RESTful Lookup — Test-Drive (2007 – 2026)

<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>64208-8235-6</NDCCode>
    <PackageDescription>1 BOTTLE, GLASS in 1 CARTON (64208-8235-6)  / 100 mL in 1 BOTTLE, GLASS (64208-8235-2) </PackageDescription>
    <NDC11Code>64208-8235-06</NDC11Code>
    <ProductNDC>64208-8235</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Gammaplex</ProprietaryName>
    <NonProprietaryName>Human Immunoglobulin G</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20170407</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125329</ApplicationNumber>
    <LabelerName>Bio Products Laboratory Ltd</LabelerName>
    <SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>g/50mL</StrengthUnit>
    <Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170407</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>GAMMAPLEX 10% is an Immune Globulin Intravenous (Human) 10% Liquid indicated for the treatment of: 1 primary humoral immunodeficiency (PI) in adults and pediatric patients 2 years of age and older (1.1), 2 chronic immune thrombocytopenic purpura (ITP) in adults (1.2).</IndicationAndUsage>
    <Description>GAMMAPLEX 10% is a ready to use sterile solution of polyclonal human Immunoglobulin G for intravenous administration that contains glycine and polysorbate 80 as stabilizers. Specifically, GAMMAPLEX 10% contains approximately 10 g normal human immunoglobulin and 200-300 mM glycine in 100 mL of buffer solution containing: &lt;30 mM acetate, &lt;30 mM sodium chloride and 1-6 mg polysorbate 80. Immunoglobulin G purity is ≥98%, the pH is in the range of 4.9 to 5.3, and osmolality is not less than 240 mOsmol/kg (typically 280 mOsmol/kg). The distribution of the four IgG subclasses reflects that of normal plasma. The content of IgA is less than 20 micrograms/mL. The anti-D and anti-A/anti-B hemagglutinin content of the drug product is strictly controlled to specification. GAMMAPLEX 10% contains no reducing carbohydrate stabilizers (e.g. sucrose, maltose) and no preservative. GAMMAPLEX 10% is prepared from large pools of human plasma by a combination of cold ethanol fractionation and ion exchange chromatography. Fab functions tested include antigen binding activity, and Fc functions tested include complement activation and rubella antibody-mediated hemolysis. GAMMAPLEX 10% is manufactured from plasma, obtained from healthy US donors, who have passed viral screening tests. All donors are subjected to medical examinations, laboratory tests, and a review of their medical history before being allowed to donate blood or plasma. All plasma donations are screened for antibody to HIV-1/2 and hepatitis C virus (HCV), and hepatitis B surface antigen (HBsAg). Additional testing of donations is carried out in plasma mini-pools (512 donations per pool) that undergo nucleic acid amplification testing (NAT) for HIV, hepatitis B virus (HBV), HCV, hepatitis A virus (HAV) and parvovirus B19. Further testing is carried out on the manufacturing pools for HBsAg, and antibody to HIV-1/2; HCV and parvovirus B19 are also tested by NAT, with the limit for B19 set to not exceed 104 IU B19 DNA per mL plasma. There are three processing steps specifically designed to remove or inactivate viruses. 1) Solvent/Detergent treatment is targeted to enveloped viruses;. 2) A virus filtration step designed to remove small viruses including non-enveloped viruses, on a size exclusion basis; and. 3) The terminal low pH incubation step is identified as contributing to the overall viral clearance capacity for enveloped and non-enveloped viruses. The capacity of the manufacturing process to remove and/or inactivate enveloped and non-enveloped viruses has been validated by laboratory spiking studies on a scaled down process model. Overall virus reduction was calculated only from steps that were mechanistically independent from each other. In addition, each step was validated to provide robust virus reduction. Table 5 presents the contribution of each process step to virus reduction and the overall process reduction.</Description>
  </NDC>
  <NDC>
    <NDCCode>58597-8235-6</NDCCode>
    <PackageDescription>100 g in 1 BOTTLE (58597-8235-6)</PackageDescription>
    <NDC11Code>58597-8235-06</NDC11Code>
    <ProductNDC>58597-8235</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20140425</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>AMERICAN PHARMACEUTICAL INGREDIENTS LLC</LabelerName>
    <SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>64208-2510-5</NDCCode>
    <PackageDescription>1 VIAL, GLASS in 1 CARTON (64208-2510-5)  / 500 mL in 1 VIAL, GLASS (64208-2510-6) </PackageDescription>
    <NDC11Code>64208-2510-05</NDC11Code>
    <ProductNDC>64208-2510</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Albuminex</ProprietaryName>
    <NonProprietaryName>Albumin Human</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20200527</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125644</ApplicationNumber>
    <LabelerName>BPL</LabelerName>
    <SubstanceName>ALBUMIN HUMAN</SubstanceName>
    <StrengthNumber>.05</StrengthNumber>
    <StrengthUnit>g/mL</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>2025-01-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200527</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ALBUMINEX 5% is a 5% albumin solution indicated for adults and children: 1 Hypovolemia (1.1), 2 Ascites (1.2), 3 Hypoalbuminemia including from burns (1.3), 4 Acute Nephrosis (1.4), 5 Acute Respiratory Distress Syndrome (ARDS) (1.5), 6 Cardiopulmonary Bypass (1.6).</IndicationAndUsage>
    <Description>ALBUMINEX 5% is a sterile, ready-for-use, clear, slightly viscous, almost colorless, yellow, amber or slightly green aqueous solution of human albumin for single dose intravenous infusion. It is prepared from the pooled plasma of US donors in FDA-licensed facilities in the US. The product also contains 130-160 mmol/L of sodium, less than 200 micrograms/L of aluminum and is stabilized with caprylate (0.08 mmol/g albumin) and acetyltryptophanate (0.08 mmol/g albumin) but does not contain any preservative. 12.5 g (250 mL) of ALBUMINEX 5% is oncotically equivalent to 250 mL plasma. 25 g (500 mL) of ALBUMINEX 5 % is oncotically equivalent to 500 mL plasma. The vials are closed with a synthetic rubber stopper. The stopper is not made with natural rubber latex. The viral risk from human plasma is minimized by the fractionation process and pasteurization of the albumin solution for 10 hours at 60°C (140°F) in its final container. These processes are effective for both enveloped and non-enveloped viruses. There have been no reports of virus transmission with products manufactured using this combination of processes. Typical reductions of experimental viral loads are shown in Table 1.</Description>
  </NDC>
  <NDC>
    <NDCCode>64208-8234-6</NDCCode>
    <PackageDescription>1 BOTTLE, GLASS in 1 CARTON (64208-8234-6)  / 100 mL in 1 BOTTLE, GLASS (64208-8234-2) </PackageDescription>
    <NDC11Code>64208-8234-06</NDC11Code>
    <ProductNDC>64208-8234</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Gammaplex</ProprietaryName>
    <NonProprietaryName>Human Immunoglobulin G</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20101101</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125329</ApplicationNumber>
    <LabelerName>Bio Products Laboratory Limited</LabelerName>
    <SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
    <StrengthNumber>5</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>2025-09-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20101101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>GAMMAPLEX 5% is an Immune Globulin Intravenous (Human) 5% Liquid indicated for the treatment of: 1 primary humoral immunodeficiency (PI) in adults and pediatric patients 2 years of age and older (1.1), 2 chronic immune thrombocytopenic purpura (ITP) (1.2).</IndicationAndUsage>
    <Description>GAMMAPLEX 5% is a ready-to-use sterile solution of polyclonal human Immunoglobulin G for intravenous administration that contains sorbitol, glycine and polysorbate 80 as stabilizers. Specifically, GAMMAPLEX 5% contains approximately 5 g normal human immunoglobulin and 5 g D-sorbitol in 100 mL of buffer solution containing: 0.6 g glycine, 0.2 g sodium acetate, 0.3 g sodium chloride and about 5 mg polysorbate 80. Immunoglobulin G purity is &gt; 95%, the pH is in the range of 4.8 to 5.1, and osmolality is not less than 240 mOsmol/kg (typically 420 to 500 mOsmol/kg). The distribution of the four IgG subclasses is approximately 64% IgG1, 30% IgG2, 5% IgG3, and 1% IgG4. The content of IgA is lower than 10 micrograms/mL. The anti-D and anti-A/anti-B hemagglutinin content of the drug product is strictly controlled to specification. GAMMAPLEX 5% contains no reducing carbohydrate stabilizers (e.g. sucrose, maltose) and no preservative. GAMMAPLEX 5% is prepared from large pools of human plasma by a combination of cold ethanol fractionation and ion exchange chromatography. Fab functions tested include antigen binding activity, and Fc functions tested include complement activation and rubella antibody-mediated hemolysis. GAMMAPLEX 5% is manufactured from plasma, obtained from healthy US donors, who have passed viral screening tests. All donors are subjected to medical examinations, laboratory tests, and a review of their medical history before being allowed to donate blood or plasma. All plasma donations are screened for antibody to HIV-1/2 and hepatitis C virus (HCV), and hepatitis B surface antigen (HBsAg). Additional testing of donations is carried out in plasma mini-pools (512 donations per pool) that undergo nucleic acid amplification testing (NAT) for HIV, hepatitis B virus (HBV), HCV, hepatitis A virus (HAV) and parvovirus B19. Further testing is carried out on the manufacturing pools for HBsAg, and antibody to HIV-1/2; HCV and parvovirus B19 are also tested by NAT, with the limit for B19 set to not exceed 104 IU B19 DNA per mL plasma. There are three processing steps specifically designed to remove or inactivate viruses. 1) Solvent/Detergent treatment is targeted to enveloped viruses;. 2) A virus filtration step designed to remove small viruses including non-enveloped viruses, on a size exclusion basis; and. 3) The terminal low pH incubation step is identified as contributing to the overall viral clearance capacity for enveloped and non-enveloped viruses. The capacity of the manufacturing process to remove and/or inactivate enveloped and non-enveloped viruses has been validated by laboratory spiking studies on a scaled down process model. Overall virus reduction was calculated only from steps that were mechanistically independent from each other. In addition, each step was validated to provide robust virus reduction. The table below presents the contribution of each process step to virus reduction and the overall process reduction.</Description>
  </NDC>
  <NDC>
    <NDCCode>64208-8235-5</NDCCode>
    <PackageDescription>1 BOTTLE, GLASS in 1 CARTON (64208-8235-5)  / 50 mL in 1 BOTTLE, GLASS (64208-8235-1) </PackageDescription>
    <NDC11Code>64208-8235-05</NDC11Code>
    <ProductNDC>64208-8235</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Gammaplex</ProprietaryName>
    <NonProprietaryName>Human Immunoglobulin G</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20170407</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125329</ApplicationNumber>
    <LabelerName>Bio Products Laboratory Ltd</LabelerName>
    <SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>g/50mL</StrengthUnit>
    <Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170407</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>GAMMAPLEX 10% is an Immune Globulin Intravenous (Human) 10% Liquid indicated for the treatment of: 1 primary humoral immunodeficiency (PI) in adults and pediatric patients 2 years of age and older (1.1), 2 chronic immune thrombocytopenic purpura (ITP) in adults (1.2).</IndicationAndUsage>
    <Description>GAMMAPLEX 10% is a ready to use sterile solution of polyclonal human Immunoglobulin G for intravenous administration that contains glycine and polysorbate 80 as stabilizers. Specifically, GAMMAPLEX 10% contains approximately 10 g normal human immunoglobulin and 200-300 mM glycine in 100 mL of buffer solution containing: &lt;30 mM acetate, &lt;30 mM sodium chloride and 1-6 mg polysorbate 80. Immunoglobulin G purity is ≥98%, the pH is in the range of 4.9 to 5.3, and osmolality is not less than 240 mOsmol/kg (typically 280 mOsmol/kg). The distribution of the four IgG subclasses reflects that of normal plasma. The content of IgA is less than 20 micrograms/mL. The anti-D and anti-A/anti-B hemagglutinin content of the drug product is strictly controlled to specification. GAMMAPLEX 10% contains no reducing carbohydrate stabilizers (e.g. sucrose, maltose) and no preservative. GAMMAPLEX 10% is prepared from large pools of human plasma by a combination of cold ethanol fractionation and ion exchange chromatography. Fab functions tested include antigen binding activity, and Fc functions tested include complement activation and rubella antibody-mediated hemolysis. GAMMAPLEX 10% is manufactured from plasma, obtained from healthy US donors, who have passed viral screening tests. All donors are subjected to medical examinations, laboratory tests, and a review of their medical history before being allowed to donate blood or plasma. All plasma donations are screened for antibody to HIV-1/2 and hepatitis C virus (HCV), and hepatitis B surface antigen (HBsAg). Additional testing of donations is carried out in plasma mini-pools (512 donations per pool) that undergo nucleic acid amplification testing (NAT) for HIV, hepatitis B virus (HBV), HCV, hepatitis A virus (HAV) and parvovirus B19. Further testing is carried out on the manufacturing pools for HBsAg, and antibody to HIV-1/2; HCV and parvovirus B19 are also tested by NAT, with the limit for B19 set to not exceed 104 IU B19 DNA per mL plasma. There are three processing steps specifically designed to remove or inactivate viruses. 1) Solvent/Detergent treatment is targeted to enveloped viruses;. 2) A virus filtration step designed to remove small viruses including non-enveloped viruses, on a size exclusion basis; and. 3) The terminal low pH incubation step is identified as contributing to the overall viral clearance capacity for enveloped and non-enveloped viruses. The capacity of the manufacturing process to remove and/or inactivate enveloped and non-enveloped viruses has been validated by laboratory spiking studies on a scaled down process model. Overall virus reduction was calculated only from steps that were mechanistically independent from each other. In addition, each step was validated to provide robust virus reduction. Table 5 presents the contribution of each process step to virus reduction and the overall process reduction.</Description>
  </NDC>
  <NDC>
    <NDCCode>64208-8235-7</NDCCode>
    <PackageDescription>1 BOTTLE, GLASS in 1 CARTON (64208-8235-7)  / 200 mL in 1 BOTTLE, GLASS (64208-8235-3) </PackageDescription>
    <NDC11Code>64208-8235-07</NDC11Code>
    <ProductNDC>64208-8235</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Gammaplex</ProprietaryName>
    <NonProprietaryName>Human Immunoglobulin G</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20170407</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125329</ApplicationNumber>
    <LabelerName>Bio Products Laboratory Ltd</LabelerName>
    <SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>g/50mL</StrengthUnit>
    <Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170407</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>GAMMAPLEX 10% is an Immune Globulin Intravenous (Human) 10% Liquid indicated for the treatment of: 1 primary humoral immunodeficiency (PI) in adults and pediatric patients 2 years of age and older (1.1), 2 chronic immune thrombocytopenic purpura (ITP) in adults (1.2).</IndicationAndUsage>
    <Description>GAMMAPLEX 10% is a ready to use sterile solution of polyclonal human Immunoglobulin G for intravenous administration that contains glycine and polysorbate 80 as stabilizers. Specifically, GAMMAPLEX 10% contains approximately 10 g normal human immunoglobulin and 200-300 mM glycine in 100 mL of buffer solution containing: &lt;30 mM acetate, &lt;30 mM sodium chloride and 1-6 mg polysorbate 80. Immunoglobulin G purity is ≥98%, the pH is in the range of 4.9 to 5.3, and osmolality is not less than 240 mOsmol/kg (typically 280 mOsmol/kg). The distribution of the four IgG subclasses reflects that of normal plasma. The content of IgA is less than 20 micrograms/mL. The anti-D and anti-A/anti-B hemagglutinin content of the drug product is strictly controlled to specification. GAMMAPLEX 10% contains no reducing carbohydrate stabilizers (e.g. sucrose, maltose) and no preservative. GAMMAPLEX 10% is prepared from large pools of human plasma by a combination of cold ethanol fractionation and ion exchange chromatography. Fab functions tested include antigen binding activity, and Fc functions tested include complement activation and rubella antibody-mediated hemolysis. GAMMAPLEX 10% is manufactured from plasma, obtained from healthy US donors, who have passed viral screening tests. All donors are subjected to medical examinations, laboratory tests, and a review of their medical history before being allowed to donate blood or plasma. All plasma donations are screened for antibody to HIV-1/2 and hepatitis C virus (HCV), and hepatitis B surface antigen (HBsAg). Additional testing of donations is carried out in plasma mini-pools (512 donations per pool) that undergo nucleic acid amplification testing (NAT) for HIV, hepatitis B virus (HBV), HCV, hepatitis A virus (HAV) and parvovirus B19. Further testing is carried out on the manufacturing pools for HBsAg, and antibody to HIV-1/2; HCV and parvovirus B19 are also tested by NAT, with the limit for B19 set to not exceed 104 IU B19 DNA per mL plasma. There are three processing steps specifically designed to remove or inactivate viruses. 1) Solvent/Detergent treatment is targeted to enveloped viruses;. 2) A virus filtration step designed to remove small viruses including non-enveloped viruses, on a size exclusion basis; and. 3) The terminal low pH incubation step is identified as contributing to the overall viral clearance capacity for enveloped and non-enveloped viruses. The capacity of the manufacturing process to remove and/or inactivate enveloped and non-enveloped viruses has been validated by laboratory spiking studies on a scaled down process model. Overall virus reduction was calculated only from steps that were mechanistically independent from each other. In addition, each step was validated to provide robust virus reduction. Table 5 presents the contribution of each process step to virus reduction and the overall process reduction.</Description>
  </NDC>
  <NDC>
    <NDCCode>64208-2510-1</NDCCode>
    <PackageDescription>1 VIAL, GLASS in 1 CARTON (64208-2510-1)  / 250 mL in 1 VIAL, GLASS (64208-2510-2) </PackageDescription>
    <NDC11Code>64208-2510-01</NDC11Code>
    <ProductNDC>64208-2510</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Albuminex</ProprietaryName>
    <NonProprietaryName>Albumin Human</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20200527</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125644</ApplicationNumber>
    <LabelerName>BPL</LabelerName>
    <SubstanceName>ALBUMIN HUMAN</SubstanceName>
    <StrengthNumber>.05</StrengthNumber>
    <StrengthUnit>g/mL</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>2025-01-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200527</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ALBUMINEX 5% is a 5% albumin solution indicated for adults and children: 1 Hypovolemia (1.1), 2 Ascites (1.2), 3 Hypoalbuminemia including from burns (1.3), 4 Acute Nephrosis (1.4), 5 Acute Respiratory Distress Syndrome (ARDS) (1.5), 6 Cardiopulmonary Bypass (1.6).</IndicationAndUsage>
    <Description>ALBUMINEX 5% is a sterile, ready-for-use, clear, slightly viscous, almost colorless, yellow, amber or slightly green aqueous solution of human albumin for single dose intravenous infusion. It is prepared from the pooled plasma of US donors in FDA-licensed facilities in the US. The product also contains 130-160 mmol/L of sodium, less than 200 micrograms/L of aluminum and is stabilized with caprylate (0.08 mmol/g albumin) and acetyltryptophanate (0.08 mmol/g albumin) but does not contain any preservative. 12.5 g (250 mL) of ALBUMINEX 5% is oncotically equivalent to 250 mL plasma. 25 g (500 mL) of ALBUMINEX 5 % is oncotically equivalent to 500 mL plasma. The vials are closed with a synthetic rubber stopper. The stopper is not made with natural rubber latex. The viral risk from human plasma is minimized by the fractionation process and pasteurization of the albumin solution for 10 hours at 60°C (140°F) in its final container. These processes are effective for both enveloped and non-enveloped viruses. There have been no reports of virus transmission with products manufactured using this combination of processes. Typical reductions of experimental viral loads are shown in Table 1.</Description>
  </NDC>
  <NDC>
    <NDCCode>64208-2512-3</NDCCode>
    <PackageDescription>1 VIAL, GLASS in 1 CARTON (64208-2512-3)  / 50 mL in 1 VIAL, GLASS (64208-2512-4) </PackageDescription>
    <NDC11Code>64208-2512-03</NDC11Code>
    <ProductNDC>64208-2512</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Albuminex</ProprietaryName>
    <NonProprietaryName>Albumin Human</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20200527</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125644</ApplicationNumber>
    <LabelerName>BPL</LabelerName>
    <SubstanceName>ALBUMIN HUMAN</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>g/mL</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>2025-01-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200527</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ALBUMINEX 25% is a 25% albumin solution indicated for adults and children : 1 Hypovolemia (1.1), 2 Ascites (1.2), 3 Hypoalbuminemia including from burns (1.3), 4 Acute Nephrosis (1.4), 5 Acute Respiratory Distress Syndrome (ARDS) (1.5), 6 Cardiopulmonary Bypass (1.6).</IndicationAndUsage>
    <Description>ALBUMINEX 25% is a sterile, ready-for-use, clear, slightly viscous, almost colorless, yellow, amber or slightly green aqueous solution of human albumin for single dose intravenous infusion. It is prepared from the pooled plasma of US donors in FDA-licensed facilities in the US. The product also contains 130-160 mmol/L of sodium, less than 200 micrograms/L of aluminum and is stabilized with caprylate (0.08 mmol/g albumin) and acetyltryptophanate (0.08 mmol/g albumin) but does not contain any preservative. 12.5 g (50 mL) of ALBUMINEX 25% is oncotically equivalent to 250 mL plasma.25 g (100 mL) of ALBUMINEX 25% is oncotically equivalent to 500 mL plasma. The vials are closed with a synthetic rubber stopper. The stopper is not made with natural rubber latex. The viral risk from human plasma is minimized by the fractionation process and pasteurization of the albumin solution for 10 hours at 60°C (140°F) in its final container. These processes are effective for both enveloped and non-enveloped viruses. There have been no reports of virus transmission with products manufactured using this combination of processes. Typical reductions of experimental viral loads are shown in Table 1.</Description>
  </NDC>
  <NDC>
    <NDCCode>64208-2512-7</NDCCode>
    <PackageDescription>1 VIAL, GLASS in 1 CARTON (64208-2512-7)  / 100 mL in 1 VIAL, GLASS (64208-2512-8) </PackageDescription>
    <NDC11Code>64208-2512-07</NDC11Code>
    <ProductNDC>64208-2512</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Albuminex</ProprietaryName>
    <NonProprietaryName>Albumin Human</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20200527</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125644</ApplicationNumber>
    <LabelerName>BPL</LabelerName>
    <SubstanceName>ALBUMIN HUMAN</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>g/mL</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>2025-01-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200527</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ALBUMINEX 25% is a 25% albumin solution indicated for adults and children : 1 Hypovolemia (1.1), 2 Ascites (1.2), 3 Hypoalbuminemia including from burns (1.3), 4 Acute Nephrosis (1.4), 5 Acute Respiratory Distress Syndrome (ARDS) (1.5), 6 Cardiopulmonary Bypass (1.6).</IndicationAndUsage>
    <Description>ALBUMINEX 25% is a sterile, ready-for-use, clear, slightly viscous, almost colorless, yellow, amber or slightly green aqueous solution of human albumin for single dose intravenous infusion. It is prepared from the pooled plasma of US donors in FDA-licensed facilities in the US. The product also contains 130-160 mmol/L of sodium, less than 200 micrograms/L of aluminum and is stabilized with caprylate (0.08 mmol/g albumin) and acetyltryptophanate (0.08 mmol/g albumin) but does not contain any preservative. 12.5 g (50 mL) of ALBUMINEX 25% is oncotically equivalent to 250 mL plasma.25 g (100 mL) of ALBUMINEX 25% is oncotically equivalent to 500 mL plasma. The vials are closed with a synthetic rubber stopper. The stopper is not made with natural rubber latex. The viral risk from human plasma is minimized by the fractionation process and pasteurization of the albumin solution for 10 hours at 60°C (140°F) in its final container. These processes are effective for both enveloped and non-enveloped viruses. There have been no reports of virus transmission with products manufactured using this combination of processes. Typical reductions of experimental viral loads are shown in Table 1.</Description>
  </NDC>
  <NDC>
    <NDCCode>64208-8234-7</NDCCode>
    <PackageDescription>1 BOTTLE, GLASS in 1 CARTON (64208-8234-7)  / 200 mL in 1 BOTTLE, GLASS (64208-8234-3) </PackageDescription>
    <NDC11Code>64208-8234-07</NDC11Code>
    <ProductNDC>64208-8234</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Gammaplex</ProprietaryName>
    <NonProprietaryName>Human Immunoglobulin G</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20101101</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125329</ApplicationNumber>
    <LabelerName>Bio Products Laboratory Limited</LabelerName>
    <SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
    <StrengthNumber>5</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>2025-09-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20101101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>GAMMAPLEX 5% is an Immune Globulin Intravenous (Human) 5% Liquid indicated for the treatment of: 1 primary humoral immunodeficiency (PI) in adults and pediatric patients 2 years of age and older (1.1), 2 chronic immune thrombocytopenic purpura (ITP) (1.2).</IndicationAndUsage>
    <Description>GAMMAPLEX 5% is a ready-to-use sterile solution of polyclonal human Immunoglobulin G for intravenous administration that contains sorbitol, glycine and polysorbate 80 as stabilizers. Specifically, GAMMAPLEX 5% contains approximately 5 g normal human immunoglobulin and 5 g D-sorbitol in 100 mL of buffer solution containing: 0.6 g glycine, 0.2 g sodium acetate, 0.3 g sodium chloride and about 5 mg polysorbate 80. Immunoglobulin G purity is &gt; 95%, the pH is in the range of 4.8 to 5.1, and osmolality is not less than 240 mOsmol/kg (typically 420 to 500 mOsmol/kg). The distribution of the four IgG subclasses is approximately 64% IgG1, 30% IgG2, 5% IgG3, and 1% IgG4. The content of IgA is lower than 10 micrograms/mL. The anti-D and anti-A/anti-B hemagglutinin content of the drug product is strictly controlled to specification. GAMMAPLEX 5% contains no reducing carbohydrate stabilizers (e.g. sucrose, maltose) and no preservative. GAMMAPLEX 5% is prepared from large pools of human plasma by a combination of cold ethanol fractionation and ion exchange chromatography. Fab functions tested include antigen binding activity, and Fc functions tested include complement activation and rubella antibody-mediated hemolysis. GAMMAPLEX 5% is manufactured from plasma, obtained from healthy US donors, who have passed viral screening tests. All donors are subjected to medical examinations, laboratory tests, and a review of their medical history before being allowed to donate blood or plasma. All plasma donations are screened for antibody to HIV-1/2 and hepatitis C virus (HCV), and hepatitis B surface antigen (HBsAg). Additional testing of donations is carried out in plasma mini-pools (512 donations per pool) that undergo nucleic acid amplification testing (NAT) for HIV, hepatitis B virus (HBV), HCV, hepatitis A virus (HAV) and parvovirus B19. Further testing is carried out on the manufacturing pools for HBsAg, and antibody to HIV-1/2; HCV and parvovirus B19 are also tested by NAT, with the limit for B19 set to not exceed 104 IU B19 DNA per mL plasma. There are three processing steps specifically designed to remove or inactivate viruses. 1) Solvent/Detergent treatment is targeted to enveloped viruses;. 2) A virus filtration step designed to remove small viruses including non-enveloped viruses, on a size exclusion basis; and. 3) The terminal low pH incubation step is identified as contributing to the overall viral clearance capacity for enveloped and non-enveloped viruses. The capacity of the manufacturing process to remove and/or inactivate enveloped and non-enveloped viruses has been validated by laboratory spiking studies on a scaled down process model. Overall virus reduction was calculated only from steps that were mechanistically independent from each other. In addition, each step was validated to provide robust virus reduction. The table below presents the contribution of each process step to virus reduction and the overall process reduction.</Description>
  </NDC>
  <NDC>
    <NDCCode>64208-8234-8</NDCCode>
    <PackageDescription>1 BOTTLE, GLASS in 1 CARTON (64208-8234-8)  / 400 mL in 1 BOTTLE, GLASS (64208-8234-4) </PackageDescription>
    <NDC11Code>64208-8234-08</NDC11Code>
    <ProductNDC>64208-8234</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Gammaplex</ProprietaryName>
    <NonProprietaryName>Human Immunoglobulin G</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20101101</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125329</ApplicationNumber>
    <LabelerName>Bio Products Laboratory Limited</LabelerName>
    <SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
    <StrengthNumber>5</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>2025-09-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20101101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>GAMMAPLEX 5% is an Immune Globulin Intravenous (Human) 5% Liquid indicated for the treatment of: 1 primary humoral immunodeficiency (PI) in adults and pediatric patients 2 years of age and older (1.1), 2 chronic immune thrombocytopenic purpura (ITP) (1.2).</IndicationAndUsage>
    <Description>GAMMAPLEX 5% is a ready-to-use sterile solution of polyclonal human Immunoglobulin G for intravenous administration that contains sorbitol, glycine and polysorbate 80 as stabilizers. Specifically, GAMMAPLEX 5% contains approximately 5 g normal human immunoglobulin and 5 g D-sorbitol in 100 mL of buffer solution containing: 0.6 g glycine, 0.2 g sodium acetate, 0.3 g sodium chloride and about 5 mg polysorbate 80. Immunoglobulin G purity is &gt; 95%, the pH is in the range of 4.8 to 5.1, and osmolality is not less than 240 mOsmol/kg (typically 420 to 500 mOsmol/kg). The distribution of the four IgG subclasses is approximately 64% IgG1, 30% IgG2, 5% IgG3, and 1% IgG4. The content of IgA is lower than 10 micrograms/mL. The anti-D and anti-A/anti-B hemagglutinin content of the drug product is strictly controlled to specification. GAMMAPLEX 5% contains no reducing carbohydrate stabilizers (e.g. sucrose, maltose) and no preservative. GAMMAPLEX 5% is prepared from large pools of human plasma by a combination of cold ethanol fractionation and ion exchange chromatography. Fab functions tested include antigen binding activity, and Fc functions tested include complement activation and rubella antibody-mediated hemolysis. GAMMAPLEX 5% is manufactured from plasma, obtained from healthy US donors, who have passed viral screening tests. All donors are subjected to medical examinations, laboratory tests, and a review of their medical history before being allowed to donate blood or plasma. All plasma donations are screened for antibody to HIV-1/2 and hepatitis C virus (HCV), and hepatitis B surface antigen (HBsAg). Additional testing of donations is carried out in plasma mini-pools (512 donations per pool) that undergo nucleic acid amplification testing (NAT) for HIV, hepatitis B virus (HBV), HCV, hepatitis A virus (HAV) and parvovirus B19. Further testing is carried out on the manufacturing pools for HBsAg, and antibody to HIV-1/2; HCV and parvovirus B19 are also tested by NAT, with the limit for B19 set to not exceed 104 IU B19 DNA per mL plasma. There are three processing steps specifically designed to remove or inactivate viruses. 1) Solvent/Detergent treatment is targeted to enveloped viruses;. 2) A virus filtration step designed to remove small viruses including non-enveloped viruses, on a size exclusion basis; and. 3) The terminal low pH incubation step is identified as contributing to the overall viral clearance capacity for enveloped and non-enveloped viruses. The capacity of the manufacturing process to remove and/or inactivate enveloped and non-enveloped viruses has been validated by laboratory spiking studies on a scaled down process model. Overall virus reduction was calculated only from steps that were mechanistically independent from each other. In addition, each step was validated to provide robust virus reduction. The table below presents the contribution of each process step to virus reduction and the overall process reduction.</Description>
  </NDC>
  <NDC>
    <NDCCode>63629-8235-1</NDCCode>
    <PackageDescription>30 TABLET, CHEWABLE in 1 BOTTLE (63629-8235-1) </PackageDescription>
    <NDC11Code>63629-8235-01</NDC11Code>
    <ProductNDC>63629-8235</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Montelukast Sodium</ProprietaryName>
    <NonProprietaryName>Montelukast</NonProprietaryName>
    <DosageFormName>TABLET, CHEWABLE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150813</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203328</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>MONTELUKAST SODIUM</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190828</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Montelukast sodium tablets, chewable tablets, and oral granules are a leukotriene receptor antagonist indicated for: 1 Prophylaxis and chronic treatment of asthma in patients 12 months of age and older (1.1). , 2 Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older (1.2). , 3 Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 2 years of age and older, and perennial allergic rhinitis (PAR) in patients 6 months of age and older. Reserve use for patients who have an inadequate response or intolerance to alternative therapies (1.3).</IndicationAndUsage>
    <Description>Montelukast sodium USP, the active ingredient in montelukast sodium tablets, chewable tablets and oral granules, is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT1 receptor. Montelukast sodium is described chemically as [R-(E)]-1-[[[1-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl] cyclopropaneacetic acid, monosodium salt. The empirical formula is C35H35ClNNaO3S, and its molecular weight is 608.18. The structural formula is. Montelukast sodium is a hygroscopic, optically active, white to off-white powder. Montelukast sodium is freely soluble in ethanol, methanol, and water and practically insoluble in acetonitrile. Each 10-mg film-coated montelukast sodium tablet contains 10.4 mg montelukast sodium USP, which is equivalent to 10 mg of montelukast, and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, hydroxypropyl cellulose, and magnesium stearate. The film coating consists of: hydroxypropyl methylcellulose, hydroxypropyl cellulose, titanium dioxide, ferric oxide red and ferric oxide yellow. Each 4-mg and 5-mg chewable montelukast sodium tablet contains 4.2 and 5.2 mg montelukast sodium USP, respectively, which are equivalent to 4 and 5 mg of montelukast, respectively. Both chewable tablets contain the following inactive ingredients: mannitol, microcrystalline cellulose, hydroxypropyl cellulose, ferric oxide red, croscarmellose sodium, cherry flavor, aspartame, and magnesium stearate. Each sachet of montelukast sodium 4-mg oral granules contains 4.2 mg montelukast sodium USP, which is equivalent to 4 mg of montelukast. The oral granule formulation contains the following inactive ingredients: mannitol, hydroxypropyl cellulose, and magnesium stearate. Montelukast sodium oral granules meets USP Dissolution Test 4.</Description>
  </NDC>
  <NDC>
    <NDCCode>64208-7752-1</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (64208-7752-1)  *  10 mL in 1 VIAL, GLASS (64208-7754-1)  *  2.5 mL in 1 VIAL, GLASS (64208-7755-1) </PackageDescription>
    <NDC11Code>64208-7752-01</NDC11Code>
    <ProductNDC>64208-7752</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Coagadex</ProprietaryName>
    <NonProprietaryName>Coagulation Factor X Human</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20151021</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125506</ApplicationNumber>
    <LabelerName>Bio Products Laboratory Ltd</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-04-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151021</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>COAGADEX, Coagulation Factor X (Human), is a plasma-derived human blood coagulation Factor indicated in adults and children with hereditary Factor X deficiency for: 1 Routine prophylaxis to reduce the frequency of bleeding episodes, 2 On-demand treatment and control of bleeding episodes, 3 Perioperative management of bleeding in patients with mild, moderate, and severe hereditary Factor X deficiency.</IndicationAndUsage>
    <Description>COAGADEX is a plasma-derived, sterile, purified concentrate of human coagulation Factor X that contains sucrose as a stabilizer. It is formulated as a lyophilized powder for solution for intravenous administration. When reconstituted with Sterile Water for Injection it forms a colorless, clear or slightly pearl-like solution. COAGADEX contains nominally (approximately) 100 IU/mL of coagulation Factor X and the following inactive ingredients: chloride, phosphate, citrate, sucrose and sodium. Each vial of COAGADEX is labeled with the actual Factor X activity/content expressed in IU per vial. Factor X activity in IU is determined using an in vitro chromogenic assay and a Factor X concentrate reference standard calibrated against the current WHO International Standard for Blood Coagulation Factors II and X Concentrate. COAGADEX contains no added biological components such as heparin, albumin or anti-thrombin. The content of Factor II and Factor IX are ≤ 1 IU/mL of the reconstituted product. Factor Xa and Factor IIa were not detectable by Non-activated Partial Thromboplastin Time (NaPTT) or Fibrinogen Clotting Time (FCT) tests for potential thrombogenicity, and comprised &lt; 10 parts per million by weight when tested by more sensitive analytical methods. The specific activity of COAGADEX is typically 80-137 IU per mg protein. The product contains no preservatives. COAGADEX is manufactured from plasma, obtained from healthy US donors, who have passed viral screening tests. All donors are subjected to medical examinations, laboratory tests, and a review of their medical history before being allowed to donate blood or plasma. All plasma donations are screened for antibody to human immunodeficiency virus (HIV)-1/2, hepatitis C virus (HCV), and hepatitis B surface antigen (HBsAg). Additional testing of donations is carried out in plasma mini-pools (512 donations per pool) with nucleic acid amplification testing (NAT) for HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), hepatitis A virus (HAV) and human parvovirus B19. Furthermore, each manufacturing pool is tested to be negative for HBsAg and anti-HIV-1/2 antibodies. Also, manufacturing pools are non-reactive by nucleic acid test for HAV, HBV, HCV, and HIV-1. The limit for human parvovirus B19 in the manufacturing pools is set not to exceed 104 IU/mL. Three processing steps specifically designed to remove or inactivate viruses are. 1) Solvent/detergent treatment targeted to inactivate enveloped viruses. 2) A 15-nm filtration step designed to remove small viruses including non-enveloped viruses. 3) Terminal dry-heat treatment at 80°C for 72 hours in the final container to inactivate enveloped and non-enveloped viruses. The capacity of the manufacturing process to remove and/or inactivate enveloped and non-enveloped viruses has been validated by laboratory spiking studies on a scaled-down process model. Overall virus reduction was calculated only from steps that were mechanistically independent from each other. Table 2 presents the contribution of each process step to virus reduction and the overall process reduction.</Description>
  </NDC>
  <NDC>
    <NDCCode>64208-7753-1</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (64208-7753-1)  *  10 mL in 1 VIAL, GLASS (64208-7756-1)  *  5 mL in 1 VIAL, GLASS (64208-7755-2) </PackageDescription>
    <NDC11Code>64208-7753-01</NDC11Code>
    <ProductNDC>64208-7753</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Coagadex</ProprietaryName>
    <NonProprietaryName>Coagulation Factor X Human</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20151021</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125506</ApplicationNumber>
    <LabelerName>Bio Products Laboratory Ltd</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-04-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151021</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>COAGADEX, Coagulation Factor X (Human), is a plasma-derived human blood coagulation Factor indicated in adults and children with hereditary Factor X deficiency for: 1 Routine prophylaxis to reduce the frequency of bleeding episodes, 2 On-demand treatment and control of bleeding episodes, 3 Perioperative management of bleeding in patients with mild, moderate, and severe hereditary Factor X deficiency.</IndicationAndUsage>
    <Description>COAGADEX is a plasma-derived, sterile, purified concentrate of human coagulation Factor X that contains sucrose as a stabilizer. It is formulated as a lyophilized powder for solution for intravenous administration. When reconstituted with Sterile Water for Injection it forms a colorless, clear or slightly pearl-like solution. COAGADEX contains nominally (approximately) 100 IU/mL of coagulation Factor X and the following inactive ingredients: chloride, phosphate, citrate, sucrose and sodium. Each vial of COAGADEX is labeled with the actual Factor X activity/content expressed in IU per vial. Factor X activity in IU is determined using an in vitro chromogenic assay and a Factor X concentrate reference standard calibrated against the current WHO International Standard for Blood Coagulation Factors II and X Concentrate. COAGADEX contains no added biological components such as heparin, albumin or anti-thrombin. The content of Factor II and Factor IX are ≤ 1 IU/mL of the reconstituted product. Factor Xa and Factor IIa were not detectable by Non-activated Partial Thromboplastin Time (NaPTT) or Fibrinogen Clotting Time (FCT) tests for potential thrombogenicity, and comprised &lt; 10 parts per million by weight when tested by more sensitive analytical methods. The specific activity of COAGADEX is typically 80-137 IU per mg protein. The product contains no preservatives. COAGADEX is manufactured from plasma, obtained from healthy US donors, who have passed viral screening tests. All donors are subjected to medical examinations, laboratory tests, and a review of their medical history before being allowed to donate blood or plasma. All plasma donations are screened for antibody to human immunodeficiency virus (HIV)-1/2, hepatitis C virus (HCV), and hepatitis B surface antigen (HBsAg). Additional testing of donations is carried out in plasma mini-pools (512 donations per pool) with nucleic acid amplification testing (NAT) for HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), hepatitis A virus (HAV) and human parvovirus B19. Furthermore, each manufacturing pool is tested to be negative for HBsAg and anti-HIV-1/2 antibodies. Also, manufacturing pools are non-reactive by nucleic acid test for HAV, HBV, HCV, and HIV-1. The limit for human parvovirus B19 in the manufacturing pools is set not to exceed 104 IU/mL. Three processing steps specifically designed to remove or inactivate viruses are. 1) Solvent/detergent treatment targeted to inactivate enveloped viruses. 2) A 15-nm filtration step designed to remove small viruses including non-enveloped viruses. 3) Terminal dry-heat treatment at 80°C for 72 hours in the final container to inactivate enveloped and non-enveloped viruses. The capacity of the manufacturing process to remove and/or inactivate enveloped and non-enveloped viruses has been validated by laboratory spiking studies on a scaled-down process model. Overall virus reduction was calculated only from steps that were mechanistically independent from each other. Table 2 presents the contribution of each process step to virus reduction and the overall process reduction.</Description>
  </NDC>
  <NDC>
    <NDCCode>64208-8234-5</NDCCode>
    <PackageDescription>1 BOTTLE, GLASS in 1 CARTON (64208-8234-5)  &gt; 50 mL in 1 BOTTLE, GLASS (64208-8234-1) </PackageDescription>
    <NDC11Code>64208-8234-05</NDC11Code>
    <ProductNDC>64208-8234</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Gammaplex</ProprietaryName>
    <NonProprietaryName>Human Immunoglobulin G</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20101101</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125329</ApplicationNumber>
    <LabelerName>Bio Products Laboratory Limited</LabelerName>
    <SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-12-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20101101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>70710-2091-3</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (70710-2091-3)  *  4 mL in 1 VIAL, GLASS (70710-2090-1)  *  50 mL in 1 VIAL, GLASS (64208-2512-4) </PackageDescription>
    <NDC11Code>70710-2091-03</NDC11Code>
    <ProductNDC>70710-2091</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Beizray</ProprietaryName>
    <NonProprietaryName>Docetaxel</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20250828</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA218711</ApplicationNumber>
    <LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-12-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250828</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>BEIZRAY is a microtubule inhibitor indicated for: : 1 Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC (1.1), 2 Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC (1.2), 3 Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer (1.3), 4 Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction (1.4), 5 Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN (1.5).</IndicationAndUsage>
    <Description>Docetaxel is an antineoplastic agent belonging to the taxoid family. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β, 20-epoxy-1,2α,4,7β,10β,13α-hex-ahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel has the following structural formula. Docetaxel is a white to almost-white powder with an empirical formula of C43H53NO14, and a molecular weight of 807.89. It is highly lipophilic and practically insoluble in water. BEIZRAY Injection for intravenous use is a sterile, non-pyrogenic, clear colorless liquid at 20 mg/mL concentration. Each mL contains 20 mg docetaxel (anhydrous) in 0.770 grams dehydrated alcohol (100% v/v) solution, with citric acid for pH adjustment. The BEIZRAY kit also contains a single dose vial of IV Solution Stabilizer, 50 mL of 25% Albumin Human USP solution. 25% Albumin Human USP is a clear, slightly viscous liquid; it is almost colorless or slightly yellow or green. The product contains 0.25 g Albumin Human USP per mL and is stabilized with 0.08 mmol sodium acetyltryptophanate and 0.08 mmol sodium caprylate per gram of albumin.</Description>
  </NDC>
  <NDC>
    <NDCCode>70710-2093-4</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (70710-2093-4)  *  4 mL in 1 VIAL, GLASS (70710-2090-1)  *  50 mL in 1 VIAL, GLASS (64208-2512-4)  *  4 mL in 1 VIAL, GLASS (70710-2090-1) </PackageDescription>
    <NDC11Code>70710-2093-04</NDC11Code>
    <ProductNDC>70710-2093</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Beizray</ProprietaryName>
    <NonProprietaryName>Docetaxel</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20250828</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA218711</ApplicationNumber>
    <LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-12-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250828</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>BEIZRAY is a microtubule inhibitor indicated for: : 1 Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC (1.1), 2 Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC (1.2), 3 Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer (1.3), 4 Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction (1.4), 5 Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN (1.5).</IndicationAndUsage>
    <Description>Docetaxel is an antineoplastic agent belonging to the taxoid family. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β, 20-epoxy-1,2α,4,7β,10β,13α-hex-ahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel has the following structural formula. Docetaxel is a white to almost-white powder with an empirical formula of C43H53NO14, and a molecular weight of 807.89. It is highly lipophilic and practically insoluble in water. BEIZRAY Injection for intravenous use is a sterile, non-pyrogenic, clear colorless liquid at 20 mg/mL concentration. Each mL contains 20 mg docetaxel (anhydrous) in 0.770 grams dehydrated alcohol (100% v/v) solution, with citric acid for pH adjustment. The BEIZRAY kit also contains a single dose vial of IV Solution Stabilizer, 50 mL of 25% Albumin Human USP solution. 25% Albumin Human USP is a clear, slightly viscous liquid; it is almost colorless or slightly yellow or green. The product contains 0.25 g Albumin Human USP per mL and is stabilized with 0.08 mmol sodium acetyltryptophanate and 0.08 mmol sodium caprylate per gram of albumin.</Description>
  </NDC>
  <NDC>
    <NDCCode>0002-8235-05</NDCCode>
    <PackageDescription>5 SYRINGE in 1 CARTON (0002-8235-05)  / 3 mL in 1 SYRINGE (0002-8235-01) </PackageDescription>
    <NDC11Code>00002-8235-05</NDC11Code>
    <ProductNDC>0002-8235</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lyumjev</ProprietaryName>
    <ProprietaryNameSuffix>Tempo Pen</ProprietaryNameSuffix>
    <NonProprietaryName>Insulin Lispro-aabc</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20200615</StartMarketingDate>
    <EndMarketingDate>20271106</EndMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761109</ApplicationNumber>
    <LabelerName>Eli Lilly and Company</LabelerName>
    <SubstanceName>INSULIN LISPRO</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>[iU]/mL</StrengthUnit>
    <Pharm_Classes>Insulin Analog [EPC], Insulin [Chemical/Ingredient]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20220929</StartMarketingDatePackage>
    <EndMarketingDatePackage>20271106</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>LYUMJEV® is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.</IndicationAndUsage>
    <Description>Insulin lispro-aabc is a rapid-acting human insulin analog used to lower blood glucose. Insulin lispro-aabc is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin lispro-aabc differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. Chemically, it is Lys(B28), Pro(B29) human insulin analog and has the empirical formula C257H383N65O77S6 and a molecular weight of 5808 daltons, both identical to that of human insulin. Insulin lispro-aabc has the following primary structure:. LYUMJEV (insulin lispro-aabc) injection is a sterile, aqueous, clear, and colorless solution for subcutaneous or intravenous administration. Each mL of LYUMJEV U-100 contains 100 units of insulin lispro-aabc and the inactive ingredients: glycerol (12.1 mg), magnesium chloride hexahydrate (1.02 mg), metacresol (3.15 mg), sodium citrate dihydrate (4.41 mg), treprostinil sodium (1.06 mcg), zinc oxide (content adjusted to provide 39 mcg zinc ion), and Water for Injection, USP. Each mL of LYUMJEV U-200 contains 200 units of insulin lispro-aabc and the inactive ingredients: glycerol (12.1 mg), magnesium chloride hexahydrate (1.02 mg), metacresol (3.15 mg), sodium citrate dihydrate (4.41 mg), treprostinil sodium (1.06 mcg), zinc oxide (content adjusted to provide 52 mcg zinc ion), and Water for Injection, USP. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH. LYUMJEV has a pH of 7.0 to 7.8.</Description>
  </NDC>
  <NDC>
    <NDCCode>0002-8235-99</NDCCode>
    <PackageDescription>1 SYRINGE in 1 CARTON (0002-8235-99)  / 3 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>00002-8235-99</NDC11Code>
    <ProductNDC>0002-8235</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lyumjev</ProprietaryName>
    <ProprietaryNameSuffix>Tempo Pen</ProprietaryNameSuffix>
    <NonProprietaryName>Insulin Lispro-aabc</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20200615</StartMarketingDate>
    <EndMarketingDate>20271106</EndMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761109</ApplicationNumber>
    <LabelerName>Eli Lilly and Company</LabelerName>
    <SubstanceName>INSULIN LISPRO</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>[iU]/mL</StrengthUnit>
    <Pharm_Classes>Insulin Analog [EPC], Insulin [Chemical/Ingredient]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20240110</StartMarketingDatePackage>
    <EndMarketingDatePackage>20271106</EndMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>LYUMJEV® is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.</IndicationAndUsage>
    <Description>Insulin lispro-aabc is a rapid-acting human insulin analog used to lower blood glucose. Insulin lispro-aabc is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin lispro-aabc differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. Chemically, it is Lys(B28), Pro(B29) human insulin analog and has the empirical formula C257H383N65O77S6 and a molecular weight of 5808 daltons, both identical to that of human insulin. Insulin lispro-aabc has the following primary structure:. LYUMJEV (insulin lispro-aabc) injection is a sterile, aqueous, clear, and colorless solution for subcutaneous or intravenous administration. Each mL of LYUMJEV U-100 contains 100 units of insulin lispro-aabc and the inactive ingredients: glycerol (12.1 mg), magnesium chloride hexahydrate (1.02 mg), metacresol (3.15 mg), sodium citrate dihydrate (4.41 mg), treprostinil sodium (1.06 mcg), zinc oxide (content adjusted to provide 39 mcg zinc ion), and Water for Injection, USP. Each mL of LYUMJEV U-200 contains 200 units of insulin lispro-aabc and the inactive ingredients: glycerol (12.1 mg), magnesium chloride hexahydrate (1.02 mg), metacresol (3.15 mg), sodium citrate dihydrate (4.41 mg), treprostinil sodium (1.06 mcg), zinc oxide (content adjusted to provide 52 mcg zinc ion), and Water for Injection, USP. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH. LYUMJEV has a pH of 7.0 to 7.8.</Description>
  </NDC>
  <NDC>
    <NDCCode>0395-8235-35</NDCCode>
    <PackageDescription>5 g in 1 CONTAINER (0395-8235-35)</PackageDescription>
    <NDC11Code>00395-8235-35</NDC11Code>
    <ProductNDC>0395-8235</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Phenoxybenzamine Hydrochloride</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20190529</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>Humco Holding Group, Inc</LabelerName>
    <SubstanceName>PHENOXYBENZAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>0395-8235-37</NDCCode>
    <PackageDescription>1 g in 1 CONTAINER (0395-8235-37)</PackageDescription>
    <NDC11Code>00395-8235-37</NDC11Code>
    <ProductNDC>0395-8235</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Phenoxybenzamine Hydrochloride</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20190529</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>Humco Holding Group, Inc</LabelerName>
    <SubstanceName>PHENOXYBENZAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>0615-8235-39</NDCCode>
    <PackageDescription>30 TABLET in 1 BLISTER PACK (0615-8235-39) </PackageDescription>
    <NDC11Code>00615-8235-39</NDC11Code>
    <ProductNDC>0615-8235</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clonazepam</ProprietaryName>
    <NonProprietaryName>Clonazepam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110603</StartMarketingDate>
    <EndMarketingDate>20230531</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077147</ApplicationNumber>
    <LabelerName>NCS HealthCare of KY, LLC dba Vangard Labs</LabelerName>
    <SubstanceName>CLONAZEPAM</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2023-06-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20181005</StartMarketingDatePackage>
    <EndMarketingDatePackage>20230531</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>48951-8235-2</NDCCode>
    <PackageDescription>1350 PELLET in 1 BOTTLE, GLASS (48951-8235-2) </PackageDescription>
    <NDC11Code>48951-8235-02</NDC11Code>
    <ProductNDC>48951-8235</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Renes Betula Special Order</ProprietaryName>
    <NonProprietaryName>Renes Betula Special Order</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090901</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Uriel Pharmacy Inc.</LabelerName>
    <SubstanceName>ARCTOSTAPHYLOS UVA-URSI LEAF; BETULA PUBESCENS LEAF; CAPSELLA BURSA-PASTORIS; COPPER; CYTISUS SCOPARIUS FLOWERING TOP; ELYMUS REPENS TOP; EQUISETUM ARVENSE TOP; ONONIS REPENS ROOT; PARSLEY; PORK KIDNEY; SOLIDAGO VIRGAUREA FLOWERING TOP</SubstanceName>
    <StrengthNumber>3; 4; 3; 9; 4; 3; 4; 3; 3; 4; 3</StrengthNumber>
    <StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Inhibit Ovum Fertilization [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Directions: FOR ORAL USE ONLY.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>58597-8235-2</NDCCode>
    <PackageDescription>5 g in 1 BOTTLE (58597-8235-2)</PackageDescription>
    <NDC11Code>58597-8235-02</NDC11Code>
    <ProductNDC>58597-8235</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20140425</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>AMERICAN PHARMACEUTICAL INGREDIENTS LLC</LabelerName>
    <SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>58597-8235-3</NDCCode>
    <PackageDescription>10 g in 1 BOTTLE (58597-8235-3)</PackageDescription>
    <NDC11Code>58597-8235-03</NDC11Code>
    <ProductNDC>58597-8235</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20140425</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>AMERICAN PHARMACEUTICAL INGREDIENTS LLC</LabelerName>
    <SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>58597-8235-4</NDCCode>
    <PackageDescription>25 g in 1 BOTTLE (58597-8235-4)</PackageDescription>
    <NDC11Code>58597-8235-04</NDC11Code>
    <ProductNDC>58597-8235</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20140425</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>AMERICAN PHARMACEUTICAL INGREDIENTS LLC</LabelerName>
    <SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>58597-8235-7</NDCCode>
    <PackageDescription>500 g in 1 BOTTLE (58597-8235-7)</PackageDescription>
    <NDC11Code>58597-8235-07</NDC11Code>
    <ProductNDC>58597-8235</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20140425</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>AMERICAN PHARMACEUTICAL INGREDIENTS LLC</LabelerName>
    <SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>68788-8235-4</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (68788-8235-4)  / 4 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>68788-8235-04</NDC11Code>
    <ProductNDC>68788-8235</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Alendronate Sodium</ProprietaryName>
    <NonProprietaryName>Alendronate Sodium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220809</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090124</ApplicationNumber>
    <LabelerName>Preferred Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>ALENDRONATE SODIUM</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Bisphosphonate [EPC], Diphosphonates [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220809</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Alendronate sodium is a bisphosphonate indicated for: 1 Treatment and prevention of osteoporosis in postmenopausal women (1.1, 1.2), 2 Treatment to increase bone mass in men with osteoporosis (1.3), 3 Treatment of glucocorticoid-induced osteoporosis (1.4), 4 Treatment of Paget's disease of bone (1.5).</IndicationAndUsage>
    <Description>Alendronate sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast-‑mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone.Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate.The molecular formula of alendronate sodium is C4H12NNaO7P23H2O and its formula weight is 325.12. The structural formula is. Alendronate sodium USP is a white, free-flowing powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform.Alendronate sodium tablets, USP for oral administration contain 13.052, 45.681, or 91.363 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 10 mg, 35 mg, and 70 mg, respectively, of free acid, and the following inactive ingredients: corn starch, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>0002-0152-01</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0002-0152-01)  / .5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>00002-0152-01</NDC11Code>
    <ProductNDC>0002-0152</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zepbound</ProprietaryName>
    <NonProprietaryName>Tirzepatide</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20240328</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA217806</ApplicationNumber>
    <LabelerName>Eli Lilly and Company</LabelerName>
    <SubstanceName>TIRZEPATIDE</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/.5mL</StrengthUnit>
    <Pharm_Classes>G-Protein-linked Receptor Interactions [MoA], GLP-1 Receptor Agonist [EPC], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], Glucose-dependent Insulinotropic Polypeptide Receptor Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240328</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ZEPBOUND® is indicated in combination with a reduced-calorie diet and increased physical activity: : 1 to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition. , 2 to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity. .</IndicationAndUsage>
    <Description>ZEPBOUND (tirzepatide) injection, for subcutaneous use, contains tirzepatide, a GIP receptor and GLP-1 receptor agonist. Tirzepatide is based on the GIP sequence and contains aminoisobutyric acid (Aib) in positions 2 and 13, a C-terminal amide, and Lys residue at position 20 that is attached to 1,20-eicosanedioic acid via a linker. The molecular weight is 4813.53 Da and the empirical formula is C225H348N48O68. Structural formula:. ZEPBOUND is a clear, colorless to slightly yellow, sterile solution for subcutaneous use. Each single-dose pen or single-dose vial contains a 0.5 mL solution of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg of tirzepatide and the following excipients: sodium chloride (4.1 mg), sodium phosphate dibasic heptahydrate (0.7 mg), and water for injection. Each multi-dose vial or single-patient-use KwikPen contains 2.4 mL of solution, which provides 4 doses of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg of tirzepatide per 0.6 mL. Each dose contains the following excipients: benzyl alcohol (5.4 mg), glycerin (4.8 mg), phenol (1.08 mg), sodium chloride (1.05 mg), sodium phosphate dibasic heptahydrate (0.8 mg), and water for injection. Hydrochloric acid solution and/or sodium hydroxide solution may have been added to adjust the pH. ZEPBOUND has a pH of 6.5 to 7.5. Each single-patient-use KwikPen contains additional volume to allow for device priming.</Description>
  </NDC>
  <NDC>
    <NDCCode>0002-0152-04</NDCCode>
    <PackageDescription>4 VIAL, SINGLE-DOSE in 1 CARTON (0002-0152-04)  / .5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>00002-0152-04</NDC11Code>
    <ProductNDC>0002-0152</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zepbound</ProprietaryName>
    <NonProprietaryName>Tirzepatide</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20240328</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA217806</ApplicationNumber>
    <LabelerName>Eli Lilly and Company</LabelerName>
    <SubstanceName>TIRZEPATIDE</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/.5mL</StrengthUnit>
    <Pharm_Classes>G-Protein-linked Receptor Interactions [MoA], GLP-1 Receptor Agonist [EPC], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], Glucose-dependent Insulinotropic Polypeptide Receptor Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240808</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ZEPBOUND® is indicated in combination with a reduced-calorie diet and increased physical activity: : 1 to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition. , 2 to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity. .</IndicationAndUsage>
    <Description>ZEPBOUND (tirzepatide) injection, for subcutaneous use, contains tirzepatide, a GIP receptor and GLP-1 receptor agonist. Tirzepatide is based on the GIP sequence and contains aminoisobutyric acid (Aib) in positions 2 and 13, a C-terminal amide, and Lys residue at position 20 that is attached to 1,20-eicosanedioic acid via a linker. The molecular weight is 4813.53 Da and the empirical formula is C225H348N48O68. Structural formula:. ZEPBOUND is a clear, colorless to slightly yellow, sterile solution for subcutaneous use. Each single-dose pen or single-dose vial contains a 0.5 mL solution of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg of tirzepatide and the following excipients: sodium chloride (4.1 mg), sodium phosphate dibasic heptahydrate (0.7 mg), and water for injection. Each multi-dose vial or single-patient-use KwikPen contains 2.4 mL of solution, which provides 4 doses of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg of tirzepatide per 0.6 mL. Each dose contains the following excipients: benzyl alcohol (5.4 mg), glycerin (4.8 mg), phenol (1.08 mg), sodium chloride (1.05 mg), sodium phosphate dibasic heptahydrate (0.8 mg), and water for injection. Hydrochloric acid solution and/or sodium hydroxide solution may have been added to adjust the pH. ZEPBOUND has a pH of 6.5 to 7.5. Each single-patient-use KwikPen contains additional volume to allow for device priming.</Description>
  </NDC>
</NDCList>