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How to Find 51885-7500-9 NDC Data Using DataLabs API

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{
  "NDC": [
    {
      "NDCCode": "51885-7500-9",
      "PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (51885-7500-9)  > 20 mL in 1 BOTTLE, SPRAY",
      "NDC11Code": "51885-7500-09",
      "ProductNDC": "51885-7500",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Vinceel",
      "NonProprietaryName": "Apis Mellifera And Cynanchum Vincetoxicum Leaf And Atropa Belladonna And Calendula Officinalis Flowering Top And Echinacea Purpurea And Phytolacca Americana Root And Plantago Major And Sage",
      "DosageFormName": "SPRAY",
      "RouteName": "ORAL",
      "StartMarketingDate": "20060831",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Biologische Heilmittel Heel",
      "SubstanceName": "APIS MELLIFERA; CYNANCHUM VINCETOXICUM LEAF; ATROPA BELLADONNA; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA PURPUREA; PHYTOLACCA AMERICANA ROOT; PLANTAGO MAJOR; SAGE",
      "StrengthNumber": "7; 5; 5; 3; 5; 3; 3; 3",
      "StrengthUnit": "[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "For the temporary relief of: 1 Sore throat, 2 Hoarseness, 3 Canker sores."
    },
    {
      "NDCCode": "51885-3260-9",
      "PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (51885-3260-9)  > 20 mL in 1 BOTTLE, PUMP",
      "NDC11Code": "51885-3260-09",
      "ProductNDC": "51885-3260",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sinusin",
      "NonProprietaryName": "Silver Nitrate, Euphorbia Resinifera Resin, Calcium Sulfide, Luffa Operculata Fruit, Mercuric Iodide, Sus Scrofa Nasal Mucosa, Pulsatilla Vulgaris And Sinusitisinum",
      "DosageFormName": "SPRAY",
      "RouteName": "NASAL",
      "StartMarketingDate": "20120203",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Biologische Heilmittel Heel",
      "SubstanceName": "SILVER NITRATE; EUPHORBIA RESINIFERA RESIN; CALCIUM SULFIDE; LUFFA OPERCULATA FRUIT; MERCURIC IODIDE; SUS SCROFA NASAL MUCOSA; PULSATILLA VULGARIS; SINUSITISINUM",
      "StrengthNumber": "10; 4; 10; 2; 8; 8; 2; 13",
      "StrengthUnit": "[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL",
      "Status": "Deprecated",
      "LastUpdate": "2017-01-30"
    },
    {
      "NDCCode": "52483-0100-0",
      "PackageDescription": "9 BAG in 1 DRUM (52483-0100-0)  > 7500 CAPSULE in 1 BAG",
      "NDC11Code": "52483-0100-00",
      "ProductNDC": "52483-0100",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Temozolomide",
      "DosageFormName": "CAPSULE",
      "StartMarketingDate": "20150701",
      "EndMarketingDate": "20220101",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Orion Corporation, Orion Pharma",
      "SubstanceName": "TEMOZOLOMIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "StartMarketingDatePackage": "01-JUL-15",
      "EndMarketingDatePackage": "01-JAN-22"
    },
    {
      "NDCCode": "71399-7500-9",
      "PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (71399-7500-9) ",
      "NDC11Code": "71399-7500-09",
      "ProductNDC": "71399-7500",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clopidogrel Bisulfate",
      "NonProprietaryName": "Clopidogrel Bisulfate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180523",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204165",
      "LabelerName": "Akron Pharma Inc",
      "SubstanceName": "CLOPIDOGREL BISULFATE",
      "StrengthNumber": "75",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20180523",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0069-0206-02",
      "PackageDescription": "10 SYRINGE in 1 CARTON (0069-0206-02)  / .3 mL in 1 SYRINGE (0069-0206-01) ",
      "NDC11Code": "00069-0206-02",
      "ProductNDC": "0069-0206",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fragmin",
      "NonProprietaryName": "Dalteparin Sodium",
      "DosageFormName": "INJECTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20150401",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020287",
      "LabelerName": "Pfizer Laboratories Div Pfizer Inc",
      "SubstanceName": "DALTEPARIN SODIUM",
      "StrengthNumber": "7500",
      "StrengthUnit": "[iU]/.3mL",
      "Pharm_Classes": "Anti-coagulant [EPC], Heparin, Low-Molecular-Weight [CS], Low Molecular Weight Heparin [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-10-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20150401",
      "SamplePackage": "N",
      "IndicationAndUsage": "FRAGMIN is a low molecular weight heparin (LMWH) indicated for: 1 Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction (1.1), 2 Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery or medical patients with severely restricted mobility during acute illness (1.2), 3 Extended treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in adult patients with cancer. In these patients, the FRAGMIN therapy begins with the initial VTE treatment and continues for six months (1.3), 4 Treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in pediatric patients from birth (gestational age at least 35 weeks) (1.4), 5 Limitations of UseFRAGMIN is not indicated for the acute treatment of VTE (1.5).",
      "Description": "FRAGMIN Injection (dalteparin sodium injection) is a sterile, low molecular weight heparin. It is available in single-dose, prefilled syringes preassembled with a needle guard device, and multiple-dose vials. With reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard, each syringe contains either 2,500 units, 5,000 units, 7,500 units, 10,000 units, 12,500 units, 15,000 units or 18,000 anti-Xa international units (units), equivalent to 16 mg, 32 mg, 48 mg, 64 mg, 80 mg, 96 mg or 115.2 mg dalteparin sodium, respectively. Each multiple-dose vial contains 25,000 anti-Xa units per 1 mL (equivalent to 160 mg dalteparin sodium), for a total of 95,000 anti-Xa units per vial. Each single-dose vial contains 2,500 anti-Xa units per 1 mL (equivalent to 16 mg dalteparin sodium) for a total of 10,000 anti-Xa units per vial. Each prefilled syringe also contains Water for Injection and sodium chloride, when required, to maintain physiologic ionic strength. The prefilled syringes are preservative-free. Each multiple-dose vial also contains Water for Injection and 14 mg of benzyl alcohol per mL as a preservative. The pH of both formulations is 5.0 to 7.5. When necessary, the pH of FRAGMIN is adjusted with hydrochloric acid and/or sodium hydroxide [see Dosage and Administration (2.7) and How Supplied/Storage and Handling (16)]. Dalteparin sodium is produced through controlled nitrous acid depolymerization of sodium heparin from porcine intestinal mucosa followed by a chromatographic purification process. It is composed of strongly acidic sulfated polysaccharide chains (oligosaccharide, containing 2,5-anhydro-D-mannitol residues as end groups) with an average molecular weight of 5,000 and about 90% of the material within the range 2,000–9,000. The molecular weight distribution is. Structural Formula."
    },
    {
      "NDCCode": "11014-0436-2",
      "PackageDescription": "2 BAG in 1 CARTON (11014-0436-2)  / 7500 CAPSULE in 1 BAG",
      "NDC11Code": "11014-0436-02",
      "ProductNDC": "11014-0436",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Voclosporin",
      "DosageFormName": "CAPSULE",
      "StartMarketingDate": "20210122",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Catalent Pharma Solutions, LLC",
      "SubstanceName": "VOCLOSPORIN",
      "StrengthNumber": "7.9",
      "StrengthUnit": "mg/1",
      "Status": "Unfinished",
      "LastUpdate": "2026-05-04",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "31-MAY-24"
    },
    {
      "NDCCode": "11014-0448-1",
      "PackageDescription": "2 BAG in 1 CARTON (11014-0448-1)  / 7500 CAPSULE in 1 BAG",
      "NDC11Code": "11014-0448-01",
      "ProductNDC": "11014-0448",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Voclosporin",
      "DosageFormName": "CAPSULE",
      "StartMarketingDate": "20231118",
      "MarketingCategoryName": "EXPORT ONLY",
      "LabelerName": "Catalent Pharma Solutions, LLC",
      "SubstanceName": "VOCLOSPORIN",
      "StrengthNumber": "7.9",
      "StrengthUnit": "mg/1",
      "Status": "Unfinished",
      "LastUpdate": "2026-05-04",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "18-NOV-23"
    },
    {
      "NDCCode": "11014-0480-1",
      "PackageDescription": "2 BAG in 1 CARTON (11014-0480-1)  > 7500 CAPSULE in 1 BAG",
      "NDC11Code": "11014-0480-01",
      "ProductNDC": "11014-0480",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Voclosporin",
      "DosageFormName": "CAPSULE",
      "StartMarketingDate": "20220504",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Catalent Pharma Solutions, LLC",
      "SubstanceName": "VOCLOSPORIN",
      "StrengthNumber": "7.9",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "04-MAY-22"
    },
    {
      "NDCCode": "58118-7500-8",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (58118-7500-8) ",
      "NDC11Code": "58118-7500-08",
      "ProductNDC": "58118-7500",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ondansetron Hydrochloride",
      "NonProprietaryName": "Ondansetron Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20181213",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078539",
      "LabelerName": "Clinical Solutions Wholesale, LLC",
      "SubstanceName": "ONDANSETRON HYDROCHLORIDE",
      "StrengthNumber": "4",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20181213",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: 1 highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m 2, 2 initial and repeat courses of moderately emetogenic cancer chemotherapy , 3 radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen .",
      "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. 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": "81298-7500-1",
      "PackageDescription": "1 VIAL, GLASS in 1 CARTON (81298-7500-1)  / 20 mL in 1 VIAL, GLASS",
      "NDC11Code": "81298-7500-01",
      "ProductNDC": "81298-7500",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Methadone Hydrochloride",
      "NonProprietaryName": "Methadone Hydrochloride",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20250628",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208306",
      "LabelerName": "Long Grove Pharmaceuticals, LLC",
      "SubstanceName": "METHADONE HYDROCHLORIDE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/20mL",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2026-08-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250628",
      "SamplePackage": "N",
      "IndicationAndUsage": "Methadone Hydrochloride Injection is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.Limitations of UseBecause of the risks of addiction, abuse, and misuse overdose, and death, which can occur at any dosage or duration (see WARNINGS), and persist over the course of therapy, reserve opioid analgesics, including Methadone Hydrochloride Injection, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.Methadone Hydrochloride Injection is not indicated as an as-needed (prn) analgesic. For use in temporary treatment of opioid dependence in patients unable to take oral medication.Limitations of UseInjectable methadone products are not approved for the outpatient treatment of opioid dependence. In this patient population, parenteral methadone is to be used only for patients unable to take oral medication, such as hospitalized patients.",
      "Description": "Methadone Hydrochloride Injection USP, 10 mg/mL is an opioid analgesic for parenteral use (intravenous, intramuscular or subcutaneous use). Methadone Hydrochloride Injection USP, 10 mg/mL contains methadone hydrochloride as the active pharmaceutical ingredient. Methadone hydrochloride is a white, crystalline material that is water-soluble. Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-hepatanone hydrochloride. Its molecular formula is C21H27NOHCl and it has a molecular weight of 345.91. Methadone hydrochloride has a melting point of 235°C, and a pKa of 8.25 in water at 20°C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5. Methadone hydrochloride has the following structural formula:. Methadone Hydrochloride Injection is a sterile injectable solution available in 20 mL multiple-dose vials. Each mL of the Methadone Hydrochloride Injection contains: 10 mg of methadone hydrochloride (equivalent to 8.95 mg of methadone free base), 5 mg of chlorobutanol, as a preservative, 9 mg of sodium chloride, as tonicity agent, and hydrochloric acid and sodium hydroxide as pH adjusters, in water for injection. The pH of the sterile injectable solution is between 3.0 to 6.5."
    },
    {
      "NDCCode": "0066-7500-04",
      "PackageDescription": "118 mL in 1 BOTTLE, PLASTIC (0066-7500-04)",
      "NDC11Code": "00066-7500-04",
      "ProductNDC": "0066-7500",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Klaron",
      "NonProprietaryName": "Sulfacetamide Sodium",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "19961223",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019931",
      "LabelerName": "Dermik Laboratories",
      "SubstanceName": "SULFACETAMIDE SODIUM",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2014-05-12"
    },
    {
      "NDCCode": "0113-7500-01",
      "PackageDescription": "20 BLISTER PACK in 1 CARTON (0113-7500-01)  > 1 TABLET, CHEWABLE in 1 BLISTER PACK",
      "NDC11Code": "00113-7500-01",
      "ProductNDC": "0113-7500",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Basic Care Childrens Allergy Relief",
      "NonProprietaryName": "Loratadine",
      "DosageFormName": "TABLET, CHEWABLE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190731",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210033",
      "LabelerName": "L. Perrigo Company",
      "SubstanceName": "LORATADINE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2022-11-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20190731",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0113-7500-49",
      "PackageDescription": "40 BLISTER PACK in 1 CARTON (0113-7500-49)  > 1 TABLET, CHEWABLE in 1 BLISTER PACK",
      "NDC11Code": "00113-7500-49",
      "ProductNDC": "0113-7500",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Basic Care Childrens Allergy Relief",
      "NonProprietaryName": "Loratadine",
      "DosageFormName": "TABLET, CHEWABLE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190731",
      "EndMarketingDate": "20230228",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210033",
      "LabelerName": "L. Perrigo Company",
      "SubstanceName": "LORATADINE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2023-03-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20190731",
      "EndMarketingDatePackage": "20230228",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0264-7500-00",
      "PackageDescription": "12 CONTAINER in 1 CASE (0264-7500-00)  / 1000 mL in 1 CONTAINER",
      "NDC11Code": "00264-7500-00",
      "ProductNDC": "0264-7500",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lactated Ringers",
      "NonProprietaryName": "Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20230301",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019632",
      "LabelerName": "B. Braun Medical Inc.",
      "SubstanceName": "CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE",
      "StrengthNumber": ".02; .03; .6; .31",
      "StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL",
      "Pharm_Classes": "Acidifying Activity [MoA], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-05-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230301",
      "SamplePackage": "N",
      "IndicationAndUsage": "Lactated Ringer’s Injection is indicated for use as a source of water and electrolytes or as an alkalinizing agent in adults and pediatric patients.",
      "Description": "Lactated Ringer’s Injection USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in a single-dose container intended for intravenous administration. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1. Table 1. The chemical name, structural formula, and molecular weight of the active ingredients are shown in Table 2. Table 2. Not made with natural rubber latex, PVC or DEHP. The plastic container is made from a multilayered film developed for parenteral drugs. It contains no plasticizers and has minimal leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. The closure system has two ports; the one for the administration set has a tamper evident foil cover and the other is a medication addition site [see Dosage and Administration (2.3)]."
    },
    {
      "NDCCode": "0264-7500-10",
      "PackageDescription": "24 CONTAINER in 1 CASE (0264-7500-10)  / 500 mL in 1 CONTAINER",
      "NDC11Code": "00264-7500-10",
      "ProductNDC": "0264-7500",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lactated Ringers",
      "NonProprietaryName": "Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20230301",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019632",
      "LabelerName": "B. Braun Medical Inc.",
      "SubstanceName": "CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE",
      "StrengthNumber": ".02; .03; .6; .31",
      "StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL",
      "Pharm_Classes": "Acidifying Activity [MoA], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-05-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230301",
      "SamplePackage": "N",
      "IndicationAndUsage": "Lactated Ringer’s Injection is indicated for use as a source of water and electrolytes or as an alkalinizing agent in adults and pediatric patients.",
      "Description": "Lactated Ringer’s Injection USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in a single-dose container intended for intravenous administration. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1. Table 1. The chemical name, structural formula, and molecular weight of the active ingredients are shown in Table 2. Table 2. Not made with natural rubber latex, PVC or DEHP. The plastic container is made from a multilayered film developed for parenteral drugs. It contains no plasticizers and has minimal leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. The closure system has two ports; the one for the administration set has a tamper evident foil cover and the other is a medication addition site [see Dosage and Administration (2.3)]."
    },
    {
      "NDCCode": "0363-7500-50",
      "PackageDescription": "1 TUBE in 1 CARTON (0363-7500-50)  / 3.5 g in 1 TUBE",
      "NDC11Code": "00363-7500-50",
      "ProductNDC": "0363-7500",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Walgreens Sodium Chloride Ophthalmic 5 Percent Hypertonicity Eye",
      "NonProprietaryName": "Sodium Chloride",
      "DosageFormName": "OINTMENT",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20190401",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M018",
      "LabelerName": "Walgreen Company",
      "SubstanceName": "SODIUM CHLORIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/g",
      "Status": "Active",
      "LastUpdate": "2026-04-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190401",
      "SamplePackage": "N",
      "IndicationAndUsage": " For the temporary relief of corneal edema."
    },
    {
      "NDCCode": "0463-7500-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0463-7500-01)",
      "NDC11Code": "00463-7500-01",
      "ProductNDC": "0463-7500",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Phendimetrazine Tartrate",
      "NonProprietaryName": "Phendimetrazine Tartrate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20000329",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA089452",
      "LabelerName": "C.O. Truxton, Inc.",
      "SubstanceName": "PHENDIMETRAZINE TARTRATE",
      "StrengthNumber": "35",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]",
      "DEASchedule": "CIII",
      "Status": "Deprecated",
      "LastUpdate": "2018-09-15",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "0463-7500-10",
      "PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (0463-7500-10)",
      "NDC11Code": "00463-7500-10",
      "ProductNDC": "0463-7500",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Phendimetrazine Tartrate",
      "NonProprietaryName": "Phendimetrazine Tartrate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20000329",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA089452",
      "LabelerName": "C.O. Truxton, Inc.",
      "SubstanceName": "PHENDIMETRAZINE TARTRATE",
      "StrengthNumber": "35",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]",
      "DEASchedule": "CIII",
      "Status": "Deprecated",
      "LastUpdate": "2018-09-15",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "0498-7500-50",
      "PackageDescription": "250 BOX in 1 BOX (0498-7500-50)  > 125 BOX in 1 BOX (0498-7500-25)  > 50 PACKET in 1 BOX (0498-7500-10)  > 2 TABLET in 1 PACKET (0498-7500-01)",
      "NDC11Code": "00498-7500-50",
      "ProductNDC": "0498-7500",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cedaprin",
      "NonProprietaryName": "Ibuprofen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120307",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA079129",
      "LabelerName": "North Safety Products LLC",
      "SubstanceName": "IBUPROFEN",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2017-12-13",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "0536-7500-01",
      "PackageDescription": ".4 mL in 1 POUCH (0536-7500-01)",
      "NDC11Code": "00536-7500-01",
      "ProductNDC": "0536-7500",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Alcohol Prep Pad",
      "NonProprietaryName": "Isopropyl Alcohol",
      "DosageFormName": "SWAB",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20150102",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Rugby Laboratories",
      "SubstanceName": "ISOPROPYL ALCOHOL",
      "StrengthNumber": ".7",
      "StrengthUnit": "mL/mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-13",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "0904-7500-04",
      "PackageDescription": "30 BLISTER PACK in 1 CARTON (0904-7500-04)  / 1 TABLET in 1 BLISTER PACK",
      "NDC11Code": "00904-7500-04",
      "ProductNDC": "0904-7500",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Nebivolol",
      "NonProprietaryName": "Nebivolol",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260514",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212682",
      "LabelerName": "Major Pharmaceuticals",
      "SubstanceName": "NEBIVOLOL",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-07-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260514",
      "SamplePackage": "N",
      "IndicationAndUsage": "Nebivolol is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).",
      "Description": "The chemical name for the active ingredient in nebivolol tablets (nebivolol) tablets is (1RS,1’RS)-1,1’-[(2RS,2’SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]- 2,2’-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C22H25F2NO4HCl) with the following structural formula. Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene. Nebivolol tablets for oral administration contain nebivolol hydrochloride equivalent to 2.5 mg, 5 mg, 10 mg, and 20 mg of nebivolol base. In addition, nebivolol tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80, pregelatinized starch, sodium lauryl sulfate, D&C Red No. 27 Aluminum Lake (10 mg), FD&C Blue No. 2 Aluminum Lake (2.5 mg and 20 mg), and FD&C Yellow No. 6 Aluminum Lake (5 mg)."
    },
    {
      "NDCCode": "10006-002-04",
      "PackageDescription": "7500 L in 1 CYLINDER (10006-002-04)",
      "NDC11Code": "10006-0002-04",
      "ProductNDC": "10006-002",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Nitrous Oxide",
      "NonProprietaryName": "Nitrous Oxide",
      "DosageFormName": "GAS",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "19360101",
      "MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
      "LabelerName": "Acetylene Oxygen Company",
      "SubstanceName": "NITROUS OXIDE",
      "StrengthNumber": "99",
      "StrengthUnit": "L/100L",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "11014-0220-2",
      "PackageDescription": "2 BAG in 1 CARTON (11014-0220-2)  / 7500 CAPSULE in 1 BAG",
      "NDC11Code": "11014-0220-02",
      "ProductNDC": "11014-0220",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Advil Rf",
      "DosageFormName": "CAPSULE",
      "StartMarketingDate": "20170310",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Catalent Pharma Solutions, LLC",
      "SubstanceName": "IBUPROFEN",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Status": "Unfinished",
      "LastUpdate": "2026-05-04",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "10-MAR-17"
    },
    {
      "NDCCode": "24794-300-01",
      "PackageDescription": "30 mL in 1 JAR (24794-300-01) ",
      "NDC11Code": "24794-0300-01",
      "ProductNDC": "24794-300",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hemostatic Solution",
      "NonProprietaryName": "Aluminum Chloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20130115",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Crosstex International Inc.",
      "SubstanceName": "ALUMINUM CHLORIDE",
      "StrengthNumber": "7500",
      "StrengthUnit": "mg/30mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-02-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20130115",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "25000-021-21",
      "PackageDescription": "4 BAG in 1 BOX (25000-021-21)  > 7500 CAPSULE, LIQUID FILLED in 1 BAG",
      "NDC11Code": "25000-0021-21",
      "ProductNDC": "25000-021",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Loratadine",
      "NonProprietaryName": "Loratadine",
      "DosageFormName": "CAPSULE, LIQUID FILLED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20161001",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206214",
      "LabelerName": "MARKSANS PHARMA LIMITED",
      "SubstanceName": "LORATADINE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Status": "Active",
      "LastUpdate": "2021-11-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20161001",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies.  runny nose.  itchy, watery eyes.  sneezing.  itching of the nose or throat."
    },
    {
      "NDCCode": "25000-138-21",
      "PackageDescription": "4 BAG in 1 BOX (25000-138-21)  / 7500 TABLET in 1 BAG",
      "NDC11Code": "25000-0138-21",
      "ProductNDC": "25000-138",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Naproxen",
      "NonProprietaryName": "Naproxen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110228",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091416",
      "LabelerName": "MARKSANS PHARMA LIMITED",
      "SubstanceName": "NAPROXEN",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-12-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20110228",
      "SamplePackage": "N",
      "IndicationAndUsage": "Naproxen Tablets are indicated for. the relief of the signs and symptoms of. ·         rheumatoid arthritis. ·         osteoarthritis. ·         ankylosing spondylitis. ·         Polyarticular Juvenile Idiopathic Arthritis. ·         tendonitis. ·         bursitis. ·         acute gout. the management of. ·         pain. ·         primary dysmenorrhea.",
      "Description": "Naproxen Tablets, USP is nonsteroidal anti-inflammatory drug productavailable as follows: White tablets containing 250 mg, 375 mg and 500 mg of naproxen for oral administration. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen, USP is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen, USP has the following structural formula:.                                          Molecular Formula:     C14H14O3.                                          MW = 230.26. Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8.The inactive ingredients in naproxen tablets include: croscarmellose sodium, povidone and magnesium stearate."
    },
    {
      "NDCCode": "25000-138-31",
      "PackageDescription": "6 BAG in 1 BOX (25000-138-31)  / 7500 TABLET in 1 BAG",
      "NDC11Code": "25000-0138-31",
      "ProductNDC": "25000-138",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Naproxen",
      "NonProprietaryName": "Naproxen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110228",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091416",
      "LabelerName": "MARKSANS PHARMA LIMITED",
      "SubstanceName": "NAPROXEN",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-12-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20110228",
      "SamplePackage": "N",
      "IndicationAndUsage": "Naproxen Tablets are indicated for. the relief of the signs and symptoms of. ·         rheumatoid arthritis. ·         osteoarthritis. ·         ankylosing spondylitis. ·         Polyarticular Juvenile Idiopathic Arthritis. ·         tendonitis. ·         bursitis. ·         acute gout. the management of. ·         pain. ·         primary dysmenorrhea.",
      "Description": "Naproxen Tablets, USP is nonsteroidal anti-inflammatory drug productavailable as follows: White tablets containing 250 mg, 375 mg and 500 mg of naproxen for oral administration. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen, USP is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen, USP has the following structural formula:.                                          Molecular Formula:     C14H14O3.                                          MW = 230.26. Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8.The inactive ingredients in naproxen tablets include: croscarmellose sodium, povidone and magnesium stearate."
    },
    {
      "NDCCode": "29336-750-75",
      "PackageDescription": "7500 mg in 1 BOTTLE, PUMP (29336-750-75)",
      "NDC11Code": "29336-0750-75",
      "ProductNDC": "29336-750",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Zyclara",
      "NonProprietaryName": "Imiquimod",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20111015",
      "EndMarketingDate": "20150131",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022483",
      "LabelerName": "Graceway Pharmaceuticals, LLC",
      "SubstanceName": "IMIQUIMOD",
      "StrengthNumber": "3.75",
      "StrengthUnit": "mg/100mg",
      "Pharm_Classes": "Increased Cytokine Activity [PE],Increased Cytokine Production [PE],Interferon Inducers [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2015-02-06"
    },
    {
      "NDCCode": "42658-154-07",
      "PackageDescription": "7500 mg in 1 BOTTLE (42658-154-07) ",
      "NDC11Code": "42658-0154-07",
      "ProductNDC": "42658-154",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olanzapine",
      "NonProprietaryName": "Olanzapine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206924",
      "LabelerName": "Hisun Pharmaceuticals USA, Inc.",
      "SubstanceName": "OLANZAPINE",
      "StrengthNumber": "15",
      "StrengthUnit": "mg/15mg",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-05-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250101",
      "SamplePackage": "N",
      "Description": "Olanzapine, USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)- 10H-thieno[2,3- b] [1,5]benzodiazepine. The molecular formula is C 17H 20N 4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine Tablets, USP are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 mcmol), 5 mg (16 mcmol), 7.5 mg (24 mcmol), 10 mg (32 mcmol), 15 mg (48 mcmol), or 20 mg (64 mcmol). Inactive ingredients are lactose monohydrate, maize starch, colloidal silicon dioxide, magnesium stearate, crospovidone, microcrystalline cellulose and talc. Olanzapine orally disintegrating tablets are intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 mcmol), 10 mg (32 mcmol), 15 mg (48 mcmol) or 20 mg (64 mcmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets also contain the following inactive ingredients: aspartame, lactose monohydrate, maize starch, colloidal silicon dioxide, magnesium stearate, crospovidone, microcrystalline cellulose and talc. Olanzapine orally disintegrating tablets meet USP Disintegration Test 2."
    },
    {
      "NDCCode": "42658-158-07",
      "PackageDescription": "7500 mg in 1 BOTTLE (42658-158-07) ",
      "NDC11Code": "42658-0158-07",
      "ProductNDC": "42658-158",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olanzapine",
      "NonProprietaryName": "Olanzapine",
      "DosageFormName": "TABLET, ORALLY DISINTEGRATING",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206892",
      "LabelerName": "Hisun Pharmaceuticals USA, Inc.",
      "SubstanceName": "OLANZAPINE",
      "StrengthNumber": "15",
      "StrengthUnit": "mg/15mg",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-05-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250101",
      "SamplePackage": "N",
      "Description": "Olanzapine, USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)- 10H-thieno[2,3- b] [1,5]benzodiazepine. The molecular formula is C 17H 20N 4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine Tablets, USP are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 mcmol), 5 mg (16 mcmol), 7.5 mg (24 mcmol), 10 mg (32 mcmol), 15 mg (48 mcmol), or 20 mg (64 mcmol). Inactive ingredients are lactose monohydrate, maize starch, colloidal silicon dioxide, magnesium stearate, crospovidone, microcrystalline cellulose and talc. Olanzapine orally disintegrating tablets are intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 mcmol), 10 mg (32 mcmol), 15 mg (48 mcmol) or 20 mg (64 mcmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets also contain the following inactive ingredients: aspartame, lactose monohydrate, maize starch, colloidal silicon dioxide, magnesium stearate, crospovidone, microcrystalline cellulose and talc. Olanzapine orally disintegrating tablets meet USP Disintegration Test 2."
    }
  ]
}
                    
{"NDC":[{"NDCCode":"51885-7500-9","ProprietaryName":"Vinceel","NonProprietaryName":"Apis Mellifera And Cynanchum Vincetoxicum Leaf And Atropa Belladonna And Calendula Officinalis Flowering Top And Echinacea Purpurea And Phytolacca Americana Root And Plantago Major And Sage"},{"NDCCode":"51885-3260-9","ProprietaryName":"Sinusin","NonProprietaryName":"Silver Nitrate, Euphorbia Resinifera Resin, Calcium Sulfide, Luffa Operculata Fruit, Mercuric Iodide, Sus Scrofa Nasal Mucosa, Pulsatilla Vulgaris And Sinusitisinum"},{"NDCCode":"52483-0100-0","NonProprietaryName":"Temozolomide"},{"NDCCode":"71399-7500-9","ProprietaryName":"Clopidogrel Bisulfate","NonProprietaryName":"Clopidogrel Bisulfate"},{"NDCCode":"0069-0206-02","ProprietaryName":"Fragmin","NonProprietaryName":"Dalteparin Sodium"},{"NDCCode":"11014-0436-2","NonProprietaryName":"Voclosporin"},{"NDCCode":"11014-0448-1","NonProprietaryName":"Voclosporin"},{"NDCCode":"11014-0480-1","NonProprietaryName":"Voclosporin"},{"NDCCode":"58118-7500-8","ProprietaryName":"Ondansetron Hydrochloride","NonProprietaryName":"Ondansetron Hydrochloride"},{"NDCCode":"81298-7500-1","ProprietaryName":"Methadone Hydrochloride","NonProprietaryName":"Methadone Hydrochloride"},{"NDCCode":"0066-7500-04","ProprietaryName":"Klaron","NonProprietaryName":"Sulfacetamide Sodium"},{"NDCCode":"0113-7500-01","ProprietaryName":"Basic Care Childrens Allergy Relief","NonProprietaryName":"Loratadine"},{"NDCCode":"0113-7500-49","ProprietaryName":"Basic Care Childrens Allergy Relief","NonProprietaryName":"Loratadine"},{"NDCCode":"0264-7500-00","ProprietaryName":"Lactated Ringers","NonProprietaryName":"Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride"},{"NDCCode":"0264-7500-10","ProprietaryName":"Lactated Ringers","NonProprietaryName":"Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride"},{"NDCCode":"0363-7500-50","ProprietaryName":"Walgreens Sodium Chloride Ophthalmic 5 Percent Hypertonicity Eye","NonProprietaryName":"Sodium Chloride"},{"NDCCode":"0463-7500-01","ProprietaryName":"Phendimetrazine Tartrate","NonProprietaryName":"Phendimetrazine Tartrate"},{"NDCCode":"0463-7500-10","ProprietaryName":"Phendimetrazine Tartrate","NonProprietaryName":"Phendimetrazine Tartrate"},{"NDCCode":"0498-7500-50","ProprietaryName":"Cedaprin","NonProprietaryName":"Ibuprofen"},{"NDCCode":"0536-7500-01","ProprietaryName":"Alcohol Prep Pad","NonProprietaryName":"Isopropyl Alcohol"},{"NDCCode":"0904-7500-04","ProprietaryName":"Nebivolol","NonProprietaryName":"Nebivolol"},{"NDCCode":"10006-002-04","ProprietaryName":"Nitrous Oxide","NonProprietaryName":"Nitrous Oxide"},{"NDCCode":"11014-0220-2","NonProprietaryName":"Advil Rf"},{"NDCCode":"24794-300-01","ProprietaryName":"Hemostatic Solution","NonProprietaryName":"Aluminum Chloride"},{"NDCCode":"25000-021-21","ProprietaryName":"Loratadine","NonProprietaryName":"Loratadine"},{"NDCCode":"25000-138-21","ProprietaryName":"Naproxen","NonProprietaryName":"Naproxen"},{"NDCCode":"25000-138-31","ProprietaryName":"Naproxen","NonProprietaryName":"Naproxen"},{"NDCCode":"29336-750-75","ProprietaryName":"Zyclara","NonProprietaryName":"Imiquimod"},{"NDCCode":"42658-154-07","ProprietaryName":"Olanzapine","NonProprietaryName":"Olanzapine"},{"NDCCode":"42658-158-07","ProprietaryName":"Olanzapine","NonProprietaryName":"Olanzapine"}]}
                    
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    <NDCCode>51885-7500-9</NDCCode>
    <PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (51885-7500-9)  &gt; 20 mL in 1 BOTTLE, SPRAY</PackageDescription>
    <NDC11Code>51885-7500-09</NDC11Code>
    <ProductNDC>51885-7500</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Vinceel</ProprietaryName>
    <NonProprietaryName>Apis Mellifera And Cynanchum Vincetoxicum Leaf And Atropa Belladonna And Calendula Officinalis Flowering Top And Echinacea Purpurea And Phytolacca Americana Root And Plantago Major And Sage</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20060831</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Biologische Heilmittel Heel</LabelerName>
    <SubstanceName>APIS MELLIFERA; CYNANCHUM VINCETOXICUM LEAF; ATROPA BELLADONNA; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA PURPUREA; PHYTOLACCA AMERICANA ROOT; PLANTAGO MAJOR; SAGE</SubstanceName>
    <StrengthNumber>7; 5; 5; 3; 5; 3; 3; 3</StrengthNumber>
    <StrengthUnit>[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>For the temporary relief of: 1 Sore throat, 2 Hoarseness, 3 Canker sores.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>51885-3260-9</NDCCode>
    <PackageDescription>1 BOTTLE, PUMP in 1 CARTON (51885-3260-9)  &gt; 20 mL in 1 BOTTLE, PUMP</PackageDescription>
    <NDC11Code>51885-3260-09</NDC11Code>
    <ProductNDC>51885-3260</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sinusin</ProprietaryName>
    <NonProprietaryName>Silver Nitrate, Euphorbia Resinifera Resin, Calcium Sulfide, Luffa Operculata Fruit, Mercuric Iodide, Sus Scrofa Nasal Mucosa, Pulsatilla Vulgaris And Sinusitisinum</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>NASAL</RouteName>
    <StartMarketingDate>20120203</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Biologische Heilmittel Heel</LabelerName>
    <SubstanceName>SILVER NITRATE; EUPHORBIA RESINIFERA RESIN; CALCIUM SULFIDE; LUFFA OPERCULATA FRUIT; MERCURIC IODIDE; SUS SCROFA NASAL MUCOSA; PULSATILLA VULGARIS; SINUSITISINUM</SubstanceName>
    <StrengthNumber>10; 4; 10; 2; 8; 8; 2; 13</StrengthNumber>
    <StrengthUnit>[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-01-30</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>52483-0100-0</NDCCode>
    <PackageDescription>9 BAG in 1 DRUM (52483-0100-0)  &gt; 7500 CAPSULE in 1 BAG</PackageDescription>
    <NDC11Code>52483-0100-00</NDC11Code>
    <ProductNDC>52483-0100</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Temozolomide</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <StartMarketingDate>20150701</StartMarketingDate>
    <EndMarketingDate>20220101</EndMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Orion Corporation, Orion Pharma</LabelerName>
    <SubstanceName>TEMOZOLOMIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <StartMarketingDatePackage>01-JUL-15</StartMarketingDatePackage>
    <EndMarketingDatePackage>01-JAN-22</EndMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>71399-7500-9</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (71399-7500-9) </PackageDescription>
    <NDC11Code>71399-7500-09</NDC11Code>
    <ProductNDC>71399-7500</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clopidogrel Bisulfate</ProprietaryName>
    <NonProprietaryName>Clopidogrel Bisulfate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180523</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204165</ApplicationNumber>
    <LabelerName>Akron Pharma Inc</LabelerName>
    <SubstanceName>CLOPIDOGREL BISULFATE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180523</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0069-0206-02</NDCCode>
    <PackageDescription>10 SYRINGE in 1 CARTON (0069-0206-02)  / .3 mL in 1 SYRINGE (0069-0206-01) </PackageDescription>
    <NDC11Code>00069-0206-02</NDC11Code>
    <ProductNDC>0069-0206</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fragmin</ProprietaryName>
    <NonProprietaryName>Dalteparin Sodium</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20150401</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020287</ApplicationNumber>
    <LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
    <SubstanceName>DALTEPARIN SODIUM</SubstanceName>
    <StrengthNumber>7500</StrengthNumber>
    <StrengthUnit>[iU]/.3mL</StrengthUnit>
    <Pharm_Classes>Anti-coagulant [EPC], Heparin, Low-Molecular-Weight [CS], Low Molecular Weight Heparin [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>FRAGMIN is a low molecular weight heparin (LMWH) indicated for: 1 Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction (1.1), 2 Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery or medical patients with severely restricted mobility during acute illness (1.2), 3 Extended treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in adult patients with cancer. In these patients, the FRAGMIN therapy begins with the initial VTE treatment and continues for six months (1.3), 4 Treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in pediatric patients from birth (gestational age at least 35 weeks) (1.4), 5 Limitations of UseFRAGMIN is not indicated for the acute treatment of VTE (1.5).</IndicationAndUsage>
    <Description>FRAGMIN Injection (dalteparin sodium injection) is a sterile, low molecular weight heparin. It is available in single-dose, prefilled syringes preassembled with a needle guard device, and multiple-dose vials. With reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard, each syringe contains either 2,500 units, 5,000 units, 7,500 units, 10,000 units, 12,500 units, 15,000 units or 18,000 anti-Xa international units (units), equivalent to 16 mg, 32 mg, 48 mg, 64 mg, 80 mg, 96 mg or 115.2 mg dalteparin sodium, respectively. Each multiple-dose vial contains 25,000 anti-Xa units per 1 mL (equivalent to 160 mg dalteparin sodium), for a total of 95,000 anti-Xa units per vial. Each single-dose vial contains 2,500 anti-Xa units per 1 mL (equivalent to 16 mg dalteparin sodium) for a total of 10,000 anti-Xa units per vial. Each prefilled syringe also contains Water for Injection and sodium chloride, when required, to maintain physiologic ionic strength. The prefilled syringes are preservative-free. Each multiple-dose vial also contains Water for Injection and 14 mg of benzyl alcohol per mL as a preservative. The pH of both formulations is 5.0 to 7.5. When necessary, the pH of FRAGMIN is adjusted with hydrochloric acid and/or sodium hydroxide [see Dosage and Administration (2.7) and How Supplied/Storage and Handling (16)]. Dalteparin sodium is produced through controlled nitrous acid depolymerization of sodium heparin from porcine intestinal mucosa followed by a chromatographic purification process. It is composed of strongly acidic sulfated polysaccharide chains (oligosaccharide, containing 2,5-anhydro-D-mannitol residues as end groups) with an average molecular weight of 5,000 and about 90% of the material within the range 2,000–9,000. The molecular weight distribution is. Structural Formula.</Description>
  </NDC>
  <NDC>
    <NDCCode>11014-0436-2</NDCCode>
    <PackageDescription>2 BAG in 1 CARTON (11014-0436-2)  / 7500 CAPSULE in 1 BAG</PackageDescription>
    <NDC11Code>11014-0436-02</NDC11Code>
    <ProductNDC>11014-0436</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Voclosporin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <StartMarketingDate>20210122</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Catalent Pharma Solutions, LLC</LabelerName>
    <SubstanceName>VOCLOSPORIN</SubstanceName>
    <StrengthNumber>7.9</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-05-04</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>31-MAY-24</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>11014-0448-1</NDCCode>
    <PackageDescription>2 BAG in 1 CARTON (11014-0448-1)  / 7500 CAPSULE in 1 BAG</PackageDescription>
    <NDC11Code>11014-0448-01</NDC11Code>
    <ProductNDC>11014-0448</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Voclosporin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <StartMarketingDate>20231118</StartMarketingDate>
    <MarketingCategoryName>EXPORT ONLY</MarketingCategoryName>
    <LabelerName>Catalent Pharma Solutions, LLC</LabelerName>
    <SubstanceName>VOCLOSPORIN</SubstanceName>
    <StrengthNumber>7.9</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-05-04</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>18-NOV-23</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>11014-0480-1</NDCCode>
    <PackageDescription>2 BAG in 1 CARTON (11014-0480-1)  &gt; 7500 CAPSULE in 1 BAG</PackageDescription>
    <NDC11Code>11014-0480-01</NDC11Code>
    <ProductNDC>11014-0480</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Voclosporin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <StartMarketingDate>20220504</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Catalent Pharma Solutions, LLC</LabelerName>
    <SubstanceName>VOCLOSPORIN</SubstanceName>
    <StrengthNumber>7.9</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>04-MAY-22</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>58118-7500-8</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (58118-7500-8) </PackageDescription>
    <NDC11Code>58118-7500-08</NDC11Code>
    <ProductNDC>58118-7500</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ondansetron Hydrochloride</ProprietaryName>
    <NonProprietaryName>Ondansetron Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20181213</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078539</ApplicationNumber>
    <LabelerName>Clinical Solutions Wholesale, LLC</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>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181213</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: 1 highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m 2, 2 initial and repeat courses of moderately emetogenic cancer chemotherapy , 3 radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen .</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. 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>81298-7500-1</NDCCode>
    <PackageDescription>1 VIAL, GLASS in 1 CARTON (81298-7500-1)  / 20 mL in 1 VIAL, GLASS</PackageDescription>
    <NDC11Code>81298-7500-01</NDC11Code>
    <ProductNDC>81298-7500</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methadone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Methadone Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20250628</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208306</ApplicationNumber>
    <LabelerName>Long Grove Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>METHADONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/20mL</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-08-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250628</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Methadone Hydrochloride Injection is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.Limitations of UseBecause of the risks of addiction, abuse, and misuse overdose, and death, which can occur at any dosage or duration (see WARNINGS), and persist over the course of therapy, reserve opioid analgesics, including Methadone Hydrochloride Injection, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.Methadone Hydrochloride Injection is not indicated as an as-needed (prn) analgesic. For use in temporary treatment of opioid dependence in patients unable to take oral medication.Limitations of UseInjectable methadone products are not approved for the outpatient treatment of opioid dependence. In this patient population, parenteral methadone is to be used only for patients unable to take oral medication, such as hospitalized patients.</IndicationAndUsage>
    <Description>Methadone Hydrochloride Injection USP, 10 mg/mL is an opioid analgesic for parenteral use (intravenous, intramuscular or subcutaneous use). Methadone Hydrochloride Injection USP, 10 mg/mL contains methadone hydrochloride as the active pharmaceutical ingredient. Methadone hydrochloride is a white, crystalline material that is water-soluble. Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-hepatanone hydrochloride. Its molecular formula is C21H27NOHCl and it has a molecular weight of 345.91. Methadone hydrochloride has a melting point of 235°C, and a pKa of 8.25 in water at 20°C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5. Methadone hydrochloride has the following structural formula:. Methadone Hydrochloride Injection is a sterile injectable solution available in 20 mL multiple-dose vials. Each mL of the Methadone Hydrochloride Injection contains: 10 mg of methadone hydrochloride (equivalent to 8.95 mg of methadone free base), 5 mg of chlorobutanol, as a preservative, 9 mg of sodium chloride, as tonicity agent, and hydrochloric acid and sodium hydroxide as pH adjusters, in water for injection. The pH of the sterile injectable solution is between 3.0 to 6.5.</Description>
  </NDC>
  <NDC>
    <NDCCode>0066-7500-04</NDCCode>
    <PackageDescription>118 mL in 1 BOTTLE, PLASTIC (0066-7500-04)</PackageDescription>
    <NDC11Code>00066-7500-04</NDC11Code>
    <ProductNDC>0066-7500</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Klaron</ProprietaryName>
    <NonProprietaryName>Sulfacetamide Sodium</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>19961223</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019931</ApplicationNumber>
    <LabelerName>Dermik Laboratories</LabelerName>
    <SubstanceName>SULFACETAMIDE SODIUM</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2014-05-12</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0113-7500-01</NDCCode>
    <PackageDescription>20 BLISTER PACK in 1 CARTON (0113-7500-01)  &gt; 1 TABLET, CHEWABLE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00113-7500-01</NDC11Code>
    <ProductNDC>0113-7500</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Basic Care Childrens Allergy Relief</ProprietaryName>
    <NonProprietaryName>Loratadine</NonProprietaryName>
    <DosageFormName>TABLET, CHEWABLE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190731</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210033</ApplicationNumber>
    <LabelerName>L. Perrigo Company</LabelerName>
    <SubstanceName>LORATADINE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-11-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190731</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0113-7500-49</NDCCode>
    <PackageDescription>40 BLISTER PACK in 1 CARTON (0113-7500-49)  &gt; 1 TABLET, CHEWABLE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00113-7500-49</NDC11Code>
    <ProductNDC>0113-7500</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Basic Care Childrens Allergy Relief</ProprietaryName>
    <NonProprietaryName>Loratadine</NonProprietaryName>
    <DosageFormName>TABLET, CHEWABLE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190731</StartMarketingDate>
    <EndMarketingDate>20230228</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210033</ApplicationNumber>
    <LabelerName>L. Perrigo Company</LabelerName>
    <SubstanceName>LORATADINE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-03-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20190731</StartMarketingDatePackage>
    <EndMarketingDatePackage>20230228</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0264-7500-00</NDCCode>
    <PackageDescription>12 CONTAINER in 1 CASE (0264-7500-00)  / 1000 mL in 1 CONTAINER</PackageDescription>
    <NDC11Code>00264-7500-00</NDC11Code>
    <ProductNDC>0264-7500</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lactated Ringers</ProprietaryName>
    <NonProprietaryName>Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20230301</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019632</ApplicationNumber>
    <LabelerName>B. Braun Medical Inc.</LabelerName>
    <SubstanceName>CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE</SubstanceName>
    <StrengthNumber>.02; .03; .6; .31</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
    <Pharm_Classes>Acidifying Activity [MoA], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-05-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230301</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lactated Ringer’s Injection is indicated for use as a source of water and electrolytes or as an alkalinizing agent in adults and pediatric patients.</IndicationAndUsage>
    <Description>Lactated Ringer’s Injection USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in a single-dose container intended for intravenous administration. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1. Table 1. The chemical name, structural formula, and molecular weight of the active ingredients are shown in Table 2. Table 2. Not made with natural rubber latex, PVC or DEHP. The plastic container is made from a multilayered film developed for parenteral drugs. It contains no plasticizers and has minimal leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. The closure system has two ports; the one for the administration set has a tamper evident foil cover and the other is a medication addition site [see Dosage and Administration (2.3)].</Description>
  </NDC>
  <NDC>
    <NDCCode>0264-7500-10</NDCCode>
    <PackageDescription>24 CONTAINER in 1 CASE (0264-7500-10)  / 500 mL in 1 CONTAINER</PackageDescription>
    <NDC11Code>00264-7500-10</NDC11Code>
    <ProductNDC>0264-7500</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lactated Ringers</ProprietaryName>
    <NonProprietaryName>Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20230301</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019632</ApplicationNumber>
    <LabelerName>B. Braun Medical Inc.</LabelerName>
    <SubstanceName>CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE</SubstanceName>
    <StrengthNumber>.02; .03; .6; .31</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
    <Pharm_Classes>Acidifying Activity [MoA], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-05-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230301</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lactated Ringer’s Injection is indicated for use as a source of water and electrolytes or as an alkalinizing agent in adults and pediatric patients.</IndicationAndUsage>
    <Description>Lactated Ringer’s Injection USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in a single-dose container intended for intravenous administration. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1. Table 1. The chemical name, structural formula, and molecular weight of the active ingredients are shown in Table 2. Table 2. Not made with natural rubber latex, PVC or DEHP. The plastic container is made from a multilayered film developed for parenteral drugs. It contains no plasticizers and has minimal leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. The closure system has two ports; the one for the administration set has a tamper evident foil cover and the other is a medication addition site [see Dosage and Administration (2.3)].</Description>
  </NDC>
  <NDC>
    <NDCCode>0363-7500-50</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (0363-7500-50)  / 3.5 g in 1 TUBE</PackageDescription>
    <NDC11Code>00363-7500-50</NDC11Code>
    <ProductNDC>0363-7500</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Walgreens Sodium Chloride Ophthalmic 5 Percent Hypertonicity Eye</ProprietaryName>
    <NonProprietaryName>Sodium Chloride</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20190401</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M018</ApplicationNumber>
    <LabelerName>Walgreen Company</LabelerName>
    <SubstanceName>SODIUM CHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-04-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage> For the temporary relief of corneal edema.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0463-7500-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (0463-7500-01)</PackageDescription>
    <NDC11Code>00463-7500-01</NDC11Code>
    <ProductNDC>0463-7500</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phendimetrazine Tartrate</ProprietaryName>
    <NonProprietaryName>Phendimetrazine Tartrate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20000329</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA089452</ApplicationNumber>
    <LabelerName>C.O. Truxton, Inc.</LabelerName>
    <SubstanceName>PHENDIMETRAZINE TARTRATE</SubstanceName>
    <StrengthNumber>35</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
    <DEASchedule>CIII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2018-09-15</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>0463-7500-10</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE, PLASTIC (0463-7500-10)</PackageDescription>
    <NDC11Code>00463-7500-10</NDC11Code>
    <ProductNDC>0463-7500</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phendimetrazine Tartrate</ProprietaryName>
    <NonProprietaryName>Phendimetrazine Tartrate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20000329</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA089452</ApplicationNumber>
    <LabelerName>C.O. Truxton, Inc.</LabelerName>
    <SubstanceName>PHENDIMETRAZINE TARTRATE</SubstanceName>
    <StrengthNumber>35</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
    <DEASchedule>CIII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2018-09-15</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>0498-7500-50</NDCCode>
    <PackageDescription>250 BOX in 1 BOX (0498-7500-50)  &gt; 125 BOX in 1 BOX (0498-7500-25)  &gt; 50 PACKET in 1 BOX (0498-7500-10)  &gt; 2 TABLET in 1 PACKET (0498-7500-01)</PackageDescription>
    <NDC11Code>00498-7500-50</NDC11Code>
    <ProductNDC>0498-7500</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cedaprin</ProprietaryName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120307</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA079129</ApplicationNumber>
    <LabelerName>North Safety Products LLC</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-12-13</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>0536-7500-01</NDCCode>
    <PackageDescription>.4 mL in 1 POUCH (0536-7500-01)</PackageDescription>
    <NDC11Code>00536-7500-01</NDC11Code>
    <ProductNDC>0536-7500</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Alcohol Prep Pad</ProprietaryName>
    <NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
    <DosageFormName>SWAB</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20150102</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Rugby Laboratories</LabelerName>
    <SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
    <StrengthNumber>.7</StrengthNumber>
    <StrengthUnit>mL/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-13</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>0904-7500-04</NDCCode>
    <PackageDescription>30 BLISTER PACK in 1 CARTON (0904-7500-04)  / 1 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00904-7500-04</NDC11Code>
    <ProductNDC>0904-7500</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nebivolol</ProprietaryName>
    <NonProprietaryName>Nebivolol</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260514</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212682</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <SubstanceName>NEBIVOLOL</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260514</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Nebivolol is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).</IndicationAndUsage>
    <Description>The chemical name for the active ingredient in nebivolol tablets (nebivolol) tablets is (1RS,1’RS)-1,1’-[(2RS,2’SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]- 2,2’-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C22H25F2NO4HCl) with the following structural formula. Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene. Nebivolol tablets for oral administration contain nebivolol hydrochloride equivalent to 2.5 mg, 5 mg, 10 mg, and 20 mg of nebivolol base. In addition, nebivolol tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80, pregelatinized starch, sodium lauryl sulfate, D&amp;C Red No. 27 Aluminum Lake (10 mg), FD&amp;C Blue No. 2 Aluminum Lake (2.5 mg and 20 mg), and FD&amp;C Yellow No. 6 Aluminum Lake (5 mg).</Description>
  </NDC>
  <NDC>
    <NDCCode>10006-002-04</NDCCode>
    <PackageDescription>7500 L in 1 CYLINDER (10006-002-04)</PackageDescription>
    <NDC11Code>10006-0002-04</NDC11Code>
    <ProductNDC>10006-002</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nitrous Oxide</ProprietaryName>
    <NonProprietaryName>Nitrous Oxide</NonProprietaryName>
    <DosageFormName>GAS</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>19360101</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
    <LabelerName>Acetylene Oxygen Company</LabelerName>
    <SubstanceName>NITROUS OXIDE</SubstanceName>
    <StrengthNumber>99</StrengthNumber>
    <StrengthUnit>L/100L</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>11014-0220-2</NDCCode>
    <PackageDescription>2 BAG in 1 CARTON (11014-0220-2)  / 7500 CAPSULE in 1 BAG</PackageDescription>
    <NDC11Code>11014-0220-02</NDC11Code>
    <ProductNDC>11014-0220</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Advil Rf</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <StartMarketingDate>20170310</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Catalent Pharma Solutions, LLC</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-05-04</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>10-MAR-17</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>24794-300-01</NDCCode>
    <PackageDescription>30 mL in 1 JAR (24794-300-01) </PackageDescription>
    <NDC11Code>24794-0300-01</NDC11Code>
    <ProductNDC>24794-300</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hemostatic Solution</ProprietaryName>
    <NonProprietaryName>Aluminum Chloride</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20130115</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Crosstex International Inc.</LabelerName>
    <SubstanceName>ALUMINUM CHLORIDE</SubstanceName>
    <StrengthNumber>7500</StrengthNumber>
    <StrengthUnit>mg/30mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-02-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>25000-021-21</NDCCode>
    <PackageDescription>4 BAG in 1 BOX (25000-021-21)  &gt; 7500 CAPSULE, LIQUID FILLED in 1 BAG</PackageDescription>
    <NDC11Code>25000-0021-21</NDC11Code>
    <ProductNDC>25000-021</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Loratadine</ProprietaryName>
    <NonProprietaryName>Loratadine</NonProprietaryName>
    <DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20161001</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206214</ApplicationNumber>
    <LabelerName>MARKSANS PHARMA LIMITED</LabelerName>
    <SubstanceName>LORATADINE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2021-11-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies.  runny nose.  itchy, watery eyes.  sneezing.  itching of the nose or throat.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>25000-138-21</NDCCode>
    <PackageDescription>4 BAG in 1 BOX (25000-138-21)  / 7500 TABLET in 1 BAG</PackageDescription>
    <NDC11Code>25000-0138-21</NDC11Code>
    <ProductNDC>25000-138</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Naproxen</ProprietaryName>
    <NonProprietaryName>Naproxen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110228</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091416</ApplicationNumber>
    <LabelerName>MARKSANS PHARMA LIMITED</LabelerName>
    <SubstanceName>NAPROXEN</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110228</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Naproxen Tablets are indicated for. the relief of the signs and symptoms of. ·         rheumatoid arthritis. ·         osteoarthritis. ·         ankylosing spondylitis. ·         Polyarticular Juvenile Idiopathic Arthritis. ·         tendonitis. ·         bursitis. ·         acute gout. the management of. ·         pain. ·         primary dysmenorrhea.</IndicationAndUsage>
    <Description>Naproxen Tablets, USP is nonsteroidal anti-inflammatory drug productavailable as follows: White tablets containing 250 mg, 375 mg and 500 mg of naproxen for oral administration. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen, USP is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen, USP has the following structural formula:.                                          Molecular Formula:     C14H14O3.                                          MW = 230.26. Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8.The inactive ingredients in naproxen tablets include: croscarmellose sodium, povidone and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>25000-138-31</NDCCode>
    <PackageDescription>6 BAG in 1 BOX (25000-138-31)  / 7500 TABLET in 1 BAG</PackageDescription>
    <NDC11Code>25000-0138-31</NDC11Code>
    <ProductNDC>25000-138</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Naproxen</ProprietaryName>
    <NonProprietaryName>Naproxen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110228</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091416</ApplicationNumber>
    <LabelerName>MARKSANS PHARMA LIMITED</LabelerName>
    <SubstanceName>NAPROXEN</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110228</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Naproxen Tablets are indicated for. the relief of the signs and symptoms of. ·         rheumatoid arthritis. ·         osteoarthritis. ·         ankylosing spondylitis. ·         Polyarticular Juvenile Idiopathic Arthritis. ·         tendonitis. ·         bursitis. ·         acute gout. the management of. ·         pain. ·         primary dysmenorrhea.</IndicationAndUsage>
    <Description>Naproxen Tablets, USP is nonsteroidal anti-inflammatory drug productavailable as follows: White tablets containing 250 mg, 375 mg and 500 mg of naproxen for oral administration. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen, USP is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen, USP has the following structural formula:.                                          Molecular Formula:     C14H14O3.                                          MW = 230.26. Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8.The inactive ingredients in naproxen tablets include: croscarmellose sodium, povidone and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>29336-750-75</NDCCode>
    <PackageDescription>7500 mg in 1 BOTTLE, PUMP (29336-750-75)</PackageDescription>
    <NDC11Code>29336-0750-75</NDC11Code>
    <ProductNDC>29336-750</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zyclara</ProprietaryName>
    <NonProprietaryName>Imiquimod</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20111015</StartMarketingDate>
    <EndMarketingDate>20150131</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022483</ApplicationNumber>
    <LabelerName>Graceway Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>IMIQUIMOD</SubstanceName>
    <StrengthNumber>3.75</StrengthNumber>
    <StrengthUnit>mg/100mg</StrengthUnit>
    <Pharm_Classes>Increased Cytokine Activity [PE],Increased Cytokine Production [PE],Interferon Inducers [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2015-02-06</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>42658-154-07</NDCCode>
    <PackageDescription>7500 mg in 1 BOTTLE (42658-154-07) </PackageDescription>
    <NDC11Code>42658-0154-07</NDC11Code>
    <ProductNDC>42658-154</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Olanzapine</ProprietaryName>
    <NonProprietaryName>Olanzapine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206924</ApplicationNumber>
    <LabelerName>Hisun Pharmaceuticals USA, Inc.</LabelerName>
    <SubstanceName>OLANZAPINE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/15mg</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-05-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Olanzapine, USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)- 10H-thieno[2,3- b] [1,5]benzodiazepine. The molecular formula is C 17H 20N 4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine Tablets, USP are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 mcmol), 5 mg (16 mcmol), 7.5 mg (24 mcmol), 10 mg (32 mcmol), 15 mg (48 mcmol), or 20 mg (64 mcmol). Inactive ingredients are lactose monohydrate, maize starch, colloidal silicon dioxide, magnesium stearate, crospovidone, microcrystalline cellulose and talc. Olanzapine orally disintegrating tablets are intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 mcmol), 10 mg (32 mcmol), 15 mg (48 mcmol) or 20 mg (64 mcmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets also contain the following inactive ingredients: aspartame, lactose monohydrate, maize starch, colloidal silicon dioxide, magnesium stearate, crospovidone, microcrystalline cellulose and talc. Olanzapine orally disintegrating tablets meet USP Disintegration Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>42658-158-07</NDCCode>
    <PackageDescription>7500 mg in 1 BOTTLE (42658-158-07) </PackageDescription>
    <NDC11Code>42658-0158-07</NDC11Code>
    <ProductNDC>42658-158</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Olanzapine</ProprietaryName>
    <NonProprietaryName>Olanzapine</NonProprietaryName>
    <DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206892</ApplicationNumber>
    <LabelerName>Hisun Pharmaceuticals USA, Inc.</LabelerName>
    <SubstanceName>OLANZAPINE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/15mg</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-05-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Olanzapine, USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)- 10H-thieno[2,3- b] [1,5]benzodiazepine. The molecular formula is C 17H 20N 4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine Tablets, USP are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 mcmol), 5 mg (16 mcmol), 7.5 mg (24 mcmol), 10 mg (32 mcmol), 15 mg (48 mcmol), or 20 mg (64 mcmol). Inactive ingredients are lactose monohydrate, maize starch, colloidal silicon dioxide, magnesium stearate, crospovidone, microcrystalline cellulose and talc. Olanzapine orally disintegrating tablets are intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 mcmol), 10 mg (32 mcmol), 15 mg (48 mcmol) or 20 mg (64 mcmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets also contain the following inactive ingredients: aspartame, lactose monohydrate, maize starch, colloidal silicon dioxide, magnesium stearate, crospovidone, microcrystalline cellulose and talc. Olanzapine orally disintegrating tablets meet USP Disintegration Test 2.</Description>
  </NDC>
</NDCList>
                    
<NDCList><NDC><NDCCode>51885-7500-9</NDCCode><ProprietaryName>Vinceel</ProprietaryName><NonProprietaryName>Apis Mellifera And Cynanchum Vincetoxicum Leaf And Atropa Belladonna And Calendula Officinalis Flowering Top And Echinacea Purpurea And Phytolacca Americana Root And Plantago Major And Sage</NonProprietaryName></NDC><NDC><NDCCode>51885-3260-9</NDCCode><ProprietaryName>Sinusin</ProprietaryName><NonProprietaryName>Silver Nitrate, Euphorbia Resinifera Resin, Calcium Sulfide, Luffa Operculata Fruit, Mercuric Iodide, Sus Scrofa Nasal Mucosa, Pulsatilla Vulgaris And Sinusitisinum</NonProprietaryName></NDC><NDC><NDCCode>52483-0100-0</NDCCode><NonProprietaryName>Temozolomide</NonProprietaryName></NDC><NDC><NDCCode>71399-7500-9</NDCCode><ProprietaryName>Clopidogrel Bisulfate</ProprietaryName><NonProprietaryName>Clopidogrel Bisulfate</NonProprietaryName></NDC><NDC><NDCCode>0069-0206-02</NDCCode><ProprietaryName>Fragmin</ProprietaryName><NonProprietaryName>Dalteparin Sodium</NonProprietaryName></NDC><NDC><NDCCode>11014-0436-2</NDCCode><NonProprietaryName>Voclosporin</NonProprietaryName></NDC><NDC><NDCCode>11014-0448-1</NDCCode><NonProprietaryName>Voclosporin</NonProprietaryName></NDC><NDC><NDCCode>11014-0480-1</NDCCode><NonProprietaryName>Voclosporin</NonProprietaryName></NDC><NDC><NDCCode>58118-7500-8</NDCCode><ProprietaryName>Ondansetron Hydrochloride</ProprietaryName><NonProprietaryName>Ondansetron Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>81298-7500-1</NDCCode><ProprietaryName>Methadone Hydrochloride</ProprietaryName><NonProprietaryName>Methadone Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0066-7500-04</NDCCode><ProprietaryName>Klaron</ProprietaryName><NonProprietaryName>Sulfacetamide Sodium</NonProprietaryName></NDC><NDC><NDCCode>0113-7500-01</NDCCode><ProprietaryName>Basic Care Childrens Allergy Relief</ProprietaryName><NonProprietaryName>Loratadine</NonProprietaryName></NDC><NDC><NDCCode>0113-7500-49</NDCCode><ProprietaryName>Basic Care Childrens Allergy Relief</ProprietaryName><NonProprietaryName>Loratadine</NonProprietaryName></NDC><NDC><NDCCode>0264-7500-00</NDCCode><ProprietaryName>Lactated Ringers</ProprietaryName><NonProprietaryName>Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride</NonProprietaryName></NDC><NDC><NDCCode>0264-7500-10</NDCCode><ProprietaryName>Lactated Ringers</ProprietaryName><NonProprietaryName>Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride</NonProprietaryName></NDC><NDC><NDCCode>0363-7500-50</NDCCode><ProprietaryName>Walgreens Sodium Chloride Ophthalmic 5 Percent Hypertonicity Eye</ProprietaryName><NonProprietaryName>Sodium Chloride</NonProprietaryName></NDC><NDC><NDCCode>0463-7500-01</NDCCode><ProprietaryName>Phendimetrazine Tartrate</ProprietaryName><NonProprietaryName>Phendimetrazine Tartrate</NonProprietaryName></NDC><NDC><NDCCode>0463-7500-10</NDCCode><ProprietaryName>Phendimetrazine Tartrate</ProprietaryName><NonProprietaryName>Phendimetrazine Tartrate</NonProprietaryName></NDC><NDC><NDCCode>0498-7500-50</NDCCode><ProprietaryName>Cedaprin</ProprietaryName><NonProprietaryName>Ibuprofen</NonProprietaryName></NDC><NDC><NDCCode>0536-7500-01</NDCCode><ProprietaryName>Alcohol Prep Pad</ProprietaryName><NonProprietaryName>Isopropyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>0904-7500-04</NDCCode><ProprietaryName>Nebivolol</ProprietaryName><NonProprietaryName>Nebivolol</NonProprietaryName></NDC><NDC><NDCCode>10006-002-04</NDCCode><ProprietaryName>Nitrous Oxide</ProprietaryName><NonProprietaryName>Nitrous Oxide</NonProprietaryName></NDC><NDC><NDCCode>11014-0220-2</NDCCode><NonProprietaryName>Advil Rf</NonProprietaryName></NDC><NDC><NDCCode>24794-300-01</NDCCode><ProprietaryName>Hemostatic Solution</ProprietaryName><NonProprietaryName>Aluminum Chloride</NonProprietaryName></NDC><NDC><NDCCode>25000-021-21</NDCCode><ProprietaryName>Loratadine</ProprietaryName><NonProprietaryName>Loratadine</NonProprietaryName></NDC><NDC><NDCCode>25000-138-21</NDCCode><ProprietaryName>Naproxen</ProprietaryName><NonProprietaryName>Naproxen</NonProprietaryName></NDC><NDC><NDCCode>25000-138-31</NDCCode><ProprietaryName>Naproxen</ProprietaryName><NonProprietaryName>Naproxen</NonProprietaryName></NDC><NDC><NDCCode>29336-750-75</NDCCode><ProprietaryName>Zyclara</ProprietaryName><NonProprietaryName>Imiquimod</NonProprietaryName></NDC><NDC><NDCCode>42658-154-07</NDCCode><ProprietaryName>Olanzapine</ProprietaryName><NonProprietaryName>Olanzapine</NonProprietaryName></NDC><NDC><NDCCode>42658-158-07</NDCCode><ProprietaryName>Olanzapine</ProprietaryName><NonProprietaryName>Olanzapine</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

DataLabs Coding Library - Quering NPI Registry - REST API Examples

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

Output

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
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      "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 ...
            
        

Full Text Search Fundamentals

Facts

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

How does it work

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

Full Text Search & DataLabs REST API

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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