RESTful Lookup — Test-Drive (2007 – 2026)

Query complete (39 ms elapsed)

{
  "NDC": [
    {
      "NDCCode": "77153-100-67",
      "PackageDescription": "200 mL in 1 BOTTLE, PLASTIC (77153-100-67) ",
      "NDC11Code": "77153-0100-67",
      "ProductNDC": "77153-100",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hand Sanitizer",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200330",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Yahara Bay Distillers, Inc.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "80",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2021-07-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200330",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "77153-100-25",
      "PackageDescription": "750 mL in 1 BOTTLE, PLASTIC (77153-100-25) ",
      "NDC11Code": "77153-0100-25",
      "ProductNDC": "77153-100",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hand Sanitizer",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200330",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Yahara Bay Distillers, Inc.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "80",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2021-07-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200330",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "77153-100-60",
      "PackageDescription": "60 mL in 1 BOTTLE, SPRAY (77153-100-60) ",
      "NDC11Code": "77153-0100-60",
      "ProductNDC": "77153-100",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hand Sanitizer",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200330",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Yahara Bay Distillers, Inc.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "80",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2021-07-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200330",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0409-7100-67",
      "PackageDescription": "10 POUCH in 1 CASE (0409-7100-67)  / 5 BAG in 1 POUCH / 100 mL in 1 BAG (0409-7100-69) ",
      "NDC11Code": "00409-7100-67",
      "ProductNDC": "0409-7100",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dextrose",
      "NonProprietaryName": "Dextrose Monohydrate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20050627",
      "EndMarketingDate": "20261130",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019466",
      "LabelerName": "Hospira, Inc.",
      "SubstanceName": "DEXTROSE MONOHYDRATE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2026-06-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20050914",
      "EndMarketingDatePackage": "20261130",
      "SamplePackage": "N",
      "IndicationAndUsage": "Dextrose Injection (5%) is indicated as a source of water and calories in adult and pediatric patients and may also be used as a diluent for reconstitution of a powder or liquid drug product.",
      "Description": "Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6  H2O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula. Water for Injection, USP is chemically designated H2O. Dextrose Injection, USP (5%) is a clear, sterile, non-pyrogenic solutions of Dextrose, USP in Water for Injection in a polyvinylchloride flexible plastic container for intravenous administration after admixture with a single-dose powdered or liquid (up to 10 mL) drug vial [see Dosage and Administration (2.1)]. Partial-fill containers, designed to facilitate admixture, are available in 50 mL, 100 mL, and 250 mL sizes. See Table 1 for the content and characteristics of this solution. The solution contains no bacteriostatic, antimicrobial agent or added buffer and is supplied as single-dose containers. The pH is 4.3 (range is 3.2 to 6.5). Dextrose is derived from corn. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period."
    },
    {
      "NDCCode": "0409-7101-67",
      "PackageDescription": "10 POUCH in 1 CASE (0409-7101-67)  / 5 BAG in 1 POUCH / 100 mL in 1 BAG (0409-7101-69) ",
      "NDC11Code": "00409-7101-67",
      "ProductNDC": "0409-7101",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Chloride",
      "NonProprietaryName": "Sodium Chloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20050630",
      "EndMarketingDate": "20261231",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019465",
      "LabelerName": "Hospira, Inc.",
      "SubstanceName": "SODIUM CHLORIDE",
      "StrengthNumber": "900",
      "StrengthUnit": "mg/100mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-05-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20050824",
      "EndMarketingDatePackage": "20261231",
      "SamplePackage": "N",
      "IndicationAndUsage": "Intravenous solutions containing sodium chloride are indicated for parenteral replenishment of fluid and sodium chloride as required by the clinical condition of the patient. In this dosage form, Sodium Chloride Injection, USP is intended to be used as a diluent for the contents of an ADD-Vantage vial, or single-dose vials with 20 mm closure using the ADD-Vantage ADDAPTOR.",
      "Description": "Sodium Chloride Injection, USP solutions are sterile and nonpyrogenic. They are parenteral solutions containing various concentrations of sodium chloride in water for injection intended for intravenous administration after admixing with an ADD-Vantage vial, or single-dose powdered drug vials with 20 mm closure using the ADD-Vantage ADDAPTOR (WARNING: DO NOT USE WITH CHEMOTHERAPY AGENTS). Each 100 mL of 0.45% Sodium Chloride Injection, USP contains 450 mg sodium chloride in water for injection. Electrolytes per 1000 mL: sodium 77 mEq; chloride 77 mEq. The osmolarity is 154 mOsmol/L (calc.), which is hypotonic. Each 100 mL of 0.9% Sodium Chloride Injection, USP contains 900 mg sodium chloride in water for injection. Electrolytes per 1000 mL: sodium 154 mEq; chloride 154 mEq. The osmolarity is 308 mOsmol/L (calc.), which is isotonic. The pH for both concentrations is 5.6 (4.5 to 7.0). The solutions contain no bacteriostat, antimicrobial agent or added buffer and each is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded. The solutions are parenteral fluid and electrolyte replenishers. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period."
    },
    {
      "NDCCode": "0409-7132-67",
      "PackageDescription": "10 POUCH in 1 CASE (0409-7132-67)  > 5 BAG in 1 POUCH > 100 mL in 1 BAG (0409-7132-69) ",
      "NDC11Code": "00409-7132-67",
      "ProductNDC": "0409-7132",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Chloride",
      "NonProprietaryName": "Sodium Chloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20050913",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019759",
      "LabelerName": "Hospira, Inc.",
      "SubstanceName": "SODIUM CHLORIDE",
      "StrengthNumber": "450",
      "StrengthUnit": "mg/100mL",
      "Pharm_Classes": "Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-10-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20051115",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "25021-132-67",
      "PackageDescription": "24 POUCH in 1 CARTON (25021-132-67)  > 1 BAG in 1 POUCH > 100 mL in 1 BAG",
      "NDC11Code": "25021-0132-67",
      "ProductNDC": "25021-132",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levofloxacin",
      "NonProprietaryName": "Levofloxacin",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20130715",
      "EndMarketingDate": "20200930",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090343",
      "LabelerName": "Sagent Pharmaceuticals",
      "SubstanceName": "LEVOFLOXACIN",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20130715",
      "EndMarketingDatePackage": "20190831",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "25021-826-67",
      "PackageDescription": "1 BAG in 1 CARTON (25021-826-67)  > 100 mL in 1 BAG",
      "NDC11Code": "25021-0826-67",
      "ProductNDC": "25021-826",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Zoledronic Acid",
      "NonProprietaryName": "Zoledronic Acid",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20150901",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA203231",
      "LabelerName": "Sagent Pharmaceuticals",
      "SubstanceName": "ZOLEDRONIC ACID",
      "StrengthNumber": ".04",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Bisphosphonate [EPC], Diphosphonates [CS]",
      "Status": "Active",
      "LastUpdate": "2022-03-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20150901",
      "SamplePackage": "N",
      "IndicationAndUsage": "Zoledronic Acid Injection is a bisphosphonate indicated for the treatment of: : 1 Hypercalcemia of malignancy. (1.1) , 2 Patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy. (1.2) .",
      "Description": "Zoledronic Acid Injection contains zoledronic acid, a bisphosphonic acid which is an inhibitor of osteoclastic bone resorption. Zoledronic acid monohydrate is designated chemically as (1-Hydroxy-2-imidazol-1-yl-phosphonoethyl) phosphonic acid monohydrate and its structural formula is as following:. Zoledronic acid monohydrate is a white crystalline powder. Its molecular formula is C5H10N2O7P2H2O and its molar mass is 290.1g/mol. Zoledronic acid monohydrate is highly soluble in 0.1N sodium hydroxide solution, sparingly soluble in water and 0.1N hydrochloric acid, and practically insoluble in organic solvents. The pH of a 0.7% solution of zoledronic acid in water is approximately 2.0. Zoledronic Acid Injection is available in bags as a sterile liquid solution for intravenous infusion. Each 100 mL bag contains 4.264 mg of zoledronic acid monohydrate (equivalent to 4 mg zoledronic acid on an anhydrous basis), 900 mg of sodium chloride, USP, 220 mg of mannitol, USP, water for injection q.s. and 24 mg of sodium citrate to adjust pH. The pH of the solution is approximately 5.5 to 6.5."
    },
    {
      "NDCCode": "62391-100-02",
      "PackageDescription": "67.5 g in 1 JAR (62391-100-02) ",
      "NDC11Code": "62391-0100-02",
      "ProductNDC": "62391-100",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Bioflexor",
      "ProprietaryNameSuffix": "04",
      "NonProprietaryName": "Menthol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "19980301",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "Health Care Laboratories Inc.",
      "SubstanceName": "MENTHOL",
      "StrengthNumber": "3",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2024-07-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "19980301",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporarily relieves the minor aches and pains of muscles and joints associated with: 1 simple backache, 2 arthritis, 3 strains, 4 bruises, 5 sprains."
    },
    {
      "NDCCode": "63323-269-67",
      "PackageDescription": "10 VIAL in 1 BOX (63323-269-67)  / 100 mL in 1 VIAL (63323-269-21) ",
      "NDC11Code": "63323-0269-67",
      "ProductNDC": "63323-269",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Diprivan",
      "NonProprietaryName": "Propofol",
      "DosageFormName": "INJECTION, EMULSION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20091117",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019627",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "PROPOFOL",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "General Anesthesia [PE], General Anesthetic [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-09-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20091117",
      "SamplePackage": "N",
      "IndicationAndUsage": "DIPRIVAN is an intravenous general anesthetic and sedation drug indicated for: 1 Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age, 2 Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age, 3 Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients, 4 Sedation for Adult Patients in Combination with Regional Anesthesia, 5 Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients.",
      "Description": "DIPRIVAN® (propofol) injectable emulsion, USP is an anesthetic available as a sterile, nonpyrogenic white or almost white homogeneous emulsion for intravenous administration. The structural formula is. Chemical name: 2,6 diisopropylphenol. Molecular formula: C12H18O. Molecular weight: 178.27. Propofol is slightly soluble in water. The pKa is 11. The octanol/water partition coefficient for propofol is 6761:1 at a pH of 6 to 8.5. Each mL of DIPRIVAN® (Propofol) injectable emulsion, USP contains 10 mg of propofol, 100 mg of soybean oil (100 mg/mL), 22.5 mg of glycerol (22.5 mg/mL), 12 mg of purified egg phospholipids (12 mg/mL), 0.055 mg of disodium edetate anhydrous (equivalent to 0.055 mg of disodium edetate) (0.05 mg/mL) as microbial inhibitor, and sodium hydroxide to adjust pH, in water for injection. DIPRIVAN is isotonic and has a pH of 7 to 8.5."
    },
    {
      "NDCCode": "63323-270-67",
      "PackageDescription": "10 VIAL in 1 BOX (63323-270-67)  > 100 mL in 1 VIAL",
      "NDC11Code": "63323-0270-67",
      "ProductNDC": "63323-270",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Propofol",
      "NonProprietaryName": "Propofol",
      "DosageFormName": "INJECTION, EMULSION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20091023",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019627",
      "LabelerName": "APP Pharmaceuticals, LLC",
      "SubstanceName": "PROPOFOL",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "General Anesthesia [PE],General Anesthetic [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-05-22",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "63323-285-67",
      "PackageDescription": "12 BOTTLE in 1 CASE (63323-285-67)  / 100 mL in 1 BOTTLE (63323-285-55) ",
      "NDC11Code": "63323-0285-67",
      "ProductNDC": "63323-285",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Naropin",
      "NonProprietaryName": "Ropivacaine Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "EPIDURAL; INFILTRATION",
      "StartMarketingDate": "20090804",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020533",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "ROPIVACAINE HYDROCHLORIDE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2024-08-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20090804",
      "SamplePackage": "N",
      "IndicationAndUsage": "NAROPIN is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration.",
      "Description": "NAROPIN® Injection is a sterile, isotonic solution that contains ropivacaine hydrochloride as the active pharmaceutical ingredient. Ropivacaine hydrochloride is a member of the amino amide class of local anesthetics. NAROPIN® Injection is administered parenterally by for infiltration, epidural, and nerve block. Ropivacaine hydrochloride is chemically described as S-(-)-1-propyl-2',6'-pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder, with the following structural formula:. C17H26N2OHClH2O                     M.W. 328.89. At 25 °C ropivacaine hydrochloride has a solubility of 53.8 mg/mL in water, a distribution ratio between n-octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine. NAROPIN (ropivacaine hydrochloride) injection is a clear, colorless, and preservative-free solution. Each mL contains 2.1 mg, 5.3 mg, 7.9 mg or 10.6 mg ropivacaine hydrochloride monohydrate (equivalent to 2.0 mg, 5.0 mg, 7.5 mg or 10 mg of ropivacaine hydrochloride anhydrous), and 8.6 mg, 8.0 mg, 7.5 mg or 7.1 mg of sodium chloride; respectively, and sodium hydroxide and hydrochloric acid as pH adjusters, in water for injection. The pH is adjusted between 4.0 to 6.0. The specific gravity of NAROPIN Injection solutions range from 1.002 to 1.005 at 25°C."
    },
    {
      "NDCCode": "73069-100-67",
      "PackageDescription": "25 VIAL, MULTI-DOSE in 1 BOX (73069-100-67)  > 30 mL in 1 VIAL, MULTI-DOSE",
      "NDC11Code": "73069-0100-67",
      "ProductNDC": "73069-100",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Viatrexx-connectissue",
      "NonProprietaryName": "Anti-interleukin-1.alpha. Immunoglobulin G Rabbit, Ascorbic Acid, Metenkefalin, Ersofermin, Bos Taurus Cartilage, Sus Scrofa Cartilage, Pork Collagen, Bos Taurus Red Blood Cell, Sus Scrofa Red Blood Cell, Interleukin-3, Interleukin-3, Beef Liver, Pork Liver, Beef, Pork, Bos Taurus Tendon, Sus Scrofa Tendon, Cetermin",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
      "StartMarketingDate": "20190329",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "VIATREXX BIO INCORPORATED",
      "SubstanceName": "ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; ASCORBIC ACID; BOS TAURUS RED BLOOD CELL; METENKEFALIN; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); SUS SCROFA CARTILAGE; PORK COLLAGEN; SUS SCROFA RED BLOOD CELL; INTERLEUKIN-3; BEEF; PORK; BEEF LIVER; PORK LIVER; BOS TAURUS TENDON; SUS SCROFA TENDON; CETERMIN; BOS TAURUS CARTILAGE",
      "StrengthNumber": "201; 31; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201",
      "StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
      "Pharm_Classes": "Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT]",
      "Status": "Deprecated",
      "LastUpdate": "2021-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20190506",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "73962-005-67",
      "PackageDescription": "100 mL in 1 TUBE (73962-005-67) ",
      "NDC11Code": "73962-0005-67",
      "ProductNDC": "73962-005",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ushas Antibacterial Hand Sanitizer",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200713",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Zhejiang USHAS Cosmetics Co.,Ltd",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "72",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2021-11-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200713",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "73962-006-67",
      "PackageDescription": "100 mL in 1 TUBE (73962-006-67) ",
      "NDC11Code": "73962-0006-67",
      "ProductNDC": "73962-006",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hand Sanitizer",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200714",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Zhejiang USHAS Cosmetics Co.,Ltd",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "75",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2021-11-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200714",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "76150-330-67",
      "PackageDescription": "100 mL in 1 BOTTLE, PLASTIC (76150-330-67) ",
      "NDC11Code": "76150-0330-67",
      "ProductNDC": "76150-330",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Coola",
      "ProprietaryNameSuffix": "Spf 50 Classic",
      "NonProprietaryName": "Sunscreen Face Mist",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20211102",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Bell International Laboratories, Inc",
      "SubstanceName": "AVOBENZONE; OCTISALATE; OCTOCRYLENE",
      "StrengthNumber": "2.9; 4.9; 9.5",
      "StrengthUnit": "g/100mL; g/100mL; g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-02-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20211102",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "76309-100-01",
      "PackageDescription": "4.67 g in 1 TUBE (76309-100-01) ",
      "NDC11Code": "76309-0100-01",
      "ProductNDC": "76309-100",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Snugz Spf 30 Soy Lip Balm",
      "NonProprietaryName": "Spf 30 Soy Lip Balm",
      "DosageFormName": "STICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20180101",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "SnugZ/USA, LLC",
      "SubstanceName": "OCTISALATE; OCTOCRYLENE; AVOBENZONE",
      "StrengthNumber": ".23; .37; .14",
      "StrengthUnit": "g/4.67g; g/4.67g; g/4.67g",
      "Status": "Active",
      "LastUpdate": "2025-12-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180101",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "79781-217-02",
      "PackageDescription": "100 PACKAGE in 1 CANISTER (79781-217-02)  > 7.67 mL in 1 PACKAGE",
      "NDC11Code": "79781-0217-02",
      "ProductNDC": "79781-217",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Molecure",
      "ProprietaryNameSuffix": "Skincare Disinfectant Hand And Skin Wet Wipe",
      "NonProprietaryName": "Benzalkonium Chloride, Alcohol",
      "DosageFormName": "CLOTH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20201226",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Molecule Koruyucu Saglik Urunleri Sanayi Ve Ticaret Anonim Sirketi",
      "SubstanceName": "ALCOHOL; BENZALKONIUM CHLORIDE",
      "StrengthNumber": "80; .33",
      "StrengthUnit": "mL/100mL; g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-11-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20201226",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "82757-100-01",
      "PackageDescription": "67 mL in 1 BOTTLE (82757-100-01) ",
      "NDC11Code": "82757-0100-01",
      "ProductNDC": "82757-100",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "The Mug Guard",
      "ProprietaryNameSuffix": "Invisible Sunscreen For Face",
      "NonProprietaryName": "Avobenzone, Homosalate, Octisalate, And Octocrylene",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20220607",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Dune Suncare, Inc.",
      "SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
      "StrengthNumber": "20; 55; 45; 40",
      "StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-06-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20220607",
      "EndMarketingDatePackage": "20240615",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun."
    },
    {
      "NDCCode": "0024-5911-02",
      "PackageDescription": "2 SYRINGE, GLASS in 1 CARTON (0024-5911-02)  / .67 mL in 1 SYRINGE, GLASS (0024-5911-00) ",
      "NDC11Code": "00024-5911-02",
      "ProductNDC": "0024-5911",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dupixent",
      "NonProprietaryName": "Dupilumab",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20211020",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA761055",
      "LabelerName": "Sanofi-Aventis U.S. LLC",
      "SubstanceName": "DUPILUMAB",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/.67mL",
      "Pharm_Classes": "Antibodies, Monoclonal [CS], Interleukin 4 Receptor alpha Antagonists [MoA], Interleukin-4 Receptor alpha Antagonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-08-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20211020",
      "EndMarketingDatePackage": "20260731",
      "SamplePackage": "N",
      "IndicationAndUsage": "DUPIXENT is an interleukin-4 receptor alpha antagonist indicated. Atopic Dermatitis. for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe AD whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids. (1.1). Asthma. as an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma. (1.2)Limitations of Use: Not for the relief of acute bronchospasm or status asthmaticus. (1.2). Chronic Rhinosinusitis with Nasal Polyps. as an add-on maintenance treatment in adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). (1.3). Eosinophilic Esophagitis. for the treatment of adult and pediatric patients aged 1 year and older, weighing at least 15 kg, with eosinophilic esophagitis (EoE). (1.4). Prurigo Nodularis. for the treatment of adult patients with prurigo nodularis (PN). (1.5). Chronic Obstructive Pulmonary Disease. as an add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. (1.6)Limitations of Use: Not for the relief of acute bronchospasm. (1.6). Chronic Spontaneous Urticaria. for the treatment of adult and pediatric patients aged 2 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. (1.7). Limitations of Use: Not indicated for other forms of urticaria. (1.7). Bullous Pemphigoid. for the treatment of adult patients with bullous pemphigoid (BP). (1.8). Allergic Fungal Rhinosinusitis. for the treatment of adult and pediatric patients aged 6 years and older with allergic fungal rhinosinusitis (AFRS) who have a history of sino-nasal surgery. (1.9).",
      "Description": "Dupilumab, an interleukin-4 receptor alpha antagonist, is a human monoclonal antibody of the IgG4 subclass that binds to the IL-4Rα subunit and inhibits IL-4 and IL-13 signaling. Dupilumab has an approximate molecular weight of 147 kDa. Dupilumab is produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. DUPIXENT (dupilumab) Injection is supplied as a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution for subcutaneous injection. DUPIXENT is provided as either a single-dose pre-filled syringe with needle shield or a single-dose pre-filled pen in a siliconized Type-1 clear glass syringe. The needle cap is not made with natural rubber latex. Each 300 mg pre-filled syringe or pre-filled pen delivers 300 mg dupilumab in 2 mL which also contains L-arginine hydrochloride (10.5 mg), L-histidine (6.2 mg), polysorbate 80 (4 mg), sodium acetate (2 mg), sucrose (100 mg), and water for injection, pH 5.9. Each 200 mg pre-filled syringe or pre-filled pen delivers 200 mg dupilumab in 1.14 mL which also contains L-arginine hydrochloride (12 mg), L-histidine (3.5 mg), polysorbate 80 (2.3 mg), sodium acetate (1.2 mg), sucrose (57 mg), and water for injection, pH 5.9."
    },
    {
      "NDCCode": "0024-5911-20",
      "PackageDescription": "2 SYRINGE, GLASS in 1 CARTON (0024-5911-20)  / .67 mL in 1 SYRINGE, GLASS (0024-5911-01) ",
      "NDC11Code": "00024-5911-20",
      "ProductNDC": "0024-5911",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dupixent",
      "NonProprietaryName": "Dupilumab",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20211020",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA761055",
      "LabelerName": "Sanofi-Aventis U.S. LLC",
      "SubstanceName": "DUPILUMAB",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/.67mL",
      "Pharm_Classes": "Antibodies, Monoclonal [CS], Interleukin 4 Receptor alpha Antagonists [MoA], Interleukin-4 Receptor alpha Antagonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-08-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20211020",
      "EndMarketingDatePackage": "20260731",
      "SamplePackage": "N",
      "IndicationAndUsage": "DUPIXENT is an interleukin-4 receptor alpha antagonist indicated. Atopic Dermatitis. for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe AD whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids. (1.1). Asthma. as an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma. (1.2)Limitations of Use: Not for the relief of acute bronchospasm or status asthmaticus. (1.2). Chronic Rhinosinusitis with Nasal Polyps. as an add-on maintenance treatment in adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). (1.3). Eosinophilic Esophagitis. for the treatment of adult and pediatric patients aged 1 year and older, weighing at least 15 kg, with eosinophilic esophagitis (EoE). (1.4). Prurigo Nodularis. for the treatment of adult patients with prurigo nodularis (PN). (1.5). Chronic Obstructive Pulmonary Disease. as an add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. (1.6)Limitations of Use: Not for the relief of acute bronchospasm. (1.6). Chronic Spontaneous Urticaria. for the treatment of adult and pediatric patients aged 2 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. (1.7). Limitations of Use: Not indicated for other forms of urticaria. (1.7). Bullous Pemphigoid. for the treatment of adult patients with bullous pemphigoid (BP). (1.8). Allergic Fungal Rhinosinusitis. for the treatment of adult and pediatric patients aged 6 years and older with allergic fungal rhinosinusitis (AFRS) who have a history of sino-nasal surgery. (1.9).",
      "Description": "Dupilumab, an interleukin-4 receptor alpha antagonist, is a human monoclonal antibody of the IgG4 subclass that binds to the IL-4Rα subunit and inhibits IL-4 and IL-13 signaling. Dupilumab has an approximate molecular weight of 147 kDa. Dupilumab is produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. DUPIXENT (dupilumab) Injection is supplied as a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution for subcutaneous injection. DUPIXENT is provided as either a single-dose pre-filled syringe with needle shield or a single-dose pre-filled pen in a siliconized Type-1 clear glass syringe. The needle cap is not made with natural rubber latex. Each 300 mg pre-filled syringe or pre-filled pen delivers 300 mg dupilumab in 2 mL which also contains L-arginine hydrochloride (10.5 mg), L-histidine (6.2 mg), polysorbate 80 (4 mg), sodium acetate (2 mg), sucrose (100 mg), and water for injection, pH 5.9. Each 200 mg pre-filled syringe or pre-filled pen delivers 200 mg dupilumab in 1.14 mL which also contains L-arginine hydrochloride (12 mg), L-histidine (3.5 mg), polysorbate 80 (2.3 mg), sodium acetate (1.2 mg), sucrose (57 mg), and water for injection, pH 5.9."
    },
    {
      "NDCCode": "0065-0343-02",
      "PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (0065-0343-02)  / 5 mL in 1 BOTTLE, DROPPER",
      "NDC11Code": "00065-0343-02",
      "ProductNDC": "0065-0343",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Phenylephrine Hydrochloride",
      "NonProprietaryName": "Phenylephrine Hydrochloride",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20150115",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA207926",
      "LabelerName": "Alcon Laboratories, Inc.",
      "SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-05-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250430",
      "SamplePackage": "N",
      "IndicationAndUsage": "Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%, is indicated to dilate the pupil.",
      "Description": "Phenylephrine Hydrochloride Ophthalmic Solution, USP is a sterile, clear, colorless to yellow, topical α-adrenergic agonist for ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: (R)-3-hydroxy-α[(methylamino)methyl]benzenemethanol hydrochloride. Molecular Formula: C9H13NO2.HCl. Molecular Weight: 203.67 g/mol. Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% contains: ACTIVE: Phenylephrine Hydrochloride 25 mg (2.5%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 340 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%). Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% contains: ACTIVE: Phenylephrine Hydrochloride 100 mg (10%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 985 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%)."
    },
    {
      "NDCCode": "0065-0349-04",
      "PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (0065-0349-04)  / 15 mL in 1 BOTTLE, DROPPER",
      "NDC11Code": "00065-0349-04",
      "ProductNDC": "0065-0349",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Phenylephrine Hydrochloride",
      "NonProprietaryName": "Phenylephrine Hydrochloride",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20150115",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA207926",
      "LabelerName": "Alcon Laboratories, Inc.",
      "SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-04-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20241028",
      "SamplePackage": "N",
      "IndicationAndUsage": "Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%, is indicated to dilate the pupil.",
      "Description": "Phenylephrine Hydrochloride Ophthalmic Solution, USP is a sterile, clear, colorless to yellow, topical α-adrenergic agonist for ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: (R)-3-hydroxy-α[(methylamino)methyl]benzenemethanol hydrochloride. Molecular Formula: C9H13NO2.HCl. Molecular Weight: 203.67 g/mol. Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% contains: ACTIVE: Phenylephrine Hydrochloride 25 mg (2.5%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 340 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%). Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% contains: ACTIVE: Phenylephrine Hydrochloride 100 mg (10%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 985 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%)."
    },
    {
      "NDCCode": "0065-0349-05",
      "PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (0065-0349-05)  / 2 mL in 1 BOTTLE, DROPPER",
      "NDC11Code": "00065-0349-05",
      "ProductNDC": "0065-0349",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Phenylephrine Hydrochloride",
      "NonProprietaryName": "Phenylephrine Hydrochloride",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20150115",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA207926",
      "LabelerName": "Alcon Laboratories, Inc.",
      "SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-04-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20241028",
      "SamplePackage": "N",
      "IndicationAndUsage": "Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%, is indicated to dilate the pupil.",
      "Description": "Phenylephrine Hydrochloride Ophthalmic Solution, USP is a sterile, clear, colorless to yellow, topical α-adrenergic agonist for ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: (R)-3-hydroxy-α[(methylamino)methyl]benzenemethanol hydrochloride. Molecular Formula: C9H13NO2.HCl. Molecular Weight: 203.67 g/mol. Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% contains: ACTIVE: Phenylephrine Hydrochloride 25 mg (2.5%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 340 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%). Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% contains: ACTIVE: Phenylephrine Hydrochloride 100 mg (10%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 985 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%)."
    },
    {
      "NDCCode": "0093-1177-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE (0093-1177-01) ",
      "NDC11Code": "00093-1177-01",
      "ProductNDC": "0093-1177",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Neomycin Sulfate",
      "NonProprietaryName": "Neomycin Sulfate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19900930",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA060304",
      "LabelerName": "Teva Pharmaceuticals USA, Inc.",
      "SubstanceName": "NEOMYCIN SULFATE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]",
      "Status": "Active",
      "LastUpdate": "2023-03-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19900930",
      "SamplePackage": "N",
      "IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of neomycin sulfate tablets, USP and other antibacterial drugs, neomycin sulfate tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
      "Description": "Neomycin sulfate tablets, USP, for oral administration, contain neomycin which is an antibiotic obtained from the metabolic products of the actinomycete Streptomyces fradiae. Structurally, neomycin sulfate may be represented as follows. C23H46N6O13·2½ H2SO4 MW 614.67. Chemically, it is 0-2,6-diamino-2,6-dideoxy-α-D-glucopyranosyl-(1→3)-0-β-D-ribofuranosyl-(1→5)-0-[2,6-diamino-2,6-dideoxy-α-D-glucopyranosyl-(1→4)]-2-deoxy-D-streptamine. Neomycin B is identical except that the a-D-glucopyranosyl residue in the neobiosamine moiety is β-L-idopyranosyl. Each tablet contains 500 mg neomycin sulfate (equivalent to 350 mg neomycin base). Inactive ingredients: calcium stearate, povidone."
    },
    {
      "NDCCode": "0115-0511-01",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE (0115-0511-01) ",
      "NDC11Code": "00115-0511-01",
      "ProductNDC": "0115-0511",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fenofibrate",
      "NonProprietaryName": "Fenofibrate",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100201",
      "EndMarketingDate": "20231207",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075868",
      "LabelerName": "Amneal Pharmaceuticals of New York LLC",
      "SubstanceName": "FENOFIBRATE",
      "StrengthNumber": "67",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-12-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20100201",
      "EndMarketingDatePackage": "20231207",
      "SamplePackage": "N",
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      "NDC11Code": "00115-0522-01",
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      "IndicationAndUsage": "Treatment of Hypercholesterolemia. Fenofibrate capsules are indicated as adjunctive therapy to diet for the reduction of LDL-C, Total-C, Triglycerides and Apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below). Treatment of Hypertriglyceridemia. Fenofibrate capsules are also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (Fredrickson Types IV and V hyperlipidemia). Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention. Markedly elevated levels of serum triglycerides (e.g., > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV and V hyperlipoproteinemia2. The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, like thiazide diuretics and beta-blockers, is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with non-drug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet (see WARNINGS and PRECAUTIONS). Fredrickson Classification of Hyperlipoproteinemias. The NCEP Treatment Guidelines.",
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      "IndicationAndUsage": "Treatment of Hypercholesterolemia. Fenofibrate capsules are indicated as adjunctive therapy to diet for the reduction of LDL-C, Total-C, Triglycerides and Apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below). Treatment of Hypertriglyceridemia. Fenofibrate capsules are also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (Fredrickson Types IV and V hyperlipidemia). Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention. Markedly elevated levels of serum triglycerides (e.g., > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV and V hyperlipoproteinemia2. The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, like thiazide diuretics and beta-blockers, is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with non-drug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet (see WARNINGS and PRECAUTIONS). Fredrickson Classification of Hyperlipoproteinemias. The NCEP Treatment Guidelines.",
      "Description": "Fenofibrate capsules (micronized), is a lipid regulating agent available as capsules for oral administration. Each capsule contains 67 mg, 134 mg or 200 mg of micronized fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79° to 82°C. Fenofibrate is a white solid which is stable under ordinary conditions. Inactive Ingredients: The inactive ingredients in fenofibrate capsules include croscarmellose sodium, hypromellose type 2910/6 cP, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The capsule shells contain gelatin and titanium dioxide. The 67 mg capsule shells also contain D&C Yellow No. 10 and FD&C Yellow No. 6. The 200 mg capsule shells also contain D&C Red No. 28, D&C Yellow No. 10, and FD&C Red No. 40. Additionally, the capsule imprint ink contains shellac glaze, ferrosoferric oxide, propylene glycol, FD&C Blue No. 2, FD&C Red No. 40, D&C Yellow No. 10 Aluminum Lake, and FD&C Blue No. 1."
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      "IndicationAndUsage": "Daptomycin for Injection is a lipopeptide antibacterial indicated for the treatment of: 1 Complicated skin and skin structure infections (cSSSI) in adult and pediatric patients (1 to 17 years of age) (1.1) and,, 2 Staphylococcus aureus bloodstream infections (bacteremia), in adult patients including those with right-sided infective endocarditis, (1.2), 3 Staphylococcus aureus bloodstream infections (bacteremia) in pediatric patients (1 to 17 years of age). (1.3).",
      "Description": "Daptomycin for Injection contains daptomycin, a cyclic lipopeptide antibacterial agent derived from the fermentation of Streptomyces roseosporus. The chemical name is N-decanoyl-L-tryptophyl-D-asparaginyl-L-aspartyl-L-threonylglycyl-L-ornithyl-L-aspartyl-D-alanyl-L-aspartylglycyl-D-seryl-threo-3-methyl-L-glutamyl-3-anthraniloyl-L-alanine ε1-lactone. The chemical structure is:. The empirical formula is C72H101N17O26; the molecular weight is 1620.67. Daptomycin for Injection is supplied in a single-dose vial as a sterile, preservative-free, pale yellow to light brown, lyophilized powder or cake containing 350 mg or 500 mg of daptomycin for intravenous (IV) use following reconstitution [see Dosage and Administration (2.7)]. Daptomycin for Injection 350 mg per vial contains 350 mg daptomycin, 188.1 mg of L-arginine, 100.5 mg of L-histidine, and 28.3 mg of L-isoleucine. Hydrochloric acid is used to adjust the pH. Daptomycin for Injection 500 mg per vial contains 500 mg daptomycin, 268.7 mg of L-arginine, 143.6 mg of L-histidine, and 40.5 mg of L-isoleucine. Hydrochloric acid is used to adjust the pH. The pH of the solution upon reconstitution is between 5.7 and 6.7. Freshly reconstituted solutions of Daptomycin for Injection range in color from pale yellow to light brown."
    }
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}
                    

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    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20050914</StartMarketingDatePackage>
    <EndMarketingDatePackage>20261130</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dextrose Injection (5%) is indicated as a source of water and calories in adult and pediatric patients and may also be used as a diluent for reconstitution of a powder or liquid drug product.</IndicationAndUsage>
    <Description>Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6  H2O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula. Water for Injection, USP is chemically designated H2O. Dextrose Injection, USP (5%) is a clear, sterile, non-pyrogenic solutions of Dextrose, USP in Water for Injection in a polyvinylchloride flexible plastic container for intravenous administration after admixture with a single-dose powdered or liquid (up to 10 mL) drug vial [see Dosage and Administration (2.1)]. Partial-fill containers, designed to facilitate admixture, are available in 50 mL, 100 mL, and 250 mL sizes. See Table 1 for the content and characteristics of this solution. The solution contains no bacteriostatic, antimicrobial agent or added buffer and is supplied as single-dose containers. The pH is 4.3 (range is 3.2 to 6.5). Dextrose is derived from corn. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.</Description>
  </NDC>
  <NDC>
    <NDCCode>0409-7101-67</NDCCode>
    <PackageDescription>10 POUCH in 1 CASE (0409-7101-67)  / 5 BAG in 1 POUCH / 100 mL in 1 BAG (0409-7101-69) </PackageDescription>
    <NDC11Code>00409-7101-67</NDC11Code>
    <ProductNDC>0409-7101</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Chloride</ProprietaryName>
    <NonProprietaryName>Sodium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20050630</StartMarketingDate>
    <EndMarketingDate>20261231</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019465</ApplicationNumber>
    <LabelerName>Hospira, Inc.</LabelerName>
    <SubstanceName>SODIUM CHLORIDE</SubstanceName>
    <StrengthNumber>900</StrengthNumber>
    <StrengthUnit>mg/100mL</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20050824</StartMarketingDatePackage>
    <EndMarketingDatePackage>20261231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Intravenous solutions containing sodium chloride are indicated for parenteral replenishment of fluid and sodium chloride as required by the clinical condition of the patient. In this dosage form, Sodium Chloride Injection, USP is intended to be used as a diluent for the contents of an ADD-Vantage vial, or single-dose vials with 20 mm closure using the ADD-Vantage ADDAPTOR.</IndicationAndUsage>
    <Description>Sodium Chloride Injection, USP solutions are sterile and nonpyrogenic. They are parenteral solutions containing various concentrations of sodium chloride in water for injection intended for intravenous administration after admixing with an ADD-Vantage vial, or single-dose powdered drug vials with 20 mm closure using the ADD-Vantage ADDAPTOR (WARNING: DO NOT USE WITH CHEMOTHERAPY AGENTS). Each 100 mL of 0.45% Sodium Chloride Injection, USP contains 450 mg sodium chloride in water for injection. Electrolytes per 1000 mL: sodium 77 mEq; chloride 77 mEq. The osmolarity is 154 mOsmol/L (calc.), which is hypotonic. Each 100 mL of 0.9% Sodium Chloride Injection, USP contains 900 mg sodium chloride in water for injection. Electrolytes per 1000 mL: sodium 154 mEq; chloride 154 mEq. The osmolarity is 308 mOsmol/L (calc.), which is isotonic. The pH for both concentrations is 5.6 (4.5 to 7.0). The solutions contain no bacteriostat, antimicrobial agent or added buffer and each is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded. The solutions are parenteral fluid and electrolyte replenishers. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.</Description>
  </NDC>
  <NDC>
    <NDCCode>0409-7132-67</NDCCode>
    <PackageDescription>10 POUCH in 1 CASE (0409-7132-67)  &gt; 5 BAG in 1 POUCH &gt; 100 mL in 1 BAG (0409-7132-69) </PackageDescription>
    <NDC11Code>00409-7132-67</NDC11Code>
    <ProductNDC>0409-7132</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Chloride</ProprietaryName>
    <NonProprietaryName>Sodium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20050913</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019759</ApplicationNumber>
    <LabelerName>Hospira, Inc.</LabelerName>
    <SubstanceName>SODIUM CHLORIDE</SubstanceName>
    <StrengthNumber>450</StrengthNumber>
    <StrengthUnit>mg/100mL</StrengthUnit>
    <Pharm_Classes>Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-10-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20051115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>25021-132-67</NDCCode>
    <PackageDescription>24 POUCH in 1 CARTON (25021-132-67)  &gt; 1 BAG in 1 POUCH &gt; 100 mL in 1 BAG</PackageDescription>
    <NDC11Code>25021-0132-67</NDC11Code>
    <ProductNDC>25021-132</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levofloxacin</ProprietaryName>
    <NonProprietaryName>Levofloxacin</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20130715</StartMarketingDate>
    <EndMarketingDate>20200930</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090343</ApplicationNumber>
    <LabelerName>Sagent Pharmaceuticals</LabelerName>
    <SubstanceName>LEVOFLOXACIN</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20130715</StartMarketingDatePackage>
    <EndMarketingDatePackage>20190831</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>25021-826-67</NDCCode>
    <PackageDescription>1 BAG in 1 CARTON (25021-826-67)  &gt; 100 mL in 1 BAG</PackageDescription>
    <NDC11Code>25021-0826-67</NDC11Code>
    <ProductNDC>25021-826</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zoledronic Acid</ProprietaryName>
    <NonProprietaryName>Zoledronic Acid</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20150901</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA203231</ApplicationNumber>
    <LabelerName>Sagent Pharmaceuticals</LabelerName>
    <SubstanceName>ZOLEDRONIC ACID</SubstanceName>
    <StrengthNumber>.04</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Bisphosphonate [EPC], Diphosphonates [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-03-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Zoledronic Acid Injection is a bisphosphonate indicated for the treatment of: : 1 Hypercalcemia of malignancy. (1.1) , 2 Patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy. (1.2) .</IndicationAndUsage>
    <Description>Zoledronic Acid Injection contains zoledronic acid, a bisphosphonic acid which is an inhibitor of osteoclastic bone resorption. Zoledronic acid monohydrate is designated chemically as (1-Hydroxy-2-imidazol-1-yl-phosphonoethyl) phosphonic acid monohydrate and its structural formula is as following:. Zoledronic acid monohydrate is a white crystalline powder. Its molecular formula is C5H10N2O7P2H2O and its molar mass is 290.1g/mol. Zoledronic acid monohydrate is highly soluble in 0.1N sodium hydroxide solution, sparingly soluble in water and 0.1N hydrochloric acid, and practically insoluble in organic solvents. The pH of a 0.7% solution of zoledronic acid in water is approximately 2.0. Zoledronic Acid Injection is available in bags as a sterile liquid solution for intravenous infusion. Each 100 mL bag contains 4.264 mg of zoledronic acid monohydrate (equivalent to 4 mg zoledronic acid on an anhydrous basis), 900 mg of sodium chloride, USP, 220 mg of mannitol, USP, water for injection q.s. and 24 mg of sodium citrate to adjust pH. The pH of the solution is approximately 5.5 to 6.5.</Description>
  </NDC>
  <NDC>
    <NDCCode>62391-100-02</NDCCode>
    <PackageDescription>67.5 g in 1 JAR (62391-100-02) </PackageDescription>
    <NDC11Code>62391-0100-02</NDC11Code>
    <ProductNDC>62391-100</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Bioflexor</ProprietaryName>
    <ProprietaryNameSuffix>04</ProprietaryNameSuffix>
    <NonProprietaryName>Menthol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>19980301</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>Health Care Laboratories Inc.</LabelerName>
    <SubstanceName>MENTHOL</SubstanceName>
    <StrengthNumber>3</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19980301</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temporarily relieves the minor aches and pains of muscles and joints associated with: 1 simple backache, 2 arthritis, 3 strains, 4 bruises, 5 sprains.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>63323-269-67</NDCCode>
    <PackageDescription>10 VIAL in 1 BOX (63323-269-67)  / 100 mL in 1 VIAL (63323-269-21) </PackageDescription>
    <NDC11Code>63323-0269-67</NDC11Code>
    <ProductNDC>63323-269</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diprivan</ProprietaryName>
    <NonProprietaryName>Propofol</NonProprietaryName>
    <DosageFormName>INJECTION, EMULSION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20091117</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019627</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>PROPOFOL</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>General Anesthesia [PE], General Anesthetic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20091117</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>DIPRIVAN is an intravenous general anesthetic and sedation drug indicated for: 1 Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age, 2 Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age, 3 Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients, 4 Sedation for Adult Patients in Combination with Regional Anesthesia, 5 Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients.</IndicationAndUsage>
    <Description>DIPRIVAN® (propofol) injectable emulsion, USP is an anesthetic available as a sterile, nonpyrogenic white or almost white homogeneous emulsion for intravenous administration. The structural formula is. Chemical name: 2,6 diisopropylphenol. Molecular formula: C12H18O. Molecular weight: 178.27. Propofol is slightly soluble in water. The pKa is 11. The octanol/water partition coefficient for propofol is 6761:1 at a pH of 6 to 8.5. Each mL of DIPRIVAN® (Propofol) injectable emulsion, USP contains 10 mg of propofol, 100 mg of soybean oil (100 mg/mL), 22.5 mg of glycerol (22.5 mg/mL), 12 mg of purified egg phospholipids (12 mg/mL), 0.055 mg of disodium edetate anhydrous (equivalent to 0.055 mg of disodium edetate) (0.05 mg/mL) as microbial inhibitor, and sodium hydroxide to adjust pH, in water for injection. DIPRIVAN is isotonic and has a pH of 7 to 8.5.</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-270-67</NDCCode>
    <PackageDescription>10 VIAL in 1 BOX (63323-270-67)  &gt; 100 mL in 1 VIAL</PackageDescription>
    <NDC11Code>63323-0270-67</NDC11Code>
    <ProductNDC>63323-270</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Propofol</ProprietaryName>
    <NonProprietaryName>Propofol</NonProprietaryName>
    <DosageFormName>INJECTION, EMULSION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20091023</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019627</ApplicationNumber>
    <LabelerName>APP Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>PROPOFOL</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>General Anesthesia [PE],General Anesthetic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-05-22</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>63323-285-67</NDCCode>
    <PackageDescription>12 BOTTLE in 1 CASE (63323-285-67)  / 100 mL in 1 BOTTLE (63323-285-55) </PackageDescription>
    <NDC11Code>63323-0285-67</NDC11Code>
    <ProductNDC>63323-285</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Naropin</ProprietaryName>
    <NonProprietaryName>Ropivacaine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>EPIDURAL; INFILTRATION</RouteName>
    <StartMarketingDate>20090804</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020533</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>ROPIVACAINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-08-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090804</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>NAROPIN is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration.</IndicationAndUsage>
    <Description>NAROPIN® Injection is a sterile, isotonic solution that contains ropivacaine hydrochloride as the active pharmaceutical ingredient. Ropivacaine hydrochloride is a member of the amino amide class of local anesthetics. NAROPIN® Injection is administered parenterally by for infiltration, epidural, and nerve block. Ropivacaine hydrochloride is chemically described as S-(-)-1-propyl-2',6'-pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder, with the following structural formula:. C17H26N2OHClH2O                     M.W. 328.89. At 25 °C ropivacaine hydrochloride has a solubility of 53.8 mg/mL in water, a distribution ratio between n-octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine. NAROPIN (ropivacaine hydrochloride) injection is a clear, colorless, and preservative-free solution. Each mL contains 2.1 mg, 5.3 mg, 7.9 mg or 10.6 mg ropivacaine hydrochloride monohydrate (equivalent to 2.0 mg, 5.0 mg, 7.5 mg or 10 mg of ropivacaine hydrochloride anhydrous), and 8.6 mg, 8.0 mg, 7.5 mg or 7.1 mg of sodium chloride; respectively, and sodium hydroxide and hydrochloric acid as pH adjusters, in water for injection. The pH is adjusted between 4.0 to 6.0. The specific gravity of NAROPIN Injection solutions range from 1.002 to 1.005 at 25°C.</Description>
  </NDC>
  <NDC>
    <NDCCode>73069-100-67</NDCCode>
    <PackageDescription>25 VIAL, MULTI-DOSE in 1 BOX (73069-100-67)  &gt; 30 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
    <NDC11Code>73069-0100-67</NDC11Code>
    <ProductNDC>73069-100</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Viatrexx-connectissue</ProprietaryName>
    <NonProprietaryName>Anti-interleukin-1.alpha. Immunoglobulin G Rabbit, Ascorbic Acid, Metenkefalin, Ersofermin, Bos Taurus Cartilage, Sus Scrofa Cartilage, Pork Collagen, Bos Taurus Red Blood Cell, Sus Scrofa Red Blood Cell, Interleukin-3, Interleukin-3, Beef Liver, Pork Liver, Beef, Pork, Bos Taurus Tendon, Sus Scrofa Tendon, Cetermin</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20190329</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
    <SubstanceName>ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; ASCORBIC ACID; BOS TAURUS RED BLOOD CELL; METENKEFALIN; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); SUS SCROFA CARTILAGE; PORK COLLAGEN; SUS SCROFA RED BLOOD CELL; INTERLEUKIN-3; BEEF; PORK; BEEF LIVER; PORK LIVER; BOS TAURUS TENDON; SUS SCROFA TENDON; CETERMIN; BOS TAURUS CARTILAGE</SubstanceName>
    <StrengthNumber>201; 31; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201</StrengthNumber>
    <StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
    <Pharm_Classes>Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190506</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>73962-005-67</NDCCode>
    <PackageDescription>100 mL in 1 TUBE (73962-005-67) </PackageDescription>
    <NDC11Code>73962-0005-67</NDC11Code>
    <ProductNDC>73962-005</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ushas Antibacterial Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200713</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Zhejiang USHAS Cosmetics Co.,Ltd</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>72</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-11-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200713</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>73962-006-67</NDCCode>
    <PackageDescription>100 mL in 1 TUBE (73962-006-67) </PackageDescription>
    <NDC11Code>73962-0006-67</NDC11Code>
    <ProductNDC>73962-006</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200714</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Zhejiang USHAS Cosmetics Co.,Ltd</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-11-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200714</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>76150-330-67</NDCCode>
    <PackageDescription>100 mL in 1 BOTTLE, PLASTIC (76150-330-67) </PackageDescription>
    <NDC11Code>76150-0330-67</NDC11Code>
    <ProductNDC>76150-330</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Coola</ProprietaryName>
    <ProprietaryNameSuffix>Spf 50 Classic</ProprietaryNameSuffix>
    <NonProprietaryName>Sunscreen Face Mist</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20211102</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Bell International Laboratories, Inc</LabelerName>
    <SubstanceName>AVOBENZONE; OCTISALATE; OCTOCRYLENE</SubstanceName>
    <StrengthNumber>2.9; 4.9; 9.5</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL; g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-02-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211102</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>76309-100-01</NDCCode>
    <PackageDescription>4.67 g in 1 TUBE (76309-100-01) </PackageDescription>
    <NDC11Code>76309-0100-01</NDC11Code>
    <ProductNDC>76309-100</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Snugz Spf 30 Soy Lip Balm</ProprietaryName>
    <NonProprietaryName>Spf 30 Soy Lip Balm</NonProprietaryName>
    <DosageFormName>STICK</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20180101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>SnugZ/USA, LLC</LabelerName>
    <SubstanceName>OCTISALATE; OCTOCRYLENE; AVOBENZONE</SubstanceName>
    <StrengthNumber>.23; .37; .14</StrengthNumber>
    <StrengthUnit>g/4.67g; g/4.67g; g/4.67g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-12-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>79781-217-02</NDCCode>
    <PackageDescription>100 PACKAGE in 1 CANISTER (79781-217-02)  &gt; 7.67 mL in 1 PACKAGE</PackageDescription>
    <NDC11Code>79781-0217-02</NDC11Code>
    <ProductNDC>79781-217</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Molecure</ProprietaryName>
    <ProprietaryNameSuffix>Skincare Disinfectant Hand And Skin Wet Wipe</ProprietaryNameSuffix>
    <NonProprietaryName>Benzalkonium Chloride, Alcohol</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20201226</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Molecule Koruyucu Saglik Urunleri Sanayi Ve Ticaret Anonim Sirketi</LabelerName>
    <SubstanceName>ALCOHOL; BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>80; .33</StrengthNumber>
    <StrengthUnit>mL/100mL; g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-11-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201226</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>82757-100-01</NDCCode>
    <PackageDescription>67 mL in 1 BOTTLE (82757-100-01) </PackageDescription>
    <NDC11Code>82757-0100-01</NDC11Code>
    <ProductNDC>82757-100</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>The Mug Guard</ProprietaryName>
    <ProprietaryNameSuffix>Invisible Sunscreen For Face</ProprietaryNameSuffix>
    <NonProprietaryName>Avobenzone, Homosalate, Octisalate, And Octocrylene</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20220607</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Dune Suncare, Inc.</LabelerName>
    <SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
    <StrengthNumber>20; 55; 45; 40</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-06-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220607</StartMarketingDatePackage>
    <EndMarketingDatePackage>20240615</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0024-5911-02</NDCCode>
    <PackageDescription>2 SYRINGE, GLASS in 1 CARTON (0024-5911-02)  / .67 mL in 1 SYRINGE, GLASS (0024-5911-00) </PackageDescription>
    <NDC11Code>00024-5911-02</NDC11Code>
    <ProductNDC>0024-5911</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dupixent</ProprietaryName>
    <NonProprietaryName>Dupilumab</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20211020</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761055</ApplicationNumber>
    <LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
    <SubstanceName>DUPILUMAB</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/.67mL</StrengthUnit>
    <Pharm_Classes>Antibodies, Monoclonal [CS], Interleukin 4 Receptor alpha Antagonists [MoA], Interleukin-4 Receptor alpha Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-08-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211020</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260731</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>DUPIXENT is an interleukin-4 receptor alpha antagonist indicated. Atopic Dermatitis. for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe AD whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids. (1.1). Asthma. as an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma. (1.2)Limitations of Use: Not for the relief of acute bronchospasm or status asthmaticus. (1.2). Chronic Rhinosinusitis with Nasal Polyps. as an add-on maintenance treatment in adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). (1.3). Eosinophilic Esophagitis. for the treatment of adult and pediatric patients aged 1 year and older, weighing at least 15 kg, with eosinophilic esophagitis (EoE). (1.4). Prurigo Nodularis. for the treatment of adult patients with prurigo nodularis (PN). (1.5). Chronic Obstructive Pulmonary Disease. as an add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. (1.6)Limitations of Use: Not for the relief of acute bronchospasm. (1.6). Chronic Spontaneous Urticaria. for the treatment of adult and pediatric patients aged 2 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. (1.7). Limitations of Use: Not indicated for other forms of urticaria. (1.7). Bullous Pemphigoid. for the treatment of adult patients with bullous pemphigoid (BP). (1.8). Allergic Fungal Rhinosinusitis. for the treatment of adult and pediatric patients aged 6 years and older with allergic fungal rhinosinusitis (AFRS) who have a history of sino-nasal surgery. (1.9).</IndicationAndUsage>
    <Description>Dupilumab, an interleukin-4 receptor alpha antagonist, is a human monoclonal antibody of the IgG4 subclass that binds to the IL-4Rα subunit and inhibits IL-4 and IL-13 signaling. Dupilumab has an approximate molecular weight of 147 kDa. Dupilumab is produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. DUPIXENT (dupilumab) Injection is supplied as a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution for subcutaneous injection. DUPIXENT is provided as either a single-dose pre-filled syringe with needle shield or a single-dose pre-filled pen in a siliconized Type-1 clear glass syringe. The needle cap is not made with natural rubber latex. Each 300 mg pre-filled syringe or pre-filled pen delivers 300 mg dupilumab in 2 mL which also contains L-arginine hydrochloride (10.5 mg), L-histidine (6.2 mg), polysorbate 80 (4 mg), sodium acetate (2 mg), sucrose (100 mg), and water for injection, pH 5.9. Each 200 mg pre-filled syringe or pre-filled pen delivers 200 mg dupilumab in 1.14 mL which also contains L-arginine hydrochloride (12 mg), L-histidine (3.5 mg), polysorbate 80 (2.3 mg), sodium acetate (1.2 mg), sucrose (57 mg), and water for injection, pH 5.9.</Description>
  </NDC>
  <NDC>
    <NDCCode>0024-5911-20</NDCCode>
    <PackageDescription>2 SYRINGE, GLASS in 1 CARTON (0024-5911-20)  / .67 mL in 1 SYRINGE, GLASS (0024-5911-01) </PackageDescription>
    <NDC11Code>00024-5911-20</NDC11Code>
    <ProductNDC>0024-5911</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dupixent</ProprietaryName>
    <NonProprietaryName>Dupilumab</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20211020</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761055</ApplicationNumber>
    <LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
    <SubstanceName>DUPILUMAB</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/.67mL</StrengthUnit>
    <Pharm_Classes>Antibodies, Monoclonal [CS], Interleukin 4 Receptor alpha Antagonists [MoA], Interleukin-4 Receptor alpha Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-08-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211020</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260731</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>DUPIXENT is an interleukin-4 receptor alpha antagonist indicated. Atopic Dermatitis. for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe AD whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids. (1.1). Asthma. as an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma. (1.2)Limitations of Use: Not for the relief of acute bronchospasm or status asthmaticus. (1.2). Chronic Rhinosinusitis with Nasal Polyps. as an add-on maintenance treatment in adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). (1.3). Eosinophilic Esophagitis. for the treatment of adult and pediatric patients aged 1 year and older, weighing at least 15 kg, with eosinophilic esophagitis (EoE). (1.4). Prurigo Nodularis. for the treatment of adult patients with prurigo nodularis (PN). (1.5). Chronic Obstructive Pulmonary Disease. as an add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. (1.6)Limitations of Use: Not for the relief of acute bronchospasm. (1.6). Chronic Spontaneous Urticaria. for the treatment of adult and pediatric patients aged 2 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. (1.7). Limitations of Use: Not indicated for other forms of urticaria. (1.7). Bullous Pemphigoid. for the treatment of adult patients with bullous pemphigoid (BP). (1.8). Allergic Fungal Rhinosinusitis. for the treatment of adult and pediatric patients aged 6 years and older with allergic fungal rhinosinusitis (AFRS) who have a history of sino-nasal surgery. (1.9).</IndicationAndUsage>
    <Description>Dupilumab, an interleukin-4 receptor alpha antagonist, is a human monoclonal antibody of the IgG4 subclass that binds to the IL-4Rα subunit and inhibits IL-4 and IL-13 signaling. Dupilumab has an approximate molecular weight of 147 kDa. Dupilumab is produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. DUPIXENT (dupilumab) Injection is supplied as a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution for subcutaneous injection. DUPIXENT is provided as either a single-dose pre-filled syringe with needle shield or a single-dose pre-filled pen in a siliconized Type-1 clear glass syringe. The needle cap is not made with natural rubber latex. Each 300 mg pre-filled syringe or pre-filled pen delivers 300 mg dupilumab in 2 mL which also contains L-arginine hydrochloride (10.5 mg), L-histidine (6.2 mg), polysorbate 80 (4 mg), sodium acetate (2 mg), sucrose (100 mg), and water for injection, pH 5.9. Each 200 mg pre-filled syringe or pre-filled pen delivers 200 mg dupilumab in 1.14 mL which also contains L-arginine hydrochloride (12 mg), L-histidine (3.5 mg), polysorbate 80 (2.3 mg), sodium acetate (1.2 mg), sucrose (57 mg), and water for injection, pH 5.9.</Description>
  </NDC>
  <NDC>
    <NDCCode>0065-0343-02</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (0065-0343-02)  / 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>00065-0343-02</NDC11Code>
    <ProductNDC>0065-0343</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phenylephrine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20150115</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA207926</ApplicationNumber>
    <LabelerName>Alcon Laboratories, Inc.</LabelerName>
    <SubstanceName>PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-05-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250430</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%, is indicated to dilate the pupil.</IndicationAndUsage>
    <Description>Phenylephrine Hydrochloride Ophthalmic Solution, USP is a sterile, clear, colorless to yellow, topical α-adrenergic agonist for ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: (R)-3-hydroxy-α[(methylamino)methyl]benzenemethanol hydrochloride. Molecular Formula: C9H13NO2.HCl. Molecular Weight: 203.67 g/mol. Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% contains: ACTIVE: Phenylephrine Hydrochloride 25 mg (2.5%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 340 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%). Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% contains: ACTIVE: Phenylephrine Hydrochloride 100 mg (10%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 985 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%).</Description>
  </NDC>
  <NDC>
    <NDCCode>0065-0349-04</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (0065-0349-04)  / 15 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>00065-0349-04</NDC11Code>
    <ProductNDC>0065-0349</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phenylephrine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20150115</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA207926</ApplicationNumber>
    <LabelerName>Alcon Laboratories, Inc.</LabelerName>
    <SubstanceName>PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241028</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%, is indicated to dilate the pupil.</IndicationAndUsage>
    <Description>Phenylephrine Hydrochloride Ophthalmic Solution, USP is a sterile, clear, colorless to yellow, topical α-adrenergic agonist for ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: (R)-3-hydroxy-α[(methylamino)methyl]benzenemethanol hydrochloride. Molecular Formula: C9H13NO2.HCl. Molecular Weight: 203.67 g/mol. Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% contains: ACTIVE: Phenylephrine Hydrochloride 25 mg (2.5%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 340 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%). Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% contains: ACTIVE: Phenylephrine Hydrochloride 100 mg (10%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 985 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%).</Description>
  </NDC>
  <NDC>
    <NDCCode>0065-0349-05</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (0065-0349-05)  / 2 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>00065-0349-05</NDC11Code>
    <ProductNDC>0065-0349</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phenylephrine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20150115</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA207926</ApplicationNumber>
    <LabelerName>Alcon Laboratories, Inc.</LabelerName>
    <SubstanceName>PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241028</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%, is indicated to dilate the pupil.</IndicationAndUsage>
    <Description>Phenylephrine Hydrochloride Ophthalmic Solution, USP is a sterile, clear, colorless to yellow, topical α-adrenergic agonist for ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: (R)-3-hydroxy-α[(methylamino)methyl]benzenemethanol hydrochloride. Molecular Formula: C9H13NO2.HCl. Molecular Weight: 203.67 g/mol. Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% contains: ACTIVE: Phenylephrine Hydrochloride 25 mg (2.5%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 340 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%). Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% contains: ACTIVE: Phenylephrine Hydrochloride 100 mg (10%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 985 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%).</Description>
  </NDC>
  <NDC>
    <NDCCode>0093-1177-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (0093-1177-01) </PackageDescription>
    <NDC11Code>00093-1177-01</NDC11Code>
    <ProductNDC>0093-1177</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Neomycin Sulfate</ProprietaryName>
    <NonProprietaryName>Neomycin Sulfate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19900930</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA060304</ApplicationNumber>
    <LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
    <SubstanceName>NEOMYCIN SULFATE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-03-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19900930</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of neomycin sulfate tablets, USP and other antibacterial drugs, neomycin sulfate tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
    <Description>Neomycin sulfate tablets, USP, for oral administration, contain neomycin which is an antibiotic obtained from the metabolic products of the actinomycete Streptomyces fradiae. Structurally, neomycin sulfate may be represented as follows. C23H46N6O13·2½ H2SO4 MW 614.67. Chemically, it is 0-2,6-diamino-2,6-dideoxy-α-D-glucopyranosyl-(1→3)-0-β-D-ribofuranosyl-(1→5)-0-[2,6-diamino-2,6-dideoxy-α-D-glucopyranosyl-(1→4)]-2-deoxy-D-streptamine. Neomycin B is identical except that the a-D-glucopyranosyl residue in the neobiosamine moiety is β-L-idopyranosyl. Each tablet contains 500 mg neomycin sulfate (equivalent to 350 mg neomycin base). Inactive ingredients: calcium stearate, povidone.</Description>
  </NDC>
  <NDC>
    <NDCCode>0115-0511-01</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (0115-0511-01) </PackageDescription>
    <NDC11Code>00115-0511-01</NDC11Code>
    <ProductNDC>0115-0511</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fenofibrate</ProprietaryName>
    <NonProprietaryName>Fenofibrate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100201</StartMarketingDate>
    <EndMarketingDate>20231207</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075868</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
    <SubstanceName>FENOFIBRATE</SubstanceName>
    <StrengthNumber>67</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-12-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20100201</StartMarketingDatePackage>
    <EndMarketingDatePackage>20231207</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Treatment of Hypercholesterolemia. Fenofibrate capsules are indicated as adjunctive therapy to diet for the reduction of LDL-C, Total-C, Triglycerides and Apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below). Treatment of Hypertriglyceridemia. Fenofibrate capsules are also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (Fredrickson Types IV and V hyperlipidemia). Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention. Markedly elevated levels of serum triglycerides (e.g., &gt; 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV and V hyperlipoproteinemia2. The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, like thiazide diuretics and beta-blockers, is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with non-drug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet (see WARNINGS and PRECAUTIONS). Fredrickson Classification of Hyperlipoproteinemias. The NCEP Treatment Guidelines.</IndicationAndUsage>
    <Description>Fenofibrate capsules (micronized), is a lipid regulating agent available as capsules for oral administration. Each capsule contains 67 mg, 134 mg or 200 mg of micronized fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79° to 82°C. Fenofibrate is a white solid which is stable under ordinary conditions. Inactive Ingredients: The inactive ingredients in fenofibrate capsules include croscarmellose sodium, hypromellose type 2910/6 cP, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The capsule shells contain gelatin and titanium dioxide. The 67 mg capsule shells also contain D&amp;C Yellow No. 10 and FD&amp;C Yellow No. 6. The 200 mg capsule shells also contain D&amp;C Red No. 28, D&amp;C Yellow No. 10, and FD&amp;C Red No. 40. Additionally, the capsule imprint ink contains shellac glaze, ferrosoferric oxide, propylene glycol, FD&amp;C Blue No. 2, FD&amp;C Red No. 40, D&amp;C Yellow No. 10 Aluminum Lake, and FD&amp;C Blue No. 1.</Description>
  </NDC>
  <NDC>
    <NDCCode>0115-0522-01</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (0115-0522-01) </PackageDescription>
    <NDC11Code>00115-0522-01</NDC11Code>
    <ProductNDC>0115-0522</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fenofibrate</ProprietaryName>
    <NonProprietaryName>Fenofibrate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075868</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
    <SubstanceName>FENOFIBRATE</SubstanceName>
    <StrengthNumber>134</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Treatment of Hypercholesterolemia. Fenofibrate capsules are indicated as adjunctive therapy to diet for the reduction of LDL-C, Total-C, Triglycerides and Apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below). Treatment of Hypertriglyceridemia. Fenofibrate capsules are also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (Fredrickson Types IV and V hyperlipidemia). Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention. Markedly elevated levels of serum triglycerides (e.g., &gt; 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV and V hyperlipoproteinemia2. The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, like thiazide diuretics and beta-blockers, is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with non-drug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet (see WARNINGS and PRECAUTIONS). Fredrickson Classification of Hyperlipoproteinemias. The NCEP Treatment Guidelines.</IndicationAndUsage>
    <Description>Fenofibrate capsules (micronized), is a lipid regulating agent available as capsules for oral administration. Each capsule contains 67 mg, 134 mg or 200 mg of micronized fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79° to 82°C. Fenofibrate is a white solid which is stable under ordinary conditions. Inactive Ingredients: The inactive ingredients in fenofibrate capsules include croscarmellose sodium, hypromellose type 2910/6 cP, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The capsule shells contain gelatin and titanium dioxide. The 67 mg capsule shells also contain D&amp;C Yellow No. 10 and FD&amp;C Yellow No. 6. The 200 mg capsule shells also contain D&amp;C Red No. 28, D&amp;C Yellow No. 10, and FD&amp;C Red No. 40. Additionally, the capsule imprint ink contains shellac glaze, ferrosoferric oxide, propylene glycol, FD&amp;C Blue No. 2, FD&amp;C Red No. 40, D&amp;C Yellow No. 10 Aluminum Lake, and FD&amp;C Blue No. 1.</Description>
  </NDC>
  <NDC>
    <NDCCode>0115-0533-01</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (0115-0533-01) </PackageDescription>
    <NDC11Code>00115-0533-01</NDC11Code>
    <ProductNDC>0115-0533</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fenofibrate</ProprietaryName>
    <NonProprietaryName>Fenofibrate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075868</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
    <SubstanceName>FENOFIBRATE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Treatment of Hypercholesterolemia. Fenofibrate capsules are indicated as adjunctive therapy to diet for the reduction of LDL-C, Total-C, Triglycerides and Apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below). Treatment of Hypertriglyceridemia. Fenofibrate capsules are also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (Fredrickson Types IV and V hyperlipidemia). Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention. Markedly elevated levels of serum triglycerides (e.g., &gt; 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV and V hyperlipoproteinemia2. The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, like thiazide diuretics and beta-blockers, is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with non-drug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet (see WARNINGS and PRECAUTIONS). Fredrickson Classification of Hyperlipoproteinemias. The NCEP Treatment Guidelines.</IndicationAndUsage>
    <Description>Fenofibrate capsules (micronized), is a lipid regulating agent available as capsules for oral administration. Each capsule contains 67 mg, 134 mg or 200 mg of micronized fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79° to 82°C. Fenofibrate is a white solid which is stable under ordinary conditions. Inactive Ingredients: The inactive ingredients in fenofibrate capsules include croscarmellose sodium, hypromellose type 2910/6 cP, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The capsule shells contain gelatin and titanium dioxide. The 67 mg capsule shells also contain D&amp;C Yellow No. 10 and FD&amp;C Yellow No. 6. The 200 mg capsule shells also contain D&amp;C Red No. 28, D&amp;C Yellow No. 10, and FD&amp;C Red No. 40. Additionally, the capsule imprint ink contains shellac glaze, ferrosoferric oxide, propylene glycol, FD&amp;C Blue No. 2, FD&amp;C Red No. 40, D&amp;C Yellow No. 10 Aluminum Lake, and FD&amp;C Blue No. 1.</Description>
  </NDC>
  <NDC>
    <NDCCode>0143-9445-01</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (0143-9445-01)  / 10 mL in 1 VIAL, SINGLE-USE</PackageDescription>
    <NDC11Code>00143-9445-01</NDC11Code>
    <ProductNDC>0143-9445</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Daptomycin</ProprietaryName>
    <NonProprietaryName>Daptomycin</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20251211</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA217415</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>DAPTOMYCIN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/10mL</StrengthUnit>
    <Pharm_Classes>Lipopeptide Antibacterial [EPC], Lipopeptides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251211</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Daptomycin for Injection is a lipopeptide antibacterial indicated for the treatment of: 1 Complicated skin and skin structure infections (cSSSI) in adult and pediatric patients (1 to 17 years of age) (1.1) and,, 2 Staphylococcus aureus bloodstream infections (bacteremia), in adult patients including those with right-sided infective endocarditis, (1.2), 3 Staphylococcus aureus bloodstream infections (bacteremia) in pediatric patients (1 to 17 years of age). (1.3).</IndicationAndUsage>
    <Description>Daptomycin for Injection contains daptomycin, a cyclic lipopeptide antibacterial agent derived from the fermentation of Streptomyces roseosporus. The chemical name is N-decanoyl-L-tryptophyl-D-asparaginyl-L-aspartyl-L-threonylglycyl-L-ornithyl-L-aspartyl-D-alanyl-L-aspartylglycyl-D-seryl-threo-3-methyl-L-glutamyl-3-anthraniloyl-L-alanine ε1-lactone. The chemical structure is:. The empirical formula is C72H101N17O26; the molecular weight is 1620.67. Daptomycin for Injection is supplied in a single-dose vial as a sterile, preservative-free, pale yellow to light brown, lyophilized powder or cake containing 350 mg or 500 mg of daptomycin for intravenous (IV) use following reconstitution [see Dosage and Administration (2.7)]. Daptomycin for Injection 350 mg per vial contains 350 mg daptomycin, 188.1 mg of L-arginine, 100.5 mg of L-histidine, and 28.3 mg of L-isoleucine. Hydrochloric acid is used to adjust the pH. Daptomycin for Injection 500 mg per vial contains 500 mg daptomycin, 268.7 mg of L-arginine, 143.6 mg of L-histidine, and 40.5 mg of L-isoleucine. Hydrochloric acid is used to adjust the pH. The pH of the solution upon reconstitution is between 5.7 and 6.7. Freshly reconstituted solutions of Daptomycin for Injection range in color from pale yellow to light brown.</Description>
  </NDC>
  <NDC>
    <NDCCode>0143-9456-01</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (0143-9456-01)  / 7 mL in 1 VIAL, SINGLE-USE</PackageDescription>
    <NDC11Code>00143-9456-01</NDC11Code>
    <ProductNDC>0143-9456</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Daptomycin</ProprietaryName>
    <NonProprietaryName>Daptomycin</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20251211</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA217415</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>DAPTOMYCIN</SubstanceName>
    <StrengthNumber>350</StrengthNumber>
    <StrengthUnit>mg/7mL</StrengthUnit>
    <Pharm_Classes>Lipopeptide Antibacterial [EPC], Lipopeptides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251211</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Daptomycin for Injection is a lipopeptide antibacterial indicated for the treatment of: 1 Complicated skin and skin structure infections (cSSSI) in adult and pediatric patients (1 to 17 years of age) (1.1) and,, 2 Staphylococcus aureus bloodstream infections (bacteremia), in adult patients including those with right-sided infective endocarditis, (1.2), 3 Staphylococcus aureus bloodstream infections (bacteremia) in pediatric patients (1 to 17 years of age). (1.3).</IndicationAndUsage>
    <Description>Daptomycin for Injection contains daptomycin, a cyclic lipopeptide antibacterial agent derived from the fermentation of Streptomyces roseosporus. The chemical name is N-decanoyl-L-tryptophyl-D-asparaginyl-L-aspartyl-L-threonylglycyl-L-ornithyl-L-aspartyl-D-alanyl-L-aspartylglycyl-D-seryl-threo-3-methyl-L-glutamyl-3-anthraniloyl-L-alanine ε1-lactone. The chemical structure is:. The empirical formula is C72H101N17O26; the molecular weight is 1620.67. Daptomycin for Injection is supplied in a single-dose vial as a sterile, preservative-free, pale yellow to light brown, lyophilized powder or cake containing 350 mg or 500 mg of daptomycin for intravenous (IV) use following reconstitution [see Dosage and Administration (2.7)]. Daptomycin for Injection 350 mg per vial contains 350 mg daptomycin, 188.1 mg of L-arginine, 100.5 mg of L-histidine, and 28.3 mg of L-isoleucine. Hydrochloric acid is used to adjust the pH. Daptomycin for Injection 500 mg per vial contains 500 mg daptomycin, 268.7 mg of L-arginine, 143.6 mg of L-histidine, and 40.5 mg of L-isoleucine. Hydrochloric acid is used to adjust the pH. The pH of the solution upon reconstitution is between 5.7 and 6.7. Freshly reconstituted solutions of Daptomycin for Injection range in color from pale yellow to light brown.</Description>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>77153-100-67</NDCCode><ProprietaryName>Hand Sanitizer</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>77153-100-25</NDCCode><ProprietaryName>Hand Sanitizer</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>77153-100-60</NDCCode><ProprietaryName>Hand Sanitizer</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>0409-7100-67</NDCCode><ProprietaryName>Dextrose</ProprietaryName><NonProprietaryName>Dextrose Monohydrate</NonProprietaryName></NDC><NDC><NDCCode>0409-7101-67</NDCCode><ProprietaryName>Sodium Chloride</ProprietaryName><NonProprietaryName>Sodium Chloride</NonProprietaryName></NDC><NDC><NDCCode>0409-7132-67</NDCCode><ProprietaryName>Sodium Chloride</ProprietaryName><NonProprietaryName>Sodium Chloride</NonProprietaryName></NDC><NDC><NDCCode>25021-132-67</NDCCode><ProprietaryName>Levofloxacin</ProprietaryName><NonProprietaryName>Levofloxacin</NonProprietaryName></NDC><NDC><NDCCode>25021-826-67</NDCCode><ProprietaryName>Zoledronic Acid</ProprietaryName><NonProprietaryName>Zoledronic Acid</NonProprietaryName></NDC><NDC><NDCCode>62391-100-02</NDCCode><ProprietaryName>Bioflexor</ProprietaryName><NonProprietaryName>Menthol</NonProprietaryName></NDC><NDC><NDCCode>63323-269-67</NDCCode><ProprietaryName>Diprivan</ProprietaryName><NonProprietaryName>Propofol</NonProprietaryName></NDC><NDC><NDCCode>63323-270-67</NDCCode><ProprietaryName>Propofol</ProprietaryName><NonProprietaryName>Propofol</NonProprietaryName></NDC><NDC><NDCCode>63323-285-67</NDCCode><ProprietaryName>Naropin</ProprietaryName><NonProprietaryName>Ropivacaine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>73069-100-67</NDCCode><ProprietaryName>Viatrexx-connectissue</ProprietaryName><NonProprietaryName>Anti-interleukin-1.alpha. Immunoglobulin G Rabbit, Ascorbic Acid, Metenkefalin, Ersofermin, Bos Taurus Cartilage, Sus Scrofa Cartilage, Pork Collagen, Bos Taurus Red Blood Cell, Sus Scrofa Red Blood Cell, Interleukin-3, Interleukin-3, Beef Liver, Pork Liver, Beef, Pork, Bos Taurus Tendon, Sus Scrofa Tendon, Cetermin</NonProprietaryName></NDC><NDC><NDCCode>73962-005-67</NDCCode><ProprietaryName>Ushas Antibacterial Hand Sanitizer</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>73962-006-67</NDCCode><ProprietaryName>Hand Sanitizer</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>76150-330-67</NDCCode><ProprietaryName>Coola</ProprietaryName><NonProprietaryName>Sunscreen Face Mist</NonProprietaryName></NDC><NDC><NDCCode>76309-100-01</NDCCode><ProprietaryName>Snugz Spf 30 Soy Lip Balm</ProprietaryName><NonProprietaryName>Spf 30 Soy Lip Balm</NonProprietaryName></NDC><NDC><NDCCode>79781-217-02</NDCCode><ProprietaryName>Molecure</ProprietaryName><NonProprietaryName>Benzalkonium Chloride, Alcohol</NonProprietaryName></NDC><NDC><NDCCode>82757-100-01</NDCCode><ProprietaryName>The Mug Guard</ProprietaryName><NonProprietaryName>Avobenzone, Homosalate, Octisalate, And Octocrylene</NonProprietaryName></NDC><NDC><NDCCode>0024-5911-02</NDCCode><ProprietaryName>Dupixent</ProprietaryName><NonProprietaryName>Dupilumab</NonProprietaryName></NDC><NDC><NDCCode>0024-5911-20</NDCCode><ProprietaryName>Dupixent</ProprietaryName><NonProprietaryName>Dupilumab</NonProprietaryName></NDC><NDC><NDCCode>0065-0343-02</NDCCode><ProprietaryName>Phenylephrine Hydrochloride</ProprietaryName><NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0065-0349-04</NDCCode><ProprietaryName>Phenylephrine Hydrochloride</ProprietaryName><NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0065-0349-05</NDCCode><ProprietaryName>Phenylephrine Hydrochloride</ProprietaryName><NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0093-1177-01</NDCCode><ProprietaryName>Neomycin Sulfate</ProprietaryName><NonProprietaryName>Neomycin Sulfate</NonProprietaryName></NDC><NDC><NDCCode>0115-0511-01</NDCCode><ProprietaryName>Fenofibrate</ProprietaryName><NonProprietaryName>Fenofibrate</NonProprietaryName></NDC><NDC><NDCCode>0115-0522-01</NDCCode><ProprietaryName>Fenofibrate</ProprietaryName><NonProprietaryName>Fenofibrate</NonProprietaryName></NDC><NDC><NDCCode>0115-0533-01</NDCCode><ProprietaryName>Fenofibrate</ProprietaryName><NonProprietaryName>Fenofibrate</NonProprietaryName></NDC><NDC><NDCCode>0143-9445-01</NDCCode><ProprietaryName>Daptomycin</ProprietaryName><NonProprietaryName>Daptomycin</NonProprietaryName></NDC><NDC><NDCCode>0143-9456-01</NDCCode><ProprietaryName>Daptomycin</ProprietaryName><NonProprietaryName>Daptomycin</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/04/2006",
      "LastUpdateDate": "12/11/2007",
      "AuthorizedOfficialLastName": "MONTECILLO",
      "AuthorizedOfficialFirstName": "RANIA",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-7363",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "801TX",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1346319878",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "REDMOND EYE CLINIC PLLC",
      "FirstLineMailingAddress": "16150 NE 85TH ST STE 206",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3543",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-3574",
      "MailingAddressFaxNumber": "425-881-0230",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "PracticeLocationAddressFaxNumber": "425-881-0230",
      "EnumerationDate": "11/07/2006",
      "LastUpdateDate": "07/08/2007",
      "AuthorizedOfficialLastName": "OTTEN",
      "AuthorizedOfficialFirstName": "LARRY",
      "AuthorizedOfficialMiddleName": "C",
      "AuthorizedOfficialTitle": "DR",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-3574",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "OD00001172",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
    },
    {
      "NPI": "1376755009",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "PERIMAN",
      "FirstName": "LAURA",
      "MiddleName": "MARIE",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "FirstLineMailingAddress": "623 W HIGHLAND DR",
      "MailingAddressCityName": "SEATTLE",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98119-3446",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "206-282-2716",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "SecondLinePracticeLocationAddress": "REDMOND EYE CLINIC",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "EnumerationDate": "05/04/2007",
      "LastUpdateDate": "07/08/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207W00000X",
      "Taxonomy1": "Ophthalmology",
      "LicenseNumber1": "MD00039796",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1659320539",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "MONTECILLO",
      "FirstName": "RANIA",
      "MiddleName": "B",
      "NamePrefix": "DR.",
      "Credential": "OD",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/09/2006",
      "LastUpdateDate": "12/19/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "3680",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1427560267",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ABOU SHADI",
      "FirstName": "RANIA",
      "NamePrefix": "MRS.",
      "Credential": "RPH",
      "FirstLineMailingAddress": "8862 161ST AVENUE NE",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-883-9532",
      "MailingAddressFaxNumber": "425-882-2743",
      "FirstLinePracticeLocationAddress": "8862 161ST AVENUE NE",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-883-9532",
      "PracticeLocationAddressFaxNumber": "425-882-2743",
      "EnumerationDate": "11/02/2017",
      "LastUpdateDate": "11/02/2017",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "3336C0003X",
      "Taxonomy1": "Community/Retail Pharmacy",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1528050523",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "DESCHUTES EYE CLINIC PC",
      "OtherOrgName": "THE EYE SURGERY INSTITUTE",
      "OtherOrgNameTypeCode": "3",
      "FirstLineMailingAddress": "813 SW HIGHLAND AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-3123",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-548-7170",
      "MailingAddressFaxNumber": "541-548-3842",
      "FirstLinePracticeLocationAddress": "813 SW HIGHLAND AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-3123",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-548-7170",
      "PracticeLocationAddressFaxNumber": "541-548-3842",
      "EnumerationDate": "08/17/2005",
      "LastUpdateDate": "12/01/2010",
      "AuthorizedOfficialLastName": "TRAUSTASON",
      "AuthorizedOfficialFirstName": "OLI",
      "AuthorizedOfficialMiddleName": "I",
      "AuthorizedOfficialTitle": "PRESIDENT",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "M.D.",
      "AuthorizedOfficialTelephoneNumber": "541-548-7170",
      "TaxonomyCode1": "207W00000X",
      "Taxonomy1": "Ophthalmology",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "053857000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierState1": "OR",
      "OtherIdentifierIssuer1": "REGENCE BCBS",
      "OtherIdentifier2": "CJ8770",
      "OtherIdentifierType2": "OTHER",
      "OtherIdentifierState2": "OR",
      "OtherIdentifierIssuer2": "RAILROAD MEDICARE",
      "OtherIdentifier3": "38080A",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierState3": "OR",
      "OtherIdentifierIssuer3": "CLEAR CHOICE",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1477596252",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "EYE CARE SPECIALISTS NORTHWEST PLLC",
      "OtherOrgName": "THE CHILDRENS EYE DOCTORS, THE FAMILY EYE DOCTORS, WOODLAWN OPTICAL",
      "OtherOrgNameTypeCode": "3",
      "FirstLineMailingAddress": "17130 AVONDALE WAY NE",
      "SecondLineMailingAddress": "SUITE 111",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-6600",
      "MailingAddressFaxNumber": "425-885-6580",
      "FirstLinePracticeLocationAddress": "17130 AVONDALE WAY NE",
      "SecondLinePracticeLocationAddress": "SUITE 111",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-6600",
      "PracticeLocationAddressFaxNumber": "425-885-6580",
      "EnumerationDate": "06/13/2006",
      "LastUpdateDate": "03/03/2008",
      "AuthorizedOfficialLastName": "LENART",
      "AuthorizedOfficialFirstName": "THOMAS",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "MD PHD",
      "AuthorizedOfficialTelephoneNumber": "425-885-6600",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "156FX1800X",
      "Taxonomy2": "Optician",
      "PrimaryTaxonomySwitch2": "N",
      "TaxonomyCode3": "207W00000X",
      "Taxonomy3": "Ophthalmology",
      "PrimaryTaxonomySwitch3": "Y",
      "OtherIdentifier1": "1568514032",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "NPI",
      "OtherIdentifier2": "1740297829",
      "OtherIdentifierType2": "OTHER",
      "OtherIdentifierIssuer2": "NPI",
      "OtherIdentifier3": "1205989522",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "NPI",
      "HealthcareProviderTaxonomyGroup1": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization.",
      "HealthcareProviderTaxonomyGroup2": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription2": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization.",
      "HealthcareProviderTaxonomyGroup3": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription3": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
    },
    {
      "NPI": "1215029343",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "EYE HEALTH PROFESSIONALS, P.C.",
      "FirstLineMailingAddress": "85 BARNES RD",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "WALLINGFORD",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06492-1832",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "203-284-9448",
      "MailingAddressFaxNumber": "203-269-1361",
      "FirstLinePracticeLocationAddress": "85 BARNES RD",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "WALLINGFORD",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06492-1832",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "203-284-9448",
      "PracticeLocationAddressFaxNumber": "203-269-1361",
      "EnumerationDate": "09/28/2006",
      "LastUpdateDate": "03/07/2008",
      "AuthorizedOfficialLastName": "REDMOND",
      "AuthorizedOfficialFirstName": "JOHN",
      "AuthorizedOfficialMiddleName": "W",
      "AuthorizedOfficialTitle": "PRESIDENT",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "M.D.",
      "AuthorizedOfficialTelephoneNumber": "203-284-9448",
      "TaxonomyCode1": "207W00000X",
      "Taxonomy1": "Ophthalmology",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1982789863",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "OVERLAKE EYE DESIGNS, P.C.",
      "FirstLineMailingAddress": "15230 NE 24TH ST STE Q",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-5540",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-562-2015",
      "MailingAddressFaxNumber": "425-562-2010",
      "FirstLinePracticeLocationAddress": "15230 NE 24TH ST STE Q",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-5540",
      "PracticeLocationAddressCountryCode": "US",
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      "MailingAddressFaxNumber": "407-645-4587",
      "FirstLinePracticeLocationAddress": "7900 FOREST CITY RD",
      "PracticeLocationAddressCityName": "ORLANDO",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "32810-3002",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "407-905-8827",
      "PracticeLocationAddressFaxNumber": "407-645-4587",
      "EnumerationDate": "02/28/2006",
      "LastUpdateDate": "07/28/2017",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1223G0001X",
      "Taxonomy1": "General Practice",
      "LicenseNumber1": "DN15582",
      "LicenseNumberStateCode1": "FL",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "122300000X",
      "Taxonomy2": "Dentist",
      "LicenseNumber2": "DN15582",
      "LicenseNumberStateCode2": "FL",
      "PrimaryTaxonomySwitch2": "Y",
      "OtherIdentifier1": "075156100",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "FL"
    },
    {
      "NPI": "1720032899",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ALBATAINEH",
      "FirstName": "RANIA",
      "MiddleName": "QASSIEM",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "11476 OKEECHOBEE BLVD",
      "MailingAddressCityName": "ROYAL PALM BEACH",
      "MailingAddressStateName": "FL",
      "MailingAddressPostalCode": "33411-8715",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "561-204-5111",
      "MailingAddressFaxNumber": "561-204-5150",
      "FirstLinePracticeLocationAddress": "11476 OKEECHOBEE BLVD",
      "PracticeLocationAddressCityName": "ROYAL PALM BEACH",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "33411-8715",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "561-204-5111",
      "PracticeLocationAddressFaxNumber": "561-204-5150",
      "EnumerationDate": "05/21/2006",
      "LastUpdateDate": "09/11/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "ME 79876",
      "LicenseNumberStateCode1": "FL",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1326095100",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ROSBOROUGH",
      "FirstName": "RANIA",
      "MiddleName": "BAJWA",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "3100 WYMAN PARK DR",
      "MailingAddressCityName": "BALTIMORE",
      "MailingAddressStateName": "MD",
      "MailingAddressPostalCode": "21211-2803",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "410-338-3500",
      "FirstLinePracticeLocationAddress": "3601 SW 160TH AVE",
      "SecondLinePracticeLocationAddress": "SUITE 250",
      "PracticeLocationAddressCityName": "MIRAMAR",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "33027-6308",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "877-866-7123",
      "EnumerationDate": "05/27/2006",
      "LastUpdateDate": "12/10/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "D0063732",
      "LicenseNumberStateCode1": "MD",
      "PrimaryTaxonomySwitch1": "Y",
      "TaxonomyCode2": "207Q00000X",
      "Taxonomy2": "Family Medicine",
      "LicenseNumber2": "0101257197",
      "LicenseNumberStateCode2": "VA",
      "PrimaryTaxonomySwitch2": "N"
    },
    {
      "NPI": "1528015310",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "HUSSEINI",
      "FirstName": "RANIA",
      "MiddleName": "I",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "111 CYPRESS ST",
      "MailingAddressCityName": "BROOKLINE",
      "MailingAddressStateName": "MA",
      "MailingAddressPostalCode": "02445-6002",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "508-718-4050",
      "FirstLinePracticeLocationAddress": "20 PATRIOT PL",
      "PracticeLocationAddressCityName": "FOXBORO",
      "PracticeLocationAddressStateName": "MA",
      "PracticeLocationAddressPostalCode": "02035-1375",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "508-718-4050",
      "EnumerationDate": "05/27/2006",
      "LastUpdateDate": "04/17/2012",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "209649",
      "LicenseNumberStateCode1": "MA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1760429591",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "RAYES-DANAN",
      "FirstName": "RANIA",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "OtherLastName": "RAYES",
      "OtherFirstName": "RANIA",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2500 METROHEALTH DR",
      "MailingAddressCityName": "CLEVELAND",
      "MailingAddressStateName": "OH",
      "MailingAddressPostalCode": "44109-1900",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "216-778-7800",
      "FirstLinePracticeLocationAddress": "2500 METROHEALTH DR",
      "PracticeLocationAddressCityName": "CLEVELAND",
      "PracticeLocationAddressStateName": "OH",
      "PracticeLocationAddressPostalCode": "44109-1900",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "216-778-7800",
      "EnumerationDate": "06/01/2006",
      "LastUpdateDate": "01/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207ZP0102X",
      "Taxonomy1": "Anatomic Pathology & Clinical Pathology",
      "LicenseNumber1": "35086346",
      "LicenseNumberStateCode1": "OH",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "2687703",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "OH"
    },
    {
      "NPI": "1699717660",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "AMPEY",
      "FirstName": "RANIA",
      "MiddleName": "L",
      "Credential": "LPC",
      "FirstLineMailingAddress": "5930 LOVERS LN",
      "SecondLineMailingAddress": "PREMIER NEUROPSYCHIATRY, PLC",
      "MailingAddressCityName": "PORTAGE",
      "MailingAddressStateName": "MI",
      "MailingAddressPostalCode": "49002-1673",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "269-873-1611",
      "FirstLinePracticeLocationAddress": "5930 LOVERS LN",
      "SecondLinePracticeLocationAddress": "PREMIER NEUROPSYCHIATRY, PLC",
      "PracticeLocationAddressCityName": "PORTAGE",
      "PracticeLocationAddressStateName": "MI",
      "PracticeLocationAddressPostalCode": "49002-1673",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "269-873-1611",
      "EnumerationDate": "06/12/2006",
      "LastUpdateDate": "12/30/2010",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional",
      "LicenseNumber1": "6401007658",
      "LicenseNumberStateCode1": "MI",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1801839667",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ABOUJAOUDE",
      "FirstName": "RANIA",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "PO BOX 1283",
      "MailingAddressCityName": "MEDFORD",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08055-6283",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "609-677-1046",
      "MailingAddressFaxNumber": "609-677-1306",
      "FirstLinePracticeLocationAddress": "200 TRENTON RD",
      "PracticeLocationAddressCityName": "BROWNS MILLS",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08015-1705",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "609-677-1046",
      "PracticeLocationAddressFaxNumber": "609-677-1306",
      "EnumerationDate": "06/13/2006",
      "LastUpdateDate": "09/15/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207RI0200X",
      "Taxonomy1": "Infectious Disease",
      "LicenseNumber1": "39215",
      "LicenseNumberStateCode1": "KY",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "207RI0200X",
      "Taxonomy2": "Infectious Disease",
      "LicenseNumber2": "25MA07672000",
      "LicenseNumberStateCode2": "NJ",
      "PrimaryTaxonomySwitch2": "Y"
    },
    {
      "NPI": "1184645301",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "BAIK",
      "FirstName": "RANIA",
      "Credential": "D.O.",
      "FirstLineMailingAddress": "602 ROUTE 169",
      "SecondLineMailingAddress": "PO BOX 865",
      "MailingAddressCityName": "WOODSTOCK",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06281-2225",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "860-821-3406",
      "MailingAddressFaxNumber": "860-821-3407",
      "FirstLinePracticeLocationAddress": "602 ROUTE 169",
      "PracticeLocationAddressCityName": "WOODSTOCK",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06281-2225",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "860-821-3406",
      "PracticeLocationAddressFaxNumber": "860-821-3407",
      "EnumerationDate": "07/22/2006",
      "LastUpdateDate": "01/14/2016",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "000260",
      "LicenseNumberStateCode1": "CT",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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