{
"NDC": [
{
"NDCCode": "68982-349-02",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (68982-349-02) / 100 mL in 1 BOTTLE, GLASS (68982-349-82) ",
"NDC11Code": "68982-0349-02",
"ProductNDC": "68982-349",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Fibryga",
"NonProprietaryName": "Fibrinogen (human)",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20241220",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125612",
"LabelerName": "Octapharma USA Inc",
"SubstanceName": "FIBRINOGEN HUMAN",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Blood Coagulation Factors [CS], Human Blood Coagulation Factor [EPC], Increased Coagulation Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-08-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241220",
"SamplePackage": "N",
"Description": "FIBRYGA [fibrinogen (human)] is a human plasma-derived, sterile, purified, virus-inactivated and nanofiltered (20 nm) fibrinogen concentrate. FIBRYGA is supplied as a lyophilized powder, white or pale yellow in color, for reconstitution for intravenous use. FIBRYGA contains no preservatives. Each bottle contains approximately 1 g or 2 g of fibrinogen. The actual potency of fibrinogen in mg is stated on each FIBRYGA carton and bottle. The diluent for reconstitution of the lyophilized powder is 50 mL (1 g) or 100 mL (2 g) sterile Water for Injection. The nominal composition of FIBRYGA is as follows. All units of human plasma used in the manufacture of FIBRYGA are provided by FDA-approved blood establishments, and are tested by FDA-licensed serological tests for Hepatitis B surface antigen (HBsAg), antibodies to Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1/2. As an additional safety measure, the plasma is tested with Nucleic Acid Tests (NATs) for Hepatitis A Virus (HAV), Hepatitis B Virus (HBV), HCV and HIV-1 and found to be non-reactive (negative). The plasma is also screened for Human Parvovirus (B19V) by NAT. The limit for B19V DNA in the mini-pool is set not to exceed 10 3 IU/mL. Only plasma that passed virus screening is used for production. The FIBRYGA manufacturing process includes a solvent/detergent (S/D) step for virus inactivation, and a nanofiltration step (Planova 20N nanofilter or Pegasus SV4 nanofilter) for virus removal. The mean cumulative virus reduction factors of these steps are summarized in Table 2 below. Table 2: Cumulative Virus Reduction Factors (Log 10 ) During FIBRYGA Manufacture. PRV: Pseudorabies Virus, model for large enveloped DNA viruses. BVDV: Bovine Virus Diarrhea Virus, model for HCV. PPV: Porcine Parvovirus, model for B19V. n.a.: not applicable. * When the nanofiltration step was performed using a Pegasus SV4 nanofilter, the virus reduction factors for HIV-1, PRV, BVDV, HAV, and PPV were ≥ 3.9, ≥ 6.3, ≥ 5.0, ≥ 5.2, and 4.5, respectively. The cumulative virus reduction factors (S/D treatment + Pegasus SV4 nanofiltration) were ≥ 9.0, ≥ 12.9, ≥ 10.8, ≥ 5.2, and 4.5, respectively."
},
{
"NDCCode": "68982-349-01",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (68982-349-01) / 50 mL in 1 BOTTLE, GLASS (68982-349-81) ",
"NDC11Code": "68982-0349-01",
"ProductNDC": "68982-349",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Fibryga",
"NonProprietaryName": "Fibrinogen (human)",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20241220",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125612",
"LabelerName": "Octapharma USA Inc",
"SubstanceName": "FIBRINOGEN HUMAN",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Blood Coagulation Factors [CS], Human Blood Coagulation Factor [EPC], Increased Coagulation Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-08-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241220",
"SamplePackage": "N",
"Description": "FIBRYGA [fibrinogen (human)] is a human plasma-derived, sterile, purified, virus-inactivated and nanofiltered (20 nm) fibrinogen concentrate. FIBRYGA is supplied as a lyophilized powder, white or pale yellow in color, for reconstitution for intravenous use. FIBRYGA contains no preservatives. Each bottle contains approximately 1 g or 2 g of fibrinogen. The actual potency of fibrinogen in mg is stated on each FIBRYGA carton and bottle. The diluent for reconstitution of the lyophilized powder is 50 mL (1 g) or 100 mL (2 g) sterile Water for Injection. The nominal composition of FIBRYGA is as follows. All units of human plasma used in the manufacture of FIBRYGA are provided by FDA-approved blood establishments, and are tested by FDA-licensed serological tests for Hepatitis B surface antigen (HBsAg), antibodies to Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1/2. As an additional safety measure, the plasma is tested with Nucleic Acid Tests (NATs) for Hepatitis A Virus (HAV), Hepatitis B Virus (HBV), HCV and HIV-1 and found to be non-reactive (negative). The plasma is also screened for Human Parvovirus (B19V) by NAT. The limit for B19V DNA in the mini-pool is set not to exceed 10 3 IU/mL. Only plasma that passed virus screening is used for production. The FIBRYGA manufacturing process includes a solvent/detergent (S/D) step for virus inactivation, and a nanofiltration step (Planova 20N nanofilter or Pegasus SV4 nanofilter) for virus removal. The mean cumulative virus reduction factors of these steps are summarized in Table 2 below. Table 2: Cumulative Virus Reduction Factors (Log 10 ) During FIBRYGA Manufacture. PRV: Pseudorabies Virus, model for large enveloped DNA viruses. BVDV: Bovine Virus Diarrhea Virus, model for HCV. PPV: Porcine Parvovirus, model for B19V. n.a.: not applicable. * When the nanofiltration step was performed using a Pegasus SV4 nanofilter, the virus reduction factors for HIV-1, PRV, BVDV, HAV, and PPV were ≥ 3.9, ≥ 6.3, ≥ 5.0, ≥ 5.2, and 4.5, respectively. The cumulative virus reduction factors (S/D treatment + Pegasus SV4 nanofiltration) were ≥ 9.0, ≥ 12.9, ≥ 10.8, ≥ 5.2, and 4.5, respectively."
},
{
"NDCCode": "68982-182-02",
"PackageDescription": "10 mL in 1 VIAL (68982-182-02) ",
"NDC11Code": "68982-0182-02",
"ProductNDC": "68982-182",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Wilate - Von Willebrand Factor/coagulation Factor Viii Complex (human)",
"NonProprietaryName": "Von Willebrand Factor/coagulation Factor Viii Complex (human)",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20091204",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125251",
"LabelerName": "Octapharma USA Inc",
"SubstanceName": "ANTIHEMOPHILIC FACTOR HUMAN; VON WILLEBRAND FACTOR HUMAN",
"StrengthNumber": "100; 100",
"StrengthUnit": "[iU]/mL; [iU]/mL",
"Pharm_Classes": "Blood Coagulation Factors [CS], Blood Coagulation Factors [CS], Factor VIII [CS], Human Antihemophilic Factor [EPC], Human Blood Coagulation Factor [EPC], Increased Coagulation Activity [PE], Increased Coagulation Activity [PE], Increased Platelet Aggregation [PE], von Willebrand Factor [CS]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20091204",
"SamplePackage": "N",
"IndicationAndUsage": "WILATE is indicated in adult and pediatric patients with von Willebrand disease (VWD) for: 1 On-demand treatment and control of bleeding episodes, 2 Perioperative management of bleeding, 3 Routine prophylaxis to reduce the frequency of bleeding episodes.",
"Description": "WILATE is a human plasma-derived, sterile, purified, double virus inactivated von Willebrand Factor/Coagulation Factor VIII Complex. WILATE is supplied as a lyophilized powder for reconstitution for intravenous injection. The diluent for reconstitution of the lyophilized powder is Water for Injection with 0.1% Polysorbate 80. WILATE contains no preservative. No albumin is added as a stabilizer. WILATE is labeled with the actual VWF:RCo and FVIII activities in IU per vial. The VWF activity (VWF:RCo) is determined using a manual agglutination method referenced to the current “WHO International Standard for von Willebrand Factor Concentrate”. The FVIII activity is determined using a chromogenic substrate assay referenced to the current “WHO International Standard for Human Coagulation Factor VIII Concentrate”. The assay methodologies are according to European Pharmacopoeia (Ph.Eur.). The resulting specific activity of WILATE is ≥ 60 IU VWF:RCo and ≥ 60 IU FVIII activities per mg of total protein. The nominal composition of WILATE is as follows. Von Willebrand Factor/Coagulation Factor VIII complex is the active ingredient in WILATE. It is derived from large pools of human plasma collected in U.S. plasma donation centers. All plasma donations are tested for viral markers in compliance with requirements of EU CPMP and FDA guidance. In addition, the limit for the titer of human parvovirus B19 DNA in the manufacturing pool is set not to exceed 104 IU/mL. The product is manufactured from cryoprecipitate, which is reconstituted in a buffer and treated with aluminum hydroxide followed by two different chromatography steps, ultra- and diafiltration, and sterile filtration. The manufacturing process includes two virus inactivation steps, namely, treatment with an organic solvent/detergent (S/D) mixture, composed of tri-n-butyl phosphate (TNBP) and Octoxynol-9, and a terminal dry heat (TDH) treatment of the lyophilized product in final container [at +100°C (212°F) for 120 minutes at a specified residual moisture level of 0.7-1.6%]. In addition, the ion-exchange chromatography step utilized during WILATE manufacturing also removes some viruses. Table 6 Virus Reduction During WILATE Manufacturing. na: not applicable. nd: not done (S/D reagents present). HIV-1: Human Immunodeficiency Virus - 1. SBV: Sindbis Virus. BVDV: Bovine Viral Diarrhea Virus. PRV: Pseudorabies Virus. REO 3: Reovirus Type 3. HAV: Hepatitis A Virus. PPV: Porcine Parvovirus."
},
{
"NDCCode": "68982-261-02",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (68982-261-02) / 40 mL in 1 VIAL, GLASS (68982-261-82) ",
"NDC11Code": "68982-0261-02",
"ProductNDC": "68982-261",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Balfaxar",
"NonProprietaryName": "Prothrombin Complex Concentrate (human)",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20231130",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125776",
"LabelerName": "Octapharma USA Inc",
"SubstanceName": "COAGULATION FACTOR IX HUMAN; PROTHROMBIN; COAGULATION FACTOR VII HUMAN; COAGULATION FACTOR X HUMAN; PROTEIN C; PROTEIN S HUMAN",
"StrengthNumber": "25.5; 26; 16.5; 24; 22; 22",
"StrengthUnit": "[iU]/mL; [iU]/mL; [iU]/mL; [iU]/mL; [iU]/mL; [iU]/mL",
"Pharm_Classes": "Anti-coagulant [EPC], Blood Coagulation Factor [EPC], Blood Coagulation Factors [CS], Blood Coagulation Factors [CS], Blood Coagulation Factors [CS], Blood Coagulation Factors [CS], Decreased Coagulation Factor Activity [PE], Enzyme Precursors [CS], Human Blood Coagulation Factor [EPC], Human Blood Coagulation Factor [EPC], Human Blood Coagulation Factor [EPC], Increased Coagulation Activity [PE], Increased Coagulation Activity [PE], Increased Coagulation Activity [PE], Increased Coagulation Activity [PE], Protein C [CS]",
"Status": "Active",
"LastUpdate": "2023-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231130",
"SamplePackage": "N",
"IndicationAndUsage": "BALFAXAR (prothrombin complex concentrate, human-lans) is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need for an urgent surgery/invasive procedure.",
"Description": "BALFAXAR is a human plasma-derived, purified, virus inactivated and nanofiltered non-activated Prothrombin Complex Concentrate (PCC) containing the coagulation factors II, VII, IX, and X and antithrombotic Proteins C and S. BALFAXAR is supplied as a lyophilized powder for reconstitution for intravenous use. The actual potency printed on the vial label represents the potency of Factor IX. BALFAXAR is sterile, endotoxin-free, and does not contain preservatives. No albumin is added as a stabilizer, and the excipients are heparin and sodium citrate. The diluent for reconstitution of the lyophilized powder is sterile Water for Injection. The composition of BALFAXAR is as follows. All human plasma used in the manufacture of BALFAXAR is obtained from U.S. donors, collected in FDA-approved blood and plasma establishments, and tested by FDA-licensed serological tests for viral markers (Hepatitis B surface antigen (HBsAg), antibodies to HIV-1/2 and HCV). The plasma is tested with Nucleic Acid Testing (NAT) for HCV, HIV-1, HAV, and HBV, and found to be non-reactive (negative), and the plasma is also tested by NAT for B19V to exclude donations with high titers. The limit for the titer of B19V DNA in the manufacturing pool is set not to exceed 10 4 IU/mL. Only plasma that passed virus screening is used for production. The BALFAXAR manufacturing process has the capability to clear viruses by a solvent/detergent (S/D) virus inactivation step and a virus removal nanofiltration step. The mean cumulative virus reduction factors of these steps are summarized in Table 4 . Table 4 Virus Reduction During BALFAXAR Manufacturing. n.a.: not applicable. BVDV: Bovine Viral Diarrhea Virus, model for HCV. PRV: Pseudorabies Virus, model for large enveloped DNA viruses, e.g., HBV. PPV: Porcine Parvovirus, model for B19V."
},
{
"NDCCode": "68982-623-02",
"PackageDescription": "250 mL in 1 BOTTLE, GLASS (68982-623-02) ",
"NDC11Code": "68982-0623-02",
"ProductNDC": "68982-623",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Albumin (human)",
"NonProprietaryName": "Albumin Human",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20061017",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125154",
"LabelerName": "Octapharma USA Inc",
"SubstanceName": "ALBUMIN HUMAN",
"StrengthNumber": "50",
"StrengthUnit": "g/1000mL",
"Pharm_Classes": "Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]",
"Status": "Active",
"LastUpdate": "2020-04-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20061017",
"SamplePackage": "N",
"IndicationAndUsage": "ALBUMIN (HUMAN) 5% is indicated for the restoration and maintenance of circulating blood volume for. Hypovolemia. ( 1.1 ). Hypoalbuminemia. ( 1.2 ). Prevention of central volume depletion after paracentesis due to cirrhotic ascites. ( 1.3 ).",
"Description": "ALBUMIN (HUMAN) 5% is a sterile, liquid preparation of albumin derived from large pools of human plasma. All units of human plasma used in the manufacture of ALBUMIN (HUMAN) 5% are provided by FDA approved blood establishments only. The product is manufactured by cold ethanol fractionation followed by ultra- and diafiltration. The manufacturing process includes final container pasteurization and additional bulk pasteurization at 60 +/- 0.5°C for 10 – 11 hours. The ALBUMIN (HUMAN) 5% manufacturing process provides a significant viral reduction in in vitro studies (table 2). These reductions are achieved through a combination of process steps including cold ethanol fractionation and final container pasteurization. No procedure, however, has been shown to be completely effective in removing viral infectivity from derivatives of human plasma. [see Warnings and Precautions, Infection Risk from Human Plasma (5.7)]. Table 2 In vitro reduction factor during ALBUMIN (HUMAN) 5% manufacturing. PRV: Pseudorabies Virus. SBV: Sindbis Virus. HIV-1: Human Immunodeficiency Virus - 1. Reo 3: Reovirus Type 3. PPV: Porcine Parvovirus. HAV: Hepatitis A Virus. ALBUMIN (HUMAN) 5% is a clear, slightly viscous liquid; it is almost colorless or slightly yellow or green. The composition of ALBUMIN (HUMAN) 5% is as follows. ALBUMIN (HUMAN) 5% contains no preservatives and components used in its packaging are latex-free."
},
{
"NDCCode": "68982-633-02",
"PackageDescription": "100 mL in 1 BOTTLE, GLASS (68982-633-02) ",
"NDC11Code": "68982-0633-02",
"ProductNDC": "68982-633",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Albumin (human)",
"NonProprietaryName": "Albumin Human",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20061017",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125154",
"LabelerName": "Octapharma USA Inc",
"SubstanceName": "ALBUMIN HUMAN",
"StrengthNumber": "200",
"StrengthUnit": "g/1000mL",
"Pharm_Classes": "Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]",
"Status": "Active",
"LastUpdate": "2020-04-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20061017",
"SamplePackage": "N",
"IndicationAndUsage": "ALBUMIN (HUMAN) 20% is indicated for the restoration and maintenance of circulating blood volume for. Hypovolemia. ( 1.1 ). Hypoalbuminemia. ( 1.2 ). Prevention of central volume depletion after paracentesis due to cirrhotic ascites. ( 1.3 ). Ovarian hyperstimulation syndrome (OHSS). ( 1.4 ). Adult respiratory distress syndrome (ARDS). ( 1.5 ). Acute nephrosis. ( 1.6 ). Hemolytic Disease of the Newborn (HDN). ( 1.7 ).",
"Description": "ALBUMIN (HUMAN) 20% is a sterile, liquid preparation of albumin derived from large pools of human plasma. All units of human plasma used in the manufacture of ALBUMIN (HUMAN) 20% are provided by FDA approved blood establishments only. The product is manufactured by cold ethanol fractionation followed by ultra- and diafiltration. The manufacturing process includes final container pasteurization and additional bulk pasteurization at 60 +/- 0.5°C for 10 – 11 hours. The ALBUMIN (HUMAN) 20% manufacturing process provides a significant viral reduction in in vitro studies (table 2). These reductions are achieved through a combination of process steps including cold ethanol fractionation and final container pasteurization. No procedure, however, has been shown to be completely effective in removing viral infectivity from derivatives of human plasma.[see Warnings and Precautions, Infection Risk from Human Plasma (5.7)]. Table 2 In vitro reduction factor during ALBUMIN (HUMAN) 20% manufacturing. PRV:Pseudorabies Virus. SBV: Sindbis Virus. HIV-1:Human Immunodeficiency Virus - 1. Reo 3:Reovirus Type 3. PPV:Porcine Parvovirus. HAV:Hepatitis A Virus. ALBUMIN (HUMAN) 20% is a clear, slightly viscous liquid; it is almost colorless or slightly yellow or green. The composition of ALBUMIN (HUMAN) 20% is as follows. ALBUMIN (HUMAN) 20% contains no preservatives and components used in its packaging are latex-free."
},
{
"NDCCode": "68982-643-02",
"PackageDescription": "100 mL in 1 BOTTLE, GLASS (68982-643-02) ",
"NDC11Code": "68982-0643-02",
"ProductNDC": "68982-643",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Albumin (human)",
"NonProprietaryName": "Albumin Human",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20061017",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125154",
"LabelerName": "Octapharma USA Inc",
"SubstanceName": "ALBUMIN HUMAN",
"StrengthNumber": "250",
"StrengthUnit": "g/1000mL",
"Pharm_Classes": "Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]",
"Status": "Active",
"LastUpdate": "2020-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20061017",
"SamplePackage": "N",
"IndicationAndUsage": "ALBUMIN (HUMAN) 25% is indicated for the restoration and maintenance of circulating blood volume for. Hypovolemia. ( 1.1 ). Hypoalbuminemia. ( 1.2 ). Prevention of central volume depletion after paracentesis due to cirrhotic ascites. ( 1.3 ). Ovarian hyperstimulation syndrome (OHSS). ( 1.4 ). Adult respiratory distress syndrome (ARDS). ( 1.5 ). Acute nephrosis. ( 1.6 ). Hemolytic disease of the newborn (HDN). ( 1.7 ).",
"Description": "ALBUMIN (HUMAN) 25% is a sterile, liquid preparation of albumin derived from large pools of human plasma. All units of human plasma used in the manufacture of ALBUMIN (HUMAN) 25% are provided by FDA approved blood establishments only. The product is manufactured by cold ethanol fractionation followed by ultra- and diafiltration. The manufacturing process includes final container pasteurization and additional bulk pasteurization at 60 +/- 0.5°C for 10 – 11 hours. The ALBUMIN (HUMAN) 25% manufacturing process provides a significant viral reduction in in vitro studies (table 3). These reductions are achieved through a combination of process steps including cold ethanol fractionation and final container pasteurization. No procedure, however, has been shown to be completely effective in removing viral infectivity from derivatives of human plasma. [see Warnings and Precautions, Infection Risk from Human Plasma (5.7)]. Table 3 In vitro reduction factor during ALBUMIN (HUMAN) 25% manufacturing. PRV: Pseudorabies Virus. SBV: Sindbis Virus. HIV-1: Human Immunodeficiency Virus - 1. Reo 3: Reovirus Type 3. PPV: Porcine Parvovirus. HAV: Hepatitis A Virus. ALBUMIN (HUMAN) 25% is a clear, slightly viscous liquid; it is almost colorless or slightly yellow or green. The composition of ALBUMIN (HUMAN) 25% is as follows. ALBUMIN (HUMAN) 25% contains no preservatives and components used in its packaging are latex-free."
},
{
"NDCCode": "68982-810-02",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (68982-810-02) > 10 mL in 1 VIAL, GLASS (68982-810-82) ",
"NDC11Code": "68982-0810-02",
"ProductNDC": "68982-810",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Cutaquig",
"NonProprietaryName": "Immunoglobulin G",
"DosageFormName": "SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20190503",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125668",
"LabelerName": "Octapharma USA Inc",
"SubstanceName": "HUMAN IMMUNOGLOBULIN G",
"StrengthNumber": "165",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
"Status": "Active",
"LastUpdate": "2022-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190503",
"SamplePackage": "N",
"IndicationAndUsage": "CUTAQUIG (Immune Globulin Subcutaneous (Human) - hipp) is a 16.5% immune globulin solution for subcutaneous infusion (IGSC), indicated as replacement therapy for primary humoral immunodeficiency (PI) in adults and pediatric patients 2 years of age and older. This includes, but is not limited to, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.",
"Description": "CUTAQUIG (Immune Globulin Subcutaneous (Human) - hipp), is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. CUTAQUIG is a solution for injection to be administered subcutaneously. This preparation contains approximately 165 mg of protein per mL (16.5%), of which not less than 96% is normal human immunoglobulin G. CUTAQUIG contains not more than 3% aggregates, not less than 94% monomers and dimers, and not more than 3% fragments. The product contains on average 0.206 mg of IgA /mL. The sodium content of the final solution is not more than 30 mmol/L and the pH is between 5.0 and 5.5. The osmolality is 310 - 380 mOsmol/kg. The manufacturing process for CUTAQUIG isolates IgG without additional chemical or enzymatic modification, and the Fc portion is maintained intact. CUTAQUIG contains the IgG antibody activities present in the donor population. IgG subclasses are fully represented with the following approximate percent of total IgG: IgG1 is 70%, IgG2 is 25%, IgG3 is 3% and IgG4 is 2%. CUTAQUIG contains a broad spectrum of IgG antibodies against bacterial and viral agents that are capable of opsonization and neutralization of microbes and toxins. It contains maltose (79 mg/mL), but no preservatives or sucrose. All units of human plasma used in the manufacture of CUTAQUIG are provided by FDA-approved blood and plasma establishments, and are tested by FDA-licensed serological tests for HBsAg, antibodies to HCV and HIV and Nucleic Acid Test (NAT) for HCV and HIV-1 and found to be non-reactive (negative). The product is manufactured by the cold ethanol fractionation process followed by ultrafiltration and chromatography. The manufacturing process includes treatment with an organic S/D mixture composed of tri-n-butyl phosphate (TNBP) and Octoxynol. The CUTAQUIG manufacturing process shows significant viral reduction in in vitro studies ( Table 6 ). These reductions are achieved through a combination of process steps including cold ethanol fractionation, S/D treatment and pH 4 treatment. Table 6 Pathogen Reduction During CUTAQUIG Manufacturing. * Not calculated for global Log 10 Reduction Factor. HIV-1: Human Immunodeficiency Virus - 1. PRV: Pseudorabies Virus, model virus for e.g. Hepatitis B Virus (HBV). SBV: Sindbis Virus, model virus for Hepatitis C Virus (HCV). MEV: Mouse Encephalomyelitis Virus, model virus for Human Parvovirus B19. PPV: Porcine Parvovirus, model virus for Hepatitis A Virus (HAV). n.a.: not applicable."
},
{
"NDCCode": "68982-820-02",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (68982-820-02) > 25 mL in 1 BOTTLE, GLASS (68982-820-82) ",
"NDC11Code": "68982-0820-02",
"ProductNDC": "68982-820",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Panzyga",
"NonProprietaryName": "Immune Globulin Intravenous (human)",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20181112",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125587",
"LabelerName": "Octapharma USA 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": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20181112",
"SamplePackage": "N",
"Description": "Immune Globulin Intravenous (Human), PANZYGA, is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. PANZYGA is a solution for infusion to be administered intravenously. This preparation contains approximately 100 mg of protein per mL (10%), of which not less than 96% is normal human immunoglobulin G. PANZYGA contains not more than 3% aggregates, not less than 90% monomers and dimers, and not more than 3% fragments. On average, the product contains 100 µg/mL of IgA, and lower amounts of IgM. PANZYGA contains only trace amounts of sodium, and the pH is between 4.5 and 5.0. The osmolality is in the range of 240-310 mosmol/kg. The manufacturing process for PANZYGA isolates IgG without additional chemical or enzymatic modification, and the Fc portion is maintained intact. PANZYGA contains the IgG antibody activities present in the donor population. IgG subclasses are fully represented with the following approximate percents of total IgG: IgG 1 is 65%, IgG 2 is 28%, IgG 3 is 3% and IgG 4 is 4%. PANZYGA contains a broad spectrum of IgG antibodies against bacterial and viral agents that are capable of opsonization and neutralization of microbes and toxins. PANZYGA contains glycine (15.0-19.5 mg/mL), but no preservatives or sucrose. All units of human plasma used in the manufacture of PANZYGA are provided by FDA-approved blood and plasma establishments, and are tested by FDA-licensed serological tests for HBsAg, antibodies to HCV and HIV and Nucleic Acid Test (NAT) for HCV and HIV1 and found to be non-reactive (negative). The product is manufactured by the cold ethanol fractionation process followed by purification methodologies, as well as S/D treatment and nanofiltration (20 nm). The S/D mixture used is composed of tri-n-butyl phosphate (TNBP, solvent) and Triton X-100 (Octoxynol, detergent). The PANZYGA manufacturing process shows significant viral reduction and inactivation, demonstrated by in vitro infectivity studies ( Table 4 ). The virus safety of PANZYGA is achieved through a combination of various process steps, including S/D treatment, ion-exchange chromatography, and nanofiltration (20 nm). Table 4 shows the virus clearance during the manufacturing process for PANZYGA, expressed as the mean log 10 reduction factor (LRF). Table 4: Virus Reduction by PANZYGA Manufacturing Process. HIV-1: Human Immunodeficiency Virus – 1, a model for HIV-1 and HIV-2;. PRV: Pseudorabies Virus, a model for large enveloped DNA viruses (e.g., herpes virus);. BVDV: Bovine Viral Diarrhea Virus, a model for e.g., Hepatitis C virus (HCV) and West-Nile virus (WNV);. MEV: Mouse Encephalomyelitis virus, a model for Hepatitis A virus (HAV);. PPV: Porcine Parvovirus, a model for Human Parvovirus B19;. n.a.: not applicable;. n.d: not done. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents. [ 10 ]. Several of the individual production steps in the PANZYGA manufacturing process were shown to decrease TSE infectivity of that experimental model agent. TSE reduction steps include ion-exchange chromatography and nanofiltration, which together give a total of at least 10.4 log10 decrease of infectivity. These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed."
},
{
"NDCCode": "68982-822-02",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (68982-822-02) / 25 mL in 1 BOTTLE, GLASS (68982-822-82) ",
"NDC11Code": "68982-0822-02",
"ProductNDC": "68982-822",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Panzyga",
"NonProprietaryName": "Immune Globulin Intravenous (human)",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20181112",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125587",
"LabelerName": "Octapharma USA 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": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181112",
"SamplePackage": "N",
"Description": "Immune Globulin Intravenous (Human), PANZYGA, is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. PANZYGA is a solution for infusion to be administered intravenously. This preparation contains approximately 100 mg of protein per mL (10%), of which not less than 96% is normal human immunoglobulin G. PANZYGA contains not more than 3% aggregates, not less than 94% monomers and dimers, and not more than 4% fragments. On average, the product contains 100 µg/mL of IgA, and lower amounts of IgM. PANZYGA contains only trace amounts of sodium, and the pH is between 4.5 and 5.0. The osmolality is in the range of 240-310 mosmol/kg. The manufacturing process for PANZYGA isolates IgG without additional chemical or enzymatic modification, and the Fc portion is maintained intact. PANZYGA contains the IgG antibody activities present in the donor population. IgG subclasses are fully represented with the following approximate percents of total IgG: IgG 1 is 65%, IgG 2 is 28%, IgG 3 is 3% and IgG 4 is 4%. PANZYGA contains a broad spectrum of IgG antibodies against bacterial and viral agents that are capable of opsonization and neutralization of microbes and toxins. PANZYGA contains glycine (15.0-19.5 mg/mL), but no preservatives or sucrose. All units of human plasma used in the manufacture of PANZYGA are provided by FDA-approved blood and plasma establishments, and are tested by FDA-licensed serological tests for HBsAg, antibodies to HCV and HIV and Nucleic Acid Test (NAT) for HCV and HIV1 and found to be non-reactive (negative). The product is manufactured by the cold ethanol fractionation process followed by purification methodologies, as well as S/D treatment and nanofiltration (20 nm). The S/D mixture used is composed of tri-n-butyl phosphate (TNBP, solvent) and Triton X-100 (Octoxynol, detergent). The PANZYGA manufacturing process shows significant viral reduction and inactivation, demonstrated by in vitro infectivity studies ( Table 4 ). The virus safety of PANZYGA is achieved through a combination of various process steps, including S/D treatment, ion-exchange chromatography, and nanofiltration (20 nm). Table 4 shows the virus clearance during the manufacturing process for PANZYGA, expressed as the mean log 10 reduction factor (LRF). Table 4: Virus Reduction by PANZYGA Manufacturing Process. HIV-1: Human Immunodeficiency Virus – 1, a model for HIV-1 and HIV-2;. PRV: Pseudorabies Virus, a model for large enveloped DNA viruses (e.g., herpes virus);. BVDV: Bovine Viral Diarrhea Virus, a model for e.g., Hepatitis C virus (HCV) and West-Nile virus (WNV);. MEV: Mouse Encephalomyelitis virus, a model for Hepatitis A virus (HAV);. PPV: Porcine Parvovirus, a model for Human Parvovirus B19;. n.a.: not applicable;. n.d: not done. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents. [ 10 ]. Several of the individual production steps in the PANZYGA manufacturing process were shown to decrease TSE infectivity of that experimental model agent. TSE reduction steps include ion-exchange chromatography and nanofiltration, which together give a total of at least 10.4 log10 decrease of infectivity. These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed."
},
{
"NDCCode": "68982-840-02",
"PackageDescription": "50 mL in 1 BOTTLE, GLASS (68982-840-02) ",
"NDC11Code": "68982-0840-02",
"ProductNDC": "68982-840",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Octagam Immune Globulin (human)",
"NonProprietaryName": "Immune Globulin",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20040521",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125062",
"LabelerName": "Octapharma USA Inc",
"SubstanceName": "HUMAN IMMUNOGLOBULIN G",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
"Status": "Active",
"LastUpdate": "2022-11-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20040521",
"SamplePackage": "N",
"IndicationAndUsage": "Octagam is an immune globulin intravenous (human), 5% liquid, indicated for treatment of primary humoral immunodeficiency (PI) ( 1 ).",
"Description": "Immune Globulin Intravenous (Human), Octagam 5% liquid, is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. Octagam 5% liquid is a solution for infusion which must be administered intravenously. All units of human plasma used in the manufacture of Octagam 5% liquid are provided by FDA-approved blood establishments only, and are tested by FDA-licensed serological tests for HBsAg, antibodies to HCV and HIV and Nucleic Acid Test (NAT) for HCV and HIV-1 and found to be non-reactive (negative). The product is manufactured by the cold ethanol fractionation process followed by ultrafiltration and chromatography. The manufacturing process includes treatment with an organic S/D mixture composed of tri-n-butyl phosphate (TNBP) and Triton X-100 (Octoxynol). The Octagam 5% liquid manufacturing process provides a significant viral reduction in in vitro studies (Table 3). These reductions are achieved through a combination of process steps including cold ethanol fractionation, S/D treatment and pH 4 treatment. Table 3: In vitro reduction factor during Octagam 5% liquid manufacturing. *not calculated for global LRF. HIV-1: Human Immunodeficiency Virus - 1. PRV: Pseudorabies Virus. SBV: Sindbis Virus. MEV: Mouse Encephalomyelitis Virus. PPV: Porcine Parvovirus."
},
{
"NDCCode": "68982-850-02",
"PackageDescription": "50 mL in 1 BOTTLE, GLASS (68982-850-02) ",
"NDC11Code": "68982-0850-02",
"ProductNDC": "68982-850",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Octagam Immune Globulin (human)",
"NonProprietaryName": "Immune Globulin",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20040521",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125062",
"LabelerName": "Octapharma USA 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": "2022-04-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20040521",
"SamplePackage": "N",
"IndicationAndUsage": "Octagam 10% is an immune globulin intravenous (human) liquid preparation indicated for the treatment of. Chronic immune thrombocytopenic purpura (ITP) in adults ( 1.1 ). Dermatomyositis (DM) in adults ( 1.2 ).",
"Description": "Immune Globulin Intravenous (Human), Octagam 10%, is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. Octagam 10% is a solution for infusion to be administered intravenously. This preparation contains approximately 100 mg of protein per mL (10%) of which not less than 96% is normal human immunoglobulin G. Octagam 10% contains not more than 3% aggregates, not less than 94% monomers and dimers and not more than 3% fragments. On average, the product contains 106 µg/mL of IgA and even lower amounts of IgM. The sodium content of the final solution is not more than 30 mmol/L and the pH is between 4.5 and 5.0. The osmolality is 310 - 380 mosmol/kg. The manufacturing process for Octagam 10% isolates IgG without additional chemical or enzymatic modification, and the Fc portion is maintained intact Octagam 10% contains the IgG antibody activities present in the donor population. IgG subclasses are fully represented with the following approximate percents of total IgG: IgG 1 is 65%, IgG 2 is 30%, IgG 3 is 3% and IgG 4 is 2%. Octagam 10% contains a broad spectrum of IgG antibodies against bacterial and viral agents that are capable of opsonization and neutralization of microbes and toxins. It contains maltose (90 mg/mL), but no preservatives or sucrose. All units of human plasma used in the manufacture of Octagam 10% are provided by FDA-approved blood establishments, and are tested by FDA-licensed serological tests for HBsAg, antibodies to HCV and HIV and Nucleic Acid Test (NAT) for HCV and HIV-1 and found to be non-reactive (negative). The product is manufactured by the cold ethanol fractionation process followed by ultrafiltration and chromatography. The manufacturing process includes treatment with an organic S/D mixture composed of tri-n-butyl phosphate (TNBP) and Triton X-100 (Octoxynol). The Octagam 10% manufacturing process shows significant viral reduction in in vitro studies (Table 6). These reductions are achieved through a combination of process steps including cold ethanol fractionation, S/D treatment and pH 4 treatment. Table 6: In vitro reduction factor during Octagam 10% manufacturing. *not calculated for global LRF. HIV-1: Human Immunodeficiency Virus - 1. PRV: Pseudorabies Virus. SBV: Sindbis Virus. MEV: Mouse Encephalomyelitis Virus. PPV: Porcine Parvovirus."
},
{
"NDCCode": "13537-349-02",
"PackageDescription": "1 TUBE in 1 BOX (13537-349-02) > 4 g in 1 TUBE (13537-349-01)",
"NDC11Code": "13537-0349-02",
"ProductNDC": "13537-349",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esika",
"ProprietaryNameSuffix": "Maximum Color Spf 18",
"NonProprietaryName": "Octinoxate And Oxybenzone",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110517",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation (San Juan, P.R)",
"SubstanceName": "OCTINOXATE; OXYBENZONE",
"StrengthNumber": ".073; .0165",
"StrengthUnit": "g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "24236-349-02",
"PackageDescription": "30 CAPSULE in 1 BLISTER PACK (24236-349-02)",
"NDC11Code": "24236-0349-02",
"ProductNDC": "24236-349",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Thiothixene",
"NonProprietaryName": "Thiothixene",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20070516",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071093",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "THIOTHIXENE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Typical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-10-20",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "36800-349-02",
"PackageDescription": "1 KIT in 1 CARTON (36800-349-02) * 12 TABLET, COATED in 1 BLISTER PACK * 8 TABLET, COATED in 1 BLISTER PACK",
"NDC11Code": "36800-0349-02",
"ProductNDC": "36800-349",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sinus Plus Headache Day And Night",
"NonProprietaryName": "Acetaminophen, Chlorpheniramine Maleate, And Phenylephrine Hydrochloride",
"DosageFormName": "KIT",
"StartMarketingDate": "20210618",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "TOPCO ASSOCIATES LLC",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210618",
"SamplePackage": "N"
},
{
"NDCCode": "49349-349-02",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (49349-349-02)",
"NDC11Code": "49349-0349-02",
"ProductNDC": "49349-349",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110823",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076708",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "49967-349-02",
"PackageDescription": "1 BOTTLE in 1 CARTON (49967-349-02) > 18 mL in 1 BOTTLE",
"NDC11Code": "49967-0349-02",
"ProductNDC": "49967-349",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Giorgio Armani Power Fabric Long Wear High Cover Foundation Broad Spectrum Spf 25 Sunscreen",
"NonProprietaryName": "Octinoxate",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160810",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "L'Oreal USA Products Inc.",
"SubstanceName": "OCTINOXATE",
"StrengthNumber": "67",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2023-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20160810",
"SamplePackage": "N"
},
{
"NDCCode": "52125-349-02",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (52125-349-02)",
"NDC11Code": "52125-0349-02",
"ProductNDC": "52125-349",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydralazine Hydrochloride",
"NonProprietaryName": "Hydralazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121208",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040901",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "54575-349-02",
"PackageDescription": "2 mL in 1 VIAL, MULTI-DOSE (54575-349-02)",
"NDC11Code": "54575-0349-02",
"ProductNDC": "54575-349",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Green String Bean",
"NonProprietaryName": "String Bean",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Allergy Laboratories, Inc.",
"SubstanceName": "STRING BEAN",
"StrengthNumber": "1",
"StrengthUnit": "g/20mL",
"Pharm_Classes": "Dietary Proteins [CS],Plant Proteins [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
"Description": "Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established: Coffee Cottonseed Flaxseed Housefly Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens."
},
{
"NDCCode": "63545-349-02",
"PackageDescription": "500 PELLET in 1 VIAL, GLASS (63545-349-02) ",
"NDC11Code": "63545-0349-02",
"ProductNDC": "63545-349",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Badiaga",
"NonProprietaryName": "Badiaga",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210618",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, Inc.",
"SubstanceName": "SPONGILLA LACUSTRIS",
"StrengthNumber": "200",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2021-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210618",
"SamplePackage": "N"
},
{
"NDCCode": "63824-349-02",
"PackageDescription": "251 mL in 1 BOTTLE (63824-349-02)",
"NDC11Code": "63824-0349-02",
"ProductNDC": "63824-349",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lysol Healthy Touch",
"NonProprietaryName": "Benzethonium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110721",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Reckitt Benckiser LLC",
"SubstanceName": "BENZETHONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "68180-349-02",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (68180-349-02) ",
"NDC11Code": "68180-0349-02",
"ProductNDC": "68180-349",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180824",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209306",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2018-12-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180824",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin tablets are indicated for: : 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.",
"Description": "The active ingredient in gabapentin tablets USP is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each gabapentin tablets USP contains 600 mg or 800 mg of gabapentin and the following inactive ingredients: copovidone, corn starch, hydroxypropyl cellulose, magnesium stearate, polyethylene glycol, poloxamer and talc."
},
{
"NDCCode": "68393-349-02",
"PackageDescription": "59.1 mL in 1 BOTTLE, DISPENSING (68393-349-02) ",
"NDC11Code": "68393-0349-02",
"ProductNDC": "68393-349",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Chondro-pro",
"ProprietaryNameSuffix": "Pain Relief Roll On",
"NonProprietaryName": "Menthol, Unspecified Form",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140304",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "MDR Fitness Corp.",
"SubstanceName": "MENTHOL, UNSPECIFIED FORM",
"StrengthNumber": "1",
"StrengthUnit": "mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20140304",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of minor aches and pains of muscles and joints associated with: 1 arthritis, 2 simple backache, 3 strains, 4 sprains, 5 bruises."
},
{
"NDCCode": "68703-349-02",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (68703-349-02) ",
"NDC11Code": "68703-0349-02",
"ProductNDC": "68703-349",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stress Away Anxiety Relief",
"NonProprietaryName": "Aconitum Nap, Alfalfa, Avena, Chamomilla, Gelsemium, Humulus Lupulus, Ignatia, Kali Ars, Kali Phos, Muriaticum Ac, Nat Phos, Passiflora, Phos, Staphysag, Stramonium",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20191001",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Silver Star Brands",
"SubstanceName": "HYDROCHLORIC ACID; PHOSPHORUS P-32; DATURA STRAMONIUM; DELPHINIUM STAPHISAGRIA SEED; ALFALFA; MATRICARIA CHAMOMILLA FLOWERING TOP OIL; POTASSIUM PHOSPHATE, UNSPECIFIED FORM; SODIUM PHOSPHATE, DIBASIC; ACONITUM NAPELLUS; GELSEMIUM SEMPERVIRENS ROOT; HUMULUS LUPULUS WHOLE; STRYCHNOS IGNATII WHOLE; POTASSIUM ARSENITE ANHYDROUS; PASSIFLORA INCARNATA FLOWERING TOP; AVENA SATIVA LEAF",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191001",
"SamplePackage": "N",
"IndicationAndUsage": "Uses*: Temporarily relieves minor anxiousness and nervousness."
},
{
"NDCCode": "70748-349-02",
"PackageDescription": "10 VIAL in 1 CARTON (70748-349-02) / 10 mL in 1 VIAL",
"NDC11Code": "70748-0349-02",
"ProductNDC": "70748-349",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rocuronium Bromide",
"NonProprietaryName": "Rocuronium Bromide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20231023",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216234",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "ROCURONIUM BROMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-11-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20231023",
"SamplePackage": "N",
"IndicationAndUsage": "Rocuronium bromide injection is indicated for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.",
"Description": "Rocuronium bromide injection is a nondepolarizing neuromuscular blocking agent with a rapid to intermediate onset depending on dose and intermediate duration. Rocuronium bromide is chemically designated as 1-[17β-(acetyloxy)-3α-hydroxy-2β-(4-morpholinyl)-5α-androstan-16β-yl]-1-(2-propenyl) pyrrolidinium bromide. The structural formula is. The chemical formula is C32H53BrN2O4 with a molecular weight of 609.70. The partition coefficient of rocuronium bromide in n-octanol/water is 0.5 at 20°C. Rocuronium bromide is supplied as a sterile, nonpyrogenic, isotonic solution that is clear, colorless to yellow or orange, for intravenous injection only. Each mL contains 10 mg rocuronium bromide and 2 mg sodium acetate. The aqueous solution is adjusted to isotonicity with sodium chloride and to a pH of 4 with acetic acid and/or sodium hydroxide."
},
{
"NDCCode": "76157-349-02",
"PackageDescription": "1 BOTTLE in 1 CARTON (76157-349-02) > 50 mL in 1 BOTTLE (76157-349-01)",
"NDC11Code": "76157-0349-02",
"ProductNDC": "76157-349",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti-aging Day Broad Spectrum Spf 30",
"ProprietaryNameSuffix": "La Prairie Group Ag",
"NonProprietaryName": "Avobenzone, Octinoxate, Octisalate, Octocrylene",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130116",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "La Prairie Group AG",
"SubstanceName": "AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "3; 7.5; 5; 2.5",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2017-12-20",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "78536-006-02",
"PackageDescription": "24 PAIL in 1 CARTON (78536-006-02) > 70 NOT APPLICABLE in 1 PAIL > 349 mL in 1 NOT APPLICABLE",
"NDC11Code": "78536-0006-02",
"ProductNDC": "78536-006",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pure Care Household Wipes",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200930",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Zhejiang Yiwu Mingou Biotechnology Co., Ltd.",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200930",
"SamplePackage": "N",
"IndicationAndUsage": "Wipe surface to help reduce bacteria that can potentially cause disease."
},
{
"NDCCode": "84756-349-02",
"PackageDescription": "15 g in 1 BOX (84756-349-02) ",
"NDC11Code": "84756-0349-02",
"ProductNDC": "84756-349",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kojic Acid Vitamin C Cream",
"NonProprietaryName": "Kojic Acid Vitamin C Cream",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241118",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Yucheng E Commerce Co Ltd",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241118",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "0049-3160-44",
"PackageDescription": "1 BOTTLE in 1 CARTON (0049-3160-44) / 75 mL in 1 BOTTLE",
"NDC11Code": "00049-3160-44",
"ProductNDC": "0049-3160",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vfend",
"NonProprietaryName": "Voriconazole",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20030328",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021630",
"LabelerName": "Roerig",
"SubstanceName": "VORICONAZOLE",
"StrengthNumber": "40",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20030328",
"SamplePackage": "N",
"IndicationAndUsage": "VFEND is an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with: 1 Invasive aspergillosis (1.1), 2 Candidemia in non-neutropenics and other deep tissue Candida infections (1.2), 3 Esophageal candidiasis (1.3), 4 Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani, in patients intolerant of, or refractory to, other therapy (1.4).",
"Description": "VFEND (voriconazole), an azole antifungal agent is available as a lyophilized powder for solution for intravenous infusion, film-coated tablets for oral administration, and as a powder for oral suspension. The structural formula is. Voriconazole is designated chemically as (2R,3S)-2-(2, 4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4-triazol-1-yl)-2-butanol with an empirical formula of C16H14F3N5O and a molecular weight of 349.3. Voriconazole drug substance is a white to light-colored powder. VFEND I.V. is a white lyophilized powder containing nominally 200 mg voriconazole and 3200 mg sulfobutyl ether beta-cyclodextrin sodium in a 30 mL Type I clear glass vial. VFEND I.V. is intended for administration by intravenous infusion. It is a single-dose, unpreserved product. Vials containing 200 mg lyophilized voriconazole are intended for reconstitution with Water for Injection to produce a solution containing 10 mg/mL VFEND and 160 mg/mL of sulfobutyl ether beta-cyclodextrin sodium. The resultant solution is further diluted prior to administration as an intravenous infusion [see Dosage and Administration (2)]. VFEND Tablets contain 50 mg or 200 mg of voriconazole. The inactive ingredients include croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, pregelatinized starch, and a coating containing hypromellose, lactose monohydrate, titanium dioxide, and triacetin. VFEND for Oral Suspension is a white to off-white powder providing a white to off-white orange-flavored suspension when reconstituted. Bottles containing 45 grams powder for oral suspension, which contain 3 g of voriconazole, are intended for reconstitution with water to produce a suspension containing 40 mg/mL voriconazole. The inactive ingredients include anhydrous citric acid, colloidal silicon dioxide, natural orange flavor, sodium benzoate, sodium citrate dihydrate, sucrose, titanium dioxide, and xanthan gum."
},
{
"NDCCode": "0049-3180-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0049-3180-30) ",
"NDC11Code": "00049-3180-30",
"ProductNDC": "0049-3180",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vfend",
"NonProprietaryName": "Voriconazole",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20030328",
"EndMarketingDate": "20270430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021266",
"LabelerName": "Roerig",
"SubstanceName": "VORICONAZOLE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20030328",
"EndMarketingDatePackage": "20270430",
"SamplePackage": "N",
"IndicationAndUsage": "VFEND is an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with: 1 Invasive aspergillosis (1.1), 2 Candidemia in non-neutropenics and other deep tissue Candida infections (1.2), 3 Esophageal candidiasis (1.3), 4 Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani, in patients intolerant of, or refractory to, other therapy (1.4).",
"Description": "VFEND (voriconazole), an azole antifungal agent is available as a lyophilized powder for solution for intravenous infusion, film-coated tablets for oral administration, and as a powder for oral suspension. The structural formula is. Voriconazole is designated chemically as (2R,3S)-2-(2, 4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4-triazol-1-yl)-2-butanol with an empirical formula of C16H14F3N5O and a molecular weight of 349.3. Voriconazole drug substance is a white to light-colored powder. VFEND I.V. is a white lyophilized powder containing nominally 200 mg voriconazole and 3200 mg sulfobutyl ether beta-cyclodextrin sodium in a 30 mL Type I clear glass vial. VFEND I.V. is intended for administration by intravenous infusion. It is a single-dose, unpreserved product. Vials containing 200 mg lyophilized voriconazole are intended for reconstitution with Water for Injection to produce a solution containing 10 mg/mL VFEND and 160 mg/mL of sulfobutyl ether beta-cyclodextrin sodium. The resultant solution is further diluted prior to administration as an intravenous infusion [see Dosage and Administration (2)]. VFEND Tablets contain 50 mg or 200 mg of voriconazole. The inactive ingredients include croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, pregelatinized starch, and a coating containing hypromellose, lactose monohydrate, titanium dioxide, and triacetin. VFEND for Oral Suspension is a white to off-white powder providing a white to off-white orange-flavored suspension when reconstituted. Bottles containing 45 grams powder for oral suspension, which contain 3 g of voriconazole, are intended for reconstitution with water to produce a suspension containing 40 mg/mL voriconazole. The inactive ingredients include anhydrous citric acid, colloidal silicon dioxide, natural orange flavor, sodium benzoate, sodium citrate dihydrate, sucrose, titanium dioxide, and xanthan gum."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>68982-349-02</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (68982-349-02) / 100 mL in 1 BOTTLE, GLASS (68982-349-82) </PackageDescription>
<NDC11Code>68982-0349-02</NDC11Code>
<ProductNDC>68982-349</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Fibryga</ProprietaryName>
<NonProprietaryName>Fibrinogen (human)</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20241220</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125612</ApplicationNumber>
<LabelerName>Octapharma USA Inc</LabelerName>
<SubstanceName>FIBRINOGEN HUMAN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factors [CS], Human Blood Coagulation Factor [EPC], Increased Coagulation Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-08-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>FIBRYGA [fibrinogen (human)] is a human plasma-derived, sterile, purified, virus-inactivated and nanofiltered (20 nm) fibrinogen concentrate. FIBRYGA is supplied as a lyophilized powder, white or pale yellow in color, for reconstitution for intravenous use. FIBRYGA contains no preservatives. Each bottle contains approximately 1 g or 2 g of fibrinogen. The actual potency of fibrinogen in mg is stated on each FIBRYGA carton and bottle. The diluent for reconstitution of the lyophilized powder is 50 mL (1 g) or 100 mL (2 g) sterile Water for Injection. The nominal composition of FIBRYGA is as follows. All units of human plasma used in the manufacture of FIBRYGA are provided by FDA-approved blood establishments, and are tested by FDA-licensed serological tests for Hepatitis B surface antigen (HBsAg), antibodies to Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1/2. As an additional safety measure, the plasma is tested with Nucleic Acid Tests (NATs) for Hepatitis A Virus (HAV), Hepatitis B Virus (HBV), HCV and HIV-1 and found to be non-reactive (negative). The plasma is also screened for Human Parvovirus (B19V) by NAT. The limit for B19V DNA in the mini-pool is set not to exceed 10 3 IU/mL. Only plasma that passed virus screening is used for production. The FIBRYGA manufacturing process includes a solvent/detergent (S/D) step for virus inactivation, and a nanofiltration step (Planova 20N nanofilter or Pegasus SV4 nanofilter) for virus removal. The mean cumulative virus reduction factors of these steps are summarized in Table 2 below. Table 2: Cumulative Virus Reduction Factors (Log 10 ) During FIBRYGA Manufacture. PRV: Pseudorabies Virus, model for large enveloped DNA viruses. BVDV: Bovine Virus Diarrhea Virus, model for HCV. PPV: Porcine Parvovirus, model for B19V. n.a.: not applicable. * When the nanofiltration step was performed using a Pegasus SV4 nanofilter, the virus reduction factors for HIV-1, PRV, BVDV, HAV, and PPV were ≥ 3.9, ≥ 6.3, ≥ 5.0, ≥ 5.2, and 4.5, respectively. The cumulative virus reduction factors (S/D treatment + Pegasus SV4 nanofiltration) were ≥ 9.0, ≥ 12.9, ≥ 10.8, ≥ 5.2, and 4.5, respectively.</Description>
</NDC>
<NDC>
<NDCCode>68982-349-01</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (68982-349-01) / 50 mL in 1 BOTTLE, GLASS (68982-349-81) </PackageDescription>
<NDC11Code>68982-0349-01</NDC11Code>
<ProductNDC>68982-349</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Fibryga</ProprietaryName>
<NonProprietaryName>Fibrinogen (human)</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20241220</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125612</ApplicationNumber>
<LabelerName>Octapharma USA Inc</LabelerName>
<SubstanceName>FIBRINOGEN HUMAN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factors [CS], Human Blood Coagulation Factor [EPC], Increased Coagulation Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>FIBRYGA [fibrinogen (human)] is a human plasma-derived, sterile, purified, virus-inactivated and nanofiltered (20 nm) fibrinogen concentrate. FIBRYGA is supplied as a lyophilized powder, white or pale yellow in color, for reconstitution for intravenous use. FIBRYGA contains no preservatives. Each bottle contains approximately 1 g or 2 g of fibrinogen. The actual potency of fibrinogen in mg is stated on each FIBRYGA carton and bottle. The diluent for reconstitution of the lyophilized powder is 50 mL (1 g) or 100 mL (2 g) sterile Water for Injection. The nominal composition of FIBRYGA is as follows. All units of human plasma used in the manufacture of FIBRYGA are provided by FDA-approved blood establishments, and are tested by FDA-licensed serological tests for Hepatitis B surface antigen (HBsAg), antibodies to Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1/2. As an additional safety measure, the plasma is tested with Nucleic Acid Tests (NATs) for Hepatitis A Virus (HAV), Hepatitis B Virus (HBV), HCV and HIV-1 and found to be non-reactive (negative). The plasma is also screened for Human Parvovirus (B19V) by NAT. The limit for B19V DNA in the mini-pool is set not to exceed 10 3 IU/mL. Only plasma that passed virus screening is used for production. The FIBRYGA manufacturing process includes a solvent/detergent (S/D) step for virus inactivation, and a nanofiltration step (Planova 20N nanofilter or Pegasus SV4 nanofilter) for virus removal. The mean cumulative virus reduction factors of these steps are summarized in Table 2 below. Table 2: Cumulative Virus Reduction Factors (Log 10 ) During FIBRYGA Manufacture. PRV: Pseudorabies Virus, model for large enveloped DNA viruses. BVDV: Bovine Virus Diarrhea Virus, model for HCV. PPV: Porcine Parvovirus, model for B19V. n.a.: not applicable. * When the nanofiltration step was performed using a Pegasus SV4 nanofilter, the virus reduction factors for HIV-1, PRV, BVDV, HAV, and PPV were ≥ 3.9, ≥ 6.3, ≥ 5.0, ≥ 5.2, and 4.5, respectively. The cumulative virus reduction factors (S/D treatment + Pegasus SV4 nanofiltration) were ≥ 9.0, ≥ 12.9, ≥ 10.8, ≥ 5.2, and 4.5, respectively.</Description>
</NDC>
<NDC>
<NDCCode>68982-182-02</NDCCode>
<PackageDescription>10 mL in 1 VIAL (68982-182-02) </PackageDescription>
<NDC11Code>68982-0182-02</NDC11Code>
<ProductNDC>68982-182</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Wilate - Von Willebrand Factor/coagulation Factor Viii Complex (human)</ProprietaryName>
<NonProprietaryName>Von Willebrand Factor/coagulation Factor Viii Complex (human)</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20091204</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125251</ApplicationNumber>
<LabelerName>Octapharma USA Inc</LabelerName>
<SubstanceName>ANTIHEMOPHILIC FACTOR HUMAN; VON WILLEBRAND FACTOR HUMAN</SubstanceName>
<StrengthNumber>100; 100</StrengthNumber>
<StrengthUnit>[iU]/mL; [iU]/mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factors [CS], Blood Coagulation Factors [CS], Factor VIII [CS], Human Antihemophilic Factor [EPC], Human Blood Coagulation Factor [EPC], Increased Coagulation Activity [PE], Increased Coagulation Activity [PE], Increased Platelet Aggregation [PE], von Willebrand Factor [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>WILATE is indicated in adult and pediatric patients with von Willebrand disease (VWD) for: 1 On-demand treatment and control of bleeding episodes, 2 Perioperative management of bleeding, 3 Routine prophylaxis to reduce the frequency of bleeding episodes.</IndicationAndUsage>
<Description>WILATE is a human plasma-derived, sterile, purified, double virus inactivated von Willebrand Factor/Coagulation Factor VIII Complex. WILATE is supplied as a lyophilized powder for reconstitution for intravenous injection. The diluent for reconstitution of the lyophilized powder is Water for Injection with 0.1% Polysorbate 80. WILATE contains no preservative. No albumin is added as a stabilizer. WILATE is labeled with the actual VWF:RCo and FVIII activities in IU per vial. The VWF activity (VWF:RCo) is determined using a manual agglutination method referenced to the current “WHO International Standard for von Willebrand Factor Concentrate”. The FVIII activity is determined using a chromogenic substrate assay referenced to the current “WHO International Standard for Human Coagulation Factor VIII Concentrate”. The assay methodologies are according to European Pharmacopoeia (Ph.Eur.). The resulting specific activity of WILATE is ≥ 60 IU VWF:RCo and ≥ 60 IU FVIII activities per mg of total protein. The nominal composition of WILATE is as follows. Von Willebrand Factor/Coagulation Factor VIII complex is the active ingredient in WILATE. It is derived from large pools of human plasma collected in U.S. plasma donation centers. All plasma donations are tested for viral markers in compliance with requirements of EU CPMP and FDA guidance. In addition, the limit for the titer of human parvovirus B19 DNA in the manufacturing pool is set not to exceed 104 IU/mL. The product is manufactured from cryoprecipitate, which is reconstituted in a buffer and treated with aluminum hydroxide followed by two different chromatography steps, ultra- and diafiltration, and sterile filtration. The manufacturing process includes two virus inactivation steps, namely, treatment with an organic solvent/detergent (S/D) mixture, composed of tri-n-butyl phosphate (TNBP) and Octoxynol-9, and a terminal dry heat (TDH) treatment of the lyophilized product in final container [at +100°C (212°F) for 120 minutes at a specified residual moisture level of 0.7-1.6%]. In addition, the ion-exchange chromatography step utilized during WILATE manufacturing also removes some viruses. Table 6 Virus Reduction During WILATE Manufacturing. na: not applicable. nd: not done (S/D reagents present). HIV-1: Human Immunodeficiency Virus - 1. SBV: Sindbis Virus. BVDV: Bovine Viral Diarrhea Virus. PRV: Pseudorabies Virus. REO 3: Reovirus Type 3. HAV: Hepatitis A Virus. PPV: Porcine Parvovirus.</Description>
</NDC>
<NDC>
<NDCCode>68982-261-02</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (68982-261-02) / 40 mL in 1 VIAL, GLASS (68982-261-82) </PackageDescription>
<NDC11Code>68982-0261-02</NDC11Code>
<ProductNDC>68982-261</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Balfaxar</ProprietaryName>
<NonProprietaryName>Prothrombin Complex Concentrate (human)</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20231130</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125776</ApplicationNumber>
<LabelerName>Octapharma USA Inc</LabelerName>
<SubstanceName>COAGULATION FACTOR IX HUMAN; PROTHROMBIN; COAGULATION FACTOR VII HUMAN; COAGULATION FACTOR X HUMAN; PROTEIN C; PROTEIN S HUMAN</SubstanceName>
<StrengthNumber>25.5; 26; 16.5; 24; 22; 22</StrengthNumber>
<StrengthUnit>[iU]/mL; [iU]/mL; [iU]/mL; [iU]/mL; [iU]/mL; [iU]/mL</StrengthUnit>
<Pharm_Classes>Anti-coagulant [EPC], Blood Coagulation Factor [EPC], Blood Coagulation Factors [CS], Blood Coagulation Factors [CS], Blood Coagulation Factors [CS], Blood Coagulation Factors [CS], Decreased Coagulation Factor Activity [PE], Enzyme Precursors [CS], Human Blood Coagulation Factor [EPC], Human Blood Coagulation Factor [EPC], Human Blood Coagulation Factor [EPC], Increased Coagulation Activity [PE], Increased Coagulation Activity [PE], Increased Coagulation Activity [PE], Increased Coagulation Activity [PE], Protein C [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BALFAXAR (prothrombin complex concentrate, human-lans) is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need for an urgent surgery/invasive procedure.</IndicationAndUsage>
<Description>BALFAXAR is a human plasma-derived, purified, virus inactivated and nanofiltered non-activated Prothrombin Complex Concentrate (PCC) containing the coagulation factors II, VII, IX, and X and antithrombotic Proteins C and S. BALFAXAR is supplied as a lyophilized powder for reconstitution for intravenous use. The actual potency printed on the vial label represents the potency of Factor IX. BALFAXAR is sterile, endotoxin-free, and does not contain preservatives. No albumin is added as a stabilizer, and the excipients are heparin and sodium citrate. The diluent for reconstitution of the lyophilized powder is sterile Water for Injection. The composition of BALFAXAR is as follows. All human plasma used in the manufacture of BALFAXAR is obtained from U.S. donors, collected in FDA-approved blood and plasma establishments, and tested by FDA-licensed serological tests for viral markers (Hepatitis B surface antigen (HBsAg), antibodies to HIV-1/2 and HCV). The plasma is tested with Nucleic Acid Testing (NAT) for HCV, HIV-1, HAV, and HBV, and found to be non-reactive (negative), and the plasma is also tested by NAT for B19V to exclude donations with high titers. The limit for the titer of B19V DNA in the manufacturing pool is set not to exceed 10 4 IU/mL. Only plasma that passed virus screening is used for production. The BALFAXAR manufacturing process has the capability to clear viruses by a solvent/detergent (S/D) virus inactivation step and a virus removal nanofiltration step. The mean cumulative virus reduction factors of these steps are summarized in Table 4 . Table 4 Virus Reduction During BALFAXAR Manufacturing. n.a.: not applicable. BVDV: Bovine Viral Diarrhea Virus, model for HCV. PRV: Pseudorabies Virus, model for large enveloped DNA viruses, e.g., HBV. PPV: Porcine Parvovirus, model for B19V.</Description>
</NDC>
<NDC>
<NDCCode>68982-623-02</NDCCode>
<PackageDescription>250 mL in 1 BOTTLE, GLASS (68982-623-02) </PackageDescription>
<NDC11Code>68982-0623-02</NDC11Code>
<ProductNDC>68982-623</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Albumin (human)</ProprietaryName>
<NonProprietaryName>Albumin Human</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20061017</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125154</ApplicationNumber>
<LabelerName>Octapharma USA Inc</LabelerName>
<SubstanceName>ALBUMIN HUMAN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>g/1000mL</StrengthUnit>
<Pharm_Classes>Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-04-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20061017</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ALBUMIN (HUMAN) 5% is indicated for the restoration and maintenance of circulating blood volume for. Hypovolemia. ( 1.1 ). Hypoalbuminemia. ( 1.2 ). Prevention of central volume depletion after paracentesis due to cirrhotic ascites. ( 1.3 ).</IndicationAndUsage>
<Description>ALBUMIN (HUMAN) 5% is a sterile, liquid preparation of albumin derived from large pools of human plasma. All units of human plasma used in the manufacture of ALBUMIN (HUMAN) 5% are provided by FDA approved blood establishments only. The product is manufactured by cold ethanol fractionation followed by ultra- and diafiltration. The manufacturing process includes final container pasteurization and additional bulk pasteurization at 60 +/- 0.5°C for 10 – 11 hours. The ALBUMIN (HUMAN) 5% manufacturing process provides a significant viral reduction in in vitro studies (table 2). These reductions are achieved through a combination of process steps including cold ethanol fractionation and final container pasteurization. No procedure, however, has been shown to be completely effective in removing viral infectivity from derivatives of human plasma. [see Warnings and Precautions, Infection Risk from Human Plasma (5.7)]. Table 2 In vitro reduction factor during ALBUMIN (HUMAN) 5% manufacturing. PRV: Pseudorabies Virus. SBV: Sindbis Virus. HIV-1: Human Immunodeficiency Virus - 1. Reo 3: Reovirus Type 3. PPV: Porcine Parvovirus. HAV: Hepatitis A Virus. ALBUMIN (HUMAN) 5% is a clear, slightly viscous liquid; it is almost colorless or slightly yellow or green. The composition of ALBUMIN (HUMAN) 5% is as follows. ALBUMIN (HUMAN) 5% contains no preservatives and components used in its packaging are latex-free.</Description>
</NDC>
<NDC>
<NDCCode>68982-633-02</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE, GLASS (68982-633-02) </PackageDescription>
<NDC11Code>68982-0633-02</NDC11Code>
<ProductNDC>68982-633</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Albumin (human)</ProprietaryName>
<NonProprietaryName>Albumin Human</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20061017</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125154</ApplicationNumber>
<LabelerName>Octapharma USA Inc</LabelerName>
<SubstanceName>ALBUMIN HUMAN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>g/1000mL</StrengthUnit>
<Pharm_Classes>Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-04-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20061017</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ALBUMIN (HUMAN) 20% is indicated for the restoration and maintenance of circulating blood volume for. Hypovolemia. ( 1.1 ). Hypoalbuminemia. ( 1.2 ). Prevention of central volume depletion after paracentesis due to cirrhotic ascites. ( 1.3 ). Ovarian hyperstimulation syndrome (OHSS). ( 1.4 ). Adult respiratory distress syndrome (ARDS). ( 1.5 ). Acute nephrosis. ( 1.6 ). Hemolytic Disease of the Newborn (HDN). ( 1.7 ).</IndicationAndUsage>
<Description>ALBUMIN (HUMAN) 20% is a sterile, liquid preparation of albumin derived from large pools of human plasma. All units of human plasma used in the manufacture of ALBUMIN (HUMAN) 20% are provided by FDA approved blood establishments only. The product is manufactured by cold ethanol fractionation followed by ultra- and diafiltration. The manufacturing process includes final container pasteurization and additional bulk pasteurization at 60 +/- 0.5°C for 10 – 11 hours. The ALBUMIN (HUMAN) 20% manufacturing process provides a significant viral reduction in in vitro studies (table 2). These reductions are achieved through a combination of process steps including cold ethanol fractionation and final container pasteurization. No procedure, however, has been shown to be completely effective in removing viral infectivity from derivatives of human plasma.[see Warnings and Precautions, Infection Risk from Human Plasma (5.7)]. Table 2 In vitro reduction factor during ALBUMIN (HUMAN) 20% manufacturing. PRV:Pseudorabies Virus. SBV: Sindbis Virus. HIV-1:Human Immunodeficiency Virus - 1. Reo 3:Reovirus Type 3. PPV:Porcine Parvovirus. HAV:Hepatitis A Virus. ALBUMIN (HUMAN) 20% is a clear, slightly viscous liquid; it is almost colorless or slightly yellow or green. The composition of ALBUMIN (HUMAN) 20% is as follows. ALBUMIN (HUMAN) 20% contains no preservatives and components used in its packaging are latex-free.</Description>
</NDC>
<NDC>
<NDCCode>68982-643-02</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE, GLASS (68982-643-02) </PackageDescription>
<NDC11Code>68982-0643-02</NDC11Code>
<ProductNDC>68982-643</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Albumin (human)</ProprietaryName>
<NonProprietaryName>Albumin Human</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20061017</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125154</ApplicationNumber>
<LabelerName>Octapharma USA Inc</LabelerName>
<SubstanceName>ALBUMIN HUMAN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>g/1000mL</StrengthUnit>
<Pharm_Classes>Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20061017</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ALBUMIN (HUMAN) 25% is indicated for the restoration and maintenance of circulating blood volume for. Hypovolemia. ( 1.1 ). Hypoalbuminemia. ( 1.2 ). Prevention of central volume depletion after paracentesis due to cirrhotic ascites. ( 1.3 ). Ovarian hyperstimulation syndrome (OHSS). ( 1.4 ). Adult respiratory distress syndrome (ARDS). ( 1.5 ). Acute nephrosis. ( 1.6 ). Hemolytic disease of the newborn (HDN). ( 1.7 ).</IndicationAndUsage>
<Description>ALBUMIN (HUMAN) 25% is a sterile, liquid preparation of albumin derived from large pools of human plasma. All units of human plasma used in the manufacture of ALBUMIN (HUMAN) 25% are provided by FDA approved blood establishments only. The product is manufactured by cold ethanol fractionation followed by ultra- and diafiltration. The manufacturing process includes final container pasteurization and additional bulk pasteurization at 60 +/- 0.5°C for 10 – 11 hours. The ALBUMIN (HUMAN) 25% manufacturing process provides a significant viral reduction in in vitro studies (table 3). These reductions are achieved through a combination of process steps including cold ethanol fractionation and final container pasteurization. No procedure, however, has been shown to be completely effective in removing viral infectivity from derivatives of human plasma. [see Warnings and Precautions, Infection Risk from Human Plasma (5.7)]. Table 3 In vitro reduction factor during ALBUMIN (HUMAN) 25% manufacturing. PRV: Pseudorabies Virus. SBV: Sindbis Virus. HIV-1: Human Immunodeficiency Virus - 1. Reo 3: Reovirus Type 3. PPV: Porcine Parvovirus. HAV: Hepatitis A Virus. ALBUMIN (HUMAN) 25% is a clear, slightly viscous liquid; it is almost colorless or slightly yellow or green. The composition of ALBUMIN (HUMAN) 25% is as follows. ALBUMIN (HUMAN) 25% contains no preservatives and components used in its packaging are latex-free.</Description>
</NDC>
<NDC>
<NDCCode>68982-810-02</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (68982-810-02) > 10 mL in 1 VIAL, GLASS (68982-810-82) </PackageDescription>
<NDC11Code>68982-0810-02</NDC11Code>
<ProductNDC>68982-810</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Cutaquig</ProprietaryName>
<NonProprietaryName>Immunoglobulin G</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190503</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125668</ApplicationNumber>
<LabelerName>Octapharma USA Inc</LabelerName>
<SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
<StrengthNumber>165</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190503</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CUTAQUIG (Immune Globulin Subcutaneous (Human) - hipp) is a 16.5% immune globulin solution for subcutaneous infusion (IGSC), indicated as replacement therapy for primary humoral immunodeficiency (PI) in adults and pediatric patients 2 years of age and older. This includes, but is not limited to, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.</IndicationAndUsage>
<Description>CUTAQUIG (Immune Globulin Subcutaneous (Human) - hipp), is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. CUTAQUIG is a solution for injection to be administered subcutaneously. This preparation contains approximately 165 mg of protein per mL (16.5%), of which not less than 96% is normal human immunoglobulin G. CUTAQUIG contains not more than 3% aggregates, not less than 94% monomers and dimers, and not more than 3% fragments. The product contains on average 0.206 mg of IgA /mL. The sodium content of the final solution is not more than 30 mmol/L and the pH is between 5.0 and 5.5. The osmolality is 310 - 380 mOsmol/kg. The manufacturing process for CUTAQUIG isolates IgG without additional chemical or enzymatic modification, and the Fc portion is maintained intact. CUTAQUIG contains the IgG antibody activities present in the donor population. IgG subclasses are fully represented with the following approximate percent of total IgG: IgG1 is 70%, IgG2 is 25%, IgG3 is 3% and IgG4 is 2%. CUTAQUIG contains a broad spectrum of IgG antibodies against bacterial and viral agents that are capable of opsonization and neutralization of microbes and toxins. It contains maltose (79 mg/mL), but no preservatives or sucrose. All units of human plasma used in the manufacture of CUTAQUIG are provided by FDA-approved blood and plasma establishments, and are tested by FDA-licensed serological tests for HBsAg, antibodies to HCV and HIV and Nucleic Acid Test (NAT) for HCV and HIV-1 and found to be non-reactive (negative). The product is manufactured by the cold ethanol fractionation process followed by ultrafiltration and chromatography. The manufacturing process includes treatment with an organic S/D mixture composed of tri-n-butyl phosphate (TNBP) and Octoxynol. The CUTAQUIG manufacturing process shows significant viral reduction in in vitro studies ( Table 6 ). These reductions are achieved through a combination of process steps including cold ethanol fractionation, S/D treatment and pH 4 treatment. Table 6 Pathogen Reduction During CUTAQUIG Manufacturing. * Not calculated for global Log 10 Reduction Factor. HIV-1: Human Immunodeficiency Virus - 1. PRV: Pseudorabies Virus, model virus for e.g. Hepatitis B Virus (HBV). SBV: Sindbis Virus, model virus for Hepatitis C Virus (HCV). MEV: Mouse Encephalomyelitis Virus, model virus for Human Parvovirus B19. PPV: Porcine Parvovirus, model virus for Hepatitis A Virus (HAV). n.a.: not applicable.</Description>
</NDC>
<NDC>
<NDCCode>68982-820-02</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (68982-820-02) > 25 mL in 1 BOTTLE, GLASS (68982-820-82) </PackageDescription>
<NDC11Code>68982-0820-02</NDC11Code>
<ProductNDC>68982-820</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Panzyga</ProprietaryName>
<NonProprietaryName>Immune Globulin Intravenous (human)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20181112</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125587</ApplicationNumber>
<LabelerName>Octapharma USA Inc</LabelerName>
<SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181112</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Immune Globulin Intravenous (Human), PANZYGA, is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. PANZYGA is a solution for infusion to be administered intravenously. This preparation contains approximately 100 mg of protein per mL (10%), of which not less than 96% is normal human immunoglobulin G. PANZYGA contains not more than 3% aggregates, not less than 90% monomers and dimers, and not more than 3% fragments. On average, the product contains 100 µg/mL of IgA, and lower amounts of IgM. PANZYGA contains only trace amounts of sodium, and the pH is between 4.5 and 5.0. The osmolality is in the range of 240-310 mosmol/kg. The manufacturing process for PANZYGA isolates IgG without additional chemical or enzymatic modification, and the Fc portion is maintained intact. PANZYGA contains the IgG antibody activities present in the donor population. IgG subclasses are fully represented with the following approximate percents of total IgG: IgG 1 is 65%, IgG 2 is 28%, IgG 3 is 3% and IgG 4 is 4%. PANZYGA contains a broad spectrum of IgG antibodies against bacterial and viral agents that are capable of opsonization and neutralization of microbes and toxins. PANZYGA contains glycine (15.0-19.5 mg/mL), but no preservatives or sucrose. All units of human plasma used in the manufacture of PANZYGA are provided by FDA-approved blood and plasma establishments, and are tested by FDA-licensed serological tests for HBsAg, antibodies to HCV and HIV and Nucleic Acid Test (NAT) for HCV and HIV1 and found to be non-reactive (negative). The product is manufactured by the cold ethanol fractionation process followed by purification methodologies, as well as S/D treatment and nanofiltration (20 nm). The S/D mixture used is composed of tri-n-butyl phosphate (TNBP, solvent) and Triton X-100 (Octoxynol, detergent). The PANZYGA manufacturing process shows significant viral reduction and inactivation, demonstrated by in vitro infectivity studies ( Table 4 ). The virus safety of PANZYGA is achieved through a combination of various process steps, including S/D treatment, ion-exchange chromatography, and nanofiltration (20 nm). Table 4 shows the virus clearance during the manufacturing process for PANZYGA, expressed as the mean log 10 reduction factor (LRF). Table 4: Virus Reduction by PANZYGA Manufacturing Process. HIV-1: Human Immunodeficiency Virus – 1, a model for HIV-1 and HIV-2;. PRV: Pseudorabies Virus, a model for large enveloped DNA viruses (e.g., herpes virus);. BVDV: Bovine Viral Diarrhea Virus, a model for e.g., Hepatitis C virus (HCV) and West-Nile virus (WNV);. MEV: Mouse Encephalomyelitis virus, a model for Hepatitis A virus (HAV);. PPV: Porcine Parvovirus, a model for Human Parvovirus B19;. n.a.: not applicable;. n.d: not done. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents. [ 10 ]. Several of the individual production steps in the PANZYGA manufacturing process were shown to decrease TSE infectivity of that experimental model agent. TSE reduction steps include ion-exchange chromatography and nanofiltration, which together give a total of at least 10.4 log10 decrease of infectivity. These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed.</Description>
</NDC>
<NDC>
<NDCCode>68982-822-02</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (68982-822-02) / 25 mL in 1 BOTTLE, GLASS (68982-822-82) </PackageDescription>
<NDC11Code>68982-0822-02</NDC11Code>
<ProductNDC>68982-822</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Panzyga</ProprietaryName>
<NonProprietaryName>Immune Globulin Intravenous (human)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20181112</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125587</ApplicationNumber>
<LabelerName>Octapharma USA Inc</LabelerName>
<SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181112</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Immune Globulin Intravenous (Human), PANZYGA, is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. PANZYGA is a solution for infusion to be administered intravenously. This preparation contains approximately 100 mg of protein per mL (10%), of which not less than 96% is normal human immunoglobulin G. PANZYGA contains not more than 3% aggregates, not less than 94% monomers and dimers, and not more than 4% fragments. On average, the product contains 100 µg/mL of IgA, and lower amounts of IgM. PANZYGA contains only trace amounts of sodium, and the pH is between 4.5 and 5.0. The osmolality is in the range of 240-310 mosmol/kg. The manufacturing process for PANZYGA isolates IgG without additional chemical or enzymatic modification, and the Fc portion is maintained intact. PANZYGA contains the IgG antibody activities present in the donor population. IgG subclasses are fully represented with the following approximate percents of total IgG: IgG 1 is 65%, IgG 2 is 28%, IgG 3 is 3% and IgG 4 is 4%. PANZYGA contains a broad spectrum of IgG antibodies against bacterial and viral agents that are capable of opsonization and neutralization of microbes and toxins. PANZYGA contains glycine (15.0-19.5 mg/mL), but no preservatives or sucrose. All units of human plasma used in the manufacture of PANZYGA are provided by FDA-approved blood and plasma establishments, and are tested by FDA-licensed serological tests for HBsAg, antibodies to HCV and HIV and Nucleic Acid Test (NAT) for HCV and HIV1 and found to be non-reactive (negative). The product is manufactured by the cold ethanol fractionation process followed by purification methodologies, as well as S/D treatment and nanofiltration (20 nm). The S/D mixture used is composed of tri-n-butyl phosphate (TNBP, solvent) and Triton X-100 (Octoxynol, detergent). The PANZYGA manufacturing process shows significant viral reduction and inactivation, demonstrated by in vitro infectivity studies ( Table 4 ). The virus safety of PANZYGA is achieved through a combination of various process steps, including S/D treatment, ion-exchange chromatography, and nanofiltration (20 nm). Table 4 shows the virus clearance during the manufacturing process for PANZYGA, expressed as the mean log 10 reduction factor (LRF). Table 4: Virus Reduction by PANZYGA Manufacturing Process. HIV-1: Human Immunodeficiency Virus – 1, a model for HIV-1 and HIV-2;. PRV: Pseudorabies Virus, a model for large enveloped DNA viruses (e.g., herpes virus);. BVDV: Bovine Viral Diarrhea Virus, a model for e.g., Hepatitis C virus (HCV) and West-Nile virus (WNV);. MEV: Mouse Encephalomyelitis virus, a model for Hepatitis A virus (HAV);. PPV: Porcine Parvovirus, a model for Human Parvovirus B19;. n.a.: not applicable;. n.d: not done. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents. [ 10 ]. Several of the individual production steps in the PANZYGA manufacturing process were shown to decrease TSE infectivity of that experimental model agent. TSE reduction steps include ion-exchange chromatography and nanofiltration, which together give a total of at least 10.4 log10 decrease of infectivity. These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed.</Description>
</NDC>
<NDC>
<NDCCode>68982-840-02</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE, GLASS (68982-840-02) </PackageDescription>
<NDC11Code>68982-0840-02</NDC11Code>
<ProductNDC>68982-840</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Octagam Immune Globulin (human)</ProprietaryName>
<NonProprietaryName>Immune Globulin</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20040521</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125062</ApplicationNumber>
<LabelerName>Octapharma USA Inc</LabelerName>
<SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-11-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040521</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Octagam is an immune globulin intravenous (human), 5% liquid, indicated for treatment of primary humoral immunodeficiency (PI) ( 1 ).</IndicationAndUsage>
<Description>Immune Globulin Intravenous (Human), Octagam 5% liquid, is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. Octagam 5% liquid is a solution for infusion which must be administered intravenously. All units of human plasma used in the manufacture of Octagam 5% liquid are provided by FDA-approved blood establishments only, and are tested by FDA-licensed serological tests for HBsAg, antibodies to HCV and HIV and Nucleic Acid Test (NAT) for HCV and HIV-1 and found to be non-reactive (negative). The product is manufactured by the cold ethanol fractionation process followed by ultrafiltration and chromatography. The manufacturing process includes treatment with an organic S/D mixture composed of tri-n-butyl phosphate (TNBP) and Triton X-100 (Octoxynol). The Octagam 5% liquid manufacturing process provides a significant viral reduction in in vitro studies (Table 3). These reductions are achieved through a combination of process steps including cold ethanol fractionation, S/D treatment and pH 4 treatment. Table 3: In vitro reduction factor during Octagam 5% liquid manufacturing. *not calculated for global LRF. HIV-1: Human Immunodeficiency Virus - 1. PRV: Pseudorabies Virus. SBV: Sindbis Virus. MEV: Mouse Encephalomyelitis Virus. PPV: Porcine Parvovirus.</Description>
</NDC>
<NDC>
<NDCCode>68982-850-02</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE, GLASS (68982-850-02) </PackageDescription>
<NDC11Code>68982-0850-02</NDC11Code>
<ProductNDC>68982-850</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Octagam Immune Globulin (human)</ProprietaryName>
<NonProprietaryName>Immune Globulin</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20040521</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125062</ApplicationNumber>
<LabelerName>Octapharma USA Inc</LabelerName>
<SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-04-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040521</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Octagam 10% is an immune globulin intravenous (human) liquid preparation indicated for the treatment of. Chronic immune thrombocytopenic purpura (ITP) in adults ( 1.1 ). Dermatomyositis (DM) in adults ( 1.2 ).</IndicationAndUsage>
<Description>Immune Globulin Intravenous (Human), Octagam 10%, is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. Octagam 10% is a solution for infusion to be administered intravenously. This preparation contains approximately 100 mg of protein per mL (10%) of which not less than 96% is normal human immunoglobulin G. Octagam 10% contains not more than 3% aggregates, not less than 94% monomers and dimers and not more than 3% fragments. On average, the product contains 106 µg/mL of IgA and even lower amounts of IgM. The sodium content of the final solution is not more than 30 mmol/L and the pH is between 4.5 and 5.0. The osmolality is 310 - 380 mosmol/kg. The manufacturing process for Octagam 10% isolates IgG without additional chemical or enzymatic modification, and the Fc portion is maintained intact Octagam 10% contains the IgG antibody activities present in the donor population. IgG subclasses are fully represented with the following approximate percents of total IgG: IgG 1 is 65%, IgG 2 is 30%, IgG 3 is 3% and IgG 4 is 2%. Octagam 10% contains a broad spectrum of IgG antibodies against bacterial and viral agents that are capable of opsonization and neutralization of microbes and toxins. It contains maltose (90 mg/mL), but no preservatives or sucrose. All units of human plasma used in the manufacture of Octagam 10% are provided by FDA-approved blood establishments, and are tested by FDA-licensed serological tests for HBsAg, antibodies to HCV and HIV and Nucleic Acid Test (NAT) for HCV and HIV-1 and found to be non-reactive (negative). The product is manufactured by the cold ethanol fractionation process followed by ultrafiltration and chromatography. The manufacturing process includes treatment with an organic S/D mixture composed of tri-n-butyl phosphate (TNBP) and Triton X-100 (Octoxynol). The Octagam 10% manufacturing process shows significant viral reduction in in vitro studies (Table 6). These reductions are achieved through a combination of process steps including cold ethanol fractionation, S/D treatment and pH 4 treatment. Table 6: In vitro reduction factor during Octagam 10% manufacturing. *not calculated for global LRF. HIV-1: Human Immunodeficiency Virus - 1. PRV: Pseudorabies Virus. SBV: Sindbis Virus. MEV: Mouse Encephalomyelitis Virus. PPV: Porcine Parvovirus.</Description>
</NDC>
<NDC>
<NDCCode>13537-349-02</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (13537-349-02) > 4 g in 1 TUBE (13537-349-01)</PackageDescription>
<NDC11Code>13537-0349-02</NDC11Code>
<ProductNDC>13537-349</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esika</ProprietaryName>
<ProprietaryNameSuffix>Maximum Color Spf 18</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110517</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation (San Juan, P.R)</LabelerName>
<SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
<StrengthNumber>.073; .0165</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>24236-349-02</NDCCode>
<PackageDescription>30 CAPSULE in 1 BLISTER PACK (24236-349-02)</PackageDescription>
<NDC11Code>24236-0349-02</NDC11Code>
<ProductNDC>24236-349</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Thiothixene</ProprietaryName>
<NonProprietaryName>Thiothixene</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070516</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071093</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>THIOTHIXENE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Typical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-10-20</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>36800-349-02</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (36800-349-02) * 12 TABLET, COATED in 1 BLISTER PACK * 8 TABLET, COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>36800-0349-02</NDC11Code>
<ProductNDC>36800-349</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sinus Plus Headache Day And Night</ProprietaryName>
<NonProprietaryName>Acetaminophen, Chlorpheniramine Maleate, And Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20210618</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>TOPCO ASSOCIATES LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210618</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49349-349-02</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (49349-349-02)</PackageDescription>
<NDC11Code>49349-0349-02</NDC11Code>
<ProductNDC>49349-349</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110823</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076708</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>49967-349-02</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (49967-349-02) > 18 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>49967-0349-02</NDC11Code>
<ProductNDC>49967-349</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Giorgio Armani Power Fabric Long Wear High Cover Foundation Broad Spectrum Spf 25 Sunscreen</ProprietaryName>
<NonProprietaryName>Octinoxate</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160810</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>L'Oreal USA Products Inc.</LabelerName>
<SubstanceName>OCTINOXATE</SubstanceName>
<StrengthNumber>67</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160810</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>52125-349-02</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (52125-349-02)</PackageDescription>
<NDC11Code>52125-0349-02</NDC11Code>
<ProductNDC>52125-349</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121208</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040901</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>HYDRALAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>54575-349-02</NDCCode>
<PackageDescription>2 mL in 1 VIAL, MULTI-DOSE (54575-349-02)</PackageDescription>
<NDC11Code>54575-0349-02</NDC11Code>
<ProductNDC>54575-349</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Green String Bean</ProprietaryName>
<NonProprietaryName>String Bean</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Allergy Laboratories, Inc.</LabelerName>
<SubstanceName>STRING BEAN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/20mL</StrengthUnit>
<Pharm_Classes>Dietary Proteins [CS],Plant Proteins [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established: Coffee Cottonseed Flaxseed Housefly Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens.</Description>
</NDC>
<NDC>
<NDCCode>63545-349-02</NDCCode>
<PackageDescription>500 PELLET in 1 VIAL, GLASS (63545-349-02) </PackageDescription>
<NDC11Code>63545-0349-02</NDC11Code>
<ProductNDC>63545-349</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Badiaga</ProprietaryName>
<NonProprietaryName>Badiaga</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210618</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, Inc.</LabelerName>
<SubstanceName>SPONGILLA LACUSTRIS</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210618</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63824-349-02</NDCCode>
<PackageDescription>251 mL in 1 BOTTLE (63824-349-02)</PackageDescription>
<NDC11Code>63824-0349-02</NDC11Code>
<ProductNDC>63824-349</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lysol Healthy Touch</ProprietaryName>
<NonProprietaryName>Benzethonium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110721</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Reckitt Benckiser LLC</LabelerName>
<SubstanceName>BENZETHONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.13</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>68180-349-02</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (68180-349-02) </PackageDescription>
<NDC11Code>68180-0349-02</NDC11Code>
<ProductNDC>68180-349</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180824</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209306</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-12-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180824</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin tablets are indicated for: : 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.</IndicationAndUsage>
<Description>The active ingredient in gabapentin tablets USP is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each gabapentin tablets USP contains 600 mg or 800 mg of gabapentin and the following inactive ingredients: copovidone, corn starch, hydroxypropyl cellulose, magnesium stearate, polyethylene glycol, poloxamer and talc.</Description>
</NDC>
<NDC>
<NDCCode>68393-349-02</NDCCode>
<PackageDescription>59.1 mL in 1 BOTTLE, DISPENSING (68393-349-02) </PackageDescription>
<NDC11Code>68393-0349-02</NDC11Code>
<ProductNDC>68393-349</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Chondro-pro</ProprietaryName>
<ProprietaryNameSuffix>Pain Relief Roll On</ProprietaryNameSuffix>
<NonProprietaryName>Menthol, Unspecified Form</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140304</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>MDR Fitness Corp.</LabelerName>
<SubstanceName>MENTHOL, UNSPECIFIED FORM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140304</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of minor aches and pains of muscles and joints associated with: 1 arthritis, 2 simple backache, 3 strains, 4 sprains, 5 bruises.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68703-349-02</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (68703-349-02) </PackageDescription>
<NDC11Code>68703-0349-02</NDC11Code>
<ProductNDC>68703-349</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stress Away Anxiety Relief</ProprietaryName>
<NonProprietaryName>Aconitum Nap, Alfalfa, Avena, Chamomilla, Gelsemium, Humulus Lupulus, Ignatia, Kali Ars, Kali Phos, Muriaticum Ac, Nat Phos, Passiflora, Phos, Staphysag, Stramonium</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191001</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Silver Star Brands</LabelerName>
<SubstanceName>HYDROCHLORIC ACID; PHOSPHORUS P-32; DATURA STRAMONIUM; DELPHINIUM STAPHISAGRIA SEED; ALFALFA; MATRICARIA CHAMOMILLA FLOWERING TOP OIL; POTASSIUM PHOSPHATE, UNSPECIFIED FORM; SODIUM PHOSPHATE, DIBASIC; ACONITUM NAPELLUS; GELSEMIUM SEMPERVIRENS ROOT; HUMULUS LUPULUS WHOLE; STRYCHNOS IGNATII WHOLE; POTASSIUM ARSENITE ANHYDROUS; PASSIFLORA INCARNATA FLOWERING TOP; AVENA SATIVA LEAF</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses*: Temporarily relieves minor anxiousness and nervousness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70748-349-02</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (70748-349-02) / 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>70748-0349-02</NDC11Code>
<ProductNDC>70748-349</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rocuronium Bromide</ProprietaryName>
<NonProprietaryName>Rocuronium Bromide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20231023</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216234</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ROCURONIUM BROMIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231023</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rocuronium bromide injection is indicated for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.</IndicationAndUsage>
<Description>Rocuronium bromide injection is a nondepolarizing neuromuscular blocking agent with a rapid to intermediate onset depending on dose and intermediate duration. Rocuronium bromide is chemically designated as 1-[17β-(acetyloxy)-3α-hydroxy-2β-(4-morpholinyl)-5α-androstan-16β-yl]-1-(2-propenyl) pyrrolidinium bromide. The structural formula is. The chemical formula is C32H53BrN2O4 with a molecular weight of 609.70. The partition coefficient of rocuronium bromide in n-octanol/water is 0.5 at 20°C. Rocuronium bromide is supplied as a sterile, nonpyrogenic, isotonic solution that is clear, colorless to yellow or orange, for intravenous injection only. Each mL contains 10 mg rocuronium bromide and 2 mg sodium acetate. The aqueous solution is adjusted to isotonicity with sodium chloride and to a pH of 4 with acetic acid and/or sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>76157-349-02</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (76157-349-02) > 50 mL in 1 BOTTLE (76157-349-01)</PackageDescription>
<NDC11Code>76157-0349-02</NDC11Code>
<ProductNDC>76157-349</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-aging Day Broad Spectrum Spf 30</ProprietaryName>
<ProprietaryNameSuffix>La Prairie Group Ag</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Octinoxate, Octisalate, Octocrylene</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130116</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>La Prairie Group AG</LabelerName>
<SubstanceName>AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>3; 7.5; 5; 2.5</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-20</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>78536-006-02</NDCCode>
<PackageDescription>24 PAIL in 1 CARTON (78536-006-02) > 70 NOT APPLICABLE in 1 PAIL > 349 mL in 1 NOT APPLICABLE</PackageDescription>
<NDC11Code>78536-0006-02</NDC11Code>
<ProductNDC>78536-006</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pure Care Household Wipes</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200930</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Zhejiang Yiwu Mingou Biotechnology Co., Ltd.</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Wipe surface to help reduce bacteria that can potentially cause disease.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84756-349-02</NDCCode>
<PackageDescription>15 g in 1 BOX (84756-349-02) </PackageDescription>
<NDC11Code>84756-0349-02</NDC11Code>
<ProductNDC>84756-349</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kojic Acid Vitamin C Cream</ProprietaryName>
<NonProprietaryName>Kojic Acid Vitamin C Cream</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241118</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Yucheng E Commerce Co Ltd</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241118</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0049-3160-44</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0049-3160-44) / 75 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>00049-3160-44</NDC11Code>
<ProductNDC>0049-3160</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vfend</ProprietaryName>
<NonProprietaryName>Voriconazole</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030328</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021630</ApplicationNumber>
<LabelerName>Roerig</LabelerName>
<SubstanceName>VORICONAZOLE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030328</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VFEND is an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with: 1 Invasive aspergillosis (1.1), 2 Candidemia in non-neutropenics and other deep tissue Candida infections (1.2), 3 Esophageal candidiasis (1.3), 4 Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani, in patients intolerant of, or refractory to, other therapy (1.4).</IndicationAndUsage>
<Description>VFEND (voriconazole), an azole antifungal agent is available as a lyophilized powder for solution for intravenous infusion, film-coated tablets for oral administration, and as a powder for oral suspension. The structural formula is. Voriconazole is designated chemically as (2R,3S)-2-(2, 4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4-triazol-1-yl)-2-butanol with an empirical formula of C16H14F3N5O and a molecular weight of 349.3. Voriconazole drug substance is a white to light-colored powder. VFEND I.V. is a white lyophilized powder containing nominally 200 mg voriconazole and 3200 mg sulfobutyl ether beta-cyclodextrin sodium in a 30 mL Type I clear glass vial. VFEND I.V. is intended for administration by intravenous infusion. It is a single-dose, unpreserved product. Vials containing 200 mg lyophilized voriconazole are intended for reconstitution with Water for Injection to produce a solution containing 10 mg/mL VFEND and 160 mg/mL of sulfobutyl ether beta-cyclodextrin sodium. The resultant solution is further diluted prior to administration as an intravenous infusion [see Dosage and Administration (2)]. VFEND Tablets contain 50 mg or 200 mg of voriconazole. The inactive ingredients include croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, pregelatinized starch, and a coating containing hypromellose, lactose monohydrate, titanium dioxide, and triacetin. VFEND for Oral Suspension is a white to off-white powder providing a white to off-white orange-flavored suspension when reconstituted. Bottles containing 45 grams powder for oral suspension, which contain 3 g of voriconazole, are intended for reconstitution with water to produce a suspension containing 40 mg/mL voriconazole. The inactive ingredients include anhydrous citric acid, colloidal silicon dioxide, natural orange flavor, sodium benzoate, sodium citrate dihydrate, sucrose, titanium dioxide, and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>0049-3180-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0049-3180-30) </PackageDescription>
<NDC11Code>00049-3180-30</NDC11Code>
<ProductNDC>0049-3180</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vfend</ProprietaryName>
<NonProprietaryName>Voriconazole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030328</StartMarketingDate>
<EndMarketingDate>20270430</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021266</ApplicationNumber>
<LabelerName>Roerig</LabelerName>
<SubstanceName>VORICONAZOLE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20030328</StartMarketingDatePackage>
<EndMarketingDatePackage>20270430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VFEND is an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with: 1 Invasive aspergillosis (1.1), 2 Candidemia in non-neutropenics and other deep tissue Candida infections (1.2), 3 Esophageal candidiasis (1.3), 4 Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani, in patients intolerant of, or refractory to, other therapy (1.4).</IndicationAndUsage>
<Description>VFEND (voriconazole), an azole antifungal agent is available as a lyophilized powder for solution for intravenous infusion, film-coated tablets for oral administration, and as a powder for oral suspension. The structural formula is. Voriconazole is designated chemically as (2R,3S)-2-(2, 4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4-triazol-1-yl)-2-butanol with an empirical formula of C16H14F3N5O and a molecular weight of 349.3. Voriconazole drug substance is a white to light-colored powder. VFEND I.V. is a white lyophilized powder containing nominally 200 mg voriconazole and 3200 mg sulfobutyl ether beta-cyclodextrin sodium in a 30 mL Type I clear glass vial. VFEND I.V. is intended for administration by intravenous infusion. It is a single-dose, unpreserved product. Vials containing 200 mg lyophilized voriconazole are intended for reconstitution with Water for Injection to produce a solution containing 10 mg/mL VFEND and 160 mg/mL of sulfobutyl ether beta-cyclodextrin sodium. The resultant solution is further diluted prior to administration as an intravenous infusion [see Dosage and Administration (2)]. VFEND Tablets contain 50 mg or 200 mg of voriconazole. The inactive ingredients include croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, pregelatinized starch, and a coating containing hypromellose, lactose monohydrate, titanium dioxide, and triacetin. VFEND for Oral Suspension is a white to off-white powder providing a white to off-white orange-flavored suspension when reconstituted. Bottles containing 45 grams powder for oral suspension, which contain 3 g of voriconazole, are intended for reconstitution with water to produce a suspension containing 40 mg/mL voriconazole. The inactive ingredients include anhydrous citric acid, colloidal silicon dioxide, natural orange flavor, sodium benzoate, sodium citrate dihydrate, sucrose, titanium dioxide, and xanthan gum.</Description>
</NDC>
</NDCList>