{
"NDC": [
{
"NDCCode": "49591-532-51",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (49591-532-51) / 50 mL in 1 VIAL, GLASS (49591-532-50) ",
"NDC11Code": "49591-0532-51",
"ProductNDC": "49591-532",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Cytogam",
"NonProprietaryName": "Human Cytomegalovirus Immune Globulin",
"DosageFormName": "LIQUID",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20230601",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103189",
"LabelerName": "Kamada Ltd.",
"SubstanceName": "HUMAN CYTOMEGALOVIRUS IMMUNE GLOBULIN",
"StrengthNumber": "2500",
"StrengthUnit": "mg/50mL",
"Pharm_Classes": "Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE], Virus Neutralization [MoA], Virus-specific Hyperimmune Globulins [EXT]",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230601",
"SamplePackage": "N",
"IndicationAndUsage": "Cytomegalovirus Immune Globulin Intravenous (Human) is indicated for the prophylaxis of cytomegalovirus disease associated with transplantation of kidney, lung, liver, pancreas and heart. In transplants of these organs other than kidney from CMV seropositive donors into seronegative recipients, prophylactic CMV-IGIV should be considered in combination with ganciclovir.",
"Description": "CytoGam ®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMVIGIV), is an immunoglobulin G (IgG) containing a standardized amount of antibody to Cytomegalovirus (CMV). CMV-IGIV is formulated in final vial as a sterile liquid. The globulin is stabilized with 5% sucrose and 1% Albumin (Human). CytoGam ®contains no preservative. The purified immunoglobulin is derived from pooled adult human plasma selected for high titers of antibody for Cytomegalovirus (CMV) (1). Source material for fractionation may be obtained from another U.S. licensed manufacturer. Pooled plasma was fractionated by ethanol precipitation of the proteins according to Cohn Methods 6 and 9, modified to yield a product suitable for intravenous administration. A widely utilized solvent-detergent viral inactivation process is also used (2). Certain manufacturing operations may be performed by other firms. Each milliliter contains: 50 ± 10 mg of immunoglobulin, primarily IgG, and trace amounts of IgA and IgM; 50 mg of sucrose; 10 mg of Albumin (Human). The sodium content is 20-30 mEq per liter, i.e., 0.4- 0.6 mEq per 20 mL or 1.0-1.5 mEq per 50 mL. The solution should appear colorless and translucent."
},
{
"NDCCode": "70257-532-51",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (70257-532-51) / 50 mL in 1 VIAL, GLASS (70257-532-50) ",
"NDC11Code": "70257-0532-51",
"ProductNDC": "70257-532",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Cytogam",
"NonProprietaryName": "Human Cytomegalovirus Immune Globulin",
"DosageFormName": "LIQUID",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20201030",
"EndMarketingDate": "20240110",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103189",
"LabelerName": "Saol Therapeutics Inc.",
"SubstanceName": "HUMAN CYTOMEGALOVIRUS IMMUNE GLOBULIN",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE], Virus Neutralization [MoA], Virus-specific Hyperimmune Globulins [EXT]",
"Status": "Deprecated",
"LastUpdate": "2024-01-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20201030",
"EndMarketingDatePackage": "20240110",
"SamplePackage": "N",
"IndicationAndUsage": "Cytomegalovirus Immune Globulin Intravenous (Human) is indicated for the prophylaxis of cytomegalovirus disease associated with transplantation of kidney, lung, liver, pancreas and heart. In transplants of these organs other than kidney from CMV seropositive donors into seronegative recipients, prophylactic CMV-IGIV should be considered in combination with ganciclovir.",
"Description": "CYTOGAM, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV), is an immunoglobulin G (IgG) containing a standardized amount of antibody to Cytomegalovirus (CMV). CMV-IGIV is formulated in final vial as a sterile liquid. The globulin is stabilized with 5% sucrose and 1% Albumin (Human). CYTOGAM contains no preservative. The purified immunoglobulin is derived from pooled adult human plasma selected for high titers of antibody for Cytomegalovirus (CMV).1 Source material for fractionation may be obtained from another U.S. licensed manufacturer. Pooled plasma was fractionated by ethanol precipitation of the proteins according to Cohn Methods 6 and 9, modified to yield a product suitable for intravenous administration. A widely utilized solvent-detergent viral inactivation process is also used.2 Certain manufacturing operations may be performed by other firms. Each milliliter contains: 50 ± 10 mg of immunoglobulin, primarily IgG, and trace amounts of IgA and IgM; 50 mg of sucrose; 10 mg of Albumin (Human). The sodium content is 20-30 mEq per liter, i.e., 0.4-0.6 mEq per 20 mL or 1.0-1.5 mEq per 50 mL. The solution should appear colorless and translucent."
},
{
"NDCCode": "49591-051-51",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (49591-051-51) / 5 mL in 1 VIAL, GLASS (49591-051-05) ",
"NDC11Code": "49591-0051-51",
"ProductNDC": "49591-051",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Hepagam B",
"NonProprietaryName": "Human Hepatitis B Virus Immune Globulin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20251001",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125035",
"LabelerName": "Kamada Ltd.",
"SubstanceName": "HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN",
"StrengthNumber": "312",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Human Immunoglobulin [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE], Virus Neutralization [MoA], Virus-specific Hyperimmune Globulins [EXT]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251001",
"SamplePackage": "N",
"IndicationAndUsage": "HepaGam B [Hepatitis B immune globulin intravenous (Human)] is an intravenous immune globulin indicated for the following.",
"Description": "HepaGam B, Hepatitis B Immune Globulin Intravenous (Human), is a solvent/detergent-treated sterile solution of purified gamma globulin containing anti-HBs. It is prepared from plasma donated by healthy, screened donors with high titers of anti-HBs that is purified by an anion-exchange column chromatography manufacturing method 9,10. HepaGam B is formulated as a 5% (50 milligrams per milliliter) protein solution with 10% maltose and 0.03% polysorbate 80 at pH 5.6. It is available in 1 milliliter and 5 milliliters single dose vials. The product appears as a clear to opalescent liquid. HepaGam B does not contain mercury. It contains no preservatives. This product is intended for single use. HepaGam B may be administered intravenously or intramuscularly dependent upon indication [see Dosage and Administration (2.)]. The source plasma used in the manufacture of this product was tested by FDA licensed Nucleic Acid testing (NAT) for HIV-1, HBV and HCV and found to be negative. Plasma also has been tested by in-process NAT for hepatitis A virus (HAV) and parvovirus B19 (B19) via minipool testing and the limit for B19 in the manufacturing pool is set not to exceed 10 4international units of B19 DNA per milliliter. The manufacturing process contains two steps implemented specifically for virus clearance. The solvent and detergent step (using tri-n-butyl phosphate and Triton ®X-100) is effective in the inactivation of enveloped viruses, such as hepatitis B, hepatitis C and HIV 11. Virus filtration, using a Planova ®20N virus filter, is effective for the removal of viruses based on their size, including some non-enveloped viruses 12. These two viral clearance steps are designed to increase product safety by reducing the risk of transmission of enveloped and non-enveloped viruses. In addition to these two specific steps, the process step of anion-exchange chromatography was identified as contributing to the overall viral clearance capacity for small non-enveloped viruses. The inactivation and reduction of known enveloped and non–enveloped model viruses were validated in laboratory studies as summarized in Table 4. The viruses employed for spiking studies were selected to represent those viruses that are potential contaminants in the product, and to represent a wide range of physiochemical properties in order to challenge the manufacturing process's ability for viral clearance in general. The product potency is expressed in international units by comparison to the World Health Organization (WHO) standard Hepatitis B Immune Globulin. Each vial contains greater than 312 international units per milliliter. The measured potency of each lot is stamped on the vial label [ see Dosage Forms and Strengths ( 3) ]."
},
{
"NDCCode": "49591-052-51",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (49591-052-51) / 1 mL in 1 VIAL, GLASS (49591-052-11) ",
"NDC11Code": "49591-0052-51",
"ProductNDC": "49591-052",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Hepagam B",
"NonProprietaryName": "Human Hepatitis B Virus Immune Globulin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20251001",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125035",
"LabelerName": "Kamada Ltd.",
"SubstanceName": "HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN",
"StrengthNumber": "312",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Human Immunoglobulin [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE], Virus Neutralization [MoA], Virus-specific Hyperimmune Globulins [EXT]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251001",
"SamplePackage": "N",
"IndicationAndUsage": "HepaGam B [Hepatitis B immune globulin intravenous (Human)] is an intravenous immune globulin indicated for the following.",
"Description": "HepaGam B, Hepatitis B Immune Globulin Intravenous (Human), is a solvent/detergent-treated sterile solution of purified gamma globulin containing anti-HBs. It is prepared from plasma donated by healthy, screened donors with high titers of anti-HBs that is purified by an anion-exchange column chromatography manufacturing method 9,10. HepaGam B is formulated as a 5% (50 milligrams per milliliter) protein solution with 10% maltose and 0.03% polysorbate 80 at pH 5.6. It is available in 1 milliliter and 5 milliliters single dose vials. The product appears as a clear to opalescent liquid. HepaGam B does not contain mercury. It contains no preservatives. This product is intended for single use. HepaGam B may be administered intravenously or intramuscularly dependent upon indication [see Dosage and Administration (2.)]. The source plasma used in the manufacture of this product was tested by FDA licensed Nucleic Acid testing (NAT) for HIV-1, HBV and HCV and found to be negative. Plasma also has been tested by in-process NAT for hepatitis A virus (HAV) and parvovirus B19 (B19) via minipool testing and the limit for B19 in the manufacturing pool is set not to exceed 10 4international units of B19 DNA per milliliter. The manufacturing process contains two steps implemented specifically for virus clearance. The solvent and detergent step (using tri-n-butyl phosphate and Triton ®X-100) is effective in the inactivation of enveloped viruses, such as hepatitis B, hepatitis C and HIV 11. Virus filtration, using a Planova ®20N virus filter, is effective for the removal of viruses based on their size, including some non-enveloped viruses 12. These two viral clearance steps are designed to increase product safety by reducing the risk of transmission of enveloped and non-enveloped viruses. In addition to these two specific steps, the process step of anion-exchange chromatography was identified as contributing to the overall viral clearance capacity for small non-enveloped viruses. The inactivation and reduction of known enveloped and non–enveloped model viruses were validated in laboratory studies as summarized in Table 4. The viruses employed for spiking studies were selected to represent those viruses that are potential contaminants in the product, and to represent a wide range of physiochemical properties in order to challenge the manufacturing process's ability for viral clearance in general. The product potency is expressed in international units by comparison to the World Health Organization (WHO) standard Hepatitis B Immune Globulin. Each vial contains greater than 312 international units per milliliter. The measured potency of each lot is stamped on the vial label [ see Dosage Forms and Strengths ( 3) ]."
},
{
"NDCCode": "49591-126-51",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (49591-126-51) / 1.2 mL in 1 VIAL, GLASS (49591-126-11) ",
"NDC11Code": "49591-0126-51",
"ProductNDC": "49591-126",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Varizig",
"NonProprietaryName": "Human Varicella-zoster Immune Globulin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20240301",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125430",
"LabelerName": "Kamada Ltd.",
"SubstanceName": "HUMAN VARICELLA-ZOSTER IMMUNE GLOBULIN",
"StrengthNumber": "125",
"StrengthUnit": "[iU]/1.2mL",
"Status": "Active",
"LastUpdate": "2026-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240301",
"SamplePackage": "N",
"IndicationAndUsage": "VARIZIG ®[Varicella Zoster Immune Globulin (Human)] is indicated for post-exposure prophylaxis of varicella in high risk individuals. High risk groups include: : 1 immunocompromised children and adults,, 2 newborns of mothers with varicella shortly before or after delivery,, 3 premature infants,, 4 neonates and infants less than one year of age,, 5 adults without evidence of immunity,, 6 pregnant women.",
"Description": "VARIZIG [Varicella Zoster Immune Globulin (Human)] is a solvent/detergent-treated sterile liquid preparation of purified human immune globulin G (IgG) containing antibodies to varicella zoster virus (anti-VZV). VZV is the causative agent of chickenpox. VARIZIG is prepared from plasma donated by healthy, screened donors with high titers of antibodies to VZV, which is purified by an anion-exchange column chromatography manufacturing method. This donor selection process includes donors with high anti-VZV titers due to recent natural infection by VZV, or due to recurrent zoster infection (shingles). VARIZIG is intended for single use and should be administered intramuscularly [see 2DOSAGE AND ADMINISTRATION]. The product potency is expressed in international units by comparison to the World Health Organization (WHO) international reference preparation for anti-VZV immune globulin. Each vial contains 125 international units of anti-VZV. VARIZIG is formulated with 10% maltose and 0.03% polysorbate 80. VARIZIG has a pH of 5.0 – 6.5 and contains no preservative. The presence of anti-Protein S antibodies has been reported to arise transiently in patients after VZV infection (4). Low levels of anti-Protein S antibodies have been reported in VARIZIG. The source plasma used in the manufacture of this product was tested by FDA licensed nucleic acid testing (NAT) for human immunodeficiency virus-1 (HIV-1), hepatitis B virus (HBV) and hepatitis C virus (HCV) and found to be negative. Plasma also was tested by in-process NAT for hepatitis A virus (HAV) and parvovirus B19 (B19) via minipool testing; the limit for B19 in the manufacturing pool is set not to exceed 10 4international units of B19 DNA per milliliter. The manufacturing process contains two steps implemented specifically for virus clearance. The solvent/detergent step (using tri-n-butyl phosphate and Triton ®X-100) is effective in the inactivation of enveloped viruses, such as HBV, HCV and HIV-1. Virus filtration, using a Planova ®20N virus filter, is effective for the removal of viruses based on their size, including some non-enveloped viruses. These two viral clearance steps are designed to increase product safety by reducing the risk of transmission of enveloped and non-enveloped viruses. In addition to these two specific steps, the process step of anion-exchange chromatography was identified as contributing to the overall viral clearance capacity for small non-enveloped viruses. The inactivation and reduction of known enveloped and non-enveloped model viruses were validated in laboratory studies as summarized in Table 2. The viruses employed for spiking studies were selected to represent those viruses that are potential contaminants in the product, and to represent a wide range of physiochemical properties in order to challenge the manufacturing process's ability for viral clearance in general."
},
{
"NDCCode": "49591-300-51",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (49591-300-51) / 13 mL in 1 VIAL, GLASS (49591-300-13) ",
"NDC11Code": "49591-0300-51",
"ProductNDC": "49591-300",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Winrho Sdf",
"NonProprietaryName": "Human Rho(d) Immune Globulin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20230801",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103649",
"LabelerName": "Kamada Ltd.",
"SubstanceName": "HUMAN RHO(D) IMMUNE GLOBULIN",
"StrengthNumber": "15000",
"StrengthUnit": "[iU]/13mL",
"Pharm_Classes": "Endogenous Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230801",
"SamplePackage": "N",
"IndicationAndUsage": "WinRho ®SDF is a Rh o(D) Immune Globulin Intravenous (Human) (anti-D) product that is indicated for the treatment of ITP in Rh o(D)-positive patients and for the suppression of Rh isoimmunization in non-sensitized Rh o(D)-negative patients.",
"Description": "WinRho ®SDF is a sterile, liquid gamma globulin (IgG) fraction containing antibodies to the Rh o(D) antigen (D antigen). WinRho ®SDF is to be administered intravenously for the treatment of ITP and either intravenously or intramuscularly for the suppression of Rh isoimmunization. WinRho ®SDF is prepared from human plasma by an anion-exchange column chromatography method. The manufacturing process includes two steps implemented specifically for viral clearance. The solvent detergent treatment step (using tri-n-butyl phosphate and octoxynol) is effective in inactivating lipid enveloped viruses such as hepatitis B, hepatitis C, and HIV. Virus filtration, using a 20N virus filter, is effective in the removal of some non-lipid enveloped viruses. These two processes are designed to increase product safety by reducing the risk of transmission of enveloped and non-enveloped viruses, respectively. In addition to the two specific steps, the anion-exchange chromatography step contributes to the removal of small non-lipid enveloped viruses. The inactivation and reduction of known enveloped and non-enveloped model viruses were validated in laboratory studies as summarized in Table 6. The product potency is expressed in international units (IU) by comparison to the World Health Organization (WHO) standard. In the past, a full dose of Rh o(D) Immune Globulin (Human) has traditionally been referred to as a “300 microgram (mcg)” dose. Potency and dosing recommendations are now expressed in IU by comparison to the WHO anti-Rh o(D) standard. The conversion of mcg to IU is: 1 mcg = 5 IU. A 1,500 IU (300 mcg) vial contains sufficient anti-Rh o(D) to effectively suppress the immunizing potential of approximately 17 mL of Rh o(D) (D-positive) RBCs. The liquid formulation is stabilized with 10% maltose and 0.03% polysorbate 80. There are no preservatives in the formulation. WinRho ®SDF does not contain mercury. This product contains ≤ 40 mcg/mL IgA."
},
{
"NDCCode": "49591-310-51",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (49591-310-51) / 4.4 mL in 1 VIAL, GLASS (49591-310-04) ",
"NDC11Code": "49591-0310-51",
"ProductNDC": "49591-310",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Winrho Sdf",
"NonProprietaryName": "Human Rho(d) Immune Globulin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20230801",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103649",
"LabelerName": "Kamada Ltd.",
"SubstanceName": "HUMAN RHO(D) IMMUNE GLOBULIN",
"StrengthNumber": "5000",
"StrengthUnit": "[iU]/4.4mL",
"Pharm_Classes": "Endogenous Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230801",
"SamplePackage": "N",
"IndicationAndUsage": "WinRho ®SDF is a Rh o(D) Immune Globulin Intravenous (Human) (anti-D) product that is indicated for the treatment of ITP in Rh o(D)-positive patients and for the suppression of Rh isoimmunization in non-sensitized Rh o(D)-negative patients.",
"Description": "WinRho ®SDF is a sterile, liquid gamma globulin (IgG) fraction containing antibodies to the Rh o(D) antigen (D antigen). WinRho ®SDF is to be administered intravenously for the treatment of ITP and either intravenously or intramuscularly for the suppression of Rh isoimmunization. WinRho ®SDF is prepared from human plasma by an anion-exchange column chromatography method. The manufacturing process includes two steps implemented specifically for viral clearance. The solvent detergent treatment step (using tri-n-butyl phosphate and octoxynol) is effective in inactivating lipid enveloped viruses such as hepatitis B, hepatitis C, and HIV. Virus filtration, using a 20N virus filter, is effective in the removal of some non-lipid enveloped viruses. These two processes are designed to increase product safety by reducing the risk of transmission of enveloped and non-enveloped viruses, respectively. In addition to the two specific steps, the anion-exchange chromatography step contributes to the removal of small non-lipid enveloped viruses. The inactivation and reduction of known enveloped and non-enveloped model viruses were validated in laboratory studies as summarized in Table 6. The product potency is expressed in international units (IU) by comparison to the World Health Organization (WHO) standard. In the past, a full dose of Rh o(D) Immune Globulin (Human) has traditionally been referred to as a “300 microgram (mcg)” dose. Potency and dosing recommendations are now expressed in IU by comparison to the WHO anti-Rh o(D) standard. The conversion of mcg to IU is: 1 mcg = 5 IU. A 1,500 IU (300 mcg) vial contains sufficient anti-Rh o(D) to effectively suppress the immunizing potential of approximately 17 mL of Rh o(D) (D-positive) RBCs. The liquid formulation is stabilized with 10% maltose and 0.03% polysorbate 80. There are no preservatives in the formulation. WinRho ®SDF does not contain mercury. This product contains ≤ 40 mcg/mL IgA."
},
{
"NDCCode": "49591-330-51",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (49591-330-51) / 1.3 mL in 1 VIAL, GLASS (49591-330-11) ",
"NDC11Code": "49591-0330-51",
"ProductNDC": "49591-330",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Winrho Sdf",
"NonProprietaryName": "Human Rho(d) Immune Globulin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20230801",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103649",
"LabelerName": "Kamada Ltd.",
"SubstanceName": "HUMAN RHO(D) IMMUNE GLOBULIN",
"StrengthNumber": "1500",
"StrengthUnit": "[iU]/1.3mL",
"Pharm_Classes": "Endogenous Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
"Status": "Active",
"LastUpdate": "2026-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230801",
"SamplePackage": "N",
"IndicationAndUsage": "WinRho ®SDF is a Rh o(D) Immune Globulin Intravenous (Human) (anti-D) product that is indicated for the treatment of ITP in Rh o(D)-positive patients and for the suppression of Rh isoimmunization in non-sensitized Rh o(D)-negative patients.",
"Description": "WinRho ®SDF is a sterile, liquid gamma globulin (IgG) fraction containing antibodies to the Rh o(D) antigen (D antigen). WinRho ®SDF is to be administered intravenously for the treatment of ITP and either intravenously or intramuscularly for the suppression of Rh isoimmunization. WinRho ®SDF is prepared from human plasma by an anion-exchange column chromatography method. The manufacturing process includes two steps implemented specifically for viral clearance. The solvent detergent treatment step (using tri-n-butyl phosphate and octoxynol) is effective in inactivating lipid enveloped viruses such as hepatitis B, hepatitis C, and HIV. Virus filtration, using a 20N virus filter, is effective in the removal of some non-lipid enveloped viruses. These two processes are designed to increase product safety by reducing the risk of transmission of enveloped and non-enveloped viruses, respectively. In addition to the two specific steps, the anion-exchange chromatography step contributes to the removal of small non-lipid enveloped viruses. The inactivation and reduction of known enveloped and non-enveloped model viruses were validated in laboratory studies as summarized in Table 6. The product potency is expressed in international units (IU) by comparison to the World Health Organization (WHO) standard. In the past, a full dose of Rh o(D) Immune Globulin (Human) has traditionally been referred to as a “300 microgram (mcg)” dose. Potency and dosing recommendations are now expressed in IU by comparison to the WHO anti-Rh o(D) standard. The conversion of mcg to IU is: 1 mcg = 5 IU. A 1,500 IU (300 mcg) vial contains sufficient anti-Rh o(D) to effectively suppress the immunizing potential of approximately 17 mL of Rh o(D) (D-positive) RBCs. The liquid formulation is stabilized with 10% maltose and 0.03% polysorbate 80. There are no preservatives in the formulation. WinRho ®SDF does not contain mercury. This product contains ≤ 40 mcg/mL IgA."
},
{
"NDCCode": "49591-350-51",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (49591-350-51) / 2.2 mL in 1 VIAL, GLASS (49591-350-02) ",
"NDC11Code": "49591-0350-51",
"ProductNDC": "49591-350",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Winrho Sdf",
"NonProprietaryName": "Human Rho(d) Immune Globulin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20230801",
"EndMarketingDate": "20260531",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103649",
"LabelerName": "Kamada Ltd.",
"SubstanceName": "HUMAN RHO(D) IMMUNE GLOBULIN",
"StrengthNumber": "2500",
"StrengthUnit": "[iU]/2.2mL",
"Pharm_Classes": "Endogenous Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230801",
"EndMarketingDatePackage": "20260531",
"SamplePackage": "N",
"IndicationAndUsage": "WinRho ®SDF is a Rh o(D) Immune Globulin Intravenous (Human) (anti-D) product that is indicated for the treatment of ITP in Rh o(D)-positive patients and for the suppression of Rh isoimmunization in non-sensitized Rh o(D)-negative patients.",
"Description": "WinRho ®SDF is a sterile, liquid gamma globulin (IgG) fraction containing antibodies to the Rh o(D) antigen (D antigen). WinRho ®SDF is to be administered intravenously for the treatment of ITP and either intravenously or intramuscularly for the suppression of Rh isoimmunization. WinRho ®SDF is prepared from human plasma by an anion-exchange column chromatography method. The manufacturing process includes two steps implemented specifically for viral clearance. The solvent detergent treatment step (using tri-n-butyl phosphate and octoxynol) is effective in inactivating lipid enveloped viruses such as hepatitis B, hepatitis C, and HIV. Virus filtration, using a 20N virus filter, is effective in the removal of some non-lipid enveloped viruses. These two processes are designed to increase product safety by reducing the risk of transmission of enveloped and non-enveloped viruses, respectively. In addition to the two specific steps, the anion-exchange chromatography step contributes to the removal of small non-lipid enveloped viruses. The inactivation and reduction of known enveloped and non-enveloped model viruses were validated in laboratory studies as summarized in Table 6. The product potency is expressed in international units (IU) by comparison to the World Health Organization (WHO) standard. In the past, a full dose of Rh o(D) Immune Globulin (Human) has traditionally been referred to as a “300 microgram (mcg)” dose. Potency and dosing recommendations are now expressed in IU by comparison to the WHO anti-Rh o(D) standard. The conversion of mcg to IU is: 1 mcg = 5 IU. A 1,500 IU (300 mcg) vial contains sufficient anti-Rh o(D) to effectively suppress the immunizing potential of approximately 17 mL of Rh o(D) (D-positive) RBCs. The liquid formulation is stabilized with 10% maltose and 0.03% polysorbate 80. There are no preservatives in the formulation. WinRho ®SDF does not contain mercury. This product contains ≤ 40 mcg/mL IgA."
},
{
"NDCCode": "0069-0550-38",
"PackageDescription": "28 CAPSULE in 1 BOTTLE (0069-0550-38) ",
"NDC11Code": "00069-0550-38",
"ProductNDC": "0069-0550",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sutent",
"NonProprietaryName": "Sunitinib Malate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20060126",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021938",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "SUNITINIB MALATE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060126",
"SamplePackage": "N",
"IndicationAndUsage": "SUTENT is a kinase inhibitor indicated for: 1 treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. (1.1), 2 treatment of adult patients with advanced renal cell carcinoma (RCC). (1.2), 3 adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. (1.3), 4 treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. (1.4).",
"Description": "Sunitinib is a kinase inhibitor present in SUTENT capsules as the malate salt. Sunitinib malate is described chemically as (2S)-2-hydroxybutanedoic acid with N-[2-(diethylamino)ethyl]-5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidine)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide (1:1). The molecular formula is C22H27FN4O2 ∙ C4H6O5 and the molecular weight is 532.6 Daltons. The chemical structure of sunitinib malate is. Sunitinib malate is a yellow to orange powder with a pKa of 8.95. The solubility of sunitinib malate in aqueous media over the range pH 1.2 to pH 6.8 is in excess of 25 mg/mL. The log of the distribution coefficient (octanol/water) at pH 7 is 5.2. SUTENT (sunitinib malate) capsules are supplied as printed hard shell capsules containing 12.5 mg, 25 mg, 37.5 mg or 50 mg of sunitinib (equivalent to 16.7 mg, 33.4 mg, 50.1 mg, or 66.8 mg of sunitinib malate, respectively). The capsules contain the following inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, and povidone (K-25). The orange gelatin capsule shells contain titanium dioxide and red iron oxide; the caramel gelatin capsule shells contain titanium dioxide, red iron oxide, yellow iron oxide, and black iron oxide; and the yellow gelatin capsule shells contain titanium dioxide and yellow iron oxide. The white printing ink contains shellac, propylene glycol, sodium hydroxide, povidone, and titanium dioxide and the black printing ink contains shellac, propylene glycol, potassium hydroxide, and black iron oxide."
},
{
"NDCCode": "0069-0770-38",
"PackageDescription": "28 CAPSULE in 1 BOTTLE (0069-0770-38) ",
"NDC11Code": "00069-0770-38",
"ProductNDC": "0069-0770",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sutent",
"NonProprietaryName": "Sunitinib Malate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20060126",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021938",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "SUNITINIB MALATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060126",
"SamplePackage": "N",
"IndicationAndUsage": "SUTENT is a kinase inhibitor indicated for: 1 treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. (1.1), 2 treatment of adult patients with advanced renal cell carcinoma (RCC). (1.2), 3 adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. (1.3), 4 treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. (1.4).",
"Description": "Sunitinib is a kinase inhibitor present in SUTENT capsules as the malate salt. Sunitinib malate is described chemically as (2S)-2-hydroxybutanedoic acid with N-[2-(diethylamino)ethyl]-5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidine)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide (1:1). The molecular formula is C22H27FN4O2 ∙ C4H6O5 and the molecular weight is 532.6 Daltons. The chemical structure of sunitinib malate is. Sunitinib malate is a yellow to orange powder with a pKa of 8.95. The solubility of sunitinib malate in aqueous media over the range pH 1.2 to pH 6.8 is in excess of 25 mg/mL. The log of the distribution coefficient (octanol/water) at pH 7 is 5.2. SUTENT (sunitinib malate) capsules are supplied as printed hard shell capsules containing 12.5 mg, 25 mg, 37.5 mg or 50 mg of sunitinib (equivalent to 16.7 mg, 33.4 mg, 50.1 mg, or 66.8 mg of sunitinib malate, respectively). The capsules contain the following inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, and povidone (K-25). The orange gelatin capsule shells contain titanium dioxide and red iron oxide; the caramel gelatin capsule shells contain titanium dioxide, red iron oxide, yellow iron oxide, and black iron oxide; and the yellow gelatin capsule shells contain titanium dioxide and yellow iron oxide. The white printing ink contains shellac, propylene glycol, sodium hydroxide, povidone, and titanium dioxide and the black printing ink contains shellac, propylene glycol, potassium hydroxide, and black iron oxide."
},
{
"NDCCode": "0069-0830-38",
"PackageDescription": "28 CAPSULE in 1 BOTTLE (0069-0830-38) ",
"NDC11Code": "00069-0830-38",
"ProductNDC": "0069-0830",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sutent",
"NonProprietaryName": "Sunitinib Malate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20140712",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021938",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "SUNITINIB MALATE",
"StrengthNumber": "37.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140712",
"SamplePackage": "N",
"IndicationAndUsage": "SUTENT is a kinase inhibitor indicated for: 1 treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. (1.1), 2 treatment of adult patients with advanced renal cell carcinoma (RCC). (1.2), 3 adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. (1.3), 4 treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. (1.4).",
"Description": "Sunitinib is a kinase inhibitor present in SUTENT capsules as the malate salt. Sunitinib malate is described chemically as (2S)-2-hydroxybutanedoic acid with N-[2-(diethylamino)ethyl]-5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidine)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide (1:1). The molecular formula is C22H27FN4O2 ∙ C4H6O5 and the molecular weight is 532.6 Daltons. The chemical structure of sunitinib malate is. Sunitinib malate is a yellow to orange powder with a pKa of 8.95. The solubility of sunitinib malate in aqueous media over the range pH 1.2 to pH 6.8 is in excess of 25 mg/mL. The log of the distribution coefficient (octanol/water) at pH 7 is 5.2. SUTENT (sunitinib malate) capsules are supplied as printed hard shell capsules containing 12.5 mg, 25 mg, 37.5 mg or 50 mg of sunitinib (equivalent to 16.7 mg, 33.4 mg, 50.1 mg, or 66.8 mg of sunitinib malate, respectively). The capsules contain the following inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, and povidone (K-25). The orange gelatin capsule shells contain titanium dioxide and red iron oxide; the caramel gelatin capsule shells contain titanium dioxide, red iron oxide, yellow iron oxide, and black iron oxide; and the yellow gelatin capsule shells contain titanium dioxide and yellow iron oxide. The white printing ink contains shellac, propylene glycol, sodium hydroxide, povidone, and titanium dioxide and the black printing ink contains shellac, propylene glycol, potassium hydroxide, and black iron oxide."
},
{
"NDCCode": "0069-0980-38",
"PackageDescription": "28 CAPSULE in 1 BOTTLE (0069-0980-38) ",
"NDC11Code": "00069-0980-38",
"ProductNDC": "0069-0980",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sutent",
"NonProprietaryName": "Sunitinib Malate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20060126",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021938",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "SUNITINIB MALATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060126",
"SamplePackage": "N",
"IndicationAndUsage": "SUTENT is a kinase inhibitor indicated for: 1 treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. (1.1), 2 treatment of adult patients with advanced renal cell carcinoma (RCC). (1.2), 3 adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. (1.3), 4 treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. (1.4).",
"Description": "Sunitinib is a kinase inhibitor present in SUTENT capsules as the malate salt. Sunitinib malate is described chemically as (2S)-2-hydroxybutanedoic acid with N-[2-(diethylamino)ethyl]-5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidine)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide (1:1). The molecular formula is C22H27FN4O2 ∙ C4H6O5 and the molecular weight is 532.6 Daltons. The chemical structure of sunitinib malate is. Sunitinib malate is a yellow to orange powder with a pKa of 8.95. The solubility of sunitinib malate in aqueous media over the range pH 1.2 to pH 6.8 is in excess of 25 mg/mL. The log of the distribution coefficient (octanol/water) at pH 7 is 5.2. SUTENT (sunitinib malate) capsules are supplied as printed hard shell capsules containing 12.5 mg, 25 mg, 37.5 mg or 50 mg of sunitinib (equivalent to 16.7 mg, 33.4 mg, 50.1 mg, or 66.8 mg of sunitinib malate, respectively). The capsules contain the following inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, and povidone (K-25). The orange gelatin capsule shells contain titanium dioxide and red iron oxide; the caramel gelatin capsule shells contain titanium dioxide, red iron oxide, yellow iron oxide, and black iron oxide; and the yellow gelatin capsule shells contain titanium dioxide and yellow iron oxide. The white printing ink contains shellac, propylene glycol, sodium hydroxide, povidone, and titanium dioxide and the black printing ink contains shellac, propylene glycol, potassium hydroxide, and black iron oxide."
},
{
"NDCCode": "0093-8199-28",
"PackageDescription": "28 CAPSULE in 1 BOTTLE (0093-8199-28) ",
"NDC11Code": "00093-8199-28",
"ProductNDC": "0093-8199",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sunitinib Malate",
"NonProprietaryName": "Sunitinib Malate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20211222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213803",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "SUNITINIB MALATE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211222",
"SamplePackage": "N",
"IndicationAndUsage": "Sunitinib malate capsules are a kinase inhibitor indicated for: 1 treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. (1.1), 2 treatment of adult patients with advanced renal cell carcinoma (RCC). (1.2), 3 adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. (1.3), 4 treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. (1.4).",
"Description": "Sunitinib is a kinase inhibitor present in sunitinib malate capsules as the malate salt. Sunitinib malate is described chemically as (2S)-2-hydroxybutanedoic acid with N-[2-(diethylamino)ethyl]-5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidine)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide (1:1). The molecular formula is C22H27FN4O2 ● C4H6O5 and the molecular weight is 532.6 Daltons. The chemical structure of sunitinib malate is. Sunitinib malate is a yellow to orange powder with a pKa of 8.95. The solubility of sunitinib malate in aqueous media over the range pH 1.2 to pH 6.8 is in excess of 0.4 mg/mL. The log of the distribution coefficient (octanol/water) at pH 7 is 5.2. Sunitinib malate capsules are supplied as printed hard shell capsules containing 12.5 mg, 25 mg, 37.5 mg or 50 mg of sunitinib (equivalent to 16.7 mg, 33.4 mg, 50.1 mg, or 66.8 mg of sunitinib malate, respectively). The capsules contain the following inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, and povidone K-30. The 12.5 mg capsule shell contains D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, and titanium dioxide. The 25 mg capsule shell contains D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, and titanium dioxide. The 37.5 mg capsule shell contains gelatin, titanium dioxide, and yellow iron oxide. The 50 mg capsule shell contains FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, and titanium dioxide. The black printing ink which is common for all strengths contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, shellac, and may also contain propylene glycol."
},
{
"NDCCode": "0093-8224-28",
"PackageDescription": "28 CAPSULE in 1 BOTTLE (0093-8224-28) ",
"NDC11Code": "00093-8224-28",
"ProductNDC": "0093-8224",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sunitinib Malate",
"NonProprietaryName": "Sunitinib Malate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20211222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213803",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "SUNITINIB MALATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211222",
"SamplePackage": "N",
"IndicationAndUsage": "Sunitinib malate capsules are a kinase inhibitor indicated for: 1 treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. (1.1), 2 treatment of adult patients with advanced renal cell carcinoma (RCC). (1.2), 3 adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. (1.3), 4 treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. (1.4).",
"Description": "Sunitinib is a kinase inhibitor present in sunitinib malate capsules as the malate salt. Sunitinib malate is described chemically as (2S)-2-hydroxybutanedoic acid with N-[2-(diethylamino)ethyl]-5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidine)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide (1:1). The molecular formula is C22H27FN4O2 ● C4H6O5 and the molecular weight is 532.6 Daltons. The chemical structure of sunitinib malate is. Sunitinib malate is a yellow to orange powder with a pKa of 8.95. The solubility of sunitinib malate in aqueous media over the range pH 1.2 to pH 6.8 is in excess of 0.4 mg/mL. The log of the distribution coefficient (octanol/water) at pH 7 is 5.2. Sunitinib malate capsules are supplied as printed hard shell capsules containing 12.5 mg, 25 mg, 37.5 mg or 50 mg of sunitinib (equivalent to 16.7 mg, 33.4 mg, 50.1 mg, or 66.8 mg of sunitinib malate, respectively). The capsules contain the following inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, and povidone K-30. The 12.5 mg capsule shell contains D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, and titanium dioxide. The 25 mg capsule shell contains D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, and titanium dioxide. The 37.5 mg capsule shell contains gelatin, titanium dioxide, and yellow iron oxide. The 50 mg capsule shell contains FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, and titanium dioxide. The black printing ink which is common for all strengths contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, shellac, and may also contain propylene glycol."
},
{
"NDCCode": "0093-8229-28",
"PackageDescription": "28 CAPSULE in 1 BOTTLE (0093-8229-28) ",
"NDC11Code": "00093-8229-28",
"ProductNDC": "0093-8229",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sunitinib Malate",
"NonProprietaryName": "Sunitinib Malate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20211222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213803",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "SUNITINIB MALATE",
"StrengthNumber": "37.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211222",
"SamplePackage": "N",
"IndicationAndUsage": "Sunitinib malate capsules are a kinase inhibitor indicated for: 1 treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. (1.1), 2 treatment of adult patients with advanced renal cell carcinoma (RCC). (1.2), 3 adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. (1.3), 4 treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. (1.4).",
"Description": "Sunitinib is a kinase inhibitor present in sunitinib malate capsules as the malate salt. Sunitinib malate is described chemically as (2S)-2-hydroxybutanedoic acid with N-[2-(diethylamino)ethyl]-5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidine)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide (1:1). The molecular formula is C22H27FN4O2 ● C4H6O5 and the molecular weight is 532.6 Daltons. The chemical structure of sunitinib malate is. Sunitinib malate is a yellow to orange powder with a pKa of 8.95. The solubility of sunitinib malate in aqueous media over the range pH 1.2 to pH 6.8 is in excess of 0.4 mg/mL. The log of the distribution coefficient (octanol/water) at pH 7 is 5.2. Sunitinib malate capsules are supplied as printed hard shell capsules containing 12.5 mg, 25 mg, 37.5 mg or 50 mg of sunitinib (equivalent to 16.7 mg, 33.4 mg, 50.1 mg, or 66.8 mg of sunitinib malate, respectively). The capsules contain the following inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, and povidone K-30. The 12.5 mg capsule shell contains D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, and titanium dioxide. The 25 mg capsule shell contains D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, and titanium dioxide. The 37.5 mg capsule shell contains gelatin, titanium dioxide, and yellow iron oxide. The 50 mg capsule shell contains FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, and titanium dioxide. The black printing ink which is common for all strengths contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, shellac, and may also contain propylene glycol."
},
{
"NDCCode": "0093-8231-28",
"PackageDescription": "28 CAPSULE in 1 BOTTLE (0093-8231-28) ",
"NDC11Code": "00093-8231-28",
"ProductNDC": "0093-8231",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sunitinib Malate",
"NonProprietaryName": "Sunitinib Malate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20211222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213803",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "SUNITINIB MALATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211222",
"SamplePackage": "N",
"IndicationAndUsage": "Sunitinib malate capsules are a kinase inhibitor indicated for: 1 treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. (1.1), 2 treatment of adult patients with advanced renal cell carcinoma (RCC). (1.2), 3 adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. (1.3), 4 treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. (1.4).",
"Description": "Sunitinib is a kinase inhibitor present in sunitinib malate capsules as the malate salt. Sunitinib malate is described chemically as (2S)-2-hydroxybutanedoic acid with N-[2-(diethylamino)ethyl]-5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidine)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide (1:1). The molecular formula is C22H27FN4O2 ● C4H6O5 and the molecular weight is 532.6 Daltons. The chemical structure of sunitinib malate is. Sunitinib malate is a yellow to orange powder with a pKa of 8.95. The solubility of sunitinib malate in aqueous media over the range pH 1.2 to pH 6.8 is in excess of 0.4 mg/mL. The log of the distribution coefficient (octanol/water) at pH 7 is 5.2. Sunitinib malate capsules are supplied as printed hard shell capsules containing 12.5 mg, 25 mg, 37.5 mg or 50 mg of sunitinib (equivalent to 16.7 mg, 33.4 mg, 50.1 mg, or 66.8 mg of sunitinib malate, respectively). The capsules contain the following inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, and povidone K-30. The 12.5 mg capsule shell contains D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, and titanium dioxide. The 25 mg capsule shell contains D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, and titanium dioxide. The 37.5 mg capsule shell contains gelatin, titanium dioxide, and yellow iron oxide. The 50 mg capsule shell contains FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, and titanium dioxide. The black printing ink which is common for all strengths contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, shellac, and may also contain propylene glycol."
},
{
"NDCCode": "0116-0767-18",
"PackageDescription": "532 mL in 1 BOTTLE, PUMP (0116-0767-18) ",
"NDC11Code": "00116-0767-18",
"ProductNDC": "0116-0767",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antiseptic Skin Cleanser",
"NonProprietaryName": "Chlorhexidine Gluconate 4%",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110831",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019125",
"LabelerName": "Xttrium Laboratories, Inc.",
"SubstanceName": "CHLORHEXIDINE GLUCONATE",
"StrengthNumber": "4",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Decreased Cell Wall Integrity [PE]",
"Status": "Active",
"LastUpdate": "2026-03-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221114",
"EndMarketingDatePackage": "20270131",
"SamplePackage": "N",
"IndicationAndUsage": ": 1 healthcare personnel handwash: helps reduce bacteria that potentially can cause disease , 2 skin wound and general skin cleansing."
},
{
"NDCCode": "0116-1061-18",
"PackageDescription": "532 mL in 1 BOTTLE (0116-1061-18) ",
"NDC11Code": "00116-1061-18",
"ProductNDC": "0116-1061",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antiseptic Skin Cleanser",
"NonProprietaryName": "Chlorhexidine Gluconate",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110831",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019125",
"LabelerName": "Xttrium Laboratories, Inc.",
"SubstanceName": "CHLORHEXIDINE GLUCONATE",
"StrengthNumber": "4",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Decreased Cell Wall Integrity [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110831",
"EndMarketingDatePackage": "20260831",
"SamplePackage": "N",
"IndicationAndUsage": "surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care . healthcare personnel handwash: helps reduce bacteria that potentially can cause disease . skin wound and general skin cleansing."
},
{
"NDCCode": "0168-0346-46",
"PackageDescription": "45 g in 1 TUBE, WITH APPLICATOR (0168-0346-46) ",
"NDC11Code": "00168-0346-46",
"ProductNDC": "0168-0346",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Terconazole",
"NonProprietaryName": "Terconazole",
"DosageFormName": "CREAM",
"RouteName": "VAGINAL",
"StartMarketingDate": "20050218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076712",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC",
"SubstanceName": "TERCONAZOLE",
"StrengthNumber": "4",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Active",
"LastUpdate": "2026-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20050218",
"SamplePackage": "N",
"IndicationAndUsage": "Terconazole vaginal cream 0.4% is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As terconazole vaginal cream 0.4% is effective only for vulvovaginitis caused by the genus Candida, the diagnosis should be confirmed by KOH smears and/or cultures.",
"Description": "Terconazole vaginal cream 0.4% is a white to off-white, water washable cream for intravaginal administration containing 0.4% of the antifungal agent terconazole, cis-1-[p-[[2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-4-isopropylpiperazine, compounded in a cream base consisting of butylated hydroxyanisole, cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, propylene glycol, stearyl alcohol, and purified water. The structural formula of terconazole is as follows:. Terconazole, a triazole derivative, is a white to almost white powder with a molecular weight of 532.47. It is insoluble in water; sparingly soluble in ethanol; and soluble in butanol."
},
{
"NDCCode": "0168-0347-20",
"PackageDescription": "20 g in 1 TUBE, WITH APPLICATOR (0168-0347-20) ",
"NDC11Code": "00168-0347-20",
"ProductNDC": "0168-0347",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Terconazole",
"ProprietaryNameSuffix": "Vaginal Cream 0.8%",
"NonProprietaryName": "Terconazole",
"DosageFormName": "CREAM",
"RouteName": "VAGINAL",
"StartMarketingDate": "20050201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021735",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC",
"SubstanceName": "TERCONAZOLE",
"StrengthNumber": "8",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Active",
"LastUpdate": "2026-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201201",
"SamplePackage": "N",
"IndicationAndUsage": "Terconazole Vaginal Cream, is indicated for the treatment of vulvovaginal candidiasis in adult females.",
"Description": "Terconazole Vaginal Cream, 0.8% is a white to off-white, water washable cream for intravaginal administration containing 0.8% of the antifungal agent terconazole, cis-1-[p[[2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4- yl]methoxy]phenyl]-4-isopropylpiperazine, compounded in a cream base consisting of butylated hydroxyanisole, cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, propylene glycol, stearyl alcohol, and purified water. The structural formula of terconazole is as follows. Terconazole, a triazole derivative, is a white to almost white powder with a molecular weight of 532.47. It is insoluble in water; sparingly soluble in ethanol; and soluble in butanol."
},
{
"NDCCode": "0363-0070-44",
"PackageDescription": "532 mL in 1 BOTTLE, PLASTIC (0363-0070-44) ",
"NDC11Code": "00363-0070-44",
"ProductNDC": "0363-0070",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anticavity",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "RINSE",
"RouteName": "ORAL",
"StartMarketingDate": "20130923",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "Walgreen Co.",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": ".05",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2020-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20130923",
"SamplePackage": "N"
},
{
"NDCCode": "0363-0619-44",
"PackageDescription": "532 g in 1 BOTTLE, PLASTIC (0363-0619-44) ",
"NDC11Code": "00363-0619-44",
"ProductNDC": "0363-0619",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Daily Moisturizing",
"NonProprietaryName": "Daily Moistruizing",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130206",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Walgreen, Co.",
"SubstanceName": "DIMETHICONE",
"StrengthNumber": "13",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Skin Barrier Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20130206",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent and temporarily protects chafed, chapped, or cracked skin. helps protect from the drying effects of wind and cold weather."
},
{
"NDCCode": "0363-1061-18",
"PackageDescription": "532 mL in 1 BOTTLE, PUMP (0363-1061-18) ",
"NDC11Code": "00363-1061-18",
"ProductNDC": "0363-1061",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antiseptic Skin Cleanser",
"NonProprietaryName": "Chlorhexidine Gluconate 4%",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110501",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019125",
"LabelerName": "Walgreen Co.",
"SubstanceName": "CHLORHEXIDINE GLUCONATE",
"StrengthNumber": "4",
"StrengthUnit": "mg/100mL",
"Pharm_Classes": "Decreased Cell Wall Integrity [PE]",
"Status": "Active",
"LastUpdate": "2024-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210111",
"SamplePackage": "N",
"IndicationAndUsage": "healthcare personnel handwash: helps reduce bacteria that potentially can cause disease . skin wound and general skin cleansing."
},
{
"NDCCode": "0363-1571-44",
"PackageDescription": "532 mL in 1 BOTTLE (0363-1571-44) ",
"NDC11Code": "00363-1571-44",
"ProductNDC": "0363-1571",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Moisturizing Skin Relief",
"NonProprietaryName": "Dimethicone 1.2%",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200817",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Walgreens",
"SubstanceName": "DIMETHICONE",
"StrengthNumber": "12",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Skin Barrier Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200817",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent, temporarily protects chafed, chapped or cracked skin. helps prevent and protect from the drying effects of wind and cold weather."
},
{
"NDCCode": "0363-3701-80",
"PackageDescription": "532 mL in 1 BOTTLE, PLASTIC (0363-3701-80)",
"NDC11Code": "00363-3701-80",
"ProductNDC": "0363-3701",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Studio 35",
"ProprietaryNameSuffix": "Spring Morning",
"NonProprietaryName": "Triclosan",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130708",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "WALGREEN COMPANY",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "FOR WASHING TO DECREASE BACTERIA ON THE SKIN."
},
{
"NDCCode": "0363-5990-18",
"PackageDescription": "532 mL in 1 BOTTLE, PLASTIC (0363-5990-18) ",
"NDC11Code": "00363-5990-18",
"ProductNDC": "0363-5990",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Daily Moisturizer",
"NonProprietaryName": "Lotion",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230911",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Walgreen",
"SubstanceName": "DIMETHICONE",
"StrengthNumber": "1200",
"StrengthUnit": "mg/100mL",
"Pharm_Classes": "Skin Barrier Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230911",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent and temporarily protects chafed, chapped or cracked skin. Helps protect from the drying effects of winf and cold weather."
},
{
"NDCCode": "0363-5995-18",
"PackageDescription": "532 mL in 1 BOTTLE, PLASTIC (0363-5995-18) ",
"NDC11Code": "00363-5995-18",
"ProductNDC": "0363-5995",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Skin Relief",
"NonProprietaryName": "Lotion",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230911",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Walgreen",
"SubstanceName": "DIMETHICONE",
"StrengthNumber": "1200",
"StrengthUnit": "mg/100mL",
"Pharm_Classes": "Skin Barrier Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230911",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent and temporarily protects chafed, chapped or cracked skin. Helps protect from the drying effects of wind and cold weather."
},
{
"NDCCode": "0378-6678-28",
"PackageDescription": "28 CAPSULE in 1 BOTTLE, PLASTIC (0378-6678-28) ",
"NDC11Code": "00378-6678-28",
"ProductNDC": "0378-6678",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sunitinib Malate",
"NonProprietaryName": "Sunitinib Malate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220104",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201275",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "SUNITINIB MALATE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-05-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220104",
"SamplePackage": "N",
"IndicationAndUsage": "Sunitinib malate capsules are a kinase inhibitor indicated for: 1 treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. (1.1), 2 treatment of adult patients with advanced renal cell carcinoma (RCC). (1.2), 3 adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. (1.3), 4 treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. (1.4).",
"Description": "Sunitinib is a kinase inhibitor present in sunitinib malate capsules as the malate salt. Sunitinib malate is described chemically as N-[2-(Diethylamino)ethyl]-5-[(Z)-(5-fluoro-2-oxo-1,2-dihydro-3H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide hydrogen (2S)-2-hydroxybutanedioate. The molecular formula is C22H27FN4O2 C4H6O5 and the molecular weight is 532.6. The chemical structure of sunitinib malate is:. Sunitinib malate is a yellow to orange powder with a pKa of 8.95. The solubility of sunitinib malate in aqueous media over the range pH 1.2 to pH 6.8 is in excess of 25 mg/mL. The log of the distribution coefficient (octanol/water) at pH 7 is 5.2. Sunitinib malate capsules are supplied as printed hard-shell capsules containing 12.5 mg, 25 mg, 37.5 mg or 50 mg of sunitinib (equivalent to 16.7 mg, 33.4 mg, 50.1 mg, or 66.8 mg of sunitinib malate, respectively). The capsules contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, gelatin, magnesium stearate, mannitol, sodium lauryl sulfate and titanium dioxide. The 12.5 mg and 25 mg strengths also contain red iron oxide. The 25 mg, 37.5 mg and 50 mg strengths also contain yellow iron oxide. In addition, the black imprinting ink contains the following: ammonium hydroxide, black iron oxide, propylene glycol and shellac glaze."
},
{
"NDCCode": "0378-6679-28",
"PackageDescription": "28 CAPSULE in 1 BOTTLE, PLASTIC (0378-6679-28) ",
"NDC11Code": "00378-6679-28",
"ProductNDC": "0378-6679",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sunitinib Malate",
"NonProprietaryName": "Sunitinib Malate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220104",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201275",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "SUNITINIB MALATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-05-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220104",
"SamplePackage": "N",
"IndicationAndUsage": "Sunitinib malate capsules are a kinase inhibitor indicated for: 1 treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. (1.1), 2 treatment of adult patients with advanced renal cell carcinoma (RCC). (1.2), 3 adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. (1.3), 4 treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. (1.4).",
"Description": "Sunitinib is a kinase inhibitor present in sunitinib malate capsules as the malate salt. Sunitinib malate is described chemically as N-[2-(Diethylamino)ethyl]-5-[(Z)-(5-fluoro-2-oxo-1,2-dihydro-3H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide hydrogen (2S)-2-hydroxybutanedioate. The molecular formula is C22H27FN4O2 C4H6O5 and the molecular weight is 532.6. The chemical structure of sunitinib malate is:. Sunitinib malate is a yellow to orange powder with a pKa of 8.95. The solubility of sunitinib malate in aqueous media over the range pH 1.2 to pH 6.8 is in excess of 25 mg/mL. The log of the distribution coefficient (octanol/water) at pH 7 is 5.2. Sunitinib malate capsules are supplied as printed hard-shell capsules containing 12.5 mg, 25 mg, 37.5 mg or 50 mg of sunitinib (equivalent to 16.7 mg, 33.4 mg, 50.1 mg, or 66.8 mg of sunitinib malate, respectively). The capsules contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, gelatin, magnesium stearate, mannitol, sodium lauryl sulfate and titanium dioxide. The 12.5 mg and 25 mg strengths also contain red iron oxide. The 25 mg, 37.5 mg and 50 mg strengths also contain yellow iron oxide. In addition, the black imprinting ink contains the following: ammonium hydroxide, black iron oxide, propylene glycol and shellac glaze."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>49591-532-51</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (49591-532-51) / 50 mL in 1 VIAL, GLASS (49591-532-50) </PackageDescription>
<NDC11Code>49591-0532-51</NDC11Code>
<ProductNDC>49591-532</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Cytogam</ProprietaryName>
<NonProprietaryName>Human Cytomegalovirus Immune Globulin</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20230601</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103189</ApplicationNumber>
<LabelerName>Kamada Ltd.</LabelerName>
<SubstanceName>HUMAN CYTOMEGALOVIRUS IMMUNE GLOBULIN</SubstanceName>
<StrengthNumber>2500</StrengthNumber>
<StrengthUnit>mg/50mL</StrengthUnit>
<Pharm_Classes>Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE], Virus Neutralization [MoA], Virus-specific Hyperimmune Globulins [EXT]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cytomegalovirus Immune Globulin Intravenous (Human) is indicated for the prophylaxis of cytomegalovirus disease associated with transplantation of kidney, lung, liver, pancreas and heart. In transplants of these organs other than kidney from CMV seropositive donors into seronegative recipients, prophylactic CMV-IGIV should be considered in combination with ganciclovir.</IndicationAndUsage>
<Description>CytoGam ®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMVIGIV), is an immunoglobulin G (IgG) containing a standardized amount of antibody to Cytomegalovirus (CMV). CMV-IGIV is formulated in final vial as a sterile liquid. The globulin is stabilized with 5% sucrose and 1% Albumin (Human). CytoGam ®contains no preservative. The purified immunoglobulin is derived from pooled adult human plasma selected for high titers of antibody for Cytomegalovirus (CMV) (1). Source material for fractionation may be obtained from another U.S. licensed manufacturer. Pooled plasma was fractionated by ethanol precipitation of the proteins according to Cohn Methods 6 and 9, modified to yield a product suitable for intravenous administration. A widely utilized solvent-detergent viral inactivation process is also used (2). Certain manufacturing operations may be performed by other firms. Each milliliter contains: 50 ± 10 mg of immunoglobulin, primarily IgG, and trace amounts of IgA and IgM; 50 mg of sucrose; 10 mg of Albumin (Human). The sodium content is 20-30 mEq per liter, i.e., 0.4- 0.6 mEq per 20 mL or 1.0-1.5 mEq per 50 mL. The solution should appear colorless and translucent.</Description>
</NDC>
<NDC>
<NDCCode>70257-532-51</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (70257-532-51) / 50 mL in 1 VIAL, GLASS (70257-532-50) </PackageDescription>
<NDC11Code>70257-0532-51</NDC11Code>
<ProductNDC>70257-532</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Cytogam</ProprietaryName>
<NonProprietaryName>Human Cytomegalovirus Immune Globulin</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20201030</StartMarketingDate>
<EndMarketingDate>20240110</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103189</ApplicationNumber>
<LabelerName>Saol Therapeutics Inc.</LabelerName>
<SubstanceName>HUMAN CYTOMEGALOVIRUS IMMUNE GLOBULIN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE], Virus Neutralization [MoA], Virus-specific Hyperimmune Globulins [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20201030</StartMarketingDatePackage>
<EndMarketingDatePackage>20240110</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cytomegalovirus Immune Globulin Intravenous (Human) is indicated for the prophylaxis of cytomegalovirus disease associated with transplantation of kidney, lung, liver, pancreas and heart. In transplants of these organs other than kidney from CMV seropositive donors into seronegative recipients, prophylactic CMV-IGIV should be considered in combination with ganciclovir.</IndicationAndUsage>
<Description>CYTOGAM, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV), is an immunoglobulin G (IgG) containing a standardized amount of antibody to Cytomegalovirus (CMV). CMV-IGIV is formulated in final vial as a sterile liquid. The globulin is stabilized with 5% sucrose and 1% Albumin (Human). CYTOGAM contains no preservative. The purified immunoglobulin is derived from pooled adult human plasma selected for high titers of antibody for Cytomegalovirus (CMV).1 Source material for fractionation may be obtained from another U.S. licensed manufacturer. Pooled plasma was fractionated by ethanol precipitation of the proteins according to Cohn Methods 6 and 9, modified to yield a product suitable for intravenous administration. A widely utilized solvent-detergent viral inactivation process is also used.2 Certain manufacturing operations may be performed by other firms. Each milliliter contains: 50 ± 10 mg of immunoglobulin, primarily IgG, and trace amounts of IgA and IgM; 50 mg of sucrose; 10 mg of Albumin (Human). The sodium content is 20-30 mEq per liter, i.e., 0.4-0.6 mEq per 20 mL or 1.0-1.5 mEq per 50 mL. The solution should appear colorless and translucent.</Description>
</NDC>
<NDC>
<NDCCode>49591-051-51</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (49591-051-51) / 5 mL in 1 VIAL, GLASS (49591-051-05) </PackageDescription>
<NDC11Code>49591-0051-51</NDC11Code>
<ProductNDC>49591-051</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Hepagam B</ProprietaryName>
<NonProprietaryName>Human Hepatitis B Virus Immune Globulin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20251001</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125035</ApplicationNumber>
<LabelerName>Kamada Ltd.</LabelerName>
<SubstanceName>HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN</SubstanceName>
<StrengthNumber>312</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Human Immunoglobulin [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE], Virus Neutralization [MoA], Virus-specific Hyperimmune Globulins [EXT]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HepaGam B [Hepatitis B immune globulin intravenous (Human)] is an intravenous immune globulin indicated for the following.</IndicationAndUsage>
<Description>HepaGam B, Hepatitis B Immune Globulin Intravenous (Human), is a solvent/detergent-treated sterile solution of purified gamma globulin containing anti-HBs. It is prepared from plasma donated by healthy, screened donors with high titers of anti-HBs that is purified by an anion-exchange column chromatography manufacturing method 9,10. HepaGam B is formulated as a 5% (50 milligrams per milliliter) protein solution with 10% maltose and 0.03% polysorbate 80 at pH 5.6. It is available in 1 milliliter and 5 milliliters single dose vials. The product appears as a clear to opalescent liquid. HepaGam B does not contain mercury. It contains no preservatives. This product is intended for single use. HepaGam B may be administered intravenously or intramuscularly dependent upon indication [see Dosage and Administration (2.)]. The source plasma used in the manufacture of this product was tested by FDA licensed Nucleic Acid testing (NAT) for HIV-1, HBV and HCV and found to be negative. Plasma also has been tested by in-process NAT for hepatitis A virus (HAV) and parvovirus B19 (B19) via minipool testing and the limit for B19 in the manufacturing pool is set not to exceed 10 4international units of B19 DNA per milliliter. The manufacturing process contains two steps implemented specifically for virus clearance. The solvent and detergent step (using tri-n-butyl phosphate and Triton ®X-100) is effective in the inactivation of enveloped viruses, such as hepatitis B, hepatitis C and HIV 11. Virus filtration, using a Planova ®20N virus filter, is effective for the removal of viruses based on their size, including some non-enveloped viruses 12. These two viral clearance steps are designed to increase product safety by reducing the risk of transmission of enveloped and non-enveloped viruses. In addition to these two specific steps, the process step of anion-exchange chromatography was identified as contributing to the overall viral clearance capacity for small non-enveloped viruses. The inactivation and reduction of known enveloped and non–enveloped model viruses were validated in laboratory studies as summarized in Table 4. The viruses employed for spiking studies were selected to represent those viruses that are potential contaminants in the product, and to represent a wide range of physiochemical properties in order to challenge the manufacturing process's ability for viral clearance in general. The product potency is expressed in international units by comparison to the World Health Organization (WHO) standard Hepatitis B Immune Globulin. Each vial contains greater than 312 international units per milliliter. The measured potency of each lot is stamped on the vial label [ see Dosage Forms and Strengths ( 3) ].</Description>
</NDC>
<NDC>
<NDCCode>49591-052-51</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (49591-052-51) / 1 mL in 1 VIAL, GLASS (49591-052-11) </PackageDescription>
<NDC11Code>49591-0052-51</NDC11Code>
<ProductNDC>49591-052</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Hepagam B</ProprietaryName>
<NonProprietaryName>Human Hepatitis B Virus Immune Globulin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20251001</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125035</ApplicationNumber>
<LabelerName>Kamada Ltd.</LabelerName>
<SubstanceName>HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN</SubstanceName>
<StrengthNumber>312</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Human Immunoglobulin [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE], Virus Neutralization [MoA], Virus-specific Hyperimmune Globulins [EXT]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HepaGam B [Hepatitis B immune globulin intravenous (Human)] is an intravenous immune globulin indicated for the following.</IndicationAndUsage>
<Description>HepaGam B, Hepatitis B Immune Globulin Intravenous (Human), is a solvent/detergent-treated sterile solution of purified gamma globulin containing anti-HBs. It is prepared from plasma donated by healthy, screened donors with high titers of anti-HBs that is purified by an anion-exchange column chromatography manufacturing method 9,10. HepaGam B is formulated as a 5% (50 milligrams per milliliter) protein solution with 10% maltose and 0.03% polysorbate 80 at pH 5.6. It is available in 1 milliliter and 5 milliliters single dose vials. The product appears as a clear to opalescent liquid. HepaGam B does not contain mercury. It contains no preservatives. This product is intended for single use. HepaGam B may be administered intravenously or intramuscularly dependent upon indication [see Dosage and Administration (2.)]. The source plasma used in the manufacture of this product was tested by FDA licensed Nucleic Acid testing (NAT) for HIV-1, HBV and HCV and found to be negative. Plasma also has been tested by in-process NAT for hepatitis A virus (HAV) and parvovirus B19 (B19) via minipool testing and the limit for B19 in the manufacturing pool is set not to exceed 10 4international units of B19 DNA per milliliter. The manufacturing process contains two steps implemented specifically for virus clearance. The solvent and detergent step (using tri-n-butyl phosphate and Triton ®X-100) is effective in the inactivation of enveloped viruses, such as hepatitis B, hepatitis C and HIV 11. Virus filtration, using a Planova ®20N virus filter, is effective for the removal of viruses based on their size, including some non-enveloped viruses 12. These two viral clearance steps are designed to increase product safety by reducing the risk of transmission of enveloped and non-enveloped viruses. In addition to these two specific steps, the process step of anion-exchange chromatography was identified as contributing to the overall viral clearance capacity for small non-enveloped viruses. The inactivation and reduction of known enveloped and non–enveloped model viruses were validated in laboratory studies as summarized in Table 4. The viruses employed for spiking studies were selected to represent those viruses that are potential contaminants in the product, and to represent a wide range of physiochemical properties in order to challenge the manufacturing process's ability for viral clearance in general. The product potency is expressed in international units by comparison to the World Health Organization (WHO) standard Hepatitis B Immune Globulin. Each vial contains greater than 312 international units per milliliter. The measured potency of each lot is stamped on the vial label [ see Dosage Forms and Strengths ( 3) ].</Description>
</NDC>
<NDC>
<NDCCode>49591-126-51</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (49591-126-51) / 1.2 mL in 1 VIAL, GLASS (49591-126-11) </PackageDescription>
<NDC11Code>49591-0126-51</NDC11Code>
<ProductNDC>49591-126</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Varizig</ProprietaryName>
<NonProprietaryName>Human Varicella-zoster Immune Globulin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20240301</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125430</ApplicationNumber>
<LabelerName>Kamada Ltd.</LabelerName>
<SubstanceName>HUMAN VARICELLA-ZOSTER IMMUNE GLOBULIN</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>[iU]/1.2mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VARIZIG ®[Varicella Zoster Immune Globulin (Human)] is indicated for post-exposure prophylaxis of varicella in high risk individuals. High risk groups include: : 1 immunocompromised children and adults,, 2 newborns of mothers with varicella shortly before or after delivery,, 3 premature infants,, 4 neonates and infants less than one year of age,, 5 adults without evidence of immunity,, 6 pregnant women.</IndicationAndUsage>
<Description>VARIZIG [Varicella Zoster Immune Globulin (Human)] is a solvent/detergent-treated sterile liquid preparation of purified human immune globulin G (IgG) containing antibodies to varicella zoster virus (anti-VZV). VZV is the causative agent of chickenpox. VARIZIG is prepared from plasma donated by healthy, screened donors with high titers of antibodies to VZV, which is purified by an anion-exchange column chromatography manufacturing method. This donor selection process includes donors with high anti-VZV titers due to recent natural infection by VZV, or due to recurrent zoster infection (shingles). VARIZIG is intended for single use and should be administered intramuscularly [see 2DOSAGE AND ADMINISTRATION]. The product potency is expressed in international units by comparison to the World Health Organization (WHO) international reference preparation for anti-VZV immune globulin. Each vial contains 125 international units of anti-VZV. VARIZIG is formulated with 10% maltose and 0.03% polysorbate 80. VARIZIG has a pH of 5.0 – 6.5 and contains no preservative. The presence of anti-Protein S antibodies has been reported to arise transiently in patients after VZV infection (4). Low levels of anti-Protein S antibodies have been reported in VARIZIG. The source plasma used in the manufacture of this product was tested by FDA licensed nucleic acid testing (NAT) for human immunodeficiency virus-1 (HIV-1), hepatitis B virus (HBV) and hepatitis C virus (HCV) and found to be negative. Plasma also was tested by in-process NAT for hepatitis A virus (HAV) and parvovirus B19 (B19) via minipool testing; the limit for B19 in the manufacturing pool is set not to exceed 10 4international units of B19 DNA per milliliter. The manufacturing process contains two steps implemented specifically for virus clearance. The solvent/detergent step (using tri-n-butyl phosphate and Triton ®X-100) is effective in the inactivation of enveloped viruses, such as HBV, HCV and HIV-1. Virus filtration, using a Planova ®20N virus filter, is effective for the removal of viruses based on their size, including some non-enveloped viruses. These two viral clearance steps are designed to increase product safety by reducing the risk of transmission of enveloped and non-enveloped viruses. In addition to these two specific steps, the process step of anion-exchange chromatography was identified as contributing to the overall viral clearance capacity for small non-enveloped viruses. The inactivation and reduction of known enveloped and non-enveloped model viruses were validated in laboratory studies as summarized in Table 2. The viruses employed for spiking studies were selected to represent those viruses that are potential contaminants in the product, and to represent a wide range of physiochemical properties in order to challenge the manufacturing process's ability for viral clearance in general.</Description>
</NDC>
<NDC>
<NDCCode>49591-300-51</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (49591-300-51) / 13 mL in 1 VIAL, GLASS (49591-300-13) </PackageDescription>
<NDC11Code>49591-0300-51</NDC11Code>
<ProductNDC>49591-300</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Winrho Sdf</ProprietaryName>
<NonProprietaryName>Human Rho(d) Immune Globulin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20230801</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103649</ApplicationNumber>
<LabelerName>Kamada Ltd.</LabelerName>
<SubstanceName>HUMAN RHO(D) IMMUNE GLOBULIN</SubstanceName>
<StrengthNumber>15000</StrengthNumber>
<StrengthUnit>[iU]/13mL</StrengthUnit>
<Pharm_Classes>Endogenous Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>WinRho ®SDF is a Rh o(D) Immune Globulin Intravenous (Human) (anti-D) product that is indicated for the treatment of ITP in Rh o(D)-positive patients and for the suppression of Rh isoimmunization in non-sensitized Rh o(D)-negative patients.</IndicationAndUsage>
<Description>WinRho ®SDF is a sterile, liquid gamma globulin (IgG) fraction containing antibodies to the Rh o(D) antigen (D antigen). WinRho ®SDF is to be administered intravenously for the treatment of ITP and either intravenously or intramuscularly for the suppression of Rh isoimmunization. WinRho ®SDF is prepared from human plasma by an anion-exchange column chromatography method. The manufacturing process includes two steps implemented specifically for viral clearance. The solvent detergent treatment step (using tri-n-butyl phosphate and octoxynol) is effective in inactivating lipid enveloped viruses such as hepatitis B, hepatitis C, and HIV. Virus filtration, using a 20N virus filter, is effective in the removal of some non-lipid enveloped viruses. These two processes are designed to increase product safety by reducing the risk of transmission of enveloped and non-enveloped viruses, respectively. In addition to the two specific steps, the anion-exchange chromatography step contributes to the removal of small non-lipid enveloped viruses. The inactivation and reduction of known enveloped and non-enveloped model viruses were validated in laboratory studies as summarized in Table 6. The product potency is expressed in international units (IU) by comparison to the World Health Organization (WHO) standard. In the past, a full dose of Rh o(D) Immune Globulin (Human) has traditionally been referred to as a “300 microgram (mcg)” dose. Potency and dosing recommendations are now expressed in IU by comparison to the WHO anti-Rh o(D) standard. The conversion of mcg to IU is: 1 mcg = 5 IU. A 1,500 IU (300 mcg) vial contains sufficient anti-Rh o(D) to effectively suppress the immunizing potential of approximately 17 mL of Rh o(D) (D-positive) RBCs. The liquid formulation is stabilized with 10% maltose and 0.03% polysorbate 80. There are no preservatives in the formulation. WinRho ®SDF does not contain mercury. This product contains ≤ 40 mcg/mL IgA.</Description>
</NDC>
<NDC>
<NDCCode>49591-310-51</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (49591-310-51) / 4.4 mL in 1 VIAL, GLASS (49591-310-04) </PackageDescription>
<NDC11Code>49591-0310-51</NDC11Code>
<ProductNDC>49591-310</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Winrho Sdf</ProprietaryName>
<NonProprietaryName>Human Rho(d) Immune Globulin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20230801</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103649</ApplicationNumber>
<LabelerName>Kamada Ltd.</LabelerName>
<SubstanceName>HUMAN RHO(D) IMMUNE GLOBULIN</SubstanceName>
<StrengthNumber>5000</StrengthNumber>
<StrengthUnit>[iU]/4.4mL</StrengthUnit>
<Pharm_Classes>Endogenous Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>WinRho ®SDF is a Rh o(D) Immune Globulin Intravenous (Human) (anti-D) product that is indicated for the treatment of ITP in Rh o(D)-positive patients and for the suppression of Rh isoimmunization in non-sensitized Rh o(D)-negative patients.</IndicationAndUsage>
<Description>WinRho ®SDF is a sterile, liquid gamma globulin (IgG) fraction containing antibodies to the Rh o(D) antigen (D antigen). WinRho ®SDF is to be administered intravenously for the treatment of ITP and either intravenously or intramuscularly for the suppression of Rh isoimmunization. WinRho ®SDF is prepared from human plasma by an anion-exchange column chromatography method. The manufacturing process includes two steps implemented specifically for viral clearance. The solvent detergent treatment step (using tri-n-butyl phosphate and octoxynol) is effective in inactivating lipid enveloped viruses such as hepatitis B, hepatitis C, and HIV. Virus filtration, using a 20N virus filter, is effective in the removal of some non-lipid enveloped viruses. These two processes are designed to increase product safety by reducing the risk of transmission of enveloped and non-enveloped viruses, respectively. In addition to the two specific steps, the anion-exchange chromatography step contributes to the removal of small non-lipid enveloped viruses. The inactivation and reduction of known enveloped and non-enveloped model viruses were validated in laboratory studies as summarized in Table 6. The product potency is expressed in international units (IU) by comparison to the World Health Organization (WHO) standard. In the past, a full dose of Rh o(D) Immune Globulin (Human) has traditionally been referred to as a “300 microgram (mcg)” dose. Potency and dosing recommendations are now expressed in IU by comparison to the WHO anti-Rh o(D) standard. The conversion of mcg to IU is: 1 mcg = 5 IU. A 1,500 IU (300 mcg) vial contains sufficient anti-Rh o(D) to effectively suppress the immunizing potential of approximately 17 mL of Rh o(D) (D-positive) RBCs. The liquid formulation is stabilized with 10% maltose and 0.03% polysorbate 80. There are no preservatives in the formulation. WinRho ®SDF does not contain mercury. This product contains ≤ 40 mcg/mL IgA.</Description>
</NDC>
<NDC>
<NDCCode>49591-330-51</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (49591-330-51) / 1.3 mL in 1 VIAL, GLASS (49591-330-11) </PackageDescription>
<NDC11Code>49591-0330-51</NDC11Code>
<ProductNDC>49591-330</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Winrho Sdf</ProprietaryName>
<NonProprietaryName>Human Rho(d) Immune Globulin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20230801</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103649</ApplicationNumber>
<LabelerName>Kamada Ltd.</LabelerName>
<SubstanceName>HUMAN RHO(D) IMMUNE GLOBULIN</SubstanceName>
<StrengthNumber>1500</StrengthNumber>
<StrengthUnit>[iU]/1.3mL</StrengthUnit>
<Pharm_Classes>Endogenous Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>WinRho ®SDF is a Rh o(D) Immune Globulin Intravenous (Human) (anti-D) product that is indicated for the treatment of ITP in Rh o(D)-positive patients and for the suppression of Rh isoimmunization in non-sensitized Rh o(D)-negative patients.</IndicationAndUsage>
<Description>WinRho ®SDF is a sterile, liquid gamma globulin (IgG) fraction containing antibodies to the Rh o(D) antigen (D antigen). WinRho ®SDF is to be administered intravenously for the treatment of ITP and either intravenously or intramuscularly for the suppression of Rh isoimmunization. WinRho ®SDF is prepared from human plasma by an anion-exchange column chromatography method. The manufacturing process includes two steps implemented specifically for viral clearance. The solvent detergent treatment step (using tri-n-butyl phosphate and octoxynol) is effective in inactivating lipid enveloped viruses such as hepatitis B, hepatitis C, and HIV. Virus filtration, using a 20N virus filter, is effective in the removal of some non-lipid enveloped viruses. These two processes are designed to increase product safety by reducing the risk of transmission of enveloped and non-enveloped viruses, respectively. In addition to the two specific steps, the anion-exchange chromatography step contributes to the removal of small non-lipid enveloped viruses. The inactivation and reduction of known enveloped and non-enveloped model viruses were validated in laboratory studies as summarized in Table 6. The product potency is expressed in international units (IU) by comparison to the World Health Organization (WHO) standard. In the past, a full dose of Rh o(D) Immune Globulin (Human) has traditionally been referred to as a “300 microgram (mcg)” dose. Potency and dosing recommendations are now expressed in IU by comparison to the WHO anti-Rh o(D) standard. The conversion of mcg to IU is: 1 mcg = 5 IU. A 1,500 IU (300 mcg) vial contains sufficient anti-Rh o(D) to effectively suppress the immunizing potential of approximately 17 mL of Rh o(D) (D-positive) RBCs. The liquid formulation is stabilized with 10% maltose and 0.03% polysorbate 80. There are no preservatives in the formulation. WinRho ®SDF does not contain mercury. This product contains ≤ 40 mcg/mL IgA.</Description>
</NDC>
<NDC>
<NDCCode>49591-350-51</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (49591-350-51) / 2.2 mL in 1 VIAL, GLASS (49591-350-02) </PackageDescription>
<NDC11Code>49591-0350-51</NDC11Code>
<ProductNDC>49591-350</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Winrho Sdf</ProprietaryName>
<NonProprietaryName>Human Rho(d) Immune Globulin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20230801</StartMarketingDate>
<EndMarketingDate>20260531</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103649</ApplicationNumber>
<LabelerName>Kamada Ltd.</LabelerName>
<SubstanceName>HUMAN RHO(D) IMMUNE GLOBULIN</SubstanceName>
<StrengthNumber>2500</StrengthNumber>
<StrengthUnit>[iU]/2.2mL</StrengthUnit>
<Pharm_Classes>Endogenous Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230801</StartMarketingDatePackage>
<EndMarketingDatePackage>20260531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>WinRho ®SDF is a Rh o(D) Immune Globulin Intravenous (Human) (anti-D) product that is indicated for the treatment of ITP in Rh o(D)-positive patients and for the suppression of Rh isoimmunization in non-sensitized Rh o(D)-negative patients.</IndicationAndUsage>
<Description>WinRho ®SDF is a sterile, liquid gamma globulin (IgG) fraction containing antibodies to the Rh o(D) antigen (D antigen). WinRho ®SDF is to be administered intravenously for the treatment of ITP and either intravenously or intramuscularly for the suppression of Rh isoimmunization. WinRho ®SDF is prepared from human plasma by an anion-exchange column chromatography method. The manufacturing process includes two steps implemented specifically for viral clearance. The solvent detergent treatment step (using tri-n-butyl phosphate and octoxynol) is effective in inactivating lipid enveloped viruses such as hepatitis B, hepatitis C, and HIV. Virus filtration, using a 20N virus filter, is effective in the removal of some non-lipid enveloped viruses. These two processes are designed to increase product safety by reducing the risk of transmission of enveloped and non-enveloped viruses, respectively. In addition to the two specific steps, the anion-exchange chromatography step contributes to the removal of small non-lipid enveloped viruses. The inactivation and reduction of known enveloped and non-enveloped model viruses were validated in laboratory studies as summarized in Table 6. The product potency is expressed in international units (IU) by comparison to the World Health Organization (WHO) standard. In the past, a full dose of Rh o(D) Immune Globulin (Human) has traditionally been referred to as a “300 microgram (mcg)” dose. Potency and dosing recommendations are now expressed in IU by comparison to the WHO anti-Rh o(D) standard. The conversion of mcg to IU is: 1 mcg = 5 IU. A 1,500 IU (300 mcg) vial contains sufficient anti-Rh o(D) to effectively suppress the immunizing potential of approximately 17 mL of Rh o(D) (D-positive) RBCs. The liquid formulation is stabilized with 10% maltose and 0.03% polysorbate 80. There are no preservatives in the formulation. WinRho ®SDF does not contain mercury. This product contains ≤ 40 mcg/mL IgA.</Description>
</NDC>
<NDC>
<NDCCode>0069-0550-38</NDCCode>
<PackageDescription>28 CAPSULE in 1 BOTTLE (0069-0550-38) </PackageDescription>
<NDC11Code>00069-0550-38</NDC11Code>
<ProductNDC>0069-0550</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sutent</ProprietaryName>
<NonProprietaryName>Sunitinib Malate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060126</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021938</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>SUNITINIB MALATE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060126</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SUTENT is a kinase inhibitor indicated for: 1 treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. (1.1), 2 treatment of adult patients with advanced renal cell carcinoma (RCC). (1.2), 3 adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. (1.3), 4 treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. (1.4).</IndicationAndUsage>
<Description>Sunitinib is a kinase inhibitor present in SUTENT capsules as the malate salt. Sunitinib malate is described chemically as (2S)-2-hydroxybutanedoic acid with N-[2-(diethylamino)ethyl]-5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidine)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide (1:1). The molecular formula is C22H27FN4O2 ∙ C4H6O5 and the molecular weight is 532.6 Daltons. The chemical structure of sunitinib malate is. Sunitinib malate is a yellow to orange powder with a pKa of 8.95. The solubility of sunitinib malate in aqueous media over the range pH 1.2 to pH 6.8 is in excess of 25 mg/mL. The log of the distribution coefficient (octanol/water) at pH 7 is 5.2. SUTENT (sunitinib malate) capsules are supplied as printed hard shell capsules containing 12.5 mg, 25 mg, 37.5 mg or 50 mg of sunitinib (equivalent to 16.7 mg, 33.4 mg, 50.1 mg, or 66.8 mg of sunitinib malate, respectively). The capsules contain the following inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, and povidone (K-25). The orange gelatin capsule shells contain titanium dioxide and red iron oxide; the caramel gelatin capsule shells contain titanium dioxide, red iron oxide, yellow iron oxide, and black iron oxide; and the yellow gelatin capsule shells contain titanium dioxide and yellow iron oxide. The white printing ink contains shellac, propylene glycol, sodium hydroxide, povidone, and titanium dioxide and the black printing ink contains shellac, propylene glycol, potassium hydroxide, and black iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>0069-0770-38</NDCCode>
<PackageDescription>28 CAPSULE in 1 BOTTLE (0069-0770-38) </PackageDescription>
<NDC11Code>00069-0770-38</NDC11Code>
<ProductNDC>0069-0770</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sutent</ProprietaryName>
<NonProprietaryName>Sunitinib Malate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060126</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021938</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>SUNITINIB MALATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060126</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SUTENT is a kinase inhibitor indicated for: 1 treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. (1.1), 2 treatment of adult patients with advanced renal cell carcinoma (RCC). (1.2), 3 adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. (1.3), 4 treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. (1.4).</IndicationAndUsage>
<Description>Sunitinib is a kinase inhibitor present in SUTENT capsules as the malate salt. Sunitinib malate is described chemically as (2S)-2-hydroxybutanedoic acid with N-[2-(diethylamino)ethyl]-5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidine)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide (1:1). The molecular formula is C22H27FN4O2 ∙ C4H6O5 and the molecular weight is 532.6 Daltons. The chemical structure of sunitinib malate is. Sunitinib malate is a yellow to orange powder with a pKa of 8.95. The solubility of sunitinib malate in aqueous media over the range pH 1.2 to pH 6.8 is in excess of 25 mg/mL. The log of the distribution coefficient (octanol/water) at pH 7 is 5.2. SUTENT (sunitinib malate) capsules are supplied as printed hard shell capsules containing 12.5 mg, 25 mg, 37.5 mg or 50 mg of sunitinib (equivalent to 16.7 mg, 33.4 mg, 50.1 mg, or 66.8 mg of sunitinib malate, respectively). The capsules contain the following inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, and povidone (K-25). The orange gelatin capsule shells contain titanium dioxide and red iron oxide; the caramel gelatin capsule shells contain titanium dioxide, red iron oxide, yellow iron oxide, and black iron oxide; and the yellow gelatin capsule shells contain titanium dioxide and yellow iron oxide. The white printing ink contains shellac, propylene glycol, sodium hydroxide, povidone, and titanium dioxide and the black printing ink contains shellac, propylene glycol, potassium hydroxide, and black iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>0069-0830-38</NDCCode>
<PackageDescription>28 CAPSULE in 1 BOTTLE (0069-0830-38) </PackageDescription>
<NDC11Code>00069-0830-38</NDC11Code>
<ProductNDC>0069-0830</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sutent</ProprietaryName>
<NonProprietaryName>Sunitinib Malate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140712</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021938</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>SUNITINIB MALATE</SubstanceName>
<StrengthNumber>37.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140712</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SUTENT is a kinase inhibitor indicated for: 1 treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. (1.1), 2 treatment of adult patients with advanced renal cell carcinoma (RCC). (1.2), 3 adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. (1.3), 4 treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. (1.4).</IndicationAndUsage>
<Description>Sunitinib is a kinase inhibitor present in SUTENT capsules as the malate salt. Sunitinib malate is described chemically as (2S)-2-hydroxybutanedoic acid with N-[2-(diethylamino)ethyl]-5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidine)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide (1:1). The molecular formula is C22H27FN4O2 ∙ C4H6O5 and the molecular weight is 532.6 Daltons. The chemical structure of sunitinib malate is. Sunitinib malate is a yellow to orange powder with a pKa of 8.95. The solubility of sunitinib malate in aqueous media over the range pH 1.2 to pH 6.8 is in excess of 25 mg/mL. The log of the distribution coefficient (octanol/water) at pH 7 is 5.2. SUTENT (sunitinib malate) capsules are supplied as printed hard shell capsules containing 12.5 mg, 25 mg, 37.5 mg or 50 mg of sunitinib (equivalent to 16.7 mg, 33.4 mg, 50.1 mg, or 66.8 mg of sunitinib malate, respectively). The capsules contain the following inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, and povidone (K-25). The orange gelatin capsule shells contain titanium dioxide and red iron oxide; the caramel gelatin capsule shells contain titanium dioxide, red iron oxide, yellow iron oxide, and black iron oxide; and the yellow gelatin capsule shells contain titanium dioxide and yellow iron oxide. The white printing ink contains shellac, propylene glycol, sodium hydroxide, povidone, and titanium dioxide and the black printing ink contains shellac, propylene glycol, potassium hydroxide, and black iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>0069-0980-38</NDCCode>
<PackageDescription>28 CAPSULE in 1 BOTTLE (0069-0980-38) </PackageDescription>
<NDC11Code>00069-0980-38</NDC11Code>
<ProductNDC>0069-0980</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sutent</ProprietaryName>
<NonProprietaryName>Sunitinib Malate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060126</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021938</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>SUNITINIB MALATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060126</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SUTENT is a kinase inhibitor indicated for: 1 treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. (1.1), 2 treatment of adult patients with advanced renal cell carcinoma (RCC). (1.2), 3 adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. (1.3), 4 treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. (1.4).</IndicationAndUsage>
<Description>Sunitinib is a kinase inhibitor present in SUTENT capsules as the malate salt. Sunitinib malate is described chemically as (2S)-2-hydroxybutanedoic acid with N-[2-(diethylamino)ethyl]-5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidine)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide (1:1). The molecular formula is C22H27FN4O2 ∙ C4H6O5 and the molecular weight is 532.6 Daltons. The chemical structure of sunitinib malate is. Sunitinib malate is a yellow to orange powder with a pKa of 8.95. The solubility of sunitinib malate in aqueous media over the range pH 1.2 to pH 6.8 is in excess of 25 mg/mL. The log of the distribution coefficient (octanol/water) at pH 7 is 5.2. SUTENT (sunitinib malate) capsules are supplied as printed hard shell capsules containing 12.5 mg, 25 mg, 37.5 mg or 50 mg of sunitinib (equivalent to 16.7 mg, 33.4 mg, 50.1 mg, or 66.8 mg of sunitinib malate, respectively). The capsules contain the following inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, and povidone (K-25). The orange gelatin capsule shells contain titanium dioxide and red iron oxide; the caramel gelatin capsule shells contain titanium dioxide, red iron oxide, yellow iron oxide, and black iron oxide; and the yellow gelatin capsule shells contain titanium dioxide and yellow iron oxide. The white printing ink contains shellac, propylene glycol, sodium hydroxide, povidone, and titanium dioxide and the black printing ink contains shellac, propylene glycol, potassium hydroxide, and black iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>0093-8199-28</NDCCode>
<PackageDescription>28 CAPSULE in 1 BOTTLE (0093-8199-28) </PackageDescription>
<NDC11Code>00093-8199-28</NDC11Code>
<ProductNDC>0093-8199</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sunitinib Malate</ProprietaryName>
<NonProprietaryName>Sunitinib Malate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213803</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>SUNITINIB MALATE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sunitinib malate capsules are a kinase inhibitor indicated for: 1 treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. (1.1), 2 treatment of adult patients with advanced renal cell carcinoma (RCC). (1.2), 3 adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. (1.3), 4 treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. (1.4).</IndicationAndUsage>
<Description>Sunitinib is a kinase inhibitor present in sunitinib malate capsules as the malate salt. Sunitinib malate is described chemically as (2S)-2-hydroxybutanedoic acid with N-[2-(diethylamino)ethyl]-5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidine)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide (1:1). The molecular formula is C22H27FN4O2 ● C4H6O5 and the molecular weight is 532.6 Daltons. The chemical structure of sunitinib malate is. Sunitinib malate is a yellow to orange powder with a pKa of 8.95. The solubility of sunitinib malate in aqueous media over the range pH 1.2 to pH 6.8 is in excess of 0.4 mg/mL. The log of the distribution coefficient (octanol/water) at pH 7 is 5.2. Sunitinib malate capsules are supplied as printed hard shell capsules containing 12.5 mg, 25 mg, 37.5 mg or 50 mg of sunitinib (equivalent to 16.7 mg, 33.4 mg, 50.1 mg, or 66.8 mg of sunitinib malate, respectively). The capsules contain the following inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, and povidone K-30. The 12.5 mg capsule shell contains D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, and titanium dioxide. The 25 mg capsule shell contains D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, and titanium dioxide. The 37.5 mg capsule shell contains gelatin, titanium dioxide, and yellow iron oxide. The 50 mg capsule shell contains FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, and titanium dioxide. The black printing ink which is common for all strengths contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, shellac, and may also contain propylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>0093-8224-28</NDCCode>
<PackageDescription>28 CAPSULE in 1 BOTTLE (0093-8224-28) </PackageDescription>
<NDC11Code>00093-8224-28</NDC11Code>
<ProductNDC>0093-8224</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sunitinib Malate</ProprietaryName>
<NonProprietaryName>Sunitinib Malate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213803</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>SUNITINIB MALATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sunitinib malate capsules are a kinase inhibitor indicated for: 1 treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. (1.1), 2 treatment of adult patients with advanced renal cell carcinoma (RCC). (1.2), 3 adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. (1.3), 4 treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. (1.4).</IndicationAndUsage>
<Description>Sunitinib is a kinase inhibitor present in sunitinib malate capsules as the malate salt. Sunitinib malate is described chemically as (2S)-2-hydroxybutanedoic acid with N-[2-(diethylamino)ethyl]-5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidine)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide (1:1). The molecular formula is C22H27FN4O2 ● C4H6O5 and the molecular weight is 532.6 Daltons. The chemical structure of sunitinib malate is. Sunitinib malate is a yellow to orange powder with a pKa of 8.95. The solubility of sunitinib malate in aqueous media over the range pH 1.2 to pH 6.8 is in excess of 0.4 mg/mL. The log of the distribution coefficient (octanol/water) at pH 7 is 5.2. Sunitinib malate capsules are supplied as printed hard shell capsules containing 12.5 mg, 25 mg, 37.5 mg or 50 mg of sunitinib (equivalent to 16.7 mg, 33.4 mg, 50.1 mg, or 66.8 mg of sunitinib malate, respectively). The capsules contain the following inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, and povidone K-30. The 12.5 mg capsule shell contains D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, and titanium dioxide. The 25 mg capsule shell contains D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, and titanium dioxide. The 37.5 mg capsule shell contains gelatin, titanium dioxide, and yellow iron oxide. The 50 mg capsule shell contains FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, and titanium dioxide. The black printing ink which is common for all strengths contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, shellac, and may also contain propylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>0093-8229-28</NDCCode>
<PackageDescription>28 CAPSULE in 1 BOTTLE (0093-8229-28) </PackageDescription>
<NDC11Code>00093-8229-28</NDC11Code>
<ProductNDC>0093-8229</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sunitinib Malate</ProprietaryName>
<NonProprietaryName>Sunitinib Malate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213803</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>SUNITINIB MALATE</SubstanceName>
<StrengthNumber>37.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sunitinib malate capsules are a kinase inhibitor indicated for: 1 treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. (1.1), 2 treatment of adult patients with advanced renal cell carcinoma (RCC). (1.2), 3 adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. (1.3), 4 treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. (1.4).</IndicationAndUsage>
<Description>Sunitinib is a kinase inhibitor present in sunitinib malate capsules as the malate salt. Sunitinib malate is described chemically as (2S)-2-hydroxybutanedoic acid with N-[2-(diethylamino)ethyl]-5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidine)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide (1:1). The molecular formula is C22H27FN4O2 ● C4H6O5 and the molecular weight is 532.6 Daltons. The chemical structure of sunitinib malate is. Sunitinib malate is a yellow to orange powder with a pKa of 8.95. The solubility of sunitinib malate in aqueous media over the range pH 1.2 to pH 6.8 is in excess of 0.4 mg/mL. The log of the distribution coefficient (octanol/water) at pH 7 is 5.2. Sunitinib malate capsules are supplied as printed hard shell capsules containing 12.5 mg, 25 mg, 37.5 mg or 50 mg of sunitinib (equivalent to 16.7 mg, 33.4 mg, 50.1 mg, or 66.8 mg of sunitinib malate, respectively). The capsules contain the following inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, and povidone K-30. The 12.5 mg capsule shell contains D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, and titanium dioxide. The 25 mg capsule shell contains D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, and titanium dioxide. The 37.5 mg capsule shell contains gelatin, titanium dioxide, and yellow iron oxide. The 50 mg capsule shell contains FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, and titanium dioxide. The black printing ink which is common for all strengths contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, shellac, and may also contain propylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>0093-8231-28</NDCCode>
<PackageDescription>28 CAPSULE in 1 BOTTLE (0093-8231-28) </PackageDescription>
<NDC11Code>00093-8231-28</NDC11Code>
<ProductNDC>0093-8231</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sunitinib Malate</ProprietaryName>
<NonProprietaryName>Sunitinib Malate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213803</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>SUNITINIB MALATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sunitinib malate capsules are a kinase inhibitor indicated for: 1 treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. (1.1), 2 treatment of adult patients with advanced renal cell carcinoma (RCC). (1.2), 3 adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. (1.3), 4 treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. (1.4).</IndicationAndUsage>
<Description>Sunitinib is a kinase inhibitor present in sunitinib malate capsules as the malate salt. Sunitinib malate is described chemically as (2S)-2-hydroxybutanedoic acid with N-[2-(diethylamino)ethyl]-5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidine)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide (1:1). The molecular formula is C22H27FN4O2 ● C4H6O5 and the molecular weight is 532.6 Daltons. The chemical structure of sunitinib malate is. Sunitinib malate is a yellow to orange powder with a pKa of 8.95. The solubility of sunitinib malate in aqueous media over the range pH 1.2 to pH 6.8 is in excess of 0.4 mg/mL. The log of the distribution coefficient (octanol/water) at pH 7 is 5.2. Sunitinib malate capsules are supplied as printed hard shell capsules containing 12.5 mg, 25 mg, 37.5 mg or 50 mg of sunitinib (equivalent to 16.7 mg, 33.4 mg, 50.1 mg, or 66.8 mg of sunitinib malate, respectively). The capsules contain the following inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, and povidone K-30. The 12.5 mg capsule shell contains D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, and titanium dioxide. The 25 mg capsule shell contains D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, and titanium dioxide. The 37.5 mg capsule shell contains gelatin, titanium dioxide, and yellow iron oxide. The 50 mg capsule shell contains FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, and titanium dioxide. The black printing ink which is common for all strengths contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, shellac, and may also contain propylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>0116-0767-18</NDCCode>
<PackageDescription>532 mL in 1 BOTTLE, PUMP (0116-0767-18) </PackageDescription>
<NDC11Code>00116-0767-18</NDC11Code>
<ProductNDC>0116-0767</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antiseptic Skin Cleanser</ProprietaryName>
<NonProprietaryName>Chlorhexidine Gluconate 4%</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110831</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019125</ApplicationNumber>
<LabelerName>Xttrium Laboratories, Inc.</LabelerName>
<SubstanceName>CHLORHEXIDINE GLUCONATE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Decreased Cell Wall Integrity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221114</StartMarketingDatePackage>
<EndMarketingDatePackage>20270131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>: 1 healthcare personnel handwash: helps reduce bacteria that potentially can cause disease , 2 skin wound and general skin cleansing.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0116-1061-18</NDCCode>
<PackageDescription>532 mL in 1 BOTTLE (0116-1061-18) </PackageDescription>
<NDC11Code>00116-1061-18</NDC11Code>
<ProductNDC>0116-1061</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antiseptic Skin Cleanser</ProprietaryName>
<NonProprietaryName>Chlorhexidine Gluconate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110831</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019125</ApplicationNumber>
<LabelerName>Xttrium Laboratories, Inc.</LabelerName>
<SubstanceName>CHLORHEXIDINE GLUCONATE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Decreased Cell Wall Integrity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110831</StartMarketingDatePackage>
<EndMarketingDatePackage>20260831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care . healthcare personnel handwash: helps reduce bacteria that potentially can cause disease . skin wound and general skin cleansing.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0168-0346-46</NDCCode>
<PackageDescription>45 g in 1 TUBE, WITH APPLICATOR (0168-0346-46) </PackageDescription>
<NDC11Code>00168-0346-46</NDC11Code>
<ProductNDC>0168-0346</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Terconazole</ProprietaryName>
<NonProprietaryName>Terconazole</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>VAGINAL</RouteName>
<StartMarketingDate>20050218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076712</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC</LabelerName>
<SubstanceName>TERCONAZOLE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Terconazole vaginal cream 0.4% is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As terconazole vaginal cream 0.4% is effective only for vulvovaginitis caused by the genus Candida, the diagnosis should be confirmed by KOH smears and/or cultures.</IndicationAndUsage>
<Description>Terconazole vaginal cream 0.4% is a white to off-white, water washable cream for intravaginal administration containing 0.4% of the antifungal agent terconazole, cis-1-[p-[[2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-4-isopropylpiperazine, compounded in a cream base consisting of butylated hydroxyanisole, cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, propylene glycol, stearyl alcohol, and purified water. The structural formula of terconazole is as follows:. Terconazole, a triazole derivative, is a white to almost white powder with a molecular weight of 532.47. It is insoluble in water; sparingly soluble in ethanol; and soluble in butanol.</Description>
</NDC>
<NDC>
<NDCCode>0168-0347-20</NDCCode>
<PackageDescription>20 g in 1 TUBE, WITH APPLICATOR (0168-0347-20) </PackageDescription>
<NDC11Code>00168-0347-20</NDC11Code>
<ProductNDC>0168-0347</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Terconazole</ProprietaryName>
<ProprietaryNameSuffix>Vaginal Cream 0.8%</ProprietaryNameSuffix>
<NonProprietaryName>Terconazole</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>VAGINAL</RouteName>
<StartMarketingDate>20050201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021735</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC</LabelerName>
<SubstanceName>TERCONAZOLE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Terconazole Vaginal Cream, is indicated for the treatment of vulvovaginal candidiasis in adult females.</IndicationAndUsage>
<Description>Terconazole Vaginal Cream, 0.8% is a white to off-white, water washable cream for intravaginal administration containing 0.8% of the antifungal agent terconazole, cis-1-[p[[2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4- yl]methoxy]phenyl]-4-isopropylpiperazine, compounded in a cream base consisting of butylated hydroxyanisole, cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, propylene glycol, stearyl alcohol, and purified water. The structural formula of terconazole is as follows. Terconazole, a triazole derivative, is a white to almost white powder with a molecular weight of 532.47. It is insoluble in water; sparingly soluble in ethanol; and soluble in butanol.</Description>
</NDC>
<NDC>
<NDCCode>0363-0070-44</NDCCode>
<PackageDescription>532 mL in 1 BOTTLE, PLASTIC (0363-0070-44) </PackageDescription>
<NDC11Code>00363-0070-44</NDC11Code>
<ProductNDC>0363-0070</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anticavity</ProprietaryName>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>RINSE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130923</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part355</ApplicationNumber>
<LabelerName>Walgreen Co.</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130923</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0363-0619-44</NDCCode>
<PackageDescription>532 g in 1 BOTTLE, PLASTIC (0363-0619-44) </PackageDescription>
<NDC11Code>00363-0619-44</NDC11Code>
<ProductNDC>0363-0619</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Daily Moisturizing</ProprietaryName>
<NonProprietaryName>Daily Moistruizing</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130206</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Walgreen, Co.</LabelerName>
<SubstanceName>DIMETHICONE</SubstanceName>
<StrengthNumber>13</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent and temporarily protects chafed, chapped, or cracked skin. helps protect from the drying effects of wind and cold weather.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0363-1061-18</NDCCode>
<PackageDescription>532 mL in 1 BOTTLE, PUMP (0363-1061-18) </PackageDescription>
<NDC11Code>00363-1061-18</NDC11Code>
<ProductNDC>0363-1061</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antiseptic Skin Cleanser</ProprietaryName>
<NonProprietaryName>Chlorhexidine Gluconate 4%</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110501</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019125</ApplicationNumber>
<LabelerName>Walgreen Co.</LabelerName>
<SubstanceName>CHLORHEXIDINE GLUCONATE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Pharm_Classes>Decreased Cell Wall Integrity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210111</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>healthcare personnel handwash: helps reduce bacteria that potentially can cause disease . skin wound and general skin cleansing.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0363-1571-44</NDCCode>
<PackageDescription>532 mL in 1 BOTTLE (0363-1571-44) </PackageDescription>
<NDC11Code>00363-1571-44</NDC11Code>
<ProductNDC>0363-1571</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Moisturizing Skin Relief</ProprietaryName>
<NonProprietaryName>Dimethicone 1.2%</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200817</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Walgreens</LabelerName>
<SubstanceName>DIMETHICONE</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200817</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent, temporarily protects chafed, chapped or cracked skin. helps prevent and protect from the drying effects of wind and cold weather.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0363-3701-80</NDCCode>
<PackageDescription>532 mL in 1 BOTTLE, PLASTIC (0363-3701-80)</PackageDescription>
<NDC11Code>00363-3701-80</NDC11Code>
<ProductNDC>0363-3701</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Studio 35</ProprietaryName>
<ProprietaryNameSuffix>Spring Morning</ProprietaryNameSuffix>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130708</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>WALGREEN COMPANY</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>FOR WASHING TO DECREASE BACTERIA ON THE SKIN.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0363-5990-18</NDCCode>
<PackageDescription>532 mL in 1 BOTTLE, PLASTIC (0363-5990-18) </PackageDescription>
<NDC11Code>00363-5990-18</NDC11Code>
<ProductNDC>0363-5990</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Daily Moisturizer</ProprietaryName>
<NonProprietaryName>Lotion</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230911</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Walgreen</LabelerName>
<SubstanceName>DIMETHICONE</SubstanceName>
<StrengthNumber>1200</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230911</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent and temporarily protects chafed, chapped or cracked skin. Helps protect from the drying effects of winf and cold weather.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0363-5995-18</NDCCode>
<PackageDescription>532 mL in 1 BOTTLE, PLASTIC (0363-5995-18) </PackageDescription>
<NDC11Code>00363-5995-18</NDC11Code>
<ProductNDC>0363-5995</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Skin Relief</ProprietaryName>
<NonProprietaryName>Lotion</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230911</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Walgreen</LabelerName>
<SubstanceName>DIMETHICONE</SubstanceName>
<StrengthNumber>1200</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230911</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent and temporarily protects chafed, chapped or cracked skin. Helps protect from the drying effects of wind and cold weather.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0378-6678-28</NDCCode>
<PackageDescription>28 CAPSULE in 1 BOTTLE, PLASTIC (0378-6678-28) </PackageDescription>
<NDC11Code>00378-6678-28</NDC11Code>
<ProductNDC>0378-6678</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sunitinib Malate</ProprietaryName>
<NonProprietaryName>Sunitinib Malate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220104</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201275</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>SUNITINIB MALATE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sunitinib malate capsules are a kinase inhibitor indicated for: 1 treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. (1.1), 2 treatment of adult patients with advanced renal cell carcinoma (RCC). (1.2), 3 adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. (1.3), 4 treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. (1.4).</IndicationAndUsage>
<Description>Sunitinib is a kinase inhibitor present in sunitinib malate capsules as the malate salt. Sunitinib malate is described chemically as N-[2-(Diethylamino)ethyl]-5-[(Z)-(5-fluoro-2-oxo-1,2-dihydro-3H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide hydrogen (2S)-2-hydroxybutanedioate. The molecular formula is C22H27FN4O2 C4H6O5 and the molecular weight is 532.6. The chemical structure of sunitinib malate is:. Sunitinib malate is a yellow to orange powder with a pKa of 8.95. The solubility of sunitinib malate in aqueous media over the range pH 1.2 to pH 6.8 is in excess of 25 mg/mL. The log of the distribution coefficient (octanol/water) at pH 7 is 5.2. Sunitinib malate capsules are supplied as printed hard-shell capsules containing 12.5 mg, 25 mg, 37.5 mg or 50 mg of sunitinib (equivalent to 16.7 mg, 33.4 mg, 50.1 mg, or 66.8 mg of sunitinib malate, respectively). The capsules contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, gelatin, magnesium stearate, mannitol, sodium lauryl sulfate and titanium dioxide. The 12.5 mg and 25 mg strengths also contain red iron oxide. The 25 mg, 37.5 mg and 50 mg strengths also contain yellow iron oxide. In addition, the black imprinting ink contains the following: ammonium hydroxide, black iron oxide, propylene glycol and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>0378-6679-28</NDCCode>
<PackageDescription>28 CAPSULE in 1 BOTTLE, PLASTIC (0378-6679-28) </PackageDescription>
<NDC11Code>00378-6679-28</NDC11Code>
<ProductNDC>0378-6679</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sunitinib Malate</ProprietaryName>
<NonProprietaryName>Sunitinib Malate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220104</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201275</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>SUNITINIB MALATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sunitinib malate capsules are a kinase inhibitor indicated for: 1 treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. (1.1), 2 treatment of adult patients with advanced renal cell carcinoma (RCC). (1.2), 3 adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. (1.3), 4 treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. (1.4).</IndicationAndUsage>
<Description>Sunitinib is a kinase inhibitor present in sunitinib malate capsules as the malate salt. Sunitinib malate is described chemically as N-[2-(Diethylamino)ethyl]-5-[(Z)-(5-fluoro-2-oxo-1,2-dihydro-3H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide hydrogen (2S)-2-hydroxybutanedioate. The molecular formula is C22H27FN4O2 C4H6O5 and the molecular weight is 532.6. The chemical structure of sunitinib malate is:. Sunitinib malate is a yellow to orange powder with a pKa of 8.95. The solubility of sunitinib malate in aqueous media over the range pH 1.2 to pH 6.8 is in excess of 25 mg/mL. The log of the distribution coefficient (octanol/water) at pH 7 is 5.2. Sunitinib malate capsules are supplied as printed hard-shell capsules containing 12.5 mg, 25 mg, 37.5 mg or 50 mg of sunitinib (equivalent to 16.7 mg, 33.4 mg, 50.1 mg, or 66.8 mg of sunitinib malate, respectively). The capsules contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, gelatin, magnesium stearate, mannitol, sodium lauryl sulfate and titanium dioxide. The 12.5 mg and 25 mg strengths also contain red iron oxide. The 25 mg, 37.5 mg and 50 mg strengths also contain yellow iron oxide. In addition, the black imprinting ink contains the following: ammonium hydroxide, black iron oxide, propylene glycol and shellac glaze.</Description>
</NDC>
</NDCList>