RESTful Lookup — Test-Drive (2007 – 2026)

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  <NDC>
    <NDCCode>68982-623-03</NDCCode>
    <PackageDescription>500 mL in 1 BOTTLE, GLASS (68982-623-03) </PackageDescription>
    <NDC11Code>68982-0623-03</NDC11Code>
    <ProductNDC>68982-623</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Albumin (human)</ProprietaryName>
    <NonProprietaryName>Albumin Human</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20061017</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125154</ApplicationNumber>
    <LabelerName>Octapharma USA Inc</LabelerName>
    <SubstanceName>ALBUMIN HUMAN</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>g/1000mL</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>2020-04-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20061017</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ALBUMIN (HUMAN) 5% is indicated for the restoration and maintenance of circulating blood volume for. Hypovolemia. ( 1.1 ). Hypoalbuminemia. ( 1.2 ). Prevention of central volume depletion after paracentesis due to cirrhotic ascites. ( 1.3 ).</IndicationAndUsage>
    <Description>ALBUMIN (HUMAN) 5% is a sterile, liquid preparation of albumin derived from large pools of human plasma. All units of human plasma used in the manufacture of ALBUMIN (HUMAN) 5% are provided by FDA approved blood establishments only. The product is manufactured by cold ethanol fractionation followed by ultra- and diafiltration. The manufacturing process includes final container pasteurization and additional bulk pasteurization at 60 +/- 0.5°C for 10 – 11 hours. The ALBUMIN (HUMAN) 5% manufacturing process provides a significant viral reduction in in vitro studies (table 2). These reductions are achieved through a combination of process steps including cold ethanol fractionation and final container pasteurization. No procedure, however, has been shown to be completely effective in removing viral infectivity from derivatives of human plasma. [see Warnings and Precautions, Infection Risk from Human Plasma (5.7)]. Table 2 In vitro reduction factor during ALBUMIN (HUMAN) 5% manufacturing. PRV: Pseudorabies Virus. SBV: Sindbis Virus. HIV-1: Human Immunodeficiency Virus - 1. Reo 3: Reovirus Type 3. PPV: Porcine Parvovirus. HAV: Hepatitis A Virus. ALBUMIN (HUMAN) 5% is a clear, slightly viscous liquid; it is almost colorless or slightly yellow or green. The composition of ALBUMIN (HUMAN) 5% is as follows. ALBUMIN (HUMAN) 5% contains no preservatives and components used in its packaging are latex-free.</Description>
  </NDC>
  <NDC>
    <NDCCode>68982-623-01</NDCCode>
    <PackageDescription>100 mL in 1 BOTTLE, GLASS (68982-623-01) </PackageDescription>
    <NDC11Code>68982-0623-01</NDC11Code>
    <ProductNDC>68982-623</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Albumin (human)</ProprietaryName>
    <NonProprietaryName>Albumin Human</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20061017</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125154</ApplicationNumber>
    <LabelerName>Octapharma USA Inc</LabelerName>
    <SubstanceName>ALBUMIN HUMAN</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>g/1000mL</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>2020-04-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20061017</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ALBUMIN (HUMAN) 5% is indicated for the restoration and maintenance of circulating blood volume for. Hypovolemia. ( 1.1 ). Hypoalbuminemia. ( 1.2 ). Prevention of central volume depletion after paracentesis due to cirrhotic ascites. ( 1.3 ).</IndicationAndUsage>
    <Description>ALBUMIN (HUMAN) 5% is a sterile, liquid preparation of albumin derived from large pools of human plasma. All units of human plasma used in the manufacture of ALBUMIN (HUMAN) 5% are provided by FDA approved blood establishments only. The product is manufactured by cold ethanol fractionation followed by ultra- and diafiltration. The manufacturing process includes final container pasteurization and additional bulk pasteurization at 60 +/- 0.5°C for 10 – 11 hours. The ALBUMIN (HUMAN) 5% manufacturing process provides a significant viral reduction in in vitro studies (table 2). These reductions are achieved through a combination of process steps including cold ethanol fractionation and final container pasteurization. No procedure, however, has been shown to be completely effective in removing viral infectivity from derivatives of human plasma. [see Warnings and Precautions, Infection Risk from Human Plasma (5.7)]. Table 2 In vitro reduction factor during ALBUMIN (HUMAN) 5% manufacturing. PRV: Pseudorabies Virus. SBV: Sindbis Virus. HIV-1: Human Immunodeficiency Virus - 1. Reo 3: Reovirus Type 3. PPV: Porcine Parvovirus. HAV: Hepatitis A Virus. ALBUMIN (HUMAN) 5% is a clear, slightly viscous liquid; it is almost colorless or slightly yellow or green. The composition of ALBUMIN (HUMAN) 5% is as follows. ALBUMIN (HUMAN) 5% contains no preservatives and components used in its packaging are latex-free.</Description>
  </NDC>
  <NDC>
    <NDCCode>68982-623-02</NDCCode>
    <PackageDescription>250 mL in 1 BOTTLE, GLASS (68982-623-02) </PackageDescription>
    <NDC11Code>68982-0623-02</NDC11Code>
    <ProductNDC>68982-623</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Albumin (human)</ProprietaryName>
    <NonProprietaryName>Albumin Human</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20061017</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125154</ApplicationNumber>
    <LabelerName>Octapharma USA Inc</LabelerName>
    <SubstanceName>ALBUMIN HUMAN</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>g/1000mL</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>2020-04-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20061017</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ALBUMIN (HUMAN) 5% is indicated for the restoration and maintenance of circulating blood volume for. Hypovolemia. ( 1.1 ). Hypoalbuminemia. ( 1.2 ). Prevention of central volume depletion after paracentesis due to cirrhotic ascites. ( 1.3 ).</IndicationAndUsage>
    <Description>ALBUMIN (HUMAN) 5% is a sterile, liquid preparation of albumin derived from large pools of human plasma. All units of human plasma used in the manufacture of ALBUMIN (HUMAN) 5% are provided by FDA approved blood establishments only. The product is manufactured by cold ethanol fractionation followed by ultra- and diafiltration. The manufacturing process includes final container pasteurization and additional bulk pasteurization at 60 +/- 0.5°C for 10 – 11 hours. The ALBUMIN (HUMAN) 5% manufacturing process provides a significant viral reduction in in vitro studies (table 2). These reductions are achieved through a combination of process steps including cold ethanol fractionation and final container pasteurization. No procedure, however, has been shown to be completely effective in removing viral infectivity from derivatives of human plasma. [see Warnings and Precautions, Infection Risk from Human Plasma (5.7)]. Table 2 In vitro reduction factor during ALBUMIN (HUMAN) 5% manufacturing. PRV: Pseudorabies Virus. SBV: Sindbis Virus. HIV-1: Human Immunodeficiency Virus - 1. Reo 3: Reovirus Type 3. PPV: Porcine Parvovirus. HAV: Hepatitis A Virus. ALBUMIN (HUMAN) 5% is a clear, slightly viscous liquid; it is almost colorless or slightly yellow or green. The composition of ALBUMIN (HUMAN) 5% is as follows. ALBUMIN (HUMAN) 5% contains no preservatives and components used in its packaging are latex-free.</Description>
  </NDC>
  <NDC>
    <NDCCode>68982-810-03</NDCCode>
    <PackageDescription>1 VIAL, GLASS in 1 CARTON (68982-810-03)  &gt; 12 mL in 1 VIAL, GLASS (68982-810-83) </PackageDescription>
    <NDC11Code>68982-0810-03</NDC11Code>
    <ProductNDC>68982-810</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Cutaquig</ProprietaryName>
    <NonProprietaryName>Immunoglobulin G</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20190503</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125668</ApplicationNumber>
    <LabelerName>Octapharma USA Inc</LabelerName>
    <SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
    <StrengthNumber>165</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-04-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190503</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>CUTAQUIG (Immune Globulin Subcutaneous (Human) - hipp) is a 16.5% immune globulin solution for subcutaneous infusion (IGSC), indicated as replacement therapy for primary humoral immunodeficiency (PI) in adults and pediatric patients 2 years of age and older. This includes, but is not limited to, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.</IndicationAndUsage>
    <Description>CUTAQUIG (Immune Globulin Subcutaneous (Human) - hipp), is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. CUTAQUIG is a solution for injection to be administered subcutaneously. This preparation contains approximately 165 mg of protein per mL (16.5%), of which not less than 96% is normal human immunoglobulin G. CUTAQUIG contains not more than 3% aggregates, not less than 94% monomers and dimers, and not more than 3% fragments. The product contains on average 0.206 mg of IgA /mL. The sodium content of the final solution is not more than 30 mmol/L and the pH is between 5.0 and 5.5. The osmolality is 310 - 380 mOsmol/kg. The manufacturing process for CUTAQUIG isolates IgG without additional chemical or enzymatic modification, and the Fc portion is maintained intact. CUTAQUIG contains the IgG antibody activities present in the donor population. IgG subclasses are fully represented with the following approximate percent of total IgG: IgG1 is 70%, IgG2 is 25%, IgG3 is 3% and IgG4 is 2%. CUTAQUIG contains a broad spectrum of IgG antibodies against bacterial and viral agents that are capable of opsonization and neutralization of microbes and toxins. It contains maltose (79 mg/mL), but no preservatives or sucrose. All units of human plasma used in the manufacture of CUTAQUIG are provided by FDA-approved blood and plasma establishments, and are tested by FDA-licensed serological tests for HBsAg, antibodies to HCV and HIV and Nucleic Acid Test (NAT) for HCV and HIV-1 and found to be non-reactive (negative). The product is manufactured by the cold ethanol fractionation process followed by ultrafiltration and chromatography. The manufacturing process includes treatment with an organic S/D mixture composed of tri-n-butyl phosphate (TNBP) and Octoxynol. The CUTAQUIG manufacturing process shows significant viral reduction in in vitro studies ( Table 6 ). These reductions are achieved through a combination of process steps including cold ethanol fractionation, S/D treatment and pH 4 treatment. Table 6 Pathogen Reduction During CUTAQUIG Manufacturing. * Not calculated for global Log 10 Reduction Factor. HIV-1: Human Immunodeficiency Virus - 1. PRV: Pseudorabies Virus, model virus for e.g. Hepatitis B Virus (HBV). SBV: Sindbis Virus, model virus for Hepatitis C Virus (HCV). MEV: Mouse Encephalomyelitis Virus, model virus for Human Parvovirus B19. PPV: Porcine Parvovirus, model virus for Hepatitis A Virus (HAV). n.a.: not applicable.</Description>
  </NDC>
  <NDC>
    <NDCCode>68982-820-03</NDCCode>
    <PackageDescription>1 BOTTLE, GLASS in 1 CARTON (68982-820-03)  &gt; 50 mL in 1 BOTTLE, GLASS (68982-820-83) </PackageDescription>
    <NDC11Code>68982-0820-03</NDC11Code>
    <ProductNDC>68982-820</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Panzyga</ProprietaryName>
    <NonProprietaryName>Immune Globulin Intravenous (human)</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20181112</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125587</ApplicationNumber>
    <LabelerName>Octapharma USA Inc</LabelerName>
    <SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181112</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Immune Globulin Intravenous (Human), PANZYGA, is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. PANZYGA is a solution for infusion to be administered intravenously. This preparation contains approximately 100 mg of protein per mL (10%), of which not less than 96% is normal human immunoglobulin G. PANZYGA contains not more than 3% aggregates, not less than 90% monomers and dimers, and not more than 3% fragments. On average, the product contains 100 µg/mL of IgA, and lower amounts of IgM. PANZYGA contains only trace amounts of sodium, and the pH is between 4.5 and 5.0. The osmolality is in the range of 240-310 mosmol/kg. The manufacturing process for PANZYGA isolates IgG without additional chemical or enzymatic modification, and the Fc portion is maintained intact. PANZYGA contains the IgG antibody activities present in the donor population. IgG subclasses are fully represented with the following approximate percents of total IgG: IgG 1 is 65%, IgG 2 is 28%, IgG 3 is 3% and IgG 4 is 4%. PANZYGA contains a broad spectrum of IgG antibodies against bacterial and viral agents that are capable of opsonization and neutralization of microbes and toxins. PANZYGA contains glycine (15.0-19.5 mg/mL), but no preservatives or sucrose. All units of human plasma used in the manufacture of PANZYGA are provided by FDA-approved blood and plasma establishments, and are tested by FDA-licensed serological tests for HBsAg, antibodies to HCV and HIV and Nucleic Acid Test (NAT) for HCV and HIV1 and found to be non-reactive (negative). The product is manufactured by the cold ethanol fractionation process followed by purification methodologies, as well as S/D treatment and nanofiltration (20 nm). The S/D mixture used is composed of tri-n-butyl phosphate (TNBP, solvent) and Triton X-100 (Octoxynol, detergent). The PANZYGA manufacturing process shows significant viral reduction and inactivation, demonstrated by in vitro infectivity studies ( Table 4 ). The virus safety of PANZYGA is achieved through a combination of various process steps, including S/D treatment, ion-exchange chromatography, and nanofiltration (20 nm). Table 4 shows the virus clearance during the manufacturing process for PANZYGA, expressed as the mean log 10 reduction factor (LRF). Table 4: Virus Reduction by PANZYGA Manufacturing Process. HIV-1: Human Immunodeficiency Virus – 1, a model for HIV-1 and HIV-2;. PRV: Pseudorabies Virus, a model for large enveloped DNA viruses (e.g., herpes virus);. BVDV: Bovine Viral Diarrhea Virus, a model for e.g., Hepatitis C virus (HCV) and West-Nile virus (WNV);. MEV: Mouse Encephalomyelitis virus, a model for Hepatitis A virus (HAV);. PPV: Porcine Parvovirus, a model for Human Parvovirus B19;. n.a.: not applicable;. n.d: not done. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents. [ 10 ]. Several of the individual production steps in the PANZYGA manufacturing process were shown to decrease TSE infectivity of that experimental model agent. TSE reduction steps include ion-exchange chromatography and nanofiltration, which together give a total of at least 10.4 log10 decrease of infectivity. These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed.</Description>
  </NDC>
  <NDC>
    <NDCCode>68982-822-03</NDCCode>
    <PackageDescription>1 BOTTLE, GLASS in 1 CARTON (68982-822-03)  / 50 mL in 1 BOTTLE, GLASS (68982-822-83) </PackageDescription>
    <NDC11Code>68982-0822-03</NDC11Code>
    <ProductNDC>68982-822</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Panzyga</ProprietaryName>
    <NonProprietaryName>Immune Globulin Intravenous (human)</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20181112</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125587</ApplicationNumber>
    <LabelerName>Octapharma USA Inc</LabelerName>
    <SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181112</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Immune Globulin Intravenous (Human), PANZYGA, is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. PANZYGA is a solution for infusion to be administered intravenously. This preparation contains approximately 100 mg of protein per mL (10%), of which not less than 96% is normal human immunoglobulin G. PANZYGA contains not more than 3% aggregates, not less than 94% monomers and dimers, and not more than 4% fragments. On average, the product contains 100 µg/mL of IgA, and lower amounts of IgM. PANZYGA contains only trace amounts of sodium, and the pH is between 4.5 and 5.0. The osmolality is in the range of 240-310 mosmol/kg. The manufacturing process for PANZYGA isolates IgG without additional chemical or enzymatic modification, and the Fc portion is maintained intact. PANZYGA contains the IgG antibody activities present in the donor population. IgG subclasses are fully represented with the following approximate percents of total IgG: IgG 1 is 65%, IgG 2 is 28%, IgG 3 is 3% and IgG 4 is 4%. PANZYGA contains a broad spectrum of IgG antibodies against bacterial and viral agents that are capable of opsonization and neutralization of microbes and toxins. PANZYGA contains glycine (15.0-19.5 mg/mL), but no preservatives or sucrose. All units of human plasma used in the manufacture of PANZYGA are provided by FDA-approved blood and plasma establishments, and are tested by FDA-licensed serological tests for HBsAg, antibodies to HCV and HIV and Nucleic Acid Test (NAT) for HCV and HIV1 and found to be non-reactive (negative). The product is manufactured by the cold ethanol fractionation process followed by purification methodologies, as well as S/D treatment and nanofiltration (20 nm). The S/D mixture used is composed of tri-n-butyl phosphate (TNBP, solvent) and Triton X-100 (Octoxynol, detergent). The PANZYGA manufacturing process shows significant viral reduction and inactivation, demonstrated by in vitro infectivity studies ( Table 4 ). The virus safety of PANZYGA is achieved through a combination of various process steps, including S/D treatment, ion-exchange chromatography, and nanofiltration (20 nm). Table 4 shows the virus clearance during the manufacturing process for PANZYGA, expressed as the mean log 10 reduction factor (LRF). Table 4: Virus Reduction by PANZYGA Manufacturing Process. HIV-1: Human Immunodeficiency Virus – 1, a model for HIV-1 and HIV-2;. PRV: Pseudorabies Virus, a model for large enveloped DNA viruses (e.g., herpes virus);. BVDV: Bovine Viral Diarrhea Virus, a model for e.g., Hepatitis C virus (HCV) and West-Nile virus (WNV);. MEV: Mouse Encephalomyelitis virus, a model for Hepatitis A virus (HAV);. PPV: Porcine Parvovirus, a model for Human Parvovirus B19;. n.a.: not applicable;. n.d: not done. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents. [ 10 ]. Several of the individual production steps in the PANZYGA manufacturing process were shown to decrease TSE infectivity of that experimental model agent. TSE reduction steps include ion-exchange chromatography and nanofiltration, which together give a total of at least 10.4 log10 decrease of infectivity. These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed.</Description>
  </NDC>
  <NDC>
    <NDCCode>68982-840-03</NDCCode>
    <PackageDescription>100 mL in 1 BOTTLE, GLASS (68982-840-03) </PackageDescription>
    <NDC11Code>68982-0840-03</NDC11Code>
    <ProductNDC>68982-840</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Octagam Immune Globulin (human)</ProprietaryName>
    <NonProprietaryName>Immune Globulin</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20040521</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125062</ApplicationNumber>
    <LabelerName>Octapharma USA Inc</LabelerName>
    <SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-11-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20040521</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Octagam is an immune globulin intravenous (human), 5% liquid, indicated for treatment of primary humoral immunodeficiency (PI) ( 1 ).</IndicationAndUsage>
    <Description>Immune Globulin Intravenous (Human), Octagam 5% liquid, is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. Octagam 5% liquid is a solution for infusion which must be administered intravenously. All units of human plasma used in the manufacture of Octagam 5% liquid are provided by FDA-approved blood establishments only, and are tested by FDA-licensed serological tests for HBsAg, antibodies to HCV and HIV and Nucleic Acid Test (NAT) for HCV and HIV-1 and found to be non-reactive (negative). The product is manufactured by the cold ethanol fractionation process followed by ultrafiltration and chromatography. The manufacturing process includes treatment with an organic S/D mixture composed of tri-n-butyl phosphate (TNBP) and Triton X-100 (Octoxynol). The Octagam 5% liquid manufacturing process provides a significant viral reduction in in vitro studies (Table 3). These reductions are achieved through a combination of process steps including cold ethanol fractionation, S/D treatment and pH 4 treatment. Table 3: In vitro reduction factor during Octagam 5% liquid manufacturing. *not calculated for global LRF. HIV-1: Human Immunodeficiency Virus - 1. PRV: Pseudorabies Virus. SBV: Sindbis Virus. MEV: Mouse Encephalomyelitis Virus. PPV: Porcine Parvovirus.</Description>
  </NDC>
  <NDC>
    <NDCCode>68982-850-03</NDCCode>
    <PackageDescription>100 mL in 1 BOTTLE, GLASS (68982-850-03) </PackageDescription>
    <NDC11Code>68982-0850-03</NDC11Code>
    <ProductNDC>68982-850</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Octagam Immune Globulin (human)</ProprietaryName>
    <NonProprietaryName>Immune Globulin</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20040521</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125062</ApplicationNumber>
    <LabelerName>Octapharma USA Inc</LabelerName>
    <SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-04-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20040521</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Octagam 10% is an immune globulin intravenous (human) liquid preparation indicated for the treatment of. Chronic immune thrombocytopenic purpura (ITP) in adults ( 1.1 ). Dermatomyositis (DM) in adults ( 1.2 ).</IndicationAndUsage>
    <Description>Immune Globulin Intravenous (Human), Octagam 10%, is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. Octagam 10% is a solution for infusion to be administered intravenously. This preparation contains approximately 100 mg of protein per mL (10%) of which not less than 96% is normal human immunoglobulin G. Octagam 10% contains not more than 3% aggregates, not less than 94% monomers and dimers and not more than 3% fragments. On average, the product contains 106 µg/mL of IgA and even lower amounts of IgM. The sodium content of the final solution is not more than 30 mmol/L and the pH is between 4.5 and 5.0. The osmolality is 310 - 380 mosmol/kg. The manufacturing process for Octagam 10% isolates IgG without additional chemical or enzymatic modification, and the Fc portion is maintained intact Octagam 10% contains the IgG antibody activities present in the donor population. IgG subclasses are fully represented with the following approximate percents of total IgG: IgG 1 is 65%, IgG 2 is 30%, IgG 3 is 3% and IgG 4 is 2%. Octagam 10% contains a broad spectrum of IgG antibodies against bacterial and viral agents that are capable of opsonization and neutralization of microbes and toxins. It contains maltose (90 mg/mL), but no preservatives or sucrose. All units of human plasma used in the manufacture of Octagam 10% are provided by FDA-approved blood establishments, and are tested by FDA-licensed serological tests for HBsAg, antibodies to HCV and HIV and Nucleic Acid Test (NAT) for HCV and HIV-1 and found to be non-reactive (negative). The product is manufactured by the cold ethanol fractionation process followed by ultrafiltration and chromatography. The manufacturing process includes treatment with an organic S/D mixture composed of tri-n-butyl phosphate (TNBP) and Triton X-100 (Octoxynol). The Octagam 10% manufacturing process shows significant viral reduction in in vitro studies (Table 6). These reductions are achieved through a combination of process steps including cold ethanol fractionation, S/D treatment and pH 4 treatment. Table 6: In vitro reduction factor during Octagam 10% manufacturing. *not calculated for global LRF. HIV-1: Human Immunodeficiency Virus - 1. PRV: Pseudorabies Virus. SBV: Sindbis Virus. MEV: Mouse Encephalomyelitis Virus. PPV: Porcine Parvovirus.</Description>
  </NDC>
  <NDC>
    <NDCCode>21220-200-03</NDCCode>
    <PackageDescription>623 L in 1 CYLINDER (21220-200-03) </PackageDescription>
    <NDC11Code>21220-0200-03</NDC11Code>
    <ProductNDC>21220-200</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Helium</ProprietaryName>
    <NonProprietaryName>Helium</NonProprietaryName>
    <DosageFormName>GAS</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>19580101</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA216307</ApplicationNumber>
    <LabelerName>General Air Service &amp; Supply Co</LabelerName>
    <SubstanceName>HELIUM</SubstanceName>
    <StrengthNumber>990</StrengthNumber>
    <StrengthUnit>mL/L</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-11-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19580101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>24694-001-03</NDCCode>
    <PackageDescription>623 L in 1 CYLINDER (24694-001-03) </PackageDescription>
    <NDC11Code>24694-0001-03</NDC11Code>
    <ProductNDC>24694-001</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxygen</ProprietaryName>
    <NonProprietaryName>Oxygen</NonProprietaryName>
    <DosageFormName>GAS</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>19980101</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA205849</ApplicationNumber>
    <LabelerName>Greenville Truck and Welding Supplies LLC</LabelerName>
    <SubstanceName>OXYGEN</SubstanceName>
    <StrengthNumber>99</StrengthNumber>
    <StrengthUnit>L/100L</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-10-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19980101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>42192-623-03</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (42192-623-03)  / 1 KIT in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>42192-0623-03</NDC11Code>
    <ProductNDC>42192-623</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levonorgestrel And Ethinyl Estradiol</ProprietaryName>
    <NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20230821</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA208612</ApplicationNumber>
    <LabelerName>Acella Pharmaceuticals</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230821</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets are indicated for use by females of reproductive potential to prevent pregnancy.</IndicationAndUsage>
    <Description>Levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets provide an oral contraceptive regimen consisting of 21 orange active tablets and 7 blue inactive tablets. : 1 21 orange active tablets each containing 0.10 mg of levonorgestrel, d(-)-13β-ethyl-17α-ethinyl-17β-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol, an estrogenic compound., 2 7 blue inactive tablets each containing 36.5 mg ferrous bisglycinate.</Description>
  </NDC>
  <NDC>
    <NDCCode>46123-008-03</NDCCode>
    <PackageDescription>623 L in 1 CYLINDER (46123-008-03) </PackageDescription>
    <NDC11Code>46123-0008-03</NDC11Code>
    <ProductNDC>46123-008</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Helium</ProprietaryName>
    <NonProprietaryName>Helium</NonProprietaryName>
    <DosageFormName>GAS</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>19670101</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA205864</ApplicationNumber>
    <LabelerName>Roberts Oxygen Company, Inc.</LabelerName>
    <SubstanceName>HELIUM</SubstanceName>
    <StrengthNumber>990</StrengthNumber>
    <StrengthUnit>mL/L</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19670101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>46123-800-03</NDCCode>
    <PackageDescription>623 L in 1 CYLINDER (46123-800-03) </PackageDescription>
    <NDC11Code>46123-0800-03</NDC11Code>
    <ProductNDC>46123-800</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Helium</ProprietaryName>
    <NonProprietaryName>Helium</NonProprietaryName>
    <DosageFormName>GAS</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>19670101</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA213609</ApplicationNumber>
    <LabelerName>Roberts Oxygen Company, Inc.</LabelerName>
    <SubstanceName>HELIUM</SubstanceName>
    <StrengthNumber>990</StrengthNumber>
    <StrengthUnit>mL/L</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-11-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19670101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>49035-623-03</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (49035-623-03)  / 118 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>49035-0623-03</NDC11Code>
    <ProductNDC>49035-623</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Equate Childrens Multi Symptom Cold Nighttime</ProprietaryName>
    <NonProprietaryName>Acetaminophen, Diphenhydramine Hcl, Phenylephrine Hcl</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170801</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>Wal-Mart Stores, Inc.</LabelerName>
    <SubstanceName>ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>325; 12.5; 5</StrengthNumber>
    <StrengthUnit>mg/10mL; mg/10mL; mg/10mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170801</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves these common cold and flu symptoms: 1 cough , 2 sore throat, 3 nasal congestion, 4 runny nose, 5 minor aches and pains, 6 headache, 7 sinus congestion and pressure, 8 sneezing, 9 temporarily reduces fever, 10 controls cough to help your child get to sleep.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>51407-623-03</NDCCode>
    <PackageDescription>300 TABLET, EXTENDED RELEASE in 1 BOTTLE (51407-623-03) </PackageDescription>
    <NDC11Code>51407-0623-03</NDC11Code>
    <ProductNDC>51407-623</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nifedipine</ProprietaryName>
    <NonProprietaryName>Nifedipine</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160825</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202987</ApplicationNumber>
    <LabelerName>Golden State Medical Supply, Inc.</LabelerName>
    <SubstanceName>NIFEDIPINE</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220105</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Nifedipine extended-release tablets, USP are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
    <Description>Nifedipine extended-release tablets, USP are an extended release tablet dosage form of the calcium channel blocker nifedipine. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-dimethyl ester, C 17H 18N 2O 6, and has the structural formula:. Product meets USP dissolution test 10. Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3. Nifedipine extended release tablets contain either: 30, 60, or 90 mg of nifedipine for once-a-day oral administration. Inert ingredients in the 30mg nifedipine extended-release tablet formulation are lactose monohydrate, microcrystalline cellulose, hypromellose, magnesium stearate, polyvinyl alcohol, talc, titanium dioxide, macrogol/polyethylene glycol 3350, lecithin (soy), iron oxide yellow and iron oxide black. Inert ingredients in the 60mg nifedipine extended-release tablet formulation are lactose monohydrate, microcrystalline cellulose, hypromellose, magnesium stearate, polyvinyl alcohol, titanium dioxide, talc, macrogol/polyethylene glycol 3350, lecithin (soy), iron oxide red, iron oxide black and iron oxide yellow. Inert ingredients in the 90mg nifedipine extended-release tablet formulation are: lactose monohydrate, microcrystalline cellulose, hypromellose, magnesium stearate, polyvinyl alcohol, iron oxide red, talc, macrogol/polyethylene glycol 3350, iron oxide yellow, titanium dioxide, lecithin (soy) and iron oxide black.</Description>
  </NDC>
  <NDC>
    <NDCCode>63304-623-03</NDCCode>
    <PackageDescription>10 TABLET in 1 BOTTLE (63304-623-03)</PackageDescription>
    <NDC11Code>63304-0623-03</NDC11Code>
    <ProductNDC>63304-623</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atenolol</ProprietaryName>
    <NonProprietaryName>Atenolol</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20071204</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077877</ApplicationNumber>
    <LabelerName>Ranbaxy Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>ATENOLOL</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Atenolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (eg, on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Atenolol tablets may be administered with other antihypertensive agents.</IndicationAndUsage>
    <Description>Atenolol, a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as benzeneacetamide, 4 -[2’-hydroxy-3’-[(1- methylethyl) amino] propoxy]-. The molecular formula is C14H22N2O3 and its structural formula is:. Atenolol (free base) has a molecular weight of 266. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37° C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25° C) and less soluble in chloroform (3 mg/mL at 25° C). Atenolol tablets, USP are available as 25, 50 and 100 mg tablets for oral administration. Inactive Ingredients: Colloidal silicon dioxide, corn starch, magnesium carbonate, magnesium stearate, sodium lauryl sulfate, sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>63545-623-03</NDCCode>
    <PackageDescription>4000 PELLET in 1 BOTTLE, GLASS (63545-623-03) </PackageDescription>
    <NDC11Code>63545-0623-03</NDC11Code>
    <ProductNDC>63545-623</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Caladium Seguinum</ProprietaryName>
    <NonProprietaryName>Caladium Seguinum</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220509</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Hahnemann Laboratories, INC.</LabelerName>
    <SubstanceName>DIEFFENBACHIA SEGUINE</SubstanceName>
    <StrengthNumber>12</StrengthNumber>
    <StrengthUnit>[hp_C]/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2022-05-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220509</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>67467-623-03</NDCCode>
    <PackageDescription>500 mL in 1 BOTTLE, GLASS (67467-623-03)</PackageDescription>
    <NDC11Code>67467-0623-03</NDC11Code>
    <ProductNDC>67467-623</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Albumin (human)</ProprietaryName>
    <NonProprietaryName>Albumin Human</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20061017</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125154</ApplicationNumber>
    <LabelerName>Octapharma Pharmazeutika Produktionsgesellschaft m.b.H.</LabelerName>
    <SubstanceName>ALBUMIN (HUMAN)</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>g/1000mL</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>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>ALBUMIN (HUMAN) 5% is indicated for the restoration and maintenance of circulating blood volume for. Hypovolemia. (1.1). Hypoalbuminemia. (1.2). Prevention of central volume depletion after paracentesis due to cirrhotic ascites. (1.3).</IndicationAndUsage>
    <Description>ALBUMIN (HUMAN) 5% is a sterile, liquid preparation of albumin derived from large pools of human plasma. All units of human plasma used in the manufacture of ALBUMIN (HUMAN) 5% are provided by FDA approved blood establishments only. The product is manufactured by cold ethanol fractionation followed by ultra- and diafiltration. The manufacturing process includes final container pasteurization and additional bulk pasteurization at 60 +/- 0.5°C for 10 – 11 hours. The ALBUMIN (HUMAN) 5% manufacturing process provides a significant viral reduction in in vitro studies (table 2). These reductions are achieved through a combination of process steps including Cohn fractionation and final container pasteurization. No procedure, however, has been shown to be completely effective in removing viral infectivity from derivatives of human plasma. [see Warnings and Precautions, Infection Risk from Human Plasma (5.7)]. Table 2 In vitro reduction factor during ALBUMIN (HUMAN) 5% manufacturing. PRV: Pseudorabies Virus. SBV: Sindbis Virus. HIV-1: Human Immunodeficiency Virus - 1. Reo 3: Reovirus Type 3. PPV: Porcine Parvovirus. HAV: Hepatitis A Virus. ALBUMIN (HUMAN) 5% is a clear, slightly viscous liquid; it is almost colorless or slightly yellow or green. The composition of ALBUMIN (HUMAN) 5% is as follows. ALBUMIN (HUMAN) 5% contains no preservatives and components used in its packaging are latex-free.</Description>
  </NDC>
  <NDC>
    <NDCCode>68428-623-03</NDCCode>
    <PackageDescription>75 PELLET in 1 VIAL, GLASS (68428-623-03) </PackageDescription>
    <NDC11Code>68428-0623-03</NDC11Code>
    <ProductNDC>68428-623</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sarcolacticum Acidum</ProprietaryName>
    <NonProprietaryName>Lactic Acid, L-</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20101007</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Washington Homeopathic Products</LabelerName>
    <SubstanceName>LACTIC ACID, L-</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>[hp_C]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-04-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20101007</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>75936-623-03</NDCCode>
    <PackageDescription>15 mL in 1 TUBE (75936-623-03) </PackageDescription>
    <NDC11Code>75936-0623-03</NDC11Code>
    <ProductNDC>75936-623</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Mineral Unseen Sunscreen Spf 40</ProprietaryName>
    <NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20231023</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Supergoop, LLC</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>1.33; 17.68</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-06-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231023</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>84756-623-03</NDCCode>
    <PackageDescription>30 g in 1 BOX (84756-623-03) </PackageDescription>
    <NDC11Code>84756-0623-03</NDC11Code>
    <ProductNDC>84756-623</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Papaya Kojic Acid Glutathione</ProprietaryName>
    <NonProprietaryName>Papaya Kojic Acid Glutathione</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20241212</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>Yiwu Luoxin E Commerce Co Ltd</LabelerName>
    <SubstanceName>NIACINAMIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241212</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>68982-820-01</NDCCode>
    <PackageDescription>1 BOTTLE, GLASS in 1 CARTON (68982-820-01)  &gt; 10 mL in 1 BOTTLE, GLASS (68982-820-81) </PackageDescription>
    <NDC11Code>68982-0820-01</NDC11Code>
    <ProductNDC>68982-820</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Panzyga</ProprietaryName>
    <NonProprietaryName>Immune Globulin Intravenous (human)</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20181112</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125587</ApplicationNumber>
    <LabelerName>Octapharma USA Inc</LabelerName>
    <SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181112</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Immune Globulin Intravenous (Human), PANZYGA, is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. PANZYGA is a solution for infusion to be administered intravenously. This preparation contains approximately 100 mg of protein per mL (10%), of which not less than 96% is normal human immunoglobulin G. PANZYGA contains not more than 3% aggregates, not less than 90% monomers and dimers, and not more than 3% fragments. On average, the product contains 100 µg/mL of IgA, and lower amounts of IgM. PANZYGA contains only trace amounts of sodium, and the pH is between 4.5 and 5.0. The osmolality is in the range of 240-310 mosmol/kg. The manufacturing process for PANZYGA isolates IgG without additional chemical or enzymatic modification, and the Fc portion is maintained intact. PANZYGA contains the IgG antibody activities present in the donor population. IgG subclasses are fully represented with the following approximate percents of total IgG: IgG 1 is 65%, IgG 2 is 28%, IgG 3 is 3% and IgG 4 is 4%. PANZYGA contains a broad spectrum of IgG antibodies against bacterial and viral agents that are capable of opsonization and neutralization of microbes and toxins. PANZYGA contains glycine (15.0-19.5 mg/mL), but no preservatives or sucrose. All units of human plasma used in the manufacture of PANZYGA are provided by FDA-approved blood and plasma establishments, and are tested by FDA-licensed serological tests for HBsAg, antibodies to HCV and HIV and Nucleic Acid Test (NAT) for HCV and HIV1 and found to be non-reactive (negative). The product is manufactured by the cold ethanol fractionation process followed by purification methodologies, as well as S/D treatment and nanofiltration (20 nm). The S/D mixture used is composed of tri-n-butyl phosphate (TNBP, solvent) and Triton X-100 (Octoxynol, detergent). The PANZYGA manufacturing process shows significant viral reduction and inactivation, demonstrated by in vitro infectivity studies ( Table 4 ). The virus safety of PANZYGA is achieved through a combination of various process steps, including S/D treatment, ion-exchange chromatography, and nanofiltration (20 nm). Table 4 shows the virus clearance during the manufacturing process for PANZYGA, expressed as the mean log 10 reduction factor (LRF). Table 4: Virus Reduction by PANZYGA Manufacturing Process. HIV-1: Human Immunodeficiency Virus – 1, a model for HIV-1 and HIV-2;. PRV: Pseudorabies Virus, a model for large enveloped DNA viruses (e.g., herpes virus);. BVDV: Bovine Viral Diarrhea Virus, a model for e.g., Hepatitis C virus (HCV) and West-Nile virus (WNV);. MEV: Mouse Encephalomyelitis virus, a model for Hepatitis A virus (HAV);. PPV: Porcine Parvovirus, a model for Human Parvovirus B19;. n.a.: not applicable;. n.d: not done. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents. [ 10 ]. Several of the individual production steps in the PANZYGA manufacturing process were shown to decrease TSE infectivity of that experimental model agent. TSE reduction steps include ion-exchange chromatography and nanofiltration, which together give a total of at least 10.4 log10 decrease of infectivity. These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed.</Description>
  </NDC>
  <NDC>
    <NDCCode>68982-820-02</NDCCode>
    <PackageDescription>1 BOTTLE, GLASS in 1 CARTON (68982-820-02)  &gt; 25 mL in 1 BOTTLE, GLASS (68982-820-82) </PackageDescription>
    <NDC11Code>68982-0820-02</NDC11Code>
    <ProductNDC>68982-820</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Panzyga</ProprietaryName>
    <NonProprietaryName>Immune Globulin Intravenous (human)</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20181112</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125587</ApplicationNumber>
    <LabelerName>Octapharma USA Inc</LabelerName>
    <SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181112</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Immune Globulin Intravenous (Human), PANZYGA, is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. PANZYGA is a solution for infusion to be administered intravenously. This preparation contains approximately 100 mg of protein per mL (10%), of which not less than 96% is normal human immunoglobulin G. PANZYGA contains not more than 3% aggregates, not less than 90% monomers and dimers, and not more than 3% fragments. On average, the product contains 100 µg/mL of IgA, and lower amounts of IgM. PANZYGA contains only trace amounts of sodium, and the pH is between 4.5 and 5.0. The osmolality is in the range of 240-310 mosmol/kg. The manufacturing process for PANZYGA isolates IgG without additional chemical or enzymatic modification, and the Fc portion is maintained intact. PANZYGA contains the IgG antibody activities present in the donor population. IgG subclasses are fully represented with the following approximate percents of total IgG: IgG 1 is 65%, IgG 2 is 28%, IgG 3 is 3% and IgG 4 is 4%. PANZYGA contains a broad spectrum of IgG antibodies against bacterial and viral agents that are capable of opsonization and neutralization of microbes and toxins. PANZYGA contains glycine (15.0-19.5 mg/mL), but no preservatives or sucrose. All units of human plasma used in the manufacture of PANZYGA are provided by FDA-approved blood and plasma establishments, and are tested by FDA-licensed serological tests for HBsAg, antibodies to HCV and HIV and Nucleic Acid Test (NAT) for HCV and HIV1 and found to be non-reactive (negative). The product is manufactured by the cold ethanol fractionation process followed by purification methodologies, as well as S/D treatment and nanofiltration (20 nm). The S/D mixture used is composed of tri-n-butyl phosphate (TNBP, solvent) and Triton X-100 (Octoxynol, detergent). The PANZYGA manufacturing process shows significant viral reduction and inactivation, demonstrated by in vitro infectivity studies ( Table 4 ). The virus safety of PANZYGA is achieved through a combination of various process steps, including S/D treatment, ion-exchange chromatography, and nanofiltration (20 nm). Table 4 shows the virus clearance during the manufacturing process for PANZYGA, expressed as the mean log 10 reduction factor (LRF). Table 4: Virus Reduction by PANZYGA Manufacturing Process. HIV-1: Human Immunodeficiency Virus – 1, a model for HIV-1 and HIV-2;. PRV: Pseudorabies Virus, a model for large enveloped DNA viruses (e.g., herpes virus);. BVDV: Bovine Viral Diarrhea Virus, a model for e.g., Hepatitis C virus (HCV) and West-Nile virus (WNV);. MEV: Mouse Encephalomyelitis virus, a model for Hepatitis A virus (HAV);. PPV: Porcine Parvovirus, a model for Human Parvovirus B19;. n.a.: not applicable;. n.d: not done. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents. [ 10 ]. Several of the individual production steps in the PANZYGA manufacturing process were shown to decrease TSE infectivity of that experimental model agent. TSE reduction steps include ion-exchange chromatography and nanofiltration, which together give a total of at least 10.4 log10 decrease of infectivity. These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed.</Description>
  </NDC>
  <NDC>
    <NDCCode>68982-820-04</NDCCode>
    <PackageDescription>1 BOTTLE, GLASS in 1 CARTON (68982-820-04)  &gt; 100 mL in 1 BOTTLE, GLASS (68982-820-84) </PackageDescription>
    <NDC11Code>68982-0820-04</NDC11Code>
    <ProductNDC>68982-820</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Panzyga</ProprietaryName>
    <NonProprietaryName>Immune Globulin Intravenous (human)</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20181112</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125587</ApplicationNumber>
    <LabelerName>Octapharma USA Inc</LabelerName>
    <SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181112</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Immune Globulin Intravenous (Human), PANZYGA, is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. PANZYGA is a solution for infusion to be administered intravenously. This preparation contains approximately 100 mg of protein per mL (10%), of which not less than 96% is normal human immunoglobulin G. PANZYGA contains not more than 3% aggregates, not less than 90% monomers and dimers, and not more than 3% fragments. On average, the product contains 100 µg/mL of IgA, and lower amounts of IgM. PANZYGA contains only trace amounts of sodium, and the pH is between 4.5 and 5.0. The osmolality is in the range of 240-310 mosmol/kg. The manufacturing process for PANZYGA isolates IgG without additional chemical or enzymatic modification, and the Fc portion is maintained intact. PANZYGA contains the IgG antibody activities present in the donor population. IgG subclasses are fully represented with the following approximate percents of total IgG: IgG 1 is 65%, IgG 2 is 28%, IgG 3 is 3% and IgG 4 is 4%. PANZYGA contains a broad spectrum of IgG antibodies against bacterial and viral agents that are capable of opsonization and neutralization of microbes and toxins. PANZYGA contains glycine (15.0-19.5 mg/mL), but no preservatives or sucrose. All units of human plasma used in the manufacture of PANZYGA are provided by FDA-approved blood and plasma establishments, and are tested by FDA-licensed serological tests for HBsAg, antibodies to HCV and HIV and Nucleic Acid Test (NAT) for HCV and HIV1 and found to be non-reactive (negative). The product is manufactured by the cold ethanol fractionation process followed by purification methodologies, as well as S/D treatment and nanofiltration (20 nm). The S/D mixture used is composed of tri-n-butyl phosphate (TNBP, solvent) and Triton X-100 (Octoxynol, detergent). The PANZYGA manufacturing process shows significant viral reduction and inactivation, demonstrated by in vitro infectivity studies ( Table 4 ). The virus safety of PANZYGA is achieved through a combination of various process steps, including S/D treatment, ion-exchange chromatography, and nanofiltration (20 nm). Table 4 shows the virus clearance during the manufacturing process for PANZYGA, expressed as the mean log 10 reduction factor (LRF). Table 4: Virus Reduction by PANZYGA Manufacturing Process. HIV-1: Human Immunodeficiency Virus – 1, a model for HIV-1 and HIV-2;. PRV: Pseudorabies Virus, a model for large enveloped DNA viruses (e.g., herpes virus);. BVDV: Bovine Viral Diarrhea Virus, a model for e.g., Hepatitis C virus (HCV) and West-Nile virus (WNV);. MEV: Mouse Encephalomyelitis virus, a model for Hepatitis A virus (HAV);. PPV: Porcine Parvovirus, a model for Human Parvovirus B19;. n.a.: not applicable;. n.d: not done. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents. [ 10 ]. Several of the individual production steps in the PANZYGA manufacturing process were shown to decrease TSE infectivity of that experimental model agent. TSE reduction steps include ion-exchange chromatography and nanofiltration, which together give a total of at least 10.4 log10 decrease of infectivity. These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed.</Description>
  </NDC>
  <NDC>
    <NDCCode>68982-820-05</NDCCode>
    <PackageDescription>1 BOTTLE, GLASS in 1 CARTON (68982-820-05)  &gt; 200 mL in 1 BOTTLE, GLASS (68982-820-85) </PackageDescription>
    <NDC11Code>68982-0820-05</NDC11Code>
    <ProductNDC>68982-820</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Panzyga</ProprietaryName>
    <NonProprietaryName>Immune Globulin Intravenous (human)</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20181112</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125587</ApplicationNumber>
    <LabelerName>Octapharma USA Inc</LabelerName>
    <SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181112</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Immune Globulin Intravenous (Human), PANZYGA, is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. PANZYGA is a solution for infusion to be administered intravenously. This preparation contains approximately 100 mg of protein per mL (10%), of which not less than 96% is normal human immunoglobulin G. PANZYGA contains not more than 3% aggregates, not less than 90% monomers and dimers, and not more than 3% fragments. On average, the product contains 100 µg/mL of IgA, and lower amounts of IgM. PANZYGA contains only trace amounts of sodium, and the pH is between 4.5 and 5.0. The osmolality is in the range of 240-310 mosmol/kg. The manufacturing process for PANZYGA isolates IgG without additional chemical or enzymatic modification, and the Fc portion is maintained intact. PANZYGA contains the IgG antibody activities present in the donor population. IgG subclasses are fully represented with the following approximate percents of total IgG: IgG 1 is 65%, IgG 2 is 28%, IgG 3 is 3% and IgG 4 is 4%. PANZYGA contains a broad spectrum of IgG antibodies against bacterial and viral agents that are capable of opsonization and neutralization of microbes and toxins. PANZYGA contains glycine (15.0-19.5 mg/mL), but no preservatives or sucrose. All units of human plasma used in the manufacture of PANZYGA are provided by FDA-approved blood and plasma establishments, and are tested by FDA-licensed serological tests for HBsAg, antibodies to HCV and HIV and Nucleic Acid Test (NAT) for HCV and HIV1 and found to be non-reactive (negative). The product is manufactured by the cold ethanol fractionation process followed by purification methodologies, as well as S/D treatment and nanofiltration (20 nm). The S/D mixture used is composed of tri-n-butyl phosphate (TNBP, solvent) and Triton X-100 (Octoxynol, detergent). The PANZYGA manufacturing process shows significant viral reduction and inactivation, demonstrated by in vitro infectivity studies ( Table 4 ). The virus safety of PANZYGA is achieved through a combination of various process steps, including S/D treatment, ion-exchange chromatography, and nanofiltration (20 nm). Table 4 shows the virus clearance during the manufacturing process for PANZYGA, expressed as the mean log 10 reduction factor (LRF). Table 4: Virus Reduction by PANZYGA Manufacturing Process. HIV-1: Human Immunodeficiency Virus – 1, a model for HIV-1 and HIV-2;. PRV: Pseudorabies Virus, a model for large enveloped DNA viruses (e.g., herpes virus);. BVDV: Bovine Viral Diarrhea Virus, a model for e.g., Hepatitis C virus (HCV) and West-Nile virus (WNV);. MEV: Mouse Encephalomyelitis virus, a model for Hepatitis A virus (HAV);. PPV: Porcine Parvovirus, a model for Human Parvovirus B19;. n.a.: not applicable;. n.d: not done. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents. [ 10 ]. Several of the individual production steps in the PANZYGA manufacturing process were shown to decrease TSE infectivity of that experimental model agent. TSE reduction steps include ion-exchange chromatography and nanofiltration, which together give a total of at least 10.4 log10 decrease of infectivity. These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed.</Description>
  </NDC>
  <NDC>
    <NDCCode>68982-820-06</NDCCode>
    <PackageDescription>1 BOTTLE, GLASS in 1 CARTON (68982-820-06)  &gt; 300 mL in 1 BOTTLE, GLASS (68982-820-86) </PackageDescription>
    <NDC11Code>68982-0820-06</NDC11Code>
    <ProductNDC>68982-820</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Panzyga</ProprietaryName>
    <NonProprietaryName>Immune Globulin Intravenous (human)</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20181112</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125587</ApplicationNumber>
    <LabelerName>Octapharma USA Inc</LabelerName>
    <SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181112</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Immune Globulin Intravenous (Human), PANZYGA, is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. PANZYGA is a solution for infusion to be administered intravenously. This preparation contains approximately 100 mg of protein per mL (10%), of which not less than 96% is normal human immunoglobulin G. PANZYGA contains not more than 3% aggregates, not less than 90% monomers and dimers, and not more than 3% fragments. On average, the product contains 100 µg/mL of IgA, and lower amounts of IgM. PANZYGA contains only trace amounts of sodium, and the pH is between 4.5 and 5.0. The osmolality is in the range of 240-310 mosmol/kg. The manufacturing process for PANZYGA isolates IgG without additional chemical or enzymatic modification, and the Fc portion is maintained intact. PANZYGA contains the IgG antibody activities present in the donor population. IgG subclasses are fully represented with the following approximate percents of total IgG: IgG 1 is 65%, IgG 2 is 28%, IgG 3 is 3% and IgG 4 is 4%. PANZYGA contains a broad spectrum of IgG antibodies against bacterial and viral agents that are capable of opsonization and neutralization of microbes and toxins. PANZYGA contains glycine (15.0-19.5 mg/mL), but no preservatives or sucrose. All units of human plasma used in the manufacture of PANZYGA are provided by FDA-approved blood and plasma establishments, and are tested by FDA-licensed serological tests for HBsAg, antibodies to HCV and HIV and Nucleic Acid Test (NAT) for HCV and HIV1 and found to be non-reactive (negative). The product is manufactured by the cold ethanol fractionation process followed by purification methodologies, as well as S/D treatment and nanofiltration (20 nm). The S/D mixture used is composed of tri-n-butyl phosphate (TNBP, solvent) and Triton X-100 (Octoxynol, detergent). The PANZYGA manufacturing process shows significant viral reduction and inactivation, demonstrated by in vitro infectivity studies ( Table 4 ). The virus safety of PANZYGA is achieved through a combination of various process steps, including S/D treatment, ion-exchange chromatography, and nanofiltration (20 nm). Table 4 shows the virus clearance during the manufacturing process for PANZYGA, expressed as the mean log 10 reduction factor (LRF). Table 4: Virus Reduction by PANZYGA Manufacturing Process. HIV-1: Human Immunodeficiency Virus – 1, a model for HIV-1 and HIV-2;. PRV: Pseudorabies Virus, a model for large enveloped DNA viruses (e.g., herpes virus);. BVDV: Bovine Viral Diarrhea Virus, a model for e.g., Hepatitis C virus (HCV) and West-Nile virus (WNV);. MEV: Mouse Encephalomyelitis virus, a model for Hepatitis A virus (HAV);. PPV: Porcine Parvovirus, a model for Human Parvovirus B19;. n.a.: not applicable;. n.d: not done. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents. [ 10 ]. Several of the individual production steps in the PANZYGA manufacturing process were shown to decrease TSE infectivity of that experimental model agent. TSE reduction steps include ion-exchange chromatography and nanofiltration, which together give a total of at least 10.4 log10 decrease of infectivity. These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed.</Description>
  </NDC>
  <NDC>
    <NDCCode>11383-256-04</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (11383-256-04)  &gt; 118 mL in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>11383-0256-04</NDC11Code>
    <ProductNDC>11383-256</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Weeks And Leo Medicated Vaporizing Steam</ProprietaryName>
    <NonProprietaryName>Camphor (synthetic)</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20111102</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>Weeks &amp; Leo Co., Inc.</LabelerName>
    <SubstanceName>CAMPHOR (SYNTHETIC)</SubstanceName>
    <StrengthNumber>.623</StrengthNumber>
    <StrengthUnit>g/10mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2017-03-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140701</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves cough ocurring with a cold.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>11383-256-08</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (11383-256-08)  &gt; 236 mL in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>11383-0256-08</NDC11Code>
    <ProductNDC>11383-256</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Weeks And Leo Medicated Vaporizing Steam</ProprietaryName>
    <NonProprietaryName>Camphor (synthetic)</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20111102</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>Weeks &amp; Leo Co., Inc.</LabelerName>
    <SubstanceName>CAMPHOR (SYNTHETIC)</SubstanceName>
    <StrengthNumber>.623</StrengthNumber>
    <StrengthUnit>g/10mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2017-03-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140701</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves cough ocurring with a cold.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>12578-623-00</NDCCode>
    <PackageDescription>30 kg in 1 DRUM (12578-623-00) </PackageDescription>
    <NDC11Code>12578-0623-00</NDC11Code>
    <ProductNDC>12578-623</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Icotrokinra</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20260317</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Janssen Pharmaceutica NV</LabelerName>
    <SubstanceName>ICOTROKINRA</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-03-21</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>17-MAR-26</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>31722-623-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (31722-623-30) </PackageDescription>
    <NDC11Code>31722-0623-30</NDC11Code>
    <ProductNDC>31722-623</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Roflumilast</ProprietaryName>
    <NonProprietaryName>Roflumilast</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20221015</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208213</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>ROFLUMILAST</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>ug/1</StrengthUnit>
    <Pharm_Classes>Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-05-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221015</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Roflumilast tablet is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. Limitations of Use Roflumilast tablet is not a bronchodilator and is not indicated for the relief of acute bronchospasm. Roflumilast 250 mcg is a starting dose, for the first 4 weeks of treatment only and is not the effective (therapeutic) dose.</IndicationAndUsage>
    <Description>The active ingredient in roflumilast tablets is roflumilast. Roflumilast and its active metabolite (roflumilast N-oxide) are selective phosphodiesterase 4 (PDE4) inhibitors. The chemical name of roflumilast is 3-(Cyclopropylmethoxy)-N-(3,5-dichloro-4-pyridinyl)-4-(difluoromethoxy) benzamide.  Its empirical formula is C 17H 14C l2F 2N 2O 3 and the molecular weight is 403.21. The chemical structure is:. The drug substance is a light brown to white color powder with a melting point of 154 to 160°C. It is soluble in acetone and slightly soluble in ethanol. Roflumilast tablets are supplied as white to off white, round, flat bevel edged tablets, debossed with 'H' on one side and 'T' (for 250 mcg), and 'I' (for 500 mcg) on the other side. Each tablet contains 250 mcg or 500 mcg of roflumilast. Each tablet of roflumilast for oral administration contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, mannitol, and microcrystalline cellulose.</Description>
  </NDC>
</NDCList>