01",
      "ProductNDC": "0115-2134",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pyridostigmine Bromide",
      "NonProprietaryName": "Pyridostigmine Bromide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220808",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040502",
      "LabelerName": "Amneal Pharmaceuticals of New York LLC",
      "SubstanceName": "PYRIDOSTIGMINE BROMIDE",
      "StrengthNumber": "30",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20220808",
      "SamplePackage": "N",
      "IndicationAndUsage": "Pyridostigmine bromide tablets are useful in the treatment of myasthenia gravis.",
      "Description": "Pyridostigmine bromide is an orally active cholinesterase inhibitor. Chemically, pyridostigmine bromide is 3-hydroxy-1-methylpyridinium bromide dimethylcarbamate. Its structural formula is. Molecular formula: C9H13BrN2O2. Molecular weight: 261.1 g/mol. Each pyridostigmine bromide tablets USP, 30 mg for oral administration, contains 30 mg pyridostigmine bromide, USP and the following inactive ingredients: colloidal silicon dioxide, lactose anhydrous, magnesium stearate and stearic acid."
    },
    {
      "NDCCode": "0143-9530-01",
      "PackageDescription": "1 VIAL in 1 BOX (0143-9530-01)  / 60 mL in 1 VIAL",
      "NDC11Code": "00143-9530-01",
      "ProductNDC": "0143-9530",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ifosfamide",
      "NonProprietaryName": "Ifosfamide",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20170610",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076619",
      "LabelerName": "Hikma Pharmaceuticals USA Inc.",
      "SubstanceName": "IFOSFAMIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-04-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20170610",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ifosfamide Injection is indicated for use in combination with certain other approved antineoplastic agentsfor third-line chemotherapy of germ cell testicular cancer. It should be used in combination with mesna for prophylaxis of hemorrhagic cystitis.",
      "Description": "Ifosfamide injection is presented in sterile, single-dose vials for administration by intravenous infusion. Each mL contains ifosfamide, 50 mg, monobasic sodium phosphate monohydrate, 1.035 mg, dibasic sodium phosphate, 3.55 mg and water for injection, q.s.. Ifosfamide is a chemotherapeutic agent chemically related to the nitrogen mustards and a synthetic analog cyclophosphamide. Ifosfamide is 3-(2-ChloroethyI)-2-[(2-chloroethyl) amino]tetrahydro-2H-1,3,2- oxazaphosphorine 2-oxide. Its structural formula is. C7H15Cl2N2O2P. M. W. = 261.09. Ifosfamide is a white crystalline powder that is soluble in water."
    },
    {
      "NDCCode": "0143-9531-01",
      "PackageDescription": "1 VIAL in 1 BOX (0143-9531-01)  / 20 mL in 1 VIAL",
      "NDC11Code": "00143-9531-01",
      "ProductNDC": "0143-9531",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ifosfamide",
      "NonProprietaryName": "Ifosfamide",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20170610",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076619",
      "LabelerName": "Hikma Pharmaceuticals USA Inc.",
      "SubstanceName": "IFOSFAMIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-04-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20170610",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ifosfamide Injection is indicated for use in combination with certain other approved antineoplastic agentsfor third-line chemotherapy of germ cell testicular cancer. It should be used in combination with mesna for prophylaxis of hemorrhagic cystitis.",
      "Description": "Ifosfamide injection is presented in sterile, single-dose vials for administration by intravenous infusion. Each mL contains ifosfamide, 50 mg, monobasic sodium phosphate monohydrate, 1.035 mg, dibasic sodium phosphate, 3.55 mg and water for injection, q.s.. Ifosfamide is a chemotherapeutic agent chemically related to the nitrogen mustards and a synthetic analog cyclophosphamide. Ifosfamide is 3-(2-ChloroethyI)-2-[(2-chloroethyl) amino]tetrahydro-2H-1,3,2- oxazaphosphorine 2-oxide. Its structural formula is. C7H15Cl2N2O2P. M. W. = 261.09. Ifosfamide is a white crystalline powder that is soluble in water."
    },
    {
      "NDCCode": "0338-0202-06",
      "PackageDescription": "6 BAG in 1 CARTON (0338-0202-06)  / 1000 mL in 1 BAG (0338-0202-01) ",
      "NDC11Code": "00338-0202-06",
      "ProductNDC": "0338-0202",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clinimix E",
      "NonProprietaryName": "Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20200921",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020678",
      "LabelerName": "Baxter Healthcare Company",
      "SubstanceName": "LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE",
      "StrengthNumber": "584; 448; 464; 320; 480; 464; 384; 336; 144; 1656; 824; 920; 544; 400; 32; 261; 51; 205; 33; 14",
      "StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL",
      "Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2026-06-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20200921",
      "SamplePackage": "N",
      "IndicationAndUsage": "CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX E may be used to treat negative nitrogen balance in patients.",
      "Description": "CLINIMIX E sulfite-free (amino acids with electrolytes in dextrose with calcium) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids with electrolytes. The formulas for the individual electrolytes and amino acids are provided in Table 8. The injection port chamber contains dextrose with calcium. The formula for Calcium Chloride is: CaCl22H2O. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6  H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX E contains no more than 25 mcg/L of aluminum."
    },
    {
      "NDCCode": "0338-0206-04",
      "PackageDescription": "4 BAG in 1 CARTON (0338-0206-04)  / 2000 mL in 1 BAG (0338-0206-01) ",
      "NDC11Code": "00338-0206-04",
      "ProductNDC": "0338-0206",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clinimix E",
      "NonProprietaryName": "Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20200921",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020678",
      "LabelerName": "Baxter Healthcare Company",
      "SubstanceName": "LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE",
      "StrengthNumber": "584; 448; 464; 320; 480; 464; 384; 336; 144; 1656; 824; 920; 544; 400; 32; 261; 51; 205; 33; 14",
      "StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL",
      "Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2026-06-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20200921",
      "SamplePackage": "N",
      "IndicationAndUsage": "CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX E may be used to treat negative nitrogen balance in patients.",
      "Description": "CLINIMIX E sulfite-free (amino acids with electrolytes in dextrose with calcium) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids with electrolytes. The formulas for the individual electrolytes and amino acids are provided in Table 8. The injection port chamber contains dextrose with calcium. The formula for Calcium Chloride is: CaCl22H2O. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6  H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX E contains no more than 25 mcg/L of aluminum."
    },
    {
      "NDCCode": "0338-0210-06",
      "PackageDescription": "6 BAG in 1 CARTON (0338-0210-06)  / 1000 mL in 1 BAG (0338-0210-01) ",
      "NDC11Code": "00338-0210-06",
      "ProductNDC": "0338-0210",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clinimix E",
      "NonProprietaryName": "Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20200921",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020678",
      "LabelerName": "Baxter Healthcare Company",
      "SubstanceName": "LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE",
      "StrengthNumber": "584; 448; 464; 320; 480; 464; 384; 336; 144; 1656; 824; 920; 544; 400; 32; 261; 51; 205; 33; 10",
      "StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL",
      "Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2026-06-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20200921",
      "SamplePackage": "N",
      "IndicationAndUsage": "CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX E may be used to treat negative nitrogen balance in patients.",
      "Description": "CLINIMIX E sulfite-free (amino acids with electrolytes in dextrose with calcium) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids with electrolytes. The formulas for the individual electrolytes and amino acids are provided in Table 8. The injection port chamber contains dextrose with calcium. The formula for Calcium Chloride is: CaCl22H2O. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6  H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX E contains no more than 25 mcg/L of aluminum."
    },
    {
      "NDCCode": "0338-0214-04",
      "PackageDescription": "4 BAG in 1 CARTON (0338-0214-04)  / 2000 mL in 1 BAG (0338-0214-01) ",
      "NDC11Code": "00338-0214-04",
      "ProductNDC": "0338-0214",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clinimix E",
      "NonProprietaryName": "Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20200921",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020678",
      "LabelerName": "Baxter Healthcare Company",
      "SubstanceName": "LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE",
      "StrengthNumber": "584; 448; 464; 320; 480; 464; 384; 336; 144; 1656; 824; 920; 544; 400; 32; 261; 51; 205; 33; 10",
      "StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL",
      "Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2026-06-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20200921",
      "SamplePackage": "N",
      "IndicationAndUsage": "CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX E may be used to treat negative nitrogen balance in patients.",
      "Description": "CLINIMIX E sulfite-free (amino acids with electrolytes in dextrose with calcium) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids with electrolytes. The formulas for the individual electrolytes and amino acids are provided in Table 8. The injection port chamber contains dextrose with calcium. The formula for Calcium Chloride is: CaCl22H2O. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6  H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX E contains no more than 25 mcg/L of aluminum."
    },
    {
      "NDCCode": "0338-1005-02",
      "PackageDescription": "18 BAG in 1 CARTON (0338-1005-02)  / 250 mL in 1 BAG",
      "NDC11Code": "00338-1005-02",
      "ProductNDC": "0338-1005",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dopamine Hydrochloride And Dextrose",
      "NonProprietaryName": "Dopamine Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19870327",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019615",
      "LabelerName": "Baxter Healthcare Corporation",
      "SubstanceName": "DOPAMINE HYDROCHLORIDE",
      "StrengthNumber": "80",
      "StrengthUnit": "mg/100mL",
      "Pharm_Classes": "Catecholamine [EPC], Catecholamines [CS]",
      "Status": "Active",
      "LastUpdate": "2026-02-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19870327",
      "SamplePackage": "N",
      "IndicationAndUsage": "Dopamine hydrochloride is indicated for the correction of hemodynamic imbalances present in the shock syndrome due to myocardial infarctions, trauma, endotoxic septicemia, open heart surgery, renal failure and chronic cardiac decompensation as in congestive failure. Where appropriate, restoration of blood volume with a suitable plasma expander or whole blood should be instituted or completed prior to administration of dopamine hydrochloride. Patients most likely to respond adequately to dopamine hydrochloride are those in whom physiological parameters, such as urine flow, myocardial function and blood pressure have not undergone profound deterioration. Reports indicate that the shorter the time interval between onset of signs and symptoms and initiation of therapy with volume correction and dopamine hydrochloride, the better the prognosis.",
      "Description": "Dopamine Hydrochloride and 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution of Dopamine Hydrochloride, USP and Dextrose, USP in Water for Injection. Structural formulas are shown below. Dopamine Hydrochloride and 5% Dextrose Injection, USP is intended for intravenous use only. It contains no antimicrobial agents. The pH is adjusted with hydrochloric acid and is 3.5 (2.5 to 4.5). Approximately 5 mEq/L sodium bisulfite is added as a stabilizer. The solution provides a caloric content of 170 kcal/L. The solution is intended for single use only. When smaller doses are required, the unused portion should be discarded. Composition and osmolarity are given below. 800 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 800 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 261 mOsmol/L (calc). 1600 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 1600 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 269 mOsmol/L (calc). 3200 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 3200 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 286 mOsmol/L (calc). Dopamine administered intravenously is a myocardial inotropic agent which also may increase mesenteric and renal blood flow plus urinary output. Dopamine hydrochloride is designated chemically as 3,4-dihydroxyphenethylamine hydrochloride, a white crystalline powder freely soluble in water. Dopamine (also referred to as 3-hydroxytyramine) is a naturally occurring biochemical catecholamine precursor of norepinephrine. This VIAFLEX Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 2207 Plastic). VIAFLEX containers, including VIAFLEX Plus containers, are made of flexible plastic and are for parenteral use. VIAFLEX Plus on the container indicates the presence of a drug additive in a drug vehicle. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies."
    },
    {
      "NDCCode": "0338-1005-03",
      "PackageDescription": "12 BAG in 1 CARTON (0338-1005-03)  / 500 mL in 1 BAG",
      "NDC11Code": "00338-1005-03",
      "ProductNDC": "0338-1005",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dopamine Hydrochloride And Dextrose",
      "NonProprietaryName": "Dopamine Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19870327",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019615",
      "LabelerName": "Baxter Healthcare Corporation",
      "SubstanceName": "DOPAMINE HYDROCHLORIDE",
      "StrengthNumber": "80",
      "StrengthUnit": "mg/100mL",
      "Pharm_Classes": "Catecholamine [EPC], Catecholamines [CS]",
      "Status": "Active",
      "LastUpdate": "2026-02-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19870327",
      "SamplePackage": "N",
      "IndicationAndUsage": "Dopamine hydrochloride is indicated for the correction of hemodynamic imbalances present in the shock syndrome due to myocardial infarctions, trauma, endotoxic septicemia, open heart surgery, renal failure and chronic cardiac decompensation as in congestive failure. Where appropriate, restoration of blood volume with a suitable plasma expander or whole blood should be instituted or completed prior to administration of dopamine hydrochloride. Patients most likely to respond adequately to dopamine hydrochloride are those in whom physiological parameters, such as urine flow, myocardial function and blood pressure have not undergone profound deterioration. Reports indicate that the shorter the time interval between onset of signs and symptoms and initiation of therapy with volume correction and dopamine hydrochloride, the better the prognosis.",
      "Description": "Dopamine Hydrochloride and 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution of Dopamine Hydrochloride, USP and Dextrose, USP in Water for Injection. Structural formulas are shown below. Dopamine Hydrochloride and 5% Dextrose Injection, USP is intended for intravenous use only. It contains no antimicrobial agents. The pH is adjusted with hydrochloric acid and is 3.5 (2.5 to 4.5). Approximately 5 mEq/L sodium bisulfite is added as a stabilizer. The solution provides a caloric content of 170 kcal/L. The solution is intended for single use only. When smaller doses are required, the unused portion should be discarded. Composition and osmolarity are given below. 800 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 800 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 261 mOsmol/L (calc). 1600 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 1600 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 269 mOsmol/L (calc). 3200 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 3200 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 286 mOsmol/L (calc). Dopamine administered intravenously is a myocardial inotropic agent which also may increase mesenteric and renal blood flow plus urinary output. Dopamine hydrochloride is designated chemically as 3,4-dihydroxyphenethylamine hydrochloride, a white crystalline powder freely soluble in water. Dopamine (also referred to as 3-hydroxytyramine) is a naturally occurring biochemical catecholamine precursor of norepinephrine. This VIAFLEX Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 2207 Plastic). VIAFLEX containers, including VIAFLEX Plus containers, are made of flexible plastic and are for parenteral use. VIAFLEX Plus on the container indicates the presence of a drug additive in a drug vehicle. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies."
    },
    {
      "NDCCode": "0338-1007-02",
      "PackageDescription": "18 BAG in 1 CARTON (0338-1007-02)  / 250 mL in 1 BAG",
      "NDC11Code": "00338-1007-02",
      "ProductNDC": "0338-1007",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dopamine Hydrochloride And Dextrose",
      "NonProprietaryName": "Dopamine Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19870327",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019615",
      "LabelerName": "Baxter Healthcare Corporation",
      "SubstanceName": "DOPAMINE HYDROCHLORIDE",
      "StrengthNumber": "160",
      "StrengthUnit": "mg/100mL",
      "Pharm_Classes": "Catecholamine [EPC], Catecholamines [CS]",
      "Status": "Active",
      "LastUpdate": "2026-02-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19870327",
      "SamplePackage": "N",
      "IndicationAndUsage": "Dopamine hydrochloride is indicated for the correction of hemodynamic imbalances present in the shock syndrome due to myocardial infarctions, trauma, endotoxic septicemia, open heart surgery, renal failure and chronic cardiac decompensation as in congestive failure. Where appropriate, restoration of blood volume with a suitable plasma expander or whole blood should be instituted or completed prior to administration of dopamine hydrochloride. Patients most likely to respond adequately to dopamine hydrochloride are those in whom physiological parameters, such as urine flow, myocardial function and blood pressure have not undergone profound deterioration. Reports indicate that the shorter the time interval between onset of signs and symptoms and initiation of therapy with volume correction and dopamine hydrochloride, the better the prognosis.",
      "Description": "Dopamine Hydrochloride and 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution of Dopamine Hydrochloride, USP and Dextrose, USP in Water for Injection. Structural formulas are shown below. Dopamine Hydrochloride and 5% Dextrose Injection, USP is intended for intravenous use only. It contains no antimicrobial agents. The pH is adjusted with hydrochloric acid and is 3.5 (2.5 to 4.5). Approximately 5 mEq/L sodium bisulfite is added as a stabilizer. The solution provides a caloric content of 170 kcal/L. The solution is intended for single use only. When smaller doses are required, the unused portion should be discarded. Composition and osmolarity are given below. 800 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 800 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 261 mOsmol/L (calc). 1600 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 1600 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 269 mOsmol/L (calc). 3200 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 3200 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 286 mOsmol/L (calc). Dopamine administered intravenously is a myocardial inotropic agent which also may increase mesenteric and renal blood flow plus urinary output. Dopamine hydrochloride is designated chemically as 3,4-dihydroxyphenethylamine hydrochloride, a white crystalline powder freely soluble in water. Dopamine (also referred to as 3-hydroxytyramine) is a naturally occurring biochemical catecholamine precursor of norepinephrine. This VIAFLEX Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 2207 Plastic). VIAFLEX containers, including VIAFLEX Plus containers, are made of flexible plastic and are for parenteral use. VIAFLEX Plus on the container indicates the presence of a drug additive in a drug vehicle. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies."
    },
    {
      "NDCCode": "0338-1007-03",
      "PackageDescription": "12 BAG in 1 CARTON (0338-1007-03)  / 500 mL in 1 BAG",
      "NDC11Code": "00338-1007-03",
      "ProductNDC": "0338-1007",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dopamine Hydrochloride And Dextrose",
      "NonProprietaryName": "Dopamine Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19870327",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019615",
      "LabelerName": "Baxter Healthcare Corporation",
      "SubstanceName": "DOPAMINE HYDROCHLORIDE",
      "StrengthNumber": "160",
      "StrengthUnit": "mg/100mL",
      "Pharm_Classes": "Catecholamine [EPC], Catecholamines [CS]",
      "Status": "Active",
      "LastUpdate": "2026-02-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19870327",
      "SamplePackage": "N",
      "IndicationAndUsage": "Dopamine hydrochloride is indicated for the correction of hemodynamic imbalances present in the shock syndrome due to myocardial infarctions, trauma, endotoxic septicemia, open heart surgery, renal failure and chronic cardiac decompensation as in congestive failure. Where appropriate, restoration of blood volume with a suitable plasma expander or whole blood should be instituted or completed prior to administration of dopamine hydrochloride. Patients most likely to respond adequately to dopamine hydrochloride are those in whom physiological parameters, such as urine flow, myocardial function and blood pressure have not undergone profound deterioration. Reports indicate that the shorter the time interval between onset of signs and symptoms and initiation of therapy with volume correction and dopamine hydrochloride, the better the prognosis.",
      "Description": "Dopamine Hydrochloride and 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution of Dopamine Hydrochloride, USP and Dextrose, USP in Water for Injection. Structural formulas are shown below. Dopamine Hydrochloride and 5% Dextrose Injection, USP is intended for intravenous use only. It contains no antimicrobial agents. The pH is adjusted with hydrochloric acid and is 3.5 (2.5 to 4.5). Approximately 5 mEq/L sodium bisulfite is added as a stabilizer. The solution provides a caloric content of 170 kcal/L. The solution is intended for single use only. When smaller doses are required, the unused portion should be discarded. Composition and osmolarity are given below. 800 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 800 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 261 mOsmol/L (calc). 1600 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 1600 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 269 mOsmol/L (calc). 3200 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 3200 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 286 mOsmol/L (calc). Dopamine administered intravenously is a myocardial inotropic agent which also may increase mesenteric and renal blood flow plus urinary output. Dopamine hydrochloride is designated chemically as 3,4-dihydroxyphenethylamine hydrochloride, a white crystalline powder freely soluble in water. Dopamine (also referred to as 3-hydroxytyramine) is a naturally occurring biochemical catecholamine precursor of norepinephrine. This VIAFLEX Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 2207 Plastic). VIAFLEX containers, including VIAFLEX Plus containers, are made of flexible plastic and are for parenteral use. VIAFLEX Plus on the container indicates the presence of a drug additive in a drug vehicle. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies."
    },
    {
      "NDCCode": "0338-1009-02",
      "PackageDescription": "18 BAG in 1 CARTON (0338-1009-02)  / 250 mL in 1 BAG",
      "NDC11Code": "00338-1009-02",
      "ProductNDC": "0338-1009",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dopamine Hydrochloride And Dextrose",
      "NonProprietaryName": "Dopamine Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19870327",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019615",
      "LabelerName": "Baxter Healthcare Corporation",
      "SubstanceName": "DOPAMINE HYDROCHLORIDE",
      "StrengthNumber": "320",
      "StrengthUnit": "mg/100mL",
      "Pharm_Classes": "Catecholamine [EPC], Catecholamines [CS]",
      "Status": "Active",
      "LastUpdate": "2026-02-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19870327",
      "SamplePackage": "N",
      "IndicationAndUsage": "Dopamine hydrochloride is indicated for the correction of hemodynamic imbalances present in the shock syndrome due to myocardial infarctions, trauma, endotoxic septicemia, open heart surgery, renal failure and chronic cardiac decompensation as in congestive failure. Where appropriate, restoration of blood volume with a suitable plasma expander or whole blood should be instituted or completed prior to administration of dopamine hydrochloride. Patients most likely to respond adequately to dopamine hydrochloride are those in whom physiological parameters, such as urine flow, myocardial function and blood pressure have not undergone profound deterioration. Reports indicate that the shorter the time interval between onset of signs and symptoms and initiation of therapy with volume correction and dopamine hydrochloride, the better the prognosis.",
      "Description": "Dopamine Hydrochloride and 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution of Dopamine Hydrochloride, USP and Dextrose, USP in Water for Injection. Structural formulas are shown below. Dopamine Hydrochloride and 5% Dextrose Injection, USP is intended for intravenous use only. It contains no antimicrobial agents. The pH is adjusted with hydrochloric acid and is 3.5 (2.5 to 4.5). Approximately 5 mEq/L sodium bisulfite is added as a stabilizer. The solution provides a caloric content of 170 kcal/L. The solution is intended for single use only. When smaller doses are required, the unused portion should be discarded. Composition and osmolarity are given below. 800 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 800 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 261 mOsmol/L (calc). 1600 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 1600 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 269 mOsmol/L (calc). 3200 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 3200 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 286 mOsmol/L (calc). Dopamine administered intravenously is a myocardial inotropic agent which also may increase mesenteric and renal blood flow plus urinary output. Dopamine hydrochloride is designated chemically as 3,4-dihydroxyphenethylamine hydrochloride, a white crystalline powder freely soluble in water. Dopamine (also referred to as 3-hydroxytyramine) is a naturally occurring biochemical catecholamine precursor of norepinephrine. This VIAFLEX Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 2207 Plastic). VIAFLEX containers, including VIAFLEX Plus containers, are made of flexible plastic and are for parenteral use. VIAFLEX Plus on the container indicates the presence of a drug additive in a drug vehicle. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies."
    },
    {
      "NDCCode": "0338-1107-04",
      "PackageDescription": "2000 mL in 1 BAG (0338-1107-04) ",
      "NDC11Code": "00338-1107-04",
      "ProductNDC": "0338-1107",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clinimix E",
      "NonProprietaryName": "Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19970326",
      "EndMarketingDate": "20190831",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020678",
      "LabelerName": "Baxter Healthcare Corporation",
      "SubstanceName": "LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; SODIUM ACETATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE",
      "StrengthNumber": "201; 154; 159; 110; 165; 160; 132; 116; 50; 570; 283; 316; 187; 138; 11; 217; 261; 51; 112; 33; 5",
      "StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL",
      "Pharm_Classes": "Amino Acid [EPC],Amino Acids [CS],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "19970326",
      "EndMarketingDatePackage": "20190831",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0338-1109-04",
      "PackageDescription": "2000 mL in 1 BAG (0338-1109-04) ",
      "NDC11Code": "00338-1109-04",
      "ProductNDC": "0338-1109",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clinimix E",
      "NonProprietaryName": "Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19970326",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020678",
      "LabelerName": "Baxter Healthcare Corporation",
      "SubstanceName": "LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; SODIUM ACETATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE",
      "StrengthNumber": "201; 154; 159; 110; 165; 160; 132; 116; 50; 570; 283; 316; 187; 138; 11; 217; 261; 51; 112; 33; 10",
      "StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL",
      "Pharm_Classes": "Amino Acid [EPC],Amino Acids [CS],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2018-12-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "19970326",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0338-1113-04",
      "PackageDescription": "2000 mL in 1 BAG (0338-1113-04) ",
      "NDC11Code": "00338-1113-04",
      "ProductNDC": "0338-1113",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clinimix E",
      "NonProprietaryName": "Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19970326",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020678",
      "LabelerName": "Baxter Healthcare Company",
      "SubstanceName": "LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; SODIUM ACETATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE",
      "StrengthNumber": "311; 238; 247; 170; 255; 247; 204; 179; 77; 880; 438; 489; 289; 213; 17; 297; 261; 51; 77; 33; 5",
      "StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL",
      "Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2026-06-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19970326",
      "SamplePackage": "N",
      "IndicationAndUsage": "CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX E may be used to treat negative nitrogen balance in patients.",
      "Description": "CLINIMIX E sulfite-free (amino acids with electrolytes in dextrose with calcium) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids with electrolytes. The formulas for the individual electrolytes and amino acids are provided in Table 8. The injection port chamber contains dextrose with calcium. The formula for Calcium Chloride is: CaCl22H2O. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6  H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX E contains no more than 25 mcg/L of aluminum."
    },
    {
      "NDCCode": "0338-1115-04",
      "PackageDescription": "2000 mL in 1 BAG (0338-1115-04) ",
      "NDC11Code": "00338-1115-04",
      "ProductNDC": "0338-1115",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clinimix E",
      "NonProprietaryName": "Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19970326",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020678",
      "LabelerName": "Baxter Healthcare Company",
      "SubstanceName": "LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; SODIUM ACETATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE",
      "StrengthNumber": "311; 238; 247; 170; 255; 247; 204; 179; 77; 880; 438; 489; 289; 213; 17; 297; 261; 51; 77; 33; 10",
      "StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL",
      "Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2026-06-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19970326",
      "SamplePackage": "N",
      "IndicationAndUsage": "CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX E may be used to treat negative nitrogen balance in patients.",
      "Description": "CLINIMIX E sulfite-free (amino acids with electrolytes in dextrose with calcium) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids with electrolytes. The formulas for the individual electrolytes and amino acids are provided in Table 8. The injection port chamber contains dextrose with calcium. The formula for Calcium Chloride is: CaCl22H2O. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6  H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX E contains no more than 25 mcg/L of aluminum."
    },
    {
      "NDCCode": "0338-1119-04",
      "PackageDescription": "2000 mL in 1 BAG (0338-1119-04) ",
      "NDC11Code": "00338-1119-04",
      "ProductNDC": "0338-1119",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clinimix E",
      "NonProprietaryName": "Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19970326",
      "EndMarketingDate": "20190831",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020678",
      "LabelerName": "Baxter Healthcare Corporation",
      "SubstanceName": "LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; SODIUM ACETATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE",
      "StrengthNumber": "311; 238; 247; 170; 255; 247; 204; 179; 77; 880; 438; 489; 289; 213; 17; 297; 261; 51; 77; 33; 25",
      "StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL",
      "Pharm_Classes": "Amino Acid [EPC],Amino Acids [CS],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "19970326",
      "EndMarketingDatePackage": "20190831",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0338-1123-04",
      "PackageDescription": "2000 mL in 1 BAG (0338-1123-04) ",
      "NDC11Code": "00338-1123-04",
      "ProductNDC": "0338-1123",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clinimix E",
      "NonProprietaryName": "Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19970326",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020678",
      "LabelerName": "Baxter Healthcare Company",
      "SubstanceName": "LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; SODIUM ACETATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE",
      "StrengthNumber": "365; 280; 290; 200; 300; 290; 240; 210; 90; 1035; 515; 575; 340; 250; 20; 340; 261; 51; 59; 33; 15",
      "StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL",
      "Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2026-06-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19970326",
      "SamplePackage": "N",
      "IndicationAndUsage": "CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX E may be used to treat negative nitrogen balance in patients.",
      "Description": "CLINIMIX E sulfite-free (amino acids with electrolytes in dextrose with calcium) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids with electrolytes. The formulas for the individual electrolytes and amino acids are provided in Table 8. The injection port chamber contains dextrose with calcium. The formula for Calcium Chloride is: CaCl22H2O. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6  H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX E contains no more than 25 mcg/L of aluminum."
    },
    {
      "NDCCode": "0338-1125-04",
      "PackageDescription": "2000 mL in 1 BAG (0338-1125-04) ",
      "NDC11Code": "00338-1125-04",
      "ProductNDC": "0338-1125",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clinimix E",
      "NonProprietaryName": "Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19970326",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020678",
      "LabelerName": "Baxter Healthcare Company",
      "SubstanceName": "LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; SODIUM ACETATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE",
      "StrengthNumber": "365; 280; 290; 200; 300; 290; 240; 210; 90; 1035; 515; 575; 340; 250; 20; 340; 261; 51; 59; 33; 20",
      "StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL",
      "Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2026-06-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19970326",
      "SamplePackage": "N",
      "IndicationAndUsage": "CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX E may be used to treat negative nitrogen balance in patients.",
      "Description": "CLINIMIX E sulfite-free (amino acids with electrolytes in dextrose with calcium) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids with electrolytes. The formulas for the individual electrolytes and amino acids are provided in Table 8. The injection port chamber contains dextrose with calcium. The formula for Calcium Chloride is: CaCl22H2O. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6  H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX E contains no more than 25 mcg/L of aluminum."
    },
    {
      "NDCCode": "0338-1127-04",
      "PackageDescription": "2000 mL in 1 BAG (0338-1127-04) ",
      "NDC11Code": "00338-1127-04",
      "ProductNDC": "0338-1127",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clinimix E",
      "NonProprietaryName": "Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19970326",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020678",
      "LabelerName": "Baxter Healthcare Corporation",
      "SubstanceName": "LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; SODIUM ACETATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE",
      "StrengthNumber": "365; 280; 290; 200; 300; 290; 240; 210; 90; 1035; 515; 575; 340; 250; 20; 340; 261; 51; 59; 33; 25",
      "StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL",
      "Pharm_Classes": "Amino Acid [EPC],Amino Acids [CS],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2018-12-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "19970326",
      "SamplePackage": "N"
    }
  ]
}
                    

{"NDC":[{"NDCCode":"59651-261-48","ProprietaryName":"Clozapine","NonProprietaryName":"Clozapine"},{"NDCCode":"59651-261-01","ProprietaryName":"Clozapine","NonProprietaryName":"Clozapine"},{"NDCCode":"59651-262-48","ProprietaryName":"Clozapine","NonProprietaryName":"Clozapine"},{"NDCCode":"59651-263-48","ProprietaryName":"Clozapine","NonProprietaryName":"Clozapine"},{"NDCCode":"59651-264-48","ProprietaryName":"Clozapine","NonProprietaryName":"Clozapine"},{"NDCCode":"51407-261-30","ProprietaryName":"Olanzapine","NonProprietaryName":"Olanzapine"},{"NDCCode":"59651-104-69","ProprietaryName":"Eletriptan Hydrobromide","NonProprietaryName":"Eletriptan Hydrobromide"},{"NDCCode":"59651-105-69","ProprietaryName":"Eletriptan Hydrobromide","NonProprietaryName":"Eletriptan Hydrobromide"},{"NDCCode":"59651-105-93","ProprietaryName":"Eletriptan Hydrobromide","NonProprietaryName":"Eletriptan Hydrobromide"},{"NDCCode":"59651-597-60","ProprietaryName":"Oseltamivir Phosphate","NonProprietaryName":"Oseltamivir Phosphate"},{"NDCCode":"0115-2134-01","ProprietaryName":"Pyridostigmine Bromide","NonProprietaryName":"Pyridostigmine Bromide"},{"NDCCode":"0143-9530-01","ProprietaryName":"Ifosfamide","NonProprietaryName":"Ifosfamide"},{"NDCCode":"0143-9531-01","ProprietaryName":"Ifosfamide","NonProprietaryName":"Ifosfamide"},{"NDCCode":"0338-0202-06","ProprietaryName":"Clinimix E","NonProprietaryName":"Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose"},{"NDCCode":"0338-0206-04","ProprietaryName":"Clinimix E","NonProprietaryName":"Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose"},{"NDCCode":"0338-0210-06","ProprietaryName":"Clinimix E","NonProprietaryName":"Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose"},{"NDCCode":"0338-0214-04","ProprietaryName":"Clinimix E","NonProprietaryName":"Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose"},{"NDCCode":"0338-1005-02","ProprietaryName":"Dopamine Hydrochloride And Dextrose","NonProprietaryName":"Dopamine Hydrochloride"},{"NDCCode":"0338-1005-03","ProprietaryName":"Dopamine Hydrochloride And Dextrose","NonProprietaryName":"Dopamine Hydrochloride"},{"NDCCode":"0338-1007-02","ProprietaryName":"Dopamine Hydrochloride And Dextrose","NonProprietaryName":"Dopamine Hydrochloride"},{"NDCCode":"0338-1007-03","ProprietaryName":"Dopamine Hydrochloride And Dextrose","NonProprietaryName":"Dopamine Hydrochloride"},{"NDCCode":"0338-1009-02","ProprietaryName":"Dopamine Hydrochloride And Dextrose","NonProprietaryName":"Dopamine Hydrochloride"},{"NDCCode":"0338-1107-04","ProprietaryName":"Clinimix E","NonProprietaryName":"Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose"},{"NDCCode":"0338-1109-04","ProprietaryName":"Clinimix E","NonProprietaryName":"Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose"},{"NDCCode":"0338-1113-04","ProprietaryName":"Clinimix E","NonProprietaryName":"Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose"},{"NDCCode":"0338-1115-04","ProprietaryName":"Clinimix E","NonProprietaryName":"Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose"},{"NDCCode":"0338-1119-04","ProprietaryName":"Clinimix E","NonProprietaryName":"Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose"},{"NDCCode":"0338-1123-04","ProprietaryName":"Clinimix E","NonProprietaryName":"Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose"},{"NDCCode":"0338-1125-04","ProprietaryName":"Clinimix E","NonProprietaryName":"Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose"},{"NDCCode":"0338-1127-04","ProprietaryName":"Clinimix E","NonProprietaryName":"Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose"}]}
                    

<NDCList><NDC><NDCCode>59651-261-48</NDCCode><ProprietaryName>Clozapine</ProprietaryName><NonProprietaryName>Clozapine</NonProprietaryName></NDC><NDC><NDCCode>59651-261-01</NDCCode><ProprietaryName>Clozapine</ProprietaryName><NonProprietaryName>Clozapine</NonProprietaryName></NDC><NDC><NDCCode>59651-262-48</NDCCode><ProprietaryName>Clozapine</ProprietaryName><NonProprietaryName>Clozapine</NonProprietaryName></NDC><NDC><NDCCode>59651-263-48</NDCCode><ProprietaryName>Clozapine</ProprietaryName><NonProprietaryName>Clozapine</NonProprietaryName></NDC><NDC><NDCCode>59651-264-48</NDCCode><ProprietaryName>Clozapine</ProprietaryName><NonProprietaryName>Clozapine</NonProprietaryName></NDC><NDC><NDCCode>51407-261-30</NDCCode><ProprietaryName>Olanzapine</ProprietaryName><NonProprietaryName>Olanzapine</NonProprietaryName></NDC><NDC><NDCCode>59651-104-69</NDCCode><ProprietaryName>Eletriptan Hydrobromide</ProprietaryName><NonProprietaryName>Eletriptan Hydrobromide</NonProprietaryName></NDC><NDC><NDCCode>59651-105-69</NDCCode><ProprietaryName>Eletriptan Hydrobromide</ProprietaryName><NonProprietaryName>Eletriptan Hydrobromide</NonProprietaryName></NDC><NDC><NDCCode>59651-105-93</NDCCode><ProprietaryName>Eletriptan Hydrobromide</ProprietaryName><NonProprietaryName>Eletriptan Hydrobromide</NonProprietaryName></NDC><NDC><NDCCode>59651-597-60</NDCCode><ProprietaryName>Oseltamivir Phosphate</ProprietaryName><NonProprietaryName>Oseltamivir Phosphate</NonProprietaryName></NDC><NDC><NDCCode>0115-2134-01</NDCCode><ProprietaryName>Pyridostigmine Bromide</ProprietaryName><NonProprietaryName>Pyridostigmine Bromide</NonProprietaryName></NDC><NDC><NDCCode>0143-9530-01</NDCCode><ProprietaryName>Ifosfamide</ProprietaryName><NonProprietaryName>Ifosfamide</NonProprietaryName></NDC><NDC><NDCCode>0143-9531-01</NDCCode><ProprietaryName>Ifosfamide</ProprietaryName><NonProprietaryName>Ifosfamide</NonProprietaryName></NDC><NDC><NDCCode>0338-0202-06</NDCCode><ProprietaryName>Clinimix E</ProprietaryName><NonProprietaryName>Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose</NonProprietaryName></NDC><NDC><NDCCode>0338-0206-04</NDCCode><ProprietaryName>Clinimix E</ProprietaryName><NonProprietaryName>Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose</NonProprietaryName></NDC><NDC><NDCCode>0338-0210-06</NDCCode><ProprietaryName>Clinimix E</ProprietaryName><NonProprietaryName>Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose</NonProprietaryName></NDC><NDC><NDCCode>0338-0214-04</NDCCode><ProprietaryName>Clinimix E</ProprietaryName><NonProprietaryName>Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose</NonProprietaryName></NDC><NDC><NDCCode>0338-1005-02</NDCCode><ProprietaryName>Dopamine Hydrochloride And Dextrose</ProprietaryName><NonProprietaryName>Dopamine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0338-1005-03</NDCCode><ProprietaryName>Dopamine Hydrochloride And Dextrose</ProprietaryName><NonProprietaryName>Dopamine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0338-1007-02</NDCCode><ProprietaryName>Dopamine Hydrochloride And Dextrose</ProprietaryName><NonProprietaryName>Dopamine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0338-1007-03</NDCCode><ProprietaryName>Dopamine Hydrochloride And Dextrose</ProprietaryName><NonProprietaryName>Dopamine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0338-1009-02</NDCCode><ProprietaryName>Dopamine Hydrochloride And Dextrose</ProprietaryName><NonProprietaryName>Dopamine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0338-1107-04</NDCCode><ProprietaryName>Clinimix E</ProprietaryName><NonProprietaryName>Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose</NonProprietaryName></NDC><NDC><NDCCode>0338-1109-04</NDCCode><ProprietaryName>Clinimix E</ProprietaryName><NonProprietaryName>Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose</NonProprietaryName></NDC><NDC><NDCCode>0338-1113-04</NDCCode><ProprietaryName>Clinimix E</ProprietaryName><NonProprietaryName>Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose</NonProprietaryName></NDC><NDC><NDCCode>0338-1115-04</NDCCode><ProprietaryName>Clinimix E</ProprietaryName><NonProprietaryName>Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose</NonProprietaryName></NDC><NDC><NDCCode>0338-1119-04</NDCCode><ProprietaryName>Clinimix E</ProprietaryName><NonProprietaryName>Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose</NonProprietaryName></NDC><NDC><NDCCode>0338-1123-04</NDCCode><ProprietaryName>Clinimix E</ProprietaryName><NonProprietaryName>Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose</NonProprietaryName></NDC><NDC><NDCCode>0338-1125-04</NDCCode><ProprietaryName>Clinimix E</ProprietaryName><NonProprietaryName>Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose</NonProprietaryName></NDC><NDC><NDCCode>0338-1127-04</NDCCode><ProprietaryName>Clinimix E</ProprietaryName><NonProprietaryName>Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose</NonProprietaryName></NDC></NDCList>