RESTful Lookup — Test-Drive (2007 – 2026)

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{
  "NDC": [
    {
      "NDCCode": "59469-318-10",
      "PackageDescription": "1 BOTTLE, GLASS in 1 BOX (59469-318-10)  > 50 mL in 1 BOTTLE, GLASS",
      "NDC11Code": "59469-0318-10",
      "ProductNDC": "59469-318",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Toxex",
      "NonProprietaryName": "Silver Nitrate, Bryonia Dioica Root, Clematis Recta Flowering Top, Goldenseal, Echinacea, Unspecified, Galium Aparine, Glechoma Hederacea Flowering Top, And Rhododendron Tomentosum Leafy Twig",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190624",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "PEKANA Naturheilmittel GmbH",
      "SubstanceName": "SILVER NITRATE; BRYONIA CRETICA SUBSP. DIOICA ROOT; CLEMATIS RECTA FLOWERING TOP; GOLDENSEAL; ECHINACEA, UNSPECIFIED; GALIUM APARINE WHOLE; GLECHOMA HEDERACEA FLOWERING TOP; RHODODENDRON TOMENTOSUM LEAFY TWIG",
      "StrengthNumber": "6; 4; 4; 5; 12; 6; 6; 6",
      "StrengthUnit": "[hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL",
      "Status": "Active",
      "LastUpdate": "2023-01-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190624",
      "SamplePackage": "N",
      "IndicationAndUsage": "For support of general body cleansing processes. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated."
    },
    {
      "NDCCode": "10695-318-10",
      "PackageDescription": "1 kg in 1 CONTAINER (10695-318-10) ",
      "NDC11Code": "10695-0318-10",
      "ProductNDC": "10695-318",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Ezetimibe",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20260729",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Willow Birch Pharma, LLC.",
      "SubstanceName": "EZETIMIBE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2026-07-31",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "29-JUL-26"
    },
    {
      "NDCCode": "13533-318-01",
      "PackageDescription": "1 VIAL in 1 CARTON (13533-318-01)  / 1 mL in 1 VIAL (13533-318-10) ",
      "NDC11Code": "13533-0318-01",
      "ProductNDC": "13533-318",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Hyperrab",
      "NonProprietaryName": "Rabies Immune Globulin (human)",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INFILTRATION; INTRAMUSCULAR",
      "StartMarketingDate": "19740612",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101144",
      "LabelerName": "GRIFOLS USA, LLC",
      "SubstanceName": "HUMAN RABIES VIRUS IMMUNE GLOBULIN",
      "StrengthNumber": "300",
      "StrengthUnit": "[iU]/mL",
      "Status": "Active",
      "LastUpdate": "2024-10-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19740612",
      "SamplePackage": "N",
      "IndicationAndUsage": "HYPERRAB is a human rabies immune globulin indicated for postexposure prophylaxis, along with rabies vaccine, for all persons suspected of exposure to rabies. Limitations of Use. Persons who have been previously immunized with rabies vaccine and have a confirmed adequate rabies antibody titer should receive only vaccine.(1-3). For unvaccinated persons, the combination of HYPERRAB and vaccine is recommended for both bite and nonbite exposures regardless of the time interval between exposure and initiation of postexposure prophylaxis.(1-3). Beyond 7 days (after the first vaccine dose), HYPERRAB is not indicated since an antibody response to vaccine is presumed to have occurred.",
      "Description": "HYPERRAB is a clear or slightly opalescent, and colorless or pale yellow sterile solution of human antirabies immune globulin for infiltration and intramuscular administration. HYPERRAB is provided in a single-dose vial and contains no preservative.  HYPERRAB is prepared from pools of human plasma collected from healthy donors (hyperimmunized with rabies vaccine) by a combination of cold ethanol fractionation, caprylate precipitation and filtration, caprylate incubation, anion-exchange chromatography, nanofiltration and low pH incubation. HYPERRAB consists of 15 to 18% protein at pH 4.1 to 4.8 in 0.16 to 0.26 M glycine. The product is standardized against the U.S. Standard Rabies Immune Globulin to contain a potency value of not less than 300 IU/mL. The U.S. unit of potency is equivalent to the international unit (IU) for rabies antibody. When medicinal biological products are administered, infectious diseases due to transmission of pathogens cannot be totally excluded. However, in the case of products prepared from human plasma, the risk of transmission of pathogens is reduced by epidemiological surveillance of the donor population and selection of individual donors by medical interview; testing of individual donations and plasma pools; and the presence in the manufacturing processes of steps with demonstrated capacity to inactivate/remove pathogens. In the manufacturing process of HYPERRAB, there are several steps with the capacity for virus inactivation or removal.(6) The main steps of the manufacturing process that contribute to the virus clearance capacity are as follows: 1 Caprylate precipitation/depth filtration, 2 Caprylate incubation, 3 Depth filtration, 4 Column chromatography, 5 Nanofiltration, 6 Low pH final container incubation."
    },
    {
      "NDCCode": "14593-318-01",
      "PackageDescription": "10 VIAL in 1 CARTON (14593-318-01)  / 10 mL in 1 VIAL",
      "NDC11Code": "14593-0318-01",
      "ProductNDC": "14593-318",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tranexamic Acid",
      "NonProprietaryName": "Tranexamic Acid",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20241028",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203521",
      "LabelerName": "Emcure Pharmaceuticals Limited",
      "SubstanceName": "TRANEXAMIC ACID",
      "StrengthNumber": "1",
      "StrengthUnit": "g/10mL",
      "Pharm_Classes": "Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]",
      "Status": "Active",
      "LastUpdate": "2024-10-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20241028",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tranexamic acid injection, USP is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction."
    },
    {
      "NDCCode": "16729-318-10",
      "PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-318-10)",
      "NDC11Code": "16729-0318-10",
      "ProductNDC": "16729-318",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxybutynin Chloride",
      "NonProprietaryName": "Oxybutynin Chloride",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20161010",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207138",
      "LabelerName": "Accord Healthcare, Inc.",
      "SubstanceName": "OXYBUTYNIN CHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-22"
    },
    {
      "NDCCode": "25021-318-02",
      "PackageDescription": "10 VIAL in 1 CARTON (25021-318-02)  / 2 mL in 1 VIAL",
      "NDC11Code": "25021-0318-02",
      "ProductNDC": "25021-318",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Adenosine",
      "NonProprietaryName": "Adenosine",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20230315",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206778",
      "LabelerName": "Sagent Pharmaceuticals",
      "SubstanceName": "ADENOSINE",
      "StrengthNumber": "3",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Adenosine Receptor Agonist [EPC], Adenosine Receptor Agonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-08-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230315",
      "SamplePackage": "N",
      "IndicationAndUsage": "Intravenous adenosine injection is indicated for the following. Conversion to sinus rhythm of paroxysmal supraventricular tachycardia (PSVT), including that associated with accessory bypass tracts (Wolff-Parkinson-White Syndrome). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver), should be attempted prior to adenosine injection administration. It is important to be sure the adenosine injection solution actually reaches the systemic circulation (see DOSAGE AND ADMINISTRATION). Adenosine Injection does not convert atrial flutter, atrial fibrillation, or ventricular tachycardia to normal sinus rhythm. In the presence of atrial flutter or atrial fibrillation, a transient modest slowing of ventricular response may occur immediately following adenosine injection administration.",
      "Description": "Adenosine is an endogenous nucleoside occurring in all cells of the body. It is chemically 6-amino-9-β-D-ribofuranosyl-9-H-purine and has the following structural formula:. Adenosine is a white crystalline powder. It is soluble in water and practically insoluble in alcohol. Solubility increases by warming and lowering the pH. Adenosine is not chemically related to other antiarrhythmic drugs. Adenosine Injection is a sterile, nonpyrogenic solution for rapid bolus intravenous injection. Each mL contains 3 mg adenosine and 9 mg sodium chloride in Water for Injection. The pH of the solution is between 4.5 and 7.5."
    },
    {
      "NDCCode": "25021-318-04",
      "PackageDescription": "10 VIAL in 1 CARTON (25021-318-04)  / 4 mL in 1 VIAL",
      "NDC11Code": "25021-0318-04",
      "ProductNDC": "25021-318",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Adenosine",
      "NonProprietaryName": "Adenosine",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20230315",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206778",
      "LabelerName": "Sagent Pharmaceuticals",
      "SubstanceName": "ADENOSINE",
      "StrengthNumber": "3",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Adenosine Receptor Agonist [EPC], Adenosine Receptor Agonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-08-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230315",
      "SamplePackage": "N",
      "IndicationAndUsage": "Intravenous adenosine injection is indicated for the following. Conversion to sinus rhythm of paroxysmal supraventricular tachycardia (PSVT), including that associated with accessory bypass tracts (Wolff-Parkinson-White Syndrome). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver), should be attempted prior to adenosine injection administration. It is important to be sure the adenosine injection solution actually reaches the systemic circulation (see DOSAGE AND ADMINISTRATION). Adenosine Injection does not convert atrial flutter, atrial fibrillation, or ventricular tachycardia to normal sinus rhythm. In the presence of atrial flutter or atrial fibrillation, a transient modest slowing of ventricular response may occur immediately following adenosine injection administration.",
      "Description": "Adenosine is an endogenous nucleoside occurring in all cells of the body. It is chemically 6-amino-9-β-D-ribofuranosyl-9-H-purine and has the following structural formula:. Adenosine is a white crystalline powder. It is soluble in water and practically insoluble in alcohol. Solubility increases by warming and lowering the pH. Adenosine is not chemically related to other antiarrhythmic drugs. Adenosine Injection is a sterile, nonpyrogenic solution for rapid bolus intravenous injection. Each mL contains 3 mg adenosine and 9 mg sodium chloride in Water for Injection. The pH of the solution is between 4.5 and 7.5."
    },
    {
      "NDCCode": "33332-318-01",
      "PackageDescription": "10 SYRINGE, GLASS in 1 CARTON (33332-318-01)  > .5 mL in 1 SYRINGE, GLASS (33332-318-02) ",
      "NDC11Code": "33332-0318-01",
      "ProductNDC": "33332-318",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Afluria Quadrivalent",
      "NonProprietaryName": "Influenza A Virus A/singapore/gp1908/2015 Ivr-180a (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/singapore/infimh-16-0019/2016 Ivr-186 (h3n2) Antigen (propiolactone Inactivated), Influenza B Virus B/maryland/15/2016 Antigen (propiolactone Inactivated), And Influenza B Virus B/phuket/3073/2013 Bvr-1b Antigen (propiolactone Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20160928",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125254",
      "LabelerName": "Seqirus Pty Ltd",
      "SubstanceName": "INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 IVR-186 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED)",
      "StrengthNumber": "15; 15; 15; 15",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-11-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20160928",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "33342-318-10",
      "PackageDescription": "90 TABLET in 1 BOTTLE (33342-318-10) ",
      "NDC11Code": "33342-0318-10",
      "ProductNDC": "33342-318",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Atorvastatin Calcium",
      "NonProprietaryName": "Atorvastatin Calcium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240603",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208480",
      "LabelerName": "Macleods Pharmaceuticals Limited",
      "SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
      "StrengthNumber": "80",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-07-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240603",
      "SamplePackage": "N",
      "IndicationAndUsage": "Atorvastatin calcium tablets is indicated:  To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD  As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).  As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).  As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.",
      "Description": "Atorvastatin, USP is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium, USP is [R-R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium, USP is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium, USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium, USP is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USPfor oral administration contain 10, 20, 40, or 80 mg (equivalent to 10.34 mg, 20.68 mg, 41.36 mg, or 82.72 mg atorvastatin calcium anhydrous) atorvastatin and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, polysorbate 80, magnesium stearate, hypromellose, talc, titanium dioxide, polyethylene glycol."
    },
    {
      "NDCCode": "33342-318-12",
      "PackageDescription": "10 BLISTER PACK in 1 CARTON (33342-318-12)  / 10 TABLET in 1 BLISTER PACK",
      "NDC11Code": "33342-0318-12",
      "ProductNDC": "33342-318",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Atorvastatin Calcium",
      "NonProprietaryName": "Atorvastatin Calcium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240603",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208480",
      "LabelerName": "Macleods Pharmaceuticals Limited",
      "SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
      "StrengthNumber": "80",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-07-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240603",
      "SamplePackage": "N",
      "IndicationAndUsage": "Atorvastatin calcium tablets is indicated:  To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD  As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).  As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).  As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.",
      "Description": "Atorvastatin, USP is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium, USP is [R-R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium, USP is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium, USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium, USP is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USPfor oral administration contain 10, 20, 40, or 80 mg (equivalent to 10.34 mg, 20.68 mg, 41.36 mg, or 82.72 mg atorvastatin calcium anhydrous) atorvastatin and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, polysorbate 80, magnesium stearate, hypromellose, talc, titanium dioxide, polyethylene glycol."
    },
    {
      "NDCCode": "49643-318-10",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (49643-318-10) ",
      "NDC11Code": "49643-0318-10",
      "ProductNDC": "49643-318",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Standardized Sweet Vernal Grass",
      "NonProprietaryName": "Anthoxanthum Odoratum",
      "DosageFormName": "INJECTION",
      "RouteName": "CUTANEOUS; INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19961202",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102220",
      "LabelerName": "Allermed Laboratories, Inc.",
      "SubstanceName": "ANTHOXANTHUM ODORATUM POLLEN",
      "StrengthNumber": "100000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-06-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19961202",
      "SamplePackage": "N",
      "IndicationAndUsage": "Standardized grass pollen extract is indicated for use in the diagnosis of grass allergy in patients with a history of allergic symptoms that occur during grass pollination. Skin tests with standardized grass pollen extract should be done first by the puncture method using 10,000 BAU/mL extract. If these tests are negative, they may be repeated by the puncture method with 100,000 BAU/mL extract, or by the intradermal method using an appropriate dilution (see DOSAGE AND ADMINISTRATION). The extract also is indicated for use in the treatment of allergic symptoms by immunotherapy in patients with a history of grass pollen allergy and established sensitivity to grass pollen extract by skin testing. The availability of 10,000 and 100,000 BAU/mL extracts facilitates dose selection for safe switching to standardized grass pollen extracts. Previously untreated patients should be initially treated with appropriately diluted 10,000 BAU/mL. If tolerated, higher doses may be indicated. The use of grass pollen extract for the above purposes should be made only by physicians with special familiarity and knowledge of allergy as described in a standard allergy textbook (13). Allermed's standardized grass pollen extracts labeled in BAU/mL are not interchangeable with alum-precipitated grass pollen extracts, grass pollen extracts labeled in AU/mL or non-standardized grass pollen extracts.",
      "Description": "Standardized grass pollen extract is a sterile solution containing the extractables of grass pollen in 0.25% sodium chloride, 0.125% sodium bicarbonate, 50% glycerol v/v and 0.4% phenol w/v. Standardized grass pollen extracts include Bermuda Grass ( Cynodon dactylon), June Grass ( Poa pratensis), Meadow Fescue Grass ( Festuca elatior), Orchard Grass ( Dactylis glomerata), Perennial Rye Grass ( Lolium perenne), Redtop Grass ( Agrostis alba), Sweet Vernal Grass ( Anthoxanthum odoratum) and Timothy Grass ( Phleum pratense). The extract may be administered by the scratch, prick, puncture, or intradermal methods of skin testing for diagnostic purposes and subcutaneously for therapeutic purposes as directed under Dosage and Administration. The potency of standardized grass pollen extracts is expressed in Bioequivalent Allergy Units per mL (BAU/mL) and is determined by an in vitro ELISA Competition Assay comparing the extract to a U.S. reference grass pollen extract available from the Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration. Bioequivalent Allergy Units per mL (BAU/mL) have been assigned to the reference extract based on quantitative skin testing (see CLINICAL PHARMACOLOGY). CBER reference extract labeled 100,000 BAU/mL can be diluted 1:5 million and yield a 50 mm sum of erythema diameter response intradermally in highly puncture reactive subjects. CBER reference extract labeled 10,000 BAU/mL can be diluted 1:500,000 for the same response (12). Allermed's standardized grass pollen extracts labeled in BAU/mL are not interchangeable with alum-precipitated grass pollen extracts, grass pollen extracts labeled in AU/mL or non-standardized grass pollen extracts."
    },
    {
      "NDCCode": "50580-318-10",
      "PackageDescription": "1 BOTTLE in 1 CARTON (50580-318-10)  > 100 mL in 1 BOTTLE",
      "NDC11Code": "50580-0318-10",
      "ProductNDC": "50580-318",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Childrens Tylenol",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "SUSPENSION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100730",
      "EndMarketingDate": "20151231",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part343",
      "LabelerName": "Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "160",
      "StrengthUnit": "mg/5mL",
      "Status": "Deprecated",
      "LastUpdate": "2016-01-01"
    },
    {
      "NDCCode": "51991-318-10",
      "PackageDescription": "1000 TABLET in 1 BOTTLE (51991-318-10)",
      "NDC11Code": "51991-0318-10",
      "ProductNDC": "51991-318",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Risperidone",
      "NonProprietaryName": "Risperidone",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120425",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA201003",
      "LabelerName": "Breckenridge Pharmaceutical, Inc.",
      "SubstanceName": "RISPERIDONE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2017-09-19"
    },
    {
      "NDCCode": "52686-318-10",
      "PackageDescription": "1 BOTTLE in 1 CARTON (52686-318-10)  > 35.88 g in 1 BOTTLE",
      "NDC11Code": "52686-0318-10",
      "ProductNDC": "52686-318",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Shiseido Radiant Lifting Foundation",
      "ProprietaryNameSuffix": "O00",
      "NonProprietaryName": "Octinoxate And Titanium Dioxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20120801",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "SHISEIDO AMERICA INC.",
      "SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
      "StrengthNumber": "682; 1471",
      "StrengthUnit": "mg/35.88g; mg/35.88g",
      "Status": "Deprecated",
      "LastUpdate": "2021-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20120801",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "52817-318-10",
      "PackageDescription": "100 TABLET in 1 BOTTLE (52817-318-10) ",
      "NDC11Code": "52817-0318-10",
      "ProductNDC": "52817-318",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Baclofen",
      "NonProprietaryName": "Baclofen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240205",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209102",
      "LabelerName": "TruPharma LLC",
      "SubstanceName": "BACLOFEN",
      "StrengthNumber": "15",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-04-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240401",
      "SamplePackage": "N",
      "IndicationAndUsage": "Baclofen tablets, USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets, USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets, USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.",
      "Description": "Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. C 10H 12ClNO 2M.W. 213.66. Baclofen, USP is a white to off-white odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg, 15 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: Microcrystalline Cellulose, Pregelatinized Starch, Sodium Starch Glycolate, Colloidal Silicon dioxide and Magnesium Stearate."
    },
    {
      "NDCCode": "54575-318-10",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (54575-318-10)",
      "NDC11Code": "54575-0318-10",
      "ProductNDC": "54575-318",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "American Cockroach",
      "NonProprietaryName": "Periplaneta Americana",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19671207",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101376",
      "LabelerName": "Allergy Laboratories, Inc.",
      "SubstanceName": "PERIPLANETA AMERICANA",
      "StrengthNumber": "1",
      "StrengthUnit": "g/20mL",
      "Pharm_Classes": "Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established:             Coffee             Cottonseed       Flaxseed             Housefly             Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens."
    },
    {
      "NDCCode": "57237-318-11",
      "PackageDescription": "100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (57237-318-11)  / 10 mL in 1 CUP, UNIT-DOSE (57237-318-01) ",
      "NDC11Code": "57237-0318-11",
      "ProductNDC": "57237-318",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Diphenhydramine Hcl Oral Solution",
      "NonProprietaryName": "Diphenhydramine Hcl Oral",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20231215",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M009.50",
      "LabelerName": "Rising Pharma Holdings, Inc.",
      "SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/10mL",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-07-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20231215",
      "SamplePackage": "N",
      "IndicationAndUsage": " Temporarily relieves these symptoms due to hay fever or other respiratory allergies.     runny nose    sneezing    itchy, watery eyes    itching of the nose or throat."
    },
    {
      "NDCCode": "57278-318-02",
      "PackageDescription": "4 POUCH in 1 CARTON (57278-318-02)  > 10 AMPULE in 1 POUCH (57278-318-01)  > 4.5 mL in 1 AMPULE",
      "NDC11Code": "57278-0318-02",
      "ProductNDC": "57278-318",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Triferic Avnu",
      "NonProprietaryName": "Ferric Pyrophosphate Citrate",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20200330",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA212860",
      "LabelerName": "Rockwell Medical Inc.",
      "SubstanceName": "FERRIC PYROPHOSPHATE CITRATE",
      "StrengthNumber": "1.5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20200330",
      "SamplePackage": "N",
      "IndicationAndUsage": "Triferic AVNU is an iron replacement product indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD). Limitations of Use: 1 Triferic AVNU is not intended for use in patients receiving peritoneal dialysis. , 2 Triferic AVNU  has not been studied in patients receiving home hemodialysis.",
      "Description": "Triferic AVNU (ferric pyrophosphate citrate), an iron replacement product, is a mixed-ligand iron complex in which iron (III) is bound to pyrophosphate and citrate.  It has a molecular formula of Fe 4(C 6H 4O 7) 3(H 2P 2O 7) 2(P 2O 7)and a relative molecular weight of approximately 1313 daltons. Ferric pyrophosphate citrate has the following structure:. Triferic AVNU (ferric pyrophosphate citrate) injection is a clear, slightly yellow-green color sterile solution containing 6.75 mg of elemental iron (III) per 4.5 mL (1.5 mg iron (III) per mL) filled in a 5 mL low density polyethylene (LDPE) luer-lock ampule. Each Triferic AVNU ampule contains iron (0.14-0.17 % w/w), and less than 0.1% w/w citrate, pyrophosphate, phosphate, sodium and sulfate. One Triferic AVNU ampule is administered directly into the pre-dialyzer infusion line, post-dialyzer infusion line, or to a separate connection to the venous blood line over 3 to 4 hours."
    },
    {
      "NDCCode": "59467-318-10",
      "PackageDescription": "1000 CAPSULE in 1 BOTTLE (59467-318-10) ",
      "NDC11Code": "59467-0318-10",
      "ProductNDC": "59467-318",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Mitigare",
      "NonProprietaryName": "Colchicine",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20141001",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA204820",
      "LabelerName": "Hikma Specialty USA Inc.",
      "SubstanceName": "COLCHICINE",
      "StrengthNumber": ".6",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Alkaloid [EPC], Alkaloids [CS]",
      "Status": "Active",
      "LastUpdate": "2024-05-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20141001",
      "SamplePackage": "N",
      "IndicationAndUsage": "MITIGARE (colchicine) capsules are indicated for prophylaxis of gout flares in adults. Limitations of Use. The safety and effectiveness of MITIGARE for acute treatment of gout flares during prophylaxis has not been studied. MITIGARE is not an analgesic medication and should not be used to treat pain from other causes.",
      "Description": "Colchicine is an alkaloid obtained from the plant colchicum autumnale. The chemical name for colchicine is (S)-N-(5,6,7,9- tetrahydro-1,2,3,10-tetramethoxy-9 oxobenzol[a]heptalen-7-yl) acetamide. The structural formula is represented below. Colchicine consists of pale yellow scales or powder; it darkens on exposure to light. Colchicine is soluble in water, freely soluble in alcohol, and slightly soluble in ether. MITIGARE (colchicine) capsules are supplied for oral administration. Each capsule contains 0.6 mg colchicine, USP and the following inactive ingredients: colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The capsule shell contains gelatin, purified water, titanium dioxide, erythrosine, Brilliant Blue FCF, and may contain D&C Red No. 28, FD&C Red No. 40 and Quinoline Yellow."
    },
    {
      "NDCCode": "60429-318-10",
      "PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60429-318-10) ",
      "NDC11Code": "60429-0318-10",
      "ProductNDC": "60429-318",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Losartan Potassium",
      "NonProprietaryName": "Losartan Potassium",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20111220",
      "EndMarketingDate": "20200302",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091129",
      "LabelerName": "Golden State Medical Supply, Inc.",
      "SubstanceName": "LOSARTAN POTASSIUM",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2020-02-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20111220",
      "EndMarketingDatePackage": "20200131",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "60592-318-10",
      "PackageDescription": "1000 g in 1 BOTTLE (60592-318-10) ",
      "NDC11Code": "60592-0318-10",
      "ProductNDC": "60592-318",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Itraconazole",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20190610",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Kalchem International inc",
      "SubstanceName": "ITRACONAZOLE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Unfinished",
      "LastUpdate": "2025-10-06",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "10-JUN-19"
    },
    {
      "NDCCode": "61314-318-10",
      "PackageDescription": "2 BLISTER PACK in 1 CARTON (61314-318-10)  / 5 SYRINGE in 1 BLISTER PACK (61314-318-05)  / .5 mL in 1 SYRINGE",
      "NDC11Code": "61314-0318-10",
      "ProductNDC": "61314-318",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Zarxio",
      "NonProprietaryName": "Filgrastim-sndz",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS; SUBCUTANEOUS",
      "StartMarketingDate": "20150306",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125553",
      "LabelerName": "Sandoz Inc.",
      "SubstanceName": "FILGRASTIM",
      "StrengthNumber": "300",
      "StrengthUnit": "ug/.5mL",
      "Pharm_Classes": "Granulocyte Colony-Stimulating Factor [CS], Increased Myeloid Cell Production [PE], Leukocyte Growth Factor [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-06-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20180222",
      "SamplePackage": "N",
      "IndicationAndUsage": "ZARXIO is a leukocyte growth factor indicated to: 1 Decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti‑cancer drugs associated with a significant incidence of severe neutropenia with fever (1.1), 2 Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) (1.2), 3 Reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT) (1.3), 4 Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis (1.4), 5 Reduce the incidence and duration of sequelae of severe neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia (1.5), 6 Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) (1.6).",
      "Description": "Filgrastim-sndz is a 175 amino acid human granulocyte colony-stimulating factor (G-CSF) manufactured by recombinant DNA technology. Filgrastim-sndz is produced by Escherichia coli (E coli) bacteria into which has been inserted the human granulocyte colony-stimulating factor gene. Filgrastim-sndz has a molecular weight of 18‚800 daltons. The protein has an amino acid sequence that is identical to the natural sequence predicted from human DNA sequence analysis‚ except for the addition of an N-terminal methionine necessary for expression in E coli. Because filgrastim-sndz is produced in E coli‚ the product is non-glycosylated and thus differs from G-CSF isolated from a human cell. ZARXIO (filgrastim-sndz) injection is a sterile‚ clear‚ colorless to slightly yellowish‚ preservative-free liquid containing filgrastim-sndz at a specific activity of 1 x 108 U/mg (as measured by a proliferation assay). The product is available in single-dose vials and single-dose prefilled syringes for subcutaneous or intravenous use. The single-dose vials contain either 300 mcg/mL or 480 mcg/1.6 mL of filgrastim-sndz. The single-dose prefilled syringes contain either 300 mcg/0.5 mL or 480 mcg/0.8 mL of filgrastim-sndz. The ZARXIO drug product has a pH of 4.4. See Table 4 below for product composition of each single-dose vial and prefilled syringe. Table 4. Product Composition. *q.s.: quantity sufficient to make."
    },
    {
      "NDCCode": "61503-318-22",
      "PackageDescription": "1 BAG in 1 BOX (61503-318-22)  > 10 kg in 1 BAG",
      "NDC11Code": "61503-0318-22",
      "ProductNDC": "61503-318",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Titanium Dioxide",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20150831",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Tayca Corporation",
      "SubstanceName": "TITANIUM DIOXIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "kg/10kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "31-AUG-15"
    },
    {
      "NDCCode": "64092-318-02",
      "PackageDescription": "2 BOTTLE in 1 PACKAGE (64092-318-02)  > 10 mL in 1 BOTTLE (64092-318-01)",
      "NDC11Code": "64092-0318-02",
      "ProductNDC": "64092-318",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Instant Hand Sanitizer",
      "NonProprietaryName": "Ethyl Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130705",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "Great Lakes Wholesale & Marketing, LLC",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "6",
      "StrengthUnit": "mL/10mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "USE: : 1 hand sanitizer to help reduce bacteria on the skin that may cause disease."
    },
    {
      "NDCCode": "66267-318-10",
      "PackageDescription": "10 TABLET in 1 BOTTLE (66267-318-10) ",
      "NDC11Code": "66267-0318-10",
      "ProductNDC": "66267-318",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prochlorperazine Maleate",
      "NonProprietaryName": "Prochlorperazine Maleate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19980301",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040268",
      "LabelerName": "NuCare Pharmaceuticals,Inc.",
      "SubstanceName": "PROCHLORPERAZINE MALEATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Phenothiazine [EPC],Phenothiazines [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2021-03-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20181030",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "68083-318-10",
      "PackageDescription": "10 SYRINGE in 1 CARTON (68083-318-10)  > 5 mL in 1 SYRINGE (68083-318-01)",
      "NDC11Code": "68083-0318-10",
      "ProductNDC": "68083-318",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Milrinone Lactate",
      "NonProprietaryName": "Milrinone Lactate",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20170728",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077190",
      "LabelerName": "Gland Pharma Limited",
      "SubstanceName": "MILRINONE LACTATE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "Milrinone lactate injection is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. Patients receiving milrinone should be observed closely with appropriate electrocardiographic equipment. The facility for immediate treatment of potential cardiac events, which may include life threatening ventricular arrhythmias, must be available. The majority of experience with intravenous milrinone has been in patients receiving digoxin and diuretics. There is no experience in controlled trials with infusions of milrinone for periods exceeding 48 hours.",
      "Description": "Milrinone lactate injection is a member of a new class of bipyridine inotropic/vasodilator agents with phosphodiesterase inhibitor activity, distinct from digitalis glycosides or catecholamines. Milrinone lactate is designated chemically as 1,6-dihydro-2-methyl-6-oxo-[3,4´-bipyridine]-5-carbonitrile lactate and has the following structure. Milrinone is an off-white to tan crystalline compound with a molecular weight of 211.2 and a molecular formula of C12H9N3O. It is slightly soluble in methanol, and very slightly soluble in chloroform and in water. As the lactate salt, it is stable and colorless to pale yellow in solution. Milrinone lactate is available as sterile aqueous solutions of the lactate salt of milrinone for injection or infusion intravenously.Sterile, single-dose syringes: Single-dose syringes of 5 mL contain in each mL milrinone lactate equivalent to 1 mg milrinone USP and 47 mg dextrose anhydrous USP in Water for Injection USP. The pH is adjusted to between 3.2 and 4.0 with lactic acid USP or sodium hydroxide NF. The total concentration of lactic acid USP can vary between 0.95 mg/mL and 1.29 mg/mL. These syringes require preparation of dilutions prior to administration to patients intravenously."
    },
    {
      "NDCCode": "69230-318-10",
      "PackageDescription": "1000 TABLET, DELAYED RELEASE in 1 BOTTLE (69230-318-10) ",
      "NDC11Code": "69230-0318-10",
      "ProductNDC": "69230-318",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Omeprazole",
      "NonProprietaryName": "Omeprazole",
      "DosageFormName": "TABLET, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200325",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211732",
      "LabelerName": "Camber Consumer Care Inc",
      "SubstanceName": "OMEPRAZOLE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2022-11-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201029",
      "SamplePackage": "N",
      "IndicationAndUsage": " treats frequent heartburn (occurs 2 or more days a week)  not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect."
    },
    {
      "NDCCode": "70461-318-03",
      "PackageDescription": "10 SYRINGE, GLASS in 1 CARTON (70461-318-03)  > .5 mL in 1 SYRINGE, GLASS (70461-318-04) ",
      "NDC11Code": "70461-0318-03",
      "ProductNDC": "70461-318",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Flucelvax Quadrivalent (prefilled Syringe)",
      "NonProprietaryName": "Influenza A Virus A/singapore/gp1908/2015 Ivr-180 (h1n1) Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza A Virus A/north Carolina/04/2016 (h3n2) Hemagglutinin Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza B Virus B/iowa/06/2017 Hemagglutinin Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza B Virus B/singapore/inftt-16-0610/2016 Hemagglutinin Antigen (mdck Cell Derived, Propiolactone Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20160523",
      "EndMarketingDate": "20190731",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125408",
      "LabelerName": "Seqirus, Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/NORTH CAROLINA/04/2016 (H3N2) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/IOWA/06/2017 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)",
      "StrengthNumber": "15; 15; 15; 15",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-08-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20160523",
      "EndMarketingDatePackage": "20190731",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "70934-318-10",
      "PackageDescription": "10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-318-10) ",
      "NDC11Code": "70934-0318-10",
      "ProductNDC": "70934-318",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ondansetron Hydrochloride",
      "NonProprietaryName": "Ondansetron Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190313",
      "EndMarketingDate": "20250228",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078539",
      "LabelerName": "Denton Pharma, Inc. DBA Northwind Pharmaceuticals",
      "SubstanceName": "ONDANSETRON HYDROCHLORIDE",
      "StrengthNumber": "4",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-02-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20190404",
      "EndMarketingDatePackage": "20250228",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with. Ondansetron tablets are also indicated for the prevention of postoperative nausea and/or vomiting.",
      "Description": "The active ingredient in ondansetron tablets, USP is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT 3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula: The molecular formula is C 18H 19N 3OHCl2H 2O, representing a molecular weight of 365.9 g/mol. Ondansetron hydrochloride USP (dihydrate) is a white to off-white powder that is soluble in water and normal saline. Ondansetron tablets, USP for oral administration contain ondansetron hydrochloride USP (dihydrate) equivalent to 4 mg or 8 mg of ondansetron. Each film-coated tablet also contains the inactive ingredients anhydrous lactose, microcrystalline cellulose, pregelatinized starch (maize), magnesium stearate, triacetin, titanium dioxide and hypromellose. In addition 8 mg tablet also contains iron oxide yellow. Meets USP dissolution test 6."
    },
    {
      "NDCCode": "71919-318-10",
      "PackageDescription": "100 mL in 1 BOTTLE, GLASS (71919-318-10) ",
      "NDC11Code": "71919-0318-10",
      "ProductNDC": "71919-318",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Glonoinum",
      "NonProprietaryName": "Nitroglycerin",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100203",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Washington Homeopathic Products",
      "SubstanceName": "NITROGLYCERIN",
      "StrengthNumber": "30",
      "StrengthUnit": "[hp_C]/mL",
      "Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2022-03-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20100203",
      "SamplePackage": "N"
    }
  ]
}
                    

{"NDC":[{"NDCCode":"59469-318-10","ProprietaryName":"Toxex","NonProprietaryName":"Silver Nitrate, Bryonia Dioica Root, Clematis Recta Flowering Top, Goldenseal, Echinacea, Unspecified, Galium Aparine, Glechoma Hederacea Flowering Top, And Rhododendron Tomentosum Leafy Twig"},{"NDCCode":"10695-318-10","NonProprietaryName":"Ezetimibe"},{"NDCCode":"13533-318-01","ProprietaryName":"Hyperrab","NonProprietaryName":"Rabies Immune Globulin (human)"},{"NDCCode":"14593-318-01","ProprietaryName":"Tranexamic Acid","NonProprietaryName":"Tranexamic Acid"},{"NDCCode":"16729-318-10","ProprietaryName":"Oxybutynin Chloride","NonProprietaryName":"Oxybutynin Chloride"},{"NDCCode":"25021-318-02","ProprietaryName":"Adenosine","NonProprietaryName":"Adenosine"},{"NDCCode":"25021-318-04","ProprietaryName":"Adenosine","NonProprietaryName":"Adenosine"},{"NDCCode":"33332-318-01","ProprietaryName":"Afluria Quadrivalent","NonProprietaryName":"Influenza A Virus A/singapore/gp1908/2015 Ivr-180a (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/singapore/infimh-16-0019/2016 Ivr-186 (h3n2) Antigen (propiolactone Inactivated), Influenza B Virus B/maryland/15/2016 Antigen (propiolactone Inactivated), And Influenza B Virus B/phuket/3073/2013 Bvr-1b Antigen (propiolactone Inactivated)"},{"NDCCode":"33342-318-10","ProprietaryName":"Atorvastatin Calcium","NonProprietaryName":"Atorvastatin Calcium"},{"NDCCode":"33342-318-12","ProprietaryName":"Atorvastatin Calcium","NonProprietaryName":"Atorvastatin Calcium"},{"NDCCode":"49643-318-10","ProprietaryName":"Standardized Sweet Vernal Grass","NonProprietaryName":"Anthoxanthum Odoratum"},{"NDCCode":"50580-318-10","ProprietaryName":"Childrens Tylenol","NonProprietaryName":"Acetaminophen"},{"NDCCode":"51991-318-10","ProprietaryName":"Risperidone","NonProprietaryName":"Risperidone"},{"NDCCode":"52686-318-10","ProprietaryName":"Shiseido Radiant Lifting Foundation","NonProprietaryName":"Octinoxate And Titanium Dioxide"},{"NDCCode":"52817-318-10","ProprietaryName":"Baclofen","NonProprietaryName":"Baclofen"},{"NDCCode":"54575-318-10","ProprietaryName":"American Cockroach","NonProprietaryName":"Periplaneta Americana"},{"NDCCode":"57237-318-11","ProprietaryName":"Diphenhydramine Hcl Oral Solution","NonProprietaryName":"Diphenhydramine Hcl Oral"},{"NDCCode":"57278-318-02","ProprietaryName":"Triferic Avnu","NonProprietaryName":"Ferric Pyrophosphate Citrate"},{"NDCCode":"59467-318-10","ProprietaryName":"Mitigare","NonProprietaryName":"Colchicine"},{"NDCCode":"60429-318-10","ProprietaryName":"Losartan Potassium","NonProprietaryName":"Losartan Potassium"},{"NDCCode":"60592-318-10","NonProprietaryName":"Itraconazole"},{"NDCCode":"61314-318-10","ProprietaryName":"Zarxio","NonProprietaryName":"Filgrastim-sndz"},{"NDCCode":"61503-318-22","NonProprietaryName":"Titanium Dioxide"},{"NDCCode":"64092-318-02","ProprietaryName":"Instant Hand Sanitizer","NonProprietaryName":"Ethyl Alcohol"},{"NDCCode":"66267-318-10","ProprietaryName":"Prochlorperazine Maleate","NonProprietaryName":"Prochlorperazine Maleate"},{"NDCCode":"68083-318-10","ProprietaryName":"Milrinone Lactate","NonProprietaryName":"Milrinone Lactate"},{"NDCCode":"69230-318-10","ProprietaryName":"Omeprazole","NonProprietaryName":"Omeprazole"},{"NDCCode":"70461-318-03","ProprietaryName":"Flucelvax Quadrivalent (prefilled Syringe)","NonProprietaryName":"Influenza A Virus A/singapore/gp1908/2015 Ivr-180 (h1n1) Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza A Virus A/north Carolina/04/2016 (h3n2) Hemagglutinin Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza B Virus B/iowa/06/2017 Hemagglutinin Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza B Virus B/singapore/inftt-16-0610/2016 Hemagglutinin Antigen (mdck Cell Derived, Propiolactone Inactivated)"},{"NDCCode":"70934-318-10","ProprietaryName":"Ondansetron Hydrochloride","NonProprietaryName":"Ondansetron Hydrochloride"},{"NDCCode":"71919-318-10","ProprietaryName":"Glonoinum","NonProprietaryName":"Nitroglycerin"}]}
                    

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    <NDCCode>59469-318-10</NDCCode>
    <PackageDescription>1 BOTTLE, GLASS in 1 BOX (59469-318-10)  &gt; 50 mL in 1 BOTTLE, GLASS</PackageDescription>
    <NDC11Code>59469-0318-10</NDC11Code>
    <ProductNDC>59469-318</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Toxex</ProprietaryName>
    <NonProprietaryName>Silver Nitrate, Bryonia Dioica Root, Clematis Recta Flowering Top, Goldenseal, Echinacea, Unspecified, Galium Aparine, Glechoma Hederacea Flowering Top, And Rhododendron Tomentosum Leafy Twig</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190624</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>PEKANA Naturheilmittel GmbH</LabelerName>
    <SubstanceName>SILVER NITRATE; BRYONIA CRETICA SUBSP. DIOICA ROOT; CLEMATIS RECTA FLOWERING TOP; GOLDENSEAL; ECHINACEA, UNSPECIFIED; GALIUM APARINE WHOLE; GLECHOMA HEDERACEA FLOWERING TOP; RHODODENDRON TOMENTOSUM LEAFY TWIG</SubstanceName>
    <StrengthNumber>6; 4; 4; 5; 12; 6; 6; 6</StrengthNumber>
    <StrengthUnit>[hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2023-01-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190624</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For support of general body cleansing processes. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10695-318-10</NDCCode>
    <PackageDescription>1 kg in 1 CONTAINER (10695-318-10) </PackageDescription>
    <NDC11Code>10695-0318-10</NDC11Code>
    <ProductNDC>10695-318</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Ezetimibe</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20260729</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Willow Birch Pharma, LLC.</LabelerName>
    <SubstanceName>EZETIMIBE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-07-31</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>29-JUL-26</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>13533-318-01</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (13533-318-01)  / 1 mL in 1 VIAL (13533-318-10) </PackageDescription>
    <NDC11Code>13533-0318-01</NDC11Code>
    <ProductNDC>13533-318</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Hyperrab</ProprietaryName>
    <NonProprietaryName>Rabies Immune Globulin (human)</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INFILTRATION; INTRAMUSCULAR</RouteName>
    <StartMarketingDate>19740612</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101144</ApplicationNumber>
    <LabelerName>GRIFOLS USA, LLC</LabelerName>
    <SubstanceName>HUMAN RABIES VIRUS IMMUNE GLOBULIN</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>[iU]/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-10-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19740612</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>HYPERRAB is a human rabies immune globulin indicated for postexposure prophylaxis, along with rabies vaccine, for all persons suspected of exposure to rabies. Limitations of Use. Persons who have been previously immunized with rabies vaccine and have a confirmed adequate rabies antibody titer should receive only vaccine.(1-3). For unvaccinated persons, the combination of HYPERRAB and vaccine is recommended for both bite and nonbite exposures regardless of the time interval between exposure and initiation of postexposure prophylaxis.(1-3). Beyond 7 days (after the first vaccine dose), HYPERRAB is not indicated since an antibody response to vaccine is presumed to have occurred.</IndicationAndUsage>
    <Description>HYPERRAB is a clear or slightly opalescent, and colorless or pale yellow sterile solution of human antirabies immune globulin for infiltration and intramuscular administration. HYPERRAB is provided in a single-dose vial and contains no preservative.  HYPERRAB is prepared from pools of human plasma collected from healthy donors (hyperimmunized with rabies vaccine) by a combination of cold ethanol fractionation, caprylate precipitation and filtration, caprylate incubation, anion-exchange chromatography, nanofiltration and low pH incubation. HYPERRAB consists of 15 to 18% protein at pH 4.1 to 4.8 in 0.16 to 0.26 M glycine. The product is standardized against the U.S. Standard Rabies Immune Globulin to contain a potency value of not less than 300 IU/mL. The U.S. unit of potency is equivalent to the international unit (IU) for rabies antibody. When medicinal biological products are administered, infectious diseases due to transmission of pathogens cannot be totally excluded. However, in the case of products prepared from human plasma, the risk of transmission of pathogens is reduced by epidemiological surveillance of the donor population and selection of individual donors by medical interview; testing of individual donations and plasma pools; and the presence in the manufacturing processes of steps with demonstrated capacity to inactivate/remove pathogens. In the manufacturing process of HYPERRAB, there are several steps with the capacity for virus inactivation or removal.(6) The main steps of the manufacturing process that contribute to the virus clearance capacity are as follows: 1 Caprylate precipitation/depth filtration, 2 Caprylate incubation, 3 Depth filtration, 4 Column chromatography, 5 Nanofiltration, 6 Low pH final container incubation.</Description>
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  <NDC>
    <NDCCode>14593-318-01</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (14593-318-01)  / 10 mL in 1 VIAL</PackageDescription>
    <NDC11Code>14593-0318-01</NDC11Code>
    <ProductNDC>14593-318</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tranexamic Acid</ProprietaryName>
    <NonProprietaryName>Tranexamic Acid</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20241028</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203521</ApplicationNumber>
    <LabelerName>Emcure Pharmaceuticals Limited</LabelerName>
    <SubstanceName>TRANEXAMIC ACID</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/10mL</StrengthUnit>
    <Pharm_Classes>Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-10-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241028</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tranexamic acid injection, USP is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>16729-318-10</NDCCode>
    <PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-318-10)</PackageDescription>
    <NDC11Code>16729-0318-10</NDC11Code>
    <ProductNDC>16729-318</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxybutynin Chloride</ProprietaryName>
    <NonProprietaryName>Oxybutynin Chloride</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20161010</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207138</ApplicationNumber>
    <LabelerName>Accord Healthcare, Inc.</LabelerName>
    <SubstanceName>OXYBUTYNIN CHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-22</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>25021-318-02</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (25021-318-02)  / 2 mL in 1 VIAL</PackageDescription>
    <NDC11Code>25021-0318-02</NDC11Code>
    <ProductNDC>25021-318</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Adenosine</ProprietaryName>
    <NonProprietaryName>Adenosine</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20230315</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206778</ApplicationNumber>
    <LabelerName>Sagent Pharmaceuticals</LabelerName>
    <SubstanceName>ADENOSINE</SubstanceName>
    <StrengthNumber>3</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adenosine Receptor Agonist [EPC], Adenosine Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230315</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Intravenous adenosine injection is indicated for the following. Conversion to sinus rhythm of paroxysmal supraventricular tachycardia (PSVT), including that associated with accessory bypass tracts (Wolff-Parkinson-White Syndrome). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver), should be attempted prior to adenosine injection administration. It is important to be sure the adenosine injection solution actually reaches the systemic circulation (see DOSAGE AND ADMINISTRATION). Adenosine Injection does not convert atrial flutter, atrial fibrillation, or ventricular tachycardia to normal sinus rhythm. In the presence of atrial flutter or atrial fibrillation, a transient modest slowing of ventricular response may occur immediately following adenosine injection administration.</IndicationAndUsage>
    <Description>Adenosine is an endogenous nucleoside occurring in all cells of the body. It is chemically 6-amino-9-β-D-ribofuranosyl-9-H-purine and has the following structural formula:. Adenosine is a white crystalline powder. It is soluble in water and practically insoluble in alcohol. Solubility increases by warming and lowering the pH. Adenosine is not chemically related to other antiarrhythmic drugs. Adenosine Injection is a sterile, nonpyrogenic solution for rapid bolus intravenous injection. Each mL contains 3 mg adenosine and 9 mg sodium chloride in Water for Injection. The pH of the solution is between 4.5 and 7.5.</Description>
  </NDC>
  <NDC>
    <NDCCode>25021-318-04</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (25021-318-04)  / 4 mL in 1 VIAL</PackageDescription>
    <NDC11Code>25021-0318-04</NDC11Code>
    <ProductNDC>25021-318</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Adenosine</ProprietaryName>
    <NonProprietaryName>Adenosine</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20230315</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206778</ApplicationNumber>
    <LabelerName>Sagent Pharmaceuticals</LabelerName>
    <SubstanceName>ADENOSINE</SubstanceName>
    <StrengthNumber>3</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adenosine Receptor Agonist [EPC], Adenosine Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230315</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Intravenous adenosine injection is indicated for the following. Conversion to sinus rhythm of paroxysmal supraventricular tachycardia (PSVT), including that associated with accessory bypass tracts (Wolff-Parkinson-White Syndrome). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver), should be attempted prior to adenosine injection administration. It is important to be sure the adenosine injection solution actually reaches the systemic circulation (see DOSAGE AND ADMINISTRATION). Adenosine Injection does not convert atrial flutter, atrial fibrillation, or ventricular tachycardia to normal sinus rhythm. In the presence of atrial flutter or atrial fibrillation, a transient modest slowing of ventricular response may occur immediately following adenosine injection administration.</IndicationAndUsage>
    <Description>Adenosine is an endogenous nucleoside occurring in all cells of the body. It is chemically 6-amino-9-β-D-ribofuranosyl-9-H-purine and has the following structural formula:. Adenosine is a white crystalline powder. It is soluble in water and practically insoluble in alcohol. Solubility increases by warming and lowering the pH. Adenosine is not chemically related to other antiarrhythmic drugs. Adenosine Injection is a sterile, nonpyrogenic solution for rapid bolus intravenous injection. Each mL contains 3 mg adenosine and 9 mg sodium chloride in Water for Injection. The pH of the solution is between 4.5 and 7.5.</Description>
  </NDC>
  <NDC>
    <NDCCode>33332-318-01</NDCCode>
    <PackageDescription>10 SYRINGE, GLASS in 1 CARTON (33332-318-01)  &gt; .5 mL in 1 SYRINGE, GLASS (33332-318-02) </PackageDescription>
    <NDC11Code>33332-0318-01</NDC11Code>
    <ProductNDC>33332-318</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Afluria Quadrivalent</ProprietaryName>
    <NonProprietaryName>Influenza A Virus A/singapore/gp1908/2015 Ivr-180a (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/singapore/infimh-16-0019/2016 Ivr-186 (h3n2) Antigen (propiolactone Inactivated), Influenza B Virus B/maryland/15/2016 Antigen (propiolactone Inactivated), And Influenza B Virus B/phuket/3073/2013 Bvr-1b Antigen (propiolactone Inactivated)</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20160928</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125254</ApplicationNumber>
    <LabelerName>Seqirus Pty Ltd</LabelerName>
    <SubstanceName>INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 IVR-186 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED)</SubstanceName>
    <StrengthNumber>15; 15; 15; 15</StrengthNumber>
    <StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-11-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160928</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>33342-318-10</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (33342-318-10) </PackageDescription>
    <NDC11Code>33342-0318-10</NDC11Code>
    <ProductNDC>33342-318</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atorvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240603</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208480</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240603</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atorvastatin calcium tablets is indicated:  To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD  As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).  As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).  As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.</IndicationAndUsage>
    <Description>Atorvastatin, USP is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium, USP is [R-R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium, USP is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium, USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium, USP is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USPfor oral administration contain 10, 20, 40, or 80 mg (equivalent to 10.34 mg, 20.68 mg, 41.36 mg, or 82.72 mg atorvastatin calcium anhydrous) atorvastatin and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, polysorbate 80, magnesium stearate, hypromellose, talc, titanium dioxide, polyethylene glycol.</Description>
  </NDC>
  <NDC>
    <NDCCode>33342-318-12</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (33342-318-12)  / 10 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>33342-0318-12</NDC11Code>
    <ProductNDC>33342-318</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atorvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240603</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208480</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240603</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atorvastatin calcium tablets is indicated:  To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD  As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).  As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).  As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.</IndicationAndUsage>
    <Description>Atorvastatin, USP is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium, USP is [R-R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium, USP is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium, USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium, USP is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USPfor oral administration contain 10, 20, 40, or 80 mg (equivalent to 10.34 mg, 20.68 mg, 41.36 mg, or 82.72 mg atorvastatin calcium anhydrous) atorvastatin and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, polysorbate 80, magnesium stearate, hypromellose, talc, titanium dioxide, polyethylene glycol.</Description>
  </NDC>
  <NDC>
    <NDCCode>49643-318-10</NDCCode>
    <PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (49643-318-10) </PackageDescription>
    <NDC11Code>49643-0318-10</NDC11Code>
    <ProductNDC>49643-318</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Standardized Sweet Vernal Grass</ProprietaryName>
    <NonProprietaryName>Anthoxanthum Odoratum</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>CUTANEOUS; INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19961202</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102220</ApplicationNumber>
    <LabelerName>Allermed Laboratories, Inc.</LabelerName>
    <SubstanceName>ANTHOXANTHUM ODORATUM POLLEN</SubstanceName>
    <StrengthNumber>100000</StrengthNumber>
    <StrengthUnit>[BAU]/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19961202</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Standardized grass pollen extract is indicated for use in the diagnosis of grass allergy in patients with a history of allergic symptoms that occur during grass pollination. Skin tests with standardized grass pollen extract should be done first by the puncture method using 10,000 BAU/mL extract. If these tests are negative, they may be repeated by the puncture method with 100,000 BAU/mL extract, or by the intradermal method using an appropriate dilution (see DOSAGE AND ADMINISTRATION). The extract also is indicated for use in the treatment of allergic symptoms by immunotherapy in patients with a history of grass pollen allergy and established sensitivity to grass pollen extract by skin testing. The availability of 10,000 and 100,000 BAU/mL extracts facilitates dose selection for safe switching to standardized grass pollen extracts. Previously untreated patients should be initially treated with appropriately diluted 10,000 BAU/mL. If tolerated, higher doses may be indicated. The use of grass pollen extract for the above purposes should be made only by physicians with special familiarity and knowledge of allergy as described in a standard allergy textbook (13). Allermed's standardized grass pollen extracts labeled in BAU/mL are not interchangeable with alum-precipitated grass pollen extracts, grass pollen extracts labeled in AU/mL or non-standardized grass pollen extracts.</IndicationAndUsage>
    <Description>Standardized grass pollen extract is a sterile solution containing the extractables of grass pollen in 0.25% sodium chloride, 0.125% sodium bicarbonate, 50% glycerol v/v and 0.4% phenol w/v. Standardized grass pollen extracts include Bermuda Grass ( Cynodon dactylon), June Grass ( Poa pratensis), Meadow Fescue Grass ( Festuca elatior), Orchard Grass ( Dactylis glomerata), Perennial Rye Grass ( Lolium perenne), Redtop Grass ( Agrostis alba), Sweet Vernal Grass ( Anthoxanthum odoratum) and Timothy Grass ( Phleum pratense). The extract may be administered by the scratch, prick, puncture, or intradermal methods of skin testing for diagnostic purposes and subcutaneously for therapeutic purposes as directed under Dosage and Administration. The potency of standardized grass pollen extracts is expressed in Bioequivalent Allergy Units per mL (BAU/mL) and is determined by an in vitro ELISA Competition Assay comparing the extract to a U.S. reference grass pollen extract available from the Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration. Bioequivalent Allergy Units per mL (BAU/mL) have been assigned to the reference extract based on quantitative skin testing (see CLINICAL PHARMACOLOGY). CBER reference extract labeled 100,000 BAU/mL can be diluted 1:5 million and yield a 50 mm sum of erythema diameter response intradermally in highly puncture reactive subjects. CBER reference extract labeled 10,000 BAU/mL can be diluted 1:500,000 for the same response (12). Allermed's standardized grass pollen extracts labeled in BAU/mL are not interchangeable with alum-precipitated grass pollen extracts, grass pollen extracts labeled in AU/mL or non-standardized grass pollen extracts.</Description>
  </NDC>
  <NDC>
    <NDCCode>50580-318-10</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (50580-318-10)  &gt; 100 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>50580-0318-10</NDC11Code>
    <ProductNDC>50580-318</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Childrens Tylenol</ProprietaryName>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100730</StartMarketingDate>
    <EndMarketingDate>20151231</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part343</ApplicationNumber>
    <LabelerName>Johnson &amp; Johnson Consumer Inc., McNeil Consumer Healthcare Division</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>160</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2016-01-01</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>51991-318-10</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (51991-318-10)</PackageDescription>
    <NDC11Code>51991-0318-10</NDC11Code>
    <ProductNDC>51991-318</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Risperidone</ProprietaryName>
    <NonProprietaryName>Risperidone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120425</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA201003</ApplicationNumber>
    <LabelerName>Breckenridge Pharmaceutical, Inc.</LabelerName>
    <SubstanceName>RISPERIDONE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-09-19</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>52686-318-10</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (52686-318-10)  &gt; 35.88 g in 1 BOTTLE</PackageDescription>
    <NDC11Code>52686-0318-10</NDC11Code>
    <ProductNDC>52686-318</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Shiseido Radiant Lifting Foundation</ProprietaryName>
    <ProprietaryNameSuffix>O00</ProprietaryNameSuffix>
    <NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20120801</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>SHISEIDO AMERICA INC.</LabelerName>
    <SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>682; 1471</StrengthNumber>
    <StrengthUnit>mg/35.88g; mg/35.88g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120801</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>52817-318-10</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (52817-318-10) </PackageDescription>
    <NDC11Code>52817-0318-10</NDC11Code>
    <ProductNDC>52817-318</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Baclofen</ProprietaryName>
    <NonProprietaryName>Baclofen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240205</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209102</ApplicationNumber>
    <LabelerName>TruPharma LLC</LabelerName>
    <SubstanceName>BACLOFEN</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-04-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Baclofen tablets, USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets, USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets, USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.</IndicationAndUsage>
    <Description>Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. C 10H 12ClNO 2M.W. 213.66. Baclofen, USP is a white to off-white odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg, 15 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: Microcrystalline Cellulose, Pregelatinized Starch, Sodium Starch Glycolate, Colloidal Silicon dioxide and Magnesium Stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>54575-318-10</NDCCode>
    <PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (54575-318-10)</PackageDescription>
    <NDC11Code>54575-0318-10</NDC11Code>
    <ProductNDC>54575-318</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>American Cockroach</ProprietaryName>
    <NonProprietaryName>Periplaneta Americana</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19671207</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101376</ApplicationNumber>
    <LabelerName>Allergy Laboratories, Inc.</LabelerName>
    <SubstanceName>PERIPLANETA AMERICANA</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/20mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [CS],Allergens [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
    <Description>Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established:             Coffee             Cottonseed       Flaxseed             Housefly             Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens.</Description>
  </NDC>
  <NDC>
    <NDCCode>57237-318-11</NDCCode>
    <PackageDescription>100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (57237-318-11)  / 10 mL in 1 CUP, UNIT-DOSE (57237-318-01) </PackageDescription>
    <NDC11Code>57237-0318-11</NDC11Code>
    <ProductNDC>57237-318</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Diphenhydramine Hcl Oral Solution</ProprietaryName>
    <NonProprietaryName>Diphenhydramine Hcl Oral</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20231215</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M009.50</ApplicationNumber>
    <LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
    <SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/10mL</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231215</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage> Temporarily relieves these symptoms due to hay fever or other respiratory allergies.     runny nose    sneezing    itchy, watery eyes    itching of the nose or throat.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>57278-318-02</NDCCode>
    <PackageDescription>4 POUCH in 1 CARTON (57278-318-02)  &gt; 10 AMPULE in 1 POUCH (57278-318-01)  &gt; 4.5 mL in 1 AMPULE</PackageDescription>
    <NDC11Code>57278-0318-02</NDC11Code>
    <ProductNDC>57278-318</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Triferic Avnu</ProprietaryName>
    <NonProprietaryName>Ferric Pyrophosphate Citrate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20200330</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA212860</ApplicationNumber>
    <LabelerName>Rockwell Medical Inc.</LabelerName>
    <SubstanceName>FERRIC PYROPHOSPHATE CITRATE</SubstanceName>
    <StrengthNumber>1.5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200330</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Triferic AVNU is an iron replacement product indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD). Limitations of Use: 1 Triferic AVNU is not intended for use in patients receiving peritoneal dialysis. , 2 Triferic AVNU  has not been studied in patients receiving home hemodialysis.</IndicationAndUsage>
    <Description>Triferic AVNU (ferric pyrophosphate citrate), an iron replacement product, is a mixed-ligand iron complex in which iron (III) is bound to pyrophosphate and citrate.  It has a molecular formula of Fe 4(C 6H 4O 7) 3(H 2P 2O 7) 2(P 2O 7)and a relative molecular weight of approximately 1313 daltons. Ferric pyrophosphate citrate has the following structure:. Triferic AVNU (ferric pyrophosphate citrate) injection is a clear, slightly yellow-green color sterile solution containing 6.75 mg of elemental iron (III) per 4.5 mL (1.5 mg iron (III) per mL) filled in a 5 mL low density polyethylene (LDPE) luer-lock ampule. Each Triferic AVNU ampule contains iron (0.14-0.17 % w/w), and less than 0.1% w/w citrate, pyrophosphate, phosphate, sodium and sulfate. One Triferic AVNU ampule is administered directly into the pre-dialyzer infusion line, post-dialyzer infusion line, or to a separate connection to the venous blood line over 3 to 4 hours.</Description>
  </NDC>
  <NDC>
    <NDCCode>59467-318-10</NDCCode>
    <PackageDescription>1000 CAPSULE in 1 BOTTLE (59467-318-10) </PackageDescription>
    <NDC11Code>59467-0318-10</NDC11Code>
    <ProductNDC>59467-318</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Mitigare</ProprietaryName>
    <NonProprietaryName>Colchicine</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20141001</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA204820</ApplicationNumber>
    <LabelerName>Hikma Specialty USA Inc.</LabelerName>
    <SubstanceName>COLCHICINE</SubstanceName>
    <StrengthNumber>.6</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Alkaloid [EPC], Alkaloids [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-05-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20141001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>MITIGARE (colchicine) capsules are indicated for prophylaxis of gout flares in adults. Limitations of Use. The safety and effectiveness of MITIGARE for acute treatment of gout flares during prophylaxis has not been studied. MITIGARE is not an analgesic medication and should not be used to treat pain from other causes.</IndicationAndUsage>
    <Description>Colchicine is an alkaloid obtained from the plant colchicum autumnale. The chemical name for colchicine is (S)-N-(5,6,7,9- tetrahydro-1,2,3,10-tetramethoxy-9 oxobenzol[a]heptalen-7-yl) acetamide. The structural formula is represented below. Colchicine consists of pale yellow scales or powder; it darkens on exposure to light. Colchicine is soluble in water, freely soluble in alcohol, and slightly soluble in ether. MITIGARE (colchicine) capsules are supplied for oral administration. Each capsule contains 0.6 mg colchicine, USP and the following inactive ingredients: colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The capsule shell contains gelatin, purified water, titanium dioxide, erythrosine, Brilliant Blue FCF, and may contain D&amp;C Red No. 28, FD&amp;C Red No. 40 and Quinoline Yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>60429-318-10</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60429-318-10) </PackageDescription>
    <NDC11Code>60429-0318-10</NDC11Code>
    <ProductNDC>60429-318</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Losartan Potassium</ProprietaryName>
    <NonProprietaryName>Losartan Potassium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20111220</StartMarketingDate>
    <EndMarketingDate>20200302</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091129</ApplicationNumber>
    <LabelerName>Golden State Medical Supply, Inc.</LabelerName>
    <SubstanceName>LOSARTAN POTASSIUM</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-02-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20111220</StartMarketingDatePackage>
    <EndMarketingDatePackage>20200131</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>60592-318-10</NDCCode>
    <PackageDescription>1000 g in 1 BOTTLE (60592-318-10) </PackageDescription>
    <NDC11Code>60592-0318-10</NDC11Code>
    <ProductNDC>60592-318</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Itraconazole</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20190610</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Kalchem International inc</LabelerName>
    <SubstanceName>ITRACONAZOLE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-10-06</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>10-JUN-19</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>61314-318-10</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 CARTON (61314-318-10)  / 5 SYRINGE in 1 BLISTER PACK (61314-318-05)  / .5 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>61314-0318-10</NDC11Code>
    <ProductNDC>61314-318</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zarxio</ProprietaryName>
    <NonProprietaryName>Filgrastim-sndz</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20150306</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125553</ApplicationNumber>
    <LabelerName>Sandoz Inc.</LabelerName>
    <SubstanceName>FILGRASTIM</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>ug/.5mL</StrengthUnit>
    <Pharm_Classes>Granulocyte Colony-Stimulating Factor [CS], Increased Myeloid Cell Production [PE], Leukocyte Growth Factor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180222</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ZARXIO is a leukocyte growth factor indicated to: 1 Decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti‑cancer drugs associated with a significant incidence of severe neutropenia with fever (1.1), 2 Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) (1.2), 3 Reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT) (1.3), 4 Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis (1.4), 5 Reduce the incidence and duration of sequelae of severe neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia (1.5), 6 Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) (1.6).</IndicationAndUsage>
    <Description>Filgrastim-sndz is a 175 amino acid human granulocyte colony-stimulating factor (G-CSF) manufactured by recombinant DNA technology. Filgrastim-sndz is produced by Escherichia coli (E coli) bacteria into which has been inserted the human granulocyte colony-stimulating factor gene. Filgrastim-sndz has a molecular weight of 18‚800 daltons. The protein has an amino acid sequence that is identical to the natural sequence predicted from human DNA sequence analysis‚ except for the addition of an N-terminal methionine necessary for expression in E coli. Because filgrastim-sndz is produced in E coli‚ the product is non-glycosylated and thus differs from G-CSF isolated from a human cell. ZARXIO (filgrastim-sndz) injection is a sterile‚ clear‚ colorless to slightly yellowish‚ preservative-free liquid containing filgrastim-sndz at a specific activity of 1 x 108 U/mg (as measured by a proliferation assay). The product is available in single-dose vials and single-dose prefilled syringes for subcutaneous or intravenous use. The single-dose vials contain either 300 mcg/mL or 480 mcg/1.6 mL of filgrastim-sndz. The single-dose prefilled syringes contain either 300 mcg/0.5 mL or 480 mcg/0.8 mL of filgrastim-sndz. The ZARXIO drug product has a pH of 4.4. See Table 4 below for product composition of each single-dose vial and prefilled syringe. Table 4. Product Composition. *q.s.: quantity sufficient to make.</Description>
  </NDC>
  <NDC>
    <NDCCode>61503-318-22</NDCCode>
    <PackageDescription>1 BAG in 1 BOX (61503-318-22)  &gt; 10 kg in 1 BAG</PackageDescription>
    <NDC11Code>61503-0318-22</NDC11Code>
    <ProductNDC>61503-318</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Titanium Dioxide</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20150831</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Tayca Corporation</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>kg/10kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>31-AUG-15</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>64092-318-02</NDCCode>
    <PackageDescription>2 BOTTLE in 1 PACKAGE (64092-318-02)  &gt; 10 mL in 1 BOTTLE (64092-318-01)</PackageDescription>
    <NDC11Code>64092-0318-02</NDC11Code>
    <ProductNDC>64092-318</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Instant Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130705</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>Great Lakes Wholesale &amp; Marketing, LLC</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>6</StrengthNumber>
    <StrengthUnit>mL/10mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>USE: : 1 hand sanitizer to help reduce bacteria on the skin that may cause disease.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>66267-318-10</NDCCode>
    <PackageDescription>10 TABLET in 1 BOTTLE (66267-318-10) </PackageDescription>
    <NDC11Code>66267-0318-10</NDC11Code>
    <ProductNDC>66267-318</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prochlorperazine Maleate</ProprietaryName>
    <NonProprietaryName>Prochlorperazine Maleate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19980301</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040268</ApplicationNumber>
    <LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
    <SubstanceName>PROCHLORPERAZINE MALEATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Phenothiazine [EPC],Phenothiazines [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-03-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181030</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>68083-318-10</NDCCode>
    <PackageDescription>10 SYRINGE in 1 CARTON (68083-318-10)  &gt; 5 mL in 1 SYRINGE (68083-318-01)</PackageDescription>
    <NDC11Code>68083-0318-10</NDC11Code>
    <ProductNDC>68083-318</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Milrinone Lactate</ProprietaryName>
    <NonProprietaryName>Milrinone Lactate</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20170728</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077190</ApplicationNumber>
    <LabelerName>Gland Pharma Limited</LabelerName>
    <SubstanceName>MILRINONE LACTATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Milrinone lactate injection is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. Patients receiving milrinone should be observed closely with appropriate electrocardiographic equipment. The facility for immediate treatment of potential cardiac events, which may include life threatening ventricular arrhythmias, must be available. The majority of experience with intravenous milrinone has been in patients receiving digoxin and diuretics. There is no experience in controlled trials with infusions of milrinone for periods exceeding 48 hours.</IndicationAndUsage>
    <Description>Milrinone lactate injection is a member of a new class of bipyridine inotropic/vasodilator agents with phosphodiesterase inhibitor activity, distinct from digitalis glycosides or catecholamines. Milrinone lactate is designated chemically as 1,6-dihydro-2-methyl-6-oxo-[3,4´-bipyridine]-5-carbonitrile lactate and has the following structure. Milrinone is an off-white to tan crystalline compound with a molecular weight of 211.2 and a molecular formula of C12H9N3O. It is slightly soluble in methanol, and very slightly soluble in chloroform and in water. As the lactate salt, it is stable and colorless to pale yellow in solution. Milrinone lactate is available as sterile aqueous solutions of the lactate salt of milrinone for injection or infusion intravenously.Sterile, single-dose syringes: Single-dose syringes of 5 mL contain in each mL milrinone lactate equivalent to 1 mg milrinone USP and 47 mg dextrose anhydrous USP in Water for Injection USP. The pH is adjusted to between 3.2 and 4.0 with lactic acid USP or sodium hydroxide NF. The total concentration of lactic acid USP can vary between 0.95 mg/mL and 1.29 mg/mL. These syringes require preparation of dilutions prior to administration to patients intravenously.</Description>
  </NDC>
  <NDC>
    <NDCCode>69230-318-10</NDCCode>
    <PackageDescription>1000 TABLET, DELAYED RELEASE in 1 BOTTLE (69230-318-10) </PackageDescription>
    <NDC11Code>69230-0318-10</NDC11Code>
    <ProductNDC>69230-318</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Omeprazole</ProprietaryName>
    <NonProprietaryName>Omeprazole</NonProprietaryName>
    <DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200325</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211732</ApplicationNumber>
    <LabelerName>Camber Consumer Care Inc</LabelerName>
    <SubstanceName>OMEPRAZOLE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-11-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201029</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage> treats frequent heartburn (occurs 2 or more days a week)  not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>70461-318-03</NDCCode>
    <PackageDescription>10 SYRINGE, GLASS in 1 CARTON (70461-318-03)  &gt; .5 mL in 1 SYRINGE, GLASS (70461-318-04) </PackageDescription>
    <NDC11Code>70461-0318-03</NDC11Code>
    <ProductNDC>70461-318</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Flucelvax Quadrivalent (prefilled Syringe)</ProprietaryName>
    <NonProprietaryName>Influenza A Virus A/singapore/gp1908/2015 Ivr-180 (h1n1) Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza A Virus A/north Carolina/04/2016 (h3n2) Hemagglutinin Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza B Virus B/iowa/06/2017 Hemagglutinin Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza B Virus B/singapore/inftt-16-0610/2016 Hemagglutinin Antigen (mdck Cell Derived, Propiolactone Inactivated)</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20160523</StartMarketingDate>
    <EndMarketingDate>20190731</EndMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125408</ApplicationNumber>
    <LabelerName>Seqirus, Inc.</LabelerName>
    <SubstanceName>INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/NORTH CAROLINA/04/2016 (H3N2) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/IOWA/06/2017 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)</SubstanceName>
    <StrengthNumber>15; 15; 15; 15</StrengthNumber>
    <StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-08-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20160523</StartMarketingDatePackage>
    <EndMarketingDatePackage>20190731</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>70934-318-10</NDCCode>
    <PackageDescription>10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-318-10) </PackageDescription>
    <NDC11Code>70934-0318-10</NDC11Code>
    <ProductNDC>70934-318</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ondansetron Hydrochloride</ProprietaryName>
    <NonProprietaryName>Ondansetron Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190313</StartMarketingDate>
    <EndMarketingDate>20250228</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078539</ApplicationNumber>
    <LabelerName>Denton Pharma, Inc. DBA Northwind Pharmaceuticals</LabelerName>
    <SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-02-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20190404</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250228</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with. Ondansetron tablets are also indicated for the prevention of postoperative nausea and/or vomiting.</IndicationAndUsage>
    <Description>The active ingredient in ondansetron tablets, USP is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT 3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula: The molecular formula is C 18H 19N 3OHCl2H 2O, representing a molecular weight of 365.9 g/mol. Ondansetron hydrochloride USP (dihydrate) is a white to off-white powder that is soluble in water and normal saline. Ondansetron tablets, USP for oral administration contain ondansetron hydrochloride USP (dihydrate) equivalent to 4 mg or 8 mg of ondansetron. Each film-coated tablet also contains the inactive ingredients anhydrous lactose, microcrystalline cellulose, pregelatinized starch (maize), magnesium stearate, triacetin, titanium dioxide and hypromellose. In addition 8 mg tablet also contains iron oxide yellow. Meets USP dissolution test 6.</Description>
  </NDC>
  <NDC>
    <NDCCode>71919-318-10</NDCCode>
    <PackageDescription>100 mL in 1 BOTTLE, GLASS (71919-318-10) </PackageDescription>
    <NDC11Code>71919-0318-10</NDC11Code>
    <ProductNDC>71919-318</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Glonoinum</ProprietaryName>
    <NonProprietaryName>Nitroglycerin</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100203</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Washington Homeopathic Products</LabelerName>
    <SubstanceName>NITROGLYCERIN</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>[hp_C]/mL</StrengthUnit>
    <Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-03-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/04/2006",
      "LastUpdateDate": "12/11/2007",
      "AuthorizedOfficialLastName": "MONTECILLO",
      "AuthorizedOfficialFirstName": "RANIA",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-7363",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "801TX",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1346319878",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "REDMOND EYE CLINIC PLLC",
      "FirstLineMailingAddress": "16150 NE 85TH ST STE 206",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3543",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-3574",
      "MailingAddressFaxNumber": "425-881-0230",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "PracticeLocationAddressFaxNumber": "425-881-0230",
      "EnumerationDate": "11/07/2006",
      "LastUpdateDate": "07/08/2007",
      "AuthorizedOfficialLastName": "OTTEN",
      "AuthorizedOfficialFirstName": "LARRY",
      "AuthorizedOfficialMiddleName": "C",
      "AuthorizedOfficialTitle": "DR",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-3574",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "OD00001172",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
    },
    {
      "NPI": "1376755009",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "PERIMAN",
      "FirstName": "LAURA",
      "MiddleName": "MARIE",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "FirstLineMailingAddress": "623 W HIGHLAND DR",
      "MailingAddressCityName": "SEATTLE",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98119-3446",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "206-282-2716",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "SecondLinePracticeLocationAddress": "REDMOND EYE CLINIC",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "EnumerationDate": "05/04/2007",
      "LastUpdateDate": "07/08/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207W00000X",
      "Taxonomy1": "Ophthalmology",
      "LicenseNumber1": "MD00039796",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1659320539",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "MONTECILLO",
      "FirstName": "RANIA",
      "MiddleName": "B",
      "NamePrefix": "DR.",
      "Credential": "OD",
      "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": "05/09/2006",
      "LastUpdateDate": "12/19/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "3680",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1427560267",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ABOU SHADI",
      "FirstName": "RANIA",
      "NamePrefix": "MRS.",
      "Credential": "RPH",
      "FirstLineMailingAddress": "8862 161ST AVENUE NE",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-883-9532",
      "MailingAddressFaxNumber": "425-882-2743",
      "FirstLinePracticeLocationAddress": "8862 161ST AVENUE NE",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-883-9532",
      "PracticeLocationAddressFaxNumber": "425-882-2743",
      "EnumerationDate": "11/02/2017",
      "LastUpdateDate": "11/02/2017",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "3336C0003X",
      "Taxonomy1": "Community/Retail Pharmacy",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1528050523",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "DESCHUTES EYE CLINIC PC",
      "OtherOrgName": "THE EYE SURGERY INSTITUTE",
      "OtherOrgNameTypeCode": "3",
      "FirstLineMailingAddress": "813 SW HIGHLAND AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-3123",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-548-7170",
      "MailingAddressFaxNumber": "541-548-3842",
      "FirstLinePracticeLocationAddress": "813 SW HIGHLAND AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-3123",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-548-7170",
      "PracticeLocationAddressFaxNumber": "541-548-3842",
      "EnumerationDate": "08/17/2005",
      "LastUpdateDate": "12/01/2010",
      "AuthorizedOfficialLastName": "TRAUSTASON",
      "AuthorizedOfficialFirstName": "OLI",
      "AuthorizedOfficialMiddleName": "I",
      "AuthorizedOfficialTitle": "PRESIDENT",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "M.D.",
      "AuthorizedOfficialTelephoneNumber": "541-548-7170",
      "TaxonomyCode1": "207W00000X",
      "Taxonomy1": "Ophthalmology",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "053857000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierState1": "OR",
      "OtherIdentifierIssuer1": "REGENCE BCBS",
      "OtherIdentifier2": "CJ8770",
      "OtherIdentifierType2": "OTHER",
      "OtherIdentifierState2": "OR",
      "OtherIdentifierIssuer2": "RAILROAD MEDICARE",
      "OtherIdentifier3": "38080A",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierState3": "OR",
      "OtherIdentifierIssuer3": "CLEAR CHOICE",
      "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": "1477596252",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "EYE CARE SPECIALISTS NORTHWEST PLLC",
      "OtherOrgName": "THE CHILDRENS EYE DOCTORS, THE FAMILY EYE DOCTORS, WOODLAWN OPTICAL",
      "OtherOrgNameTypeCode": "3",
      "FirstLineMailingAddress": "17130 AVONDALE WAY NE",
      "SecondLineMailingAddress": "SUITE 111",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-6600",
      "MailingAddressFaxNumber": "425-885-6580",
      "FirstLinePracticeLocationAddress": "17130 AVONDALE WAY NE",
      "SecondLinePracticeLocationAddress": "SUITE 111",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-6600",
      "PracticeLocationAddressFaxNumber": "425-885-6580",
      "EnumerationDate": "06/13/2006",
      "LastUpdateDate": "03/03/2008",
      "AuthorizedOfficialLastName": "LENART",
      "AuthorizedOfficialFirstName": "THOMAS",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "MD PHD",
      "AuthorizedOfficialTelephoneNumber": "425-885-6600",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "156FX1800X",
      "Taxonomy2": "Optician",
      "PrimaryTaxonomySwitch2": "N",
      "TaxonomyCode3": "207W00000X",
      "Taxonomy3": "Ophthalmology",
      "PrimaryTaxonomySwitch3": "Y",
      "OtherIdentifier1": "1568514032",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "NPI",
      "OtherIdentifier2": "1740297829",
      "OtherIdentifierType2": "OTHER",
      "OtherIdentifierIssuer2": "NPI",
      "OtherIdentifier3": "1205989522",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "NPI",
      "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.",
      "HealthcareProviderTaxonomyGroup2": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription2": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization.",
      "HealthcareProviderTaxonomyGroup3": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription3": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
    },
    {
      "NPI": "1215029343",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "EYE HEALTH PROFESSIONALS, P.C.",
      "FirstLineMailingAddress": "85 BARNES RD",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "WALLINGFORD",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06492-1832",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "203-284-9448",
      "MailingAddressFaxNumber": "203-269-1361",
      "FirstLinePracticeLocationAddress": "85 BARNES RD",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "WALLINGFORD",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06492-1832",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "203-284-9448",
      "PracticeLocationAddressFaxNumber": "203-269-1361",
      "EnumerationDate": "09/28/2006",
      "LastUpdateDate": "03/07/2008",
      "AuthorizedOfficialLastName": "REDMOND",
      "AuthorizedOfficialFirstName": "JOHN",
      "AuthorizedOfficialMiddleName": "W",
      "AuthorizedOfficialTitle": "PRESIDENT",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "M.D.",
      "AuthorizedOfficialTelephoneNumber": "203-284-9448",
      "TaxonomyCode1": "207W00000X",
      "Taxonomy1": "Ophthalmology",
      "PrimaryTaxonomySwitch1": "Y",
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      "OtherIdentifier1": "2621621",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "OH",
      "OtherIdentifier2": "P00401238",
      "OtherIdentifierType2": "OTHER",
      "OtherIdentifierState2": "OH",
      "OtherIdentifierIssuer2": "RAILROAD MEDICARE"
    },
    {
      "NPI": "1033186986",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "NICOLA",
      "FirstName": "RANIA",
      "MiddleName": "SOLIMAN",
      "NamePrefix": "DR.",
      "Credential": "DDS",
      "FirstLineMailingAddress": "110 S WOODLAND ST",
      "MailingAddressCityName": "WINTER GARDEN",
      "MailingAddressStateName": "FL",
      "MailingAddressPostalCode": "34787-3546",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "407-905-8827",
      "MailingAddressFaxNumber": "407-645-4587",
      "FirstLinePracticeLocationAddress": "7900 FOREST CITY RD",
      "PracticeLocationAddressCityName": "ORLANDO",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "32810-3002",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "407-905-8827",
      "PracticeLocationAddressFaxNumber": "407-645-4587",
      "EnumerationDate": "02/28/2006",
      "LastUpdateDate": "07/28/2017",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1223G0001X",
      "Taxonomy1": "General Practice",
      "LicenseNumber1": "DN15582",
      "LicenseNumberStateCode1": "FL",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "122300000X",
      "Taxonomy2": "Dentist",
      "LicenseNumber2": "DN15582",
      "LicenseNumberStateCode2": "FL",
      "PrimaryTaxonomySwitch2": "Y",
      "OtherIdentifier1": "075156100",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "FL"
    },
    {
      "NPI": "1720032899",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ALBATAINEH",
      "FirstName": "RANIA",
      "MiddleName": "QASSIEM",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "11476 OKEECHOBEE BLVD",
      "MailingAddressCityName": "ROYAL PALM BEACH",
      "MailingAddressStateName": "FL",
      "MailingAddressPostalCode": "33411-8715",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "561-204-5111",
      "MailingAddressFaxNumber": "561-204-5150",
      "FirstLinePracticeLocationAddress": "11476 OKEECHOBEE BLVD",
      "PracticeLocationAddressCityName": "ROYAL PALM BEACH",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "33411-8715",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "561-204-5111",
      "PracticeLocationAddressFaxNumber": "561-204-5150",
      "EnumerationDate": "05/21/2006",
      "LastUpdateDate": "09/11/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "ME 79876",
      "LicenseNumberStateCode1": "FL",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1326095100",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ROSBOROUGH",
      "FirstName": "RANIA",
      "MiddleName": "BAJWA",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "3100 WYMAN PARK DR",
      "MailingAddressCityName": "BALTIMORE",
      "MailingAddressStateName": "MD",
      "MailingAddressPostalCode": "21211-2803",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "410-338-3500",
      "FirstLinePracticeLocationAddress": "3601 SW 160TH AVE",
      "SecondLinePracticeLocationAddress": "SUITE 250",
      "PracticeLocationAddressCityName": "MIRAMAR",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "33027-6308",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "877-866-7123",
      "EnumerationDate": "05/27/2006",
      "LastUpdateDate": "12/10/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "D0063732",
      "LicenseNumberStateCode1": "MD",
      "PrimaryTaxonomySwitch1": "Y",
      "TaxonomyCode2": "207Q00000X",
      "Taxonomy2": "Family Medicine",
      "LicenseNumber2": "0101257197",
      "LicenseNumberStateCode2": "VA",
      "PrimaryTaxonomySwitch2": "N"
    },
    {
      "NPI": "1528015310",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "HUSSEINI",
      "FirstName": "RANIA",
      "MiddleName": "I",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "111 CYPRESS ST",
      "MailingAddressCityName": "BROOKLINE",
      "MailingAddressStateName": "MA",
      "MailingAddressPostalCode": "02445-6002",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "508-718-4050",
      "FirstLinePracticeLocationAddress": "20 PATRIOT PL",
      "PracticeLocationAddressCityName": "FOXBORO",
      "PracticeLocationAddressStateName": "MA",
      "PracticeLocationAddressPostalCode": "02035-1375",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "508-718-4050",
      "EnumerationDate": "05/27/2006",
      "LastUpdateDate": "04/17/2012",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "209649",
      "LicenseNumberStateCode1": "MA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1760429591",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "RAYES-DANAN",
      "FirstName": "RANIA",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "OtherLastName": "RAYES",
      "OtherFirstName": "RANIA",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2500 METROHEALTH DR",
      "MailingAddressCityName": "CLEVELAND",
      "MailingAddressStateName": "OH",
      "MailingAddressPostalCode": "44109-1900",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "216-778-7800",
      "FirstLinePracticeLocationAddress": "2500 METROHEALTH DR",
      "PracticeLocationAddressCityName": "CLEVELAND",
      "PracticeLocationAddressStateName": "OH",
      "PracticeLocationAddressPostalCode": "44109-1900",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "216-778-7800",
      "EnumerationDate": "06/01/2006",
      "LastUpdateDate": "01/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207ZP0102X",
      "Taxonomy1": "Anatomic Pathology & Clinical Pathology",
      "LicenseNumber1": "35086346",
      "LicenseNumberStateCode1": "OH",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "2687703",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "OH"
    },
    {
      "NPI": "1699717660",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "AMPEY",
      "FirstName": "RANIA",
      "MiddleName": "L",
      "Credential": "LPC",
      "FirstLineMailingAddress": "5930 LOVERS LN",
      "SecondLineMailingAddress": "PREMIER NEUROPSYCHIATRY, PLC",
      "MailingAddressCityName": "PORTAGE",
      "MailingAddressStateName": "MI",
      "MailingAddressPostalCode": "49002-1673",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "269-873-1611",
      "FirstLinePracticeLocationAddress": "5930 LOVERS LN",
      "SecondLinePracticeLocationAddress": "PREMIER NEUROPSYCHIATRY, PLC",
      "PracticeLocationAddressCityName": "PORTAGE",
      "PracticeLocationAddressStateName": "MI",
      "PracticeLocationAddressPostalCode": "49002-1673",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "269-873-1611",
      "EnumerationDate": "06/12/2006",
      "LastUpdateDate": "12/30/2010",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional",
      "LicenseNumber1": "6401007658",
      "LicenseNumberStateCode1": "MI",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1801839667",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ABOUJAOUDE",
      "FirstName": "RANIA",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "PO BOX 1283",
      "MailingAddressCityName": "MEDFORD",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08055-6283",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "609-677-1046",
      "MailingAddressFaxNumber": "609-677-1306",
      "FirstLinePracticeLocationAddress": "200 TRENTON RD",
      "PracticeLocationAddressCityName": "BROWNS MILLS",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08015-1705",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "609-677-1046",
      "PracticeLocationAddressFaxNumber": "609-677-1306",
      "EnumerationDate": "06/13/2006",
      "LastUpdateDate": "09/15/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207RI0200X",
      "Taxonomy1": "Infectious Disease",
      "LicenseNumber1": "39215",
      "LicenseNumberStateCode1": "KY",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "207RI0200X",
      "Taxonomy2": "Infectious Disease",
      "LicenseNumber2": "25MA07672000",
      "LicenseNumberStateCode2": "NJ",
      "PrimaryTaxonomySwitch2": "Y"
    },
    {
      "NPI": "1184645301",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "BAIK",
      "FirstName": "RANIA",
      "Credential": "D.O.",
      "FirstLineMailingAddress": "602 ROUTE 169",
      "SecondLineMailingAddress": "PO BOX 865",
      "MailingAddressCityName": "WOODSTOCK",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06281-2225",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "860-821-3406",
      "MailingAddressFaxNumber": "860-821-3407",
      "FirstLinePracticeLocationAddress": "602 ROUTE 169",
      "PracticeLocationAddressCityName": "WOODSTOCK",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06281-2225",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "860-821-3406",
      "PracticeLocationAddressFaxNumber": "860-821-3407",
      "EnumerationDate": "07/22/2006",
      "LastUpdateDate": "01/14/2016",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "000260",
      "LicenseNumberStateCode1": "CT",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

                
{
  "NPI": [
    {
      "NPI": "1083349906",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "STAFFORD",
      "FirstName": "KADY",
      "NamePrefix": "MS.",
      "Credential": "LPC",
      "FirstLineMailingAddress": "13574 SW HIGHWAY 126",
      "MailingAddressCityName": "POWELL BUTTE",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97753-1541",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-480-6360",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-203-0307",
      "EnumerationDate": "07/24/2022",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional Counselor",
      "LicenseNumber1": "LPC6225",
      "LicenseNumberStateCode1": "ID",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C9084",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "04/21/2025",
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}
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