{
"NDC": [
{
"NDCCode": "0944-2700-06",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (0944-2700-06) / 200 mL in 1 BOTTLE, GLASS (0944-2700-12) ",
"NDC11Code": "00944-2700-06",
"ProductNDC": "0944-2700",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Gammagard Liquid",
"NonProprietaryName": "Immune Globulin Infusion (human)",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20050427",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125105",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": "HUMAN IMMUNOGLOBULIN G",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20050427",
"SamplePackage": "N",
"Description": "GAMMAGARD LIQUID is a ready-for-use sterile, liquid preparation of highly purified and concentrated immunoglobulin G (IgG) antibodies. The distribution of the IgG subclasses is similar to that of normal plasma. The Fc and Fab functions are maintained in GAMMAGARD LIQUID. Pre-kallikrein activator activity is not detectable. GAMMAGARD LIQUID contains 100 mg/mL protein. At least 98% of the protein is immune globulin, the average immunoglobulin A (IgA) concentration is 37 µg/mL, and immunoglobulin M is present in trace amounts. GAMMAGARD LIQUID contains a broad spectrum of IgG antibodies against bacterial and viral agents. Glycine (0.25M) serves as a stabilizing and buffering agent. There are no added sugars, sodium or preservatives. The pH is 4.6 to 5.1. The osmolality is 240 to 300 mOsmol/kg, which is similar to physiological osmolality (285 to 295 mOsmol/kg). GAMMAGARD LIQUID 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 GAMMAGARD LIQUID 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) and found to be negative. To further improve the margin of safety, validated virus inactivation/removal steps have been integrated into the manufacturing and formulation processes, namely solvent/detergent (S/D) treatment,10 35 nm nanofiltration, and a low pH incubation at elevated temperature (30 C to 32 C). 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. S/D treatment inactivates the lipid-enveloped viruses investigated to below detection limits within minutes.12. 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, 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 GAMMAGARD LIQUID performed in accordance with good laboratory practices are summarized in Table 12."
},
{
"NDCCode": "71335-2700-6",
"PackageDescription": "21 CAPSULE in 1 BOTTLE (71335-2700-6) ",
"NDC11Code": "71335-2700-06",
"ProductNDC": "71335-2700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20080131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078787",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-09-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250925",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin capsules are indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy .",
"Description": "The active ingredient in gabapentin capsules, USP is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin USP is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each capsule contains the following inactive ingredients: corn starch and talc. The empty hard gelatin capsule shell consists of gelatin, sodium lauryl sulfate, and titanium dioxide. In addition 300 mg also contains yellow iron oxide and 400 mg also contains yellow iron oxide and red iron oxide. The capsules are printed with edible ink containing black iron oxide and shellac."
},
{
"NDCCode": "0944-2700-02",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (0944-2700-02) / 10 mL in 1 BOTTLE, GLASS (0944-2700-08) ",
"NDC11Code": "00944-2700-02",
"ProductNDC": "0944-2700",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Gammagard Liquid",
"NonProprietaryName": "Immune Globulin Infusion (human)",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20050427",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125105",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": "HUMAN IMMUNOGLOBULIN G",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20050427",
"SamplePackage": "N",
"Description": "GAMMAGARD LIQUID is a ready-for-use sterile, liquid preparation of highly purified and concentrated immunoglobulin G (IgG) antibodies. The distribution of the IgG subclasses is similar to that of normal plasma. The Fc and Fab functions are maintained in GAMMAGARD LIQUID. Pre-kallikrein activator activity is not detectable. GAMMAGARD LIQUID contains 100 mg/mL protein. At least 98% of the protein is immune globulin, the average immunoglobulin A (IgA) concentration is 37 µg/mL, and immunoglobulin M is present in trace amounts. GAMMAGARD LIQUID contains a broad spectrum of IgG antibodies against bacterial and viral agents. Glycine (0.25M) serves as a stabilizing and buffering agent. There are no added sugars, sodium or preservatives. The pH is 4.6 to 5.1. The osmolality is 240 to 300 mOsmol/kg, which is similar to physiological osmolality (285 to 295 mOsmol/kg). GAMMAGARD LIQUID 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 GAMMAGARD LIQUID 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) and found to be negative. To further improve the margin of safety, validated virus inactivation/removal steps have been integrated into the manufacturing and formulation processes, namely solvent/detergent (S/D) treatment,10 35 nm nanofiltration, and a low pH incubation at elevated temperature (30 C to 32 C). 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. S/D treatment inactivates the lipid-enveloped viruses investigated to below detection limits within minutes.12. 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, 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 GAMMAGARD LIQUID performed in accordance with good laboratory practices are summarized in Table 12."
},
{
"NDCCode": "0944-2700-03",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (0944-2700-03) / 25 mL in 1 BOTTLE, GLASS (0944-2700-09) ",
"NDC11Code": "00944-2700-03",
"ProductNDC": "0944-2700",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Gammagard Liquid",
"NonProprietaryName": "Immune Globulin Infusion (human)",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20050427",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125105",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": "HUMAN IMMUNOGLOBULIN G",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20050427",
"SamplePackage": "N",
"Description": "GAMMAGARD LIQUID is a ready-for-use sterile, liquid preparation of highly purified and concentrated immunoglobulin G (IgG) antibodies. The distribution of the IgG subclasses is similar to that of normal plasma. The Fc and Fab functions are maintained in GAMMAGARD LIQUID. Pre-kallikrein activator activity is not detectable. GAMMAGARD LIQUID contains 100 mg/mL protein. At least 98% of the protein is immune globulin, the average immunoglobulin A (IgA) concentration is 37 µg/mL, and immunoglobulin M is present in trace amounts. GAMMAGARD LIQUID contains a broad spectrum of IgG antibodies against bacterial and viral agents. Glycine (0.25M) serves as a stabilizing and buffering agent. There are no added sugars, sodium or preservatives. The pH is 4.6 to 5.1. The osmolality is 240 to 300 mOsmol/kg, which is similar to physiological osmolality (285 to 295 mOsmol/kg). GAMMAGARD LIQUID 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 GAMMAGARD LIQUID 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) and found to be negative. To further improve the margin of safety, validated virus inactivation/removal steps have been integrated into the manufacturing and formulation processes, namely solvent/detergent (S/D) treatment,10 35 nm nanofiltration, and a low pH incubation at elevated temperature (30 C to 32 C). 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. S/D treatment inactivates the lipid-enveloped viruses investigated to below detection limits within minutes.12. 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, 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 GAMMAGARD LIQUID performed in accordance with good laboratory practices are summarized in Table 12."
},
{
"NDCCode": "0944-2700-04",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (0944-2700-04) / 50 mL in 1 BOTTLE, GLASS (0944-2700-10) ",
"NDC11Code": "00944-2700-04",
"ProductNDC": "0944-2700",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Gammagard Liquid",
"NonProprietaryName": "Immune Globulin Infusion (human)",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20050427",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125105",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": "HUMAN IMMUNOGLOBULIN G",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20050427",
"SamplePackage": "N",
"Description": "GAMMAGARD LIQUID is a ready-for-use sterile, liquid preparation of highly purified and concentrated immunoglobulin G (IgG) antibodies. The distribution of the IgG subclasses is similar to that of normal plasma. The Fc and Fab functions are maintained in GAMMAGARD LIQUID. Pre-kallikrein activator activity is not detectable. GAMMAGARD LIQUID contains 100 mg/mL protein. At least 98% of the protein is immune globulin, the average immunoglobulin A (IgA) concentration is 37 µg/mL, and immunoglobulin M is present in trace amounts. GAMMAGARD LIQUID contains a broad spectrum of IgG antibodies against bacterial and viral agents. Glycine (0.25M) serves as a stabilizing and buffering agent. There are no added sugars, sodium or preservatives. The pH is 4.6 to 5.1. The osmolality is 240 to 300 mOsmol/kg, which is similar to physiological osmolality (285 to 295 mOsmol/kg). GAMMAGARD LIQUID 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 GAMMAGARD LIQUID 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) and found to be negative. To further improve the margin of safety, validated virus inactivation/removal steps have been integrated into the manufacturing and formulation processes, namely solvent/detergent (S/D) treatment,10 35 nm nanofiltration, and a low pH incubation at elevated temperature (30 C to 32 C). 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. S/D treatment inactivates the lipid-enveloped viruses investigated to below detection limits within minutes.12. 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, 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 GAMMAGARD LIQUID performed in accordance with good laboratory practices are summarized in Table 12."
},
{
"NDCCode": "0944-2700-05",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (0944-2700-05) / 100 mL in 1 BOTTLE, GLASS (0944-2700-11) ",
"NDC11Code": "00944-2700-05",
"ProductNDC": "0944-2700",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Gammagard Liquid",
"NonProprietaryName": "Immune Globulin Infusion (human)",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20050427",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125105",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": "HUMAN IMMUNOGLOBULIN G",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20050427",
"SamplePackage": "N",
"Description": "GAMMAGARD LIQUID is a ready-for-use sterile, liquid preparation of highly purified and concentrated immunoglobulin G (IgG) antibodies. The distribution of the IgG subclasses is similar to that of normal plasma. The Fc and Fab functions are maintained in GAMMAGARD LIQUID. Pre-kallikrein activator activity is not detectable. GAMMAGARD LIQUID contains 100 mg/mL protein. At least 98% of the protein is immune globulin, the average immunoglobulin A (IgA) concentration is 37 µg/mL, and immunoglobulin M is present in trace amounts. GAMMAGARD LIQUID contains a broad spectrum of IgG antibodies against bacterial and viral agents. Glycine (0.25M) serves as a stabilizing and buffering agent. There are no added sugars, sodium or preservatives. The pH is 4.6 to 5.1. The osmolality is 240 to 300 mOsmol/kg, which is similar to physiological osmolality (285 to 295 mOsmol/kg). GAMMAGARD LIQUID 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 GAMMAGARD LIQUID 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) and found to be negative. To further improve the margin of safety, validated virus inactivation/removal steps have been integrated into the manufacturing and formulation processes, namely solvent/detergent (S/D) treatment,10 35 nm nanofiltration, and a low pH incubation at elevated temperature (30 C to 32 C). 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. S/D treatment inactivates the lipid-enveloped viruses investigated to below detection limits within minutes.12. 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, 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 GAMMAGARD LIQUID performed in accordance with good laboratory practices are summarized in Table 12."
},
{
"NDCCode": "0944-2700-07",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (0944-2700-07) / 300 mL in 1 BOTTLE, GLASS (0944-2700-13) ",
"NDC11Code": "00944-2700-07",
"ProductNDC": "0944-2700",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Gammagard Liquid",
"NonProprietaryName": "Immune Globulin Infusion (human)",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20050427",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125105",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": "HUMAN IMMUNOGLOBULIN G",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20050427",
"SamplePackage": "N",
"Description": "GAMMAGARD LIQUID is a ready-for-use sterile, liquid preparation of highly purified and concentrated immunoglobulin G (IgG) antibodies. The distribution of the IgG subclasses is similar to that of normal plasma. The Fc and Fab functions are maintained in GAMMAGARD LIQUID. Pre-kallikrein activator activity is not detectable. GAMMAGARD LIQUID contains 100 mg/mL protein. At least 98% of the protein is immune globulin, the average immunoglobulin A (IgA) concentration is 37 µg/mL, and immunoglobulin M is present in trace amounts. GAMMAGARD LIQUID contains a broad spectrum of IgG antibodies against bacterial and viral agents. Glycine (0.25M) serves as a stabilizing and buffering agent. There are no added sugars, sodium or preservatives. The pH is 4.6 to 5.1. The osmolality is 240 to 300 mOsmol/kg, which is similar to physiological osmolality (285 to 295 mOsmol/kg). GAMMAGARD LIQUID 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 GAMMAGARD LIQUID 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) and found to be negative. To further improve the margin of safety, validated virus inactivation/removal steps have been integrated into the manufacturing and formulation processes, namely solvent/detergent (S/D) treatment,10 35 nm nanofiltration, and a low pH incubation at elevated temperature (30 C to 32 C). 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. S/D treatment inactivates the lipid-enveloped viruses investigated to below detection limits within minutes.12. 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, 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 GAMMAGARD LIQUID performed in accordance with good laboratory practices are summarized in Table 12."
},
{
"NDCCode": "0944-0495-05",
"PackageDescription": "2 BAG in 1 CARTON (0944-0495-05) / 250 mL in 1 BAG (0944-0495-06) ",
"NDC11Code": "00944-0495-05",
"ProductNDC": "0944-0495",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Flexbumin",
"NonProprietaryName": "Albumin Human",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20140731",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101452",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": "ALBUMIN HUMAN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140731",
"SamplePackage": "N",
"IndicationAndUsage": "FLEXBUMIN® 5% [Albumin (Human)] is indicated for hypovolemia, hypoalbuminemia and cardiopulmonary bypass surgery.",
"Description": "FLEXBUMIN 5% is a sterile, nonpyrogenic preparation of albumin in single dosage form for intravenous administration. Each 100 mL contains 5 g of albumin. It has been adjusted to physiological pH with sodium bicarbonate and/or sodium hydroxide and stabilized with N-acetyltryptophan (0.004M) and sodium caprylate (0.004M). The sodium content is 145 ± 15 mEq/L. FLEXBUMIN 5% contains no preservative and none of the coagulation factors found in fresh whole blood or plasma. FLEXBUMIN 5% is a transparent or slightly opalescent solution which may have a greenish tint or may vary from a pale straw to an amber color and is clear of particulate matter. FLEXBUMIN 5% is manufactured from human plasma by the modified Cohn-Oncley cold ethanol fractionation process, which includes a series of cold-ethanol precipitation, centrifugation and/or filtration steps followed by pasteurization of the final product at 60 ± 0.5°C for 10 to 11 hours. This process accomplishes both purification of albumin and reduction of viruses. In vitro studies demonstrate that the manufacturing process for FLEXBUMIN 5% provides for effective viral reduction. These viral reduction studies, summarized in Table 2, demonstrate viral clearance during the manufacturing process for FLEXBUMIN 5%. These studies indicate that specific steps in the manufacturing of FLEXBUMIN 5% are capable of eliminating/inactivating a wide range of relevant and model viruses. Since the mechanism of virus elimination/inactivation by fractionation and by heating steps is different, the overall manufacturing process of FLEXBUMIN 5% is effective in reducing viral load. The likelihood of the presence of viable hepatitis viruses has been minimized by testing the plasma at three stages for the presence of hepatitis viruses, by fractionation steps with demonstrated virus removal capacity and by heating the product for 10 hours at 60°C. This procedure has been shown to be an effective method of inactivating hepatitis virus in albumin solutions even when those solutions were prepared from plasma known to be infective.1,2,3 FLEXBUMIN 5% contains no blood group isoagglutinins, thereby permitting its administration without regard to the recipient's blood group."
},
{
"NDCCode": "0944-2623-02",
"PackageDescription": "1 KIT in 1 CARTON (0944-2623-02) * 50 mL in 1 VIAL, GLASS (0338-0001-65) * 50 mL in 1 BOTTLE (0944-2624-06) ",
"NDC11Code": "00944-2623-02",
"ProductNDC": "0944-2623",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Gammagard",
"ProprietaryNameSuffix": "S/d",
"NonProprietaryName": "Immune Globulin Intravenous (human)",
"DosageFormName": "KIT",
"StartMarketingDate": "19940510",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103133",
"LabelerName": "Baxalta US Inc.",
"Status": "Deprecated",
"LastUpdate": "2019-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "19940510",
"SamplePackage": "N"
},
{
"NDCCode": "0944-2850-05",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (0944-2850-05) / 20 mL in 1 VIAL, SINGLE-USE (0944-2850-06) ",
"NDC11Code": "00944-2850-05",
"ProductNDC": "0944-2850",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Cuvitru",
"NonProprietaryName": "Immune Globulin Subcutaneous (human)",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20161018",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125596",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": "HUMAN IMMUNOGLOBULIN G",
"StrengthNumber": "200",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
"Status": "Active",
"LastUpdate": "2025-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20161018",
"SamplePackage": "N",
"IndicationAndUsage": "CUVITRU is an Immune Globulin Subcutaneous (Human) (IGSC), 20% Solution indicated as replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age and older. This includes, but is not limited to, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies1,2.",
"Description": "CUVITRU is a ready-for-use, sterile, liquid preparation of highly purified and concentrated immunoglobulin G (IgG) antibodies. The distribution of the IgG subclasses is similar to that of normal plasma. The Fc and Fab functions are maintained in CUVITRU. CUVITRU has a purity ≥98% IgG and a pH of 4.6 to 5.1. The osmolality is 280-292 milli-osmoles per kilogram. CUVITRU contains 200 milligram/mL protein. The average immunoglobulin A (IgA) concentration is 80 mcg/mL. CUVITRU contains a broad spectrum of IgG antibodies against bacterial and viral agents. Glycine (0.25M) serves as a stabilizing and buffering agent, and there are no added sugars, sodium or preservatives. CUVITRU 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 CUVITRU 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) and found to be negative. To further improve the margin of safety, validated virus inactivation/removal steps have been integrated into the manufacturing and formulation processes, namely solvent/detergent (S/D) treatment13, 35 nm nanofiltration, and a low pH incubation at elevated temperature (30°C to 32°C). 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. S/D treatment inactivates the lipid-enveloped viruses investigated to below detection limits within minutes13. The ethanol fractionation process provides an additional virus clearance capacity. 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 CUVITRU performed in accordance with good laboratory practices are summarized in Table 7."
},
{
"NDCCode": "0944-2884-05",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (0944-2884-05) / 250 mL in 1 VIAL, GLASS (0944-2884-06) ",
"NDC11Code": "00944-2884-05",
"ProductNDC": "0944-2884",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Glassia",
"NonProprietaryName": "Alpha.1-proteinase Inhibitor Human",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20100701",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125325",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": ".ALPHA.1-PROTEINASE INHIBITOR HUMAN",
"StrengthNumber": "1",
"StrengthUnit": "g/50mL",
"Pharm_Classes": "Human alpha-1 Proteinase Inhibitor [EPC], Trypsin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100701",
"SamplePackage": "N",
"IndicationAndUsage": "GLASSIA is an Alpha1-Proteinase Inhibitor (Human), indicated for chronic augmentation and maintenance therapy in individuals with clinically evident emphysema due to severe hereditary deficiency of Alpha1-PI, also known as alpha1-antitrypsin (AAT) deficiency. Limitations of Use: 1 The effect of augmentation therapy with GLASSIA or any Alpha1-PI product on pulmonary exacerbations and on the progression of emphysema in Alpha1-PI deficiency has not been conclusively demonstrated in randomized, controlled clinical trials., 2 Clinical data demonstrating the long-term effects of chronic augmentation and maintenance therapy of individuals with GLASSIA are not available., 3 GLASSIA is not indicated as therapy for lung disease in patients in whom severe Alpha1-PI deficiency has not been established.",
"Description": "GLASSIA is a sterile, ready to use, liquid preparation of purified human Alpha1-proteinase inhibitor (Alpha1-PI), also known as alpha1-antitrypsin (AAT). The solution contains 2% active Alpha1-PI in a phosphate-buffered saline solution. The specific activity of GLASSIA is ≥ 0.7 mg functional Alpha1-PI per mg of total protein. Not less than 90% of the Alpha1-PI in GLASSIA is of the monomeric form as measured by size-exclusion chromatography. GLASSIA is prepared from human plasma obtained from US-licensed plasma collection centers by a modified version of the cold ethanol fractionation process and the Alpha1-PI is then purified using chromatographic methods. Individual plasma units used for production of GLASSIA are tested using FDA- licensed serological assays for hepatitis B surface antigen (HBsAg) and for antibodies to hepatitis C virus (HCV) and human immunodeficiency virus types 1 and 2 (HIV-1/2), as well as by FDA-licensed Nucleic Acid Testing (NAT) for HCV and HIV-1. Each plasma unit must be non-reactive (negative) in all tests. Plasma is also tested by in-process NAT procedures for parvovirus B19 and the limit for B19 DNA in the manufacturing pool is set not to exceed 104 IU per mL. To reduce the risk of viral transmission, the manufacturing process for GLASSIA includes two steps specifically designed to remove or inactivate viruses. The first of these is nanofiltration (NF) through a 15 nm filter which can remove both enveloped and non–enveloped viral agents and the second is solvent/detergent (S/D) treatment with a mixture of tri-(n-butyl) phosphate (TNBP) and Polysorbate 80 (Tween 80) which inactivates enveloped viral agents such as HIV, HBV and HCV. The effectiveness of the S/D treatment and nanofiltration procedures for reducing virus content has been assessed using a series of viruses with a range of physico-chemical characteristics. The results of the viral challenge studies are summarized in Table 4."
},
{
"NDCCode": "38779-0944-6",
"PackageDescription": "1 g in 1 VIAL (38779-0944-6) ",
"NDC11Code": "38779-0944-06",
"ProductNDC": "38779-0944",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Alprostadil",
"DosageFormName": "POWDER",
"StartMarketingDate": "20170822",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Medisca Inc.",
"SubstanceName": "ALPROSTADIL",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2025-08-06",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "22-AUG-17"
},
{
"NDCCode": "68428-944-06",
"PackageDescription": "1200 PELLET in 1 BOTTLE, GLASS (68428-944-06)",
"NDC11Code": "68428-0944-06",
"ProductNDC": "68428-944",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fucus Vesiculosus",
"NonProprietaryName": "Fucus Vesiculosus",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130925",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "FUCUS VESICULOSUS",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"IndicationAndUsage": "Indications. FUCUS Constipation."
},
{
"NDCCode": "0944-4622-01",
"PackageDescription": "1 KIT in 1 CARTON (0944-4622-01) / 1 CONTAINER in 1 KIT (0944-4622-02) / 1 KIT in 1 CONTAINER (0944-4622-03) * 5 mL in 1 VIAL, GLASS (0944-4137-01) * 2 mL in 1 VIAL, GLASS (64764-514-02) ",
"NDC11Code": "00944-4622-01",
"ProductNDC": "0944-4622",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Adynovate",
"NonProprietaryName": "Antihemophilic Factor (recombinant) Pegylated",
"DosageFormName": "KIT",
"StartMarketingDate": "20160728",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125566",
"LabelerName": "Takeda Pharmaceuticals Amercia, Inc.",
"Status": "Active",
"LastUpdate": "2026-07-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160728",
"SamplePackage": "N",
"IndicationAndUsage": "ADYNOVATE® is indicated in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes., 2 Perioperative management., 3 Routine prophylaxis to reduce the frequency of bleeding episodes.",
"Description": "ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is formulated as a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution for intravenous injection. The product is supplied in single-dose vials containing nominal (approximate) potencies of 250, 500, 750, 1000, 1500, 2000, or 3000 international units (IU). Each vial of ADYNOVATE is labeled with the actual factor VIII activity in IU determined using one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for factor VIII concentrates. One IU, as defined by the WHO standard for blood coagulation factor VIII, human, is approximately equal to the level of factor VIII activity found in 1 mL of fresh pooled human plasma. When reconstituted with 2 mL or 5 mL sterile water for injection, the final solution contains the following excipients and stabilizers in targeted amounts per mL of reconstituted product:. ADYNOVATE contains no preservative. The specific activity of ADYNOVATE is 2700-8000 IU/mg protein. ADYNOVATE is a recombinant full-length human coagulation factor VIII (2,332 amino acids with a molecular weight (MW) of 280 kDa) covalently conjugated with one or more molecules of polyethylene glycol (MW 20 kDa) [see Clinical Pharmacology (12.1)]. The therapeutic activity of ADYNOVATE is derived from its parent drug substance, ADVATE [Antihemophilic Factor (Recombinant)], which is produced by recombinant DNA technology from the CHO cell line. ADVATE is purified from the culture medium using a series of chromatography columns. The purification process includes an immunoaffinity chromatography step in which a monoclonal antibody directed against factor VIII is employed to selectively isolate the factor VIII from the medium. The production process includes a dedicated, viral inactivation solvent-detergent treatment step. The ADVATE molecule is then covalently conjugated with the polyethylene glycol, which mainly targets lysine residues. The cell culture, pegylation, purification process and formulation used in the manufacture of ADYNOVATE do not use additives of human or animal origins."
},
{
"NDCCode": "0944-4623-01",
"PackageDescription": "1 KIT in 1 CARTON (0944-4623-01) / 1 CONTAINER in 1 KIT (0944-4623-02) / 1 KIT in 1 CONTAINER (0944-4623-03) * 5 mL in 1 VIAL, GLASS (0944-4138-01) * 2 mL in 1 VIAL, GLASS (64764-514-02) ",
"NDC11Code": "00944-4623-01",
"ProductNDC": "0944-4623",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Adynovate",
"NonProprietaryName": "Antihemophilic Factor (recombinant) Pegylated",
"DosageFormName": "KIT",
"StartMarketingDate": "20151113",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125566",
"LabelerName": "Takeda Pharmaceuticals Amercia, Inc.",
"Status": "Active",
"LastUpdate": "2026-07-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20151113",
"SamplePackage": "N",
"IndicationAndUsage": "ADYNOVATE® is indicated in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes., 2 Perioperative management., 3 Routine prophylaxis to reduce the frequency of bleeding episodes.",
"Description": "ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is formulated as a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution for intravenous injection. The product is supplied in single-dose vials containing nominal (approximate) potencies of 250, 500, 750, 1000, 1500, 2000, or 3000 international units (IU). Each vial of ADYNOVATE is labeled with the actual factor VIII activity in IU determined using one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for factor VIII concentrates. One IU, as defined by the WHO standard for blood coagulation factor VIII, human, is approximately equal to the level of factor VIII activity found in 1 mL of fresh pooled human plasma. When reconstituted with 2 mL or 5 mL sterile water for injection, the final solution contains the following excipients and stabilizers in targeted amounts per mL of reconstituted product:. ADYNOVATE contains no preservative. The specific activity of ADYNOVATE is 2700-8000 IU/mg protein. ADYNOVATE is a recombinant full-length human coagulation factor VIII (2,332 amino acids with a molecular weight (MW) of 280 kDa) covalently conjugated with one or more molecules of polyethylene glycol (MW 20 kDa) [see Clinical Pharmacology (12.1)]. The therapeutic activity of ADYNOVATE is derived from its parent drug substance, ADVATE [Antihemophilic Factor (Recombinant)], which is produced by recombinant DNA technology from the CHO cell line. ADVATE is purified from the culture medium using a series of chromatography columns. The purification process includes an immunoaffinity chromatography step in which a monoclonal antibody directed against factor VIII is employed to selectively isolate the factor VIII from the medium. The production process includes a dedicated, viral inactivation solvent-detergent treatment step. The ADVATE molecule is then covalently conjugated with the polyethylene glycol, which mainly targets lysine residues. The cell culture, pegylation, purification process and formulation used in the manufacture of ADYNOVATE do not use additives of human or animal origins."
},
{
"NDCCode": "0944-4624-01",
"PackageDescription": "1 KIT in 1 CARTON (0944-4624-01) / 1 CONTAINER in 1 KIT (0944-4624-02) / 1 KIT in 1 CONTAINER (0944-4624-03) * 5 mL in 1 VIAL, GLASS (0944-4140-01) * 2 mL in 1 VIAL, GLASS (64764-514-02) ",
"NDC11Code": "00944-4624-01",
"ProductNDC": "0944-4624",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Adynovate",
"NonProprietaryName": "Antihemophilic Factor (recombinant) Pegylated",
"DosageFormName": "KIT",
"StartMarketingDate": "20161025",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125566",
"LabelerName": "Takeda Pharmaceuticals Amercia, Inc.",
"Status": "Active",
"LastUpdate": "2026-07-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20161025",
"SamplePackage": "N",
"IndicationAndUsage": "ADYNOVATE® is indicated in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes., 2 Perioperative management., 3 Routine prophylaxis to reduce the frequency of bleeding episodes.",
"Description": "ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is formulated as a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution for intravenous injection. The product is supplied in single-dose vials containing nominal (approximate) potencies of 250, 500, 750, 1000, 1500, 2000, or 3000 international units (IU). Each vial of ADYNOVATE is labeled with the actual factor VIII activity in IU determined using one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for factor VIII concentrates. One IU, as defined by the WHO standard for blood coagulation factor VIII, human, is approximately equal to the level of factor VIII activity found in 1 mL of fresh pooled human plasma. When reconstituted with 2 mL or 5 mL sterile water for injection, the final solution contains the following excipients and stabilizers in targeted amounts per mL of reconstituted product:. ADYNOVATE contains no preservative. The specific activity of ADYNOVATE is 2700-8000 IU/mg protein. ADYNOVATE is a recombinant full-length human coagulation factor VIII (2,332 amino acids with a molecular weight (MW) of 280 kDa) covalently conjugated with one or more molecules of polyethylene glycol (MW 20 kDa) [see Clinical Pharmacology (12.1)]. The therapeutic activity of ADYNOVATE is derived from its parent drug substance, ADVATE [Antihemophilic Factor (Recombinant)], which is produced by recombinant DNA technology from the CHO cell line. ADVATE is purified from the culture medium using a series of chromatography columns. The purification process includes an immunoaffinity chromatography step in which a monoclonal antibody directed against factor VIII is employed to selectively isolate the factor VIII from the medium. The production process includes a dedicated, viral inactivation solvent-detergent treatment step. The ADVATE molecule is then covalently conjugated with the polyethylene glycol, which mainly targets lysine residues. The cell culture, pegylation, purification process and formulation used in the manufacture of ADYNOVATE do not use additives of human or animal origins."
},
{
"NDCCode": "0944-4625-01",
"PackageDescription": "1 KIT in 1 CARTON (0944-4625-01) / 1 CONTAINER in 1 KIT (0944-4625-02) / 1 KIT in 1 CONTAINER (0944-4625-03) * 5 mL in 1 VIAL, GLASS (0944-4257-01) * 5 mL in 1 VIAL, GLASS (64764-515-50) ",
"NDC11Code": "00944-4625-01",
"ProductNDC": "0944-4625",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Adynovate",
"NonProprietaryName": "Antihemophilic Factor (recombinant) Pegylated",
"DosageFormName": "KIT",
"StartMarketingDate": "20151113",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125566",
"LabelerName": "Takeda Pharmaceuticals Amercia, Inc.",
"Status": "Active",
"LastUpdate": "2026-07-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20151113",
"SamplePackage": "N",
"IndicationAndUsage": "ADYNOVATE® is indicated in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes., 2 Perioperative management., 3 Routine prophylaxis to reduce the frequency of bleeding episodes.",
"Description": "ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is formulated as a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution for intravenous injection. The product is supplied in single-dose vials containing nominal (approximate) potencies of 250, 500, 750, 1000, 1500, 2000, or 3000 international units (IU). Each vial of ADYNOVATE is labeled with the actual factor VIII activity in IU determined using one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for factor VIII concentrates. One IU, as defined by the WHO standard for blood coagulation factor VIII, human, is approximately equal to the level of factor VIII activity found in 1 mL of fresh pooled human plasma. When reconstituted with 2 mL or 5 mL sterile water for injection, the final solution contains the following excipients and stabilizers in targeted amounts per mL of reconstituted product:. ADYNOVATE contains no preservative. The specific activity of ADYNOVATE is 2700-8000 IU/mg protein. ADYNOVATE is a recombinant full-length human coagulation factor VIII (2,332 amino acids with a molecular weight (MW) of 280 kDa) covalently conjugated with one or more molecules of polyethylene glycol (MW 20 kDa) [see Clinical Pharmacology (12.1)]. The therapeutic activity of ADYNOVATE is derived from its parent drug substance, ADVATE [Antihemophilic Factor (Recombinant)], which is produced by recombinant DNA technology from the CHO cell line. ADVATE is purified from the culture medium using a series of chromatography columns. The purification process includes an immunoaffinity chromatography step in which a monoclonal antibody directed against factor VIII is employed to selectively isolate the factor VIII from the medium. The production process includes a dedicated, viral inactivation solvent-detergent treatment step. The ADVATE molecule is then covalently conjugated with the polyethylene glycol, which mainly targets lysine residues. The cell culture, pegylation, purification process and formulation used in the manufacture of ADYNOVATE do not use additives of human or animal origins."
},
{
"NDCCode": "0944-4626-01",
"PackageDescription": "1 KIT in 1 CARTON (0944-4626-01) / 1 CONTAINER in 1 KIT (0944-4626-02) / 1 KIT in 1 CONTAINER (0944-4626-03) * 5 mL in 1 VIAL, GLASS (0944-4139-01) * 2 mL in 1 VIAL, GLASS (64764-514-02) ",
"NDC11Code": "00944-4626-01",
"ProductNDC": "0944-4626",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Adynovate",
"NonProprietaryName": "Antihemophilic Factor (recombinant) Pegylated",
"DosageFormName": "KIT",
"StartMarketingDate": "20161025",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125566",
"LabelerName": "Takeda Pharmaceuticals Amercia, Inc.",
"Status": "Active",
"LastUpdate": "2026-07-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20161025",
"SamplePackage": "N",
"IndicationAndUsage": "ADYNOVATE® is indicated in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes., 2 Perioperative management., 3 Routine prophylaxis to reduce the frequency of bleeding episodes.",
"Description": "ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is formulated as a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution for intravenous injection. The product is supplied in single-dose vials containing nominal (approximate) potencies of 250, 500, 750, 1000, 1500, 2000, or 3000 international units (IU). Each vial of ADYNOVATE is labeled with the actual factor VIII activity in IU determined using one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for factor VIII concentrates. One IU, as defined by the WHO standard for blood coagulation factor VIII, human, is approximately equal to the level of factor VIII activity found in 1 mL of fresh pooled human plasma. When reconstituted with 2 mL or 5 mL sterile water for injection, the final solution contains the following excipients and stabilizers in targeted amounts per mL of reconstituted product:. ADYNOVATE contains no preservative. The specific activity of ADYNOVATE is 2700-8000 IU/mg protein. ADYNOVATE is a recombinant full-length human coagulation factor VIII (2,332 amino acids with a molecular weight (MW) of 280 kDa) covalently conjugated with one or more molecules of polyethylene glycol (MW 20 kDa) [see Clinical Pharmacology (12.1)]. The therapeutic activity of ADYNOVATE is derived from its parent drug substance, ADVATE [Antihemophilic Factor (Recombinant)], which is produced by recombinant DNA technology from the CHO cell line. ADVATE is purified from the culture medium using a series of chromatography columns. The purification process includes an immunoaffinity chromatography step in which a monoclonal antibody directed against factor VIII is employed to selectively isolate the factor VIII from the medium. The production process includes a dedicated, viral inactivation solvent-detergent treatment step. The ADVATE molecule is then covalently conjugated with the polyethylene glycol, which mainly targets lysine residues. The cell culture, pegylation, purification process and formulation used in the manufacture of ADYNOVATE do not use additives of human or animal origins."
},
{
"NDCCode": "0944-4627-01",
"PackageDescription": "1 KIT in 1 CARTON (0944-4627-01) / 1 CONTAINER in 1 KIT (0944-4627-02) / 1 KIT in 1 CONTAINER (0944-4627-03) * 5 mL in 1 VIAL, GLASS (0944-4141-01) * 2 mL in 1 VIAL, GLASS (64764-514-02) ",
"NDC11Code": "00944-4627-01",
"ProductNDC": "0944-4627",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Adynovate",
"NonProprietaryName": "Antihemophilic Factor (recombinant) Pegylated",
"DosageFormName": "KIT",
"StartMarketingDate": "20151113",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125566",
"LabelerName": "Takeda Pharmaceuticals Amercia, Inc.",
"Status": "Active",
"LastUpdate": "2026-07-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20151113",
"SamplePackage": "N",
"IndicationAndUsage": "ADYNOVATE® is indicated in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes., 2 Perioperative management., 3 Routine prophylaxis to reduce the frequency of bleeding episodes.",
"Description": "ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is formulated as a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution for intravenous injection. The product is supplied in single-dose vials containing nominal (approximate) potencies of 250, 500, 750, 1000, 1500, 2000, or 3000 international units (IU). Each vial of ADYNOVATE is labeled with the actual factor VIII activity in IU determined using one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for factor VIII concentrates. One IU, as defined by the WHO standard for blood coagulation factor VIII, human, is approximately equal to the level of factor VIII activity found in 1 mL of fresh pooled human plasma. When reconstituted with 2 mL or 5 mL sterile water for injection, the final solution contains the following excipients and stabilizers in targeted amounts per mL of reconstituted product:. ADYNOVATE contains no preservative. The specific activity of ADYNOVATE is 2700-8000 IU/mg protein. ADYNOVATE is a recombinant full-length human coagulation factor VIII (2,332 amino acids with a molecular weight (MW) of 280 kDa) covalently conjugated with one or more molecules of polyethylene glycol (MW 20 kDa) [see Clinical Pharmacology (12.1)]. The therapeutic activity of ADYNOVATE is derived from its parent drug substance, ADVATE [Antihemophilic Factor (Recombinant)], which is produced by recombinant DNA technology from the CHO cell line. ADVATE is purified from the culture medium using a series of chromatography columns. The purification process includes an immunoaffinity chromatography step in which a monoclonal antibody directed against factor VIII is employed to selectively isolate the factor VIII from the medium. The production process includes a dedicated, viral inactivation solvent-detergent treatment step. The ADVATE molecule is then covalently conjugated with the polyethylene glycol, which mainly targets lysine residues. The cell culture, pegylation, purification process and formulation used in the manufacture of ADYNOVATE do not use additives of human or animal origins."
},
{
"NDCCode": "0944-4628-01",
"PackageDescription": "1 KIT in 1 CARTON (0944-4628-01) / 1 CONTAINER in 1 KIT (0944-4628-02) / 1 KIT in 1 CONTAINER (0944-4628-03) * 5 mL in 1 VIAL, GLASS (64764-515-50) * 5 mL in 1 VIAL, GLASS (0944-4263-01) ",
"NDC11Code": "00944-4628-01",
"ProductNDC": "0944-4628",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Adynovate",
"NonProprietaryName": "Antihemophilic Factor (recombinant) Pegylated",
"DosageFormName": "KIT",
"StartMarketingDate": "20161025",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125566",
"LabelerName": "Takeda Pharmaceuticals Amercia, Inc.",
"Status": "Active",
"LastUpdate": "2026-07-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20161025",
"SamplePackage": "N",
"IndicationAndUsage": "ADYNOVATE® is indicated in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes., 2 Perioperative management., 3 Routine prophylaxis to reduce the frequency of bleeding episodes.",
"Description": "ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is formulated as a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution for intravenous injection. The product is supplied in single-dose vials containing nominal (approximate) potencies of 250, 500, 750, 1000, 1500, 2000, or 3000 international units (IU). Each vial of ADYNOVATE is labeled with the actual factor VIII activity in IU determined using one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for factor VIII concentrates. One IU, as defined by the WHO standard for blood coagulation factor VIII, human, is approximately equal to the level of factor VIII activity found in 1 mL of fresh pooled human plasma. When reconstituted with 2 mL or 5 mL sterile water for injection, the final solution contains the following excipients and stabilizers in targeted amounts per mL of reconstituted product:. ADYNOVATE contains no preservative. The specific activity of ADYNOVATE is 2700-8000 IU/mg protein. ADYNOVATE is a recombinant full-length human coagulation factor VIII (2,332 amino acids with a molecular weight (MW) of 280 kDa) covalently conjugated with one or more molecules of polyethylene glycol (MW 20 kDa) [see Clinical Pharmacology (12.1)]. The therapeutic activity of ADYNOVATE is derived from its parent drug substance, ADVATE [Antihemophilic Factor (Recombinant)], which is produced by recombinant DNA technology from the CHO cell line. ADVATE is purified from the culture medium using a series of chromatography columns. The purification process includes an immunoaffinity chromatography step in which a monoclonal antibody directed against factor VIII is employed to selectively isolate the factor VIII from the medium. The production process includes a dedicated, viral inactivation solvent-detergent treatment step. The ADVATE molecule is then covalently conjugated with the polyethylene glycol, which mainly targets lysine residues. The cell culture, pegylation, purification process and formulation used in the manufacture of ADYNOVATE do not use additives of human or animal origins."
},
{
"NDCCode": "43419-580-14",
"PackageDescription": "5 mL in 1 TUBE (43419-580-14) ",
"NDC11Code": "43419-0580-14",
"ProductNDC": "43419-580",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Amorepacific Natural Protector",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, And Octocrylene",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160118",
"EndMarketingDate": "20200530",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "AMOREPACIFIC CORPORATION",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "1500; 5400; 2700; 5400",
"StrengthUnit": "mg/60mL; mg/60mL; mg/60mL; mg/60mL",
"Status": "Deprecated",
"LastUpdate": "2020-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180801",
"EndMarketingDatePackage": "20200530",
"SamplePackage": "N"
},
{
"NDCCode": "43419-580-18",
"PackageDescription": "1 TUBE in 1 CARTON (43419-580-18) > 60 mL in 1 TUBE",
"NDC11Code": "43419-0580-18",
"ProductNDC": "43419-580",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Amorepacific Natural Protector",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, And Octocrylene",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160118",
"EndMarketingDate": "20200530",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "AMOREPACIFIC CORPORATION",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "1500; 5400; 2700; 5400",
"StrengthUnit": "mg/60mL; mg/60mL; mg/60mL; mg/60mL",
"Status": "Deprecated",
"LastUpdate": "2020-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160118",
"EndMarketingDatePackage": "20200530",
"SamplePackage": "N"
},
{
"NDCCode": "43419-580-24",
"PackageDescription": "30 mL in 1 TUBE (43419-580-24) ",
"NDC11Code": "43419-0580-24",
"ProductNDC": "43419-580",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Amorepacific Natural Protector",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, And Octocrylene",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160118",
"EndMarketingDate": "20200530",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "AMOREPACIFIC CORPORATION",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "1500; 5400; 2700; 5400",
"StrengthUnit": "mg/60mL; mg/60mL; mg/60mL; mg/60mL",
"Status": "Deprecated",
"LastUpdate": "2020-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180801",
"EndMarketingDatePackage": "20200530",
"SamplePackage": "N"
},
{
"NDCCode": "61957-2800-0",
"PackageDescription": "1 KIT in 1 KIT (61957-2800-0) * 1 TUBE in 1 BOX (61957-2700-1) > 75 g in 1 TUBE",
"NDC11Code": "61957-2800-00",
"ProductNDC": "61957-2800",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dior Homme Eau For Men",
"NonProprietaryName": "Aluminum Zirconium Tetrachlorohydrex Gly",
"DosageFormName": "KIT",
"StartMarketingDate": "20170314",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part350",
"LabelerName": "Parfums Christian Dior",
"Status": "Deprecated",
"LastUpdate": "2018-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231",
"StartMarketingDatePackage": "20170314",
"SamplePackage": "N"
},
{
"NDCCode": "72893-001-01",
"PackageDescription": "1 VIAL in 1 CARTON (72893-001-01) / 20 mL in 1 VIAL",
"NDC11Code": "72893-0001-01",
"ProductNDC": "72893-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Evomela",
"NonProprietaryName": "Melphalan",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20160331",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207155",
"LabelerName": "Acrotech Biopharma Inc",
"SubstanceName": "MELPHALAN HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160331",
"SamplePackage": "N",
"IndicationAndUsage": "Evomela is an alkylating drug indicated for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma. (1.1).",
"Description": "Evomela contains melphalan hydrochloride, an alkylating drug, as the active ingredient. The chemical name of melphalan hydrochloride is 4-[bis(2-chloroethyl)amino]-L-phenylalanine hydrochloride. Its molecular formula is C13H18Cl2N2O2 HCl and the molecular weight is 341.67. The structural formula is:. Melphalan hydrochloride is a white to off-white powder, with a melting range of 199°C − 201°C. It is practically insoluble in water, but freely soluble in 1N HCl and methanol. Evomela (melphalan) for injection is supplied as a sterile white to off-white lyophilized powder in a single-dose vial for intravenous use. Each vial contains 50 mg melphalan free base equivalent to 56 mg melphalan hydrochloride and 2700 mg Betadex Sulfobutyl Ether Sodium, NF. Sodium hydroxide and if necessary, hydrochloric acid are added as a pH adjuster."
},
{
"NDCCode": "76331-909-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (76331-909-30)",
"NDC11Code": "76331-0909-30",
"ProductNDC": "76331-909",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nata Komplete",
"NonProprietaryName": "Vitamin A, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol, Thiamine, Riboflavin, Niacin, Pyridoxine, Folic Acid, Cyanocobalamin, Biotin, Pantothenic Acid, Calcium, Iron, Magnesium, Zinc, Selenium, Copper, Choline Bitartrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110625",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "WH Nutritionals, LLC",
"SubstanceName": "VITAMIN A; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL; THIAMINE; RIBOFLAVIN; NIACIN; PYRIDOXINE; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; PANTOTHENIC ACID; CALCIUM; IRON; MAGNESIUM; ZINC; SELENIUM; COPPER; CHOLINE BITARTRATE",
"StrengthNumber": "2700; 120; 400; 20; 3; 3.5; 20; 30; 1; 12; 30; 8; 100; 25; 50; 15; 50; 2; 55",
"StrengthUnit": "[iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1",
"Pharm_Classes": "Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE]",
"Status": "Deprecated",
"LastUpdate": "2016-12-06"
},
{
"NDCCode": "0944-2510-02",
"PackageDescription": "1 KIT in 1 CARTON (0944-2510-02) * 25 mL in 1 VIAL, GLASS (0944-2715-25) * 1.25 mL in 1 VIAL, GLASS (0944-2720-03) ",
"NDC11Code": "00944-2510-02",
"ProductNDC": "0944-2510",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Hyqvia",
"NonProprietaryName": "Immune Globulin Infusion (human), 10% With Recombinant Human Hyaluronidase",
"DosageFormName": "KIT",
"StartMarketingDate": "20140912",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125402",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"Status": "Active",
"LastUpdate": "2026-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140912",
"SamplePackage": "N",
"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)."
},
{
"NDCCode": "0944-2511-02",
"PackageDescription": "1 KIT in 1 CARTON (0944-2511-02) * 50 mL in 1 VIAL, GLASS (0944-2716-05) * 2.5 mL in 1 VIAL, GLASS (0944-2721-03) ",
"NDC11Code": "00944-2511-02",
"ProductNDC": "0944-2511",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Hyqvia",
"NonProprietaryName": "Immune Globulin Infusion (human), 10% With Recombinant Human Hyaluronidase",
"DosageFormName": "KIT",
"StartMarketingDate": "20140912",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125402",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"Status": "Active",
"LastUpdate": "2026-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140912",
"SamplePackage": "N",
"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)."
},
{
"NDCCode": "0944-2512-02",
"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) ",
"NDC11Code": "00944-2512-02",
"ProductNDC": "0944-2512",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Hyqvia",
"NonProprietaryName": "Immune Globulin Infusion (human), 10% With Recombinant Human Hyaluronidase",
"DosageFormName": "KIT",
"StartMarketingDate": "20140912",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125402",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"Status": "Active",
"LastUpdate": "2026-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140912",
"SamplePackage": "N",
"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)."
},
{
"NDCCode": "0944-2513-02",
"PackageDescription": "1 KIT in 1 CARTON (0944-2513-02) * 200 mL in 1 VIAL, GLASS (0944-2718-20) * 10 mL in 1 VIAL, GLASS (0944-2723-03) ",
"NDC11Code": "00944-2513-02",
"ProductNDC": "0944-2513",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Hyqvia",
"NonProprietaryName": "Immune Globulin Infusion (human), 10% With Recombinant Human Hyaluronidase",
"DosageFormName": "KIT",
"StartMarketingDate": "20140912",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125402",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"Status": "Active",
"LastUpdate": "2026-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140912",
"SamplePackage": "N",
"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)."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>0944-2700-06</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (0944-2700-06) / 200 mL in 1 BOTTLE, GLASS (0944-2700-12) </PackageDescription>
<NDC11Code>00944-2700-06</NDC11Code>
<ProductNDC>0944-2700</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Gammagard Liquid</ProprietaryName>
<NonProprietaryName>Immune Globulin Infusion (human)</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20050427</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125105</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050427</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>GAMMAGARD LIQUID is a ready-for-use sterile, liquid preparation of highly purified and concentrated immunoglobulin G (IgG) antibodies. The distribution of the IgG subclasses is similar to that of normal plasma. The Fc and Fab functions are maintained in GAMMAGARD LIQUID. Pre-kallikrein activator activity is not detectable. GAMMAGARD LIQUID contains 100 mg/mL protein. At least 98% of the protein is immune globulin, the average immunoglobulin A (IgA) concentration is 37 µg/mL, and immunoglobulin M is present in trace amounts. GAMMAGARD LIQUID contains a broad spectrum of IgG antibodies against bacterial and viral agents. Glycine (0.25M) serves as a stabilizing and buffering agent. There are no added sugars, sodium or preservatives. The pH is 4.6 to 5.1. The osmolality is 240 to 300 mOsmol/kg, which is similar to physiological osmolality (285 to 295 mOsmol/kg). GAMMAGARD LIQUID 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 GAMMAGARD LIQUID 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) and found to be negative. To further improve the margin of safety, validated virus inactivation/removal steps have been integrated into the manufacturing and formulation processes, namely solvent/detergent (S/D) treatment,10 35 nm nanofiltration, and a low pH incubation at elevated temperature (30 C to 32 C). 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. S/D treatment inactivates the lipid-enveloped viruses investigated to below detection limits within minutes.12. 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, 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 GAMMAGARD LIQUID performed in accordance with good laboratory practices are summarized in Table 12.</Description>
</NDC>
<NDC>
<NDCCode>71335-2700-6</NDCCode>
<PackageDescription>21 CAPSULE in 1 BOTTLE (71335-2700-6) </PackageDescription>
<NDC11Code>71335-2700-06</NDC11Code>
<ProductNDC>71335-2700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080131</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078787</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250925</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin capsules are indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy .</IndicationAndUsage>
<Description>The active ingredient in gabapentin capsules, USP is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin USP is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each capsule contains the following inactive ingredients: corn starch and talc. The empty hard gelatin capsule shell consists of gelatin, sodium lauryl sulfate, and titanium dioxide. In addition 300 mg also contains yellow iron oxide and 400 mg also contains yellow iron oxide and red iron oxide. The capsules are printed with edible ink containing black iron oxide and shellac.</Description>
</NDC>
<NDC>
<NDCCode>0944-2700-02</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (0944-2700-02) / 10 mL in 1 BOTTLE, GLASS (0944-2700-08) </PackageDescription>
<NDC11Code>00944-2700-02</NDC11Code>
<ProductNDC>0944-2700</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Gammagard Liquid</ProprietaryName>
<NonProprietaryName>Immune Globulin Infusion (human)</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20050427</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125105</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050427</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>GAMMAGARD LIQUID is a ready-for-use sterile, liquid preparation of highly purified and concentrated immunoglobulin G (IgG) antibodies. The distribution of the IgG subclasses is similar to that of normal plasma. The Fc and Fab functions are maintained in GAMMAGARD LIQUID. Pre-kallikrein activator activity is not detectable. GAMMAGARD LIQUID contains 100 mg/mL protein. At least 98% of the protein is immune globulin, the average immunoglobulin A (IgA) concentration is 37 µg/mL, and immunoglobulin M is present in trace amounts. GAMMAGARD LIQUID contains a broad spectrum of IgG antibodies against bacterial and viral agents. Glycine (0.25M) serves as a stabilizing and buffering agent. There are no added sugars, sodium or preservatives. The pH is 4.6 to 5.1. The osmolality is 240 to 300 mOsmol/kg, which is similar to physiological osmolality (285 to 295 mOsmol/kg). GAMMAGARD LIQUID 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 GAMMAGARD LIQUID 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) and found to be negative. To further improve the margin of safety, validated virus inactivation/removal steps have been integrated into the manufacturing and formulation processes, namely solvent/detergent (S/D) treatment,10 35 nm nanofiltration, and a low pH incubation at elevated temperature (30 C to 32 C). 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. S/D treatment inactivates the lipid-enveloped viruses investigated to below detection limits within minutes.12. 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, 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 GAMMAGARD LIQUID performed in accordance with good laboratory practices are summarized in Table 12.</Description>
</NDC>
<NDC>
<NDCCode>0944-2700-03</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (0944-2700-03) / 25 mL in 1 BOTTLE, GLASS (0944-2700-09) </PackageDescription>
<NDC11Code>00944-2700-03</NDC11Code>
<ProductNDC>0944-2700</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Gammagard Liquid</ProprietaryName>
<NonProprietaryName>Immune Globulin Infusion (human)</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20050427</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125105</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050427</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>GAMMAGARD LIQUID is a ready-for-use sterile, liquid preparation of highly purified and concentrated immunoglobulin G (IgG) antibodies. The distribution of the IgG subclasses is similar to that of normal plasma. The Fc and Fab functions are maintained in GAMMAGARD LIQUID. Pre-kallikrein activator activity is not detectable. GAMMAGARD LIQUID contains 100 mg/mL protein. At least 98% of the protein is immune globulin, the average immunoglobulin A (IgA) concentration is 37 µg/mL, and immunoglobulin M is present in trace amounts. GAMMAGARD LIQUID contains a broad spectrum of IgG antibodies against bacterial and viral agents. Glycine (0.25M) serves as a stabilizing and buffering agent. There are no added sugars, sodium or preservatives. The pH is 4.6 to 5.1. The osmolality is 240 to 300 mOsmol/kg, which is similar to physiological osmolality (285 to 295 mOsmol/kg). GAMMAGARD LIQUID 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 GAMMAGARD LIQUID 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) and found to be negative. To further improve the margin of safety, validated virus inactivation/removal steps have been integrated into the manufacturing and formulation processes, namely solvent/detergent (S/D) treatment,10 35 nm nanofiltration, and a low pH incubation at elevated temperature (30 C to 32 C). 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. S/D treatment inactivates the lipid-enveloped viruses investigated to below detection limits within minutes.12. 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, 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 GAMMAGARD LIQUID performed in accordance with good laboratory practices are summarized in Table 12.</Description>
</NDC>
<NDC>
<NDCCode>0944-2700-04</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (0944-2700-04) / 50 mL in 1 BOTTLE, GLASS (0944-2700-10) </PackageDescription>
<NDC11Code>00944-2700-04</NDC11Code>
<ProductNDC>0944-2700</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Gammagard Liquid</ProprietaryName>
<NonProprietaryName>Immune Globulin Infusion (human)</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20050427</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125105</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050427</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>GAMMAGARD LIQUID is a ready-for-use sterile, liquid preparation of highly purified and concentrated immunoglobulin G (IgG) antibodies. The distribution of the IgG subclasses is similar to that of normal plasma. The Fc and Fab functions are maintained in GAMMAGARD LIQUID. Pre-kallikrein activator activity is not detectable. GAMMAGARD LIQUID contains 100 mg/mL protein. At least 98% of the protein is immune globulin, the average immunoglobulin A (IgA) concentration is 37 µg/mL, and immunoglobulin M is present in trace amounts. GAMMAGARD LIQUID contains a broad spectrum of IgG antibodies against bacterial and viral agents. Glycine (0.25M) serves as a stabilizing and buffering agent. There are no added sugars, sodium or preservatives. The pH is 4.6 to 5.1. The osmolality is 240 to 300 mOsmol/kg, which is similar to physiological osmolality (285 to 295 mOsmol/kg). GAMMAGARD LIQUID 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 GAMMAGARD LIQUID 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) and found to be negative. To further improve the margin of safety, validated virus inactivation/removal steps have been integrated into the manufacturing and formulation processes, namely solvent/detergent (S/D) treatment,10 35 nm nanofiltration, and a low pH incubation at elevated temperature (30 C to 32 C). 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. S/D treatment inactivates the lipid-enveloped viruses investigated to below detection limits within minutes.12. 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, 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 GAMMAGARD LIQUID performed in accordance with good laboratory practices are summarized in Table 12.</Description>
</NDC>
<NDC>
<NDCCode>0944-2700-05</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (0944-2700-05) / 100 mL in 1 BOTTLE, GLASS (0944-2700-11) </PackageDescription>
<NDC11Code>00944-2700-05</NDC11Code>
<ProductNDC>0944-2700</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Gammagard Liquid</ProprietaryName>
<NonProprietaryName>Immune Globulin Infusion (human)</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20050427</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125105</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050427</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>GAMMAGARD LIQUID is a ready-for-use sterile, liquid preparation of highly purified and concentrated immunoglobulin G (IgG) antibodies. The distribution of the IgG subclasses is similar to that of normal plasma. The Fc and Fab functions are maintained in GAMMAGARD LIQUID. Pre-kallikrein activator activity is not detectable. GAMMAGARD LIQUID contains 100 mg/mL protein. At least 98% of the protein is immune globulin, the average immunoglobulin A (IgA) concentration is 37 µg/mL, and immunoglobulin M is present in trace amounts. GAMMAGARD LIQUID contains a broad spectrum of IgG antibodies against bacterial and viral agents. Glycine (0.25M) serves as a stabilizing and buffering agent. There are no added sugars, sodium or preservatives. The pH is 4.6 to 5.1. The osmolality is 240 to 300 mOsmol/kg, which is similar to physiological osmolality (285 to 295 mOsmol/kg). GAMMAGARD LIQUID 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 GAMMAGARD LIQUID 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) and found to be negative. To further improve the margin of safety, validated virus inactivation/removal steps have been integrated into the manufacturing and formulation processes, namely solvent/detergent (S/D) treatment,10 35 nm nanofiltration, and a low pH incubation at elevated temperature (30 C to 32 C). 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. S/D treatment inactivates the lipid-enveloped viruses investigated to below detection limits within minutes.12. 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, 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 GAMMAGARD LIQUID performed in accordance with good laboratory practices are summarized in Table 12.</Description>
</NDC>
<NDC>
<NDCCode>0944-2700-07</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (0944-2700-07) / 300 mL in 1 BOTTLE, GLASS (0944-2700-13) </PackageDescription>
<NDC11Code>00944-2700-07</NDC11Code>
<ProductNDC>0944-2700</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Gammagard Liquid</ProprietaryName>
<NonProprietaryName>Immune Globulin Infusion (human)</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20050427</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125105</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050427</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>GAMMAGARD LIQUID is a ready-for-use sterile, liquid preparation of highly purified and concentrated immunoglobulin G (IgG) antibodies. The distribution of the IgG subclasses is similar to that of normal plasma. The Fc and Fab functions are maintained in GAMMAGARD LIQUID. Pre-kallikrein activator activity is not detectable. GAMMAGARD LIQUID contains 100 mg/mL protein. At least 98% of the protein is immune globulin, the average immunoglobulin A (IgA) concentration is 37 µg/mL, and immunoglobulin M is present in trace amounts. GAMMAGARD LIQUID contains a broad spectrum of IgG antibodies against bacterial and viral agents. Glycine (0.25M) serves as a stabilizing and buffering agent. There are no added sugars, sodium or preservatives. The pH is 4.6 to 5.1. The osmolality is 240 to 300 mOsmol/kg, which is similar to physiological osmolality (285 to 295 mOsmol/kg). GAMMAGARD LIQUID 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 GAMMAGARD LIQUID 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) and found to be negative. To further improve the margin of safety, validated virus inactivation/removal steps have been integrated into the manufacturing and formulation processes, namely solvent/detergent (S/D) treatment,10 35 nm nanofiltration, and a low pH incubation at elevated temperature (30 C to 32 C). 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. S/D treatment inactivates the lipid-enveloped viruses investigated to below detection limits within minutes.12. 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, 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 GAMMAGARD LIQUID performed in accordance with good laboratory practices are summarized in Table 12.</Description>
</NDC>
<NDC>
<NDCCode>0944-0495-05</NDCCode>
<PackageDescription>2 BAG in 1 CARTON (0944-0495-05) / 250 mL in 1 BAG (0944-0495-06) </PackageDescription>
<NDC11Code>00944-0495-05</NDC11Code>
<ProductNDC>0944-0495</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Flexbumin</ProprietaryName>
<NonProprietaryName>Albumin Human</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20140731</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101452</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</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>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FLEXBUMIN® 5% [Albumin (Human)] is indicated for hypovolemia, hypoalbuminemia and cardiopulmonary bypass surgery.</IndicationAndUsage>
<Description>FLEXBUMIN 5% is a sterile, nonpyrogenic preparation of albumin in single dosage form for intravenous administration. Each 100 mL contains 5 g of albumin. It has been adjusted to physiological pH with sodium bicarbonate and/or sodium hydroxide and stabilized with N-acetyltryptophan (0.004M) and sodium caprylate (0.004M). The sodium content is 145 ± 15 mEq/L. FLEXBUMIN 5% contains no preservative and none of the coagulation factors found in fresh whole blood or plasma. FLEXBUMIN 5% is a transparent or slightly opalescent solution which may have a greenish tint or may vary from a pale straw to an amber color and is clear of particulate matter. FLEXBUMIN 5% is manufactured from human plasma by the modified Cohn-Oncley cold ethanol fractionation process, which includes a series of cold-ethanol precipitation, centrifugation and/or filtration steps followed by pasteurization of the final product at 60 ± 0.5°C for 10 to 11 hours. This process accomplishes both purification of albumin and reduction of viruses. In vitro studies demonstrate that the manufacturing process for FLEXBUMIN 5% provides for effective viral reduction. These viral reduction studies, summarized in Table 2, demonstrate viral clearance during the manufacturing process for FLEXBUMIN 5%. These studies indicate that specific steps in the manufacturing of FLEXBUMIN 5% are capable of eliminating/inactivating a wide range of relevant and model viruses. Since the mechanism of virus elimination/inactivation by fractionation and by heating steps is different, the overall manufacturing process of FLEXBUMIN 5% is effective in reducing viral load. The likelihood of the presence of viable hepatitis viruses has been minimized by testing the plasma at three stages for the presence of hepatitis viruses, by fractionation steps with demonstrated virus removal capacity and by heating the product for 10 hours at 60°C. This procedure has been shown to be an effective method of inactivating hepatitis virus in albumin solutions even when those solutions were prepared from plasma known to be infective.1,2,3 FLEXBUMIN 5% contains no blood group isoagglutinins, thereby permitting its administration without regard to the recipient's blood group.</Description>
</NDC>
<NDC>
<NDCCode>0944-2623-02</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0944-2623-02) * 50 mL in 1 VIAL, GLASS (0338-0001-65) * 50 mL in 1 BOTTLE (0944-2624-06) </PackageDescription>
<NDC11Code>00944-2623-02</NDC11Code>
<ProductNDC>0944-2623</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Gammagard</ProprietaryName>
<ProprietaryNameSuffix>S/d</ProprietaryNameSuffix>
<NonProprietaryName>Immune Globulin Intravenous (human)</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19940510</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103133</ApplicationNumber>
<LabelerName>Baxalta US Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19940510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0944-2850-05</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (0944-2850-05) / 20 mL in 1 VIAL, SINGLE-USE (0944-2850-06) </PackageDescription>
<NDC11Code>00944-2850-05</NDC11Code>
<ProductNDC>0944-2850</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Cuvitru</ProprietaryName>
<NonProprietaryName>Immune Globulin Subcutaneous (human)</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20161018</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125596</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161018</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CUVITRU is an Immune Globulin Subcutaneous (Human) (IGSC), 20% Solution indicated as replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age and older. This includes, but is not limited to, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies1,2.</IndicationAndUsage>
<Description>CUVITRU is a ready-for-use, sterile, liquid preparation of highly purified and concentrated immunoglobulin G (IgG) antibodies. The distribution of the IgG subclasses is similar to that of normal plasma. The Fc and Fab functions are maintained in CUVITRU. CUVITRU has a purity ≥98% IgG and a pH of 4.6 to 5.1. The osmolality is 280-292 milli-osmoles per kilogram. CUVITRU contains 200 milligram/mL protein. The average immunoglobulin A (IgA) concentration is 80 mcg/mL. CUVITRU contains a broad spectrum of IgG antibodies against bacterial and viral agents. Glycine (0.25M) serves as a stabilizing and buffering agent, and there are no added sugars, sodium or preservatives. CUVITRU 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 CUVITRU 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) and found to be negative. To further improve the margin of safety, validated virus inactivation/removal steps have been integrated into the manufacturing and formulation processes, namely solvent/detergent (S/D) treatment13, 35 nm nanofiltration, and a low pH incubation at elevated temperature (30°C to 32°C). 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. S/D treatment inactivates the lipid-enveloped viruses investigated to below detection limits within minutes13. The ethanol fractionation process provides an additional virus clearance capacity. 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 CUVITRU performed in accordance with good laboratory practices are summarized in Table 7.</Description>
</NDC>
<NDC>
<NDCCode>0944-2884-05</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (0944-2884-05) / 250 mL in 1 VIAL, GLASS (0944-2884-06) </PackageDescription>
<NDC11Code>00944-2884-05</NDC11Code>
<ProductNDC>0944-2884</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Glassia</ProprietaryName>
<NonProprietaryName>Alpha.1-proteinase Inhibitor Human</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20100701</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125325</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<SubstanceName>.ALPHA.1-PROTEINASE INHIBITOR HUMAN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/50mL</StrengthUnit>
<Pharm_Classes>Human alpha-1 Proteinase Inhibitor [EPC], Trypsin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GLASSIA is an Alpha1-Proteinase Inhibitor (Human), indicated for chronic augmentation and maintenance therapy in individuals with clinically evident emphysema due to severe hereditary deficiency of Alpha1-PI, also known as alpha1-antitrypsin (AAT) deficiency. Limitations of Use: 1 The effect of augmentation therapy with GLASSIA or any Alpha1-PI product on pulmonary exacerbations and on the progression of emphysema in Alpha1-PI deficiency has not been conclusively demonstrated in randomized, controlled clinical trials., 2 Clinical data demonstrating the long-term effects of chronic augmentation and maintenance therapy of individuals with GLASSIA are not available., 3 GLASSIA is not indicated as therapy for lung disease in patients in whom severe Alpha1-PI deficiency has not been established.</IndicationAndUsage>
<Description>GLASSIA is a sterile, ready to use, liquid preparation of purified human Alpha1-proteinase inhibitor (Alpha1-PI), also known as alpha1-antitrypsin (AAT). The solution contains 2% active Alpha1-PI in a phosphate-buffered saline solution. The specific activity of GLASSIA is ≥ 0.7 mg functional Alpha1-PI per mg of total protein. Not less than 90% of the Alpha1-PI in GLASSIA is of the monomeric form as measured by size-exclusion chromatography. GLASSIA is prepared from human plasma obtained from US-licensed plasma collection centers by a modified version of the cold ethanol fractionation process and the Alpha1-PI is then purified using chromatographic methods. Individual plasma units used for production of GLASSIA are tested using FDA- licensed serological assays for hepatitis B surface antigen (HBsAg) and for antibodies to hepatitis C virus (HCV) and human immunodeficiency virus types 1 and 2 (HIV-1/2), as well as by FDA-licensed Nucleic Acid Testing (NAT) for HCV and HIV-1. Each plasma unit must be non-reactive (negative) in all tests. Plasma is also tested by in-process NAT procedures for parvovirus B19 and the limit for B19 DNA in the manufacturing pool is set not to exceed 104 IU per mL. To reduce the risk of viral transmission, the manufacturing process for GLASSIA includes two steps specifically designed to remove or inactivate viruses. The first of these is nanofiltration (NF) through a 15 nm filter which can remove both enveloped and non–enveloped viral agents and the second is solvent/detergent (S/D) treatment with a mixture of tri-(n-butyl) phosphate (TNBP) and Polysorbate 80 (Tween 80) which inactivates enveloped viral agents such as HIV, HBV and HCV. The effectiveness of the S/D treatment and nanofiltration procedures for reducing virus content has been assessed using a series of viruses with a range of physico-chemical characteristics. The results of the viral challenge studies are summarized in Table 4.</Description>
</NDC>
<NDC>
<NDCCode>38779-0944-6</NDCCode>
<PackageDescription>1 g in 1 VIAL (38779-0944-6) </PackageDescription>
<NDC11Code>38779-0944-06</NDC11Code>
<ProductNDC>38779-0944</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Alprostadil</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20170822</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Medisca Inc.</LabelerName>
<SubstanceName>ALPROSTADIL</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-08-06</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>22-AUG-17</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>68428-944-06</NDCCode>
<PackageDescription>1200 PELLET in 1 BOTTLE, GLASS (68428-944-06)</PackageDescription>
<NDC11Code>68428-0944-06</NDC11Code>
<ProductNDC>68428-944</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fucus Vesiculosus</ProprietaryName>
<NonProprietaryName>Fucus Vesiculosus</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130925</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>FUCUS VESICULOSUS</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications. FUCUS Constipation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0944-4622-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0944-4622-01) / 1 CONTAINER in 1 KIT (0944-4622-02) / 1 KIT in 1 CONTAINER (0944-4622-03) * 5 mL in 1 VIAL, GLASS (0944-4137-01) * 2 mL in 1 VIAL, GLASS (64764-514-02) </PackageDescription>
<NDC11Code>00944-4622-01</NDC11Code>
<ProductNDC>0944-4622</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Adynovate</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor (recombinant) Pegylated</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20160728</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125566</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals Amercia, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160728</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ADYNOVATE® is indicated in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes., 2 Perioperative management., 3 Routine prophylaxis to reduce the frequency of bleeding episodes.</IndicationAndUsage>
<Description>ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is formulated as a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution for intravenous injection. The product is supplied in single-dose vials containing nominal (approximate) potencies of 250, 500, 750, 1000, 1500, 2000, or 3000 international units (IU). Each vial of ADYNOVATE is labeled with the actual factor VIII activity in IU determined using one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for factor VIII concentrates. One IU, as defined by the WHO standard for blood coagulation factor VIII, human, is approximately equal to the level of factor VIII activity found in 1 mL of fresh pooled human plasma. When reconstituted with 2 mL or 5 mL sterile water for injection, the final solution contains the following excipients and stabilizers in targeted amounts per mL of reconstituted product:. ADYNOVATE contains no preservative. The specific activity of ADYNOVATE is 2700-8000 IU/mg protein. ADYNOVATE is a recombinant full-length human coagulation factor VIII (2,332 amino acids with a molecular weight (MW) of 280 kDa) covalently conjugated with one or more molecules of polyethylene glycol (MW 20 kDa) [see Clinical Pharmacology (12.1)]. The therapeutic activity of ADYNOVATE is derived from its parent drug substance, ADVATE [Antihemophilic Factor (Recombinant)], which is produced by recombinant DNA technology from the CHO cell line. ADVATE is purified from the culture medium using a series of chromatography columns. The purification process includes an immunoaffinity chromatography step in which a monoclonal antibody directed against factor VIII is employed to selectively isolate the factor VIII from the medium. The production process includes a dedicated, viral inactivation solvent-detergent treatment step. The ADVATE molecule is then covalently conjugated with the polyethylene glycol, which mainly targets lysine residues. The cell culture, pegylation, purification process and formulation used in the manufacture of ADYNOVATE do not use additives of human or animal origins.</Description>
</NDC>
<NDC>
<NDCCode>0944-4623-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0944-4623-01) / 1 CONTAINER in 1 KIT (0944-4623-02) / 1 KIT in 1 CONTAINER (0944-4623-03) * 5 mL in 1 VIAL, GLASS (0944-4138-01) * 2 mL in 1 VIAL, GLASS (64764-514-02) </PackageDescription>
<NDC11Code>00944-4623-01</NDC11Code>
<ProductNDC>0944-4623</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Adynovate</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor (recombinant) Pegylated</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20151113</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125566</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals Amercia, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ADYNOVATE® is indicated in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes., 2 Perioperative management., 3 Routine prophylaxis to reduce the frequency of bleeding episodes.</IndicationAndUsage>
<Description>ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is formulated as a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution for intravenous injection. The product is supplied in single-dose vials containing nominal (approximate) potencies of 250, 500, 750, 1000, 1500, 2000, or 3000 international units (IU). Each vial of ADYNOVATE is labeled with the actual factor VIII activity in IU determined using one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for factor VIII concentrates. One IU, as defined by the WHO standard for blood coagulation factor VIII, human, is approximately equal to the level of factor VIII activity found in 1 mL of fresh pooled human plasma. When reconstituted with 2 mL or 5 mL sterile water for injection, the final solution contains the following excipients and stabilizers in targeted amounts per mL of reconstituted product:. ADYNOVATE contains no preservative. The specific activity of ADYNOVATE is 2700-8000 IU/mg protein. ADYNOVATE is a recombinant full-length human coagulation factor VIII (2,332 amino acids with a molecular weight (MW) of 280 kDa) covalently conjugated with one or more molecules of polyethylene glycol (MW 20 kDa) [see Clinical Pharmacology (12.1)]. The therapeutic activity of ADYNOVATE is derived from its parent drug substance, ADVATE [Antihemophilic Factor (Recombinant)], which is produced by recombinant DNA technology from the CHO cell line. ADVATE is purified from the culture medium using a series of chromatography columns. The purification process includes an immunoaffinity chromatography step in which a monoclonal antibody directed against factor VIII is employed to selectively isolate the factor VIII from the medium. The production process includes a dedicated, viral inactivation solvent-detergent treatment step. The ADVATE molecule is then covalently conjugated with the polyethylene glycol, which mainly targets lysine residues. The cell culture, pegylation, purification process and formulation used in the manufacture of ADYNOVATE do not use additives of human or animal origins.</Description>
</NDC>
<NDC>
<NDCCode>0944-4624-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0944-4624-01) / 1 CONTAINER in 1 KIT (0944-4624-02) / 1 KIT in 1 CONTAINER (0944-4624-03) * 5 mL in 1 VIAL, GLASS (0944-4140-01) * 2 mL in 1 VIAL, GLASS (64764-514-02) </PackageDescription>
<NDC11Code>00944-4624-01</NDC11Code>
<ProductNDC>0944-4624</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Adynovate</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor (recombinant) Pegylated</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20161025</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125566</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals Amercia, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161025</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ADYNOVATE® is indicated in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes., 2 Perioperative management., 3 Routine prophylaxis to reduce the frequency of bleeding episodes.</IndicationAndUsage>
<Description>ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is formulated as a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution for intravenous injection. The product is supplied in single-dose vials containing nominal (approximate) potencies of 250, 500, 750, 1000, 1500, 2000, or 3000 international units (IU). Each vial of ADYNOVATE is labeled with the actual factor VIII activity in IU determined using one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for factor VIII concentrates. One IU, as defined by the WHO standard for blood coagulation factor VIII, human, is approximately equal to the level of factor VIII activity found in 1 mL of fresh pooled human plasma. When reconstituted with 2 mL or 5 mL sterile water for injection, the final solution contains the following excipients and stabilizers in targeted amounts per mL of reconstituted product:. ADYNOVATE contains no preservative. The specific activity of ADYNOVATE is 2700-8000 IU/mg protein. ADYNOVATE is a recombinant full-length human coagulation factor VIII (2,332 amino acids with a molecular weight (MW) of 280 kDa) covalently conjugated with one or more molecules of polyethylene glycol (MW 20 kDa) [see Clinical Pharmacology (12.1)]. The therapeutic activity of ADYNOVATE is derived from its parent drug substance, ADVATE [Antihemophilic Factor (Recombinant)], which is produced by recombinant DNA technology from the CHO cell line. ADVATE is purified from the culture medium using a series of chromatography columns. The purification process includes an immunoaffinity chromatography step in which a monoclonal antibody directed against factor VIII is employed to selectively isolate the factor VIII from the medium. The production process includes a dedicated, viral inactivation solvent-detergent treatment step. The ADVATE molecule is then covalently conjugated with the polyethylene glycol, which mainly targets lysine residues. The cell culture, pegylation, purification process and formulation used in the manufacture of ADYNOVATE do not use additives of human or animal origins.</Description>
</NDC>
<NDC>
<NDCCode>0944-4625-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0944-4625-01) / 1 CONTAINER in 1 KIT (0944-4625-02) / 1 KIT in 1 CONTAINER (0944-4625-03) * 5 mL in 1 VIAL, GLASS (0944-4257-01) * 5 mL in 1 VIAL, GLASS (64764-515-50) </PackageDescription>
<NDC11Code>00944-4625-01</NDC11Code>
<ProductNDC>0944-4625</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Adynovate</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor (recombinant) Pegylated</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20151113</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125566</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals Amercia, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ADYNOVATE® is indicated in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes., 2 Perioperative management., 3 Routine prophylaxis to reduce the frequency of bleeding episodes.</IndicationAndUsage>
<Description>ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is formulated as a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution for intravenous injection. The product is supplied in single-dose vials containing nominal (approximate) potencies of 250, 500, 750, 1000, 1500, 2000, or 3000 international units (IU). Each vial of ADYNOVATE is labeled with the actual factor VIII activity in IU determined using one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for factor VIII concentrates. One IU, as defined by the WHO standard for blood coagulation factor VIII, human, is approximately equal to the level of factor VIII activity found in 1 mL of fresh pooled human plasma. When reconstituted with 2 mL or 5 mL sterile water for injection, the final solution contains the following excipients and stabilizers in targeted amounts per mL of reconstituted product:. ADYNOVATE contains no preservative. The specific activity of ADYNOVATE is 2700-8000 IU/mg protein. ADYNOVATE is a recombinant full-length human coagulation factor VIII (2,332 amino acids with a molecular weight (MW) of 280 kDa) covalently conjugated with one or more molecules of polyethylene glycol (MW 20 kDa) [see Clinical Pharmacology (12.1)]. The therapeutic activity of ADYNOVATE is derived from its parent drug substance, ADVATE [Antihemophilic Factor (Recombinant)], which is produced by recombinant DNA technology from the CHO cell line. ADVATE is purified from the culture medium using a series of chromatography columns. The purification process includes an immunoaffinity chromatography step in which a monoclonal antibody directed against factor VIII is employed to selectively isolate the factor VIII from the medium. The production process includes a dedicated, viral inactivation solvent-detergent treatment step. The ADVATE molecule is then covalently conjugated with the polyethylene glycol, which mainly targets lysine residues. The cell culture, pegylation, purification process and formulation used in the manufacture of ADYNOVATE do not use additives of human or animal origins.</Description>
</NDC>
<NDC>
<NDCCode>0944-4626-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0944-4626-01) / 1 CONTAINER in 1 KIT (0944-4626-02) / 1 KIT in 1 CONTAINER (0944-4626-03) * 5 mL in 1 VIAL, GLASS (0944-4139-01) * 2 mL in 1 VIAL, GLASS (64764-514-02) </PackageDescription>
<NDC11Code>00944-4626-01</NDC11Code>
<ProductNDC>0944-4626</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Adynovate</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor (recombinant) Pegylated</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20161025</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125566</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals Amercia, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161025</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ADYNOVATE® is indicated in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes., 2 Perioperative management., 3 Routine prophylaxis to reduce the frequency of bleeding episodes.</IndicationAndUsage>
<Description>ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is formulated as a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution for intravenous injection. The product is supplied in single-dose vials containing nominal (approximate) potencies of 250, 500, 750, 1000, 1500, 2000, or 3000 international units (IU). Each vial of ADYNOVATE is labeled with the actual factor VIII activity in IU determined using one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for factor VIII concentrates. One IU, as defined by the WHO standard for blood coagulation factor VIII, human, is approximately equal to the level of factor VIII activity found in 1 mL of fresh pooled human plasma. When reconstituted with 2 mL or 5 mL sterile water for injection, the final solution contains the following excipients and stabilizers in targeted amounts per mL of reconstituted product:. ADYNOVATE contains no preservative. The specific activity of ADYNOVATE is 2700-8000 IU/mg protein. ADYNOVATE is a recombinant full-length human coagulation factor VIII (2,332 amino acids with a molecular weight (MW) of 280 kDa) covalently conjugated with one or more molecules of polyethylene glycol (MW 20 kDa) [see Clinical Pharmacology (12.1)]. The therapeutic activity of ADYNOVATE is derived from its parent drug substance, ADVATE [Antihemophilic Factor (Recombinant)], which is produced by recombinant DNA technology from the CHO cell line. ADVATE is purified from the culture medium using a series of chromatography columns. The purification process includes an immunoaffinity chromatography step in which a monoclonal antibody directed against factor VIII is employed to selectively isolate the factor VIII from the medium. The production process includes a dedicated, viral inactivation solvent-detergent treatment step. The ADVATE molecule is then covalently conjugated with the polyethylene glycol, which mainly targets lysine residues. The cell culture, pegylation, purification process and formulation used in the manufacture of ADYNOVATE do not use additives of human or animal origins.</Description>
</NDC>
<NDC>
<NDCCode>0944-4627-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0944-4627-01) / 1 CONTAINER in 1 KIT (0944-4627-02) / 1 KIT in 1 CONTAINER (0944-4627-03) * 5 mL in 1 VIAL, GLASS (0944-4141-01) * 2 mL in 1 VIAL, GLASS (64764-514-02) </PackageDescription>
<NDC11Code>00944-4627-01</NDC11Code>
<ProductNDC>0944-4627</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Adynovate</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor (recombinant) Pegylated</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20151113</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125566</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals Amercia, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ADYNOVATE® is indicated in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes., 2 Perioperative management., 3 Routine prophylaxis to reduce the frequency of bleeding episodes.</IndicationAndUsage>
<Description>ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is formulated as a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution for intravenous injection. The product is supplied in single-dose vials containing nominal (approximate) potencies of 250, 500, 750, 1000, 1500, 2000, or 3000 international units (IU). Each vial of ADYNOVATE is labeled with the actual factor VIII activity in IU determined using one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for factor VIII concentrates. One IU, as defined by the WHO standard for blood coagulation factor VIII, human, is approximately equal to the level of factor VIII activity found in 1 mL of fresh pooled human plasma. When reconstituted with 2 mL or 5 mL sterile water for injection, the final solution contains the following excipients and stabilizers in targeted amounts per mL of reconstituted product:. ADYNOVATE contains no preservative. The specific activity of ADYNOVATE is 2700-8000 IU/mg protein. ADYNOVATE is a recombinant full-length human coagulation factor VIII (2,332 amino acids with a molecular weight (MW) of 280 kDa) covalently conjugated with one or more molecules of polyethylene glycol (MW 20 kDa) [see Clinical Pharmacology (12.1)]. The therapeutic activity of ADYNOVATE is derived from its parent drug substance, ADVATE [Antihemophilic Factor (Recombinant)], which is produced by recombinant DNA technology from the CHO cell line. ADVATE is purified from the culture medium using a series of chromatography columns. The purification process includes an immunoaffinity chromatography step in which a monoclonal antibody directed against factor VIII is employed to selectively isolate the factor VIII from the medium. The production process includes a dedicated, viral inactivation solvent-detergent treatment step. The ADVATE molecule is then covalently conjugated with the polyethylene glycol, which mainly targets lysine residues. The cell culture, pegylation, purification process and formulation used in the manufacture of ADYNOVATE do not use additives of human or animal origins.</Description>
</NDC>
<NDC>
<NDCCode>0944-4628-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0944-4628-01) / 1 CONTAINER in 1 KIT (0944-4628-02) / 1 KIT in 1 CONTAINER (0944-4628-03) * 5 mL in 1 VIAL, GLASS (64764-515-50) * 5 mL in 1 VIAL, GLASS (0944-4263-01) </PackageDescription>
<NDC11Code>00944-4628-01</NDC11Code>
<ProductNDC>0944-4628</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Adynovate</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor (recombinant) Pegylated</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20161025</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125566</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals Amercia, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161025</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ADYNOVATE® is indicated in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes., 2 Perioperative management., 3 Routine prophylaxis to reduce the frequency of bleeding episodes.</IndicationAndUsage>
<Description>ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is formulated as a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution for intravenous injection. The product is supplied in single-dose vials containing nominal (approximate) potencies of 250, 500, 750, 1000, 1500, 2000, or 3000 international units (IU). Each vial of ADYNOVATE is labeled with the actual factor VIII activity in IU determined using one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for factor VIII concentrates. One IU, as defined by the WHO standard for blood coagulation factor VIII, human, is approximately equal to the level of factor VIII activity found in 1 mL of fresh pooled human plasma. When reconstituted with 2 mL or 5 mL sterile water for injection, the final solution contains the following excipients and stabilizers in targeted amounts per mL of reconstituted product:. ADYNOVATE contains no preservative. The specific activity of ADYNOVATE is 2700-8000 IU/mg protein. ADYNOVATE is a recombinant full-length human coagulation factor VIII (2,332 amino acids with a molecular weight (MW) of 280 kDa) covalently conjugated with one or more molecules of polyethylene glycol (MW 20 kDa) [see Clinical Pharmacology (12.1)]. The therapeutic activity of ADYNOVATE is derived from its parent drug substance, ADVATE [Antihemophilic Factor (Recombinant)], which is produced by recombinant DNA technology from the CHO cell line. ADVATE is purified from the culture medium using a series of chromatography columns. The purification process includes an immunoaffinity chromatography step in which a monoclonal antibody directed against factor VIII is employed to selectively isolate the factor VIII from the medium. The production process includes a dedicated, viral inactivation solvent-detergent treatment step. The ADVATE molecule is then covalently conjugated with the polyethylene glycol, which mainly targets lysine residues. The cell culture, pegylation, purification process and formulation used in the manufacture of ADYNOVATE do not use additives of human or animal origins.</Description>
</NDC>
<NDC>
<NDCCode>43419-580-14</NDCCode>
<PackageDescription>5 mL in 1 TUBE (43419-580-14) </PackageDescription>
<NDC11Code>43419-0580-14</NDC11Code>
<ProductNDC>43419-580</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Amorepacific Natural Protector</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, And Octocrylene</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160118</StartMarketingDate>
<EndMarketingDate>20200530</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>AMOREPACIFIC CORPORATION</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>1500; 5400; 2700; 5400</StrengthNumber>
<StrengthUnit>mg/60mL; mg/60mL; mg/60mL; mg/60mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180801</StartMarketingDatePackage>
<EndMarketingDatePackage>20200530</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>43419-580-18</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (43419-580-18) > 60 mL in 1 TUBE</PackageDescription>
<NDC11Code>43419-0580-18</NDC11Code>
<ProductNDC>43419-580</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Amorepacific Natural Protector</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, And Octocrylene</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160118</StartMarketingDate>
<EndMarketingDate>20200530</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>AMOREPACIFIC CORPORATION</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>1500; 5400; 2700; 5400</StrengthNumber>
<StrengthUnit>mg/60mL; mg/60mL; mg/60mL; mg/60mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160118</StartMarketingDatePackage>
<EndMarketingDatePackage>20200530</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>43419-580-24</NDCCode>
<PackageDescription>30 mL in 1 TUBE (43419-580-24) </PackageDescription>
<NDC11Code>43419-0580-24</NDC11Code>
<ProductNDC>43419-580</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Amorepacific Natural Protector</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, And Octocrylene</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160118</StartMarketingDate>
<EndMarketingDate>20200530</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>AMOREPACIFIC CORPORATION</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>1500; 5400; 2700; 5400</StrengthNumber>
<StrengthUnit>mg/60mL; mg/60mL; mg/60mL; mg/60mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180801</StartMarketingDatePackage>
<EndMarketingDatePackage>20200530</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>61957-2800-0</NDCCode>
<PackageDescription>1 KIT in 1 KIT (61957-2800-0) * 1 TUBE in 1 BOX (61957-2700-1) > 75 g in 1 TUBE</PackageDescription>
<NDC11Code>61957-2800-00</NDC11Code>
<ProductNDC>61957-2800</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dior Homme Eau For Men</ProprietaryName>
<NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20170314</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part350</ApplicationNumber>
<LabelerName>Parfums Christian Dior</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2018-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170314</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72893-001-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (72893-001-01) / 20 mL in 1 VIAL</PackageDescription>
<NDC11Code>72893-0001-01</NDC11Code>
<ProductNDC>72893-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Evomela</ProprietaryName>
<NonProprietaryName>Melphalan</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20160331</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207155</ApplicationNumber>
<LabelerName>Acrotech Biopharma Inc</LabelerName>
<SubstanceName>MELPHALAN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160331</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Evomela is an alkylating drug indicated for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma. (1.1).</IndicationAndUsage>
<Description>Evomela contains melphalan hydrochloride, an alkylating drug, as the active ingredient. The chemical name of melphalan hydrochloride is 4-[bis(2-chloroethyl)amino]-L-phenylalanine hydrochloride. Its molecular formula is C13H18Cl2N2O2 HCl and the molecular weight is 341.67. The structural formula is:. Melphalan hydrochloride is a white to off-white powder, with a melting range of 199°C − 201°C. It is practically insoluble in water, but freely soluble in 1N HCl and methanol. Evomela (melphalan) for injection is supplied as a sterile white to off-white lyophilized powder in a single-dose vial for intravenous use. Each vial contains 50 mg melphalan free base equivalent to 56 mg melphalan hydrochloride and 2700 mg Betadex Sulfobutyl Ether Sodium, NF. Sodium hydroxide and if necessary, hydrochloric acid are added as a pH adjuster.</Description>
</NDC>
<NDC>
<NDCCode>76331-909-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (76331-909-30)</PackageDescription>
<NDC11Code>76331-0909-30</NDC11Code>
<ProductNDC>76331-909</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nata Komplete</ProprietaryName>
<NonProprietaryName>Vitamin A, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol, Thiamine, Riboflavin, Niacin, Pyridoxine, Folic Acid, Cyanocobalamin, Biotin, Pantothenic Acid, Calcium, Iron, Magnesium, Zinc, Selenium, Copper, Choline Bitartrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110625</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>WH Nutritionals, LLC</LabelerName>
<SubstanceName>VITAMIN A; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL; THIAMINE; RIBOFLAVIN; NIACIN; PYRIDOXINE; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; PANTOTHENIC ACID; CALCIUM; IRON; MAGNESIUM; ZINC; SELENIUM; COPPER; CHOLINE BITARTRATE</SubstanceName>
<StrengthNumber>2700; 120; 400; 20; 3; 3.5; 20; 30; 1; 12; 30; 8; 100; 25; 50; 15; 50; 2; 55</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-06</LastUpdate>
</NDC>
<NDC>
<NDCCode>0944-2510-02</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0944-2510-02) * 25 mL in 1 VIAL, GLASS (0944-2715-25) * 1.25 mL in 1 VIAL, GLASS (0944-2720-03) </PackageDescription>
<NDC11Code>00944-2510-02</NDC11Code>
<ProductNDC>0944-2510</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>0944-2511-02</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0944-2511-02) * 50 mL in 1 VIAL, GLASS (0944-2716-05) * 2.5 mL in 1 VIAL, GLASS (0944-2721-03) </PackageDescription>
<NDC11Code>00944-2511-02</NDC11Code>
<ProductNDC>0944-2511</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>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>0944-2513-02</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0944-2513-02) * 200 mL in 1 VIAL, GLASS (0944-2718-20) * 10 mL in 1 VIAL, GLASS (0944-2723-03) </PackageDescription>
<NDC11Code>00944-2513-02</NDC11Code>
<ProductNDC>0944-2513</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>
</NDCList>