RESTful Lookup — Test-Drive (2007 – 2026)

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{
  "NDC": [
    {
      "NDCCode": "60492-0249-2",
      "PackageDescription": "7 VIAL in 1 CARTON (60492-0249-2)  / 35 mL in 1 VIAL (60492-0249-1) ",
      "NDC11Code": "60492-0249-02",
      "ProductNDC": "60492-0249",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Anthrasil",
      "NonProprietaryName": "Anthrax Immune Globulin (human)",
      "DosageFormName": "LIQUID",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20151005",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125562",
      "LabelerName": "Emergent BioSolutions Canada Inc.",
      "SubstanceName": "ANTHRAX IMMUNE GLOBULIN HUMAN",
      "StrengthNumber": "60",
      "StrengthUnit": "[iU]/35mL",
      "Status": "Active",
      "LastUpdate": "2026-01-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20151005",
      "SamplePackage": "N",
      "IndicationAndUsage": "ANTHRASIL is an Anthrax Immune Globulin Intravenous (Human) indicated for the treatment of inhalational anthrax in adult and pediatric patients in combination with appropriate antibacterial drugs. The effectiveness of ANTHRASIL is based solely on efficacy studies conducted in animal models of inhalational anthrax [See 13.2 Animal Toxicology and/or Pharmacology]. Limitations: 1 ANTHRASIL does not have direct antibacterial activity., 2 ANTHRASIL does not cross the blood-brain barrier and does not prevent or treat meningitis., 3 There have been no studies of ANTHRASIL in the pediatric, geriatric, or obese populations.",
      "Description": "ANTHRASIL, Anthrax Immune Globulin Intravenous (Human), is a sterile solution of purified human immune globulin G (IgG) containing polyclonal antibodies that bind the protective antigen (PA) component of Bacillus anthracis lethal and edema toxins. It is stabilized with 10% maltose and 0.03% polysorbate 80 (pH is between 5.0 and 6.5) and contains no preservative. The product is a clear or slightly opalescent colorless liquid, free of foreign particles, supplied in a 50 mL vial with variable fill volume. The total protein concentration ranges from 40 to 70 mg per mL. An adult dosage of 420 units (seven vials) of ANTHRASIL contains up to 0.368 g protein per kg body weight, and an adult dosage of 840 units (14 vials) contains up to 0.736 g protein per kg body weight. The protein load exposure to pediatric patients due to ANTHRASIL administration may range from 0.32 to 1.26 g per kg of body weight, depending on the weight-based pediatric dose. ANTHRASIL is prepared using plasma collected from healthy, screened donors who were immunized with BioThrax® (Anthrax Vaccine Adsorbed) to achieve high titers of anti-anthrax antibody (meeting minimum potency specifications) and purified by an anion-exchange column chromatography method. The source plasma is tested by FDA licensed nucleic acid testing (NAT) for human immunodeficiency virus 1 (HIV-1), hepatitis B virus (HBV) and hepatitis C virus (HCV). Plasma also was tested by in-process NAT for hepatitis A virus (HAV) and parvovirus B19 (B19) via minipool testing; the limit for B19 in the manufacturing pool is set not to exceed 104 International Units of B19 DNA per mL. The manufacturing process contains two steps implemented specifically for virus clearance. The solvent and detergent step (using tri-n-butyl phosphate and Triton X-100) is effective in the inactivation of enveloped viruses such as HBV, HCV and HIV. Virus filtration, using a Planova 20N virus filter, is effective for the removal of viruses based on their size, including some non-enveloped viruses. These two viral clearance steps are designed to increase product safety by reducing the risk of transmission of enveloped and non-enveloped viruses. In addition to these two specific steps, the process step of anion-exchange chromatography was identified as contributing to the overall viral clearance capacity for small non-lipid enveloped viruses. The inactivation and reduction of known enveloped and non-enveloped model viruses were validated in laboratory studies as summarized in Table 2. The viruses employed for spiking studies were selected to represent those viruses that are potential contaminants in the product, and to represent a wide range of physiochemical properties in order to challenge the manufacturing process’s ability for viral clearance in general. The product potency, as determined by an in vitro toxin neutralization assay (TNA), is expressed in arbitrary units by comparison to a standard calibrated against the Centers for Disease Control and Prevention (CDC) Reference Serum standard. Each vial contains approximately 40 to 70 mg per mL total protein and ≥60 units of toxin neutralizing activity. The product contains ≤40 mcg per mL of immune globulin A (IgA) as well as residual amounts of solvent and detergent, which are used to inactivate lipid-enveloped viruses."
    },
    {
      "NDCCode": "60492-0075-2",
      "PackageDescription": "6 VIAL, GLASS in 1 CARTON (60492-0075-2)  / 50 mL in 1 VIAL, GLASS (60492-0075-1) ",
      "NDC11Code": "60492-0075-02",
      "ProductNDC": "60492-0075",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Bat",
      "NonProprietaryName": "Botulism Antitoxin Heptavalent",
      "DosageFormName": "LIQUID",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20130301",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125462",
      "LabelerName": "Emergent BioSolutions Canada Inc",
      "SubstanceName": "EQUINE BOTULINUM NEUROTOXIN A IMMUNE FAB2; EQUINE BOTULINUM NEUROTOXIN B IMMUNE FAB2; EQUINE BOTULINUM NEUROTOXIN C IMMUNE FAB2; EQUINE BOTULINUM NEUROTOXIN D IMMUNE FAB2; EQUINE BOTULINUM NEUROTOXIN E IMMUNE FAB2; EQUINE BOTULINUM NEUROTOXIN F IMMUNE FAB2; EQUINE BOTULINUM NEUROTOXIN G IMMUNE FAB2",
      "StrengthNumber": "4500; 3300; 3000; 600; 5100; 3000; 600",
      "StrengthUnit": "[iU]/10mL; [iU]/10mL; [iU]/10mL; [iU]/10mL; [iU]/10mL; [iU]/10mL; [iU]/10mL",
      "Status": "Active",
      "LastUpdate": "2026-07-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20130301",
      "SamplePackage": "N",
      "IndicationAndUsage": "BAT [Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) – (Equine)] is a mixture of immune globulin fragments indicated for the treatment of symptomatic botulism following documented or suspected exposure to botulinum neurotoxin serotypes A, B, C, D, E, F, or G in adults and pediatric patients. The effectiveness of BAT is based on efficacy studies conducted in animal models of botulism.",
      "Description": "BAT [Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) – (Equine)] is a sterile solution of F(ab’)2 and F(ab') 2-related antibody fragments prepared from plasma obtained from horses that have been immunized with a specific serotype of botulinum toxoid and toxin. To obtain the final heptavalent product, the seven antitoxin serotypes are blended. BAT is supplied in a 50 milliliter vial size, with a fill volume ranging from 10 to 26 milliliters per vial. BAT is administered intravenously. The manufacturing process for each antitoxin type includes cation-exchange chromatography to purify the immune globulin fraction, digestion with pepsin to produce F(ab')2 plus F(ab')2-related immune globulin fragments, anion exchange chromatography to remove the pepsin as well as other impurities and filtration. In addition, the manufacturing process includes two viral inactivation/removal steps; solvent/detergent (S/D) treatment and virus filtration [Table 4]. The S/D treatment step is effective at inactivating known lipid-enveloped viruses such as equine encephalitis, equine arteritis, West Nile virus, equine infectious anemia, equine herpes virus, rabies, and equine influenza. The BAT manufacturing process also includes a robust filtration step that is effective in reducing the levels of some lipid-enveloped viruses (listed above) as well as non-enveloped viruses including equine rhinovirus, equine adenoviruses and adeno-associated viruses, and equine parvovirus. BAT is formulated with 10% maltose and 0.03% polysorbate 80. The formulated bulk material contains approximately 3-7 g% (30-70 milligrams/milliliter) protein. The product potency is expressed in units based on the mouse neutralization assay (MNA). Each unit of BAT is designed to neutralize 10,000 mouse intraperitoneal lethal dose 50% units (MIPLD50) of botulinum neurotoxin for serotype A, B, C, D, F, and G and 1,000 MIPLD50 of serotype E."
    },
    {
      "NDCCode": "60492-0173-2",
      "PackageDescription": "24 VIAL, SINGLE-USE in 1 CARTON (60492-0173-2)  / 12 mL in 1 VIAL, SINGLE-USE (60492-0173-1) ",
      "NDC11Code": "60492-0173-02",
      "ProductNDC": "60492-0173",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cnj-016",
      "NonProprietaryName": "Vaccinia Immune Globulin Intravenous (human)",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20050502",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125109",
      "LabelerName": "Emergent BioSolutions Canada Inc.",
      "SubstanceName": "HUMAN VACCINIA VIRUS IMMUNE GLOBULIN",
      "StrengthNumber": "1",
      "StrengthUnit": "[iU]/mL",
      "Pharm_Classes": "Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE], Virus Neutralization [MoA], Virus-specific Hyperimmune Globulins [EXT]",
      "Status": "Active",
      "LastUpdate": "2026-01-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20180112",
      "SamplePackage": "N",
      "IndicationAndUsage": "VIGIV (vaccinia immune globulin intravenous, human) is indicated for the treatment and/or modification of the following conditions: 1 Eczema vaccinatum, 2 Progressive vaccinia, 3 Severe generalized vaccinia, 4 Vaccinia infections in individuals who have skin conditions such as burns, impetigo, varicella-zoster, or poison ivy; or in individuals who have eczematous skin lesions because of either the activity or extensiveness of such lesions, 5 Aberrant infections induced by vaccinia virus that include its accidental implantation in eyes (except in cases of isolated keratitis), mouth, or other areas where vaccinia infection would constitute a special hazard.",
      "Description": "VIGIV is a solvent/detergent-treated, filtered sterile solution of purified gamma globulin (IgG) fraction of human plasma containing antibodies to vaccinia virus. It is stabilized with 10% maltose and 0.03% polysorbate 80 (pH is between 5.0 and 6.5) and contains no preservative. The product is a clear to opalescent liquid. VIGIV is manufactured from plasma collected from healthy, screened donors with high titers of anti-vaccinia antibody (meeting minimum potency specifications) that is purified by an anion-exchange column chromatography method (3, 4). The plasma donors were boosted with vaccinia vaccine prior to donating plasma used in the production of the product. Each plasma donation used for the manufacture of VIGIV is tested for the presence of hepatitis B virus (HBV) surface antigen (HBsAg) and antibodies to human immunodeficiency viruses (HIV) 1/2 and hepatitis C virus (HCV) using FDA-licensed serological tests. Plasma used in the manufacture of this product was tested by FDA licensed Nucleic Acid Testing (NAT) for HIV-1 and HCV and found to be negative. A NAT for HBV was also performed on all Source Plasma used and found to be negative; however, the significance of a negative result has not been established. The Source Plasma has also been tested by NAT for hepatitis A virus (HAV) and parvovirus B19 and the limit for B19 in the manufacturing pool is set not to exceed 104 IU of B19 DNA per mL. The manufacturing process contains two steps implemented specifically for virus clearance. The solvent and detergent step (using tri-n-butyl phosphate and Triton X-100) is effective in the inactivation of enveloped viruses, such as HBV, HCV and HIV (5). Virus filtration, using a Planova 20N virus filter, is effective for the removal of viruses based on their size, including some non-enveloped viruses (6). In addition to the two specific steps, the anion-exchange chromatography step contributes to the removal of small non–lipid enveloped viruses. The inactivation and reduction of known enveloped and non–enveloped model viruses were validated in laboratory studies as summarized in Table 2. The product potency (as determined by a plaque reduction neutralization test) is expressed in arbitrary units (U) by comparison to the FDA reference standard. Each vial contains approximately 40 to 80 mg/mL total protein and ≥50,000 units of vaccinia antibody neutralizing activity. The product contains ≤40 mcg/mL of Immune globulin A (IgA)."
    },
    {
      "NDCCode": "15631-0249-2",
      "PackageDescription": "400 PELLET in 1 PACKAGE (15631-0249-2) ",
      "NDC11Code": "15631-0249-02",
      "ProductNDC": "15631-0249",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Kali Carbonicum",
      "NonProprietaryName": "Kali Carbonicum",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150905",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
      "SubstanceName": "POTASSIUM CARBONATE",
      "StrengthNumber": "2",
      "StrengthUnit": "[hp_X]/1",
      "Status": "Active",
      "LastUpdate": "2021-09-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Condition listed above or as directed by the physician."
    },
    {
      "NDCCode": "27816-0249-1",
      "PackageDescription": "1 BAG in 1 BOX (27816-0249-1)  > 25 kg in 1 BAG (27816-0249-2)",
      "NDC11Code": "27816-0249-01",
      "ProductNDC": "27816-0249",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Aminophylline",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20101012",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Wuhan Fortuna Chemical Co Ltd",
      "SubstanceName": "AMINOPHYLLINE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "37662-0249-2",
      "PackageDescription": "500 PELLET in 1 VIAL, GLASS (37662-0249-2) ",
      "NDC11Code": "37662-0249-02",
      "ProductNDC": "37662-0249",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Chlorinum",
      "NonProprietaryName": "Chlorinum",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220531",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Hahnemann Laboratories, INC.",
      "SubstanceName": "CHLORINE",
      "StrengthNumber": "1",
      "StrengthUnit": "[hp_M]/1",
      "Status": "Active",
      "LastUpdate": "2022-06-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220531",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "49288-0249-1",
      "PackageDescription": "2 mL in 1 VIAL, MULTI-DOSE (49288-0249-1)",
      "NDC11Code": "49288-0249-01",
      "ProductNDC": "49288-0249",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Helminthosporium",
      "NonProprietaryName": "Helminthosporium",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "COCHLIOBOLUS SATIVUS",
      "StrengthNumber": ".025",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
    },
    {
      "NDCCode": "49288-0249-2",
      "PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49288-0249-2)",
      "NDC11Code": "49288-0249-02",
      "ProductNDC": "49288-0249",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Helminthosporium",
      "NonProprietaryName": "Helminthosporium",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "COCHLIOBOLUS SATIVUS",
      "StrengthNumber": ".025",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
    },
    {
      "NDCCode": "50845-0249-2",
      "PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (50845-0249-2)  / 30 mL in 1 BOTTLE, SPRAY (50845-0249-1) ",
      "NDC11Code": "50845-0249-02",
      "ProductNDC": "50845-0249",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Metals",
      "NonProprietaryName": "Alumina, Aurum Metallicum, Carbo Vegetabilis, Causticum, Cysteinum, Hepar Suis, Hepar Sulphuris Calcareum, Nitricum Acidum, Nux Vomica, Phytolacca Decandra, Platinum Metallicum, Stannum Metallicum, Stillingia Sylvatica, Tellurium Metallicum, X-ray",
      "DosageFormName": "SPRAY",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190321",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Liddell Laboratories, Inc.",
      "SubstanceName": "ALUMINUM OXIDE; GOLD; ACTIVATED CHARCOAL; CAUSTICUM; CYSTEINE; PORK LIVER; CALCIUM SULFIDE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; PLATINUM; TIN; STILLINGIA SYLVATICA ROOT; TELLURIUM; ALCOHOL, X-RAY EXPOSED (1000 RAD)",
      "StrengthNumber": "30; 30; 12; 12; 12; 6; 12; 30; 12; 6; 30; 30; 6; 30; 30",
      "StrengthUnit": "[hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL",
      "Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Standardized Chemical Allergen [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-07-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190321",
      "SamplePackage": "N",
      "IndicationAndUsage": "May help detoxify accumulated heavy metals (mercury, aluminum, lead, nickel, arsenic, tin) and may temporarily relieve associated symptoms.  headaches.  poor concentration.  poor mood.  fatigue.  restless sleep.  muscle pain**. **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
    },
    {
      "NDCCode": "67995-0249-1",
      "PackageDescription": "1 BAG in 1 BOX (67995-0249-1)  > 25 kg in 1 BAG (67995-0249-2)",
      "NDC11Code": "67995-0249-01",
      "ProductNDC": "67995-0249",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Aminophylline",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20101203",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Yicheng Chemical Corp.",
      "SubstanceName": "AMINOPHYLLINE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "70000-0249-1",
      "PackageDescription": "2 BLISTER PACK in 1 CARTON (70000-0249-1)  > 16 TABLET in 1 BLISTER PACK",
      "NDC11Code": "70000-0249-01",
      "ProductNDC": "70000-0249",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sleep Aid",
      "ProprietaryNameSuffix": "Nighttime",
      "NonProprietaryName": "Doxylamine Succinate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20020411",
      "EndMarketingDate": "20230203",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040564",
      "LabelerName": "Cardinal Health",
      "SubstanceName": "DOXYLAMINE SUCCINATE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2023-02-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20020411",
      "EndMarketingDatePackage": "20230203",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "71335-0249-2",
      "PackageDescription": "30 TABLET in 1 BOTTLE (71335-0249-2) ",
      "NDC11Code": "71335-0249-02",
      "ProductNDC": "71335-0249",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Losartan Potassium",
      "NonProprietaryName": "Losartan Potassium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20101006",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090467",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "LOSARTAN POTASSIUM",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20110713",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0069-0249-01",
      "PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (0069-0249-01)  / 50 mL in 1 VIAL, SINGLE-USE",
      "NDC11Code": "00069-0249-01",
      "ProductNDC": "0069-0249",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ruxience",
      "NonProprietaryName": "Rituximab-pvvr",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20200123",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA761103",
      "LabelerName": "Pfizer Laboratories Div Pfizer Inc",
      "SubstanceName": "RITUXIMAB",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/50mL",
      "Pharm_Classes": "CD20-directed Antibody Interactions [MoA], CD20-directed Cytolytic Antibody [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-08-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20200123",
      "SamplePackage": "N",
      "IndicationAndUsage": "RUXIENCE is a CD20-directed cytolytic antibody indicated for the treatment of: 1 Adult patients with Non-Hodgkin's Lymphoma (NHL) (1.1).oRelapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent.oPreviously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy.oNon-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.oPreviously untreated diffuse large B-cell, CD20-positive NHL in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens., 2 Adult patients with Chronic Lymphocytic Leukemia (CLL) (1.2).oPreviously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC)., 3 Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately-to-severely-active RA who have inadequate response to one or more TNF antagonist therapies (1.3)., 4 Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids (1.4)., 5 Moderate to severe Pemphigus Vulgaris (PV) in adult patients (1.5).",
      "Description": "Rituximab-pvvr is a genetically engineered chimeric murine/human monoclonal IgG1 kappa antibody directed against the CD20 antigen. Rituximab-pvvr has an approximate molecular weight of 145 kD. Rituximab-pvvr is produced by mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium. RUXIENCE (rituximab-pvvr) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale brownish-yellow solution for intravenous infusion. RUXIENCE is supplied at a concentration of 10 mg/mL in either 100 mg/10 mL or 500 mg/50 mL single-dose vials. Each mL of solution contains 10 mg rituximab-pvvr, 0.056 mg of edetate disodium dihydrate, 1.2 mg of L-histidine, 2.57 mg of L-histidine hydrochloride monohydrate, 0.2 mg of polysorbate 80, 85 mg of sucrose, and Water for Injection, USP. The pH is 5.8."
    },
    {
      "NDCCode": "0078-0249-15",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0078-0249-15) ",
      "NDC11Code": "00078-0249-15",
      "ProductNDC": "0078-0249",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Femara",
      "NonProprietaryName": "Letrozole",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "19970731",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020726",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "LETROZOLE",
      "StrengthNumber": "2.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Aromatase Inhibitor [EPC], Aromatase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-06-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19970731",
      "SamplePackage": "N",
      "IndicationAndUsage": "Femara is an aromatase inhibitor indicated for: 1 Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. (1.1), 2 Extended adjuvant treatment of postmenopausal women with early breast cancer who have received prior standard adjuvant tamoxifen therapy. (1.2), 3 First and second-line treatment of postmenopausal women with hormone receptor positive or unknown advanced breast cancer. (1.3).",
      "Description": "Femara tablets for oral administration contains 2.5 mg of letrozole, a nonsteroidal aromatase inhibitor (inhibitor of estrogen synthesis). It is chemically described as 4,4'-(1H-1,2,4-Triazol-1-ylmethylene) dibenzonitrile, and its structural formula is. Letrozole is a white to yellowish crystalline powder, practically odorless, freely soluble in dichloromethane, slightly soluble in ethanol, and practically insoluble in water. It has a molecular weight of 285.31 g/mol, empirical formula C17H11N5, and a melting range of 184°C to 185°C. Femara is available as 2.5 mg tablets for oral administration. Inactive Ingredients: Colloidal silicon dioxide, ferric oxide, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, maize starch, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc, and titanium dioxide."
    },
    {
      "NDCCode": "0179-0249-06",
      "PackageDescription": "6 TABLET in 1 BOTTLE (0179-0249-06) ",
      "NDC11Code": "00179-0249-06",
      "ProductNDC": "0179-0249",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sulfamethoxazole And Trimethoprim",
      "NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180830",
      "EndMarketingDate": "20200831",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090624",
      "LabelerName": "KAISER FOUNDATION HOSPITALS",
      "SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
      "StrengthNumber": "800; 160",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2020-09-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20180830",
      "EndMarketingDatePackage": "20200831",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0179-0249-14",
      "PackageDescription": "14 TABLET in 1 BOTTLE (0179-0249-14) ",
      "NDC11Code": "00179-0249-14",
      "ProductNDC": "0179-0249",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sulfamethoxazole And Trimethoprim",
      "NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180830",
      "EndMarketingDate": "20200831",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090624",
      "LabelerName": "KAISER FOUNDATION HOSPITALS",
      "SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
      "StrengthNumber": "800; 160",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2020-09-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20180830",
      "EndMarketingDatePackage": "20200831",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0179-0249-20",
      "PackageDescription": "20 TABLET in 1 BOTTLE (0179-0249-20) ",
      "NDC11Code": "00179-0249-20",
      "ProductNDC": "0179-0249",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sulfamethoxazole And Trimethoprim",
      "NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180830",
      "EndMarketingDate": "20200831",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090624",
      "LabelerName": "KAISER FOUNDATION HOSPITALS",
      "SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
      "StrengthNumber": "800; 160",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2020-09-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20180830",
      "EndMarketingDatePackage": "20200831",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "13668-249-05",
      "PackageDescription": "500 TABLET in 1 BOTTLE (13668-249-05) ",
      "NDC11Code": "13668-0249-05",
      "ProductNDC": "13668-249",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olmesartan Medoxomil",
      "NonProprietaryName": "Olmesartan Medoxomil",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170424",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202375",
      "LabelerName": "Torrent Pharmaceuticals Limited",
      "SubstanceName": "OLMESARTAN MEDOXOMIL",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-08-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20170424",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "13668-249-30",
      "PackageDescription": "30 TABLET in 1 BOTTLE (13668-249-30) ",
      "NDC11Code": "13668-0249-30",
      "ProductNDC": "13668-249",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olmesartan Medoxomil",
      "NonProprietaryName": "Olmesartan Medoxomil",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170424",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202375",
      "LabelerName": "Torrent Pharmaceuticals Limited",
      "SubstanceName": "OLMESARTAN MEDOXOMIL",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-08-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20170424",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "13668-249-74",
      "PackageDescription": "100 TABLET in 1 CARTON (13668-249-74) ",
      "NDC11Code": "13668-0249-74",
      "ProductNDC": "13668-249",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olmesartan Medoxomil",
      "NonProprietaryName": "Olmesartan Medoxomil",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170424",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202375",
      "LabelerName": "Torrent Pharmaceuticals Limited",
      "SubstanceName": "OLMESARTAN MEDOXOMIL",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2022-06-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20170424",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "13668-249-90",
      "PackageDescription": "90 TABLET in 1 BOTTLE (13668-249-90) ",
      "NDC11Code": "13668-0249-90",
      "ProductNDC": "13668-249",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olmesartan Medoxomil",
      "NonProprietaryName": "Olmesartan Medoxomil",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170424",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202375",
      "LabelerName": "Torrent Pharmaceuticals Limited",
      "SubstanceName": "OLMESARTAN MEDOXOMIL",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-08-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20170424",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "15631-0249-0",
      "PackageDescription": "100 PELLET in 1 PACKAGE (15631-0249-0) ",
      "NDC11Code": "15631-0249-00",
      "ProductNDC": "15631-0249",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Kali Carbonicum",
      "NonProprietaryName": "Kali Carbonicum",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150905",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
      "SubstanceName": "POTASSIUM CARBONATE",
      "StrengthNumber": "2",
      "StrengthUnit": "[hp_X]/1",
      "Status": "Active",
      "LastUpdate": "2021-09-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Condition listed above or as directed by the physician."
    },
    {
      "NDCCode": "15631-0249-1",
      "PackageDescription": "200 PELLET in 1 PACKAGE (15631-0249-1) ",
      "NDC11Code": "15631-0249-01",
      "ProductNDC": "15631-0249",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Kali Carbonicum",
      "NonProprietaryName": "Kali Carbonicum",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150905",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
      "SubstanceName": "POTASSIUM CARBONATE",
      "StrengthNumber": "2",
      "StrengthUnit": "[hp_X]/1",
      "Status": "Active",
      "LastUpdate": "2021-09-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Condition listed above or as directed by the physician."
    },
    {
      "NDCCode": "15631-0249-3",
      "PackageDescription": "750 PELLET in 1 PACKAGE (15631-0249-3) ",
      "NDC11Code": "15631-0249-03",
      "ProductNDC": "15631-0249",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Kali Carbonicum",
      "NonProprietaryName": "Kali Carbonicum",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150905",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
      "SubstanceName": "POTASSIUM CARBONATE",
      "StrengthNumber": "2",
      "StrengthUnit": "[hp_X]/1",
      "Status": "Active",
      "LastUpdate": "2021-09-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Condition listed above or as directed by the physician."
    },
    {
      "NDCCode": "15631-0249-4",
      "PackageDescription": "2500 PELLET in 1 PACKAGE (15631-0249-4) ",
      "NDC11Code": "15631-0249-04",
      "ProductNDC": "15631-0249",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Kali Carbonicum",
      "NonProprietaryName": "Kali Carbonicum",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150905",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
      "SubstanceName": "POTASSIUM CARBONATE",
      "StrengthNumber": "2",
      "StrengthUnit": "[hp_X]/1",
      "Status": "Active",
      "LastUpdate": "2021-09-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Condition listed above or as directed by the physician."
    },
    {
      "NDCCode": "15631-0249-5",
      "PackageDescription": "12500 PELLET in 1 PACKAGE (15631-0249-5) ",
      "NDC11Code": "15631-0249-05",
      "ProductNDC": "15631-0249",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Kali Carbonicum",
      "NonProprietaryName": "Kali Carbonicum",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150905",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
      "SubstanceName": "POTASSIUM CARBONATE",
      "StrengthNumber": "2",
      "StrengthUnit": "[hp_X]/1",
      "Status": "Active",
      "LastUpdate": "2021-09-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Condition listed above or as directed by the physician."
    },
    {
      "NDCCode": "15631-0249-6",
      "PackageDescription": "500 PELLET in 1 PACKAGE (15631-0249-6) ",
      "NDC11Code": "15631-0249-06",
      "ProductNDC": "15631-0249",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Kali Carbonicum",
      "NonProprietaryName": "Kali Carbonicum",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150905",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
      "SubstanceName": "POTASSIUM CARBONATE",
      "StrengthNumber": "2",
      "StrengthUnit": "[hp_X]/1",
      "Status": "Active",
      "LastUpdate": "2021-09-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210823",
      "SamplePackage": "N",
      "IndicationAndUsage": "Condition listed above or as directed by the physician."
    },
    {
      "NDCCode": "15631-0249-7",
      "PackageDescription": "1000 PELLET in 1 PACKAGE (15631-0249-7) ",
      "NDC11Code": "15631-0249-07",
      "ProductNDC": "15631-0249",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Kali Carbonicum",
      "NonProprietaryName": "Kali Carbonicum",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150905",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
      "SubstanceName": "POTASSIUM CARBONATE",
      "StrengthNumber": "2",
      "StrengthUnit": "[hp_X]/1",
      "Status": "Active",
      "LastUpdate": "2021-09-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210823",
      "SamplePackage": "N",
      "IndicationAndUsage": "Condition listed above or as directed by the physician."
    },
    {
      "NDCCode": "21130-249-65",
      "PackageDescription": "30 BLISTER PACK in 1 CARTON (21130-249-65)  / 1 TABLET, FILM COATED in 1 BLISTER PACK",
      "NDC11Code": "21130-0249-65",
      "ProductNDC": "21130-249",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Signature Care Acid Controller",
      "NonProprietaryName": "Famotidine",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150904",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075400",
      "LabelerName": "Safeway",
      "SubstanceName": "FAMOTIDINE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-02-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20150904",
      "EndMarketingDatePackage": "20250228",
      "SamplePackage": "N",
      "IndicationAndUsage": "relieves heartburn associated with acid indigestion and sour stomach. prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages."
    },
    {
      "NDCCode": "21130-249-75",
      "PackageDescription": "1 BOTTLE in 1 CARTON (21130-249-75)  / 90 TABLET, FILM COATED in 1 BOTTLE",
      "NDC11Code": "21130-0249-75",
      "ProductNDC": "21130-249",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Signature Care Acid Controller",
      "NonProprietaryName": "Famotidine",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150904",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075400",
      "LabelerName": "Safeway",
      "SubstanceName": "FAMOTIDINE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-02-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210311",
      "SamplePackage": "N",
      "IndicationAndUsage": "relieves heartburn associated with acid indigestion and sour stomach. prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"60492-0249-2","ProprietaryName":"Anthrasil","NonProprietaryName":"Anthrax Immune Globulin (human)"},{"NDCCode":"60492-0075-2","ProprietaryName":"Bat","NonProprietaryName":"Botulism Antitoxin Heptavalent"},{"NDCCode":"60492-0173-2","ProprietaryName":"Cnj-016","NonProprietaryName":"Vaccinia Immune Globulin Intravenous (human)"},{"NDCCode":"15631-0249-2","ProprietaryName":"Kali Carbonicum","NonProprietaryName":"Kali Carbonicum"},{"NDCCode":"27816-0249-1","NonProprietaryName":"Aminophylline"},{"NDCCode":"37662-0249-2","ProprietaryName":"Chlorinum","NonProprietaryName":"Chlorinum"},{"NDCCode":"49288-0249-1","ProprietaryName":"Helminthosporium","NonProprietaryName":"Helminthosporium"},{"NDCCode":"49288-0249-2","ProprietaryName":"Helminthosporium","NonProprietaryName":"Helminthosporium"},{"NDCCode":"50845-0249-2","ProprietaryName":"Metals","NonProprietaryName":"Alumina, Aurum Metallicum, Carbo Vegetabilis, Causticum, Cysteinum, Hepar Suis, Hepar Sulphuris Calcareum, Nitricum Acidum, Nux Vomica, Phytolacca Decandra, Platinum Metallicum, Stannum Metallicum, Stillingia Sylvatica, Tellurium Metallicum, X-ray"},{"NDCCode":"67995-0249-1","NonProprietaryName":"Aminophylline"},{"NDCCode":"70000-0249-1","ProprietaryName":"Sleep Aid","NonProprietaryName":"Doxylamine Succinate"},{"NDCCode":"71335-0249-2","ProprietaryName":"Losartan Potassium","NonProprietaryName":"Losartan Potassium"},{"NDCCode":"0069-0249-01","ProprietaryName":"Ruxience","NonProprietaryName":"Rituximab-pvvr"},{"NDCCode":"0078-0249-15","ProprietaryName":"Femara","NonProprietaryName":"Letrozole"},{"NDCCode":"0179-0249-06","ProprietaryName":"Sulfamethoxazole And Trimethoprim","NonProprietaryName":"Sulfamethoxazole And Trimethoprim"},{"NDCCode":"0179-0249-14","ProprietaryName":"Sulfamethoxazole And Trimethoprim","NonProprietaryName":"Sulfamethoxazole And Trimethoprim"},{"NDCCode":"0179-0249-20","ProprietaryName":"Sulfamethoxazole And Trimethoprim","NonProprietaryName":"Sulfamethoxazole And Trimethoprim"},{"NDCCode":"13668-249-05","ProprietaryName":"Olmesartan Medoxomil","NonProprietaryName":"Olmesartan Medoxomil"},{"NDCCode":"13668-249-30","ProprietaryName":"Olmesartan Medoxomil","NonProprietaryName":"Olmesartan Medoxomil"},{"NDCCode":"13668-249-74","ProprietaryName":"Olmesartan Medoxomil","NonProprietaryName":"Olmesartan Medoxomil"},{"NDCCode":"13668-249-90","ProprietaryName":"Olmesartan Medoxomil","NonProprietaryName":"Olmesartan Medoxomil"},{"NDCCode":"15631-0249-0","ProprietaryName":"Kali Carbonicum","NonProprietaryName":"Kali Carbonicum"},{"NDCCode":"15631-0249-1","ProprietaryName":"Kali Carbonicum","NonProprietaryName":"Kali Carbonicum"},{"NDCCode":"15631-0249-3","ProprietaryName":"Kali Carbonicum","NonProprietaryName":"Kali Carbonicum"},{"NDCCode":"15631-0249-4","ProprietaryName":"Kali Carbonicum","NonProprietaryName":"Kali Carbonicum"},{"NDCCode":"15631-0249-5","ProprietaryName":"Kali Carbonicum","NonProprietaryName":"Kali Carbonicum"},{"NDCCode":"15631-0249-6","ProprietaryName":"Kali Carbonicum","NonProprietaryName":"Kali Carbonicum"},{"NDCCode":"15631-0249-7","ProprietaryName":"Kali Carbonicum","NonProprietaryName":"Kali Carbonicum"},{"NDCCode":"21130-249-65","ProprietaryName":"Signature Care Acid Controller","NonProprietaryName":"Famotidine"},{"NDCCode":"21130-249-75","ProprietaryName":"Signature Care Acid Controller","NonProprietaryName":"Famotidine"}]}
                    

<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>60492-0249-2</NDCCode>
    <PackageDescription>7 VIAL in 1 CARTON (60492-0249-2)  / 35 mL in 1 VIAL (60492-0249-1) </PackageDescription>
    <NDC11Code>60492-0249-02</NDC11Code>
    <ProductNDC>60492-0249</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Anthrasil</ProprietaryName>
    <NonProprietaryName>Anthrax Immune Globulin (human)</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20151005</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125562</ApplicationNumber>
    <LabelerName>Emergent BioSolutions Canada Inc.</LabelerName>
    <SubstanceName>ANTHRAX IMMUNE GLOBULIN HUMAN</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>[iU]/35mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-01-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151005</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ANTHRASIL is an Anthrax Immune Globulin Intravenous (Human) indicated for the treatment of inhalational anthrax in adult and pediatric patients in combination with appropriate antibacterial drugs. The effectiveness of ANTHRASIL is based solely on efficacy studies conducted in animal models of inhalational anthrax [See 13.2 Animal Toxicology and/or Pharmacology]. Limitations: 1 ANTHRASIL does not have direct antibacterial activity., 2 ANTHRASIL does not cross the blood-brain barrier and does not prevent or treat meningitis., 3 There have been no studies of ANTHRASIL in the pediatric, geriatric, or obese populations.</IndicationAndUsage>
    <Description>ANTHRASIL, Anthrax Immune Globulin Intravenous (Human), is a sterile solution of purified human immune globulin G (IgG) containing polyclonal antibodies that bind the protective antigen (PA) component of Bacillus anthracis lethal and edema toxins. It is stabilized with 10% maltose and 0.03% polysorbate 80 (pH is between 5.0 and 6.5) and contains no preservative. The product is a clear or slightly opalescent colorless liquid, free of foreign particles, supplied in a 50 mL vial with variable fill volume. The total protein concentration ranges from 40 to 70 mg per mL. An adult dosage of 420 units (seven vials) of ANTHRASIL contains up to 0.368 g protein per kg body weight, and an adult dosage of 840 units (14 vials) contains up to 0.736 g protein per kg body weight. The protein load exposure to pediatric patients due to ANTHRASIL administration may range from 0.32 to 1.26 g per kg of body weight, depending on the weight-based pediatric dose. ANTHRASIL is prepared using plasma collected from healthy, screened donors who were immunized with BioThrax® (Anthrax Vaccine Adsorbed) to achieve high titers of anti-anthrax antibody (meeting minimum potency specifications) and purified by an anion-exchange column chromatography method. The source plasma is tested by FDA licensed nucleic acid testing (NAT) for human immunodeficiency virus 1 (HIV-1), hepatitis B virus (HBV) and hepatitis C virus (HCV). Plasma also was tested by in-process NAT for hepatitis A virus (HAV) and parvovirus B19 (B19) via minipool testing; the limit for B19 in the manufacturing pool is set not to exceed 104 International Units of B19 DNA per mL. The manufacturing process contains two steps implemented specifically for virus clearance. The solvent and detergent step (using tri-n-butyl phosphate and Triton X-100) is effective in the inactivation of enveloped viruses such as HBV, HCV and HIV. Virus filtration, using a Planova 20N virus filter, is effective for the removal of viruses based on their size, including some non-enveloped viruses. These two viral clearance steps are designed to increase product safety by reducing the risk of transmission of enveloped and non-enveloped viruses. In addition to these two specific steps, the process step of anion-exchange chromatography was identified as contributing to the overall viral clearance capacity for small non-lipid enveloped viruses. The inactivation and reduction of known enveloped and non-enveloped model viruses were validated in laboratory studies as summarized in Table 2. The viruses employed for spiking studies were selected to represent those viruses that are potential contaminants in the product, and to represent a wide range of physiochemical properties in order to challenge the manufacturing process’s ability for viral clearance in general. The product potency, as determined by an in vitro toxin neutralization assay (TNA), is expressed in arbitrary units by comparison to a standard calibrated against the Centers for Disease Control and Prevention (CDC) Reference Serum standard. Each vial contains approximately 40 to 70 mg per mL total protein and ≥60 units of toxin neutralizing activity. The product contains ≤40 mcg per mL of immune globulin A (IgA) as well as residual amounts of solvent and detergent, which are used to inactivate lipid-enveloped viruses.</Description>
  </NDC>
  <NDC>
    <NDCCode>60492-0075-2</NDCCode>
    <PackageDescription>6 VIAL, GLASS in 1 CARTON (60492-0075-2)  / 50 mL in 1 VIAL, GLASS (60492-0075-1) </PackageDescription>
    <NDC11Code>60492-0075-02</NDC11Code>
    <ProductNDC>60492-0075</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Bat</ProprietaryName>
    <NonProprietaryName>Botulism Antitoxin Heptavalent</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20130301</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125462</ApplicationNumber>
    <LabelerName>Emergent BioSolutions Canada Inc</LabelerName>
    <SubstanceName>EQUINE BOTULINUM NEUROTOXIN A IMMUNE FAB2; EQUINE BOTULINUM NEUROTOXIN B IMMUNE FAB2; EQUINE BOTULINUM NEUROTOXIN C IMMUNE FAB2; EQUINE BOTULINUM NEUROTOXIN D IMMUNE FAB2; EQUINE BOTULINUM NEUROTOXIN E IMMUNE FAB2; EQUINE BOTULINUM NEUROTOXIN F IMMUNE FAB2; EQUINE BOTULINUM NEUROTOXIN G IMMUNE FAB2</SubstanceName>
    <StrengthNumber>4500; 3300; 3000; 600; 5100; 3000; 600</StrengthNumber>
    <StrengthUnit>[iU]/10mL; [iU]/10mL; [iU]/10mL; [iU]/10mL; [iU]/10mL; [iU]/10mL; [iU]/10mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-07-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130301</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>BAT [Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) – (Equine)] is a mixture of immune globulin fragments indicated for the treatment of symptomatic botulism following documented or suspected exposure to botulinum neurotoxin serotypes A, B, C, D, E, F, or G in adults and pediatric patients. The effectiveness of BAT is based on efficacy studies conducted in animal models of botulism.</IndicationAndUsage>
    <Description>BAT [Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) – (Equine)] is a sterile solution of F(ab’)2 and F(ab') 2-related antibody fragments prepared from plasma obtained from horses that have been immunized with a specific serotype of botulinum toxoid and toxin. To obtain the final heptavalent product, the seven antitoxin serotypes are blended. BAT is supplied in a 50 milliliter vial size, with a fill volume ranging from 10 to 26 milliliters per vial. BAT is administered intravenously. The manufacturing process for each antitoxin type includes cation-exchange chromatography to purify the immune globulin fraction, digestion with pepsin to produce F(ab')2 plus F(ab')2-related immune globulin fragments, anion exchange chromatography to remove the pepsin as well as other impurities and filtration. In addition, the manufacturing process includes two viral inactivation/removal steps; solvent/detergent (S/D) treatment and virus filtration [Table 4]. The S/D treatment step is effective at inactivating known lipid-enveloped viruses such as equine encephalitis, equine arteritis, West Nile virus, equine infectious anemia, equine herpes virus, rabies, and equine influenza. The BAT manufacturing process also includes a robust filtration step that is effective in reducing the levels of some lipid-enveloped viruses (listed above) as well as non-enveloped viruses including equine rhinovirus, equine adenoviruses and adeno-associated viruses, and equine parvovirus. BAT is formulated with 10% maltose and 0.03% polysorbate 80. The formulated bulk material contains approximately 3-7 g% (30-70 milligrams/milliliter) protein. The product potency is expressed in units based on the mouse neutralization assay (MNA). Each unit of BAT is designed to neutralize 10,000 mouse intraperitoneal lethal dose 50% units (MIPLD50) of botulinum neurotoxin for serotype A, B, C, D, F, and G and 1,000 MIPLD50 of serotype E.</Description>
  </NDC>
  <NDC>
    <NDCCode>60492-0173-2</NDCCode>
    <PackageDescription>24 VIAL, SINGLE-USE in 1 CARTON (60492-0173-2)  / 12 mL in 1 VIAL, SINGLE-USE (60492-0173-1) </PackageDescription>
    <NDC11Code>60492-0173-02</NDC11Code>
    <ProductNDC>60492-0173</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cnj-016</ProprietaryName>
    <NonProprietaryName>Vaccinia Immune Globulin Intravenous (human)</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20050502</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125109</ApplicationNumber>
    <LabelerName>Emergent BioSolutions Canada Inc.</LabelerName>
    <SubstanceName>HUMAN VACCINIA VIRUS IMMUNE GLOBULIN</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>[iU]/mL</StrengthUnit>
    <Pharm_Classes>Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE], Virus Neutralization [MoA], Virus-specific Hyperimmune Globulins [EXT]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180112</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>VIGIV (vaccinia immune globulin intravenous, human) is indicated for the treatment and/or modification of the following conditions: 1 Eczema vaccinatum, 2 Progressive vaccinia, 3 Severe generalized vaccinia, 4 Vaccinia infections in individuals who have skin conditions such as burns, impetigo, varicella-zoster, or poison ivy; or in individuals who have eczematous skin lesions because of either the activity or extensiveness of such lesions, 5 Aberrant infections induced by vaccinia virus that include its accidental implantation in eyes (except in cases of isolated keratitis), mouth, or other areas where vaccinia infection would constitute a special hazard.</IndicationAndUsage>
    <Description>VIGIV is a solvent/detergent-treated, filtered sterile solution of purified gamma globulin (IgG) fraction of human plasma containing antibodies to vaccinia virus. It is stabilized with 10% maltose and 0.03% polysorbate 80 (pH is between 5.0 and 6.5) and contains no preservative. The product is a clear to opalescent liquid. VIGIV is manufactured from plasma collected from healthy, screened donors with high titers of anti-vaccinia antibody (meeting minimum potency specifications) that is purified by an anion-exchange column chromatography method (3, 4). The plasma donors were boosted with vaccinia vaccine prior to donating plasma used in the production of the product. Each plasma donation used for the manufacture of VIGIV is tested for the presence of hepatitis B virus (HBV) surface antigen (HBsAg) and antibodies to human immunodeficiency viruses (HIV) 1/2 and hepatitis C virus (HCV) using FDA-licensed serological tests. Plasma used in the manufacture of this product was tested by FDA licensed Nucleic Acid Testing (NAT) for HIV-1 and HCV and found to be negative. A NAT for HBV was also performed on all Source Plasma used and found to be negative; however, the significance of a negative result has not been established. The Source Plasma has also been tested by NAT for hepatitis A virus (HAV) and parvovirus B19 and the limit for B19 in the manufacturing pool is set not to exceed 104 IU of B19 DNA per mL. The manufacturing process contains two steps implemented specifically for virus clearance. The solvent and detergent step (using tri-n-butyl phosphate and Triton X-100) is effective in the inactivation of enveloped viruses, such as HBV, HCV and HIV (5). Virus filtration, using a Planova 20N virus filter, is effective for the removal of viruses based on their size, including some non-enveloped viruses (6). In addition to the two specific steps, the anion-exchange chromatography step contributes to the removal of small non–lipid enveloped viruses. The inactivation and reduction of known enveloped and non–enveloped model viruses were validated in laboratory studies as summarized in Table 2. The product potency (as determined by a plaque reduction neutralization test) is expressed in arbitrary units (U) by comparison to the FDA reference standard. Each vial contains approximately 40 to 80 mg/mL total protein and ≥50,000 units of vaccinia antibody neutralizing activity. The product contains ≤40 mcg/mL of Immune globulin A (IgA).</Description>
  </NDC>
  <NDC>
    <NDCCode>15631-0249-2</NDCCode>
    <PackageDescription>400 PELLET in 1 PACKAGE (15631-0249-2) </PackageDescription>
    <NDC11Code>15631-0249-02</NDC11Code>
    <ProductNDC>15631-0249</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Kali Carbonicum</ProprietaryName>
    <NonProprietaryName>Kali Carbonicum</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150905</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
    <SubstanceName>POTASSIUM CARBONATE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>[hp_X]/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2021-09-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>27816-0249-1</NDCCode>
    <PackageDescription>1 BAG in 1 BOX (27816-0249-1)  &gt; 25 kg in 1 BAG (27816-0249-2)</PackageDescription>
    <NDC11Code>27816-0249-01</NDC11Code>
    <ProductNDC>27816-0249</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Aminophylline</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20101012</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Wuhan Fortuna Chemical Co Ltd</LabelerName>
    <SubstanceName>AMINOPHYLLINE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>37662-0249-2</NDCCode>
    <PackageDescription>500 PELLET in 1 VIAL, GLASS (37662-0249-2) </PackageDescription>
    <NDC11Code>37662-0249-02</NDC11Code>
    <ProductNDC>37662-0249</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Chlorinum</ProprietaryName>
    <NonProprietaryName>Chlorinum</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220531</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Hahnemann Laboratories, INC.</LabelerName>
    <SubstanceName>CHLORINE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>[hp_M]/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2022-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220531</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>49288-0249-1</NDCCode>
    <PackageDescription>2 mL in 1 VIAL, MULTI-DOSE (49288-0249-1)</PackageDescription>
    <NDC11Code>49288-0249-01</NDC11Code>
    <ProductNDC>49288-0249</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Helminthosporium</ProprietaryName>
    <NonProprietaryName>Helminthosporium</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19740323</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102223</ApplicationNumber>
    <LabelerName>Antigen Laboratories, Inc.</LabelerName>
    <SubstanceName>COCHLIOBOLUS SATIVUS</SubstanceName>
    <StrengthNumber>.025</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
    <Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
  </NDC>
  <NDC>
    <NDCCode>49288-0249-2</NDCCode>
    <PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (49288-0249-2)</PackageDescription>
    <NDC11Code>49288-0249-02</NDC11Code>
    <ProductNDC>49288-0249</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Helminthosporium</ProprietaryName>
    <NonProprietaryName>Helminthosporium</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19740323</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102223</ApplicationNumber>
    <LabelerName>Antigen Laboratories, Inc.</LabelerName>
    <SubstanceName>COCHLIOBOLUS SATIVUS</SubstanceName>
    <StrengthNumber>.025</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
    <Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
  </NDC>
  <NDC>
    <NDCCode>50845-0249-2</NDCCode>
    <PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (50845-0249-2)  / 30 mL in 1 BOTTLE, SPRAY (50845-0249-1) </PackageDescription>
    <NDC11Code>50845-0249-02</NDC11Code>
    <ProductNDC>50845-0249</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Metals</ProprietaryName>
    <NonProprietaryName>Alumina, Aurum Metallicum, Carbo Vegetabilis, Causticum, Cysteinum, Hepar Suis, Hepar Sulphuris Calcareum, Nitricum Acidum, Nux Vomica, Phytolacca Decandra, Platinum Metallicum, Stannum Metallicum, Stillingia Sylvatica, Tellurium Metallicum, X-ray</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190321</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Liddell Laboratories, Inc.</LabelerName>
    <SubstanceName>ALUMINUM OXIDE; GOLD; ACTIVATED CHARCOAL; CAUSTICUM; CYSTEINE; PORK LIVER; CALCIUM SULFIDE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; PLATINUM; TIN; STILLINGIA SYLVATICA ROOT; TELLURIUM; ALCOHOL, X-RAY EXPOSED (1000 RAD)</SubstanceName>
    <StrengthNumber>30; 30; 12; 12; 12; 6; 12; 30; 12; 6; 30; 30; 6; 30; 30</StrengthNumber>
    <StrengthUnit>[hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Standardized Chemical Allergen [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-07-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190321</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>May help detoxify accumulated heavy metals (mercury, aluminum, lead, nickel, arsenic, tin) and may temporarily relieve associated symptoms.  headaches.  poor concentration.  poor mood.  fatigue.  restless sleep.  muscle pain**. **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>67995-0249-1</NDCCode>
    <PackageDescription>1 BAG in 1 BOX (67995-0249-1)  &gt; 25 kg in 1 BAG (67995-0249-2)</PackageDescription>
    <NDC11Code>67995-0249-01</NDC11Code>
    <ProductNDC>67995-0249</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Aminophylline</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20101203</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Yicheng Chemical Corp.</LabelerName>
    <SubstanceName>AMINOPHYLLINE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>70000-0249-1</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 CARTON (70000-0249-1)  &gt; 16 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>70000-0249-01</NDC11Code>
    <ProductNDC>70000-0249</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sleep Aid</ProprietaryName>
    <ProprietaryNameSuffix>Nighttime</ProprietaryNameSuffix>
    <NonProprietaryName>Doxylamine Succinate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20020411</StartMarketingDate>
    <EndMarketingDate>20230203</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040564</ApplicationNumber>
    <LabelerName>Cardinal Health</LabelerName>
    <SubstanceName>DOXYLAMINE SUCCINATE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-02-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20020411</StartMarketingDatePackage>
    <EndMarketingDatePackage>20230203</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>71335-0249-2</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (71335-0249-2) </PackageDescription>
    <NDC11Code>71335-0249-02</NDC11Code>
    <ProductNDC>71335-0249</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Losartan Potassium</ProprietaryName>
    <NonProprietaryName>Losartan Potassium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20101006</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090467</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>LOSARTAN POTASSIUM</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110713</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0069-0249-01</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (0069-0249-01)  / 50 mL in 1 VIAL, SINGLE-USE</PackageDescription>
    <NDC11Code>00069-0249-01</NDC11Code>
    <ProductNDC>0069-0249</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ruxience</ProprietaryName>
    <NonProprietaryName>Rituximab-pvvr</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20200123</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761103</ApplicationNumber>
    <LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
    <SubstanceName>RITUXIMAB</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/50mL</StrengthUnit>
    <Pharm_Classes>CD20-directed Antibody Interactions [MoA], CD20-directed Cytolytic Antibody [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200123</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>RUXIENCE is a CD20-directed cytolytic antibody indicated for the treatment of: 1 Adult patients with Non-Hodgkin's Lymphoma (NHL) (1.1).oRelapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent.oPreviously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy.oNon-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.oPreviously untreated diffuse large B-cell, CD20-positive NHL in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens., 2 Adult patients with Chronic Lymphocytic Leukemia (CLL) (1.2).oPreviously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC)., 3 Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately-to-severely-active RA who have inadequate response to one or more TNF antagonist therapies (1.3)., 4 Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids (1.4)., 5 Moderate to severe Pemphigus Vulgaris (PV) in adult patients (1.5).</IndicationAndUsage>
    <Description>Rituximab-pvvr is a genetically engineered chimeric murine/human monoclonal IgG1 kappa antibody directed against the CD20 antigen. Rituximab-pvvr has an approximate molecular weight of 145 kD. Rituximab-pvvr is produced by mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium. RUXIENCE (rituximab-pvvr) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale brownish-yellow solution for intravenous infusion. RUXIENCE is supplied at a concentration of 10 mg/mL in either 100 mg/10 mL or 500 mg/50 mL single-dose vials. Each mL of solution contains 10 mg rituximab-pvvr, 0.056 mg of edetate disodium dihydrate, 1.2 mg of L-histidine, 2.57 mg of L-histidine hydrochloride monohydrate, 0.2 mg of polysorbate 80, 85 mg of sucrose, and Water for Injection, USP. The pH is 5.8.</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-0249-15</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0078-0249-15) </PackageDescription>
    <NDC11Code>00078-0249-15</NDC11Code>
    <ProductNDC>0078-0249</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Femara</ProprietaryName>
    <NonProprietaryName>Letrozole</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19970731</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020726</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>LETROZOLE</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aromatase Inhibitor [EPC], Aromatase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19970731</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Femara is an aromatase inhibitor indicated for: 1 Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. (1.1), 2 Extended adjuvant treatment of postmenopausal women with early breast cancer who have received prior standard adjuvant tamoxifen therapy. (1.2), 3 First and second-line treatment of postmenopausal women with hormone receptor positive or unknown advanced breast cancer. (1.3).</IndicationAndUsage>
    <Description>Femara tablets for oral administration contains 2.5 mg of letrozole, a nonsteroidal aromatase inhibitor (inhibitor of estrogen synthesis). It is chemically described as 4,4'-(1H-1,2,4-Triazol-1-ylmethylene) dibenzonitrile, and its structural formula is. Letrozole is a white to yellowish crystalline powder, practically odorless, freely soluble in dichloromethane, slightly soluble in ethanol, and practically insoluble in water. It has a molecular weight of 285.31 g/mol, empirical formula C17H11N5, and a melting range of 184°C to 185°C. Femara is available as 2.5 mg tablets for oral administration. Inactive Ingredients: Colloidal silicon dioxide, ferric oxide, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, maize starch, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0179-0249-06</NDCCode>
    <PackageDescription>6 TABLET in 1 BOTTLE (0179-0249-06) </PackageDescription>
    <NDC11Code>00179-0249-06</NDC11Code>
    <ProductNDC>0179-0249</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
    <NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180830</StartMarketingDate>
    <EndMarketingDate>20200831</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090624</ApplicationNumber>
    <LabelerName>KAISER FOUNDATION HOSPITALS</LabelerName>
    <SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
    <StrengthNumber>800; 160</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-09-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20180830</StartMarketingDatePackage>
    <EndMarketingDatePackage>20200831</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0179-0249-14</NDCCode>
    <PackageDescription>14 TABLET in 1 BOTTLE (0179-0249-14) </PackageDescription>
    <NDC11Code>00179-0249-14</NDC11Code>
    <ProductNDC>0179-0249</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
    <NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180830</StartMarketingDate>
    <EndMarketingDate>20200831</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090624</ApplicationNumber>
    <LabelerName>KAISER FOUNDATION HOSPITALS</LabelerName>
    <SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
    <StrengthNumber>800; 160</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-09-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20180830</StartMarketingDatePackage>
    <EndMarketingDatePackage>20200831</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0179-0249-20</NDCCode>
    <PackageDescription>20 TABLET in 1 BOTTLE (0179-0249-20) </PackageDescription>
    <NDC11Code>00179-0249-20</NDC11Code>
    <ProductNDC>0179-0249</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
    <NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180830</StartMarketingDate>
    <EndMarketingDate>20200831</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090624</ApplicationNumber>
    <LabelerName>KAISER FOUNDATION HOSPITALS</LabelerName>
    <SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
    <StrengthNumber>800; 160</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-09-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20180830</StartMarketingDatePackage>
    <EndMarketingDatePackage>20200831</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>13668-249-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (13668-249-05) </PackageDescription>
    <NDC11Code>13668-0249-05</NDC11Code>
    <ProductNDC>13668-249</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Olmesartan Medoxomil</ProprietaryName>
    <NonProprietaryName>Olmesartan Medoxomil</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170424</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202375</ApplicationNumber>
    <LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
    <SubstanceName>OLMESARTAN MEDOXOMIL</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-08-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170424</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>13668-249-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (13668-249-30) </PackageDescription>
    <NDC11Code>13668-0249-30</NDC11Code>
    <ProductNDC>13668-249</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Olmesartan Medoxomil</ProprietaryName>
    <NonProprietaryName>Olmesartan Medoxomil</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170424</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202375</ApplicationNumber>
    <LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
    <SubstanceName>OLMESARTAN MEDOXOMIL</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-08-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170424</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>13668-249-74</NDCCode>
    <PackageDescription>100 TABLET in 1 CARTON (13668-249-74) </PackageDescription>
    <NDC11Code>13668-0249-74</NDC11Code>
    <ProductNDC>13668-249</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Olmesartan Medoxomil</ProprietaryName>
    <NonProprietaryName>Olmesartan Medoxomil</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170424</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202375</ApplicationNumber>
    <LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
    <SubstanceName>OLMESARTAN MEDOXOMIL</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-06-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170424</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>13668-249-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (13668-249-90) </PackageDescription>
    <NDC11Code>13668-0249-90</NDC11Code>
    <ProductNDC>13668-249</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Olmesartan Medoxomil</ProprietaryName>
    <NonProprietaryName>Olmesartan Medoxomil</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170424</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202375</ApplicationNumber>
    <LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
    <SubstanceName>OLMESARTAN MEDOXOMIL</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-08-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170424</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>15631-0249-0</NDCCode>
    <PackageDescription>100 PELLET in 1 PACKAGE (15631-0249-0) </PackageDescription>
    <NDC11Code>15631-0249-00</NDC11Code>
    <ProductNDC>15631-0249</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Kali Carbonicum</ProprietaryName>
    <NonProprietaryName>Kali Carbonicum</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150905</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
    <SubstanceName>POTASSIUM CARBONATE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>[hp_X]/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2021-09-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>15631-0249-1</NDCCode>
    <PackageDescription>200 PELLET in 1 PACKAGE (15631-0249-1) </PackageDescription>
    <NDC11Code>15631-0249-01</NDC11Code>
    <ProductNDC>15631-0249</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Kali Carbonicum</ProprietaryName>
    <NonProprietaryName>Kali Carbonicum</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150905</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
    <SubstanceName>POTASSIUM CARBONATE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>[hp_X]/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2021-09-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>15631-0249-3</NDCCode>
    <PackageDescription>750 PELLET in 1 PACKAGE (15631-0249-3) </PackageDescription>
    <NDC11Code>15631-0249-03</NDC11Code>
    <ProductNDC>15631-0249</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Kali Carbonicum</ProprietaryName>
    <NonProprietaryName>Kali Carbonicum</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150905</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
    <SubstanceName>POTASSIUM CARBONATE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>[hp_X]/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2021-09-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>15631-0249-4</NDCCode>
    <PackageDescription>2500 PELLET in 1 PACKAGE (15631-0249-4) </PackageDescription>
    <NDC11Code>15631-0249-04</NDC11Code>
    <ProductNDC>15631-0249</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Kali Carbonicum</ProprietaryName>
    <NonProprietaryName>Kali Carbonicum</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150905</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
    <SubstanceName>POTASSIUM CARBONATE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>[hp_X]/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2021-09-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>15631-0249-5</NDCCode>
    <PackageDescription>12500 PELLET in 1 PACKAGE (15631-0249-5) </PackageDescription>
    <NDC11Code>15631-0249-05</NDC11Code>
    <ProductNDC>15631-0249</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Kali Carbonicum</ProprietaryName>
    <NonProprietaryName>Kali Carbonicum</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150905</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
    <SubstanceName>POTASSIUM CARBONATE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>[hp_X]/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2021-09-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>15631-0249-6</NDCCode>
    <PackageDescription>500 PELLET in 1 PACKAGE (15631-0249-6) </PackageDescription>
    <NDC11Code>15631-0249-06</NDC11Code>
    <ProductNDC>15631-0249</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Kali Carbonicum</ProprietaryName>
    <NonProprietaryName>Kali Carbonicum</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150905</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
    <SubstanceName>POTASSIUM CARBONATE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>[hp_X]/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2021-09-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210823</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>15631-0249-7</NDCCode>
    <PackageDescription>1000 PELLET in 1 PACKAGE (15631-0249-7) </PackageDescription>
    <NDC11Code>15631-0249-07</NDC11Code>
    <ProductNDC>15631-0249</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Kali Carbonicum</ProprietaryName>
    <NonProprietaryName>Kali Carbonicum</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150905</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
    <SubstanceName>POTASSIUM CARBONATE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>[hp_X]/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2021-09-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210823</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>21130-249-65</NDCCode>
    <PackageDescription>30 BLISTER PACK in 1 CARTON (21130-249-65)  / 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>21130-0249-65</NDC11Code>
    <ProductNDC>21130-249</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Signature Care Acid Controller</ProprietaryName>
    <NonProprietaryName>Famotidine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150904</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075400</ApplicationNumber>
    <LabelerName>Safeway</LabelerName>
    <SubstanceName>FAMOTIDINE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-02-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150904</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250228</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>relieves heartburn associated with acid indigestion and sour stomach. prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>21130-249-75</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (21130-249-75)  / 90 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
    <NDC11Code>21130-0249-75</NDC11Code>
    <ProductNDC>21130-249</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Signature Care Acid Controller</ProprietaryName>
    <NonProprietaryName>Famotidine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150904</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075400</ApplicationNumber>
    <LabelerName>Safeway</LabelerName>
    <SubstanceName>FAMOTIDINE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-02-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210311</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>relieves heartburn associated with acid indigestion and sour stomach. prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages.</IndicationAndUsage>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>60492-0249-2</NDCCode><ProprietaryName>Anthrasil</ProprietaryName><NonProprietaryName>Anthrax Immune Globulin (human)</NonProprietaryName></NDC><NDC><NDCCode>60492-0075-2</NDCCode><ProprietaryName>Bat</ProprietaryName><NonProprietaryName>Botulism Antitoxin Heptavalent</NonProprietaryName></NDC><NDC><NDCCode>60492-0173-2</NDCCode><ProprietaryName>Cnj-016</ProprietaryName><NonProprietaryName>Vaccinia Immune Globulin Intravenous (human)</NonProprietaryName></NDC><NDC><NDCCode>15631-0249-2</NDCCode><ProprietaryName>Kali Carbonicum</ProprietaryName><NonProprietaryName>Kali Carbonicum</NonProprietaryName></NDC><NDC><NDCCode>27816-0249-1</NDCCode><NonProprietaryName>Aminophylline</NonProprietaryName></NDC><NDC><NDCCode>37662-0249-2</NDCCode><ProprietaryName>Chlorinum</ProprietaryName><NonProprietaryName>Chlorinum</NonProprietaryName></NDC><NDC><NDCCode>49288-0249-1</NDCCode><ProprietaryName>Helminthosporium</ProprietaryName><NonProprietaryName>Helminthosporium</NonProprietaryName></NDC><NDC><NDCCode>49288-0249-2</NDCCode><ProprietaryName>Helminthosporium</ProprietaryName><NonProprietaryName>Helminthosporium</NonProprietaryName></NDC><NDC><NDCCode>50845-0249-2</NDCCode><ProprietaryName>Metals</ProprietaryName><NonProprietaryName>Alumina, Aurum Metallicum, Carbo Vegetabilis, Causticum, Cysteinum, Hepar Suis, Hepar Sulphuris Calcareum, Nitricum Acidum, Nux Vomica, Phytolacca Decandra, Platinum Metallicum, Stannum Metallicum, Stillingia Sylvatica, Tellurium Metallicum, X-ray</NonProprietaryName></NDC><NDC><NDCCode>67995-0249-1</NDCCode><NonProprietaryName>Aminophylline</NonProprietaryName></NDC><NDC><NDCCode>70000-0249-1</NDCCode><ProprietaryName>Sleep Aid</ProprietaryName><NonProprietaryName>Doxylamine Succinate</NonProprietaryName></NDC><NDC><NDCCode>71335-0249-2</NDCCode><ProprietaryName>Losartan Potassium</ProprietaryName><NonProprietaryName>Losartan Potassium</NonProprietaryName></NDC><NDC><NDCCode>0069-0249-01</NDCCode><ProprietaryName>Ruxience</ProprietaryName><NonProprietaryName>Rituximab-pvvr</NonProprietaryName></NDC><NDC><NDCCode>0078-0249-15</NDCCode><ProprietaryName>Femara</ProprietaryName><NonProprietaryName>Letrozole</NonProprietaryName></NDC><NDC><NDCCode>0179-0249-06</NDCCode><ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName><NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName></NDC><NDC><NDCCode>0179-0249-14</NDCCode><ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName><NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName></NDC><NDC><NDCCode>0179-0249-20</NDCCode><ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName><NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName></NDC><NDC><NDCCode>13668-249-05</NDCCode><ProprietaryName>Olmesartan Medoxomil</ProprietaryName><NonProprietaryName>Olmesartan Medoxomil</NonProprietaryName></NDC><NDC><NDCCode>13668-249-30</NDCCode><ProprietaryName>Olmesartan Medoxomil</ProprietaryName><NonProprietaryName>Olmesartan Medoxomil</NonProprietaryName></NDC><NDC><NDCCode>13668-249-74</NDCCode><ProprietaryName>Olmesartan Medoxomil</ProprietaryName><NonProprietaryName>Olmesartan Medoxomil</NonProprietaryName></NDC><NDC><NDCCode>13668-249-90</NDCCode><ProprietaryName>Olmesartan Medoxomil</ProprietaryName><NonProprietaryName>Olmesartan Medoxomil</NonProprietaryName></NDC><NDC><NDCCode>15631-0249-0</NDCCode><ProprietaryName>Kali Carbonicum</ProprietaryName><NonProprietaryName>Kali Carbonicum</NonProprietaryName></NDC><NDC><NDCCode>15631-0249-1</NDCCode><ProprietaryName>Kali Carbonicum</ProprietaryName><NonProprietaryName>Kali Carbonicum</NonProprietaryName></NDC><NDC><NDCCode>15631-0249-3</NDCCode><ProprietaryName>Kali Carbonicum</ProprietaryName><NonProprietaryName>Kali Carbonicum</NonProprietaryName></NDC><NDC><NDCCode>15631-0249-4</NDCCode><ProprietaryName>Kali Carbonicum</ProprietaryName><NonProprietaryName>Kali Carbonicum</NonProprietaryName></NDC><NDC><NDCCode>15631-0249-5</NDCCode><ProprietaryName>Kali Carbonicum</ProprietaryName><NonProprietaryName>Kali Carbonicum</NonProprietaryName></NDC><NDC><NDCCode>15631-0249-6</NDCCode><ProprietaryName>Kali Carbonicum</ProprietaryName><NonProprietaryName>Kali Carbonicum</NonProprietaryName></NDC><NDC><NDCCode>15631-0249-7</NDCCode><ProprietaryName>Kali Carbonicum</ProprietaryName><NonProprietaryName>Kali Carbonicum</NonProprietaryName></NDC><NDC><NDCCode>21130-249-65</NDCCode><ProprietaryName>Signature Care Acid Controller</ProprietaryName><NonProprietaryName>Famotidine</NonProprietaryName></NDC><NDC><NDCCode>21130-249-75</NDCCode><ProprietaryName>Signature Care Acid Controller</ProprietaryName><NonProprietaryName>Famotidine</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",
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      "FirstName": "RANIA",
      "Credential": "D.O.",
      "FirstLineMailingAddress": "602 ROUTE 169",
      "SecondLineMailingAddress": "PO BOX 865",
      "MailingAddressCityName": "WOODSTOCK",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06281-2225",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "860-821-3406",
      "MailingAddressFaxNumber": "860-821-3407",
      "FirstLinePracticeLocationAddress": "602 ROUTE 169",
      "PracticeLocationAddressCityName": "WOODSTOCK",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06281-2225",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "860-821-3406",
      "PracticeLocationAddressFaxNumber": "860-821-3407",
      "EnumerationDate": "07/22/2006",
      "LastUpdateDate": "01/14/2016",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "000260",
      "LicenseNumberStateCode1": "CT",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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",
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}
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