{
"NDC": [
{
"NDCCode": "0003-2188-11",
"PackageDescription": "4 SYRINGE, GLASS in 1 CARTON (0003-2188-11) / 1 mL in 1 SYRINGE, GLASS",
"NDC11Code": "00003-2188-11",
"ProductNDC": "0003-2188",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Orencia",
"NonProprietaryName": "Abatacept",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20110729",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125118",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "ABATACEPT",
"StrengthNumber": "125",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Cytokine Activity [PE], Recombinant Fusion Proteins [CS], Selective T Cell Costimulation Modulator [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20131001",
"SamplePackage": "N",
"IndicationAndUsage": "ORENCIA is a selective T cell costimulation modulator indicated for: 1 the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). (1.1), 2 the treatment of patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA). (1.2), 3 the treatment of patients 2 years of age and older with active psoriatic arthritis (PsA). (1.3), 4 the prophylaxis of acute graft versus host disease (aGVHD), in combination with a calcineurin inhibitor and methotrexate, in adults and pediatric patients 2 years of age and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated donor. (1.4).",
"Description": "Abatacept is a selective T-cell costimulation modulator. Abatacept is a soluble fusion protein that consists of the extracellular domain of human cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) linked to the modified Fc (hinge, CH2, and CH3 domains) portion of human immunoglobulin G1 (IgG1). Abatacept is produced by recombinant DNA technology in a mammalian cell expression system. The apparent molecular weight of abatacept is 92 kilodaltons. ORENCIA (abatacept) for injection is a sterile, white, preservative-free lyophilized powder for reconstitution and dilution prior to intravenous infusion. Following reconstitution of the lyophilized powder with 10 mL of Sterile Water for Injection, USP, the reconstituted solution of ORENCIA is clear, colorless to pale yellow, with a concentration of 25 mg/mL and with a pH range of 7.2 to 7.8. Each single-dose vial of ORENCIA provides 250 mg abatacept, maltose (500 mg), monobasic sodium phosphate (17.2 mg), and sodium chloride (14.6 mg). ORENCIA (abatacept) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale-yellow solution with a pH range of 6.8 to 7.4 for subcutaneous administration. ORENCIA injection is supplied as a single-dose prefilled syringe or as a single-dose ClickJect autoinjector (see Table 6). Unlike the lyophilized formulation for intravenous use, the ORENCIA solutions for subcutaneous administration contain no maltose."
},
{
"NDCCode": "0003-2188-21",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (0003-2188-21) / 1 mL in 1 SYRINGE, GLASS",
"NDC11Code": "00003-2188-21",
"ProductNDC": "0003-2188",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Orencia",
"NonProprietaryName": "Abatacept",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20110729",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125118",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "ABATACEPT",
"StrengthNumber": "125",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Cytokine Activity [PE], Recombinant Fusion Proteins [CS], Selective T Cell Costimulation Modulator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20131001",
"SamplePackage": "N",
"IndicationAndUsage": "ORENCIA is a selective T cell costimulation modulator indicated for: 1 the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). (1.1), 2 the treatment of patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA). (1.2), 3 the treatment of patients 2 years of age and older with active psoriatic arthritis (PsA). (1.3), 4 the prophylaxis of acute graft versus host disease (aGVHD), in combination with a calcineurin inhibitor and methotrexate, in adults and pediatric patients 2 years of age and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated donor. (1.4).",
"Description": "Abatacept is a selective T-cell costimulation modulator. Abatacept is a soluble fusion protein that consists of the extracellular domain of human cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) linked to the modified Fc (hinge, CH2, and CH3 domains) portion of human immunoglobulin G1 (IgG1). Abatacept is produced by recombinant DNA technology in a mammalian cell expression system. The apparent molecular weight of abatacept is 92 kilodaltons. ORENCIA (abatacept) for injection is a sterile, white, preservative-free lyophilized powder for reconstitution and dilution prior to intravenous infusion. Following reconstitution of the lyophilized powder with 10 mL of Sterile Water for Injection, USP, the reconstituted solution of ORENCIA is clear, colorless to pale yellow, with a concentration of 25 mg/mL and with a pH range of 7.2 to 7.8. Each single-dose vial of ORENCIA provides 250 mg abatacept, maltose (500 mg), monobasic sodium phosphate (17.2 mg), and sodium chloride (14.6 mg). ORENCIA (abatacept) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale-yellow solution with a pH range of 6.8 to 7.4 for subcutaneous administration. ORENCIA injection is supplied as a single-dose prefilled syringe or as a single-dose ClickJect autoinjector (see Table 6). Unlike the lyophilized formulation for intravenous use, the ORENCIA solutions for subcutaneous administration contain no maltose."
},
{
"NDCCode": "0003-2188-31",
"PackageDescription": "4 SYRINGE, GLASS in 1 CARTON (0003-2188-31) > 1 mL in 1 SYRINGE, GLASS",
"NDC11Code": "00003-2188-31",
"ProductNDC": "0003-2188",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Orencia",
"NonProprietaryName": "Abatacept",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20110729",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125118",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "ABATACEPT",
"StrengthNumber": "125",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Cytokine Activity [PE],Selective T Cell Costimulation Modulator [EPC],Recombinant Fusion Proteins [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2015-01-16"
},
{
"NDCCode": "0003-2188-41",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (0003-2188-41) > 1 mL in 1 SYRINGE, GLASS",
"NDC11Code": "00003-2188-41",
"ProductNDC": "0003-2188",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Orencia",
"NonProprietaryName": "Abatacept",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20110729",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125118",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "ABATACEPT",
"StrengthNumber": "125",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Cytokine Activity [PE],Selective T Cell Costimulation Modulator [EPC],Recombinant Fusion Proteins [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2015-01-16"
},
{
"NDCCode": "0003-2188-50",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (0003-2188-50) / 1 mL in 1 SYRINGE, GLASS",
"NDC11Code": "00003-2188-50",
"ProductNDC": "0003-2188",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Orencia",
"NonProprietaryName": "Abatacept",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20110729",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125118",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "ABATACEPT",
"StrengthNumber": "125",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Cytokine Activity [PE], Recombinant Fusion Proteins [CS], Selective T Cell Costimulation Modulator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160705",
"SamplePackage": "N",
"IndicationAndUsage": "ORENCIA is a selective T cell costimulation modulator indicated for: 1 the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). (1.1), 2 the treatment of patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA). (1.2), 3 the treatment of patients 2 years of age and older with active psoriatic arthritis (PsA). (1.3), 4 the prophylaxis of acute graft versus host disease (aGVHD), in combination with a calcineurin inhibitor and methotrexate, in adults and pediatric patients 2 years of age and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated donor. (1.4).",
"Description": "Abatacept is a selective T-cell costimulation modulator. Abatacept is a soluble fusion protein that consists of the extracellular domain of human cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) linked to the modified Fc (hinge, CH2, and CH3 domains) portion of human immunoglobulin G1 (IgG1). Abatacept is produced by recombinant DNA technology in a mammalian cell expression system. The apparent molecular weight of abatacept is 92 kilodaltons. ORENCIA (abatacept) for injection is a sterile, white, preservative-free lyophilized powder for reconstitution and dilution prior to intravenous infusion. Following reconstitution of the lyophilized powder with 10 mL of Sterile Water for Injection, USP, the reconstituted solution of ORENCIA is clear, colorless to pale yellow, with a concentration of 25 mg/mL and with a pH range of 7.2 to 7.8. Each single-dose vial of ORENCIA provides 250 mg abatacept, maltose (500 mg), monobasic sodium phosphate (17.2 mg), and sodium chloride (14.6 mg). ORENCIA (abatacept) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale-yellow solution with a pH range of 6.8 to 7.4 for subcutaneous administration. ORENCIA injection is supplied as a single-dose prefilled syringe or as a single-dose ClickJect autoinjector (see Table 6). Unlike the lyophilized formulation for intravenous use, the ORENCIA solutions for subcutaneous administration contain no maltose."
},
{
"NDCCode": "0003-2188-51",
"PackageDescription": "4 SYRINGE, GLASS in 1 CARTON (0003-2188-51) / 1 mL in 1 SYRINGE, GLASS",
"NDC11Code": "00003-2188-51",
"ProductNDC": "0003-2188",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Orencia",
"NonProprietaryName": "Abatacept",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20110729",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125118",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "ABATACEPT",
"StrengthNumber": "125",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Cytokine Activity [PE], Recombinant Fusion Proteins [CS], Selective T Cell Costimulation Modulator [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160607",
"SamplePackage": "N",
"IndicationAndUsage": "ORENCIA is a selective T cell costimulation modulator indicated for: 1 the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). (1.1), 2 the treatment of patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA). (1.2), 3 the treatment of patients 2 years of age and older with active psoriatic arthritis (PsA). (1.3), 4 the prophylaxis of acute graft versus host disease (aGVHD), in combination with a calcineurin inhibitor and methotrexate, in adults and pediatric patients 2 years of age and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated donor. (1.4).",
"Description": "Abatacept is a selective T-cell costimulation modulator. Abatacept is a soluble fusion protein that consists of the extracellular domain of human cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) linked to the modified Fc (hinge, CH2, and CH3 domains) portion of human immunoglobulin G1 (IgG1). Abatacept is produced by recombinant DNA technology in a mammalian cell expression system. The apparent molecular weight of abatacept is 92 kilodaltons. ORENCIA (abatacept) for injection is a sterile, white, preservative-free lyophilized powder for reconstitution and dilution prior to intravenous infusion. Following reconstitution of the lyophilized powder with 10 mL of Sterile Water for Injection, USP, the reconstituted solution of ORENCIA is clear, colorless to pale yellow, with a concentration of 25 mg/mL and with a pH range of 7.2 to 7.8. Each single-dose vial of ORENCIA provides 250 mg abatacept, maltose (500 mg), monobasic sodium phosphate (17.2 mg), and sodium chloride (14.6 mg). ORENCIA (abatacept) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale-yellow solution with a pH range of 6.8 to 7.4 for subcutaneous administration. ORENCIA injection is supplied as a single-dose prefilled syringe or as a single-dose ClickJect autoinjector (see Table 6). Unlike the lyophilized formulation for intravenous use, the ORENCIA solutions for subcutaneous administration contain no maltose."
},
{
"NDCCode": "0003-2188-82",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (0003-2188-82) > 1 mL in 1 SYRINGE, GLASS",
"NDC11Code": "00003-2188-82",
"ProductNDC": "0003-2188",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Orencia",
"NonProprietaryName": "Abatacept",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20110729",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125118",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "ABATACEPT",
"StrengthNumber": "125",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Cytokine Activity [PE],Selective T Cell Costimulation Modulator [EPC],Recombinant Fusion Proteins [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2015-01-16"
},
{
"NDCCode": "0003-2188-90",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (0003-2188-90) / 1 mL in 1 SYRINGE, GLASS",
"NDC11Code": "00003-2188-90",
"ProductNDC": "0003-2188",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Orencia",
"NonProprietaryName": "Abatacept",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20110729",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125118",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "ABATACEPT",
"StrengthNumber": "125",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Cytokine Activity [PE], Recombinant Fusion Proteins [CS], Selective T Cell Costimulation Modulator [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160712",
"SamplePackage": "Y",
"IndicationAndUsage": "ORENCIA is a selective T cell costimulation modulator indicated for: 1 the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). (1.1), 2 the treatment of patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA). (1.2), 3 the treatment of patients 2 years of age and older with active psoriatic arthritis (PsA). (1.3), 4 the prophylaxis of acute graft versus host disease (aGVHD), in combination with a calcineurin inhibitor and methotrexate, in adults and pediatric patients 2 years of age and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated donor. (1.4).",
"Description": "Abatacept is a selective T-cell costimulation modulator. Abatacept is a soluble fusion protein that consists of the extracellular domain of human cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) linked to the modified Fc (hinge, CH2, and CH3 domains) portion of human immunoglobulin G1 (IgG1). Abatacept is produced by recombinant DNA technology in a mammalian cell expression system. The apparent molecular weight of abatacept is 92 kilodaltons. ORENCIA (abatacept) for injection is a sterile, white, preservative-free lyophilized powder for reconstitution and dilution prior to intravenous infusion. Following reconstitution of the lyophilized powder with 10 mL of Sterile Water for Injection, USP, the reconstituted solution of ORENCIA is clear, colorless to pale yellow, with a concentration of 25 mg/mL and with a pH range of 7.2 to 7.8. Each single-dose vial of ORENCIA provides 250 mg abatacept, maltose (500 mg), monobasic sodium phosphate (17.2 mg), and sodium chloride (14.6 mg). ORENCIA (abatacept) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale-yellow solution with a pH range of 6.8 to 7.4 for subcutaneous administration. ORENCIA injection is supplied as a single-dose prefilled syringe or as a single-dose ClickJect autoinjector (see Table 6). Unlike the lyophilized formulation for intravenous use, the ORENCIA solutions for subcutaneous administration contain no maltose."
},
{
"NDCCode": "0003-2188-91",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (0003-2188-91) / 1 mL in 1 SYRINGE, GLASS",
"NDC11Code": "00003-2188-91",
"ProductNDC": "0003-2188",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Orencia",
"NonProprietaryName": "Abatacept",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20110729",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125118",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "ABATACEPT",
"StrengthNumber": "125",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Cytokine Activity [PE], Recombinant Fusion Proteins [CS], Selective T Cell Costimulation Modulator [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20131001",
"SamplePackage": "Y",
"IndicationAndUsage": "ORENCIA is a selective T cell costimulation modulator indicated for: 1 the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). (1.1), 2 the treatment of patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA). (1.2), 3 the treatment of patients 2 years of age and older with active psoriatic arthritis (PsA). (1.3), 4 the prophylaxis of acute graft versus host disease (aGVHD), in combination with a calcineurin inhibitor and methotrexate, in adults and pediatric patients 2 years of age and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated donor. (1.4).",
"Description": "Abatacept is a selective T-cell costimulation modulator. Abatacept is a soluble fusion protein that consists of the extracellular domain of human cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) linked to the modified Fc (hinge, CH2, and CH3 domains) portion of human immunoglobulin G1 (IgG1). Abatacept is produced by recombinant DNA technology in a mammalian cell expression system. The apparent molecular weight of abatacept is 92 kilodaltons. ORENCIA (abatacept) for injection is a sterile, white, preservative-free lyophilized powder for reconstitution and dilution prior to intravenous infusion. Following reconstitution of the lyophilized powder with 10 mL of Sterile Water for Injection, USP, the reconstituted solution of ORENCIA is clear, colorless to pale yellow, with a concentration of 25 mg/mL and with a pH range of 7.2 to 7.8. Each single-dose vial of ORENCIA provides 250 mg abatacept, maltose (500 mg), monobasic sodium phosphate (17.2 mg), and sodium chloride (14.6 mg). ORENCIA (abatacept) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale-yellow solution with a pH range of 6.8 to 7.4 for subcutaneous administration. ORENCIA injection is supplied as a single-dose prefilled syringe or as a single-dose ClickJect autoinjector (see Table 6). Unlike the lyophilized formulation for intravenous use, the ORENCIA solutions for subcutaneous administration contain no maltose."
},
{
"NDCCode": "74620-003-08",
"PackageDescription": "2188 mL in 1 BOTTLE (74620-003-08) ",
"NDC11Code": "74620-0003-08",
"ProductNDC": "74620-003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Instant Hand Sanitizer Gel",
"NonProprietaryName": "Instant Hand Sanitizer Gel",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200407",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "COSBE LABORA TORY INC.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200407",
"SamplePackage": "N"
},
{
"NDCCode": "43742-2188-1",
"PackageDescription": "960 mL in 1 CONTAINER (43742-2188-1) ",
"NDC11Code": "43742-2188-01",
"ProductNDC": "43742-2188",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Borrelia Burgdorferi Nosode, Borrelia Burgdorferi Nosode Dna",
"DosageFormName": "LIQUID",
"StartMarketingDate": "20241118",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Deseret Biologicals, Inc.",
"SubstanceName": "BORRELIA BURGDORFERI; BORRELIA BURGDORFERI DNA",
"StrengthNumber": "1; 1",
"StrengthUnit": "[hp_M]/mL; [hp_M]/mL",
"Status": "Unfinished",
"LastUpdate": "2024-11-20",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "18-NOV-24"
},
{
"NDCCode": "71335-2188-1",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (71335-2188-1) ",
"NDC11Code": "71335-2188-01",
"ProductNDC": "71335-2188",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin Hydrochloride",
"NonProprietaryName": "Doxepin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20191220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212624",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2023-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221115",
"SamplePackage": "N",
"IndicationAndUsage": "Doxepin Hydrochloride Capsules, USP are recommended for the treatment of: 1 Psychoneurotic patients with depression and/or anxiety., 2 Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol)., 3 Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly). , 4 Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders. .",
"Description": "Doxepin hydrochloride, USP is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. The molecular formula of the compound is C19H21NOHCl having a molecular weight of 316. It is a white or almost white crystalline powder freely soluble in water, alcohols and methylene chloride. It may be represented by the following structural formula. Chemically, doxepin hydrochloride, USP is a dibenzoxepin derivative and is the first of a family of tricyclic psychotherapeutic agents. Specifically, it is an isomeric mixture of:1-Propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-, hydrochloride. Each 10 mg, 25 mg, 50 mg, 75 mg and 100 mg doxepin capsule, USP for oral administration contains doxepin hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg, 75 mg and 100 mg doxepin, respectively and the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and magnesium stearate. The hard gelatin capsule shell contain titanium dioxide, gelatin, sodium lauryl sulfate, FD & C Yellow 6, D & C Yellow 10, and FD & C Green 3. The imprinting ink contains shellac, propylene glycol, black iron oxide and potassium hydroxide."
},
{
"NDCCode": "71335-2188-2",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (71335-2188-2) ",
"NDC11Code": "71335-2188-02",
"ProductNDC": "71335-2188",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin Hydrochloride",
"NonProprietaryName": "Doxepin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20191220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212624",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2023-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221115",
"SamplePackage": "N",
"IndicationAndUsage": "Doxepin Hydrochloride Capsules, USP are recommended for the treatment of: 1 Psychoneurotic patients with depression and/or anxiety., 2 Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol)., 3 Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly). , 4 Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders. .",
"Description": "Doxepin hydrochloride, USP is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. The molecular formula of the compound is C19H21NOHCl having a molecular weight of 316. It is a white or almost white crystalline powder freely soluble in water, alcohols and methylene chloride. It may be represented by the following structural formula. Chemically, doxepin hydrochloride, USP is a dibenzoxepin derivative and is the first of a family of tricyclic psychotherapeutic agents. Specifically, it is an isomeric mixture of:1-Propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-, hydrochloride. Each 10 mg, 25 mg, 50 mg, 75 mg and 100 mg doxepin capsule, USP for oral administration contains doxepin hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg, 75 mg and 100 mg doxepin, respectively and the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and magnesium stearate. The hard gelatin capsule shell contain titanium dioxide, gelatin, sodium lauryl sulfate, FD & C Yellow 6, D & C Yellow 10, and FD & C Green 3. The imprinting ink contains shellac, propylene glycol, black iron oxide and potassium hydroxide."
},
{
"NDCCode": "71335-2188-3",
"PackageDescription": "28 CAPSULE in 1 BOTTLE (71335-2188-3) ",
"NDC11Code": "71335-2188-03",
"ProductNDC": "71335-2188",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin Hydrochloride",
"NonProprietaryName": "Doxepin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20191220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212624",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2023-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221115",
"SamplePackage": "N",
"IndicationAndUsage": "Doxepin Hydrochloride Capsules, USP are recommended for the treatment of: 1 Psychoneurotic patients with depression and/or anxiety., 2 Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol)., 3 Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly). , 4 Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders. .",
"Description": "Doxepin hydrochloride, USP is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. The molecular formula of the compound is C19H21NOHCl having a molecular weight of 316. It is a white or almost white crystalline powder freely soluble in water, alcohols and methylene chloride. It may be represented by the following structural formula. Chemically, doxepin hydrochloride, USP is a dibenzoxepin derivative and is the first of a family of tricyclic psychotherapeutic agents. Specifically, it is an isomeric mixture of:1-Propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-, hydrochloride. Each 10 mg, 25 mg, 50 mg, 75 mg and 100 mg doxepin capsule, USP for oral administration contains doxepin hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg, 75 mg and 100 mg doxepin, respectively and the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and magnesium stearate. The hard gelatin capsule shell contain titanium dioxide, gelatin, sodium lauryl sulfate, FD & C Yellow 6, D & C Yellow 10, and FD & C Green 3. The imprinting ink contains shellac, propylene glycol, black iron oxide and potassium hydroxide."
},
{
"NDCCode": "71335-2188-4",
"PackageDescription": "18 CAPSULE in 1 BOTTLE (71335-2188-4) ",
"NDC11Code": "71335-2188-04",
"ProductNDC": "71335-2188",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin Hydrochloride",
"NonProprietaryName": "Doxepin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20191220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212624",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2023-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221115",
"SamplePackage": "N",
"IndicationAndUsage": "Doxepin Hydrochloride Capsules, USP are recommended for the treatment of: 1 Psychoneurotic patients with depression and/or anxiety., 2 Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol)., 3 Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly). , 4 Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders. .",
"Description": "Doxepin hydrochloride, USP is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. The molecular formula of the compound is C19H21NOHCl having a molecular weight of 316. It is a white or almost white crystalline powder freely soluble in water, alcohols and methylene chloride. It may be represented by the following structural formula. Chemically, doxepin hydrochloride, USP is a dibenzoxepin derivative and is the first of a family of tricyclic psychotherapeutic agents. Specifically, it is an isomeric mixture of:1-Propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-, hydrochloride. Each 10 mg, 25 mg, 50 mg, 75 mg and 100 mg doxepin capsule, USP for oral administration contains doxepin hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg, 75 mg and 100 mg doxepin, respectively and the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and magnesium stearate. The hard gelatin capsule shell contain titanium dioxide, gelatin, sodium lauryl sulfate, FD & C Yellow 6, D & C Yellow 10, and FD & C Green 3. The imprinting ink contains shellac, propylene glycol, black iron oxide and potassium hydroxide."
},
{
"NDCCode": "71335-2188-5",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (71335-2188-5) ",
"NDC11Code": "71335-2188-05",
"ProductNDC": "71335-2188",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin Hydrochloride",
"NonProprietaryName": "Doxepin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20191220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212624",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2023-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221115",
"SamplePackage": "N",
"IndicationAndUsage": "Doxepin Hydrochloride Capsules, USP are recommended for the treatment of: 1 Psychoneurotic patients with depression and/or anxiety., 2 Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol)., 3 Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly). , 4 Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders. .",
"Description": "Doxepin hydrochloride, USP is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. The molecular formula of the compound is C19H21NOHCl having a molecular weight of 316. It is a white or almost white crystalline powder freely soluble in water, alcohols and methylene chloride. It may be represented by the following structural formula. Chemically, doxepin hydrochloride, USP is a dibenzoxepin derivative and is the first of a family of tricyclic psychotherapeutic agents. Specifically, it is an isomeric mixture of:1-Propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-, hydrochloride. Each 10 mg, 25 mg, 50 mg, 75 mg and 100 mg doxepin capsule, USP for oral administration contains doxepin hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg, 75 mg and 100 mg doxepin, respectively and the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and magnesium stearate. The hard gelatin capsule shell contain titanium dioxide, gelatin, sodium lauryl sulfate, FD & C Yellow 6, D & C Yellow 10, and FD & C Green 3. The imprinting ink contains shellac, propylene glycol, black iron oxide and potassium hydroxide."
},
{
"NDCCode": "84891-2188-1",
"PackageDescription": "30 mL in 1 TUBE (84891-2188-1) ",
"NDC11Code": "84891-2188-01",
"ProductNDC": "84891-2188",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Solarium Daily Essentials Skin Perfecting Primer",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241121",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Solarium Brands LLC",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "165",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2025-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241121",
"SamplePackage": "N"
},
{
"NDCCode": "0003-0524-11",
"PackageDescription": "1 BOTTLE in 1 CARTON (0003-0524-11) / 60 TABLET in 1 BOTTLE",
"NDC11Code": "00003-0524-11",
"ProductNDC": "0003-0524",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sprycel",
"NonProprietaryName": "Dasatinib",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060627",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021986",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "DASATINIB",
"StrengthNumber": "70",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060627",
"SamplePackage": "N"
},
{
"NDCCode": "0003-0527-11",
"PackageDescription": "1 BOTTLE in 1 CARTON (0003-0527-11) / 60 TABLET in 1 BOTTLE",
"NDC11Code": "00003-0527-11",
"ProductNDC": "0003-0527",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sprycel",
"NonProprietaryName": "Dasatinib",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060627",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021986",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "DASATINIB",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060627",
"SamplePackage": "N"
},
{
"NDCCode": "0003-0528-11",
"PackageDescription": "1 BOTTLE in 1 CARTON (0003-0528-11) / 60 TABLET in 1 BOTTLE",
"NDC11Code": "00003-0528-11",
"ProductNDC": "0003-0528",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sprycel",
"NonProprietaryName": "Dasatinib",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060627",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021986",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "DASATINIB",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060627",
"SamplePackage": "N"
},
{
"NDCCode": "0003-0895-11",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0003-0895-11) ",
"NDC11Code": "00003-0895-11",
"ProductNDC": "0003-0895",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sotyktu",
"NonProprietaryName": "Deucravacitinib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220909",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214958",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "DEUCRAVACITINIB",
"StrengthNumber": "6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tyrosine Kinase 2 Inhibitor [EPC], Tyrosine Kinase 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220909",
"SamplePackage": "N",
"IndicationAndUsage": "SOTYKTU is a tyrosine kinase 2 (TYK2) inhibitor indicated for: 1 the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. (1.1).",
"Description": "Deucravacitinib is a tyrosine kinase 2 (TYK2) inhibitor and is described chemically as:. 6-(cyclopropanecarbonylamido)-4-[2-methoxy-3-(1-methyl-1,2,4-triazol-3-yl)anilino]-N-(trideuteriomethyl)pyridazine-3-carboxamide. The molecular formula is C20H19D3N8O3 and the molecular weight of the free base is 425.47. Deucravacitinib has the structural formula. Deucravacitinib is a white to yellow powder. The solubility of deucravacitinib is pH dependent. Solubility decreases with increasing pH. SOTYKTU (deucravacitinib) tablets are supplied in 6 mg strength for oral administration. Each tablet contains deucravacitinib as the active ingredient and the following inactive ingredients: anhydrous lactose, croscarmellose sodium, hypromellose acetate succinate, magnesium stearate, microcrystalline cellulose, and silicon dioxide. In addition, the film coating Opadry® II Pink contains the following inactive ingredients: iron oxide red, iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide."
},
{
"NDCCode": "0003-1427-11",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0003-1427-11)",
"NDC11Code": "00003-1427-11",
"ProductNDC": "0003-1427",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Farxiga",
"NonProprietaryName": "Dapagliflozin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140108",
"EndMarketingDate": "20170430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202293",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "DAPAGLIFLOZIN PROPANEDIOL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-05-02"
},
{
"NDCCode": "0003-1428-11",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0003-1428-11)",
"NDC11Code": "00003-1428-11",
"ProductNDC": "0003-1428",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Farxiga",
"NonProprietaryName": "Dapagliflozin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140108",
"EndMarketingDate": "20170831",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202293",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "DAPAGLIFLOZIN PROPANEDIOL",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-09-01"
},
{
"NDCCode": "0003-2230-11",
"PackageDescription": "24 CONTAINER in 1 PACKAGE (0003-2230-11) > 50 mL in 1 CONTAINER",
"NDC11Code": "00003-2230-11",
"ProductNDC": "0003-2230",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azactam",
"NonProprietaryName": "Aztreonam",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20100401",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050632",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "AZTREONAM",
"StrengthNumber": "1",
"StrengthUnit": "g/50mL",
"Pharm_Classes": "Monobactam Antibacterial [EPC],Monobactams [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20100401",
"SamplePackage": "N"
},
{
"NDCCode": "0003-2240-11",
"PackageDescription": "24 CONTAINER in 1 PACKAGE (0003-2240-11) > 50 mL in 1 CONTAINER",
"NDC11Code": "00003-2240-11",
"ProductNDC": "0003-2240",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azactam",
"NonProprietaryName": "Aztreonam",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20100401",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050632",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "AZTREONAM",
"StrengthNumber": "2",
"StrengthUnit": "g/50mL",
"Pharm_Classes": "Monobactam Antibacterial [EPC],Monobactams [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20100401",
"SamplePackage": "N"
},
{
"NDCCode": "0003-2291-11",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (0003-2291-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE",
"NDC11Code": "00003-2291-11",
"ProductNDC": "0003-2291",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Empliciti",
"NonProprietaryName": "Elotuzumab",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20151130",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761035",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "ELOTUZUMAB",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antibodies, Monoclonal [CS], SLAMF7-directed Antibody Interactions [MoA], SLAMF7-directed Immunostimulatory Antibody [EPC]",
"Status": "Active",
"LastUpdate": "2024-06-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151130",
"SamplePackage": "N",
"IndicationAndUsage": "EMPLICITI is indicated in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one to three prior therapies. EMPLICITI is indicated in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.",
"Description": "Elotuzumab is a humanized recombinant monoclonal antibody directed to SLAMF7, a cell surface glycoprotein. Elotuzumab consists of the complementary determining regions (CDR) of the mouse antibody, MuLuc63, grafted onto human IgG1 heavy and kappa light chain frameworks. Elotuzumab is produced in NS0 cells by recombinant DNA technology. Elotuzumab has a theoretical mass of 148.1 kDa for the intact antibody. EMPLICITI (elotuzumab) is a sterile, nonpyrogenic, preservative-free lyophilized powder that is white to off-white, whole or fragmented cake in single-dose vials. EMPLICITI for Injection is supplied as 300 mg per vial and 400 mg per vial and requires reconstitution with Sterile Water for Injection, USP (13 mL and 17 mL, respectively) to obtain a solution with a concentration of 25 mg/mL. After reconstitution, each vial contains overfill to allow for withdrawal of 12 mL (300 mg) and 16 mL (400 mg). The reconstituted solution is colorless to slightly yellow, clear to slightly opalescent. Prior to intravenous infusion, the reconstituted solution is diluted with either 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP [see Dosage and Administration (2.6)]. Each 300 mg single-dose vial of EMPLICITI also contains the following inactive ingredients: citric acid monohydrate (2.44 mg), polysorbate 80 (3.4 mg), sodium citrate (16.6 mg), and sucrose (510 mg). Each 400 mg single-dose vial of EMPLICITI also contains the following inactive ingredients: citric acid monohydrate (3.17 mg), polysorbate 80 (4.4 mg), sodium citrate (21.5 mg), and sucrose (660 mg)."
},
{
"NDCCode": "0003-2327-11",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (0003-2327-11) / 10 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "00003-2327-11",
"ProductNDC": "0003-2327",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Yervoy",
"NonProprietaryName": "Ipilimumab",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20110325",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125377",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "IPILIMUMAB",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "CTLA-4-directed Antibody Interactions [MoA], CTLA-4-directed Blocking Antibody [EPC], Increased T Lymphocyte Activation [PE]",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110325",
"SamplePackage": "N"
},
{
"NDCCode": "0003-2814-11",
"PackageDescription": "4 SYRINGE, GLASS in 1 CARTON (0003-2814-11) / .4 mL in 1 SYRINGE, GLASS",
"NDC11Code": "00003-2814-11",
"ProductNDC": "0003-2814",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Orencia",
"NonProprietaryName": "Abatacept",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20110729",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125118",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "ABATACEPT",
"StrengthNumber": "50",
"StrengthUnit": "mg/.4mL",
"Pharm_Classes": "Decreased Cytokine Activity [PE], Recombinant Fusion Proteins [CS], Selective T Cell Costimulation Modulator [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
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"Description": "EVOTAZ® is a fixed-dose tablet for oral administration containing the active ingredients atazanavir and cobicistat. Atazanavir is an HIV-1 protease inhibitor. Cobicistat is a mechanism-based inhibitor of cytochrome P450 (CYP) enzymes of the CYP3A family. EVOTAZ tablets contain 342 mg of atazanavir sulfate, equivalent to 300 mg of atazanavir, and 150 mg of cobicistat, as well as the following inactive ingredients in the tablet core: croscarmellose sodium, crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium starch glycolate, and stearic acid. The tablets are film-coated with a coating material containing the following inactive ingredients: hypromellose, red iron oxide, talc, titanium dioxide, triacetin. Atazanavir: Atazanavir is present as the sulfate salt. The chemical name for atazanavir sulfate is (3S,8S,9S,12S)-3,12-bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2-pyridinyl)phenyl]methyl]-2,5,6,10,13-pentaazatetradecanedioic acid dimethyl ester, sulfate (1:1). Its molecular formula is C38H52N6O7H2SO4, which corresponds to a molecular weight of 802.9 (sulfuric acid salt). The free base molecular weight is 704.9. Atazanavir sulfate has the following structural formula. Atazanavir sulfate is a white to pale-yellow crystalline powder. It is slightly soluble in water (4-5 mg/mL, free base equivalent) with the pH of a saturated solution in water being about 1.9 at 24 ± 3°C. Cobicistat: The chemical name for cobicistat is 1,3-thiazol-5-ylmethyl [(2R,5R)-5-{[(2S)-2-[(methyl{[2-(propan-2-yl)-1,3-thiazol-4-yl]methyl}carbamoyl)amino]-4-(morpholin-4-yl)butanoyl]amino}-1,6-diphenylhexan-2-yl]carbamate. It has a molecular formula of C40H53N7O5S2 and a molecular weight of 776.0. It has the following structural formula. Cobicistat is adsorbed onto silicon dioxide. Cobicistat on silicon dioxide is a white to pale yellow solid with a solubility of 0.1 mg/mL in water at 20°C."
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<StartMarketingDate>20110729</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125118</ApplicationNumber>
<LabelerName>E.R. Squibb & Sons, L.L.C.</LabelerName>
<SubstanceName>ABATACEPT</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Cytokine Activity [PE], Recombinant Fusion Proteins [CS], Selective T Cell Costimulation Modulator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160712</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>ORENCIA is a selective T cell costimulation modulator indicated for: 1 the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). (1.1), 2 the treatment of patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA). (1.2), 3 the treatment of patients 2 years of age and older with active psoriatic arthritis (PsA). (1.3), 4 the prophylaxis of acute graft versus host disease (aGVHD), in combination with a calcineurin inhibitor and methotrexate, in adults and pediatric patients 2 years of age and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated donor. (1.4).</IndicationAndUsage>
<Description>Abatacept is a selective T-cell costimulation modulator. Abatacept is a soluble fusion protein that consists of the extracellular domain of human cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) linked to the modified Fc (hinge, CH2, and CH3 domains) portion of human immunoglobulin G1 (IgG1). Abatacept is produced by recombinant DNA technology in a mammalian cell expression system. The apparent molecular weight of abatacept is 92 kilodaltons. ORENCIA (abatacept) for injection is a sterile, white, preservative-free lyophilized powder for reconstitution and dilution prior to intravenous infusion. Following reconstitution of the lyophilized powder with 10 mL of Sterile Water for Injection, USP, the reconstituted solution of ORENCIA is clear, colorless to pale yellow, with a concentration of 25 mg/mL and with a pH range of 7.2 to 7.8. Each single-dose vial of ORENCIA provides 250 mg abatacept, maltose (500 mg), monobasic sodium phosphate (17.2 mg), and sodium chloride (14.6 mg). ORENCIA (abatacept) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale-yellow solution with a pH range of 6.8 to 7.4 for subcutaneous administration. ORENCIA injection is supplied as a single-dose prefilled syringe or as a single-dose ClickJect autoinjector (see Table 6). Unlike the lyophilized formulation for intravenous use, the ORENCIA solutions for subcutaneous administration contain no maltose.</Description>
</NDC>
<NDC>
<NDCCode>0003-2188-91</NDCCode>
<PackageDescription>1 SYRINGE, GLASS in 1 CARTON (0003-2188-91) / 1 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>00003-2188-91</NDC11Code>
<ProductNDC>0003-2188</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Orencia</ProprietaryName>
<NonProprietaryName>Abatacept</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20110729</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125118</ApplicationNumber>
<LabelerName>E.R. Squibb & Sons, L.L.C.</LabelerName>
<SubstanceName>ABATACEPT</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Cytokine Activity [PE], Recombinant Fusion Proteins [CS], Selective T Cell Costimulation Modulator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131001</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>ORENCIA is a selective T cell costimulation modulator indicated for: 1 the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). (1.1), 2 the treatment of patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA). (1.2), 3 the treatment of patients 2 years of age and older with active psoriatic arthritis (PsA). (1.3), 4 the prophylaxis of acute graft versus host disease (aGVHD), in combination with a calcineurin inhibitor and methotrexate, in adults and pediatric patients 2 years of age and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated donor. (1.4).</IndicationAndUsage>
<Description>Abatacept is a selective T-cell costimulation modulator. Abatacept is a soluble fusion protein that consists of the extracellular domain of human cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) linked to the modified Fc (hinge, CH2, and CH3 domains) portion of human immunoglobulin G1 (IgG1). Abatacept is produced by recombinant DNA technology in a mammalian cell expression system. The apparent molecular weight of abatacept is 92 kilodaltons. ORENCIA (abatacept) for injection is a sterile, white, preservative-free lyophilized powder for reconstitution and dilution prior to intravenous infusion. Following reconstitution of the lyophilized powder with 10 mL of Sterile Water for Injection, USP, the reconstituted solution of ORENCIA is clear, colorless to pale yellow, with a concentration of 25 mg/mL and with a pH range of 7.2 to 7.8. Each single-dose vial of ORENCIA provides 250 mg abatacept, maltose (500 mg), monobasic sodium phosphate (17.2 mg), and sodium chloride (14.6 mg). ORENCIA (abatacept) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale-yellow solution with a pH range of 6.8 to 7.4 for subcutaneous administration. ORENCIA injection is supplied as a single-dose prefilled syringe or as a single-dose ClickJect autoinjector (see Table 6). Unlike the lyophilized formulation for intravenous use, the ORENCIA solutions for subcutaneous administration contain no maltose.</Description>
</NDC>
<NDC>
<NDCCode>74620-003-08</NDCCode>
<PackageDescription>2188 mL in 1 BOTTLE (74620-003-08) </PackageDescription>
<NDC11Code>74620-0003-08</NDC11Code>
<ProductNDC>74620-003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Instant Hand Sanitizer Gel</ProprietaryName>
<NonProprietaryName>Instant Hand Sanitizer Gel</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200407</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>COSBE LABORA TORY INC.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200407</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>43742-2188-1</NDCCode>
<PackageDescription>960 mL in 1 CONTAINER (43742-2188-1) </PackageDescription>
<NDC11Code>43742-2188-01</NDC11Code>
<ProductNDC>43742-2188</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Borrelia Burgdorferi Nosode, Borrelia Burgdorferi Nosode Dna</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<StartMarketingDate>20241118</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Deseret Biologicals, Inc.</LabelerName>
<SubstanceName>BORRELIA BURGDORFERI; BORRELIA BURGDORFERI DNA</SubstanceName>
<StrengthNumber>1; 1</StrengthNumber>
<StrengthUnit>[hp_M]/mL; [hp_M]/mL</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-11-20</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>18-NOV-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>71335-2188-1</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (71335-2188-1) </PackageDescription>
<NDC11Code>71335-2188-01</NDC11Code>
<ProductNDC>71335-2188</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212624</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxepin Hydrochloride Capsules, USP are recommended for the treatment of: 1 Psychoneurotic patients with depression and/or anxiety., 2 Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol)., 3 Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly). , 4 Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders. .</IndicationAndUsage>
<Description>Doxepin hydrochloride, USP is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. The molecular formula of the compound is C19H21NOHCl having a molecular weight of 316. It is a white or almost white crystalline powder freely soluble in water, alcohols and methylene chloride. It may be represented by the following structural formula. Chemically, doxepin hydrochloride, USP is a dibenzoxepin derivative and is the first of a family of tricyclic psychotherapeutic agents. Specifically, it is an isomeric mixture of:1-Propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-, hydrochloride. Each 10 mg, 25 mg, 50 mg, 75 mg and 100 mg doxepin capsule, USP for oral administration contains doxepin hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg, 75 mg and 100 mg doxepin, respectively and the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and magnesium stearate. The hard gelatin capsule shell contain titanium dioxide, gelatin, sodium lauryl sulfate, FD & C Yellow 6, D & C Yellow 10, and FD & C Green 3. The imprinting ink contains shellac, propylene glycol, black iron oxide and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>71335-2188-2</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (71335-2188-2) </PackageDescription>
<NDC11Code>71335-2188-02</NDC11Code>
<ProductNDC>71335-2188</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212624</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxepin Hydrochloride Capsules, USP are recommended for the treatment of: 1 Psychoneurotic patients with depression and/or anxiety., 2 Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol)., 3 Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly). , 4 Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders. .</IndicationAndUsage>
<Description>Doxepin hydrochloride, USP is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. The molecular formula of the compound is C19H21NOHCl having a molecular weight of 316. It is a white or almost white crystalline powder freely soluble in water, alcohols and methylene chloride. It may be represented by the following structural formula. Chemically, doxepin hydrochloride, USP is a dibenzoxepin derivative and is the first of a family of tricyclic psychotherapeutic agents. Specifically, it is an isomeric mixture of:1-Propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-, hydrochloride. Each 10 mg, 25 mg, 50 mg, 75 mg and 100 mg doxepin capsule, USP for oral administration contains doxepin hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg, 75 mg and 100 mg doxepin, respectively and the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and magnesium stearate. The hard gelatin capsule shell contain titanium dioxide, gelatin, sodium lauryl sulfate, FD & C Yellow 6, D & C Yellow 10, and FD & C Green 3. The imprinting ink contains shellac, propylene glycol, black iron oxide and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>71335-2188-3</NDCCode>
<PackageDescription>28 CAPSULE in 1 BOTTLE (71335-2188-3) </PackageDescription>
<NDC11Code>71335-2188-03</NDC11Code>
<ProductNDC>71335-2188</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212624</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxepin Hydrochloride Capsules, USP are recommended for the treatment of: 1 Psychoneurotic patients with depression and/or anxiety., 2 Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol)., 3 Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly). , 4 Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders. .</IndicationAndUsage>
<Description>Doxepin hydrochloride, USP is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. The molecular formula of the compound is C19H21NOHCl having a molecular weight of 316. It is a white or almost white crystalline powder freely soluble in water, alcohols and methylene chloride. It may be represented by the following structural formula. Chemically, doxepin hydrochloride, USP is a dibenzoxepin derivative and is the first of a family of tricyclic psychotherapeutic agents. Specifically, it is an isomeric mixture of:1-Propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-, hydrochloride. Each 10 mg, 25 mg, 50 mg, 75 mg and 100 mg doxepin capsule, USP for oral administration contains doxepin hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg, 75 mg and 100 mg doxepin, respectively and the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and magnesium stearate. The hard gelatin capsule shell contain titanium dioxide, gelatin, sodium lauryl sulfate, FD & C Yellow 6, D & C Yellow 10, and FD & C Green 3. The imprinting ink contains shellac, propylene glycol, black iron oxide and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>71335-2188-4</NDCCode>
<PackageDescription>18 CAPSULE in 1 BOTTLE (71335-2188-4) </PackageDescription>
<NDC11Code>71335-2188-04</NDC11Code>
<ProductNDC>71335-2188</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212624</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxepin Hydrochloride Capsules, USP are recommended for the treatment of: 1 Psychoneurotic patients with depression and/or anxiety., 2 Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol)., 3 Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly). , 4 Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders. .</IndicationAndUsage>
<Description>Doxepin hydrochloride, USP is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. The molecular formula of the compound is C19H21NOHCl having a molecular weight of 316. It is a white or almost white crystalline powder freely soluble in water, alcohols and methylene chloride. It may be represented by the following structural formula. Chemically, doxepin hydrochloride, USP is a dibenzoxepin derivative and is the first of a family of tricyclic psychotherapeutic agents. Specifically, it is an isomeric mixture of:1-Propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-, hydrochloride. Each 10 mg, 25 mg, 50 mg, 75 mg and 100 mg doxepin capsule, USP for oral administration contains doxepin hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg, 75 mg and 100 mg doxepin, respectively and the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and magnesium stearate. The hard gelatin capsule shell contain titanium dioxide, gelatin, sodium lauryl sulfate, FD & C Yellow 6, D & C Yellow 10, and FD & C Green 3. The imprinting ink contains shellac, propylene glycol, black iron oxide and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>71335-2188-5</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (71335-2188-5) </PackageDescription>
<NDC11Code>71335-2188-05</NDC11Code>
<ProductNDC>71335-2188</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212624</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxepin Hydrochloride Capsules, USP are recommended for the treatment of: 1 Psychoneurotic patients with depression and/or anxiety., 2 Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol)., 3 Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly). , 4 Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders. .</IndicationAndUsage>
<Description>Doxepin hydrochloride, USP is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. The molecular formula of the compound is C19H21NOHCl having a molecular weight of 316. It is a white or almost white crystalline powder freely soluble in water, alcohols and methylene chloride. It may be represented by the following structural formula. Chemically, doxepin hydrochloride, USP is a dibenzoxepin derivative and is the first of a family of tricyclic psychotherapeutic agents. Specifically, it is an isomeric mixture of:1-Propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-, hydrochloride. Each 10 mg, 25 mg, 50 mg, 75 mg and 100 mg doxepin capsule, USP for oral administration contains doxepin hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg, 75 mg and 100 mg doxepin, respectively and the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and magnesium stearate. The hard gelatin capsule shell contain titanium dioxide, gelatin, sodium lauryl sulfate, FD & C Yellow 6, D & C Yellow 10, and FD & C Green 3. The imprinting ink contains shellac, propylene glycol, black iron oxide and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>84891-2188-1</NDCCode>
<PackageDescription>30 mL in 1 TUBE (84891-2188-1) </PackageDescription>
<NDC11Code>84891-2188-01</NDC11Code>
<ProductNDC>84891-2188</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Solarium Daily Essentials Skin Perfecting Primer</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241121</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Solarium Brands LLC</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>165</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0003-0524-11</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0003-0524-11) / 60 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>00003-0524-11</NDC11Code>
<ProductNDC>0003-0524</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sprycel</ProprietaryName>
<NonProprietaryName>Dasatinib</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060627</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021986</ApplicationNumber>
<LabelerName>E.R. Squibb & Sons, L.L.C.</LabelerName>
<SubstanceName>DASATINIB</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060627</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0003-0527-11</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0003-0527-11) / 60 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>00003-0527-11</NDC11Code>
<ProductNDC>0003-0527</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sprycel</ProprietaryName>
<NonProprietaryName>Dasatinib</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060627</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021986</ApplicationNumber>
<LabelerName>E.R. Squibb & Sons, L.L.C.</LabelerName>
<SubstanceName>DASATINIB</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060627</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0003-0528-11</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0003-0528-11) / 60 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>00003-0528-11</NDC11Code>
<ProductNDC>0003-0528</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sprycel</ProprietaryName>
<NonProprietaryName>Dasatinib</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060627</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021986</ApplicationNumber>
<LabelerName>E.R. Squibb & Sons, L.L.C.</LabelerName>
<SubstanceName>DASATINIB</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060627</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0003-0895-11</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0003-0895-11) </PackageDescription>
<NDC11Code>00003-0895-11</NDC11Code>
<ProductNDC>0003-0895</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sotyktu</ProprietaryName>
<NonProprietaryName>Deucravacitinib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220909</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA214958</ApplicationNumber>
<LabelerName>E.R. Squibb & Sons, L.L.C.</LabelerName>
<SubstanceName>DEUCRAVACITINIB</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tyrosine Kinase 2 Inhibitor [EPC], Tyrosine Kinase 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220909</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SOTYKTU is a tyrosine kinase 2 (TYK2) inhibitor indicated for: 1 the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. (1.1).</IndicationAndUsage>
<Description>Deucravacitinib is a tyrosine kinase 2 (TYK2) inhibitor and is described chemically as:. 6-(cyclopropanecarbonylamido)-4-[2-methoxy-3-(1-methyl-1,2,4-triazol-3-yl)anilino]-N-(trideuteriomethyl)pyridazine-3-carboxamide. The molecular formula is C20H19D3N8O3 and the molecular weight of the free base is 425.47. Deucravacitinib has the structural formula. Deucravacitinib is a white to yellow powder. The solubility of deucravacitinib is pH dependent. Solubility decreases with increasing pH. SOTYKTU (deucravacitinib) tablets are supplied in 6 mg strength for oral administration. Each tablet contains deucravacitinib as the active ingredient and the following inactive ingredients: anhydrous lactose, croscarmellose sodium, hypromellose acetate succinate, magnesium stearate, microcrystalline cellulose, and silicon dioxide. In addition, the film coating Opadry® II Pink contains the following inactive ingredients: iron oxide red, iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0003-1427-11</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0003-1427-11)</PackageDescription>
<NDC11Code>00003-1427-11</NDC11Code>
<ProductNDC>0003-1427</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Farxiga</ProprietaryName>
<NonProprietaryName>Dapagliflozin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140108</StartMarketingDate>
<EndMarketingDate>20170430</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202293</ApplicationNumber>
<LabelerName>E.R. Squibb & Sons, L.L.C.</LabelerName>
<SubstanceName>DAPAGLIFLOZIN PROPANEDIOL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-05-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>0003-1428-11</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0003-1428-11)</PackageDescription>
<NDC11Code>00003-1428-11</NDC11Code>
<ProductNDC>0003-1428</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Farxiga</ProprietaryName>
<NonProprietaryName>Dapagliflozin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140108</StartMarketingDate>
<EndMarketingDate>20170831</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202293</ApplicationNumber>
<LabelerName>E.R. Squibb & Sons, L.L.C.</LabelerName>
<SubstanceName>DAPAGLIFLOZIN PROPANEDIOL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-09-01</LastUpdate>
</NDC>
<NDC>
<NDCCode>0003-2230-11</NDCCode>
<PackageDescription>24 CONTAINER in 1 PACKAGE (0003-2230-11) > 50 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00003-2230-11</NDC11Code>
<ProductNDC>0003-2230</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azactam</ProprietaryName>
<NonProprietaryName>Aztreonam</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20100401</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050632</ApplicationNumber>
<LabelerName>E.R. Squibb & Sons, L.L.C.</LabelerName>
<SubstanceName>AZTREONAM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/50mL</StrengthUnit>
<Pharm_Classes>Monobactam Antibacterial [EPC],Monobactams [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0003-2240-11</NDCCode>
<PackageDescription>24 CONTAINER in 1 PACKAGE (0003-2240-11) > 50 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00003-2240-11</NDC11Code>
<ProductNDC>0003-2240</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azactam</ProprietaryName>
<NonProprietaryName>Aztreonam</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20100401</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050632</ApplicationNumber>
<LabelerName>E.R. Squibb & Sons, L.L.C.</LabelerName>
<SubstanceName>AZTREONAM</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>g/50mL</StrengthUnit>
<Pharm_Classes>Monobactam Antibacterial [EPC],Monobactams [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0003-2291-11</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (0003-2291-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>00003-2291-11</NDC11Code>
<ProductNDC>0003-2291</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Empliciti</ProprietaryName>
<NonProprietaryName>Elotuzumab</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20151130</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761035</ApplicationNumber>
<LabelerName>E.R. Squibb & Sons, L.L.C.</LabelerName>
<SubstanceName>ELOTUZUMAB</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antibodies, Monoclonal [CS], SLAMF7-directed Antibody Interactions [MoA], SLAMF7-directed Immunostimulatory Antibody [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EMPLICITI is indicated in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one to three prior therapies. EMPLICITI is indicated in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.</IndicationAndUsage>
<Description>Elotuzumab is a humanized recombinant monoclonal antibody directed to SLAMF7, a cell surface glycoprotein. Elotuzumab consists of the complementary determining regions (CDR) of the mouse antibody, MuLuc63, grafted onto human IgG1 heavy and kappa light chain frameworks. Elotuzumab is produced in NS0 cells by recombinant DNA technology. Elotuzumab has a theoretical mass of 148.1 kDa for the intact antibody. EMPLICITI (elotuzumab) is a sterile, nonpyrogenic, preservative-free lyophilized powder that is white to off-white, whole or fragmented cake in single-dose vials. EMPLICITI for Injection is supplied as 300 mg per vial and 400 mg per vial and requires reconstitution with Sterile Water for Injection, USP (13 mL and 17 mL, respectively) to obtain a solution with a concentration of 25 mg/mL. After reconstitution, each vial contains overfill to allow for withdrawal of 12 mL (300 mg) and 16 mL (400 mg). The reconstituted solution is colorless to slightly yellow, clear to slightly opalescent. Prior to intravenous infusion, the reconstituted solution is diluted with either 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP [see Dosage and Administration (2.6)]. Each 300 mg single-dose vial of EMPLICITI also contains the following inactive ingredients: citric acid monohydrate (2.44 mg), polysorbate 80 (3.4 mg), sodium citrate (16.6 mg), and sucrose (510 mg). Each 400 mg single-dose vial of EMPLICITI also contains the following inactive ingredients: citric acid monohydrate (3.17 mg), polysorbate 80 (4.4 mg), sodium citrate (21.5 mg), and sucrose (660 mg).</Description>
</NDC>
<NDC>
<NDCCode>0003-2327-11</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (0003-2327-11) / 10 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>00003-2327-11</NDC11Code>
<ProductNDC>0003-2327</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Yervoy</ProprietaryName>
<NonProprietaryName>Ipilimumab</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20110325</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125377</ApplicationNumber>
<LabelerName>E.R. Squibb & Sons, L.L.C.</LabelerName>
<SubstanceName>IPILIMUMAB</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>CTLA-4-directed Antibody Interactions [MoA], CTLA-4-directed Blocking Antibody [EPC], Increased T Lymphocyte Activation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110325</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0003-2814-11</NDCCode>
<PackageDescription>4 SYRINGE, GLASS in 1 CARTON (0003-2814-11) / .4 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>00003-2814-11</NDC11Code>
<ProductNDC>0003-2814</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Orencia</ProprietaryName>
<NonProprietaryName>Abatacept</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20110729</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125118</ApplicationNumber>
<LabelerName>E.R. Squibb & Sons, L.L.C.</LabelerName>
<SubstanceName>ABATACEPT</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/.4mL</StrengthUnit>
<Pharm_Classes>Decreased Cytokine Activity [PE], Recombinant Fusion Proteins [CS], Selective T Cell Costimulation Modulator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ORENCIA is a selective T cell costimulation modulator indicated for: 1 the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). (1.1), 2 the treatment of patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA). (1.2), 3 the treatment of patients 2 years of age and older with active psoriatic arthritis (PsA). (1.3), 4 the prophylaxis of acute graft versus host disease (aGVHD), in combination with a calcineurin inhibitor and methotrexate, in adults and pediatric patients 2 years of age and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated donor. (1.4).</IndicationAndUsage>
<Description>Abatacept is a selective T-cell costimulation modulator. Abatacept is a soluble fusion protein that consists of the extracellular domain of human cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) linked to the modified Fc (hinge, CH2, and CH3 domains) portion of human immunoglobulin G1 (IgG1). Abatacept is produced by recombinant DNA technology in a mammalian cell expression system. The apparent molecular weight of abatacept is 92 kilodaltons. ORENCIA (abatacept) for injection is a sterile, white, preservative-free lyophilized powder for reconstitution and dilution prior to intravenous infusion. Following reconstitution of the lyophilized powder with 10 mL of Sterile Water for Injection, USP, the reconstituted solution of ORENCIA is clear, colorless to pale yellow, with a concentration of 25 mg/mL and with a pH range of 7.2 to 7.8. Each single-dose vial of ORENCIA provides 250 mg abatacept, maltose (500 mg), monobasic sodium phosphate (17.2 mg), and sodium chloride (14.6 mg). ORENCIA (abatacept) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale-yellow solution with a pH range of 6.8 to 7.4 for subcutaneous administration. ORENCIA injection is supplied as a single-dose prefilled syringe or as a single-dose ClickJect autoinjector (see Table 6). Unlike the lyophilized formulation for intravenous use, the ORENCIA solutions for subcutaneous administration contain no maltose.</Description>
</NDC>
<NDC>
<NDCCode>0003-2818-11</NDCCode>
<PackageDescription>4 SYRINGE, GLASS in 1 CARTON (0003-2818-11) / .7 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>00003-2818-11</NDC11Code>
<ProductNDC>0003-2818</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Orencia</ProprietaryName>
<NonProprietaryName>Abatacept</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20110729</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125118</ApplicationNumber>
<LabelerName>E.R. Squibb & Sons, L.L.C.</LabelerName>
<SubstanceName>ABATACEPT</SubstanceName>
<StrengthNumber>87.5</StrengthNumber>
<StrengthUnit>mg/.7mL</StrengthUnit>
<Pharm_Classes>Decreased Cytokine Activity [PE], Recombinant Fusion Proteins [CS], Selective T Cell Costimulation Modulator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ORENCIA is a selective T cell costimulation modulator indicated for: 1 the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). (1.1), 2 the treatment of patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA). (1.2), 3 the treatment of patients 2 years of age and older with active psoriatic arthritis (PsA). (1.3), 4 the prophylaxis of acute graft versus host disease (aGVHD), in combination with a calcineurin inhibitor and methotrexate, in adults and pediatric patients 2 years of age and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated donor. (1.4).</IndicationAndUsage>
<Description>Abatacept is a selective T-cell costimulation modulator. Abatacept is a soluble fusion protein that consists of the extracellular domain of human cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) linked to the modified Fc (hinge, CH2, and CH3 domains) portion of human immunoglobulin G1 (IgG1). Abatacept is produced by recombinant DNA technology in a mammalian cell expression system. The apparent molecular weight of abatacept is 92 kilodaltons. ORENCIA (abatacept) for injection is a sterile, white, preservative-free lyophilized powder for reconstitution and dilution prior to intravenous infusion. Following reconstitution of the lyophilized powder with 10 mL of Sterile Water for Injection, USP, the reconstituted solution of ORENCIA is clear, colorless to pale yellow, with a concentration of 25 mg/mL and with a pH range of 7.2 to 7.8. Each single-dose vial of ORENCIA provides 250 mg abatacept, maltose (500 mg), monobasic sodium phosphate (17.2 mg), and sodium chloride (14.6 mg). ORENCIA (abatacept) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale-yellow solution with a pH range of 6.8 to 7.4 for subcutaneous administration. ORENCIA injection is supplied as a single-dose prefilled syringe or as a single-dose ClickJect autoinjector (see Table 6). Unlike the lyophilized formulation for intravenous use, the ORENCIA solutions for subcutaneous administration contain no maltose.</Description>
</NDC>
<NDC>
<NDCCode>0003-3641-11</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (0003-3641-11) </PackageDescription>
<NDC11Code>00003-3641-11</NDC11Code>
<ProductNDC>0003-3641</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Evotaz</ProprietaryName>
<NonProprietaryName>Atazanavir And Cobicistat</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150129</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206353</ApplicationNumber>
<LabelerName>E.R. Squibb & Sons, L.L.C.</LabelerName>
<SubstanceName>ATAZANAVIR SULFATE; COBICISTAT</SubstanceName>
<StrengthNumber>300; 150</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inhibitors [MoA], UGT1A1 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EVOTAZ is a two-drug combination of atazanavir, a human immunodeficiency virus (HIV-1) protease inhibitor, and cobicistat, a CYP3A inhibitor indicated for use in combination with other antiretroviral agents for the treatment of HIV‑1 infection in adults and pediatric patients weighing at least 35 kg. (1). Limitations of Use. Use of EVOTAZ in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions. (1).</IndicationAndUsage>
<Description>EVOTAZ® is a fixed-dose tablet for oral administration containing the active ingredients atazanavir and cobicistat. Atazanavir is an HIV-1 protease inhibitor. Cobicistat is a mechanism-based inhibitor of cytochrome P450 (CYP) enzymes of the CYP3A family. EVOTAZ tablets contain 342 mg of atazanavir sulfate, equivalent to 300 mg of atazanavir, and 150 mg of cobicistat, as well as the following inactive ingredients in the tablet core: croscarmellose sodium, crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium starch glycolate, and stearic acid. The tablets are film-coated with a coating material containing the following inactive ingredients: hypromellose, red iron oxide, talc, titanium dioxide, triacetin. Atazanavir: Atazanavir is present as the sulfate salt. The chemical name for atazanavir sulfate is (3S,8S,9S,12S)-3,12-bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2-pyridinyl)phenyl]methyl]-2,5,6,10,13-pentaazatetradecanedioic acid dimethyl ester, sulfate (1:1). Its molecular formula is C38H52N6O7H2SO4, which corresponds to a molecular weight of 802.9 (sulfuric acid salt). The free base molecular weight is 704.9. Atazanavir sulfate has the following structural formula. Atazanavir sulfate is a white to pale-yellow crystalline powder. It is slightly soluble in water (4-5 mg/mL, free base equivalent) with the pH of a saturated solution in water being about 1.9 at 24 ± 3°C. Cobicistat: The chemical name for cobicistat is 1,3-thiazol-5-ylmethyl [(2R,5R)-5-{[(2S)-2-[(methyl{[2-(propan-2-yl)-1,3-thiazol-4-yl]methyl}carbamoyl)amino]-4-(morpholin-4-yl)butanoyl]amino}-1,6-diphenylhexan-2-yl]carbamate. It has a molecular formula of C40H53N7O5S2 and a molecular weight of 776.0. It has the following structural formula. Cobicistat is adsorbed onto silicon dioxide. Cobicistat on silicon dioxide is a white to pale yellow solid with a solubility of 0.1 mg/mL in water at 20°C.</Description>
</NDC>
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