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How to Find 76150-166-23 NDC Data Using DataLabs API

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{
  "NDC": [
    {
      "NDCCode": "76150-166-23",
      "PackageDescription": "89 mL in 1 CAN (76150-166-23)",
      "NDC11Code": "76150-0166-23",
      "ProductNDC": "76150-166",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Tropical Coconut",
      "ProprietaryNameSuffix": "Spf 30 Broad Spectrum",
      "NonProprietaryName": "Classic Body Sunscreen",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160101",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Bell International Laboratories, Inc.",
      "SubstanceName": "AVOBENZONE; OCTOCRYLENE; OCTINOXATE; OCTISALATE",
      "StrengthNumber": "2; 7; 7.5; 4",
      "StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2021-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231"
    },
    {
      "NDCCode": "76150-166-24",
      "PackageDescription": "236 mL in 1 CAN (76150-166-24)",
      "NDC11Code": "76150-0166-24",
      "ProductNDC": "76150-166",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Tropical Coconut",
      "ProprietaryNameSuffix": "Spf 30 Broad Spectrum",
      "NonProprietaryName": "Classic Body Sunscreen",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160101",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Bell International Laboratories, Inc.",
      "SubstanceName": "AVOBENZONE; OCTOCRYLENE; OCTINOXATE; OCTISALATE",
      "StrengthNumber": "2; 7; 7.5; 4",
      "StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2021-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231"
    },
    {
      "NDCCode": "76150-119-23",
      "PackageDescription": "90 mL in 1 CAN (76150-119-23)",
      "NDC11Code": "76150-0119-23",
      "ProductNDC": "76150-119",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Pina Colada Body",
      "ProprietaryNameSuffix": "Spf 30 Broad Spectrum",
      "NonProprietaryName": "Classic Sunscreen",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130101",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Bell International Laboratories, Inc.",
      "SubstanceName": "OCTOCRYLENE; OCTISALATE; AVOBENZONE; OCTINOXATE",
      "StrengthNumber": "7; 4; 2; 7.5",
      "StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2021-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231"
    },
    {
      "NDCCode": "76150-163-23",
      "PackageDescription": "89 mL in 1 CAN (76150-163-23)",
      "NDC11Code": "76150-0163-23",
      "ProductNDC": "76150-163",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Classic Sport Unscented",
      "ProprietaryNameSuffix": "Spf 50 Broad Spectrum",
      "NonProprietaryName": "Classic Continuous",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160101",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Bell International Laboratories, Inc.",
      "SubstanceName": "AVOBENZONE; OCTINOXATE; OCTOCRYLENE",
      "StrengthNumber": "3; 7.5; 10",
      "StrengthUnit": "g/100mL; g/100mL; g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2021-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231"
    },
    {
      "NDCCode": "76150-164-23",
      "PackageDescription": "100 mL in 1 CAN (76150-164-23)",
      "NDC11Code": "76150-0164-23",
      "ProductNDC": "76150-164",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Guava Mango Sport",
      "ProprietaryNameSuffix": "Spf 30 Broad Spectrum",
      "NonProprietaryName": "Classic Sunscreen",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160101",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Bell International Laboratories, Inc.",
      "SubstanceName": "AVOBENZONE; OCTINOXATE; OCTOCRYLENE",
      "StrengthNumber": "3; 7.5; 10",
      "StrengthUnit": "g/100mL; g/100mL; g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2021-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231"
    },
    {
      "NDCCode": "76150-165-23",
      "PackageDescription": "89 mL in 1 CAN (76150-165-23)",
      "NDC11Code": "76150-0165-23",
      "ProductNDC": "76150-165",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Fresh Cucumber Classic Body",
      "ProprietaryNameSuffix": "Spf 30 Broad Spectrum",
      "NonProprietaryName": "Sunscreen",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20150101",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Bell International Laboratories, Inc.",
      "SubstanceName": "OCTOCRYLENE; AVOBENZONE; OCTISALATE; OCTINOXATE",
      "StrengthNumber": "7; 2; 4; 7.5",
      "StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2021-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231"
    },
    {
      "NDCCode": "76150-211-23",
      "PackageDescription": "90 mL in 1 CAN (76150-211-23)",
      "NDC11Code": "76150-0211-23",
      "ProductNDC": "76150-211",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Yerba Mate Mineral",
      "ProprietaryNameSuffix": "Spf 30 Broad Spectrum",
      "NonProprietaryName": "Sunscreen",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20150801",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Bell International Labroatories, Inc",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "12",
      "StrengthUnit": "g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "11673-166-28",
      "PackageDescription": "1 BOTTLE in 1 CARTON (11673-166-28)  > 148 mL in 1 BOTTLE",
      "NDC11Code": "11673-0166-28",
      "ProductNDC": "11673-166",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Up And Up Childrens Ibuprofen",
      "NonProprietaryName": "Ibuprofen",
      "DosageFormName": "SUSPENSION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090612",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074937",
      "LabelerName": "Target Corporation",
      "SubstanceName": "IBUPROFEN",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/5mL",
      "Status": "Deprecated",
      "LastUpdate": "2017-10-23"
    },
    {
      "NDCCode": "25021-797-05",
      "PackageDescription": "10 VIAL in 1 CARTON (25021-797-05)  / 5 mL in 1 VIAL",
      "NDC11Code": "25021-0797-05",
      "ProductNDC": "25021-797",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Valproate Sodium",
      "NonProprietaryName": "Valproate Sodium",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20241201",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076295",
      "LabelerName": "Sagent Pharmaceuticals",
      "SubstanceName": "VALPROATE SODIUM",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-06-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20241201",
      "SamplePackage": "N",
      "IndicationAndUsage": "Valproate Sodium Injection is indicated as an intravenous alternative in patients in whom oral administration of valproate products is temporarily not feasible in the following conditions: : 1 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1) .",
      "Description": "Valproate sodium is the sodium salt of valproic acid designated as sodium 2-propylpentanoate. Valproate sodium has the following structure:. Valproate sodium has a molecular weight of 166.2. It occurs as an essentially white and odorless, crystalline, deliquescent powder. Valproate Sodium Injection, USP is available in 5 mL single-dose vials for intravenous injection. Each mL contains valproate sodium equivalent to 100 mg valproic acid, edetate disodium 0.40 mg, and water for injection to volume. The pH is adjusted to 7.6 with sodium hydroxide and/or hydrochloric acid. The solution is clear and colorless."
    },
    {
      "NDCCode": "33342-166-10",
      "PackageDescription": "90 CAPSULE in 1 BOTTLE (33342-166-10) ",
      "NDC11Code": "33342-0166-10",
      "ProductNDC": "33342-166",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pregablin",
      "NonProprietaryName": "Pregablin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20241113",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA205924",
      "LabelerName": "Macleods Pharmaceuticals Limited",
      "SubstanceName": "PREGABALIN",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "DEASchedule": "CV",
      "Status": "Active",
      "LastUpdate": "2025-07-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20241113",
      "SamplePackage": "N",
      "IndicationAndUsage": "Pregabalin capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older , 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.",
      "Description": "Pregabalin, USP is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is - 1.35.Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, pregelatinized starch, talc as inactive ingredients. The capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide."
    },
    {
      "NDCCode": "42806-512-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE (42806-512-01) ",
      "NDC11Code": "42806-0512-01",
      "ProductNDC": "42806-512",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Quinidine Sulfate",
      "NonProprietaryName": "Quinidine Sulfate Tablet",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20211215",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA088072",
      "LabelerName": "EPIC PHARMA, LLC",
      "SubstanceName": "QUINIDINE SULFATE",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antiarrhythmic [EPC], Cytochrome P450 2D6 Inhibitor [EPC], Cytochrome P450 2D6 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2023-12-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20211215",
      "SamplePackage": "N",
      "IndicationAndUsage": "In patients with symptomatic atrial fibrillation/flutter whose symptoms are not adequately controlled by measures that reduce the rate of ventricular response, quinidine sulfate is indicated as a means of restoring normal sinus rhythm. If this use of quinidine sulfate does not restore sinus rhythm within a reasonable time (see DOSAGE AND ADMINISTRATION), then quinidine sulfate should be discontinued.",
      "Description": "Quinidine is an antimalarial schizonticide and an antiarrhythmic agent with class 1A activity; it is the d-isomer of quinine, and its molecular weight is 324.43. Quinidine sulfate is the sulfate salt of quinidine; its chemical name is cinchonan-9-ol, 6’- methoxy-, (9S)-, sulfate (2:1) dihydrate; its structural formula is. Its molecular formula is: C40H48N4O4∙H2SO4∙2H2O; and its molecular weight is 782.96, of which 82.9% is quinidine base. Quinidine sulfate occurs as fine needle-like, white crystals, frequently cohering in masses, or fine, white powder. It is odorless, has a very bitter taste, and darkens on exposure to light. It is slightly soluble in water, soluble in alcohol and in chloroform, and insoluble in ether. Each tablet, for oral administration, contains 200 mg of quinidine sulfate (equivalent to 166 mg of quinidine base) 300 mg of quinidine sulfate (equivalent to 249 mg of quinidine base). In addition, each tablet contains the following inactive ingredients: confectioner’s sugar, corn starch, microcrystalline cellulose, pregelatinized starch and zinc stearate."
    },
    {
      "NDCCode": "42806-512-30",
      "PackageDescription": "30 TABLET in 1 BOTTLE (42806-512-30) ",
      "NDC11Code": "42806-0512-30",
      "ProductNDC": "42806-512",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Quinidine Sulfate",
      "NonProprietaryName": "Quinidine Sulfate Tablet",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20211215",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA088072",
      "LabelerName": "EPIC PHARMA, LLC",
      "SubstanceName": "QUINIDINE SULFATE",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antiarrhythmic [EPC], Cytochrome P450 2D6 Inhibitor [EPC], Cytochrome P450 2D6 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2023-12-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220102",
      "SamplePackage": "N",
      "IndicationAndUsage": "In patients with symptomatic atrial fibrillation/flutter whose symptoms are not adequately controlled by measures that reduce the rate of ventricular response, quinidine sulfate is indicated as a means of restoring normal sinus rhythm. If this use of quinidine sulfate does not restore sinus rhythm within a reasonable time (see DOSAGE AND ADMINISTRATION), then quinidine sulfate should be discontinued.",
      "Description": "Quinidine is an antimalarial schizonticide and an antiarrhythmic agent with class 1A activity; it is the d-isomer of quinine, and its molecular weight is 324.43. Quinidine sulfate is the sulfate salt of quinidine; its chemical name is cinchonan-9-ol, 6’- methoxy-, (9S)-, sulfate (2:1) dihydrate; its structural formula is. Its molecular formula is: C40H48N4O4∙H2SO4∙2H2O; and its molecular weight is 782.96, of which 82.9% is quinidine base. Quinidine sulfate occurs as fine needle-like, white crystals, frequently cohering in masses, or fine, white powder. It is odorless, has a very bitter taste, and darkens on exposure to light. It is slightly soluble in water, soluble in alcohol and in chloroform, and insoluble in ether. Each tablet, for oral administration, contains 200 mg of quinidine sulfate (equivalent to 166 mg of quinidine base) 300 mg of quinidine sulfate (equivalent to 249 mg of quinidine base). In addition, each tablet contains the following inactive ingredients: confectioner’s sugar, corn starch, microcrystalline cellulose, pregelatinized starch and zinc stearate."
    },
    {
      "NDCCode": "42806-513-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE (42806-513-01) ",
      "NDC11Code": "42806-0513-01",
      "ProductNDC": "42806-513",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Quinidine Sulfate",
      "NonProprietaryName": "Quinidine Sulfate Tablet",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20211215",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA088072",
      "LabelerName": "EPIC PHARMA, LLC",
      "SubstanceName": "QUINIDINE SULFATE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antiarrhythmic [EPC], Cytochrome P450 2D6 Inhibitor [EPC], Cytochrome P450 2D6 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2023-12-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20211215",
      "SamplePackage": "N",
      "IndicationAndUsage": "In patients with symptomatic atrial fibrillation/flutter whose symptoms are not adequately controlled by measures that reduce the rate of ventricular response, quinidine sulfate is indicated as a means of restoring normal sinus rhythm. If this use of quinidine sulfate does not restore sinus rhythm within a reasonable time (see DOSAGE AND ADMINISTRATION), then quinidine sulfate should be discontinued.",
      "Description": "Quinidine is an antimalarial schizonticide and an antiarrhythmic agent with class 1A activity; it is the d-isomer of quinine, and its molecular weight is 324.43. Quinidine sulfate is the sulfate salt of quinidine; its chemical name is cinchonan-9-ol, 6’- methoxy-, (9S)-, sulfate (2:1) dihydrate; its structural formula is. Its molecular formula is: C40H48N4O4∙H2SO4∙2H2O; and its molecular weight is 782.96, of which 82.9% is quinidine base. Quinidine sulfate occurs as fine needle-like, white crystals, frequently cohering in masses, or fine, white powder. It is odorless, has a very bitter taste, and darkens on exposure to light. It is slightly soluble in water, soluble in alcohol and in chloroform, and insoluble in ether. Each tablet, for oral administration, contains 200 mg of quinidine sulfate (equivalent to 166 mg of quinidine base) 300 mg of quinidine sulfate (equivalent to 249 mg of quinidine base). In addition, each tablet contains the following inactive ingredients: confectioner’s sugar, corn starch, microcrystalline cellulose, pregelatinized starch and zinc stearate."
    },
    {
      "NDCCode": "42806-513-30",
      "PackageDescription": "30 TABLET in 1 BOTTLE (42806-513-30) ",
      "NDC11Code": "42806-0513-30",
      "ProductNDC": "42806-513",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Quinidine Sulfate",
      "NonProprietaryName": "Quinidine Sulfate Tablet",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20211215",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA088072",
      "LabelerName": "EPIC PHARMA, LLC",
      "SubstanceName": "QUINIDINE SULFATE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antiarrhythmic [EPC], Cytochrome P450 2D6 Inhibitor [EPC], Cytochrome P450 2D6 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2023-12-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220102",
      "SamplePackage": "N",
      "IndicationAndUsage": "In patients with symptomatic atrial fibrillation/flutter whose symptoms are not adequately controlled by measures that reduce the rate of ventricular response, quinidine sulfate is indicated as a means of restoring normal sinus rhythm. If this use of quinidine sulfate does not restore sinus rhythm within a reasonable time (see DOSAGE AND ADMINISTRATION), then quinidine sulfate should be discontinued.",
      "Description": "Quinidine is an antimalarial schizonticide and an antiarrhythmic agent with class 1A activity; it is the d-isomer of quinine, and its molecular weight is 324.43. Quinidine sulfate is the sulfate salt of quinidine; its chemical name is cinchonan-9-ol, 6’- methoxy-, (9S)-, sulfate (2:1) dihydrate; its structural formula is. Its molecular formula is: C40H48N4O4∙H2SO4∙2H2O; and its molecular weight is 782.96, of which 82.9% is quinidine base. Quinidine sulfate occurs as fine needle-like, white crystals, frequently cohering in masses, or fine, white powder. It is odorless, has a very bitter taste, and darkens on exposure to light. It is slightly soluble in water, soluble in alcohol and in chloroform, and insoluble in ether. Each tablet, for oral administration, contains 200 mg of quinidine sulfate (equivalent to 166 mg of quinidine base) 300 mg of quinidine sulfate (equivalent to 249 mg of quinidine base). In addition, each tablet contains the following inactive ingredients: confectioner’s sugar, corn starch, microcrystalline cellulose, pregelatinized starch and zinc stearate."
    },
    {
      "NDCCode": "42858-166-01",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (42858-166-01) ",
      "NDC11Code": "42858-0166-01",
      "ProductNDC": "42858-166",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lisdexamfetamine Dimesylate",
      "NonProprietaryName": "Lisdexamfetamine Dimesylate",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240130",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215330",
      "LabelerName": "Rhodes Pharmaceuticals LLC",
      "SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
      "StrengthNumber": "60",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2026-05-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240130",
      "SamplePackage": "N",
      "IndicationAndUsage": "Lisdexamfetamine Dimesylate Capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].",
      "Description": "Lisdexamfetamine dimesylate capsules, a CNS stimulant, are for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O∙(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. The capsule shells (imprinted with RP##) contain gelatin, titanium dioxide, and one or more of the following: D&C Red #28, FD&C Blue #1, FD&C Red #3, FD&C Red #40, FD&C Yellow #6, Iron Oxide Black, Iron Oxide Red, and Iron Oxide Yellow. Additionally, the imprint ink contains the following non-volatile ingredients: shellac, black iron oxide, and potassium hydroxide."
    },
    {
      "NDCCode": "44087-0022-3",
      "PackageDescription": "12 SYRINGE, GLASS in 1 CARTON (44087-0022-3)  / .5 mL in 1 SYRINGE, GLASS (44087-0022-9) ",
      "NDC11Code": "44087-0022-03",
      "ProductNDC": "44087-0022",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Rebif",
      "NonProprietaryName": "Interferon Beta-1a",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20020307",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103780",
      "LabelerName": "EMD Serono, Inc.",
      "SubstanceName": "INTERFERON BETA-1A",
      "StrengthNumber": "22",
      "StrengthUnit": "ug/.5mL",
      "Pharm_Classes": "Interferon beta [EPC], Interferon-beta [CS]",
      "Status": "Active",
      "LastUpdate": "2025-09-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20020307",
      "SamplePackage": "N",
      "IndicationAndUsage": "REBIF is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.",
      "Description": "REBIF (interferon beta-1a) is a purified 166 amino acid glycoprotein with a molecular weight of approximately 22,500 daltons. It is produced by recombinant DNA technology using genetically engineered Chinese Hamster Ovary cells into which the human interferon beta gene has been introduced. The amino acid sequence of REBIF is identical to that of natural fibroblast derived human interferon beta. Natural interferon beta and interferon beta-1a (REBIF) are glycosylated with each containing a single N-linked complex carbohydrate moiety. Using a reference standard calibrated against the World Health Organization natural interferon beta standard (Second International Standard for Interferon, Human Fibroblast GB 23 902 531), REBIF has a specific activity of approximately 270 million international units (MIU) of antiviral activity per mg of interferon beta-1a determined specifically by an in vitro cytopathic effect bioassay using WISH cells and Vesicular Stomatitis virus. REBIF 8.8 mcg, 22 mcg and 44 mcg contains approximately 2.4 million international units, 6 million international units or 12 million international units, respectively, of antiviral activity using this method. REBIF (interferon beta-1a) is formulated as a sterile solution in a prefilled syringe or REBIF Rebidose autoinjector intended for subcutaneous (sc) injection. Each 0.5 mL (0.5 cc) of REBIF contains either 22 mcg or 44 mcg of interferon beta-1a, 2 mg or 4 mg albumin (human), 27.3 mg mannitol, 0.4 mg sodium acetate, and water for injection. Each 0.2 mL (0.2 cc) of REBIF contains 8.8 mcg of interferon beta-1a, 0.8 mg albumin (human), 10.9 mg mannitol, 0.16 mg sodium acetate, and water for injection."
    },
    {
      "NDCCode": "44087-0044-3",
      "PackageDescription": "12 SYRINGE, GLASS in 1 CARTON (44087-0044-3)  / .5 mL in 1 SYRINGE, GLASS (44087-0044-9) ",
      "NDC11Code": "44087-0044-03",
      "ProductNDC": "44087-0044",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Rebif",
      "NonProprietaryName": "Interferon Beta-1a",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20020307",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103780",
      "LabelerName": "EMD Serono, Inc.",
      "SubstanceName": "INTERFERON BETA-1A",
      "StrengthNumber": "44",
      "StrengthUnit": "ug/.5mL",
      "Pharm_Classes": "Interferon beta [EPC], Interferon-beta [CS]",
      "Status": "Active",
      "LastUpdate": "2025-09-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20020307",
      "SamplePackage": "N",
      "IndicationAndUsage": "REBIF is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.",
      "Description": "REBIF (interferon beta-1a) is a purified 166 amino acid glycoprotein with a molecular weight of approximately 22,500 daltons. It is produced by recombinant DNA technology using genetically engineered Chinese Hamster Ovary cells into which the human interferon beta gene has been introduced. The amino acid sequence of REBIF is identical to that of natural fibroblast derived human interferon beta. Natural interferon beta and interferon beta-1a (REBIF) are glycosylated with each containing a single N-linked complex carbohydrate moiety. Using a reference standard calibrated against the World Health Organization natural interferon beta standard (Second International Standard for Interferon, Human Fibroblast GB 23 902 531), REBIF has a specific activity of approximately 270 million international units (MIU) of antiviral activity per mg of interferon beta-1a determined specifically by an in vitro cytopathic effect bioassay using WISH cells and Vesicular Stomatitis virus. REBIF 8.8 mcg, 22 mcg and 44 mcg contains approximately 2.4 million international units, 6 million international units or 12 million international units, respectively, of antiviral activity using this method. REBIF (interferon beta-1a) is formulated as a sterile solution in a prefilled syringe or REBIF Rebidose autoinjector intended for subcutaneous (sc) injection. Each 0.5 mL (0.5 cc) of REBIF contains either 22 mcg or 44 mcg of interferon beta-1a, 2 mg or 4 mg albumin (human), 27.3 mg mannitol, 0.4 mg sodium acetate, and water for injection. Each 0.2 mL (0.2 cc) of REBIF contains 8.8 mcg of interferon beta-1a, 0.8 mg albumin (human), 10.9 mg mannitol, 0.16 mg sodium acetate, and water for injection."
    },
    {
      "NDCCode": "44087-0188-1",
      "PackageDescription": "1 KIT in 1 CARTON (44087-0188-1)  *  .2 mL in 1 PACKAGE *  .5 mL in 1 PACKAGE",
      "NDC11Code": "44087-0188-01",
      "ProductNDC": "44087-0188",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Rebif Rebidose",
      "NonProprietaryName": "Interferon Beta-1a",
      "DosageFormName": "KIT",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20121221",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103780",
      "LabelerName": "EMD Serono, Inc.",
      "Status": "Active",
      "LastUpdate": "2025-09-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20121221",
      "SamplePackage": "N",
      "IndicationAndUsage": "REBIF is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.",
      "Description": "REBIF (interferon beta-1a) is a purified 166 amino acid glycoprotein with a molecular weight of approximately 22,500 daltons. It is produced by recombinant DNA technology using genetically engineered Chinese Hamster Ovary cells into which the human interferon beta gene has been introduced. The amino acid sequence of REBIF is identical to that of natural fibroblast derived human interferon beta. Natural interferon beta and interferon beta-1a (REBIF) are glycosylated with each containing a single N-linked complex carbohydrate moiety. Using a reference standard calibrated against the World Health Organization natural interferon beta standard (Second International Standard for Interferon, Human Fibroblast GB 23 902 531), REBIF has a specific activity of approximately 270 million international units (MIU) of antiviral activity per mg of interferon beta-1a determined specifically by an in vitro cytopathic effect bioassay using WISH cells and Vesicular Stomatitis virus. REBIF 8.8 mcg, 22 mcg and 44 mcg contains approximately 2.4 million international units, 6 million international units or 12 million international units, respectively, of antiviral activity using this method. REBIF (interferon beta-1a) is formulated as a sterile solution in a prefilled syringe or REBIF Rebidose autoinjector intended for subcutaneous (sc) injection. Each 0.5 mL (0.5 cc) of REBIF contains either 22 mcg or 44 mcg of interferon beta-1a, 2 mg or 4 mg albumin (human), 27.3 mg mannitol, 0.4 mg sodium acetate, and water for injection. Each 0.2 mL (0.2 cc) of REBIF contains 8.8 mcg of interferon beta-1a, 0.8 mg albumin (human), 10.9 mg mannitol, 0.16 mg sodium acetate, and water for injection."
    },
    {
      "NDCCode": "44087-3322-1",
      "PackageDescription": "12 PACKAGE in 1 CARTON (44087-3322-1)  / .5 mL in 1 PACKAGE (44087-3322-9) ",
      "NDC11Code": "44087-3322-01",
      "ProductNDC": "44087-3322",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Rebif Rebidose",
      "NonProprietaryName": "Interferon Beta-1a",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20121221",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103780",
      "LabelerName": "EMD Serono, Inc.",
      "SubstanceName": "INTERFERON BETA-1A",
      "StrengthNumber": "22",
      "StrengthUnit": "ug/.5mL",
      "Pharm_Classes": "Interferon beta [EPC], Interferon-beta [CS]",
      "Status": "Active",
      "LastUpdate": "2025-09-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20121221",
      "SamplePackage": "N",
      "IndicationAndUsage": "REBIF is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.",
      "Description": "REBIF (interferon beta-1a) is a purified 166 amino acid glycoprotein with a molecular weight of approximately 22,500 daltons. It is produced by recombinant DNA technology using genetically engineered Chinese Hamster Ovary cells into which the human interferon beta gene has been introduced. The amino acid sequence of REBIF is identical to that of natural fibroblast derived human interferon beta. Natural interferon beta and interferon beta-1a (REBIF) are glycosylated with each containing a single N-linked complex carbohydrate moiety. Using a reference standard calibrated against the World Health Organization natural interferon beta standard (Second International Standard for Interferon, Human Fibroblast GB 23 902 531), REBIF has a specific activity of approximately 270 million international units (MIU) of antiviral activity per mg of interferon beta-1a determined specifically by an in vitro cytopathic effect bioassay using WISH cells and Vesicular Stomatitis virus. REBIF 8.8 mcg, 22 mcg and 44 mcg contains approximately 2.4 million international units, 6 million international units or 12 million international units, respectively, of antiviral activity using this method. REBIF (interferon beta-1a) is formulated as a sterile solution in a prefilled syringe or REBIF Rebidose autoinjector intended for subcutaneous (sc) injection. Each 0.5 mL (0.5 cc) of REBIF contains either 22 mcg or 44 mcg of interferon beta-1a, 2 mg or 4 mg albumin (human), 27.3 mg mannitol, 0.4 mg sodium acetate, and water for injection. Each 0.2 mL (0.2 cc) of REBIF contains 8.8 mcg of interferon beta-1a, 0.8 mg albumin (human), 10.9 mg mannitol, 0.16 mg sodium acetate, and water for injection."
    },
    {
      "NDCCode": "44087-3344-1",
      "PackageDescription": "12 PACKAGE in 1 CARTON (44087-3344-1)  / .5 mL in 1 PACKAGE (44087-3344-9) ",
      "NDC11Code": "44087-3344-01",
      "ProductNDC": "44087-3344",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Rebif Rebidose",
      "NonProprietaryName": "Interferon Beta-1a",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20121221",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103780",
      "LabelerName": "EMD Serono, Inc.",
      "SubstanceName": "INTERFERON BETA-1A",
      "StrengthNumber": "44",
      "StrengthUnit": "ug/.5mL",
      "Pharm_Classes": "Interferon beta [EPC], Interferon-beta [CS]",
      "Status": "Active",
      "LastUpdate": "2025-09-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20121221",
      "SamplePackage": "N",
      "IndicationAndUsage": "REBIF is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.",
      "Description": "REBIF (interferon beta-1a) is a purified 166 amino acid glycoprotein with a molecular weight of approximately 22,500 daltons. It is produced by recombinant DNA technology using genetically engineered Chinese Hamster Ovary cells into which the human interferon beta gene has been introduced. The amino acid sequence of REBIF is identical to that of natural fibroblast derived human interferon beta. Natural interferon beta and interferon beta-1a (REBIF) are glycosylated with each containing a single N-linked complex carbohydrate moiety. Using a reference standard calibrated against the World Health Organization natural interferon beta standard (Second International Standard for Interferon, Human Fibroblast GB 23 902 531), REBIF has a specific activity of approximately 270 million international units (MIU) of antiviral activity per mg of interferon beta-1a determined specifically by an in vitro cytopathic effect bioassay using WISH cells and Vesicular Stomatitis virus. REBIF 8.8 mcg, 22 mcg and 44 mcg contains approximately 2.4 million international units, 6 million international units or 12 million international units, respectively, of antiviral activity using this method. REBIF (interferon beta-1a) is formulated as a sterile solution in a prefilled syringe or REBIF Rebidose autoinjector intended for subcutaneous (sc) injection. Each 0.5 mL (0.5 cc) of REBIF contains either 22 mcg or 44 mcg of interferon beta-1a, 2 mg or 4 mg albumin (human), 27.3 mg mannitol, 0.4 mg sodium acetate, and water for injection. Each 0.2 mL (0.2 cc) of REBIF contains 8.8 mcg of interferon beta-1a, 0.8 mg albumin (human), 10.9 mg mannitol, 0.16 mg sodium acetate, and water for injection."
    },
    {
      "NDCCode": "44087-8822-1",
      "PackageDescription": "1 KIT in 1 CARTON (44087-8822-1)  *  .2 mL in 1 SYRINGE, GLASS *  .5 mL in 1 SYRINGE, GLASS",
      "NDC11Code": "44087-8822-01",
      "ProductNDC": "44087-8822",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Rebif",
      "NonProprietaryName": "Interferon Beta-1a",
      "DosageFormName": "KIT",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20041217",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103780",
      "LabelerName": "EMD Serono, Inc.",
      "Status": "Active",
      "LastUpdate": "2025-09-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20041217",
      "SamplePackage": "N",
      "IndicationAndUsage": "REBIF is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.",
      "Description": "REBIF (interferon beta-1a) is a purified 166 amino acid glycoprotein with a molecular weight of approximately 22,500 daltons. It is produced by recombinant DNA technology using genetically engineered Chinese Hamster Ovary cells into which the human interferon beta gene has been introduced. The amino acid sequence of REBIF is identical to that of natural fibroblast derived human interferon beta. Natural interferon beta and interferon beta-1a (REBIF) are glycosylated with each containing a single N-linked complex carbohydrate moiety. Using a reference standard calibrated against the World Health Organization natural interferon beta standard (Second International Standard for Interferon, Human Fibroblast GB 23 902 531), REBIF has a specific activity of approximately 270 million international units (MIU) of antiviral activity per mg of interferon beta-1a determined specifically by an in vitro cytopathic effect bioassay using WISH cells and Vesicular Stomatitis virus. REBIF 8.8 mcg, 22 mcg and 44 mcg contains approximately 2.4 million international units, 6 million international units or 12 million international units, respectively, of antiviral activity using this method. REBIF (interferon beta-1a) is formulated as a sterile solution in a prefilled syringe or REBIF Rebidose autoinjector intended for subcutaneous (sc) injection. Each 0.5 mL (0.5 cc) of REBIF contains either 22 mcg or 44 mcg of interferon beta-1a, 2 mg or 4 mg albumin (human), 27.3 mg mannitol, 0.4 mg sodium acetate, and water for injection. Each 0.2 mL (0.2 cc) of REBIF contains 8.8 mcg of interferon beta-1a, 0.8 mg albumin (human), 10.9 mg mannitol, 0.16 mg sodium acetate, and water for injection."
    },
    {
      "NDCCode": "55718-166-01",
      "PackageDescription": "25 POUCH in 1 CARTON (55718-166-01)  / 10.5 mL in 1 POUCH",
      "NDC11Code": "55718-0166-01",
      "ProductNDC": "55718-166",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Isopropyl Alcohol",
      "DosageFormName": "SOLUTION",
      "StartMarketingDate": "20230227",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Isomedix Operations Inc",
      "SubstanceName": "ISOPROPYL ALCOHOL",
      "StrengthNumber": ".7",
      "StrengthUnit": "mL/mL",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "27-FEB-23"
    },
    {
      "NDCCode": "55718-166-02",
      "PackageDescription": "25 POUCH in 1 BOX (55718-166-02)  / 26 mL in 1 POUCH",
      "NDC11Code": "55718-0166-02",
      "ProductNDC": "55718-166",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Isopropyl Alcohol",
      "DosageFormName": "SOLUTION",
      "StartMarketingDate": "20230227",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Isomedix Operations Inc",
      "SubstanceName": "ISOPROPYL ALCOHOL",
      "StrengthNumber": ".7",
      "StrengthUnit": "mL/mL",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "27-FEB-23"
    },
    {
      "NDCCode": "57665-101-41",
      "PackageDescription": "1 VIAL in 1 CARTON (57665-101-41)  / 20 mL in 1 VIAL",
      "NDC11Code": "57665-0101-41",
      "ProductNDC": "57665-101",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Abelcet",
      "NonProprietaryName": "Amphotericin B, Dimyristoylphosphatidylcholine, Dl- And Dimyristoylphosphatidylglycerol, Dl-",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20101018",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA050724",
      "LabelerName": "Leadiant Biosciences, Inc.",
      "SubstanceName": "AMPHOTERICIN B; DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL-; DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL-",
      "StrengthNumber": "5; 3.4; 1.5",
      "StrengthUnit": "mg/mL; mg/mL; mg/mL",
      "Pharm_Classes": "Lipid-based Polyene Antifungal [EPC], Polyene Antifungal [EPC], Polyenes [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2025-09-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20101018",
      "SamplePackage": "N",
      "IndicationAndUsage": "ABELCET ®is indicated for the treatment of invasive fungal infections in patients who are refractory to or intolerant of conventional amphotericin B therapy. This is based on open-label treatment of patients judged by their physicians to be intolerant to or failing conventional amphotericin B therapy (See DESCRIPTION OF CLINICAL STUDIES). DESCRIPTION OF CLINICAL STUDIES. Fungal Infections. Data from 473 patients were pooled from three open-label studies in which ABELCET ®was provided for the treatment of patients with invasive fungal infections who were judged by their physicians to be refractory to or intolerant of conventional amphotericin B, or who had preexisting nephrotoxicity. Results of these studies demonstrated effectiveness of ABELCET ®in the treatment of invasive fungal infections as a second line therapy. Patients were defined by their individual physician as being refractory to or failing conventional amphotericin B therapy based on overall clinical judgement after receiving a minimum total dose of 500 mg of amphotericin B. Nephrotoxicity was defined as a serum creatinine that had increased to >2.5 mg/dL in adults and >1.5 mg/dL in pediatric patients, or a creatinine clearance of <25 mL/min while receiving conventional amphotericin B therapy. Of the 473 patients, four were enrolled more than once; each enrollment contributed separately to the denominator. The median age was 39 years (range of <1 to 93 years); 307 patients were male and 166 female. Patients were Caucasian (381, 81%), African-American (41, 9%), Hispanic (27, 6%), Asian (10, 2%), and various other races (14, 3%). The median baseline neutrophil count was 4,000 PMN/mm3; of these, 101 (21%) had a baseline neutrophil count <500/mm 3. Two-hundred eighty-two patients of the 473 patients were considered evaluable for response to therapy; the other 191 patients were excluded on the basis of unconfirmed diagnosis, confounding factors, concomitant systemic antifungal therapy, or receiving 4 doses or less of ABELCET ®. For evaluable patients, the following fungal infections were treated (n=282): aspergillosis (n=111), candidiasis (n=87), zygomycosis (n=25), cryptococcosis (n=16), and fusariosis (n=11). There were fewer than 10 evaluable patients for each of several other fungal species treated. For each type of fungal infection listed above there were some patients successfully treated. However, in the absence of controlled studies it is unknown how response would have compared to either continuing conventional amphotericin B therapy or the use of alternative antifungal agents. Renal Function:Patients with aspergillosis who initiated treatment with ABELCET ®when serum creatinine was above 2.5 mg/dL experienced a decline in serum creatinine during treatment (Figure 1). Serum creatinine levels were also lower during treatment with ABELCET ®when compared to the serum creatinine levels of patients treated with conventional amphotericin B in a retrospective historical control study. Meaningful statistical testing of the differences between these two groups is precluded since these data were obtained from two separate studies. [ ]= Number of patients at each time point. Note: These curves do not represent the clinical course of a given patient, but that of an open-label cohort of patients. [ ]= Number of patients at each time point. Note: These curves do not represent the clinical course of a given patient, but that of an open-label cohort of patients. In a randomized study of ABELCET ®for the treatment of invasive candidiasis in patients with normal baseline renal function, the incidence of nephrotoxicity was significantly less for ABELCET ®at a dose of 5 mg/kg/day than for conventional amphotericin B at a dose of 0.7 mg/kg/day. Despite generally less nephrotoxicity of ABELCET ®observed at a dose of 5 mg/kg/day compared with conventional amphotericin B therapy at a dose range of 0.6-1 mg/kg/day, dose-limiting renal toxicity may still be observed with ABELCET ®. Renal toxicity of doses greater than 5 mg/kg/day of ABELCET ®has not been formally studied.",
      "Description": "ABELCET ®is a sterile, pyrogen-free suspension for intravenous infusion. ABELCET ®consists of amphotericin B complexed with two phospholipids in a 1:1 drug-to-lipid molar ratio. The two phospholipids, l-α-dimyristoylphosphatidylcholine (DMPC) and l-α-dimyristoylphosphatidylglycerol (DMPG), are present in a 7:3 molar ratio. ABELCET ®is yellow and opaque in appearance, with a pH of 5 - 7. NOTE: Liposomal encapsulation or incorporation in a lipid complex can substantially affect a drug’s functional properties relative to those of the unencapsulated or nonlipid-associated drug. In addition, different liposomal or lipid-complexed products with a common active ingredient may vary from one another in the chemical composition and physical form of the lipid component. Such differences may affect functional properties of these drug products. Amphotericin B is a polyene, antifungal antibiotic produced from a strain of Streptomyces nodosus. Amphotericin B is designated chemically as [1R-(1R*, 3S*, 5R*, 6R*, 9R*, 11R*, 15S*, 16R*, 17R*, 18S*, 19E, 21E, 23E, 25E, 27E, 29E, 31E, 33R*, 35S*, 36R*, 37S*)]-33-[(3-Amino-3, 6-dideoxy- β-D-mannopyranosyl) oxy]-1,3,5,6,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-14,39-dioxabicyclo[33.3.1] nonatriaconta-19, 21, 23, 25, 27, 29, 31-heptaene-36-carboxylic acid. It has a molecular weight of 924.09 and a molecular formula of C 47H 73NO 17. The structural formula is:. ABELCET ®is provided as a sterile, opaque suspension in 20 mL glass, single-use vials. Each 20 mL vial contains 100 mg of amphotericin B in 20 mL of suspension (see DOSAGE AND ADMINISTRATION), and each mL of ABELCET ®contains:. Amphotericin B USP 5.0 mg. l-α-dimyristoylphosphatidylcholine (DMPC) 3.4 mg. l-α-dimyristoylphosphatidylglycerol (DMPG) 1.5 mg. Sodium Chloride USP 9.0 mg. Water for Injection USP, q.s. 1.0 mL. MICROBIOLOGY. Mechanism of Action. The active component of ABELCET ®, amphotericin B, acts by binding to sterols in the cell membrane of susceptible fungi, with a resultant change in the permeability of the membrane. Mammalian cell membranes also contain sterols, and damage to human cells is believed to occur through the same mechanism of action. Activity in vitroand in vivo. ABELCET ®shows in vitro activity against Aspergillussp. (n=3) and Candidasp. (n=10), with MICs generally <1 μg/mL. Depending upon the species and strain of Aspergillusand Candidatested, significant in vitrodifferences in susceptibility to amphotericin B have been reported (MICs ranging from 0.1 to >10 μg/mL). ABELCET ®is active in animal models against Aspergillus fumigatus, Candida albicans, C. guillermondii, C. stellatoideae, and C. tropicalis, Cryptococcussp., Coccidioidomycessp., Histoplasmasp., and Blastomycessp. in which end-points were clearance of microorganisms from target organ(s) and/or prolonged survival of infected animals. Drug Resistance. Fungal species with decreased susceptibility to amphotericin B have been isolated after serial passage in culture media containing the drug, and from some patients receiving prolonged therapy. Although the relevance of drug resistance to clinical outcome has not been established, fungal species which are resistant to amphotericin B may also be resistant to ABELCET ®. Susceptibility Testing. For specific information regarding susceptibility test interpretive criteria, and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC."
    },
    {
      "NDCCode": "65862-166-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE (65862-166-01) ",
      "NDC11Code": "65862-0166-01",
      "ProductNDC": "65862-166",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Trandolapril",
      "NonProprietaryName": "Trandolapril",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20070612",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078438",
      "LabelerName": "Aurobindo Pharma Limited",
      "SubstanceName": "TRANDOLAPRIL",
      "StrengthNumber": "4",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-04-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20070612",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hypertension Trandolapril tablets USP are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive medication such as hydrochlorothiazide. Heart Failure Post Myocardial Infarction or Left-Ventricular Dysfunction Post Myocardial Infarction Trandolapril tablets USP are indicated in stable patients who have evidence of left-ventricular systolic dysfunction (identified by wall motion abnormalities) or who are symptomatic from congestive heart failure within the first few days after sustaining acute myocardial infarction. Administration of trandolapril to Caucasian patients has been shown to decrease the risk of death (principally cardiovascular death) and to decrease the risk of heart failure-related hospitalization (see CLINICAL PHARMACOLOGY - Heart Failure or Left-Ventricular Dysfunction Post Myocardial Infarction for details of the survival trial).",
      "Description": "Trandolapril is the ethyl ester prodrug of a nonsulfhydryl angiotensin converting enzyme (ACE) inhibitor, trandolaprilat. Trandolapril is chemically described as (2S,3aR,7aS)-1-[(S)-N-[(S)-1-Carboxy-3-phenylpropyl]alanyl] hexahydro-2-indolinecarboxylic acid, 1-ethyl ester. Its molecular formula is C24H34N2O5 and its structural formula is. M.W. = 430.54Melting Point = 125°CTrandolapril USP is a white or almost white powder that is soluble (>100 mg/mL) in chloroform, dichloromethane, and methanol. Trandolapril tablets USP contain 1 mg, 2 mg, or 4 mg of trandolapril USP for oral administration. Each tablet also contains lactose monohydrate, corn starch, croscarmellose sodium, hypromellose, povidone, and sodium stearyl fumarate. In addition 1 mg and 4 mg tablet also contains ferric oxide red and 2 mg tablet contains ferric oxide yellow."
    },
    {
      "NDCCode": "65862-166-61",
      "PackageDescription": "6000 TABLET in 1 BAG (65862-166-61) ",
      "NDC11Code": "65862-0166-61",
      "ProductNDC": "65862-166",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Trandolapril",
      "DosageFormName": "TABLET",
      "StartMarketingDate": "20070612",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Aurobindo Pharma Limited",
      "SubstanceName": "TRANDOLAPRIL",
      "StrengthNumber": "4",
      "StrengthUnit": "mg/1",
      "Status": "Unfinished",
      "LastUpdate": "2024-04-23",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "12-JUN-07"
    },
    {
      "NDCCode": "65862-166-99",
      "PackageDescription": "1000 TABLET in 1 BOTTLE (65862-166-99) ",
      "NDC11Code": "65862-0166-99",
      "ProductNDC": "65862-166",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Trandolapril",
      "NonProprietaryName": "Trandolapril",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20070612",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078438",
      "LabelerName": "Aurobindo Pharma Limited",
      "SubstanceName": "TRANDOLAPRIL",
      "StrengthNumber": "4",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-04-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20070612",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hypertension Trandolapril tablets USP are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive medication such as hydrochlorothiazide. Heart Failure Post Myocardial Infarction or Left-Ventricular Dysfunction Post Myocardial Infarction Trandolapril tablets USP are indicated in stable patients who have evidence of left-ventricular systolic dysfunction (identified by wall motion abnormalities) or who are symptomatic from congestive heart failure within the first few days after sustaining acute myocardial infarction. Administration of trandolapril to Caucasian patients has been shown to decrease the risk of death (principally cardiovascular death) and to decrease the risk of heart failure-related hospitalization (see CLINICAL PHARMACOLOGY - Heart Failure or Left-Ventricular Dysfunction Post Myocardial Infarction for details of the survival trial).",
      "Description": "Trandolapril is the ethyl ester prodrug of a nonsulfhydryl angiotensin converting enzyme (ACE) inhibitor, trandolaprilat. Trandolapril is chemically described as (2S,3aR,7aS)-1-[(S)-N-[(S)-1-Carboxy-3-phenylpropyl]alanyl] hexahydro-2-indolinecarboxylic acid, 1-ethyl ester. Its molecular formula is C24H34N2O5 and its structural formula is. M.W. = 430.54Melting Point = 125°CTrandolapril USP is a white or almost white powder that is soluble (>100 mg/mL) in chloroform, dichloromethane, and methanol. Trandolapril tablets USP contain 1 mg, 2 mg, or 4 mg of trandolapril USP for oral administration. Each tablet also contains lactose monohydrate, corn starch, croscarmellose sodium, hypromellose, povidone, and sodium stearyl fumarate. In addition 1 mg and 4 mg tablet also contains ferric oxide red and 2 mg tablet contains ferric oxide yellow."
    },
    {
      "NDCCode": "70056-001-02",
      "PackageDescription": "1 CONTAINER in 1 CARTON (70056-001-02)  > 18 g in 1 CONTAINER (70056-001-01)",
      "NDC11Code": "70056-0001-02",
      "ProductNDC": "70056-001",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Son And Park Air Chou Foundation 21",
      "NonProprietaryName": "Titanium Dioxide, Octinoxate",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20150901",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "S&P Cosmetic Co., Ltd",
      "SubstanceName": "TITANIUM DIOXIDE; OCTINOXATE",
      "StrengthNumber": "3.166; 1.35",
      "StrengthUnit": "g/18g; g/18g",
      "Status": "Deprecated",
      "LastUpdate": "2017-08-23"
    },
    {
      "NDCCode": "70056-002-02",
      "PackageDescription": "1 CONTAINER in 1 CARTON (70056-002-02)  > 18 g in 1 CONTAINER (70056-002-01)",
      "NDC11Code": "70056-0002-02",
      "ProductNDC": "70056-002",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Son And Park Air Chou Foundation 23",
      "NonProprietaryName": "Titanium Dioxide, Octinoxate",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20150905",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "S&P Cosmetic Co., Ltd",
      "SubstanceName": "TITANIUM DIOXIDE; OCTINOXATE",
      "StrengthNumber": "3.166; 1.35",
      "StrengthUnit": "g/18g; g/18g",
      "Status": "Deprecated",
      "LastUpdate": "2017-08-23"
    },
    {
      "NDCCode": "70436-166-01",
      "PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70436-166-01) ",
      "NDC11Code": "70436-0166-01",
      "ProductNDC": "70436-166",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metoprolol Succinate",
      "NonProprietaryName": "Metoprolol Succinate",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210429",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA213854",
      "LabelerName": "Slate Run Pharmaceuticals, LLC",
      "SubstanceName": "METOPROLOL SUCCINATE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-05-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210429",
      "SamplePackage": "N",
      "IndicationAndUsage": "Metoprolol succinate, is a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris. ( 1.2) , 3 Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure. ( 1.3) .",
      "Description": "Metoprolol succinate, is a beta 1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol Succinate Extended-Release Tablets, USP have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1-(isopropyl amino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate, USP is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethyl ether and heptane. Inactive ingredients: colloidal silicon dioxide, crospovidone, ethylcellulose, hypromellose, lactose monohydrate (25 mg and 50 mg), magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-partially hydrolyzed, sugar spheres (composed of corn starch and sucrose), talc, titanium dioxide and triethyl citrate. FDA approved dissolution test specifications differ from USP."
    }
  ]
}
                    
{"NDC":[{"NDCCode":"76150-166-23","ProprietaryName":"Tropical Coconut","NonProprietaryName":"Classic Body Sunscreen"},{"NDCCode":"76150-166-24","ProprietaryName":"Tropical Coconut","NonProprietaryName":"Classic Body Sunscreen"},{"NDCCode":"76150-119-23","ProprietaryName":"Pina Colada Body","NonProprietaryName":"Classic Sunscreen"},{"NDCCode":"76150-163-23","ProprietaryName":"Classic Sport Unscented","NonProprietaryName":"Classic Continuous"},{"NDCCode":"76150-164-23","ProprietaryName":"Guava Mango Sport","NonProprietaryName":"Classic Sunscreen"},{"NDCCode":"76150-165-23","ProprietaryName":"Fresh Cucumber Classic Body","NonProprietaryName":"Sunscreen"},{"NDCCode":"76150-211-23","ProprietaryName":"Yerba Mate Mineral","NonProprietaryName":"Sunscreen"},{"NDCCode":"11673-166-28","ProprietaryName":"Up And Up Childrens Ibuprofen","NonProprietaryName":"Ibuprofen"},{"NDCCode":"25021-797-05","ProprietaryName":"Valproate Sodium","NonProprietaryName":"Valproate Sodium"},{"NDCCode":"33342-166-10","ProprietaryName":"Pregablin","NonProprietaryName":"Pregablin"},{"NDCCode":"42806-512-01","ProprietaryName":"Quinidine Sulfate","NonProprietaryName":"Quinidine Sulfate Tablet"},{"NDCCode":"42806-512-30","ProprietaryName":"Quinidine Sulfate","NonProprietaryName":"Quinidine Sulfate Tablet"},{"NDCCode":"42806-513-01","ProprietaryName":"Quinidine Sulfate","NonProprietaryName":"Quinidine Sulfate Tablet"},{"NDCCode":"42806-513-30","ProprietaryName":"Quinidine Sulfate","NonProprietaryName":"Quinidine Sulfate Tablet"},{"NDCCode":"42858-166-01","ProprietaryName":"Lisdexamfetamine Dimesylate","NonProprietaryName":"Lisdexamfetamine Dimesylate"},{"NDCCode":"44087-0022-3","ProprietaryName":"Rebif","NonProprietaryName":"Interferon Beta-1a"},{"NDCCode":"44087-0044-3","ProprietaryName":"Rebif","NonProprietaryName":"Interferon Beta-1a"},{"NDCCode":"44087-0188-1","ProprietaryName":"Rebif Rebidose","NonProprietaryName":"Interferon Beta-1a"},{"NDCCode":"44087-3322-1","ProprietaryName":"Rebif Rebidose","NonProprietaryName":"Interferon Beta-1a"},{"NDCCode":"44087-3344-1","ProprietaryName":"Rebif Rebidose","NonProprietaryName":"Interferon Beta-1a"},{"NDCCode":"44087-8822-1","ProprietaryName":"Rebif","NonProprietaryName":"Interferon Beta-1a"},{"NDCCode":"55718-166-01","NonProprietaryName":"Isopropyl Alcohol"},{"NDCCode":"55718-166-02","NonProprietaryName":"Isopropyl Alcohol"},{"NDCCode":"57665-101-41","ProprietaryName":"Abelcet","NonProprietaryName":"Amphotericin B, Dimyristoylphosphatidylcholine, Dl- And Dimyristoylphosphatidylglycerol, Dl-"},{"NDCCode":"65862-166-01","ProprietaryName":"Trandolapril","NonProprietaryName":"Trandolapril"},{"NDCCode":"65862-166-61","NonProprietaryName":"Trandolapril"},{"NDCCode":"65862-166-99","ProprietaryName":"Trandolapril","NonProprietaryName":"Trandolapril"},{"NDCCode":"70056-001-02","ProprietaryName":"Son And Park Air Chou Foundation 21","NonProprietaryName":"Titanium Dioxide, Octinoxate"},{"NDCCode":"70056-002-02","ProprietaryName":"Son And Park Air Chou Foundation 23","NonProprietaryName":"Titanium Dioxide, Octinoxate"},{"NDCCode":"70436-166-01","ProprietaryName":"Metoprolol Succinate","NonProprietaryName":"Metoprolol Succinate"}]}
                    
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<NDCList>
  <NDC>
    <NDCCode>76150-166-23</NDCCode>
    <PackageDescription>89 mL in 1 CAN (76150-166-23)</PackageDescription>
    <NDC11Code>76150-0166-23</NDC11Code>
    <ProductNDC>76150-166</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Tropical Coconut</ProprietaryName>
    <ProprietaryNameSuffix>Spf 30 Broad Spectrum</ProprietaryNameSuffix>
    <NonProprietaryName>Classic Body Sunscreen</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20160101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Bell International Laboratories, Inc.</LabelerName>
    <SubstanceName>AVOBENZONE; OCTOCRYLENE; OCTINOXATE; OCTISALATE</SubstanceName>
    <StrengthNumber>2; 7; 7.5; 4</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>76150-166-24</NDCCode>
    <PackageDescription>236 mL in 1 CAN (76150-166-24)</PackageDescription>
    <NDC11Code>76150-0166-24</NDC11Code>
    <ProductNDC>76150-166</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Tropical Coconut</ProprietaryName>
    <ProprietaryNameSuffix>Spf 30 Broad Spectrum</ProprietaryNameSuffix>
    <NonProprietaryName>Classic Body Sunscreen</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20160101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Bell International Laboratories, Inc.</LabelerName>
    <SubstanceName>AVOBENZONE; OCTOCRYLENE; OCTINOXATE; OCTISALATE</SubstanceName>
    <StrengthNumber>2; 7; 7.5; 4</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>76150-119-23</NDCCode>
    <PackageDescription>90 mL in 1 CAN (76150-119-23)</PackageDescription>
    <NDC11Code>76150-0119-23</NDC11Code>
    <ProductNDC>76150-119</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Pina Colada Body</ProprietaryName>
    <ProprietaryNameSuffix>Spf 30 Broad Spectrum</ProprietaryNameSuffix>
    <NonProprietaryName>Classic Sunscreen</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Bell International Laboratories, Inc.</LabelerName>
    <SubstanceName>OCTOCRYLENE; OCTISALATE; AVOBENZONE; OCTINOXATE</SubstanceName>
    <StrengthNumber>7; 4; 2; 7.5</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>76150-163-23</NDCCode>
    <PackageDescription>89 mL in 1 CAN (76150-163-23)</PackageDescription>
    <NDC11Code>76150-0163-23</NDC11Code>
    <ProductNDC>76150-163</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Classic Sport Unscented</ProprietaryName>
    <ProprietaryNameSuffix>Spf 50 Broad Spectrum</ProprietaryNameSuffix>
    <NonProprietaryName>Classic Continuous</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20160101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Bell International Laboratories, Inc.</LabelerName>
    <SubstanceName>AVOBENZONE; OCTINOXATE; OCTOCRYLENE</SubstanceName>
    <StrengthNumber>3; 7.5; 10</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL; g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>76150-164-23</NDCCode>
    <PackageDescription>100 mL in 1 CAN (76150-164-23)</PackageDescription>
    <NDC11Code>76150-0164-23</NDC11Code>
    <ProductNDC>76150-164</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Guava Mango Sport</ProprietaryName>
    <ProprietaryNameSuffix>Spf 30 Broad Spectrum</ProprietaryNameSuffix>
    <NonProprietaryName>Classic Sunscreen</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20160101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Bell International Laboratories, Inc.</LabelerName>
    <SubstanceName>AVOBENZONE; OCTINOXATE; OCTOCRYLENE</SubstanceName>
    <StrengthNumber>3; 7.5; 10</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL; g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>76150-165-23</NDCCode>
    <PackageDescription>89 mL in 1 CAN (76150-165-23)</PackageDescription>
    <NDC11Code>76150-0165-23</NDC11Code>
    <ProductNDC>76150-165</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Fresh Cucumber Classic Body</ProprietaryName>
    <ProprietaryNameSuffix>Spf 30 Broad Spectrum</ProprietaryNameSuffix>
    <NonProprietaryName>Sunscreen</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20150101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Bell International Laboratories, Inc.</LabelerName>
    <SubstanceName>OCTOCRYLENE; AVOBENZONE; OCTISALATE; OCTINOXATE</SubstanceName>
    <StrengthNumber>7; 2; 4; 7.5</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>76150-211-23</NDCCode>
    <PackageDescription>90 mL in 1 CAN (76150-211-23)</PackageDescription>
    <NDC11Code>76150-0211-23</NDC11Code>
    <ProductNDC>76150-211</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Yerba Mate Mineral</ProprietaryName>
    <ProprietaryNameSuffix>Spf 30 Broad Spectrum</ProprietaryNameSuffix>
    <NonProprietaryName>Sunscreen</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20150801</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Bell International Labroatories, Inc</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>12</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>11673-166-28</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (11673-166-28)  &gt; 148 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>11673-0166-28</NDC11Code>
    <ProductNDC>11673-166</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Up And Up Childrens Ibuprofen</ProprietaryName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090612</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074937</ApplicationNumber>
    <LabelerName>Target Corporation</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-10-23</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>25021-797-05</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (25021-797-05)  / 5 mL in 1 VIAL</PackageDescription>
    <NDC11Code>25021-0797-05</NDC11Code>
    <ProductNDC>25021-797</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Valproate Sodium</ProprietaryName>
    <NonProprietaryName>Valproate Sodium</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20241201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076295</ApplicationNumber>
    <LabelerName>Sagent Pharmaceuticals</LabelerName>
    <SubstanceName>VALPROATE SODIUM</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Valproate Sodium Injection is indicated as an intravenous alternative in patients in whom oral administration of valproate products is temporarily not feasible in the following conditions: : 1 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1) .</IndicationAndUsage>
    <Description>Valproate sodium is the sodium salt of valproic acid designated as sodium 2-propylpentanoate. Valproate sodium has the following structure:. Valproate sodium has a molecular weight of 166.2. It occurs as an essentially white and odorless, crystalline, deliquescent powder. Valproate Sodium Injection, USP is available in 5 mL single-dose vials for intravenous injection. Each mL contains valproate sodium equivalent to 100 mg valproic acid, edetate disodium 0.40 mg, and water for injection to volume. The pH is adjusted to 7.6 with sodium hydroxide and/or hydrochloric acid. The solution is clear and colorless.</Description>
  </NDC>
  <NDC>
    <NDCCode>33342-166-10</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (33342-166-10) </PackageDescription>
    <NDC11Code>33342-0166-10</NDC11Code>
    <ProductNDC>33342-166</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pregablin</ProprietaryName>
    <NonProprietaryName>Pregablin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241113</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205924</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-07-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241113</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pregabalin capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older , 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
    <Description>Pregabalin, USP is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is - 1.35.Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, pregelatinized starch, talc as inactive ingredients. The capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>42806-512-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (42806-512-01) </PackageDescription>
    <NDC11Code>42806-0512-01</NDC11Code>
    <ProductNDC>42806-512</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Quinidine Sulfate</ProprietaryName>
    <NonProprietaryName>Quinidine Sulfate Tablet</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20211215</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA088072</ApplicationNumber>
    <LabelerName>EPIC PHARMA, LLC</LabelerName>
    <SubstanceName>QUINIDINE SULFATE</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antiarrhythmic [EPC], Cytochrome P450 2D6 Inhibitor [EPC], Cytochrome P450 2D6 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-12-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211215</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>In patients with symptomatic atrial fibrillation/flutter whose symptoms are not adequately controlled by measures that reduce the rate of ventricular response, quinidine sulfate is indicated as a means of restoring normal sinus rhythm. If this use of quinidine sulfate does not restore sinus rhythm within a reasonable time (see DOSAGE AND ADMINISTRATION), then quinidine sulfate should be discontinued.</IndicationAndUsage>
    <Description>Quinidine is an antimalarial schizonticide and an antiarrhythmic agent with class 1A activity; it is the d-isomer of quinine, and its molecular weight is 324.43. Quinidine sulfate is the sulfate salt of quinidine; its chemical name is cinchonan-9-ol, 6’- methoxy-, (9S)-, sulfate (2:1) dihydrate; its structural formula is. Its molecular formula is: C40H48N4O4∙H2SO4∙2H2O; and its molecular weight is 782.96, of which 82.9% is quinidine base. Quinidine sulfate occurs as fine needle-like, white crystals, frequently cohering in masses, or fine, white powder. It is odorless, has a very bitter taste, and darkens on exposure to light. It is slightly soluble in water, soluble in alcohol and in chloroform, and insoluble in ether. Each tablet, for oral administration, contains 200 mg of quinidine sulfate (equivalent to 166 mg of quinidine base) 300 mg of quinidine sulfate (equivalent to 249 mg of quinidine base). In addition, each tablet contains the following inactive ingredients: confectioner’s sugar, corn starch, microcrystalline cellulose, pregelatinized starch and zinc stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>42806-512-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (42806-512-30) </PackageDescription>
    <NDC11Code>42806-0512-30</NDC11Code>
    <ProductNDC>42806-512</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Quinidine Sulfate</ProprietaryName>
    <NonProprietaryName>Quinidine Sulfate Tablet</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20211215</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA088072</ApplicationNumber>
    <LabelerName>EPIC PHARMA, LLC</LabelerName>
    <SubstanceName>QUINIDINE SULFATE</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antiarrhythmic [EPC], Cytochrome P450 2D6 Inhibitor [EPC], Cytochrome P450 2D6 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-12-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220102</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>In patients with symptomatic atrial fibrillation/flutter whose symptoms are not adequately controlled by measures that reduce the rate of ventricular response, quinidine sulfate is indicated as a means of restoring normal sinus rhythm. If this use of quinidine sulfate does not restore sinus rhythm within a reasonable time (see DOSAGE AND ADMINISTRATION), then quinidine sulfate should be discontinued.</IndicationAndUsage>
    <Description>Quinidine is an antimalarial schizonticide and an antiarrhythmic agent with class 1A activity; it is the d-isomer of quinine, and its molecular weight is 324.43. Quinidine sulfate is the sulfate salt of quinidine; its chemical name is cinchonan-9-ol, 6’- methoxy-, (9S)-, sulfate (2:1) dihydrate; its structural formula is. Its molecular formula is: C40H48N4O4∙H2SO4∙2H2O; and its molecular weight is 782.96, of which 82.9% is quinidine base. Quinidine sulfate occurs as fine needle-like, white crystals, frequently cohering in masses, or fine, white powder. It is odorless, has a very bitter taste, and darkens on exposure to light. It is slightly soluble in water, soluble in alcohol and in chloroform, and insoluble in ether. Each tablet, for oral administration, contains 200 mg of quinidine sulfate (equivalent to 166 mg of quinidine base) 300 mg of quinidine sulfate (equivalent to 249 mg of quinidine base). In addition, each tablet contains the following inactive ingredients: confectioner’s sugar, corn starch, microcrystalline cellulose, pregelatinized starch and zinc stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>42806-513-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (42806-513-01) </PackageDescription>
    <NDC11Code>42806-0513-01</NDC11Code>
    <ProductNDC>42806-513</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Quinidine Sulfate</ProprietaryName>
    <NonProprietaryName>Quinidine Sulfate Tablet</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20211215</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA088072</ApplicationNumber>
    <LabelerName>EPIC PHARMA, LLC</LabelerName>
    <SubstanceName>QUINIDINE SULFATE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antiarrhythmic [EPC], Cytochrome P450 2D6 Inhibitor [EPC], Cytochrome P450 2D6 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-12-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211215</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>In patients with symptomatic atrial fibrillation/flutter whose symptoms are not adequately controlled by measures that reduce the rate of ventricular response, quinidine sulfate is indicated as a means of restoring normal sinus rhythm. If this use of quinidine sulfate does not restore sinus rhythm within a reasonable time (see DOSAGE AND ADMINISTRATION), then quinidine sulfate should be discontinued.</IndicationAndUsage>
    <Description>Quinidine is an antimalarial schizonticide and an antiarrhythmic agent with class 1A activity; it is the d-isomer of quinine, and its molecular weight is 324.43. Quinidine sulfate is the sulfate salt of quinidine; its chemical name is cinchonan-9-ol, 6’- methoxy-, (9S)-, sulfate (2:1) dihydrate; its structural formula is. Its molecular formula is: C40H48N4O4∙H2SO4∙2H2O; and its molecular weight is 782.96, of which 82.9% is quinidine base. Quinidine sulfate occurs as fine needle-like, white crystals, frequently cohering in masses, or fine, white powder. It is odorless, has a very bitter taste, and darkens on exposure to light. It is slightly soluble in water, soluble in alcohol and in chloroform, and insoluble in ether. Each tablet, for oral administration, contains 200 mg of quinidine sulfate (equivalent to 166 mg of quinidine base) 300 mg of quinidine sulfate (equivalent to 249 mg of quinidine base). In addition, each tablet contains the following inactive ingredients: confectioner’s sugar, corn starch, microcrystalline cellulose, pregelatinized starch and zinc stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>42806-513-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (42806-513-30) </PackageDescription>
    <NDC11Code>42806-0513-30</NDC11Code>
    <ProductNDC>42806-513</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Quinidine Sulfate</ProprietaryName>
    <NonProprietaryName>Quinidine Sulfate Tablet</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20211215</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA088072</ApplicationNumber>
    <LabelerName>EPIC PHARMA, LLC</LabelerName>
    <SubstanceName>QUINIDINE SULFATE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antiarrhythmic [EPC], Cytochrome P450 2D6 Inhibitor [EPC], Cytochrome P450 2D6 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-12-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220102</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>In patients with symptomatic atrial fibrillation/flutter whose symptoms are not adequately controlled by measures that reduce the rate of ventricular response, quinidine sulfate is indicated as a means of restoring normal sinus rhythm. If this use of quinidine sulfate does not restore sinus rhythm within a reasonable time (see DOSAGE AND ADMINISTRATION), then quinidine sulfate should be discontinued.</IndicationAndUsage>
    <Description>Quinidine is an antimalarial schizonticide and an antiarrhythmic agent with class 1A activity; it is the d-isomer of quinine, and its molecular weight is 324.43. Quinidine sulfate is the sulfate salt of quinidine; its chemical name is cinchonan-9-ol, 6’- methoxy-, (9S)-, sulfate (2:1) dihydrate; its structural formula is. Its molecular formula is: C40H48N4O4∙H2SO4∙2H2O; and its molecular weight is 782.96, of which 82.9% is quinidine base. Quinidine sulfate occurs as fine needle-like, white crystals, frequently cohering in masses, or fine, white powder. It is odorless, has a very bitter taste, and darkens on exposure to light. It is slightly soluble in water, soluble in alcohol and in chloroform, and insoluble in ether. Each tablet, for oral administration, contains 200 mg of quinidine sulfate (equivalent to 166 mg of quinidine base) 300 mg of quinidine sulfate (equivalent to 249 mg of quinidine base). In addition, each tablet contains the following inactive ingredients: confectioner’s sugar, corn starch, microcrystalline cellulose, pregelatinized starch and zinc stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>42858-166-01</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE, PLASTIC (42858-166-01) </PackageDescription>
    <NDC11Code>42858-0166-01</NDC11Code>
    <ProductNDC>42858-166</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
    <NonProprietaryName>Lisdexamfetamine Dimesylate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240130</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215330</ApplicationNumber>
    <LabelerName>Rhodes Pharmaceuticals LLC</LabelerName>
    <SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-05-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240130</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lisdexamfetamine Dimesylate Capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].</IndicationAndUsage>
    <Description>Lisdexamfetamine dimesylate capsules, a CNS stimulant, are for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O∙(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. The capsule shells (imprinted with RP##) contain gelatin, titanium dioxide, and one or more of the following: D&amp;C Red #28, FD&amp;C Blue #1, FD&amp;C Red #3, FD&amp;C Red #40, FD&amp;C Yellow #6, Iron Oxide Black, Iron Oxide Red, and Iron Oxide Yellow. Additionally, the imprint ink contains the following non-volatile ingredients: shellac, black iron oxide, and potassium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>44087-0022-3</NDCCode>
    <PackageDescription>12 SYRINGE, GLASS in 1 CARTON (44087-0022-3)  / .5 mL in 1 SYRINGE, GLASS (44087-0022-9) </PackageDescription>
    <NDC11Code>44087-0022-03</NDC11Code>
    <ProductNDC>44087-0022</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rebif</ProprietaryName>
    <NonProprietaryName>Interferon Beta-1a</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20020307</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103780</ApplicationNumber>
    <LabelerName>EMD Serono, Inc.</LabelerName>
    <SubstanceName>INTERFERON BETA-1A</SubstanceName>
    <StrengthNumber>22</StrengthNumber>
    <StrengthUnit>ug/.5mL</StrengthUnit>
    <Pharm_Classes>Interferon beta [EPC], Interferon-beta [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20020307</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>REBIF is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
    <Description>REBIF (interferon beta-1a) is a purified 166 amino acid glycoprotein with a molecular weight of approximately 22,500 daltons. It is produced by recombinant DNA technology using genetically engineered Chinese Hamster Ovary cells into which the human interferon beta gene has been introduced. The amino acid sequence of REBIF is identical to that of natural fibroblast derived human interferon beta. Natural interferon beta and interferon beta-1a (REBIF) are glycosylated with each containing a single N-linked complex carbohydrate moiety. Using a reference standard calibrated against the World Health Organization natural interferon beta standard (Second International Standard for Interferon, Human Fibroblast GB 23 902 531), REBIF has a specific activity of approximately 270 million international units (MIU) of antiviral activity per mg of interferon beta-1a determined specifically by an in vitro cytopathic effect bioassay using WISH cells and Vesicular Stomatitis virus. REBIF 8.8 mcg, 22 mcg and 44 mcg contains approximately 2.4 million international units, 6 million international units or 12 million international units, respectively, of antiviral activity using this method. REBIF (interferon beta-1a) is formulated as a sterile solution in a prefilled syringe or REBIF Rebidose autoinjector intended for subcutaneous (sc) injection. Each 0.5 mL (0.5 cc) of REBIF contains either 22 mcg or 44 mcg of interferon beta-1a, 2 mg or 4 mg albumin (human), 27.3 mg mannitol, 0.4 mg sodium acetate, and water for injection. Each 0.2 mL (0.2 cc) of REBIF contains 8.8 mcg of interferon beta-1a, 0.8 mg albumin (human), 10.9 mg mannitol, 0.16 mg sodium acetate, and water for injection.</Description>
  </NDC>
  <NDC>
    <NDCCode>44087-0044-3</NDCCode>
    <PackageDescription>12 SYRINGE, GLASS in 1 CARTON (44087-0044-3)  / .5 mL in 1 SYRINGE, GLASS (44087-0044-9) </PackageDescription>
    <NDC11Code>44087-0044-03</NDC11Code>
    <ProductNDC>44087-0044</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rebif</ProprietaryName>
    <NonProprietaryName>Interferon Beta-1a</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20020307</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103780</ApplicationNumber>
    <LabelerName>EMD Serono, Inc.</LabelerName>
    <SubstanceName>INTERFERON BETA-1A</SubstanceName>
    <StrengthNumber>44</StrengthNumber>
    <StrengthUnit>ug/.5mL</StrengthUnit>
    <Pharm_Classes>Interferon beta [EPC], Interferon-beta [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20020307</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>REBIF is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
    <Description>REBIF (interferon beta-1a) is a purified 166 amino acid glycoprotein with a molecular weight of approximately 22,500 daltons. It is produced by recombinant DNA technology using genetically engineered Chinese Hamster Ovary cells into which the human interferon beta gene has been introduced. The amino acid sequence of REBIF is identical to that of natural fibroblast derived human interferon beta. Natural interferon beta and interferon beta-1a (REBIF) are glycosylated with each containing a single N-linked complex carbohydrate moiety. Using a reference standard calibrated against the World Health Organization natural interferon beta standard (Second International Standard for Interferon, Human Fibroblast GB 23 902 531), REBIF has a specific activity of approximately 270 million international units (MIU) of antiviral activity per mg of interferon beta-1a determined specifically by an in vitro cytopathic effect bioassay using WISH cells and Vesicular Stomatitis virus. REBIF 8.8 mcg, 22 mcg and 44 mcg contains approximately 2.4 million international units, 6 million international units or 12 million international units, respectively, of antiviral activity using this method. REBIF (interferon beta-1a) is formulated as a sterile solution in a prefilled syringe or REBIF Rebidose autoinjector intended for subcutaneous (sc) injection. Each 0.5 mL (0.5 cc) of REBIF contains either 22 mcg or 44 mcg of interferon beta-1a, 2 mg or 4 mg albumin (human), 27.3 mg mannitol, 0.4 mg sodium acetate, and water for injection. Each 0.2 mL (0.2 cc) of REBIF contains 8.8 mcg of interferon beta-1a, 0.8 mg albumin (human), 10.9 mg mannitol, 0.16 mg sodium acetate, and water for injection.</Description>
  </NDC>
  <NDC>
    <NDCCode>44087-0188-1</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (44087-0188-1)  *  .2 mL in 1 PACKAGE *  .5 mL in 1 PACKAGE</PackageDescription>
    <NDC11Code>44087-0188-01</NDC11Code>
    <ProductNDC>44087-0188</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rebif Rebidose</ProprietaryName>
    <NonProprietaryName>Interferon Beta-1a</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20121221</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103780</ApplicationNumber>
    <LabelerName>EMD Serono, Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-09-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20121221</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>REBIF is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
    <Description>REBIF (interferon beta-1a) is a purified 166 amino acid glycoprotein with a molecular weight of approximately 22,500 daltons. It is produced by recombinant DNA technology using genetically engineered Chinese Hamster Ovary cells into which the human interferon beta gene has been introduced. The amino acid sequence of REBIF is identical to that of natural fibroblast derived human interferon beta. Natural interferon beta and interferon beta-1a (REBIF) are glycosylated with each containing a single N-linked complex carbohydrate moiety. Using a reference standard calibrated against the World Health Organization natural interferon beta standard (Second International Standard for Interferon, Human Fibroblast GB 23 902 531), REBIF has a specific activity of approximately 270 million international units (MIU) of antiviral activity per mg of interferon beta-1a determined specifically by an in vitro cytopathic effect bioassay using WISH cells and Vesicular Stomatitis virus. REBIF 8.8 mcg, 22 mcg and 44 mcg contains approximately 2.4 million international units, 6 million international units or 12 million international units, respectively, of antiviral activity using this method. REBIF (interferon beta-1a) is formulated as a sterile solution in a prefilled syringe or REBIF Rebidose autoinjector intended for subcutaneous (sc) injection. Each 0.5 mL (0.5 cc) of REBIF contains either 22 mcg or 44 mcg of interferon beta-1a, 2 mg or 4 mg albumin (human), 27.3 mg mannitol, 0.4 mg sodium acetate, and water for injection. Each 0.2 mL (0.2 cc) of REBIF contains 8.8 mcg of interferon beta-1a, 0.8 mg albumin (human), 10.9 mg mannitol, 0.16 mg sodium acetate, and water for injection.</Description>
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    <NDCCode>44087-3322-1</NDCCode>
    <PackageDescription>12 PACKAGE in 1 CARTON (44087-3322-1)  / .5 mL in 1 PACKAGE (44087-3322-9) </PackageDescription>
    <NDC11Code>44087-3322-01</NDC11Code>
    <ProductNDC>44087-3322</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rebif Rebidose</ProprietaryName>
    <NonProprietaryName>Interferon Beta-1a</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20121221</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103780</ApplicationNumber>
    <LabelerName>EMD Serono, Inc.</LabelerName>
    <SubstanceName>INTERFERON BETA-1A</SubstanceName>
    <StrengthNumber>22</StrengthNumber>
    <StrengthUnit>ug/.5mL</StrengthUnit>
    <Pharm_Classes>Interferon beta [EPC], Interferon-beta [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20121221</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>REBIF is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
    <Description>REBIF (interferon beta-1a) is a purified 166 amino acid glycoprotein with a molecular weight of approximately 22,500 daltons. It is produced by recombinant DNA technology using genetically engineered Chinese Hamster Ovary cells into which the human interferon beta gene has been introduced. The amino acid sequence of REBIF is identical to that of natural fibroblast derived human interferon beta. Natural interferon beta and interferon beta-1a (REBIF) are glycosylated with each containing a single N-linked complex carbohydrate moiety. Using a reference standard calibrated against the World Health Organization natural interferon beta standard (Second International Standard for Interferon, Human Fibroblast GB 23 902 531), REBIF has a specific activity of approximately 270 million international units (MIU) of antiviral activity per mg of interferon beta-1a determined specifically by an in vitro cytopathic effect bioassay using WISH cells and Vesicular Stomatitis virus. REBIF 8.8 mcg, 22 mcg and 44 mcg contains approximately 2.4 million international units, 6 million international units or 12 million international units, respectively, of antiviral activity using this method. REBIF (interferon beta-1a) is formulated as a sterile solution in a prefilled syringe or REBIF Rebidose autoinjector intended for subcutaneous (sc) injection. Each 0.5 mL (0.5 cc) of REBIF contains either 22 mcg or 44 mcg of interferon beta-1a, 2 mg or 4 mg albumin (human), 27.3 mg mannitol, 0.4 mg sodium acetate, and water for injection. Each 0.2 mL (0.2 cc) of REBIF contains 8.8 mcg of interferon beta-1a, 0.8 mg albumin (human), 10.9 mg mannitol, 0.16 mg sodium acetate, and water for injection.</Description>
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    <NDCCode>44087-3344-1</NDCCode>
    <PackageDescription>12 PACKAGE in 1 CARTON (44087-3344-1)  / .5 mL in 1 PACKAGE (44087-3344-9) </PackageDescription>
    <NDC11Code>44087-3344-01</NDC11Code>
    <ProductNDC>44087-3344</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rebif Rebidose</ProprietaryName>
    <NonProprietaryName>Interferon Beta-1a</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20121221</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103780</ApplicationNumber>
    <LabelerName>EMD Serono, Inc.</LabelerName>
    <SubstanceName>INTERFERON BETA-1A</SubstanceName>
    <StrengthNumber>44</StrengthNumber>
    <StrengthUnit>ug/.5mL</StrengthUnit>
    <Pharm_Classes>Interferon beta [EPC], Interferon-beta [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20121221</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>REBIF is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
    <Description>REBIF (interferon beta-1a) is a purified 166 amino acid glycoprotein with a molecular weight of approximately 22,500 daltons. It is produced by recombinant DNA technology using genetically engineered Chinese Hamster Ovary cells into which the human interferon beta gene has been introduced. The amino acid sequence of REBIF is identical to that of natural fibroblast derived human interferon beta. Natural interferon beta and interferon beta-1a (REBIF) are glycosylated with each containing a single N-linked complex carbohydrate moiety. Using a reference standard calibrated against the World Health Organization natural interferon beta standard (Second International Standard for Interferon, Human Fibroblast GB 23 902 531), REBIF has a specific activity of approximately 270 million international units (MIU) of antiviral activity per mg of interferon beta-1a determined specifically by an in vitro cytopathic effect bioassay using WISH cells and Vesicular Stomatitis virus. REBIF 8.8 mcg, 22 mcg and 44 mcg contains approximately 2.4 million international units, 6 million international units or 12 million international units, respectively, of antiviral activity using this method. REBIF (interferon beta-1a) is formulated as a sterile solution in a prefilled syringe or REBIF Rebidose autoinjector intended for subcutaneous (sc) injection. Each 0.5 mL (0.5 cc) of REBIF contains either 22 mcg or 44 mcg of interferon beta-1a, 2 mg or 4 mg albumin (human), 27.3 mg mannitol, 0.4 mg sodium acetate, and water for injection. Each 0.2 mL (0.2 cc) of REBIF contains 8.8 mcg of interferon beta-1a, 0.8 mg albumin (human), 10.9 mg mannitol, 0.16 mg sodium acetate, and water for injection.</Description>
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  <NDC>
    <NDCCode>44087-8822-1</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (44087-8822-1)  *  .2 mL in 1 SYRINGE, GLASS *  .5 mL in 1 SYRINGE, GLASS</PackageDescription>
    <NDC11Code>44087-8822-01</NDC11Code>
    <ProductNDC>44087-8822</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rebif</ProprietaryName>
    <NonProprietaryName>Interferon Beta-1a</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20041217</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103780</ApplicationNumber>
    <LabelerName>EMD Serono, Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-09-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20041217</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>REBIF is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
    <Description>REBIF (interferon beta-1a) is a purified 166 amino acid glycoprotein with a molecular weight of approximately 22,500 daltons. It is produced by recombinant DNA technology using genetically engineered Chinese Hamster Ovary cells into which the human interferon beta gene has been introduced. The amino acid sequence of REBIF is identical to that of natural fibroblast derived human interferon beta. Natural interferon beta and interferon beta-1a (REBIF) are glycosylated with each containing a single N-linked complex carbohydrate moiety. Using a reference standard calibrated against the World Health Organization natural interferon beta standard (Second International Standard for Interferon, Human Fibroblast GB 23 902 531), REBIF has a specific activity of approximately 270 million international units (MIU) of antiviral activity per mg of interferon beta-1a determined specifically by an in vitro cytopathic effect bioassay using WISH cells and Vesicular Stomatitis virus. REBIF 8.8 mcg, 22 mcg and 44 mcg contains approximately 2.4 million international units, 6 million international units or 12 million international units, respectively, of antiviral activity using this method. REBIF (interferon beta-1a) is formulated as a sterile solution in a prefilled syringe or REBIF Rebidose autoinjector intended for subcutaneous (sc) injection. Each 0.5 mL (0.5 cc) of REBIF contains either 22 mcg or 44 mcg of interferon beta-1a, 2 mg or 4 mg albumin (human), 27.3 mg mannitol, 0.4 mg sodium acetate, and water for injection. Each 0.2 mL (0.2 cc) of REBIF contains 8.8 mcg of interferon beta-1a, 0.8 mg albumin (human), 10.9 mg mannitol, 0.16 mg sodium acetate, and water for injection.</Description>
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  <NDC>
    <NDCCode>55718-166-01</NDCCode>
    <PackageDescription>25 POUCH in 1 CARTON (55718-166-01)  / 10.5 mL in 1 POUCH</PackageDescription>
    <NDC11Code>55718-0166-01</NDC11Code>
    <ProductNDC>55718-166</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <StartMarketingDate>20230227</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Isomedix Operations Inc</LabelerName>
    <SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
    <StrengthNumber>.7</StrengthNumber>
    <StrengthUnit>mL/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>27-FEB-23</StartMarketingDatePackage>
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  <NDC>
    <NDCCode>55718-166-02</NDCCode>
    <PackageDescription>25 POUCH in 1 BOX (55718-166-02)  / 26 mL in 1 POUCH</PackageDescription>
    <NDC11Code>55718-0166-02</NDC11Code>
    <ProductNDC>55718-166</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <StartMarketingDate>20230227</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Isomedix Operations Inc</LabelerName>
    <SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
    <StrengthNumber>.7</StrengthNumber>
    <StrengthUnit>mL/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>27-FEB-23</StartMarketingDatePackage>
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  <NDC>
    <NDCCode>57665-101-41</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (57665-101-41)  / 20 mL in 1 VIAL</PackageDescription>
    <NDC11Code>57665-0101-41</NDC11Code>
    <ProductNDC>57665-101</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Abelcet</ProprietaryName>
    <NonProprietaryName>Amphotericin B, Dimyristoylphosphatidylcholine, Dl- And Dimyristoylphosphatidylglycerol, Dl-</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20101018</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA050724</ApplicationNumber>
    <LabelerName>Leadiant Biosciences, Inc.</LabelerName>
    <SubstanceName>AMPHOTERICIN B; DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL-; DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL-</SubstanceName>
    <StrengthNumber>5; 3.4; 1.5</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Lipid-based Polyene Antifungal [EPC], Polyene Antifungal [EPC], Polyenes [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-09-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20101018</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ABELCET ®is indicated for the treatment of invasive fungal infections in patients who are refractory to or intolerant of conventional amphotericin B therapy. This is based on open-label treatment of patients judged by their physicians to be intolerant to or failing conventional amphotericin B therapy (See DESCRIPTION OF CLINICAL STUDIES). DESCRIPTION OF CLINICAL STUDIES. Fungal Infections. Data from 473 patients were pooled from three open-label studies in which ABELCET ®was provided for the treatment of patients with invasive fungal infections who were judged by their physicians to be refractory to or intolerant of conventional amphotericin B, or who had preexisting nephrotoxicity. Results of these studies demonstrated effectiveness of ABELCET ®in the treatment of invasive fungal infections as a second line therapy. Patients were defined by their individual physician as being refractory to or failing conventional amphotericin B therapy based on overall clinical judgement after receiving a minimum total dose of 500 mg of amphotericin B. Nephrotoxicity was defined as a serum creatinine that had increased to &gt;2.5 mg/dL in adults and &gt;1.5 mg/dL in pediatric patients, or a creatinine clearance of &lt;25 mL/min while receiving conventional amphotericin B therapy. Of the 473 patients, four were enrolled more than once; each enrollment contributed separately to the denominator. The median age was 39 years (range of &lt;1 to 93 years); 307 patients were male and 166 female. Patients were Caucasian (381, 81%), African-American (41, 9%), Hispanic (27, 6%), Asian (10, 2%), and various other races (14, 3%). The median baseline neutrophil count was 4,000 PMN/mm3; of these, 101 (21%) had a baseline neutrophil count &lt;500/mm 3. Two-hundred eighty-two patients of the 473 patients were considered evaluable for response to therapy; the other 191 patients were excluded on the basis of unconfirmed diagnosis, confounding factors, concomitant systemic antifungal therapy, or receiving 4 doses or less of ABELCET ®. For evaluable patients, the following fungal infections were treated (n=282): aspergillosis (n=111), candidiasis (n=87), zygomycosis (n=25), cryptococcosis (n=16), and fusariosis (n=11). There were fewer than 10 evaluable patients for each of several other fungal species treated. For each type of fungal infection listed above there were some patients successfully treated. However, in the absence of controlled studies it is unknown how response would have compared to either continuing conventional amphotericin B therapy or the use of alternative antifungal agents. Renal Function:Patients with aspergillosis who initiated treatment with ABELCET ®when serum creatinine was above 2.5 mg/dL experienced a decline in serum creatinine during treatment (Figure 1). Serum creatinine levels were also lower during treatment with ABELCET ®when compared to the serum creatinine levels of patients treated with conventional amphotericin B in a retrospective historical control study. Meaningful statistical testing of the differences between these two groups is precluded since these data were obtained from two separate studies. [ ]= Number of patients at each time point. Note: These curves do not represent the clinical course of a given patient, but that of an open-label cohort of patients. [ ]= Number of patients at each time point. Note: These curves do not represent the clinical course of a given patient, but that of an open-label cohort of patients. In a randomized study of ABELCET ®for the treatment of invasive candidiasis in patients with normal baseline renal function, the incidence of nephrotoxicity was significantly less for ABELCET ®at a dose of 5 mg/kg/day than for conventional amphotericin B at a dose of 0.7 mg/kg/day. Despite generally less nephrotoxicity of ABELCET ®observed at a dose of 5 mg/kg/day compared with conventional amphotericin B therapy at a dose range of 0.6-1 mg/kg/day, dose-limiting renal toxicity may still be observed with ABELCET ®. Renal toxicity of doses greater than 5 mg/kg/day of ABELCET ®has not been formally studied.</IndicationAndUsage>
    <Description>ABELCET ®is a sterile, pyrogen-free suspension for intravenous infusion. ABELCET ®consists of amphotericin B complexed with two phospholipids in a 1:1 drug-to-lipid molar ratio. The two phospholipids, l-α-dimyristoylphosphatidylcholine (DMPC) and l-α-dimyristoylphosphatidylglycerol (DMPG), are present in a 7:3 molar ratio. ABELCET ®is yellow and opaque in appearance, with a pH of 5 - 7. NOTE: Liposomal encapsulation or incorporation in a lipid complex can substantially affect a drug’s functional properties relative to those of the unencapsulated or nonlipid-associated drug. In addition, different liposomal or lipid-complexed products with a common active ingredient may vary from one another in the chemical composition and physical form of the lipid component. Such differences may affect functional properties of these drug products. Amphotericin B is a polyene, antifungal antibiotic produced from a strain of Streptomyces nodosus. Amphotericin B is designated chemically as [1R-(1R*, 3S*, 5R*, 6R*, 9R*, 11R*, 15S*, 16R*, 17R*, 18S*, 19E, 21E, 23E, 25E, 27E, 29E, 31E, 33R*, 35S*, 36R*, 37S*)]-33-[(3-Amino-3, 6-dideoxy- β-D-mannopyranosyl) oxy]-1,3,5,6,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-14,39-dioxabicyclo[33.3.1] nonatriaconta-19, 21, 23, 25, 27, 29, 31-heptaene-36-carboxylic acid. It has a molecular weight of 924.09 and a molecular formula of C 47H 73NO 17. The structural formula is:. ABELCET ®is provided as a sterile, opaque suspension in 20 mL glass, single-use vials. Each 20 mL vial contains 100 mg of amphotericin B in 20 mL of suspension (see DOSAGE AND ADMINISTRATION), and each mL of ABELCET ®contains:. Amphotericin B USP 5.0 mg. l-α-dimyristoylphosphatidylcholine (DMPC) 3.4 mg. l-α-dimyristoylphosphatidylglycerol (DMPG) 1.5 mg. Sodium Chloride USP 9.0 mg. Water for Injection USP, q.s. 1.0 mL. MICROBIOLOGY. Mechanism of Action. The active component of ABELCET ®, amphotericin B, acts by binding to sterols in the cell membrane of susceptible fungi, with a resultant change in the permeability of the membrane. Mammalian cell membranes also contain sterols, and damage to human cells is believed to occur through the same mechanism of action. Activity in vitroand in vivo. ABELCET ®shows in vitro activity against Aspergillussp. (n=3) and Candidasp. (n=10), with MICs generally &lt;1 μg/mL. Depending upon the species and strain of Aspergillusand Candidatested, significant in vitrodifferences in susceptibility to amphotericin B have been reported (MICs ranging from 0.1 to &gt;10 μg/mL). ABELCET ®is active in animal models against Aspergillus fumigatus, Candida albicans, C. guillermondii, C. stellatoideae, and C. tropicalis, Cryptococcussp., Coccidioidomycessp., Histoplasmasp., and Blastomycessp. in which end-points were clearance of microorganisms from target organ(s) and/or prolonged survival of infected animals. Drug Resistance. Fungal species with decreased susceptibility to amphotericin B have been isolated after serial passage in culture media containing the drug, and from some patients receiving prolonged therapy. Although the relevance of drug resistance to clinical outcome has not been established, fungal species which are resistant to amphotericin B may also be resistant to ABELCET ®. Susceptibility Testing. For specific information regarding susceptibility test interpretive criteria, and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC.</Description>
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  <NDC>
    <NDCCode>65862-166-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (65862-166-01) </PackageDescription>
    <NDC11Code>65862-0166-01</NDC11Code>
    <ProductNDC>65862-166</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Trandolapril</ProprietaryName>
    <NonProprietaryName>Trandolapril</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070612</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078438</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>TRANDOLAPRIL</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-04-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20070612</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hypertension Trandolapril tablets USP are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive medication such as hydrochlorothiazide. Heart Failure Post Myocardial Infarction or Left-Ventricular Dysfunction Post Myocardial Infarction Trandolapril tablets USP are indicated in stable patients who have evidence of left-ventricular systolic dysfunction (identified by wall motion abnormalities) or who are symptomatic from congestive heart failure within the first few days after sustaining acute myocardial infarction. Administration of trandolapril to Caucasian patients has been shown to decrease the risk of death (principally cardiovascular death) and to decrease the risk of heart failure-related hospitalization (see CLINICAL PHARMACOLOGY - Heart Failure or Left-Ventricular Dysfunction Post Myocardial Infarction for details of the survival trial).</IndicationAndUsage>
    <Description>Trandolapril is the ethyl ester prodrug of a nonsulfhydryl angiotensin converting enzyme (ACE) inhibitor, trandolaprilat. Trandolapril is chemically described as (2S,3aR,7aS)-1-[(S)-N-[(S)-1-Carboxy-3-phenylpropyl]alanyl] hexahydro-2-indolinecarboxylic acid, 1-ethyl ester. Its molecular formula is C24H34N2O5 and its structural formula is. M.W. = 430.54Melting Point = 125°CTrandolapril USP is a white or almost white powder that is soluble (&gt;100 mg/mL) in chloroform, dichloromethane, and methanol. Trandolapril tablets USP contain 1 mg, 2 mg, or 4 mg of trandolapril USP for oral administration. Each tablet also contains lactose monohydrate, corn starch, croscarmellose sodium, hypromellose, povidone, and sodium stearyl fumarate. In addition 1 mg and 4 mg tablet also contains ferric oxide red and 2 mg tablet contains ferric oxide yellow.</Description>
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    <NDCCode>65862-166-61</NDCCode>
    <PackageDescription>6000 TABLET in 1 BAG (65862-166-61) </PackageDescription>
    <NDC11Code>65862-0166-61</NDC11Code>
    <ProductNDC>65862-166</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Trandolapril</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <StartMarketingDate>20070612</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>TRANDOLAPRIL</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2024-04-23</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>12-JUN-07</StartMarketingDatePackage>
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    <NDCCode>65862-166-99</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (65862-166-99) </PackageDescription>
    <NDC11Code>65862-0166-99</NDC11Code>
    <ProductNDC>65862-166</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Trandolapril</ProprietaryName>
    <NonProprietaryName>Trandolapril</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070612</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078438</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>TRANDOLAPRIL</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-04-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20070612</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hypertension Trandolapril tablets USP are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive medication such as hydrochlorothiazide. Heart Failure Post Myocardial Infarction or Left-Ventricular Dysfunction Post Myocardial Infarction Trandolapril tablets USP are indicated in stable patients who have evidence of left-ventricular systolic dysfunction (identified by wall motion abnormalities) or who are symptomatic from congestive heart failure within the first few days after sustaining acute myocardial infarction. Administration of trandolapril to Caucasian patients has been shown to decrease the risk of death (principally cardiovascular death) and to decrease the risk of heart failure-related hospitalization (see CLINICAL PHARMACOLOGY - Heart Failure or Left-Ventricular Dysfunction Post Myocardial Infarction for details of the survival trial).</IndicationAndUsage>
    <Description>Trandolapril is the ethyl ester prodrug of a nonsulfhydryl angiotensin converting enzyme (ACE) inhibitor, trandolaprilat. Trandolapril is chemically described as (2S,3aR,7aS)-1-[(S)-N-[(S)-1-Carboxy-3-phenylpropyl]alanyl] hexahydro-2-indolinecarboxylic acid, 1-ethyl ester. Its molecular formula is C24H34N2O5 and its structural formula is. M.W. = 430.54Melting Point = 125°CTrandolapril USP is a white or almost white powder that is soluble (&gt;100 mg/mL) in chloroform, dichloromethane, and methanol. Trandolapril tablets USP contain 1 mg, 2 mg, or 4 mg of trandolapril USP for oral administration. Each tablet also contains lactose monohydrate, corn starch, croscarmellose sodium, hypromellose, povidone, and sodium stearyl fumarate. In addition 1 mg and 4 mg tablet also contains ferric oxide red and 2 mg tablet contains ferric oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>70056-001-02</NDCCode>
    <PackageDescription>1 CONTAINER in 1 CARTON (70056-001-02)  &gt; 18 g in 1 CONTAINER (70056-001-01)</PackageDescription>
    <NDC11Code>70056-0001-02</NDC11Code>
    <ProductNDC>70056-001</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Son And Park Air Chou Foundation 21</ProprietaryName>
    <NonProprietaryName>Titanium Dioxide, Octinoxate</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20150901</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>S&amp;P Cosmetic Co., Ltd</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; OCTINOXATE</SubstanceName>
    <StrengthNumber>3.166; 1.35</StrengthNumber>
    <StrengthUnit>g/18g; g/18g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-08-23</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>70056-002-02</NDCCode>
    <PackageDescription>1 CONTAINER in 1 CARTON (70056-002-02)  &gt; 18 g in 1 CONTAINER (70056-002-01)</PackageDescription>
    <NDC11Code>70056-0002-02</NDC11Code>
    <ProductNDC>70056-002</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Son And Park Air Chou Foundation 23</ProprietaryName>
    <NonProprietaryName>Titanium Dioxide, Octinoxate</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20150905</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>S&amp;P Cosmetic Co., Ltd</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; OCTINOXATE</SubstanceName>
    <StrengthNumber>3.166; 1.35</StrengthNumber>
    <StrengthUnit>g/18g; g/18g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-08-23</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>70436-166-01</NDCCode>
    <PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70436-166-01) </PackageDescription>
    <NDC11Code>70436-0166-01</NDC11Code>
    <ProductNDC>70436-166</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metoprolol Succinate</ProprietaryName>
    <NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210429</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213854</ApplicationNumber>
    <LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-05-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210429</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Metoprolol succinate, is a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris. ( 1.2) , 3 Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure. ( 1.3) .</IndicationAndUsage>
    <Description>Metoprolol succinate, is a beta 1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol Succinate Extended-Release Tablets, USP have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1-(isopropyl amino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate, USP is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethyl ether and heptane. Inactive ingredients: colloidal silicon dioxide, crospovidone, ethylcellulose, hypromellose, lactose monohydrate (25 mg and 50 mg), magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-partially hydrolyzed, sugar spheres (composed of corn starch and sucrose), talc, titanium dioxide and triethyl citrate. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
</NDCList>
                    
<NDCList><NDC><NDCCode>76150-166-23</NDCCode><ProprietaryName>Tropical Coconut</ProprietaryName><NonProprietaryName>Classic Body Sunscreen</NonProprietaryName></NDC><NDC><NDCCode>76150-166-24</NDCCode><ProprietaryName>Tropical Coconut</ProprietaryName><NonProprietaryName>Classic Body Sunscreen</NonProprietaryName></NDC><NDC><NDCCode>76150-119-23</NDCCode><ProprietaryName>Pina Colada Body</ProprietaryName><NonProprietaryName>Classic Sunscreen</NonProprietaryName></NDC><NDC><NDCCode>76150-163-23</NDCCode><ProprietaryName>Classic Sport Unscented</ProprietaryName><NonProprietaryName>Classic Continuous</NonProprietaryName></NDC><NDC><NDCCode>76150-164-23</NDCCode><ProprietaryName>Guava Mango Sport</ProprietaryName><NonProprietaryName>Classic Sunscreen</NonProprietaryName></NDC><NDC><NDCCode>76150-165-23</NDCCode><ProprietaryName>Fresh Cucumber Classic Body</ProprietaryName><NonProprietaryName>Sunscreen</NonProprietaryName></NDC><NDC><NDCCode>76150-211-23</NDCCode><ProprietaryName>Yerba Mate Mineral</ProprietaryName><NonProprietaryName>Sunscreen</NonProprietaryName></NDC><NDC><NDCCode>11673-166-28</NDCCode><ProprietaryName>Up And Up Childrens Ibuprofen</ProprietaryName><NonProprietaryName>Ibuprofen</NonProprietaryName></NDC><NDC><NDCCode>25021-797-05</NDCCode><ProprietaryName>Valproate Sodium</ProprietaryName><NonProprietaryName>Valproate Sodium</NonProprietaryName></NDC><NDC><NDCCode>33342-166-10</NDCCode><ProprietaryName>Pregablin</ProprietaryName><NonProprietaryName>Pregablin</NonProprietaryName></NDC><NDC><NDCCode>42806-512-01</NDCCode><ProprietaryName>Quinidine Sulfate</ProprietaryName><NonProprietaryName>Quinidine Sulfate Tablet</NonProprietaryName></NDC><NDC><NDCCode>42806-512-30</NDCCode><ProprietaryName>Quinidine Sulfate</ProprietaryName><NonProprietaryName>Quinidine Sulfate Tablet</NonProprietaryName></NDC><NDC><NDCCode>42806-513-01</NDCCode><ProprietaryName>Quinidine Sulfate</ProprietaryName><NonProprietaryName>Quinidine Sulfate Tablet</NonProprietaryName></NDC><NDC><NDCCode>42806-513-30</NDCCode><ProprietaryName>Quinidine Sulfate</ProprietaryName><NonProprietaryName>Quinidine Sulfate Tablet</NonProprietaryName></NDC><NDC><NDCCode>42858-166-01</NDCCode><ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName><NonProprietaryName>Lisdexamfetamine Dimesylate</NonProprietaryName></NDC><NDC><NDCCode>44087-0022-3</NDCCode><ProprietaryName>Rebif</ProprietaryName><NonProprietaryName>Interferon Beta-1a</NonProprietaryName></NDC><NDC><NDCCode>44087-0044-3</NDCCode><ProprietaryName>Rebif</ProprietaryName><NonProprietaryName>Interferon Beta-1a</NonProprietaryName></NDC><NDC><NDCCode>44087-0188-1</NDCCode><ProprietaryName>Rebif Rebidose</ProprietaryName><NonProprietaryName>Interferon Beta-1a</NonProprietaryName></NDC><NDC><NDCCode>44087-3322-1</NDCCode><ProprietaryName>Rebif Rebidose</ProprietaryName><NonProprietaryName>Interferon Beta-1a</NonProprietaryName></NDC><NDC><NDCCode>44087-3344-1</NDCCode><ProprietaryName>Rebif Rebidose</ProprietaryName><NonProprietaryName>Interferon Beta-1a</NonProprietaryName></NDC><NDC><NDCCode>44087-8822-1</NDCCode><ProprietaryName>Rebif</ProprietaryName><NonProprietaryName>Interferon Beta-1a</NonProprietaryName></NDC><NDC><NDCCode>55718-166-01</NDCCode><NonProprietaryName>Isopropyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>55718-166-02</NDCCode><NonProprietaryName>Isopropyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>57665-101-41</NDCCode><ProprietaryName>Abelcet</ProprietaryName><NonProprietaryName>Amphotericin B, Dimyristoylphosphatidylcholine, Dl- And Dimyristoylphosphatidylglycerol, Dl-</NonProprietaryName></NDC><NDC><NDCCode>65862-166-01</NDCCode><ProprietaryName>Trandolapril</ProprietaryName><NonProprietaryName>Trandolapril</NonProprietaryName></NDC><NDC><NDCCode>65862-166-61</NDCCode><NonProprietaryName>Trandolapril</NonProprietaryName></NDC><NDC><NDCCode>65862-166-99</NDCCode><ProprietaryName>Trandolapril</ProprietaryName><NonProprietaryName>Trandolapril</NonProprietaryName></NDC><NDC><NDCCode>70056-001-02</NDCCode><ProprietaryName>Son And Park Air Chou Foundation 21</ProprietaryName><NonProprietaryName>Titanium Dioxide, Octinoxate</NonProprietaryName></NDC><NDC><NDCCode>70056-002-02</NDCCode><ProprietaryName>Son And Park Air Chou Foundation 23</ProprietaryName><NonProprietaryName>Titanium Dioxide, Octinoxate</NonProprietaryName></NDC><NDC><NDCCode>70436-166-01</NDCCode><ProprietaryName>Metoprolol Succinate</ProprietaryName><NonProprietaryName>Metoprolol Succinate</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.

Parameter Meaning Notes
domain Domain
  • Currently following data domains are supported:
    • NPI - NPI Number Lookup
    • HCPCS - Healthcare Provider Procedure Coding System Lookup
    • NDC - National Drug Code Lookup
    • NDCA - Animal Drug Product Listing Directory Lookup
    • CLIA - Clinical Laboratory Improvement Amendments
    • HPTC - Healthcare Provider Taxonomy Code Lookup
    • NAICS - North American Industry Classification System Lookup
    • LOINC - Logical Observation Identifiers Names and Codes (LOINC®) Lookup
    • DRG - Diagnosis-Related Group Lookup
    • ICD9 - Ninth Revision of the International Classification of Diseases Lookup
    • ICD10 - Tenth Revision of the International Classification of Diseases Lookup
    • ICD10DRUGS - ICD-10-CM Table Of Drugs And Chemicals Lookup
    • ZIP - Postal Codes used by the United States Postal Service
operation Operation
  • Generic operations:
    • check_status - this method allows to get current code status.
    • search - allows retrieval of set of items (up to 30) 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.
    • 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.
  • 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.
q Query
  • The search expression. May vary depending on the operation.
    • Free form text like: “q=blood glucose monitor” (search operation)
    • Exact code value : “q=1285636522” (getcode operation)
    • List of codes : “q=1285636522,1730198755,1427145176,1487730636” (getcodes operation)
zipcode Query for NPI by Zip code/radius Lookup
  • The search expression for zip code.
    • Exact code value : “zipcode=98052” (search operation)
radius Query for NPI by Zip code/radius Lookup
  • The search expression for radius.
    • Exact code value : “radius=20” (search operation)
fromdate Query for Deactivated NPI
  • The search expression for fromdate.
    • Exact code value : “fromdate=05/01/2023” (search operation - format MM/DD/YYYY)
todate Query for Deactivated NPI
  • The search expression for tomdate.
    • Exact code value : “todate=05/31/2023” (search operation - format MM/DD/YYYY)
tin Query for IRS Lookup
  • The search expression for tin number.
    • Exact code value : “tin=942404110” (search operation)
tinname Query for IRS Lookup
  • The search expression for tin name.
    • Free form text like: “tinname=apple inc.” (search operation)
rt Data format
  • If you don't specify an rt parameter, the API returns data in the JSON format. This is equivalent to rt=json.
  • Accepted values are:
    • json
    • minjson (minified json)
    • xml
    • minxml (minified xml)
token Your API key
num Number of search results to return
  • You can specify the how many results to return for the current search.
  • Valid values are integers between 1 and 100, inclusive.
  • If num is not used, a value of 30 is assumed.
friendlyprint Returns a response with indentations and line breaks
  • If friendlyprint is not used, a “true” value is assumed. This is equivalent to friendlyprint=true.
  • Accepted values are:
    • true - the results returned by the server will be more “human readable”.
    • false - the results returned by the server will not have indentations and line breaks.
ICD9/ICD10 Parameters
codeType Specifies whether ICD code is "dx"(Diagnosis) or "pcs"(Procedure).
  • Required for ICD only.
  • If you don't specify an codeType parameter this is equivalent to codeType=dx.
  • Accepted values are:
    • dx (diagnosis)
    • pcs (procedure)
qf Specifies predicate in form of tuple "qf=City:true:Phoenix".
  • Expected to be one or many "qf" parameters in request.
  • Required for following operations:
    • validate
    • paginate_with_predicates
    • search_with_predicates
  • Tuple values are (order based):
    • NPI Field Name
      • NPI
      • Phone
      • Fax
      • FirstName
      • LastName
      • OrganizationName
      • OtherOrganizationName
      • Address1
      • Address2
      • Zip
      • City
      • State
      • IndividualOrganizationCode
    • Exact Match
      • true
      • false
    • Expected Field Value
orderField Sort order field name
  • Expected to be one "orderField" parameter in request.
  • Required for following operations:
    • paginate_with_predicates
  • Values are:
    • NPI
    • Phone
    • Fax
    • FirstName
    • LastName
    • OrganizationName
    • OtherOrganizationName
    • Address1
    • Address2
    • Zip
    • City
    • State
    • IndividualOrganizationCode
pageNo Page Number
  • Ordinal page number.
  • Required for following operations:
    • paginate_with_predicates
    • zipradius
    • npideactivated
pageSize Page Size
  • Expected page size.
  • Required for following operations:
    • paginate_with_predicates

DataLabs Coding Library - Quering NPI Registry - REST API Examples

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();
    }
}
            
        

Output

            
{
  "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",
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      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

Full Text Search Fundamentals

Facts

Everybody uses full text search. Full-text search is the most common technique used in search engines. The amount of information has just become too much to access it using navigation and categories alone. Full-text search reduces the hassle of searching for a keyword in huge amounts of metadata, such as the World Wide Web and commercial-scale databases. Full-text search became popular in late 1990s, when the Internet and Big Data began to became a part of everyday life.

How does it work

Users only provide keywords and expect the search engine to provide good results. Relevancy of documents is expected to be good and users want the results they are looking to be present in the top ten. How relevant a document is search engine decides based on scientifically proven algorithms. Besides getting the best results the user wants to be supported during the search process. Features like suggestions and highlighting on the result excerpt can help with this.

Full Text Search & DataLabs REST API

DataLabs REST API allows you to search the full text of healthcare providers database (NPI Registry). To find the information you need and make your search easy, please use our REST API for automation, or visit our NPI Lookup page for manual search ( NPI Number Lookup). We are still improving and enhancing Full Text NPI Search based on users feedbacks. Please email your comments and suggestions for improvement using our feedback page.

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();
        }
    }
                
            

Output

                
    {
      "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();
        }
    }
                
            

Output

                
    {
      "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();
        }
    }
                
            

Output

                
    {
      "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();
        }
    }
                
            

Output

                
{
  "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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