RESTful Lookup — Test-Drive (2007 – 2026)

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{
  "NDC": [
    {
      "NDCCode": "13533-700-02",
      "PackageDescription": "1 KIT in 1 CARTON (13533-700-02)  *  20 mL in 1 VIAL, SINGLE-DOSE (13533-702-11)  *  20 mL in 1 VIAL, SINGLE-DOSE (13533-000-06) ",
      "NDC11Code": "13533-0700-02",
      "ProductNDC": "13533-700",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Prolastin-c",
      "NonProprietaryName": "Alpha-1-proteinase Inhibitor (human)",
      "DosageFormName": "KIT",
      "StartMarketingDate": "19871202",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103174",
      "LabelerName": "GRIFOLS USA, LLC",
      "Status": "Active",
      "LastUpdate": "2022-03-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19871202",
      "SamplePackage": "N",
      "IndicationAndUsage": "PROLASTIN-C is an Alpha1-Proteinase Inhibitor (Human) (Alpha1-PI) indicated for chronic augmentation and maintenance therapy in adults with clinical evidence of emphysema due to severe hereditary deficiency of Alpha1-PI (alpha1-antitrypsin deficiency). PROLASTIN-C increases antigenic and functional (anti-neutrophil elastase capacity, ANEC) serum levels and antigenic lung epithelial lining fluid levels of Alpha1-PI. Limitations of Use: 1 The effect of augmentation therapy with any Alpha1-PI, including PROLASTIN-C, on pulmonary exacerbations and on the progression of emphysema in Alpha1-PI deficiency has not been conclusively demonstrated in randomized, controlled clinical trials., 2 Clinical data demonstrating the long-term effects of chronic augmentation or maintenance therapy with PROLASTIN-C are not available., 3 PROLASTIN-C is not indicated as therapy for lung disease in patients in whom severe Alpha1-PI deficiency has not been established.",
      "Description": "PROLASTIN-C is a sterile, white to beige-colored concentrate of Alpha1-PI in lyophilized powder form for reconstitution for intravenous infusion. Each vial contains approximately 1,000 mg of functionally active Alpha1-PI as determined by capacity to neutralize porcine pancreatic elastase.  The specific activity of PROLASTIN-C is ≥ 0.7 mg functional Alpha1-PI per mg of total protein. PROLASTIN-C has a purity of ≥ 90% Alpha1-PI (Alpha1-PI protein/total protein). When reconstituted with 20 mL of Sterile Water for Injection, USP, PROLASTIN-C has a pH of 6.6–7.4, a sodium content of 100–210 mM, a chloride content of 60–180 mM and a sodium phosphate content of 13–25 mM. PROLASTIN-C contains no preservative. PROLASTIN-C is produced from pooled human plasma through modifications of the PROLASTIN process using purification by polyethylene glycol (PEG) precipitation, anion exchange chromatography, and cation exchange chromatography. All Source Plasma used in the manufacture of PROLASTIN-C is non-reactive (negative) by FDA-licensed serological test methods for hepatitis B surface antigen (HBsAg) and antibodies to hepatitis C virus (HCV) and human immunodeficiency virus types 1 and 2 and negative by FDA-licensed Nucleic Acid Technologies (NAT) for HCV and human immunodeficiency virus type 1 (HIV-1). In addition, all Source Plasma is negative for hepatitis B virus (HBV) by either an FDA-licensed or investigational NAT assay. The goal of the investigational HBV NAT test is to detect low levels of viral nucleic acid; however, the significance of a negative result for the investigational HBV NAT test has not been established. By in-process NAT, all Source Plasma is negative for hepatitis A virus (HAV). As a final plasma safety step, all plasma manufacturing pools are tested by serological test methods and NAT. To evaluate further the virus safety profile of PROLASTIN-C, in vitro studies have been conducted to validate the capacity of the manufacturing process to reduce the infectious titer of a wide range of viruses with diverse physicochemical properties. These studies evaluated the inactivation/removal of clinically relevant viruses, including human immunodeficiency virus type 1 (HIV-1) and hepatitis A virus (HAV), as well as the following model viruses: bovine viral diarrhea virus (BVDV), a surrogate for hepatitis C virus; pseudorabies virus (PRV), a surrogate for large enveloped DNA viruses (e.g., herpes viruses); vesicular stomatitis virus (VSV), a model for enveloped viruses; reovirus type 3 (Reo3), a non-specific model for non-enveloped viruses; and porcine parvovirus (PPV), a model for human parvovirus B19. The PROLASTIN-C manufacturing process has several steps (Cold Ethanol Fractionation, PEG Precipitation, and Depth Filtration) that are important for purifying Alpha1-PI as well as removing potential virus contaminants. Two additional steps, Solvent/Detergent Treatment and 15 nm Virus Removal Nanofiltration, are included in the process as dedicated pathogen reduction steps. The Solvent/Detergent Treatment step effectively inactivates enveloped viruses (such as HIV-1, VSV, HBV, and HCV). The 15 nm Virus Removal Nanofiltration step has been implemented to reduce the risk of transmission of enveloped and non-enveloped viruses as small as 18 nm. The table below presents the virus reduction capacity of each process step and the accumulated virus reduction for the process as determined in viral validation studies in which virus was deliberately added to a process model in order to study virus reduction. In addition, the Solvent/Detergent Treatment step inactivates ≥ 5.4 log10 of West Nile virus, a clinically relevant enveloped virus. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the variant Creutzfeldt-Jakob disease (vCJD) and Creutzfeldt-Jakob disease (CJD) agents. Studies of the PROLASTIN-C manufacturing process demonstrate that a minimum of 6 log10 reduction of TSE infectivity is achieved. These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed."
    },
    {
      "NDCCode": "13533-700-01",
      "PackageDescription": "1 KIT in 1 CARTON (13533-700-01)  *  20 mL in 1 VIAL, SINGLE-DOSE *  20 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "13533-0700-01",
      "ProductNDC": "13533-700",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Prolastin-c",
      "NonProprietaryName": "Alpha-1-proteinase Inhibitor Human",
      "DosageFormName": "KIT",
      "StartMarketingDate": "19871202",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103174",
      "LabelerName": "GRIFOLS USA, LLC",
      "Status": "Deprecated",
      "LastUpdate": "2014-09-26"
    },
    {
      "NDCCode": "13533-502-01",
      "PackageDescription": "1 KIT in 1 CARTON (13533-502-01)  *  50 mL in 1 VIAL, GLASS (13533-503-02)  *  50 mL in 1 VIAL, GLASS (13533-200-50) ",
      "NDC11Code": "13533-0502-01",
      "ProductNDC": "13533-502",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Fesilty",
      "NonProprietaryName": "Fibrinogen, Human-chmt",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20251216",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125833",
      "LabelerName": "Grifols USA LLC",
      "Status": "Active",
      "LastUpdate": "2026-08-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20251216",
      "SamplePackage": "N",
      "IndicationAndUsage": "FESILTY is indicated for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including hypo- or afibrinogenemia.Limitations of Use: FESILTY is not indicated for dysfibrinogenemia.",
      "Description": "FESILTY (fibrinogen, human – chmt), is a purified, sterile, non-pyrogenic, lyophilized powder of human fibrinogen for reconstitution for intravenous administration. Human fibrinogen is purified from Source Plasma from the cryoprecipitate fraction and processed using a combination of aluminum hydroxide purification, solvent/detergent (S/D) treatment, anion and cation exchange chromatography, glycine precipitation, and Ultraviolet (UV)-C irradiation. FESILTY is supplied in a single-dose vial containing nominally 1 gram of fibrinogen. The actual amount of fibrinogen is printed on the vial label and carton in milligrams fibrinogen per vial. When reconstituted with 50 mL sterile water for injection, FESILTY contains approximately 20 mg/mL protein, of which not less than 80% is fibrinogen monomer. Each vial of FESILTY also contains 421.3 mg arginine hydrochloride, 292.2 mg sodium chloride, 73.5 mg sodium citrate dihydrate, 25.5 mg polysorbate 80, and 567.5 mg trehalose dihydrate. FESILTY has a pH of 6.5 to 7.5 and an osmolality of ≥ 240 mOsmol/kg. FESILTY does not contain preservatives and is not made with natural rubber latex.FESILTY is prepared from pooled Source Plasma obtained from healthy volunteer donors. Each plasma donation used for the manufacture of FESILTY is collected from FDA-licensed facilities. Plasma donations must test negative for hepatitis B virus (HBV) surface antigen (HBsAg), antibodies to human immunodeficiency virus (HIV) strains 1 and 2 (anti-HIV-1/2), and antibodies to the hepatitis C virus (anti-HCV) as determined by enzyme immunoassay (EIA). In addition, samples from manufacturing pools must test non-reactive for HIV RNA, HCV RNA, HBV DNA, and Hepatitis A Virus (HAV) RNA, by Nucleic Acid Amplification Testing (NAT). Parvovirus B19 (B19V) DNA is also tested by NAT and must not exceed 104 IU/mL in the manufacturing pool.The manufacturing process for FESILTY employs several steps to remove/inactivate adventitious viruses to further increase the margins of safety. These steps include S/D treatment, UV-C irradiation, and heat treatment of lyophilized fibrinogen. Virus clearance studies with a scaled-down process have been performed for these steps to determine their capacity to inactivate or remove both enveloped and non-enveloped viruses. The results are shown in Table 3. The manufacturing process was also investigated for its capacity to reduce the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered a model for CJD and its variant, vCJD. One chromatographic purification step has been shown to reduce TSE infectivity of an experimental model agent. These studies provide reasonable assurance that low levels (at least 3.27 log10) of vCJD/CJD agent infectivity, if present in the starting material, would be removed."
    },
    {
      "NDCCode": "13533-618-02",
      "PackageDescription": "1 VIAL, GLASS in 1 CARTON (13533-618-02)  > 2 mL in 1 VIAL, GLASS (13533-618-20) ",
      "NDC11Code": "13533-0618-02",
      "ProductNDC": "13533-618",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Hyperrab",
      "ProprietaryNameSuffix": "S/d",
      "NonProprietaryName": "Rabies Immune Globulin (human)",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "19960814",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101144",
      "LabelerName": "GRIFOLS USA, LLC",
      "SubstanceName": "HUMAN RABIES VIRUS IMMUNE GLOBULIN",
      "StrengthNumber": "150",
      "StrengthUnit": "[iU]/mL",
      "Status": "Active",
      "LastUpdate": "2022-11-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19960814",
      "SamplePackage": "N",
      "IndicationAndUsage": "Rabies vaccine and HyperRAB S/D should be given to all persons suspected of exposure to rabies with one exception: persons who have been previously immunized with rabies vaccine and have a confirmed adequate rabies antibody titer should receive only vaccine. HyperRAB S/D should be administered as promptly as possible after exposure, but can be administered up to the eighth day after the first dose of vaccine is given. Recommendations for use of passive and active immunization after exposure to an animal suspected of having rabies have been detailed by the U.S. Public Health Service Advisory Committee on Immunization Practices (ACIP). [19]. Every exposure to possible rabies infection must be individually evaluated. The following factors should be considered before specific antirabies treatment is initiated.",
      "Description": "Rabies Immune Globulin (Human) — HyperRAB® S/D treated with solvent/detergent is a colorless to pale yellow or pink sterile solution of antirabies immune globulin for intramuscular administration; it is preservative-free and latex-free. HyperRAB S/D is prepared by cold ethanol fractionation from the plasma of donors hyperimmunized with rabies vaccine. The immune globulin is isolated from solubilized Cohn Fraction II. The Fraction II solution is adjusted to a final concentration of 0.3% tri-n-butyl phosphate (TNBP) and 0.2% sodium cholate. After the addition of solvent (TNBP) and detergent (sodium cholate), the solution is heated to 30°C and maintained at that temperature for not less than 6 hours. After the viral inactivation step, the reactants are removed by precipitation, filtration and finally ultrafiltration and diafiltration. HyperRAB S/D is formulated as a 15–18% protein solution at a pH of 6.4–7.2 in 0.21–0.32 M glycine. HyperRAB S/D is then incubated in the final container for 21–28 days at 20–27°C. The product is standardized against the U.S. Standard Rabies Immune Globulin to contain an average potency value of 150 IU/mL. The U.S. unit of potency is equivalent to the international unit (IU) for rabies antibody. The removal and inactivation of spiked model enveloped and non-enveloped viruses during the manufacturing process for HyperRAB S/D has been validated in laboratory studies. Human Immunodeficiency Virus, Type 1 (HIV-1), was chosen as the relevant virus for blood products; Bovine Viral Diarrhea Virus (BVDV) was chosen to model Hepatitis C virus; Pseudorabies virus (PRV) was chosen to model Human Herpes viruses and other large enveloped DNA viruses; and Reo virus type 3 (Reo) was chosen to model non-enveloped viruses and for its resistance to physical and chemical inactivation. Significant removal of model enveloped and non-enveloped viruses is achieved at two steps in the Cohn fractionation process leading to the collection of Cohn Fraction II: the precipitation and removal of Fraction III in the processing of Fraction II + IIIW suspension to Effluent III and the filtration step in the processing of Effluent III to Filtrate III. Significant inactivation of enveloped viruses is achieved at the time of treatment of solubilized Cohn Fraction II with TNBP/sodium cholate. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents. [27-30]. Studies of the HyperRAB S/D manufacturing process demonstrate that TSE clearance is achieved during the Pooled Plasma to Effluent III Fractionation Process (6.7 log10). These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed."
    },
    {
      "NDCCode": "13533-631-02",
      "PackageDescription": "1 SYRINGE in 1 CARTON (13533-631-02)  / 1 mL in 1 SYRINGE (13533-631-20) ",
      "NDC11Code": "13533-0631-02",
      "ProductNDC": "13533-631",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Hyperrho",
      "ProprietaryNameSuffix": "Full Dose",
      "NonProprietaryName": "Rho(d) Immune Globulin (human)",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "19960814",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101141",
      "LabelerName": "GRIFOLS USA, LLC",
      "SubstanceName": "HUMAN RHO(D) IMMUNE GLOBULIN",
      "StrengthNumber": "1500",
      "StrengthUnit": "[iU]/mL",
      "Pharm_Classes": "Endogenous Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
      "Status": "Active",
      "LastUpdate": "2025-07-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19960814",
      "SamplePackage": "N",
      "IndicationAndUsage": "HyperRHO Full Dose is recommended for the prevention of Rh hemolytic disease of the newborn by its administration to the Rho(D) negative mother within 72 hours after birth of an Rho(D) positive infant,(13) providing the following criteria are met: 1 The mother must be Rho(D) negative and must not already be sensitized to the Rho(D) factor., 2 Her child must be Rho(D) positive, and should have a negative direct antiglobulin test (see PRECAUTIONS). .",
      "Description": "Rho(D) Immune Globulin (Human) — HyperRHO® Full Dose is a clear or slightly opalescent and, colorless or pale yellow sterile solution of human rho(D) immune globulin containing antibodies to Rho(D) for intramuscular administration; it contains no preservative. HyperRHO Full Dose is prepared from pools of human plasma collected from healthy donors by a combination of cold ethanol fractionation, caprylate precipitation and filtration, caprylate incubation, anion exchange chromatography, nanofiltration and low pH incubation. HyperRHO Full Dose is formulated as a 15% to 18% protein solution at a pH of 4.1 to 4.8 in 0.16 M to 0.26 M glycine. The potency is equal to or greater than 1500 IU (300 mcg) per 1 mL. Each single-dose syringe contains sufficient anti-Rho(D) to effectively suppress the immunizing potential of 15 mL of Rho(D) positive red blood cells.(1-4). When medicinal biological products are administered, the risk of infectious diseases due to transmission of pathogens cannot be totally excluded. However, in the case of products prepared from human plasma, the risk of transmission of pathogens is reduced by epidemiological surveillance of the donor population and selection of individual donors by medical interview; testing of individual donations and plasma pools; and the presence in the manufacturing processes of steps with demonstrated capacity to inactivate/remove pathogen. In the manufacturing process of HyperRHO Full Dose, there are several steps with the capacity for viral inactivation or removal.(5) The main steps of the manufacturing process that contribute to the virus clearance capacity are as follows: 1 Caprylate precipitation/depth filtration , 2 Caprylate incubation , 3 Depth filtration , 4 Column chromatography , 5 Nanofiltration , 6 Low pH final container incubation."
    },
    {
      "NDCCode": "13533-634-02",
      "PackageDescription": "1 SYRINGE, GLASS in 1 BOX (13533-634-02)  / 1 mL in 1 SYRINGE, GLASS (13533-634-20) ",
      "NDC11Code": "13533-0634-02",
      "ProductNDC": "13533-634",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Hypertet",
      "NonProprietaryName": "Tetanus Immune Globulin (human)",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "19960814",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101142",
      "LabelerName": "GRIFOLS USA, LLC",
      "SubstanceName": "HUMAN CLOSTRIDIUM TETANI TOXOID IMMUNE GLOBULIN",
      "StrengthNumber": "250",
      "StrengthUnit": "[iU]/mL",
      "Status": "Active",
      "LastUpdate": "2024-10-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19960814",
      "SamplePackage": "N",
      "IndicationAndUsage": "HyperTET is indicated for prophylaxis against tetanus following injury in patients whose immunization is incomplete or uncertain (see below). It is also indicated, although evidence of effectiveness is limited, in the regimen of treatment of active cases of tetanus.(8,9,16). A thorough attempt must be made to determine whether a patient has completed primary vaccination. Patients with unknown or uncertain previous vaccination histories should be considered to have had no previous tetanus toxoid doses. Persons who had military service since 1941 can be considered to have received at least one dose, and although most of them may have completed a primary series of tetanus toxoid, this cannot be assumed for each individual. Patients who have not completed a primary series may require tetanus toxoid and passive immunization at the time of wound cleaning and debridement.(3). The following table is a summary guide to tetanus prophylaxis in wound management.",
      "Description": "Tetanus Immune Globulin (Human) — HyperTET® is a clear or slightly opalescent, and colorless or pale yellow sterile solution of human tetanus immune globulin for intramuscular administration. HyperTET contains no preservative.  HyperTET is prepared from pools of human plasma collected from healthy donors by a combination of cold ethanol fractionation, caprylate precipitation and filtration, caprylate incubation, anion exchange chromatography, nanofiltration and low pH incubation. HyperTET consists of a 15% to 18% protein solution at a pH of 4.1 to 4.8 in 0.16 M to 0.26 M glycine. The product is standardized against the U.S. Standard Antitoxin and the U.S. Control Tetanus Toxin and contains not less than 250 tetanus antitoxin units per 1 mL. When medicinal biological products are administered, the risk of infectious diseases due to transmission of pathogens cannot be totally excluded. However, in the case of products  prepared from human plasma, the risk of transmission of pathogens is reduced by epidemiological surveillance of the donor population and selection of individual donors by medical interview; testing of individual donations and plasma pools; and the presence in the manufacturing processes of steps with demonstrated capacity to inactivate/remove pathogen. In the manufacturing process of HyperTET, there are several steps with the capacity for viral inactivation or removal.(1) The main steps of the manufacturing process that contribute to the virus clearance capacity are as follows: 1 Caprylate precipitation/depth filtration, 2 Caprylate incubation, 3 Depth filtration, 4 Column chromatography, 5 Nanofiltration, 6 Low pH final container incubation."
    },
    {
      "NDCCode": "13533-635-02",
      "PackageDescription": "10 VIAL in 1 CARTON (13533-635-02)  > 2 mL in 1 VIAL (13533-635-40) ",
      "NDC11Code": "13533-0635-02",
      "ProductNDC": "13533-635",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Gamastan",
      "ProprietaryNameSuffix": "S/d",
      "NonProprietaryName": "Immune Globulin (human)",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "19960814",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101134",
      "LabelerName": "GRIFOLS USA, LLC",
      "SubstanceName": "HUMAN IMMUNOGLOBULIN G",
      "StrengthNumber": ".165",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-06-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "13533-636-02",
      "PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (13533-636-02)  / 1 mL in 1 SYRINGE, GLASS (13533-636-20) ",
      "NDC11Code": "13533-0636-02",
      "ProductNDC": "13533-636",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Hyperhep B",
      "NonProprietaryName": "Hepatitis B Immune Globulin (human)",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "19961009",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101146",
      "LabelerName": "GRIFOLS USA, LLC",
      "SubstanceName": "HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN",
      "StrengthNumber": "220",
      "StrengthUnit": "[iU]/mL",
      "Pharm_Classes": "Human Immunoglobulin [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE], Virus Neutralization [MoA], Virus-specific Hyperimmune Globulins [EXT]",
      "Status": "Active",
      "LastUpdate": "2024-10-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19961009",
      "SamplePackage": "N",
      "IndicationAndUsage": "Recommendations on post-exposure prophylaxis are based on available efficacy data and on the likelihood of future HBV exposure for the person requiring treatment. In all exposures, a regimen combining Hepatitis B Immune Globulin (Human) with hepatitis B vaccine will provide both short- and long-term protection, will be less costly than the two-dose Hepatitis B Immune Globulin (Human) treatment alone, and is the treatment of choice.(9). HyperHEP B is indicated for post-exposure prophylaxis in the following situations.",
      "Description": "Hepatitis B Immune Globulin (Human) — HyperHEP B® is a clear or slightly opalescent, and colorless or pale yellow sterile solution of human hepatitis B immune globulin for intramuscular administration. HyperHEP B contains no preservative. HyperHEP B is prepared from pools of human plasma collected from healthy donors by a combination of  cold ethanol fractionation, caprylate precipitation and filtration, caprylate incubation, anion exchange chromatography, nanofiltration and low pH incubation. HyperHEP B consists of a 15% to 18% protein solution at a pH of 4.1 to 4.8 in 0.16 M to 0.26 M glycine. The product contains anti-HBs antibody equivalent to or exceeding the potency of anti-HBs in a U.S. reference hepatitis B immune globulin (Center for Biologics Evaluation and Research, FDA). The U.S. reference has been tested against the World Health Organization standard Hepatitis B Immune Globulin and found to be equal to 220 international units (IU) per mL. When medicinal biological products are administered, the risk of infectious diseases due to transmission of pathogens cannot be totally excluded. However, in the case of products  prepared from human plasma, the risk of transmission of pathogens is reduced by epidemiological surveillance of the donor population and selection of individual donors by medical interview; testing of individual donations and plasma pools; and the presence in the manufacturing processes of steps with demonstrated capacity to inactivate/remove pathogen. In the manufacturing process of HyperHEP B, there are several steps with the capacity for viral inactivation or removal.(1) The main steps of the manufacturing process that contribute to the virus clearance capacity are as follows: 1 Caprylate precipitation/depth filtration, 2 Caprylate incubation, 3 Depth filtration, 4 Column chromatography, 5 Nanofiltration, 6 Low pH final container incubation."
    },
    {
      "NDCCode": "10893-700-02",
      "PackageDescription": "2 PACKET in 1 CARTON (10893-700-02)  / 141.7 g in 1 PACKET",
      "NDC11Code": "10893-0700-02",
      "ProductNDC": "10893-700",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Naturasil Sulfur Lavender Multi-purpose Relief 5 Oz 2 Pk",
      "NonProprietaryName": "Sulfur, Thuja Occidentalis",
      "DosageFormName": "SOAP",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20260529",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Nature's Innovation, Inc.",
      "SubstanceName": "SULFUR; CEDAR LEAF OIL",
      "StrengthNumber": "1; 6",
      "StrengthUnit": "[hp_X]/141.7g; [hp_X]/141.7g",
      "Status": "Active",
      "LastUpdate": "2026-06-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260529",
      "SamplePackage": "N",
      "IndicationAndUsage": "Symptomatic homeopathic topical treatment of common fungal and parasitic skin conditions and nail fungus."
    },
    {
      "NDCCode": "10920-700-02",
      "PackageDescription": "2 BAG in 1 DRUM (10920-700-02)  / 1 BAG in 1 BAG / 5 kg in 1 BAG",
      "NDC11Code": "10920-0700-02",
      "ProductNDC": "10920-700",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Esketamine Hydrochloride",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20220112",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Arevipharma GmbH",
      "SubstanceName": "ESKETAMINE HYDROCHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "DEASchedule": "CIII",
      "Status": "Unfinished",
      "LastUpdate": "2025-04-10",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "12-JAN-22"
    },
    {
      "NDCCode": "11084-700-02",
      "PackageDescription": "47 mL in 1 BOTTLE, PLASTIC (11084-700-02)",
      "NDC11Code": "11084-0700-02",
      "ProductNDC": "11084-700",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Deb Instantfoam Alcohol Sanitizer",
      "NonProprietaryName": "Ethyl Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20120515",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "Deb USA, Inc.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2017-10-16"
    },
    {
      "NDCCode": "14789-700-02",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (14789-700-02)  / 2 mL in 1 VIAL, SINGLE-DOSE (14789-700-07) ",
      "NDC11Code": "14789-0700-02",
      "ProductNDC": "14789-700",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prochlorperazine Edisylate",
      "NonProprietaryName": "Prochlorperazine Edisylate",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20190225",
      "EndMarketingDate": "20260101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204860",
      "LabelerName": "Nexus Pharmaceuticals LLC",
      "SubstanceName": "PROCHLORPERAZINE EDISYLATE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20190225",
      "EndMarketingDatePackage": "20260101",
      "SamplePackage": "N",
      "IndicationAndUsage": "To control severe nausea and vomiting. For the treatment of schizophrenia. Prochlorperazine has not been shown effective in the management of behavioral complications in patients with mental retardation.",
      "Description": "Prochlorperazine edisylate, 2-Chloro-10-[3-(4-methyl-1-piperazinyl)propyl] phenothiazine 1,2-ethanedisulfonate (1:1), has the following structural formula. Prochlorperazine Edisylate Injection, an antiemetic and antipsychotic, is a sterile solution intended for intramuscular or intravenous administration. Each mL contains prochlorperazine 5 mg as the edisylate, monobasic sodium phosphate monohydrate 5 mg, sodium tartrate dihydrate 12 mg, saccharin sodium 0.9 mg and benzyl alcohol 7.5 mg in Water for Injection. pH 4.2-6.2."
    },
    {
      "NDCCode": "17271-700-02",
      "PackageDescription": "60 BAG in 1 CASE (17271-700-02)  / 50 mL in 1 BAG",
      "NDC11Code": "17271-0700-02",
      "ProductNDC": "17271-700",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Chloride",
      "NonProprietaryName": "Sodium Chloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20180723",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208122",
      "LabelerName": "Becton Dickinson and Company",
      "SubstanceName": "SODIUM CHLORIDE",
      "StrengthNumber": "450",
      "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": "2024-08-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180723",
      "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.",
      "Description": "0.45% Sodium Chloride Injection, USP solution is a sterile and nonpyrogenic solution intended for intravenous administration. Each 100 mL of 0.45% Sodium Chloride Injection, USP contains 450 mg sodium chloride in water for injection. Electrolytes per 1,000 mL: sodium 77 mEq; chloride 77 mEq. The osmolarity is 154 mOsmol/L (calc.). The pH in the 100 mL and smaller containers is 6.0; for the 250 mL and larger containers, the pH is 5.6. The pH range is 4.5 to 7.0 for all containers. The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded. 0.45% Sodium Chloride Injection, USP is a parenteral fluid and electrolyte replenisher. 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 non-plasticized, film containing polypropylene and thermoplastic elastomers (freeflex® bag). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers."
    },
    {
      "NDCCode": "21749-700-02",
      "PackageDescription": "24 BOTTLE in 1 CASE (21749-700-02)  > 59 mL in 1 BOTTLE",
      "NDC11Code": "21749-0700-02",
      "ProductNDC": "21749-700",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Purell Advanced Instant Hand Sanitizer",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110510",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "GOJO Industries, Inc.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": ".7",
      "StrengthUnit": "mL/mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-12-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20110510",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hand sanitizer to help reduce bacteria on the skin that could cause disease."
    },
    {
      "NDCCode": "24338-700-10",
      "PackageDescription": "10 BLISTER PACK in 1 CARTON (24338-700-10)  > 2 TABLET, EFFERVESCENT in 1 BLISTER PACK (24338-700-02)",
      "NDC11Code": "24338-0700-10",
      "ProductNDC": "24338-700",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cetylev",
      "NonProprietaryName": "Acetylcysteine",
      "DosageFormName": "TABLET, EFFERVESCENT",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160627",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA207916",
      "LabelerName": "Arbor Pharmaceuticals",
      "SubstanceName": "ACETYLCYSTEINE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-04-03",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "43063-700-02",
      "PackageDescription": "2 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-700-02) ",
      "NDC11Code": "43063-0700-02",
      "ProductNDC": "43063-700",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Azithromycin",
      "NonProprietaryName": "Azithromycin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20051114",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065212",
      "LabelerName": "PD-Rx Pharmaceuticals, Inc.",
      "SubstanceName": "AZITHROMYCIN MONOHYDRATE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Macrolide Antimicrobial [EPC],Macrolides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2021-12-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20160804",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "43386-700-02",
      "PackageDescription": "1 BOTTLE in 1 CONTAINER (43386-700-02)  / 177 mL in 1 BOTTLE",
      "NDC11Code": "43386-0700-02",
      "ProductNDC": "43386-700",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Sulfate, Potassium Sulfate, Magnesium Sulfate",
      "NonProprietaryName": "Sodium Sulfate, Potassium Sulfate, Magnesium Sulfate",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20221230",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202511",
      "LabelerName": "Lupin Pharmaceuticals, Inc.",
      "SubstanceName": "MAGNESIUM SULFATE ANHYDROUS; POTASSIUM SULFATE; SODIUM SULFATE",
      "StrengthNumber": "1.6; 3.13; 17.5",
      "StrengthUnit": "g/177mL; g/177mL; g/177mL",
      "Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2025-12-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20221230",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is indicated for cleansing of the colon as a preparation for colonoscopy in adults.",
      "Description": "Each Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution contains two 6 ounce bottles of solution. Each 6 ounce bottle contains: sodium sulfate 17.5 grams, potassium sulfate 3.13 grams, magnesium sulfate 1.6 grams. Inactive ingredients include: sodium benzoate, sucralose, malic acid, citric acid, lemon flavor, purified water. The solution is a clear to slightly hazy liquid. The solution is clear and colorless when diluted to a final volume of 16 ounces with water. Sodium Sulfate, USP. The chemical name is Na2SO4. The average Molecular Weight is 142.04. The structural formula is. Potassium Sulfate, FCC, Granular. The chemical name is K2SO4. The average Molecular Weight is 174.26. The structural formula is. Magnesium Sulfate, USP. The chemical name is MgSO4. The average Molecular Weight: 120.37. The structural formula is. Each Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution package also contains a polypropylene mixing container."
    },
    {
      "NDCCode": "45802-700-02",
      "PackageDescription": "1 TUBE in 1 CARTON (45802-700-02)  / 100 g in 1 TUBE",
      "NDC11Code": "45802-0700-02",
      "ProductNDC": "45802-700",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tacrolimus",
      "NonProprietaryName": "Tacrolimus",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20141120",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA050777",
      "LabelerName": "Padagis Israel Pharmaceuticals Ltd",
      "SubstanceName": "TACROLIMUS",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2023-05-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20141120",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tacrolimus Ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. Tacrolimus Ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGS and PRECAUTIONS: Pediatric Use).",
      "Description": "Tacrolimus Ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10, 12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone,monohydrate. It has the following structural formula. Tacrolimus has an empirical formula of C44H69NO12∙H2O and a formula weight of 822.03. Each gram of Tacrolimus Ointment contains (w/w) either 0.03% or 0.1% of tacrolimus in a base of mineral oil with all-rac-α-tocopherol, paraffin, propylene carbonate, white petrolatum with butylhydroxytoluene, and white wax."
    },
    {
      "NDCCode": "49283-700-02",
      "PackageDescription": "59 mL in 1 BOTTLE, PUMP (49283-700-02) ",
      "NDC11Code": "49283-0700-02",
      "ProductNDC": "49283-700",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ethyl Alcohol",
      "NonProprietaryName": "Ethyl Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200707",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Chemco Corporation",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200707",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "49349-700-02",
      "PackageDescription": "30 TABLET in 1 BLISTER PACK (49349-700-02)",
      "NDC11Code": "49349-0700-02",
      "ProductNDC": "49349-700",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Benztropine Mesylate",
      "NonProprietaryName": "Benztropine Mesylate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110406",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040715",
      "LabelerName": "REMEDYREPACK INC.",
      "SubstanceName": "BENZTROPINE MESYLATE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "49657-700-02",
      "PackageDescription": "2 kg in 1 DRUM (49657-700-02)",
      "NDC11Code": "49657-0700-02",
      "ProductNDC": "49657-700",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Reserpine Crystalline",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20080801",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "ALCON BIOSCIENCES PVT LTD",
      "SubstanceName": "RESERPINE",
      "StrengthNumber": "2",
      "StrengthUnit": "kg/2kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "51167-700-02",
      "PackageDescription": "4 CARTON in 1 BOX (51167-700-02)  / 7 BLISTER PACK in 1 CARTON / 4 TABLET, FILM COATED in 1 BLISTER PACK",
      "NDC11Code": "51167-0700-02",
      "ProductNDC": "51167-700",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Orkambi",
      "NonProprietaryName": "Lumacaftor And Ivacaftor",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160928",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA206038",
      "LabelerName": "Vertex Pharmaceuticals Incorporated",
      "SubstanceName": "LUMACAFTOR; IVACAFTOR",
      "StrengthNumber": "100; 125",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Chloride Channel Activation Potentiators [MoA], Cystic Fibrosis Transmembrane Conductance Regulator Potentiator [EPC], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inducers [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-03-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20160928",
      "SamplePackage": "N",
      "IndicationAndUsage": "ORKAMBI is indicated for the treatment of cystic fibrosis (CF) in patients aged 1 year and older who are homozygous for the F508del mutation in the CFTR gene. If the patient's genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of the F508del mutation on both alleles of the CFTR gene.",
      "Description": "The active ingredients in ORKAMBI tablets are lumacaftor, which has the following chemical name: 3-[6-({[1-(2,2-difluoro-1,3-benzodioxol-5-yl)cyclopropyl]carbonyl}amino)-3-methylpyridin-2-yl]benzoic acid, and ivacaftor, a CFTR potentiator, which has the following chemical name: N-(2,4-di-tert-butyl-5-hydroxyphenyl)-1,4-dihydro-4-oxoquinoline-3-carboxamide. The molecular formula for lumacaftor is C24H18F2N2O5 and for ivacaftor is C24H28N2O3. The molecular weights for lumacaftor and ivacaftor are 452.41 and 392.49, respectively. The structural formulas are. Lumacaftor is a white to off-white powder that is practically insoluble in water (0.02 mg/mL). Ivacaftor is a white to off-white powder that is practically insoluble in water (<0.05 µg/mL). ORKAMBI is available as a pink, oval-shaped, film-coated tablet for oral administration containing 200 mg of lumacaftor and 125 mg of ivacaftor. Each ORKAMBI tablet contains 200 mg of lumacaftor and 125 mg of ivacaftor, and the following inactive ingredients: cellulose, microcrystalline; croscarmellose sodium; hypromellose acetate succinate; magnesium stearate; povidone; and sodium lauryl sulfate. The tablet film coat contains carmine, FD&C Blue #1, FD&C Blue #2, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. The printing ink contains ammonium hydroxide, iron oxide black, propylene glycol, and shellac. ORKAMBI is also available as a pink, oval-shaped, film-coated tablet for oral administration containing 100 mg of lumacaftor and 125 mg of ivacaftor. Each ORKAMBI tablet contains 100 mg of lumacaftor and 125 mg of ivacaftor, and the following inactive ingredients: cellulose, microcrystalline; croscarmellose sodium; hypromellose acetate succinate; magnesium stearate; povidone; and sodium lauryl sulfate. The tablet film coat contains carmine, FD&C Blue #1, FD&C Blue #2, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. The printing ink contains ammonium hydroxide, iron oxide black, propylene glycol, and shellac. ORKAMBI is also available as white to off-white granules for oral administration and enclosed in a unit-dose packet containing lumacaftor 75 mg/ivacaftor 94 mg, lumacaftor 100 mg/ivacaftor 125 mg or lumacaftor 150 mg/ivacaftor 188 mg per packet. Each unit-dose packet of ORKAMBI oral granules contains lumacaftor 75 mg/ivacaftor 94 mg, lumacaftor 100 mg/ivacaftor 125 mg or lumacaftor 150 mg/ivacaftor 188 mg per packet and the following inactive ingredients: cellulose, microcrystalline; croscarmellose sodium; hypromellose acetate succinate; povidone; and sodium lauryl sulfate."
    },
    {
      "NDCCode": "51414-700-02",
      "PackageDescription": "7 g in 1 PACKAGE (51414-700-02) ",
      "NDC11Code": "51414-0700-02",
      "ProductNDC": "51414-700",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lens Cleaner",
      "NonProprietaryName": "Isopropyl Alcohol",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20121128",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part344",
      "LabelerName": "Yuyao Jessie Commodity Co.,Ltd.",
      "SubstanceName": "ISOPROPYL ALCOHOL",
      "StrengthNumber": "15",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20180105",
      "SamplePackage": "N",
      "IndicationAndUsage": "Clean smudged and dirty lenses at your convenience with these handy individual packets.Also ,ideal for use on cameras,camcorders,computer&TV screens."
    },
    {
      "NDCCode": "52641-700-02",
      "PackageDescription": "75 PACKET in 1 BOX (52641-700-02)  > 1.2 mL in 1 PACKET",
      "NDC11Code": "52641-0700-02",
      "ProductNDC": "52641-700",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Antiseptic",
      "NonProprietaryName": "Isopropyl Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110623",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "ReliaMed",
      "SubstanceName": "ISOPROPYL ALCOHOL",
      "StrengthNumber": ".56118",
      "StrengthUnit": "g/mL",
      "Status": "Deprecated",
      "LastUpdate": "2021-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20110623",
      "SamplePackage": "N",
      "IndicationAndUsage": "For preparation of the skin prior to injection or venipuncture."
    },
    {
      "NDCCode": "52793-700-02",
      "PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (52793-700-02)  > 60 mL in 1 BOTTLE, SPRAY",
      "NDC11Code": "52793-0700-02",
      "ProductNDC": "52793-700",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ahealon",
      "NonProprietaryName": "Arnica Montana, Calendula Officinalis Flowering Top, Echinacea Angustifolia, St. Johns Wort, Silver, Sulfur, Allylthiourea And Urtica Urens",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20120409",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "PRINCETON BIOTECHNOLOGY CORPORATION",
      "SubstanceName": "ALLYLTHIOUREA; ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; SILVER; ST. JOHN'S WORT; SULFUR; URTICA URENS",
      "StrengthNumber": "30; 30; 30; 30; 30; 30; 30; 30",
      "StrengthUnit": "[kp_C]/60mL; [kp_C]/60mL; [kp_C]/60mL; [kp_C]/60mL; [kp_C]/60mL; [kp_C]/60mL; [kp_C]/60mL; [kp_C]/60mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20120409",
      "SamplePackage": "N",
      "IndicationAndUsage": "AHEALON is indicated for the acute and chronic treatment of pain and or inflammation, as well as a general healing aid, an infection deterrent, an agent to help reduce scar tissue and a source of moisturization (dry/cracked/burned skin), that include: all burn injuries, radiation dermatitis, surgical incisions, rashes, pruritic conditions, arthritis/joint pain, lower back pain, wounds, pressure sores, tumors, neuropathic discomfort and any generally painful and or inflamed area. Pain remediation can secondarily benefit sleep quality and duration; pain reduction can also relieve chronic stress induced Cortisol production and thus contribute to less patient stress and anxiety and the reversal of chronic non-healing wounds. Expedited use on pain/trauma patients may quickly control pain such as to reduce the possibility of shock.",
      "Description": "AHEALON® is a US Patent Pending biochemical homeopathic medication indicated for the treatment of pain and or inflammation, as well as a general healing aid, an infection deterrent, an agent to help reduce scar tissue and a source of moisturization (dry/cracked/burned skin); treatment can include: burn injuries, radiation dermatitis, arthritis (including osteoarthritis, rheumatoid arthritis, and psoriatic arthritis), rashes, wounds (chronic/acute), pressure sores, neuropathic discomfort and any generally inflamed area. The active ingredients in AHEALON consist of the following: Arnica 10C/30C/50M, Calendula 10C/30C/50M, Echinacea ANG 10C/30C/50M, Hypericum 10C/30C/50M, Silver 10C/30C/50M, Sulfur 10C/30C/50M, Thiosinaminum 10C/30C/50M, Urtica 10C/30C/50M. These drug ingredients are listed in the Homoeopathic Pharmacopoeia of the United States (HPUS).[1]. Inactive ingredients: Sea Minerals, Silver, Water. Pharmacological Class: Homeopathic drug. Dosage form: Liquid; may be used topically at 0.15 ML per spray application. Liquid; may be used as a gauze saturant. Liquid; may be aerosolized for bronchial/sinus use."
    },
    {
      "NDCCode": "54340-700-02",
      "PackageDescription": "591 mL in 1 BOTTLE, PLASTIC (54340-700-02)",
      "NDC11Code": "54340-0700-02",
      "ProductNDC": "54340-700",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dial Country Orchard Antibacterial Soap",
      "ProprietaryNameSuffix": "With Moisturizer",
      "NonProprietaryName": "Triclosan",
      "DosageFormName": "SOLUTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20090101",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "The Dial Corporation",
      "SubstanceName": "TRICLOSAN",
      "StrengthNumber": ".15",
      "StrengthUnit": "mL/1000mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "55037-700-02",
      "PackageDescription": "710 L in 1 CYLINDER (55037-700-02) ",
      "NDC11Code": "55037-0700-02",
      "ProductNDC": "55037-700",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Carbon Dioxide/oxygen 5/95",
      "NonProprietaryName": "Carbon Dioxide/oxygen 5/95",
      "DosageFormName": "GAS",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "19870101",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA205849",
      "LabelerName": "MATHESON TRI-GAS, INC.",
      "SubstanceName": "OXYGEN",
      "StrengthNumber": "950",
      "StrengthUnit": "mL/L",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "19870101",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "55614-700-02",
      "PackageDescription": "1 PATCH in 1 CANISTER (55614-700-02)  / 1 g in 1 PATCH",
      "NDC11Code": "55614-0700-02",
      "ProductNDC": "55614-700",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Wu Yang Brand Pain Relieving Medicated",
      "NonProprietaryName": "Menthol And Camphor",
      "DosageFormName": "PLASTER",
      "RouteName": "TRANSDERMAL",
      "StartMarketingDate": "20200831",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "MADISON ONE ACME INC",
      "SubstanceName": "MENTHOL; CAMPHOR (SYNTHETIC)",
      "StrengthNumber": "5; 3",
      "StrengthUnit": "g/100g; g/100g",
      "Status": "Active",
      "LastUpdate": "2025-11-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201228",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses For the temporary relief of minor aches and pains of muscles and joints due to: ■ arthritis ■ strains ■ simple backache ■ bruises ■ sprains."
    },
    {
      "NDCCode": "57297-700-02",
      "PackageDescription": "1 DRUM in 1 DRUM (57297-700-02)  / 5 kg in 1 DRUM",
      "NDC11Code": "57297-0700-02",
      "ProductNDC": "57297-700",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Cefdinir Monohydrate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20200609",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "LUPIN LIMITED",
      "SubstanceName": "CEFDINIR MONOHYDRATE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2024-11-07",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "09-JUN-20"
    },
    {
      "NDCCode": "63347-700-02",
      "PackageDescription": "2 BOTTLE in 1 BOX (63347-700-02)  > 3 mL in 1 BOTTLE (63347-700-01)",
      "NDC11Code": "63347-0700-02",
      "ProductNDC": "63347-700",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Verucide Physician Formula",
      "NonProprietaryName": "Salicyllic Acid",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20100101",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part358F",
      "LabelerName": "Blaine Labs Inc.",
      "SubstanceName": "SALICYLIC ACID",
      "StrengthNumber": "17",
      "StrengthUnit": "mL/10mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "For the removal of common warts (easily recognized by the rough cauliflower-like appearance of the surface)  For the removal of plantar warts that are located on the bottom of the foot."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"13533-700-02","ProprietaryName":"Prolastin-c","NonProprietaryName":"Alpha-1-proteinase Inhibitor (human)"},{"NDCCode":"13533-700-01","ProprietaryName":"Prolastin-c","NonProprietaryName":"Alpha-1-proteinase Inhibitor Human"},{"NDCCode":"13533-502-01","ProprietaryName":"Fesilty","NonProprietaryName":"Fibrinogen, Human-chmt"},{"NDCCode":"13533-618-02","ProprietaryName":"Hyperrab","NonProprietaryName":"Rabies Immune Globulin (human)"},{"NDCCode":"13533-631-02","ProprietaryName":"Hyperrho","NonProprietaryName":"Rho(d) Immune Globulin (human)"},{"NDCCode":"13533-634-02","ProprietaryName":"Hypertet","NonProprietaryName":"Tetanus Immune Globulin (human)"},{"NDCCode":"13533-635-02","ProprietaryName":"Gamastan","NonProprietaryName":"Immune Globulin (human)"},{"NDCCode":"13533-636-02","ProprietaryName":"Hyperhep B","NonProprietaryName":"Hepatitis B Immune Globulin (human)"},{"NDCCode":"10893-700-02","ProprietaryName":"Naturasil Sulfur Lavender Multi-purpose Relief 5 Oz 2 Pk","NonProprietaryName":"Sulfur, Thuja Occidentalis"},{"NDCCode":"10920-700-02","NonProprietaryName":"Esketamine Hydrochloride"},{"NDCCode":"11084-700-02","ProprietaryName":"Deb Instantfoam Alcohol Sanitizer","NonProprietaryName":"Ethyl Alcohol"},{"NDCCode":"14789-700-02","ProprietaryName":"Prochlorperazine Edisylate","NonProprietaryName":"Prochlorperazine Edisylate"},{"NDCCode":"17271-700-02","ProprietaryName":"Sodium Chloride","NonProprietaryName":"Sodium Chloride"},{"NDCCode":"21749-700-02","ProprietaryName":"Purell Advanced Instant Hand Sanitizer","NonProprietaryName":"Alcohol"},{"NDCCode":"24338-700-10","ProprietaryName":"Cetylev","NonProprietaryName":"Acetylcysteine"},{"NDCCode":"43063-700-02","ProprietaryName":"Azithromycin","NonProprietaryName":"Azithromycin"},{"NDCCode":"43386-700-02","ProprietaryName":"Sodium Sulfate, Potassium Sulfate, Magnesium Sulfate","NonProprietaryName":"Sodium Sulfate, Potassium Sulfate, Magnesium Sulfate"},{"NDCCode":"45802-700-02","ProprietaryName":"Tacrolimus","NonProprietaryName":"Tacrolimus"},{"NDCCode":"49283-700-02","ProprietaryName":"Ethyl Alcohol","NonProprietaryName":"Ethyl Alcohol"},{"NDCCode":"49349-700-02","ProprietaryName":"Benztropine Mesylate","NonProprietaryName":"Benztropine Mesylate"},{"NDCCode":"49657-700-02","NonProprietaryName":"Reserpine Crystalline"},{"NDCCode":"51167-700-02","ProprietaryName":"Orkambi","NonProprietaryName":"Lumacaftor And Ivacaftor"},{"NDCCode":"51414-700-02","ProprietaryName":"Lens Cleaner","NonProprietaryName":"Isopropyl Alcohol"},{"NDCCode":"52641-700-02","ProprietaryName":"Antiseptic","NonProprietaryName":"Isopropyl Alcohol"},{"NDCCode":"52793-700-02","ProprietaryName":"Ahealon","NonProprietaryName":"Arnica Montana, Calendula Officinalis Flowering Top, Echinacea Angustifolia, St. Johns Wort, Silver, Sulfur, Allylthiourea And Urtica Urens"},{"NDCCode":"54340-700-02","ProprietaryName":"Dial Country Orchard Antibacterial Soap","NonProprietaryName":"Triclosan"},{"NDCCode":"55037-700-02","ProprietaryName":"Carbon Dioxide/oxygen 5/95","NonProprietaryName":"Carbon Dioxide/oxygen 5/95"},{"NDCCode":"55614-700-02","ProprietaryName":"Wu Yang Brand Pain Relieving Medicated","NonProprietaryName":"Menthol And Camphor"},{"NDCCode":"57297-700-02","NonProprietaryName":"Cefdinir Monohydrate"},{"NDCCode":"63347-700-02","ProprietaryName":"Verucide Physician Formula","NonProprietaryName":"Salicyllic Acid"}]}
                    

<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>13533-700-02</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (13533-700-02)  *  20 mL in 1 VIAL, SINGLE-DOSE (13533-702-11)  *  20 mL in 1 VIAL, SINGLE-DOSE (13533-000-06) </PackageDescription>
    <NDC11Code>13533-0700-02</NDC11Code>
    <ProductNDC>13533-700</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Prolastin-c</ProprietaryName>
    <NonProprietaryName>Alpha-1-proteinase Inhibitor (human)</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>19871202</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103174</ApplicationNumber>
    <LabelerName>GRIFOLS USA, LLC</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2022-03-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19871202</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>PROLASTIN-C is an Alpha1-Proteinase Inhibitor (Human) (Alpha1-PI) indicated for chronic augmentation and maintenance therapy in adults with clinical evidence of emphysema due to severe hereditary deficiency of Alpha1-PI (alpha1-antitrypsin deficiency). PROLASTIN-C increases antigenic and functional (anti-neutrophil elastase capacity, ANEC) serum levels and antigenic lung epithelial lining fluid levels of Alpha1-PI. Limitations of Use: 1 The effect of augmentation therapy with any Alpha1-PI, including PROLASTIN-C, on pulmonary exacerbations and on the progression of emphysema in Alpha1-PI deficiency has not been conclusively demonstrated in randomized, controlled clinical trials., 2 Clinical data demonstrating the long-term effects of chronic augmentation or maintenance therapy with PROLASTIN-C are not available., 3 PROLASTIN-C is not indicated as therapy for lung disease in patients in whom severe Alpha1-PI deficiency has not been established.</IndicationAndUsage>
    <Description>PROLASTIN-C is a sterile, white to beige-colored concentrate of Alpha1-PI in lyophilized powder form for reconstitution for intravenous infusion. Each vial contains approximately 1,000 mg of functionally active Alpha1-PI as determined by capacity to neutralize porcine pancreatic elastase.  The specific activity of PROLASTIN-C is ≥ 0.7 mg functional Alpha1-PI per mg of total protein. PROLASTIN-C has a purity of ≥ 90% Alpha1-PI (Alpha1-PI protein/total protein). When reconstituted with 20 mL of Sterile Water for Injection, USP, PROLASTIN-C has a pH of 6.6–7.4, a sodium content of 100–210 mM, a chloride content of 60–180 mM and a sodium phosphate content of 13–25 mM. PROLASTIN-C contains no preservative. PROLASTIN-C is produced from pooled human plasma through modifications of the PROLASTIN process using purification by polyethylene glycol (PEG) precipitation, anion exchange chromatography, and cation exchange chromatography. All Source Plasma used in the manufacture of PROLASTIN-C is non-reactive (negative) by FDA-licensed serological test methods for hepatitis B surface antigen (HBsAg) and antibodies to hepatitis C virus (HCV) and human immunodeficiency virus types 1 and 2 and negative by FDA-licensed Nucleic Acid Technologies (NAT) for HCV and human immunodeficiency virus type 1 (HIV-1). In addition, all Source Plasma is negative for hepatitis B virus (HBV) by either an FDA-licensed or investigational NAT assay. The goal of the investigational HBV NAT test is to detect low levels of viral nucleic acid; however, the significance of a negative result for the investigational HBV NAT test has not been established. By in-process NAT, all Source Plasma is negative for hepatitis A virus (HAV). As a final plasma safety step, all plasma manufacturing pools are tested by serological test methods and NAT. To evaluate further the virus safety profile of PROLASTIN-C, in vitro studies have been conducted to validate the capacity of the manufacturing process to reduce the infectious titer of a wide range of viruses with diverse physicochemical properties. These studies evaluated the inactivation/removal of clinically relevant viruses, including human immunodeficiency virus type 1 (HIV-1) and hepatitis A virus (HAV), as well as the following model viruses: bovine viral diarrhea virus (BVDV), a surrogate for hepatitis C virus; pseudorabies virus (PRV), a surrogate for large enveloped DNA viruses (e.g., herpes viruses); vesicular stomatitis virus (VSV), a model for enveloped viruses; reovirus type 3 (Reo3), a non-specific model for non-enveloped viruses; and porcine parvovirus (PPV), a model for human parvovirus B19. The PROLASTIN-C manufacturing process has several steps (Cold Ethanol Fractionation, PEG Precipitation, and Depth Filtration) that are important for purifying Alpha1-PI as well as removing potential virus contaminants. Two additional steps, Solvent/Detergent Treatment and 15 nm Virus Removal Nanofiltration, are included in the process as dedicated pathogen reduction steps. The Solvent/Detergent Treatment step effectively inactivates enveloped viruses (such as HIV-1, VSV, HBV, and HCV). The 15 nm Virus Removal Nanofiltration step has been implemented to reduce the risk of transmission of enveloped and non-enveloped viruses as small as 18 nm. The table below presents the virus reduction capacity of each process step and the accumulated virus reduction for the process as determined in viral validation studies in which virus was deliberately added to a process model in order to study virus reduction. In addition, the Solvent/Detergent Treatment step inactivates ≥ 5.4 log10 of West Nile virus, a clinically relevant enveloped virus. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the variant Creutzfeldt-Jakob disease (vCJD) and Creutzfeldt-Jakob disease (CJD) agents. Studies of the PROLASTIN-C manufacturing process demonstrate that a minimum of 6 log10 reduction of TSE infectivity is achieved. These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed.</Description>
  </NDC>
  <NDC>
    <NDCCode>13533-700-01</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (13533-700-01)  *  20 mL in 1 VIAL, SINGLE-DOSE *  20 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>13533-0700-01</NDC11Code>
    <ProductNDC>13533-700</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Prolastin-c</ProprietaryName>
    <NonProprietaryName>Alpha-1-proteinase Inhibitor Human</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>19871202</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103174</ApplicationNumber>
    <LabelerName>GRIFOLS USA, LLC</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2014-09-26</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>13533-502-01</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (13533-502-01)  *  50 mL in 1 VIAL, GLASS (13533-503-02)  *  50 mL in 1 VIAL, GLASS (13533-200-50) </PackageDescription>
    <NDC11Code>13533-0502-01</NDC11Code>
    <ProductNDC>13533-502</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Fesilty</ProprietaryName>
    <NonProprietaryName>Fibrinogen, Human-chmt</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20251216</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125833</ApplicationNumber>
    <LabelerName>Grifols USA LLC</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-08-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251216</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>FESILTY is indicated for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including hypo- or afibrinogenemia.Limitations of Use: FESILTY is not indicated for dysfibrinogenemia.</IndicationAndUsage>
    <Description>FESILTY (fibrinogen, human – chmt), is a purified, sterile, non-pyrogenic, lyophilized powder of human fibrinogen for reconstitution for intravenous administration. Human fibrinogen is purified from Source Plasma from the cryoprecipitate fraction and processed using a combination of aluminum hydroxide purification, solvent/detergent (S/D) treatment, anion and cation exchange chromatography, glycine precipitation, and Ultraviolet (UV)-C irradiation. FESILTY is supplied in a single-dose vial containing nominally 1 gram of fibrinogen. The actual amount of fibrinogen is printed on the vial label and carton in milligrams fibrinogen per vial. When reconstituted with 50 mL sterile water for injection, FESILTY contains approximately 20 mg/mL protein, of which not less than 80% is fibrinogen monomer. Each vial of FESILTY also contains 421.3 mg arginine hydrochloride, 292.2 mg sodium chloride, 73.5 mg sodium citrate dihydrate, 25.5 mg polysorbate 80, and 567.5 mg trehalose dihydrate. FESILTY has a pH of 6.5 to 7.5 and an osmolality of ≥ 240 mOsmol/kg. FESILTY does not contain preservatives and is not made with natural rubber latex.FESILTY is prepared from pooled Source Plasma obtained from healthy volunteer donors. Each plasma donation used for the manufacture of FESILTY is collected from FDA-licensed facilities. Plasma donations must test negative for hepatitis B virus (HBV) surface antigen (HBsAg), antibodies to human immunodeficiency virus (HIV) strains 1 and 2 (anti-HIV-1/2), and antibodies to the hepatitis C virus (anti-HCV) as determined by enzyme immunoassay (EIA). In addition, samples from manufacturing pools must test non-reactive for HIV RNA, HCV RNA, HBV DNA, and Hepatitis A Virus (HAV) RNA, by Nucleic Acid Amplification Testing (NAT). Parvovirus B19 (B19V) DNA is also tested by NAT and must not exceed 104 IU/mL in the manufacturing pool.The manufacturing process for FESILTY employs several steps to remove/inactivate adventitious viruses to further increase the margins of safety. These steps include S/D treatment, UV-C irradiation, and heat treatment of lyophilized fibrinogen. Virus clearance studies with a scaled-down process have been performed for these steps to determine their capacity to inactivate or remove both enveloped and non-enveloped viruses. The results are shown in Table 3. The manufacturing process was also investigated for its capacity to reduce the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered a model for CJD and its variant, vCJD. One chromatographic purification step has been shown to reduce TSE infectivity of an experimental model agent. These studies provide reasonable assurance that low levels (at least 3.27 log10) of vCJD/CJD agent infectivity, if present in the starting material, would be removed.</Description>
  </NDC>
  <NDC>
    <NDCCode>13533-618-02</NDCCode>
    <PackageDescription>1 VIAL, GLASS in 1 CARTON (13533-618-02)  &gt; 2 mL in 1 VIAL, GLASS (13533-618-20) </PackageDescription>
    <NDC11Code>13533-0618-02</NDC11Code>
    <ProductNDC>13533-618</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Hyperrab</ProprietaryName>
    <ProprietaryNameSuffix>S/d</ProprietaryNameSuffix>
    <NonProprietaryName>Rabies Immune Globulin (human)</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>19960814</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101144</ApplicationNumber>
    <LabelerName>GRIFOLS USA, LLC</LabelerName>
    <SubstanceName>HUMAN RABIES VIRUS IMMUNE GLOBULIN</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>[iU]/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2022-11-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19960814</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Rabies vaccine and HyperRAB S/D should be given to all persons suspected of exposure to rabies with one exception: persons who have been previously immunized with rabies vaccine and have a confirmed adequate rabies antibody titer should receive only vaccine. HyperRAB S/D should be administered as promptly as possible after exposure, but can be administered up to the eighth day after the first dose of vaccine is given. Recommendations for use of passive and active immunization after exposure to an animal suspected of having rabies have been detailed by the U.S. Public Health Service Advisory Committee on Immunization Practices (ACIP). [19]. Every exposure to possible rabies infection must be individually evaluated. The following factors should be considered before specific antirabies treatment is initiated.</IndicationAndUsage>
    <Description>Rabies Immune Globulin (Human) — HyperRAB® S/D treated with solvent/detergent is a colorless to pale yellow or pink sterile solution of antirabies immune globulin for intramuscular administration; it is preservative-free and latex-free. HyperRAB S/D is prepared by cold ethanol fractionation from the plasma of donors hyperimmunized with rabies vaccine. The immune globulin is isolated from solubilized Cohn Fraction II. The Fraction II solution is adjusted to a final concentration of 0.3% tri-n-butyl phosphate (TNBP) and 0.2% sodium cholate. After the addition of solvent (TNBP) and detergent (sodium cholate), the solution is heated to 30°C and maintained at that temperature for not less than 6 hours. After the viral inactivation step, the reactants are removed by precipitation, filtration and finally ultrafiltration and diafiltration. HyperRAB S/D is formulated as a 15–18% protein solution at a pH of 6.4–7.2 in 0.21–0.32 M glycine. HyperRAB S/D is then incubated in the final container for 21–28 days at 20–27°C. The product is standardized against the U.S. Standard Rabies Immune Globulin to contain an average potency value of 150 IU/mL. The U.S. unit of potency is equivalent to the international unit (IU) for rabies antibody. The removal and inactivation of spiked model enveloped and non-enveloped viruses during the manufacturing process for HyperRAB S/D has been validated in laboratory studies. Human Immunodeficiency Virus, Type 1 (HIV-1), was chosen as the relevant virus for blood products; Bovine Viral Diarrhea Virus (BVDV) was chosen to model Hepatitis C virus; Pseudorabies virus (PRV) was chosen to model Human Herpes viruses and other large enveloped DNA viruses; and Reo virus type 3 (Reo) was chosen to model non-enveloped viruses and for its resistance to physical and chemical inactivation. Significant removal of model enveloped and non-enveloped viruses is achieved at two steps in the Cohn fractionation process leading to the collection of Cohn Fraction II: the precipitation and removal of Fraction III in the processing of Fraction II + IIIW suspension to Effluent III and the filtration step in the processing of Effluent III to Filtrate III. Significant inactivation of enveloped viruses is achieved at the time of treatment of solubilized Cohn Fraction II with TNBP/sodium cholate. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents. [27-30]. Studies of the HyperRAB S/D manufacturing process demonstrate that TSE clearance is achieved during the Pooled Plasma to Effluent III Fractionation Process (6.7 log10). These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed.</Description>
  </NDC>
  <NDC>
    <NDCCode>13533-631-02</NDCCode>
    <PackageDescription>1 SYRINGE in 1 CARTON (13533-631-02)  / 1 mL in 1 SYRINGE (13533-631-20) </PackageDescription>
    <NDC11Code>13533-0631-02</NDC11Code>
    <ProductNDC>13533-631</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Hyperrho</ProprietaryName>
    <ProprietaryNameSuffix>Full Dose</ProprietaryNameSuffix>
    <NonProprietaryName>Rho(d) Immune Globulin (human)</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>19960814</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101141</ApplicationNumber>
    <LabelerName>GRIFOLS USA, LLC</LabelerName>
    <SubstanceName>HUMAN RHO(D) IMMUNE GLOBULIN</SubstanceName>
    <StrengthNumber>1500</StrengthNumber>
    <StrengthUnit>[iU]/mL</StrengthUnit>
    <Pharm_Classes>Endogenous Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19960814</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>HyperRHO Full Dose is recommended for the prevention of Rh hemolytic disease of the newborn by its administration to the Rho(D) negative mother within 72 hours after birth of an Rho(D) positive infant,(13) providing the following criteria are met: 1 The mother must be Rho(D) negative and must not already be sensitized to the Rho(D) factor., 2 Her child must be Rho(D) positive, and should have a negative direct antiglobulin test (see PRECAUTIONS). .</IndicationAndUsage>
    <Description>Rho(D) Immune Globulin (Human) — HyperRHO® Full Dose is a clear or slightly opalescent and, colorless or pale yellow sterile solution of human rho(D) immune globulin containing antibodies to Rho(D) for intramuscular administration; it contains no preservative. HyperRHO Full Dose is prepared from pools of human plasma collected from healthy donors by a combination of cold ethanol fractionation, caprylate precipitation and filtration, caprylate incubation, anion exchange chromatography, nanofiltration and low pH incubation. HyperRHO Full Dose is formulated as a 15% to 18% protein solution at a pH of 4.1 to 4.8 in 0.16 M to 0.26 M glycine. The potency is equal to or greater than 1500 IU (300 mcg) per 1 mL. Each single-dose syringe contains sufficient anti-Rho(D) to effectively suppress the immunizing potential of 15 mL of Rho(D) positive red blood cells.(1-4). When medicinal biological products are administered, the risk of infectious diseases due to transmission of pathogens cannot be totally excluded. However, in the case of products prepared from human plasma, the risk of transmission of pathogens is reduced by epidemiological surveillance of the donor population and selection of individual donors by medical interview; testing of individual donations and plasma pools; and the presence in the manufacturing processes of steps with demonstrated capacity to inactivate/remove pathogen. In the manufacturing process of HyperRHO Full Dose, there are several steps with the capacity for viral inactivation or removal.(5) The main steps of the manufacturing process that contribute to the virus clearance capacity are as follows: 1 Caprylate precipitation/depth filtration , 2 Caprylate incubation , 3 Depth filtration , 4 Column chromatography , 5 Nanofiltration , 6 Low pH final container incubation.</Description>
  </NDC>
  <NDC>
    <NDCCode>13533-634-02</NDCCode>
    <PackageDescription>1 SYRINGE, GLASS in 1 BOX (13533-634-02)  / 1 mL in 1 SYRINGE, GLASS (13533-634-20) </PackageDescription>
    <NDC11Code>13533-0634-02</NDC11Code>
    <ProductNDC>13533-634</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Hypertet</ProprietaryName>
    <NonProprietaryName>Tetanus Immune Globulin (human)</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>19960814</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101142</ApplicationNumber>
    <LabelerName>GRIFOLS USA, LLC</LabelerName>
    <SubstanceName>HUMAN CLOSTRIDIUM TETANI TOXOID IMMUNE GLOBULIN</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>[iU]/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-10-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19960814</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>HyperTET is indicated for prophylaxis against tetanus following injury in patients whose immunization is incomplete or uncertain (see below). It is also indicated, although evidence of effectiveness is limited, in the regimen of treatment of active cases of tetanus.(8,9,16). A thorough attempt must be made to determine whether a patient has completed primary vaccination. Patients with unknown or uncertain previous vaccination histories should be considered to have had no previous tetanus toxoid doses. Persons who had military service since 1941 can be considered to have received at least one dose, and although most of them may have completed a primary series of tetanus toxoid, this cannot be assumed for each individual. Patients who have not completed a primary series may require tetanus toxoid and passive immunization at the time of wound cleaning and debridement.(3). The following table is a summary guide to tetanus prophylaxis in wound management.</IndicationAndUsage>
    <Description>Tetanus Immune Globulin (Human) — HyperTET® is a clear or slightly opalescent, and colorless or pale yellow sterile solution of human tetanus immune globulin for intramuscular administration. HyperTET contains no preservative.  HyperTET is prepared from pools of human plasma collected from healthy donors by a combination of cold ethanol fractionation, caprylate precipitation and filtration, caprylate incubation, anion exchange chromatography, nanofiltration and low pH incubation. HyperTET consists of a 15% to 18% protein solution at a pH of 4.1 to 4.8 in 0.16 M to 0.26 M glycine. The product is standardized against the U.S. Standard Antitoxin and the U.S. Control Tetanus Toxin and contains not less than 250 tetanus antitoxin units per 1 mL. When medicinal biological products are administered, the risk of infectious diseases due to transmission of pathogens cannot be totally excluded. However, in the case of products  prepared from human plasma, the risk of transmission of pathogens is reduced by epidemiological surveillance of the donor population and selection of individual donors by medical interview; testing of individual donations and plasma pools; and the presence in the manufacturing processes of steps with demonstrated capacity to inactivate/remove pathogen. In the manufacturing process of HyperTET, there are several steps with the capacity for viral inactivation or removal.(1) The main steps of the manufacturing process that contribute to the virus clearance capacity are as follows: 1 Caprylate precipitation/depth filtration, 2 Caprylate incubation, 3 Depth filtration, 4 Column chromatography, 5 Nanofiltration, 6 Low pH final container incubation.</Description>
  </NDC>
  <NDC>
    <NDCCode>13533-635-02</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (13533-635-02)  &gt; 2 mL in 1 VIAL (13533-635-40) </PackageDescription>
    <NDC11Code>13533-0635-02</NDC11Code>
    <ProductNDC>13533-635</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Gamastan</ProprietaryName>
    <ProprietaryNameSuffix>S/d</ProprietaryNameSuffix>
    <NonProprietaryName>Immune Globulin (human)</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>19960814</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101134</ApplicationNumber>
    <LabelerName>GRIFOLS USA, LLC</LabelerName>
    <SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
    <StrengthNumber>.165</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Pharm_Classes>Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-06-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>13533-636-02</NDCCode>
    <PackageDescription>1 SYRINGE, GLASS in 1 CARTON (13533-636-02)  / 1 mL in 1 SYRINGE, GLASS (13533-636-20) </PackageDescription>
    <NDC11Code>13533-0636-02</NDC11Code>
    <ProductNDC>13533-636</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Hyperhep B</ProprietaryName>
    <NonProprietaryName>Hepatitis B Immune Globulin (human)</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>19961009</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101146</ApplicationNumber>
    <LabelerName>GRIFOLS USA, LLC</LabelerName>
    <SubstanceName>HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN</SubstanceName>
    <StrengthNumber>220</StrengthNumber>
    <StrengthUnit>[iU]/mL</StrengthUnit>
    <Pharm_Classes>Human Immunoglobulin [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE], Virus Neutralization [MoA], Virus-specific Hyperimmune Globulins [EXT]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-10-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19961009</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Recommendations on post-exposure prophylaxis are based on available efficacy data and on the likelihood of future HBV exposure for the person requiring treatment. In all exposures, a regimen combining Hepatitis B Immune Globulin (Human) with hepatitis B vaccine will provide both short- and long-term protection, will be less costly than the two-dose Hepatitis B Immune Globulin (Human) treatment alone, and is the treatment of choice.(9). HyperHEP B is indicated for post-exposure prophylaxis in the following situations.</IndicationAndUsage>
    <Description>Hepatitis B Immune Globulin (Human) — HyperHEP B® is a clear or slightly opalescent, and colorless or pale yellow sterile solution of human hepatitis B immune globulin for intramuscular administration. HyperHEP B contains no preservative. HyperHEP B is prepared from pools of human plasma collected from healthy donors by a combination of  cold ethanol fractionation, caprylate precipitation and filtration, caprylate incubation, anion exchange chromatography, nanofiltration and low pH incubation. HyperHEP B consists of a 15% to 18% protein solution at a pH of 4.1 to 4.8 in 0.16 M to 0.26 M glycine. The product contains anti-HBs antibody equivalent to or exceeding the potency of anti-HBs in a U.S. reference hepatitis B immune globulin (Center for Biologics Evaluation and Research, FDA). The U.S. reference has been tested against the World Health Organization standard Hepatitis B Immune Globulin and found to be equal to 220 international units (IU) per mL. When medicinal biological products are administered, the risk of infectious diseases due to transmission of pathogens cannot be totally excluded. However, in the case of products  prepared from human plasma, the risk of transmission of pathogens is reduced by epidemiological surveillance of the donor population and selection of individual donors by medical interview; testing of individual donations and plasma pools; and the presence in the manufacturing processes of steps with demonstrated capacity to inactivate/remove pathogen. In the manufacturing process of HyperHEP B, there are several steps with the capacity for viral inactivation or removal.(1) The main steps of the manufacturing process that contribute to the virus clearance capacity are as follows: 1 Caprylate precipitation/depth filtration, 2 Caprylate incubation, 3 Depth filtration, 4 Column chromatography, 5 Nanofiltration, 6 Low pH final container incubation.</Description>
  </NDC>
  <NDC>
    <NDCCode>10893-700-02</NDCCode>
    <PackageDescription>2 PACKET in 1 CARTON (10893-700-02)  / 141.7 g in 1 PACKET</PackageDescription>
    <NDC11Code>10893-0700-02</NDC11Code>
    <ProductNDC>10893-700</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Naturasil Sulfur Lavender Multi-purpose Relief 5 Oz 2 Pk</ProprietaryName>
    <NonProprietaryName>Sulfur, Thuja Occidentalis</NonProprietaryName>
    <DosageFormName>SOAP</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20260529</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Nature's Innovation, Inc.</LabelerName>
    <SubstanceName>SULFUR; CEDAR LEAF OIL</SubstanceName>
    <StrengthNumber>1; 6</StrengthNumber>
    <StrengthUnit>[hp_X]/141.7g; [hp_X]/141.7g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-06-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260529</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Symptomatic homeopathic topical treatment of common fungal and parasitic skin conditions and nail fungus.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10920-700-02</NDCCode>
    <PackageDescription>2 BAG in 1 DRUM (10920-700-02)  / 1 BAG in 1 BAG / 5 kg in 1 BAG</PackageDescription>
    <NDC11Code>10920-0700-02</NDC11Code>
    <ProductNDC>10920-700</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Esketamine Hydrochloride</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20220112</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Arevipharma GmbH</LabelerName>
    <SubstanceName>ESKETAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <DEASchedule>CIII</DEASchedule>
    <Status>Unfinished</Status>
    <LastUpdate>2025-04-10</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>12-JAN-22</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>11084-700-02</NDCCode>
    <PackageDescription>47 mL in 1 BOTTLE, PLASTIC (11084-700-02)</PackageDescription>
    <NDC11Code>11084-0700-02</NDC11Code>
    <ProductNDC>11084-700</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Deb Instantfoam Alcohol Sanitizer</ProprietaryName>
    <NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20120515</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>Deb USA, Inc.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-10-16</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>14789-700-02</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (14789-700-02)  / 2 mL in 1 VIAL, SINGLE-DOSE (14789-700-07) </PackageDescription>
    <NDC11Code>14789-0700-02</NDC11Code>
    <ProductNDC>14789-700</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prochlorperazine Edisylate</ProprietaryName>
    <NonProprietaryName>Prochlorperazine Edisylate</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20190225</StartMarketingDate>
    <EndMarketingDate>20260101</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204860</ApplicationNumber>
    <LabelerName>Nexus Pharmaceuticals LLC</LabelerName>
    <SubstanceName>PROCHLORPERAZINE EDISYLATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20190225</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260101</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To control severe nausea and vomiting. For the treatment of schizophrenia. Prochlorperazine has not been shown effective in the management of behavioral complications in patients with mental retardation.</IndicationAndUsage>
    <Description>Prochlorperazine edisylate, 2-Chloro-10-[3-(4-methyl-1-piperazinyl)propyl] phenothiazine 1,2-ethanedisulfonate (1:1), has the following structural formula. Prochlorperazine Edisylate Injection, an antiemetic and antipsychotic, is a sterile solution intended for intramuscular or intravenous administration. Each mL contains prochlorperazine 5 mg as the edisylate, monobasic sodium phosphate monohydrate 5 mg, sodium tartrate dihydrate 12 mg, saccharin sodium 0.9 mg and benzyl alcohol 7.5 mg in Water for Injection. pH 4.2-6.2.</Description>
  </NDC>
  <NDC>
    <NDCCode>17271-700-02</NDCCode>
    <PackageDescription>60 BAG in 1 CASE (17271-700-02)  / 50 mL in 1 BAG</PackageDescription>
    <NDC11Code>17271-0700-02</NDC11Code>
    <ProductNDC>17271-700</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Chloride</ProprietaryName>
    <NonProprietaryName>Sodium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20180723</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208122</ApplicationNumber>
    <LabelerName>Becton Dickinson and Company</LabelerName>
    <SubstanceName>SODIUM CHLORIDE</SubstanceName>
    <StrengthNumber>450</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>2024-08-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180723</StartMarketingDatePackage>
    <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.</IndicationAndUsage>
    <Description>0.45% Sodium Chloride Injection, USP solution is a sterile and nonpyrogenic solution intended for intravenous administration. Each 100 mL of 0.45% Sodium Chloride Injection, USP contains 450 mg sodium chloride in water for injection. Electrolytes per 1,000 mL: sodium 77 mEq; chloride 77 mEq. The osmolarity is 154 mOsmol/L (calc.). The pH in the 100 mL and smaller containers is 6.0; for the 250 mL and larger containers, the pH is 5.6. The pH range is 4.5 to 7.0 for all containers. The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded. 0.45% Sodium Chloride Injection, USP is a parenteral fluid and electrolyte replenisher. 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 non-plasticized, film containing polypropylene and thermoplastic elastomers (freeflex® bag). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers.</Description>
  </NDC>
  <NDC>
    <NDCCode>21749-700-02</NDCCode>
    <PackageDescription>24 BOTTLE in 1 CASE (21749-700-02)  &gt; 59 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>21749-0700-02</NDC11Code>
    <ProductNDC>21749-700</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Purell Advanced Instant Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110510</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>GOJO Industries, Inc.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>.7</StrengthNumber>
    <StrengthUnit>mL/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110510</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hand sanitizer to help reduce bacteria on the skin that could cause disease.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>24338-700-10</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (24338-700-10)  &gt; 2 TABLET, EFFERVESCENT in 1 BLISTER PACK (24338-700-02)</PackageDescription>
    <NDC11Code>24338-0700-10</NDC11Code>
    <ProductNDC>24338-700</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cetylev</ProprietaryName>
    <NonProprietaryName>Acetylcysteine</NonProprietaryName>
    <DosageFormName>TABLET, EFFERVESCENT</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160627</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA207916</ApplicationNumber>
    <LabelerName>Arbor Pharmaceuticals</LabelerName>
    <SubstanceName>ACETYLCYSTEINE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-04-03</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>43063-700-02</NDCCode>
    <PackageDescription>2 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-700-02) </PackageDescription>
    <NDC11Code>43063-0700-02</NDC11Code>
    <ProductNDC>43063-700</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Azithromycin</ProprietaryName>
    <NonProprietaryName>Azithromycin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20051114</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065212</ApplicationNumber>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>AZITHROMYCIN MONOHYDRATE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Macrolide Antimicrobial [EPC],Macrolides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-12-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160804</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>43386-700-02</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CONTAINER (43386-700-02)  / 177 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>43386-0700-02</NDC11Code>
    <ProductNDC>43386-700</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Sulfate, Potassium Sulfate, Magnesium Sulfate</ProprietaryName>
    <NonProprietaryName>Sodium Sulfate, Potassium Sulfate, Magnesium Sulfate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20221230</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202511</ApplicationNumber>
    <LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>MAGNESIUM SULFATE ANHYDROUS; POTASSIUM SULFATE; SODIUM SULFATE</SubstanceName>
    <StrengthNumber>1.6; 3.13; 17.5</StrengthNumber>
    <StrengthUnit>g/177mL; g/177mL; g/177mL</StrengthUnit>
    <Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-12-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221230</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is indicated for cleansing of the colon as a preparation for colonoscopy in adults.</IndicationAndUsage>
    <Description>Each Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution contains two 6 ounce bottles of solution. Each 6 ounce bottle contains: sodium sulfate 17.5 grams, potassium sulfate 3.13 grams, magnesium sulfate 1.6 grams. Inactive ingredients include: sodium benzoate, sucralose, malic acid, citric acid, lemon flavor, purified water. The solution is a clear to slightly hazy liquid. The solution is clear and colorless when diluted to a final volume of 16 ounces with water. Sodium Sulfate, USP. The chemical name is Na2SO4. The average Molecular Weight is 142.04. The structural formula is. Potassium Sulfate, FCC, Granular. The chemical name is K2SO4. The average Molecular Weight is 174.26. The structural formula is. Magnesium Sulfate, USP. The chemical name is MgSO4. The average Molecular Weight: 120.37. The structural formula is. Each Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution package also contains a polypropylene mixing container.</Description>
  </NDC>
  <NDC>
    <NDCCode>45802-700-02</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (45802-700-02)  / 100 g in 1 TUBE</PackageDescription>
    <NDC11Code>45802-0700-02</NDC11Code>
    <ProductNDC>45802-700</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tacrolimus</ProprietaryName>
    <NonProprietaryName>Tacrolimus</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20141120</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA050777</ApplicationNumber>
    <LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
    <SubstanceName>TACROLIMUS</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-05-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20141120</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tacrolimus Ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. Tacrolimus Ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGS and PRECAUTIONS: Pediatric Use).</IndicationAndUsage>
    <Description>Tacrolimus Ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10, 12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone,monohydrate. It has the following structural formula. Tacrolimus has an empirical formula of C44H69NO12∙H2O and a formula weight of 822.03. Each gram of Tacrolimus Ointment contains (w/w) either 0.03% or 0.1% of tacrolimus in a base of mineral oil with all-rac-α-tocopherol, paraffin, propylene carbonate, white petrolatum with butylhydroxytoluene, and white wax.</Description>
  </NDC>
  <NDC>
    <NDCCode>49283-700-02</NDCCode>
    <PackageDescription>59 mL in 1 BOTTLE, PUMP (49283-700-02) </PackageDescription>
    <NDC11Code>49283-0700-02</NDC11Code>
    <ProductNDC>49283-700</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ethyl Alcohol</ProprietaryName>
    <NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200707</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Chemco Corporation</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200707</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>49349-700-02</NDCCode>
    <PackageDescription>30 TABLET in 1 BLISTER PACK (49349-700-02)</PackageDescription>
    <NDC11Code>49349-0700-02</NDC11Code>
    <ProductNDC>49349-700</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Benztropine Mesylate</ProprietaryName>
    <NonProprietaryName>Benztropine Mesylate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110406</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040715</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</LabelerName>
    <SubstanceName>BENZTROPINE MESYLATE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>49657-700-02</NDCCode>
    <PackageDescription>2 kg in 1 DRUM (49657-700-02)</PackageDescription>
    <NDC11Code>49657-0700-02</NDC11Code>
    <ProductNDC>49657-700</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Reserpine Crystalline</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20080801</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>ALCON BIOSCIENCES PVT LTD</LabelerName>
    <SubstanceName>RESERPINE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>kg/2kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>51167-700-02</NDCCode>
    <PackageDescription>4 CARTON in 1 BOX (51167-700-02)  / 7 BLISTER PACK in 1 CARTON / 4 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>51167-0700-02</NDC11Code>
    <ProductNDC>51167-700</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Orkambi</ProprietaryName>
    <NonProprietaryName>Lumacaftor And Ivacaftor</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160928</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA206038</ApplicationNumber>
    <LabelerName>Vertex Pharmaceuticals Incorporated</LabelerName>
    <SubstanceName>LUMACAFTOR; IVACAFTOR</SubstanceName>
    <StrengthNumber>100; 125</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Chloride Channel Activation Potentiators [MoA], Cystic Fibrosis Transmembrane Conductance Regulator Potentiator [EPC], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inducers [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160928</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ORKAMBI is indicated for the treatment of cystic fibrosis (CF) in patients aged 1 year and older who are homozygous for the F508del mutation in the CFTR gene. If the patient's genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of the F508del mutation on both alleles of the CFTR gene.</IndicationAndUsage>
    <Description>The active ingredients in ORKAMBI tablets are lumacaftor, which has the following chemical name: 3-[6-({[1-(2,2-difluoro-1,3-benzodioxol-5-yl)cyclopropyl]carbonyl}amino)-3-methylpyridin-2-yl]benzoic acid, and ivacaftor, a CFTR potentiator, which has the following chemical name: N-(2,4-di-tert-butyl-5-hydroxyphenyl)-1,4-dihydro-4-oxoquinoline-3-carboxamide. The molecular formula for lumacaftor is C24H18F2N2O5 and for ivacaftor is C24H28N2O3. The molecular weights for lumacaftor and ivacaftor are 452.41 and 392.49, respectively. The structural formulas are. Lumacaftor is a white to off-white powder that is practically insoluble in water (0.02 mg/mL). Ivacaftor is a white to off-white powder that is practically insoluble in water (&lt;0.05 µg/mL). ORKAMBI is available as a pink, oval-shaped, film-coated tablet for oral administration containing 200 mg of lumacaftor and 125 mg of ivacaftor. Each ORKAMBI tablet contains 200 mg of lumacaftor and 125 mg of ivacaftor, and the following inactive ingredients: cellulose, microcrystalline; croscarmellose sodium; hypromellose acetate succinate; magnesium stearate; povidone; and sodium lauryl sulfate. The tablet film coat contains carmine, FD&amp;C Blue #1, FD&amp;C Blue #2, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. The printing ink contains ammonium hydroxide, iron oxide black, propylene glycol, and shellac. ORKAMBI is also available as a pink, oval-shaped, film-coated tablet for oral administration containing 100 mg of lumacaftor and 125 mg of ivacaftor. Each ORKAMBI tablet contains 100 mg of lumacaftor and 125 mg of ivacaftor, and the following inactive ingredients: cellulose, microcrystalline; croscarmellose sodium; hypromellose acetate succinate; magnesium stearate; povidone; and sodium lauryl sulfate. The tablet film coat contains carmine, FD&amp;C Blue #1, FD&amp;C Blue #2, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. The printing ink contains ammonium hydroxide, iron oxide black, propylene glycol, and shellac. ORKAMBI is also available as white to off-white granules for oral administration and enclosed in a unit-dose packet containing lumacaftor 75 mg/ivacaftor 94 mg, lumacaftor 100 mg/ivacaftor 125 mg or lumacaftor 150 mg/ivacaftor 188 mg per packet. Each unit-dose packet of ORKAMBI oral granules contains lumacaftor 75 mg/ivacaftor 94 mg, lumacaftor 100 mg/ivacaftor 125 mg or lumacaftor 150 mg/ivacaftor 188 mg per packet and the following inactive ingredients: cellulose, microcrystalline; croscarmellose sodium; hypromellose acetate succinate; povidone; and sodium lauryl sulfate.</Description>
  </NDC>
  <NDC>
    <NDCCode>51414-700-02</NDCCode>
    <PackageDescription>7 g in 1 PACKAGE (51414-700-02) </PackageDescription>
    <NDC11Code>51414-0700-02</NDC11Code>
    <ProductNDC>51414-700</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lens Cleaner</ProprietaryName>
    <NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20121128</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part344</ApplicationNumber>
    <LabelerName>Yuyao Jessie Commodity Co.,Ltd.</LabelerName>
    <SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180105</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Clean smudged and dirty lenses at your convenience with these handy individual packets.Also ,ideal for use on cameras,camcorders,computer&amp;TV screens.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>52641-700-02</NDCCode>
    <PackageDescription>75 PACKET in 1 BOX (52641-700-02)  &gt; 1.2 mL in 1 PACKET</PackageDescription>
    <NDC11Code>52641-0700-02</NDC11Code>
    <ProductNDC>52641-700</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Antiseptic</ProprietaryName>
    <NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110623</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>ReliaMed</LabelerName>
    <SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
    <StrengthNumber>.56118</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110623</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For preparation of the skin prior to injection or venipuncture.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>52793-700-02</NDCCode>
    <PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (52793-700-02)  &gt; 60 mL in 1 BOTTLE, SPRAY</PackageDescription>
    <NDC11Code>52793-0700-02</NDC11Code>
    <ProductNDC>52793-700</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ahealon</ProprietaryName>
    <NonProprietaryName>Arnica Montana, Calendula Officinalis Flowering Top, Echinacea Angustifolia, St. Johns Wort, Silver, Sulfur, Allylthiourea And Urtica Urens</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20120409</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>PRINCETON BIOTECHNOLOGY CORPORATION</LabelerName>
    <SubstanceName>ALLYLTHIOUREA; ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; SILVER; ST. JOHN'S WORT; SULFUR; URTICA URENS</SubstanceName>
    <StrengthNumber>30; 30; 30; 30; 30; 30; 30; 30</StrengthNumber>
    <StrengthUnit>[kp_C]/60mL; [kp_C]/60mL; [kp_C]/60mL; [kp_C]/60mL; [kp_C]/60mL; [kp_C]/60mL; [kp_C]/60mL; [kp_C]/60mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120409</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>AHEALON is indicated for the acute and chronic treatment of pain and or inflammation, as well as a general healing aid, an infection deterrent, an agent to help reduce scar tissue and a source of moisturization (dry/cracked/burned skin), that include: all burn injuries, radiation dermatitis, surgical incisions, rashes, pruritic conditions, arthritis/joint pain, lower back pain, wounds, pressure sores, tumors, neuropathic discomfort and any generally painful and or inflamed area. Pain remediation can secondarily benefit sleep quality and duration; pain reduction can also relieve chronic stress induced Cortisol production and thus contribute to less patient stress and anxiety and the reversal of chronic non-healing wounds. Expedited use on pain/trauma patients may quickly control pain such as to reduce the possibility of shock.</IndicationAndUsage>
    <Description>AHEALON® is a US Patent Pending biochemical homeopathic medication indicated for the treatment of pain and or inflammation, as well as a general healing aid, an infection deterrent, an agent to help reduce scar tissue and a source of moisturization (dry/cracked/burned skin); treatment can include: burn injuries, radiation dermatitis, arthritis (including osteoarthritis, rheumatoid arthritis, and psoriatic arthritis), rashes, wounds (chronic/acute), pressure sores, neuropathic discomfort and any generally inflamed area. The active ingredients in AHEALON consist of the following: Arnica 10C/30C/50M, Calendula 10C/30C/50M, Echinacea ANG 10C/30C/50M, Hypericum 10C/30C/50M, Silver 10C/30C/50M, Sulfur 10C/30C/50M, Thiosinaminum 10C/30C/50M, Urtica 10C/30C/50M. These drug ingredients are listed in the Homoeopathic Pharmacopoeia of the United States (HPUS).[1]. Inactive ingredients: Sea Minerals, Silver, Water. Pharmacological Class: Homeopathic drug. Dosage form: Liquid; may be used topically at 0.15 ML per spray application. Liquid; may be used as a gauze saturant. Liquid; may be aerosolized for bronchial/sinus use.</Description>
  </NDC>
  <NDC>
    <NDCCode>54340-700-02</NDCCode>
    <PackageDescription>591 mL in 1 BOTTLE, PLASTIC (54340-700-02)</PackageDescription>
    <NDC11Code>54340-0700-02</NDC11Code>
    <ProductNDC>54340-700</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dial Country Orchard Antibacterial Soap</ProprietaryName>
    <ProprietaryNameSuffix>With Moisturizer</ProprietaryNameSuffix>
    <NonProprietaryName>Triclosan</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20090101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>The Dial Corporation</LabelerName>
    <SubstanceName>TRICLOSAN</SubstanceName>
    <StrengthNumber>.15</StrengthNumber>
    <StrengthUnit>mL/1000mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>55037-700-02</NDCCode>
    <PackageDescription>710 L in 1 CYLINDER (55037-700-02) </PackageDescription>
    <NDC11Code>55037-0700-02</NDC11Code>
    <ProductNDC>55037-700</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carbon Dioxide/oxygen 5/95</ProprietaryName>
    <NonProprietaryName>Carbon Dioxide/oxygen 5/95</NonProprietaryName>
    <DosageFormName>GAS</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>19870101</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA205849</ApplicationNumber>
    <LabelerName>MATHESON TRI-GAS, INC.</LabelerName>
    <SubstanceName>OXYGEN</SubstanceName>
    <StrengthNumber>950</StrengthNumber>
    <StrengthUnit>mL/L</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19870101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>55614-700-02</NDCCode>
    <PackageDescription>1 PATCH in 1 CANISTER (55614-700-02)  / 1 g in 1 PATCH</PackageDescription>
    <NDC11Code>55614-0700-02</NDC11Code>
    <ProductNDC>55614-700</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Wu Yang Brand Pain Relieving Medicated</ProprietaryName>
    <NonProprietaryName>Menthol And Camphor</NonProprietaryName>
    <DosageFormName>PLASTER</DosageFormName>
    <RouteName>TRANSDERMAL</RouteName>
    <StartMarketingDate>20200831</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>MADISON ONE ACME INC</LabelerName>
    <SubstanceName>MENTHOL; CAMPHOR (SYNTHETIC)</SubstanceName>
    <StrengthNumber>5; 3</StrengthNumber>
    <StrengthUnit>g/100g; g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-11-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201228</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses For the temporary relief of minor aches and pains of muscles and joints due to: ■ arthritis ■ strains ■ simple backache ■ bruises ■ sprains.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>57297-700-02</NDCCode>
    <PackageDescription>1 DRUM in 1 DRUM (57297-700-02)  / 5 kg in 1 DRUM</PackageDescription>
    <NDC11Code>57297-0700-02</NDC11Code>
    <ProductNDC>57297-700</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Cefdinir Monohydrate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20200609</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>LUPIN LIMITED</LabelerName>
    <SubstanceName>CEFDINIR MONOHYDRATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2024-11-07</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>09-JUN-20</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>63347-700-02</NDCCode>
    <PackageDescription>2 BOTTLE in 1 BOX (63347-700-02)  &gt; 3 mL in 1 BOTTLE (63347-700-01)</PackageDescription>
    <NDC11Code>63347-0700-02</NDC11Code>
    <ProductNDC>63347-700</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Verucide Physician Formula</ProprietaryName>
    <NonProprietaryName>Salicyllic Acid</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20100101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part358F</ApplicationNumber>
    <LabelerName>Blaine Labs Inc.</LabelerName>
    <SubstanceName>SALICYLIC ACID</SubstanceName>
    <StrengthNumber>17</StrengthNumber>
    <StrengthUnit>mL/10mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>For the removal of common warts (easily recognized by the rough cauliflower-like appearance of the surface)  For the removal of plantar warts that are located on the bottom of the foot.</IndicationAndUsage>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>13533-700-02</NDCCode><ProprietaryName>Prolastin-c</ProprietaryName><NonProprietaryName>Alpha-1-proteinase Inhibitor (human)</NonProprietaryName></NDC><NDC><NDCCode>13533-700-01</NDCCode><ProprietaryName>Prolastin-c</ProprietaryName><NonProprietaryName>Alpha-1-proteinase Inhibitor Human</NonProprietaryName></NDC><NDC><NDCCode>13533-502-01</NDCCode><ProprietaryName>Fesilty</ProprietaryName><NonProprietaryName>Fibrinogen, Human-chmt</NonProprietaryName></NDC><NDC><NDCCode>13533-618-02</NDCCode><ProprietaryName>Hyperrab</ProprietaryName><NonProprietaryName>Rabies Immune Globulin (human)</NonProprietaryName></NDC><NDC><NDCCode>13533-631-02</NDCCode><ProprietaryName>Hyperrho</ProprietaryName><NonProprietaryName>Rho(d) Immune Globulin (human)</NonProprietaryName></NDC><NDC><NDCCode>13533-634-02</NDCCode><ProprietaryName>Hypertet</ProprietaryName><NonProprietaryName>Tetanus Immune Globulin (human)</NonProprietaryName></NDC><NDC><NDCCode>13533-635-02</NDCCode><ProprietaryName>Gamastan</ProprietaryName><NonProprietaryName>Immune Globulin (human)</NonProprietaryName></NDC><NDC><NDCCode>13533-636-02</NDCCode><ProprietaryName>Hyperhep B</ProprietaryName><NonProprietaryName>Hepatitis B Immune Globulin (human)</NonProprietaryName></NDC><NDC><NDCCode>10893-700-02</NDCCode><ProprietaryName>Naturasil Sulfur Lavender Multi-purpose Relief 5 Oz 2 Pk</ProprietaryName><NonProprietaryName>Sulfur, Thuja Occidentalis</NonProprietaryName></NDC><NDC><NDCCode>10920-700-02</NDCCode><NonProprietaryName>Esketamine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>11084-700-02</NDCCode><ProprietaryName>Deb Instantfoam Alcohol Sanitizer</ProprietaryName><NonProprietaryName>Ethyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>14789-700-02</NDCCode><ProprietaryName>Prochlorperazine Edisylate</ProprietaryName><NonProprietaryName>Prochlorperazine Edisylate</NonProprietaryName></NDC><NDC><NDCCode>17271-700-02</NDCCode><ProprietaryName>Sodium Chloride</ProprietaryName><NonProprietaryName>Sodium Chloride</NonProprietaryName></NDC><NDC><NDCCode>21749-700-02</NDCCode><ProprietaryName>Purell Advanced Instant Hand Sanitizer</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>24338-700-10</NDCCode><ProprietaryName>Cetylev</ProprietaryName><NonProprietaryName>Acetylcysteine</NonProprietaryName></NDC><NDC><NDCCode>43063-700-02</NDCCode><ProprietaryName>Azithromycin</ProprietaryName><NonProprietaryName>Azithromycin</NonProprietaryName></NDC><NDC><NDCCode>43386-700-02</NDCCode><ProprietaryName>Sodium Sulfate, Potassium Sulfate, Magnesium Sulfate</ProprietaryName><NonProprietaryName>Sodium Sulfate, Potassium Sulfate, Magnesium Sulfate</NonProprietaryName></NDC><NDC><NDCCode>45802-700-02</NDCCode><ProprietaryName>Tacrolimus</ProprietaryName><NonProprietaryName>Tacrolimus</NonProprietaryName></NDC><NDC><NDCCode>49283-700-02</NDCCode><ProprietaryName>Ethyl Alcohol</ProprietaryName><NonProprietaryName>Ethyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>49349-700-02</NDCCode><ProprietaryName>Benztropine Mesylate</ProprietaryName><NonProprietaryName>Benztropine Mesylate</NonProprietaryName></NDC><NDC><NDCCode>49657-700-02</NDCCode><NonProprietaryName>Reserpine Crystalline</NonProprietaryName></NDC><NDC><NDCCode>51167-700-02</NDCCode><ProprietaryName>Orkambi</ProprietaryName><NonProprietaryName>Lumacaftor And Ivacaftor</NonProprietaryName></NDC><NDC><NDCCode>51414-700-02</NDCCode><ProprietaryName>Lens Cleaner</ProprietaryName><NonProprietaryName>Isopropyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>52641-700-02</NDCCode><ProprietaryName>Antiseptic</ProprietaryName><NonProprietaryName>Isopropyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>52793-700-02</NDCCode><ProprietaryName>Ahealon</ProprietaryName><NonProprietaryName>Arnica Montana, Calendula Officinalis Flowering Top, Echinacea Angustifolia, St. Johns Wort, Silver, Sulfur, Allylthiourea And Urtica Urens</NonProprietaryName></NDC><NDC><NDCCode>54340-700-02</NDCCode><ProprietaryName>Dial Country Orchard Antibacterial Soap</ProprietaryName><NonProprietaryName>Triclosan</NonProprietaryName></NDC><NDC><NDCCode>55037-700-02</NDCCode><ProprietaryName>Carbon Dioxide/oxygen 5/95</ProprietaryName><NonProprietaryName>Carbon Dioxide/oxygen 5/95</NonProprietaryName></NDC><NDC><NDCCode>55614-700-02</NDCCode><ProprietaryName>Wu Yang Brand Pain Relieving Medicated</ProprietaryName><NonProprietaryName>Menthol And Camphor</NonProprietaryName></NDC><NDC><NDCCode>57297-700-02</NDCCode><NonProprietaryName>Cefdinir Monohydrate</NonProprietaryName></NDC><NDC><NDCCode>63347-700-02</NDCCode><ProprietaryName>Verucide Physician Formula</ProprietaryName><NonProprietaryName>Salicyllic Acid</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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",
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      "Taxonomy2": "Optician",
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      "NPI": "1922502889",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "FADLALLA",
      "FirstName": "RANIA",
      "MiddleName": "ABDALLA DAW ELBEIT",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 BAY AVE",
      "MailingAddressCityName": "MONTCLAIR",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "07042-4837",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "973-429-6196",
      "FirstLinePracticeLocationAddress": "1 BAY AVE",
      "PracticeLocationAddressCityName": "MONTCLAIR",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "07042-4837",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "973-429-6196",
      "EnumerationDate": "03/23/2018",
      "LastUpdateDate": "03/23/2018",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "390200000X",
      "Taxonomy1": "Student in an Organized Health Care Education/Training Program",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1629068499",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "FAHOURY",
      "FirstName": "RANIA",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "FirstLineMailingAddress": "4411 N HOLLAND SYLVANIA RD",
      "SecondLineMailingAddress": "SUITE 201",
      "MailingAddressCityName": "TOLEDO",
      "MailingAddressStateName": "OH",
      "MailingAddressPostalCode": "43623-3525",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "419-843-3627",
      "MailingAddressFaxNumber": "419-843-9697",
      "FirstLinePracticeLocationAddress": "4411 N HOLLAND SYLVANIA RD",
      "SecondLinePracticeLocationAddress": "SUITE 201",
      "PracticeLocationAddressCityName": "TOLEDO",
      "PracticeLocationAddressStateName": "OH",
      "PracticeLocationAddressPostalCode": "43623-3525",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "419-843-3627",
      "PracticeLocationAddressFaxNumber": "419-843-9697",
      "EnumerationDate": "10/24/2005",
      "LastUpdateDate": "09/02/2011",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "35086663",
      "LicenseNumberStateCode1": "OH",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "2621621",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "OH",
      "OtherIdentifier2": "P00401238",
      "OtherIdentifierType2": "OTHER",
      "OtherIdentifierState2": "OH",
      "OtherIdentifierIssuer2": "RAILROAD MEDICARE"
    },
    {
      "NPI": "1033186986",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "NICOLA",
      "FirstName": "RANIA",
      "MiddleName": "SOLIMAN",
      "NamePrefix": "DR.",
      "Credential": "DDS",
      "FirstLineMailingAddress": "110 S WOODLAND ST",
      "MailingAddressCityName": "WINTER GARDEN",
      "MailingAddressStateName": "FL",
      "MailingAddressPostalCode": "34787-3546",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "407-905-8827",
      "MailingAddressFaxNumber": "407-645-4587",
      "FirstLinePracticeLocationAddress": "7900 FOREST CITY RD",
      "PracticeLocationAddressCityName": "ORLANDO",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "32810-3002",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "407-905-8827",
      "PracticeLocationAddressFaxNumber": "407-645-4587",
      "EnumerationDate": "02/28/2006",
      "LastUpdateDate": "07/28/2017",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1223G0001X",
      "Taxonomy1": "General Practice",
      "LicenseNumber1": "DN15582",
      "LicenseNumberStateCode1": "FL",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "122300000X",
      "Taxonomy2": "Dentist",
      "LicenseNumber2": "DN15582",
      "LicenseNumberStateCode2": "FL",
      "PrimaryTaxonomySwitch2": "Y",
      "OtherIdentifier1": "075156100",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "FL"
    },
    {
      "NPI": "1720032899",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ALBATAINEH",
      "FirstName": "RANIA",
      "MiddleName": "QASSIEM",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "11476 OKEECHOBEE BLVD",
      "MailingAddressCityName": "ROYAL PALM BEACH",
      "MailingAddressStateName": "FL",
      "MailingAddressPostalCode": "33411-8715",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "561-204-5111",
      "MailingAddressFaxNumber": "561-204-5150",
      "FirstLinePracticeLocationAddress": "11476 OKEECHOBEE BLVD",
      "PracticeLocationAddressCityName": "ROYAL PALM BEACH",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "33411-8715",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "561-204-5111",
      "PracticeLocationAddressFaxNumber": "561-204-5150",
      "EnumerationDate": "05/21/2006",
      "LastUpdateDate": "09/11/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "ME 79876",
      "LicenseNumberStateCode1": "FL",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1326095100",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ROSBOROUGH",
      "FirstName": "RANIA",
      "MiddleName": "BAJWA",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "3100 WYMAN PARK DR",
      "MailingAddressCityName": "BALTIMORE",
      "MailingAddressStateName": "MD",
      "MailingAddressPostalCode": "21211-2803",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "410-338-3500",
      "FirstLinePracticeLocationAddress": "3601 SW 160TH AVE",
      "SecondLinePracticeLocationAddress": "SUITE 250",
      "PracticeLocationAddressCityName": "MIRAMAR",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "33027-6308",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "877-866-7123",
      "EnumerationDate": "05/27/2006",
      "LastUpdateDate": "12/10/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "D0063732",
      "LicenseNumberStateCode1": "MD",
      "PrimaryTaxonomySwitch1": "Y",
      "TaxonomyCode2": "207Q00000X",
      "Taxonomy2": "Family Medicine",
      "LicenseNumber2": "0101257197",
      "LicenseNumberStateCode2": "VA",
      "PrimaryTaxonomySwitch2": "N"
    },
    {
      "NPI": "1528015310",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "HUSSEINI",
      "FirstName": "RANIA",
      "MiddleName": "I",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "111 CYPRESS ST",
      "MailingAddressCityName": "BROOKLINE",
      "MailingAddressStateName": "MA",
      "MailingAddressPostalCode": "02445-6002",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "508-718-4050",
      "FirstLinePracticeLocationAddress": "20 PATRIOT PL",
      "PracticeLocationAddressCityName": "FOXBORO",
      "PracticeLocationAddressStateName": "MA",
      "PracticeLocationAddressPostalCode": "02035-1375",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "508-718-4050",
      "EnumerationDate": "05/27/2006",
      "LastUpdateDate": "04/17/2012",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "209649",
      "LicenseNumberStateCode1": "MA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1760429591",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "RAYES-DANAN",
      "FirstName": "RANIA",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "OtherLastName": "RAYES",
      "OtherFirstName": "RANIA",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2500 METROHEALTH DR",
      "MailingAddressCityName": "CLEVELAND",
      "MailingAddressStateName": "OH",
      "MailingAddressPostalCode": "44109-1900",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "216-778-7800",
      "FirstLinePracticeLocationAddress": "2500 METROHEALTH DR",
      "PracticeLocationAddressCityName": "CLEVELAND",
      "PracticeLocationAddressStateName": "OH",
      "PracticeLocationAddressPostalCode": "44109-1900",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "216-778-7800",
      "EnumerationDate": "06/01/2006",
      "LastUpdateDate": "01/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207ZP0102X",
      "Taxonomy1": "Anatomic Pathology & Clinical Pathology",
      "LicenseNumber1": "35086346",
      "LicenseNumberStateCode1": "OH",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "2687703",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "OH"
    },
    {
      "NPI": "1699717660",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "AMPEY",
      "FirstName": "RANIA",
      "MiddleName": "L",
      "Credential": "LPC",
      "FirstLineMailingAddress": "5930 LOVERS LN",
      "SecondLineMailingAddress": "PREMIER NEUROPSYCHIATRY, PLC",
      "MailingAddressCityName": "PORTAGE",
      "MailingAddressStateName": "MI",
      "MailingAddressPostalCode": "49002-1673",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "269-873-1611",
      "FirstLinePracticeLocationAddress": "5930 LOVERS LN",
      "SecondLinePracticeLocationAddress": "PREMIER NEUROPSYCHIATRY, PLC",
      "PracticeLocationAddressCityName": "PORTAGE",
      "PracticeLocationAddressStateName": "MI",
      "PracticeLocationAddressPostalCode": "49002-1673",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "269-873-1611",
      "EnumerationDate": "06/12/2006",
      "LastUpdateDate": "12/30/2010",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional",
      "LicenseNumber1": "6401007658",
      "LicenseNumberStateCode1": "MI",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1801839667",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ABOUJAOUDE",
      "FirstName": "RANIA",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "PO BOX 1283",
      "MailingAddressCityName": "MEDFORD",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08055-6283",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "609-677-1046",
      "MailingAddressFaxNumber": "609-677-1306",
      "FirstLinePracticeLocationAddress": "200 TRENTON RD",
      "PracticeLocationAddressCityName": "BROWNS MILLS",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08015-1705",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "609-677-1046",
      "PracticeLocationAddressFaxNumber": "609-677-1306",
      "EnumerationDate": "06/13/2006",
      "LastUpdateDate": "09/15/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207RI0200X",
      "Taxonomy1": "Infectious Disease",
      "LicenseNumber1": "39215",
      "LicenseNumberStateCode1": "KY",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "207RI0200X",
      "Taxonomy2": "Infectious Disease",
      "LicenseNumber2": "25MA07672000",
      "LicenseNumberStateCode2": "NJ",
      "PrimaryTaxonomySwitch2": "Y"
    },
    {
      "NPI": "1184645301",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "BAIK",
      "FirstName": "RANIA",
      "Credential": "D.O.",
      "FirstLineMailingAddress": "602 ROUTE 169",
      "SecondLineMailingAddress": "PO BOX 865",
      "MailingAddressCityName": "WOODSTOCK",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06281-2225",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "860-821-3406",
      "MailingAddressFaxNumber": "860-821-3407",
      "FirstLinePracticeLocationAddress": "602 ROUTE 169",
      "PracticeLocationAddressCityName": "WOODSTOCK",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06281-2225",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "860-821-3406",
      "PracticeLocationAddressFaxNumber": "860-821-3407",
      "EnumerationDate": "07/22/2006",
      "LastUpdateDate": "01/14/2016",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "000260",
      "LicenseNumberStateCode1": "CT",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

                
{
  "NPI": [
    {
      "NPI": "1083349906",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "STAFFORD",
      "FirstName": "KADY",
      "NamePrefix": "MS.",
      "Credential": "LPC",
      "FirstLineMailingAddress": "13574 SW HIGHWAY 126",
      "MailingAddressCityName": "POWELL BUTTE",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97753-1541",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-480-6360",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-203-0307",
      "EnumerationDate": "07/24/2022",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional Counselor",
      "LicenseNumber1": "LPC6225",
      "LicenseNumberStateCode1": "ID",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C9084",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1215724679",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "SCHAY",
      "FirstName": "ANGELICA",
      "MiddleName": "NICOLE",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1841",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1841",
      "EnumerationDate": "04/21/2025",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101Y00000X",
      "Taxonomy1": "Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101Y00000X",
      "PrimaryTaxonomy": "Counselor"
    },
    {
      "NPI": "1013556505",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "IVENS",
      "FirstName": "KRYSTA",
      "FirstLineMailingAddress": "743 NW QUINCE AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-1250",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "360-526-1448",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "971-217-6150",
      "EnumerationDate": "12/31/2019",
      "LastUpdateDate": "02/15/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C7963",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "02/15/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1497336275",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ARANT",
      "FirstName": "ERIN",
      "MiddleName": "HENNESSEY",
      "FirstLineMailingAddress": "4639 SW 37TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-6776",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "04/14/2021",
      "LastUpdateDate": "04/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "225X00000X",
      "Taxonomy1": "Occupational Therapist",
      "LicenseNumber1": "390047",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/14/2021",
      "PrimaryTaxonomyCode": "225X00000X",
      "PrimaryTaxonomy": "Occupational Therapist"
    },
    {
      "NPI": "1174191407",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "GRIMALT",
      "FirstName": "EUGENIA",
      "MiddleName": "N",
      "Credential": "PT",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "06/14/2021",
      "LastUpdateDate": "06/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "2251P0200X",
      "Taxonomy1": "Pediatric Physical Therapist",
      "LicenseNumber1": "63979",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization.",
      "CertificationDate": "06/14/2021",
      "PrimaryTaxonomyCode": "2251P0200X",
      "PrimaryTaxonomy": "Pediatric Physical Therapist"
    },
    {
      "NPI": "1912604117",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "PAINTER",
      "FirstName": "JENNIFER",
      "FirstLineMailingAddress": "20080 DOANNA WAY UNIT 3",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-2931",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "209-743-9813",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/08/2023",
      "LastUpdateDate": "02/08/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/08/2023",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1396434700",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "GROVE",
      "FirstName": "JENNIFER",
      "MiddleName": "RHEA",
      "FirstLineMailingAddress": "303 NW BROADWAY ST",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97703-2658",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "801-573-6047",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "801-573-6047",
      "EnumerationDate": "05/02/2023",
      "LastUpdateDate": "05/02/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1041C0700X",
      "Taxonomy1": "Clinical Social Worker",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "05/02/2023",
      "PrimaryTaxonomyCode": "1041C0700X",
      "PrimaryTaxonomy": "Clinical Social Worker"
    },
    {
      "NPI": "1407698970",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "REDDEN",
      "FirstName": "SHANNON",
      "Credential": "CHW",
      "OtherLastName": "MCDOUGALL",
      "OtherFirstName": "SHANNON",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2312 NE 5TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8488",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-460-2192",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "PracticeLocationAddressFaxNumber": "541-550-7956",
      "EnumerationDate": "06/06/2024",
      "LastUpdateDate": "06/06/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "172V00000X",
      "Taxonomy1": "Community Health Worker",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "06/06/2024",
      "PrimaryTaxonomyCode": "172V00000X",
      "PrimaryTaxonomy": "Community Health Worker"
    },
    {
      "NPI": "1942022256",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "JACQUOT",
      "FirstName": "SHAYLA",
      "FirstLineMailingAddress": "PO BOX 1397",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97709-1397",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "10/28/2024",
      "LastUpdateDate": "10/28/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "10/26/2024",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1912723131",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "WEIMER",
      "FirstName": "ALAYNA",
      "FirstLineMailingAddress": "2748 NW 19TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-7766",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-499-8292",
      "EnumerationDate": "12/03/2024",
      "LastUpdateDate": "12/03/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "171M00000X",
      "Taxonomy1": "Case Manager/Care Coordinator",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/03/2024",
      "PrimaryTaxonomyCode": "171M00000X",
      "PrimaryTaxonomy": "Case Manager/Care Coordinator"
    },
    {
      "NPI": "1790594125",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "WIDDER",
      "FirstName": "JENNIFER",
      "MiddleName": "LYNN",
      "FirstLineMailingAddress": "22350 CALGARY DR",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-9216",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-749-8895",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1858",
      "EnumerationDate": "12/31/2024",
      "LastUpdateDate": "12/31/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "175T00000X",
      "Taxonomy1": "Peer Specialist",
      "LicenseNumber1": "112910",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/31/2024",
      "PrimaryTaxonomyCode": "175T00000X",
      "PrimaryTaxonomy": "Peer Specialist"
    },
    {
      "NPI": "1538965306",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "PARSONS",
      "FirstName": "JEANINE",
      "MiddleName": "JEWELL",
      "FirstLineMailingAddress": "2821 SW 28TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8681",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "760-927-4761",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/21/2025",
      "LastUpdateDate": "02/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "175T00000X",
      "Taxonomy1": "Peer Specialist",
      "LicenseNumber1": "113398",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/21/2025",
      "PrimaryTaxonomyCode": "175T00000X",
      "PrimaryTaxonomy": "Peer Specialist"
    }
  ]
}
Done. Press any key to exit ...