{
"NDC": [
{
"NDCCode": "0944-2841-10",
"PackageDescription": "1 KIT in 1 CARTON (0944-2841-10) * 10 mL in 1 VIAL, GLASS (0944-2831-01) * 5 mL in 1 VIAL, GLASS (64764-515-50) ",
"NDC11Code": "00944-2841-10",
"ProductNDC": "0944-2841",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Recombinate",
"NonProprietaryName": "Antihemophilic Factor Recombinant",
"DosageFormName": "KIT",
"StartMarketingDate": "20090410",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103375",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"Status": "Active",
"LastUpdate": "2025-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090410",
"SamplePackage": "N",
"IndicationAndUsage": "The use of RECOMBINATE [Antihemophilic Factor (Recombinant)] is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes.2 RECOMBINATE is also indicated in the perioperative management of patients with hemophilia A (classical hemophilia). RECOMBINATE can be of therapeutic value in patients with acquired Factor VIII inhibitors not exceeding 10 Bethesda Units per mL.3 In clinical studies with RECOMBINATE, patients with inhibitors who were entered into the previously treated patient trial and those previously untreated children who have developed inhibitor activity on study, showed clinical hemostatic response when the titer of inhibitor was less than 10 Bethesda Units per mL. However, in such uses, the dosage of RECOMBINATE should be controlled by frequent laboratory determinations of circulating Factor VIII levels as well as the clinical status of the patient. RECOMBINATE is not indicated in von Willebrand's disease.",
"Description": "RECOMBINATE [Antihemophilic Factor (Recombinant)] is a glycoprotein synthesized by a genetically engineered Chinese Hamster Ovary (CHO) cell line. In culture, the CHO cell line secretes recombinant Factor VIII (rFVIII) into the cell culture medium. The rFVIII is purified from the culture medium utilizing a series of chromatography columns. A key step in the purification process is an immunoaffinity chromatography methodology in which a purification matrix, prepared by immobilization of a monoclonal antibody directed to Factor VIII, is utilized to selectively isolate the rFVIII in the medium. The synthesized rFVIII produced by the CHO cells has the same biological effects as human Factor VIII. Structurally the protein has a similar combination of heterogenous heavy and light chains as found in human Factor VIII. RECOMBINATE is formulated as a sterile, nonpyrogenic, off-white to faint yellow, lyophilized powder preparation of concentrated recombinant Factor VIII for intravenous injection. RECOMBINATE is available in single-dose vials, which contain nominally 250, 500, 1000, 1500, and 2000 International Units per vial. When reconstituted with the appropriate volume of diluent, the product contains the following stabilizers in maximum amounts: For 5 mL reconstitution volume: 25 mg/mL Albumin (Human), 0.40 mg/mL calcium, 3 mg/mL polyethylene glycol (3350), 360 mEq/L sodium, 110 mM histidine, 1.5 µg/Factor VIII International Unit (IU) polysorbate-80. Recombinant Von Willebrand Factor (rVWF) is coexpressed with the rFVIII and helps to stabilize it. The final product contains not more than 2 ng rVWF/IU rFVIII, which will not have any clinically relevant effect in patients with von Willebrand's disease. The product contains no preservative. Each vial of RECOMBINATE is labeled with the Factor VIII activity expressed in IU per vial. Biological potency is determined by an in vitro assay which is referenced to the World Health Organization (WHO) International Standard for Factor VIII:C Concentrate."
},
{
"NDCCode": "36987-2841-2",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (36987-2841-2)",
"NDC11Code": "36987-2841-02",
"ProductNDC": "36987-2841",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "California Black Oak",
"NonProprietaryName": "California Black Oak",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "QUERCUS KELLOGGII POLLEN",
"StrengthNumber": "40000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "54868-2841-3",
"PackageDescription": "10 CAPSULE in 1 BOTTLE, PLASTIC (54868-2841-3)",
"NDC11Code": "54868-2841-03",
"ProductNDC": "54868-2841",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mycobutin",
"NonProprietaryName": "Rifabutin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19950315",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050689",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "RIFABUTIN",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Rifamycin Antimycobacterial [EPC],Rifamycins [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "MYCOBUTIN Capsules are indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection.",
"Description": "MYCOBUTIN Capsules contain the antimycobacterial agent rifabutin, which is a semisynthetic ansamycin antibiotic derived from rifamycin S. MYCOBUTIN Capsules for oral administration contain 150 mg of rifabutin, USP, per capsule, along with the inactive ingredients microcrystalline cellulose, magnesium stearate, red iron oxide, silica gel, sodium lauryl sulfate, titanium dioxide, and edible white ink. The chemical name for rifabutin is 1',4-didehydro-1-deoxy-1,4-dihydro-5'-(2-methylpropyl)-1-oxorifamycin XIV (Chemical Abstracts Service, 9th Collective Index) or (9S, 12E, 14S, 15R, 16S, 17R, 18R, 19R, 20S, 21S, 22E, 24Z)-6,16,18,20-tetrahydroxy-1'-isobutyl-14-methoxy-7,9,15,17,19,21,25-heptamethyl-spiro [9,4-(epoxypentadeca[1,11,13]trienimino)-2H-furo[2',3':7,8]naphth[1,2-d] imidazole-2,4'-piperidine]-5,10,26-(3H,9H)-trione-16-acetate. Rifabutin has a molecular formula of C46H62N4O11, a molecular weight of 847.02 and the following structure. Rifabutin is a red-violet powder soluble in chloroform and methanol, sparingly soluble in ethanol, and very slightly soluble in water (0.19 mg/mL). Its log P value (the base 10 logarithm of the partition coefficient between n-octanol and water) is 3.2 (n-octanol/water)."
},
{
"NDCCode": "54868-2841-0",
"PackageDescription": "50 CAPSULE in 1 BOTTLE, PLASTIC (54868-2841-0)",
"NDC11Code": "54868-2841-00",
"ProductNDC": "54868-2841",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mycobutin",
"NonProprietaryName": "Rifabutin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19950315",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050689",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "RIFABUTIN",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Rifamycin Antimycobacterial [EPC],Rifamycins [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "MYCOBUTIN Capsules are indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection.",
"Description": "MYCOBUTIN Capsules contain the antimycobacterial agent rifabutin, which is a semisynthetic ansamycin antibiotic derived from rifamycin S. MYCOBUTIN Capsules for oral administration contain 150 mg of rifabutin, USP, per capsule, along with the inactive ingredients microcrystalline cellulose, magnesium stearate, red iron oxide, silica gel, sodium lauryl sulfate, titanium dioxide, and edible white ink. The chemical name for rifabutin is 1',4-didehydro-1-deoxy-1,4-dihydro-5'-(2-methylpropyl)-1-oxorifamycin XIV (Chemical Abstracts Service, 9th Collective Index) or (9S, 12E, 14S, 15R, 16S, 17R, 18R, 19R, 20S, 21S, 22E, 24Z)-6,16,18,20-tetrahydroxy-1'-isobutyl-14-methoxy-7,9,15,17,19,21,25-heptamethyl-spiro [9,4-(epoxypentadeca[1,11,13]trienimino)-2H-furo[2',3':7,8]naphth[1,2-d] imidazole-2,4'-piperidine]-5,10,26-(3H,9H)-trione-16-acetate. Rifabutin has a molecular formula of C46H62N4O11, a molecular weight of 847.02 and the following structure. Rifabutin is a red-violet powder soluble in chloroform and methanol, sparingly soluble in ethanol, and very slightly soluble in water (0.19 mg/mL). Its log P value (the base 10 logarithm of the partition coefficient between n-octanol and water) is 3.2 (n-octanol/water)."
},
{
"NDCCode": "54868-2841-1",
"PackageDescription": "60 CAPSULE in 1 BOTTLE, PLASTIC (54868-2841-1)",
"NDC11Code": "54868-2841-01",
"ProductNDC": "54868-2841",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mycobutin",
"NonProprietaryName": "Rifabutin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19950315",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050689",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "RIFABUTIN",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Rifamycin Antimycobacterial [EPC],Rifamycins [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "MYCOBUTIN Capsules are indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection.",
"Description": "MYCOBUTIN Capsules contain the antimycobacterial agent rifabutin, which is a semisynthetic ansamycin antibiotic derived from rifamycin S. MYCOBUTIN Capsules for oral administration contain 150 mg of rifabutin, USP, per capsule, along with the inactive ingredients microcrystalline cellulose, magnesium stearate, red iron oxide, silica gel, sodium lauryl sulfate, titanium dioxide, and edible white ink. The chemical name for rifabutin is 1',4-didehydro-1-deoxy-1,4-dihydro-5'-(2-methylpropyl)-1-oxorifamycin XIV (Chemical Abstracts Service, 9th Collective Index) or (9S, 12E, 14S, 15R, 16S, 17R, 18R, 19R, 20S, 21S, 22E, 24Z)-6,16,18,20-tetrahydroxy-1'-isobutyl-14-methoxy-7,9,15,17,19,21,25-heptamethyl-spiro [9,4-(epoxypentadeca[1,11,13]trienimino)-2H-furo[2',3':7,8]naphth[1,2-d] imidazole-2,4'-piperidine]-5,10,26-(3H,9H)-trione-16-acetate. Rifabutin has a molecular formula of C46H62N4O11, a molecular weight of 847.02 and the following structure. Rifabutin is a red-violet powder soluble in chloroform and methanol, sparingly soluble in ethanol, and very slightly soluble in water (0.19 mg/mL). Its log P value (the base 10 logarithm of the partition coefficient between n-octanol and water) is 3.2 (n-octanol/water)."
},
{
"NDCCode": "54868-2841-2",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (54868-2841-2)",
"NDC11Code": "54868-2841-02",
"ProductNDC": "54868-2841",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mycobutin",
"NonProprietaryName": "Rifabutin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19950315",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050689",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "RIFABUTIN",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Rifamycin Antimycobacterial [EPC],Rifamycins [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "MYCOBUTIN Capsules are indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection.",
"Description": "MYCOBUTIN Capsules contain the antimycobacterial agent rifabutin, which is a semisynthetic ansamycin antibiotic derived from rifamycin S. MYCOBUTIN Capsules for oral administration contain 150 mg of rifabutin, USP, per capsule, along with the inactive ingredients microcrystalline cellulose, magnesium stearate, red iron oxide, silica gel, sodium lauryl sulfate, titanium dioxide, and edible white ink. The chemical name for rifabutin is 1',4-didehydro-1-deoxy-1,4-dihydro-5'-(2-methylpropyl)-1-oxorifamycin XIV (Chemical Abstracts Service, 9th Collective Index) or (9S, 12E, 14S, 15R, 16S, 17R, 18R, 19R, 20S, 21S, 22E, 24Z)-6,16,18,20-tetrahydroxy-1'-isobutyl-14-methoxy-7,9,15,17,19,21,25-heptamethyl-spiro [9,4-(epoxypentadeca[1,11,13]trienimino)-2H-furo[2',3':7,8]naphth[1,2-d] imidazole-2,4'-piperidine]-5,10,26-(3H,9H)-trione-16-acetate. Rifabutin has a molecular formula of C46H62N4O11, a molecular weight of 847.02 and the following structure. Rifabutin is a red-violet powder soluble in chloroform and methanol, sparingly soluble in ethanol, and very slightly soluble in water (0.19 mg/mL). Its log P value (the base 10 logarithm of the partition coefficient between n-octanol and water) is 3.2 (n-octanol/water)."
},
{
"NDCCode": "54868-2841-4",
"PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (54868-2841-4)",
"NDC11Code": "54868-2841-04",
"ProductNDC": "54868-2841",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mycobutin",
"NonProprietaryName": "Rifabutin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19950315",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050689",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "RIFABUTIN",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Rifamycin Antimycobacterial [EPC],Rifamycins [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "MYCOBUTIN Capsules are indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection.",
"Description": "MYCOBUTIN Capsules contain the antimycobacterial agent rifabutin, which is a semisynthetic ansamycin antibiotic derived from rifamycin S. MYCOBUTIN Capsules for oral administration contain 150 mg of rifabutin, USP, per capsule, along with the inactive ingredients microcrystalline cellulose, magnesium stearate, red iron oxide, silica gel, sodium lauryl sulfate, titanium dioxide, and edible white ink. The chemical name for rifabutin is 1',4-didehydro-1-deoxy-1,4-dihydro-5'-(2-methylpropyl)-1-oxorifamycin XIV (Chemical Abstracts Service, 9th Collective Index) or (9S, 12E, 14S, 15R, 16S, 17R, 18R, 19R, 20S, 21S, 22E, 24Z)-6,16,18,20-tetrahydroxy-1'-isobutyl-14-methoxy-7,9,15,17,19,21,25-heptamethyl-spiro [9,4-(epoxypentadeca[1,11,13]trienimino)-2H-furo[2',3':7,8]naphth[1,2-d] imidazole-2,4'-piperidine]-5,10,26-(3H,9H)-trione-16-acetate. Rifabutin has a molecular formula of C46H62N4O11, a molecular weight of 847.02 and the following structure. Rifabutin is a red-violet powder soluble in chloroform and methanol, sparingly soluble in ethanol, and very slightly soluble in water (0.19 mg/mL). Its log P value (the base 10 logarithm of the partition coefficient between n-octanol and water) is 3.2 (n-octanol/water)."
},
{
"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)."
},
{
"NDCCode": "0944-2620-01",
"PackageDescription": "1 KIT in 1 CARTON (0944-2620-01) * 1 BOTTLE in 1 CARTON > 10 mL in 1 BOTTLE * 10 mL in 1 BOTTLE (0338-0764-61)",
"NDC11Code": "00944-2620-01",
"ProductNDC": "0944-2620",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Gammagard",
"ProprietaryNameSuffix": "S/d",
"NonProprietaryName": "Human Immunoglobulin G",
"DosageFormName": "KIT",
"StartMarketingDate": "19980501",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103133",
"LabelerName": "Baxalta US Inc.",
"Status": "Deprecated",
"LastUpdate": "2018-12-05",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"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": "0944-2700-04",
"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": "0944-2705-10",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (0944-2705-10) / 100 mL in 1 VIAL, GLASS (0944-2705-01) ",
"NDC11Code": "00944-2705-10",
"ProductNDC": "0944-2705",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Gammagard Liquid Erc",
"NonProprietaryName": "Immune Globulin Infusion (human)",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20250714",
"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": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250714",
"SamplePackage": "N",
"IndicationAndUsage": "GAMMAGARD LIQUID ERC is 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 immunodeficiencies.",
"Description": "GAMMAGARD LIQUID ERC (human immunoglobulin) is a single-dose sterile, liquid preparation of purified and concentrated IgG antibodies. GAMMAGARD LIQUID ERC has an IgA concentration less than or equal to 2 µg/mL, in a 10% solution. The distribution of the IgG subclasses is similar to that of normal plasma with lower levels of IgG4 and IgG3. The Fc and Fab functions are maintained in GAMMAGARD LIQUID ERC. Pre-kallikrein activator activity is not detectable. GAMMAGARD LIQUID ERC contains 100 mg/mL protein. At least 98% of the protein is immune globulin, the average IgA concentration is less than or equal to 2 µg/mL, in a 10% solution and immunoglobulin M is present in trace amounts. GAMMAGARD LIQUID ERC 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 ERC 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. GAMMAGARD LIQUID ERC shares its manufacturing process with GAMMAGARD LIQUID. The differentiation occurs with the modified parameters applied during the anion exchange chromatography step enhanced removal capability (ERC) to reduce IgA content, resulting in a product with IgA less than or equal to 2 µg/mL in a 10% solution. 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 ERC 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 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, nanofiltration, and a low pH incubation at elevated temperature (30° 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° to 25°C for a minimum of 60 minutes. S/D treatment inactivates the lipid-enveloped viruses investigated to below detection limits within 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, 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 ERC performed in accordance with good laboratory practices are summarized in Table 6."
},
{
"NDCCode": "0944-2831-10",
"PackageDescription": "1 KIT in 1 CARTON (0944-2831-10) * 1 VIAL, GLASS in 1 CARTON > 10 mL in 1 VIAL, GLASS * 1 VIAL, GLASS in 1 CARTON > 10 mL in 1 VIAL, GLASS",
"NDC11Code": "00944-2831-10",
"ProductNDC": "0944-2831",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Recombinate",
"NonProprietaryName": "Antihemophilic Factor Recombinant",
"DosageFormName": "KIT",
"StartMarketingDate": "20100208",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103375",
"LabelerName": "Baxter Healthcare Corporation",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0944-2831-15",
"PackageDescription": "1 KIT in 1 CARTON (0944-2831-15) * 1 VIAL, GLASS in 1 CARTON > 10 mL in 1 VIAL, GLASS * 1 VIAL, GLASS in 1 CARTON > 10 mL in 1 VIAL, GLASS",
"NDC11Code": "00944-2831-15",
"ProductNDC": "0944-2831",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Recombinate",
"NonProprietaryName": "Antihemophilic Factor Recombinant",
"DosageFormName": "KIT",
"StartMarketingDate": "20100208",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103375",
"LabelerName": "Baxter Healthcare Corporation",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0944-2832-10",
"PackageDescription": "1 KIT in 1 CARTON (0944-2832-10) * 1 VIAL, GLASS in 1 CARTON > 10 mL in 1 VIAL, GLASS * 1 VIAL, GLASS in 1 CARTON > 10 mL in 1 VIAL, GLASS",
"NDC11Code": "00944-2832-10",
"ProductNDC": "0944-2832",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Recombinate",
"NonProprietaryName": "Antihemophilic Factor Recombinant",
"DosageFormName": "KIT",
"StartMarketingDate": "20100208",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103375",
"LabelerName": "Baxter Healthcare Corporation",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0944-2832-15",
"PackageDescription": "1 KIT in 1 CARTON (0944-2832-15) * 1 VIAL, GLASS in 1 CARTON > 10 mL in 1 VIAL, GLASS * 1 VIAL, GLASS in 1 CARTON > 10 mL in 1 VIAL, GLASS",
"NDC11Code": "00944-2832-15",
"ProductNDC": "0944-2832",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Recombinate",
"NonProprietaryName": "Antihemophilic Factor Recombinant",
"DosageFormName": "KIT",
"StartMarketingDate": "20100208",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103375",
"LabelerName": "Baxter Healthcare Corporation",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0944-2833-10",
"PackageDescription": "1 KIT in 1 CARTON (0944-2833-10) * 1 VIAL, GLASS in 1 CARTON > 10 mL in 1 VIAL, GLASS * 1 VIAL, GLASS in 1 CARTON > 10 mL in 1 VIAL, GLASS",
"NDC11Code": "00944-2833-10",
"ProductNDC": "0944-2833",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Recombinate",
"NonProprietaryName": "Antihemophilic Factor Recombinant",
"DosageFormName": "KIT",
"StartMarketingDate": "20100208",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103375",
"LabelerName": "Baxter Healthcare Corporation",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0944-2833-15",
"PackageDescription": "1 KIT in 1 CARTON (0944-2833-15) * 1 VIAL, GLASS in 1 CARTON > 10 mL in 1 VIAL, GLASS * 1 VIAL, GLASS in 1 CARTON > 10 mL in 1 VIAL, GLASS",
"NDC11Code": "00944-2833-15",
"ProductNDC": "0944-2833",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Recombinate",
"NonProprietaryName": "Antihemophilic Factor Recombinant",
"DosageFormName": "KIT",
"StartMarketingDate": "20100208",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103375",
"LabelerName": "Baxter Healthcare Corporation",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0944-2842-10",
"PackageDescription": "1 KIT in 1 CARTON (0944-2842-10) * 10 mL in 1 VIAL, GLASS (0944-2832-01) * 5 mL in 1 VIAL, GLASS (64764-515-50) ",
"NDC11Code": "00944-2842-10",
"ProductNDC": "0944-2842",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Recombinate",
"NonProprietaryName": "Antihemophilic Factor Recombinant",
"DosageFormName": "KIT",
"StartMarketingDate": "20090410",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103375",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"Status": "Active",
"LastUpdate": "2025-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090410",
"SamplePackage": "N",
"IndicationAndUsage": "The use of RECOMBINATE [Antihemophilic Factor (Recombinant)] is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes.2 RECOMBINATE is also indicated in the perioperative management of patients with hemophilia A (classical hemophilia). RECOMBINATE can be of therapeutic value in patients with acquired Factor VIII inhibitors not exceeding 10 Bethesda Units per mL.3 In clinical studies with RECOMBINATE, patients with inhibitors who were entered into the previously treated patient trial and those previously untreated children who have developed inhibitor activity on study, showed clinical hemostatic response when the titer of inhibitor was less than 10 Bethesda Units per mL. However, in such uses, the dosage of RECOMBINATE should be controlled by frequent laboratory determinations of circulating Factor VIII levels as well as the clinical status of the patient. RECOMBINATE is not indicated in von Willebrand's disease.",
"Description": "RECOMBINATE [Antihemophilic Factor (Recombinant)] is a glycoprotein synthesized by a genetically engineered Chinese Hamster Ovary (CHO) cell line. In culture, the CHO cell line secretes recombinant Factor VIII (rFVIII) into the cell culture medium. The rFVIII is purified from the culture medium utilizing a series of chromatography columns. A key step in the purification process is an immunoaffinity chromatography methodology in which a purification matrix, prepared by immobilization of a monoclonal antibody directed to Factor VIII, is utilized to selectively isolate the rFVIII in the medium. The synthesized rFVIII produced by the CHO cells has the same biological effects as human Factor VIII. Structurally the protein has a similar combination of heterogenous heavy and light chains as found in human Factor VIII. RECOMBINATE is formulated as a sterile, nonpyrogenic, off-white to faint yellow, lyophilized powder preparation of concentrated recombinant Factor VIII for intravenous injection. RECOMBINATE is available in single-dose vials, which contain nominally 250, 500, 1000, 1500, and 2000 International Units per vial. When reconstituted with the appropriate volume of diluent, the product contains the following stabilizers in maximum amounts: For 5 mL reconstitution volume: 25 mg/mL Albumin (Human), 0.40 mg/mL calcium, 3 mg/mL polyethylene glycol (3350), 360 mEq/L sodium, 110 mM histidine, 1.5 µg/Factor VIII International Unit (IU) polysorbate-80. Recombinant Von Willebrand Factor (rVWF) is coexpressed with the rFVIII and helps to stabilize it. The final product contains not more than 2 ng rVWF/IU rFVIII, which will not have any clinically relevant effect in patients with von Willebrand's disease. The product contains no preservative. Each vial of RECOMBINATE is labeled with the Factor VIII activity expressed in IU per vial. Biological potency is determined by an in vitro assay which is referenced to the World Health Organization (WHO) International Standard for Factor VIII:C Concentrate."
},
{
"NDCCode": "0944-2843-10",
"PackageDescription": "1 KIT in 1 CARTON (0944-2843-10) * 10 mL in 1 VIAL, GLASS (0944-2833-01) * 5 mL in 1 VIAL, GLASS (64764-515-50) ",
"NDC11Code": "00944-2843-10",
"ProductNDC": "0944-2843",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Recombinate",
"NonProprietaryName": "Antihemophilic Factor Recombinant",
"DosageFormName": "KIT",
"StartMarketingDate": "20090410",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103375",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"Status": "Active",
"LastUpdate": "2025-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090410",
"SamplePackage": "N",
"IndicationAndUsage": "The use of RECOMBINATE [Antihemophilic Factor (Recombinant)] is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes.2 RECOMBINATE is also indicated in the perioperative management of patients with hemophilia A (classical hemophilia). RECOMBINATE can be of therapeutic value in patients with acquired Factor VIII inhibitors not exceeding 10 Bethesda Units per mL.3 In clinical studies with RECOMBINATE, patients with inhibitors who were entered into the previously treated patient trial and those previously untreated children who have developed inhibitor activity on study, showed clinical hemostatic response when the titer of inhibitor was less than 10 Bethesda Units per mL. However, in such uses, the dosage of RECOMBINATE should be controlled by frequent laboratory determinations of circulating Factor VIII levels as well as the clinical status of the patient. RECOMBINATE is not indicated in von Willebrand's disease.",
"Description": "RECOMBINATE [Antihemophilic Factor (Recombinant)] is a glycoprotein synthesized by a genetically engineered Chinese Hamster Ovary (CHO) cell line. In culture, the CHO cell line secretes recombinant Factor VIII (rFVIII) into the cell culture medium. The rFVIII is purified from the culture medium utilizing a series of chromatography columns. A key step in the purification process is an immunoaffinity chromatography methodology in which a purification matrix, prepared by immobilization of a monoclonal antibody directed to Factor VIII, is utilized to selectively isolate the rFVIII in the medium. The synthesized rFVIII produced by the CHO cells has the same biological effects as human Factor VIII. Structurally the protein has a similar combination of heterogenous heavy and light chains as found in human Factor VIII. RECOMBINATE is formulated as a sterile, nonpyrogenic, off-white to faint yellow, lyophilized powder preparation of concentrated recombinant Factor VIII for intravenous injection. RECOMBINATE is available in single-dose vials, which contain nominally 250, 500, 1000, 1500, and 2000 International Units per vial. When reconstituted with the appropriate volume of diluent, the product contains the following stabilizers in maximum amounts: For 5 mL reconstitution volume: 25 mg/mL Albumin (Human), 0.40 mg/mL calcium, 3 mg/mL polyethylene glycol (3350), 360 mEq/L sodium, 110 mM histidine, 1.5 µg/Factor VIII International Unit (IU) polysorbate-80. Recombinant Von Willebrand Factor (rVWF) is coexpressed with the rFVIII and helps to stabilize it. The final product contains not more than 2 ng rVWF/IU rFVIII, which will not have any clinically relevant effect in patients with von Willebrand's disease. The product contains no preservative. Each vial of RECOMBINATE is labeled with the Factor VIII activity expressed in IU per vial. Biological potency is determined by an in vitro assay which is referenced to the World Health Organization (WHO) International Standard for Factor VIII:C Concentrate."
},
{
"NDCCode": "0944-2844-10",
"PackageDescription": "1 KIT in 1 CARTON (0944-2844-10) * 10 mL in 1 VIAL, GLASS (0944-2834-01) * 5 mL in 1 VIAL, GLASS (64764-515-50) ",
"NDC11Code": "00944-2844-10",
"ProductNDC": "0944-2844",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Recombinate",
"NonProprietaryName": "Antihemophilic Factor Recombinant",
"DosageFormName": "KIT",
"StartMarketingDate": "20100315",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103375",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"Status": "Active",
"LastUpdate": "2025-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100315",
"SamplePackage": "N",
"IndicationAndUsage": "The use of RECOMBINATE [Antihemophilic Factor (Recombinant)] is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes.2 RECOMBINATE is also indicated in the perioperative management of patients with hemophilia A (classical hemophilia). RECOMBINATE can be of therapeutic value in patients with acquired Factor VIII inhibitors not exceeding 10 Bethesda Units per mL.3 In clinical studies with RECOMBINATE, patients with inhibitors who were entered into the previously treated patient trial and those previously untreated children who have developed inhibitor activity on study, showed clinical hemostatic response when the titer of inhibitor was less than 10 Bethesda Units per mL. However, in such uses, the dosage of RECOMBINATE should be controlled by frequent laboratory determinations of circulating Factor VIII levels as well as the clinical status of the patient. RECOMBINATE is not indicated in von Willebrand's disease.",
"Description": "RECOMBINATE [Antihemophilic Factor (Recombinant)] is a glycoprotein synthesized by a genetically engineered Chinese Hamster Ovary (CHO) cell line. In culture, the CHO cell line secretes recombinant Factor VIII (rFVIII) into the cell culture medium. The rFVIII is purified from the culture medium utilizing a series of chromatography columns. A key step in the purification process is an immunoaffinity chromatography methodology in which a purification matrix, prepared by immobilization of a monoclonal antibody directed to Factor VIII, is utilized to selectively isolate the rFVIII in the medium. The synthesized rFVIII produced by the CHO cells has the same biological effects as human Factor VIII. Structurally the protein has a similar combination of heterogenous heavy and light chains as found in human Factor VIII. RECOMBINATE is formulated as a sterile, nonpyrogenic, off-white to faint yellow, lyophilized powder preparation of concentrated recombinant Factor VIII for intravenous injection. RECOMBINATE is available in single-dose vials, which contain nominally 250, 500, 1000, 1500, and 2000 International Units per vial. When reconstituted with the appropriate volume of diluent, the product contains the following stabilizers in maximum amounts: For 5 mL reconstitution volume: 25 mg/mL Albumin (Human), 0.40 mg/mL calcium, 3 mg/mL polyethylene glycol (3350), 360 mEq/L sodium, 110 mM histidine, 1.5 µg/Factor VIII International Unit (IU) polysorbate-80. Recombinant Von Willebrand Factor (rVWF) is coexpressed with the rFVIII and helps to stabilize it. The final product contains not more than 2 ng rVWF/IU rFVIII, which will not have any clinically relevant effect in patients with von Willebrand's disease. The product contains no preservative. Each vial of RECOMBINATE is labeled with the Factor VIII activity expressed in IU per vial. Biological potency is determined by an in vitro assay which is referenced to the World Health Organization (WHO) International Standard for Factor VIII:C Concentrate."
},
{
"NDCCode": "0944-2845-10",
"PackageDescription": "1 KIT in 1 CARTON (0944-2845-10) * 10 mL in 1 VIAL, GLASS (0944-2835-01) * 5 mL in 1 VIAL, GLASS (64764-515-50) ",
"NDC11Code": "00944-2845-10",
"ProductNDC": "0944-2845",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Recombinate",
"NonProprietaryName": "Antihemophilic Factor Recombinant",
"DosageFormName": "KIT",
"StartMarketingDate": "20100315",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103375",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"Status": "Active",
"LastUpdate": "2025-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100315",
"SamplePackage": "N",
"IndicationAndUsage": "The use of RECOMBINATE [Antihemophilic Factor (Recombinant)] is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes.2 RECOMBINATE is also indicated in the perioperative management of patients with hemophilia A (classical hemophilia). RECOMBINATE can be of therapeutic value in patients with acquired Factor VIII inhibitors not exceeding 10 Bethesda Units per mL.3 In clinical studies with RECOMBINATE, patients with inhibitors who were entered into the previously treated patient trial and those previously untreated children who have developed inhibitor activity on study, showed clinical hemostatic response when the titer of inhibitor was less than 10 Bethesda Units per mL. However, in such uses, the dosage of RECOMBINATE should be controlled by frequent laboratory determinations of circulating Factor VIII levels as well as the clinical status of the patient. RECOMBINATE is not indicated in von Willebrand's disease.",
"Description": "RECOMBINATE [Antihemophilic Factor (Recombinant)] is a glycoprotein synthesized by a genetically engineered Chinese Hamster Ovary (CHO) cell line. In culture, the CHO cell line secretes recombinant Factor VIII (rFVIII) into the cell culture medium. The rFVIII is purified from the culture medium utilizing a series of chromatography columns. A key step in the purification process is an immunoaffinity chromatography methodology in which a purification matrix, prepared by immobilization of a monoclonal antibody directed to Factor VIII, is utilized to selectively isolate the rFVIII in the medium. The synthesized rFVIII produced by the CHO cells has the same biological effects as human Factor VIII. Structurally the protein has a similar combination of heterogenous heavy and light chains as found in human Factor VIII. RECOMBINATE is formulated as a sterile, nonpyrogenic, off-white to faint yellow, lyophilized powder preparation of concentrated recombinant Factor VIII for intravenous injection. RECOMBINATE is available in single-dose vials, which contain nominally 250, 500, 1000, 1500, and 2000 International Units per vial. When reconstituted with the appropriate volume of diluent, the product contains the following stabilizers in maximum amounts: For 5 mL reconstitution volume: 25 mg/mL Albumin (Human), 0.40 mg/mL calcium, 3 mg/mL polyethylene glycol (3350), 360 mEq/L sodium, 110 mM histidine, 1.5 µg/Factor VIII International Unit (IU) polysorbate-80. Recombinant Von Willebrand Factor (rVWF) is coexpressed with the rFVIII and helps to stabilize it. The final product contains not more than 2 ng rVWF/IU rFVIII, which will not have any clinically relevant effect in patients with von Willebrand's disease. The product contains no preservative. Each vial of RECOMBINATE is labeled with the Factor VIII activity expressed in IU per vial. Biological potency is determined by an in vitro assay which is referenced to the World Health Organization (WHO) International Standard for Factor VIII:C Concentrate."
},
{
"NDCCode": "0944-2850-03",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (0944-2850-03) / 10 mL in 1 VIAL, SINGLE-USE (0944-2850-04) ",
"NDC11Code": "00944-2850-03",
"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": "0944-2850-09",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (0944-2850-09) / 50 mL in 1 BOTTLE, GLASS (0944-2850-10) ",
"NDC11Code": "00944-2850-09",
"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": "0944-2948-10",
"PackageDescription": "1 KIT in 1 CARTON (0944-2948-10) * 5 mL in 1 VIAL, GLASS (0944-2947-01) * 5 mL in 1 VIAL, GLASS (52919-003-08) ",
"NDC11Code": "00944-2948-10",
"ProductNDC": "0944-2948",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Advate",
"NonProprietaryName": "Antihemophilic Factor, Human Recombinant",
"DosageFormName": "KIT",
"StartMarketingDate": "20120712",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125063",
"LabelerName": "Baxalta US Inc.",
"Status": "Deprecated",
"LastUpdate": "2018-12-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20120712",
"SamplePackage": "N"
},
{
"NDCCode": "0944-2960-10",
"PackageDescription": "1 KIT in 1 CARTON (0944-2960-10) * 5 mL in 1 VIAL, GLASS (0944-2941-01) * 5 mL in 1 VIAL, GLASS (0338-0001-56)",
"NDC11Code": "00944-2960-10",
"ProductNDC": "0944-2960",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Advate",
"NonProprietaryName": "Antihemophilic Factor, Human Recombinant",
"DosageFormName": "KIT",
"StartMarketingDate": "20030725",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125063",
"LabelerName": "Baxter Healthcare Corporation",
"Status": "Deprecated",
"LastUpdate": "2018-01-26",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0944-2961-10",
"PackageDescription": "1 KIT in 1 CARTON (0944-2961-10) * 5 mL in 1 VIAL, GLASS (0944-2942-01) * 5 mL in 1 VIAL, GLASS (0338-0001-56)",
"NDC11Code": "00944-2961-10",
"ProductNDC": "0944-2961",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Advate",
"NonProprietaryName": "Antihemophilic Factor, Human Recombinant",
"DosageFormName": "KIT",
"StartMarketingDate": "20030725",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125063",
"LabelerName": "Baxter Healthcare Corporation",
"Status": "Deprecated",
"LastUpdate": "2018-01-26",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0944-2962-10",
"PackageDescription": "1 KIT in 1 CARTON (0944-2962-10) * 5 mL in 1 VIAL, GLASS (0944-2943-01) * 5 mL in 1 VIAL, GLASS (0338-0001-56)",
"NDC11Code": "00944-2962-10",
"ProductNDC": "0944-2962",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Advate",
"NonProprietaryName": "Antihemophilic Factor, Human Recombinant",
"DosageFormName": "KIT",
"StartMarketingDate": "20030725",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125063",
"LabelerName": "Baxter Healthcare Corporation",
"Status": "Deprecated",
"LastUpdate": "2018-01-26",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0944-2963-10",
"PackageDescription": "1 KIT in 1 CARTON (0944-2963-10) * 5 mL in 1 VIAL, GLASS (0944-2944-01) * 5 mL in 1 VIAL, GLASS (0338-0001-56)",
"NDC11Code": "00944-2963-10",
"ProductNDC": "0944-2963",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Advate",
"NonProprietaryName": "Antihemophilic Factor, Human Recombinant",
"DosageFormName": "KIT",
"StartMarketingDate": "20030725",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125063",
"LabelerName": "Baxter Healthcare Corporation",
"Status": "Deprecated",
"LastUpdate": "2018-01-26",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>0944-2841-10</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0944-2841-10) * 10 mL in 1 VIAL, GLASS (0944-2831-01) * 5 mL in 1 VIAL, GLASS (64764-515-50) </PackageDescription>
<NDC11Code>00944-2841-10</NDC11Code>
<ProductNDC>0944-2841</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Recombinate</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor Recombinant</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20090410</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103375</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090410</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>The use of RECOMBINATE [Antihemophilic Factor (Recombinant)] is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes.2 RECOMBINATE is also indicated in the perioperative management of patients with hemophilia A (classical hemophilia). RECOMBINATE can be of therapeutic value in patients with acquired Factor VIII inhibitors not exceeding 10 Bethesda Units per mL.3 In clinical studies with RECOMBINATE, patients with inhibitors who were entered into the previously treated patient trial and those previously untreated children who have developed inhibitor activity on study, showed clinical hemostatic response when the titer of inhibitor was less than 10 Bethesda Units per mL. However, in such uses, the dosage of RECOMBINATE should be controlled by frequent laboratory determinations of circulating Factor VIII levels as well as the clinical status of the patient. RECOMBINATE is not indicated in von Willebrand's disease.</IndicationAndUsage>
<Description>RECOMBINATE [Antihemophilic Factor (Recombinant)] is a glycoprotein synthesized by a genetically engineered Chinese Hamster Ovary (CHO) cell line. In culture, the CHO cell line secretes recombinant Factor VIII (rFVIII) into the cell culture medium. The rFVIII is purified from the culture medium utilizing a series of chromatography columns. A key step in the purification process is an immunoaffinity chromatography methodology in which a purification matrix, prepared by immobilization of a monoclonal antibody directed to Factor VIII, is utilized to selectively isolate the rFVIII in the medium. The synthesized rFVIII produced by the CHO cells has the same biological effects as human Factor VIII. Structurally the protein has a similar combination of heterogenous heavy and light chains as found in human Factor VIII. RECOMBINATE is formulated as a sterile, nonpyrogenic, off-white to faint yellow, lyophilized powder preparation of concentrated recombinant Factor VIII for intravenous injection. RECOMBINATE is available in single-dose vials, which contain nominally 250, 500, 1000, 1500, and 2000 International Units per vial. When reconstituted with the appropriate volume of diluent, the product contains the following stabilizers in maximum amounts: For 5 mL reconstitution volume: 25 mg/mL Albumin (Human), 0.40 mg/mL calcium, 3 mg/mL polyethylene glycol (3350), 360 mEq/L sodium, 110 mM histidine, 1.5 µg/Factor VIII International Unit (IU) polysorbate-80. Recombinant Von Willebrand Factor (rVWF) is coexpressed with the rFVIII and helps to stabilize it. The final product contains not more than 2 ng rVWF/IU rFVIII, which will not have any clinically relevant effect in patients with von Willebrand's disease. The product contains no preservative. Each vial of RECOMBINATE is labeled with the Factor VIII activity expressed in IU per vial. Biological potency is determined by an in vitro assay which is referenced to the World Health Organization (WHO) International Standard for Factor VIII:C Concentrate.</Description>
</NDC>
<NDC>
<NDCCode>36987-2841-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (36987-2841-2)</PackageDescription>
<NDC11Code>36987-2841-02</NDC11Code>
<ProductNDC>36987-2841</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>California Black Oak</ProprietaryName>
<NonProprietaryName>California Black Oak</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>QUERCUS KELLOGGII POLLEN</SubstanceName>
<StrengthNumber>40000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>54868-2841-3</NDCCode>
<PackageDescription>10 CAPSULE in 1 BOTTLE, PLASTIC (54868-2841-3)</PackageDescription>
<NDC11Code>54868-2841-03</NDC11Code>
<ProductNDC>54868-2841</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mycobutin</ProprietaryName>
<NonProprietaryName>Rifabutin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950315</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050689</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>RIFABUTIN</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Rifamycin Antimycobacterial [EPC],Rifamycins [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>MYCOBUTIN Capsules are indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection.</IndicationAndUsage>
<Description>MYCOBUTIN Capsules contain the antimycobacterial agent rifabutin, which is a semisynthetic ansamycin antibiotic derived from rifamycin S. MYCOBUTIN Capsules for oral administration contain 150 mg of rifabutin, USP, per capsule, along with the inactive ingredients microcrystalline cellulose, magnesium stearate, red iron oxide, silica gel, sodium lauryl sulfate, titanium dioxide, and edible white ink. The chemical name for rifabutin is 1',4-didehydro-1-deoxy-1,4-dihydro-5'-(2-methylpropyl)-1-oxorifamycin XIV (Chemical Abstracts Service, 9th Collective Index) or (9S, 12E, 14S, 15R, 16S, 17R, 18R, 19R, 20S, 21S, 22E, 24Z)-6,16,18,20-tetrahydroxy-1'-isobutyl-14-methoxy-7,9,15,17,19,21,25-heptamethyl-spiro [9,4-(epoxypentadeca[1,11,13]trienimino)-2H-furo[2',3':7,8]naphth[1,2-d] imidazole-2,4'-piperidine]-5,10,26-(3H,9H)-trione-16-acetate. Rifabutin has a molecular formula of C46H62N4O11, a molecular weight of 847.02 and the following structure. Rifabutin is a red-violet powder soluble in chloroform and methanol, sparingly soluble in ethanol, and very slightly soluble in water (0.19 mg/mL). Its log P value (the base 10 logarithm of the partition coefficient between n-octanol and water) is 3.2 (n-octanol/water).</Description>
</NDC>
<NDC>
<NDCCode>54868-2841-0</NDCCode>
<PackageDescription>50 CAPSULE in 1 BOTTLE, PLASTIC (54868-2841-0)</PackageDescription>
<NDC11Code>54868-2841-00</NDC11Code>
<ProductNDC>54868-2841</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mycobutin</ProprietaryName>
<NonProprietaryName>Rifabutin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950315</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050689</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>RIFABUTIN</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Rifamycin Antimycobacterial [EPC],Rifamycins [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>MYCOBUTIN Capsules are indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection.</IndicationAndUsage>
<Description>MYCOBUTIN Capsules contain the antimycobacterial agent rifabutin, which is a semisynthetic ansamycin antibiotic derived from rifamycin S. MYCOBUTIN Capsules for oral administration contain 150 mg of rifabutin, USP, per capsule, along with the inactive ingredients microcrystalline cellulose, magnesium stearate, red iron oxide, silica gel, sodium lauryl sulfate, titanium dioxide, and edible white ink. The chemical name for rifabutin is 1',4-didehydro-1-deoxy-1,4-dihydro-5'-(2-methylpropyl)-1-oxorifamycin XIV (Chemical Abstracts Service, 9th Collective Index) or (9S, 12E, 14S, 15R, 16S, 17R, 18R, 19R, 20S, 21S, 22E, 24Z)-6,16,18,20-tetrahydroxy-1'-isobutyl-14-methoxy-7,9,15,17,19,21,25-heptamethyl-spiro [9,4-(epoxypentadeca[1,11,13]trienimino)-2H-furo[2',3':7,8]naphth[1,2-d] imidazole-2,4'-piperidine]-5,10,26-(3H,9H)-trione-16-acetate. Rifabutin has a molecular formula of C46H62N4O11, a molecular weight of 847.02 and the following structure. Rifabutin is a red-violet powder soluble in chloroform and methanol, sparingly soluble in ethanol, and very slightly soluble in water (0.19 mg/mL). Its log P value (the base 10 logarithm of the partition coefficient between n-octanol and water) is 3.2 (n-octanol/water).</Description>
</NDC>
<NDC>
<NDCCode>54868-2841-1</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE, PLASTIC (54868-2841-1)</PackageDescription>
<NDC11Code>54868-2841-01</NDC11Code>
<ProductNDC>54868-2841</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mycobutin</ProprietaryName>
<NonProprietaryName>Rifabutin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950315</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050689</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>RIFABUTIN</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Rifamycin Antimycobacterial [EPC],Rifamycins [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>MYCOBUTIN Capsules are indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection.</IndicationAndUsage>
<Description>MYCOBUTIN Capsules contain the antimycobacterial agent rifabutin, which is a semisynthetic ansamycin antibiotic derived from rifamycin S. MYCOBUTIN Capsules for oral administration contain 150 mg of rifabutin, USP, per capsule, along with the inactive ingredients microcrystalline cellulose, magnesium stearate, red iron oxide, silica gel, sodium lauryl sulfate, titanium dioxide, and edible white ink. The chemical name for rifabutin is 1',4-didehydro-1-deoxy-1,4-dihydro-5'-(2-methylpropyl)-1-oxorifamycin XIV (Chemical Abstracts Service, 9th Collective Index) or (9S, 12E, 14S, 15R, 16S, 17R, 18R, 19R, 20S, 21S, 22E, 24Z)-6,16,18,20-tetrahydroxy-1'-isobutyl-14-methoxy-7,9,15,17,19,21,25-heptamethyl-spiro [9,4-(epoxypentadeca[1,11,13]trienimino)-2H-furo[2',3':7,8]naphth[1,2-d] imidazole-2,4'-piperidine]-5,10,26-(3H,9H)-trione-16-acetate. Rifabutin has a molecular formula of C46H62N4O11, a molecular weight of 847.02 and the following structure. Rifabutin is a red-violet powder soluble in chloroform and methanol, sparingly soluble in ethanol, and very slightly soluble in water (0.19 mg/mL). Its log P value (the base 10 logarithm of the partition coefficient between n-octanol and water) is 3.2 (n-octanol/water).</Description>
</NDC>
<NDC>
<NDCCode>54868-2841-2</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (54868-2841-2)</PackageDescription>
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<ProductNDC>54868-2841</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mycobutin</ProprietaryName>
<NonProprietaryName>Rifabutin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950315</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050689</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>RIFABUTIN</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Rifamycin Antimycobacterial [EPC],Rifamycins [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>MYCOBUTIN Capsules are indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection.</IndicationAndUsage>
<Description>MYCOBUTIN Capsules contain the antimycobacterial agent rifabutin, which is a semisynthetic ansamycin antibiotic derived from rifamycin S. MYCOBUTIN Capsules for oral administration contain 150 mg of rifabutin, USP, per capsule, along with the inactive ingredients microcrystalline cellulose, magnesium stearate, red iron oxide, silica gel, sodium lauryl sulfate, titanium dioxide, and edible white ink. The chemical name for rifabutin is 1',4-didehydro-1-deoxy-1,4-dihydro-5'-(2-methylpropyl)-1-oxorifamycin XIV (Chemical Abstracts Service, 9th Collective Index) or (9S, 12E, 14S, 15R, 16S, 17R, 18R, 19R, 20S, 21S, 22E, 24Z)-6,16,18,20-tetrahydroxy-1'-isobutyl-14-methoxy-7,9,15,17,19,21,25-heptamethyl-spiro [9,4-(epoxypentadeca[1,11,13]trienimino)-2H-furo[2',3':7,8]naphth[1,2-d] imidazole-2,4'-piperidine]-5,10,26-(3H,9H)-trione-16-acetate. Rifabutin has a molecular formula of C46H62N4O11, a molecular weight of 847.02 and the following structure. Rifabutin is a red-violet powder soluble in chloroform and methanol, sparingly soluble in ethanol, and very slightly soluble in water (0.19 mg/mL). Its log P value (the base 10 logarithm of the partition coefficient between n-octanol and water) is 3.2 (n-octanol/water).</Description>
</NDC>
<NDC>
<NDCCode>54868-2841-4</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE, PLASTIC (54868-2841-4)</PackageDescription>
<NDC11Code>54868-2841-04</NDC11Code>
<ProductNDC>54868-2841</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mycobutin</ProprietaryName>
<NonProprietaryName>Rifabutin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950315</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050689</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>RIFABUTIN</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Rifamycin Antimycobacterial [EPC],Rifamycins [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>MYCOBUTIN Capsules are indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection.</IndicationAndUsage>
<Description>MYCOBUTIN Capsules contain the antimycobacterial agent rifabutin, which is a semisynthetic ansamycin antibiotic derived from rifamycin S. MYCOBUTIN Capsules for oral administration contain 150 mg of rifabutin, USP, per capsule, along with the inactive ingredients microcrystalline cellulose, magnesium stearate, red iron oxide, silica gel, sodium lauryl sulfate, titanium dioxide, and edible white ink. The chemical name for rifabutin is 1',4-didehydro-1-deoxy-1,4-dihydro-5'-(2-methylpropyl)-1-oxorifamycin XIV (Chemical Abstracts Service, 9th Collective Index) or (9S, 12E, 14S, 15R, 16S, 17R, 18R, 19R, 20S, 21S, 22E, 24Z)-6,16,18,20-tetrahydroxy-1'-isobutyl-14-methoxy-7,9,15,17,19,21,25-heptamethyl-spiro [9,4-(epoxypentadeca[1,11,13]trienimino)-2H-furo[2',3':7,8]naphth[1,2-d] imidazole-2,4'-piperidine]-5,10,26-(3H,9H)-trione-16-acetate. Rifabutin has a molecular formula of C46H62N4O11, a molecular weight of 847.02 and the following structure. Rifabutin is a red-violet powder soluble in chloroform and methanol, sparingly soluble in ethanol, and very slightly soluble in water (0.19 mg/mL). Its log P value (the base 10 logarithm of the partition coefficient between n-octanol and water) is 3.2 (n-octanol/water).</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>
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<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>
<NDC>
<NDCCode>0944-2620-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0944-2620-01) * 1 BOTTLE in 1 CARTON > 10 mL in 1 BOTTLE * 10 mL in 1 BOTTLE (0338-0764-61)</PackageDescription>
<NDC11Code>00944-2620-01</NDC11Code>
<ProductNDC>0944-2620</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Gammagard</ProprietaryName>
<ProprietaryNameSuffix>S/d</ProprietaryNameSuffix>
<NonProprietaryName>Human Immunoglobulin G</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19980501</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103133</ApplicationNumber>
<LabelerName>Baxalta US Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2018-12-05</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</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>0944-2700-04</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>0944-2705-10</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (0944-2705-10) / 100 mL in 1 VIAL, GLASS (0944-2705-01) </PackageDescription>
<NDC11Code>00944-2705-10</NDC11Code>
<ProductNDC>0944-2705</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Gammagard Liquid Erc</ProprietaryName>
<NonProprietaryName>Immune Globulin Infusion (human)</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20250714</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>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250714</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GAMMAGARD LIQUID ERC is 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 immunodeficiencies.</IndicationAndUsage>
<Description>GAMMAGARD LIQUID ERC (human immunoglobulin) is a single-dose sterile, liquid preparation of purified and concentrated IgG antibodies. GAMMAGARD LIQUID ERC has an IgA concentration less than or equal to 2 µg/mL, in a 10% solution. The distribution of the IgG subclasses is similar to that of normal plasma with lower levels of IgG4 and IgG3. The Fc and Fab functions are maintained in GAMMAGARD LIQUID ERC. Pre-kallikrein activator activity is not detectable. GAMMAGARD LIQUID ERC contains 100 mg/mL protein. At least 98% of the protein is immune globulin, the average IgA concentration is less than or equal to 2 µg/mL, in a 10% solution and immunoglobulin M is present in trace amounts. GAMMAGARD LIQUID ERC 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 ERC 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. GAMMAGARD LIQUID ERC shares its manufacturing process with GAMMAGARD LIQUID. The differentiation occurs with the modified parameters applied during the anion exchange chromatography step enhanced removal capability (ERC) to reduce IgA content, resulting in a product with IgA less than or equal to 2 µg/mL in a 10% solution. 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 ERC 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 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, nanofiltration, and a low pH incubation at elevated temperature (30° 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° to 25°C for a minimum of 60 minutes. S/D treatment inactivates the lipid-enveloped viruses investigated to below detection limits within 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, 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 ERC performed in accordance with good laboratory practices are summarized in Table 6.</Description>
</NDC>
<NDC>
<NDCCode>0944-2831-10</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0944-2831-10) * 1 VIAL, GLASS in 1 CARTON > 10 mL in 1 VIAL, GLASS * 1 VIAL, GLASS in 1 CARTON > 10 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>00944-2831-10</NDC11Code>
<ProductNDC>0944-2831</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Recombinate</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor Recombinant</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20100208</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103375</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0944-2831-15</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0944-2831-15) * 1 VIAL, GLASS in 1 CARTON > 10 mL in 1 VIAL, GLASS * 1 VIAL, GLASS in 1 CARTON > 10 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>00944-2831-15</NDC11Code>
<ProductNDC>0944-2831</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Recombinate</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor Recombinant</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20100208</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103375</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0944-2832-10</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0944-2832-10) * 1 VIAL, GLASS in 1 CARTON > 10 mL in 1 VIAL, GLASS * 1 VIAL, GLASS in 1 CARTON > 10 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>00944-2832-10</NDC11Code>
<ProductNDC>0944-2832</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Recombinate</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor Recombinant</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20100208</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103375</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0944-2832-15</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0944-2832-15) * 1 VIAL, GLASS in 1 CARTON > 10 mL in 1 VIAL, GLASS * 1 VIAL, GLASS in 1 CARTON > 10 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>00944-2832-15</NDC11Code>
<ProductNDC>0944-2832</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Recombinate</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor Recombinant</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20100208</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103375</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0944-2833-10</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0944-2833-10) * 1 VIAL, GLASS in 1 CARTON > 10 mL in 1 VIAL, GLASS * 1 VIAL, GLASS in 1 CARTON > 10 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>00944-2833-10</NDC11Code>
<ProductNDC>0944-2833</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Recombinate</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor Recombinant</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20100208</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103375</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0944-2833-15</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0944-2833-15) * 1 VIAL, GLASS in 1 CARTON > 10 mL in 1 VIAL, GLASS * 1 VIAL, GLASS in 1 CARTON > 10 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>00944-2833-15</NDC11Code>
<ProductNDC>0944-2833</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Recombinate</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor Recombinant</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20100208</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103375</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0944-2842-10</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0944-2842-10) * 10 mL in 1 VIAL, GLASS (0944-2832-01) * 5 mL in 1 VIAL, GLASS (64764-515-50) </PackageDescription>
<NDC11Code>00944-2842-10</NDC11Code>
<ProductNDC>0944-2842</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Recombinate</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor Recombinant</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20090410</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103375</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090410</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>The use of RECOMBINATE [Antihemophilic Factor (Recombinant)] is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes.2 RECOMBINATE is also indicated in the perioperative management of patients with hemophilia A (classical hemophilia). RECOMBINATE can be of therapeutic value in patients with acquired Factor VIII inhibitors not exceeding 10 Bethesda Units per mL.3 In clinical studies with RECOMBINATE, patients with inhibitors who were entered into the previously treated patient trial and those previously untreated children who have developed inhibitor activity on study, showed clinical hemostatic response when the titer of inhibitor was less than 10 Bethesda Units per mL. However, in such uses, the dosage of RECOMBINATE should be controlled by frequent laboratory determinations of circulating Factor VIII levels as well as the clinical status of the patient. RECOMBINATE is not indicated in von Willebrand's disease.</IndicationAndUsage>
<Description>RECOMBINATE [Antihemophilic Factor (Recombinant)] is a glycoprotein synthesized by a genetically engineered Chinese Hamster Ovary (CHO) cell line. In culture, the CHO cell line secretes recombinant Factor VIII (rFVIII) into the cell culture medium. The rFVIII is purified from the culture medium utilizing a series of chromatography columns. A key step in the purification process is an immunoaffinity chromatography methodology in which a purification matrix, prepared by immobilization of a monoclonal antibody directed to Factor VIII, is utilized to selectively isolate the rFVIII in the medium. The synthesized rFVIII produced by the CHO cells has the same biological effects as human Factor VIII. Structurally the protein has a similar combination of heterogenous heavy and light chains as found in human Factor VIII. RECOMBINATE is formulated as a sterile, nonpyrogenic, off-white to faint yellow, lyophilized powder preparation of concentrated recombinant Factor VIII for intravenous injection. RECOMBINATE is available in single-dose vials, which contain nominally 250, 500, 1000, 1500, and 2000 International Units per vial. When reconstituted with the appropriate volume of diluent, the product contains the following stabilizers in maximum amounts: For 5 mL reconstitution volume: 25 mg/mL Albumin (Human), 0.40 mg/mL calcium, 3 mg/mL polyethylene glycol (3350), 360 mEq/L sodium, 110 mM histidine, 1.5 µg/Factor VIII International Unit (IU) polysorbate-80. Recombinant Von Willebrand Factor (rVWF) is coexpressed with the rFVIII and helps to stabilize it. The final product contains not more than 2 ng rVWF/IU rFVIII, which will not have any clinically relevant effect in patients with von Willebrand's disease. The product contains no preservative. Each vial of RECOMBINATE is labeled with the Factor VIII activity expressed in IU per vial. Biological potency is determined by an in vitro assay which is referenced to the World Health Organization (WHO) International Standard for Factor VIII:C Concentrate.</Description>
</NDC>
<NDC>
<NDCCode>0944-2843-10</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0944-2843-10) * 10 mL in 1 VIAL, GLASS (0944-2833-01) * 5 mL in 1 VIAL, GLASS (64764-515-50) </PackageDescription>
<NDC11Code>00944-2843-10</NDC11Code>
<ProductNDC>0944-2843</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Recombinate</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor Recombinant</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20090410</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103375</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090410</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>The use of RECOMBINATE [Antihemophilic Factor (Recombinant)] is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes.2 RECOMBINATE is also indicated in the perioperative management of patients with hemophilia A (classical hemophilia). RECOMBINATE can be of therapeutic value in patients with acquired Factor VIII inhibitors not exceeding 10 Bethesda Units per mL.3 In clinical studies with RECOMBINATE, patients with inhibitors who were entered into the previously treated patient trial and those previously untreated children who have developed inhibitor activity on study, showed clinical hemostatic response when the titer of inhibitor was less than 10 Bethesda Units per mL. However, in such uses, the dosage of RECOMBINATE should be controlled by frequent laboratory determinations of circulating Factor VIII levels as well as the clinical status of the patient. RECOMBINATE is not indicated in von Willebrand's disease.</IndicationAndUsage>
<Description>RECOMBINATE [Antihemophilic Factor (Recombinant)] is a glycoprotein synthesized by a genetically engineered Chinese Hamster Ovary (CHO) cell line. In culture, the CHO cell line secretes recombinant Factor VIII (rFVIII) into the cell culture medium. The rFVIII is purified from the culture medium utilizing a series of chromatography columns. A key step in the purification process is an immunoaffinity chromatography methodology in which a purification matrix, prepared by immobilization of a monoclonal antibody directed to Factor VIII, is utilized to selectively isolate the rFVIII in the medium. The synthesized rFVIII produced by the CHO cells has the same biological effects as human Factor VIII. Structurally the protein has a similar combination of heterogenous heavy and light chains as found in human Factor VIII. RECOMBINATE is formulated as a sterile, nonpyrogenic, off-white to faint yellow, lyophilized powder preparation of concentrated recombinant Factor VIII for intravenous injection. RECOMBINATE is available in single-dose vials, which contain nominally 250, 500, 1000, 1500, and 2000 International Units per vial. When reconstituted with the appropriate volume of diluent, the product contains the following stabilizers in maximum amounts: For 5 mL reconstitution volume: 25 mg/mL Albumin (Human), 0.40 mg/mL calcium, 3 mg/mL polyethylene glycol (3350), 360 mEq/L sodium, 110 mM histidine, 1.5 µg/Factor VIII International Unit (IU) polysorbate-80. Recombinant Von Willebrand Factor (rVWF) is coexpressed with the rFVIII and helps to stabilize it. The final product contains not more than 2 ng rVWF/IU rFVIII, which will not have any clinically relevant effect in patients with von Willebrand's disease. The product contains no preservative. Each vial of RECOMBINATE is labeled with the Factor VIII activity expressed in IU per vial. Biological potency is determined by an in vitro assay which is referenced to the World Health Organization (WHO) International Standard for Factor VIII:C Concentrate.</Description>
</NDC>
<NDC>
<NDCCode>0944-2844-10</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0944-2844-10) * 10 mL in 1 VIAL, GLASS (0944-2834-01) * 5 mL in 1 VIAL, GLASS (64764-515-50) </PackageDescription>
<NDC11Code>00944-2844-10</NDC11Code>
<ProductNDC>0944-2844</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Recombinate</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor Recombinant</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20100315</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103375</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>The use of RECOMBINATE [Antihemophilic Factor (Recombinant)] is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes.2 RECOMBINATE is also indicated in the perioperative management of patients with hemophilia A (classical hemophilia). RECOMBINATE can be of therapeutic value in patients with acquired Factor VIII inhibitors not exceeding 10 Bethesda Units per mL.3 In clinical studies with RECOMBINATE, patients with inhibitors who were entered into the previously treated patient trial and those previously untreated children who have developed inhibitor activity on study, showed clinical hemostatic response when the titer of inhibitor was less than 10 Bethesda Units per mL. However, in such uses, the dosage of RECOMBINATE should be controlled by frequent laboratory determinations of circulating Factor VIII levels as well as the clinical status of the patient. RECOMBINATE is not indicated in von Willebrand's disease.</IndicationAndUsage>
<Description>RECOMBINATE [Antihemophilic Factor (Recombinant)] is a glycoprotein synthesized by a genetically engineered Chinese Hamster Ovary (CHO) cell line. In culture, the CHO cell line secretes recombinant Factor VIII (rFVIII) into the cell culture medium. The rFVIII is purified from the culture medium utilizing a series of chromatography columns. A key step in the purification process is an immunoaffinity chromatography methodology in which a purification matrix, prepared by immobilization of a monoclonal antibody directed to Factor VIII, is utilized to selectively isolate the rFVIII in the medium. The synthesized rFVIII produced by the CHO cells has the same biological effects as human Factor VIII. Structurally the protein has a similar combination of heterogenous heavy and light chains as found in human Factor VIII. RECOMBINATE is formulated as a sterile, nonpyrogenic, off-white to faint yellow, lyophilized powder preparation of concentrated recombinant Factor VIII for intravenous injection. RECOMBINATE is available in single-dose vials, which contain nominally 250, 500, 1000, 1500, and 2000 International Units per vial. When reconstituted with the appropriate volume of diluent, the product contains the following stabilizers in maximum amounts: For 5 mL reconstitution volume: 25 mg/mL Albumin (Human), 0.40 mg/mL calcium, 3 mg/mL polyethylene glycol (3350), 360 mEq/L sodium, 110 mM histidine, 1.5 µg/Factor VIII International Unit (IU) polysorbate-80. Recombinant Von Willebrand Factor (rVWF) is coexpressed with the rFVIII and helps to stabilize it. The final product contains not more than 2 ng rVWF/IU rFVIII, which will not have any clinically relevant effect in patients with von Willebrand's disease. The product contains no preservative. Each vial of RECOMBINATE is labeled with the Factor VIII activity expressed in IU per vial. Biological potency is determined by an in vitro assay which is referenced to the World Health Organization (WHO) International Standard for Factor VIII:C Concentrate.</Description>
</NDC>
<NDC>
<NDCCode>0944-2845-10</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0944-2845-10) * 10 mL in 1 VIAL, GLASS (0944-2835-01) * 5 mL in 1 VIAL, GLASS (64764-515-50) </PackageDescription>
<NDC11Code>00944-2845-10</NDC11Code>
<ProductNDC>0944-2845</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Recombinate</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor Recombinant</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20100315</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103375</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>The use of RECOMBINATE [Antihemophilic Factor (Recombinant)] is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes.2 RECOMBINATE is also indicated in the perioperative management of patients with hemophilia A (classical hemophilia). RECOMBINATE can be of therapeutic value in patients with acquired Factor VIII inhibitors not exceeding 10 Bethesda Units per mL.3 In clinical studies with RECOMBINATE, patients with inhibitors who were entered into the previously treated patient trial and those previously untreated children who have developed inhibitor activity on study, showed clinical hemostatic response when the titer of inhibitor was less than 10 Bethesda Units per mL. However, in such uses, the dosage of RECOMBINATE should be controlled by frequent laboratory determinations of circulating Factor VIII levels as well as the clinical status of the patient. RECOMBINATE is not indicated in von Willebrand's disease.</IndicationAndUsage>
<Description>RECOMBINATE [Antihemophilic Factor (Recombinant)] is a glycoprotein synthesized by a genetically engineered Chinese Hamster Ovary (CHO) cell line. In culture, the CHO cell line secretes recombinant Factor VIII (rFVIII) into the cell culture medium. The rFVIII is purified from the culture medium utilizing a series of chromatography columns. A key step in the purification process is an immunoaffinity chromatography methodology in which a purification matrix, prepared by immobilization of a monoclonal antibody directed to Factor VIII, is utilized to selectively isolate the rFVIII in the medium. The synthesized rFVIII produced by the CHO cells has the same biological effects as human Factor VIII. Structurally the protein has a similar combination of heterogenous heavy and light chains as found in human Factor VIII. RECOMBINATE is formulated as a sterile, nonpyrogenic, off-white to faint yellow, lyophilized powder preparation of concentrated recombinant Factor VIII for intravenous injection. RECOMBINATE is available in single-dose vials, which contain nominally 250, 500, 1000, 1500, and 2000 International Units per vial. When reconstituted with the appropriate volume of diluent, the product contains the following stabilizers in maximum amounts: For 5 mL reconstitution volume: 25 mg/mL Albumin (Human), 0.40 mg/mL calcium, 3 mg/mL polyethylene glycol (3350), 360 mEq/L sodium, 110 mM histidine, 1.5 µg/Factor VIII International Unit (IU) polysorbate-80. Recombinant Von Willebrand Factor (rVWF) is coexpressed with the rFVIII and helps to stabilize it. The final product contains not more than 2 ng rVWF/IU rFVIII, which will not have any clinically relevant effect in patients with von Willebrand's disease. The product contains no preservative. Each vial of RECOMBINATE is labeled with the Factor VIII activity expressed in IU per vial. Biological potency is determined by an in vitro assay which is referenced to the World Health Organization (WHO) International Standard for Factor VIII:C Concentrate.</Description>
</NDC>
<NDC>
<NDCCode>0944-2850-03</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (0944-2850-03) / 10 mL in 1 VIAL, SINGLE-USE (0944-2850-04) </PackageDescription>
<NDC11Code>00944-2850-03</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>
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<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (0944-2850-09) / 50 mL in 1 BOTTLE, GLASS (0944-2850-10) </PackageDescription>
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<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20161018</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125596</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
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<StrengthUnit>mg/mL</StrengthUnit>
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<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>0944-2948-10</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0944-2948-10) * 5 mL in 1 VIAL, GLASS (0944-2947-01) * 5 mL in 1 VIAL, GLASS (52919-003-08) </PackageDescription>
<NDC11Code>00944-2948-10</NDC11Code>
<ProductNDC>0944-2948</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Advate</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor, Human Recombinant</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20120712</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125063</ApplicationNumber>
<LabelerName>Baxalta US Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2018-12-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120712</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0944-2960-10</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0944-2960-10) * 5 mL in 1 VIAL, GLASS (0944-2941-01) * 5 mL in 1 VIAL, GLASS (0338-0001-56)</PackageDescription>
<NDC11Code>00944-2960-10</NDC11Code>
<ProductNDC>0944-2960</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Advate</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor, Human Recombinant</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20030725</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125063</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2018-01-26</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0944-2961-10</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0944-2961-10) * 5 mL in 1 VIAL, GLASS (0944-2942-01) * 5 mL in 1 VIAL, GLASS (0338-0001-56)</PackageDescription>
<NDC11Code>00944-2961-10</NDC11Code>
<ProductNDC>0944-2961</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Advate</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor, Human Recombinant</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20030725</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125063</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2018-01-26</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0944-2962-10</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0944-2962-10) * 5 mL in 1 VIAL, GLASS (0944-2943-01) * 5 mL in 1 VIAL, GLASS (0338-0001-56)</PackageDescription>
<NDC11Code>00944-2962-10</NDC11Code>
<ProductNDC>0944-2962</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Advate</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor, Human Recombinant</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20030725</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125063</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2018-01-26</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0944-2963-10</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0944-2963-10) * 5 mL in 1 VIAL, GLASS (0944-2944-01) * 5 mL in 1 VIAL, GLASS (0338-0001-56)</PackageDescription>
<NDC11Code>00944-2963-10</NDC11Code>
<ProductNDC>0944-2963</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Advate</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor, Human Recombinant</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20030725</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125063</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2018-01-26</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
</NDCList>