RESTful Lookup — Test-Drive (2007 – 2025)

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{
  "NDC": [
    {
      "NDCCode": "43386-551-02",
      "PackageDescription": "20 TABLET in 1 BOTTLE (43386-551-02) ",
      "NDC11Code": "43386-0551-02",
      "ProductNDC": "43386-551",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tinidazole",
      "NonProprietaryName": "Tinidazole",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120430",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202044",
      "LabelerName": "Lupin Pharmaceuticals,Inc.",
      "SubstanceName": "TINIDAZOLE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]",
      "Status": "Active",
      "LastUpdate": "2023-06-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20120430",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tinidazole Tablets is a nitroimidazole antimicrobial indicated for: 1 Trichomoniasis (1.1), 2 Giardiasis: in patients age 3 and older (1.2), 3 Amebiasis: in patients age 3 and older (1.3), 4 Bacterial Vaginosis: in adult women (1.4, 8.1).",
      "Description": "Tinidazole is a synthetic antiprotozoal and antibacterial agent. It is 1-[2-(ethylsulfonyl)ethyl]-2-methyl-5-nitroimidazole, a second-generation 2-methyl-5-nitroimidazole, which has the following chemical structure. Tinidazole pink oral tablets contain 250 mg or 500 mg of tinidazole. Inactive ingredients include pregelatinized starch NF, croscarmellose sodium NF, magnesium stearate NF, microcrystalline cellulose NF, polyvinyl alcohol-part hydrolyzed USP, titanium dioxide USP, polyethylene glycol 3000 NF, talc USP, and FD&C red # 40 aluminum lake."
    },
    {
      "NDCCode": "43386-551-06",
      "PackageDescription": "60 TABLET in 1 BOTTLE (43386-551-06) ",
      "NDC11Code": "43386-0551-06",
      "ProductNDC": "43386-551",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tinidazole",
      "NonProprietaryName": "Tinidazole",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120430",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202044",
      "LabelerName": "Lupin Pharmaceuticals,Inc.",
      "SubstanceName": "TINIDAZOLE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]",
      "Status": "Active",
      "LastUpdate": "2023-06-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20120430",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tinidazole Tablets is a nitroimidazole antimicrobial indicated for: 1 Trichomoniasis (1.1), 2 Giardiasis: in patients age 3 and older (1.2), 3 Amebiasis: in patients age 3 and older (1.3), 4 Bacterial Vaginosis: in adult women (1.4, 8.1).",
      "Description": "Tinidazole is a synthetic antiprotozoal and antibacterial agent. It is 1-[2-(ethylsulfonyl)ethyl]-2-methyl-5-nitroimidazole, a second-generation 2-methyl-5-nitroimidazole, which has the following chemical structure. Tinidazole pink oral tablets contain 250 mg or 500 mg of tinidazole. Inactive ingredients include pregelatinized starch NF, croscarmellose sodium NF, magnesium stearate NF, microcrystalline cellulose NF, polyvinyl alcohol-part hydrolyzed USP, titanium dioxide USP, polyethylene glycol 3000 NF, talc USP, and FD&C red # 40 aluminum lake."
    },
    {
      "NDCCode": "43386-022-02",
      "PackageDescription": "20 TABLET in 1 BOTTLE (43386-022-02) ",
      "NDC11Code": "43386-0022-02",
      "ProductNDC": "43386-022",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Linezolid",
      "NonProprietaryName": "Linezolid",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160822",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207526",
      "LabelerName": "Lupin Pharmaceuticals,Inc.",
      "SubstanceName": "LINEZOLID",
      "StrengthNumber": "600",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2024-03-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20160822",
      "SamplePackage": "N",
      "IndicationAndUsage": "Linezolid tablets are an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia (1.1); Community-acquired pneumonia (1.2); Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis (1.3); Uncomplicated skin and skin structure infections (1.4); Vancomycin-resistant Enterococcus faecium infections (1.5). Limitations of Use (1.6): 1 Linezolid Tablets are not indicated for the treatment of Gram-negative infections., 2 The safety and efficacy of Linezolid formulations given for longer than 28 days have not been evaluated in controlled, 3 clinical trials.",
      "Description": "Linezolid Tablets contain linezolid, which is a synthetic antibacterial agent of the oxazolidinone class. The chemical name for linezolid is (S)-N-[[3-[3-Fluoro-4-(4- morpholinyl)phenyl]-2-oxo-5-oxazolidinyl] methyl]-acetamide. The empirical formula is C16H20FN3O4. Its molecular weight is 337.35, and its chemical structure is represented below:. Linezolid tablets for oral administration contain 600 mg linezolid, supplied as white, oval, film-coated tablets, debossed with \"n 022\" on one side and plain on other side. Inactive ingredients are microcrystalline cellulose, hydroxypropyl cellulose, crospovidine, magnesium stearate, titanium dioxide, polydextrose, hypromellose, triacetin, and polyethylene glycol."
    },
    {
      "NDCCode": "43386-026-02",
      "PackageDescription": "1 BOTTLE in 1 CARTON (43386-026-02)  > 20 mL in 1 BOTTLE",
      "NDC11Code": "43386-0026-02",
      "ProductNDC": "43386-026",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fluocinonide",
      "NonProprietaryName": "Fluocinonide",
      "DosageFormName": "SOLUTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20170721",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206003",
      "LabelerName": "Lupin Pharmaceuticals,Inc.",
      "SubstanceName": "FLUOCINONIDE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2018-12-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20170721",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fluocinonide Topical Solution USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
      "Description": "Fluocinonide Topical Solution USP, 0.05% is intended for topical administration. The active component is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6α,11β,16α)-. It has the following chemical structure. Fluocinonide Topical Solution USP, 0.05% contains fluocinonide 0.5 mg/mL in a solution of citric acid, ethyl alcohol (35%), diisopropyl adipate, propylene glycol and purified water. In this formulation, the active ingredient is totally in solution."
    },
    {
      "NDCCode": "43386-280-02",
      "PackageDescription": "1 PACKAGE in 1 CARTON (43386-280-02)  / 2 SYRINGE in 1 PACKAGE (43386-280-01)  / 2 g in 1 SYRINGE (43386-280-03) ",
      "NDC11Code": "43386-0280-02",
      "ProductNDC": "43386-280",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Diazepam",
      "NonProprietaryName": "Diazepam",
      "DosageFormName": "GEL",
      "RouteName": "RECTAL",
      "StartMarketingDate": "20231030",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091076",
      "LabelerName": "Lupin Pharmaceuticals,Inc.",
      "SubstanceName": "DIAZEPAM",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/2g",
      "Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
      "DEASchedule": "CIV",
      "Status": "Active",
      "LastUpdate": "2023-12-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20231030",
      "SamplePackage": "N",
      "IndicationAndUsage": "Diazepam rectal gel is intended for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 2 years of age and older.",
      "Description": "Diazepam rectal gel rectal delivery system is a non-sterile diazepam gel provided in a prefilled, unit-dose, rectal delivery system. Diazepam rectal gel contains 5 mg/g diazepam, benzoic acid, benzyl alcohol, polyethylene glycol-400, povidone, propylene glycol, sodium benzoate and water. Diazepam rectal gel is clear to slightly yellow and has a pH between 5.8 – 6.5. Diazepam, the active ingredient of diazepam rectal gel, is a benzodiazepine anticonvulsant with the chemical name 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. The structural formula is as follows."
    },
    {
      "NDCCode": "43386-281-02",
      "PackageDescription": "1 PACKAGE in 1 CARTON (43386-281-02)  / 2 SYRINGE in 1 PACKAGE (43386-281-01)  / 4 g in 1 SYRINGE (43386-281-03) ",
      "NDC11Code": "43386-0281-02",
      "ProductNDC": "43386-281",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Diazepam",
      "NonProprietaryName": "Diazepam",
      "DosageFormName": "GEL",
      "RouteName": "RECTAL",
      "StartMarketingDate": "20231030",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091076",
      "LabelerName": "Lupin Pharmaceuticals,Inc.",
      "SubstanceName": "DIAZEPAM",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/4g",
      "Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
      "DEASchedule": "CIV",
      "Status": "Active",
      "LastUpdate": "2023-12-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20231030",
      "SamplePackage": "N",
      "IndicationAndUsage": "Diazepam rectal gel is intended for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 2 years of age and older.",
      "Description": "Diazepam rectal gel rectal delivery system is a non-sterile diazepam gel provided in a prefilled, unit-dose, rectal delivery system. Diazepam rectal gel contains 5 mg/g diazepam, benzoic acid, benzyl alcohol, polyethylene glycol-400, povidone, propylene glycol, sodium benzoate and water. Diazepam rectal gel is clear to slightly yellow and has a pH between 5.8 – 6.5. Diazepam, the active ingredient of diazepam rectal gel, is a benzodiazepine anticonvulsant with the chemical name 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. The structural formula is as follows."
    },
    {
      "NDCCode": "43386-530-02",
      "PackageDescription": "30 g in 1 BOTTLE, PLASTIC (43386-530-02) ",
      "NDC11Code": "43386-0530-02",
      "ProductNDC": "43386-530",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Nystatin",
      "NonProprietaryName": "Nystatin",
      "DosageFormName": "POWDER",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140926",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065138",
      "LabelerName": "Lupin Pharmaceuticals,Inc.",
      "SubstanceName": "NYSTATIN",
      "StrengthNumber": "100000",
      "StrengthUnit": "U/g",
      "Pharm_Classes": "Polyene Antifungal [EPC], Polyenes [CS]",
      "Status": "Active",
      "LastUpdate": "2024-02-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20140926",
      "SamplePackage": "N",
      "IndicationAndUsage": "Nystatin topical powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. Nystatin topical powder is not indicated for systemic, oral, intravaginal or ophthalmic use.",
      "Description": "Nystatin is a polyene antifungal antibiotic obtained from Streptomyces noursei. The molecular formula for Nystatin is C47H75NO17. The molecular weight of Nystatin is 926.1. Structural formula. Nystatin topical powder is for dermatologic use. Nystatin topical powder contains 100,000 USP nystatin units per gram dispersed in talc."
    },
    {
      "NDCCode": "43386-700-02",
      "PackageDescription": "1 BOTTLE in 1 CONTAINER (43386-700-02)  / 177 mL in 1 BOTTLE",
      "NDC11Code": "43386-0700-02",
      "ProductNDC": "43386-700",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Sulfate, Potassium Sulfate, Magnesium Sulfate",
      "NonProprietaryName": "Sodium Sulfate, Potassium Sulfate, Magnesium Sulfate",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20221230",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202511",
      "LabelerName": "Lupin Pharmaceuticals, Inc.",
      "SubstanceName": "MAGNESIUM SULFATE ANHYDROUS; POTASSIUM SULFATE; SODIUM SULFATE",
      "StrengthNumber": "1.6; 3.13; 17.5",
      "StrengthUnit": "g/177mL; g/177mL; g/177mL",
      "Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2023-12-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20221230",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is indicated for cleansing of the colon as a preparation for colonoscopy in adults.",
      "Description": "Each Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution contains two 6 ounce bottles of solution. Each 6 ounce bottle contains: sodium sulfate 17.5 grams, potassium sulfate 3.13 grams, magnesium sulfate 1.6 grams. Inactive ingredients include: sodium benzoate, sucralose, malic acid, citric acid, lemon flavor, purified water. The solution is a clear to slightly hazy liquid. The solution is clear and colorless when diluted to a final volume of 16 ounces with water. Sodium Sulfate, USP. The chemical name is Na2SO4. The average Molecular Weight is 142.04. The structural formula is. Potassium Sulfate, FCC, Granular. The chemical name is K2SO4. The average Molecular Weight is 174.26. The structural formula is. Magnesium Sulfate, USP. The chemical name is MgSO4. The average Molecular Weight: 120.37. The structural formula is. Each Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution package also contains a polypropylene mixing container."
    },
    {
      "NDCCode": "43386-792-02",
      "PackageDescription": "250 CAPSULE in 1 BOTTLE (43386-792-02) ",
      "NDC11Code": "43386-0792-02",
      "ProductNDC": "43386-792",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Doxycycline",
      "NonProprietaryName": "Doxycycline",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150708",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204446",
      "LabelerName": "Lupin Pharmaceuticals,Inc.",
      "SubstanceName": "DOXYCYCLINE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
      "Status": "Active",
      "LastUpdate": "2024-02-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20150708",
      "SamplePackage": "N",
      "IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline capsules, USP and other antibacterial drugs, doxycycline capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.      Doxycycline is indicated for the treatment of the following infections.      Rocky mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae.      Respiratory tract infections caused by Mycoplasma  pneumoniae.      Lymphogranuloma  venereum caused by Chlamydia  trachomatis.      Psittacosis (ornithosis) caused by Chlamydophila psittaci.      Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated as judged by immunofluorescence.      Inclusion conjunctivitis caused by Chlamydia trachomatis.      Uncomplicated urethral, endocervical or rectal infections in adults caused by Chlamydia trachomatis.      Nongonococcal urethritis caused by Ureaplasma  urealyticum.      Relapsing fever due to Borrelia  recurrentis. Doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms.      Chancroid caused by Haemophilus ducreyi.      Plague due to Yersinia pestis.      Tularemia due to Francisella  tularensis.      Cholera caused by Vibrio cholerae.      Campylobacter fetus infections caused by Campylobacter fetus.      Brucellosis due to Brucella species (in conjunction with streptomycin).      Bartonellosis due to Bartonella  bacilliformis.      Granuloma inguinale caused by Calymmatobacterium  granulomatis. Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. Doxycycline is indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug.      Escherichia coli.      Enterobacter  aerogenes.      Shigella species.      Acinetobacter species.      Respiratory tract infections caused by Haemophilus  influenzae.      Respiratory tract and urinary tract infections caused by Klebsiella species. Doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug.       Upper respiratory infections caused by Streptococcus pneumoniae.      Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. When penicillin is contraindicated, doxycycline is an alternative  in the treatment of the following infections.      Uncomplicated gonorrhea caused by Neisseria  gonorrhoeae.      Syphilis caused by Treponema  pallidum.      Yaws caused by Treponema  pertenue.      Listeriosis due to Listeria  monocytogenes.      Vincent's infection caused by Fusobacterium  fusiforme.      Actinomycosis caused by Actinomyces  israelii.      Infections caused by Clostridium species. In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. In severe acne, doxycycline may be useful adjunctive therapy.",
      "Description": "Doxycycline is a broad-spectrum antibacterial synthetically derived from oxytetracycline. Doxycycline capsules USP, 50 mg, 75 mg, and 100 mg contain doxycycline monohydrate equivalent to 50 mg, 75 mg, and 100 mg of doxycycline for oral administration. The chemical designation of the light yellow to pale yellow powder is 2-Naphthacenecarboxamide,4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-,[4S-(4α,4aα,5α,5aα,6α,12aα)]-,monohydrate. Structural formula. C22H24N2O8  H2O               M.W. = 462.45. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Inert ingredients: colloidal silicon dioxide; magnesium stearate; microcrystalline cellulose; sodium starch glycolate; and a hard gelatin capsule which contains titanium dioxide, FD&C Red # 3, D&C Yellow # 10, gelatin, sodium lauryl sulfate, for the 50 mg strength; iron oxide black, iron oxide red, iron oxide yellow, titanium dioxide, gelatin, sodium lauryl sulfate for the 75 mg strength and  iron oxide black, Iron Oxide Red, Iron Oxide Yellow, Titanium Dioxide, FD & C Red# 3, D&C Yellow # 10, gelatin, sodium lauryl sulfate for the 100 mg strength. The capsules are printed with edible ink containing shellac, titanium dioxide, black iron oxide, red iron oxide and potassium hydroxide for 50 mg, 75 mg and 100 mg strengths."
    },
    {
      "NDCCode": "43386-794-02",
      "PackageDescription": "20 TABLET in 1 BOTTLE (43386-794-02) ",
      "NDC11Code": "43386-0794-02",
      "ProductNDC": "43386-794",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Doxycycline Hyclate",
      "NonProprietaryName": "Doxycycline Hyclate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170906",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207558",
      "LabelerName": "Lupin Pharmaceuticals,Inc.",
      "SubstanceName": "DOXYCYCLINE HYCLATE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2024-02-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20170906",
      "SamplePackage": "N",
      "IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Tablets, USP and other antibacterial drugs, Doxycycline Hyclate Tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Treatment:. Doxycycline is indicated for the treatment of the following infections: 1 Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae., 2 Respiratory tract infections caused by Mycoplasma pneumoniae. , 3 Lymphogranuloma venereum caused by Chlamydia trachomatis . , 4 Psittacosis (ornithosis) caused by Chlamydophila psittaci . , 5 Trachoma caused by Chlamydia trachomatis , although the infectious agent is not always eliminated, as judged by immunofluorescence. , 6 Inclusion conjunctivitis caused by Chlamydia trachomatis . , 7 Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis . , 8 Nongonococcal urethritis caused by Ureaplasma urealyticum . , 9 Relapsing fever due to  Borrelia recurrentis . .",
      "Description": "Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as Doxycycline Hyclate Tablets (doxycycline hydrochloride hemiethanolate hemihydrate) for oral administration. The structural formula of doxycycline hyclate is. With a molecular formula of C 22H 24N 2O 8H 2O and a molecular weight of 462.46. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate. The molecular formula for doxycycline hydrochloride hemiethanolate hemihydrate is (C 22H 24N 2O 8HCl) 2C 2H 6OH 2O and the molecular weight is 1025.89. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Inert ingredients are: colloidal silicon dioxide, corn starch, croscarmellose sodium, docusate sodium, magnesium stearate, microcrystalline cellulose, ethyl alcohol and a coating containing hypromellose, polyethylene glycol, titanium dioxide, FD&C Blue No. 2 and FD&C Yellow No. 6."
    },
    {
      "NDCCode": "13537-551-02",
      "PackageDescription": "1 TUBE in 1 BOX (13537-551-02)  > 4 g in 1 TUBE (13537-551-01)",
      "NDC11Code": "13537-0551-02",
      "ProductNDC": "13537-551",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lbel Couleur Luxe Amplifier Xp",
      "ProprietaryNameSuffix": "Amplifying Spf 15 - Rouge Provocation",
      "NonProprietaryName": "Octinoxate And Oxybenzone",
      "DosageFormName": "LIPSTICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130527",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Ventura Corporation LTD.",
      "SubstanceName": "OCTINOXATE; OXYBENZONE",
      "StrengthNumber": ".047; .009",
      "StrengthUnit": "g/g; g/g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Helps prevent sunburn."
    },
    {
      "NDCCode": "16714-551-02",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE (16714-551-02)",
      "NDC11Code": "16714-0551-02",
      "ProductNDC": "16714-551",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Zaleplon",
      "NonProprietaryName": "Zaleplon",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100623",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090374",
      "LabelerName": "Northstar Rx LLC",
      "SubstanceName": "ZALEPLON",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE]",
      "DEASchedule": "CIV",
      "Status": "Deprecated",
      "LastUpdate": "2018-10-26",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "49349-551-02",
      "PackageDescription": "30 TABLET in 1 BLISTER PACK (49349-551-02)",
      "NDC11Code": "49349-0551-02",
      "ProductNDC": "49349-551",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ranitidine Hydrochloride",
      "NonProprietaryName": "Ranitidine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20111003",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077824",
      "LabelerName": "REMEDYREPACK INC.",
      "SubstanceName": "RANITIDINE HYDROCHLORIDE",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "50804-551-02",
      "PackageDescription": "1 KIT in 1 CARTON (50804-551-02)  *  12 TABLET, COATED in 1 BLISTER PACK *  8 TABLET, COATED in 1 BLISTER PACK",
      "NDC11Code": "50804-0551-02",
      "ProductNDC": "50804-551",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cold Multi-symptom Daytime And Nighttime",
      "NonProprietaryName": "Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20111231",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "GoodSense",
      "Status": "Active",
      "LastUpdate": "2024-12-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20111231",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "53208-551-02",
      "PackageDescription": "1 CONTAINER in 1 BOX (53208-551-02)  > 13 g in 1 CONTAINER (53208-551-01)",
      "NDC11Code": "53208-0551-02",
      "ProductNDC": "53208-551",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Oh Age Recovery Tri Shield Pact 10",
      "NonProprietaryName": "Titanium Dioxide, Octinoxate",
      "DosageFormName": "POWDER",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110927",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "LG Household and Healthcare, Inc.",
      "SubstanceName": "TITANIUM DIOXIDE; OCTINOXATE",
      "StrengthNumber": "4.9; 2",
      "StrengthUnit": "g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "61504-551-02",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (61504-551-02)  / 3.80564 kg in 1 BOTTLE, PLASTIC (61504-551-01) ",
      "NDC11Code": "61504-0551-02",
      "ProductNDC": "61504-551",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "First Street Antibacterial Liquid Hand",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240130",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M",
      "LabelerName": "Amerifoods Trading Company",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": ".13",
      "StrengthUnit": "kg/100kg",
      "Status": "Active",
      "LastUpdate": "2025-11-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240130",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "61786-551-02",
      "PackageDescription": "30 TABLET in 1 BLISTER PACK (61786-551-02) ",
      "NDC11Code": "61786-0551-02",
      "ProductNDC": "61786-551",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Guanfacine",
      "NonProprietaryName": "Guanfacine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160125",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074673",
      "LabelerName": "REMEDYREPACK INC.",
      "SubstanceName": "GUANFACINE HYDROCHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-11-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20160125",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "63545-551-02",
      "PackageDescription": "200 PELLET in 1 VIAL, GLASS (63545-551-02) ",
      "NDC11Code": "63545-0551-02",
      "ProductNDC": "63545-551",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Bryonia Alba",
      "NonProprietaryName": "Bryonia Alba",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220505",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Hahnemann Laboratories, INC.",
      "SubstanceName": "BRYONIA ALBA ROOT",
      "StrengthNumber": "30",
      "StrengthUnit": "[hp_C]/1",
      "Status": "Active",
      "LastUpdate": "2022-05-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220505",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "65649-551-02",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (65649-551-02)  / .6 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "65649-0551-02",
      "ProductNDC": "65649-551",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Relistor",
      "NonProprietaryName": "Methylnaltrexone Bromide",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20080424",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021964",
      "LabelerName": "Salix Pharmaceuticals, Inc.",
      "SubstanceName": "METHYLNALTREXONE BROMIDE",
      "StrengthNumber": "12",
      "StrengthUnit": "mg/.6mL",
      "Pharm_Classes": "Opioid Antagonist [EPC], Opioid Antagonists [MoA], Quaternary Ammonium Compounds [CS]",
      "Status": "Active",
      "LastUpdate": "2025-06-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20080424",
      "SamplePackage": "N",
      "IndicationAndUsage": "RELISTOR is an opioid antagonist. RELISTOR tablets and RELISTOR injection are indicated for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. ( 1.1) . RELISTOR injection is indicated for the treatment of OIC in adults with advanced illness or pain caused by active cancer who require opioid dosage escalation for palliative care. ( 1.2) .",
      "Description": "RELISTOR ®(methylnaltrexone bromide) is a mu-opioid receptor antagonist. The chemical name for methylnaltrexone bromide is ( R)- N-(cyclopropylmethyl) noroxymorphone methobromide. The molecular formula is C 21H 26NO 4Br, and the molecular weight is 436.36. The structural formula is. RELISTOR tablets for oral administration are film-coated and contain 150 mg of methylnaltrexone bromide (equivalent to 122.5 mg methylnaltrexone). Inactive ingredients are silicified microcrystalline cellulose, microcrystalline cellulose, sodium lauryl sulfate, croscarmellose sodium, crospovidone, poloxamer 407, stearic acid (vegetable source), colloidal silicon dioxide, edetate calcium disodium, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. RELISTOR for subcutaneous administration is a sterile, clear and colorless to pale yellow aqueous solution. Each 3 mL vial contains 12 mg of methylnaltrexone bromide (equivalent to 9.8 mg of methylnaltrexone) in 0.6 mL of water. The excipients are 3.9 mg sodium chloride USP, 0.24 mg edetate calcium disodium USP, and 0.18 mg glycine hydrochloride. During manufacture, the pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. Each 8 mg/0.4 mL pre-filled syringe (1 mL syringe) contains 8 mg of methylnaltrexone bromide (equivalent to 6.5 mg of methylnaltrexone) in 0.4 mL of water. The excipients are 2.6 mg sodium chloride USP, 0.16 mg edetate calcium disodium USP, and 0.12 mg glycine hydrochloride. Each 12 mg/0.6 mL pre-filled syringe (1 mL syringe) contains 12 mg of methylnaltrexone bromide (equivalent to 9.8 mg of methylnaltrexone) in 0.6 mL of water. The excipients are 3.9 mg sodium chloride USP, 0.24 mg edetate calcium disodium USP, and 0.18 mg glycine hydrochloride."
    },
    {
      "NDCCode": "69774-551-02",
      "PackageDescription": "1 TUBE in 1 BOX (69774-551-02)  > 120 mL in 1 TUBE",
      "NDC11Code": "69774-0551-02",
      "ProductNDC": "69774-551",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Vmv Hypoallergenics Id Skin-buffing Cleansing Scrub",
      "NonProprietaryName": "Salicylic Acid",
      "DosageFormName": "EMULSION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20170515",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part333D",
      "LabelerName": "SKIN SCIENCES LABORATORY INC.",
      "SubstanceName": "SALICYLIC ACID",
      "StrengthNumber": "1.2",
      "StrengthUnit": "g/120mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Purpose Acne Treatment. Uses - Treats acne - Helps prevent development of new acne blemishes."
    },
    {
      "NDCCode": "69842-551-02",
      "PackageDescription": "1 g in 1 CONTAINER (69842-551-02)",
      "NDC11Code": "69842-0551-02",
      "ProductNDC": "69842-551",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cvs Health Cherry Spf 15 Lip Balm",
      "NonProprietaryName": "Oxybenzone, Octinoxate, Petrolatum",
      "DosageFormName": "STICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20150817",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "CVS",
      "SubstanceName": "OCTINOXATE; OXYBENZONE; PETROLATUM",
      "StrengthNumber": "7.5; 3.5; 44",
      "StrengthUnit": "mg/g; mg/g; mg/g",
      "Status": "Active",
      "LastUpdate": "2016-12-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20150817",
      "SamplePackage": "N",
      "IndicationAndUsage": "Helps prevent sunburn. Helps prevent and temporarily protects dry, chapped or windburned lips."
    },
    {
      "NDCCode": "76309-551-02",
      "PackageDescription": "56 mL in 1 BOTTLE (76309-551-02) ",
      "NDC11Code": "76309-0551-02",
      "ProductNDC": "76309-551",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Snugz Spf 50 Broad Spectrum Sunscreen",
      "NonProprietaryName": "Spf 50 Broad Spectrum Sunscreen",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20190101",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "SnugZ/USA, LLC",
      "SubstanceName": "AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE",
      "StrengthNumber": "2.7; 6.7; 4.5; 4.5",
      "StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL",
      "Status": "Active",
      "LastUpdate": "2024-12-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20190101",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "80353-551-01",
      "PackageDescription": "1 BOTTLE in 1 BOX (80353-551-01)  / 1 CAPSULE in 1 BOTTLE (80353-551-02)  / 60 CAPSULE in 1 CAPSULE (80353-551-03) ",
      "NDC11Code": "80353-0551-01",
      "ProductNDC": "80353-551",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Archibone",
      "NonProprietaryName": "Rheumatoid Arthritis And Osteoarthritis Recovery, And Cartilage Restore",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20211119",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "HCBIOPHARM LLC",
      "SubstanceName": "ACHYRANTHES JAPONICA ROOT; PRUNUS PERSICA WHOLE",
      "StrengthNumber": "1; 1",
      "StrengthUnit": "[hp_X]/1; [hp_X]/1",
      "Status": "Active",
      "LastUpdate": "2025-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20211119",
      "SamplePackage": "N",
      "IndicationAndUsage": "To reverse rheumatoid arthritis . To reverse osteoarthritis. To rebuild cartilage. To relieve joint pain."
    },
    {
      "NDCCode": "84756-551-02",
      "PackageDescription": "15 g in 1 BOX (84756-551-02) ",
      "NDC11Code": "84756-0551-02",
      "ProductNDC": "84756-551",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Trstay Retinol Moisturizing Crean",
      "NonProprietaryName": "Trstay Retinol Moisturizing Crean",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20241202",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "Yiwu Yucheng E Commerce Co Ltd",
      "SubstanceName": "NIACINAMIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2024-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20241202",
      "SamplePackage": "N",
      "IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
    },
    {
      "NDCCode": "24236-551-20",
      "PackageDescription": "100 TABLET in 1 VIAL (24236-551-20)",
      "NDC11Code": "24236-0551-20",
      "ProductNDC": "24236-551",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxybutynin Chloride",
      "NonProprietaryName": "Oxybutynin Chloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130405",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA071655",
      "LabelerName": "REMEDYREPACK INC.",
      "SubstanceName": "OXYBUTYNIN CHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "41163-551-40",
      "PackageDescription": "355 mL in 1 BOTTLE (41163-551-40) ",
      "NDC11Code": "41163-0551-40",
      "ProductNDC": "41163-551",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Equaline Nighttime Cough Relief",
      "NonProprietaryName": "Dextromethorphan Hbr, Doxylamine Succinate",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140520",
      "EndMarketingDate": "20250731",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "United Natural Foods, Inc. dba UNFI",
      "SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
      "StrengthNumber": "30; 12.5",
      "StrengthUnit": "mg/30mL; mg/30mL",
      "Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2025-08-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20140520",
      "EndMarketingDatePackage": "20250731",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves cold symptoms: 1 cough due to minor throat and bronchial irritation, 2 runny nose and sneezing."
    },
    {
      "NDCCode": "43538-551-60",
      "PackageDescription": "1 KIT in 1 CARTON (43538-551-60)  *  60 mL in 1 BOTTLE *  454 g in 1 BOTTLE, PUMP",
      "NDC11Code": "43538-0551-60",
      "ProductNDC": "43538-551",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Loprox",
      "NonProprietaryName": "Ciclopirox Olamine",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20161014",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019824",
      "LabelerName": "Medimetriks Pharmaceuticals, Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2023-08-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20161014",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "43547-551-10",
      "PackageDescription": "100 TABLET in 1 BOTTLE (43547-551-10) ",
      "NDC11Code": "43547-0551-10",
      "ProductNDC": "43547-551",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Potassium Chloride",
      "NonProprietaryName": "Potassium Chloride Extended-release",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190430",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209922",
      "LabelerName": "Solco Healthcare LLC",
      "SubstanceName": "POTASSIUM CHLORIDE",
      "StrengthNumber": "1125",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
      "Status": "Active",
      "LastUpdate": "2020-02-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190430",
      "SamplePackage": "N",
      "Description": "The potassium chloride extended-release tablets, USP 20 mEq product is an immediately dispersing extended release oral dosage form of potassium chloride containing 1500 mg of microencapsulated potassium chloride, USP equivalent to 20 mEq of potassium in a tablet. The potassium chloride extended-release tablets, USP 15 mEq product is an immediately dispersing extended release oral dosage form of potassium chloride containing 1125 mg of microencapsulated potassium chloride, USP equivalent to 15 mEq of potassium in a tablet. The potassium chloride extended-release tablets, USP 10 mEq product is an immediately dispersing extended release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. These formulations are intended to slow the release of potassium so that the likelihood of a high localized concentration of potassium chloride within the gastrointestinal tract is reduced. Potassium chloride is an electrolyte replenisher. The chemical name of the active ingredient is potassium chloride, and the structural formula is KCl. Potassium chloride, USP occurs as a white, granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Potassium chloride is a tablet formulation (not enteric coated or wax matrix) containing individually microencapsulated potassium chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of out-side agitation, potassium chloride tablets begin disintegrating into microencapsulated crystals within seconds and completely disintegrates within 1 minute. The microencapsulated crystals are formulated to provide an extended release of potassium chloride. Inactive Ingredients: croscarmellose sodium, ethylcellulose, microcrystalline cellulose, copovidone and sodium stearyl fumarate. USP sample preparation 2 is used in the assay. FDA approved dissolution test specifications differ from USP."
    },
    {
      "NDCCode": "47781-551-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (47781-551-01) ",
      "NDC11Code": "47781-0551-01",
      "ProductNDC": "47781-551",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Felbamate",
      "NonProprietaryName": "Felbamate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20161228",
      "EndMarketingDate": "20200901",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204595",
      "LabelerName": "Alvogen Inc.",
      "SubstanceName": "FELBAMATE",
      "StrengthNumber": "600",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2020-09-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20161228",
      "EndMarketingDatePackage": "20200901",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "49035-551-38",
      "PackageDescription": "283 g in 1 BOTTLE (49035-551-38)",
      "NDC11Code": "49035-0551-38",
      "ProductNDC": "49035-551",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Body",
      "NonProprietaryName": "Menthol, Zinc Oxide",
      "DosageFormName": "POWDER",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20030731",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part348",
      "LabelerName": "Wal-Mart Stores,Inc",
      "SubstanceName": "MENTHOL; ZINC OXIDE",
      "StrengthNumber": "1.5; 10",
      "StrengthUnit": "mg/g; mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2017-05-02"
    }
  ]
}
                    

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<NDCList>
  <NDC>
    <NDCCode>43386-551-02</NDCCode>
    <PackageDescription>20 TABLET in 1 BOTTLE (43386-551-02) </PackageDescription>
    <NDC11Code>43386-0551-02</NDC11Code>
    <ProductNDC>43386-551</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tinidazole</ProprietaryName>
    <NonProprietaryName>Tinidazole</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120430</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202044</ApplicationNumber>
    <LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
    <SubstanceName>TINIDAZOLE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-06-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120430</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tinidazole Tablets is a nitroimidazole antimicrobial indicated for: 1 Trichomoniasis (1.1), 2 Giardiasis: in patients age 3 and older (1.2), 3 Amebiasis: in patients age 3 and older (1.3), 4 Bacterial Vaginosis: in adult women (1.4, 8.1).</IndicationAndUsage>
    <Description>Tinidazole is a synthetic antiprotozoal and antibacterial agent. It is 1-[2-(ethylsulfonyl)ethyl]-2-methyl-5-nitroimidazole, a second-generation 2-methyl-5-nitroimidazole, which has the following chemical structure. Tinidazole pink oral tablets contain 250 mg or 500 mg of tinidazole. Inactive ingredients include pregelatinized starch NF, croscarmellose sodium NF, magnesium stearate NF, microcrystalline cellulose NF, polyvinyl alcohol-part hydrolyzed USP, titanium dioxide USP, polyethylene glycol 3000 NF, talc USP, and FD&amp;C red # 40 aluminum lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>43386-551-06</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE (43386-551-06) </PackageDescription>
    <NDC11Code>43386-0551-06</NDC11Code>
    <ProductNDC>43386-551</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tinidazole</ProprietaryName>
    <NonProprietaryName>Tinidazole</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120430</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202044</ApplicationNumber>
    <LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
    <SubstanceName>TINIDAZOLE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-06-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120430</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tinidazole Tablets is a nitroimidazole antimicrobial indicated for: 1 Trichomoniasis (1.1), 2 Giardiasis: in patients age 3 and older (1.2), 3 Amebiasis: in patients age 3 and older (1.3), 4 Bacterial Vaginosis: in adult women (1.4, 8.1).</IndicationAndUsage>
    <Description>Tinidazole is a synthetic antiprotozoal and antibacterial agent. It is 1-[2-(ethylsulfonyl)ethyl]-2-methyl-5-nitroimidazole, a second-generation 2-methyl-5-nitroimidazole, which has the following chemical structure. Tinidazole pink oral tablets contain 250 mg or 500 mg of tinidazole. Inactive ingredients include pregelatinized starch NF, croscarmellose sodium NF, magnesium stearate NF, microcrystalline cellulose NF, polyvinyl alcohol-part hydrolyzed USP, titanium dioxide USP, polyethylene glycol 3000 NF, talc USP, and FD&amp;C red # 40 aluminum lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>43386-022-02</NDCCode>
    <PackageDescription>20 TABLET in 1 BOTTLE (43386-022-02) </PackageDescription>
    <NDC11Code>43386-0022-02</NDC11Code>
    <ProductNDC>43386-022</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Linezolid</ProprietaryName>
    <NonProprietaryName>Linezolid</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160822</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207526</ApplicationNumber>
    <LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
    <SubstanceName>LINEZOLID</SubstanceName>
    <StrengthNumber>600</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-03-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160822</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Linezolid tablets are an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia (1.1); Community-acquired pneumonia (1.2); Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis (1.3); Uncomplicated skin and skin structure infections (1.4); Vancomycin-resistant Enterococcus faecium infections (1.5). Limitations of Use (1.6): 1 Linezolid Tablets are not indicated for the treatment of Gram-negative infections., 2 The safety and efficacy of Linezolid formulations given for longer than 28 days have not been evaluated in controlled, 3 clinical trials.</IndicationAndUsage>
    <Description>Linezolid Tablets contain linezolid, which is a synthetic antibacterial agent of the oxazolidinone class. The chemical name for linezolid is (S)-N-[[3-[3-Fluoro-4-(4- morpholinyl)phenyl]-2-oxo-5-oxazolidinyl] methyl]-acetamide. The empirical formula is C16H20FN3O4. Its molecular weight is 337.35, and its chemical structure is represented below:. Linezolid tablets for oral administration contain 600 mg linezolid, supplied as white, oval, film-coated tablets, debossed with "n 022" on one side and plain on other side. Inactive ingredients are microcrystalline cellulose, hydroxypropyl cellulose, crospovidine, magnesium stearate, titanium dioxide, polydextrose, hypromellose, triacetin, and polyethylene glycol.</Description>
  </NDC>
  <NDC>
    <NDCCode>43386-026-02</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (43386-026-02)  &gt; 20 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>43386-0026-02</NDC11Code>
    <ProductNDC>43386-026</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluocinonide</ProprietaryName>
    <NonProprietaryName>Fluocinonide</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20170721</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206003</ApplicationNumber>
    <LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
    <SubstanceName>FLUOCINONIDE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2018-12-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170721</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluocinonide Topical Solution USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
    <Description>Fluocinonide Topical Solution USP, 0.05% is intended for topical administration. The active component is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6α,11β,16α)-. It has the following chemical structure. Fluocinonide Topical Solution USP, 0.05% contains fluocinonide 0.5 mg/mL in a solution of citric acid, ethyl alcohol (35%), diisopropyl adipate, propylene glycol and purified water. In this formulation, the active ingredient is totally in solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>43386-280-02</NDCCode>
    <PackageDescription>1 PACKAGE in 1 CARTON (43386-280-02)  / 2 SYRINGE in 1 PACKAGE (43386-280-01)  / 2 g in 1 SYRINGE (43386-280-03) </PackageDescription>
    <NDC11Code>43386-0280-02</NDC11Code>
    <ProductNDC>43386-280</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diazepam</ProprietaryName>
    <NonProprietaryName>Diazepam</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>RECTAL</RouteName>
    <StartMarketingDate>20231030</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091076</ApplicationNumber>
    <LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
    <SubstanceName>DIAZEPAM</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/2g</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2023-12-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231030</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Diazepam rectal gel is intended for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 2 years of age and older.</IndicationAndUsage>
    <Description>Diazepam rectal gel rectal delivery system is a non-sterile diazepam gel provided in a prefilled, unit-dose, rectal delivery system. Diazepam rectal gel contains 5 mg/g diazepam, benzoic acid, benzyl alcohol, polyethylene glycol-400, povidone, propylene glycol, sodium benzoate and water. Diazepam rectal gel is clear to slightly yellow and has a pH between 5.8 – 6.5. Diazepam, the active ingredient of diazepam rectal gel, is a benzodiazepine anticonvulsant with the chemical name 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. The structural formula is as follows.</Description>
  </NDC>
  <NDC>
    <NDCCode>43386-281-02</NDCCode>
    <PackageDescription>1 PACKAGE in 1 CARTON (43386-281-02)  / 2 SYRINGE in 1 PACKAGE (43386-281-01)  / 4 g in 1 SYRINGE (43386-281-03) </PackageDescription>
    <NDC11Code>43386-0281-02</NDC11Code>
    <ProductNDC>43386-281</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diazepam</ProprietaryName>
    <NonProprietaryName>Diazepam</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>RECTAL</RouteName>
    <StartMarketingDate>20231030</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091076</ApplicationNumber>
    <LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
    <SubstanceName>DIAZEPAM</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/4g</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2023-12-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231030</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Diazepam rectal gel is intended for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 2 years of age and older.</IndicationAndUsage>
    <Description>Diazepam rectal gel rectal delivery system is a non-sterile diazepam gel provided in a prefilled, unit-dose, rectal delivery system. Diazepam rectal gel contains 5 mg/g diazepam, benzoic acid, benzyl alcohol, polyethylene glycol-400, povidone, propylene glycol, sodium benzoate and water. Diazepam rectal gel is clear to slightly yellow and has a pH between 5.8 – 6.5. Diazepam, the active ingredient of diazepam rectal gel, is a benzodiazepine anticonvulsant with the chemical name 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. The structural formula is as follows.</Description>
  </NDC>
  <NDC>
    <NDCCode>43386-530-02</NDCCode>
    <PackageDescription>30 g in 1 BOTTLE, PLASTIC (43386-530-02) </PackageDescription>
    <NDC11Code>43386-0530-02</NDC11Code>
    <ProductNDC>43386-530</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nystatin</ProprietaryName>
    <NonProprietaryName>Nystatin</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20140926</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065138</ApplicationNumber>
    <LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
    <SubstanceName>NYSTATIN</SubstanceName>
    <StrengthNumber>100000</StrengthNumber>
    <StrengthUnit>U/g</StrengthUnit>
    <Pharm_Classes>Polyene Antifungal [EPC], Polyenes [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-02-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140926</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Nystatin topical powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. Nystatin topical powder is not indicated for systemic, oral, intravaginal or ophthalmic use.</IndicationAndUsage>
    <Description>Nystatin is a polyene antifungal antibiotic obtained from Streptomyces noursei. The molecular formula for Nystatin is C47H75NO17. The molecular weight of Nystatin is 926.1. Structural formula. Nystatin topical powder is for dermatologic use. Nystatin topical powder contains 100,000 USP nystatin units per gram dispersed in talc.</Description>
  </NDC>
  <NDC>
    <NDCCode>43386-700-02</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CONTAINER (43386-700-02)  / 177 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>43386-0700-02</NDC11Code>
    <ProductNDC>43386-700</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Sulfate, Potassium Sulfate, Magnesium Sulfate</ProprietaryName>
    <NonProprietaryName>Sodium Sulfate, Potassium Sulfate, Magnesium Sulfate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20221230</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202511</ApplicationNumber>
    <LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>MAGNESIUM SULFATE ANHYDROUS; POTASSIUM SULFATE; SODIUM SULFATE</SubstanceName>
    <StrengthNumber>1.6; 3.13; 17.5</StrengthNumber>
    <StrengthUnit>g/177mL; g/177mL; g/177mL</StrengthUnit>
    <Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-12-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221230</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is indicated for cleansing of the colon as a preparation for colonoscopy in adults.</IndicationAndUsage>
    <Description>Each Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution contains two 6 ounce bottles of solution. Each 6 ounce bottle contains: sodium sulfate 17.5 grams, potassium sulfate 3.13 grams, magnesium sulfate 1.6 grams. Inactive ingredients include: sodium benzoate, sucralose, malic acid, citric acid, lemon flavor, purified water. The solution is a clear to slightly hazy liquid. The solution is clear and colorless when diluted to a final volume of 16 ounces with water. Sodium Sulfate, USP. The chemical name is Na2SO4. The average Molecular Weight is 142.04. The structural formula is. Potassium Sulfate, FCC, Granular. The chemical name is K2SO4. The average Molecular Weight is 174.26. The structural formula is. Magnesium Sulfate, USP. The chemical name is MgSO4. The average Molecular Weight: 120.37. The structural formula is. Each Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution package also contains a polypropylene mixing container.</Description>
  </NDC>
  <NDC>
    <NDCCode>43386-792-02</NDCCode>
    <PackageDescription>250 CAPSULE in 1 BOTTLE (43386-792-02) </PackageDescription>
    <NDC11Code>43386-0792-02</NDC11Code>
    <ProductNDC>43386-792</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline</ProprietaryName>
    <NonProprietaryName>Doxycycline</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150708</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204446</ApplicationNumber>
    <LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
    <SubstanceName>DOXYCYCLINE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-02-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150708</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline capsules, USP and other antibacterial drugs, doxycycline capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.      Doxycycline is indicated for the treatment of the following infections.      Rocky mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae.      Respiratory tract infections caused by Mycoplasma  pneumoniae.      Lymphogranuloma  venereum caused by Chlamydia  trachomatis.      Psittacosis (ornithosis) caused by Chlamydophila psittaci.      Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated as judged by immunofluorescence.      Inclusion conjunctivitis caused by Chlamydia trachomatis.      Uncomplicated urethral, endocervical or rectal infections in adults caused by Chlamydia trachomatis.      Nongonococcal urethritis caused by Ureaplasma  urealyticum.      Relapsing fever due to Borrelia  recurrentis. Doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms.      Chancroid caused by Haemophilus ducreyi.      Plague due to Yersinia pestis.      Tularemia due to Francisella  tularensis.      Cholera caused by Vibrio cholerae.      Campylobacter fetus infections caused by Campylobacter fetus.      Brucellosis due to Brucella species (in conjunction with streptomycin).      Bartonellosis due to Bartonella  bacilliformis.      Granuloma inguinale caused by Calymmatobacterium  granulomatis. Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. Doxycycline is indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug.      Escherichia coli.      Enterobacter  aerogenes.      Shigella species.      Acinetobacter species.      Respiratory tract infections caused by Haemophilus  influenzae.      Respiratory tract and urinary tract infections caused by Klebsiella species. Doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug.       Upper respiratory infections caused by Streptococcus pneumoniae.      Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. When penicillin is contraindicated, doxycycline is an alternative  in the treatment of the following infections.      Uncomplicated gonorrhea caused by Neisseria  gonorrhoeae.      Syphilis caused by Treponema  pallidum.      Yaws caused by Treponema  pertenue.      Listeriosis due to Listeria  monocytogenes.      Vincent's infection caused by Fusobacterium  fusiforme.      Actinomycosis caused by Actinomyces  israelii.      Infections caused by Clostridium species. In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. In severe acne, doxycycline may be useful adjunctive therapy.</IndicationAndUsage>
    <Description>Doxycycline is a broad-spectrum antibacterial synthetically derived from oxytetracycline. Doxycycline capsules USP, 50 mg, 75 mg, and 100 mg contain doxycycline monohydrate equivalent to 50 mg, 75 mg, and 100 mg of doxycycline for oral administration. The chemical designation of the light yellow to pale yellow powder is 2-Naphthacenecarboxamide,4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-,[4S-(4α,4aα,5α,5aα,6α,12aα)]-,monohydrate. Structural formula. C22H24N2O8  H2O               M.W. = 462.45. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Inert ingredients: colloidal silicon dioxide; magnesium stearate; microcrystalline cellulose; sodium starch glycolate; and a hard gelatin capsule which contains titanium dioxide, FD&amp;C Red # 3, D&amp;C Yellow # 10, gelatin, sodium lauryl sulfate, for the 50 mg strength; iron oxide black, iron oxide red, iron oxide yellow, titanium dioxide, gelatin, sodium lauryl sulfate for the 75 mg strength and  iron oxide black, Iron Oxide Red, Iron Oxide Yellow, Titanium Dioxide, FD &amp; C Red# 3, D&amp;C Yellow # 10, gelatin, sodium lauryl sulfate for the 100 mg strength. The capsules are printed with edible ink containing shellac, titanium dioxide, black iron oxide, red iron oxide and potassium hydroxide for 50 mg, 75 mg and 100 mg strengths.</Description>
  </NDC>
  <NDC>
    <NDCCode>43386-794-02</NDCCode>
    <PackageDescription>20 TABLET in 1 BOTTLE (43386-794-02) </PackageDescription>
    <NDC11Code>43386-0794-02</NDC11Code>
    <ProductNDC>43386-794</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline Hyclate</ProprietaryName>
    <NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170906</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207558</ApplicationNumber>
    <LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
    <SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-02-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170906</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Tablets, USP and other antibacterial drugs, Doxycycline Hyclate Tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Treatment:. Doxycycline is indicated for the treatment of the following infections: 1 Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae., 2 Respiratory tract infections caused by Mycoplasma pneumoniae. , 3 Lymphogranuloma venereum caused by Chlamydia trachomatis . , 4 Psittacosis (ornithosis) caused by Chlamydophila psittaci . , 5 Trachoma caused by Chlamydia trachomatis , although the infectious agent is not always eliminated, as judged by immunofluorescence. , 6 Inclusion conjunctivitis caused by Chlamydia trachomatis . , 7 Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis . , 8 Nongonococcal urethritis caused by Ureaplasma urealyticum . , 9 Relapsing fever due to  Borrelia recurrentis . .</IndicationAndUsage>
    <Description>Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as Doxycycline Hyclate Tablets (doxycycline hydrochloride hemiethanolate hemihydrate) for oral administration. The structural formula of doxycycline hyclate is. With a molecular formula of C 22H 24N 2O 8H 2O and a molecular weight of 462.46. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate. The molecular formula for doxycycline hydrochloride hemiethanolate hemihydrate is (C 22H 24N 2O 8HCl) 2C 2H 6OH 2O and the molecular weight is 1025.89. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Inert ingredients are: colloidal silicon dioxide, corn starch, croscarmellose sodium, docusate sodium, magnesium stearate, microcrystalline cellulose, ethyl alcohol and a coating containing hypromellose, polyethylene glycol, titanium dioxide, FD&amp;C Blue No. 2 and FD&amp;C Yellow No. 6.</Description>
  </NDC>
  <NDC>
    <NDCCode>13537-551-02</NDCCode>
    <PackageDescription>1 TUBE in 1 BOX (13537-551-02)  &gt; 4 g in 1 TUBE (13537-551-01)</PackageDescription>
    <NDC11Code>13537-0551-02</NDC11Code>
    <ProductNDC>13537-551</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lbel Couleur Luxe Amplifier Xp</ProprietaryName>
    <ProprietaryNameSuffix>Amplifying Spf 15 - Rouge Provocation</ProprietaryNameSuffix>
    <NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName>
    <DosageFormName>LIPSTICK</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130527</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Ventura Corporation LTD.</LabelerName>
    <SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
    <StrengthNumber>.047; .009</StrengthNumber>
    <StrengthUnit>g/g; g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>16714-551-02</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (16714-551-02)</PackageDescription>
    <NDC11Code>16714-0551-02</NDC11Code>
    <ProductNDC>16714-551</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zaleplon</ProprietaryName>
    <NonProprietaryName>Zaleplon</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100623</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090374</ApplicationNumber>
    <LabelerName>Northstar Rx LLC</LabelerName>
    <SubstanceName>ZALEPLON</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2018-10-26</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>49349-551-02</NDCCode>
    <PackageDescription>30 TABLET in 1 BLISTER PACK (49349-551-02)</PackageDescription>
    <NDC11Code>49349-0551-02</NDC11Code>
    <ProductNDC>49349-551</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ranitidine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Ranitidine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20111003</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077824</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</LabelerName>
    <SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>50804-551-02</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (50804-551-02)  *  12 TABLET, COATED in 1 BLISTER PACK *  8 TABLET, COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>50804-0551-02</NDC11Code>
    <ProductNDC>50804-551</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cold Multi-symptom Daytime And Nighttime</ProprietaryName>
    <NonProprietaryName>Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20111231</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>GoodSense</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2024-12-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20111231</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>53208-551-02</NDCCode>
    <PackageDescription>1 CONTAINER in 1 BOX (53208-551-02)  &gt; 13 g in 1 CONTAINER (53208-551-01)</PackageDescription>
    <NDC11Code>53208-0551-02</NDC11Code>
    <ProductNDC>53208-551</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Oh Age Recovery Tri Shield Pact 10</ProprietaryName>
    <NonProprietaryName>Titanium Dioxide, Octinoxate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110927</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>LG Household and Healthcare, Inc.</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; OCTINOXATE</SubstanceName>
    <StrengthNumber>4.9; 2</StrengthNumber>
    <StrengthUnit>g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>61504-551-02</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (61504-551-02)  / 3.80564 kg in 1 BOTTLE, PLASTIC (61504-551-01) </PackageDescription>
    <NDC11Code>61504-0551-02</NDC11Code>
    <ProductNDC>61504-551</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>First Street Antibacterial Liquid Hand</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240130</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M</ApplicationNumber>
    <LabelerName>Amerifoods Trading Company</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>.13</StrengthNumber>
    <StrengthUnit>kg/100kg</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-11-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240130</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>61786-551-02</NDCCode>
    <PackageDescription>30 TABLET in 1 BLISTER PACK (61786-551-02) </PackageDescription>
    <NDC11Code>61786-0551-02</NDC11Code>
    <ProductNDC>61786-551</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Guanfacine</ProprietaryName>
    <NonProprietaryName>Guanfacine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160125</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074673</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</LabelerName>
    <SubstanceName>GUANFACINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-11-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160125</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>63545-551-02</NDCCode>
    <PackageDescription>200 PELLET in 1 VIAL, GLASS (63545-551-02) </PackageDescription>
    <NDC11Code>63545-0551-02</NDC11Code>
    <ProductNDC>63545-551</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Bryonia Alba</ProprietaryName>
    <NonProprietaryName>Bryonia Alba</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220505</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Hahnemann Laboratories, INC.</LabelerName>
    <SubstanceName>BRYONIA ALBA ROOT</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>[hp_C]/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2022-05-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220505</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>65649-551-02</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (65649-551-02)  / .6 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>65649-0551-02</NDC11Code>
    <ProductNDC>65649-551</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Relistor</ProprietaryName>
    <NonProprietaryName>Methylnaltrexone Bromide</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20080424</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021964</ApplicationNumber>
    <LabelerName>Salix Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>METHYLNALTREXONE BROMIDE</SubstanceName>
    <StrengthNumber>12</StrengthNumber>
    <StrengthUnit>mg/.6mL</StrengthUnit>
    <Pharm_Classes>Opioid Antagonist [EPC], Opioid Antagonists [MoA], Quaternary Ammonium Compounds [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20080424</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>RELISTOR is an opioid antagonist. RELISTOR tablets and RELISTOR injection are indicated for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. ( 1.1) . RELISTOR injection is indicated for the treatment of OIC in adults with advanced illness or pain caused by active cancer who require opioid dosage escalation for palliative care. ( 1.2) .</IndicationAndUsage>
    <Description>RELISTOR ®(methylnaltrexone bromide) is a mu-opioid receptor antagonist. The chemical name for methylnaltrexone bromide is ( R)- N-(cyclopropylmethyl) noroxymorphone methobromide. The molecular formula is C 21H 26NO 4Br, and the molecular weight is 436.36. The structural formula is. RELISTOR tablets for oral administration are film-coated and contain 150 mg of methylnaltrexone bromide (equivalent to 122.5 mg methylnaltrexone). Inactive ingredients are silicified microcrystalline cellulose, microcrystalline cellulose, sodium lauryl sulfate, croscarmellose sodium, crospovidone, poloxamer 407, stearic acid (vegetable source), colloidal silicon dioxide, edetate calcium disodium, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. RELISTOR for subcutaneous administration is a sterile, clear and colorless to pale yellow aqueous solution. Each 3 mL vial contains 12 mg of methylnaltrexone bromide (equivalent to 9.8 mg of methylnaltrexone) in 0.6 mL of water. The excipients are 3.9 mg sodium chloride USP, 0.24 mg edetate calcium disodium USP, and 0.18 mg glycine hydrochloride. During manufacture, the pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. Each 8 mg/0.4 mL pre-filled syringe (1 mL syringe) contains 8 mg of methylnaltrexone bromide (equivalent to 6.5 mg of methylnaltrexone) in 0.4 mL of water. The excipients are 2.6 mg sodium chloride USP, 0.16 mg edetate calcium disodium USP, and 0.12 mg glycine hydrochloride. Each 12 mg/0.6 mL pre-filled syringe (1 mL syringe) contains 12 mg of methylnaltrexone bromide (equivalent to 9.8 mg of methylnaltrexone) in 0.6 mL of water. The excipients are 3.9 mg sodium chloride USP, 0.24 mg edetate calcium disodium USP, and 0.18 mg glycine hydrochloride.</Description>
  </NDC>
  <NDC>
    <NDCCode>69774-551-02</NDCCode>
    <PackageDescription>1 TUBE in 1 BOX (69774-551-02)  &gt; 120 mL in 1 TUBE</PackageDescription>
    <NDC11Code>69774-0551-02</NDC11Code>
    <ProductNDC>69774-551</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Vmv Hypoallergenics Id Skin-buffing Cleansing Scrub</ProprietaryName>
    <NonProprietaryName>Salicylic Acid</NonProprietaryName>
    <DosageFormName>EMULSION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20170515</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part333D</ApplicationNumber>
    <LabelerName>SKIN SCIENCES LABORATORY INC.</LabelerName>
    <SubstanceName>SALICYLIC ACID</SubstanceName>
    <StrengthNumber>1.2</StrengthNumber>
    <StrengthUnit>g/120mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Purpose Acne Treatment. Uses - Treats acne - Helps prevent development of new acne blemishes.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>69842-551-02</NDCCode>
    <PackageDescription>1 g in 1 CONTAINER (69842-551-02)</PackageDescription>
    <NDC11Code>69842-0551-02</NDC11Code>
    <ProductNDC>69842-551</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cvs Health Cherry Spf 15 Lip Balm</ProprietaryName>
    <NonProprietaryName>Oxybenzone, Octinoxate, Petrolatum</NonProprietaryName>
    <DosageFormName>STICK</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20150817</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>CVS</LabelerName>
    <SubstanceName>OCTINOXATE; OXYBENZONE; PETROLATUM</SubstanceName>
    <StrengthNumber>7.5; 3.5; 44</StrengthNumber>
    <StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2016-12-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150817</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Helps prevent sunburn. Helps prevent and temporarily protects dry, chapped or windburned lips.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>76309-551-02</NDCCode>
    <PackageDescription>56 mL in 1 BOTTLE (76309-551-02) </PackageDescription>
    <NDC11Code>76309-0551-02</NDC11Code>
    <ProductNDC>76309-551</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Snugz Spf 50 Broad Spectrum Sunscreen</ProprietaryName>
    <NonProprietaryName>Spf 50 Broad Spectrum Sunscreen</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20190101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>SnugZ/USA, LLC</LabelerName>
    <SubstanceName>AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
    <StrengthNumber>2.7; 6.7; 4.5; 4.5</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-12-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>80353-551-01</NDCCode>
    <PackageDescription>1 BOTTLE in 1 BOX (80353-551-01)  / 1 CAPSULE in 1 BOTTLE (80353-551-02)  / 60 CAPSULE in 1 CAPSULE (80353-551-03) </PackageDescription>
    <NDC11Code>80353-0551-01</NDC11Code>
    <ProductNDC>80353-551</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Archibone</ProprietaryName>
    <NonProprietaryName>Rheumatoid Arthritis And Osteoarthritis Recovery, And Cartilage Restore</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20211119</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>HCBIOPHARM LLC</LabelerName>
    <SubstanceName>ACHYRANTHES JAPONICA ROOT; PRUNUS PERSICA WHOLE</SubstanceName>
    <StrengthNumber>1; 1</StrengthNumber>
    <StrengthUnit>[hp_X]/1; [hp_X]/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211119</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reverse rheumatoid arthritis . To reverse osteoarthritis. To rebuild cartilage. To relieve joint pain.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>84756-551-02</NDCCode>
    <PackageDescription>15 g in 1 BOX (84756-551-02) </PackageDescription>
    <NDC11Code>84756-0551-02</NDC11Code>
    <ProductNDC>84756-551</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Trstay Retinol Moisturizing Crean</ProprietaryName>
    <NonProprietaryName>Trstay Retinol Moisturizing Crean</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20241202</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>Yiwu Yucheng E Commerce Co Ltd</LabelerName>
    <SubstanceName>NIACINAMIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241202</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>24236-551-20</NDCCode>
    <PackageDescription>100 TABLET in 1 VIAL (24236-551-20)</PackageDescription>
    <NDC11Code>24236-0551-20</NDC11Code>
    <ProductNDC>24236-551</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxybutynin Chloride</ProprietaryName>
    <NonProprietaryName>Oxybutynin Chloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130405</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA071655</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</LabelerName>
    <SubstanceName>OXYBUTYNIN CHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>41163-551-40</NDCCode>
    <PackageDescription>355 mL in 1 BOTTLE (41163-551-40) </PackageDescription>
    <NDC11Code>41163-0551-40</NDC11Code>
    <ProductNDC>41163-551</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Equaline Nighttime Cough Relief</ProprietaryName>
    <NonProprietaryName>Dextromethorphan Hbr, Doxylamine Succinate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140520</StartMarketingDate>
    <EndMarketingDate>20250731</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>United Natural Foods, Inc. dba UNFI</LabelerName>
    <SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE</SubstanceName>
    <StrengthNumber>30; 12.5</StrengthNumber>
    <StrengthUnit>mg/30mL; mg/30mL</StrengthUnit>
    <Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-08-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20140520</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250731</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves cold symptoms: 1 cough due to minor throat and bronchial irritation, 2 runny nose and sneezing.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>43538-551-60</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (43538-551-60)  *  60 mL in 1 BOTTLE *  454 g in 1 BOTTLE, PUMP</PackageDescription>
    <NDC11Code>43538-0551-60</NDC11Code>
    <ProductNDC>43538-551</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Loprox</ProprietaryName>
    <NonProprietaryName>Ciclopirox Olamine</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20161014</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019824</ApplicationNumber>
    <LabelerName>Medimetriks Pharmaceuticals, Inc.</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2023-08-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161014</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>43547-551-10</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (43547-551-10) </PackageDescription>
    <NDC11Code>43547-0551-10</NDC11Code>
    <ProductNDC>43547-551</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Potassium Chloride</ProprietaryName>
    <NonProprietaryName>Potassium Chloride Extended-release</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190430</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209922</ApplicationNumber>
    <LabelerName>Solco Healthcare LLC</LabelerName>
    <SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
    <StrengthNumber>1125</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2020-02-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190430</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>The potassium chloride extended-release tablets, USP 20 mEq product is an immediately dispersing extended release oral dosage form of potassium chloride containing 1500 mg of microencapsulated potassium chloride, USP equivalent to 20 mEq of potassium in a tablet. The potassium chloride extended-release tablets, USP 15 mEq product is an immediately dispersing extended release oral dosage form of potassium chloride containing 1125 mg of microencapsulated potassium chloride, USP equivalent to 15 mEq of potassium in a tablet. The potassium chloride extended-release tablets, USP 10 mEq product is an immediately dispersing extended release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. These formulations are intended to slow the release of potassium so that the likelihood of a high localized concentration of potassium chloride within the gastrointestinal tract is reduced. Potassium chloride is an electrolyte replenisher. The chemical name of the active ingredient is potassium chloride, and the structural formula is KCl. Potassium chloride, USP occurs as a white, granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Potassium chloride is a tablet formulation (not enteric coated or wax matrix) containing individually microencapsulated potassium chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of out-side agitation, potassium chloride tablets begin disintegrating into microencapsulated crystals within seconds and completely disintegrates within 1 minute. The microencapsulated crystals are formulated to provide an extended release of potassium chloride. Inactive Ingredients: croscarmellose sodium, ethylcellulose, microcrystalline cellulose, copovidone and sodium stearyl fumarate. USP sample preparation 2 is used in the assay. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>47781-551-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (47781-551-01) </PackageDescription>
    <NDC11Code>47781-0551-01</NDC11Code>
    <ProductNDC>47781-551</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Felbamate</ProprietaryName>
    <NonProprietaryName>Felbamate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20161228</StartMarketingDate>
    <EndMarketingDate>20200901</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204595</ApplicationNumber>
    <LabelerName>Alvogen Inc.</LabelerName>
    <SubstanceName>FELBAMATE</SubstanceName>
    <StrengthNumber>600</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-09-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20161228</StartMarketingDatePackage>
    <EndMarketingDatePackage>20200901</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>49035-551-38</NDCCode>
    <PackageDescription>283 g in 1 BOTTLE (49035-551-38)</PackageDescription>
    <NDC11Code>49035-0551-38</NDC11Code>
    <ProductNDC>49035-551</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Body</ProprietaryName>
    <NonProprietaryName>Menthol, Zinc Oxide</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20030731</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part348</ApplicationNumber>
    <LabelerName>Wal-Mart Stores,Inc</LabelerName>
    <SubstanceName>MENTHOL; ZINC OXIDE</SubstanceName>
    <StrengthNumber>1.5; 10</StrengthNumber>
    <StrengthUnit>mg/g; mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-05-02</LastUpdate>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>43386-551-02</NDCCode><ProprietaryName>Tinidazole</ProprietaryName><NonProprietaryName>Tinidazole</NonProprietaryName></NDC><NDC><NDCCode>43386-551-06</NDCCode><ProprietaryName>Tinidazole</ProprietaryName><NonProprietaryName>Tinidazole</NonProprietaryName></NDC><NDC><NDCCode>43386-022-02</NDCCode><ProprietaryName>Linezolid</ProprietaryName><NonProprietaryName>Linezolid</NonProprietaryName></NDC><NDC><NDCCode>43386-026-02</NDCCode><ProprietaryName>Fluocinonide</ProprietaryName><NonProprietaryName>Fluocinonide</NonProprietaryName></NDC><NDC><NDCCode>43386-280-02</NDCCode><ProprietaryName>Diazepam</ProprietaryName><NonProprietaryName>Diazepam</NonProprietaryName></NDC><NDC><NDCCode>43386-281-02</NDCCode><ProprietaryName>Diazepam</ProprietaryName><NonProprietaryName>Diazepam</NonProprietaryName></NDC><NDC><NDCCode>43386-530-02</NDCCode><ProprietaryName>Nystatin</ProprietaryName><NonProprietaryName>Nystatin</NonProprietaryName></NDC><NDC><NDCCode>43386-700-02</NDCCode><ProprietaryName>Sodium Sulfate, Potassium Sulfate, Magnesium Sulfate</ProprietaryName><NonProprietaryName>Sodium Sulfate, Potassium Sulfate, Magnesium Sulfate</NonProprietaryName></NDC><NDC><NDCCode>43386-792-02</NDCCode><ProprietaryName>Doxycycline</ProprietaryName><NonProprietaryName>Doxycycline</NonProprietaryName></NDC><NDC><NDCCode>43386-794-02</NDCCode><ProprietaryName>Doxycycline Hyclate</ProprietaryName><NonProprietaryName>Doxycycline Hyclate</NonProprietaryName></NDC><NDC><NDCCode>13537-551-02</NDCCode><ProprietaryName>Lbel Couleur Luxe Amplifier Xp</ProprietaryName><NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName></NDC><NDC><NDCCode>16714-551-02</NDCCode><ProprietaryName>Zaleplon</ProprietaryName><NonProprietaryName>Zaleplon</NonProprietaryName></NDC><NDC><NDCCode>49349-551-02</NDCCode><ProprietaryName>Ranitidine Hydrochloride</ProprietaryName><NonProprietaryName>Ranitidine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>50804-551-02</NDCCode><ProprietaryName>Cold Multi-symptom Daytime And Nighttime</ProprietaryName><NonProprietaryName>Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>53208-551-02</NDCCode><ProprietaryName>Oh Age Recovery Tri Shield Pact 10</ProprietaryName><NonProprietaryName>Titanium Dioxide, Octinoxate</NonProprietaryName></NDC><NDC><NDCCode>61504-551-02</NDCCode><ProprietaryName>First Street Antibacterial Liquid Hand</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>61786-551-02</NDCCode><ProprietaryName>Guanfacine</ProprietaryName><NonProprietaryName>Guanfacine</NonProprietaryName></NDC><NDC><NDCCode>63545-551-02</NDCCode><ProprietaryName>Bryonia Alba</ProprietaryName><NonProprietaryName>Bryonia Alba</NonProprietaryName></NDC><NDC><NDCCode>65649-551-02</NDCCode><ProprietaryName>Relistor</ProprietaryName><NonProprietaryName>Methylnaltrexone Bromide</NonProprietaryName></NDC><NDC><NDCCode>69774-551-02</NDCCode><ProprietaryName>Vmv Hypoallergenics Id Skin-buffing Cleansing Scrub</ProprietaryName><NonProprietaryName>Salicylic Acid</NonProprietaryName></NDC><NDC><NDCCode>69842-551-02</NDCCode><ProprietaryName>Cvs Health Cherry Spf 15 Lip Balm</ProprietaryName><NonProprietaryName>Oxybenzone, Octinoxate, Petrolatum</NonProprietaryName></NDC><NDC><NDCCode>76309-551-02</NDCCode><ProprietaryName>Snugz Spf 50 Broad Spectrum Sunscreen</ProprietaryName><NonProprietaryName>Spf 50 Broad Spectrum Sunscreen</NonProprietaryName></NDC><NDC><NDCCode>80353-551-01</NDCCode><ProprietaryName>Archibone</ProprietaryName><NonProprietaryName>Rheumatoid Arthritis And Osteoarthritis Recovery, And Cartilage Restore</NonProprietaryName></NDC><NDC><NDCCode>84756-551-02</NDCCode><ProprietaryName>Trstay Retinol Moisturizing Crean</ProprietaryName><NonProprietaryName>Trstay Retinol Moisturizing Crean</NonProprietaryName></NDC><NDC><NDCCode>24236-551-20</NDCCode><ProprietaryName>Oxybutynin Chloride</ProprietaryName><NonProprietaryName>Oxybutynin Chloride</NonProprietaryName></NDC><NDC><NDCCode>41163-551-40</NDCCode><ProprietaryName>Equaline Nighttime Cough Relief</ProprietaryName><NonProprietaryName>Dextromethorphan Hbr, Doxylamine Succinate</NonProprietaryName></NDC><NDC><NDCCode>43538-551-60</NDCCode><ProprietaryName>Loprox</ProprietaryName><NonProprietaryName>Ciclopirox Olamine</NonProprietaryName></NDC><NDC><NDCCode>43547-551-10</NDCCode><ProprietaryName>Potassium Chloride</ProprietaryName><NonProprietaryName>Potassium Chloride Extended-release</NonProprietaryName></NDC><NDC><NDCCode>47781-551-01</NDCCode><ProprietaryName>Felbamate</ProprietaryName><NonProprietaryName>Felbamate</NonProprietaryName></NDC><NDC><NDCCode>49035-551-38</NDCCode><ProprietaryName>Body</ProprietaryName><NonProprietaryName>Menthol, Zinc Oxide</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/04/2006",
      "LastUpdateDate": "12/11/2007",
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      "PracticeLocationAddressPostalCode": "06281-2225",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "860-821-3406",
      "PracticeLocationAddressFaxNumber": "860-821-3407",
      "EnumerationDate": "07/22/2006",
      "LastUpdateDate": "01/14/2016",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "000260",
      "LicenseNumberStateCode1": "CT",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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