{
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"PackageDescription": "1 KIT in 1 CARTON (69911-478-02) * 5 mL in 1 VIAL, SINGLE-USE (69911-765-84) * 5 mL in 1 VIAL, SINGLE-USE (69911-488-01) ",
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"Description": "AFSTYLA is a single-chain recombinant Factor VIII produced in chinese hamster ovary (CHO) cells. It is a construct where the B-domain occurring in wild type full-length Factor VIII has been truncated and 4 amino acids of the adjacent acidic a3 domain were removed (amino acids 765 to 1652 of full-length Factor VIII). AFSTYLA is expressed as a single-chain Factor VIII molecule with covalent linkage between heavy and light chains; thereby keeping the molecule in the single-chain form resulting in increased stability and increased von Willebrand Factor (VWF) affinity. Except for a new N-glycosylation site at the junction between heavy and light chains, the post-translational modifications are comparable to endogenous Factor VIII. AFSTYLA is purified by a controlled multi-step process including two virus reduction steps complementing each other in their mode of action. No human or animal derived proteins are used in the purification or formulation processes. AFSTYLA is a preservative-free, sterile, non-pyrogenic, lyophilized powder to be reconstituted with sterile water for injection (sWFI) for intravenous injection. AFSTYLA is available in single-dose vials containing the labeled amount of Factor VIII activity, expressed in IU. Each vial contains nominally 250, 500, 1000, 1500, 2000, 2500, or 3000 IU of AFSTYLA. The actual potency is labeled on each AFSTYLA vial and carton. After reconstitution of the lyophilized powder, all dosage strengths yield an almost colorless to slightly opalescent solution. The concentrations of excipients based on the vial size, as well as the amount of sWFI for reconstitution are provided in Table 4 below. The number of units of Factor VIII administered is expressed in IU, which are related to the current WHO standard for Factor VIII products. One IU of Factor VIII activity in plasma is equivalent to that quantity of Factor VIII in 1 mL of normal plasma. Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or in IU (relative to an International Standard for Factor VIII in plasma)."
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{
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"PackageDescription": "1 KIT in 1 CARTON (69911-474-02) * 2.5 mL in 1 VIAL, SINGLE-USE (69911-484-01) * 2.5 mL in 1 VIAL, SINGLE-USE (69911-765-83) ",
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"IndicationAndUsage": "AFSTYLA, Antihemophilic Factor (Recombinant), Single Chain is a recombinant, antihemophilic factor indicated in adults and children with hemophilia A (congenital Factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes,, 2 Routine prophylaxis to reduce the frequency of bleeding episodes,, 3 Perioperative management of bleeding.",
"Description": "AFSTYLA is a single-chain recombinant Factor VIII produced in chinese hamster ovary (CHO) cells. It is a construct where the B-domain occurring in wild type full-length Factor VIII has been truncated and 4 amino acids of the adjacent acidic a3 domain were removed (amino acids 765 to 1652 of full-length Factor VIII). AFSTYLA is expressed as a single-chain Factor VIII molecule with covalent linkage between heavy and light chains; thereby keeping the molecule in the single-chain form resulting in increased stability and increased von Willebrand Factor (VWF) affinity. Except for a new N-glycosylation site at the junction between heavy and light chains, the post-translational modifications are comparable to endogenous Factor VIII. AFSTYLA is purified by a controlled multi-step process including two virus reduction steps complementing each other in their mode of action. No human or animal derived proteins are used in the purification or formulation processes. AFSTYLA is a preservative-free, sterile, non-pyrogenic, lyophilized powder to be reconstituted with sterile water for injection (sWFI) for intravenous injection. AFSTYLA is available in single-dose vials containing the labeled amount of Factor VIII activity, expressed in IU. Each vial contains nominally 250, 500, 1000, 1500, 2000, 2500, or 3000 IU of AFSTYLA. The actual potency is labeled on each AFSTYLA vial and carton. After reconstitution of the lyophilized powder, all dosage strengths yield an almost colorless to slightly opalescent solution. The concentrations of excipients based on the vial size, as well as the amount of sWFI for reconstitution are provided in Table 4 below. The number of units of Factor VIII administered is expressed in IU, which are related to the current WHO standard for Factor VIII products. One IU of Factor VIII activity in plasma is equivalent to that quantity of Factor VIII in 1 mL of normal plasma. Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or in IU (relative to an International Standard for Factor VIII in plasma)."
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"PackageDescription": "1 KIT in 1 CARTON (69911-475-02) * 2.5 mL in 1 VIAL, SINGLE-USE (69911-765-83) * 2.5 mL in 1 VIAL, SINGLE-USE (69911-485-01) ",
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"ProductTypeName": "PLASMA DERIVATIVE",
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"IndicationAndUsage": "AFSTYLA, Antihemophilic Factor (Recombinant), Single Chain is a recombinant, antihemophilic factor indicated in adults and children with hemophilia A (congenital Factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes,, 2 Routine prophylaxis to reduce the frequency of bleeding episodes,, 3 Perioperative management of bleeding.",
"Description": "AFSTYLA is a single-chain recombinant Factor VIII produced in chinese hamster ovary (CHO) cells. It is a construct where the B-domain occurring in wild type full-length Factor VIII has been truncated and 4 amino acids of the adjacent acidic a3 domain were removed (amino acids 765 to 1652 of full-length Factor VIII). AFSTYLA is expressed as a single-chain Factor VIII molecule with covalent linkage between heavy and light chains; thereby keeping the molecule in the single-chain form resulting in increased stability and increased von Willebrand Factor (VWF) affinity. Except for a new N-glycosylation site at the junction between heavy and light chains, the post-translational modifications are comparable to endogenous Factor VIII. AFSTYLA is purified by a controlled multi-step process including two virus reduction steps complementing each other in their mode of action. No human or animal derived proteins are used in the purification or formulation processes. AFSTYLA is a preservative-free, sterile, non-pyrogenic, lyophilized powder to be reconstituted with sterile water for injection (sWFI) for intravenous injection. AFSTYLA is available in single-dose vials containing the labeled amount of Factor VIII activity, expressed in IU. Each vial contains nominally 250, 500, 1000, 1500, 2000, 2500, or 3000 IU of AFSTYLA. The actual potency is labeled on each AFSTYLA vial and carton. After reconstitution of the lyophilized powder, all dosage strengths yield an almost colorless to slightly opalescent solution. The concentrations of excipients based on the vial size, as well as the amount of sWFI for reconstitution are provided in Table 4 below. The number of units of Factor VIII administered is expressed in IU, which are related to the current WHO standard for Factor VIII products. One IU of Factor VIII activity in plasma is equivalent to that quantity of Factor VIII in 1 mL of normal plasma. Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or in IU (relative to an International Standard for Factor VIII in plasma)."
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"PackageDescription": "1 KIT in 1 CARTON (69911-476-02) * 2.5 mL in 1 VIAL, SINGLE-USE (69911-486-01) * 2.5 mL in 1 VIAL, SINGLE-USE (69911-765-83) ",
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"IndicationAndUsage": "AFSTYLA, Antihemophilic Factor (Recombinant), Single Chain is a recombinant, antihemophilic factor indicated in adults and children with hemophilia A (congenital Factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes,, 2 Routine prophylaxis to reduce the frequency of bleeding episodes,, 3 Perioperative management of bleeding.",
"Description": "AFSTYLA is a single-chain recombinant Factor VIII produced in chinese hamster ovary (CHO) cells. It is a construct where the B-domain occurring in wild type full-length Factor VIII has been truncated and 4 amino acids of the adjacent acidic a3 domain were removed (amino acids 765 to 1652 of full-length Factor VIII). AFSTYLA is expressed as a single-chain Factor VIII molecule with covalent linkage between heavy and light chains; thereby keeping the molecule in the single-chain form resulting in increased stability and increased von Willebrand Factor (VWF) affinity. Except for a new N-glycosylation site at the junction between heavy and light chains, the post-translational modifications are comparable to endogenous Factor VIII. AFSTYLA is purified by a controlled multi-step process including two virus reduction steps complementing each other in their mode of action. No human or animal derived proteins are used in the purification or formulation processes. AFSTYLA is a preservative-free, sterile, non-pyrogenic, lyophilized powder to be reconstituted with sterile water for injection (sWFI) for intravenous injection. AFSTYLA is available in single-dose vials containing the labeled amount of Factor VIII activity, expressed in IU. Each vial contains nominally 250, 500, 1000, 1500, 2000, 2500, or 3000 IU of AFSTYLA. The actual potency is labeled on each AFSTYLA vial and carton. After reconstitution of the lyophilized powder, all dosage strengths yield an almost colorless to slightly opalescent solution. The concentrations of excipients based on the vial size, as well as the amount of sWFI for reconstitution are provided in Table 4 below. The number of units of Factor VIII administered is expressed in IU, which are related to the current WHO standard for Factor VIII products. One IU of Factor VIII activity in plasma is equivalent to that quantity of Factor VIII in 1 mL of normal plasma. Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or in IU (relative to an International Standard for Factor VIII in plasma)."
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{
"NDCCode": "69911-477-02",
"PackageDescription": "1 KIT in 1 CARTON (69911-477-02) * 5 mL in 1 VIAL, SINGLE-USE (69911-487-01) * 5 mL in 1 VIAL, SINGLE-USE (69911-765-84) ",
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"IndicationAndUsage": "AFSTYLA, Antihemophilic Factor (Recombinant), Single Chain is a recombinant, antihemophilic factor indicated in adults and children with hemophilia A (congenital Factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes,, 2 Routine prophylaxis to reduce the frequency of bleeding episodes,, 3 Perioperative management of bleeding.",
"Description": "AFSTYLA is a single-chain recombinant Factor VIII produced in chinese hamster ovary (CHO) cells. It is a construct where the B-domain occurring in wild type full-length Factor VIII has been truncated and 4 amino acids of the adjacent acidic a3 domain were removed (amino acids 765 to 1652 of full-length Factor VIII). AFSTYLA is expressed as a single-chain Factor VIII molecule with covalent linkage between heavy and light chains; thereby keeping the molecule in the single-chain form resulting in increased stability and increased von Willebrand Factor (VWF) affinity. Except for a new N-glycosylation site at the junction between heavy and light chains, the post-translational modifications are comparable to endogenous Factor VIII. AFSTYLA is purified by a controlled multi-step process including two virus reduction steps complementing each other in their mode of action. No human or animal derived proteins are used in the purification or formulation processes. AFSTYLA is a preservative-free, sterile, non-pyrogenic, lyophilized powder to be reconstituted with sterile water for injection (sWFI) for intravenous injection. AFSTYLA is available in single-dose vials containing the labeled amount of Factor VIII activity, expressed in IU. Each vial contains nominally 250, 500, 1000, 1500, 2000, 2500, or 3000 IU of AFSTYLA. The actual potency is labeled on each AFSTYLA vial and carton. After reconstitution of the lyophilized powder, all dosage strengths yield an almost colorless to slightly opalescent solution. The concentrations of excipients based on the vial size, as well as the amount of sWFI for reconstitution are provided in Table 4 below. The number of units of Factor VIII administered is expressed in IU, which are related to the current WHO standard for Factor VIII products. One IU of Factor VIII activity in plasma is equivalent to that quantity of Factor VIII in 1 mL of normal plasma. Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or in IU (relative to an International Standard for Factor VIII in plasma)."
},
{
"NDCCode": "69911-480-02",
"PackageDescription": "1 KIT in 1 CARTON (69911-480-02) * 5 mL in 1 VIAL, SINGLE-USE (69911-490-01) * 5 mL in 1 VIAL, SINGLE-USE (69911-765-84) ",
"NDC11Code": "69911-0480-02",
"ProductNDC": "69911-480",
"ProductTypeName": "PLASMA DERIVATIVE",
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"StartMarketingDate": "20170328",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125591",
"LabelerName": "CSL Behring Lengnau AG",
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"IndicationAndUsage": "AFSTYLA, Antihemophilic Factor (Recombinant), Single Chain is a recombinant, antihemophilic factor indicated in adults and children with hemophilia A (congenital Factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes,, 2 Routine prophylaxis to reduce the frequency of bleeding episodes,, 3 Perioperative management of bleeding.",
"Description": "AFSTYLA is a single-chain recombinant Factor VIII produced in chinese hamster ovary (CHO) cells. It is a construct where the B-domain occurring in wild type full-length Factor VIII has been truncated and 4 amino acids of the adjacent acidic a3 domain were removed (amino acids 765 to 1652 of full-length Factor VIII). AFSTYLA is expressed as a single-chain Factor VIII molecule with covalent linkage between heavy and light chains; thereby keeping the molecule in the single-chain form resulting in increased stability and increased von Willebrand Factor (VWF) affinity. Except for a new N-glycosylation site at the junction between heavy and light chains, the post-translational modifications are comparable to endogenous Factor VIII. AFSTYLA is purified by a controlled multi-step process including two virus reduction steps complementing each other in their mode of action. No human or animal derived proteins are used in the purification or formulation processes. AFSTYLA is a preservative-free, sterile, non-pyrogenic, lyophilized powder to be reconstituted with sterile water for injection (sWFI) for intravenous injection. AFSTYLA is available in single-dose vials containing the labeled amount of Factor VIII activity, expressed in IU. Each vial contains nominally 250, 500, 1000, 1500, 2000, 2500, or 3000 IU of AFSTYLA. The actual potency is labeled on each AFSTYLA vial and carton. After reconstitution of the lyophilized powder, all dosage strengths yield an almost colorless to slightly opalescent solution. The concentrations of excipients based on the vial size, as well as the amount of sWFI for reconstitution are provided in Table 4 below. The number of units of Factor VIII administered is expressed in IU, which are related to the current WHO standard for Factor VIII products. One IU of Factor VIII activity in plasma is equivalent to that quantity of Factor VIII in 1 mL of normal plasma. Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or in IU (relative to an International Standard for Factor VIII in plasma)."
},
{
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"PackageDescription": "1 KIT in 1 CARTON (69911-481-02) * 5 mL in 1 VIAL, SINGLE-USE (69911-491-01) * 5 mL in 1 VIAL, SINGLE-USE (69911-765-84) ",
"NDC11Code": "69911-0481-02",
"ProductNDC": "69911-481",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Afstyla",
"ProprietaryNameSuffix": "Antihemophilic Factor (recombinant), Single Chain",
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"StartMarketingDate": "20170328",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125591",
"LabelerName": "CSL Behring Lengnau AG",
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"LastUpdate": "2023-07-01",
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"IndicationAndUsage": "AFSTYLA, Antihemophilic Factor (Recombinant), Single Chain is a recombinant, antihemophilic factor indicated in adults and children with hemophilia A (congenital Factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes,, 2 Routine prophylaxis to reduce the frequency of bleeding episodes,, 3 Perioperative management of bleeding.",
"Description": "AFSTYLA is a single-chain recombinant Factor VIII produced in chinese hamster ovary (CHO) cells. It is a construct where the B-domain occurring in wild type full-length Factor VIII has been truncated and 4 amino acids of the adjacent acidic a3 domain were removed (amino acids 765 to 1652 of full-length Factor VIII). AFSTYLA is expressed as a single-chain Factor VIII molecule with covalent linkage between heavy and light chains; thereby keeping the molecule in the single-chain form resulting in increased stability and increased von Willebrand Factor (VWF) affinity. Except for a new N-glycosylation site at the junction between heavy and light chains, the post-translational modifications are comparable to endogenous Factor VIII. AFSTYLA is purified by a controlled multi-step process including two virus reduction steps complementing each other in their mode of action. No human or animal derived proteins are used in the purification or formulation processes. AFSTYLA is a preservative-free, sterile, non-pyrogenic, lyophilized powder to be reconstituted with sterile water for injection (sWFI) for intravenous injection. AFSTYLA is available in single-dose vials containing the labeled amount of Factor VIII activity, expressed in IU. Each vial contains nominally 250, 500, 1000, 1500, 2000, 2500, or 3000 IU of AFSTYLA. The actual potency is labeled on each AFSTYLA vial and carton. After reconstitution of the lyophilized powder, all dosage strengths yield an almost colorless to slightly opalescent solution. The concentrations of excipients based on the vial size, as well as the amount of sWFI for reconstitution are provided in Table 4 below. The number of units of Factor VIII administered is expressed in IU, which are related to the current WHO standard for Factor VIII products. One IU of Factor VIII activity in plasma is equivalent to that quantity of Factor VIII in 1 mL of normal plasma. Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or in IU (relative to an International Standard for Factor VIII in plasma)."
},
{
"NDCCode": "69911-864-02",
"PackageDescription": "1 KIT in 1 CARTON (69911-864-02) * 2.5 mL in 1 VIAL, SINGLE-USE (69911-874-01) * 2.5 mL in 1 VIAL, SINGLE-USE (69911-765-82) ",
"NDC11Code": "69911-0864-02",
"ProductNDC": "69911-864",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Idelvion",
"NonProprietaryName": "Coagulation Factor Ix Recombinant Human",
"DosageFormName": "KIT",
"StartMarketingDate": "20160304",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125582",
"LabelerName": "CSL Behring Lengnau AG",
"Status": "Active",
"LastUpdate": "2023-07-05",
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"IndicationAndUsage": "IDELVION®, Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rIX-FP), a recombinant DNA-derived coagulation Factor IX concentrate, is indicated in children and adults with Hemophilia B (congenital Factor IX deficiency) for: : 1 On-demand treatment and control of bleeding episodes , 2 Perioperative management of bleeding , 3 Routine prophylaxis to reduce the frequency of bleeding episodes .",
"Description": "IDELVION, Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rIX-FP) is a sterile, non-pyrogenic, lyophilized powder to be reconstituted with sterile Water for Injection (sWFI) for intravenous administration. IDELVION is available in single-dose vials containing nominally 250, 500, 1000, 2000, or 3500 IU of Factor IX formulated with sodium citrate, polysorbate 80, mannitol and sucrose. The actual amount of Factor IX activity in IU is labeled on each vial. After reconstitution of the lyophilized powder, all dosage strengths yield a clear, yellow to colorless solution. IDELVION contains no preservatives. The active ingredient in IDELVION, recombinant human coagulation Factor IX albumin fusion protein, is a purified protein produced by recombinant DNA technology. It is generated by the genetic fusion of recombinant albumin to recombinant coagulation Factor IX. The genetic fusion of the cDNA of human albumin to the cDNA of human coagulation Factor IX enables the gene product to be expressed as a single recombinant protein designated as rIX-FP. The Factor IX portion of IDELVION is identical to the Thr148 allelic form of human plasma-derived Factor IX. The cleavable linker between the Factor IX and albumin moieties is derived from the endogenous activation peptide in native Factor IX. rIX-FP remains intact in the circulation until Factor IX is activated, whereupon albumin is cleaved from Factor IX, releasing activated Factor IX (FIXa) when it is needed for coagulation. IDELVION is manufactured without the addition of proteins derived from human or animal source materials. IDELVION is a glycoprotein consisting of 1018 amino acids secreted by a genetically engineered Chinese hamster ovary (CHO) cell line. The CHO cell line secretes rIX-FP into a defined cell culture medium and the rIX-FP protein is purified by a process that does not require the use of a monoclonal antibody reagent. The manufacturing process incorporates three validated virus clearance steps, including virus inactivation by solvent/detergent treatment and virus removal by filtration. The potency expressed in International Units is determined using an in vitro aPTT-based one-stage clotting assay against CSL Behring's manufacturing reference standard. This internal potency standard has been calibrated against the World Health Organization (WHO) International Standard for Factor IX concentrate by a one-stage clotting assay using synthetic silica and synthetic phospholipid-based reagents."
},
{
"NDCCode": "69911-865-02",
"PackageDescription": "1 KIT in 1 CARTON (69911-865-02) * 2.5 mL in 1 VIAL, SINGLE-USE (69911-875-01) * 2.5 mL in 1 VIAL, SINGLE-USE (69911-765-82) ",
"NDC11Code": "69911-0865-02",
"ProductNDC": "69911-865",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Idelvion",
"NonProprietaryName": "Coagulation Factor Ix Recombinant Human",
"DosageFormName": "KIT",
"StartMarketingDate": "20160304",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125582",
"LabelerName": "CSL Behring Lengnau AG",
"Status": "Active",
"LastUpdate": "2023-07-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20160304",
"SamplePackage": "N",
"IndicationAndUsage": "IDELVION®, Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rIX-FP), a recombinant DNA-derived coagulation Factor IX concentrate, is indicated in children and adults with Hemophilia B (congenital Factor IX deficiency) for: : 1 On-demand treatment and control of bleeding episodes , 2 Perioperative management of bleeding , 3 Routine prophylaxis to reduce the frequency of bleeding episodes .",
"Description": "IDELVION, Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rIX-FP) is a sterile, non-pyrogenic, lyophilized powder to be reconstituted with sterile Water for Injection (sWFI) for intravenous administration. IDELVION is available in single-dose vials containing nominally 250, 500, 1000, 2000, or 3500 IU of Factor IX formulated with sodium citrate, polysorbate 80, mannitol and sucrose. The actual amount of Factor IX activity in IU is labeled on each vial. After reconstitution of the lyophilized powder, all dosage strengths yield a clear, yellow to colorless solution. IDELVION contains no preservatives. The active ingredient in IDELVION, recombinant human coagulation Factor IX albumin fusion protein, is a purified protein produced by recombinant DNA technology. It is generated by the genetic fusion of recombinant albumin to recombinant coagulation Factor IX. The genetic fusion of the cDNA of human albumin to the cDNA of human coagulation Factor IX enables the gene product to be expressed as a single recombinant protein designated as rIX-FP. The Factor IX portion of IDELVION is identical to the Thr148 allelic form of human plasma-derived Factor IX. The cleavable linker between the Factor IX and albumin moieties is derived from the endogenous activation peptide in native Factor IX. rIX-FP remains intact in the circulation until Factor IX is activated, whereupon albumin is cleaved from Factor IX, releasing activated Factor IX (FIXa) when it is needed for coagulation. IDELVION is manufactured without the addition of proteins derived from human or animal source materials. IDELVION is a glycoprotein consisting of 1018 amino acids secreted by a genetically engineered Chinese hamster ovary (CHO) cell line. The CHO cell line secretes rIX-FP into a defined cell culture medium and the rIX-FP protein is purified by a process that does not require the use of a monoclonal antibody reagent. The manufacturing process incorporates three validated virus clearance steps, including virus inactivation by solvent/detergent treatment and virus removal by filtration. The potency expressed in International Units is determined using an in vitro aPTT-based one-stage clotting assay against CSL Behring's manufacturing reference standard. This internal potency standard has been calibrated against the World Health Organization (WHO) International Standard for Factor IX concentrate by a one-stage clotting assay using synthetic silica and synthetic phospholipid-based reagents."
},
{
"NDCCode": "69911-866-02",
"PackageDescription": "1 KIT in 1 CARTON (69911-866-02) * 2.5 mL in 1 VIAL, SINGLE-USE (69911-876-01) * 2.5 mL in 1 VIAL, SINGLE-USE (69911-765-82) ",
"NDC11Code": "69911-0866-02",
"ProductNDC": "69911-866",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Idelvion",
"NonProprietaryName": "Coagulation Factor Ix Recombinant Human",
"DosageFormName": "KIT",
"StartMarketingDate": "20160304",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125582",
"LabelerName": "CSL Behring Lengnau AG",
"Status": "Active",
"LastUpdate": "2023-07-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160304",
"SamplePackage": "N",
"IndicationAndUsage": "IDELVION®, Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rIX-FP), a recombinant DNA-derived coagulation Factor IX concentrate, is indicated in children and adults with Hemophilia B (congenital Factor IX deficiency) for: : 1 On-demand treatment and control of bleeding episodes , 2 Perioperative management of bleeding , 3 Routine prophylaxis to reduce the frequency of bleeding episodes .",
"Description": "IDELVION, Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rIX-FP) is a sterile, non-pyrogenic, lyophilized powder to be reconstituted with sterile Water for Injection (sWFI) for intravenous administration. IDELVION is available in single-dose vials containing nominally 250, 500, 1000, 2000, or 3500 IU of Factor IX formulated with sodium citrate, polysorbate 80, mannitol and sucrose. The actual amount of Factor IX activity in IU is labeled on each vial. After reconstitution of the lyophilized powder, all dosage strengths yield a clear, yellow to colorless solution. IDELVION contains no preservatives. The active ingredient in IDELVION, recombinant human coagulation Factor IX albumin fusion protein, is a purified protein produced by recombinant DNA technology. It is generated by the genetic fusion of recombinant albumin to recombinant coagulation Factor IX. The genetic fusion of the cDNA of human albumin to the cDNA of human coagulation Factor IX enables the gene product to be expressed as a single recombinant protein designated as rIX-FP. The Factor IX portion of IDELVION is identical to the Thr148 allelic form of human plasma-derived Factor IX. The cleavable linker between the Factor IX and albumin moieties is derived from the endogenous activation peptide in native Factor IX. rIX-FP remains intact in the circulation until Factor IX is activated, whereupon albumin is cleaved from Factor IX, releasing activated Factor IX (FIXa) when it is needed for coagulation. IDELVION is manufactured without the addition of proteins derived from human or animal source materials. IDELVION is a glycoprotein consisting of 1018 amino acids secreted by a genetically engineered Chinese hamster ovary (CHO) cell line. The CHO cell line secretes rIX-FP into a defined cell culture medium and the rIX-FP protein is purified by a process that does not require the use of a monoclonal antibody reagent. The manufacturing process incorporates three validated virus clearance steps, including virus inactivation by solvent/detergent treatment and virus removal by filtration. The potency expressed in International Units is determined using an in vitro aPTT-based one-stage clotting assay against CSL Behring's manufacturing reference standard. This internal potency standard has been calibrated against the World Health Organization (WHO) International Standard for Factor IX concentrate by a one-stage clotting assay using synthetic silica and synthetic phospholipid-based reagents."
},
{
"NDCCode": "69911-867-02",
"PackageDescription": "1 KIT in 1 CARTON (69911-867-02) * 5 mL in 1 VIAL, SINGLE-USE (69911-877-01) * 5 mL in 1 VIAL, SINGLE-USE (69911-765-85) ",
"NDC11Code": "69911-0867-02",
"ProductNDC": "69911-867",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Idelvion",
"NonProprietaryName": "Coagulation Factor Ix Recombinant Human",
"DosageFormName": "KIT",
"StartMarketingDate": "20160304",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125582",
"LabelerName": "CSL Behring Lengnau AG",
"Status": "Active",
"LastUpdate": "2023-07-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160304",
"SamplePackage": "N",
"IndicationAndUsage": "IDELVION®, Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rIX-FP), a recombinant DNA-derived coagulation Factor IX concentrate, is indicated in children and adults with Hemophilia B (congenital Factor IX deficiency) for: : 1 On-demand treatment and control of bleeding episodes , 2 Perioperative management of bleeding , 3 Routine prophylaxis to reduce the frequency of bleeding episodes .",
"Description": "IDELVION, Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rIX-FP) is a sterile, non-pyrogenic, lyophilized powder to be reconstituted with sterile Water for Injection (sWFI) for intravenous administration. IDELVION is available in single-dose vials containing nominally 250, 500, 1000, 2000, or 3500 IU of Factor IX formulated with sodium citrate, polysorbate 80, mannitol and sucrose. The actual amount of Factor IX activity in IU is labeled on each vial. After reconstitution of the lyophilized powder, all dosage strengths yield a clear, yellow to colorless solution. IDELVION contains no preservatives. The active ingredient in IDELVION, recombinant human coagulation Factor IX albumin fusion protein, is a purified protein produced by recombinant DNA technology. It is generated by the genetic fusion of recombinant albumin to recombinant coagulation Factor IX. The genetic fusion of the cDNA of human albumin to the cDNA of human coagulation Factor IX enables the gene product to be expressed as a single recombinant protein designated as rIX-FP. The Factor IX portion of IDELVION is identical to the Thr148 allelic form of human plasma-derived Factor IX. The cleavable linker between the Factor IX and albumin moieties is derived from the endogenous activation peptide in native Factor IX. rIX-FP remains intact in the circulation until Factor IX is activated, whereupon albumin is cleaved from Factor IX, releasing activated Factor IX (FIXa) when it is needed for coagulation. IDELVION is manufactured without the addition of proteins derived from human or animal source materials. IDELVION is a glycoprotein consisting of 1018 amino acids secreted by a genetically engineered Chinese hamster ovary (CHO) cell line. The CHO cell line secretes rIX-FP into a defined cell culture medium and the rIX-FP protein is purified by a process that does not require the use of a monoclonal antibody reagent. The manufacturing process incorporates three validated virus clearance steps, including virus inactivation by solvent/detergent treatment and virus removal by filtration. The potency expressed in International Units is determined using an in vitro aPTT-based one-stage clotting assay against CSL Behring's manufacturing reference standard. This internal potency standard has been calibrated against the World Health Organization (WHO) International Standard for Factor IX concentrate by a one-stage clotting assay using synthetic silica and synthetic phospholipid-based reagents."
},
{
"NDCCode": "69911-869-02",
"PackageDescription": "1 KIT in 1 CARTON (69911-869-02) * 5 mL in 1 VIAL, SINGLE-USE (69911-879-01) * 5 mL in 1 VIAL, SINGLE-USE (69911-765-85) ",
"NDC11Code": "69911-0869-02",
"ProductNDC": "69911-869",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Idelvion",
"NonProprietaryName": "Coagulation Factor Ix Recombinant Human",
"DosageFormName": "KIT",
"StartMarketingDate": "20180530",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125582",
"LabelerName": "CSL Behring Lengnau AG",
"Status": "Active",
"LastUpdate": "2023-07-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180530",
"SamplePackage": "N",
"IndicationAndUsage": "IDELVION®, Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rIX-FP), a recombinant DNA-derived coagulation Factor IX concentrate, is indicated in children and adults with Hemophilia B (congenital Factor IX deficiency) for: : 1 On-demand treatment and control of bleeding episodes , 2 Perioperative management of bleeding , 3 Routine prophylaxis to reduce the frequency of bleeding episodes .",
"Description": "IDELVION, Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rIX-FP) is a sterile, non-pyrogenic, lyophilized powder to be reconstituted with sterile Water for Injection (sWFI) for intravenous administration. IDELVION is available in single-dose vials containing nominally 250, 500, 1000, 2000, or 3500 IU of Factor IX formulated with sodium citrate, polysorbate 80, mannitol and sucrose. The actual amount of Factor IX activity in IU is labeled on each vial. After reconstitution of the lyophilized powder, all dosage strengths yield a clear, yellow to colorless solution. IDELVION contains no preservatives. The active ingredient in IDELVION, recombinant human coagulation Factor IX albumin fusion protein, is a purified protein produced by recombinant DNA technology. It is generated by the genetic fusion of recombinant albumin to recombinant coagulation Factor IX. The genetic fusion of the cDNA of human albumin to the cDNA of human coagulation Factor IX enables the gene product to be expressed as a single recombinant protein designated as rIX-FP. The Factor IX portion of IDELVION is identical to the Thr148 allelic form of human plasma-derived Factor IX. The cleavable linker between the Factor IX and albumin moieties is derived from the endogenous activation peptide in native Factor IX. rIX-FP remains intact in the circulation until Factor IX is activated, whereupon albumin is cleaved from Factor IX, releasing activated Factor IX (FIXa) when it is needed for coagulation. IDELVION is manufactured without the addition of proteins derived from human or animal source materials. IDELVION is a glycoprotein consisting of 1018 amino acids secreted by a genetically engineered Chinese hamster ovary (CHO) cell line. The CHO cell line secretes rIX-FP into a defined cell culture medium and the rIX-FP protein is purified by a process that does not require the use of a monoclonal antibody reagent. The manufacturing process incorporates three validated virus clearance steps, including virus inactivation by solvent/detergent treatment and virus removal by filtration. The potency expressed in International Units is determined using an in vitro aPTT-based one-stage clotting assay against CSL Behring's manufacturing reference standard. This internal potency standard has been calibrated against the World Health Organization (WHO) International Standard for Factor IX concentrate by a one-stage clotting assay using synthetic silica and synthetic phospholipid-based reagents."
},
{
"NDCCode": "13537-478-02",
"PackageDescription": "1 TUBE in 1 BOX (13537-478-02) > 4 g in 1 TUBE (13537-478-01)",
"NDC11Code": "13537-0478-02",
"ProductNDC": "13537-478",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esika Hydracolor 2 In 1 Highly Moisturizing And Coloring Spf 25",
"ProprietaryNameSuffix": "(rosa Dulzura) - Pink",
"NonProprietaryName": "Octinoxate And Oxybenzone",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161109",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "OCTINOXATE; OXYBENZONE",
"StrengthNumber": ".0664; .0151",
"StrengthUnit": "g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "16714-478-02",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (16714-478-02) ",
"NDC11Code": "16714-0478-02",
"ProductNDC": "16714-478",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20151101",
"EndMarketingDate": "20231231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065093",
"LabelerName": "Northstar RxLLC",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "875; 125",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20151101",
"EndMarketingDatePackage": "20231231",
"SamplePackage": "N"
},
{
"NDCCode": "49349-478-02",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (49349-478-02)",
"NDC11Code": "49349-0478-02",
"ProductNDC": "49349-478",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120829",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076112",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "50742-478-02",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (50742-478-02) > 1 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "50742-0478-02",
"ProductNDC": "50742-478",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenylephrine Hydrochloride",
"NonProprietaryName": "Phenylephrine Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200116",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209967",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200116",
"SamplePackage": "N"
},
{
"NDCCode": "51346-478-02",
"PackageDescription": "1 CONTAINER in 1 CARTON (51346-478-02) > 1 g in 1 CONTAINER (51346-478-01)",
"NDC11Code": "51346-0478-02",
"ProductNDC": "51346-478",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Provence Intense Cover 3 In 1 Strobing Foundation 01 Light Beige C",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170601",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "NATURE REPUBLIC CO., LTD.",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": ".21",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "52125-478-02",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (52125-478-02)",
"NDC11Code": "52125-0478-02",
"ProductNDC": "52125-478",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atenolol",
"NonProprietaryName": "Atenolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130524",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076900",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "ATENOLOL",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-01-10"
},
{
"NDCCode": "53208-478-02",
"PackageDescription": "1 CONTAINER in 1 BOX (53208-478-02) > 40 mL in 1 CONTAINER (53208-478-01)",
"NDC11Code": "53208-0478-02",
"ProductNDC": "53208-478",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Isaknox Ageless Serum Moist Pearl Base",
"NonProprietaryName": "Octinoxate, Titanium Dioxide, Dimethicone, Aluminum Hydroxide, Stearic Acid, Hydroxyproline,",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100831",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "LG Household and Healthcare, Inc.",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE; DIMETHICONE; ALUMINUM HYDROXIDE; STEARIC ACID; HYDROXYPROLINE",
"StrengthNumber": "3; 3.38; .08; .18; .18; .53",
"StrengthUnit": "mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "53489-478-02",
"PackageDescription": "50 TABLET in 1 BOTTLE, PLASTIC (53489-478-02) ",
"NDC11Code": "53489-0478-02",
"ProductNDC": "53489-478",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulindac",
"NonProprietaryName": "Sulindac",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090904",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072050",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "SULINDAC",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090904",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of sulindac tablets and other treatment options before deciding to use sulindac tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Sulindac tablets are indicated for acute or long-term use in the relief of signs and symptoms of the following: 1 Osteoarthritis, 2 Rheumatoid arthritis*, 3 Ankylosing spondylitis, 4 Acute painful shoulder (Acute subacromial bursitis/supraspinatus tendinitis), 5 Acute gouty arthritis.",
"Description": "Sulindac is a non-steroidal, anti-inflammatory indene derivative designated chemically as (Z)-5-fluoro-2-methyl-1-[[ p-(methylsulfinyl)phenyl]methylene]-1 H-indene-3-acetic acid. It is not a salicylate, pyrazolone or propionic acid derivative. Its empirical formula is C 20H 17FO 3S, with a molecular weight of 356.42. Sulindac, a yellow crystalline compound, is a weak organic acid practically insoluble in water below pH 4.5, but very soluble as the sodium salt or in buffers of pH 6 or higher. Sulindac tablets are available in 150 and 200 mg tablets for oral administration. Each tablet contains the following inactive ingredients: magnesium stearate, microcrystalline cellulose, and pregelatinized starch. Following absorption, sulindac undergoes two major biotransformations — reversible reduction to the sulfide metabolite, and irreversible oxidation to the sulfone metabolite. Available evidence indicates that the biological activity resides with the sulfide metabolite. The structural formulas of sulindac and its metabolites are."
},
{
"NDCCode": "57297-478-02",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (57297-478-02)",
"NDC11Code": "57297-0478-02",
"ProductNDC": "57297-478",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078103",
"LabelerName": "LUPIN LIMITED",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Simvastatin tablets USP are an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to: 1 Reduce the risk of total mortality by reducing CHD deaths and reduce the risk of non-fatal myocardial infarction, stroke, and the need for revascularization procedures in patients at high risk of coronary events. (1.1) , 2 Reduce elevated total-C, LDL-C, Apo B, TG and increase HDL-C in patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia. (1.2) , 3 Reduce elevated TG in patients with hypertriglyceridemia and reduce TG and VLDL-C in patients with primary dysbetalipoproteinemia. (1.2) , 4 Reduce total-C and LDL-C in adult patients with homozygous familial hypercholesterolemia. (1.2) , 5 Reduce elevated total-C, LDL-C, and Apo B in boys and postmenarchal girls, 10 to 17 years of age with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy. (1.2, 1.3).",
"Description": "Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: ascorbic acid, citric acid, hydroxy propyl cellulose, hypromellose, iron oxides, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinised starch, talc and titanium dioxide. Butylated hydroxyanisole is added as a preservative."
},
{
"NDCCode": "63545-478-02",
"PackageDescription": "500 PELLET in 1 VIAL, GLASS (63545-478-02) ",
"NDC11Code": "63545-0478-02",
"ProductNDC": "63545-478",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Chenopodium Anthelminticum",
"NonProprietaryName": "Chenopodium Anthelminticum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220511",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "DYSPHANIA AMBROSIOIDES WHOLE",
"StrengthNumber": "100",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2022-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220511",
"SamplePackage": "N"
},
{
"NDCCode": "63739-478-02",
"PackageDescription": "30 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-478-02) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "63739-0478-02",
"ProductNDC": "63739-478",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Docusate Sodium",
"NonProprietaryName": "Docusate Sodium",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20101109",
"EndMarketingDate": "20251224",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "McKesson Corporation",
"SubstanceName": "DOCUSATE SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2025-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210701",
"EndMarketingDatePackage": "20251224",
"SamplePackage": "N",
"IndicationAndUsage": "for the prevention of dry, hard stools. for relief of occasional constipation. This product generally produces a bowel movement within 12 to 72 hours."
},
{
"NDCCode": "64380-478-02",
"PackageDescription": "500 CAPSULE in 1 BOTTLE, PLASTIC (64380-478-02) ",
"NDC11Code": "64380-0478-02",
"ProductNDC": "64380-478",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atomoxetine",
"NonProprietaryName": "Atomoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079021",
"LabelerName": "Strides Pharma Science Limited",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250701",
"SamplePackage": "N",
"IndicationAndUsage": "Atomoxetine is selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).",
"Description": "Atomoxetine capsules, USP are a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is. Atomoxetine hydrochloride, USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules are intended for oral administration only. Each capsule contains atomoxetine hydrochloride equivalent to 10, 18, 25, 40, 60, 80 or 100 mg of atomoxetine. The capsules also contain colloidal silicon dioxide, gelatin, magnesium stearate, pregelatinized starch (corn), sodium lauryl sulfate and titanium dioxide. The 10 mg capsules also contain D&C Yellow No. 10, D&C Red No. 28, D&C Red No. 33, FD&C Red No. 40 and FD&C Yellow No. 6; the 18 mg capsules also contain D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40 and FD&C Yellow No. 6; the 25 mg capsules also contain FD&C Blue No. 1 and FD&C Red No. 3; the 40 mg capsules also contain D&C Red No. 28 and FD&C Blue No. 1; the 60 mg capsules also contain D&C Red No. 28, D&C Yellow No. 10, FD&C Blue No. 1 and FD&C Yellow No. 6; the 80 mg capsules also contain D&C Red No. 28, D&C Yellow No. 10 and FD&C Yellow No. 6; the 100 mg capsules also contain D&C Yellow No. 10, FD&C Red No. 3, FD&C Yellow No. 6 and red iron oxide. In addition, the imprinting ink contains the following: black iron oxide, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, D&C Yellow No. 10 Aluminum Lake, propylene glycol and shellac glaze."
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{
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"PackageDescription": "2 TABLET in 1 BOTTLE (66336-478-02)",
"NDC11Code": "66336-0478-02",
"ProductNDC": "66336-478",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diazepam",
"NonProprietaryName": "Diazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077749",
"LabelerName": "Dispensing Solutions, Inc.",
"SubstanceName": "DIAZEPAM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Diazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma); spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia); athetosis; and stiff-man syndrome. Oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. The effectiveness of diazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Diazepam is a benzodiazepine derivative. The chemical name of diazepam is 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. It is a colorless to light yellow crystalline compound, insoluble in water. The empirical formula is C16H13ClN2O and the molecular weight is 284.75. The structural formula is as follows. Diazepam is available for oral administration as tablets containing 2 mg, 5 mg or 10 mg diazepam. In addition to the active ingredient diazepam, each tablet contains the following inactive ingredients: calcium stearate, colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate and microcrystalline cellulose with the following dyes: 5-mg tablets contain D&C Yellow #10 aluminum lake; 10-mg tablets contain FD&C Blue #1 aluminum lake. Diazepam 2-mg tablets contain no dye."
},
{
"NDCCode": "68180-478-02",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (68180-478-02) ",
"NDC11Code": "68180-0478-02",
"ProductNDC": "68180-478",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078103",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-15",
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"IndicationAndUsage": "Simvastatin tablets USP are indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):In adults with primary hyperlipidemia.In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).",
"Description": "Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is:. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP are available for oral administration in strength of 5 mg, 10 mg, 20 mg, 40 mg or 80 mg. Each tablet contains following inactive ingredients: ascorbic acid, citric acid, hydroxy propyl cellulose, hypromellose, iron oxides, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinised starch, talc and titanium dioxide. Butylated hydroxyanisole is added as a preservative."
},
{
"NDCCode": "69168-478-02",
"PackageDescription": "2 BOTTLE, SPRAY in 1 CARTON (69168-478-02) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY",
"NDC11Code": "69168-0478-02",
"ProductNDC": "69168-478",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Azelastine Hydrochloride",
"NonProprietaryName": "Azelastine Hydrochloride",
"DosageFormName": "SPRAY, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20250502",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216421",
"LabelerName": "Allegiant Health",
"SubstanceName": "AZELASTINE HYDROCHLORIDE",
"StrengthNumber": "205.5",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-17",
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"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 nasal congestion , 2 runny nose, 3 sneezing , 4 itchy nose."
},
{
"NDCCode": "72205-478-02",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (72205-478-02) / 2 mL in 1 VIAL, SINGLE-DOSE (72205-478-01) ",
"NDC11Code": "72205-0478-02",
"ProductNDC": "72205-478",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sugammadex",
"NonProprietaryName": "Sugammadex",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20260728",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214368",
"LabelerName": "Novadoz Pharmaceuticals LLC",
"SubstanceName": "SUGAMMADEX SODIUM",
"StrengthNumber": "200",
"StrengthUnit": "mg/2mL",
"Pharm_Classes": "gamma-Cyclodextrins [CS]",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "Sugammadex injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients aged 2 years and older undergoing surgery. Additional pediatric use information is approved for Merck Sharp & Dohme LLC’s BRIDION® (sugammadex) injection. However, due to Merck Sharp & Dohme LLC’s marketing exclusivity rights, this drug product is not labeled with that information.",
"Description": "Sugammadex injection, for intravenous use, contains sugammadex sodium, a modified gamma cyclodextrin chemically designated as 6A,6B,6C,6D,6E,6F,6G,6H-Octakis-S-(2-carboxyethyl)- 6A,6B,6C,6D,6E,6F,6G,6H-octathio-γ-cyclodextrin sodium salt (1:8) with a molecular weight of 2178.01. The structural formula is. Sugammadex injection is supplied as a sterile, non-pyrogenic aqueous solution that is clear, colorless to slightly yellow-brown for intravenous injection only. Each mL contains 100 mg sugammadex, which is equivalent to 108.8 mg sugammadex sodium. The aqueous solution is adjusted to a pH of between 7 and 8 with hydrochloric acid and/or sodium hydroxide. The osmolality of the product is between 300 and 500 mOsmol/kg. Sugammadex injection may contain up to 7 mg/mL of the mono OH-derivative of sugammadex [see Clinical Pharmacology (12.2)]. This derivative is chemically designated as 6A,6B,6C,6D,6E,6F,6G-Heptakis-S-(2-carboxyethyl)-6A,6B,6C,6D,6E,6F,6G-heptathio-γ-cyclodextrin sodium salt (1:7) with a molecular weight of 2067.90. The structural formula is."
},
{
"NDCCode": "82280-478-02",
"PackageDescription": "56.7 g in 1 JAR (82280-478-02) ",
"NDC11Code": "82280-0478-02",
"ProductNDC": "82280-478",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Theraplex Aim Anti-itch Moisturizing",
"NonProprietaryName": "Hydrocortisone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240506",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "THERAPLEX, LLC",
"SubstanceName": "HYDROCORTISONE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-05-07",
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"IndicationAndUsage": "Temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: 1 eczema, 2 soaps, 3 detergents, 4 cosmetics, 5 seborrheic dermatitis, 6 psoriasis., 7 Other uses of this product should only be under the advice and supervision of a doctor."
},
{
"NDCCode": "84522-478-02",
"PackageDescription": "15 g in 1 BOX (84522-478-02) ",
"NDC11Code": "84522-0478-02",
"ProductNDC": "84522-478",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Trstay Kojic Acid Cream",
"NonProprietaryName": "Trstay Kojic Acid Cream",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241213",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Ziqiu Import Export Co Ltd",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
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"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
}
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<Description>AFSTYLA is a single-chain recombinant Factor VIII produced in chinese hamster ovary (CHO) cells. It is a construct where the B-domain occurring in wild type full-length Factor VIII has been truncated and 4 amino acids of the adjacent acidic a3 domain were removed (amino acids 765 to 1652 of full-length Factor VIII). AFSTYLA is expressed as a single-chain Factor VIII molecule with covalent linkage between heavy and light chains; thereby keeping the molecule in the single-chain form resulting in increased stability and increased von Willebrand Factor (VWF) affinity. Except for a new N-glycosylation site at the junction between heavy and light chains, the post-translational modifications are comparable to endogenous Factor VIII. AFSTYLA is purified by a controlled multi-step process including two virus reduction steps complementing each other in their mode of action. No human or animal derived proteins are used in the purification or formulation processes. AFSTYLA is a preservative-free, sterile, non-pyrogenic, lyophilized powder to be reconstituted with sterile water for injection (sWFI) for intravenous injection. AFSTYLA is available in single-dose vials containing the labeled amount of Factor VIII activity, expressed in IU. Each vial contains nominally 250, 500, 1000, 1500, 2000, 2500, or 3000 IU of AFSTYLA. The actual potency is labeled on each AFSTYLA vial and carton. After reconstitution of the lyophilized powder, all dosage strengths yield an almost colorless to slightly opalescent solution. The concentrations of excipients based on the vial size, as well as the amount of sWFI for reconstitution are provided in Table 4 below. The number of units of Factor VIII administered is expressed in IU, which are related to the current WHO standard for Factor VIII products. One IU of Factor VIII activity in plasma is equivalent to that quantity of Factor VIII in 1 mL of normal plasma. Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or in IU (relative to an International Standard for Factor VIII in plasma).</Description>
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<Description>AFSTYLA is a single-chain recombinant Factor VIII produced in chinese hamster ovary (CHO) cells. It is a construct where the B-domain occurring in wild type full-length Factor VIII has been truncated and 4 amino acids of the adjacent acidic a3 domain were removed (amino acids 765 to 1652 of full-length Factor VIII). AFSTYLA is expressed as a single-chain Factor VIII molecule with covalent linkage between heavy and light chains; thereby keeping the molecule in the single-chain form resulting in increased stability and increased von Willebrand Factor (VWF) affinity. Except for a new N-glycosylation site at the junction between heavy and light chains, the post-translational modifications are comparable to endogenous Factor VIII. AFSTYLA is purified by a controlled multi-step process including two virus reduction steps complementing each other in their mode of action. No human or animal derived proteins are used in the purification or formulation processes. AFSTYLA is a preservative-free, sterile, non-pyrogenic, lyophilized powder to be reconstituted with sterile water for injection (sWFI) for intravenous injection. AFSTYLA is available in single-dose vials containing the labeled amount of Factor VIII activity, expressed in IU. Each vial contains nominally 250, 500, 1000, 1500, 2000, 2500, or 3000 IU of AFSTYLA. The actual potency is labeled on each AFSTYLA vial and carton. After reconstitution of the lyophilized powder, all dosage strengths yield an almost colorless to slightly opalescent solution. The concentrations of excipients based on the vial size, as well as the amount of sWFI for reconstitution are provided in Table 4 below. The number of units of Factor VIII administered is expressed in IU, which are related to the current WHO standard for Factor VIII products. One IU of Factor VIII activity in plasma is equivalent to that quantity of Factor VIII in 1 mL of normal plasma. Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or in IU (relative to an International Standard for Factor VIII in plasma).</Description>
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<IndicationAndUsage>AFSTYLA, Antihemophilic Factor (Recombinant), Single Chain is a recombinant, antihemophilic factor indicated in adults and children with hemophilia A (congenital Factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes,, 2 Routine prophylaxis to reduce the frequency of bleeding episodes,, 3 Perioperative management of bleeding.</IndicationAndUsage>
<Description>AFSTYLA is a single-chain recombinant Factor VIII produced in chinese hamster ovary (CHO) cells. It is a construct where the B-domain occurring in wild type full-length Factor VIII has been truncated and 4 amino acids of the adjacent acidic a3 domain were removed (amino acids 765 to 1652 of full-length Factor VIII). AFSTYLA is expressed as a single-chain Factor VIII molecule with covalent linkage between heavy and light chains; thereby keeping the molecule in the single-chain form resulting in increased stability and increased von Willebrand Factor (VWF) affinity. Except for a new N-glycosylation site at the junction between heavy and light chains, the post-translational modifications are comparable to endogenous Factor VIII. AFSTYLA is purified by a controlled multi-step process including two virus reduction steps complementing each other in their mode of action. No human or animal derived proteins are used in the purification or formulation processes. AFSTYLA is a preservative-free, sterile, non-pyrogenic, lyophilized powder to be reconstituted with sterile water for injection (sWFI) for intravenous injection. AFSTYLA is available in single-dose vials containing the labeled amount of Factor VIII activity, expressed in IU. Each vial contains nominally 250, 500, 1000, 1500, 2000, 2500, or 3000 IU of AFSTYLA. The actual potency is labeled on each AFSTYLA vial and carton. After reconstitution of the lyophilized powder, all dosage strengths yield an almost colorless to slightly opalescent solution. The concentrations of excipients based on the vial size, as well as the amount of sWFI for reconstitution are provided in Table 4 below. The number of units of Factor VIII administered is expressed in IU, which are related to the current WHO standard for Factor VIII products. One IU of Factor VIII activity in plasma is equivalent to that quantity of Factor VIII in 1 mL of normal plasma. Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or in IU (relative to an International Standard for Factor VIII in plasma).</Description>
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<Description>AFSTYLA is a single-chain recombinant Factor VIII produced in chinese hamster ovary (CHO) cells. It is a construct where the B-domain occurring in wild type full-length Factor VIII has been truncated and 4 amino acids of the adjacent acidic a3 domain were removed (amino acids 765 to 1652 of full-length Factor VIII). AFSTYLA is expressed as a single-chain Factor VIII molecule with covalent linkage between heavy and light chains; thereby keeping the molecule in the single-chain form resulting in increased stability and increased von Willebrand Factor (VWF) affinity. Except for a new N-glycosylation site at the junction between heavy and light chains, the post-translational modifications are comparable to endogenous Factor VIII. AFSTYLA is purified by a controlled multi-step process including two virus reduction steps complementing each other in their mode of action. No human or animal derived proteins are used in the purification or formulation processes. AFSTYLA is a preservative-free, sterile, non-pyrogenic, lyophilized powder to be reconstituted with sterile water for injection (sWFI) for intravenous injection. AFSTYLA is available in single-dose vials containing the labeled amount of Factor VIII activity, expressed in IU. Each vial contains nominally 250, 500, 1000, 1500, 2000, 2500, or 3000 IU of AFSTYLA. The actual potency is labeled on each AFSTYLA vial and carton. After reconstitution of the lyophilized powder, all dosage strengths yield an almost colorless to slightly opalescent solution. The concentrations of excipients based on the vial size, as well as the amount of sWFI for reconstitution are provided in Table 4 below. The number of units of Factor VIII administered is expressed in IU, which are related to the current WHO standard for Factor VIII products. One IU of Factor VIII activity in plasma is equivalent to that quantity of Factor VIII in 1 mL of normal plasma. Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or in IU (relative to an International Standard for Factor VIII in plasma).</Description>
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<IndicationAndUsage>IDELVION®, Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rIX-FP), a recombinant DNA-derived coagulation Factor IX concentrate, is indicated in children and adults with Hemophilia B (congenital Factor IX deficiency) for: : 1 On-demand treatment and control of bleeding episodes , 2 Perioperative management of bleeding , 3 Routine prophylaxis to reduce the frequency of bleeding episodes .</IndicationAndUsage>
<Description>IDELVION, Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rIX-FP) is a sterile, non-pyrogenic, lyophilized powder to be reconstituted with sterile Water for Injection (sWFI) for intravenous administration. IDELVION is available in single-dose vials containing nominally 250, 500, 1000, 2000, or 3500 IU of Factor IX formulated with sodium citrate, polysorbate 80, mannitol and sucrose. The actual amount of Factor IX activity in IU is labeled on each vial. After reconstitution of the lyophilized powder, all dosage strengths yield a clear, yellow to colorless solution. IDELVION contains no preservatives. The active ingredient in IDELVION, recombinant human coagulation Factor IX albumin fusion protein, is a purified protein produced by recombinant DNA technology. It is generated by the genetic fusion of recombinant albumin to recombinant coagulation Factor IX. The genetic fusion of the cDNA of human albumin to the cDNA of human coagulation Factor IX enables the gene product to be expressed as a single recombinant protein designated as rIX-FP. The Factor IX portion of IDELVION is identical to the Thr148 allelic form of human plasma-derived Factor IX. The cleavable linker between the Factor IX and albumin moieties is derived from the endogenous activation peptide in native Factor IX. rIX-FP remains intact in the circulation until Factor IX is activated, whereupon albumin is cleaved from Factor IX, releasing activated Factor IX (FIXa) when it is needed for coagulation. IDELVION is manufactured without the addition of proteins derived from human or animal source materials. IDELVION is a glycoprotein consisting of 1018 amino acids secreted by a genetically engineered Chinese hamster ovary (CHO) cell line. The CHO cell line secretes rIX-FP into a defined cell culture medium and the rIX-FP protein is purified by a process that does not require the use of a monoclonal antibody reagent. The manufacturing process incorporates three validated virus clearance steps, including virus inactivation by solvent/detergent treatment and virus removal by filtration. The potency expressed in International Units is determined using an in vitro aPTT-based one-stage clotting assay against CSL Behring's manufacturing reference standard. This internal potency standard has been calibrated against the World Health Organization (WHO) International Standard for Factor IX concentrate by a one-stage clotting assay using synthetic silica and synthetic phospholipid-based reagents.</Description>
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<IndicationAndUsage>IDELVION®, Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rIX-FP), a recombinant DNA-derived coagulation Factor IX concentrate, is indicated in children and adults with Hemophilia B (congenital Factor IX deficiency) for: : 1 On-demand treatment and control of bleeding episodes , 2 Perioperative management of bleeding , 3 Routine prophylaxis to reduce the frequency of bleeding episodes .</IndicationAndUsage>
<Description>IDELVION, Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rIX-FP) is a sterile, non-pyrogenic, lyophilized powder to be reconstituted with sterile Water for Injection (sWFI) for intravenous administration. IDELVION is available in single-dose vials containing nominally 250, 500, 1000, 2000, or 3500 IU of Factor IX formulated with sodium citrate, polysorbate 80, mannitol and sucrose. The actual amount of Factor IX activity in IU is labeled on each vial. After reconstitution of the lyophilized powder, all dosage strengths yield a clear, yellow to colorless solution. IDELVION contains no preservatives. The active ingredient in IDELVION, recombinant human coagulation Factor IX albumin fusion protein, is a purified protein produced by recombinant DNA technology. It is generated by the genetic fusion of recombinant albumin to recombinant coagulation Factor IX. The genetic fusion of the cDNA of human albumin to the cDNA of human coagulation Factor IX enables the gene product to be expressed as a single recombinant protein designated as rIX-FP. The Factor IX portion of IDELVION is identical to the Thr148 allelic form of human plasma-derived Factor IX. The cleavable linker between the Factor IX and albumin moieties is derived from the endogenous activation peptide in native Factor IX. rIX-FP remains intact in the circulation until Factor IX is activated, whereupon albumin is cleaved from Factor IX, releasing activated Factor IX (FIXa) when it is needed for coagulation. IDELVION is manufactured without the addition of proteins derived from human or animal source materials. IDELVION is a glycoprotein consisting of 1018 amino acids secreted by a genetically engineered Chinese hamster ovary (CHO) cell line. The CHO cell line secretes rIX-FP into a defined cell culture medium and the rIX-FP protein is purified by a process that does not require the use of a monoclonal antibody reagent. The manufacturing process incorporates three validated virus clearance steps, including virus inactivation by solvent/detergent treatment and virus removal by filtration. The potency expressed in International Units is determined using an in vitro aPTT-based one-stage clotting assay against CSL Behring's manufacturing reference standard. This internal potency standard has been calibrated against the World Health Organization (WHO) International Standard for Factor IX concentrate by a one-stage clotting assay using synthetic silica and synthetic phospholipid-based reagents.</Description>
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<IndicationAndUsage>IDELVION®, Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rIX-FP), a recombinant DNA-derived coagulation Factor IX concentrate, is indicated in children and adults with Hemophilia B (congenital Factor IX deficiency) for: : 1 On-demand treatment and control of bleeding episodes , 2 Perioperative management of bleeding , 3 Routine prophylaxis to reduce the frequency of bleeding episodes .</IndicationAndUsage>
<Description>IDELVION, Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rIX-FP) is a sterile, non-pyrogenic, lyophilized powder to be reconstituted with sterile Water for Injection (sWFI) for intravenous administration. IDELVION is available in single-dose vials containing nominally 250, 500, 1000, 2000, or 3500 IU of Factor IX formulated with sodium citrate, polysorbate 80, mannitol and sucrose. The actual amount of Factor IX activity in IU is labeled on each vial. After reconstitution of the lyophilized powder, all dosage strengths yield a clear, yellow to colorless solution. IDELVION contains no preservatives. The active ingredient in IDELVION, recombinant human coagulation Factor IX albumin fusion protein, is a purified protein produced by recombinant DNA technology. It is generated by the genetic fusion of recombinant albumin to recombinant coagulation Factor IX. The genetic fusion of the cDNA of human albumin to the cDNA of human coagulation Factor IX enables the gene product to be expressed as a single recombinant protein designated as rIX-FP. The Factor IX portion of IDELVION is identical to the Thr148 allelic form of human plasma-derived Factor IX. The cleavable linker between the Factor IX and albumin moieties is derived from the endogenous activation peptide in native Factor IX. rIX-FP remains intact in the circulation until Factor IX is activated, whereupon albumin is cleaved from Factor IX, releasing activated Factor IX (FIXa) when it is needed for coagulation. IDELVION is manufactured without the addition of proteins derived from human or animal source materials. IDELVION is a glycoprotein consisting of 1018 amino acids secreted by a genetically engineered Chinese hamster ovary (CHO) cell line. The CHO cell line secretes rIX-FP into a defined cell culture medium and the rIX-FP protein is purified by a process that does not require the use of a monoclonal antibody reagent. The manufacturing process incorporates three validated virus clearance steps, including virus inactivation by solvent/detergent treatment and virus removal by filtration. The potency expressed in International Units is determined using an in vitro aPTT-based one-stage clotting assay against CSL Behring's manufacturing reference standard. This internal potency standard has been calibrated against the World Health Organization (WHO) International Standard for Factor IX concentrate by a one-stage clotting assay using synthetic silica and synthetic phospholipid-based reagents.</Description>
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<Description>IDELVION, Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rIX-FP) is a sterile, non-pyrogenic, lyophilized powder to be reconstituted with sterile Water for Injection (sWFI) for intravenous administration. IDELVION is available in single-dose vials containing nominally 250, 500, 1000, 2000, or 3500 IU of Factor IX formulated with sodium citrate, polysorbate 80, mannitol and sucrose. The actual amount of Factor IX activity in IU is labeled on each vial. After reconstitution of the lyophilized powder, all dosage strengths yield a clear, yellow to colorless solution. IDELVION contains no preservatives. The active ingredient in IDELVION, recombinant human coagulation Factor IX albumin fusion protein, is a purified protein produced by recombinant DNA technology. It is generated by the genetic fusion of recombinant albumin to recombinant coagulation Factor IX. The genetic fusion of the cDNA of human albumin to the cDNA of human coagulation Factor IX enables the gene product to be expressed as a single recombinant protein designated as rIX-FP. The Factor IX portion of IDELVION is identical to the Thr148 allelic form of human plasma-derived Factor IX. The cleavable linker between the Factor IX and albumin moieties is derived from the endogenous activation peptide in native Factor IX. rIX-FP remains intact in the circulation until Factor IX is activated, whereupon albumin is cleaved from Factor IX, releasing activated Factor IX (FIXa) when it is needed for coagulation. IDELVION is manufactured without the addition of proteins derived from human or animal source materials. IDELVION is a glycoprotein consisting of 1018 amino acids secreted by a genetically engineered Chinese hamster ovary (CHO) cell line. The CHO cell line secretes rIX-FP into a defined cell culture medium and the rIX-FP protein is purified by a process that does not require the use of a monoclonal antibody reagent. The manufacturing process incorporates three validated virus clearance steps, including virus inactivation by solvent/detergent treatment and virus removal by filtration. The potency expressed in International Units is determined using an in vitro aPTT-based one-stage clotting assay against CSL Behring's manufacturing reference standard. This internal potency standard has been calibrated against the World Health Organization (WHO) International Standard for Factor IX concentrate by a one-stage clotting assay using synthetic silica and synthetic phospholipid-based reagents.</Description>
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<Description>IDELVION, Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rIX-FP) is a sterile, non-pyrogenic, lyophilized powder to be reconstituted with sterile Water for Injection (sWFI) for intravenous administration. IDELVION is available in single-dose vials containing nominally 250, 500, 1000, 2000, or 3500 IU of Factor IX formulated with sodium citrate, polysorbate 80, mannitol and sucrose. The actual amount of Factor IX activity in IU is labeled on each vial. After reconstitution of the lyophilized powder, all dosage strengths yield a clear, yellow to colorless solution. IDELVION contains no preservatives. The active ingredient in IDELVION, recombinant human coagulation Factor IX albumin fusion protein, is a purified protein produced by recombinant DNA technology. It is generated by the genetic fusion of recombinant albumin to recombinant coagulation Factor IX. The genetic fusion of the cDNA of human albumin to the cDNA of human coagulation Factor IX enables the gene product to be expressed as a single recombinant protein designated as rIX-FP. The Factor IX portion of IDELVION is identical to the Thr148 allelic form of human plasma-derived Factor IX. The cleavable linker between the Factor IX and albumin moieties is derived from the endogenous activation peptide in native Factor IX. rIX-FP remains intact in the circulation until Factor IX is activated, whereupon albumin is cleaved from Factor IX, releasing activated Factor IX (FIXa) when it is needed for coagulation. IDELVION is manufactured without the addition of proteins derived from human or animal source materials. IDELVION is a glycoprotein consisting of 1018 amino acids secreted by a genetically engineered Chinese hamster ovary (CHO) cell line. The CHO cell line secretes rIX-FP into a defined cell culture medium and the rIX-FP protein is purified by a process that does not require the use of a monoclonal antibody reagent. The manufacturing process incorporates three validated virus clearance steps, including virus inactivation by solvent/detergent treatment and virus removal by filtration. The potency expressed in International Units is determined using an in vitro aPTT-based one-stage clotting assay against CSL Behring's manufacturing reference standard. This internal potency standard has been calibrated against the World Health Organization (WHO) International Standard for Factor IX concentrate by a one-stage clotting assay using synthetic silica and synthetic phospholipid-based reagents.</Description>
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<ProprietaryNameSuffix>(rosa Dulzura) - Pink</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20161109</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD</LabelerName>
<SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
<StrengthNumber>.0664; .0151</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16714-478-02</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (16714-478-02) </PackageDescription>
<NDC11Code>16714-0478-02</NDC11Code>
<ProductNDC>16714-478</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName>
<NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151101</StartMarketingDate>
<EndMarketingDate>20231231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065093</ApplicationNumber>
<LabelerName>Northstar RxLLC</LabelerName>
<SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>875; 125</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20151101</StartMarketingDatePackage>
<EndMarketingDatePackage>20231231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49349-478-02</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (49349-478-02)</PackageDescription>
<NDC11Code>49349-0478-02</NDC11Code>
<ProductNDC>49349-478</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120829</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076112</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>50742-478-02</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (50742-478-02) > 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>50742-0478-02</NDC11Code>
<ProductNDC>50742-478</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenylephrine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200116</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209967</ApplicationNumber>
<LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200116</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51346-478-02</NDCCode>
<PackageDescription>1 CONTAINER in 1 CARTON (51346-478-02) > 1 g in 1 CONTAINER (51346-478-01)</PackageDescription>
<NDC11Code>51346-0478-02</NDC11Code>
<ProductNDC>51346-478</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Provence Intense Cover 3 In 1 Strobing Foundation 01 Light Beige C</ProprietaryName>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>NATURE REPUBLIC CO., LTD.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>.21</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>52125-478-02</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (52125-478-02)</PackageDescription>
<NDC11Code>52125-0478-02</NDC11Code>
<ProductNDC>52125-478</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atenolol</ProprietaryName>
<NonProprietaryName>Atenolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130524</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076900</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>ATENOLOL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-10</LastUpdate>
</NDC>
<NDC>
<NDCCode>53208-478-02</NDCCode>
<PackageDescription>1 CONTAINER in 1 BOX (53208-478-02) > 40 mL in 1 CONTAINER (53208-478-01)</PackageDescription>
<NDC11Code>53208-0478-02</NDC11Code>
<ProductNDC>53208-478</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Isaknox Ageless Serum Moist Pearl Base</ProprietaryName>
<NonProprietaryName>Octinoxate, Titanium Dioxide, Dimethicone, Aluminum Hydroxide, Stearic Acid, Hydroxyproline,</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100831</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>LG Household and Healthcare, Inc.</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE; DIMETHICONE; ALUMINUM HYDROXIDE; STEARIC ACID; HYDROXYPROLINE</SubstanceName>
<StrengthNumber>3; 3.38; .08; .18; .18; .53</StrengthNumber>
<StrengthUnit>mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>53489-478-02</NDCCode>
<PackageDescription>50 TABLET in 1 BOTTLE, PLASTIC (53489-478-02) </PackageDescription>
<NDC11Code>53489-0478-02</NDC11Code>
<ProductNDC>53489-478</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulindac</ProprietaryName>
<NonProprietaryName>Sulindac</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090904</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072050</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>SULINDAC</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090904</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of sulindac tablets and other treatment options before deciding to use sulindac tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Sulindac tablets are indicated for acute or long-term use in the relief of signs and symptoms of the following: 1 Osteoarthritis, 2 Rheumatoid arthritis*, 3 Ankylosing spondylitis, 4 Acute painful shoulder (Acute subacromial bursitis/supraspinatus tendinitis), 5 Acute gouty arthritis.</IndicationAndUsage>
<Description>Sulindac is a non-steroidal, anti-inflammatory indene derivative designated chemically as (Z)-5-fluoro-2-methyl-1-[[ p-(methylsulfinyl)phenyl]methylene]-1 H-indene-3-acetic acid. It is not a salicylate, pyrazolone or propionic acid derivative. Its empirical formula is C 20H 17FO 3S, with a molecular weight of 356.42. Sulindac, a yellow crystalline compound, is a weak organic acid practically insoluble in water below pH 4.5, but very soluble as the sodium salt or in buffers of pH 6 or higher. Sulindac tablets are available in 150 and 200 mg tablets for oral administration. Each tablet contains the following inactive ingredients: magnesium stearate, microcrystalline cellulose, and pregelatinized starch. Following absorption, sulindac undergoes two major biotransformations — reversible reduction to the sulfide metabolite, and irreversible oxidation to the sulfone metabolite. Available evidence indicates that the biological activity resides with the sulfide metabolite. The structural formulas of sulindac and its metabolites are.</Description>
</NDC>
<NDC>
<NDCCode>57297-478-02</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (57297-478-02)</PackageDescription>
<NDC11Code>57297-0478-02</NDC11Code>
<ProductNDC>57297-478</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Simvastatin</ProprietaryName>
<NonProprietaryName>Simvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070612</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078103</ApplicationNumber>
<LabelerName>LUPIN LIMITED</LabelerName>
<SubstanceName>SIMVASTATIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Simvastatin tablets USP are an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to: 1 Reduce the risk of total mortality by reducing CHD deaths and reduce the risk of non-fatal myocardial infarction, stroke, and the need for revascularization procedures in patients at high risk of coronary events. (1.1) , 2 Reduce elevated total-C, LDL-C, Apo B, TG and increase HDL-C in patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia. (1.2) , 3 Reduce elevated TG in patients with hypertriglyceridemia and reduce TG and VLDL-C in patients with primary dysbetalipoproteinemia. (1.2) , 4 Reduce total-C and LDL-C in adult patients with homozygous familial hypercholesterolemia. (1.2) , 5 Reduce elevated total-C, LDL-C, and Apo B in boys and postmenarchal girls, 10 to 17 years of age with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy. (1.2, 1.3).</IndicationAndUsage>
<Description>Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: ascorbic acid, citric acid, hydroxy propyl cellulose, hypromellose, iron oxides, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinised starch, talc and titanium dioxide. Butylated hydroxyanisole is added as a preservative.</Description>
</NDC>
<NDC>
<NDCCode>63545-478-02</NDCCode>
<PackageDescription>500 PELLET in 1 VIAL, GLASS (63545-478-02) </PackageDescription>
<NDC11Code>63545-0478-02</NDC11Code>
<ProductNDC>63545-478</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Chenopodium Anthelminticum</ProprietaryName>
<NonProprietaryName>Chenopodium Anthelminticum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220511</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>DYSPHANIA AMBROSIOIDES WHOLE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220511</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63739-478-02</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-478-02) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>63739-0478-02</NDC11Code>
<ProductNDC>63739-478</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Docusate Sodium</ProprietaryName>
<NonProprietaryName>Docusate Sodium</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101109</StartMarketingDate>
<EndMarketingDate>20251224</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>McKesson Corporation</LabelerName>
<SubstanceName>DOCUSATE SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210701</StartMarketingDatePackage>
<EndMarketingDatePackage>20251224</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the prevention of dry, hard stools. for relief of occasional constipation. This product generally produces a bowel movement within 12 to 72 hours.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64380-478-02</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE, PLASTIC (64380-478-02) </PackageDescription>
<NDC11Code>64380-0478-02</NDC11Code>
<ProductNDC>64380-478</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine</ProprietaryName>
<NonProprietaryName>Atomoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079021</ApplicationNumber>
<LabelerName>Strides Pharma Science Limited</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atomoxetine is selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).</IndicationAndUsage>
<Description>Atomoxetine capsules, USP are a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is. Atomoxetine hydrochloride, USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules are intended for oral administration only. Each capsule contains atomoxetine hydrochloride equivalent to 10, 18, 25, 40, 60, 80 or 100 mg of atomoxetine. The capsules also contain colloidal silicon dioxide, gelatin, magnesium stearate, pregelatinized starch (corn), sodium lauryl sulfate and titanium dioxide. The 10 mg capsules also contain D&C Yellow No. 10, D&C Red No. 28, D&C Red No. 33, FD&C Red No. 40 and FD&C Yellow No. 6; the 18 mg capsules also contain D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40 and FD&C Yellow No. 6; the 25 mg capsules also contain FD&C Blue No. 1 and FD&C Red No. 3; the 40 mg capsules also contain D&C Red No. 28 and FD&C Blue No. 1; the 60 mg capsules also contain D&C Red No. 28, D&C Yellow No. 10, FD&C Blue No. 1 and FD&C Yellow No. 6; the 80 mg capsules also contain D&C Red No. 28, D&C Yellow No. 10 and FD&C Yellow No. 6; the 100 mg capsules also contain D&C Yellow No. 10, FD&C Red No. 3, FD&C Yellow No. 6 and red iron oxide. In addition, the imprinting ink contains the following: black iron oxide, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, D&C Yellow No. 10 Aluminum Lake, propylene glycol and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>66336-478-02</NDCCode>
<PackageDescription>2 TABLET in 1 BOTTLE (66336-478-02)</PackageDescription>
<NDC11Code>66336-0478-02</NDC11Code>
<ProductNDC>66336-478</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diazepam</ProprietaryName>
<NonProprietaryName>Diazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060331</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077749</ApplicationNumber>
<LabelerName>Dispensing Solutions, Inc.</LabelerName>
<SubstanceName>DIAZEPAM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Diazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma); spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia); athetosis; and stiff-man syndrome. Oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. The effectiveness of diazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Diazepam is a benzodiazepine derivative. The chemical name of diazepam is 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. It is a colorless to light yellow crystalline compound, insoluble in water. The empirical formula is C16H13ClN2O and the molecular weight is 284.75. The structural formula is as follows. Diazepam is available for oral administration as tablets containing 2 mg, 5 mg or 10 mg diazepam. In addition to the active ingredient diazepam, each tablet contains the following inactive ingredients: calcium stearate, colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate and microcrystalline cellulose with the following dyes: 5-mg tablets contain D&C Yellow #10 aluminum lake; 10-mg tablets contain FD&C Blue #1 aluminum lake. Diazepam 2-mg tablets contain no dye.</Description>
</NDC>
<NDC>
<NDCCode>68180-478-02</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (68180-478-02) </PackageDescription>
<NDC11Code>68180-0478-02</NDC11Code>
<ProductNDC>68180-478</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Simvastatin</ProprietaryName>
<NonProprietaryName>Simvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070612</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078103</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SIMVASTATIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Simvastatin tablets USP are indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):In adults with primary hyperlipidemia.In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).</IndicationAndUsage>
<Description>Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is:. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP are available for oral administration in strength of 5 mg, 10 mg, 20 mg, 40 mg or 80 mg. Each tablet contains following inactive ingredients: ascorbic acid, citric acid, hydroxy propyl cellulose, hypromellose, iron oxides, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinised starch, talc and titanium dioxide. Butylated hydroxyanisole is added as a preservative.</Description>
</NDC>
<NDC>
<NDCCode>69168-478-02</NDCCode>
<PackageDescription>2 BOTTLE, SPRAY in 1 CARTON (69168-478-02) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>69168-0478-02</NDC11Code>
<ProductNDC>69168-478</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Azelastine Hydrochloride</ProprietaryName>
<NonProprietaryName>Azelastine Hydrochloride</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20250502</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216421</ApplicationNumber>
<LabelerName>Allegiant Health</LabelerName>
<SubstanceName>AZELASTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>205.5</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250922</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 nasal congestion , 2 runny nose, 3 sneezing , 4 itchy nose.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72205-478-02</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (72205-478-02) / 2 mL in 1 VIAL, SINGLE-DOSE (72205-478-01) </PackageDescription>
<NDC11Code>72205-0478-02</NDC11Code>
<ProductNDC>72205-478</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sugammadex</ProprietaryName>
<NonProprietaryName>Sugammadex</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20260728</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214368</ApplicationNumber>
<LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
<SubstanceName>SUGAMMADEX SODIUM</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/2mL</StrengthUnit>
<Pharm_Classes>gamma-Cyclodextrins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260728</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sugammadex injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients aged 2 years and older undergoing surgery. Additional pediatric use information is approved for Merck Sharp & Dohme LLC’s BRIDION® (sugammadex) injection. However, due to Merck Sharp & Dohme LLC’s marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
<Description>Sugammadex injection, for intravenous use, contains sugammadex sodium, a modified gamma cyclodextrin chemically designated as 6A,6B,6C,6D,6E,6F,6G,6H-Octakis-S-(2-carboxyethyl)- 6A,6B,6C,6D,6E,6F,6G,6H-octathio-γ-cyclodextrin sodium salt (1:8) with a molecular weight of 2178.01. The structural formula is. Sugammadex injection is supplied as a sterile, non-pyrogenic aqueous solution that is clear, colorless to slightly yellow-brown for intravenous injection only. Each mL contains 100 mg sugammadex, which is equivalent to 108.8 mg sugammadex sodium. The aqueous solution is adjusted to a pH of between 7 and 8 with hydrochloric acid and/or sodium hydroxide. The osmolality of the product is between 300 and 500 mOsmol/kg. Sugammadex injection may contain up to 7 mg/mL of the mono OH-derivative of sugammadex [see Clinical Pharmacology (12.2)]. This derivative is chemically designated as 6A,6B,6C,6D,6E,6F,6G-Heptakis-S-(2-carboxyethyl)-6A,6B,6C,6D,6E,6F,6G-heptathio-γ-cyclodextrin sodium salt (1:7) with a molecular weight of 2067.90. The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>82280-478-02</NDCCode>
<PackageDescription>56.7 g in 1 JAR (82280-478-02) </PackageDescription>
<NDC11Code>82280-0478-02</NDC11Code>
<ProductNDC>82280-478</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Theraplex Aim Anti-itch Moisturizing</ProprietaryName>
<NonProprietaryName>Hydrocortisone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240506</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>THERAPLEX, LLC</LabelerName>
<SubstanceName>HYDROCORTISONE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: 1 eczema, 2 soaps, 3 detergents, 4 cosmetics, 5 seborrheic dermatitis, 6 psoriasis., 7 Other uses of this product should only be under the advice and supervision of a doctor.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84522-478-02</NDCCode>
<PackageDescription>15 g in 1 BOX (84522-478-02) </PackageDescription>
<NDC11Code>84522-0478-02</NDC11Code>
<ProductNDC>84522-478</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Trstay Kojic Acid Cream</ProprietaryName>
<NonProprietaryName>Trstay Kojic Acid Cream</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241213</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Ziqiu Import Export Co Ltd</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
</NDCList>