RESTful Lookup — Test-Drive (2007 – 2026)

Query complete (14 ms elapsed)

{
  "NDC": [
    {
      "NDCCode": "73749-101-39",
      "PackageDescription": "1.040875 L in 1 BOTTLE, PLASTIC (73749-101-39) ",
      "NDC11Code": "73749-0101-39",
      "ProductNDC": "73749-101",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Clear Lakes Products Hand Sanitizer",
      "NonProprietaryName": "Hand Sanitizer",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200318",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Clear Lakes Products, LLC",
      "SubstanceName": "ISOPROPYL ALCOHOL",
      "StrengthNumber": ".7",
      "StrengthUnit": "L/L",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200318",
      "SamplePackage": "N",
      "IndicationAndUsage": "For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use."
    },
    {
      "NDCCode": "73749-101-29",
      "PackageDescription": ".473176 L in 1 BOTTLE, PLASTIC (73749-101-29) ",
      "NDC11Code": "73749-0101-29",
      "ProductNDC": "73749-101",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Clear Lakes Products Hand Sanitizer",
      "NonProprietaryName": "Hand Sanitizer",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200318",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Clear Lakes Products, LLC",
      "SubstanceName": "ISOPROPYL ALCOHOL",
      "StrengthNumber": ".7",
      "StrengthUnit": "L/L",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200318",
      "SamplePackage": "N",
      "IndicationAndUsage": "For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use."
    },
    {
      "NDCCode": "73749-101-59",
      "PackageDescription": "3.758 L in 1 BOTTLE, PLASTIC (73749-101-59) ",
      "NDC11Code": "73749-0101-59",
      "ProductNDC": "73749-101",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Clear Lakes Products Hand Sanitizer",
      "NonProprietaryName": "Hand Sanitizer",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200318",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Clear Lakes Products, LLC",
      "SubstanceName": "ISOPROPYL ALCOHOL",
      "StrengthNumber": ".7",
      "StrengthUnit": "L/L",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200318",
      "SamplePackage": "N",
      "IndicationAndUsage": "For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use."
    },
    {
      "NDCCode": "73749-101-99",
      "PackageDescription": "1040.875 L in 1 BOTTLE, PLASTIC (73749-101-99) ",
      "NDC11Code": "73749-0101-99",
      "ProductNDC": "73749-101",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Clear Lakes Products Hand Sanitizer",
      "NonProprietaryName": "Hand Sanitizer",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200318",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Clear Lakes Products, LLC",
      "SubstanceName": "ISOPROPYL ALCOHOL",
      "StrengthNumber": ".7",
      "StrengthUnit": "L/L",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200318",
      "SamplePackage": "N",
      "IndicationAndUsage": "For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use."
    },
    {
      "NDCCode": "10356-101-39",
      "PackageDescription": "7 g in 1 JAR (10356-101-39) ",
      "NDC11Code": "10356-0101-39",
      "ProductNDC": "10356-101",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Aquaphor Healing",
      "NonProprietaryName": "Petrolatum",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "19910101",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "Beiersdorf Inc",
      "SubstanceName": "PETROLATUM",
      "StrengthNumber": "41",
      "StrengthUnit": "g/100g",
      "Status": "Active",
      "LastUpdate": "2025-12-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19910101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses.  temporarily protects minor:  cuts  scrapes  burns  temporarily protects and helps relieve chapped or cracked skin and lips  helps protect from the drying effects of wind and cold weather.  helps treat and prevent diaper rash   protects chafed skin associated with diaper rash and helps protect from wetness."
    },
    {
      "NDCCode": "52807-101-39",
      "PackageDescription": "3000 mL in 1 BOTTLE (52807-101-39) ",
      "NDC11Code": "52807-0101-39",
      "ProductNDC": "52807-101",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hand Sanitizer",
      "NonProprietaryName": "Hand Sanitizer",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200320",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Guangdong Longtai Industry Co.,LTD",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "75",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200330",
      "SamplePackage": "N",
      "IndicationAndUsage": "For hand washing to decrease bacteria on the skinre commended for repeated use."
    },
    {
      "NDCCode": "55037-101-39",
      "PackageDescription": "6300 L in 1 CYLINDER (55037-101-39) ",
      "NDC11Code": "55037-0101-39",
      "ProductNDC": "55037-101",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxygen",
      "NonProprietaryName": "Oxygen",
      "DosageFormName": "GAS",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "19870101",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA205889",
      "LabelerName": "Matheson Tri-Gas, Inc.",
      "SubstanceName": "OXYGEN",
      "StrengthNumber": "992",
      "StrengthUnit": "1/L",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "19870101",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "63940-101-39",
      "PackageDescription": "30 BLISTER PACK in 1 CARTON (63940-101-39)  > 1 TABLET in 1 BLISTER PACK",
      "NDC11Code": "63940-0101-39",
      "ProductNDC": "63940-101",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Harmon Face Values Allergy Relief",
      "NonProprietaryName": "Loratadine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20111218",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076301",
      "LabelerName": "Harmon Stores Inc.",
      "SubstanceName": "LORATADINE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "78445-101-39",
      "PackageDescription": "236 mL in 1 BOTTLE (78445-101-39) ",
      "NDC11Code": "78445-0101-39",
      "ProductNDC": "78445-101",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hand Sanitizer",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200330",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Guangzhou Kangfei Cosmetics Co., Ltd.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "75",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-08-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20200330",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
    },
    {
      "NDCCode": "84502-101-39",
      "PackageDescription": "10 g in 1 BOTTLE, PLASTIC (84502-101-39) ",
      "NDC11Code": "84502-0101-39",
      "ProductNDC": "84502-101",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Semaglutide",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20240702",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Fujian Genohope Biotech Ltd.",
      "SubstanceName": "SEMAGLUTIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Unfinished",
      "LastUpdate": "2026-06-05",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "02-JUL-24"
    },
    {
      "NDCCode": "84643-101-39",
      "PackageDescription": "2000 g in 1 CONTAINER (84643-101-39) ",
      "NDC11Code": "84643-0101-39",
      "ProductNDC": "84643-101",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Semaglutide",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20260212",
      "MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
      "LabelerName": "Zhejiang Tasln Biopharma Co., Ltd.",
      "SubstanceName": "SEMAGLUTIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Unfinished",
      "LastUpdate": "2026-03-12",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "12-FEB-26"
    },
    {
      "NDCCode": "0169-2030-11",
      "PackageDescription": "1 SYRINGE, PLASTIC in 1 CARTON (0169-2030-11)  / 1.5 mL in 1 SYRINGE, PLASTIC",
      "NDC11Code": "00169-2030-11",
      "ProductNDC": "0169-2030",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sogroya",
      "NonProprietaryName": "Somapacitan-beco",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20230501",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA761156",
      "LabelerName": "Novo Nordisk",
      "SubstanceName": "SOMAPACITAN",
      "StrengthNumber": "6.7",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2026-03-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230501",
      "SamplePackage": "N",
      "IndicationAndUsage": "SOGROYA is indicated for the treatment of pediatric patients aged 2.5 years and older with: 1 Growth failure due to inadequate secretion of endogenous growth hormone (GH)., 2 Short stature born small for gestational age (SGA) and with no catch-up growth by 2 years of age., 3 Growth failure associated with Noonan syndrome (NS)., 4 Idiopathic Short Stature (ISS).",
      "Description": "Somapacitan-beco is a human growth hormone (hGH) analog with a single substitution in the amino acid backbone (L101C) to which an albumin-binding moiety has been attached. The albumin-binding moiety (side-chain) consists of an albumin binder and a hydrophilic spacer attached to position 101 of the protein. The protein part consists of 191 amino acids. Somapacitan-beco is produced in Escherichia coli by recombinant DNA technology. The molecular formula (including the albumin-binding moiety) is C1038H1609N273O319S9 and the molecular weight is 23305.10 g/mol, of which the albumin-binding moiety is 1191.39 g/mol. Structural Formula:. SOGROYA (somapacitan-beco) injection is supplied as a sterile, clear to slightly opalescent and colorless to slightly yellow solution for subcutaneous use in a single-patient-use prefilled pen with a deliverable volume of 1.5 mL. Each mL of SOGROYA 5 mg/1.5 mL prefilled pen contains 3.3 mg of somapacitan-beco, histidine (0.68 mg), mannitol (44 mg), phenol (4 mg), poloxamer 188 (1 mg), and Water for Injection, USP. The pH is approximately 6.8. Hydrochloric acid and sodium hydroxide may be added to adjust the pH. Each mL of SOGROYA 10 mg/1.5 mL prefilled pen contains 6.7 mg of somapacitan-beco, histidine (0.68 mg), mannitol (44 mg), phenol (4 mg), poloxamer 188 (1 mg), and Water for Injection, USP. The pH is approximately 6.8. Hydrochloric acid and sodium hydroxide may be added to adjust the pH. Each mL of SOGROYA 15 mg/1.5 mL prefilled pen contains 10 mg of somapacitan-beco, histidine (0.68 mg), mannitol (44 mg), phenol (4 mg), poloxamer 188 (1 mg), and Water for Injection, USP. The pH is approximately 6.8. Hydrochloric acid and sodium hydroxide may be added to adjust the pH."
    },
    {
      "NDCCode": "0169-2030-90",
      "PackageDescription": "1 SYRINGE, PLASTIC in 1 CARTON (0169-2030-90)  / 1.5 mL in 1 SYRINGE, PLASTIC",
      "NDC11Code": "00169-2030-90",
      "ProductNDC": "0169-2030",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sogroya",
      "NonProprietaryName": "Somapacitan-beco",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20230501",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA761156",
      "LabelerName": "Novo Nordisk",
      "SubstanceName": "SOMAPACITAN",
      "StrengthNumber": "6.7",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2026-03-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230501",
      "SamplePackage": "N",
      "IndicationAndUsage": "SOGROYA is indicated for the treatment of pediatric patients aged 2.5 years and older with: 1 Growth failure due to inadequate secretion of endogenous growth hormone (GH)., 2 Short stature born small for gestational age (SGA) and with no catch-up growth by 2 years of age., 3 Growth failure associated with Noonan syndrome (NS)., 4 Idiopathic Short Stature (ISS).",
      "Description": "Somapacitan-beco is a human growth hormone (hGH) analog with a single substitution in the amino acid backbone (L101C) to which an albumin-binding moiety has been attached. The albumin-binding moiety (side-chain) consists of an albumin binder and a hydrophilic spacer attached to position 101 of the protein. The protein part consists of 191 amino acids. Somapacitan-beco is produced in Escherichia coli by recombinant DNA technology. The molecular formula (including the albumin-binding moiety) is C1038H1609N273O319S9 and the molecular weight is 23305.10 g/mol, of which the albumin-binding moiety is 1191.39 g/mol. Structural Formula:. SOGROYA (somapacitan-beco) injection is supplied as a sterile, clear to slightly opalescent and colorless to slightly yellow solution for subcutaneous use in a single-patient-use prefilled pen with a deliverable volume of 1.5 mL. Each mL of SOGROYA 5 mg/1.5 mL prefilled pen contains 3.3 mg of somapacitan-beco, histidine (0.68 mg), mannitol (44 mg), phenol (4 mg), poloxamer 188 (1 mg), and Water for Injection, USP. The pH is approximately 6.8. Hydrochloric acid and sodium hydroxide may be added to adjust the pH. Each mL of SOGROYA 10 mg/1.5 mL prefilled pen contains 6.7 mg of somapacitan-beco, histidine (0.68 mg), mannitol (44 mg), phenol (4 mg), poloxamer 188 (1 mg), and Water for Injection, USP. The pH is approximately 6.8. Hydrochloric acid and sodium hydroxide may be added to adjust the pH. Each mL of SOGROYA 15 mg/1.5 mL prefilled pen contains 10 mg of somapacitan-beco, histidine (0.68 mg), mannitol (44 mg), phenol (4 mg), poloxamer 188 (1 mg), and Water for Injection, USP. The pH is approximately 6.8. Hydrochloric acid and sodium hydroxide may be added to adjust the pH."
    },
    {
      "NDCCode": "0169-2035-11",
      "PackageDescription": "1 SYRINGE, PLASTIC in 1 CARTON (0169-2035-11)  / 1.5 mL in 1 SYRINGE, PLASTIC",
      "NDC11Code": "00169-2035-11",
      "ProductNDC": "0169-2035",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sogroya",
      "NonProprietaryName": "Somapacitan-beco",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20230501",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA761156",
      "LabelerName": "Novo Nordisk",
      "SubstanceName": "SOMAPACITAN",
      "StrengthNumber": "3.3",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2026-03-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230501",
      "SamplePackage": "N",
      "IndicationAndUsage": "SOGROYA is indicated for the treatment of pediatric patients aged 2.5 years and older with: 1 Growth failure due to inadequate secretion of endogenous growth hormone (GH)., 2 Short stature born small for gestational age (SGA) and with no catch-up growth by 2 years of age., 3 Growth failure associated with Noonan syndrome (NS)., 4 Idiopathic Short Stature (ISS).",
      "Description": "Somapacitan-beco is a human growth hormone (hGH) analog with a single substitution in the amino acid backbone (L101C) to which an albumin-binding moiety has been attached. The albumin-binding moiety (side-chain) consists of an albumin binder and a hydrophilic spacer attached to position 101 of the protein. The protein part consists of 191 amino acids. Somapacitan-beco is produced in Escherichia coli by recombinant DNA technology. The molecular formula (including the albumin-binding moiety) is C1038H1609N273O319S9 and the molecular weight is 23305.10 g/mol, of which the albumin-binding moiety is 1191.39 g/mol. Structural Formula:. SOGROYA (somapacitan-beco) injection is supplied as a sterile, clear to slightly opalescent and colorless to slightly yellow solution for subcutaneous use in a single-patient-use prefilled pen with a deliverable volume of 1.5 mL. Each mL of SOGROYA 5 mg/1.5 mL prefilled pen contains 3.3 mg of somapacitan-beco, histidine (0.68 mg), mannitol (44 mg), phenol (4 mg), poloxamer 188 (1 mg), and Water for Injection, USP. The pH is approximately 6.8. Hydrochloric acid and sodium hydroxide may be added to adjust the pH. Each mL of SOGROYA 10 mg/1.5 mL prefilled pen contains 6.7 mg of somapacitan-beco, histidine (0.68 mg), mannitol (44 mg), phenol (4 mg), poloxamer 188 (1 mg), and Water for Injection, USP. The pH is approximately 6.8. Hydrochloric acid and sodium hydroxide may be added to adjust the pH. Each mL of SOGROYA 15 mg/1.5 mL prefilled pen contains 10 mg of somapacitan-beco, histidine (0.68 mg), mannitol (44 mg), phenol (4 mg), poloxamer 188 (1 mg), and Water for Injection, USP. The pH is approximately 6.8. Hydrochloric acid and sodium hydroxide may be added to adjust the pH."
    },
    {
      "NDCCode": "0169-2035-90",
      "PackageDescription": "1 SYRINGE, PLASTIC in 1 CARTON (0169-2035-90)  / 1.5 mL in 1 SYRINGE, PLASTIC",
      "NDC11Code": "00169-2035-90",
      "ProductNDC": "0169-2035",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sogroya",
      "NonProprietaryName": "Somapacitan-beco",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20230501",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA761156",
      "LabelerName": "Novo Nordisk",
      "SubstanceName": "SOMAPACITAN",
      "StrengthNumber": "3.3",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2026-03-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230501",
      "SamplePackage": "N",
      "IndicationAndUsage": "SOGROYA is indicated for the treatment of pediatric patients aged 2.5 years and older with: 1 Growth failure due to inadequate secretion of endogenous growth hormone (GH)., 2 Short stature born small for gestational age (SGA) and with no catch-up growth by 2 years of age., 3 Growth failure associated with Noonan syndrome (NS)., 4 Idiopathic Short Stature (ISS).",
      "Description": "Somapacitan-beco is a human growth hormone (hGH) analog with a single substitution in the amino acid backbone (L101C) to which an albumin-binding moiety has been attached. The albumin-binding moiety (side-chain) consists of an albumin binder and a hydrophilic spacer attached to position 101 of the protein. The protein part consists of 191 amino acids. Somapacitan-beco is produced in Escherichia coli by recombinant DNA technology. The molecular formula (including the albumin-binding moiety) is C1038H1609N273O319S9 and the molecular weight is 23305.10 g/mol, of which the albumin-binding moiety is 1191.39 g/mol. Structural Formula:. SOGROYA (somapacitan-beco) injection is supplied as a sterile, clear to slightly opalescent and colorless to slightly yellow solution for subcutaneous use in a single-patient-use prefilled pen with a deliverable volume of 1.5 mL. Each mL of SOGROYA 5 mg/1.5 mL prefilled pen contains 3.3 mg of somapacitan-beco, histidine (0.68 mg), mannitol (44 mg), phenol (4 mg), poloxamer 188 (1 mg), and Water for Injection, USP. The pH is approximately 6.8. Hydrochloric acid and sodium hydroxide may be added to adjust the pH. Each mL of SOGROYA 10 mg/1.5 mL prefilled pen contains 6.7 mg of somapacitan-beco, histidine (0.68 mg), mannitol (44 mg), phenol (4 mg), poloxamer 188 (1 mg), and Water for Injection, USP. The pH is approximately 6.8. Hydrochloric acid and sodium hydroxide may be added to adjust the pH. Each mL of SOGROYA 15 mg/1.5 mL prefilled pen contains 10 mg of somapacitan-beco, histidine (0.68 mg), mannitol (44 mg), phenol (4 mg), poloxamer 188 (1 mg), and Water for Injection, USP. The pH is approximately 6.8. Hydrochloric acid and sodium hydroxide may be added to adjust the pH."
    },
    {
      "NDCCode": "0169-2037-11",
      "PackageDescription": "1 SYRINGE, PLASTIC in 1 CARTON (0169-2037-11)  / 1.5 mL in 1 SYRINGE, PLASTIC",
      "NDC11Code": "00169-2037-11",
      "ProductNDC": "0169-2037",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sogroya",
      "NonProprietaryName": "Somapacitan-beco",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20230501",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA761156",
      "LabelerName": "Novo Nordisk",
      "SubstanceName": "SOMAPACITAN",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2026-03-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230501",
      "SamplePackage": "N",
      "IndicationAndUsage": "SOGROYA is indicated for the treatment of pediatric patients aged 2.5 years and older with: 1 Growth failure due to inadequate secretion of endogenous growth hormone (GH)., 2 Short stature born small for gestational age (SGA) and with no catch-up growth by 2 years of age., 3 Growth failure associated with Noonan syndrome (NS)., 4 Idiopathic Short Stature (ISS).",
      "Description": "Somapacitan-beco is a human growth hormone (hGH) analog with a single substitution in the amino acid backbone (L101C) to which an albumin-binding moiety has been attached. The albumin-binding moiety (side-chain) consists of an albumin binder and a hydrophilic spacer attached to position 101 of the protein. The protein part consists of 191 amino acids. Somapacitan-beco is produced in Escherichia coli by recombinant DNA technology. The molecular formula (including the albumin-binding moiety) is C1038H1609N273O319S9 and the molecular weight is 23305.10 g/mol, of which the albumin-binding moiety is 1191.39 g/mol. Structural Formula:. SOGROYA (somapacitan-beco) injection is supplied as a sterile, clear to slightly opalescent and colorless to slightly yellow solution for subcutaneous use in a single-patient-use prefilled pen with a deliverable volume of 1.5 mL. Each mL of SOGROYA 5 mg/1.5 mL prefilled pen contains 3.3 mg of somapacitan-beco, histidine (0.68 mg), mannitol (44 mg), phenol (4 mg), poloxamer 188 (1 mg), and Water for Injection, USP. The pH is approximately 6.8. Hydrochloric acid and sodium hydroxide may be added to adjust the pH. Each mL of SOGROYA 10 mg/1.5 mL prefilled pen contains 6.7 mg of somapacitan-beco, histidine (0.68 mg), mannitol (44 mg), phenol (4 mg), poloxamer 188 (1 mg), and Water for Injection, USP. The pH is approximately 6.8. Hydrochloric acid and sodium hydroxide may be added to adjust the pH. Each mL of SOGROYA 15 mg/1.5 mL prefilled pen contains 10 mg of somapacitan-beco, histidine (0.68 mg), mannitol (44 mg), phenol (4 mg), poloxamer 188 (1 mg), and Water for Injection, USP. The pH is approximately 6.8. Hydrochloric acid and sodium hydroxide may be added to adjust the pH."
    },
    {
      "NDCCode": "0169-2037-90",
      "PackageDescription": "1 SYRINGE, PLASTIC in 1 CARTON (0169-2037-90)  / 1.5 mL in 1 SYRINGE, PLASTIC",
      "NDC11Code": "00169-2037-90",
      "ProductNDC": "0169-2037",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sogroya",
      "NonProprietaryName": "Somapacitan-beco",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20230501",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA761156",
      "LabelerName": "Novo Nordisk",
      "SubstanceName": "SOMAPACITAN",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2026-03-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230501",
      "SamplePackage": "N",
      "IndicationAndUsage": "SOGROYA is indicated for the treatment of pediatric patients aged 2.5 years and older with: 1 Growth failure due to inadequate secretion of endogenous growth hormone (GH)., 2 Short stature born small for gestational age (SGA) and with no catch-up growth by 2 years of age., 3 Growth failure associated with Noonan syndrome (NS)., 4 Idiopathic Short Stature (ISS).",
      "Description": "Somapacitan-beco is a human growth hormone (hGH) analog with a single substitution in the amino acid backbone (L101C) to which an albumin-binding moiety has been attached. The albumin-binding moiety (side-chain) consists of an albumin binder and a hydrophilic spacer attached to position 101 of the protein. The protein part consists of 191 amino acids. Somapacitan-beco is produced in Escherichia coli by recombinant DNA technology. The molecular formula (including the albumin-binding moiety) is C1038H1609N273O319S9 and the molecular weight is 23305.10 g/mol, of which the albumin-binding moiety is 1191.39 g/mol. Structural Formula:. SOGROYA (somapacitan-beco) injection is supplied as a sterile, clear to slightly opalescent and colorless to slightly yellow solution for subcutaneous use in a single-patient-use prefilled pen with a deliverable volume of 1.5 mL. Each mL of SOGROYA 5 mg/1.5 mL prefilled pen contains 3.3 mg of somapacitan-beco, histidine (0.68 mg), mannitol (44 mg), phenol (4 mg), poloxamer 188 (1 mg), and Water for Injection, USP. The pH is approximately 6.8. Hydrochloric acid and sodium hydroxide may be added to adjust the pH. Each mL of SOGROYA 10 mg/1.5 mL prefilled pen contains 6.7 mg of somapacitan-beco, histidine (0.68 mg), mannitol (44 mg), phenol (4 mg), poloxamer 188 (1 mg), and Water for Injection, USP. The pH is approximately 6.8. Hydrochloric acid and sodium hydroxide may be added to adjust the pH. Each mL of SOGROYA 15 mg/1.5 mL prefilled pen contains 10 mg of somapacitan-beco, histidine (0.68 mg), mannitol (44 mg), phenol (4 mg), poloxamer 188 (1 mg), and Water for Injection, USP. The pH is approximately 6.8. Hydrochloric acid and sodium hydroxide may be added to adjust the pH."
    },
    {
      "NDCCode": "33342-101-11",
      "PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (33342-101-11) ",
      "NDC11Code": "33342-0101-11",
      "ProductNDC": "33342-101",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Quetiapine Fumarate",
      "NonProprietaryName": "Quetiapine Fumarate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160614",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203359",
      "LabelerName": "Macleods Pharmaceuticals Limited",
      "SubstanceName": "QUETIAPINE FUMARATE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-04-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160614",
      "SamplePackage": "N",
      "IndicationAndUsage": "Quetiapine tablets are an atypical antipsychotic indicated for the treatment of:  Schizophrenia (1.1)  Bipolar I disorder manic episodes (1.2)  Bipolar disorder, depressive episodes (1.2).",
      "Description": "Quetiapine fumarate USP is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate USP is a white to off-white crystalline powder which is moderately soluble in water.Quetiapine tablets USP are supplied for oral administration as 25 mg (round, peach, one side debossed with “F71”), 50 mg (round, white, one side debossed with “F72”), 100 mg (round, yellow one side debossed with “F73”), 200 mg (round, white, one side debossed with \"F75”), 300 mg (capsule-shaped, white, one side debossed with \"F76”), and 400 mg (capsule-shaped, yellow, one side debossed with “F77”) tablets.Inactive ingredients are povidone, dibasic calcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, colloidal silicon di-oxide, hypromellose, polyethylene glycol, and titanium dioxide.The 25 mg tablets contain red ferric oxide and yellow ferric oxide and the 100 mg and 400 mg tablets contain only yellow ferric oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.51 mg of quetiapine fumarate equivalent to 400 mg quetiapine."
    },
    {
      "NDCCode": "33342-101-12",
      "PackageDescription": "10 BLISTER PACK in 1 CARTON (33342-101-12)  / 10 TABLET, FILM COATED in 1 BLISTER PACK",
      "NDC11Code": "33342-0101-12",
      "ProductNDC": "33342-101",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Quetiapine Fumarate",
      "NonProprietaryName": "Quetiapine Fumarate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160614",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203359",
      "LabelerName": "Macleods Pharmaceuticals Limited",
      "SubstanceName": "QUETIAPINE FUMARATE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-04-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160614",
      "SamplePackage": "N",
      "IndicationAndUsage": "Quetiapine tablets are an atypical antipsychotic indicated for the treatment of:  Schizophrenia (1.1)  Bipolar I disorder manic episodes (1.2)  Bipolar disorder, depressive episodes (1.2).",
      "Description": "Quetiapine fumarate USP is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate USP is a white to off-white crystalline powder which is moderately soluble in water.Quetiapine tablets USP are supplied for oral administration as 25 mg (round, peach, one side debossed with “F71”), 50 mg (round, white, one side debossed with “F72”), 100 mg (round, yellow one side debossed with “F73”), 200 mg (round, white, one side debossed with \"F75”), 300 mg (capsule-shaped, white, one side debossed with \"F76”), and 400 mg (capsule-shaped, yellow, one side debossed with “F77”) tablets.Inactive ingredients are povidone, dibasic calcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, colloidal silicon di-oxide, hypromellose, polyethylene glycol, and titanium dioxide.The 25 mg tablets contain red ferric oxide and yellow ferric oxide and the 100 mg and 400 mg tablets contain only yellow ferric oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.51 mg of quetiapine fumarate equivalent to 400 mg quetiapine."
    },
    {
      "NDCCode": "33342-101-44",
      "PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (33342-101-44) ",
      "NDC11Code": "33342-0101-44",
      "ProductNDC": "33342-101",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Quetiapine Fumarate",
      "NonProprietaryName": "Quetiapine Fumarate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160614",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203359",
      "LabelerName": "Macleods Pharmaceuticals Limited",
      "SubstanceName": "QUETIAPINE FUMARATE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-04-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160614",
      "SamplePackage": "N",
      "IndicationAndUsage": "Quetiapine tablets are an atypical antipsychotic indicated for the treatment of:  Schizophrenia (1.1)  Bipolar I disorder manic episodes (1.2)  Bipolar disorder, depressive episodes (1.2).",
      "Description": "Quetiapine fumarate USP is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate USP is a white to off-white crystalline powder which is moderately soluble in water.Quetiapine tablets USP are supplied for oral administration as 25 mg (round, peach, one side debossed with “F71”), 50 mg (round, white, one side debossed with “F72”), 100 mg (round, yellow one side debossed with “F73”), 200 mg (round, white, one side debossed with \"F75”), 300 mg (capsule-shaped, white, one side debossed with \"F76”), and 400 mg (capsule-shaped, yellow, one side debossed with “F77”) tablets.Inactive ingredients are povidone, dibasic calcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, colloidal silicon di-oxide, hypromellose, polyethylene glycol, and titanium dioxide.The 25 mg tablets contain red ferric oxide and yellow ferric oxide and the 100 mg and 400 mg tablets contain only yellow ferric oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.51 mg of quetiapine fumarate equivalent to 400 mg quetiapine."
    },
    {
      "NDCCode": "44567-101-10",
      "PackageDescription": "10 VIAL in 1 TRAY (44567-101-10)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL",
      "NDC11Code": "44567-0101-10",
      "ProductNDC": "44567-101",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ampicillin",
      "NonProprietaryName": "Ampicillin",
      "DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20120510",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090354",
      "LabelerName": "WG Critical Care, LLC",
      "SubstanceName": "AMPICILLIN SODIUM",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
      "Status": "Active",
      "LastUpdate": "2026-07-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20120510",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ampicillin for Injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions:. Respiratory Tract Infections caused by S. pneumoniae, Staphylococcus aureus (penicillinase and non-penicillinase producing), H. influenzae and Group A beta-hemolytic Streptococci. Bacterial Meningitis caused by E. coli, Group B Streptococci, and other Gram-negative bacteria (Listeria monocytogenes, N. meningitidis). The addition of an aminoglycoside with ampicillin may increase its effectiveness against Gram-negative bacteria. Septicemia and Endocarditis caused by susceptible Gram-positive organisms including Streptococcus spp., penicillin-G-susceptible staphylococci and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella spp. responds to ampicillin. Endocarditis due to enterococcal strains usually respond to intravenous therapy. The addition of an aminoglycoside may enhance the effectiveness of ampicillin when treating streptococcal endocarditis. Urinary Tract Infections caused by sensitive strains of E. coli and Proteus mirabilis. Gastrointestinal Infections caused by Salmonella typhi (typhoid fever), other Salmonella spp. and Shigella spp. (dysentery) usually respond to oral or intravenous therapy. Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Therapy may be instituted prior to obtaining results of susceptibility testing. It is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms. A change to oral ampicillin may be made as soon as appropriate. Indicated surgical procedures should be performed. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin for Injection, USP and other antibacterial drugs, Ampicillin for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
      "Description": "Ampicillin for Injection, USP the monosodium salt of [2S-[2a, 5a, 6b(S*)]]-6- [(aminophenylacetyl)amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0]heptane-2-carboxylic acid, is a synthetic penicillin. It is an antibacterial agent with a broad spectrum of bactericidal activity against both penicillin-susceptible Gram-positive organisms and many common Gram-negative pathogens. Ampicillin for Injection, USP is a dry, white to off-white powder. The reconstituted solution is clear, colorless and free from visible particulates. It has the following chemical structure. The molecular formula is C16H18N3NaO4S, and the molecular weight is 371.39. The pH range of the reconstituted solution is 8.0 to 10.0. Ampicillin for Injection, USP contains 65.8 mg [2.9 mEq] sodium per gram ampicillin. Ampicillin for Injection, USP is supplied in vials equivalent to 125 mg, 250 mg, 500 mg, 1 gram or 2 grams of ampicillin. It is to be administered by intravenous or intramuscular routes."
    },
    {
      "NDCCode": "57665-101-41",
      "PackageDescription": "1 VIAL in 1 CARTON (57665-101-41)  / 20 mL in 1 VIAL",
      "NDC11Code": "57665-0101-41",
      "ProductNDC": "57665-101",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Abelcet",
      "NonProprietaryName": "Amphotericin B, Dimyristoylphosphatidylcholine, Dl- And Dimyristoylphosphatidylglycerol, Dl-",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20101018",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA050724",
      "LabelerName": "Leadiant Biosciences, Inc.",
      "SubstanceName": "AMPHOTERICIN B; DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL-; DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL-",
      "StrengthNumber": "5; 3.4; 1.5",
      "StrengthUnit": "mg/mL; mg/mL; mg/mL",
      "Pharm_Classes": "Lipid-based Polyene Antifungal [EPC], Polyene Antifungal [EPC], Polyenes [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2025-09-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20101018",
      "SamplePackage": "N",
      "IndicationAndUsage": "ABELCET ®is indicated for the treatment of invasive fungal infections in patients who are refractory to or intolerant of conventional amphotericin B therapy. This is based on open-label treatment of patients judged by their physicians to be intolerant to or failing conventional amphotericin B therapy (See DESCRIPTION OF CLINICAL STUDIES). DESCRIPTION OF CLINICAL STUDIES. Fungal Infections. Data from 473 patients were pooled from three open-label studies in which ABELCET ®was provided for the treatment of patients with invasive fungal infections who were judged by their physicians to be refractory to or intolerant of conventional amphotericin B, or who had preexisting nephrotoxicity. Results of these studies demonstrated effectiveness of ABELCET ®in the treatment of invasive fungal infections as a second line therapy. Patients were defined by their individual physician as being refractory to or failing conventional amphotericin B therapy based on overall clinical judgement after receiving a minimum total dose of 500 mg of amphotericin B. Nephrotoxicity was defined as a serum creatinine that had increased to >2.5 mg/dL in adults and >1.5 mg/dL in pediatric patients, or a creatinine clearance of <25 mL/min while receiving conventional amphotericin B therapy. Of the 473 patients, four were enrolled more than once; each enrollment contributed separately to the denominator. The median age was 39 years (range of <1 to 93 years); 307 patients were male and 166 female. Patients were Caucasian (381, 81%), African-American (41, 9%), Hispanic (27, 6%), Asian (10, 2%), and various other races (14, 3%). The median baseline neutrophil count was 4,000 PMN/mm3; of these, 101 (21%) had a baseline neutrophil count <500/mm 3. Two-hundred eighty-two patients of the 473 patients were considered evaluable for response to therapy; the other 191 patients were excluded on the basis of unconfirmed diagnosis, confounding factors, concomitant systemic antifungal therapy, or receiving 4 doses or less of ABELCET ®. For evaluable patients, the following fungal infections were treated (n=282): aspergillosis (n=111), candidiasis (n=87), zygomycosis (n=25), cryptococcosis (n=16), and fusariosis (n=11). There were fewer than 10 evaluable patients for each of several other fungal species treated. For each type of fungal infection listed above there were some patients successfully treated. However, in the absence of controlled studies it is unknown how response would have compared to either continuing conventional amphotericin B therapy or the use of alternative antifungal agents. Renal Function:Patients with aspergillosis who initiated treatment with ABELCET ®when serum creatinine was above 2.5 mg/dL experienced a decline in serum creatinine during treatment (Figure 1). Serum creatinine levels were also lower during treatment with ABELCET ®when compared to the serum creatinine levels of patients treated with conventional amphotericin B in a retrospective historical control study. Meaningful statistical testing of the differences between these two groups is precluded since these data were obtained from two separate studies. [ ]= Number of patients at each time point. Note: These curves do not represent the clinical course of a given patient, but that of an open-label cohort of patients. [ ]= Number of patients at each time point. Note: These curves do not represent the clinical course of a given patient, but that of an open-label cohort of patients. In a randomized study of ABELCET ®for the treatment of invasive candidiasis in patients with normal baseline renal function, the incidence of nephrotoxicity was significantly less for ABELCET ®at a dose of 5 mg/kg/day than for conventional amphotericin B at a dose of 0.7 mg/kg/day. Despite generally less nephrotoxicity of ABELCET ®observed at a dose of 5 mg/kg/day compared with conventional amphotericin B therapy at a dose range of 0.6-1 mg/kg/day, dose-limiting renal toxicity may still be observed with ABELCET ®. Renal toxicity of doses greater than 5 mg/kg/day of ABELCET ®has not been formally studied.",
      "Description": "ABELCET ®is a sterile, pyrogen-free suspension for intravenous infusion. ABELCET ®consists of amphotericin B complexed with two phospholipids in a 1:1 drug-to-lipid molar ratio. The two phospholipids, l-α-dimyristoylphosphatidylcholine (DMPC) and l-α-dimyristoylphosphatidylglycerol (DMPG), are present in a 7:3 molar ratio. ABELCET ®is yellow and opaque in appearance, with a pH of 5 - 7. NOTE: Liposomal encapsulation or incorporation in a lipid complex can substantially affect a drug’s functional properties relative to those of the unencapsulated or nonlipid-associated drug. In addition, different liposomal or lipid-complexed products with a common active ingredient may vary from one another in the chemical composition and physical form of the lipid component. Such differences may affect functional properties of these drug products. Amphotericin B is a polyene, antifungal antibiotic produced from a strain of Streptomyces nodosus. Amphotericin B is designated chemically as [1R-(1R*, 3S*, 5R*, 6R*, 9R*, 11R*, 15S*, 16R*, 17R*, 18S*, 19E, 21E, 23E, 25E, 27E, 29E, 31E, 33R*, 35S*, 36R*, 37S*)]-33-[(3-Amino-3, 6-dideoxy- β-D-mannopyranosyl) oxy]-1,3,5,6,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-14,39-dioxabicyclo[33.3.1] nonatriaconta-19, 21, 23, 25, 27, 29, 31-heptaene-36-carboxylic acid. It has a molecular weight of 924.09 and a molecular formula of C 47H 73NO 17. The structural formula is:. ABELCET ®is provided as a sterile, opaque suspension in 20 mL glass, single-use vials. Each 20 mL vial contains 100 mg of amphotericin B in 20 mL of suspension (see DOSAGE AND ADMINISTRATION), and each mL of ABELCET ®contains:. Amphotericin B USP 5.0 mg. l-α-dimyristoylphosphatidylcholine (DMPC) 3.4 mg. l-α-dimyristoylphosphatidylglycerol (DMPG) 1.5 mg. Sodium Chloride USP 9.0 mg. Water for Injection USP, q.s. 1.0 mL. MICROBIOLOGY. Mechanism of Action. The active component of ABELCET ®, amphotericin B, acts by binding to sterols in the cell membrane of susceptible fungi, with a resultant change in the permeability of the membrane. Mammalian cell membranes also contain sterols, and damage to human cells is believed to occur through the same mechanism of action. Activity in vitroand in vivo. ABELCET ®shows in vitro activity against Aspergillussp. (n=3) and Candidasp. (n=10), with MICs generally <1 μg/mL. Depending upon the species and strain of Aspergillusand Candidatested, significant in vitrodifferences in susceptibility to amphotericin B have been reported (MICs ranging from 0.1 to >10 μg/mL). ABELCET ®is active in animal models against Aspergillus fumigatus, Candida albicans, C. guillermondii, C. stellatoideae, and C. tropicalis, Cryptococcussp., Coccidioidomycessp., Histoplasmasp., and Blastomycessp. in which end-points were clearance of microorganisms from target organ(s) and/or prolonged survival of infected animals. Drug Resistance. Fungal species with decreased susceptibility to amphotericin B have been isolated after serial passage in culture media containing the drug, and from some patients receiving prolonged therapy. Although the relevance of drug resistance to clinical outcome has not been established, fungal species which are resistant to amphotericin B may also be resistant to ABELCET ®. Susceptibility Testing. For specific information regarding susceptibility test interpretive criteria, and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC."
    },
    {
      "NDCCode": "64406-101-01",
      "PackageDescription": "1 VIAL in 1 CARTON (64406-101-01)  / 1.7 mL in 1 VIAL",
      "NDC11Code": "64406-0101-01",
      "ProductNDC": "64406-101",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Aduhelm",
      "NonProprietaryName": "Aducanumab",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20210607",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA761178",
      "LabelerName": "Biogen Inc.",
      "SubstanceName": "ADUCANUMAB",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Amyloid Beta-directed Antibody Interactions [MoA], Amyloid Beta-directed Antibody [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-11-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20210607",
      "SamplePackage": "N",
      "IndicationAndUsage": "ADUHELM is indicated for the treatment of Alzheimer's disease. Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with ADUHELM [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).",
      "Description": "Aducanumab-avwa is a recombinant human immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta, and is expressed in a Chinese hamster ovary cell line. Aducanumab-avwa has an approximate molecular weight of 146 kDa. ADUHELM (aducanumab-avwa) injection is a preservative-free, sterile, clear to opalescent, and colorless to yellow solution for intravenous infusion after dilution supplied in single-dose vials available in concentrations of 170 mg/1.7 mL (100 mg/mL) or 300 mg/3 mL (100 mg/mL) of ADUHELM. Each mL of solution contains 100 mg of aducanumab-avwa and L-arginine hydrochloride (31.60 mg), L-histidine (0.60 mg), L-histidine hydrochloride monohydrate (3.39 mg), L-methionine (1.49 mg), polysorbate 80 (0.50 mg), and Water for Injection at an approximate pH of 5.5."
    },
    {
      "NDCCode": "69980-101-03",
      "PackageDescription": "60 mL in 1 BOTTLE, PLASTIC (69980-101-03) ",
      "NDC11Code": "69980-0101-03",
      "ProductNDC": "69980-101",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hand Sanitizer",
      "NonProprietaryName": "65% Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200520",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Shandong Vianor Healthy Science Co., Ltd.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "39",
      "StrengthUnit": "mL/60mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200520",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hand sanitizer to help reduce bacteria on the skin."
    },
    {
      "NDCCode": "70114-101-01",
      "PackageDescription": "1 SYRINGE in 1 CARTON (70114-101-01)  / .6 mL in 1 SYRINGE",
      "NDC11Code": "70114-0101-01",
      "ProductNDC": "70114-101",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Udenyca",
      "NonProprietaryName": "Pegfilgrastim-cbqv",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20181102",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA761039",
      "LabelerName": "Coherus Oncology, Inc.",
      "SubstanceName": "PEGFILGRASTIM",
      "StrengthNumber": "6",
      "StrengthUnit": "mg/.6mL",
      "Pharm_Classes": "Granulocyte Colony-Stimulating Factor [CS], Increased Myeloid Cell Production [PE], Leukocyte Growth Factor [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-08-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20181102",
      "SamplePackage": "N",
      "IndicationAndUsage": "UDENYCA is a leukocyte growth factor indicated to : 1 Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. (1.1), 2 Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome). (1.2).",
      "Description": "Pegfilgrastim-cbqv is a covalent conjugate of recombinant methionyl human G-CSF and monomethoxypolyethylene glycol. Recombinant methionyl human G-CSF is a water-soluble, 175 amino acid protein with a molecular weight of approximately 19 kilodaltons (kDa). Recombinant methionyl human G-CSF is obtained from the bacterial fermentation of a strain of E coli transformed with a genetically engineered plasmid containing the human G-CSF gene. During the pegfilgrastim-cbqv manufacturing process, fermentation is carried out in nutrient medium containing the antibiotic kanamycin. However, kanamycin is cleared in the manufacturing process and is not detectable in the final product. To produce pegfilgrastim-cbqv, a 20 kDa monomethoxypolyethylene glycol molecule is covalently bound to the N-terminal methionyl residue of recombinant methionyl human G-CSF. The average molecular weight of pegfilgrastim-cbqv is approximately 39 kDa. UDENYCA (pegfilgrastim-cbqv) injection is provided in three presentations: 1 UDENYCA for manual subcutaneous injection is supplied in 0.6 mL prefilled syringes. The prefilled syringe does not bear graduation marks and is designed to deliver the entire contents of the syringe (6 mg/0.6 mL)., 2 UDENYCA for subcutaneous injection is supplied in a 0.6 mL prefilled single-dose autoinjector. The prefilled autoinjector delivers the entire contents (6 mg in 0.6mL) in a single injection and is not adjustable., 3 On-body injector (OBI) for UDENYCA is supplied with a prefilled syringe containing 0.67 mL of UDENYCA in solution that delivers 0.6 mL of UDENYCA in solution when used with the OBI for UDENYCA. The syringe does not bear graduation marks and is only to be used with the OBI for UDENYCA."
    },
    {
      "NDCCode": "76519-1154-1",
      "PackageDescription": "100 TABLET in 1 CONTAINER (76519-1154-1) ",
      "NDC11Code": "76519-1154-01",
      "ProductNDC": "76519-1154",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Benzphetamine Hydrochloride",
      "NonProprietaryName": "Benzphetamine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170607",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090968",
      "LabelerName": "H. J. Harkins Company Inc.",
      "SubstanceName": "BENZPHETAMINE HYDROCHLORIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]",
      "DEASchedule": "CIII",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "Benzphetamine Hydrochloride Tablets are indicated in the management of exogenous obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m2 or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds ÷2.2 = kg; inches × 0.0254 = meters. The limited usefulness of agents of this class (See CLINICAL PHARMACOLOGY) should be weighed against possible risks inherent in their use such as those described below. BODY MASS INDEX (BMI), kg/m2 Weight (pounds) Height (feet, inches) 5'0\" 5'3\" 5'6\". 5'9\" 6'0\" 6'3\" 140 27 25 23 21 19 18 150 29 27 24 22 20 19 160 31 28 26 24 22 20 170 33 30 28 25 23 21 180 35 32 29 27 25 23 190 37 34 31 28 26 24 200 39 36 32 30 27 25 210 41 37 34 31 29 26 220 43 39 36 33 30 28 230 45 41 37 34 31 29 240 47 43 39 36 33 30 250 49 44 40 37 34 31. Benzphetamine Hydrochloride Tablets are indicated for use as monotherapy only.",
      "Description": "Benzphetamine Hydrochloride Tablets contain the anorectic agent benzphetamine hydrochloride. Benzphetamine hydrochloride is a white crystalline powder readily soluble in water and 95% ethanol. The chemical name for benzphetamine hydrochloride is d-N,α-Dimethyl-N -(phenylmethyl)-benzeneethanamine hydrochloride and its molecular weight is 275.82. The structural formula (dextro form) is represented below. Each Benzphetamine Hydrochloride Tablet, for oral administration, contains 50 mg of benzphetamine hydrochloride. Inactive Ingredients: carnauba wax powder, colloidal silicon dioxide, FD&C red # 40 aluminum lake, FD&C yellow # 6 aluminum lake, lactose monohydrate, macrogol/polyethylene glycol 3350, magnesium stearate, microcrystalline cellulose 101, polyvinyl alcohol – partially hydrolyzed, sodium starch glycolate, talc and titanium dioxide."
    },
    {
      "NDCCode": "81333-101-24",
      "PackageDescription": "24 SOLUTION in 1 BAG (81333-101-24) ",
      "NDC11Code": "81333-0101-24",
      "ProductNDC": "81333-101",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cleanette Antibacterial",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200111",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Harper Hygienics S.A.",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": "2.39",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20210126",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "73749-102-15",
      "PackageDescription": "1500 mL in 1 BOTTLE, PLASTIC (73749-102-15) ",
      "NDC11Code": "73749-0102-15",
      "ProductNDC": "73749-102",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hand Sanitizer",
      "NonProprietaryName": "Isopropyl Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200403",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Clear Lakes Products, LLC",
      "SubstanceName": "ISOPROPYL ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200403",
      "SamplePackage": "N",
      "IndicationAndUsage": "For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use."
    },
    {
      "NDCCode": "73749-102-75",
      "PackageDescription": "750 mL in 1 BOTTLE, PLASTIC (73749-102-75) ",
      "NDC11Code": "73749-0102-75",
      "ProductNDC": "73749-102",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hand Sanitizer",
      "NonProprietaryName": "Isopropyl Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200403",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Clear Lakes Products, LLC",
      "SubstanceName": "ISOPROPYL ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200403",
      "SamplePackage": "N",
      "IndicationAndUsage": "For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use."
    },
    {
      "NDCCode": "0004-0352-39",
      "PackageDescription": "1 KIT in 1 CARTON (0004-0352-39)  *  4 SYRINGE, GLASS in 1 PACKET > .5 mL in 1 SYRINGE, GLASS *  4 SWAB in 1 PACKET",
      "NDC11Code": "00004-0352-39",
      "ProductNDC": "0004-0352",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pegasys",
      "NonProprietaryName": "Peginterferon Alfa-2a",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20021016",
      "EndMarketingDate": "20150731",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103964",
      "LabelerName": "Genentech, Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2015-08-07"
    }
  ]
}
                    

{"NDC":[{"NDCCode":"73749-101-39","ProprietaryName":"Clear Lakes Products Hand Sanitizer","NonProprietaryName":"Hand Sanitizer"},{"NDCCode":"73749-101-29","ProprietaryName":"Clear Lakes Products Hand Sanitizer","NonProprietaryName":"Hand Sanitizer"},{"NDCCode":"73749-101-59","ProprietaryName":"Clear Lakes Products Hand Sanitizer","NonProprietaryName":"Hand Sanitizer"},{"NDCCode":"73749-101-99","ProprietaryName":"Clear Lakes Products Hand Sanitizer","NonProprietaryName":"Hand Sanitizer"},{"NDCCode":"10356-101-39","ProprietaryName":"Aquaphor Healing","NonProprietaryName":"Petrolatum"},{"NDCCode":"52807-101-39","ProprietaryName":"Hand Sanitizer","NonProprietaryName":"Hand Sanitizer"},{"NDCCode":"55037-101-39","ProprietaryName":"Oxygen","NonProprietaryName":"Oxygen"},{"NDCCode":"63940-101-39","ProprietaryName":"Harmon Face Values Allergy Relief","NonProprietaryName":"Loratadine"},{"NDCCode":"78445-101-39","ProprietaryName":"Hand Sanitizer","NonProprietaryName":"Alcohol"},{"NDCCode":"84502-101-39","NonProprietaryName":"Semaglutide"},{"NDCCode":"84643-101-39","NonProprietaryName":"Semaglutide"},{"NDCCode":"0169-2030-11","ProprietaryName":"Sogroya","NonProprietaryName":"Somapacitan-beco"},{"NDCCode":"0169-2030-90","ProprietaryName":"Sogroya","NonProprietaryName":"Somapacitan-beco"},{"NDCCode":"0169-2035-11","ProprietaryName":"Sogroya","NonProprietaryName":"Somapacitan-beco"},{"NDCCode":"0169-2035-90","ProprietaryName":"Sogroya","NonProprietaryName":"Somapacitan-beco"},{"NDCCode":"0169-2037-11","ProprietaryName":"Sogroya","NonProprietaryName":"Somapacitan-beco"},{"NDCCode":"0169-2037-90","ProprietaryName":"Sogroya","NonProprietaryName":"Somapacitan-beco"},{"NDCCode":"33342-101-11","ProprietaryName":"Quetiapine Fumarate","NonProprietaryName":"Quetiapine Fumarate"},{"NDCCode":"33342-101-12","ProprietaryName":"Quetiapine Fumarate","NonProprietaryName":"Quetiapine Fumarate"},{"NDCCode":"33342-101-44","ProprietaryName":"Quetiapine Fumarate","NonProprietaryName":"Quetiapine Fumarate"},{"NDCCode":"44567-101-10","ProprietaryName":"Ampicillin","NonProprietaryName":"Ampicillin"},{"NDCCode":"57665-101-41","ProprietaryName":"Abelcet","NonProprietaryName":"Amphotericin B, Dimyristoylphosphatidylcholine, Dl- And Dimyristoylphosphatidylglycerol, Dl-"},{"NDCCode":"64406-101-01","ProprietaryName":"Aduhelm","NonProprietaryName":"Aducanumab"},{"NDCCode":"69980-101-03","ProprietaryName":"Hand Sanitizer","NonProprietaryName":"65% Alcohol"},{"NDCCode":"70114-101-01","ProprietaryName":"Udenyca","NonProprietaryName":"Pegfilgrastim-cbqv"},{"NDCCode":"76519-1154-1","ProprietaryName":"Benzphetamine Hydrochloride","NonProprietaryName":"Benzphetamine Hydrochloride"},{"NDCCode":"81333-101-24","ProprietaryName":"Cleanette Antibacterial","NonProprietaryName":"Benzalkonium Chloride"},{"NDCCode":"73749-102-15","ProprietaryName":"Hand Sanitizer","NonProprietaryName":"Isopropyl Alcohol"},{"NDCCode":"73749-102-75","ProprietaryName":"Hand Sanitizer","NonProprietaryName":"Isopropyl Alcohol"},{"NDCCode":"0004-0352-39","ProprietaryName":"Pegasys","NonProprietaryName":"Peginterferon Alfa-2a"}]}
                    

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<NDCList>
  <NDC>
    <NDCCode>73749-101-39</NDCCode>
    <PackageDescription>1.040875 L in 1 BOTTLE, PLASTIC (73749-101-39) </PackageDescription>
    <NDC11Code>73749-0101-39</NDC11Code>
    <ProductNDC>73749-101</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Clear Lakes Products Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Hand Sanitizer</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200318</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Clear Lakes Products, LLC</LabelerName>
    <SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
    <StrengthNumber>.7</StrengthNumber>
    <StrengthUnit>L/L</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200318</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>73749-101-29</NDCCode>
    <PackageDescription>.473176 L in 1 BOTTLE, PLASTIC (73749-101-29) </PackageDescription>
    <NDC11Code>73749-0101-29</NDC11Code>
    <ProductNDC>73749-101</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Clear Lakes Products Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Hand Sanitizer</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200318</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Clear Lakes Products, LLC</LabelerName>
    <SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
    <StrengthNumber>.7</StrengthNumber>
    <StrengthUnit>L/L</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200318</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>73749-101-59</NDCCode>
    <PackageDescription>3.758 L in 1 BOTTLE, PLASTIC (73749-101-59) </PackageDescription>
    <NDC11Code>73749-0101-59</NDC11Code>
    <ProductNDC>73749-101</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Clear Lakes Products Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Hand Sanitizer</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200318</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Clear Lakes Products, LLC</LabelerName>
    <SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
    <StrengthNumber>.7</StrengthNumber>
    <StrengthUnit>L/L</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200318</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>73749-101-99</NDCCode>
    <PackageDescription>1040.875 L in 1 BOTTLE, PLASTIC (73749-101-99) </PackageDescription>
    <NDC11Code>73749-0101-99</NDC11Code>
    <ProductNDC>73749-101</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Clear Lakes Products Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Hand Sanitizer</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200318</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Clear Lakes Products, LLC</LabelerName>
    <SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
    <StrengthNumber>.7</StrengthNumber>
    <StrengthUnit>L/L</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200318</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10356-101-39</NDCCode>
    <PackageDescription>7 g in 1 JAR (10356-101-39) </PackageDescription>
    <NDC11Code>10356-0101-39</NDC11Code>
    <ProductNDC>10356-101</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Aquaphor Healing</ProprietaryName>
    <NonProprietaryName>Petrolatum</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>19910101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>Beiersdorf Inc</LabelerName>
    <SubstanceName>PETROLATUM</SubstanceName>
    <StrengthNumber>41</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-12-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19910101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses.  temporarily protects minor:  cuts  scrapes  burns  temporarily protects and helps relieve chapped or cracked skin and lips  helps protect from the drying effects of wind and cold weather.  helps treat and prevent diaper rash   protects chafed skin associated with diaper rash and helps protect from wetness.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>52807-101-39</NDCCode>
    <PackageDescription>3000 mL in 1 BOTTLE (52807-101-39) </PackageDescription>
    <NDC11Code>52807-0101-39</NDC11Code>
    <ProductNDC>52807-101</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Hand Sanitizer</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200320</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Guangdong Longtai Industry Co.,LTD</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>20200330</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For hand washing to decrease bacteria on the skinre commended for repeated use.</IndicationAndUsage>
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  <NDC>
    <NDCCode>55037-101-39</NDCCode>
    <PackageDescription>6300 L in 1 CYLINDER (55037-101-39) </PackageDescription>
    <NDC11Code>55037-0101-39</NDC11Code>
    <ProductNDC>55037-101</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxygen</ProprietaryName>
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    <DosageFormName>GAS</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>19870101</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA205889</ApplicationNumber>
    <LabelerName>Matheson Tri-Gas, Inc.</LabelerName>
    <SubstanceName>OXYGEN</SubstanceName>
    <StrengthNumber>992</StrengthNumber>
    <StrengthUnit>1/L</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19870101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
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    <NDCCode>63940-101-39</NDCCode>
    <PackageDescription>30 BLISTER PACK in 1 CARTON (63940-101-39)  &gt; 1 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>63940-0101-39</NDC11Code>
    <ProductNDC>63940-101</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Harmon Face Values Allergy Relief</ProprietaryName>
    <NonProprietaryName>Loratadine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20111218</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076301</ApplicationNumber>
    <LabelerName>Harmon Stores Inc.</LabelerName>
    <SubstanceName>LORATADINE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>78445-101-39</NDCCode>
    <PackageDescription>236 mL in 1 BOTTLE (78445-101-39) </PackageDescription>
    <NDC11Code>78445-0101-39</NDC11Code>
    <ProductNDC>78445-101</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200330</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Guangzhou Kangfei Cosmetics Co., Ltd.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-08-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200330</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>84502-101-39</NDCCode>
    <PackageDescription>10 g in 1 BOTTLE, PLASTIC (84502-101-39) </PackageDescription>
    <NDC11Code>84502-0101-39</NDC11Code>
    <ProductNDC>84502-101</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Semaglutide</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20240702</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Fujian Genohope Biotech Ltd.</LabelerName>
    <SubstanceName>SEMAGLUTIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-06-05</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>02-JUL-24</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>84643-101-39</NDCCode>
    <PackageDescription>2000 g in 1 CONTAINER (84643-101-39) </PackageDescription>
    <NDC11Code>84643-0101-39</NDC11Code>
    <ProductNDC>84643-101</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Semaglutide</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20260212</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>Zhejiang Tasln Biopharma Co., Ltd.</LabelerName>
    <SubstanceName>SEMAGLUTIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-03-12</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>12-FEB-26</StartMarketingDatePackage>
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  <NDC>
    <NDCCode>0169-2030-11</NDCCode>
    <PackageDescription>1 SYRINGE, PLASTIC in 1 CARTON (0169-2030-11)  / 1.5 mL in 1 SYRINGE, PLASTIC</PackageDescription>
    <NDC11Code>00169-2030-11</NDC11Code>
    <ProductNDC>0169-2030</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sogroya</ProprietaryName>
    <NonProprietaryName>Somapacitan-beco</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20230501</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761156</ApplicationNumber>
    <LabelerName>Novo Nordisk</LabelerName>
    <SubstanceName>SOMAPACITAN</SubstanceName>
    <StrengthNumber>6.7</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-03-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>SOGROYA is indicated for the treatment of pediatric patients aged 2.5 years and older with: 1 Growth failure due to inadequate secretion of endogenous growth hormone (GH)., 2 Short stature born small for gestational age (SGA) and with no catch-up growth by 2 years of age., 3 Growth failure associated with Noonan syndrome (NS)., 4 Idiopathic Short Stature (ISS).</IndicationAndUsage>
    <Description>Somapacitan-beco is a human growth hormone (hGH) analog with a single substitution in the amino acid backbone (L101C) to which an albumin-binding moiety has been attached. The albumin-binding moiety (side-chain) consists of an albumin binder and a hydrophilic spacer attached to position 101 of the protein. The protein part consists of 191 amino acids. Somapacitan-beco is produced in Escherichia coli by recombinant DNA technology. The molecular formula (including the albumin-binding moiety) is C1038H1609N273O319S9 and the molecular weight is 23305.10 g/mol, of which the albumin-binding moiety is 1191.39 g/mol. Structural Formula:. SOGROYA (somapacitan-beco) injection is supplied as a sterile, clear to slightly opalescent and colorless to slightly yellow solution for subcutaneous use in a single-patient-use prefilled pen with a deliverable volume of 1.5 mL. Each mL of SOGROYA 5 mg/1.5 mL prefilled pen contains 3.3 mg of somapacitan-beco, histidine (0.68 mg), mannitol (44 mg), phenol (4 mg), poloxamer 188 (1 mg), and Water for Injection, USP. The pH is approximately 6.8. Hydrochloric acid and sodium hydroxide may be added to adjust the pH. Each mL of SOGROYA 10 mg/1.5 mL prefilled pen contains 6.7 mg of somapacitan-beco, histidine (0.68 mg), mannitol (44 mg), phenol (4 mg), poloxamer 188 (1 mg), and Water for Injection, USP. The pH is approximately 6.8. Hydrochloric acid and sodium hydroxide may be added to adjust the pH. Each mL of SOGROYA 15 mg/1.5 mL prefilled pen contains 10 mg of somapacitan-beco, histidine (0.68 mg), mannitol (44 mg), phenol (4 mg), poloxamer 188 (1 mg), and Water for Injection, USP. The pH is approximately 6.8. Hydrochloric acid and sodium hydroxide may be added to adjust the pH.</Description>
  </NDC>
  <NDC>
    <NDCCode>0169-2030-90</NDCCode>
    <PackageDescription>1 SYRINGE, PLASTIC in 1 CARTON (0169-2030-90)  / 1.5 mL in 1 SYRINGE, PLASTIC</PackageDescription>
    <NDC11Code>00169-2030-90</NDC11Code>
    <ProductNDC>0169-2030</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sogroya</ProprietaryName>
    <NonProprietaryName>Somapacitan-beco</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20230501</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761156</ApplicationNumber>
    <LabelerName>Novo Nordisk</LabelerName>
    <SubstanceName>SOMAPACITAN</SubstanceName>
    <StrengthNumber>6.7</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-03-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>SOGROYA is indicated for the treatment of pediatric patients aged 2.5 years and older with: 1 Growth failure due to inadequate secretion of endogenous growth hormone (GH)., 2 Short stature born small for gestational age (SGA) and with no catch-up growth by 2 years of age., 3 Growth failure associated with Noonan syndrome (NS)., 4 Idiopathic Short Stature (ISS).</IndicationAndUsage>
    <Description>Somapacitan-beco is a human growth hormone (hGH) analog with a single substitution in the amino acid backbone (L101C) to which an albumin-binding moiety has been attached. The albumin-binding moiety (side-chain) consists of an albumin binder and a hydrophilic spacer attached to position 101 of the protein. The protein part consists of 191 amino acids. Somapacitan-beco is produced in Escherichia coli by recombinant DNA technology. The molecular formula (including the albumin-binding moiety) is C1038H1609N273O319S9 and the molecular weight is 23305.10 g/mol, of which the albumin-binding moiety is 1191.39 g/mol. Structural Formula:. SOGROYA (somapacitan-beco) injection is supplied as a sterile, clear to slightly opalescent and colorless to slightly yellow solution for subcutaneous use in a single-patient-use prefilled pen with a deliverable volume of 1.5 mL. Each mL of SOGROYA 5 mg/1.5 mL prefilled pen contains 3.3 mg of somapacitan-beco, histidine (0.68 mg), mannitol (44 mg), phenol (4 mg), poloxamer 188 (1 mg), and Water for Injection, USP. The pH is approximately 6.8. Hydrochloric acid and sodium hydroxide may be added to adjust the pH. Each mL of SOGROYA 10 mg/1.5 mL prefilled pen contains 6.7 mg of somapacitan-beco, histidine (0.68 mg), mannitol (44 mg), phenol (4 mg), poloxamer 188 (1 mg), and Water for Injection, USP. The pH is approximately 6.8. Hydrochloric acid and sodium hydroxide may be added to adjust the pH. Each mL of SOGROYA 15 mg/1.5 mL prefilled pen contains 10 mg of somapacitan-beco, histidine (0.68 mg), mannitol (44 mg), phenol (4 mg), poloxamer 188 (1 mg), and Water for Injection, USP. The pH is approximately 6.8. Hydrochloric acid and sodium hydroxide may be added to adjust the pH.</Description>
  </NDC>
  <NDC>
    <NDCCode>0169-2035-11</NDCCode>
    <PackageDescription>1 SYRINGE, PLASTIC in 1 CARTON (0169-2035-11)  / 1.5 mL in 1 SYRINGE, PLASTIC</PackageDescription>
    <NDC11Code>00169-2035-11</NDC11Code>
    <ProductNDC>0169-2035</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sogroya</ProprietaryName>
    <NonProprietaryName>Somapacitan-beco</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20230501</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761156</ApplicationNumber>
    <LabelerName>Novo Nordisk</LabelerName>
    <SubstanceName>SOMAPACITAN</SubstanceName>
    <StrengthNumber>3.3</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-03-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>SOGROYA is indicated for the treatment of pediatric patients aged 2.5 years and older with: 1 Growth failure due to inadequate secretion of endogenous growth hormone (GH)., 2 Short stature born small for gestational age (SGA) and with no catch-up growth by 2 years of age., 3 Growth failure associated with Noonan syndrome (NS)., 4 Idiopathic Short Stature (ISS).</IndicationAndUsage>
    <Description>Somapacitan-beco is a human growth hormone (hGH) analog with a single substitution in the amino acid backbone (L101C) to which an albumin-binding moiety has been attached. The albumin-binding moiety (side-chain) consists of an albumin binder and a hydrophilic spacer attached to position 101 of the protein. The protein part consists of 191 amino acids. Somapacitan-beco is produced in Escherichia coli by recombinant DNA technology. The molecular formula (including the albumin-binding moiety) is C1038H1609N273O319S9 and the molecular weight is 23305.10 g/mol, of which the albumin-binding moiety is 1191.39 g/mol. Structural Formula:. SOGROYA (somapacitan-beco) injection is supplied as a sterile, clear to slightly opalescent and colorless to slightly yellow solution for subcutaneous use in a single-patient-use prefilled pen with a deliverable volume of 1.5 mL. Each mL of SOGROYA 5 mg/1.5 mL prefilled pen contains 3.3 mg of somapacitan-beco, histidine (0.68 mg), mannitol (44 mg), phenol (4 mg), poloxamer 188 (1 mg), and Water for Injection, USP. The pH is approximately 6.8. Hydrochloric acid and sodium hydroxide may be added to adjust the pH. Each mL of SOGROYA 10 mg/1.5 mL prefilled pen contains 6.7 mg of somapacitan-beco, histidine (0.68 mg), mannitol (44 mg), phenol (4 mg), poloxamer 188 (1 mg), and Water for Injection, USP. The pH is approximately 6.8. Hydrochloric acid and sodium hydroxide may be added to adjust the pH. Each mL of SOGROYA 15 mg/1.5 mL prefilled pen contains 10 mg of somapacitan-beco, histidine (0.68 mg), mannitol (44 mg), phenol (4 mg), poloxamer 188 (1 mg), and Water for Injection, USP. The pH is approximately 6.8. Hydrochloric acid and sodium hydroxide may be added to adjust the pH.</Description>
  </NDC>
  <NDC>
    <NDCCode>0169-2035-90</NDCCode>
    <PackageDescription>1 SYRINGE, PLASTIC in 1 CARTON (0169-2035-90)  / 1.5 mL in 1 SYRINGE, PLASTIC</PackageDescription>
    <NDC11Code>00169-2035-90</NDC11Code>
    <ProductNDC>0169-2035</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sogroya</ProprietaryName>
    <NonProprietaryName>Somapacitan-beco</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20230501</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761156</ApplicationNumber>
    <LabelerName>Novo Nordisk</LabelerName>
    <SubstanceName>SOMAPACITAN</SubstanceName>
    <StrengthNumber>3.3</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-03-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>SOGROYA is indicated for the treatment of pediatric patients aged 2.5 years and older with: 1 Growth failure due to inadequate secretion of endogenous growth hormone (GH)., 2 Short stature born small for gestational age (SGA) and with no catch-up growth by 2 years of age., 3 Growth failure associated with Noonan syndrome (NS)., 4 Idiopathic Short Stature (ISS).</IndicationAndUsage>
    <Description>Somapacitan-beco is a human growth hormone (hGH) analog with a single substitution in the amino acid backbone (L101C) to which an albumin-binding moiety has been attached. The albumin-binding moiety (side-chain) consists of an albumin binder and a hydrophilic spacer attached to position 101 of the protein. The protein part consists of 191 amino acids. Somapacitan-beco is produced in Escherichia coli by recombinant DNA technology. The molecular formula (including the albumin-binding moiety) is C1038H1609N273O319S9 and the molecular weight is 23305.10 g/mol, of which the albumin-binding moiety is 1191.39 g/mol. Structural Formula:. SOGROYA (somapacitan-beco) injection is supplied as a sterile, clear to slightly opalescent and colorless to slightly yellow solution for subcutaneous use in a single-patient-use prefilled pen with a deliverable volume of 1.5 mL. Each mL of SOGROYA 5 mg/1.5 mL prefilled pen contains 3.3 mg of somapacitan-beco, histidine (0.68 mg), mannitol (44 mg), phenol (4 mg), poloxamer 188 (1 mg), and Water for Injection, USP. The pH is approximately 6.8. Hydrochloric acid and sodium hydroxide may be added to adjust the pH. Each mL of SOGROYA 10 mg/1.5 mL prefilled pen contains 6.7 mg of somapacitan-beco, histidine (0.68 mg), mannitol (44 mg), phenol (4 mg), poloxamer 188 (1 mg), and Water for Injection, USP. The pH is approximately 6.8. Hydrochloric acid and sodium hydroxide may be added to adjust the pH. Each mL of SOGROYA 15 mg/1.5 mL prefilled pen contains 10 mg of somapacitan-beco, histidine (0.68 mg), mannitol (44 mg), phenol (4 mg), poloxamer 188 (1 mg), and Water for Injection, USP. The pH is approximately 6.8. Hydrochloric acid and sodium hydroxide may be added to adjust the pH.</Description>
  </NDC>
  <NDC>
    <NDCCode>0169-2037-11</NDCCode>
    <PackageDescription>1 SYRINGE, PLASTIC in 1 CARTON (0169-2037-11)  / 1.5 mL in 1 SYRINGE, PLASTIC</PackageDescription>
    <NDC11Code>00169-2037-11</NDC11Code>
    <ProductNDC>0169-2037</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sogroya</ProprietaryName>
    <NonProprietaryName>Somapacitan-beco</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20230501</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761156</ApplicationNumber>
    <LabelerName>Novo Nordisk</LabelerName>
    <SubstanceName>SOMAPACITAN</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-03-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>SOGROYA is indicated for the treatment of pediatric patients aged 2.5 years and older with: 1 Growth failure due to inadequate secretion of endogenous growth hormone (GH)., 2 Short stature born small for gestational age (SGA) and with no catch-up growth by 2 years of age., 3 Growth failure associated with Noonan syndrome (NS)., 4 Idiopathic Short Stature (ISS).</IndicationAndUsage>
    <Description>Somapacitan-beco is a human growth hormone (hGH) analog with a single substitution in the amino acid backbone (L101C) to which an albumin-binding moiety has been attached. The albumin-binding moiety (side-chain) consists of an albumin binder and a hydrophilic spacer attached to position 101 of the protein. The protein part consists of 191 amino acids. Somapacitan-beco is produced in Escherichia coli by recombinant DNA technology. The molecular formula (including the albumin-binding moiety) is C1038H1609N273O319S9 and the molecular weight is 23305.10 g/mol, of which the albumin-binding moiety is 1191.39 g/mol. Structural Formula:. SOGROYA (somapacitan-beco) injection is supplied as a sterile, clear to slightly opalescent and colorless to slightly yellow solution for subcutaneous use in a single-patient-use prefilled pen with a deliverable volume of 1.5 mL. Each mL of SOGROYA 5 mg/1.5 mL prefilled pen contains 3.3 mg of somapacitan-beco, histidine (0.68 mg), mannitol (44 mg), phenol (4 mg), poloxamer 188 (1 mg), and Water for Injection, USP. The pH is approximately 6.8. Hydrochloric acid and sodium hydroxide may be added to adjust the pH. Each mL of SOGROYA 10 mg/1.5 mL prefilled pen contains 6.7 mg of somapacitan-beco, histidine (0.68 mg), mannitol (44 mg), phenol (4 mg), poloxamer 188 (1 mg), and Water for Injection, USP. The pH is approximately 6.8. Hydrochloric acid and sodium hydroxide may be added to adjust the pH. Each mL of SOGROYA 15 mg/1.5 mL prefilled pen contains 10 mg of somapacitan-beco, histidine (0.68 mg), mannitol (44 mg), phenol (4 mg), poloxamer 188 (1 mg), and Water for Injection, USP. The pH is approximately 6.8. Hydrochloric acid and sodium hydroxide may be added to adjust the pH.</Description>
  </NDC>
  <NDC>
    <NDCCode>0169-2037-90</NDCCode>
    <PackageDescription>1 SYRINGE, PLASTIC in 1 CARTON (0169-2037-90)  / 1.5 mL in 1 SYRINGE, PLASTIC</PackageDescription>
    <NDC11Code>00169-2037-90</NDC11Code>
    <ProductNDC>0169-2037</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sogroya</ProprietaryName>
    <NonProprietaryName>Somapacitan-beco</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20230501</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761156</ApplicationNumber>
    <LabelerName>Novo Nordisk</LabelerName>
    <SubstanceName>SOMAPACITAN</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-03-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>SOGROYA is indicated for the treatment of pediatric patients aged 2.5 years and older with: 1 Growth failure due to inadequate secretion of endogenous growth hormone (GH)., 2 Short stature born small for gestational age (SGA) and with no catch-up growth by 2 years of age., 3 Growth failure associated with Noonan syndrome (NS)., 4 Idiopathic Short Stature (ISS).</IndicationAndUsage>
    <Description>Somapacitan-beco is a human growth hormone (hGH) analog with a single substitution in the amino acid backbone (L101C) to which an albumin-binding moiety has been attached. The albumin-binding moiety (side-chain) consists of an albumin binder and a hydrophilic spacer attached to position 101 of the protein. The protein part consists of 191 amino acids. Somapacitan-beco is produced in Escherichia coli by recombinant DNA technology. The molecular formula (including the albumin-binding moiety) is C1038H1609N273O319S9 and the molecular weight is 23305.10 g/mol, of which the albumin-binding moiety is 1191.39 g/mol. Structural Formula:. SOGROYA (somapacitan-beco) injection is supplied as a sterile, clear to slightly opalescent and colorless to slightly yellow solution for subcutaneous use in a single-patient-use prefilled pen with a deliverable volume of 1.5 mL. Each mL of SOGROYA 5 mg/1.5 mL prefilled pen contains 3.3 mg of somapacitan-beco, histidine (0.68 mg), mannitol (44 mg), phenol (4 mg), poloxamer 188 (1 mg), and Water for Injection, USP. The pH is approximately 6.8. Hydrochloric acid and sodium hydroxide may be added to adjust the pH. Each mL of SOGROYA 10 mg/1.5 mL prefilled pen contains 6.7 mg of somapacitan-beco, histidine (0.68 mg), mannitol (44 mg), phenol (4 mg), poloxamer 188 (1 mg), and Water for Injection, USP. The pH is approximately 6.8. Hydrochloric acid and sodium hydroxide may be added to adjust the pH. Each mL of SOGROYA 15 mg/1.5 mL prefilled pen contains 10 mg of somapacitan-beco, histidine (0.68 mg), mannitol (44 mg), phenol (4 mg), poloxamer 188 (1 mg), and Water for Injection, USP. The pH is approximately 6.8. Hydrochloric acid and sodium hydroxide may be added to adjust the pH.</Description>
  </NDC>
  <NDC>
    <NDCCode>33342-101-11</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (33342-101-11) </PackageDescription>
    <NDC11Code>33342-0101-11</NDC11Code>
    <ProductNDC>33342-101</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Quetiapine Fumarate</ProprietaryName>
    <NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160614</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203359</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-04-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160614</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Quetiapine tablets are an atypical antipsychotic indicated for the treatment of:  Schizophrenia (1.1)  Bipolar I disorder manic episodes (1.2)  Bipolar disorder, depressive episodes (1.2).</IndicationAndUsage>
    <Description>Quetiapine fumarate USP is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate USP is a white to off-white crystalline powder which is moderately soluble in water.Quetiapine tablets USP are supplied for oral administration as 25 mg (round, peach, one side debossed with “F71”), 50 mg (round, white, one side debossed with “F72”), 100 mg (round, yellow one side debossed with “F73”), 200 mg (round, white, one side debossed with "F75”), 300 mg (capsule-shaped, white, one side debossed with "F76”), and 400 mg (capsule-shaped, yellow, one side debossed with “F77”) tablets.Inactive ingredients are povidone, dibasic calcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, colloidal silicon di-oxide, hypromellose, polyethylene glycol, and titanium dioxide.The 25 mg tablets contain red ferric oxide and yellow ferric oxide and the 100 mg and 400 mg tablets contain only yellow ferric oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.51 mg of quetiapine fumarate equivalent to 400 mg quetiapine.</Description>
  </NDC>
  <NDC>
    <NDCCode>33342-101-12</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (33342-101-12)  / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>33342-0101-12</NDC11Code>
    <ProductNDC>33342-101</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Quetiapine Fumarate</ProprietaryName>
    <NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160614</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203359</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-04-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160614</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Quetiapine tablets are an atypical antipsychotic indicated for the treatment of:  Schizophrenia (1.1)  Bipolar I disorder manic episodes (1.2)  Bipolar disorder, depressive episodes (1.2).</IndicationAndUsage>
    <Description>Quetiapine fumarate USP is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate USP is a white to off-white crystalline powder which is moderately soluble in water.Quetiapine tablets USP are supplied for oral administration as 25 mg (round, peach, one side debossed with “F71”), 50 mg (round, white, one side debossed with “F72”), 100 mg (round, yellow one side debossed with “F73”), 200 mg (round, white, one side debossed with "F75”), 300 mg (capsule-shaped, white, one side debossed with "F76”), and 400 mg (capsule-shaped, yellow, one side debossed with “F77”) tablets.Inactive ingredients are povidone, dibasic calcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, colloidal silicon di-oxide, hypromellose, polyethylene glycol, and titanium dioxide.The 25 mg tablets contain red ferric oxide and yellow ferric oxide and the 100 mg and 400 mg tablets contain only yellow ferric oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.51 mg of quetiapine fumarate equivalent to 400 mg quetiapine.</Description>
  </NDC>
  <NDC>
    <NDCCode>33342-101-44</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (33342-101-44) </PackageDescription>
    <NDC11Code>33342-0101-44</NDC11Code>
    <ProductNDC>33342-101</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Quetiapine Fumarate</ProprietaryName>
    <NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160614</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203359</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-04-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160614</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Quetiapine tablets are an atypical antipsychotic indicated for the treatment of:  Schizophrenia (1.1)  Bipolar I disorder manic episodes (1.2)  Bipolar disorder, depressive episodes (1.2).</IndicationAndUsage>
    <Description>Quetiapine fumarate USP is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate USP is a white to off-white crystalline powder which is moderately soluble in water.Quetiapine tablets USP are supplied for oral administration as 25 mg (round, peach, one side debossed with “F71”), 50 mg (round, white, one side debossed with “F72”), 100 mg (round, yellow one side debossed with “F73”), 200 mg (round, white, one side debossed with "F75”), 300 mg (capsule-shaped, white, one side debossed with "F76”), and 400 mg (capsule-shaped, yellow, one side debossed with “F77”) tablets.Inactive ingredients are povidone, dibasic calcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, colloidal silicon di-oxide, hypromellose, polyethylene glycol, and titanium dioxide.The 25 mg tablets contain red ferric oxide and yellow ferric oxide and the 100 mg and 400 mg tablets contain only yellow ferric oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.51 mg of quetiapine fumarate equivalent to 400 mg quetiapine.</Description>
  </NDC>
  <NDC>
    <NDCCode>44567-101-10</NDCCode>
    <PackageDescription>10 VIAL in 1 TRAY (44567-101-10)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL</PackageDescription>
    <NDC11Code>44567-0101-10</NDC11Code>
    <ProductNDC>44567-101</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ampicillin</ProprietaryName>
    <NonProprietaryName>Ampicillin</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20120510</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090354</ApplicationNumber>
    <LabelerName>WG Critical Care, LLC</LabelerName>
    <SubstanceName>AMPICILLIN SODIUM</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120510</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ampicillin for Injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions:. Respiratory Tract Infections caused by S. pneumoniae, Staphylococcus aureus (penicillinase and non-penicillinase producing), H. influenzae and Group A beta-hemolytic Streptococci. Bacterial Meningitis caused by E. coli, Group B Streptococci, and other Gram-negative bacteria (Listeria monocytogenes, N. meningitidis). The addition of an aminoglycoside with ampicillin may increase its effectiveness against Gram-negative bacteria. Septicemia and Endocarditis caused by susceptible Gram-positive organisms including Streptococcus spp., penicillin-G-susceptible staphylococci and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella spp. responds to ampicillin. Endocarditis due to enterococcal strains usually respond to intravenous therapy. The addition of an aminoglycoside may enhance the effectiveness of ampicillin when treating streptococcal endocarditis. Urinary Tract Infections caused by sensitive strains of E. coli and Proteus mirabilis. Gastrointestinal Infections caused by Salmonella typhi (typhoid fever), other Salmonella spp. and Shigella spp. (dysentery) usually respond to oral or intravenous therapy. Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Therapy may be instituted prior to obtaining results of susceptibility testing. It is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms. A change to oral ampicillin may be made as soon as appropriate. Indicated surgical procedures should be performed. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin for Injection, USP and other antibacterial drugs, Ampicillin for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
    <Description>Ampicillin for Injection, USP the monosodium salt of [2S-[2a, 5a, 6b(S*)]]-6- [(aminophenylacetyl)amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0]heptane-2-carboxylic acid, is a synthetic penicillin. It is an antibacterial agent with a broad spectrum of bactericidal activity against both penicillin-susceptible Gram-positive organisms and many common Gram-negative pathogens. Ampicillin for Injection, USP is a dry, white to off-white powder. The reconstituted solution is clear, colorless and free from visible particulates. It has the following chemical structure. The molecular formula is C16H18N3NaO4S, and the molecular weight is 371.39. The pH range of the reconstituted solution is 8.0 to 10.0. Ampicillin for Injection, USP contains 65.8 mg [2.9 mEq] sodium per gram ampicillin. Ampicillin for Injection, USP is supplied in vials equivalent to 125 mg, 250 mg, 500 mg, 1 gram or 2 grams of ampicillin. It is to be administered by intravenous or intramuscular routes.</Description>
  </NDC>
  <NDC>
    <NDCCode>57665-101-41</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (57665-101-41)  / 20 mL in 1 VIAL</PackageDescription>
    <NDC11Code>57665-0101-41</NDC11Code>
    <ProductNDC>57665-101</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Abelcet</ProprietaryName>
    <NonProprietaryName>Amphotericin B, Dimyristoylphosphatidylcholine, Dl- And Dimyristoylphosphatidylglycerol, Dl-</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20101018</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA050724</ApplicationNumber>
    <LabelerName>Leadiant Biosciences, Inc.</LabelerName>
    <SubstanceName>AMPHOTERICIN B; DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL-; DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL-</SubstanceName>
    <StrengthNumber>5; 3.4; 1.5</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Lipid-based Polyene Antifungal [EPC], Polyene Antifungal [EPC], Polyenes [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-09-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20101018</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ABELCET ®is indicated for the treatment of invasive fungal infections in patients who are refractory to or intolerant of conventional amphotericin B therapy. This is based on open-label treatment of patients judged by their physicians to be intolerant to or failing conventional amphotericin B therapy (See DESCRIPTION OF CLINICAL STUDIES). DESCRIPTION OF CLINICAL STUDIES. Fungal Infections. Data from 473 patients were pooled from three open-label studies in which ABELCET ®was provided for the treatment of patients with invasive fungal infections who were judged by their physicians to be refractory to or intolerant of conventional amphotericin B, or who had preexisting nephrotoxicity. Results of these studies demonstrated effectiveness of ABELCET ®in the treatment of invasive fungal infections as a second line therapy. Patients were defined by their individual physician as being refractory to or failing conventional amphotericin B therapy based on overall clinical judgement after receiving a minimum total dose of 500 mg of amphotericin B. Nephrotoxicity was defined as a serum creatinine that had increased to &gt;2.5 mg/dL in adults and &gt;1.5 mg/dL in pediatric patients, or a creatinine clearance of &lt;25 mL/min while receiving conventional amphotericin B therapy. Of the 473 patients, four were enrolled more than once; each enrollment contributed separately to the denominator. The median age was 39 years (range of &lt;1 to 93 years); 307 patients were male and 166 female. Patients were Caucasian (381, 81%), African-American (41, 9%), Hispanic (27, 6%), Asian (10, 2%), and various other races (14, 3%). The median baseline neutrophil count was 4,000 PMN/mm3; of these, 101 (21%) had a baseline neutrophil count &lt;500/mm 3. Two-hundred eighty-two patients of the 473 patients were considered evaluable for response to therapy; the other 191 patients were excluded on the basis of unconfirmed diagnosis, confounding factors, concomitant systemic antifungal therapy, or receiving 4 doses or less of ABELCET ®. For evaluable patients, the following fungal infections were treated (n=282): aspergillosis (n=111), candidiasis (n=87), zygomycosis (n=25), cryptococcosis (n=16), and fusariosis (n=11). There were fewer than 10 evaluable patients for each of several other fungal species treated. For each type of fungal infection listed above there were some patients successfully treated. However, in the absence of controlled studies it is unknown how response would have compared to either continuing conventional amphotericin B therapy or the use of alternative antifungal agents. Renal Function:Patients with aspergillosis who initiated treatment with ABELCET ®when serum creatinine was above 2.5 mg/dL experienced a decline in serum creatinine during treatment (Figure 1). Serum creatinine levels were also lower during treatment with ABELCET ®when compared to the serum creatinine levels of patients treated with conventional amphotericin B in a retrospective historical control study. Meaningful statistical testing of the differences between these two groups is precluded since these data were obtained from two separate studies. [ ]= Number of patients at each time point. Note: These curves do not represent the clinical course of a given patient, but that of an open-label cohort of patients. [ ]= Number of patients at each time point. Note: These curves do not represent the clinical course of a given patient, but that of an open-label cohort of patients. In a randomized study of ABELCET ®for the treatment of invasive candidiasis in patients with normal baseline renal function, the incidence of nephrotoxicity was significantly less for ABELCET ®at a dose of 5 mg/kg/day than for conventional amphotericin B at a dose of 0.7 mg/kg/day. Despite generally less nephrotoxicity of ABELCET ®observed at a dose of 5 mg/kg/day compared with conventional amphotericin B therapy at a dose range of 0.6-1 mg/kg/day, dose-limiting renal toxicity may still be observed with ABELCET ®. Renal toxicity of doses greater than 5 mg/kg/day of ABELCET ®has not been formally studied.</IndicationAndUsage>
    <Description>ABELCET ®is a sterile, pyrogen-free suspension for intravenous infusion. ABELCET ®consists of amphotericin B complexed with two phospholipids in a 1:1 drug-to-lipid molar ratio. The two phospholipids, l-α-dimyristoylphosphatidylcholine (DMPC) and l-α-dimyristoylphosphatidylglycerol (DMPG), are present in a 7:3 molar ratio. ABELCET ®is yellow and opaque in appearance, with a pH of 5 - 7. NOTE: Liposomal encapsulation or incorporation in a lipid complex can substantially affect a drug’s functional properties relative to those of the unencapsulated or nonlipid-associated drug. In addition, different liposomal or lipid-complexed products with a common active ingredient may vary from one another in the chemical composition and physical form of the lipid component. Such differences may affect functional properties of these drug products. Amphotericin B is a polyene, antifungal antibiotic produced from a strain of Streptomyces nodosus. Amphotericin B is designated chemically as [1R-(1R*, 3S*, 5R*, 6R*, 9R*, 11R*, 15S*, 16R*, 17R*, 18S*, 19E, 21E, 23E, 25E, 27E, 29E, 31E, 33R*, 35S*, 36R*, 37S*)]-33-[(3-Amino-3, 6-dideoxy- β-D-mannopyranosyl) oxy]-1,3,5,6,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-14,39-dioxabicyclo[33.3.1] nonatriaconta-19, 21, 23, 25, 27, 29, 31-heptaene-36-carboxylic acid. It has a molecular weight of 924.09 and a molecular formula of C 47H 73NO 17. The structural formula is:. ABELCET ®is provided as a sterile, opaque suspension in 20 mL glass, single-use vials. Each 20 mL vial contains 100 mg of amphotericin B in 20 mL of suspension (see DOSAGE AND ADMINISTRATION), and each mL of ABELCET ®contains:. Amphotericin B USP 5.0 mg. l-α-dimyristoylphosphatidylcholine (DMPC) 3.4 mg. l-α-dimyristoylphosphatidylglycerol (DMPG) 1.5 mg. Sodium Chloride USP 9.0 mg. Water for Injection USP, q.s. 1.0 mL. MICROBIOLOGY. Mechanism of Action. The active component of ABELCET ®, amphotericin B, acts by binding to sterols in the cell membrane of susceptible fungi, with a resultant change in the permeability of the membrane. Mammalian cell membranes also contain sterols, and damage to human cells is believed to occur through the same mechanism of action. Activity in vitroand in vivo. ABELCET ®shows in vitro activity against Aspergillussp. (n=3) and Candidasp. (n=10), with MICs generally &lt;1 μg/mL. Depending upon the species and strain of Aspergillusand Candidatested, significant in vitrodifferences in susceptibility to amphotericin B have been reported (MICs ranging from 0.1 to &gt;10 μg/mL). ABELCET ®is active in animal models against Aspergillus fumigatus, Candida albicans, C. guillermondii, C. stellatoideae, and C. tropicalis, Cryptococcussp., Coccidioidomycessp., Histoplasmasp., and Blastomycessp. in which end-points were clearance of microorganisms from target organ(s) and/or prolonged survival of infected animals. Drug Resistance. Fungal species with decreased susceptibility to amphotericin B have been isolated after serial passage in culture media containing the drug, and from some patients receiving prolonged therapy. Although the relevance of drug resistance to clinical outcome has not been established, fungal species which are resistant to amphotericin B may also be resistant to ABELCET ®. Susceptibility Testing. For specific information regarding susceptibility test interpretive criteria, and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC.</Description>
  </NDC>
  <NDC>
    <NDCCode>64406-101-01</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (64406-101-01)  / 1.7 mL in 1 VIAL</PackageDescription>
    <NDC11Code>64406-0101-01</NDC11Code>
    <ProductNDC>64406-101</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Aduhelm</ProprietaryName>
    <NonProprietaryName>Aducanumab</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20210607</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761178</ApplicationNumber>
    <LabelerName>Biogen Inc.</LabelerName>
    <SubstanceName>ADUCANUMAB</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Amyloid Beta-directed Antibody Interactions [MoA], Amyloid Beta-directed Antibody [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-11-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210607</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ADUHELM is indicated for the treatment of Alzheimer's disease. Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with ADUHELM [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).</IndicationAndUsage>
    <Description>Aducanumab-avwa is a recombinant human immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta, and is expressed in a Chinese hamster ovary cell line. Aducanumab-avwa has an approximate molecular weight of 146 kDa. ADUHELM (aducanumab-avwa) injection is a preservative-free, sterile, clear to opalescent, and colorless to yellow solution for intravenous infusion after dilution supplied in single-dose vials available in concentrations of 170 mg/1.7 mL (100 mg/mL) or 300 mg/3 mL (100 mg/mL) of ADUHELM. Each mL of solution contains 100 mg of aducanumab-avwa and L-arginine hydrochloride (31.60 mg), L-histidine (0.60 mg), L-histidine hydrochloride monohydrate (3.39 mg), L-methionine (1.49 mg), polysorbate 80 (0.50 mg), and Water for Injection at an approximate pH of 5.5.</Description>
  </NDC>
  <NDC>
    <NDCCode>69980-101-03</NDCCode>
    <PackageDescription>60 mL in 1 BOTTLE, PLASTIC (69980-101-03) </PackageDescription>
    <NDC11Code>69980-0101-03</NDC11Code>
    <ProductNDC>69980-101</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>65% Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200520</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Shandong Vianor Healthy Science Co., Ltd.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>39</StrengthNumber>
    <StrengthUnit>mL/60mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200520</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hand sanitizer to help reduce bacteria on the skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>70114-101-01</NDCCode>
    <PackageDescription>1 SYRINGE in 1 CARTON (70114-101-01)  / .6 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>70114-0101-01</NDC11Code>
    <ProductNDC>70114-101</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Udenyca</ProprietaryName>
    <NonProprietaryName>Pegfilgrastim-cbqv</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20181102</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761039</ApplicationNumber>
    <LabelerName>Coherus Oncology, Inc.</LabelerName>
    <SubstanceName>PEGFILGRASTIM</SubstanceName>
    <StrengthNumber>6</StrengthNumber>
    <StrengthUnit>mg/.6mL</StrengthUnit>
    <Pharm_Classes>Granulocyte Colony-Stimulating Factor [CS], Increased Myeloid Cell Production [PE], Leukocyte Growth Factor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181102</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>UDENYCA is a leukocyte growth factor indicated to : 1 Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. (1.1), 2 Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome). (1.2).</IndicationAndUsage>
    <Description>Pegfilgrastim-cbqv is a covalent conjugate of recombinant methionyl human G-CSF and monomethoxypolyethylene glycol. Recombinant methionyl human G-CSF is a water-soluble, 175 amino acid protein with a molecular weight of approximately 19 kilodaltons (kDa). Recombinant methionyl human G-CSF is obtained from the bacterial fermentation of a strain of E coli transformed with a genetically engineered plasmid containing the human G-CSF gene. During the pegfilgrastim-cbqv manufacturing process, fermentation is carried out in nutrient medium containing the antibiotic kanamycin. However, kanamycin is cleared in the manufacturing process and is not detectable in the final product. To produce pegfilgrastim-cbqv, a 20 kDa monomethoxypolyethylene glycol molecule is covalently bound to the N-terminal methionyl residue of recombinant methionyl human G-CSF. The average molecular weight of pegfilgrastim-cbqv is approximately 39 kDa. UDENYCA (pegfilgrastim-cbqv) injection is provided in three presentations: 1 UDENYCA for manual subcutaneous injection is supplied in 0.6 mL prefilled syringes. The prefilled syringe does not bear graduation marks and is designed to deliver the entire contents of the syringe (6 mg/0.6 mL)., 2 UDENYCA for subcutaneous injection is supplied in a 0.6 mL prefilled single-dose autoinjector. The prefilled autoinjector delivers the entire contents (6 mg in 0.6mL) in a single injection and is not adjustable., 3 On-body injector (OBI) for UDENYCA is supplied with a prefilled syringe containing 0.67 mL of UDENYCA in solution that delivers 0.6 mL of UDENYCA in solution when used with the OBI for UDENYCA. The syringe does not bear graduation marks and is only to be used with the OBI for UDENYCA.</Description>
  </NDC>
  <NDC>
    <NDCCode>76519-1154-1</NDCCode>
    <PackageDescription>100 TABLET in 1 CONTAINER (76519-1154-1) </PackageDescription>
    <NDC11Code>76519-1154-01</NDC11Code>
    <ProductNDC>76519-1154</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Benzphetamine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Benzphetamine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170607</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090968</ApplicationNumber>
    <LabelerName>H. J. Harkins Company Inc.</LabelerName>
    <SubstanceName>BENZPHETAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
    <DEASchedule>CIII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Benzphetamine Hydrochloride Tablets are indicated in the management of exogenous obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m2 or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds ÷2.2 = kg; inches × 0.0254 = meters. The limited usefulness of agents of this class (See CLINICAL PHARMACOLOGY) should be weighed against possible risks inherent in their use such as those described below. BODY MASS INDEX (BMI), kg/m2 Weight (pounds) Height (feet, inches) 5'0" 5'3" 5'6". 5'9" 6'0" 6'3" 140 27 25 23 21 19 18 150 29 27 24 22 20 19 160 31 28 26 24 22 20 170 33 30 28 25 23 21 180 35 32 29 27 25 23 190 37 34 31 28 26 24 200 39 36 32 30 27 25 210 41 37 34 31 29 26 220 43 39 36 33 30 28 230 45 41 37 34 31 29 240 47 43 39 36 33 30 250 49 44 40 37 34 31. Benzphetamine Hydrochloride Tablets are indicated for use as monotherapy only.</IndicationAndUsage>
    <Description>Benzphetamine Hydrochloride Tablets contain the anorectic agent benzphetamine hydrochloride. Benzphetamine hydrochloride is a white crystalline powder readily soluble in water and 95% ethanol. The chemical name for benzphetamine hydrochloride is d-N,α-Dimethyl-N -(phenylmethyl)-benzeneethanamine hydrochloride and its molecular weight is 275.82. The structural formula (dextro form) is represented below. Each Benzphetamine Hydrochloride Tablet, for oral administration, contains 50 mg of benzphetamine hydrochloride. Inactive Ingredients: carnauba wax powder, colloidal silicon dioxide, FD&amp;C red # 40 aluminum lake, FD&amp;C yellow # 6 aluminum lake, lactose monohydrate, macrogol/polyethylene glycol 3350, magnesium stearate, microcrystalline cellulose 101, polyvinyl alcohol – partially hydrolyzed, sodium starch glycolate, talc and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>81333-101-24</NDCCode>
    <PackageDescription>24 SOLUTION in 1 BAG (81333-101-24) </PackageDescription>
    <NDC11Code>81333-0101-24</NDC11Code>
    <ProductNDC>81333-101</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cleanette Antibacterial</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200111</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Harper Hygienics S.A.</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>2.39</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210126</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>73749-102-15</NDCCode>
    <PackageDescription>1500 mL in 1 BOTTLE, PLASTIC (73749-102-15) </PackageDescription>
    <NDC11Code>73749-0102-15</NDC11Code>
    <ProductNDC>73749-102</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200403</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Clear Lakes Products, LLC</LabelerName>
    <SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200403</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>73749-102-75</NDCCode>
    <PackageDescription>750 mL in 1 BOTTLE, PLASTIC (73749-102-75) </PackageDescription>
    <NDC11Code>73749-0102-75</NDC11Code>
    <ProductNDC>73749-102</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200403</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Clear Lakes Products, LLC</LabelerName>
    <SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200403</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0004-0352-39</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (0004-0352-39)  *  4 SYRINGE, GLASS in 1 PACKET &gt; .5 mL in 1 SYRINGE, GLASS *  4 SWAB in 1 PACKET</PackageDescription>
    <NDC11Code>00004-0352-39</NDC11Code>
    <ProductNDC>0004-0352</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pegasys</ProprietaryName>
    <NonProprietaryName>Peginterferon Alfa-2a</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20021016</StartMarketingDate>
    <EndMarketingDate>20150731</EndMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103964</ApplicationNumber>
    <LabelerName>Genentech, Inc.</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2015-08-07</LastUpdate>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>73749-101-39</NDCCode><ProprietaryName>Clear Lakes Products Hand Sanitizer</ProprietaryName><NonProprietaryName>Hand Sanitizer</NonProprietaryName></NDC><NDC><NDCCode>73749-101-29</NDCCode><ProprietaryName>Clear Lakes Products Hand Sanitizer</ProprietaryName><NonProprietaryName>Hand Sanitizer</NonProprietaryName></NDC><NDC><NDCCode>73749-101-59</NDCCode><ProprietaryName>Clear Lakes Products Hand Sanitizer</ProprietaryName><NonProprietaryName>Hand Sanitizer</NonProprietaryName></NDC><NDC><NDCCode>73749-101-99</NDCCode><ProprietaryName>Clear Lakes Products Hand Sanitizer</ProprietaryName><NonProprietaryName>Hand Sanitizer</NonProprietaryName></NDC><NDC><NDCCode>10356-101-39</NDCCode><ProprietaryName>Aquaphor Healing</ProprietaryName><NonProprietaryName>Petrolatum</NonProprietaryName></NDC><NDC><NDCCode>52807-101-39</NDCCode><ProprietaryName>Hand Sanitizer</ProprietaryName><NonProprietaryName>Hand Sanitizer</NonProprietaryName></NDC><NDC><NDCCode>55037-101-39</NDCCode><ProprietaryName>Oxygen</ProprietaryName><NonProprietaryName>Oxygen</NonProprietaryName></NDC><NDC><NDCCode>63940-101-39</NDCCode><ProprietaryName>Harmon Face Values Allergy Relief</ProprietaryName><NonProprietaryName>Loratadine</NonProprietaryName></NDC><NDC><NDCCode>78445-101-39</NDCCode><ProprietaryName>Hand Sanitizer</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>84502-101-39</NDCCode><NonProprietaryName>Semaglutide</NonProprietaryName></NDC><NDC><NDCCode>84643-101-39</NDCCode><NonProprietaryName>Semaglutide</NonProprietaryName></NDC><NDC><NDCCode>0169-2030-11</NDCCode><ProprietaryName>Sogroya</ProprietaryName><NonProprietaryName>Somapacitan-beco</NonProprietaryName></NDC><NDC><NDCCode>0169-2030-90</NDCCode><ProprietaryName>Sogroya</ProprietaryName><NonProprietaryName>Somapacitan-beco</NonProprietaryName></NDC><NDC><NDCCode>0169-2035-11</NDCCode><ProprietaryName>Sogroya</ProprietaryName><NonProprietaryName>Somapacitan-beco</NonProprietaryName></NDC><NDC><NDCCode>0169-2035-90</NDCCode><ProprietaryName>Sogroya</ProprietaryName><NonProprietaryName>Somapacitan-beco</NonProprietaryName></NDC><NDC><NDCCode>0169-2037-11</NDCCode><ProprietaryName>Sogroya</ProprietaryName><NonProprietaryName>Somapacitan-beco</NonProprietaryName></NDC><NDC><NDCCode>0169-2037-90</NDCCode><ProprietaryName>Sogroya</ProprietaryName><NonProprietaryName>Somapacitan-beco</NonProprietaryName></NDC><NDC><NDCCode>33342-101-11</NDCCode><ProprietaryName>Quetiapine Fumarate</ProprietaryName><NonProprietaryName>Quetiapine Fumarate</NonProprietaryName></NDC><NDC><NDCCode>33342-101-12</NDCCode><ProprietaryName>Quetiapine Fumarate</ProprietaryName><NonProprietaryName>Quetiapine Fumarate</NonProprietaryName></NDC><NDC><NDCCode>33342-101-44</NDCCode><ProprietaryName>Quetiapine Fumarate</ProprietaryName><NonProprietaryName>Quetiapine Fumarate</NonProprietaryName></NDC><NDC><NDCCode>44567-101-10</NDCCode><ProprietaryName>Ampicillin</ProprietaryName><NonProprietaryName>Ampicillin</NonProprietaryName></NDC><NDC><NDCCode>57665-101-41</NDCCode><ProprietaryName>Abelcet</ProprietaryName><NonProprietaryName>Amphotericin B, Dimyristoylphosphatidylcholine, Dl- And Dimyristoylphosphatidylglycerol, Dl-</NonProprietaryName></NDC><NDC><NDCCode>64406-101-01</NDCCode><ProprietaryName>Aduhelm</ProprietaryName><NonProprietaryName>Aducanumab</NonProprietaryName></NDC><NDC><NDCCode>69980-101-03</NDCCode><ProprietaryName>Hand Sanitizer</ProprietaryName><NonProprietaryName>65% Alcohol</NonProprietaryName></NDC><NDC><NDCCode>70114-101-01</NDCCode><ProprietaryName>Udenyca</ProprietaryName><NonProprietaryName>Pegfilgrastim-cbqv</NonProprietaryName></NDC><NDC><NDCCode>76519-1154-1</NDCCode><ProprietaryName>Benzphetamine Hydrochloride</ProprietaryName><NonProprietaryName>Benzphetamine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>81333-101-24</NDCCode><ProprietaryName>Cleanette Antibacterial</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>73749-102-15</NDCCode><ProprietaryName>Hand Sanitizer</ProprietaryName><NonProprietaryName>Isopropyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>73749-102-75</NDCCode><ProprietaryName>Hand Sanitizer</ProprietaryName><NonProprietaryName>Isopropyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>0004-0352-39</NDCCode><ProprietaryName>Pegasys</ProprietaryName><NonProprietaryName>Peginterferon Alfa-2a</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

This document is intended for developers who want to write applications that can interact with the DataLabs REST API. With DataLabs Web Services, you can create a customized services for your own website or application. You can use the REST API to retrieve DataLabs Web Services results programmatically.

Important: The REST API requires the use of an API key, which you can get from the DataLabs MyAccount Console.

Working With DataLabs REST API

You can retrieve results for a particular operation (search, getcode, etc) by sending an HTTP GET request to its URI.
For instance, the URI for a “search” request has the following format:

https://www.datalabs.health/api/{domain}/{operation}?q={query}&rt={result type}&token={token}

If the request succeeds, the server responds with a 200 OK HTTP status code and the response data.

Four parameters are required with each “search” request:

• Use the domain parameter to specify required data domain.
• Use the operation parameter to specify “format_check” operation.
• Use the q (query) parameter to specify your query.
• Use the token (API key) query parameter to identify your application.

Optional parameter:

• Use the rt (result type) parameter to specify required result type (json/xml/min.json/min.xml).

All other query parameters (if any) are optional.

Full list of API parameters:

• Use the domain parameter to specify required data domain.
• Use the operation parameter to specify “format_check” operation.
• Use the q (query) parameter to specify your query.
• Use the token (API key) query parameter to identify your application.
• Use the tin (tin number) parameter to specify your query about tin number.
• Use the tinname (tin name) parameter to specify your query about tin name.
• Use the zipcode (zip code) parameter to specify your query about zip code.
• Use the radius (radius) parameter to specify your query about radius.
• Use the fromdate (fromdate) parameter to specify your query about from date.
• Use the todate (todate) parameter to specify your query about to date.

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

• check_status — this method allows to get current code status.
• getcode — this method allows retrieval of full infrormation regarding one item based on the provided key.
• getcodes — this method allows retrieval of full infrormation regarding number of items based on the provided keys (q=1285636522,1730198755,1427145176,1487730636).
• search — allows retrieval of set of items based on the free-form lookup query.
• search_and_keywords — returns not only free-form lookup results but also keywords relevant to the original query.

Plus there are three NPI-specific operations:

• validate — allows to determine whether provider's information is valid based on data in the CMS database.
• paginate_with_predicates — provides server side data pagination using sorting and ordering criteria.
• search_with_predicates — this method is a "blend" of free text search and traditional prdeicate-based data selection.
• zipradius — allows to get npis by zipcode & radius.
• npideactivated — allows to get deactivated npis between two dates.

REST Search Examples

Query Parameter Reference

The query parameters you can use with the DataLabs REST API are summarized in the following table.
All parameter values need to be URL encoded.

Use Case #1 - I Need to Find Healthcare Provider (Doctor or Orgranization) Having Just Partial Information

So, you have to find healthcare provider having just partial information. For instance all you have is "EYE doctor RANIA in REDMOND". Strictly speaking, it is necessary to perform a search with minimum information and the maximum level of relevance of the result.

Coding example below demonstrates simplest implementation in C# language. By default DataLabs full text search API returns 30 results and, as you may see below, the first result in the list is "REDMOND EYE DOCTORS, PLLC" where dr. Rania Montecillo specified an owner.

Feel free to use and modify this code to find doctors you may know. If you provide more or less meaningfull information you will be pleasantly surprised to see them in the search results.

            
//--------------------------------------------------------------------------------------
// Fulltext search on NPI registry. Perform "search" operation to get most relevant results.
//--------------------------------------------------------------------------------------
using System;
using System.Net.Http;
using System.Threading.Tasks;

public class Program
{
    private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

    static async Task Main(string[] args)
    {
        string endPoint = $"https://www.datalabs.health/api/npi/search?q=EYE%20RANIA%20REDMOND&token={token}";
        using HttpClient client = new HttpClient();
        string response = await client.GetStringAsync(endPoint);

        Console.WriteLine(response);

        Console.WriteLine("Done. Press any key to exit ...");
        Console.ReadKey();
    }
}
            
        

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/04/2006",
      "LastUpdateDate": "12/11/2007",
      "AuthorizedOfficialLastName": "MONTECILLO",
      "AuthorizedOfficialFirstName": "RANIA",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-7363",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "801TX",
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      "LicenseNumber1": "000260",
      "LicenseNumberStateCode1": "CT",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

Use Case #2 - I Need to Find Detailed Healthcare Provider Information Using Known NPI Number

This is very common scenario. You need to get full replica of NPI record. Again, it simple. Just use code provided below. API response may contain single NPI record, or empty list in case NPI does not exist in the CMS National Plan and Provider Enumeration System (NPPES) Registry.

                
    //--------------------------------------------------------------------------------------
    // Perform "getcode" operation to get healthcare provider information using NPI number.
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/getcode?q=1285636522&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
    {
      "NPI": [
        {
          "NPI": "1285636522",
          "EntityType": "Organization",
          "EIN": "N/A",
          "IsOrgSubpart": "N",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER, INC",
          "FirstLineMailingAddress": "PO BOX 418283",
          "MailingAddressCityName": "BOSTON",
          "MailingAddressStateName": "MA",
          "MailingAddressPostalCode": "02241-8283",
          "MailingAddressCountryCode": "US",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400",
          "EnumerationDate": "06/01/2005",
          "LastUpdateDate": "11/25/2011",
          "AuthorizedOfficialLastName": "SCHNEIDER",
          "AuthorizedOfficialFirstName": "STEPHANIE",
          "AuthorizedOfficialTitle": "VP",
          "AuthorizedOfficialTelephoneNumber": "703-558-1403",
          "TaxonomyCode1": "207R00000X",
          "Taxonomy1": "Internal Medicine",
          "LicenseNumber1": "=========",
          "LicenseNumberStateCode1": "DC",
          "PrimaryTaxonomySwitch1": "Y",
          "OtherIdentifier1": "W677",
          "OtherIdentifierType1": "OTHER",
          "OtherIdentifierState1": "DC",
          "OtherIdentifierIssuer1": "BLUE SHIELD ADULT PCP GRP",
          "OtherIdentifier2": "027174100",
          "OtherIdentifierType2": "MEDICAID",
          "OtherIdentifierState2": "DC",
          "OtherIdentifier3": "097005100",
          "OtherIdentifierType3": "MEDICAID",
          "OtherIdentifierState3": "MD",
          "OtherIdentifier4": "442AGE",
          "OtherIdentifierType4": "OTHER",
          "OtherIdentifierState4": "MD",
          "OtherIdentifierIssuer4": "BLUE SHIELD PEDS PCP GRP#",
          "OtherIdentifier5": "6572",
          "OtherIdentifierType5": "OTHER",
          "OtherIdentifierState5": "DC",
          "OtherIdentifierIssuer5": "BLUE SHIELD GROUP NUMBER",
          "OtherIdentifier6": "W675",
          "OtherIdentifierType6": "OTHER",
          "OtherIdentifierState6": "DC",
          "OtherIdentifierIssuer6": "BLUE SHIELD PEDS PCP GRP#",
          "HealthcareProviderTaxonomyGroup1": "193200000X MULTI-SPECIALTY GROUP",
          "HealthcareProviderTaxonomyGroupDescription1": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
        }
      ]
    }
    Done. Press any key to exit ...
                
            

Use Case #3 - I Need to Get Multiple Healthcare Providers Using List of NPI Numbers

You may need to perform bulk search for performance optimization. The "getcodes" operation allows you to decrease number of round trips in orders of magnitude. For instance you can get information about hundred NPI in one REST call, instead of sending NPI numbers one-by-one.

                
    //--------------------------------------------------------------------------------------
    // Perform "getcodes" operation to get multiple healthcare providers using list of NPIs. 
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/getcodes?q=1285636522,1730198755,1427145176&rt=minjson&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
    {
      "NPI": [
        {
          "NPI": "1285636522",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER, INC",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400"
        },
        {
          "NPI": "1730198755",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400"
        },
        {
          "NPI": "1427145176",
          "OrgName": "MEDSTAR - GEORGETOWN MEDICAL CENTER, INC.",
          "OtherOrgName": "GEORGETOWN UNIVERSITY HOSPITAL",
          "OtherOrgNameTypeCode": "3",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD., NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "202-444-3000",
          "PracticeLocationAddressFaxNumber": "202-444-3095"
        }
      ]
    }
    Done. Press any key to exit ...
                
            

Use Case #4 - I Need to Check NPI Number Status

Again, very common scenario. You just need to check NPI number status. It is simple. Take a look at the code below. Expected result contains requested NPI number, status, and short status description.

                
    //--------------------------------------------------------------------------------------
    // Perform "check_status" operation to get NPI Number status (active, deactivated, etc).
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/check_status?q=1285636522&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
    {
      "Code": "1285636522",
      "Status": "Active",
      "Message": "\"1285636522\" NPI Number does exist and has \"active\" status"
    }
                
    Done. Press any key to exit ...
                
            

Use Case #5 - I need to retrieve a list of healthcare providers based on specified search parameters.

The system allows users to retrieve a list of healthcare providers by filtering on specified fields (e.g., organization name, state, city, ZIP code, etc.). The example below demonstrates how to retrieve all providers with a specified city, state, and ZIP code.

                
    //--------------------------------------------------------------------------------------
    // Perform "search_with_predicates" operation to get multiple healthcare providers using specified city, state, and ZIP code. 
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/search_with_predicates?q=&qf=City:true:REDMOND&qf=State:true:OR&qf=Zip:true:97756-9069&rt=json&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
{
  "NPI": [
    {
      "NPI": "1083349906",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "STAFFORD",
      "FirstName": "KADY",
      "NamePrefix": "MS.",
      "Credential": "LPC",
      "FirstLineMailingAddress": "13574 SW HIGHWAY 126",
      "MailingAddressCityName": "POWELL BUTTE",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97753-1541",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-480-6360",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-203-0307",
      "EnumerationDate": "07/24/2022",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional Counselor",
      "LicenseNumber1": "LPC6225",
      "LicenseNumberStateCode1": "ID",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C9084",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1215724679",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "SCHAY",
      "FirstName": "ANGELICA",
      "MiddleName": "NICOLE",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1841",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1841",
      "EnumerationDate": "04/21/2025",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101Y00000X",
      "Taxonomy1": "Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101Y00000X",
      "PrimaryTaxonomy": "Counselor"
    },
    {
      "NPI": "1013556505",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "IVENS",
      "FirstName": "KRYSTA",
      "FirstLineMailingAddress": "743 NW QUINCE AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-1250",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "360-526-1448",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "971-217-6150",
      "EnumerationDate": "12/31/2019",
      "LastUpdateDate": "02/15/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C7963",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "02/15/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1497336275",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ARANT",
      "FirstName": "ERIN",
      "MiddleName": "HENNESSEY",
      "FirstLineMailingAddress": "4639 SW 37TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-6776",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "04/14/2021",
      "LastUpdateDate": "04/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "225X00000X",
      "Taxonomy1": "Occupational Therapist",
      "LicenseNumber1": "390047",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/14/2021",
      "PrimaryTaxonomyCode": "225X00000X",
      "PrimaryTaxonomy": "Occupational Therapist"
    },
    {
      "NPI": "1174191407",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "GRIMALT",
      "FirstName": "EUGENIA",
      "MiddleName": "N",
      "Credential": "PT",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "06/14/2021",
      "LastUpdateDate": "06/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "2251P0200X",
      "Taxonomy1": "Pediatric Physical Therapist",
      "LicenseNumber1": "63979",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization.",
      "CertificationDate": "06/14/2021",
      "PrimaryTaxonomyCode": "2251P0200X",
      "PrimaryTaxonomy": "Pediatric Physical Therapist"
    },
    {
      "NPI": "1912604117",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "PAINTER",
      "FirstName": "JENNIFER",
      "FirstLineMailingAddress": "20080 DOANNA WAY UNIT 3",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-2931",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "209-743-9813",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/08/2023",
      "LastUpdateDate": "02/08/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/08/2023",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1396434700",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "GROVE",
      "FirstName": "JENNIFER",
      "MiddleName": "RHEA",
      "FirstLineMailingAddress": "303 NW BROADWAY ST",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97703-2658",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "801-573-6047",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "801-573-6047",
      "EnumerationDate": "05/02/2023",
      "LastUpdateDate": "05/02/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1041C0700X",
      "Taxonomy1": "Clinical Social Worker",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "05/02/2023",
      "PrimaryTaxonomyCode": "1041C0700X",
      "PrimaryTaxonomy": "Clinical Social Worker"
    },
    {
      "NPI": "1407698970",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "REDDEN",
      "FirstName": "SHANNON",
      "Credential": "CHW",
      "OtherLastName": "MCDOUGALL",
      "OtherFirstName": "SHANNON",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2312 NE 5TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8488",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-460-2192",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "PracticeLocationAddressFaxNumber": "541-550-7956",
      "EnumerationDate": "06/06/2024",
      "LastUpdateDate": "06/06/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "172V00000X",
      "Taxonomy1": "Community Health Worker",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "06/06/2024",
      "PrimaryTaxonomyCode": "172V00000X",
      "PrimaryTaxonomy": "Community Health Worker"
    },
    {
      "NPI": "1942022256",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "JACQUOT",
      "FirstName": "SHAYLA",
      "FirstLineMailingAddress": "PO BOX 1397",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97709-1397",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "10/28/2024",
      "LastUpdateDate": "10/28/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "10/26/2024",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1912723131",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "WEIMER",
      "FirstName": "ALAYNA",
      "FirstLineMailingAddress": "2748 NW 19TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-7766",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-499-8292",
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}
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