{
"NDC": [
{
"NDCCode": "44206-300-10",
"PackageDescription": "10 SYRINGE, GLASS in 1 CARTON (44206-300-10) / 2 mL in 1 SYRINGE, GLASS (44206-300-90) ",
"NDC11Code": "44206-0300-10",
"ProductNDC": "44206-300",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Rhophylac",
"NonProprietaryName": "Human Rho(d) Immune Globulin",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20090106",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125070",
"LabelerName": "CSL Behring AG",
"SubstanceName": "HUMAN RHO(D) IMMUNE GLOBULIN",
"StrengthNumber": "1500",
"StrengthUnit": "[iU]/2mL",
"Pharm_Classes": "Endogenous Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
"Status": "Active",
"LastUpdate": "2025-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090106",
"SamplePackage": "N",
"IndicationAndUsage": "RHOPHYLAC is a Rh(D) Immune Globulin Intravenous (Human) (anti-D) product that is indicated for the suppression of Rh isoimmunization in non-sensitized Rh(D)-negative patients and for the treatment of immune thrombocytopenic purpura (ITP) in Rh(D)-positive patients.",
"Description": "RHOPHYLAC is a sterile Rh(D) Immune Globulin Intravenous (Human) (anti-D) solution in a ready-to-use prefilled glass syringe for intravenous or intramuscular injection. One syringe contains at least 1500 IU (300 mcg) of IgG antibodies to Rh(D) in a 2 mL solution, sufficient to suppress the immune response to at least 15 mL of Rh(D)-positive RBCs.1 The product potency is expressed in IUs by comparison to the World Health Organization (WHO) standard, which is also the US and the European Pharmacopoeia standard. Plasma is obtained from healthy Rh(D)-negative donors who have been immunized with Rh(D)-positive RBCs. The donors are screened carefully to reduce the risk of receiving donations containing blood-borne pathogens. Each plasma donation used in the manufacture of RHOPHYLAC is tested for the presence of HBV surface antigen (HBsAg), HIV-1/2, and HCV antibodies. In addition, plasma used in the manufacture of RHOPHYLAC is tested by FDA-licensed Nucleic Acid Testing (NAT) for HBV, HCV, and HIV-1 and found to be negative. The source plasma is also tested by NAT for hepatitis A virus (HAV) and B19 virus (B19V). RHOPHYLAC is produced by an ion-exchange chromatography isolation procedure5, using pooled plasma obtained by plasmapheresis of immunized Rh(D)-negative US donors. The manufacturing process of RHOPHYLAC includes two dedicated virus reduction steps (i.e., solvent/detergent treatment and virus filtration with a Planova® 15 nanometer (nm) virus filter) as well as one ion exchange chromatography step contributing to virus reduction.6,7 All three virus reduction steps have been independently validated in a series of in vitro experiments for their capacity to inactivate or remove enveloped and/or non-enveloped viruses. Virus models were chosen to cover a broad selection of viruses, including the major blood-transmissible viruses like human immunodeficiency virus, hepatitis B and hepatitis C virus, as well as small, non-enveloped viruses like hepatitis A virus and human parvovirus B19. Viral clearance data from validation studies of the dedicated virus reduction steps for both enveloped and nonenveloped viruses will be provided upon request by calling 1-800-504-5434. Overall virus reduction expressed as mean log10 reduction factor of model enveloped and non-enveloped viruses has been shown to be ≥11 log10 and ≥9 log10 respectively. RHOPHYLAC contains a maximum of 30 mg/mL of human plasma proteins, 10 mg/mL of which is human albumin added as a stabilizer. Prior to the addition of the stabilizer, RHOPHYLAC has a purity greater than 95% IgG. RHOPHYLAC contains less than 5 mcg/mL of IgA, which is the limit of detection. Additional excipients are approximately 20 mg/mL of glycine and up to 0.25 M of sodium chloride. RHOPHYLAC contains no preservative. Human albumin is manufactured from pooled plasma of US donors by cold ethanol fractionation, followed by pasteurization."
},
{
"NDCCode": "44206-300-01",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (44206-300-01) / 2 mL in 1 SYRINGE, GLASS (44206-300-90) ",
"NDC11Code": "44206-0300-01",
"ProductNDC": "44206-300",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Rhophylac",
"NonProprietaryName": "Human Rho(d) Immune Globulin",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20090106",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125070",
"LabelerName": "CSL Behring AG",
"SubstanceName": "HUMAN RHO(D) IMMUNE GLOBULIN",
"StrengthNumber": "1500",
"StrengthUnit": "[iU]/2mL",
"Pharm_Classes": "Endogenous Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
"Status": "Active",
"LastUpdate": "2025-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090106",
"SamplePackage": "N",
"IndicationAndUsage": "RHOPHYLAC is a Rh(D) Immune Globulin Intravenous (Human) (anti-D) product that is indicated for the suppression of Rh isoimmunization in non-sensitized Rh(D)-negative patients and for the treatment of immune thrombocytopenic purpura (ITP) in Rh(D)-positive patients.",
"Description": "RHOPHYLAC is a sterile Rh(D) Immune Globulin Intravenous (Human) (anti-D) solution in a ready-to-use prefilled glass syringe for intravenous or intramuscular injection. One syringe contains at least 1500 IU (300 mcg) of IgG antibodies to Rh(D) in a 2 mL solution, sufficient to suppress the immune response to at least 15 mL of Rh(D)-positive RBCs.1 The product potency is expressed in IUs by comparison to the World Health Organization (WHO) standard, which is also the US and the European Pharmacopoeia standard. Plasma is obtained from healthy Rh(D)-negative donors who have been immunized with Rh(D)-positive RBCs. The donors are screened carefully to reduce the risk of receiving donations containing blood-borne pathogens. Each plasma donation used in the manufacture of RHOPHYLAC is tested for the presence of HBV surface antigen (HBsAg), HIV-1/2, and HCV antibodies. In addition, plasma used in the manufacture of RHOPHYLAC is tested by FDA-licensed Nucleic Acid Testing (NAT) for HBV, HCV, and HIV-1 and found to be negative. The source plasma is also tested by NAT for hepatitis A virus (HAV) and B19 virus (B19V). RHOPHYLAC is produced by an ion-exchange chromatography isolation procedure5, using pooled plasma obtained by plasmapheresis of immunized Rh(D)-negative US donors. The manufacturing process of RHOPHYLAC includes two dedicated virus reduction steps (i.e., solvent/detergent treatment and virus filtration with a Planova® 15 nanometer (nm) virus filter) as well as one ion exchange chromatography step contributing to virus reduction.6,7 All three virus reduction steps have been independently validated in a series of in vitro experiments for their capacity to inactivate or remove enveloped and/or non-enveloped viruses. Virus models were chosen to cover a broad selection of viruses, including the major blood-transmissible viruses like human immunodeficiency virus, hepatitis B and hepatitis C virus, as well as small, non-enveloped viruses like hepatitis A virus and human parvovirus B19. Viral clearance data from validation studies of the dedicated virus reduction steps for both enveloped and nonenveloped viruses will be provided upon request by calling 1-800-504-5434. Overall virus reduction expressed as mean log10 reduction factor of model enveloped and non-enveloped viruses has been shown to be ≥11 log10 and ≥9 log10 respectively. RHOPHYLAC contains a maximum of 30 mg/mL of human plasma proteins, 10 mg/mL of which is human albumin added as a stabilizer. Prior to the addition of the stabilizer, RHOPHYLAC has a purity greater than 95% IgG. RHOPHYLAC contains less than 5 mcg/mL of IgA, which is the limit of detection. Additional excipients are approximately 20 mg/mL of glycine and up to 0.25 M of sodium chloride. RHOPHYLAC contains no preservative. Human albumin is manufactured from pooled plasma of US donors by cold ethanol fractionation, followed by pasteurization."
},
{
"NDCCode": "44206-251-10",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (44206-251-10) > 100 mL in 1 VIAL, GLASS (44206-251-91) ",
"NDC11Code": "44206-0251-10",
"ProductNDC": "44206-251",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Alburx",
"NonProprietaryName": "Albumin (human)",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20090106",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102366",
"LabelerName": "CSL Behring AG",
"SubstanceName": "ALBUMIN HUMAN",
"StrengthNumber": "12.5",
"StrengthUnit": "g/50mL",
"Pharm_Classes": "Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]",
"Status": "Active",
"LastUpdate": "2022-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090106",
"SamplePackage": "N",
"Description": "ALBURX® 25, Albumin (Human) 25% solution is a sterile aqueous solution for intravenous administration containing the albumin component of human blood. The solution is clear and slightly viscous; it is almost colorless, or yellow, amber, or green. This product is prepared from the plasma of US donors. The product has been produced by alcohol fractionation and has been heated for 10 hours at 60°C for inactivation of infectious agents. The results of virus validation studies have shown that the manufacturing process, particularly alcohol fractionation, eliminates enveloped and non-enveloped viruses. Additionally, heat treatment at 60°C for a period of 10 hours efficiently inactivates viruses. The solution contains 0.14 M (3.2 mg/mL) sodium. The aluminum content is ≤ 200 mcg/L and the potassium content is ≤ 0.002 M. The solution is stabilized with 0.02 M sodium N-acetyltryptophanate and 0.02 M sodium caprylate. The solution contains no preservative."
},
{
"NDCCode": "44206-437-10",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (44206-437-10) / 100 mL in 1 VIAL, GLASS (44206-437-91) ",
"NDC11Code": "44206-0437-10",
"ProductNDC": "44206-437",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Privigen",
"NonProprietaryName": "Human Immunoglobulin G",
"DosageFormName": "LIQUID",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20090120",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125201",
"LabelerName": "CSL Behring AG",
"SubstanceName": "HUMAN IMMUNOGLOBULIN G",
"StrengthNumber": "10",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
"Status": "Active",
"LastUpdate": "2026-05-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090120",
"SamplePackage": "N",
"IndicationAndUsage": "PRIVIGEN is an Immune Globulin Intravenous (Human), 10% Liquid indicated for the treatment of the following conditions.",
"Description": "PRIVIGEN is a ready-to-use, sterile, 10% protein liquid preparation of polyvalent human immunoglobulin G (IgG) for intravenous administration. PRIVIGEN has a purity of at least 98% IgG, consisting primarily of monomers. The balance consists of IgG dimers (≤12%), small amounts of fragments and polymers, and albumin. PRIVIGEN contains ≤25 mcg/mL IgA. The IgG subclass distribution is similar to that of normal human plasma. PRIVIGEN has an osmolality of approximately 320 mOsmol/kg (range: 240 to 440) and a pH of 4.8 (range: 4.6 to 5.0). PRIVIGEN contains approximately 250 mmol/L (range: 210 to 290) of L-proline (a nonessential amino acid) as a stabilizer and trace amounts of sodium. PRIVIGEN contains no carbohydrate stabilizers (e.g., sucrose, maltose) and no preservative. PRIVIGEN is prepared from large pools of human plasma by a combination of cold ethanol fractionation, octanoic acid fractionation, and anion exchange chromatography. The IgG proteins are not subjected to heating or to chemical or enzymatic modification. The Fc and Fab functions of the IgG molecule are retained. Fab functions tested include antigen binding capacities, and Fc functions tested include complement activation and Fc-receptor-mediated leukocyte activation (determined with complexed IgG). PRIVIGEN does not activate the complement system or prekallikrein in an unspecific manner. To specifically reduce blood group A and B antibodies (isoagglutinins A and B) the manufacturing process for PRIVIGEN includes an immunoaffinity chromatography step. All plasma units used in the manufacture of PRIVIGEN have been tested and approved for manufacture using FDA-licensed serological assays for hepatitis B surface antigen and antibodies to HCV and HIV-1/2 as well as FDA-licensed Nucleic Acid Testing (NAT) for HBV, HCV and HIV-1 and found to be nonreactive (negative). In addition, the plasma has been tested for B19 virus (B19V) DNA by NAT. Only plasma that passed virus screening is used for production, and the limit for B19V in the fractionation pool is set not to exceed 104 IU of B19V DNA per mL. The manufacturing process for PRIVIGEN includes three steps to reduce the risk of virus transmission. Two of these are dedicated virus clearance steps: pH 4 incubation to inactivate enveloped viruses and virus filtration to remove, by size exclusion, both enveloped and non-enveloped viruses as small as approximately 20 nanometers. In addition, a depth filtration step contributes to the virus reduction capacity. These steps have been independently validated in a series of in vitro experiments for their capacity to inactivate and/or remove both enveloped and non-enveloped viruses. Table 6 shows the virus clearance during the manufacturing process for PRIVIGEN, expressed as the mean log10 reduction factor (LRF)."
},
{
"NDCCode": "44206-452-02",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (44206-452-02) / 10 mL in 1 VIAL, SINGLE-DOSE (44206-452-91) ",
"NDC11Code": "44206-0452-02",
"ProductNDC": "44206-452",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Hizentra",
"NonProprietaryName": "Human Immunoglobulin G",
"DosageFormName": "LIQUID",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20111003",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125350",
"LabelerName": "CSL Behring AG",
"SubstanceName": "HUMAN IMMUNOGLOBULIN G",
"StrengthNumber": ".2",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
"Status": "Active",
"LastUpdate": "2023-05-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20111003",
"SamplePackage": "N",
"IndicationAndUsage": "HIZENTRA is an Immune Globulin Subcutaneous (Human) (IGSC), 20% Liquid indicated for the treatment of the following conditions.",
"Description": "HIZENTRA, Immune Globulin Subcutaneous (Human), 20% Liquid, is a ready-to-use, sterile 20% (0.2 g/mL) protein liquid preparation of polyvalent human immunoglobulin G (IgG) for subcutaneous administration. HIZENTRA is manufactured from large pools of human plasma by a combination of cold alcohol fractionation, octanoic acid fractionation, and anion exchange chromatography. The IgG proteins are not subjected to heating or to chemical or enzymatic modification. The Fc and Fab functions of the IgG molecule are retained. Fab functions tested include antigen binding capacities, and Fc functions tested include complement activation and Fc-receptor-mediated leukocyte activation (determined with complexed IgG). The IgG subclass distribution is similar to that of normal human plasma. HIZENTRA has a purity of ≥98% IgG and a pH of 4.6 to 5.2. This product contains approximately 250 mmol/L (range: 210 to 290 mmol/L) L-proline (a nonessential amino acid) as a stabilizer, 8 to 30 mg/L polysorbate 80, and trace amounts of sodium. HIZENTRA contains ≤50 mcg/mL IgA, no carbohydrate stabilizers (e.g., sucrose, maltose) and no preservative. Plasma units used in the manufacture of HIZENTRA are tested using FDA-licensed serological assays for hepatitis B surface antigen and antibodies to human immunodeficiency virus (HIV)-1/2 and hepatitis C virus (HCV) as well as FDA-licensed Nucleic Acid Testing (NAT) for HBV, HCV and HIV-1. All plasma units have been found to be nonreactive (negative) in these tests. In addition, the plasma has been tested for B19 virus (B19V) DNA by NAT. Only plasma that passes virus screening is used for production, and the limit for B19V in the fractionation pool is set not to exceed 104 IU of B19V DNA per mL. The manufacturing process for HIZENTRA includes three steps to reduce the risk of virus transmission. Two of these are dedicated virus clearance steps: pH 4 incubation to inactivate enveloped viruses, and virus filtration to remove, by size exclusion, both enveloped and non-enveloped viruses as small as approximately 20 nanometers. In addition, a depth filtration step contributes to the virus reduction capacity.12. These steps have been independently validated in a series of in vitro experiments for their capacity to inactivate and/or remove both enveloped and non-enveloped viruses. Table 6 shows the virus clearance during the manufacturing process for HIZENTRA, expressed as the mean log10 reduction factor (LRF)."
},
{
"NDCCode": "44206-455-10",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (44206-455-10) / 50 mL in 1 VIAL, SINGLE-DOSE (44206-455-93) ",
"NDC11Code": "44206-0455-10",
"ProductNDC": "44206-455",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Hizentra",
"NonProprietaryName": "Human Immunoglobulin G",
"DosageFormName": "LIQUID",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20111003",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125350",
"LabelerName": "CSL Behring AG",
"SubstanceName": "HUMAN IMMUNOGLOBULIN G",
"StrengthNumber": ".2",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
"Status": "Active",
"LastUpdate": "2023-05-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20111003",
"SamplePackage": "N",
"IndicationAndUsage": "HIZENTRA is an Immune Globulin Subcutaneous (Human) (IGSC), 20% Liquid indicated for the treatment of the following conditions.",
"Description": "HIZENTRA, Immune Globulin Subcutaneous (Human), 20% Liquid, is a ready-to-use, sterile 20% (0.2 g/mL) protein liquid preparation of polyvalent human immunoglobulin G (IgG) for subcutaneous administration. HIZENTRA is manufactured from large pools of human plasma by a combination of cold alcohol fractionation, octanoic acid fractionation, and anion exchange chromatography. The IgG proteins are not subjected to heating or to chemical or enzymatic modification. The Fc and Fab functions of the IgG molecule are retained. Fab functions tested include antigen binding capacities, and Fc functions tested include complement activation and Fc-receptor-mediated leukocyte activation (determined with complexed IgG). The IgG subclass distribution is similar to that of normal human plasma. HIZENTRA has a purity of ≥98% IgG and a pH of 4.6 to 5.2. This product contains approximately 250 mmol/L (range: 210 to 290 mmol/L) L-proline (a nonessential amino acid) as a stabilizer, 8 to 30 mg/L polysorbate 80, and trace amounts of sodium. HIZENTRA contains ≤50 mcg/mL IgA, no carbohydrate stabilizers (e.g., sucrose, maltose) and no preservative. Plasma units used in the manufacture of HIZENTRA are tested using FDA-licensed serological assays for hepatitis B surface antigen and antibodies to human immunodeficiency virus (HIV)-1/2 and hepatitis C virus (HCV) as well as FDA-licensed Nucleic Acid Testing (NAT) for HBV, HCV and HIV-1. All plasma units have been found to be nonreactive (negative) in these tests. In addition, the plasma has been tested for B19 virus (B19V) DNA by NAT. Only plasma that passes virus screening is used for production, and the limit for B19V in the fractionation pool is set not to exceed 104 IU of B19V DNA per mL. The manufacturing process for HIZENTRA includes three steps to reduce the risk of virus transmission. Two of these are dedicated virus clearance steps: pH 4 incubation to inactivate enveloped viruses, and virus filtration to remove, by size exclusion, both enveloped and non-enveloped viruses as small as approximately 20 nanometers. In addition, a depth filtration step contributes to the virus reduction capacity.12. These steps have been independently validated in a series of in vitro experiments for their capacity to inactivate and/or remove both enveloped and non-enveloped viruses. Table 6 shows the virus clearance during the manufacturing process for HIZENTRA, expressed as the mean log10 reduction factor (LRF)."
},
{
"NDCCode": "44206-457-22",
"PackageDescription": "1 SYRINGE in 1 CARTON (44206-457-22) / 10 mL in 1 SYRINGE (44206-457-95) ",
"NDC11Code": "44206-0457-22",
"ProductNDC": "44206-457",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Hizentra",
"NonProprietaryName": "Human Immunoglobulin G",
"DosageFormName": "LIQUID",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20200101",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125350",
"LabelerName": "CSL Behring AG",
"SubstanceName": "HUMAN IMMUNOGLOBULIN G",
"StrengthNumber": ".2",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
"Status": "Active",
"LastUpdate": "2023-05-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200101",
"SamplePackage": "N",
"IndicationAndUsage": "HIZENTRA is an Immune Globulin Subcutaneous (Human) (IGSC), 20% Liquid indicated for the treatment of the following conditions.",
"Description": "HIZENTRA, Immune Globulin Subcutaneous (Human), 20% Liquid, is a ready-to-use, sterile 20% (0.2 g/mL) protein liquid preparation of polyvalent human immunoglobulin G (IgG) for subcutaneous administration. HIZENTRA is manufactured from large pools of human plasma by a combination of cold alcohol fractionation, octanoic acid fractionation, and anion exchange chromatography. The IgG proteins are not subjected to heating or to chemical or enzymatic modification. The Fc and Fab functions of the IgG molecule are retained. Fab functions tested include antigen binding capacities, and Fc functions tested include complement activation and Fc-receptor-mediated leukocyte activation (determined with complexed IgG). The IgG subclass distribution is similar to that of normal human plasma. HIZENTRA has a purity of ≥98% IgG and a pH of 4.6 to 5.2. This product contains approximately 250 mmol/L (range: 210 to 290 mmol/L) L-proline (a nonessential amino acid) as a stabilizer, 8 to 30 mg/L polysorbate 80, and trace amounts of sodium. HIZENTRA contains ≤50 mcg/mL IgA, no carbohydrate stabilizers (e.g., sucrose, maltose) and no preservative. Plasma units used in the manufacture of HIZENTRA are tested using FDA-licensed serological assays for hepatitis B surface antigen and antibodies to human immunodeficiency virus (HIV)-1/2 and hepatitis C virus (HCV) as well as FDA-licensed Nucleic Acid Testing (NAT) for HBV, HCV and HIV-1. All plasma units have been found to be nonreactive (negative) in these tests. In addition, the plasma has been tested for B19 virus (B19V) DNA by NAT. Only plasma that passes virus screening is used for production, and the limit for B19V in the fractionation pool is set not to exceed 104 IU of B19V DNA per mL. The manufacturing process for HIZENTRA includes three steps to reduce the risk of virus transmission. Two of these are dedicated virus clearance steps: pH 4 incubation to inactivate enveloped viruses, and virus filtration to remove, by size exclusion, both enveloped and non-enveloped viruses as small as approximately 20 nanometers. In addition, a depth filtration step contributes to the virus reduction capacity.12. These steps have been independently validated in a series of in vitro experiments for their capacity to inactivate and/or remove both enveloped and non-enveloped viruses. Table 6 shows the virus clearance during the manufacturing process for HIZENTRA, expressed as the mean log10 reduction factor (LRF)."
},
{
"NDCCode": "44206-457-95",
"PackageDescription": "1 SYRINGE in 1 CARTON (44206-457-95) > 10 mL in 1 SYRINGE (44206-457-22) ",
"NDC11Code": "44206-0457-95",
"ProductNDC": "44206-457",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Hizentra",
"NonProprietaryName": "Human Immunoglobulin G",
"DosageFormName": "LIQUID",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20200101",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125350",
"LabelerName": "CSL Behring AG",
"SubstanceName": "HUMAN IMMUNOGLOBULIN G",
"StrengthNumber": ".2",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20200101",
"SamplePackage": "N"
},
{
"NDCCode": "44206-251-05",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (44206-251-05) > 50 mL in 1 VIAL, GLASS (44206-251-90) ",
"NDC11Code": "44206-0251-05",
"ProductNDC": "44206-251",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Alburx",
"NonProprietaryName": "Albumin (human)",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20090106",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102366",
"LabelerName": "CSL Behring AG",
"SubstanceName": "ALBUMIN HUMAN",
"StrengthNumber": "12.5",
"StrengthUnit": "g/50mL",
"Pharm_Classes": "Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]",
"Status": "Active",
"LastUpdate": "2022-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090106",
"SamplePackage": "N",
"Description": "ALBURX® 25, Albumin (Human) 25% solution is a sterile aqueous solution for intravenous administration containing the albumin component of human blood. The solution is clear and slightly viscous; it is almost colorless, or yellow, amber, or green. This product is prepared from the plasma of US donors. The product has been produced by alcohol fractionation and has been heated for 10 hours at 60°C for inactivation of infectious agents. The results of virus validation studies have shown that the manufacturing process, particularly alcohol fractionation, eliminates enveloped and non-enveloped viruses. Additionally, heat treatment at 60°C for a period of 10 hours efficiently inactivates viruses. The solution contains 0.14 M (3.2 mg/mL) sodium. The aluminum content is ≤ 200 mcg/L and the potassium content is ≤ 0.002 M. The solution is stabilized with 0.02 M sodium N-acetyltryptophanate and 0.02 M sodium caprylate. The solution contains no preservative."
},
{
"NDCCode": "44206-310-25",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (44206-310-25) / 250 mL in 1 VIAL, GLASS (44206-310-90) ",
"NDC11Code": "44206-0310-25",
"ProductNDC": "44206-310",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Alburx",
"NonProprietaryName": "Albumin (human)",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20090106",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102366",
"LabelerName": "CSL Behring AG",
"SubstanceName": "ALBUMIN HUMAN",
"StrengthNumber": "12.5",
"StrengthUnit": "g/250mL",
"Pharm_Classes": "Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]",
"Status": "Active",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090106",
"SamplePackage": "N",
"IndicationAndUsage": "The definitive treatment of major hemorrhage is the transfusion of red blood cells restoring a normal oxygen transport capacity of the blood. Since, however, the life-threatening event in major hemorrhage is the loss of blood volume and not the erythrocyte deficit, the blood volume can, as an emergency measure, be supported by ALBURX® 5, Albumin (Human) 5% solution or another rapidly acting plasma substitute if blood is not immediately available. This will restore cardiac output and abolish circulatory failure with tissue anoxia. Though a four- to fivefold volume of crystalloids may be equally effective, their administration takes more time and creates a general overload with sodium and water. In the presence of dehydration, electrolyte solutions such as Ringer's lactate should be administered in conjunction with albumin.",
"Description": "ALBURX® 5, Albumin (Human) 5% solution is a sterile aqueous solution for intravenous administration containing the albumin component of human blood. The solution is clear and slightly viscous; it is almost colorless, or yellow, amber, or green. This product is prepared from the plasma of US donors. The product has been produced by alcohol fractionation and has been heated for 10 hours at 60°C for inactivation of infectious agents. The results of virus validation studies have shown that the manufacturing process, particularly alcohol fractionation, eliminates enveloped and non-enveloped viruses. Additionally, heat treatment at 60°C for a period of 10 hours efficiently inactivates viruses. The solution contains 0.14 M (3.2 mg/mL) sodium. The aluminum content is ≤ 200 mcg/L and the potassium content is ≤ 0.002 M. The solution is stabilized with 0.004 M sodium N-acetyltryptophanate and 0.004 M sodium caprylate. The solution contains no preservative."
},
{
"NDCCode": "44206-310-50",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (44206-310-50) / 500 mL in 1 VIAL, GLASS (44206-310-91) ",
"NDC11Code": "44206-0310-50",
"ProductNDC": "44206-310",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Alburx",
"NonProprietaryName": "Albumin (human)",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20090106",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102366",
"LabelerName": "CSL Behring AG",
"SubstanceName": "ALBUMIN HUMAN",
"StrengthNumber": "12.5",
"StrengthUnit": "g/250mL",
"Pharm_Classes": "Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]",
"Status": "Active",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090106",
"SamplePackage": "N",
"IndicationAndUsage": "The definitive treatment of major hemorrhage is the transfusion of red blood cells restoring a normal oxygen transport capacity of the blood. Since, however, the life-threatening event in major hemorrhage is the loss of blood volume and not the erythrocyte deficit, the blood volume can, as an emergency measure, be supported by ALBURX® 5, Albumin (Human) 5% solution or another rapidly acting plasma substitute if blood is not immediately available. This will restore cardiac output and abolish circulatory failure with tissue anoxia. Though a four- to fivefold volume of crystalloids may be equally effective, their administration takes more time and creates a general overload with sodium and water. In the presence of dehydration, electrolyte solutions such as Ringer's lactate should be administered in conjunction with albumin.",
"Description": "ALBURX® 5, Albumin (Human) 5% solution is a sterile aqueous solution for intravenous administration containing the albumin component of human blood. The solution is clear and slightly viscous; it is almost colorless, or yellow, amber, or green. This product is prepared from the plasma of US donors. The product has been produced by alcohol fractionation and has been heated for 10 hours at 60°C for inactivation of infectious agents. The results of virus validation studies have shown that the manufacturing process, particularly alcohol fractionation, eliminates enveloped and non-enveloped viruses. Additionally, heat treatment at 60°C for a period of 10 hours efficiently inactivates viruses. The solution contains 0.14 M (3.2 mg/mL) sodium. The aluminum content is ≤ 200 mcg/L and the potassium content is ≤ 0.002 M. The solution is stabilized with 0.004 M sodium N-acetyltryptophanate and 0.004 M sodium caprylate. The solution contains no preservative."
},
{
"NDCCode": "44206-532-11",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (44206-532-11) / 50 mL in 1 VIAL, GLASS (44206-532-90) ",
"NDC11Code": "44206-0532-11",
"ProductNDC": "44206-532",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Cytogam",
"NonProprietaryName": "Human Cytomegalovirus Immune Globulin",
"DosageFormName": "LIQUID",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20090106",
"EndMarketingDate": "20240110",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103189",
"LabelerName": "CSL Behring AG",
"SubstanceName": "HUMAN CYTOMEGALOVIRUS IMMUNE GLOBULIN",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE], Virus Neutralization [MoA], Virus-specific Hyperimmune Globulins [EXT]",
"Status": "Deprecated",
"LastUpdate": "2024-01-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20090106",
"EndMarketingDatePackage": "20240110",
"SamplePackage": "N",
"IndicationAndUsage": "Cytomegalovirus Immune Globulin Intravenous (Human) is indicated for the prophylaxis of cytomegalovirus disease associated with transplantation of kidney, lung, liver, pancreas and heart. In transplants of these organs other than kidney from CMV seropositive donors into seronegative recipients, prophylactic CMV-IGIV should be considered in combination with ganciclovir.",
"Description": "CYTOGAM, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV), is an immunoglobulin G (IgG) containing a standardized amount of antibody to Cytomegalovirus (CMV). CMV-IGIV is formulated in final vial as a sterile liquid. The globulin is stabilized with 5% sucrose and 1% Albumin (Human). CYTOGAM contains no preservative. The purified immunoglobulin is derived from pooled adult human plasma selected for high titers of antibody for Cytomegalovirus (CMV).1 Source material for fractionation may be obtained from another U.S. licensed manufacturer. Pooled plasma was fractionated by ethanol precipitation of the proteins according to Cohn Methods 6 and 9, modified to yield a product suitable for intravenous administration. A widely utilized solvent-detergent viral inactivation process is also used.2 Certain manufacturing operations may be performed by other firms. Each milliliter contains: 50 ± 10 mg of immunoglobulin, primarily IgG, and trace amounts of IgA and IgM; 50 mg of sucrose; 10 mg of Albumin (Human). The sodium content is 20-30 mEq per liter, i.e., 0.4-0.6 mEq per 20 mL or 1.0-1.5 mEq per 50 mL. The solution should appear colorless and translucent."
},
{
"NDCCode": "0009-4992-02",
"PackageDescription": "10 BAG in 1 BOX (0009-4992-02) / 300 mL in 1 BAG (0009-4992-01) ",
"NDC11Code": "00009-4992-02",
"ProductNDC": "0009-4992",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zyvox",
"NonProprietaryName": "Linezolid",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20150706",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021131",
"LabelerName": "Pharmacia & Upjohn Company LLC",
"SubstanceName": "LINEZOLID",
"StrengthNumber": "600",
"StrengthUnit": "mg/300mL",
"Pharm_Classes": "Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150706",
"SamplePackage": "N"
},
{
"NDCCode": "0009-5140-04",
"PackageDescription": "10 BAG in 1 BOX (0009-5140-04) / 300 mL in 1 BAG (0009-5140-01) ",
"NDC11Code": "00009-5140-04",
"ProductNDC": "0009-5140",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zyvox",
"NonProprietaryName": "Linezolid",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20000418",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021131",
"LabelerName": "Pharmacia & Upjohn Company LLC",
"SubstanceName": "LINEZOLID",
"StrengthNumber": "600",
"StrengthUnit": "mg/300mL",
"Pharm_Classes": "Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20000418",
"SamplePackage": "N",
"IndicationAndUsage": "ZYVOX is an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia (1.1); Community-acquired pneumonia (1.2); Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis (1.3); Uncomplicated skin and skin structure infections (1.4); Vancomycin-resistant Enterococcus faecium infections. (1.5). Limitations of Use (1.6): 1 ZYVOX is not indicated for the treatment of Gram-negative infections., 2 The safety and efficacy of ZYVOX formulations given for longer than 28 days have not been evaluated in controlled clinical trials.",
"Description": "ZYVOX I.V. Injection, ZYVOX Tablets, and ZYVOX for Oral Suspension contain linezolid, which is a synthetic antibacterial agent of the oxazolidinone class. The chemical name for linezolid is (S)-N-[[3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl] methyl]-acetamide. The empirical formula is C16H20FN3O4. Its molecular weight is 337.35, and its chemical structure is represented below. ZYVOX I.V. Injection is supplied as a ready-to-use sterile isotonic solution for intravenous infusion. Each mL contains 2 mg of linezolid. Inactive ingredients are dextrose monohydrate 50.24 mg/mL in an aqueous vehicle for intravenous administration, sodium citrate dihydrate 1.64 mg/mL, and citric acid anhydrous 0.85 mg/mL. Sodium hydroxide NF and/or hydrochloric acid NF are used to adjust the pH. The sodium (Na+) content is 0.38 mg/mL (5 mEq/300 mL bag and 1.7 mEq/100 mL bag). ZYVOX Tablet for oral administration contains 600 mg linezolid as a film-coated compressed tablet. Inactive ingredients are carnauba wax, corn starch, hydroxypropylcellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. The sodium (Na+) content is 2.92 mg per 600 mg tablet (0.1 mEq/tablet). ZYVOX for Oral Suspension is supplied as an orange-flavored granule/powder for constitution into a suspension for oral administration. Following constitution, each 5 mL contains 100 mg of linezolid. Inactive ingredients are aspartame, citric acid, colloidal silicon dioxide, flavors, mannitol, microcrystalline cellulose and carboxymethylcellulose sodium, sodium benzoate, sodium chloride, sodium citrate, sucrose, and xanthan gum [see Patient Counseling Information (17)]. The sodium (Na+) content is 8.52 mg/5 mL (0.4 mEq/5 mL)."
},
{
"NDCCode": "0009-7807-02",
"PackageDescription": "10 BAG in 1 BOX (0009-7807-02) / 300 mL in 1 BAG (0009-7807-01) ",
"NDC11Code": "00009-7807-02",
"ProductNDC": "0009-7807",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zyvox",
"NonProprietaryName": "Linezolid",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20150218",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021131",
"LabelerName": "Pharmacia & Upjohn Company LLC",
"SubstanceName": "LINEZOLID",
"StrengthNumber": "600",
"StrengthUnit": "mg/300mL",
"Pharm_Classes": "Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]",
"Status": "Active",
"LastUpdate": "2026-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150218",
"SamplePackage": "N",
"IndicationAndUsage": "ZYVOX is an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia (1.1); Community-acquired pneumonia (1.2); Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis (1.3); Uncomplicated skin and skin structure infections (1.4); Vancomycin-resistant Enterococcus faecium infections. (1.5)Limitations of Use (1.6): 1 ZYVOX is not indicated for the treatment of Gram-negative infections., 2 The safety and efficacy of ZYVOX formulations given for longer than 28 days have not been evaluated in controlled clinical trials.",
"Description": "ZYVOX I.V. Injection contains linezolid, which is a synthetic antibacterial agent of the oxazolidinone class. The chemical name for linezolid is (S)-N-[[3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl] methyl]-acetamide. The empirical formula is C16H20FN3O4. Its molecular weight is 337.35, and its chemical structure is represented below. ZYVOX I.V. Injection is supplied as a ready-to-use sterile isotonic solution for intravenous infusion. Each mL contains 2 mg of linezolid. Inactive ingredients are dextrose monohydrate 50.24 mg/mL in an aqueous vehicle for intravenous administration, sodium citrate dihydrate 1.64 mg/mL, and citric acid anhydrous 0.85 mg/mL. Sodium hydroxide NF and/or hydrochloric acid NF are used to adjust the pH. The sodium (Na+) content is 0.38 mg/mL (5 mEq/300 mL bag)."
},
{
"NDCCode": "0121-1074-10",
"PackageDescription": "1 BOTTLE in 1 CARTON (0121-1074-10) / 300 mL in 1 BOTTLE",
"NDC11Code": "00121-1074-10",
"ProductNDC": "0121-1074",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Brivaracetam",
"NonProprietaryName": "Brivaracetam",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20260223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218494",
"LabelerName": "PAI Holdings, LLC dba PAI Pharma",
"SubstanceName": "BRIVARACETAM",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Epoxide Hydrolase Inhibitors [MoA]",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260223",
"SamplePackage": "N",
"IndicationAndUsage": "Brivaracetam oral solution is indicated for the treatment of partial-onset seizures in patients 1 month of age and older.",
"Description": "The chemical name of brivaracetam is (2S)-2-[(4R)-2-oxo-4-propyltetrahydro-1 H-pyrrol-1-yl] butanamide. Its molecular formula is C 11H 20N 2O 2and its molecular weight is 212.29. The chemical structure is. Brivaracetam is a white to off-white crystalline powder. It is very soluble in water, buffer (pH 1.2, 4.5, and 7.4), ethanol, methanol, and glacial acetic acid. It is freely soluble in acetonitrile and acetone and soluble in toluene. It is very slightly soluble in n-hexane. Oral Solution. Brivaracetam oral solution contains 10 mg of brivaracetam per mL. The inactive ingredients are sodium citrate, anhydrous citric acid, methylparaben, sodium carboxymethylcellulose, sucralose, sorbitol solution, glycerin, raspberry flavor, and purified water."
},
{
"NDCCode": "0121-1101-02",
"PackageDescription": "10 VIAL, SINGLE-USE in 1 CARTON (0121-1101-02) / 300 mg in 1 VIAL, SINGLE-USE (0121-1101-55) ",
"NDC11Code": "00121-1101-02",
"ProductNDC": "0121-1101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pentamidine Isethionate",
"NonProprietaryName": "Pentamidine Isethionate",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20260612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206666",
"LabelerName": "PAI Holdings, LLC dba PAI Pharma",
"SubstanceName": "PENTAMIDINE DIISETHIONATE",
"StrengthNumber": "300",
"StrengthUnit": "mg/300mg",
"Pharm_Classes": "Antiprotozoal [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260612",
"SamplePackage": "N",
"IndicationAndUsage": "Pentamidine isethionate for injection is indicated for the treatment of pneumonia due to Pneumocystis carinii.",
"Description": "Pentamidine isethionate for injection, an anti-protozoal agent, is a sterile, nonpyrogenic, lyophilized product. After reconstitution, it should be administered by intramuscular (IM) or intravenous (IV) routes (see DOSAGE AND ADMINISTRATION). Pentamidine isethionate is a white crystalline powder soluble in water and glycerin, slightly soluble in alcohol and insoluble in ether, acetone, and chloroform. It is chemically designated as 4,4-[1,5-pentanediylbis(oxy)]bis-benzenecarboximidamid with the following structural formula. Each vial contains:Pentamidine isethionate . . . . . . . . . . . . . 300 mg."
},
{
"NDCCode": "0143-9365-10",
"PackageDescription": "10 BAG in 1 BOX (0143-9365-10) / 300 mL in 1 BAG (0143-9365-01) ",
"NDC11Code": "00143-9365-10",
"ProductNDC": "0143-9365",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Labetalol Hcl In Sodium Chloride",
"NonProprietaryName": "Labetalol Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20201109",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213330",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "LABETALOL HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201109",
"SamplePackage": "N",
"IndicationAndUsage": "Labetalol HCl Injection is indicated in severe hypertension, to lower blood pressure.",
"Description": "Labetalol HCl in Sodium Chloride Injection, Labetalol HCl in Dextrose Injection and Labetalol Hydrochloride Injection, USP contain labetalol HCl an adrenergic receptor blocking agent that has both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions. Labetalol hydrochloride (HCl) is a racemate chemically designated as 5-[1-Hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]-salicylamide monohydrochloride and it has the following structural formula. Labetalol HCl is a white or off-white crystalline powder, soluble in water. Labetalol HCl has the molecular formula C19H24N2O3HCl and a molecular weight of 364.87. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Labetalol HCl in Sodium Chloride Injection and Labetalol HCl in Dextrose Injection are two preservative-free, ready- to use formulations of labetalol. Labetalol HCl in Sodium Chloride Injection and Labetalol HCl in Dextrose Injection are clear, colorless to pale yellow, aqueous, sterile, isotonic solution for intravenous injection. Each milliliter of Labetalol HCl in Sodium Chloride Injection contains 1 mg of labetalol HCl, 7.2 mg sodium chloride, 9 mg of anhydrous dextrose, 0.02 mg of edetate disodium; and citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range of 3.5 to 4.5. Each milliliter of Labetalol HCl in Dextrose Injection contains 1 mg of labetalol HCl, 45 mg of anhydrous dextrose, 0.02 mg of edetate disodium; and citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range of 3.5 to 4.5. Labetalol Hydrochloride Injection prefilled syringe and vial are two preservative-free, ready-to use formulations of labetalol. Labetalol Hydrochloride Injection is a clear, colorless to pale yellow, aqueous, sterile, isotonic solution for intravenous injection. Each milliliter of Labetalol Hydrochloride Injection, USP, contains 5 mg of labetalol HCI, 45 mg of anhydrous dextrose, 0.1 mg of edetate disodium, and citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range of 3.0 to 4.5."
},
{
"NDCCode": "0143-9534-10",
"PackageDescription": "10 POUCH in 1 BOX (0143-9534-10) / 1 BAG in 1 POUCH / 300 mL in 1 BAG",
"NDC11Code": "00143-9534-10",
"ProductNDC": "0143-9534",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Linezolid",
"NonProprietaryName": "Linezolid",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20221227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206454",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "LINEZOLID",
"StrengthNumber": "600",
"StrengthUnit": "mg/300mL",
"Pharm_Classes": "Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]",
"Status": "Active",
"LastUpdate": "2025-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221227",
"SamplePackage": "N",
"Description": "Linezolid Injection contains linezolid, which is a synthetic antibacterial agent of the oxazolidinone class. The chemical name for linezolid is (S)-N-[[3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl] methyl]-acetamide. The empirical formula is C16H20FN3O4. Its molecular weight is 337.35, and its chemical structure is represented below. Linezolid Injection is supplied as a ready-to-use sterile isotonic solution for intravenous infusion. Each mL contains 2 mg of linezolid. Inactive ingredients are dextrose monohydrate 50.24 mg/mL in an aqueous vehicle for intravenous administration, sodium citrate dihydrate 1.64 mg/mL, and citric acid anhydrous 0.85mg/mL. Sodium hydroxide NF and/or hydrochloric acid NF are used to adjust the pH. The sodium (Na+) content is 0.38 mg/mL (5 mEq/300 mL bag)."
},
{
"NDCCode": "0270-0149-57",
"PackageDescription": "10 BOTTLE in 1 PACKAGE (0270-0149-57) / 300 mL in 1 BOTTLE",
"NDC11Code": "00270-0149-57",
"ProductNDC": "0270-0149",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cystografin",
"NonProprietaryName": "Diatrizoate Meglumine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19701103",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA010040",
"LabelerName": "BRACCO DIAGNOSTICS INC",
"SubstanceName": "DIATRIZOATE MEGLUMINE",
"StrengthNumber": "300",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19701103",
"SamplePackage": "N",
"IndicationAndUsage": "Cystografin is indicated for retrograde cystourethrography.",
"Description": "Cystografin is a radiopaque contrast agent supplied as a sterile, clear, colorless to pale yellow, mobile or slightly viscous solution. Each mL provides 300 mg diatrizoate meglumine with 0.4 mg edetate disodium as a sequestering agent. Each mL of solution also contains approximately 141 mg organically bound iodine. At the time of manufacture, the air in the container is replaced by nitrogen. The preparation should be protected from strong light."
},
{
"NDCCode": "0270-1410-30",
"PackageDescription": "10 BOTTLE in 1 PACKAGE (0270-1410-30) / 300 mL in 1 BOTTLE",
"NDC11Code": "00270-1410-30",
"ProductNDC": "0270-1410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cystografin Dilute",
"NonProprietaryName": "Diatrizoate Meglumine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVESICAL",
"StartMarketingDate": "19821109",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA010040",
"LabelerName": "BRACCO DIAGNOSTICS INC",
"SubstanceName": "DIATRIZOATE MEGLUMINE",
"StrengthNumber": "180",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19821109",
"SamplePackage": "N",
"IndicationAndUsage": "Cystografin Dilute is indicated for retrograde cystourethrography.",
"Description": "Cystografin Dilute (Diatrizoate Meglumine Injection USP 18%) is a radiopaque contrast agent supplied as a sterile, aqueous solution. Each mL provides 180 mg diatrizoate meglumine with 0.4 mg edetate disodium as a sequestering agent. Each mL of solution also contains approximately 85 mg organically bound iodine. At the time of manufacture, the air in the container is replaced by nitrogen."
},
{
"NDCCode": "0409-4882-01",
"PackageDescription": "10 POUCH in 1 CASE (0409-4882-01) > 1 BAG in 1 POUCH > 300 mL in 1 BAG",
"NDC11Code": "00409-4882-01",
"ProductNDC": "0409-4882",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Linezolid",
"NonProprietaryName": "Linezolid",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20150707",
"EndMarketingDate": "20180701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205442",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "LINEZOLID",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "0409-4883-01",
"PackageDescription": "10 POUCH in 1 CASE (0409-4883-01) / 1 BAG in 1 POUCH / 300 mL in 1 BAG (0409-4883-11) ",
"NDC11Code": "00409-4883-01",
"ProductNDC": "0409-4883",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Linezolid",
"NonProprietaryName": "Linezolid",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20150618",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206473",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "LINEZOLID",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150618",
"SamplePackage": "N",
"IndicationAndUsage": "Linezolid injection is an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia (1.1); Community-acquired pneumonia (1.2); Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis (1.3); Vancomycin-resistant Enterococcus faecium infections. (1.4) Limitations of Use: (1.5): 1 Linezolid injection is not indicated for the treatment of Gram-negative infections., 2 The safety and efficacy of Linezolid formulations given for longer than 28 days have not been evaluated in controlled clinical trials.",
"Description": "Linezolid injection contains linezolid, which is a synthetic antibacterial agent of the oxazolidinone class. The chemical name for linezolid is (S)-N-[[3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl] methyl]-acetamide. The empirical formula is C16H20FN3O4. Its molecular weight is 337.35, and its chemical structure is represented below:. Linezolid injection is supplied as a ready-to-use sterile isotonic solution for intravenous infusion. Each container contains 600 mg of linezolid in 300 mL of a clear, colorless to slightly yellow aqueous solution. Inactive ingredients include: citric acid anhydrous USP 1.92 mg/mL, sodium chloride USP 9 mg/mL, sodium hydroxide NF 0.76 mg/mL, and water for injection USP. Sodium hydroxide NF and/or hydrochloric acid NF are used to adjust the pH. The sodium (Na+) content is 3.98 mg/mL (52 mEq/300 mL container)."
},
{
"NDCCode": "0409-4883-10",
"PackageDescription": "10 POUCH in 1 CASE (0409-4883-10) / 1 BAG in 1 POUCH / 300 mL in 1 BAG (0409-4883-03) ",
"NDC11Code": "00409-4883-10",
"ProductNDC": "0409-4883",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Linezolid",
"NonProprietaryName": "Linezolid",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20150618",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206473",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "LINEZOLID",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230619",
"SamplePackage": "N",
"IndicationAndUsage": "Linezolid injection is an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia (1.1); Community-acquired pneumonia (1.2); Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis (1.3); Vancomycin-resistant Enterococcus faecium infections. (1.4) Limitations of Use: (1.5): 1 Linezolid injection is not indicated for the treatment of Gram-negative infections., 2 The safety and efficacy of Linezolid formulations given for longer than 28 days have not been evaluated in controlled clinical trials.",
"Description": "Linezolid injection contains linezolid, which is a synthetic antibacterial agent of the oxazolidinone class. The chemical name for linezolid is (S)-N-[[3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl] methyl]-acetamide. The empirical formula is C16H20FN3O4. Its molecular weight is 337.35, and its chemical structure is represented below:. Linezolid injection is supplied as a ready-to-use sterile isotonic solution for intravenous infusion. Each container contains 600 mg of linezolid in 300 mL of a clear, colorless to slightly yellow aqueous solution. Inactive ingredients include: citric acid anhydrous USP 1.92 mg/mL, sodium chloride USP 9 mg/mL, sodium hydroxide NF 0.76 mg/mL, and water for injection USP. Sodium hydroxide NF and/or hydrochloric acid NF are used to adjust the pH. The sodium (Na+) content is 3.98 mg/mL (52 mEq/300 mL container)."
},
{
"NDCCode": "0703-9060-33",
"PackageDescription": "10 BAG in 1 CARTON (0703-9060-33) > 300 mL in 1 BAG (0703-9060-31) ",
"NDC11Code": "00703-9060-33",
"ProductNDC": "0703-9060",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Linezolid",
"NonProprietaryName": "Linezolid",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20150105",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200222",
"LabelerName": "Teva Parenteral Medicines, Inc.",
"SubstanceName": "LINEZOLID",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-11-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20150105",
"SamplePackage": "N"
},
{
"NDCCode": "0781-3433-95",
"PackageDescription": "10 BAG in 1 CARTON (0781-3433-95) / 300 mL in 1 BAG (0781-3433-46) ",
"NDC11Code": "00781-3433-95",
"ProductNDC": "0781-3433",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Linezolid",
"NonProprietaryName": "Linezolid",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20160615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200904",
"LabelerName": "Sandoz Inc",
"SubstanceName": "LINEZOLID",
"StrengthNumber": "600",
"StrengthUnit": "mg/300mL",
"Pharm_Classes": "Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]",
"Status": "Active",
"LastUpdate": "2026-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160615",
"SamplePackage": "N",
"IndicationAndUsage": "Linezolid injection is an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia (1.1); Community-acquired pneumonia (1.2); Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis (1.3); Vancomycin-resistant Enterococcus faecium infections. (1.5). Limitations of Use (1.6): 1 Linezolid is not indicated for the treatment of Gram-negative infections., 2 The safety and efficacy of Linezolid formulations given for longer than 28 days have not been evaluated in controlled clinical trials.",
"Description": "Linezolid intravenous injection contains linezolid, which is a synthetic antibacterial agent of the oxazolidinone class. The chemical name for linezolid is (S)-N-[[3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl] methyl]-acetamide. The molecular formula is C16H20FN3O4. Its molecular weight is 337.35, and its chemical structure is represented below. Linezolid intravenous injection is supplied as a ready-to-use sterile isotonic solution for intravenous infusion. Each mL contains 2 mg of linezolid. Inactive ingredients are citric acid anhydrous, dextrose in an aqueous vehicle for intravenous administration, and sodium citrate. The sodium (Na+) content is 0.38 mg/mL (5 mEq/300-mL bag and 1.7 mEq/100-mL bag). The pH has been adjusted with sodium hydroxide and/or hydrochloric acid."
},
{
"NDCCode": "13811-300-10",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (13811-300-10) ",
"NDC11Code": "13811-0300-10",
"ProductNDC": "13811-300",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenobarbital",
"NonProprietaryName": "Phenobarbital",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250401",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Trigen Laboratories, LLC",
"SubstanceName": "PHENOBARBITAL",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250401",
"SamplePackage": "N",
"IndicationAndUsage": "Phenobarbital Tablets, USP are indicated for use as a sedative or anticonvulsant.",
"Description": "Phenobarbital is a barbituric acid derivative for oral administration and occurs as a white, odorless, slightly bitter powder that is soluble in chloroform, freely soluble in alcohol or ether, and slightly soluble in water. Its saturated solution has a pH of about 5.6. Chemically, it is 5- ethyl-5-phenylbarbituric acid with the molecular formula C12H12N2O3 (232.24). The structural formula is as follows. Each Phenobarbital Tablet, USP contains 15 mg, 30 mg, 60 mg or 100 mg of phenobarbital, USP. Inactive ingredients include: colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and stearic acid."
},
{
"NDCCode": "13925-515-10",
"PackageDescription": "10 VIAL in 1 TRAY (13925-515-10) / 300 mg in 1 VIAL",
"NDC11Code": "13925-0515-10",
"ProductNDC": "13925-515",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pentamidine Isethionate",
"NonProprietaryName": "Pentamidine Isethionate",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20180401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206666",
"LabelerName": "Seton Pharmaceuticals",
"SubstanceName": "PENTAMIDINE ISETHIONATE",
"StrengthNumber": "300",
"StrengthUnit": "mg/300mg",
"Pharm_Classes": "Antiprotozoal [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180401",
"SamplePackage": "N",
"IndicationAndUsage": "Pentamidine isethionate for injection is indicated for the treatment of pneumonia due to Pneumocystis carinii.",
"Description": "Pentamidine isethionate for injection, an anti-protozoal agent, is a sterile, nonpyrogenic, lyophilized product. After reconstitution, it should be administered by intramuscular (IM) or intravenous (IV) routes (see DOSAGE AND ADMINISTRATION). Pentamidine isethionate is a white crystalline powder soluble in water and glycerin, slightly soluble in alcohol and insoluble in ether, acetone, and chloroform. It is chemically designated as 4,4-[1,5-pentanediylbis(oxy)]bis-benzenecarboximidamid with the following structural formula. Each vial contains:Pentamidine isethionate . . . . . . . . . . . . . 300 mg."
},
{
"NDCCode": "14141-300-01",
"PackageDescription": "1 CASE in 1 BOX (14141-300-01) / 10 g in 1 CASE",
"NDC11Code": "14141-0300-01",
"ProductNDC": "14141-300",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Forever Stay Polvos Compactos De Larga Duracion Fps 15 Long Lasting Compact Spf 15 Perla 100",
"NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220803",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "BEL STAR S A",
"SubstanceName": "ZINC OXIDE; TITANIUM DIOXIDE",
"StrengthNumber": "49; 57.5",
"StrengthUnit": "mg/g; mg/g",
"Status": "Active",
"LastUpdate": "2024-12-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220803",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "15452-300-04",
"PackageDescription": "10 kg in 1 DRUM (15452-300-04) ",
"NDC11Code": "15452-0300-04",
"ProductNDC": "15452-300",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Beta Nicotinamide Adenine Dinucleotide",
"DosageFormName": "POWDER",
"StartMarketingDate": "20261021",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "ZHEJIANG TOP MEDICINE CO., LTD",
"SubstanceName": "NADIDE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2026-11-03",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "22-OCT-26"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>44206-300-10</NDCCode>
<PackageDescription>10 SYRINGE, GLASS in 1 CARTON (44206-300-10) / 2 mL in 1 SYRINGE, GLASS (44206-300-90) </PackageDescription>
<NDC11Code>44206-0300-10</NDC11Code>
<ProductNDC>44206-300</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Rhophylac</ProprietaryName>
<NonProprietaryName>Human Rho(d) Immune Globulin</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20090106</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125070</ApplicationNumber>
<LabelerName>CSL Behring AG</LabelerName>
<SubstanceName>HUMAN RHO(D) IMMUNE GLOBULIN</SubstanceName>
<StrengthNumber>1500</StrengthNumber>
<StrengthUnit>[iU]/2mL</StrengthUnit>
<Pharm_Classes>Endogenous Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RHOPHYLAC is a Rh(D) Immune Globulin Intravenous (Human) (anti-D) product that is indicated for the suppression of Rh isoimmunization in non-sensitized Rh(D)-negative patients and for the treatment of immune thrombocytopenic purpura (ITP) in Rh(D)-positive patients.</IndicationAndUsage>
<Description>RHOPHYLAC is a sterile Rh(D) Immune Globulin Intravenous (Human) (anti-D) solution in a ready-to-use prefilled glass syringe for intravenous or intramuscular injection. One syringe contains at least 1500 IU (300 mcg) of IgG antibodies to Rh(D) in a 2 mL solution, sufficient to suppress the immune response to at least 15 mL of Rh(D)-positive RBCs.1 The product potency is expressed in IUs by comparison to the World Health Organization (WHO) standard, which is also the US and the European Pharmacopoeia standard. Plasma is obtained from healthy Rh(D)-negative donors who have been immunized with Rh(D)-positive RBCs. The donors are screened carefully to reduce the risk of receiving donations containing blood-borne pathogens. Each plasma donation used in the manufacture of RHOPHYLAC is tested for the presence of HBV surface antigen (HBsAg), HIV-1/2, and HCV antibodies. In addition, plasma used in the manufacture of RHOPHYLAC is tested by FDA-licensed Nucleic Acid Testing (NAT) for HBV, HCV, and HIV-1 and found to be negative. The source plasma is also tested by NAT for hepatitis A virus (HAV) and B19 virus (B19V). RHOPHYLAC is produced by an ion-exchange chromatography isolation procedure5, using pooled plasma obtained by plasmapheresis of immunized Rh(D)-negative US donors. The manufacturing process of RHOPHYLAC includes two dedicated virus reduction steps (i.e., solvent/detergent treatment and virus filtration with a Planova® 15 nanometer (nm) virus filter) as well as one ion exchange chromatography step contributing to virus reduction.6,7 All three virus reduction steps have been independently validated in a series of in vitro experiments for their capacity to inactivate or remove enveloped and/or non-enveloped viruses. Virus models were chosen to cover a broad selection of viruses, including the major blood-transmissible viruses like human immunodeficiency virus, hepatitis B and hepatitis C virus, as well as small, non-enveloped viruses like hepatitis A virus and human parvovirus B19. Viral clearance data from validation studies of the dedicated virus reduction steps for both enveloped and nonenveloped viruses will be provided upon request by calling 1-800-504-5434. Overall virus reduction expressed as mean log10 reduction factor of model enveloped and non-enveloped viruses has been shown to be ≥11 log10 and ≥9 log10 respectively. RHOPHYLAC contains a maximum of 30 mg/mL of human plasma proteins, 10 mg/mL of which is human albumin added as a stabilizer. Prior to the addition of the stabilizer, RHOPHYLAC has a purity greater than 95% IgG. RHOPHYLAC contains less than 5 mcg/mL of IgA, which is the limit of detection. Additional excipients are approximately 20 mg/mL of glycine and up to 0.25 M of sodium chloride. RHOPHYLAC contains no preservative. Human albumin is manufactured from pooled plasma of US donors by cold ethanol fractionation, followed by pasteurization.</Description>
</NDC>
<NDC>
<NDCCode>44206-300-01</NDCCode>
<PackageDescription>1 SYRINGE, GLASS in 1 CARTON (44206-300-01) / 2 mL in 1 SYRINGE, GLASS (44206-300-90) </PackageDescription>
<NDC11Code>44206-0300-01</NDC11Code>
<ProductNDC>44206-300</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Rhophylac</ProprietaryName>
<NonProprietaryName>Human Rho(d) Immune Globulin</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20090106</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125070</ApplicationNumber>
<LabelerName>CSL Behring AG</LabelerName>
<SubstanceName>HUMAN RHO(D) IMMUNE GLOBULIN</SubstanceName>
<StrengthNumber>1500</StrengthNumber>
<StrengthUnit>[iU]/2mL</StrengthUnit>
<Pharm_Classes>Endogenous Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RHOPHYLAC is a Rh(D) Immune Globulin Intravenous (Human) (anti-D) product that is indicated for the suppression of Rh isoimmunization in non-sensitized Rh(D)-negative patients and for the treatment of immune thrombocytopenic purpura (ITP) in Rh(D)-positive patients.</IndicationAndUsage>
<Description>RHOPHYLAC is a sterile Rh(D) Immune Globulin Intravenous (Human) (anti-D) solution in a ready-to-use prefilled glass syringe for intravenous or intramuscular injection. One syringe contains at least 1500 IU (300 mcg) of IgG antibodies to Rh(D) in a 2 mL solution, sufficient to suppress the immune response to at least 15 mL of Rh(D)-positive RBCs.1 The product potency is expressed in IUs by comparison to the World Health Organization (WHO) standard, which is also the US and the European Pharmacopoeia standard. Plasma is obtained from healthy Rh(D)-negative donors who have been immunized with Rh(D)-positive RBCs. The donors are screened carefully to reduce the risk of receiving donations containing blood-borne pathogens. Each plasma donation used in the manufacture of RHOPHYLAC is tested for the presence of HBV surface antigen (HBsAg), HIV-1/2, and HCV antibodies. In addition, plasma used in the manufacture of RHOPHYLAC is tested by FDA-licensed Nucleic Acid Testing (NAT) for HBV, HCV, and HIV-1 and found to be negative. The source plasma is also tested by NAT for hepatitis A virus (HAV) and B19 virus (B19V). RHOPHYLAC is produced by an ion-exchange chromatography isolation procedure5, using pooled plasma obtained by plasmapheresis of immunized Rh(D)-negative US donors. The manufacturing process of RHOPHYLAC includes two dedicated virus reduction steps (i.e., solvent/detergent treatment and virus filtration with a Planova® 15 nanometer (nm) virus filter) as well as one ion exchange chromatography step contributing to virus reduction.6,7 All three virus reduction steps have been independently validated in a series of in vitro experiments for their capacity to inactivate or remove enveloped and/or non-enveloped viruses. Virus models were chosen to cover a broad selection of viruses, including the major blood-transmissible viruses like human immunodeficiency virus, hepatitis B and hepatitis C virus, as well as small, non-enveloped viruses like hepatitis A virus and human parvovirus B19. Viral clearance data from validation studies of the dedicated virus reduction steps for both enveloped and nonenveloped viruses will be provided upon request by calling 1-800-504-5434. Overall virus reduction expressed as mean log10 reduction factor of model enveloped and non-enveloped viruses has been shown to be ≥11 log10 and ≥9 log10 respectively. RHOPHYLAC contains a maximum of 30 mg/mL of human plasma proteins, 10 mg/mL of which is human albumin added as a stabilizer. Prior to the addition of the stabilizer, RHOPHYLAC has a purity greater than 95% IgG. RHOPHYLAC contains less than 5 mcg/mL of IgA, which is the limit of detection. Additional excipients are approximately 20 mg/mL of glycine and up to 0.25 M of sodium chloride. RHOPHYLAC contains no preservative. Human albumin is manufactured from pooled plasma of US donors by cold ethanol fractionation, followed by pasteurization.</Description>
</NDC>
<NDC>
<NDCCode>44206-251-10</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (44206-251-10) > 100 mL in 1 VIAL, GLASS (44206-251-91) </PackageDescription>
<NDC11Code>44206-0251-10</NDC11Code>
<ProductNDC>44206-251</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Alburx</ProprietaryName>
<NonProprietaryName>Albumin (human)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20090106</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102366</ApplicationNumber>
<LabelerName>CSL Behring AG</LabelerName>
<SubstanceName>ALBUMIN HUMAN</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>g/50mL</StrengthUnit>
<Pharm_Classes>Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>ALBURX® 25, Albumin (Human) 25% solution is a sterile aqueous solution for intravenous administration containing the albumin component of human blood. The solution is clear and slightly viscous; it is almost colorless, or yellow, amber, or green. This product is prepared from the plasma of US donors. The product has been produced by alcohol fractionation and has been heated for 10 hours at 60°C for inactivation of infectious agents. The results of virus validation studies have shown that the manufacturing process, particularly alcohol fractionation, eliminates enveloped and non-enveloped viruses. Additionally, heat treatment at 60°C for a period of 10 hours efficiently inactivates viruses. The solution contains 0.14 M (3.2 mg/mL) sodium. The aluminum content is ≤ 200 mcg/L and the potassium content is ≤ 0.002 M. The solution is stabilized with 0.02 M sodium N-acetyltryptophanate and 0.02 M sodium caprylate. The solution contains no preservative.</Description>
</NDC>
<NDC>
<NDCCode>44206-437-10</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (44206-437-10) / 100 mL in 1 VIAL, GLASS (44206-437-91) </PackageDescription>
<NDC11Code>44206-0437-10</NDC11Code>
<ProductNDC>44206-437</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Privigen</ProprietaryName>
<NonProprietaryName>Human Immunoglobulin G</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20090120</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125201</ApplicationNumber>
<LabelerName>CSL Behring AG</LabelerName>
<SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PRIVIGEN is an Immune Globulin Intravenous (Human), 10% Liquid indicated for the treatment of the following conditions.</IndicationAndUsage>
<Description>PRIVIGEN is a ready-to-use, sterile, 10% protein liquid preparation of polyvalent human immunoglobulin G (IgG) for intravenous administration. PRIVIGEN has a purity of at least 98% IgG, consisting primarily of monomers. The balance consists of IgG dimers (≤12%), small amounts of fragments and polymers, and albumin. PRIVIGEN contains ≤25 mcg/mL IgA. The IgG subclass distribution is similar to that of normal human plasma. PRIVIGEN has an osmolality of approximately 320 mOsmol/kg (range: 240 to 440) and a pH of 4.8 (range: 4.6 to 5.0). PRIVIGEN contains approximately 250 mmol/L (range: 210 to 290) of L-proline (a nonessential amino acid) as a stabilizer and trace amounts of sodium. PRIVIGEN contains no carbohydrate stabilizers (e.g., sucrose, maltose) and no preservative. PRIVIGEN is prepared from large pools of human plasma by a combination of cold ethanol fractionation, octanoic acid fractionation, and anion exchange chromatography. The IgG proteins are not subjected to heating or to chemical or enzymatic modification. The Fc and Fab functions of the IgG molecule are retained. Fab functions tested include antigen binding capacities, and Fc functions tested include complement activation and Fc-receptor-mediated leukocyte activation (determined with complexed IgG). PRIVIGEN does not activate the complement system or prekallikrein in an unspecific manner. To specifically reduce blood group A and B antibodies (isoagglutinins A and B) the manufacturing process for PRIVIGEN includes an immunoaffinity chromatography step. All plasma units used in the manufacture of PRIVIGEN have been tested and approved for manufacture using FDA-licensed serological assays for hepatitis B surface antigen and antibodies to HCV and HIV-1/2 as well as FDA-licensed Nucleic Acid Testing (NAT) for HBV, HCV and HIV-1 and found to be nonreactive (negative). In addition, the plasma has been tested for B19 virus (B19V) DNA by NAT. Only plasma that passed virus screening is used for production, and the limit for B19V in the fractionation pool is set not to exceed 104 IU of B19V DNA per mL. The manufacturing process for PRIVIGEN includes three steps to reduce the risk of virus transmission. Two of these are dedicated virus clearance steps: pH 4 incubation to inactivate enveloped viruses and virus filtration to remove, by size exclusion, both enveloped and non-enveloped viruses as small as approximately 20 nanometers. In addition, a depth filtration step contributes to the virus reduction capacity. These steps have been independently validated in a series of in vitro experiments for their capacity to inactivate and/or remove both enveloped and non-enveloped viruses. Table 6 shows the virus clearance during the manufacturing process for PRIVIGEN, expressed as the mean log10 reduction factor (LRF).</Description>
</NDC>
<NDC>
<NDCCode>44206-452-02</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (44206-452-02) / 10 mL in 1 VIAL, SINGLE-DOSE (44206-452-91) </PackageDescription>
<NDC11Code>44206-0452-02</NDC11Code>
<ProductNDC>44206-452</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Hizentra</ProprietaryName>
<NonProprietaryName>Human Immunoglobulin G</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20111003</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125350</ApplicationNumber>
<LabelerName>CSL Behring AG</LabelerName>
<SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-05-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111003</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HIZENTRA is an Immune Globulin Subcutaneous (Human) (IGSC), 20% Liquid indicated for the treatment of the following conditions.</IndicationAndUsage>
<Description>HIZENTRA, Immune Globulin Subcutaneous (Human), 20% Liquid, is a ready-to-use, sterile 20% (0.2 g/mL) protein liquid preparation of polyvalent human immunoglobulin G (IgG) for subcutaneous administration. HIZENTRA is manufactured from large pools of human plasma by a combination of cold alcohol fractionation, octanoic acid fractionation, and anion exchange chromatography. The IgG proteins are not subjected to heating or to chemical or enzymatic modification. The Fc and Fab functions of the IgG molecule are retained. Fab functions tested include antigen binding capacities, and Fc functions tested include complement activation and Fc-receptor-mediated leukocyte activation (determined with complexed IgG). The IgG subclass distribution is similar to that of normal human plasma. HIZENTRA has a purity of ≥98% IgG and a pH of 4.6 to 5.2. This product contains approximately 250 mmol/L (range: 210 to 290 mmol/L) L-proline (a nonessential amino acid) as a stabilizer, 8 to 30 mg/L polysorbate 80, and trace amounts of sodium. HIZENTRA contains ≤50 mcg/mL IgA, no carbohydrate stabilizers (e.g., sucrose, maltose) and no preservative. Plasma units used in the manufacture of HIZENTRA are tested using FDA-licensed serological assays for hepatitis B surface antigen and antibodies to human immunodeficiency virus (HIV)-1/2 and hepatitis C virus (HCV) as well as FDA-licensed Nucleic Acid Testing (NAT) for HBV, HCV and HIV-1. All plasma units have been found to be nonreactive (negative) in these tests. In addition, the plasma has been tested for B19 virus (B19V) DNA by NAT. Only plasma that passes virus screening is used for production, and the limit for B19V in the fractionation pool is set not to exceed 104 IU of B19V DNA per mL. The manufacturing process for HIZENTRA includes three steps to reduce the risk of virus transmission. Two of these are dedicated virus clearance steps: pH 4 incubation to inactivate enveloped viruses, and virus filtration to remove, by size exclusion, both enveloped and non-enveloped viruses as small as approximately 20 nanometers. In addition, a depth filtration step contributes to the virus reduction capacity.12. These steps have been independently validated in a series of in vitro experiments for their capacity to inactivate and/or remove both enveloped and non-enveloped viruses. Table 6 shows the virus clearance during the manufacturing process for HIZENTRA, expressed as the mean log10 reduction factor (LRF).</Description>
</NDC>
<NDC>
<NDCCode>44206-455-10</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (44206-455-10) / 50 mL in 1 VIAL, SINGLE-DOSE (44206-455-93) </PackageDescription>
<NDC11Code>44206-0455-10</NDC11Code>
<ProductNDC>44206-455</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Hizentra</ProprietaryName>
<NonProprietaryName>Human Immunoglobulin G</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20111003</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125350</ApplicationNumber>
<LabelerName>CSL Behring AG</LabelerName>
<SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-05-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111003</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HIZENTRA is an Immune Globulin Subcutaneous (Human) (IGSC), 20% Liquid indicated for the treatment of the following conditions.</IndicationAndUsage>
<Description>HIZENTRA, Immune Globulin Subcutaneous (Human), 20% Liquid, is a ready-to-use, sterile 20% (0.2 g/mL) protein liquid preparation of polyvalent human immunoglobulin G (IgG) for subcutaneous administration. HIZENTRA is manufactured from large pools of human plasma by a combination of cold alcohol fractionation, octanoic acid fractionation, and anion exchange chromatography. The IgG proteins are not subjected to heating or to chemical or enzymatic modification. The Fc and Fab functions of the IgG molecule are retained. Fab functions tested include antigen binding capacities, and Fc functions tested include complement activation and Fc-receptor-mediated leukocyte activation (determined with complexed IgG). The IgG subclass distribution is similar to that of normal human plasma. HIZENTRA has a purity of ≥98% IgG and a pH of 4.6 to 5.2. This product contains approximately 250 mmol/L (range: 210 to 290 mmol/L) L-proline (a nonessential amino acid) as a stabilizer, 8 to 30 mg/L polysorbate 80, and trace amounts of sodium. HIZENTRA contains ≤50 mcg/mL IgA, no carbohydrate stabilizers (e.g., sucrose, maltose) and no preservative. Plasma units used in the manufacture of HIZENTRA are tested using FDA-licensed serological assays for hepatitis B surface antigen and antibodies to human immunodeficiency virus (HIV)-1/2 and hepatitis C virus (HCV) as well as FDA-licensed Nucleic Acid Testing (NAT) for HBV, HCV and HIV-1. All plasma units have been found to be nonreactive (negative) in these tests. In addition, the plasma has been tested for B19 virus (B19V) DNA by NAT. Only plasma that passes virus screening is used for production, and the limit for B19V in the fractionation pool is set not to exceed 104 IU of B19V DNA per mL. The manufacturing process for HIZENTRA includes three steps to reduce the risk of virus transmission. Two of these are dedicated virus clearance steps: pH 4 incubation to inactivate enveloped viruses, and virus filtration to remove, by size exclusion, both enveloped and non-enveloped viruses as small as approximately 20 nanometers. In addition, a depth filtration step contributes to the virus reduction capacity.12. These steps have been independently validated in a series of in vitro experiments for their capacity to inactivate and/or remove both enveloped and non-enveloped viruses. Table 6 shows the virus clearance during the manufacturing process for HIZENTRA, expressed as the mean log10 reduction factor (LRF).</Description>
</NDC>
<NDC>
<NDCCode>44206-457-22</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (44206-457-22) / 10 mL in 1 SYRINGE (44206-457-95) </PackageDescription>
<NDC11Code>44206-0457-22</NDC11Code>
<ProductNDC>44206-457</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Hizentra</ProprietaryName>
<NonProprietaryName>Human Immunoglobulin G</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20200101</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125350</ApplicationNumber>
<LabelerName>CSL Behring AG</LabelerName>
<SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-05-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HIZENTRA is an Immune Globulin Subcutaneous (Human) (IGSC), 20% Liquid indicated for the treatment of the following conditions.</IndicationAndUsage>
<Description>HIZENTRA, Immune Globulin Subcutaneous (Human), 20% Liquid, is a ready-to-use, sterile 20% (0.2 g/mL) protein liquid preparation of polyvalent human immunoglobulin G (IgG) for subcutaneous administration. HIZENTRA is manufactured from large pools of human plasma by a combination of cold alcohol fractionation, octanoic acid fractionation, and anion exchange chromatography. The IgG proteins are not subjected to heating or to chemical or enzymatic modification. The Fc and Fab functions of the IgG molecule are retained. Fab functions tested include antigen binding capacities, and Fc functions tested include complement activation and Fc-receptor-mediated leukocyte activation (determined with complexed IgG). The IgG subclass distribution is similar to that of normal human plasma. HIZENTRA has a purity of ≥98% IgG and a pH of 4.6 to 5.2. This product contains approximately 250 mmol/L (range: 210 to 290 mmol/L) L-proline (a nonessential amino acid) as a stabilizer, 8 to 30 mg/L polysorbate 80, and trace amounts of sodium. HIZENTRA contains ≤50 mcg/mL IgA, no carbohydrate stabilizers (e.g., sucrose, maltose) and no preservative. Plasma units used in the manufacture of HIZENTRA are tested using FDA-licensed serological assays for hepatitis B surface antigen and antibodies to human immunodeficiency virus (HIV)-1/2 and hepatitis C virus (HCV) as well as FDA-licensed Nucleic Acid Testing (NAT) for HBV, HCV and HIV-1. All plasma units have been found to be nonreactive (negative) in these tests. In addition, the plasma has been tested for B19 virus (B19V) DNA by NAT. Only plasma that passes virus screening is used for production, and the limit for B19V in the fractionation pool is set not to exceed 104 IU of B19V DNA per mL. The manufacturing process for HIZENTRA includes three steps to reduce the risk of virus transmission. Two of these are dedicated virus clearance steps: pH 4 incubation to inactivate enveloped viruses, and virus filtration to remove, by size exclusion, both enveloped and non-enveloped viruses as small as approximately 20 nanometers. In addition, a depth filtration step contributes to the virus reduction capacity.12. These steps have been independently validated in a series of in vitro experiments for their capacity to inactivate and/or remove both enveloped and non-enveloped viruses. Table 6 shows the virus clearance during the manufacturing process for HIZENTRA, expressed as the mean log10 reduction factor (LRF).</Description>
</NDC>
<NDC>
<NDCCode>44206-457-95</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (44206-457-95) > 10 mL in 1 SYRINGE (44206-457-22) </PackageDescription>
<NDC11Code>44206-0457-95</NDC11Code>
<ProductNDC>44206-457</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Hizentra</ProprietaryName>
<NonProprietaryName>Human Immunoglobulin G</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20200101</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125350</ApplicationNumber>
<LabelerName>CSL Behring AG</LabelerName>
<SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>44206-251-05</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (44206-251-05) > 50 mL in 1 VIAL, GLASS (44206-251-90) </PackageDescription>
<NDC11Code>44206-0251-05</NDC11Code>
<ProductNDC>44206-251</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Alburx</ProprietaryName>
<NonProprietaryName>Albumin (human)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20090106</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102366</ApplicationNumber>
<LabelerName>CSL Behring AG</LabelerName>
<SubstanceName>ALBUMIN HUMAN</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>g/50mL</StrengthUnit>
<Pharm_Classes>Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>ALBURX® 25, Albumin (Human) 25% solution is a sterile aqueous solution for intravenous administration containing the albumin component of human blood. The solution is clear and slightly viscous; it is almost colorless, or yellow, amber, or green. This product is prepared from the plasma of US donors. The product has been produced by alcohol fractionation and has been heated for 10 hours at 60°C for inactivation of infectious agents. The results of virus validation studies have shown that the manufacturing process, particularly alcohol fractionation, eliminates enveloped and non-enveloped viruses. Additionally, heat treatment at 60°C for a period of 10 hours efficiently inactivates viruses. The solution contains 0.14 M (3.2 mg/mL) sodium. The aluminum content is ≤ 200 mcg/L and the potassium content is ≤ 0.002 M. The solution is stabilized with 0.02 M sodium N-acetyltryptophanate and 0.02 M sodium caprylate. The solution contains no preservative.</Description>
</NDC>
<NDC>
<NDCCode>44206-310-25</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (44206-310-25) / 250 mL in 1 VIAL, GLASS (44206-310-90) </PackageDescription>
<NDC11Code>44206-0310-25</NDC11Code>
<ProductNDC>44206-310</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Alburx</ProprietaryName>
<NonProprietaryName>Albumin (human)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20090106</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102366</ApplicationNumber>
<LabelerName>CSL Behring AG</LabelerName>
<SubstanceName>ALBUMIN HUMAN</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>g/250mL</StrengthUnit>
<Pharm_Classes>Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>The definitive treatment of major hemorrhage is the transfusion of red blood cells restoring a normal oxygen transport capacity of the blood. Since, however, the life-threatening event in major hemorrhage is the loss of blood volume and not the erythrocyte deficit, the blood volume can, as an emergency measure, be supported by ALBURX® 5, Albumin (Human) 5% solution or another rapidly acting plasma substitute if blood is not immediately available. This will restore cardiac output and abolish circulatory failure with tissue anoxia. Though a four- to fivefold volume of crystalloids may be equally effective, their administration takes more time and creates a general overload with sodium and water. In the presence of dehydration, electrolyte solutions such as Ringer's lactate should be administered in conjunction with albumin.</IndicationAndUsage>
<Description>ALBURX® 5, Albumin (Human) 5% solution is a sterile aqueous solution for intravenous administration containing the albumin component of human blood. The solution is clear and slightly viscous; it is almost colorless, or yellow, amber, or green. This product is prepared from the plasma of US donors. The product has been produced by alcohol fractionation and has been heated for 10 hours at 60°C for inactivation of infectious agents. The results of virus validation studies have shown that the manufacturing process, particularly alcohol fractionation, eliminates enveloped and non-enveloped viruses. Additionally, heat treatment at 60°C for a period of 10 hours efficiently inactivates viruses. The solution contains 0.14 M (3.2 mg/mL) sodium. The aluminum content is ≤ 200 mcg/L and the potassium content is ≤ 0.002 M. The solution is stabilized with 0.004 M sodium N-acetyltryptophanate and 0.004 M sodium caprylate. The solution contains no preservative.</Description>
</NDC>
<NDC>
<NDCCode>44206-310-50</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (44206-310-50) / 500 mL in 1 VIAL, GLASS (44206-310-91) </PackageDescription>
<NDC11Code>44206-0310-50</NDC11Code>
<ProductNDC>44206-310</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Alburx</ProprietaryName>
<NonProprietaryName>Albumin (human)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20090106</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102366</ApplicationNumber>
<LabelerName>CSL Behring AG</LabelerName>
<SubstanceName>ALBUMIN HUMAN</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>g/250mL</StrengthUnit>
<Pharm_Classes>Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>The definitive treatment of major hemorrhage is the transfusion of red blood cells restoring a normal oxygen transport capacity of the blood. Since, however, the life-threatening event in major hemorrhage is the loss of blood volume and not the erythrocyte deficit, the blood volume can, as an emergency measure, be supported by ALBURX® 5, Albumin (Human) 5% solution or another rapidly acting plasma substitute if blood is not immediately available. This will restore cardiac output and abolish circulatory failure with tissue anoxia. Though a four- to fivefold volume of crystalloids may be equally effective, their administration takes more time and creates a general overload with sodium and water. In the presence of dehydration, electrolyte solutions such as Ringer's lactate should be administered in conjunction with albumin.</IndicationAndUsage>
<Description>ALBURX® 5, Albumin (Human) 5% solution is a sterile aqueous solution for intravenous administration containing the albumin component of human blood. The solution is clear and slightly viscous; it is almost colorless, or yellow, amber, or green. This product is prepared from the plasma of US donors. The product has been produced by alcohol fractionation and has been heated for 10 hours at 60°C for inactivation of infectious agents. The results of virus validation studies have shown that the manufacturing process, particularly alcohol fractionation, eliminates enveloped and non-enveloped viruses. Additionally, heat treatment at 60°C for a period of 10 hours efficiently inactivates viruses. The solution contains 0.14 M (3.2 mg/mL) sodium. The aluminum content is ≤ 200 mcg/L and the potassium content is ≤ 0.002 M. The solution is stabilized with 0.004 M sodium N-acetyltryptophanate and 0.004 M sodium caprylate. The solution contains no preservative.</Description>
</NDC>
<NDC>
<NDCCode>44206-532-11</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (44206-532-11) / 50 mL in 1 VIAL, GLASS (44206-532-90) </PackageDescription>
<NDC11Code>44206-0532-11</NDC11Code>
<ProductNDC>44206-532</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Cytogam</ProprietaryName>
<NonProprietaryName>Human Cytomegalovirus Immune Globulin</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20090106</StartMarketingDate>
<EndMarketingDate>20240110</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103189</ApplicationNumber>
<LabelerName>CSL Behring AG</LabelerName>
<SubstanceName>HUMAN CYTOMEGALOVIRUS IMMUNE GLOBULIN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE], Virus Neutralization [MoA], Virus-specific Hyperimmune Globulins [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20090106</StartMarketingDatePackage>
<EndMarketingDatePackage>20240110</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cytomegalovirus Immune Globulin Intravenous (Human) is indicated for the prophylaxis of cytomegalovirus disease associated with transplantation of kidney, lung, liver, pancreas and heart. In transplants of these organs other than kidney from CMV seropositive donors into seronegative recipients, prophylactic CMV-IGIV should be considered in combination with ganciclovir.</IndicationAndUsage>
<Description>CYTOGAM, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV), is an immunoglobulin G (IgG) containing a standardized amount of antibody to Cytomegalovirus (CMV). CMV-IGIV is formulated in final vial as a sterile liquid. The globulin is stabilized with 5% sucrose and 1% Albumin (Human). CYTOGAM contains no preservative. The purified immunoglobulin is derived from pooled adult human plasma selected for high titers of antibody for Cytomegalovirus (CMV).1 Source material for fractionation may be obtained from another U.S. licensed manufacturer. Pooled plasma was fractionated by ethanol precipitation of the proteins according to Cohn Methods 6 and 9, modified to yield a product suitable for intravenous administration. A widely utilized solvent-detergent viral inactivation process is also used.2 Certain manufacturing operations may be performed by other firms. Each milliliter contains: 50 ± 10 mg of immunoglobulin, primarily IgG, and trace amounts of IgA and IgM; 50 mg of sucrose; 10 mg of Albumin (Human). The sodium content is 20-30 mEq per liter, i.e., 0.4-0.6 mEq per 20 mL or 1.0-1.5 mEq per 50 mL. The solution should appear colorless and translucent.</Description>
</NDC>
<NDC>
<NDCCode>0009-4992-02</NDCCode>
<PackageDescription>10 BAG in 1 BOX (0009-4992-02) / 300 mL in 1 BAG (0009-4992-01) </PackageDescription>
<NDC11Code>00009-4992-02</NDC11Code>
<ProductNDC>0009-4992</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zyvox</ProprietaryName>
<NonProprietaryName>Linezolid</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20150706</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021131</ApplicationNumber>
<LabelerName>Pharmacia & Upjohn Company LLC</LabelerName>
<SubstanceName>LINEZOLID</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/300mL</StrengthUnit>
<Pharm_Classes>Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150706</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0009-5140-04</NDCCode>
<PackageDescription>10 BAG in 1 BOX (0009-5140-04) / 300 mL in 1 BAG (0009-5140-01) </PackageDescription>
<NDC11Code>00009-5140-04</NDC11Code>
<ProductNDC>0009-5140</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zyvox</ProprietaryName>
<NonProprietaryName>Linezolid</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20000418</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021131</ApplicationNumber>
<LabelerName>Pharmacia & Upjohn Company LLC</LabelerName>
<SubstanceName>LINEZOLID</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/300mL</StrengthUnit>
<Pharm_Classes>Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20000418</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZYVOX is an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia (1.1); Community-acquired pneumonia (1.2); Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis (1.3); Uncomplicated skin and skin structure infections (1.4); Vancomycin-resistant Enterococcus faecium infections. (1.5). Limitations of Use (1.6): 1 ZYVOX is not indicated for the treatment of Gram-negative infections., 2 The safety and efficacy of ZYVOX formulations given for longer than 28 days have not been evaluated in controlled clinical trials.</IndicationAndUsage>
<Description>ZYVOX I.V. Injection, ZYVOX Tablets, and ZYVOX for Oral Suspension contain linezolid, which is a synthetic antibacterial agent of the oxazolidinone class. The chemical name for linezolid is (S)-N-[[3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl] methyl]-acetamide. The empirical formula is C16H20FN3O4. Its molecular weight is 337.35, and its chemical structure is represented below. ZYVOX I.V. Injection is supplied as a ready-to-use sterile isotonic solution for intravenous infusion. Each mL contains 2 mg of linezolid. Inactive ingredients are dextrose monohydrate 50.24 mg/mL in an aqueous vehicle for intravenous administration, sodium citrate dihydrate 1.64 mg/mL, and citric acid anhydrous 0.85 mg/mL. Sodium hydroxide NF and/or hydrochloric acid NF are used to adjust the pH. The sodium (Na+) content is 0.38 mg/mL (5 mEq/300 mL bag and 1.7 mEq/100 mL bag). ZYVOX Tablet for oral administration contains 600 mg linezolid as a film-coated compressed tablet. Inactive ingredients are carnauba wax, corn starch, hydroxypropylcellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. The sodium (Na+) content is 2.92 mg per 600 mg tablet (0.1 mEq/tablet). ZYVOX for Oral Suspension is supplied as an orange-flavored granule/powder for constitution into a suspension for oral administration. Following constitution, each 5 mL contains 100 mg of linezolid. Inactive ingredients are aspartame, citric acid, colloidal silicon dioxide, flavors, mannitol, microcrystalline cellulose and carboxymethylcellulose sodium, sodium benzoate, sodium chloride, sodium citrate, sucrose, and xanthan gum [see Patient Counseling Information (17)]. The sodium (Na+) content is 8.52 mg/5 mL (0.4 mEq/5 mL).</Description>
</NDC>
<NDC>
<NDCCode>0009-7807-02</NDCCode>
<PackageDescription>10 BAG in 1 BOX (0009-7807-02) / 300 mL in 1 BAG (0009-7807-01) </PackageDescription>
<NDC11Code>00009-7807-02</NDC11Code>
<ProductNDC>0009-7807</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zyvox</ProprietaryName>
<NonProprietaryName>Linezolid</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20150218</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021131</ApplicationNumber>
<LabelerName>Pharmacia & Upjohn Company LLC</LabelerName>
<SubstanceName>LINEZOLID</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/300mL</StrengthUnit>
<Pharm_Classes>Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZYVOX is an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia (1.1); Community-acquired pneumonia (1.2); Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis (1.3); Uncomplicated skin and skin structure infections (1.4); Vancomycin-resistant Enterococcus faecium infections. (1.5)Limitations of Use (1.6): 1 ZYVOX is not indicated for the treatment of Gram-negative infections., 2 The safety and efficacy of ZYVOX formulations given for longer than 28 days have not been evaluated in controlled clinical trials.</IndicationAndUsage>
<Description>ZYVOX I.V. Injection contains linezolid, which is a synthetic antibacterial agent of the oxazolidinone class. The chemical name for linezolid is (S)-N-[[3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl] methyl]-acetamide. The empirical formula is C16H20FN3O4. Its molecular weight is 337.35, and its chemical structure is represented below. ZYVOX I.V. Injection is supplied as a ready-to-use sterile isotonic solution for intravenous infusion. Each mL contains 2 mg of linezolid. Inactive ingredients are dextrose monohydrate 50.24 mg/mL in an aqueous vehicle for intravenous administration, sodium citrate dihydrate 1.64 mg/mL, and citric acid anhydrous 0.85 mg/mL. Sodium hydroxide NF and/or hydrochloric acid NF are used to adjust the pH. The sodium (Na+) content is 0.38 mg/mL (5 mEq/300 mL bag).</Description>
</NDC>
<NDC>
<NDCCode>0121-1074-10</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0121-1074-10) / 300 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>00121-1074-10</NDC11Code>
<ProductNDC>0121-1074</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Brivaracetam</ProprietaryName>
<NonProprietaryName>Brivaracetam</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218494</ApplicationNumber>
<LabelerName>PAI Holdings, LLC dba PAI Pharma</LabelerName>
<SubstanceName>BRIVARACETAM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Epoxide Hydrolase Inhibitors [MoA]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Brivaracetam oral solution is indicated for the treatment of partial-onset seizures in patients 1 month of age and older.</IndicationAndUsage>
<Description>The chemical name of brivaracetam is (2S)-2-[(4R)-2-oxo-4-propyltetrahydro-1 H-pyrrol-1-yl] butanamide. Its molecular formula is C 11H 20N 2O 2and its molecular weight is 212.29. The chemical structure is. Brivaracetam is a white to off-white crystalline powder. It is very soluble in water, buffer (pH 1.2, 4.5, and 7.4), ethanol, methanol, and glacial acetic acid. It is freely soluble in acetonitrile and acetone and soluble in toluene. It is very slightly soluble in n-hexane. Oral Solution. Brivaracetam oral solution contains 10 mg of brivaracetam per mL. The inactive ingredients are sodium citrate, anhydrous citric acid, methylparaben, sodium carboxymethylcellulose, sucralose, sorbitol solution, glycerin, raspberry flavor, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>0121-1101-02</NDCCode>
<PackageDescription>10 VIAL, SINGLE-USE in 1 CARTON (0121-1101-02) / 300 mg in 1 VIAL, SINGLE-USE (0121-1101-55) </PackageDescription>
<NDC11Code>00121-1101-02</NDC11Code>
<ProductNDC>0121-1101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pentamidine Isethionate</ProprietaryName>
<NonProprietaryName>Pentamidine Isethionate</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20260612</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206666</ApplicationNumber>
<LabelerName>PAI Holdings, LLC dba PAI Pharma</LabelerName>
<SubstanceName>PENTAMIDINE DIISETHIONATE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/300mg</StrengthUnit>
<Pharm_Classes>Antiprotozoal [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pentamidine isethionate for injection is indicated for the treatment of pneumonia due to Pneumocystis carinii.</IndicationAndUsage>
<Description>Pentamidine isethionate for injection, an anti-protozoal agent, is a sterile, nonpyrogenic, lyophilized product. After reconstitution, it should be administered by intramuscular (IM) or intravenous (IV) routes (see DOSAGE AND ADMINISTRATION). Pentamidine isethionate is a white crystalline powder soluble in water and glycerin, slightly soluble in alcohol and insoluble in ether, acetone, and chloroform. It is chemically designated as 4,4-[1,5-pentanediylbis(oxy)]bis-benzenecarboximidamid with the following structural formula. Each vial contains:Pentamidine isethionate . . . . . . . . . . . . . 300 mg.</Description>
</NDC>
<NDC>
<NDCCode>0143-9365-10</NDCCode>
<PackageDescription>10 BAG in 1 BOX (0143-9365-10) / 300 mL in 1 BAG (0143-9365-01) </PackageDescription>
<NDC11Code>00143-9365-10</NDC11Code>
<ProductNDC>0143-9365</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Labetalol Hcl In Sodium Chloride</ProprietaryName>
<NonProprietaryName>Labetalol Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20201109</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213330</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>LABETALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201109</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Labetalol HCl Injection is indicated in severe hypertension, to lower blood pressure.</IndicationAndUsage>
<Description>Labetalol HCl in Sodium Chloride Injection, Labetalol HCl in Dextrose Injection and Labetalol Hydrochloride Injection, USP contain labetalol HCl an adrenergic receptor blocking agent that has both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions. Labetalol hydrochloride (HCl) is a racemate chemically designated as 5-[1-Hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]-salicylamide monohydrochloride and it has the following structural formula. Labetalol HCl is a white or off-white crystalline powder, soluble in water. Labetalol HCl has the molecular formula C19H24N2O3HCl and a molecular weight of 364.87. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Labetalol HCl in Sodium Chloride Injection and Labetalol HCl in Dextrose Injection are two preservative-free, ready- to use formulations of labetalol. Labetalol HCl in Sodium Chloride Injection and Labetalol HCl in Dextrose Injection are clear, colorless to pale yellow, aqueous, sterile, isotonic solution for intravenous injection. Each milliliter of Labetalol HCl in Sodium Chloride Injection contains 1 mg of labetalol HCl, 7.2 mg sodium chloride, 9 mg of anhydrous dextrose, 0.02 mg of edetate disodium; and citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range of 3.5 to 4.5. Each milliliter of Labetalol HCl in Dextrose Injection contains 1 mg of labetalol HCl, 45 mg of anhydrous dextrose, 0.02 mg of edetate disodium; and citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range of 3.5 to 4.5. Labetalol Hydrochloride Injection prefilled syringe and vial are two preservative-free, ready-to use formulations of labetalol. Labetalol Hydrochloride Injection is a clear, colorless to pale yellow, aqueous, sterile, isotonic solution for intravenous injection. Each milliliter of Labetalol Hydrochloride Injection, USP, contains 5 mg of labetalol HCI, 45 mg of anhydrous dextrose, 0.1 mg of edetate disodium, and citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range of 3.0 to 4.5.</Description>
</NDC>
<NDC>
<NDCCode>0143-9534-10</NDCCode>
<PackageDescription>10 POUCH in 1 BOX (0143-9534-10) / 1 BAG in 1 POUCH / 300 mL in 1 BAG</PackageDescription>
<NDC11Code>00143-9534-10</NDC11Code>
<ProductNDC>0143-9534</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Linezolid</ProprietaryName>
<NonProprietaryName>Linezolid</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20221227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206454</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>LINEZOLID</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/300mL</StrengthUnit>
<Pharm_Classes>Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Linezolid Injection contains linezolid, which is a synthetic antibacterial agent of the oxazolidinone class. The chemical name for linezolid is (S)-N-[[3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl] methyl]-acetamide. The empirical formula is C16H20FN3O4. Its molecular weight is 337.35, and its chemical structure is represented below. Linezolid Injection is supplied as a ready-to-use sterile isotonic solution for intravenous infusion. Each mL contains 2 mg of linezolid. Inactive ingredients are dextrose monohydrate 50.24 mg/mL in an aqueous vehicle for intravenous administration, sodium citrate dihydrate 1.64 mg/mL, and citric acid anhydrous 0.85mg/mL. Sodium hydroxide NF and/or hydrochloric acid NF are used to adjust the pH. The sodium (Na+) content is 0.38 mg/mL (5 mEq/300 mL bag).</Description>
</NDC>
<NDC>
<NDCCode>0270-0149-57</NDCCode>
<PackageDescription>10 BOTTLE in 1 PACKAGE (0270-0149-57) / 300 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>00270-0149-57</NDC11Code>
<ProductNDC>0270-0149</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cystografin</ProprietaryName>
<NonProprietaryName>Diatrizoate Meglumine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19701103</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA010040</ApplicationNumber>
<LabelerName>BRACCO DIAGNOSTICS INC</LabelerName>
<SubstanceName>DIATRIZOATE MEGLUMINE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19701103</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cystografin is indicated for retrograde cystourethrography.</IndicationAndUsage>
<Description>Cystografin is a radiopaque contrast agent supplied as a sterile, clear, colorless to pale yellow, mobile or slightly viscous solution. Each mL provides 300 mg diatrizoate meglumine with 0.4 mg edetate disodium as a sequestering agent. Each mL of solution also contains approximately 141 mg organically bound iodine. At the time of manufacture, the air in the container is replaced by nitrogen. The preparation should be protected from strong light.</Description>
</NDC>
<NDC>
<NDCCode>0270-1410-30</NDCCode>
<PackageDescription>10 BOTTLE in 1 PACKAGE (0270-1410-30) / 300 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>00270-1410-30</NDC11Code>
<ProductNDC>0270-1410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cystografin Dilute</ProprietaryName>
<NonProprietaryName>Diatrizoate Meglumine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVESICAL</RouteName>
<StartMarketingDate>19821109</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA010040</ApplicationNumber>
<LabelerName>BRACCO DIAGNOSTICS INC</LabelerName>
<SubstanceName>DIATRIZOATE MEGLUMINE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19821109</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cystografin Dilute is indicated for retrograde cystourethrography.</IndicationAndUsage>
<Description>Cystografin Dilute (Diatrizoate Meglumine Injection USP 18%) is a radiopaque contrast agent supplied as a sterile, aqueous solution. Each mL provides 180 mg diatrizoate meglumine with 0.4 mg edetate disodium as a sequestering agent. Each mL of solution also contains approximately 85 mg organically bound iodine. At the time of manufacture, the air in the container is replaced by nitrogen.</Description>
</NDC>
<NDC>
<NDCCode>0409-4882-01</NDCCode>
<PackageDescription>10 POUCH in 1 CASE (0409-4882-01) > 1 BAG in 1 POUCH > 300 mL in 1 BAG</PackageDescription>
<NDC11Code>00409-4882-01</NDC11Code>
<ProductNDC>0409-4882</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Linezolid</ProprietaryName>
<NonProprietaryName>Linezolid</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20150707</StartMarketingDate>
<EndMarketingDate>20180701</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205442</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>LINEZOLID</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>0409-4883-01</NDCCode>
<PackageDescription>10 POUCH in 1 CASE (0409-4883-01) / 1 BAG in 1 POUCH / 300 mL in 1 BAG (0409-4883-11) </PackageDescription>
<NDC11Code>00409-4883-01</NDC11Code>
<ProductNDC>0409-4883</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Linezolid</ProprietaryName>
<NonProprietaryName>Linezolid</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20150618</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206473</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>LINEZOLID</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150618</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Linezolid injection is an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia (1.1); Community-acquired pneumonia (1.2); Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis (1.3); Vancomycin-resistant Enterococcus faecium infections. (1.4) Limitations of Use: (1.5): 1 Linezolid injection is not indicated for the treatment of Gram-negative infections., 2 The safety and efficacy of Linezolid formulations given for longer than 28 days have not been evaluated in controlled clinical trials.</IndicationAndUsage>
<Description>Linezolid injection contains linezolid, which is a synthetic antibacterial agent of the oxazolidinone class. The chemical name for linezolid is (S)-N-[[3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl] methyl]-acetamide. The empirical formula is C16H20FN3O4. Its molecular weight is 337.35, and its chemical structure is represented below:. Linezolid injection is supplied as a ready-to-use sterile isotonic solution for intravenous infusion. Each container contains 600 mg of linezolid in 300 mL of a clear, colorless to slightly yellow aqueous solution. Inactive ingredients include: citric acid anhydrous USP 1.92 mg/mL, sodium chloride USP 9 mg/mL, sodium hydroxide NF 0.76 mg/mL, and water for injection USP. Sodium hydroxide NF and/or hydrochloric acid NF are used to adjust the pH. The sodium (Na+) content is 3.98 mg/mL (52 mEq/300 mL container).</Description>
</NDC>
<NDC>
<NDCCode>0409-4883-10</NDCCode>
<PackageDescription>10 POUCH in 1 CASE (0409-4883-10) / 1 BAG in 1 POUCH / 300 mL in 1 BAG (0409-4883-03) </PackageDescription>
<NDC11Code>00409-4883-10</NDC11Code>
<ProductNDC>0409-4883</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Linezolid</ProprietaryName>
<NonProprietaryName>Linezolid</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20150618</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206473</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>LINEZOLID</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230619</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Linezolid injection is an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia (1.1); Community-acquired pneumonia (1.2); Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis (1.3); Vancomycin-resistant Enterococcus faecium infections. (1.4) Limitations of Use: (1.5): 1 Linezolid injection is not indicated for the treatment of Gram-negative infections., 2 The safety and efficacy of Linezolid formulations given for longer than 28 days have not been evaluated in controlled clinical trials.</IndicationAndUsage>
<Description>Linezolid injection contains linezolid, which is a synthetic antibacterial agent of the oxazolidinone class. The chemical name for linezolid is (S)-N-[[3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl] methyl]-acetamide. The empirical formula is C16H20FN3O4. Its molecular weight is 337.35, and its chemical structure is represented below:. Linezolid injection is supplied as a ready-to-use sterile isotonic solution for intravenous infusion. Each container contains 600 mg of linezolid in 300 mL of a clear, colorless to slightly yellow aqueous solution. Inactive ingredients include: citric acid anhydrous USP 1.92 mg/mL, sodium chloride USP 9 mg/mL, sodium hydroxide NF 0.76 mg/mL, and water for injection USP. Sodium hydroxide NF and/or hydrochloric acid NF are used to adjust the pH. The sodium (Na+) content is 3.98 mg/mL (52 mEq/300 mL container).</Description>
</NDC>
<NDC>
<NDCCode>0703-9060-33</NDCCode>
<PackageDescription>10 BAG in 1 CARTON (0703-9060-33) > 300 mL in 1 BAG (0703-9060-31) </PackageDescription>
<NDC11Code>00703-9060-33</NDC11Code>
<ProductNDC>0703-9060</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Linezolid</ProprietaryName>
<NonProprietaryName>Linezolid</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20150105</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200222</ApplicationNumber>
<LabelerName>Teva Parenteral Medicines, Inc.</LabelerName>
<SubstanceName>LINEZOLID</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0781-3433-95</NDCCode>
<PackageDescription>10 BAG in 1 CARTON (0781-3433-95) / 300 mL in 1 BAG (0781-3433-46) </PackageDescription>
<NDC11Code>00781-3433-95</NDC11Code>
<ProductNDC>0781-3433</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Linezolid</ProprietaryName>
<NonProprietaryName>Linezolid</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20160615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200904</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>LINEZOLID</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/300mL</StrengthUnit>
<Pharm_Classes>Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Linezolid injection is an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia (1.1); Community-acquired pneumonia (1.2); Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis (1.3); Vancomycin-resistant Enterococcus faecium infections. (1.5). Limitations of Use (1.6): 1 Linezolid is not indicated for the treatment of Gram-negative infections., 2 The safety and efficacy of Linezolid formulations given for longer than 28 days have not been evaluated in controlled clinical trials.</IndicationAndUsage>
<Description>Linezolid intravenous injection contains linezolid, which is a synthetic antibacterial agent of the oxazolidinone class. The chemical name for linezolid is (S)-N-[[3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl] methyl]-acetamide. The molecular formula is C16H20FN3O4. Its molecular weight is 337.35, and its chemical structure is represented below. Linezolid intravenous injection is supplied as a ready-to-use sterile isotonic solution for intravenous infusion. Each mL contains 2 mg of linezolid. Inactive ingredients are citric acid anhydrous, dextrose in an aqueous vehicle for intravenous administration, and sodium citrate. The sodium (Na+) content is 0.38 mg/mL (5 mEq/300-mL bag and 1.7 mEq/100-mL bag). The pH has been adjusted with sodium hydroxide and/or hydrochloric acid.</Description>
</NDC>
<NDC>
<NDCCode>13811-300-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (13811-300-10) </PackageDescription>
<NDC11Code>13811-0300-10</NDC11Code>
<ProductNDC>13811-300</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenobarbital</ProprietaryName>
<NonProprietaryName>Phenobarbital</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250401</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Trigen Laboratories, LLC</LabelerName>
<SubstanceName>PHENOBARBITAL</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phenobarbital Tablets, USP are indicated for use as a sedative or anticonvulsant.</IndicationAndUsage>
<Description>Phenobarbital is a barbituric acid derivative for oral administration and occurs as a white, odorless, slightly bitter powder that is soluble in chloroform, freely soluble in alcohol or ether, and slightly soluble in water. Its saturated solution has a pH of about 5.6. Chemically, it is 5- ethyl-5-phenylbarbituric acid with the molecular formula C12H12N2O3 (232.24). The structural formula is as follows. Each Phenobarbital Tablet, USP contains 15 mg, 30 mg, 60 mg or 100 mg of phenobarbital, USP. Inactive ingredients include: colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>13925-515-10</NDCCode>
<PackageDescription>10 VIAL in 1 TRAY (13925-515-10) / 300 mg in 1 VIAL</PackageDescription>
<NDC11Code>13925-0515-10</NDC11Code>
<ProductNDC>13925-515</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pentamidine Isethionate</ProprietaryName>
<NonProprietaryName>Pentamidine Isethionate</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20180401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206666</ApplicationNumber>
<LabelerName>Seton Pharmaceuticals</LabelerName>
<SubstanceName>PENTAMIDINE ISETHIONATE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/300mg</StrengthUnit>
<Pharm_Classes>Antiprotozoal [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pentamidine isethionate for injection is indicated for the treatment of pneumonia due to Pneumocystis carinii.</IndicationAndUsage>
<Description>Pentamidine isethionate for injection, an anti-protozoal agent, is a sterile, nonpyrogenic, lyophilized product. After reconstitution, it should be administered by intramuscular (IM) or intravenous (IV) routes (see DOSAGE AND ADMINISTRATION). Pentamidine isethionate is a white crystalline powder soluble in water and glycerin, slightly soluble in alcohol and insoluble in ether, acetone, and chloroform. It is chemically designated as 4,4-[1,5-pentanediylbis(oxy)]bis-benzenecarboximidamid with the following structural formula. Each vial contains:Pentamidine isethionate . . . . . . . . . . . . . 300 mg.</Description>
</NDC>
<NDC>
<NDCCode>14141-300-01</NDCCode>
<PackageDescription>1 CASE in 1 BOX (14141-300-01) / 10 g in 1 CASE</PackageDescription>
<NDC11Code>14141-0300-01</NDC11Code>
<ProductNDC>14141-300</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Forever Stay Polvos Compactos De Larga Duracion Fps 15 Long Lasting Compact Spf 15 Perla 100</ProprietaryName>
<NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220803</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>BEL STAR S A</LabelerName>
<SubstanceName>ZINC OXIDE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>49; 57.5</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-12-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220803</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>15452-300-04</NDCCode>
<PackageDescription>10 kg in 1 DRUM (15452-300-04) </PackageDescription>
<NDC11Code>15452-0300-04</NDC11Code>
<ProductNDC>15452-300</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Beta Nicotinamide Adenine Dinucleotide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20261021</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>ZHEJIANG TOP MEDICINE CO., LTD</LabelerName>
<SubstanceName>NADIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-11-03</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>22-OCT-26</StartMarketingDatePackage>
</NDC>
</NDCList>