RESTful Lookup — Test-Drive (2007 – 2026)

<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <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>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>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>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>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>64208-8235-7</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>36987-2512-3</NDCCode>
    <PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (36987-2512-3)</PackageDescription>
    <NDC11Code>36987-2512-03</NDC11Code>
    <ProductNDC>36987-2512</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bayberry</ProprietaryName>
    <NonProprietaryName>Bayberry</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19720829</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102192</ApplicationNumber>
    <LabelerName>Nelco Laboratories, Inc.</LabelerName>
    <SubstanceName>MORELLA CERIFERA POLLEN</SubstanceName>
    <StrengthNumber>20000</StrengthNumber>
    <StrengthUnit>[PNU]/mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
    <Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
  </NDC>
  <NDC>
    <NDCCode>37662-2512-3</NDCCode>
    <PackageDescription>3000 PELLET in 1 BOTTLE, GLASS (37662-2512-3) </PackageDescription>
    <NDC11Code>37662-2512-03</NDC11Code>
    <ProductNDC>37662-2512</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Oenanthe Crocata</ProprietaryName>
    <NonProprietaryName>Oenanthe Crocata</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230125</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Hahnemann Laboratories, INC.</LabelerName>
    <SubstanceName>OENANTHE CROCATA ROOT</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>[hp_C]/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2023-01-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230125</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>50090-2512-3</NDCCode>
    <PackageDescription>14 TABLET in 1 BOTTLE (50090-2512-3) </PackageDescription>
    <NDC11Code>50090-2512-03</NDC11Code>
    <ProductNDC>50090-2512</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metronidazole</ProprietaryName>
    <NonProprietaryName>Metronidazole</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19900930</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA070033</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>METRONIDAZOLE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161020</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Metronidazole tablets are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures).</IndicationAndUsage>
    <Description>Metronidazole, USP is an oral synthetic antiprotozoal and antibacterial agent, 1H-Imidazole-1-ethanol, 2-methyl-5-nitro, which has the following structural formula. C6H9N3O3 M.W. 171.15. Each tablet for oral administration contains 250 mg or 500 mg of metronidazole, USP. Inactive ingredients include silicified microcrystalline cellulose, crospovidone, colloidal silicon dioxide and hydrogenated vegetable oil.</Description>
  </NDC>
  <NDC>
    <NDCCode>53002-2512-3</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (53002-2512-3) </PackageDescription>
    <NDC11Code>53002-2512-03</NDC11Code>
    <ProductNDC>53002-2512</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lamotrigine</ProprietaryName>
    <NonProprietaryName>Lamotrigine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20111101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090170</ApplicationNumber>
    <LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>LAMOTRIGINE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lamotrigine tablets are indicated for:. Epilepsy—adjunctive therapy in patients aged 2 years and older: : 1 partial-onset seizures., 2 primary generalized tonic-clonic seizures., 3 generalized seizures of Lennox-Gastaut syndrome. (1.1).</IndicationAndUsage>
    <Description>Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. It's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Lamotrigine tablets USP are supplied for oral administration as 25 mg, 100 mg, 150 mg or 200 mg tablets. Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. In addition, the 200 mg tablets contain FD&amp;C Blue No. 2 Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>60505-2512-3</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (60505-2512-3)</PackageDescription>
    <NDC11Code>60505-2512-03</NDC11Code>
    <ProductNDC>60505-2512</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fosinopril Na</ProprietaryName>
    <NonProprietaryName>Fosinopril Sodium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20050518</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076906</ApplicationNumber>
    <LabelerName>Apotex Corp.</LabelerName>
    <SubstanceName>FOSINOPRIL SODIUM</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-02-24</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>71335-2512-3</NDCCode>
    <PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2512-3) </PackageDescription>
    <NDC11Code>71335-2512-03</NDC11Code>
    <ProductNDC>71335-2512</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Desvenlafaxine</ProprietaryName>
    <NonProprietaryName>Desvenlafaxine</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220131</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204028</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>DESVENLAFAXINE SUCCINATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250604</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Desvenlafaxine extended-release tablets are indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies (14)].</IndicationAndUsage>
    <Description>Desvenlafaxine extended-release tablets are an extended-release tablets for oral administration that contain desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the empirical formula of C 16H 25NO 2(free base) and C 16H 25NO 2C 4H 6O 4H 2O (succinate monohydrate). Desvenlafaxine succinate monohydrate has a molecular weight of 399.48. The structural formula is shown below. Desvenlafaxine succinate is a white to off-white powder that is soluble in water. The solubility of desvenlafaxine succinate is pH dependent. Its octanol:aqueous system (at pH 7.0) partition coefficient is 0.21. Desvenlafaxine extended-release tablets are formulated as an extended-release tablet for once-a-day oral administration. Each tablet contains 38 mg, 76 mg or 152 mg of desvenlafaxine succinate equivalent to 25 mg, 50 mg or 100 mg of desvenlafaxine, respectively. Inactive ingredients for the 25 mg tablet consist of hypromellose, microcrystalline cellulose, talc, magnesium stearate, a film coating which consists of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, iron oxide yellow and iron oxide red. Inactive ingredients for the 50 mg tablet consist of hypromellose, microcrystalline cellulose, talc, magnesium stearate, a film coating which consists of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, FD&amp;C Red #40 and FD&amp;C Yellow #6. Inactive ingredients for the 100 mg tablet consist of hypromellose, microcrystalline cellulose, talc, magnesium stearate, a film coating which consists of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, iron oxide yellow, iron oxide red and iron oxide black.</Description>
  </NDC>
  <NDC>
    <NDCCode>0591-2512-60</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (0591-2512-60) </PackageDescription>
    <NDC11Code>00591-2512-60</NDC11Code>
    <ProductNDC>0591-2512</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bosentan</ProprietaryName>
    <NonProprietaryName>Bosentan</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190619</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207110</ApplicationNumber>
    <LabelerName>Actavis Pharma, Inc.</LabelerName>
    <SubstanceName>BOSENTAN</SubstanceName>
    <StrengthNumber>125</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190619</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Bosentan tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): 1 in adults to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with congenital heart disease with left-to-right shunts (18%) [see Clinical Studies (14.1)]., 2 in pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability.</IndicationAndUsage>
    <Description>Bosentan, an endothelin receptor antagonist that belongs to a class of highly substituted pyrimidine derivatives, with no chiral centers. It is designated chemically as 4-tert-butyl-N-[6-(2-hydroxy-ethoxy)-5-(2-methoxy-phenoxy)-[2,2´]-bipyrimidin-4-yl]-benzenesulfonamide monohydrate and has the following structural formula. C27H29N5O6SH2O           M.W. 569.64. Bosentan is a white to yellowish powder. It is poorly soluble in water (1.0 mg/100 mL) and in aqueous solutions at low pH (0.1 mg/100 mL at pH 1.1 and 4.0; 0.2 mg/100 mL at pH 5.0). Solubility increases at higher pH values (43 mg/100 mL at pH 7.5). In the solid state, bosentan is very stable, is not hygroscopic and is not light sensitive. Bosentan is available as 62.5 mg and 125 mg film-coated tablets for oral administration, and contains the following excipients: corn starch, ethyl cellulose, glyceryl behenate, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, pregelatinized corn starch, povidone K90, sodium starch glycolate, titanium dioxide and triacetin. Each bosentan 62.5 mg tablet contains 64.541 mg of bosentan monohydrate, equivalent to 62.5 mg of bosentan base. Each bosentan 125 mg tablet contains 129.082 mg of bosentan monohydrate, equivalent to 125 mg of bosentan base.</Description>
  </NDC>
  <NDC>
    <NDCCode>0944-2512-02</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (0944-2512-02)  *  100 mL in 1 VIAL, GLASS (0944-2717-10)  *  5 mL in 1 VIAL, GLASS (0944-2722-03) </PackageDescription>
    <NDC11Code>00944-2512-02</NDC11Code>
    <ProductNDC>0944-2512</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Hyqvia</ProprietaryName>
    <NonProprietaryName>Immune Globulin Infusion (human), 10% With Recombinant Human Hyaluronidase</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20140912</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125402</ApplicationNumber>
    <LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-06-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140912</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>HYQVIA is a dual vial unit with one vial of Immune Globulin Infusion (Human), 10% and one vial of rHuPH20. The Immune Globulin Infusion (Human), 10% of HYQVIA is a ready-for-use, sterile, liquid preparation of highly purified and concentrated IgG antibodies. The distribution of the IgG subclasses is similar to that of normal plasma. The Fc and Fab functions are maintained in the primary component. Pre-kallikrein activator activity is not detectable. The Immune Globulin Infusion (Human), 10% of HYQVIA contains 100 mg/mL protein. At least 98% of the protein is IgG, average immunoglobulin A (IgA) concentration is 37µg/mL, and immunoglobulin M (IgM) is present in trace amounts. The Immune Globulin Infusion (Human), 10% of HYQVIA contains a broad spectrum of IgG antibodies against bacterial and viral agents. Glycine (0.25M) serves as a stabilizing and buffering agent. There is no added sugar, sodium, or preservatives. The pH is 4.6 to 5.1. The osmolality is 240 to 300 mOsmol/kg. The Immune Globulin Infusion (Human), 10% of HYQVIA is manufactured from large pools of human plasma. IgG preparations are purified from plasma pools using a modified Cohn-Oncley cold ethanol fractionation process, as well as cation and anion exchange chromatography. Screening against potentially infectious agents begins with the donor selection process and continues throughout plasma collection and plasma preparation. Each individual plasma donation used in the manufacture of the Immune Globulin Infusion (Human), 10% of HYQVIA is collected only at FDA approved blood establishments and is tested by FDA licensed serological tests for Hepatitis B Surface Antigen (HBsAg), and for antibodies to Human Immunodeficiency Virus (HIV-1/HIV-2) and Hepatitis C Virus (HCV) in accordance with U.S. regulatory requirements. As an additional safety measure, mini-pools of the plasma are tested for the presence of HIV-1 and HCV by FDA licensed Nucleic Acid Testing (NAT). To further improve the margin of safety, three dedicated, independent and effective virus inactivation/removal steps have been integrated into the manufacturing and formulation processes, namely solvent/detergent (S/D) treatment, 35 nm nanofiltration, and a low pH incubation at elevated temperature. The S/D process includes treatment with an organic mixture of tri-n-butyl phosphate, octoxynol 9 and polysorbate 80 at 18°C to 25°C for a minimum of 60 minutes. In vitro virus spiking studies have been used to validate the capability of the manufacturing process to inactivate and remove viruses. To establish the minimum applicable virus clearance capacity of the manufacturing process, these virus clearance studies were performed under extreme conditions (e.g., at minimum S/D concentrations, incubation time and temperature for the S/D treatment). Virus clearance studies for the Immune Globulin Infusion (Human), 10% of HYQVIA performed in accordance with good laboratory practices (Table 12) have demonstrated that: 1 S/D treatment inactivates the lipid-enveloped viruses investigated to below detection limits within minutes., 2 35 nm nanofiltration removes lipid-enveloped viruses to below detection limits and reduces the nonlipid enveloped viruses HAV and B19V. As determined by a polymerase chain reaction assay, nanofiltration reduced B19V by a mean log10 reduction factor of 4.8 genome equivalents., 3 Treatment with low pH at elevated temperature of 30°C to 32°C inactivates lipid-enveloped viruses and encephalomyocarditis virus (EMCV, model for HAV) to below detection limits, and reduces mice minute virus (MMV, model for B19V).</Description>
  </NDC>
  <NDC>
    <NDCCode>53002-2512-0</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (53002-2512-0) </PackageDescription>
    <NDC11Code>53002-2512-00</NDC11Code>
    <ProductNDC>53002-2512</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lamotrigine</ProprietaryName>
    <NonProprietaryName>Lamotrigine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20111101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090170</ApplicationNumber>
    <LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>LAMOTRIGINE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lamotrigine tablets are indicated for:. Epilepsy—adjunctive therapy in patients aged 2 years and older: : 1 partial-onset seizures., 2 primary generalized tonic-clonic seizures., 3 generalized seizures of Lennox-Gastaut syndrome. (1.1).</IndicationAndUsage>
    <Description>Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. It's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Lamotrigine tablets USP are supplied for oral administration as 25 mg, 100 mg, 150 mg or 200 mg tablets. Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. In addition, the 200 mg tablets contain FD&amp;C Blue No. 2 Lake.</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>64208-2510-5</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>64208-7752-1</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>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>64208-8234-8</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>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>64208-8235-6</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>0049-2512-10</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (0049-2512-10) </PackageDescription>
    <NDC11Code>00049-2512-10</NDC11Code>
    <ProductNDC>0049-2512</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cardura</ProprietaryName>
    <NonProprietaryName>Doxazosin</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20211019</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019668</ApplicationNumber>
    <LabelerName>ROERIG</LabelerName>
    <SubstanceName>DOXAZOSIN MESYLATE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211019</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>CARDURA is an alpha1 adrenergic antagonist indicated for: 1 Signs and symptoms of Benign Prostatic Hyperplasia (BPH), 2 Treatment of Hypertension.</IndicationAndUsage>
    <Description>CARDURA® (doxazosin) is a quinazoline compound that is a selective inhibitor of the alpha1 subtype of alpha-adrenergic receptors. The chemical name of doxazosin mesylate is 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(1,4-benzodioxan-2-ylcarbonyl) piperazine methanesulfonate. The empirical formula for doxazosin mesylate is C23H25N5O5 ∙ CH4O3S and the molecular weight is 547.6. It has the following structure. CARDURA (doxazosin) is freely soluble in dimethylsulfoxide, soluble in dimethylformamide, slightly soluble in methanol, ethanol, and water (0.8% at 25°C), and very slightly soluble in acetone and methylene chloride. CARDURA is available as colored tablets for oral use and contains doxazosin mesylate equivalent to 1 mg (white), 2 mg (yellow or white), 4 mg (orange or white) and 8 mg (green or white) of doxazosin as the free base. The inactive ingredients for all tablets are microcrystalline cellulose, lactose, sodium starch glycolate, magnesium stearate and sodium lauryl sulfate. The 2 mg yellow tablet contains D &amp; C yellow 10 and FD &amp; C yellow 6; the 4 mg orange tablet contains FD &amp; C yellow 6; the 8 mg green tablet contains FD &amp; C blue 2 and D &amp; C yellow 10.</Description>
  </NDC>
  <NDC>
    <NDCCode>0378-2512-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2512-05)</PackageDescription>
    <NDC11Code>00378-2512-05</NDC11Code>
    <ProductNDC>0378-2512</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Capecitabine</ProprietaryName>
    <NonProprietaryName>Capecitabine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140808</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090943</ApplicationNumber>
    <LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>CAPECITABINE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2015-05-01</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0378-2512-78</NDCCode>
    <PackageDescription>120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2512-78) </PackageDescription>
    <NDC11Code>00378-2512-78</NDC11Code>
    <ProductNDC>0378-2512</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Capecitabine</ProprietaryName>
    <NonProprietaryName>Capecitabine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140808</StartMarketingDate>
    <EndMarketingDate>20230630</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090943</ApplicationNumber>
    <LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>CAPECITABINE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-07-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20140808</StartMarketingDatePackage>
    <EndMarketingDatePackage>20230630</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0591-2512-00</NDCCode>
    <PackageDescription>55870 TABLET, FILM COATED in 1 BOX (0591-2512-00) </PackageDescription>
    <NDC11Code>00591-2512-00</NDC11Code>
    <ProductNDC>0591-2512</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Bosentan</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <StartMarketingDate>20190603</StartMarketingDate>
    <EndMarketingDate>20260531</EndMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Actavis Pharma, Inc.</LabelerName>
    <SubstanceName>BOSENTAN</SubstanceName>
    <StrengthNumber>125</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <StartMarketingDatePackage>03-JUN-19</StartMarketingDatePackage>
    <EndMarketingDatePackage>31-JUL-25</EndMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>0591-2512-77</NDCCode>
    <PackageDescription>67044 TABLET, FILM COATED in 1 CONTAINER (0591-2512-77) </PackageDescription>
    <NDC11Code>00591-2512-77</NDC11Code>
    <ProductNDC>0591-2512</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Bosentan</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <StartMarketingDate>20190603</StartMarketingDate>
    <EndMarketingDate>20260531</EndMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Actavis Pharma, Inc.</LabelerName>
    <SubstanceName>BOSENTAN</SubstanceName>
    <StrengthNumber>125</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <StartMarketingDatePackage>05-AUG-24</StartMarketingDatePackage>
    <EndMarketingDatePackage>31-MAY-26</EndMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>36987-2512-1</NDCCode>
    <PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (36987-2512-1)</PackageDescription>
    <NDC11Code>36987-2512-01</NDC11Code>
    <ProductNDC>36987-2512</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bayberry</ProprietaryName>
    <NonProprietaryName>Bayberry</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19720829</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102192</ApplicationNumber>
    <LabelerName>Nelco Laboratories, Inc.</LabelerName>
    <SubstanceName>MORELLA CERIFERA POLLEN</SubstanceName>
    <StrengthNumber>20000</StrengthNumber>
    <StrengthUnit>[PNU]/mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
    <Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
  </NDC>
</NDCList>