RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "68071-2391-7",
      "PackageDescription": "21 TABLET, FILM COATED in 1 BOTTLE (68071-2391-7) ",
      "NDC11Code": "68071-2391-07",
      "ProductNDC": "68071-2391",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ciprofloxacin",
      "NonProprietaryName": "Ciprofloxacin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20040609",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075593",
      "LabelerName": "NuCare Pharmaceuticals,Inc.",
      "SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Quinolone Antimicrobial [EPC], Quinolones [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20210423",
      "SamplePackage": "N",
      "Description": "Ciprofloxacin tablets USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydratesalt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid.It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C 17H 18FN 3O 3HClH 2O and its chemical structure is as follows:. Ciprofloxacin film-coated tablets are available in 100 mg, 250 mg, 500 mg and 750 strengths. Each ciprofloxacin film-coated tablet contains 100 mg (equivalent to 116.4 mg ciprofloxacin hydrochloride monohydrate) or 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg of ciprofloxacin (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets are white. The inactive ingredients are colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, sodium starch glycolate, and titanium dioxide."
    },
    {
      "NDCCode": "54868-2391-7",
      "PackageDescription": "180 CAPSULE in 1 BOTTLE (54868-2391-7)",
      "NDC11Code": "54868-2391-07",
      "ProductNDC": "54868-2391",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Minocycline Hydrochloride",
      "NonProprietaryName": "Minocycline Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20001222",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065062",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Minocycline hydrochloride capsules, USP are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms. 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) due to Chlamydia psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis. Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis. Relapsing fever due to Borrelia recurrentis. 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. Minocycline is indicated for the 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. Minocycline hydrochloride capsules, USP are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:. Upper respiratory tract infections caused by Streptococcus pneumoniae. Skin and skin structure infections caused by Staphylococcus aureus. (Note: Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection.). When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections:. Uncomplicated urethritis in men due to Neisseria gonorrhoeae and for the treatment of other gonococcal infections. Infections in women caused by Neisseria gonorrhoeae. Syphilis caused by Treponema pallidum subspecies pallidum. Yaws caused by Treponema pallidum subspecies pertenue. Listeriosis due to Listeria monocytogenes. Anthrax due to Bacillus anthracis. Vincent’s infection caused by Fusobacterium fusiforme. Actinomycosis caused by Actinomyces israelii. Infections caused by Clostridium species. In acute intestinal amebiasis, minocycline may be a useful adjunct to amebicides. In severe acne, minocycline may be useful adjunctive therapy. Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high. Oral minocycline is not indicated for the treatment of meningococcal infection. Although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by Mycobacterium marinum. To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules, USP and other antibacterial drugs, minocycline hydrochloride 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.",
      "Description": "Minocycline hydrochloride, USP, is a semisynthetic derivative of tetracycline, 4,7-Bis (dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is:. C23H27N3O7HCl M.W. 493.95. Each minocycline hydrochloride capsule, USP for oral administration, contains the equivalent of 50 mg, 75 mg or 100 mg of minocycline. In addition each capsule contains the following inactive ingredients: corn starch and magnesium stearate. The 50 mg, 75 mg and 100 mg capsule shells contain: gelatin and titanium dioxide. The 75 mg and 100 mg capsule shells also contain black iron oxide. The imprinting ink contains: black iron oxide, potassium hydroxide, propylene glycol, and shellac."
    },
    {
      "NDCCode": "71335-2391-7",
      "PackageDescription": "28 TABLET in 1 BOTTLE (71335-2391-7) ",
      "NDC11Code": "71335-2391-07",
      "ProductNDC": "71335-2391",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Loratadine",
      "NonProprietaryName": "Loratadine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230728",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211718",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "LORATADINE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Status": "Active",
      "LastUpdate": "2025-06-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250618",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies."
    },
    {
      "NDCCode": "68071-2391-1",
      "PackageDescription": "10 TABLET, FILM COATED in 1 BOTTLE (68071-2391-1) ",
      "NDC11Code": "68071-2391-01",
      "ProductNDC": "68071-2391",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ciprofloxacin",
      "NonProprietaryName": "Ciprofloxacin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20040609",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075593",
      "LabelerName": "NuCare Pharmaceuticals,Inc.",
      "SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Quinolone Antimicrobial [EPC], Quinolones [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20210423",
      "SamplePackage": "N",
      "Description": "Ciprofloxacin tablets USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydratesalt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid.It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C 17H 18FN 3O 3HClH 2O and its chemical structure is as follows:. Ciprofloxacin film-coated tablets are available in 100 mg, 250 mg, 500 mg and 750 strengths. Each ciprofloxacin film-coated tablet contains 100 mg (equivalent to 116.4 mg ciprofloxacin hydrochloride monohydrate) or 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg of ciprofloxacin (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets are white. The inactive ingredients are colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, sodium starch glycolate, and titanium dioxide."
    },
    {
      "NDCCode": "68071-2391-2",
      "PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE (68071-2391-2) ",
      "NDC11Code": "68071-2391-02",
      "ProductNDC": "68071-2391",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ciprofloxacin",
      "NonProprietaryName": "Ciprofloxacin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20040609",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075593",
      "LabelerName": "NuCare Pharmaceuticals,Inc.",
      "SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Quinolone Antimicrobial [EPC], Quinolones [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20210423",
      "SamplePackage": "N",
      "Description": "Ciprofloxacin tablets USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydratesalt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid.It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C 17H 18FN 3O 3HClH 2O and its chemical structure is as follows:. Ciprofloxacin film-coated tablets are available in 100 mg, 250 mg, 500 mg and 750 strengths. Each ciprofloxacin film-coated tablet contains 100 mg (equivalent to 116.4 mg ciprofloxacin hydrochloride monohydrate) or 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg of ciprofloxacin (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets are white. The inactive ingredients are colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, sodium starch glycolate, and titanium dioxide."
    },
    {
      "NDCCode": "68071-2391-3",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (68071-2391-3) ",
      "NDC11Code": "68071-2391-03",
      "ProductNDC": "68071-2391",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ciprofloxacin",
      "NonProprietaryName": "Ciprofloxacin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20040609",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075593",
      "LabelerName": "NuCare Pharmaceuticals,Inc.",
      "SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Quinolone Antimicrobial [EPC], Quinolones [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20210423",
      "SamplePackage": "N",
      "Description": "Ciprofloxacin tablets USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydratesalt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid.It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C 17H 18FN 3O 3HClH 2O and its chemical structure is as follows:. Ciprofloxacin film-coated tablets are available in 100 mg, 250 mg, 500 mg and 750 strengths. Each ciprofloxacin film-coated tablet contains 100 mg (equivalent to 116.4 mg ciprofloxacin hydrochloride monohydrate) or 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg of ciprofloxacin (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets are white. The inactive ingredients are colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, sodium starch glycolate, and titanium dioxide."
    },
    {
      "NDCCode": "68071-2391-4",
      "PackageDescription": "14 TABLET, FILM COATED in 1 BOTTLE (68071-2391-4) ",
      "NDC11Code": "68071-2391-04",
      "ProductNDC": "68071-2391",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ciprofloxacin",
      "NonProprietaryName": "Ciprofloxacin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20040609",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075593",
      "LabelerName": "NuCare Pharmaceuticals,Inc.",
      "SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Quinolone Antimicrobial [EPC], Quinolones [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20210423",
      "SamplePackage": "N",
      "Description": "Ciprofloxacin tablets USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydratesalt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid.It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C 17H 18FN 3O 3HClH 2O and its chemical structure is as follows:. Ciprofloxacin film-coated tablets are available in 100 mg, 250 mg, 500 mg and 750 strengths. Each ciprofloxacin film-coated tablet contains 100 mg (equivalent to 116.4 mg ciprofloxacin hydrochloride monohydrate) or 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg of ciprofloxacin (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets are white. The inactive ingredients are colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, sodium starch glycolate, and titanium dioxide."
    },
    {
      "NDCCode": "68071-2391-6",
      "PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (68071-2391-6) ",
      "NDC11Code": "68071-2391-06",
      "ProductNDC": "68071-2391",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ciprofloxacin",
      "NonProprietaryName": "Ciprofloxacin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20040609",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075593",
      "LabelerName": "NuCare Pharmaceuticals,Inc.",
      "SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Quinolone Antimicrobial [EPC], Quinolones [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20210423",
      "SamplePackage": "N",
      "Description": "Ciprofloxacin tablets USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydratesalt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid.It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C 17H 18FN 3O 3HClH 2O and its chemical structure is as follows:. Ciprofloxacin film-coated tablets are available in 100 mg, 250 mg, 500 mg and 750 strengths. Each ciprofloxacin film-coated tablet contains 100 mg (equivalent to 116.4 mg ciprofloxacin hydrochloride monohydrate) or 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg of ciprofloxacin (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets are white. The inactive ingredients are colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, sodium starch glycolate, and titanium dioxide."
    },
    {
      "NDCCode": "68071-2391-8",
      "PackageDescription": "28 TABLET, FILM COATED in 1 BOTTLE (68071-2391-8) ",
      "NDC11Code": "68071-2391-08",
      "ProductNDC": "68071-2391",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ciprofloxacin",
      "NonProprietaryName": "Ciprofloxacin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20040609",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075593",
      "LabelerName": "NuCare Pharmaceuticals,Inc.",
      "SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Quinolone Antimicrobial [EPC], Quinolones [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20210423",
      "SamplePackage": "N",
      "Description": "Ciprofloxacin tablets USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydratesalt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid.It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C 17H 18FN 3O 3HClH 2O and its chemical structure is as follows:. Ciprofloxacin film-coated tablets are available in 100 mg, 250 mg, 500 mg and 750 strengths. Each ciprofloxacin film-coated tablet contains 100 mg (equivalent to 116.4 mg ciprofloxacin hydrochloride monohydrate) or 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg of ciprofloxacin (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets are white. The inactive ingredients are colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, sodium starch glycolate, and titanium dioxide."
    },
    {
      "NDCCode": "53002-2391-1",
      "PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE (53002-2391-1) ",
      "NDC11Code": "53002-2391-01",
      "ProductNDC": "53002-2391",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amoxicillin And Clavulanate Potassium",
      "NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20021127",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065117",
      "LabelerName": "RPK Pharmaceuticals, Inc.",
      "SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
      "StrengthNumber": "500; 125",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20181001",
      "SamplePackage": "N",
      "IndicationAndUsage": "Amoxicillin and clavulanate potassiumis indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: : 1 Lower Respiratory Tract Infections -caused by beta‑lactamase‑producing isolates of Haemophilus influenzae and Moraxella catarrhalis. , 2 Acute Bacterial Otitis Media -caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis. , 3 Sinusitis -caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis. , 4 Skin and Skin Structure Infections -caused by beta‑lactamase‑producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species. , 5 Urinary Tract Infections -caused by beta‑lactamase‑producing isolates of E. coli, Klebsiella species, and Enterobacter species. .",
      "Description": "Amoxicillin and clavulanate potassium is an oral antibacterial combination consisting of amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta-lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. Amoxicillin and Clavulanate Potassium Tablets, USP: 1 500 mg/125 mg: Each tablet contains 500 mg of amoxicillin as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium)., 2 875 mg/125 mg: Each tablet contains 875 mg of amoxicillin as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium)."
    },
    {
      "NDCCode": "54868-2391-0",
      "PackageDescription": "10 CAPSULE in 1 BOTTLE (54868-2391-0)",
      "NDC11Code": "54868-2391-00",
      "ProductNDC": "54868-2391",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Minocycline Hydrochloride",
      "NonProprietaryName": "Minocycline Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20001222",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065062",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Minocycline hydrochloride capsules, USP are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms. 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) due to Chlamydia psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis. Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis. Relapsing fever due to Borrelia recurrentis. 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. Minocycline is indicated for the 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. Minocycline hydrochloride capsules, USP are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:. Upper respiratory tract infections caused by Streptococcus pneumoniae. Skin and skin structure infections caused by Staphylococcus aureus. (Note: Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection.). When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections:. Uncomplicated urethritis in men due to Neisseria gonorrhoeae and for the treatment of other gonococcal infections. Infections in women caused by Neisseria gonorrhoeae. Syphilis caused by Treponema pallidum subspecies pallidum. Yaws caused by Treponema pallidum subspecies pertenue. Listeriosis due to Listeria monocytogenes. Anthrax due to Bacillus anthracis. Vincent’s infection caused by Fusobacterium fusiforme. Actinomycosis caused by Actinomyces israelii. Infections caused by Clostridium species. In acute intestinal amebiasis, minocycline may be a useful adjunct to amebicides. In severe acne, minocycline may be useful adjunctive therapy. Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high. Oral minocycline is not indicated for the treatment of meningococcal infection. Although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by Mycobacterium marinum. To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules, USP and other antibacterial drugs, minocycline hydrochloride 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.",
      "Description": "Minocycline hydrochloride, USP, is a semisynthetic derivative of tetracycline, 4,7-Bis (dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is:. C23H27N3O7HCl M.W. 493.95. Each minocycline hydrochloride capsule, USP for oral administration, contains the equivalent of 50 mg, 75 mg or 100 mg of minocycline. In addition each capsule contains the following inactive ingredients: corn starch and magnesium stearate. The 50 mg, 75 mg and 100 mg capsule shells contain: gelatin and titanium dioxide. The 75 mg and 100 mg capsule shells also contain black iron oxide. The imprinting ink contains: black iron oxide, potassium hydroxide, propylene glycol, and shellac."
    },
    {
      "NDCCode": "54868-2391-1",
      "PackageDescription": "60 CAPSULE in 1 BOTTLE (54868-2391-1)",
      "NDC11Code": "54868-2391-01",
      "ProductNDC": "54868-2391",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Minocycline Hydrochloride",
      "NonProprietaryName": "Minocycline Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20001222",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065062",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Minocycline hydrochloride capsules, USP are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms. 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) due to Chlamydia psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis. Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis. Relapsing fever due to Borrelia recurrentis. 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. Minocycline is indicated for the 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. Minocycline hydrochloride capsules, USP are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:. Upper respiratory tract infections caused by Streptococcus pneumoniae. Skin and skin structure infections caused by Staphylococcus aureus. (Note: Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection.). When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections:. Uncomplicated urethritis in men due to Neisseria gonorrhoeae and for the treatment of other gonococcal infections. Infections in women caused by Neisseria gonorrhoeae. Syphilis caused by Treponema pallidum subspecies pallidum. Yaws caused by Treponema pallidum subspecies pertenue. Listeriosis due to Listeria monocytogenes. Anthrax due to Bacillus anthracis. Vincent’s infection caused by Fusobacterium fusiforme. Actinomycosis caused by Actinomyces israelii. Infections caused by Clostridium species. In acute intestinal amebiasis, minocycline may be a useful adjunct to amebicides. In severe acne, minocycline may be useful adjunctive therapy. Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high. Oral minocycline is not indicated for the treatment of meningococcal infection. Although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by Mycobacterium marinum. To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules, USP and other antibacterial drugs, minocycline hydrochloride 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.",
      "Description": "Minocycline hydrochloride, USP, is a semisynthetic derivative of tetracycline, 4,7-Bis (dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is:. C23H27N3O7HCl M.W. 493.95. Each minocycline hydrochloride capsule, USP for oral administration, contains the equivalent of 50 mg, 75 mg or 100 mg of minocycline. In addition each capsule contains the following inactive ingredients: corn starch and magnesium stearate. The 50 mg, 75 mg and 100 mg capsule shells contain: gelatin and titanium dioxide. The 75 mg and 100 mg capsule shells also contain black iron oxide. The imprinting ink contains: black iron oxide, potassium hydroxide, propylene glycol, and shellac."
    },
    {
      "NDCCode": "54868-2391-2",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE (54868-2391-2)",
      "NDC11Code": "54868-2391-02",
      "ProductNDC": "54868-2391",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Minocycline Hydrochloride",
      "NonProprietaryName": "Minocycline Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20001222",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065062",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Minocycline hydrochloride capsules, USP are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms. 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) due to Chlamydia psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis. Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis. Relapsing fever due to Borrelia recurrentis. 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. Minocycline is indicated for the 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. Minocycline hydrochloride capsules, USP are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:. Upper respiratory tract infections caused by Streptococcus pneumoniae. Skin and skin structure infections caused by Staphylococcus aureus. (Note: Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection.). When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections:. Uncomplicated urethritis in men due to Neisseria gonorrhoeae and for the treatment of other gonococcal infections. Infections in women caused by Neisseria gonorrhoeae. Syphilis caused by Treponema pallidum subspecies pallidum. Yaws caused by Treponema pallidum subspecies pertenue. Listeriosis due to Listeria monocytogenes. Anthrax due to Bacillus anthracis. Vincent’s infection caused by Fusobacterium fusiforme. Actinomycosis caused by Actinomyces israelii. Infections caused by Clostridium species. In acute intestinal amebiasis, minocycline may be a useful adjunct to amebicides. In severe acne, minocycline may be useful adjunctive therapy. Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high. Oral minocycline is not indicated for the treatment of meningococcal infection. Although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by Mycobacterium marinum. To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules, USP and other antibacterial drugs, minocycline hydrochloride 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.",
      "Description": "Minocycline hydrochloride, USP, is a semisynthetic derivative of tetracycline, 4,7-Bis (dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is:. C23H27N3O7HCl M.W. 493.95. Each minocycline hydrochloride capsule, USP for oral administration, contains the equivalent of 50 mg, 75 mg or 100 mg of minocycline. In addition each capsule contains the following inactive ingredients: corn starch and magnesium stearate. The 50 mg, 75 mg and 100 mg capsule shells contain: gelatin and titanium dioxide. The 75 mg and 100 mg capsule shells also contain black iron oxide. The imprinting ink contains: black iron oxide, potassium hydroxide, propylene glycol, and shellac."
    },
    {
      "NDCCode": "54868-2391-3",
      "PackageDescription": "50 CAPSULE in 1 BOTTLE (54868-2391-3)",
      "NDC11Code": "54868-2391-03",
      "ProductNDC": "54868-2391",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Minocycline Hydrochloride",
      "NonProprietaryName": "Minocycline Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20001222",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065062",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Minocycline hydrochloride capsules, USP are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms. 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) due to Chlamydia psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis. Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis. Relapsing fever due to Borrelia recurrentis. 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. Minocycline is indicated for the 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. Minocycline hydrochloride capsules, USP are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:. Upper respiratory tract infections caused by Streptococcus pneumoniae. Skin and skin structure infections caused by Staphylococcus aureus. (Note: Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection.). When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections:. Uncomplicated urethritis in men due to Neisseria gonorrhoeae and for the treatment of other gonococcal infections. Infections in women caused by Neisseria gonorrhoeae. Syphilis caused by Treponema pallidum subspecies pallidum. Yaws caused by Treponema pallidum subspecies pertenue. Listeriosis due to Listeria monocytogenes. Anthrax due to Bacillus anthracis. Vincent’s infection caused by Fusobacterium fusiforme. Actinomycosis caused by Actinomyces israelii. Infections caused by Clostridium species. In acute intestinal amebiasis, minocycline may be a useful adjunct to amebicides. In severe acne, minocycline may be useful adjunctive therapy. Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high. Oral minocycline is not indicated for the treatment of meningococcal infection. Although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by Mycobacterium marinum. To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules, USP and other antibacterial drugs, minocycline hydrochloride 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.",
      "Description": "Minocycline hydrochloride, USP, is a semisynthetic derivative of tetracycline, 4,7-Bis (dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is:. C23H27N3O7HCl M.W. 493.95. Each minocycline hydrochloride capsule, USP for oral administration, contains the equivalent of 50 mg, 75 mg or 100 mg of minocycline. In addition each capsule contains the following inactive ingredients: corn starch and magnesium stearate. The 50 mg, 75 mg and 100 mg capsule shells contain: gelatin and titanium dioxide. The 75 mg and 100 mg capsule shells also contain black iron oxide. The imprinting ink contains: black iron oxide, potassium hydroxide, propylene glycol, and shellac."
    },
    {
      "NDCCode": "54868-2391-4",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE (54868-2391-4)",
      "NDC11Code": "54868-2391-04",
      "ProductNDC": "54868-2391",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Minocycline Hydrochloride",
      "NonProprietaryName": "Minocycline Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20001222",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065062",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Minocycline hydrochloride capsules, USP are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms. 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) due to Chlamydia psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis. Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis. Relapsing fever due to Borrelia recurrentis. 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. Minocycline is indicated for the 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. Minocycline hydrochloride capsules, USP are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:. Upper respiratory tract infections caused by Streptococcus pneumoniae. Skin and skin structure infections caused by Staphylococcus aureus. (Note: Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection.). When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections:. Uncomplicated urethritis in men due to Neisseria gonorrhoeae and for the treatment of other gonococcal infections. Infections in women caused by Neisseria gonorrhoeae. Syphilis caused by Treponema pallidum subspecies pallidum. Yaws caused by Treponema pallidum subspecies pertenue. Listeriosis due to Listeria monocytogenes. Anthrax due to Bacillus anthracis. Vincent’s infection caused by Fusobacterium fusiforme. Actinomycosis caused by Actinomyces israelii. Infections caused by Clostridium species. In acute intestinal amebiasis, minocycline may be a useful adjunct to amebicides. In severe acne, minocycline may be useful adjunctive therapy. Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high. Oral minocycline is not indicated for the treatment of meningococcal infection. Although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by Mycobacterium marinum. To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules, USP and other antibacterial drugs, minocycline hydrochloride 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.",
      "Description": "Minocycline hydrochloride, USP, is a semisynthetic derivative of tetracycline, 4,7-Bis (dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is:. C23H27N3O7HCl M.W. 493.95. Each minocycline hydrochloride capsule, USP for oral administration, contains the equivalent of 50 mg, 75 mg or 100 mg of minocycline. In addition each capsule contains the following inactive ingredients: corn starch and magnesium stearate. The 50 mg, 75 mg and 100 mg capsule shells contain: gelatin and titanium dioxide. The 75 mg and 100 mg capsule shells also contain black iron oxide. The imprinting ink contains: black iron oxide, potassium hydroxide, propylene glycol, and shellac."
    },
    {
      "NDCCode": "54868-2391-5",
      "PackageDescription": "90 CAPSULE in 1 BOTTLE (54868-2391-5)",
      "NDC11Code": "54868-2391-05",
      "ProductNDC": "54868-2391",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Minocycline Hydrochloride",
      "NonProprietaryName": "Minocycline Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20001222",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065062",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Minocycline hydrochloride capsules, USP are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms. 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) due to Chlamydia psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis. Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis. Relapsing fever due to Borrelia recurrentis. 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. Minocycline is indicated for the 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. Minocycline hydrochloride capsules, USP are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:. Upper respiratory tract infections caused by Streptococcus pneumoniae. Skin and skin structure infections caused by Staphylococcus aureus. (Note: Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection.). When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections:. Uncomplicated urethritis in men due to Neisseria gonorrhoeae and for the treatment of other gonococcal infections. Infections in women caused by Neisseria gonorrhoeae. Syphilis caused by Treponema pallidum subspecies pallidum. Yaws caused by Treponema pallidum subspecies pertenue. Listeriosis due to Listeria monocytogenes. Anthrax due to Bacillus anthracis. Vincent’s infection caused by Fusobacterium fusiforme. Actinomycosis caused by Actinomyces israelii. Infections caused by Clostridium species. In acute intestinal amebiasis, minocycline may be a useful adjunct to amebicides. In severe acne, minocycline may be useful adjunctive therapy. Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high. Oral minocycline is not indicated for the treatment of meningococcal infection. Although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by Mycobacterium marinum. To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules, USP and other antibacterial drugs, minocycline hydrochloride 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.",
      "Description": "Minocycline hydrochloride, USP, is a semisynthetic derivative of tetracycline, 4,7-Bis (dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is:. C23H27N3O7HCl M.W. 493.95. Each minocycline hydrochloride capsule, USP for oral administration, contains the equivalent of 50 mg, 75 mg or 100 mg of minocycline. In addition each capsule contains the following inactive ingredients: corn starch and magnesium stearate. The 50 mg, 75 mg and 100 mg capsule shells contain: gelatin and titanium dioxide. The 75 mg and 100 mg capsule shells also contain black iron oxide. The imprinting ink contains: black iron oxide, potassium hydroxide, propylene glycol, and shellac."
    },
    {
      "NDCCode": "54868-2391-6",
      "PackageDescription": "20 CAPSULE in 1 BOTTLE (54868-2391-6)",
      "NDC11Code": "54868-2391-06",
      "ProductNDC": "54868-2391",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Minocycline Hydrochloride",
      "NonProprietaryName": "Minocycline Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20001222",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065062",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Minocycline hydrochloride capsules, USP are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms. 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) due to Chlamydia psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis. Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis. Relapsing fever due to Borrelia recurrentis. 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. Minocycline is indicated for the 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. Minocycline hydrochloride capsules, USP are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:. Upper respiratory tract infections caused by Streptococcus pneumoniae. Skin and skin structure infections caused by Staphylococcus aureus. (Note: Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection.). When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections:. Uncomplicated urethritis in men due to Neisseria gonorrhoeae and for the treatment of other gonococcal infections. Infections in women caused by Neisseria gonorrhoeae. Syphilis caused by Treponema pallidum subspecies pallidum. Yaws caused by Treponema pallidum subspecies pertenue. Listeriosis due to Listeria monocytogenes. Anthrax due to Bacillus anthracis. Vincent’s infection caused by Fusobacterium fusiforme. Actinomycosis caused by Actinomyces israelii. Infections caused by Clostridium species. In acute intestinal amebiasis, minocycline may be a useful adjunct to amebicides. In severe acne, minocycline may be useful adjunctive therapy. Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high. Oral minocycline is not indicated for the treatment of meningococcal infection. Although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by Mycobacterium marinum. To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules, USP and other antibacterial drugs, minocycline hydrochloride 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.",
      "Description": "Minocycline hydrochloride, USP, is a semisynthetic derivative of tetracycline, 4,7-Bis (dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is:. C23H27N3O7HCl M.W. 493.95. Each minocycline hydrochloride capsule, USP for oral administration, contains the equivalent of 50 mg, 75 mg or 100 mg of minocycline. In addition each capsule contains the following inactive ingredients: corn starch and magnesium stearate. The 50 mg, 75 mg and 100 mg capsule shells contain: gelatin and titanium dioxide. The 75 mg and 100 mg capsule shells also contain black iron oxide. The imprinting ink contains: black iron oxide, potassium hydroxide, propylene glycol, and shellac."
    },
    {
      "NDCCode": "61995-2391-4",
      "PackageDescription": "113 g in 1 TUBE (61995-2391-4)",
      "NDC11Code": "61995-2391-04",
      "ProductNDC": "61995-2391",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Alba Sunblock Natural Ff Spf 30",
      "NonProprietaryName": "Homosalate, Octocrylene, Ethylhexyl Salicilate, Titanium Dioxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20091028",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "The Hain Celestial Group, Inc.",
      "SubstanceName": "HOMOSALATE; OCTOCRYLENE; OCTISALATE; TITANIUM DIOXIDE",
      "StrengthNumber": "7.5; 7.5; 5; 2",
      "StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "63629-2391-1",
      "PackageDescription": "100 mL in 1 BOTTLE (63629-2391-1) ",
      "NDC11Code": "63629-2391-01",
      "ProductNDC": "63629-2391",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clindamycin Palmitate Hydrochloride",
      "ProprietaryNameSuffix": "(pediatric)",
      "NonProprietaryName": "Clindamycin Palmitate Hydrochloride",
      "DosageFormName": "GRANULE, FOR SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120911",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA201821",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "CLINDAMYCIN PALMITATE HYDROCHLORIDE",
      "StrengthNumber": "75",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
      "Status": "Active",
      "LastUpdate": "2024-09-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210223",
      "SamplePackage": "N",
      "IndicationAndUsage": "Clindamycin palmitate hydrochloride for oral solution, USP (Pediatric) (clindamycin palmitate HCl) is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Clindamycin palmitate hydrochloride for oral solution (Pediatric) and other antibacterial drugs, Clindamycin palmitate hydrochloride for oral solution (Pediatric) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
      "Description": "Clindamycin palmitate hydrochloride is a water soluble hydrochloride salt of the ester of clindamycin and palmitic acid. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. The structural formula is represented below. The chemical name for clindamycin palmitate hydrochloride is Methyl 7-chloro-6, 7, 8-trideoxy-6-(1-methyl- trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo-α-D- galacto-octopyranoside 2-palmitate monohydrochloride. Clindamycin palmitate hydrochloride for oral solution, USP (Pediatric) flavored granules contain clindamycin palmitate hydrochloride for reconstitution. Each 5 mL contains the equivalent of 75 mg clindamycin. Inactive ingredients: natural cherry flavor, dextrin, ethylparaben, poloxamer 188, simethicone, sucrose."
    },
    {
      "NDCCode": "72162-2391-1",
      "PackageDescription": "100 TABLET in 1 BOTTLE (72162-2391-1) ",
      "NDC11Code": "72162-2391-01",
      "ProductNDC": "72162-2391",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metolazone",
      "NonProprietaryName": "Metolazone",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240615",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA213827",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "METOLAZONE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Increased Diuresis [PE], Thiazide-like Diuretic [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-07-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260720",
      "SamplePackage": "N",
      "IndicationAndUsage": "Metolazone tablets, USP, are indicated for the treatment of salt and water retention including. · edema accompanying congestive heart failure;. · edema accompanying renal diseases, including the nephrotic syndrome and states of diminished renal function. Metolazone tablets, USP, are also indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs of a different class. MYKROX Tablets, a more rapidly available form of metolazone, are intended for the treatment of new patients with mild to moderate hypertension. A dose titration is necessary if MYKROX Tablets are to be substituted for metolazone tablets, USP, in the treatment of hypertension. See package circular for MYKROX Tablets. Usage In Pregnancy. The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no evidence that they are useful in the treatment of developed toxemia. Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Metolazone tablets, USP, are indicated in pregnancy when edema is due to pathologic causes, just as it is in the absence of pregnancy (see PRECAUTIONS). Dependent edema in pregnancy resulting from restriction of venous return by the expanded uterus is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort which is not relieved by rest. In these cases, a short course of diuretics may be appropriate.",
      "Description": "Metolazone tablets, USP, for oral administration contain 2½, 5, or 10 mg of metolazone, USP, a diuretic/saluretic/antihypertensive drug of the quinazoline class. Metolazone has the molecular formula C 16H 16ClN 3O 3S, the chemical name 7-chloro-1,2, 3, 4-tetrahydro-2-methyl-3-(2-methylphenyl)-4- oxo-6-quinazolinesulfonamide and a molecular weight of 365.83. The structural formula is. Metolazone is only sparingly soluble in water, but more soluble in plasma, blood, alkali, and organic solvents. Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose and dye: 2 ½ mg o. 6; 5 mg - D&C Red #30; 10 mg - FD&C Yellow No.6."
    },
    {
      "NDCCode": "68071-1212-7",
      "PackageDescription": "7 CAPSULE in 1 BOTTLE (68071-1212-7) ",
      "NDC11Code": "68071-1212-07",
      "ProductNDC": "68071-1212",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Gabapentin",
      "NonProprietaryName": "Gabapentin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160629",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090705",
      "LabelerName": "NuCare Pharmaceuticals, Inc.",
      "SubstanceName": "GABAPENTIN",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20170324",
      "SamplePackage": "N",
      "IndicationAndUsage": "Gabapentin is indicated for: 1 Postherpetic neuralgia in adults ( 1) , 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy (  1)  .",
      "Description": "The active ingredient in gabapentin capsules is gabapentin, USP which has the chemical name 1-(aminomethyl) cyclohexane acetic acid. The molecular formula of gabapentin is C 9H 17NO 2 and a molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin, USP is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin Capsules, USP are supplied as imprinted hard gelatin capsules containing 100 mg, 300 mg and 400 mg of gabapentin, USP. The inactive ingredients are mannitol, pre-gelatinized starch and talc. The 100 mg capsule shell contains titanium dioxide. The 300 mg capsule contains FD&C Red 40, D&C Yellow 10 and titanium dioxide. The 400 mg capsule shell contains FD&C Red 40, D&C Yellow 10 and titanium dioxide."
    },
    {
      "NDCCode": "68071-1292-7",
      "PackageDescription": "7 TABLET in 1 BOTTLE (68071-1292-7) ",
      "NDC11Code": "68071-1292-07",
      "ProductNDC": "68071-1292",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Gabapentin",
      "NonProprietaryName": "Gabapentin",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20060401",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077662",
      "LabelerName": "NuCare Pharmaceuticals, Inc.",
      "SubstanceName": "GABAPENTIN",
      "StrengthNumber": "600",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20170222",
      "SamplePackage": "N",
      "IndicationAndUsage": "Gabapentin tablets USP are indicated for: 1 Management of postherpetic neuralgia in adults , 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy .",
      "Description": "The active ingredient in gabapentin tablets USP is gabapentin USP, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin USP is C 9H 17NO 2 and the molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin USP is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each gabapentin tablet USP contains 600 mg or 800 mg of gabapentin USP and the following inactive ingredients: corn starch, copovidone, poloxamer 407, magnesium stearate, polyethylene glycol, talc, hypromellose, titanium dioxide, macrogol, polysorbate 80 and purified water."
    },
    {
      "NDCCode": "68071-1316-7",
      "PackageDescription": "527 g in 1 BOTTLE (68071-1316-7) ",
      "NDC11Code": "68071-1316-07",
      "ProductNDC": "68071-1316",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Polyethylene Glycol 3350",
      "NonProprietaryName": "Polyethylene Glycol 3350",
      "DosageFormName": "POWDER, FOR SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20060906",
      "EndMarketingDate": "20210731",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077706",
      "LabelerName": "NuCare Pharmaceuticals,Inc.",
      "SubstanceName": "POLYETHYLENE GLYCOL 3350",
      "StrengthNumber": "17",
      "StrengthUnit": "g/17g",
      "Pharm_Classes": "Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2021-08-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20181212",
      "EndMarketingDatePackage": "20210731",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "68071-1629-7",
      "PackageDescription": "7.5 mL in 1 BOX (68071-1629-7)",
      "NDC11Code": "68071-1629-07",
      "ProductNDC": "68071-1629",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ciprodex",
      "NonProprietaryName": "Ciprofloxacin And Dexamethasone",
      "DosageFormName": "SUSPENSION/ DROPS",
      "RouteName": "AURICULAR (OTIC)",
      "StartMarketingDate": "20030804",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021537",
      "LabelerName": "NuCare Pharmaceuticals,Inc.",
      "SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE; DEXAMETHASONE",
      "StrengthNumber": "3; 1",
      "StrengthUnit": "mg/mL; mg/mL",
      "Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Quinolone Antimicrobial [EPC],Quinolones [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2020-06-19",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231"
    },
    {
      "NDCCode": "68071-1691-8",
      "PackageDescription": "8.7 AEROSOL, METERED in 1 BOX (68071-1691-8) ",
      "NDC11Code": "68071-1691-08",
      "ProductNDC": "68071-1691",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Qvar",
      "NonProprietaryName": "Beclomethasone Dipropionate",
      "DosageFormName": "AEROSOL, METERED",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20140915",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020911",
      "LabelerName": "NuCare Pharmaceuticals,Inc.",
      "SubstanceName": "BECLOMETHASONE DIPROPIONATE",
      "StrengthNumber": "40",
      "StrengthUnit": "ug/1",
      "Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2020-04-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20180521",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "68071-1703-7",
      "PackageDescription": "45 g in 1 BOX (68071-1703-7) ",
      "NDC11Code": "68071-1703-07",
      "ProductNDC": "68071-1703",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Miconazole 7",
      "NonProprietaryName": "Miconazole Nitrate",
      "DosageFormName": "CREAM",
      "RouteName": "VAGINAL",
      "StartMarketingDate": "19970401",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074164",
      "LabelerName": "NuCare Pharmaceuticals,Inc.",
      "SubstanceName": "MICONAZOLE NITRATE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2024-07-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20190304",
      "SamplePackage": "N",
      "IndicationAndUsage": "treats vaginal yeast infections. relieves external itching and irritation due to a vaginal yeast infection."
    },
    {
      "NDCCode": "68071-1753-7",
      "PackageDescription": "70 g in 1 BOX (68071-1753-7) ",
      "NDC11Code": "68071-1753-07",
      "ProductNDC": "68071-1753",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metronidazole",
      "NonProprietaryName": "Metronidazole",
      "DosageFormName": "GEL",
      "RouteName": "VAGINAL",
      "StartMarketingDate": "20150401",
      "MarketingCategoryName": "NDA AUTHORIZED GENERIC",
      "ApplicationNumber": "NDA020208",
      "LabelerName": "NuCare Pharmaceuticals,Inc.",
      "SubstanceName": "METRONIDAZOLE",
      "StrengthNumber": "7.5",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20180724",
      "SamplePackage": "N",
      "IndicationAndUsage": "Metronidazole Vaginal Gel is indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis). NOTE: 1 For purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a “fishy” amine odor when mixed with a 10% KOH solution, and (c) contains clue cells on microscopic examination. Gram’s stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent  Lactobacillus morphology, (b) predominance of  Gardnerella morphotype, and (c) absent or few white blood cells. .",
      "Description": "Metronidazole Vaginal Gel is the intravaginal dosage form of the synthetic antibacterial agent, metronidazole, USP at a concentration of 0.75%. Metronidazole is a member of the imidazole class of antibacterial agents and is classified therapeutically as an antiprotozoal and antibacterial agent. Chemically, metronidazole is a 2-methyl-5-nitroimidazole-1-ethanol. It has a chemical formula of C 6H 9N 3O 3, a molecular weight of 171.16, and has the following structure:. Metronidazole Vaginal Gel is a gelled, purified water solution, containing metronidazole at a concentration of 7.5 mg/g (0.75%). The gel is formulated at pH 4.0. The gel also contains carbomer 934P, edetate disodium, methylparaben, propylparaben, propylene glycol, and sodium hydroxide. Each applicator full of 5 grams of vaginal gel contains approximately 37.5 mg of metronidazole."
    },
    {
      "NDCCode": "68071-1865-7",
      "PackageDescription": "75 mL in 1 BOTTLE (68071-1865-7) ",
      "NDC11Code": "68071-1865-07",
      "ProductNDC": "68071-1865",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amoxicillin And Clavulanate Potassium",
      "NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
      "DosageFormName": "POWDER, FOR SUSPENSION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20071201",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065191",
      "LabelerName": "NuCare Pharmaceuticals,Inc.",
      "SubstanceName": "AMOXICILLIN; CLAVULANIC ACID",
      "StrengthNumber": "400; 57",
      "StrengthUnit": "mg/5mL; mg/5mL",
      "Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20200116",
      "SamplePackage": "N",
      "IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium Powder for Oral Suspension (amoxicillin/clavulanate potassium) and other antibacterial drugs, Amoxicillin and Clavulanate Potassium Powder for Oral Suspension should be used only to treat 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. Amoxicillin and Clavulanate Potassium Powder for Oral Suspension is a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*.",
      "Description": "Amoxicillin and Clavulanate Potassium Powder for Oral Suspension, USP is an oral antibacterial combination consisting of amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2 S,5 R,6 R)-6-[( R)-(-)-2-Amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as:. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta-lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C 8H 8KNO 5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium ( Z)(2 R,5 R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as:. Inactive Ingredients:.       Aspartame, colloidal silicon dioxide, HPMC 2910/ hypromellose 5 cP, silicon dioxide, succinic acid, xanthan gum, golden syrup flavor, orange flavor.        See PRECAUTIONS - Information for the Patient.       Each 5 mL of reconstituted amoxicillin and clavulanate potassium 400 mg/57 mg per 5 mL suspension contains 0.268 mEq of potassium.       Each 5 mL of reconstituted amoxicillin and clavulanate potassium 200 mg/28.5 mg per 5 mL suspension contains 0.143 mEq of potassium."
    },
    {
      "NDCCode": "68071-1875-7",
      "PackageDescription": "270 TABLET in 1 BOTTLE (68071-1875-7) ",
      "NDC11Code": "68071-1875-07",
      "ProductNDC": "68071-1875",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxybutynin Chloride",
      "NonProprietaryName": "Oxybutynin Chloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19900930",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA071655",
      "LabelerName": "NuCare Pharmaceuticals, Inc.",
      "SubstanceName": "OXYBUTYNIN CHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20170329",
      "SamplePackage": "N",
      "IndicationAndUsage": "Oxybutynin Chloride Tablets USP are indicated for the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder (i.e., urgency, frequency, urinary leakage, urge incontinence, dysuria).",
      "Description": "Oxybutynin Chloride Tablets USP are very pale blue, round, biconvex, scored, debossed tablets containing 5 mg of oxybutynin chloride, USP. Chemically, oxybutynin chloride, USP is d,l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochloride. The structural formula appears below. C 22H 31NO 3HCl M.W. 393.9. Oxybutynin chloride, USP is a white crystalline solid. It is readily soluble in water and acids, but relatively insoluble in alkalis. Oxybutynin Chloride Tablets USP also contain calcium stearate, microcrystalline cellulose, anhydrous lactose, sodium starch glycolate and FD&C Blue #1 Aluminum Lake. Oxybutynin Chloride Tablets USP are for oral administration. Meets USP Dissolution Test 2. Therapeutic Category: Antispasmodic, anticholinergic."
    },
    {
      "NDCCode": "68071-1876-7",
      "PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE (68071-1876-7) ",
      "NDC11Code": "68071-1876-07",
      "ProductNDC": "68071-1876",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metronidazole",
      "NonProprietaryName": "Metronidazole",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140601",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203458",
      "LabelerName": "NuCare Pharmaceuticals, Inc.",
      "SubstanceName": "METRONIDAZOLE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]",
      "Status": "Active",
      "LastUpdate": "2026-08-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260826",
      "SamplePackage": "N",
      "IndicationAndUsage": "Symptomatic Trichomoniasis. Metronidazole tablets are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis. Metronidazole tablets are indicated in the treatment of asymptomatic  T. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. Treatment of Asymptomatic Sexual Partners. T. vaginalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. In making this decision, it should be noted that there is evidence that a woman may become reinfected if her sexual partner is not treated. Also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. In any event, the sexual partner should be treated with metronidazole tablets in cases of reinfection. Amebiasis Metronidazole tablets are indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess. In amebic liver abscess, Metronidazole tablet therapy does not obviate the need for aspiration or drainage of pus. Anaerobic Bacterial Infections. Metronidazole tablets are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with metronidazole tablet therapy. In a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to metronidazole tablets. INTRA-ABDOMINAL INFECTIONS, including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroides species including the B. fragilis group ( B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus), Clostridium species, Eubacterium species, Peptococcus species, and Peptostreptococcus species. SKIN AND SKIN STRUCTURE INFECTIONS caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. GYNECOLOGIC INFECTIONS, including endometritis, endomyometritis, tubo-ovarian abscess, and postsurgical vaginal cuff infection, caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. BACTERIAL SEPTICEMIA caused by Bacteroides species including the B. fragilis group and Clostridium species. BONE AND JOINT INFECTIONS, (as adjunctive therapy), caused by Bacteroides species including the B. fragilis group. CENTRAL NERVOUS SYSTEM (CNS) INFECTIONS, including meningitis and brain abscess, caused by Bacteroides species including the B. fragilis group. LOWER RESPIRATORY TRACT INFECTIONS, including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the B. fragilis group. ENDOCARDITIS caused by Bacteroides species including the B. fragilis group. To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole tablets and other antibacterial drugs, metronidazole tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
      "Description": "Metronidazole tablets, 250 mg or 500 mg is an oral formulation of the synthetic nitroimidazole antimicrobial, 2-methyl-5-nitro-1H-imidazole-1-ethanol, which has the following structural formula. Metronidazole tablets USP contain 250 mg or 500 mg of metronidazole. Inactive ingredients include powdered cellulose, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, hypromellose, polyethylene glycol, stearic acid, and titanium dioxide."
    }
  ]
}
                    

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<NDCList><NDC><NDCCode>68071-2391-7</NDCCode><ProprietaryName>Ciprofloxacin</ProprietaryName><NonProprietaryName>Ciprofloxacin</NonProprietaryName></NDC><NDC><NDCCode>54868-2391-7</NDCCode><ProprietaryName>Minocycline Hydrochloride</ProprietaryName><NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>71335-2391-7</NDCCode><ProprietaryName>Loratadine</ProprietaryName><NonProprietaryName>Loratadine</NonProprietaryName></NDC><NDC><NDCCode>68071-2391-1</NDCCode><ProprietaryName>Ciprofloxacin</ProprietaryName><NonProprietaryName>Ciprofloxacin</NonProprietaryName></NDC><NDC><NDCCode>68071-2391-2</NDCCode><ProprietaryName>Ciprofloxacin</ProprietaryName><NonProprietaryName>Ciprofloxacin</NonProprietaryName></NDC><NDC><NDCCode>68071-2391-3</NDCCode><ProprietaryName>Ciprofloxacin</ProprietaryName><NonProprietaryName>Ciprofloxacin</NonProprietaryName></NDC><NDC><NDCCode>68071-2391-4</NDCCode><ProprietaryName>Ciprofloxacin</ProprietaryName><NonProprietaryName>Ciprofloxacin</NonProprietaryName></NDC><NDC><NDCCode>68071-2391-6</NDCCode><ProprietaryName>Ciprofloxacin</ProprietaryName><NonProprietaryName>Ciprofloxacin</NonProprietaryName></NDC><NDC><NDCCode>68071-2391-8</NDCCode><ProprietaryName>Ciprofloxacin</ProprietaryName><NonProprietaryName>Ciprofloxacin</NonProprietaryName></NDC><NDC><NDCCode>53002-2391-1</NDCCode><ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName><NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName></NDC><NDC><NDCCode>54868-2391-0</NDCCode><ProprietaryName>Minocycline Hydrochloride</ProprietaryName><NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>54868-2391-1</NDCCode><ProprietaryName>Minocycline Hydrochloride</ProprietaryName><NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>54868-2391-2</NDCCode><ProprietaryName>Minocycline Hydrochloride</ProprietaryName><NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>54868-2391-3</NDCCode><ProprietaryName>Minocycline Hydrochloride</ProprietaryName><NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>54868-2391-4</NDCCode><ProprietaryName>Minocycline Hydrochloride</ProprietaryName><NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>54868-2391-5</NDCCode><ProprietaryName>Minocycline Hydrochloride</ProprietaryName><NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>54868-2391-6</NDCCode><ProprietaryName>Minocycline Hydrochloride</ProprietaryName><NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>61995-2391-4</NDCCode><ProprietaryName>Alba Sunblock Natural Ff Spf 30</ProprietaryName><NonProprietaryName>Homosalate, Octocrylene, Ethylhexyl Salicilate, Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>63629-2391-1</NDCCode><ProprietaryName>Clindamycin Palmitate Hydrochloride</ProprietaryName><NonProprietaryName>Clindamycin Palmitate Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>72162-2391-1</NDCCode><ProprietaryName>Metolazone</ProprietaryName><NonProprietaryName>Metolazone</NonProprietaryName></NDC><NDC><NDCCode>68071-1212-7</NDCCode><ProprietaryName>Gabapentin</ProprietaryName><NonProprietaryName>Gabapentin</NonProprietaryName></NDC><NDC><NDCCode>68071-1292-7</NDCCode><ProprietaryName>Gabapentin</ProprietaryName><NonProprietaryName>Gabapentin</NonProprietaryName></NDC><NDC><NDCCode>68071-1316-7</NDCCode><ProprietaryName>Polyethylene Glycol 3350</ProprietaryName><NonProprietaryName>Polyethylene Glycol 3350</NonProprietaryName></NDC><NDC><NDCCode>68071-1629-7</NDCCode><ProprietaryName>Ciprodex</ProprietaryName><NonProprietaryName>Ciprofloxacin And Dexamethasone</NonProprietaryName></NDC><NDC><NDCCode>68071-1691-8</NDCCode><ProprietaryName>Qvar</ProprietaryName><NonProprietaryName>Beclomethasone Dipropionate</NonProprietaryName></NDC><NDC><NDCCode>68071-1703-7</NDCCode><ProprietaryName>Miconazole 7</ProprietaryName><NonProprietaryName>Miconazole Nitrate</NonProprietaryName></NDC><NDC><NDCCode>68071-1753-7</NDCCode><ProprietaryName>Metronidazole</ProprietaryName><NonProprietaryName>Metronidazole</NonProprietaryName></NDC><NDC><NDCCode>68071-1865-7</NDCCode><ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName><NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName></NDC><NDC><NDCCode>68071-1875-7</NDCCode><ProprietaryName>Oxybutynin Chloride</ProprietaryName><NonProprietaryName>Oxybutynin Chloride</NonProprietaryName></NDC><NDC><NDCCode>68071-1876-7</NDCCode><ProprietaryName>Metronidazole</ProprietaryName><NonProprietaryName>Metronidazole</NonProprietaryName></NDC></NDCList>