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How to Find 70764-104-51 NDC Data Using DataLabs API

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{
  "NDC": [
    {
      "NDCCode": "70764-104-51",
      "PackageDescription": "1 BOTTLE in 1 BOX (70764-104-51)  / 198 mL in 1 BOTTLE (70764-104-11) ",
      "NDC11Code": "70764-0104-51",
      "ProductNDC": "70764-104",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Exfo Tonic Acne Treatment",
      "NonProprietaryName": "Salicylic Acid",
      "DosageFormName": "SOLUTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160609",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M006",
      "LabelerName": "CONTROL CORRECTIVE SKINCARE INC",
      "SubstanceName": "SALICYLIC ACID",
      "StrengthNumber": "2",
      "StrengthUnit": "g/100mL",
      "Status": "Active",
      "LastUpdate": "2026-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160609",
      "SamplePackage": "N",
      "IndicationAndUsage": "AN ANTISEPTIC AND EXFOLIATING TONIC DESIGNED TO CONTROL EXCESSIVE OILINESS, REDUCE BREAKOUTS AND DISOLVE DEAD CELL BUILD UP."
    },
    {
      "NDCCode": "70764-105-51",
      "PackageDescription": "1 BOTTLE in 1 BOX (70764-105-51)  / 30 mL in 1 BOTTLE (70764-105-11) ",
      "NDC11Code": "70764-0105-51",
      "ProductNDC": "70764-105",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Acne Spot Treatment",
      "NonProprietaryName": "Salicylic Acid",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160609",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M006",
      "LabelerName": "CONTROL CORRECTIVE SKINCARE INC",
      "SubstanceName": "SALICYLIC ACID",
      "StrengthNumber": "2",
      "StrengthUnit": "g/100mL",
      "Status": "Active",
      "LastUpdate": "2026-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160609",
      "SamplePackage": "N",
      "IndicationAndUsage": "AN EXFOLIATING GEL THAT AIDS IN REDUCING ACNE BREAKOUTS."
    },
    {
      "NDCCode": "70764-106-51",
      "PackageDescription": "1 TUBE in 1 BOX (70764-106-51)  / 74 mL in 1 TUBE (70764-106-11) ",
      "NDC11Code": "70764-0106-51",
      "ProductNDC": "70764-106",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Clear Med",
      "ProprietaryNameSuffix": "5%",
      "NonProprietaryName": "Benzoyl Peroxide",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160609",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M006",
      "LabelerName": "CONTROL CORRECTIVE SKINCARE INC",
      "SubstanceName": "BENZOYL PEROXIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "g/100mL",
      "Status": "Active",
      "LastUpdate": "2026-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160609",
      "SamplePackage": "N",
      "IndicationAndUsage": "HELPS REDUCE ACNE BREAKOUTS."
    },
    {
      "NDCCode": "70764-107-51",
      "PackageDescription": "1 TUBE in 1 BOX (70764-107-51)  / 74 mL in 1 TUBE (70764-107-11) ",
      "NDC11Code": "70764-0107-51",
      "ProductNDC": "70764-107",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Clear Med",
      "ProprietaryNameSuffix": "10%",
      "NonProprietaryName": "Benzoyl Peroxide",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160609",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M006",
      "LabelerName": "CONTROL CORRECTIVE SKINCARE INC",
      "SubstanceName": "BENZOYL PEROXIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "g/100mL",
      "Status": "Active",
      "LastUpdate": "2026-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160609",
      "SamplePackage": "N",
      "IndicationAndUsage": "HELPS REDUCE ACNE BREAKOUTS."
    },
    {
      "NDCCode": "70764-301-51",
      "PackageDescription": "1 BOTTLE, DISPENSING in 1 BOX (70764-301-51)  > 30 mL in 1 BOTTLE, DISPENSING (70764-301-11) ",
      "NDC11Code": "70764-0301-51",
      "ProductNDC": "70764-301",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Multi Complex Fade",
      "NonProprietaryName": "Hydroquinone",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20180911",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part358A",
      "LabelerName": "CONTROL CORRECTIVE SKINCARE INC",
      "SubstanceName": "HYDROQUINONE",
      "StrengthNumber": "10",
      "StrengthUnit": "g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2021-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20180911",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "42934-104-51",
      "PackageDescription": "56 TABLET, FILM COATED in 1 BOTTLE (42934-104-51) ",
      "NDC11Code": "42934-0104-51",
      "ProductNDC": "42934-104",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Varenicline Tartrate",
      "NonProprietaryName": "Varenicline Tartrate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230725",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217151",
      "LabelerName": "Medley Pharmaceuticals Limited",
      "SubstanceName": "VARENICLINE TARTRATE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/561",
      "Pharm_Classes": "Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2023-10-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20230725",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "43376-104-51",
      "PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (43376-104-51)  > .5 mL in 1 SYRINGE, GLASS",
      "NDC11Code": "43376-0104-51",
      "ProductNDC": "43376-104",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sumavel Dosepro",
      "NonProprietaryName": "Sumatriptan",
      "DosageFormName": "INJECTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20131204",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022239",
      "LabelerName": "Zogenix, Inc.",
      "SubstanceName": "SUMATRIPTAN SUCCINATE",
      "StrengthNumber": "4",
      "StrengthUnit": "mg/.5mL",
      "Pharm_Classes": "Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC],Serotonin 1b Receptor Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Sumavel DosePro is indicated in adults for (1) the acute treatment of migraine, with or without aura, and (2) the acute treatment of cluster headache. Limitations of Use: : 1 Use only if a clear diagnosis of migraine or cluster headache has been established. , 2 If a patient has no response to the first migraine attack treated with Sumavel DosePro, reconsider the diagnosis of migraine before Sumavel DosePro is administered to treat any subsequent attacks. , 3 Sumavel DosePro is not indicated for the prevention of migraine attacks. .",
      "Description": "Sumavel DosePro contains sumatriptan succinate, a selective 5-HT1B/1D receptor agonist. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure. The empirical formula is C14H21N3O2SC4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate is a white to off-white powder that is readily soluble in water and in saline. Sumatriptan solution is a clear, colorless to pale yellow, sterile, nonpyrogenic solution for subcutaneous delivery. Each 0.5 mL of Sumavel DosePro 8 mg/mL solution contains 4 mg of sumatriptan (base) as the succinate salt and 3.8 mg of sodium chloride, USP in Water for Injection, USP. Each 0.5 mL of Sumavel DosePro 12 mg/mL solution contains 6 mg of sumatriptan (base) as the succinate salt and 3.5 mg of sodium chloride, USP, in water for injection, USP. The pH range of both solutions is approximately 4.2 to 5.3. The osmolality of both solutions is 291 mOsmol. Sumavel DosePro is a pre-filled, single-use, disposable, needle-free subcutaneous delivery system delivering sterile sumatriptan injection. Sumavel DosePro consists of the following components: a gray plastic handle and snap-off tip, a lavender (4 mg) or green (6 mg) lever, and a glass medication chamber that is pre-filled with 4 mg or 6 mg per 0.5 mL sumatriptan injection. Utilizing pressure from a compressed nitrogen gas source in the handle, Sumavel DosePro delivers the medication by pushing it through a small, precise hole in the glass medication chamber. The resulting stream of medication is propelled through the skin and is delivered subcutaneously without a needle, following a biphasic pressure profile."
    },
    {
      "NDCCode": "49520-104-51",
      "PackageDescription": "1 BOTTLE in 1 BOX (49520-104-51)  > 150 mL in 1 BOTTLE (49520-104-11)",
      "NDC11Code": "49520-0104-51",
      "ProductNDC": "49520-104",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Take Control Calming",
      "ProprietaryNameSuffix": "Cleanser",
      "NonProprietaryName": "Salicylic Acid",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20120927",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part333D",
      "LabelerName": "mybody",
      "SubstanceName": "SALICYLIC ACID",
      "StrengthNumber": "2",
      "StrengthUnit": "g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "USE FOR TREATMENT OF ACNE."
    },
    {
      "NDCCode": "49781-104-51",
      "PackageDescription": "1 BOTTLE in 1 CARTON (49781-104-51)  > 100 TABLET in 1 BOTTLE",
      "NDC11Code": "49781-0104-51",
      "ProductNDC": "49781-104",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Leader Pain Reliever",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140519",
      "EndMarketingDate": "20190816",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part343",
      "LabelerName": "Cardinal Health",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "325",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2019-08-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20140519",
      "EndMarketingDatePackage": "20190816",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "61715-104-51",
      "PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (61715-104-51)",
      "NDC11Code": "61715-0104-51",
      "ProductNDC": "61715-104",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Preferred Plus Arthritis Pain",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140922",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075077",
      "LabelerName": "Kinray",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "650",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2018-10-26",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "67879-104-51",
      "PackageDescription": "1 TUBE in 1 BOX (67879-104-51)  / 15 mL in 1 TUBE (67879-104-11) ",
      "NDC11Code": "67879-0104-51",
      "ProductNDC": "67879-104",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Pharma Clear Spot Treatment",
      "NonProprietaryName": "Salicylic Acid",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160615",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M006",
      "LabelerName": "PHARMAGEL INTERNATIONAL INC",
      "SubstanceName": "SALICYLIC ACID",
      "StrengthNumber": "2",
      "StrengthUnit": "g/100mL",
      "Status": "Active",
      "LastUpdate": "2026-02-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20160615",
      "SamplePackage": "N",
      "IndicationAndUsage": "Use for treatment of acne and to decrease bacteria on the skin."
    },
    {
      "NDCCode": "70474-104-51",
      "PackageDescription": "1 BOTTLE, DISPENSING in 1 BOX (70474-104-51)  > 35 mL in 1 BOTTLE, DISPENSING (70474-104-01)",
      "NDC11Code": "70474-0104-51",
      "ProductNDC": "70474-104",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Luminous Moisturizing Foundation",
      "ProprietaryNameSuffix": "Spf-15",
      "NonProprietaryName": "Octinoxate, Titanium Dioxide",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160407",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "ALTONA COSMETICS TECHNOLOGY (DBA NOTE COSMETICS)",
      "SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
      "StrengthNumber": ".9; 12.2",
      "StrengthUnit": "g/100mL; g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2021-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231"
    },
    {
      "NDCCode": "84165-104-51",
      "PackageDescription": "51 BAG in 1 BOX (84165-104-51)  / 12 g in 1 BAG (84165-104-01) ",
      "NDC11Code": "84165-0104-51",
      "ProductNDC": "84165-104",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Pain Relief Gel-patch",
      "NonProprietaryName": "Lidocaine, Menthol",
      "DosageFormName": "PATCH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240924",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "Guangzhou Zhupuyou E-commerce Co., Ltd",
      "SubstanceName": "MENTHOL; LIDOCAINE",
      "StrengthNumber": ".01; .04",
      "StrengthUnit": "g/g; g/g",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2026-01-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240924",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporarily relieves muscle soreness and minor joint pains in the wrist, knees, back,neck, hips, shoulders,elbows."
    },
    {
      "NDCCode": "33342-104-09",
      "PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (33342-104-09) ",
      "NDC11Code": "33342-0104-09",
      "ProductNDC": "33342-104",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Quetiapine Fumarate",
      "NonProprietaryName": "Quetiapine Fumarate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160614",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203359",
      "LabelerName": "Macleods Pharmaceuticals Limited",
      "SubstanceName": "QUETIAPINE FUMARATE",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-04-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160614",
      "SamplePackage": "N",
      "IndicationAndUsage": "Quetiapine tablets are an atypical antipsychotic indicated for the treatment of:  Schizophrenia (1.1)  Bipolar I disorder manic episodes (1.2)  Bipolar disorder, depressive episodes (1.2).",
      "Description": "Quetiapine fumarate USP is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate USP is a white to off-white crystalline powder which is moderately soluble in water.Quetiapine tablets USP are supplied for oral administration as 25 mg (round, peach, one side debossed with “F71”), 50 mg (round, white, one side debossed with “F72”), 100 mg (round, yellow one side debossed with “F73”), 200 mg (round, white, one side debossed with \"F75”), 300 mg (capsule-shaped, white, one side debossed with \"F76”), and 400 mg (capsule-shaped, yellow, one side debossed with “F77”) tablets.Inactive ingredients are povidone, dibasic calcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, colloidal silicon di-oxide, hypromellose, polyethylene glycol, and titanium dioxide.The 25 mg tablets contain red ferric oxide and yellow ferric oxide and the 100 mg and 400 mg tablets contain only yellow ferric oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.51 mg of quetiapine fumarate equivalent to 400 mg quetiapine."
    },
    {
      "NDCCode": "33342-104-15",
      "PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (33342-104-15) ",
      "NDC11Code": "33342-0104-15",
      "ProductNDC": "33342-104",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Quetiapine Fumarate",
      "NonProprietaryName": "Quetiapine Fumarate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160614",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203359",
      "LabelerName": "Macleods Pharmaceuticals Limited",
      "SubstanceName": "QUETIAPINE FUMARATE",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-04-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160614",
      "SamplePackage": "N",
      "IndicationAndUsage": "Quetiapine tablets are an atypical antipsychotic indicated for the treatment of:  Schizophrenia (1.1)  Bipolar I disorder manic episodes (1.2)  Bipolar disorder, depressive episodes (1.2).",
      "Description": "Quetiapine fumarate USP is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate USP is a white to off-white crystalline powder which is moderately soluble in water.Quetiapine tablets USP are supplied for oral administration as 25 mg (round, peach, one side debossed with “F71”), 50 mg (round, white, one side debossed with “F72”), 100 mg (round, yellow one side debossed with “F73”), 200 mg (round, white, one side debossed with \"F75”), 300 mg (capsule-shaped, white, one side debossed with \"F76”), and 400 mg (capsule-shaped, yellow, one side debossed with “F77”) tablets.Inactive ingredients are povidone, dibasic calcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, colloidal silicon di-oxide, hypromellose, polyethylene glycol, and titanium dioxide.The 25 mg tablets contain red ferric oxide and yellow ferric oxide and the 100 mg and 400 mg tablets contain only yellow ferric oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.51 mg of quetiapine fumarate equivalent to 400 mg quetiapine."
    },
    {
      "NDCCode": "33342-104-39",
      "PackageDescription": "9 BLISTER PACK in 1 CARTON (33342-104-39)  / 10 TABLET, FILM COATED in 1 BLISTER PACK",
      "NDC11Code": "33342-0104-39",
      "ProductNDC": "33342-104",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Quetiapine Fumarate",
      "NonProprietaryName": "Quetiapine Fumarate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160614",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203359",
      "LabelerName": "Macleods Pharmaceuticals Limited",
      "SubstanceName": "QUETIAPINE FUMARATE",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-04-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160614",
      "SamplePackage": "N",
      "IndicationAndUsage": "Quetiapine tablets are an atypical antipsychotic indicated for the treatment of:  Schizophrenia (1.1)  Bipolar I disorder manic episodes (1.2)  Bipolar disorder, depressive episodes (1.2).",
      "Description": "Quetiapine fumarate USP is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate USP is a white to off-white crystalline powder which is moderately soluble in water.Quetiapine tablets USP are supplied for oral administration as 25 mg (round, peach, one side debossed with “F71”), 50 mg (round, white, one side debossed with “F72”), 100 mg (round, yellow one side debossed with “F73”), 200 mg (round, white, one side debossed with \"F75”), 300 mg (capsule-shaped, white, one side debossed with \"F76”), and 400 mg (capsule-shaped, yellow, one side debossed with “F77”) tablets.Inactive ingredients are povidone, dibasic calcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, colloidal silicon di-oxide, hypromellose, polyethylene glycol, and titanium dioxide.The 25 mg tablets contain red ferric oxide and yellow ferric oxide and the 100 mg and 400 mg tablets contain only yellow ferric oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.51 mg of quetiapine fumarate equivalent to 400 mg quetiapine."
    },
    {
      "NDCCode": "33342-104-44",
      "PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (33342-104-44) ",
      "NDC11Code": "33342-0104-44",
      "ProductNDC": "33342-104",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Quetiapine Fumarate",
      "NonProprietaryName": "Quetiapine Fumarate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160614",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203359",
      "LabelerName": "Macleods Pharmaceuticals Limited",
      "SubstanceName": "QUETIAPINE FUMARATE",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-04-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160614",
      "SamplePackage": "N",
      "IndicationAndUsage": "Quetiapine tablets are an atypical antipsychotic indicated for the treatment of:  Schizophrenia (1.1)  Bipolar I disorder manic episodes (1.2)  Bipolar disorder, depressive episodes (1.2).",
      "Description": "Quetiapine fumarate USP is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate USP is a white to off-white crystalline powder which is moderately soluble in water.Quetiapine tablets USP are supplied for oral administration as 25 mg (round, peach, one side debossed with “F71”), 50 mg (round, white, one side debossed with “F72”), 100 mg (round, yellow one side debossed with “F73”), 200 mg (round, white, one side debossed with \"F75”), 300 mg (capsule-shaped, white, one side debossed with \"F76”), and 400 mg (capsule-shaped, yellow, one side debossed with “F77”) tablets.Inactive ingredients are povidone, dibasic calcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, colloidal silicon di-oxide, hypromellose, polyethylene glycol, and titanium dioxide.The 25 mg tablets contain red ferric oxide and yellow ferric oxide and the 100 mg and 400 mg tablets contain only yellow ferric oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.51 mg of quetiapine fumarate equivalent to 400 mg quetiapine."
    },
    {
      "NDCCode": "66993-100-06",
      "PackageDescription": "6 BLISTER PACK in 1 CARTON (66993-100-06)  / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (66993-100-51) ",
      "NDC11Code": "66993-0100-06",
      "ProductNDC": "66993-100",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levetiracetam",
      "NonProprietaryName": "Levetiracetam",
      "DosageFormName": "TABLET, FOR SUSPENSION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250120",
      "MarketingCategoryName": "NDA AUTHORIZED GENERIC",
      "ApplicationNumber": "NDA207958",
      "LabelerName": "Prasco Laboratories",
      "SubstanceName": "LEVETIRACETAM",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2026-01-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250120",
      "SamplePackage": "N",
      "IndicationAndUsage": "Levetiracetam tablets for oral suspension are indicated for the treatment of partial-onset seizures in patients 4 years of age and older weighing more than 20 kg (1.1). Levetiracetam tablets for oral suspension are indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).",
      "Description": "Levetiracetam tablets for oral suspension are an antiepileptic drug available as 250 mg and 500 mg, round, white to off-white, spearmint-flavored tablets for oral suspension. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent). Levetiracetam tablets for oral suspension contain 250 mg and 500 mg levetiracetam. Each tablet also contains the following inactive ingredients: colloidal silicon dioxide, glycerin, mannitol, microcrystalline cellulose, polysorbate 20, povidone, sucralose, butylated hydroxyanisole, and natural and artificial spearmint flavor. Levetiracetam tablets for oral suspension are unitary porous structures produced by a three-dimensional printing process that binds the powders without compression. Levetiracetam tablets for oral suspension disintegrate in a mean time of 11 seconds (ranging from 2 to 27 seconds) in the mouth, when taken with a sip of liquid, to produce small particles that may be swallowed."
    },
    {
      "NDCCode": "66993-100-60",
      "PackageDescription": "60 BLISTER PACK in 1 CARTON (66993-100-60)  / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (66993-100-51) ",
      "NDC11Code": "66993-0100-60",
      "ProductNDC": "66993-100",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levetiracetam",
      "NonProprietaryName": "Levetiracetam",
      "DosageFormName": "TABLET, FOR SUSPENSION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250120",
      "MarketingCategoryName": "NDA AUTHORIZED GENERIC",
      "ApplicationNumber": "NDA207958",
      "LabelerName": "Prasco Laboratories",
      "SubstanceName": "LEVETIRACETAM",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2026-01-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260116",
      "SamplePackage": "N",
      "IndicationAndUsage": "Levetiracetam tablets for oral suspension are indicated for the treatment of partial-onset seizures in patients 4 years of age and older weighing more than 20 kg (1.1). Levetiracetam tablets for oral suspension are indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).",
      "Description": "Levetiracetam tablets for oral suspension are an antiepileptic drug available as 250 mg and 500 mg, round, white to off-white, spearmint-flavored tablets for oral suspension. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent). Levetiracetam tablets for oral suspension contain 250 mg and 500 mg levetiracetam. Each tablet also contains the following inactive ingredients: colloidal silicon dioxide, glycerin, mannitol, microcrystalline cellulose, polysorbate 20, povidone, sucralose, butylated hydroxyanisole, and natural and artificial spearmint flavor. Levetiracetam tablets for oral suspension are unitary porous structures produced by a three-dimensional printing process that binds the powders without compression. Levetiracetam tablets for oral suspension disintegrate in a mean time of 11 seconds (ranging from 2 to 27 seconds) in the mouth, when taken with a sip of liquid, to produce small particles that may be swallowed."
    },
    {
      "NDCCode": "66993-101-60",
      "PackageDescription": "60 BLISTER PACK in 1 CARTON (66993-101-60)  / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (66993-101-51) ",
      "NDC11Code": "66993-0101-60",
      "ProductNDC": "66993-101",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levetiracetam",
      "NonProprietaryName": "Levetiracetam",
      "DosageFormName": "TABLET, FOR SUSPENSION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250120",
      "MarketingCategoryName": "NDA AUTHORIZED GENERIC",
      "ApplicationNumber": "NDA207958",
      "LabelerName": "Prasco Laboratories",
      "SubstanceName": "LEVETIRACETAM",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2026-01-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260116",
      "SamplePackage": "N",
      "IndicationAndUsage": "Levetiracetam tablets for oral suspension are indicated for the treatment of partial-onset seizures in patients 4 years of age and older weighing more than 20 kg (1.1). Levetiracetam tablets for oral suspension are indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).",
      "Description": "Levetiracetam tablets for oral suspension are an antiepileptic drug available as 250 mg and 500 mg, round, white to off-white, spearmint-flavored tablets for oral suspension. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent). Levetiracetam tablets for oral suspension contain 250 mg and 500 mg levetiracetam. Each tablet also contains the following inactive ingredients: colloidal silicon dioxide, glycerin, mannitol, microcrystalline cellulose, polysorbate 20, povidone, sucralose, butylated hydroxyanisole, and natural and artificial spearmint flavor. Levetiracetam tablets for oral suspension are unitary porous structures produced by a three-dimensional printing process that binds the powders without compression. Levetiracetam tablets for oral suspension disintegrate in a mean time of 11 seconds (ranging from 2 to 27 seconds) in the mouth, when taken with a sip of liquid, to produce small particles that may be swallowed."
    },
    {
      "NDCCode": "69879-104-35",
      "PackageDescription": "35 mL in 1 TUBE (69879-104-35) ",
      "NDC11Code": "69879-0104-35",
      "ProductNDC": "69879-104",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cover-expert Sunscreen Broad Spectrum Spf 15 No.4 Rosy Beige",
      "NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20150731",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Luxe Art Beaute SAS",
      "SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": "51; 28",
      "StrengthUnit": "mg/mL; mg/mL",
      "Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2023-09-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20150731",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "70257-051-51",
      "PackageDescription": "1 VIAL, GLASS in 1 CARTON (70257-051-51)  > 5 mL in 1 VIAL, GLASS (70257-051-05) ",
      "NDC11Code": "70257-0051-51",
      "ProductNDC": "70257-051",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hepagam B",
      "NonProprietaryName": "Hepatitis B Immune Globulin Intravenous (human)",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20190301",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125035",
      "LabelerName": "Saol Therapeutics Inc.",
      "SubstanceName": "HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN",
      "StrengthNumber": "312",
      "StrengthUnit": "[iU]/mL",
      "Pharm_Classes": "Human Immunoglobulin [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE], Virus Neutralization [MoA], Virus-specific Hyperimmune Globulins [EXT]",
      "Status": "Deprecated",
      "LastUpdate": "2025-11-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20190301",
      "SamplePackage": "N",
      "IndicationAndUsage": "HepaGam B [Hepatitis B immune globulin intravenous (Human)] is an intravenous immune globulin indicated for the following.",
      "Description": "HepaGam B, Hepatitis B Immune Globulin Intravenous (Human), is a solvent/detergent-treated sterile solution of purified gamma globulin containing anti-HBs. It is prepared from plasma donated by healthy, screened donors with high titers of anti-HBs that is purified by an anion-exchange column chromatography manufacturing method9,10. HepaGam B is formulated as a 5% (50 milligrams per milliliter) protein solution with 10% maltose and 0.03% polysorbate 80 at pH 5.6. It is available in 1 milliliter and 5 milliliters single dose vials. The product appears as a clear to opalescent liquid. HepaGam B does not contain mercury. It contains no preservatives. This product is intended for single use. HepaGam B may be administered intravenously or intramuscularly dependent upon indication [see Dosage and Administration (2.)]. The source plasma used in the manufacture of this product was tested by FDA licensed Nucleic Acid testing (NAT) for HIV-1, HBV and HCV and found to be negative. Plasma also has been tested by in-process NAT for hepatitis A virus (HAV) and parvovirus B19 (B19) via minipool testing and the limit for B19 in the manufacturing pool is set not to exceed 104 international units of B19 DNA per milliliter. The manufacturing process contains two steps implemented specifically for virus clearance. The solvent and detergent step (using tri-n-butyl phosphate and Triton® X-100) is effective in the inactivation of enveloped viruses, such as hepatitis B, hepatitis C and HIV11. Virus filtration, using a Planova® 20N virus filter, is effective for the removal of viruses based on their size, including some non-enveloped viruses12. These two viral clearance steps are designed to increase product safety by reducing the risk of transmission of enveloped and non-enveloped viruses. In addition to these two specific steps, the process step of anion-exchange chromatography was identified as contributing to the overall viral clearance capacity for small non-enveloped viruses. The inactivation and reduction of known enveloped and non–enveloped model viruses were validated in laboratory studies as summarized in Table 4. The viruses employed for spiking studies were selected to represent those viruses that are potential contaminants in the product, and to represent a wide range of physiochemical properties in order to challenge the manufacturing process’s ability for viral clearance in general. The product potency is expressed in international units by comparison to the World Health Organization (WHO) standard Hepatitis B Immune Globulin. Each vial contains greater than 312 international units per milliliter. The measured potency of each lot is stamped on the vial label [see Dosage Forms and Strengths (3)]."
    },
    {
      "NDCCode": "70257-052-51",
      "PackageDescription": "1 VIAL, GLASS in 1 CARTON (70257-052-51)  > 1 mL in 1 VIAL, GLASS (70257-052-11) ",
      "NDC11Code": "70257-0052-51",
      "ProductNDC": "70257-052",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hepagam B",
      "NonProprietaryName": "Hepatitis B Immune Globulin Intravenous (human)",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20190301",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125035",
      "LabelerName": "Saol Therapeutics Inc.",
      "SubstanceName": "HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN",
      "StrengthNumber": "312",
      "StrengthUnit": "[iU]/mL",
      "Pharm_Classes": "Human Immunoglobulin [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE], Virus Neutralization [MoA], Virus-specific Hyperimmune Globulins [EXT]",
      "Status": "Deprecated",
      "LastUpdate": "2025-11-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20190301",
      "SamplePackage": "N",
      "IndicationAndUsage": "HepaGam B [Hepatitis B immune globulin intravenous (Human)] is an intravenous immune globulin indicated for the following.",
      "Description": "HepaGam B, Hepatitis B Immune Globulin Intravenous (Human), is a solvent/detergent-treated sterile solution of purified gamma globulin containing anti-HBs. It is prepared from plasma donated by healthy, screened donors with high titers of anti-HBs that is purified by an anion-exchange column chromatography manufacturing method9,10. HepaGam B is formulated as a 5% (50 milligrams per milliliter) protein solution with 10% maltose and 0.03% polysorbate 80 at pH 5.6. It is available in 1 milliliter and 5 milliliters single dose vials. The product appears as a clear to opalescent liquid. HepaGam B does not contain mercury. It contains no preservatives. This product is intended for single use. HepaGam B may be administered intravenously or intramuscularly dependent upon indication [see Dosage and Administration (2.)]. The source plasma used in the manufacture of this product was tested by FDA licensed Nucleic Acid testing (NAT) for HIV-1, HBV and HCV and found to be negative. Plasma also has been tested by in-process NAT for hepatitis A virus (HAV) and parvovirus B19 (B19) via minipool testing and the limit for B19 in the manufacturing pool is set not to exceed 104 international units of B19 DNA per milliliter. The manufacturing process contains two steps implemented specifically for virus clearance. The solvent and detergent step (using tri-n-butyl phosphate and Triton® X-100) is effective in the inactivation of enveloped viruses, such as hepatitis B, hepatitis C and HIV11. Virus filtration, using a Planova® 20N virus filter, is effective for the removal of viruses based on their size, including some non-enveloped viruses12. These two viral clearance steps are designed to increase product safety by reducing the risk of transmission of enveloped and non-enveloped viruses. In addition to these two specific steps, the process step of anion-exchange chromatography was identified as contributing to the overall viral clearance capacity for small non-enveloped viruses. The inactivation and reduction of known enveloped and non–enveloped model viruses were validated in laboratory studies as summarized in Table 4. The viruses employed for spiking studies were selected to represent those viruses that are potential contaminants in the product, and to represent a wide range of physiochemical properties in order to challenge the manufacturing process’s ability for viral clearance in general. The product potency is expressed in international units by comparison to the World Health Organization (WHO) standard Hepatitis B Immune Globulin. Each vial contains greater than 312 international units per milliliter. The measured potency of each lot is stamped on the vial label [see Dosage Forms and Strengths (3)]."
    },
    {
      "NDCCode": "70257-126-51",
      "PackageDescription": "1 VIAL, GLASS in 1 CARTON (70257-126-51)  / 1.2 mL in 1 VIAL, GLASS (70257-126-11) ",
      "NDC11Code": "70257-0126-51",
      "ProductNDC": "70257-126",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Varizig",
      "NonProprietaryName": "Human Varicella-zoster Immune Globulin",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20190301",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125430",
      "LabelerName": "Saol Therapeutics",
      "SubstanceName": "HUMAN VARICELLA-ZOSTER IMMUNE GLOBULIN",
      "StrengthNumber": "125",
      "StrengthUnit": "[iU]/1.2mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-09-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20190301",
      "SamplePackage": "N",
      "IndicationAndUsage": "VARIZIG® [Varicella Zoster Immune Globulin (Human)] is indicated for post-exposure prophylaxis of varicella in high risk individuals. High risk groups include: 1 immunocompromised children and adults,, 2 newborns of mothers with varicella shortly before or after delivery, , 3 premature infants,, 4 neonates and infants less than one year of age, , 5 adults without evidence of immunity, , 6 pregnant women. .",
      "Description": "VARIZIG [Varicella Zoster Immune Globulin (Human)] is a solvent/detergent-treated sterile liquid preparation of purified human immune globulin G (IgG) containing antibodies to varicella zoster virus (anti-VZV). VZV is the causative agent of chickenpox. VARIZIG is prepared from plasma donated by healthy, screened donors with high titers of antibodies to VZV, which is purified by an anion-exchange column chromatography manufacturing method. This donor selection process includes donors with high anti-VZV titers due to recent natural infection by VZV, or due to recurrent zoster infection (shingles). VARIZIG is intended for single use and should be administered intramuscularly [see 2 DOSAGE AND ADMINISTRATION]. The product potency is expressed in international units by comparison to the World Health Organization (WHO) international reference preparation for anti-VZV immune globulin. Each vial contains 125 international units of anti-VZV. VARIZIG is formulated with 10% maltose and 0.03% polysorbate 80. VARIZIG has a pH of 5.0 – 6.5 and contains no preservative. The presence of anti-Protein S antibodies has been reported to arise transiently in patients after VZV infection (4). Low levels of anti-Protein S antibodies have been reported in VARIZIG. The source plasma used in the manufacture of this product was tested by FDA licensed nucleic acid testing (NAT) for human immunodeficiency virus-1 (HIV-1), hepatitis B virus (HBV) and hepatitis C virus (HCV) and found to be negative. Plasma also was tested by in-process NAT for hepatitis A virus (HAV) and parvovirus B19 (B19) via minipool testing; the limit for B19 in the manufacturing pool is set not to exceed 104 international units of B19 DNA per milliliter. The manufacturing process contains two steps implemented specifically for virus clearance. The solvent/detergent step (using tri-n-butyl phosphate and Triton® X-100) is effective in the inactivation of enveloped viruses, such as HBV, HCV and HIV-1. Virus filtration, using a Planova® 20N virus filter, is effective for the removal of viruses based on their size, including some non-enveloped viruses. These two viral clearance steps are designed to increase product safety by reducing the risk of transmission of enveloped and non-enveloped viruses. In addition to these two specific steps, the process step of anion-exchange chromatography was identified as contributing to the overall viral clearance capacity for small non-enveloped viruses. The inactivation and reduction of known enveloped and non-enveloped model viruses were validated in laboratory studies as summarized in Table 2. The viruses employed for spiking studies were selected to represent those viruses that are potential contaminants in the product, and to represent a wide range of physiochemical properties in order to challenge the manufacturing process’s ability for viral clearance in general."
    },
    {
      "NDCCode": "73750-104-10",
      "PackageDescription": "100 TABLET in 1 BOTTLE (73750-104-10) ",
      "NDC11Code": "73750-0104-10",
      "ProductNDC": "73750-104",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Vardenafil Hydrochloride",
      "NonProprietaryName": "Vardenafil Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220301",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204632",
      "LabelerName": "QYK BRANDS LLC",
      "SubstanceName": "VARDENAFIL",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2023-08-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20220301",
      "SamplePackage": "N",
      "IndicationAndUsage": "Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction.",
      "Description": "Vardenafil hydrochloride tablets are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil HCl is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1- f ][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula:. Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water. Vardenafil hydrochloride tablets are formulated as: 2.5 mg tablets are white to off white, round, film-coated tablets debossed with ‘L 50’ on one side and plain surface on the other side,5 mg tablets are orange, round, film-coated tablets debossed with ‘L 51’ on one side and plain surface on the other side, 10 mg tablets are orange, round, film-coated tablets debossed with ‘L 52’ on one side and plain surface on the other side, 20 mg tablets are orange, round, film-coated tablets debossed with ‘L 53’ on one side and plain surface on the other side. In addition to the active ingredient, vardenafil HCl, each tablet contains microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol and titanium dioxide. In addition 5 mg, 10 mg and 20 mg has yellow ferric oxide and red ferric oxide."
    },
    {
      "NDCCode": "73750-104-11",
      "PackageDescription": "10 BLISTER PACK in 1 CARTON (73750-104-11)  > 10 TABLET in 1 BLISTER PACK",
      "NDC11Code": "73750-0104-11",
      "ProductNDC": "73750-104",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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      "NonProprietaryName": "Vardenafil Hydrochloride",
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      "ApplicationNumber": "ANDA204632",
      "LabelerName": "QYK BRANDS LLC",
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      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2023-08-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20220301",
      "SamplePackage": "N",
      "IndicationAndUsage": "Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction.",
      "Description": "Vardenafil hydrochloride tablets are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil HCl is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1- f ][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula:. Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water. Vardenafil hydrochloride tablets are formulated as: 2.5 mg tablets are white to off white, round, film-coated tablets debossed with ‘L 50’ on one side and plain surface on the other side,5 mg tablets are orange, round, film-coated tablets debossed with ‘L 51’ on one side and plain surface on the other side, 10 mg tablets are orange, round, film-coated tablets debossed with ‘L 52’ on one side and plain surface on the other side, 20 mg tablets are orange, round, film-coated tablets debossed with ‘L 53’ on one side and plain surface on the other side. In addition to the active ingredient, vardenafil HCl, each tablet contains microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol and titanium dioxide. In addition 5 mg, 10 mg and 20 mg has yellow ferric oxide and red ferric oxide."
    },
    {
      "NDCCode": "73750-104-30",
      "PackageDescription": "30 TABLET in 1 BOTTLE (73750-104-30) ",
      "NDC11Code": "73750-0104-30",
      "ProductNDC": "73750-104",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Vardenafil Hydrochloride",
      "NonProprietaryName": "Vardenafil Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220301",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204632",
      "LabelerName": "QYK BRANDS LLC",
      "SubstanceName": "VARDENAFIL",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2023-08-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20220301",
      "SamplePackage": "N",
      "IndicationAndUsage": "Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction.",
      "Description": "Vardenafil hydrochloride tablets are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil HCl is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1- f ][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula:. Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water. Vardenafil hydrochloride tablets are formulated as: 2.5 mg tablets are white to off white, round, film-coated tablets debossed with ‘L 50’ on one side and plain surface on the other side,5 mg tablets are orange, round, film-coated tablets debossed with ‘L 51’ on one side and plain surface on the other side, 10 mg tablets are orange, round, film-coated tablets debossed with ‘L 52’ on one side and plain surface on the other side, 20 mg tablets are orange, round, film-coated tablets debossed with ‘L 53’ on one side and plain surface on the other side. In addition to the active ingredient, vardenafil HCl, each tablet contains microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol and titanium dioxide. In addition 5 mg, 10 mg and 20 mg has yellow ferric oxide and red ferric oxide."
    },
    {
      "NDCCode": "70764-101-16",
      "PackageDescription": "198 mL in 1 BOTTLE (70764-101-16)",
      "NDC11Code": "70764-0101-16",
      "ProductNDC": "70764-101",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Medicated Pumice Wash",
      "NonProprietaryName": "Benzoyl Peroxide",
      "DosageFormName": "LOTION",
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      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part333D",
      "LabelerName": "CONTROL CORRECTIVE SKINCARE INC",
      "SubstanceName": "BENZOYL PEROXIDE",
      "StrengthNumber": "2.5",
      "StrengthUnit": "g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2018-11-21",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "70764-101-56",
      "PackageDescription": "1 BOTTLE in 1 BOX (70764-101-56)  > 198 mL in 1 BOTTLE (70764-101-16) ",
      "NDC11Code": "70764-0101-56",
      "ProductNDC": "70764-101",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Medicated Pumice Wash",
      "NonProprietaryName": "Benzoyl Peroxide",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160607",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part333D",
      "LabelerName": "CONTROL CORRECTIVE SKINCARE INC",
      "SubstanceName": "BENZOYL PEROXIDE",
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      "Status": "Deprecated",
      "LastUpdate": "2021-01-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20160607",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "70764-102-56",
      "PackageDescription": "1 BOTTLE in 1 BOX (70764-102-56)  / 198 mL in 1 BOTTLE (70764-102-16) ",
      "NDC11Code": "70764-0102-56",
      "ProductNDC": "70764-102",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Salicylic Wash",
      "NonProprietaryName": "Salicylic Acid",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160609",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M006",
      "LabelerName": "CONTROL CORRECTIVE SKINCARE INC",
      "SubstanceName": "SALICYLIC ACID",
      "StrengthNumber": "2",
      "StrengthUnit": "g/100mL",
      "Status": "Active",
      "LastUpdate": "2026-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160609",
      "SamplePackage": "N",
      "IndicationAndUsage": "THIS GENTLE FOAMING CLEANSER WORKS TO SMOOTH AND EXFOLIATE DEAD SKIN BUILDUP. MAY BE USED DAILY OR AS DIRECTED BY YOUR SKINCARE SPECIALIST."
    }
  ]
}
                    
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    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160609</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
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    <NDCCode>70764-107-51</NDCCode>
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    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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    <SamplePackage>N</SamplePackage>
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    <NDC11Code>70764-0301-51</NDC11Code>
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    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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    <StrengthUnit>g/100mL</StrengthUnit>
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    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
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    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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    <Pharm_Classes>Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]</Pharm_Classes>
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    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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    <LabelerName>Zogenix, Inc.</LabelerName>
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    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Sumavel DosePro is indicated in adults for (1) the acute treatment of migraine, with or without aura, and (2) the acute treatment of cluster headache. Limitations of Use: : 1 Use only if a clear diagnosis of migraine or cluster headache has been established. , 2 If a patient has no response to the first migraine attack treated with Sumavel DosePro, reconsider the diagnosis of migraine before Sumavel DosePro is administered to treat any subsequent attacks. , 3 Sumavel DosePro is not indicated for the prevention of migraine attacks. .</IndicationAndUsage>
    <Description>Sumavel DosePro contains sumatriptan succinate, a selective 5-HT1B/1D receptor agonist. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure. The empirical formula is C14H21N3O2SC4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate is a white to off-white powder that is readily soluble in water and in saline. Sumatriptan solution is a clear, colorless to pale yellow, sterile, nonpyrogenic solution for subcutaneous delivery. Each 0.5 mL of Sumavel DosePro 8 mg/mL solution contains 4 mg of sumatriptan (base) as the succinate salt and 3.8 mg of sodium chloride, USP in Water for Injection, USP. Each 0.5 mL of Sumavel DosePro 12 mg/mL solution contains 6 mg of sumatriptan (base) as the succinate salt and 3.5 mg of sodium chloride, USP, in water for injection, USP. The pH range of both solutions is approximately 4.2 to 5.3. The osmolality of both solutions is 291 mOsmol. Sumavel DosePro is a pre-filled, single-use, disposable, needle-free subcutaneous delivery system delivering sterile sumatriptan injection. Sumavel DosePro consists of the following components: a gray plastic handle and snap-off tip, a lavender (4 mg) or green (6 mg) lever, and a glass medication chamber that is pre-filled with 4 mg or 6 mg per 0.5 mL sumatriptan injection. Utilizing pressure from a compressed nitrogen gas source in the handle, Sumavel DosePro delivers the medication by pushing it through a small, precise hole in the glass medication chamber. The resulting stream of medication is propelled through the skin and is delivered subcutaneously without a needle, following a biphasic pressure profile.</Description>
  </NDC>
  <NDC>
    <NDCCode>49520-104-51</NDCCode>
    <PackageDescription>1 BOTTLE in 1 BOX (49520-104-51)  &gt; 150 mL in 1 BOTTLE (49520-104-11)</PackageDescription>
    <NDC11Code>49520-0104-51</NDC11Code>
    <ProductNDC>49520-104</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Take Control Calming</ProprietaryName>
    <ProprietaryNameSuffix>Cleanser</ProprietaryNameSuffix>
    <NonProprietaryName>Salicylic Acid</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20120927</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part333D</ApplicationNumber>
    <LabelerName>mybody</LabelerName>
    <SubstanceName>SALICYLIC ACID</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>USE FOR TREATMENT OF ACNE.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>49781-104-51</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (49781-104-51)  &gt; 100 TABLET in 1 BOTTLE</PackageDescription>
    <NDC11Code>49781-0104-51</NDC11Code>
    <ProductNDC>49781-104</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Leader Pain Reliever</ProprietaryName>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140519</StartMarketingDate>
    <EndMarketingDate>20190816</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part343</ApplicationNumber>
    <LabelerName>Cardinal Health</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>325</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-08-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20140519</StartMarketingDatePackage>
    <EndMarketingDatePackage>20190816</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>61715-104-51</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (61715-104-51)</PackageDescription>
    <NDC11Code>61715-0104-51</NDC11Code>
    <ProductNDC>61715-104</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Preferred Plus Arthritis Pain</ProprietaryName>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140922</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075077</ApplicationNumber>
    <LabelerName>Kinray</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>650</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-10-26</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>67879-104-51</NDCCode>
    <PackageDescription>1 TUBE in 1 BOX (67879-104-51)  / 15 mL in 1 TUBE (67879-104-11) </PackageDescription>
    <NDC11Code>67879-0104-51</NDC11Code>
    <ProductNDC>67879-104</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Pharma Clear Spot Treatment</ProprietaryName>
    <NonProprietaryName>Salicylic Acid</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20160615</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M006</ApplicationNumber>
    <LabelerName>PHARMAGEL INTERNATIONAL INC</LabelerName>
    <SubstanceName>SALICYLIC ACID</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-02-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160615</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Use for treatment of acne and to decrease bacteria on the skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>70474-104-51</NDCCode>
    <PackageDescription>1 BOTTLE, DISPENSING in 1 BOX (70474-104-51)  &gt; 35 mL in 1 BOTTLE, DISPENSING (70474-104-01)</PackageDescription>
    <NDC11Code>70474-0104-51</NDC11Code>
    <ProductNDC>70474-104</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Luminous Moisturizing Foundation</ProprietaryName>
    <ProprietaryNameSuffix>Spf-15</ProprietaryNameSuffix>
    <NonProprietaryName>Octinoxate, Titanium Dioxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20160407</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>ALTONA COSMETICS TECHNOLOGY (DBA NOTE COSMETICS)</LabelerName>
    <SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>.9; 12.2</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>84165-104-51</NDCCode>
    <PackageDescription>51 BAG in 1 BOX (84165-104-51)  / 12 g in 1 BAG (84165-104-01) </PackageDescription>
    <NDC11Code>84165-0104-51</NDC11Code>
    <ProductNDC>84165-104</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Pain Relief Gel-patch</ProprietaryName>
    <NonProprietaryName>Lidocaine, Menthol</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240924</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>Guangzhou Zhupuyou E-commerce Co., Ltd</LabelerName>
    <SubstanceName>MENTHOL; LIDOCAINE</SubstanceName>
    <StrengthNumber>.01; .04</StrengthNumber>
    <StrengthUnit>g/g; g/g</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240924</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temporarily relieves muscle soreness and minor joint pains in the wrist, knees, back,neck, hips, shoulders,elbows.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>33342-104-09</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (33342-104-09) </PackageDescription>
    <NDC11Code>33342-0104-09</NDC11Code>
    <ProductNDC>33342-104</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Quetiapine Fumarate</ProprietaryName>
    <NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160614</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203359</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-04-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160614</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Quetiapine tablets are an atypical antipsychotic indicated for the treatment of:  Schizophrenia (1.1)  Bipolar I disorder manic episodes (1.2)  Bipolar disorder, depressive episodes (1.2).</IndicationAndUsage>
    <Description>Quetiapine fumarate USP is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate USP is a white to off-white crystalline powder which is moderately soluble in water.Quetiapine tablets USP are supplied for oral administration as 25 mg (round, peach, one side debossed with “F71”), 50 mg (round, white, one side debossed with “F72”), 100 mg (round, yellow one side debossed with “F73”), 200 mg (round, white, one side debossed with "F75”), 300 mg (capsule-shaped, white, one side debossed with "F76”), and 400 mg (capsule-shaped, yellow, one side debossed with “F77”) tablets.Inactive ingredients are povidone, dibasic calcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, colloidal silicon di-oxide, hypromellose, polyethylene glycol, and titanium dioxide.The 25 mg tablets contain red ferric oxide and yellow ferric oxide and the 100 mg and 400 mg tablets contain only yellow ferric oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.51 mg of quetiapine fumarate equivalent to 400 mg quetiapine.</Description>
  </NDC>
  <NDC>
    <NDCCode>33342-104-15</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (33342-104-15) </PackageDescription>
    <NDC11Code>33342-0104-15</NDC11Code>
    <ProductNDC>33342-104</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Quetiapine Fumarate</ProprietaryName>
    <NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160614</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203359</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-04-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160614</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Quetiapine tablets are an atypical antipsychotic indicated for the treatment of:  Schizophrenia (1.1)  Bipolar I disorder manic episodes (1.2)  Bipolar disorder, depressive episodes (1.2).</IndicationAndUsage>
    <Description>Quetiapine fumarate USP is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate USP is a white to off-white crystalline powder which is moderately soluble in water.Quetiapine tablets USP are supplied for oral administration as 25 mg (round, peach, one side debossed with “F71”), 50 mg (round, white, one side debossed with “F72”), 100 mg (round, yellow one side debossed with “F73”), 200 mg (round, white, one side debossed with "F75”), 300 mg (capsule-shaped, white, one side debossed with "F76”), and 400 mg (capsule-shaped, yellow, one side debossed with “F77”) tablets.Inactive ingredients are povidone, dibasic calcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, colloidal silicon di-oxide, hypromellose, polyethylene glycol, and titanium dioxide.The 25 mg tablets contain red ferric oxide and yellow ferric oxide and the 100 mg and 400 mg tablets contain only yellow ferric oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.51 mg of quetiapine fumarate equivalent to 400 mg quetiapine.</Description>
  </NDC>
  <NDC>
    <NDCCode>33342-104-39</NDCCode>
    <PackageDescription>9 BLISTER PACK in 1 CARTON (33342-104-39)  / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>33342-0104-39</NDC11Code>
    <ProductNDC>33342-104</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Quetiapine Fumarate</ProprietaryName>
    <NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160614</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203359</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-04-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160614</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Quetiapine tablets are an atypical antipsychotic indicated for the treatment of:  Schizophrenia (1.1)  Bipolar I disorder manic episodes (1.2)  Bipolar disorder, depressive episodes (1.2).</IndicationAndUsage>
    <Description>Quetiapine fumarate USP is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate USP is a white to off-white crystalline powder which is moderately soluble in water.Quetiapine tablets USP are supplied for oral administration as 25 mg (round, peach, one side debossed with “F71”), 50 mg (round, white, one side debossed with “F72”), 100 mg (round, yellow one side debossed with “F73”), 200 mg (round, white, one side debossed with "F75”), 300 mg (capsule-shaped, white, one side debossed with "F76”), and 400 mg (capsule-shaped, yellow, one side debossed with “F77”) tablets.Inactive ingredients are povidone, dibasic calcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, colloidal silicon di-oxide, hypromellose, polyethylene glycol, and titanium dioxide.The 25 mg tablets contain red ferric oxide and yellow ferric oxide and the 100 mg and 400 mg tablets contain only yellow ferric oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.51 mg of quetiapine fumarate equivalent to 400 mg quetiapine.</Description>
  </NDC>
  <NDC>
    <NDCCode>33342-104-44</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (33342-104-44) </PackageDescription>
    <NDC11Code>33342-0104-44</NDC11Code>
    <ProductNDC>33342-104</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Quetiapine Fumarate</ProprietaryName>
    <NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160614</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203359</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-04-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160614</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Quetiapine tablets are an atypical antipsychotic indicated for the treatment of:  Schizophrenia (1.1)  Bipolar I disorder manic episodes (1.2)  Bipolar disorder, depressive episodes (1.2).</IndicationAndUsage>
    <Description>Quetiapine fumarate USP is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate USP is a white to off-white crystalline powder which is moderately soluble in water.Quetiapine tablets USP are supplied for oral administration as 25 mg (round, peach, one side debossed with “F71”), 50 mg (round, white, one side debossed with “F72”), 100 mg (round, yellow one side debossed with “F73”), 200 mg (round, white, one side debossed with "F75”), 300 mg (capsule-shaped, white, one side debossed with "F76”), and 400 mg (capsule-shaped, yellow, one side debossed with “F77”) tablets.Inactive ingredients are povidone, dibasic calcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, colloidal silicon di-oxide, hypromellose, polyethylene glycol, and titanium dioxide.The 25 mg tablets contain red ferric oxide and yellow ferric oxide and the 100 mg and 400 mg tablets contain only yellow ferric oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.51 mg of quetiapine fumarate equivalent to 400 mg quetiapine.</Description>
  </NDC>
  <NDC>
    <NDCCode>66993-100-06</NDCCode>
    <PackageDescription>6 BLISTER PACK in 1 CARTON (66993-100-06)  / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (66993-100-51) </PackageDescription>
    <NDC11Code>66993-0100-06</NDC11Code>
    <ProductNDC>66993-100</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levetiracetam</ProprietaryName>
    <NonProprietaryName>Levetiracetam</NonProprietaryName>
    <DosageFormName>TABLET, FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250120</StartMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA207958</ApplicationNumber>
    <LabelerName>Prasco Laboratories</LabelerName>
    <SubstanceName>LEVETIRACETAM</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250120</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Levetiracetam tablets for oral suspension are indicated for the treatment of partial-onset seizures in patients 4 years of age and older weighing more than 20 kg (1.1). Levetiracetam tablets for oral suspension are indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).</IndicationAndUsage>
    <Description>Levetiracetam tablets for oral suspension are an antiepileptic drug available as 250 mg and 500 mg, round, white to off-white, spearmint-flavored tablets for oral suspension. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent). Levetiracetam tablets for oral suspension contain 250 mg and 500 mg levetiracetam. Each tablet also contains the following inactive ingredients: colloidal silicon dioxide, glycerin, mannitol, microcrystalline cellulose, polysorbate 20, povidone, sucralose, butylated hydroxyanisole, and natural and artificial spearmint flavor. Levetiracetam tablets for oral suspension are unitary porous structures produced by a three-dimensional printing process that binds the powders without compression. Levetiracetam tablets for oral suspension disintegrate in a mean time of 11 seconds (ranging from 2 to 27 seconds) in the mouth, when taken with a sip of liquid, to produce small particles that may be swallowed.</Description>
  </NDC>
  <NDC>
    <NDCCode>66993-100-60</NDCCode>
    <PackageDescription>60 BLISTER PACK in 1 CARTON (66993-100-60)  / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (66993-100-51) </PackageDescription>
    <NDC11Code>66993-0100-60</NDC11Code>
    <ProductNDC>66993-100</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levetiracetam</ProprietaryName>
    <NonProprietaryName>Levetiracetam</NonProprietaryName>
    <DosageFormName>TABLET, FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250120</StartMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA207958</ApplicationNumber>
    <LabelerName>Prasco Laboratories</LabelerName>
    <SubstanceName>LEVETIRACETAM</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260116</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Levetiracetam tablets for oral suspension are indicated for the treatment of partial-onset seizures in patients 4 years of age and older weighing more than 20 kg (1.1). Levetiracetam tablets for oral suspension are indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).</IndicationAndUsage>
    <Description>Levetiracetam tablets for oral suspension are an antiepileptic drug available as 250 mg and 500 mg, round, white to off-white, spearmint-flavored tablets for oral suspension. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent). Levetiracetam tablets for oral suspension contain 250 mg and 500 mg levetiracetam. Each tablet also contains the following inactive ingredients: colloidal silicon dioxide, glycerin, mannitol, microcrystalline cellulose, polysorbate 20, povidone, sucralose, butylated hydroxyanisole, and natural and artificial spearmint flavor. Levetiracetam tablets for oral suspension are unitary porous structures produced by a three-dimensional printing process that binds the powders without compression. Levetiracetam tablets for oral suspension disintegrate in a mean time of 11 seconds (ranging from 2 to 27 seconds) in the mouth, when taken with a sip of liquid, to produce small particles that may be swallowed.</Description>
  </NDC>
  <NDC>
    <NDCCode>66993-101-60</NDCCode>
    <PackageDescription>60 BLISTER PACK in 1 CARTON (66993-101-60)  / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (66993-101-51) </PackageDescription>
    <NDC11Code>66993-0101-60</NDC11Code>
    <ProductNDC>66993-101</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levetiracetam</ProprietaryName>
    <NonProprietaryName>Levetiracetam</NonProprietaryName>
    <DosageFormName>TABLET, FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250120</StartMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA207958</ApplicationNumber>
    <LabelerName>Prasco Laboratories</LabelerName>
    <SubstanceName>LEVETIRACETAM</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260116</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Levetiracetam tablets for oral suspension are indicated for the treatment of partial-onset seizures in patients 4 years of age and older weighing more than 20 kg (1.1). Levetiracetam tablets for oral suspension are indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).</IndicationAndUsage>
    <Description>Levetiracetam tablets for oral suspension are an antiepileptic drug available as 250 mg and 500 mg, round, white to off-white, spearmint-flavored tablets for oral suspension. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent). Levetiracetam tablets for oral suspension contain 250 mg and 500 mg levetiracetam. Each tablet also contains the following inactive ingredients: colloidal silicon dioxide, glycerin, mannitol, microcrystalline cellulose, polysorbate 20, povidone, sucralose, butylated hydroxyanisole, and natural and artificial spearmint flavor. Levetiracetam tablets for oral suspension are unitary porous structures produced by a three-dimensional printing process that binds the powders without compression. Levetiracetam tablets for oral suspension disintegrate in a mean time of 11 seconds (ranging from 2 to 27 seconds) in the mouth, when taken with a sip of liquid, to produce small particles that may be swallowed.</Description>
  </NDC>
  <NDC>
    <NDCCode>69879-104-35</NDCCode>
    <PackageDescription>35 mL in 1 TUBE (69879-104-35) </PackageDescription>
    <NDC11Code>69879-0104-35</NDC11Code>
    <ProductNDC>69879-104</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cover-expert Sunscreen Broad Spectrum Spf 15 No.4 Rosy Beige</ProprietaryName>
    <NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20150731</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Luxe Art Beaute SAS</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>51; 28</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-09-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150731</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>70257-051-51</NDCCode>
    <PackageDescription>1 VIAL, GLASS in 1 CARTON (70257-051-51)  &gt; 5 mL in 1 VIAL, GLASS (70257-051-05) </PackageDescription>
    <NDC11Code>70257-0051-51</NDC11Code>
    <ProductNDC>70257-051</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hepagam B</ProprietaryName>
    <NonProprietaryName>Hepatitis B Immune Globulin Intravenous (human)</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20190301</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125035</ApplicationNumber>
    <LabelerName>Saol Therapeutics Inc.</LabelerName>
    <SubstanceName>HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN</SubstanceName>
    <StrengthNumber>312</StrengthNumber>
    <StrengthUnit>[iU]/mL</StrengthUnit>
    <Pharm_Classes>Human Immunoglobulin [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE], Virus Neutralization [MoA], Virus-specific Hyperimmune Globulins [EXT]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190301</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>HepaGam B [Hepatitis B immune globulin intravenous (Human)] is an intravenous immune globulin indicated for the following.</IndicationAndUsage>
    <Description>HepaGam B, Hepatitis B Immune Globulin Intravenous (Human), is a solvent/detergent-treated sterile solution of purified gamma globulin containing anti-HBs. It is prepared from plasma donated by healthy, screened donors with high titers of anti-HBs that is purified by an anion-exchange column chromatography manufacturing method9,10. HepaGam B is formulated as a 5% (50 milligrams per milliliter) protein solution with 10% maltose and 0.03% polysorbate 80 at pH 5.6. It is available in 1 milliliter and 5 milliliters single dose vials. The product appears as a clear to opalescent liquid. HepaGam B does not contain mercury. It contains no preservatives. This product is intended for single use. HepaGam B may be administered intravenously or intramuscularly dependent upon indication [see Dosage and Administration (2.)]. The source plasma used in the manufacture of this product was tested by FDA licensed Nucleic Acid testing (NAT) for HIV-1, HBV and HCV and found to be negative. Plasma also has been tested by in-process NAT for hepatitis A virus (HAV) and parvovirus B19 (B19) via minipool testing and the limit for B19 in the manufacturing pool is set not to exceed 104 international units of B19 DNA per milliliter. The manufacturing process contains two steps implemented specifically for virus clearance. The solvent and detergent step (using tri-n-butyl phosphate and Triton® X-100) is effective in the inactivation of enveloped viruses, such as hepatitis B, hepatitis C and HIV11. Virus filtration, using a Planova® 20N virus filter, is effective for the removal of viruses based on their size, including some non-enveloped viruses12. These two viral clearance steps are designed to increase product safety by reducing the risk of transmission of enveloped and non-enveloped viruses. In addition to these two specific steps, the process step of anion-exchange chromatography was identified as contributing to the overall viral clearance capacity for small non-enveloped viruses. The inactivation and reduction of known enveloped and non–enveloped model viruses were validated in laboratory studies as summarized in Table 4. The viruses employed for spiking studies were selected to represent those viruses that are potential contaminants in the product, and to represent a wide range of physiochemical properties in order to challenge the manufacturing process’s ability for viral clearance in general. The product potency is expressed in international units by comparison to the World Health Organization (WHO) standard Hepatitis B Immune Globulin. Each vial contains greater than 312 international units per milliliter. The measured potency of each lot is stamped on the vial label [see Dosage Forms and Strengths (3)].</Description>
  </NDC>
  <NDC>
    <NDCCode>70257-052-51</NDCCode>
    <PackageDescription>1 VIAL, GLASS in 1 CARTON (70257-052-51)  &gt; 1 mL in 1 VIAL, GLASS (70257-052-11) </PackageDescription>
    <NDC11Code>70257-0052-51</NDC11Code>
    <ProductNDC>70257-052</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hepagam B</ProprietaryName>
    <NonProprietaryName>Hepatitis B Immune Globulin Intravenous (human)</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20190301</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125035</ApplicationNumber>
    <LabelerName>Saol Therapeutics Inc.</LabelerName>
    <SubstanceName>HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN</SubstanceName>
    <StrengthNumber>312</StrengthNumber>
    <StrengthUnit>[iU]/mL</StrengthUnit>
    <Pharm_Classes>Human Immunoglobulin [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE], Virus Neutralization [MoA], Virus-specific Hyperimmune Globulins [EXT]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190301</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>HepaGam B [Hepatitis B immune globulin intravenous (Human)] is an intravenous immune globulin indicated for the following.</IndicationAndUsage>
    <Description>HepaGam B, Hepatitis B Immune Globulin Intravenous (Human), is a solvent/detergent-treated sterile solution of purified gamma globulin containing anti-HBs. It is prepared from plasma donated by healthy, screened donors with high titers of anti-HBs that is purified by an anion-exchange column chromatography manufacturing method9,10. HepaGam B is formulated as a 5% (50 milligrams per milliliter) protein solution with 10% maltose and 0.03% polysorbate 80 at pH 5.6. It is available in 1 milliliter and 5 milliliters single dose vials. The product appears as a clear to opalescent liquid. HepaGam B does not contain mercury. It contains no preservatives. This product is intended for single use. HepaGam B may be administered intravenously or intramuscularly dependent upon indication [see Dosage and Administration (2.)]. The source plasma used in the manufacture of this product was tested by FDA licensed Nucleic Acid testing (NAT) for HIV-1, HBV and HCV and found to be negative. Plasma also has been tested by in-process NAT for hepatitis A virus (HAV) and parvovirus B19 (B19) via minipool testing and the limit for B19 in the manufacturing pool is set not to exceed 104 international units of B19 DNA per milliliter. The manufacturing process contains two steps implemented specifically for virus clearance. The solvent and detergent step (using tri-n-butyl phosphate and Triton® X-100) is effective in the inactivation of enveloped viruses, such as hepatitis B, hepatitis C and HIV11. Virus filtration, using a Planova® 20N virus filter, is effective for the removal of viruses based on their size, including some non-enveloped viruses12. These two viral clearance steps are designed to increase product safety by reducing the risk of transmission of enveloped and non-enveloped viruses. In addition to these two specific steps, the process step of anion-exchange chromatography was identified as contributing to the overall viral clearance capacity for small non-enveloped viruses. The inactivation and reduction of known enveloped and non–enveloped model viruses were validated in laboratory studies as summarized in Table 4. The viruses employed for spiking studies were selected to represent those viruses that are potential contaminants in the product, and to represent a wide range of physiochemical properties in order to challenge the manufacturing process’s ability for viral clearance in general. The product potency is expressed in international units by comparison to the World Health Organization (WHO) standard Hepatitis B Immune Globulin. Each vial contains greater than 312 international units per milliliter. The measured potency of each lot is stamped on the vial label [see Dosage Forms and Strengths (3)].</Description>
  </NDC>
  <NDC>
    <NDCCode>70257-126-51</NDCCode>
    <PackageDescription>1 VIAL, GLASS in 1 CARTON (70257-126-51)  / 1.2 mL in 1 VIAL, GLASS (70257-126-11) </PackageDescription>
    <NDC11Code>70257-0126-51</NDC11Code>
    <ProductNDC>70257-126</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Varizig</ProprietaryName>
    <NonProprietaryName>Human Varicella-zoster Immune Globulin</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20190301</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125430</ApplicationNumber>
    <LabelerName>Saol Therapeutics</LabelerName>
    <SubstanceName>HUMAN VARICELLA-ZOSTER IMMUNE GLOBULIN</SubstanceName>
    <StrengthNumber>125</StrengthNumber>
    <StrengthUnit>[iU]/1.2mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-09-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190301</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>VARIZIG® [Varicella Zoster Immune Globulin (Human)] is indicated for post-exposure prophylaxis of varicella in high risk individuals. High risk groups include: 1 immunocompromised children and adults,, 2 newborns of mothers with varicella shortly before or after delivery, , 3 premature infants,, 4 neonates and infants less than one year of age, , 5 adults without evidence of immunity, , 6 pregnant women. .</IndicationAndUsage>
    <Description>VARIZIG [Varicella Zoster Immune Globulin (Human)] is a solvent/detergent-treated sterile liquid preparation of purified human immune globulin G (IgG) containing antibodies to varicella zoster virus (anti-VZV). VZV is the causative agent of chickenpox. VARIZIG is prepared from plasma donated by healthy, screened donors with high titers of antibodies to VZV, which is purified by an anion-exchange column chromatography manufacturing method. This donor selection process includes donors with high anti-VZV titers due to recent natural infection by VZV, or due to recurrent zoster infection (shingles). VARIZIG is intended for single use and should be administered intramuscularly [see 2 DOSAGE AND ADMINISTRATION]. The product potency is expressed in international units by comparison to the World Health Organization (WHO) international reference preparation for anti-VZV immune globulin. Each vial contains 125 international units of anti-VZV. VARIZIG is formulated with 10% maltose and 0.03% polysorbate 80. VARIZIG has a pH of 5.0 – 6.5 and contains no preservative. The presence of anti-Protein S antibodies has been reported to arise transiently in patients after VZV infection (4). Low levels of anti-Protein S antibodies have been reported in VARIZIG. The source plasma used in the manufacture of this product was tested by FDA licensed nucleic acid testing (NAT) for human immunodeficiency virus-1 (HIV-1), hepatitis B virus (HBV) and hepatitis C virus (HCV) and found to be negative. Plasma also was tested by in-process NAT for hepatitis A virus (HAV) and parvovirus B19 (B19) via minipool testing; the limit for B19 in the manufacturing pool is set not to exceed 104 international units of B19 DNA per milliliter. The manufacturing process contains two steps implemented specifically for virus clearance. The solvent/detergent step (using tri-n-butyl phosphate and Triton® X-100) is effective in the inactivation of enveloped viruses, such as HBV, HCV and HIV-1. Virus filtration, using a Planova® 20N virus filter, is effective for the removal of viruses based on their size, including some non-enveloped viruses. These two viral clearance steps are designed to increase product safety by reducing the risk of transmission of enveloped and non-enveloped viruses. In addition to these two specific steps, the process step of anion-exchange chromatography was identified as contributing to the overall viral clearance capacity for small non-enveloped viruses. The inactivation and reduction of known enveloped and non-enveloped model viruses were validated in laboratory studies as summarized in Table 2. The viruses employed for spiking studies were selected to represent those viruses that are potential contaminants in the product, and to represent a wide range of physiochemical properties in order to challenge the manufacturing process’s ability for viral clearance in general.</Description>
  </NDC>
  <NDC>
    <NDCCode>73750-104-10</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (73750-104-10) </PackageDescription>
    <NDC11Code>73750-0104-10</NDC11Code>
    <ProductNDC>73750-104</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Vardenafil Hydrochloride</ProprietaryName>
    <NonProprietaryName>Vardenafil Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220301</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204632</ApplicationNumber>
    <LabelerName>QYK BRANDS LLC</LabelerName>
    <SubstanceName>VARDENAFIL</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-08-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220301</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
    <Description>Vardenafil hydrochloride tablets are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil HCl is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1- f ][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula:. Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water. Vardenafil hydrochloride tablets are formulated as: 2.5 mg tablets are white to off white, round, film-coated tablets debossed with ‘L 50’ on one side and plain surface on the other side,5 mg tablets are orange, round, film-coated tablets debossed with ‘L 51’ on one side and plain surface on the other side, 10 mg tablets are orange, round, film-coated tablets debossed with ‘L 52’ on one side and plain surface on the other side, 20 mg tablets are orange, round, film-coated tablets debossed with ‘L 53’ on one side and plain surface on the other side. In addition to the active ingredient, vardenafil HCl, each tablet contains microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol and titanium dioxide. In addition 5 mg, 10 mg and 20 mg has yellow ferric oxide and red ferric oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>73750-104-11</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (73750-104-11)  &gt; 10 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>73750-0104-11</NDC11Code>
    <ProductNDC>73750-104</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Vardenafil Hydrochloride</ProprietaryName>
    <NonProprietaryName>Vardenafil Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220301</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204632</ApplicationNumber>
    <LabelerName>QYK BRANDS LLC</LabelerName>
    <SubstanceName>VARDENAFIL</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-08-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220301</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
    <Description>Vardenafil hydrochloride tablets are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil HCl is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1- f ][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula:. Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water. Vardenafil hydrochloride tablets are formulated as: 2.5 mg tablets are white to off white, round, film-coated tablets debossed with ‘L 50’ on one side and plain surface on the other side,5 mg tablets are orange, round, film-coated tablets debossed with ‘L 51’ on one side and plain surface on the other side, 10 mg tablets are orange, round, film-coated tablets debossed with ‘L 52’ on one side and plain surface on the other side, 20 mg tablets are orange, round, film-coated tablets debossed with ‘L 53’ on one side and plain surface on the other side. In addition to the active ingredient, vardenafil HCl, each tablet contains microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol and titanium dioxide. In addition 5 mg, 10 mg and 20 mg has yellow ferric oxide and red ferric oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>73750-104-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (73750-104-30) </PackageDescription>
    <NDC11Code>73750-0104-30</NDC11Code>
    <ProductNDC>73750-104</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Vardenafil Hydrochloride</ProprietaryName>
    <NonProprietaryName>Vardenafil Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220301</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204632</ApplicationNumber>
    <LabelerName>QYK BRANDS LLC</LabelerName>
    <SubstanceName>VARDENAFIL</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-08-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220301</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
    <Description>Vardenafil hydrochloride tablets are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil HCl is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1- f ][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula:. Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water. Vardenafil hydrochloride tablets are formulated as: 2.5 mg tablets are white to off white, round, film-coated tablets debossed with ‘L 50’ on one side and plain surface on the other side,5 mg tablets are orange, round, film-coated tablets debossed with ‘L 51’ on one side and plain surface on the other side, 10 mg tablets are orange, round, film-coated tablets debossed with ‘L 52’ on one side and plain surface on the other side, 20 mg tablets are orange, round, film-coated tablets debossed with ‘L 53’ on one side and plain surface on the other side. In addition to the active ingredient, vardenafil HCl, each tablet contains microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol and titanium dioxide. In addition 5 mg, 10 mg and 20 mg has yellow ferric oxide and red ferric oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>70764-101-16</NDCCode>
    <PackageDescription>198 mL in 1 BOTTLE (70764-101-16)</PackageDescription>
    <NDC11Code>70764-0101-16</NDC11Code>
    <ProductNDC>70764-101</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Medicated Pumice Wash</ProprietaryName>
    <NonProprietaryName>Benzoyl Peroxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20160607</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part333D</ApplicationNumber>
    <LabelerName>CONTROL CORRECTIVE SKINCARE INC</LabelerName>
    <SubstanceName>BENZOYL PEROXIDE</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-11-21</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>70764-101-56</NDCCode>
    <PackageDescription>1 BOTTLE in 1 BOX (70764-101-56)  &gt; 198 mL in 1 BOTTLE (70764-101-16) </PackageDescription>
    <NDC11Code>70764-0101-56</NDC11Code>
    <ProductNDC>70764-101</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Medicated Pumice Wash</ProprietaryName>
    <NonProprietaryName>Benzoyl Peroxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20160607</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part333D</ApplicationNumber>
    <LabelerName>CONTROL CORRECTIVE SKINCARE INC</LabelerName>
    <SubstanceName>BENZOYL PEROXIDE</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-01-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160607</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>70764-102-56</NDCCode>
    <PackageDescription>1 BOTTLE in 1 BOX (70764-102-56)  / 198 mL in 1 BOTTLE (70764-102-16) </PackageDescription>
    <NDC11Code>70764-0102-56</NDC11Code>
    <ProductNDC>70764-102</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Salicylic Wash</ProprietaryName>
    <NonProprietaryName>Salicylic Acid</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20160609</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M006</ApplicationNumber>
    <LabelerName>CONTROL CORRECTIVE SKINCARE INC</LabelerName>
    <SubstanceName>SALICYLIC ACID</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160609</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>THIS GENTLE FOAMING CLEANSER WORKS TO SMOOTH AND EXFOLIATE DEAD SKIN BUILDUP. MAY BE USED DAILY OR AS DIRECTED BY YOUR SKINCARE SPECIALIST.</IndicationAndUsage>
  </NDC>
</NDCList>
                    
<NDCList><NDC><NDCCode>70764-104-51</NDCCode><ProprietaryName>Exfo Tonic Acne Treatment</ProprietaryName><NonProprietaryName>Salicylic Acid</NonProprietaryName></NDC><NDC><NDCCode>70764-105-51</NDCCode><ProprietaryName>Acne Spot Treatment</ProprietaryName><NonProprietaryName>Salicylic Acid</NonProprietaryName></NDC><NDC><NDCCode>70764-106-51</NDCCode><ProprietaryName>Clear Med</ProprietaryName><NonProprietaryName>Benzoyl Peroxide</NonProprietaryName></NDC><NDC><NDCCode>70764-107-51</NDCCode><ProprietaryName>Clear Med</ProprietaryName><NonProprietaryName>Benzoyl Peroxide</NonProprietaryName></NDC><NDC><NDCCode>70764-301-51</NDCCode><ProprietaryName>Multi Complex Fade</ProprietaryName><NonProprietaryName>Hydroquinone</NonProprietaryName></NDC><NDC><NDCCode>42934-104-51</NDCCode><ProprietaryName>Varenicline Tartrate</ProprietaryName><NonProprietaryName>Varenicline Tartrate</NonProprietaryName></NDC><NDC><NDCCode>43376-104-51</NDCCode><ProprietaryName>Sumavel Dosepro</ProprietaryName><NonProprietaryName>Sumatriptan</NonProprietaryName></NDC><NDC><NDCCode>49520-104-51</NDCCode><ProprietaryName>Take Control Calming</ProprietaryName><NonProprietaryName>Salicylic Acid</NonProprietaryName></NDC><NDC><NDCCode>49781-104-51</NDCCode><ProprietaryName>Leader Pain Reliever</ProprietaryName><NonProprietaryName>Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>61715-104-51</NDCCode><ProprietaryName>Preferred Plus Arthritis Pain</ProprietaryName><NonProprietaryName>Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>67879-104-51</NDCCode><ProprietaryName>Pharma Clear Spot Treatment</ProprietaryName><NonProprietaryName>Salicylic Acid</NonProprietaryName></NDC><NDC><NDCCode>70474-104-51</NDCCode><ProprietaryName>Luminous Moisturizing Foundation</ProprietaryName><NonProprietaryName>Octinoxate, Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>84165-104-51</NDCCode><ProprietaryName>Pain Relief Gel-patch</ProprietaryName><NonProprietaryName>Lidocaine, Menthol</NonProprietaryName></NDC><NDC><NDCCode>33342-104-09</NDCCode><ProprietaryName>Quetiapine Fumarate</ProprietaryName><NonProprietaryName>Quetiapine Fumarate</NonProprietaryName></NDC><NDC><NDCCode>33342-104-15</NDCCode><ProprietaryName>Quetiapine Fumarate</ProprietaryName><NonProprietaryName>Quetiapine Fumarate</NonProprietaryName></NDC><NDC><NDCCode>33342-104-39</NDCCode><ProprietaryName>Quetiapine Fumarate</ProprietaryName><NonProprietaryName>Quetiapine Fumarate</NonProprietaryName></NDC><NDC><NDCCode>33342-104-44</NDCCode><ProprietaryName>Quetiapine Fumarate</ProprietaryName><NonProprietaryName>Quetiapine Fumarate</NonProprietaryName></NDC><NDC><NDCCode>66993-100-06</NDCCode><ProprietaryName>Levetiracetam</ProprietaryName><NonProprietaryName>Levetiracetam</NonProprietaryName></NDC><NDC><NDCCode>66993-100-60</NDCCode><ProprietaryName>Levetiracetam</ProprietaryName><NonProprietaryName>Levetiracetam</NonProprietaryName></NDC><NDC><NDCCode>66993-101-60</NDCCode><ProprietaryName>Levetiracetam</ProprietaryName><NonProprietaryName>Levetiracetam</NonProprietaryName></NDC><NDC><NDCCode>69879-104-35</NDCCode><ProprietaryName>Cover-expert Sunscreen Broad Spectrum Spf 15 No.4 Rosy Beige</ProprietaryName><NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>70257-051-51</NDCCode><ProprietaryName>Hepagam B</ProprietaryName><NonProprietaryName>Hepatitis B Immune Globulin Intravenous (human)</NonProprietaryName></NDC><NDC><NDCCode>70257-052-51</NDCCode><ProprietaryName>Hepagam B</ProprietaryName><NonProprietaryName>Hepatitis B Immune Globulin Intravenous (human)</NonProprietaryName></NDC><NDC><NDCCode>70257-126-51</NDCCode><ProprietaryName>Varizig</ProprietaryName><NonProprietaryName>Human Varicella-zoster Immune Globulin</NonProprietaryName></NDC><NDC><NDCCode>73750-104-10</NDCCode><ProprietaryName>Vardenafil Hydrochloride</ProprietaryName><NonProprietaryName>Vardenafil Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>73750-104-11</NDCCode><ProprietaryName>Vardenafil Hydrochloride</ProprietaryName><NonProprietaryName>Vardenafil Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>73750-104-30</NDCCode><ProprietaryName>Vardenafil Hydrochloride</ProprietaryName><NonProprietaryName>Vardenafil Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>70764-101-16</NDCCode><ProprietaryName>Medicated Pumice Wash</ProprietaryName><NonProprietaryName>Benzoyl Peroxide</NonProprietaryName></NDC><NDC><NDCCode>70764-101-56</NDCCode><ProprietaryName>Medicated Pumice Wash</ProprietaryName><NonProprietaryName>Benzoyl Peroxide</NonProprietaryName></NDC><NDC><NDCCode>70764-102-56</NDCCode><ProprietaryName>Salicylic Wash</ProprietaryName><NonProprietaryName>Salicylic Acid</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",
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      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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",
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      "EnumerationDate": "12/03/2024",
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      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "171M00000X",
      "Taxonomy1": "Case Manager/Care Coordinator",
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      "PrimaryTaxonomy": "Case Manager/Care Coordinator"
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    {
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      "EnumerationDate": "02/21/2025",
      "LastUpdateDate": "02/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
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      "PrimaryTaxonomy": "Peer Specialist"
    }
  ]
}
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