RESTful Lookup — Test-Drive (2007 – 2026)

Query complete (17 ms elapsed)

{
  "NDC": [
    {
      "NDCCode": "73117-522-23",
      "PackageDescription": "100 mL in 1 CARTON (73117-522-23) ",
      "NDC11Code": "73117-0522-23",
      "ProductNDC": "73117-522",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Nebuclear Md Saline",
      "NonProprietaryName": "Nebuclear Md Saline",
      "DosageFormName": "LIQUID",
      "RouteName": "NASAL",
      "StartMarketingDate": "20260630",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M022",
      "LabelerName": "Blue Echo Care LLC",
      "SubstanceName": "SODIUM CHLORIDE",
      "StrengthNumber": "9",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2026-07-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260630",
      "SamplePackage": "N",
      "IndicationAndUsage": "Moisturizing dry nasal passages and relieves nasal dryness associated with colds, allergies, sinusitis or dry air."
    },
    {
      "NDCCode": "73117-521-23",
      "PackageDescription": "1 mL in 1 BOTTLE, SPRAY (73117-521-23) ",
      "NDC11Code": "73117-0521-23",
      "ProductNDC": "73117-521",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Device - Nebuclear Md Hand-held Rubber Bulb Nebulizer",
      "NonProprietaryName": "Device - Hand-held Rubber Bulb Nebulizer",
      "DosageFormName": "AEROSOL, SPRAY",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20251118",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "Blue Echo Care LLC",
      "SubstanceName": "RACEPINEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "11.25",
      "StrengthUnit": "mg/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2026-03-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20251118",
      "SamplePackage": "N",
      "IndicationAndUsage": "Please consult the use section of the OTC bronchodilator drug label approved for use with this device.",
      "Description": "This device is a non-sterile hand-held rubber bulb nebulizer intended to aerosolize bronchodilators for inhalation. This product is listed and approved for over-the-counter use under Monograph M012. This product contains no active or inactive ingredients."
    },
    {
      "NDCCode": "73117-522-21",
      "PackageDescription": "20 mL in 1 CARTON (73117-522-21) ",
      "NDC11Code": "73117-0522-21",
      "ProductNDC": "73117-522",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Nebuclear Md Saline",
      "NonProprietaryName": "Nebuclear Md Saline",
      "DosageFormName": "LIQUID",
      "RouteName": "NASAL",
      "StartMarketingDate": "20260601",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M022",
      "LabelerName": "Blue Echo Care LLC",
      "SubstanceName": "SODIUM CHLORIDE",
      "StrengthNumber": "9",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2026-07-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260601",
      "SamplePackage": "N",
      "IndicationAndUsage": "Moisturizing dry nasal passages and relieves nasal dryness associated with colds, allergies, sinusitis or dry air."
    },
    {
      "NDCCode": "73117-522-22",
      "PackageDescription": "40 mL in 1 CARTON (73117-522-22) ",
      "NDC11Code": "73117-0522-22",
      "ProductNDC": "73117-522",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Nebuclear Md Saline",
      "NonProprietaryName": "Nebuclear Md Saline",
      "DosageFormName": "LIQUID",
      "RouteName": "NASAL",
      "StartMarketingDate": "20260630",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M022",
      "LabelerName": "Blue Echo Care LLC",
      "SubstanceName": "SODIUM CHLORIDE",
      "StrengthNumber": "9",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2026-07-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260630",
      "SamplePackage": "N",
      "IndicationAndUsage": "Moisturizing dry nasal passages and relieves nasal dryness associated with colds, allergies, sinusitis or dry air."
    },
    {
      "NDCCode": "21749-522-89",
      "PackageDescription": "1200 mL in 1 PACKAGE (21749-522-89) ",
      "NDC11Code": "21749-0522-89",
      "ProductNDC": "21749-522",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Purell Healthcare Healthy Sp 0.5pct Pcmx Antimicrobial Foam",
      "NonProprietaryName": "Chloroxylenol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20170714",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "GOJO Industries, Inc.",
      "SubstanceName": "CHLOROXYLENOL",
      "StrengthNumber": ".005",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-12-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20170714",
      "SamplePackage": "N",
      "IndicationAndUsage": "Handwash to help reduce bacteria on the skin. Recommended for repeated use."
    },
    {
      "NDCCode": "21749-522-90",
      "PackageDescription": "1250 mL in 1 PACKAGE (21749-522-90) ",
      "NDC11Code": "21749-0522-90",
      "ProductNDC": "21749-522",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Purell Healthcare Healthy Sp 0.5pct Pcmx Antimicrobial Foam",
      "NonProprietaryName": "Chloroxylenol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20170714",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "GOJO Industries, Inc.",
      "SubstanceName": "CHLOROXYLENOL",
      "StrengthNumber": ".005",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-12-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20170714",
      "SamplePackage": "N",
      "IndicationAndUsage": "Handwash to help reduce bacteria on the skin. Recommended for repeated use."
    },
    {
      "NDCCode": "43419-522-02",
      "PackageDescription": "30 mL in 1 BOTTLE (43419-522-02) ",
      "NDC11Code": "43419-0522-02",
      "ProductNDC": "43419-522",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Amorepacific Resort Collection Sun Protection Mist",
      "NonProprietaryName": "Homosalate, Octocrylene, Octisalate, And Avobenzone",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20150213",
      "EndMarketingDate": "20201022",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "AMOREPACIFIC CORPORATION",
      "SubstanceName": "HOMOSALATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE",
      "StrengthNumber": "28000; 18000; 9000; 6000",
      "StrengthUnit": "mg/200mL; mg/200mL; mg/200mL; mg/200mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-10-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20180801",
      "EndMarketingDatePackage": "20201022",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "43419-522-37",
      "PackageDescription": "1 BOTTLE in 1 CARTON (43419-522-37)  > 200 mL in 1 BOTTLE",
      "NDC11Code": "43419-0522-37",
      "ProductNDC": "43419-522",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Amorepacific Resort Collection Sun Protection Mist",
      "NonProprietaryName": "Homosalate, Octocrylene, Octisalate, And Avobenzone",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20150213",
      "EndMarketingDate": "20201022",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "AMOREPACIFIC CORPORATION",
      "SubstanceName": "HOMOSALATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE",
      "StrengthNumber": "28000; 18000; 9000; 6000",
      "StrengthUnit": "mg/200mL; mg/200mL; mg/200mL; mg/200mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-10-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20180801",
      "EndMarketingDatePackage": "20201022",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "50242-014-03",
      "PackageDescription": "1 KIT in 1 CARTON (50242-014-03)  *  1 VIAL, SINGLE-USE in 1 CARTON (50242-009-01)  / 5 mL in 1 VIAL, SINGLE-USE *  1 VIAL, SINGLE-USE in 1 CARTON (50242-907-01)  / 5.2 mL in 1 VIAL, SINGLE-USE",
      "NDC11Code": "50242-0014-03",
      "ProductNDC": "50242-014",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tnkase",
      "NonProprietaryName": "Tenecteplase",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20250228",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103909",
      "LabelerName": "Genentech, Inc.",
      "Status": "Active",
      "LastUpdate": "2025-12-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250228",
      "SamplePackage": "N",
      "IndicationAndUsage": "TNKase is a tissue plasminogen activator (tPA) indicated: 1 for the treatment of acute ischemic stroke (AIS) in adults. (1.1), 2 to reduce the risk of death associated with acute ST elevation myocardial infarction (STEMI) in adults. (1.2).",
      "Description": "Tenecteplase is a tissue plasminogen activator (tPA) produced by recombinant DNA technology using a mammalian cell line (Chinese Hamster Ovary cells). Tenecteplase is a 527-amino acid glycoprotein developed by introducing the following modifications to the complementary DNA (cDNA) for natural human tPA: a substitution of threonine 103 with asparagine, and a substitution of asparagine 117 with glutamine, both within the kringle 1 domain, and a tetra-alanine substitution at amino acids 296–299 in the protease domain. It has a molecular weight of 58,742 daltons. Biological potency is determined by an in vitro clot lysis assay and is expressed in tenecteplase specific units. The specific activity of tenecteplase has been defined as 200 units/mg. TNKase (tenecteplase) for injection is a sterile, white to pale yellow, lyophilized powder for intravenous bolus administration after reconstitution with Sterile Water for Injection, USP. Each 25 mg single-dose vial of TNKase nominally contains 25 mg of tenecteplase, arginine (261 mg), phosphoric acid (approximately 80 mg), and polysorbate 20 (2.0 mg). Following reconstitution with the supplied 5.2 mL single-dose vial of Sterile Water for Injection, USP, the final concentration is 5 mg/mL with a pH of approximately 7.3. Each 50 mg single-dose vial of TNKase nominally contains 50 mg of tenecteplase, arginine (522 mg), phosphoric acid (approximately 160 mg), and polysorbate 20 (4.0 mg). Following reconstitution with the supplied 10 mL single-dose vial of Sterile Water for Injection, USP, the final concentration is 5 mg/mL with a pH of approximately 7.3."
    },
    {
      "NDCCode": "50242-176-01",
      "PackageDescription": "1 KIT in 1 CARTON (50242-176-01)  *  1 VIAL, SINGLE-USE in 1 CARTON (50242-037-06)  / 10 mL in 1 VIAL, SINGLE-USE *  1 VIAL, SINGLE-USE in 1 CARTON (50242-901-09)  / 10 mL in 1 VIAL, SINGLE-USE",
      "NDC11Code": "50242-0176-01",
      "ProductNDC": "50242-176",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tnkase",
      "NonProprietaryName": "Tenecteplase",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20240105",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103909",
      "LabelerName": "Genentech, Inc.",
      "Status": "Active",
      "LastUpdate": "2025-12-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240105",
      "SamplePackage": "N",
      "IndicationAndUsage": "TNKase is a tissue plasminogen activator (tPA) indicated: 1 for the treatment of acute ischemic stroke (AIS) in adults. (1.1), 2 to reduce the risk of death associated with acute ST elevation myocardial infarction (STEMI) in adults. (1.2).",
      "Description": "Tenecteplase is a tissue plasminogen activator (tPA) produced by recombinant DNA technology using a mammalian cell line (Chinese Hamster Ovary cells). Tenecteplase is a 527-amino acid glycoprotein developed by introducing the following modifications to the complementary DNA (cDNA) for natural human tPA: a substitution of threonine 103 with asparagine, and a substitution of asparagine 117 with glutamine, both within the kringle 1 domain, and a tetra-alanine substitution at amino acids 296–299 in the protease domain. It has a molecular weight of 58,742 daltons. Biological potency is determined by an in vitro clot lysis assay and is expressed in tenecteplase specific units. The specific activity of tenecteplase has been defined as 200 units/mg. TNKase (tenecteplase) for injection is a sterile, white to pale yellow, lyophilized powder for intravenous bolus administration after reconstitution with Sterile Water for Injection, USP. Each 25 mg single-dose vial of TNKase nominally contains 25 mg of tenecteplase, arginine (261 mg), phosphoric acid (approximately 80 mg), and polysorbate 20 (2.0 mg). Following reconstitution with the supplied 5.2 mL single-dose vial of Sterile Water for Injection, USP, the final concentration is 5 mg/mL with a pH of approximately 7.3. Each 50 mg single-dose vial of TNKase nominally contains 50 mg of tenecteplase, arginine (522 mg), phosphoric acid (approximately 160 mg), and polysorbate 20 (4.0 mg). Following reconstitution with the supplied 10 mL single-dose vial of Sterile Water for Injection, USP, the final concentration is 5 mg/mL with a pH of approximately 7.3."
    },
    {
      "NDCCode": "73117-111-05",
      "PackageDescription": "1 mL in 1 BOTTLE (73117-111-05) ",
      "NDC11Code": "73117-0111-05",
      "ProductNDC": "73117-111",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cleanse Right Ear Wax Drops",
      "NonProprietaryName": "Ear Wax Drops",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "IRRIGATION",
      "StartMarketingDate": "20220907",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M014",
      "LabelerName": "Blue Echo Care",
      "SubstanceName": "CARBAMIDE PEROXIDE",
      "StrengthNumber": "65",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-06-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20220907",
      "SamplePackage": "N",
      "IndicationAndUsage": "Directions FOR USE IN THE EAR ONLY. Adults and children over 12 years of age:. Tilt head sideways and place 5 to 10 drops into ear. Tip of applicator should not enter ear canal. Keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear. Use twice daily for up to 4 days if needed, or as directed by a doctor. Any earwax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe. When the ear canal is irrigated, the tip of the ear syringe should not obstruct the flow of water leaving the ear canal. Children under 12 years: consult a doctor."
    },
    {
      "NDCCode": "73117-111-10",
      "PackageDescription": "1 mL in 1 KIT (73117-111-10) ",
      "NDC11Code": "73117-0111-10",
      "ProductNDC": "73117-111",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cleanse Right Ear Wax Drops",
      "NonProprietaryName": "Ear Wax Drops",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "IRRIGATION",
      "StartMarketingDate": "20220907",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M014",
      "LabelerName": "Blue Echo Care",
      "SubstanceName": "CARBAMIDE PEROXIDE",
      "StrengthNumber": "65",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-06-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20220907",
      "SamplePackage": "N",
      "IndicationAndUsage": "Directions FOR USE IN THE EAR ONLY. Adults and children over 12 years of age:. Tilt head sideways and place 5 to 10 drops into ear. Tip of applicator should not enter ear canal. Keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear. Use twice daily for up to 4 days if needed, or as directed by a doctor. Any earwax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe. When the ear canal is irrigated, the tip of the ear syringe should not obstruct the flow of water leaving the ear canal. Children under 12 years: consult a doctor."
    },
    {
      "NDCCode": "73117-111-15",
      "PackageDescription": "1 mL in 1 KIT (73117-111-15) ",
      "NDC11Code": "73117-0111-15",
      "ProductNDC": "73117-111",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cleanse Right Ear Wax Drops",
      "NonProprietaryName": "Ear Wax Drops",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "IRRIGATION",
      "StartMarketingDate": "20220907",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M014",
      "LabelerName": "Blue Echo Care",
      "SubstanceName": "CARBAMIDE PEROXIDE",
      "StrengthNumber": "65",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-06-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20230215",
      "SamplePackage": "N",
      "IndicationAndUsage": "Directions FOR USE IN THE EAR ONLY. Adults and children over 12 years of age:. Tilt head sideways and place 5 to 10 drops into ear. Tip of applicator should not enter ear canal. Keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear. Use twice daily for up to 4 days if needed, or as directed by a doctor. Any earwax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe. When the ear canal is irrigated, the tip of the ear syringe should not obstruct the flow of water leaving the ear canal. Children under 12 years: consult a doctor."
    },
    {
      "NDCCode": "73117-111-70",
      "PackageDescription": "1 mL in 1 BOTTLE (73117-111-70) ",
      "NDC11Code": "73117-0111-70",
      "ProductNDC": "73117-111",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cleanse Right Ear Wax Drops",
      "NonProprietaryName": "Ear Wax Drops",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "IRRIGATION",
      "StartMarketingDate": "20220907",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M014",
      "LabelerName": "Blue Echo Care",
      "SubstanceName": "CARBAMIDE PEROXIDE",
      "StrengthNumber": "65",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-06-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20230115",
      "SamplePackage": "N",
      "IndicationAndUsage": "Directions FOR USE IN THE EAR ONLY. Adults and children over 12 years of age:. Tilt head sideways and place 5 to 10 drops into ear. Tip of applicator should not enter ear canal. Keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear. Use twice daily for up to 4 days if needed, or as directed by a doctor. Any earwax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe. When the ear canal is irrigated, the tip of the ear syringe should not obstruct the flow of water leaving the ear canal. Children under 12 years: consult a doctor."
    },
    {
      "NDCCode": "73117-112-10",
      "PackageDescription": "1 mL in 1 KIT (73117-112-10) ",
      "NDC11Code": "73117-0112-10",
      "ProductNDC": "73117-112",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Caring Mill Ear Wax Drops",
      "NonProprietaryName": "Ear Wax Drops",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "IRRIGATION",
      "StartMarketingDate": "20230101",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M014",
      "LabelerName": "Blue Echo Care",
      "SubstanceName": "CARBAMIDE PEROXIDE",
      "StrengthNumber": "65",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-06-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20240203",
      "SamplePackage": "N",
      "IndicationAndUsage": "Directions FOR USE IN THE EAR ONLY. Adults and children over 12 years of age:. Tilt head sideways and place 5 to 10 drops into ear. Tip of applicator should not enter ear canal. Keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear. Use twice daily for up to 4 days if needed, or as directed by a doctor. Any earwax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe. When the ear canal is irrigated, the tip of the ear syringe should not obstruct the flow of water leaving the ear canal. Children under 12 years: consult a doctor."
    },
    {
      "NDCCode": "73117-112-20",
      "PackageDescription": "2 mL in 1 BOTTLE (73117-112-20) ",
      "NDC11Code": "73117-0112-20",
      "ProductNDC": "73117-112",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Caring Mill Ear Wax Drops",
      "NonProprietaryName": "Ear Wax Drops",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "IRRIGATION",
      "StartMarketingDate": "20230101",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M014",
      "LabelerName": "Blue Echo Care",
      "SubstanceName": "CARBAMIDE PEROXIDE",
      "StrengthNumber": "65",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-06-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20230115",
      "SamplePackage": "N",
      "IndicationAndUsage": "Directions FOR USE IN THE EAR ONLY. Adults and children over 12 years of age:. Tilt head sideways and place 5 to 10 drops into ear. Tip of applicator should not enter ear canal. Keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear. Use twice daily for up to 4 days if needed, or as directed by a doctor. Any earwax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe. When the ear canal is irrigated, the tip of the ear syringe should not obstruct the flow of water leaving the ear canal. Children under 12 years: consult a doctor."
    },
    {
      "NDCCode": "73117-509-01",
      "PackageDescription": "1 mL in 1 BOTTLE, SPRAY (73117-509-01) ",
      "NDC11Code": "73117-0509-01",
      "ProductNDC": "73117-509",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Device - Nebuclear Md Hand-held Rubber Bulb Nebulizer",
      "NonProprietaryName": "Device - Hand-held Rubber Bulb Nebulizer",
      "DosageFormName": "SOLUTION",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20251118",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "Blue Echo Care LLC",
      "SubstanceName": "RACEPINEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "11.25",
      "StrengthUnit": "mg/.5mL",
      "Status": "Active",
      "LastUpdate": "2026-05-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20251118",
      "SamplePackage": "N",
      "IndicationAndUsage": "Please consult the use section of the OTC bronchodilator drug label approved for use with this device.",
      "Description": "This device is a non-sterile hand-held rubber bulb nebulizer intended to aerosolize bronchodilators for inhalation. This product is listed and approved for over-the-counter use under Monograph M012. This product contains no active or inactive ingredients."
    },
    {
      "NDCCode": "73117-518-17",
      "PackageDescription": "30 mL in 1 CARTON (73117-518-17) ",
      "NDC11Code": "73117-0518-17",
      "ProductNDC": "73117-518",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Bec Racepinephrine",
      "NonProprietaryName": "Racepinephrine",
      "DosageFormName": "LIQUID",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20250321",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "Blue Echo Care LLC",
      "SubstanceName": "RACEPINEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "11.25",
      "StrengthUnit": "mg/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2026-03-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250321",
      "SamplePackage": "N",
      "IndicationAndUsage": "For temporary relief of mild symptoms of intermittent asthma. Wheezing Tightness of chest Shortness of breath."
    },
    {
      "NDCCode": "73117-519-17",
      "PackageDescription": "30 mL in 1 CARTON (73117-519-17) ",
      "NDC11Code": "73117-0519-17",
      "ProductNDC": "73117-519",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Nebuclear Md",
      "NonProprietaryName": "Racepinephrine",
      "DosageFormName": "LIQUID",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20250520",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "Blue Echo Care LLC",
      "SubstanceName": "RACEPINEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "11.25",
      "StrengthUnit": "mg/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-07-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250520",
      "SamplePackage": "N",
      "IndicationAndUsage": "For temporary relief of mild symptoms of intermittent asthma. Wheezing Tightness of chest Shortness of breath."
    },
    {
      "NDCCode": "73117-519-18",
      "PackageDescription": "20 mL in 1 BOX (73117-519-18) ",
      "NDC11Code": "73117-0519-18",
      "ProductNDC": "73117-519",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Nebuclear Md",
      "NonProprietaryName": "Racepinephrine",
      "DosageFormName": "LIQUID",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20250920",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "Blue Echo Care LLC",
      "SubstanceName": "RACEPINEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "11.25",
      "StrengthUnit": "mg/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2026-04-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250920",
      "SamplePackage": "N",
      "IndicationAndUsage": "For temporary relief of mild symptoms of intermittent asthma. Wheezing Tightness of chest Shortness of breath."
    },
    {
      "NDCCode": "73117-520-19",
      "PackageDescription": "20 mg in 1 BOX (73117-520-19) ",
      "NDC11Code": "73117-0520-19",
      "ProductNDC": "73117-520",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Nebuclear Md",
      "NonProprietaryName": "Saline",
      "DosageFormName": "LIQUID",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20250901",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "Blue Echo Care LLC",
      "SubstanceName": "SODIUM CHLORIDE",
      "StrengthNumber": "9",
      "StrengthUnit": "mg/9mg",
      "Status": "Active",
      "LastUpdate": "2026-05-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250901",
      "SamplePackage": "N",
      "IndicationAndUsage": "For moistening of the nasal, throat and lungs."
    },
    {
      "NDCCode": "73117-521-22",
      "PackageDescription": "40 mL in 1 CARTON (73117-521-22) ",
      "NDC11Code": "73117-0521-22",
      "ProductNDC": "73117-521",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Nebuclear Md Saline",
      "NonProprietaryName": "Nebuclear Md Saline",
      "DosageFormName": "LIQUID",
      "RouteName": "NASAL",
      "StartMarketingDate": "20260630",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M022",
      "LabelerName": "Blue Echo Care LLC",
      "SubstanceName": "SODIUM CHLORIDE",
      "StrengthNumber": "6.5",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2026-07-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260630",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "73117-523-18",
      "PackageDescription": "20 mL in 1 BOX (73117-523-18) ",
      "NDC11Code": "73117-0523-18",
      "ProductNDC": "73117-523",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Nebuclear Md",
      "NonProprietaryName": "Racepinephrine Hydrochloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20251118",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "Blue Echo Care LLC",
      "SubstanceName": "RACEPINEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "11.25",
      "StrengthUnit": "mg/.5mL",
      "Status": "Active",
      "LastUpdate": "2026-05-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20251118",
      "SamplePackage": "N",
      "IndicationAndUsage": "For temporary relief of mild symptoms of intermittent asthma. Wheezing Tightness of chest Shortness of breath."
    },
    {
      "NDCCode": "73117-523-19",
      "PackageDescription": "40 mL in 1 BOX (73117-523-19) ",
      "NDC11Code": "73117-0523-19",
      "ProductNDC": "73117-523",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Nebuclear Md",
      "NonProprietaryName": "Racepinephrine Hydrochloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20260501",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "Blue Echo Care LLC",
      "SubstanceName": "RACEPINEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "11.25",
      "StrengthUnit": "mg/.5mL",
      "Status": "Active",
      "LastUpdate": "2026-05-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260501",
      "SamplePackage": "N",
      "IndicationAndUsage": "For temporary relief of mild symptoms of intermittent asthma. Wheezing Tightness of chest Shortness of breath."
    },
    {
      "NDCCode": "0009-7667-01",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (0009-7667-01)  / 3 SUPPOSITORY in 1 BLISTER PACK",
      "NDC11Code": "00009-7667-01",
      "ProductNDC": "0009-7667",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cleocin",
      "NonProprietaryName": "Clindamycin Phosphate",
      "DosageFormName": "SUPPOSITORY",
      "RouteName": "VAGINAL",
      "StartMarketingDate": "19990813",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA050767",
      "LabelerName": "Pharmacia & Upjohn Company LLC",
      "SubstanceName": "CLINDAMYCIN PHOSPHATE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19990813",
      "EndMarketingDatePackage": "20251231",
      "SamplePackage": "N",
      "IndicationAndUsage": "CLEOCIN Vaginal Ovules are indicated for 3-day treatment of bacterial vaginosis in non-pregnant women. There are no adequate and well-controlled studies of CLEOCIN Vaginal Ovules in pregnant women. NOTE: For purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a \"fishy\" amine odor when mixed with a 10% KOH solution, and (c) contains clue cells on microscopic examination. Gram's stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent Lactobacillus morphology, (b) predominance of Gardnerella morphotype, and (c) absent or few white blood cells. Other pathogens commonly associated with vulvovaginitis, e.g., Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans, and herpes simplex virus, should be ruled out.",
      "Description": "Clindamycin phosphate is a water-soluble ester of the semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate is methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). The monohydrate form has a molecular weight of 522.98, and the molecular formula is C18H34ClN2O8PSH2O. The structural formula is represented below. CLEOCIN Vaginal Ovules are semisolid, white to off-white suppositories for intravaginal administration. Each 2.5 g suppository contains clindamycin phosphate equivalent to 100 mg clindamycin in a base consisting of a mixture of glycerides of saturated fatty acids."
    },
    {
      "NDCCode": "0009-7667-05",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (0009-7667-05)  / 3 SUPPOSITORY in 1 BLISTER PACK",
      "NDC11Code": "00009-7667-05",
      "ProductNDC": "0009-7667",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cleocin",
      "NonProprietaryName": "Clindamycin Phosphate",
      "DosageFormName": "SUPPOSITORY",
      "RouteName": "VAGINAL",
      "StartMarketingDate": "20240203",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA050767",
      "LabelerName": "Pharmacia & Upjohn Company LLC",
      "SubstanceName": "CLINDAMYCIN PHOSPHATE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
      "Status": "Active",
      "LastUpdate": "2026-03-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240203",
      "SamplePackage": "N",
      "IndicationAndUsage": "CLEOCIN Vaginal Ovules are indicated for 3-day treatment of bacterial vaginosis in non-pregnant women. There are no adequate and well-controlled studies of CLEOCIN Vaginal Ovules in pregnant women. NOTE: For purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a \"fishy\" amine odor when mixed with a 10% KOH solution, and (c) contains clue cells on microscopic examination. Gram's stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent Lactobacillus morphology, (b) predominance of Gardnerella morphotype, and (c) absent or few white blood cells. Other pathogens commonly associated with vulvovaginitis, e.g., Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans, and herpes simplex virus, should be ruled out.",
      "Description": "Clindamycin phosphate is a water-soluble ester of the semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate is methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). The monohydrate form has a molecular weight of 522.98, and the molecular formula is C18H34ClN2O8PSH2O. The structural formula is represented below. CLEOCIN Vaginal Ovules are semisolid, white to off-white suppositories for intravaginal administration. Each 2.5 g suppository contains clindamycin phosphate equivalent to 100 mg clindamycin in a base consisting of a mixture of glycerides of saturated fatty acids."
    },
    {
      "NDCCode": "0024-5812-07",
      "PackageDescription": "7 TABLET, EXTENDED RELEASE in 1 BOTTLE (0024-5812-07)",
      "NDC11Code": "00024-5812-07",
      "ProductNDC": "0024-5812",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Aplenzin",
      "NonProprietaryName": "Bupropion Hydrobromide",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090330",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022108",
      "LabelerName": "sanofi-aventis U.S. LLC",
      "SubstanceName": "BUPROPION HYDROBROMIDE",
      "StrengthNumber": "522",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2017-02-03",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "0024-5812-30",
      "PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0024-5812-30)",
      "NDC11Code": "00024-5812-30",
      "ProductNDC": "0024-5812",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Aplenzin",
      "NonProprietaryName": "Bupropion Hydrobromide",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090330",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022108",
      "LabelerName": "sanofi-aventis U.S. LLC",
      "SubstanceName": "BUPROPION HYDROBROMIDE",
      "StrengthNumber": "522",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2017-09-01",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "0186-0776-60",
      "PackageDescription": "60 TABLET in 1 BOTTLE (0186-0776-60) ",
      "NDC11Code": "00186-0776-60",
      "ProductNDC": "0186-0776",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Brilinta",
      "NonProprietaryName": "Ticagrelor",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150904",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022433",
      "LabelerName": "AstraZeneca Pharmaceuticals LP",
      "SubstanceName": "TICAGRELOR",
      "StrengthNumber": "60",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P-Glycoprotein Inhibitors [MoA], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-08-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20150904",
      "SamplePackage": "N",
      "IndicationAndUsage": "BRILINTA is a P2Y12 platelet inhibitor indicated: 1 to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel.BRILINTA also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS. (1.1), 2 to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events. While use is not limited to this setting, the efficacy of BRILINTA was established in a population with type 2 diabetes mellitus (T2DM). (1.2), 3 to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score ≤5) or high-risk transient ischemic attack (TIA). (1.3).",
      "Description": "BRILINTA contains ticagrelor, a cyclopentyltriazolopyrimidine, inhibitor of platelet activation and aggregation mediated by the P2Y12 ADP-receptor. Chemically it is (1S,2S,3R,5S)-3-[7-{[(1R,2S)-2-(3,4-difluorophenyl)cyclopropyl]amino}-5-(propylthio)-3H-[1,2,3]-triazolo[4,5-d]pyrimidin-3-yl]-5-(2-hydroxyethoxy)cyclopentane-1,2-diol. The empirical formula of ticagrelor is C23H28F2N6O4S and its molecular weight is 522.57. The chemical structure of ticagrelor is. Ticagrelor is a crystalline powder with an aqueous solubility of approximately 10 μg/mL at room temperature. BRILINTA 90 mg tablets for oral administration contain 90 mg of ticagrelor and the following ingredients: mannitol, dibasic calcium phosphate, sodium starch glycolate, hydroxypropyl cellulose, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, talc, polyethylene glycol 400, and ferric oxide yellow. BRILINTA 60 mg tablets for oral administration contain 60 mg of ticagrelor and the following ingredients: mannitol, dibasic calcium phosphate, sodium starch glycolate, hydroxypropyl cellulose, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, polyethylene glycol 400, ferric oxide black, and ferric oxide red."
    },
    {
      "NDCCode": "0186-0776-94",
      "PackageDescription": "1 BLISTER PACK in 1 BOX, UNIT-DOSE (0186-0776-94)  / 14 TABLET in 1 BLISTER PACK",
      "NDC11Code": "00186-0776-94",
      "ProductNDC": "0186-0776",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Brilinta",
      "NonProprietaryName": "Ticagrelor",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150904",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022433",
      "LabelerName": "AstraZeneca Pharmaceuticals LP",
      "SubstanceName": "TICAGRELOR",
      "StrengthNumber": "60",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P-Glycoprotein Inhibitors [MoA], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2025-06-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20150904",
      "EndMarketingDatePackage": "20250531",
      "SamplePackage": "Y",
      "IndicationAndUsage": "BRILINTA is a P2Y12 platelet inhibitor indicated: 1 to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel.BRILINTA also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS. (1.1), 2 to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events. While use is not limited to this setting, the efficacy of BRILINTA was established in a population with type 2 diabetes mellitus (T2DM). (1.2), 3 to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score ≤5) or high-risk transient ischemic attack (TIA). (1.3).",
      "Description": "BRILINTA contains ticagrelor, a cyclopentyltriazolopyrimidine, inhibitor of platelet activation and aggregation mediated by the P2Y12 ADP-receptor. Chemically it is (1S,2S,3R,5S)-3-[7-{[(1R,2S)-2-(3,4-difluorophenyl)cyclopropyl]amino}-5-(propylthio)-3H-[1,2,3]-triazolo[4,5-d]pyrimidin-3-yl]-5-(2-hydroxyethoxy)cyclopentane-1,2-diol. The empirical formula of ticagrelor is C23H28F2N6O4S and its molecular weight is 522.57. The chemical structure of ticagrelor is. Ticagrelor is a crystalline powder with an aqueous solubility of approximately 10 μg/mL at room temperature. BRILINTA 90 mg tablets for oral administration contain 90 mg of ticagrelor and the following ingredients: mannitol, dibasic calcium phosphate, sodium starch glycolate, hydroxypropyl cellulose, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, talc, polyethylene glycol 400, and ferric oxide yellow. BRILINTA 60 mg tablets for oral administration contain 60 mg of ticagrelor and the following ingredients: mannitol, dibasic calcium phosphate, sodium starch glycolate, hydroxypropyl cellulose, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, polyethylene glycol 400, ferric oxide black, and ferric oxide red."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"73117-522-23","ProprietaryName":"Nebuclear Md Saline","NonProprietaryName":"Nebuclear Md Saline"},{"NDCCode":"73117-521-23","ProprietaryName":"Device - Nebuclear Md Hand-held Rubber Bulb Nebulizer","NonProprietaryName":"Device - Hand-held Rubber Bulb Nebulizer"},{"NDCCode":"73117-522-21","ProprietaryName":"Nebuclear Md Saline","NonProprietaryName":"Nebuclear Md Saline"},{"NDCCode":"73117-522-22","ProprietaryName":"Nebuclear Md Saline","NonProprietaryName":"Nebuclear Md Saline"},{"NDCCode":"21749-522-89","ProprietaryName":"Purell Healthcare Healthy Sp 0.5pct Pcmx Antimicrobial Foam","NonProprietaryName":"Chloroxylenol"},{"NDCCode":"21749-522-90","ProprietaryName":"Purell Healthcare Healthy Sp 0.5pct Pcmx Antimicrobial Foam","NonProprietaryName":"Chloroxylenol"},{"NDCCode":"43419-522-02","ProprietaryName":"Amorepacific Resort Collection Sun Protection Mist","NonProprietaryName":"Homosalate, Octocrylene, Octisalate, And Avobenzone"},{"NDCCode":"43419-522-37","ProprietaryName":"Amorepacific Resort Collection Sun Protection Mist","NonProprietaryName":"Homosalate, Octocrylene, Octisalate, And Avobenzone"},{"NDCCode":"50242-014-03","ProprietaryName":"Tnkase","NonProprietaryName":"Tenecteplase"},{"NDCCode":"50242-176-01","ProprietaryName":"Tnkase","NonProprietaryName":"Tenecteplase"},{"NDCCode":"73117-111-05","ProprietaryName":"Cleanse Right Ear Wax Drops","NonProprietaryName":"Ear Wax Drops"},{"NDCCode":"73117-111-10","ProprietaryName":"Cleanse Right Ear Wax Drops","NonProprietaryName":"Ear Wax Drops"},{"NDCCode":"73117-111-15","ProprietaryName":"Cleanse Right Ear Wax Drops","NonProprietaryName":"Ear Wax Drops"},{"NDCCode":"73117-111-70","ProprietaryName":"Cleanse Right Ear Wax Drops","NonProprietaryName":"Ear Wax Drops"},{"NDCCode":"73117-112-10","ProprietaryName":"Caring Mill Ear Wax Drops","NonProprietaryName":"Ear Wax Drops"},{"NDCCode":"73117-112-20","ProprietaryName":"Caring Mill Ear Wax Drops","NonProprietaryName":"Ear Wax Drops"},{"NDCCode":"73117-509-01","ProprietaryName":"Device - Nebuclear Md Hand-held Rubber Bulb Nebulizer","NonProprietaryName":"Device - Hand-held Rubber Bulb Nebulizer"},{"NDCCode":"73117-518-17","ProprietaryName":"Bec Racepinephrine","NonProprietaryName":"Racepinephrine"},{"NDCCode":"73117-519-17","ProprietaryName":"Nebuclear Md","NonProprietaryName":"Racepinephrine"},{"NDCCode":"73117-519-18","ProprietaryName":"Nebuclear Md","NonProprietaryName":"Racepinephrine"},{"NDCCode":"73117-520-19","ProprietaryName":"Nebuclear Md","NonProprietaryName":"Saline"},{"NDCCode":"73117-521-22","ProprietaryName":"Nebuclear Md Saline","NonProprietaryName":"Nebuclear Md Saline"},{"NDCCode":"73117-523-18","ProprietaryName":"Nebuclear Md","NonProprietaryName":"Racepinephrine Hydrochloride"},{"NDCCode":"73117-523-19","ProprietaryName":"Nebuclear Md","NonProprietaryName":"Racepinephrine Hydrochloride"},{"NDCCode":"0009-7667-01","ProprietaryName":"Cleocin","NonProprietaryName":"Clindamycin Phosphate"},{"NDCCode":"0009-7667-05","ProprietaryName":"Cleocin","NonProprietaryName":"Clindamycin Phosphate"},{"NDCCode":"0024-5812-07","ProprietaryName":"Aplenzin","NonProprietaryName":"Bupropion Hydrobromide"},{"NDCCode":"0024-5812-30","ProprietaryName":"Aplenzin","NonProprietaryName":"Bupropion Hydrobromide"},{"NDCCode":"0186-0776-60","ProprietaryName":"Brilinta","NonProprietaryName":"Ticagrelor"},{"NDCCode":"0186-0776-94","ProprietaryName":"Brilinta","NonProprietaryName":"Ticagrelor"}]}
                    

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<NDCList>
  <NDC>
    <NDCCode>73117-522-23</NDCCode>
    <PackageDescription>100 mL in 1 CARTON (73117-522-23) </PackageDescription>
    <NDC11Code>73117-0522-23</NDC11Code>
    <ProductNDC>73117-522</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Nebuclear Md Saline</ProprietaryName>
    <NonProprietaryName>Nebuclear Md Saline</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>NASAL</RouteName>
    <StartMarketingDate>20260630</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M022</ApplicationNumber>
    <LabelerName>Blue Echo Care LLC</LabelerName>
    <SubstanceName>SODIUM CHLORIDE</SubstanceName>
    <StrengthNumber>9</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-07-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260630</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Moisturizing dry nasal passages and relieves nasal dryness associated with colds, allergies, sinusitis or dry air.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>73117-521-23</NDCCode>
    <PackageDescription>1 mL in 1 BOTTLE, SPRAY (73117-521-23) </PackageDescription>
    <NDC11Code>73117-0521-23</NDC11Code>
    <ProductNDC>73117-521</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Device - Nebuclear Md Hand-held Rubber Bulb Nebulizer</ProprietaryName>
    <NonProprietaryName>Device - Hand-held Rubber Bulb Nebulizer</NonProprietaryName>
    <DosageFormName>AEROSOL, SPRAY</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20251118</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>Blue Echo Care LLC</LabelerName>
    <SubstanceName>RACEPINEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>11.25</StrengthNumber>
    <StrengthUnit>mg/.5mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-03-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251118</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Please consult the use section of the OTC bronchodilator drug label approved for use with this device.</IndicationAndUsage>
    <Description>This device is a non-sterile hand-held rubber bulb nebulizer intended to aerosolize bronchodilators for inhalation. This product is listed and approved for over-the-counter use under Monograph M012. This product contains no active or inactive ingredients.</Description>
  </NDC>
  <NDC>
    <NDCCode>73117-522-21</NDCCode>
    <PackageDescription>20 mL in 1 CARTON (73117-522-21) </PackageDescription>
    <NDC11Code>73117-0522-21</NDC11Code>
    <ProductNDC>73117-522</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Nebuclear Md Saline</ProprietaryName>
    <NonProprietaryName>Nebuclear Md Saline</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>NASAL</RouteName>
    <StartMarketingDate>20260601</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M022</ApplicationNumber>
    <LabelerName>Blue Echo Care LLC</LabelerName>
    <SubstanceName>SODIUM CHLORIDE</SubstanceName>
    <StrengthNumber>9</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-07-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Moisturizing dry nasal passages and relieves nasal dryness associated with colds, allergies, sinusitis or dry air.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>73117-522-22</NDCCode>
    <PackageDescription>40 mL in 1 CARTON (73117-522-22) </PackageDescription>
    <NDC11Code>73117-0522-22</NDC11Code>
    <ProductNDC>73117-522</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Nebuclear Md Saline</ProprietaryName>
    <NonProprietaryName>Nebuclear Md Saline</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>NASAL</RouteName>
    <StartMarketingDate>20260630</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M022</ApplicationNumber>
    <LabelerName>Blue Echo Care LLC</LabelerName>
    <SubstanceName>SODIUM CHLORIDE</SubstanceName>
    <StrengthNumber>9</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-07-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260630</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Moisturizing dry nasal passages and relieves nasal dryness associated with colds, allergies, sinusitis or dry air.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>21749-522-89</NDCCode>
    <PackageDescription>1200 mL in 1 PACKAGE (21749-522-89) </PackageDescription>
    <NDC11Code>21749-0522-89</NDC11Code>
    <ProductNDC>21749-522</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Purell Healthcare Healthy Sp 0.5pct Pcmx Antimicrobial Foam</ProprietaryName>
    <NonProprietaryName>Chloroxylenol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20170714</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>505G(a)(3)</ApplicationNumber>
    <LabelerName>GOJO Industries, Inc.</LabelerName>
    <SubstanceName>CHLOROXYLENOL</SubstanceName>
    <StrengthNumber>.005</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-12-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170714</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Handwash to help reduce bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>21749-522-90</NDCCode>
    <PackageDescription>1250 mL in 1 PACKAGE (21749-522-90) </PackageDescription>
    <NDC11Code>21749-0522-90</NDC11Code>
    <ProductNDC>21749-522</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Purell Healthcare Healthy Sp 0.5pct Pcmx Antimicrobial Foam</ProprietaryName>
    <NonProprietaryName>Chloroxylenol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20170714</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>505G(a)(3)</ApplicationNumber>
    <LabelerName>GOJO Industries, Inc.</LabelerName>
    <SubstanceName>CHLOROXYLENOL</SubstanceName>
    <StrengthNumber>.005</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-12-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170714</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Handwash to help reduce bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>43419-522-02</NDCCode>
    <PackageDescription>30 mL in 1 BOTTLE (43419-522-02) </PackageDescription>
    <NDC11Code>43419-0522-02</NDC11Code>
    <ProductNDC>43419-522</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Amorepacific Resort Collection Sun Protection Mist</ProprietaryName>
    <NonProprietaryName>Homosalate, Octocrylene, Octisalate, And Avobenzone</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20150213</StartMarketingDate>
    <EndMarketingDate>20201022</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>AMOREPACIFIC CORPORATION</LabelerName>
    <SubstanceName>HOMOSALATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE</SubstanceName>
    <StrengthNumber>28000; 18000; 9000; 6000</StrengthNumber>
    <StrengthUnit>mg/200mL; mg/200mL; mg/200mL; mg/200mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-10-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20180801</StartMarketingDatePackage>
    <EndMarketingDatePackage>20201022</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>43419-522-37</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (43419-522-37)  &gt; 200 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>43419-0522-37</NDC11Code>
    <ProductNDC>43419-522</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Amorepacific Resort Collection Sun Protection Mist</ProprietaryName>
    <NonProprietaryName>Homosalate, Octocrylene, Octisalate, And Avobenzone</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20150213</StartMarketingDate>
    <EndMarketingDate>20201022</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>AMOREPACIFIC CORPORATION</LabelerName>
    <SubstanceName>HOMOSALATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE</SubstanceName>
    <StrengthNumber>28000; 18000; 9000; 6000</StrengthNumber>
    <StrengthUnit>mg/200mL; mg/200mL; mg/200mL; mg/200mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-10-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20180801</StartMarketingDatePackage>
    <EndMarketingDatePackage>20201022</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>50242-014-03</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (50242-014-03)  *  1 VIAL, SINGLE-USE in 1 CARTON (50242-009-01)  / 5 mL in 1 VIAL, SINGLE-USE *  1 VIAL, SINGLE-USE in 1 CARTON (50242-907-01)  / 5.2 mL in 1 VIAL, SINGLE-USE</PackageDescription>
    <NDC11Code>50242-0014-03</NDC11Code>
    <ProductNDC>50242-014</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tnkase</ProprietaryName>
    <NonProprietaryName>Tenecteplase</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20250228</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103909</ApplicationNumber>
    <LabelerName>Genentech, Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-12-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250228</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>TNKase is a tissue plasminogen activator (tPA) indicated: 1 for the treatment of acute ischemic stroke (AIS) in adults. (1.1), 2 to reduce the risk of death associated with acute ST elevation myocardial infarction (STEMI) in adults. (1.2).</IndicationAndUsage>
    <Description>Tenecteplase is a tissue plasminogen activator (tPA) produced by recombinant DNA technology using a mammalian cell line (Chinese Hamster Ovary cells). Tenecteplase is a 527-amino acid glycoprotein developed by introducing the following modifications to the complementary DNA (cDNA) for natural human tPA: a substitution of threonine 103 with asparagine, and a substitution of asparagine 117 with glutamine, both within the kringle 1 domain, and a tetra-alanine substitution at amino acids 296–299 in the protease domain. It has a molecular weight of 58,742 daltons. Biological potency is determined by an in vitro clot lysis assay and is expressed in tenecteplase specific units. The specific activity of tenecteplase has been defined as 200 units/mg. TNKase (tenecteplase) for injection is a sterile, white to pale yellow, lyophilized powder for intravenous bolus administration after reconstitution with Sterile Water for Injection, USP. Each 25 mg single-dose vial of TNKase nominally contains 25 mg of tenecteplase, arginine (261 mg), phosphoric acid (approximately 80 mg), and polysorbate 20 (2.0 mg). Following reconstitution with the supplied 5.2 mL single-dose vial of Sterile Water for Injection, USP, the final concentration is 5 mg/mL with a pH of approximately 7.3. Each 50 mg single-dose vial of TNKase nominally contains 50 mg of tenecteplase, arginine (522 mg), phosphoric acid (approximately 160 mg), and polysorbate 20 (4.0 mg). Following reconstitution with the supplied 10 mL single-dose vial of Sterile Water for Injection, USP, the final concentration is 5 mg/mL with a pH of approximately 7.3.</Description>
  </NDC>
  <NDC>
    <NDCCode>50242-176-01</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (50242-176-01)  *  1 VIAL, SINGLE-USE in 1 CARTON (50242-037-06)  / 10 mL in 1 VIAL, SINGLE-USE *  1 VIAL, SINGLE-USE in 1 CARTON (50242-901-09)  / 10 mL in 1 VIAL, SINGLE-USE</PackageDescription>
    <NDC11Code>50242-0176-01</NDC11Code>
    <ProductNDC>50242-176</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tnkase</ProprietaryName>
    <NonProprietaryName>Tenecteplase</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20240105</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103909</ApplicationNumber>
    <LabelerName>Genentech, Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-12-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240105</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>TNKase is a tissue plasminogen activator (tPA) indicated: 1 for the treatment of acute ischemic stroke (AIS) in adults. (1.1), 2 to reduce the risk of death associated with acute ST elevation myocardial infarction (STEMI) in adults. (1.2).</IndicationAndUsage>
    <Description>Tenecteplase is a tissue plasminogen activator (tPA) produced by recombinant DNA technology using a mammalian cell line (Chinese Hamster Ovary cells). Tenecteplase is a 527-amino acid glycoprotein developed by introducing the following modifications to the complementary DNA (cDNA) for natural human tPA: a substitution of threonine 103 with asparagine, and a substitution of asparagine 117 with glutamine, both within the kringle 1 domain, and a tetra-alanine substitution at amino acids 296–299 in the protease domain. It has a molecular weight of 58,742 daltons. Biological potency is determined by an in vitro clot lysis assay and is expressed in tenecteplase specific units. The specific activity of tenecteplase has been defined as 200 units/mg. TNKase (tenecteplase) for injection is a sterile, white to pale yellow, lyophilized powder for intravenous bolus administration after reconstitution with Sterile Water for Injection, USP. Each 25 mg single-dose vial of TNKase nominally contains 25 mg of tenecteplase, arginine (261 mg), phosphoric acid (approximately 80 mg), and polysorbate 20 (2.0 mg). Following reconstitution with the supplied 5.2 mL single-dose vial of Sterile Water for Injection, USP, the final concentration is 5 mg/mL with a pH of approximately 7.3. Each 50 mg single-dose vial of TNKase nominally contains 50 mg of tenecteplase, arginine (522 mg), phosphoric acid (approximately 160 mg), and polysorbate 20 (4.0 mg). Following reconstitution with the supplied 10 mL single-dose vial of Sterile Water for Injection, USP, the final concentration is 5 mg/mL with a pH of approximately 7.3.</Description>
  </NDC>
  <NDC>
    <NDCCode>73117-111-05</NDCCode>
    <PackageDescription>1 mL in 1 BOTTLE (73117-111-05) </PackageDescription>
    <NDC11Code>73117-0111-05</NDC11Code>
    <ProductNDC>73117-111</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cleanse Right Ear Wax Drops</ProprietaryName>
    <NonProprietaryName>Ear Wax Drops</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>IRRIGATION</RouteName>
    <StartMarketingDate>20220907</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M014</ApplicationNumber>
    <LabelerName>Blue Echo Care</LabelerName>
    <SubstanceName>CARBAMIDE PEROXIDE</SubstanceName>
    <StrengthNumber>65</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-06-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220907</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Directions FOR USE IN THE EAR ONLY. Adults and children over 12 years of age:. Tilt head sideways and place 5 to 10 drops into ear. Tip of applicator should not enter ear canal. Keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear. Use twice daily for up to 4 days if needed, or as directed by a doctor. Any earwax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe. When the ear canal is irrigated, the tip of the ear syringe should not obstruct the flow of water leaving the ear canal. Children under 12 years: consult a doctor.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>73117-111-10</NDCCode>
    <PackageDescription>1 mL in 1 KIT (73117-111-10) </PackageDescription>
    <NDC11Code>73117-0111-10</NDC11Code>
    <ProductNDC>73117-111</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cleanse Right Ear Wax Drops</ProprietaryName>
    <NonProprietaryName>Ear Wax Drops</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>IRRIGATION</RouteName>
    <StartMarketingDate>20220907</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M014</ApplicationNumber>
    <LabelerName>Blue Echo Care</LabelerName>
    <SubstanceName>CARBAMIDE PEROXIDE</SubstanceName>
    <StrengthNumber>65</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-06-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220907</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Directions FOR USE IN THE EAR ONLY. Adults and children over 12 years of age:. Tilt head sideways and place 5 to 10 drops into ear. Tip of applicator should not enter ear canal. Keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear. Use twice daily for up to 4 days if needed, or as directed by a doctor. Any earwax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe. When the ear canal is irrigated, the tip of the ear syringe should not obstruct the flow of water leaving the ear canal. Children under 12 years: consult a doctor.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>73117-111-15</NDCCode>
    <PackageDescription>1 mL in 1 KIT (73117-111-15) </PackageDescription>
    <NDC11Code>73117-0111-15</NDC11Code>
    <ProductNDC>73117-111</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cleanse Right Ear Wax Drops</ProprietaryName>
    <NonProprietaryName>Ear Wax Drops</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>IRRIGATION</RouteName>
    <StartMarketingDate>20220907</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M014</ApplicationNumber>
    <LabelerName>Blue Echo Care</LabelerName>
    <SubstanceName>CARBAMIDE PEROXIDE</SubstanceName>
    <StrengthNumber>65</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-06-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230215</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Directions FOR USE IN THE EAR ONLY. Adults and children over 12 years of age:. Tilt head sideways and place 5 to 10 drops into ear. Tip of applicator should not enter ear canal. Keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear. Use twice daily for up to 4 days if needed, or as directed by a doctor. Any earwax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe. When the ear canal is irrigated, the tip of the ear syringe should not obstruct the flow of water leaving the ear canal. Children under 12 years: consult a doctor.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>73117-111-70</NDCCode>
    <PackageDescription>1 mL in 1 BOTTLE (73117-111-70) </PackageDescription>
    <NDC11Code>73117-0111-70</NDC11Code>
    <ProductNDC>73117-111</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cleanse Right Ear Wax Drops</ProprietaryName>
    <NonProprietaryName>Ear Wax Drops</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>IRRIGATION</RouteName>
    <StartMarketingDate>20220907</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M014</ApplicationNumber>
    <LabelerName>Blue Echo Care</LabelerName>
    <SubstanceName>CARBAMIDE PEROXIDE</SubstanceName>
    <StrengthNumber>65</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-06-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Directions FOR USE IN THE EAR ONLY. Adults and children over 12 years of age:. Tilt head sideways and place 5 to 10 drops into ear. Tip of applicator should not enter ear canal. Keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear. Use twice daily for up to 4 days if needed, or as directed by a doctor. Any earwax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe. When the ear canal is irrigated, the tip of the ear syringe should not obstruct the flow of water leaving the ear canal. Children under 12 years: consult a doctor.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>73117-112-10</NDCCode>
    <PackageDescription>1 mL in 1 KIT (73117-112-10) </PackageDescription>
    <NDC11Code>73117-0112-10</NDC11Code>
    <ProductNDC>73117-112</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Caring Mill Ear Wax Drops</ProprietaryName>
    <NonProprietaryName>Ear Wax Drops</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>IRRIGATION</RouteName>
    <StartMarketingDate>20230101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M014</ApplicationNumber>
    <LabelerName>Blue Echo Care</LabelerName>
    <SubstanceName>CARBAMIDE PEROXIDE</SubstanceName>
    <StrengthNumber>65</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-06-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240203</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Directions FOR USE IN THE EAR ONLY. Adults and children over 12 years of age:. Tilt head sideways and place 5 to 10 drops into ear. Tip of applicator should not enter ear canal. Keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear. Use twice daily for up to 4 days if needed, or as directed by a doctor. Any earwax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe. When the ear canal is irrigated, the tip of the ear syringe should not obstruct the flow of water leaving the ear canal. Children under 12 years: consult a doctor.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>73117-112-20</NDCCode>
    <PackageDescription>2 mL in 1 BOTTLE (73117-112-20) </PackageDescription>
    <NDC11Code>73117-0112-20</NDC11Code>
    <ProductNDC>73117-112</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Caring Mill Ear Wax Drops</ProprietaryName>
    <NonProprietaryName>Ear Wax Drops</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>IRRIGATION</RouteName>
    <StartMarketingDate>20230101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M014</ApplicationNumber>
    <LabelerName>Blue Echo Care</LabelerName>
    <SubstanceName>CARBAMIDE PEROXIDE</SubstanceName>
    <StrengthNumber>65</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-06-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Directions FOR USE IN THE EAR ONLY. Adults and children over 12 years of age:. Tilt head sideways and place 5 to 10 drops into ear. Tip of applicator should not enter ear canal. Keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear. Use twice daily for up to 4 days if needed, or as directed by a doctor. Any earwax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe. When the ear canal is irrigated, the tip of the ear syringe should not obstruct the flow of water leaving the ear canal. Children under 12 years: consult a doctor.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>73117-509-01</NDCCode>
    <PackageDescription>1 mL in 1 BOTTLE, SPRAY (73117-509-01) </PackageDescription>
    <NDC11Code>73117-0509-01</NDC11Code>
    <ProductNDC>73117-509</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Device - Nebuclear Md Hand-held Rubber Bulb Nebulizer</ProprietaryName>
    <NonProprietaryName>Device - Hand-held Rubber Bulb Nebulizer</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20251118</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>Blue Echo Care LLC</LabelerName>
    <SubstanceName>RACEPINEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>11.25</StrengthNumber>
    <StrengthUnit>mg/.5mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-05-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251118</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Please consult the use section of the OTC bronchodilator drug label approved for use with this device.</IndicationAndUsage>
    <Description>This device is a non-sterile hand-held rubber bulb nebulizer intended to aerosolize bronchodilators for inhalation. This product is listed and approved for over-the-counter use under Monograph M012. This product contains no active or inactive ingredients.</Description>
  </NDC>
  <NDC>
    <NDCCode>73117-518-17</NDCCode>
    <PackageDescription>30 mL in 1 CARTON (73117-518-17) </PackageDescription>
    <NDC11Code>73117-0518-17</NDC11Code>
    <ProductNDC>73117-518</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Bec Racepinephrine</ProprietaryName>
    <NonProprietaryName>Racepinephrine</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20250321</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>Blue Echo Care LLC</LabelerName>
    <SubstanceName>RACEPINEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>11.25</StrengthNumber>
    <StrengthUnit>mg/.5mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-03-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250321</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For temporary relief of mild symptoms of intermittent asthma. Wheezing Tightness of chest Shortness of breath.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>73117-519-17</NDCCode>
    <PackageDescription>30 mL in 1 CARTON (73117-519-17) </PackageDescription>
    <NDC11Code>73117-0519-17</NDC11Code>
    <ProductNDC>73117-519</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Nebuclear Md</ProprietaryName>
    <NonProprietaryName>Racepinephrine</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20250520</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>Blue Echo Care LLC</LabelerName>
    <SubstanceName>RACEPINEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>11.25</StrengthNumber>
    <StrengthUnit>mg/.5mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-07-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250520</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For temporary relief of mild symptoms of intermittent asthma. Wheezing Tightness of chest Shortness of breath.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>73117-519-18</NDCCode>
    <PackageDescription>20 mL in 1 BOX (73117-519-18) </PackageDescription>
    <NDC11Code>73117-0519-18</NDC11Code>
    <ProductNDC>73117-519</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Nebuclear Md</ProprietaryName>
    <NonProprietaryName>Racepinephrine</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20250920</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>Blue Echo Care LLC</LabelerName>
    <SubstanceName>RACEPINEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>11.25</StrengthNumber>
    <StrengthUnit>mg/.5mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-04-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250920</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For temporary relief of mild symptoms of intermittent asthma. Wheezing Tightness of chest Shortness of breath.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>73117-520-19</NDCCode>
    <PackageDescription>20 mg in 1 BOX (73117-520-19) </PackageDescription>
    <NDC11Code>73117-0520-19</NDC11Code>
    <ProductNDC>73117-520</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Nebuclear Md</ProprietaryName>
    <NonProprietaryName>Saline</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20250901</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>Blue Echo Care LLC</LabelerName>
    <SubstanceName>SODIUM CHLORIDE</SubstanceName>
    <StrengthNumber>9</StrengthNumber>
    <StrengthUnit>mg/9mg</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-05-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For moistening of the nasal, throat and lungs.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>73117-521-22</NDCCode>
    <PackageDescription>40 mL in 1 CARTON (73117-521-22) </PackageDescription>
    <NDC11Code>73117-0521-22</NDC11Code>
    <ProductNDC>73117-521</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Nebuclear Md Saline</ProprietaryName>
    <NonProprietaryName>Nebuclear Md Saline</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>NASAL</RouteName>
    <StartMarketingDate>20260630</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M022</ApplicationNumber>
    <LabelerName>Blue Echo Care LLC</LabelerName>
    <SubstanceName>SODIUM CHLORIDE</SubstanceName>
    <StrengthNumber>6.5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-07-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260630</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>73117-523-18</NDCCode>
    <PackageDescription>20 mL in 1 BOX (73117-523-18) </PackageDescription>
    <NDC11Code>73117-0523-18</NDC11Code>
    <ProductNDC>73117-523</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Nebuclear Md</ProprietaryName>
    <NonProprietaryName>Racepinephrine Hydrochloride</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20251118</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>Blue Echo Care LLC</LabelerName>
    <SubstanceName>RACEPINEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>11.25</StrengthNumber>
    <StrengthUnit>mg/.5mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-05-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251118</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For temporary relief of mild symptoms of intermittent asthma. Wheezing Tightness of chest Shortness of breath.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>73117-523-19</NDCCode>
    <PackageDescription>40 mL in 1 BOX (73117-523-19) </PackageDescription>
    <NDC11Code>73117-0523-19</NDC11Code>
    <ProductNDC>73117-523</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Nebuclear Md</ProprietaryName>
    <NonProprietaryName>Racepinephrine Hydrochloride</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20260501</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>Blue Echo Care LLC</LabelerName>
    <SubstanceName>RACEPINEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>11.25</StrengthNumber>
    <StrengthUnit>mg/.5mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-05-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For temporary relief of mild symptoms of intermittent asthma. Wheezing Tightness of chest Shortness of breath.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0009-7667-01</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (0009-7667-01)  / 3 SUPPOSITORY in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00009-7667-01</NDC11Code>
    <ProductNDC>0009-7667</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cleocin</ProprietaryName>
    <NonProprietaryName>Clindamycin Phosphate</NonProprietaryName>
    <DosageFormName>SUPPOSITORY</DosageFormName>
    <RouteName>VAGINAL</RouteName>
    <StartMarketingDate>19990813</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA050767</ApplicationNumber>
    <LabelerName>Pharmacia &amp; Upjohn Company LLC</LabelerName>
    <SubstanceName>CLINDAMYCIN PHOSPHATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19990813</StartMarketingDatePackage>
    <EndMarketingDatePackage>20251231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>CLEOCIN Vaginal Ovules are indicated for 3-day treatment of bacterial vaginosis in non-pregnant women. There are no adequate and well-controlled studies of CLEOCIN Vaginal Ovules in pregnant women. NOTE: For purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a "fishy" amine odor when mixed with a 10% KOH solution, and (c) contains clue cells on microscopic examination. Gram's stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent Lactobacillus morphology, (b) predominance of Gardnerella morphotype, and (c) absent or few white blood cells. Other pathogens commonly associated with vulvovaginitis, e.g., Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans, and herpes simplex virus, should be ruled out.</IndicationAndUsage>
    <Description>Clindamycin phosphate is a water-soluble ester of the semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate is methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). The monohydrate form has a molecular weight of 522.98, and the molecular formula is C18H34ClN2O8PSH2O. The structural formula is represented below. CLEOCIN Vaginal Ovules are semisolid, white to off-white suppositories for intravaginal administration. Each 2.5 g suppository contains clindamycin phosphate equivalent to 100 mg clindamycin in a base consisting of a mixture of glycerides of saturated fatty acids.</Description>
  </NDC>
  <NDC>
    <NDCCode>0009-7667-05</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (0009-7667-05)  / 3 SUPPOSITORY in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00009-7667-05</NDC11Code>
    <ProductNDC>0009-7667</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cleocin</ProprietaryName>
    <NonProprietaryName>Clindamycin Phosphate</NonProprietaryName>
    <DosageFormName>SUPPOSITORY</DosageFormName>
    <RouteName>VAGINAL</RouteName>
    <StartMarketingDate>20240203</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA050767</ApplicationNumber>
    <LabelerName>Pharmacia &amp; Upjohn Company LLC</LabelerName>
    <SubstanceName>CLINDAMYCIN PHOSPHATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240203</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>CLEOCIN Vaginal Ovules are indicated for 3-day treatment of bacterial vaginosis in non-pregnant women. There are no adequate and well-controlled studies of CLEOCIN Vaginal Ovules in pregnant women. NOTE: For purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a "fishy" amine odor when mixed with a 10% KOH solution, and (c) contains clue cells on microscopic examination. Gram's stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent Lactobacillus morphology, (b) predominance of Gardnerella morphotype, and (c) absent or few white blood cells. Other pathogens commonly associated with vulvovaginitis, e.g., Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans, and herpes simplex virus, should be ruled out.</IndicationAndUsage>
    <Description>Clindamycin phosphate is a water-soluble ester of the semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate is methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). The monohydrate form has a molecular weight of 522.98, and the molecular formula is C18H34ClN2O8PSH2O. The structural formula is represented below. CLEOCIN Vaginal Ovules are semisolid, white to off-white suppositories for intravaginal administration. Each 2.5 g suppository contains clindamycin phosphate equivalent to 100 mg clindamycin in a base consisting of a mixture of glycerides of saturated fatty acids.</Description>
  </NDC>
  <NDC>
    <NDCCode>0024-5812-07</NDCCode>
    <PackageDescription>7 TABLET, EXTENDED RELEASE in 1 BOTTLE (0024-5812-07)</PackageDescription>
    <NDC11Code>00024-5812-07</NDC11Code>
    <ProductNDC>0024-5812</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Aplenzin</ProprietaryName>
    <NonProprietaryName>Bupropion Hydrobromide</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090330</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022108</ApplicationNumber>
    <LabelerName>sanofi-aventis U.S. LLC</LabelerName>
    <SubstanceName>BUPROPION HYDROBROMIDE</SubstanceName>
    <StrengthNumber>522</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-02-03</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>0024-5812-30</NDCCode>
    <PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0024-5812-30)</PackageDescription>
    <NDC11Code>00024-5812-30</NDC11Code>
    <ProductNDC>0024-5812</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Aplenzin</ProprietaryName>
    <NonProprietaryName>Bupropion Hydrobromide</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090330</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022108</ApplicationNumber>
    <LabelerName>sanofi-aventis U.S. LLC</LabelerName>
    <SubstanceName>BUPROPION HYDROBROMIDE</SubstanceName>
    <StrengthNumber>522</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-09-01</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>0186-0776-60</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE (0186-0776-60) </PackageDescription>
    <NDC11Code>00186-0776-60</NDC11Code>
    <ProductNDC>0186-0776</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Brilinta</ProprietaryName>
    <NonProprietaryName>Ticagrelor</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150904</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022433</ApplicationNumber>
    <LabelerName>AstraZeneca Pharmaceuticals LP</LabelerName>
    <SubstanceName>TICAGRELOR</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P-Glycoprotein Inhibitors [MoA], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150904</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>BRILINTA is a P2Y12 platelet inhibitor indicated: 1 to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel.BRILINTA also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS. (1.1), 2 to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events. While use is not limited to this setting, the efficacy of BRILINTA was established in a population with type 2 diabetes mellitus (T2DM). (1.2), 3 to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score ≤5) or high-risk transient ischemic attack (TIA). (1.3).</IndicationAndUsage>
    <Description>BRILINTA contains ticagrelor, a cyclopentyltriazolopyrimidine, inhibitor of platelet activation and aggregation mediated by the P2Y12 ADP-receptor. Chemically it is (1S,2S,3R,5S)-3-[7-{[(1R,2S)-2-(3,4-difluorophenyl)cyclopropyl]amino}-5-(propylthio)-3H-[1,2,3]-triazolo[4,5-d]pyrimidin-3-yl]-5-(2-hydroxyethoxy)cyclopentane-1,2-diol. The empirical formula of ticagrelor is C23H28F2N6O4S and its molecular weight is 522.57. The chemical structure of ticagrelor is. Ticagrelor is a crystalline powder with an aqueous solubility of approximately 10 μg/mL at room temperature. BRILINTA 90 mg tablets for oral administration contain 90 mg of ticagrelor and the following ingredients: mannitol, dibasic calcium phosphate, sodium starch glycolate, hydroxypropyl cellulose, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, talc, polyethylene glycol 400, and ferric oxide yellow. BRILINTA 60 mg tablets for oral administration contain 60 mg of ticagrelor and the following ingredients: mannitol, dibasic calcium phosphate, sodium starch glycolate, hydroxypropyl cellulose, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, polyethylene glycol 400, ferric oxide black, and ferric oxide red.</Description>
  </NDC>
  <NDC>
    <NDCCode>0186-0776-94</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 BOX, UNIT-DOSE (0186-0776-94)  / 14 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00186-0776-94</NDC11Code>
    <ProductNDC>0186-0776</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Brilinta</ProprietaryName>
    <NonProprietaryName>Ticagrelor</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150904</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022433</ApplicationNumber>
    <LabelerName>AstraZeneca Pharmaceuticals LP</LabelerName>
    <SubstanceName>TICAGRELOR</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P-Glycoprotein Inhibitors [MoA], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150904</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250531</EndMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>BRILINTA is a P2Y12 platelet inhibitor indicated: 1 to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel.BRILINTA also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS. (1.1), 2 to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events. While use is not limited to this setting, the efficacy of BRILINTA was established in a population with type 2 diabetes mellitus (T2DM). (1.2), 3 to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score ≤5) or high-risk transient ischemic attack (TIA). (1.3).</IndicationAndUsage>
    <Description>BRILINTA contains ticagrelor, a cyclopentyltriazolopyrimidine, inhibitor of platelet activation and aggregation mediated by the P2Y12 ADP-receptor. Chemically it is (1S,2S,3R,5S)-3-[7-{[(1R,2S)-2-(3,4-difluorophenyl)cyclopropyl]amino}-5-(propylthio)-3H-[1,2,3]-triazolo[4,5-d]pyrimidin-3-yl]-5-(2-hydroxyethoxy)cyclopentane-1,2-diol. The empirical formula of ticagrelor is C23H28F2N6O4S and its molecular weight is 522.57. The chemical structure of ticagrelor is. Ticagrelor is a crystalline powder with an aqueous solubility of approximately 10 μg/mL at room temperature. BRILINTA 90 mg tablets for oral administration contain 90 mg of ticagrelor and the following ingredients: mannitol, dibasic calcium phosphate, sodium starch glycolate, hydroxypropyl cellulose, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, talc, polyethylene glycol 400, and ferric oxide yellow. BRILINTA 60 mg tablets for oral administration contain 60 mg of ticagrelor and the following ingredients: mannitol, dibasic calcium phosphate, sodium starch glycolate, hydroxypropyl cellulose, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, polyethylene glycol 400, ferric oxide black, and ferric oxide red.</Description>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>73117-522-23</NDCCode><ProprietaryName>Nebuclear Md Saline</ProprietaryName><NonProprietaryName>Nebuclear Md Saline</NonProprietaryName></NDC><NDC><NDCCode>73117-521-23</NDCCode><ProprietaryName>Device - Nebuclear Md Hand-held Rubber Bulb Nebulizer</ProprietaryName><NonProprietaryName>Device - Hand-held Rubber Bulb Nebulizer</NonProprietaryName></NDC><NDC><NDCCode>73117-522-21</NDCCode><ProprietaryName>Nebuclear Md Saline</ProprietaryName><NonProprietaryName>Nebuclear Md Saline</NonProprietaryName></NDC><NDC><NDCCode>73117-522-22</NDCCode><ProprietaryName>Nebuclear Md Saline</ProprietaryName><NonProprietaryName>Nebuclear Md Saline</NonProprietaryName></NDC><NDC><NDCCode>21749-522-89</NDCCode><ProprietaryName>Purell Healthcare Healthy Sp 0.5pct Pcmx Antimicrobial Foam</ProprietaryName><NonProprietaryName>Chloroxylenol</NonProprietaryName></NDC><NDC><NDCCode>21749-522-90</NDCCode><ProprietaryName>Purell Healthcare Healthy Sp 0.5pct Pcmx Antimicrobial Foam</ProprietaryName><NonProprietaryName>Chloroxylenol</NonProprietaryName></NDC><NDC><NDCCode>43419-522-02</NDCCode><ProprietaryName>Amorepacific Resort Collection Sun Protection Mist</ProprietaryName><NonProprietaryName>Homosalate, Octocrylene, Octisalate, And Avobenzone</NonProprietaryName></NDC><NDC><NDCCode>43419-522-37</NDCCode><ProprietaryName>Amorepacific Resort Collection Sun Protection Mist</ProprietaryName><NonProprietaryName>Homosalate, Octocrylene, Octisalate, And Avobenzone</NonProprietaryName></NDC><NDC><NDCCode>50242-014-03</NDCCode><ProprietaryName>Tnkase</ProprietaryName><NonProprietaryName>Tenecteplase</NonProprietaryName></NDC><NDC><NDCCode>50242-176-01</NDCCode><ProprietaryName>Tnkase</ProprietaryName><NonProprietaryName>Tenecteplase</NonProprietaryName></NDC><NDC><NDCCode>73117-111-05</NDCCode><ProprietaryName>Cleanse Right Ear Wax Drops</ProprietaryName><NonProprietaryName>Ear Wax Drops</NonProprietaryName></NDC><NDC><NDCCode>73117-111-10</NDCCode><ProprietaryName>Cleanse Right Ear Wax Drops</ProprietaryName><NonProprietaryName>Ear Wax Drops</NonProprietaryName></NDC><NDC><NDCCode>73117-111-15</NDCCode><ProprietaryName>Cleanse Right Ear Wax Drops</ProprietaryName><NonProprietaryName>Ear Wax Drops</NonProprietaryName></NDC><NDC><NDCCode>73117-111-70</NDCCode><ProprietaryName>Cleanse Right Ear Wax Drops</ProprietaryName><NonProprietaryName>Ear Wax Drops</NonProprietaryName></NDC><NDC><NDCCode>73117-112-10</NDCCode><ProprietaryName>Caring Mill Ear Wax Drops</ProprietaryName><NonProprietaryName>Ear Wax Drops</NonProprietaryName></NDC><NDC><NDCCode>73117-112-20</NDCCode><ProprietaryName>Caring Mill Ear Wax Drops</ProprietaryName><NonProprietaryName>Ear Wax Drops</NonProprietaryName></NDC><NDC><NDCCode>73117-509-01</NDCCode><ProprietaryName>Device - Nebuclear Md Hand-held Rubber Bulb Nebulizer</ProprietaryName><NonProprietaryName>Device - Hand-held Rubber Bulb Nebulizer</NonProprietaryName></NDC><NDC><NDCCode>73117-518-17</NDCCode><ProprietaryName>Bec Racepinephrine</ProprietaryName><NonProprietaryName>Racepinephrine</NonProprietaryName></NDC><NDC><NDCCode>73117-519-17</NDCCode><ProprietaryName>Nebuclear Md</ProprietaryName><NonProprietaryName>Racepinephrine</NonProprietaryName></NDC><NDC><NDCCode>73117-519-18</NDCCode><ProprietaryName>Nebuclear Md</ProprietaryName><NonProprietaryName>Racepinephrine</NonProprietaryName></NDC><NDC><NDCCode>73117-520-19</NDCCode><ProprietaryName>Nebuclear Md</ProprietaryName><NonProprietaryName>Saline</NonProprietaryName></NDC><NDC><NDCCode>73117-521-22</NDCCode><ProprietaryName>Nebuclear Md Saline</ProprietaryName><NonProprietaryName>Nebuclear Md Saline</NonProprietaryName></NDC><NDC><NDCCode>73117-523-18</NDCCode><ProprietaryName>Nebuclear Md</ProprietaryName><NonProprietaryName>Racepinephrine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>73117-523-19</NDCCode><ProprietaryName>Nebuclear Md</ProprietaryName><NonProprietaryName>Racepinephrine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0009-7667-01</NDCCode><ProprietaryName>Cleocin</ProprietaryName><NonProprietaryName>Clindamycin Phosphate</NonProprietaryName></NDC><NDC><NDCCode>0009-7667-05</NDCCode><ProprietaryName>Cleocin</ProprietaryName><NonProprietaryName>Clindamycin Phosphate</NonProprietaryName></NDC><NDC><NDCCode>0024-5812-07</NDCCode><ProprietaryName>Aplenzin</ProprietaryName><NonProprietaryName>Bupropion Hydrobromide</NonProprietaryName></NDC><NDC><NDCCode>0024-5812-30</NDCCode><ProprietaryName>Aplenzin</ProprietaryName><NonProprietaryName>Bupropion Hydrobromide</NonProprietaryName></NDC><NDC><NDCCode>0186-0776-60</NDCCode><ProprietaryName>Brilinta</ProprietaryName><NonProprietaryName>Ticagrelor</NonProprietaryName></NDC><NDC><NDCCode>0186-0776-94</NDCCode><ProprietaryName>Brilinta</ProprietaryName><NonProprietaryName>Ticagrelor</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",
      "LicenseNumberStateCode1": "WA",
      "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."
    },
    {
      "NPI": "1346319878",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "REDMOND EYE CLINIC PLLC",
      "FirstLineMailingAddress": "16150 NE 85TH ST STE 206",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3543",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-3574",
      "MailingAddressFaxNumber": "425-881-0230",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "PracticeLocationAddressFaxNumber": "425-881-0230",
      "EnumerationDate": "11/07/2006",
      "LastUpdateDate": "07/08/2007",
      "AuthorizedOfficialLastName": "OTTEN",
      "AuthorizedOfficialFirstName": "LARRY",
      "AuthorizedOfficialMiddleName": "C",
      "AuthorizedOfficialTitle": "DR",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-3574",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "OD00001172",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "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."
    },
    {
      "NPI": "1376755009",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "PERIMAN",
      "FirstName": "LAURA",
      "MiddleName": "MARIE",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "FirstLineMailingAddress": "623 W HIGHLAND DR",
      "MailingAddressCityName": "SEATTLE",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98119-3446",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "206-282-2716",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "SecondLinePracticeLocationAddress": "REDMOND EYE CLINIC",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
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  ]
}

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",
      "EnumerationDate": "12/03/2024",
      "LastUpdateDate": "12/03/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "171M00000X",
      "Taxonomy1": "Case Manager/Care Coordinator",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/03/2024",
      "PrimaryTaxonomyCode": "171M00000X",
      "PrimaryTaxonomy": "Case Manager/Care Coordinator"
    },
    {
      "NPI": "1790594125",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "WIDDER",
      "FirstName": "JENNIFER",
      "MiddleName": "LYNN",
      "FirstLineMailingAddress": "22350 CALGARY DR",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-9216",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-749-8895",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1858",
      "EnumerationDate": "12/31/2024",
      "LastUpdateDate": "12/31/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "175T00000X",
      "Taxonomy1": "Peer Specialist",
      "LicenseNumber1": "112910",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/31/2024",
      "PrimaryTaxonomyCode": "175T00000X",
      "PrimaryTaxonomy": "Peer Specialist"
    },
    {
      "NPI": "1538965306",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "PARSONS",
      "FirstName": "JEANINE",
      "MiddleName": "JEWELL",
      "FirstLineMailingAddress": "2821 SW 28TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8681",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "760-927-4761",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/21/2025",
      "LastUpdateDate": "02/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "175T00000X",
      "Taxonomy1": "Peer Specialist",
      "LicenseNumber1": "113398",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/21/2025",
      "PrimaryTaxonomyCode": "175T00000X",
      "PrimaryTaxonomy": "Peer Specialist"
    }
  ]
}
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