RESTful Lookup — Test-Drive (2007 – 2026)

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{
  "NDC": [
    {
      "NDCCode": "65734-511-72",
      "PackageDescription": "72 APPLICATOR in 1 PACKAGE (65734-511-72)  > .15 mL in 1 APPLICATOR (65734-511-00)",
      "NDC11Code": "65734-0511-72",
      "ProductNDC": "65734-511",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Isodine Copitos",
      "NonProprietaryName": "Povidone-iodine",
      "DosageFormName": "SOLUTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20080601",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part333C",
      "LabelerName": "Swabplus Inc.",
      "SubstanceName": "POVIDONE-IODINE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Hold the swab vertically, with the color ring tip upwards, Hold n the center of the tube with one hand at the color ring with the other. Gently snap the tip with the color ring, Formula inside the tube flows down and fills the opposite tip. Apply the product to the affected area. Discard swab after use."
    },
    {
      "NDCCode": "68016-511-72",
      "PackageDescription": "538 g in 1 BOTTLE, PLASTIC (68016-511-72) ",
      "NDC11Code": "68016-0511-72",
      "ProductNDC": "68016-511",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Premier Value Fiber Therapy",
      "ProprietaryNameSuffix": "Original Coarse",
      "NonProprietaryName": "Psyllium Husk",
      "DosageFormName": "POWDER",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190520",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M007",
      "LabelerName": "PHARMACY VALUE ALLIANCE, LLC",
      "SubstanceName": "PSYLLIUM HUSK",
      "StrengthNumber": "3.4",
      "StrengthUnit": "g/7g",
      "Status": "Active",
      "LastUpdate": "2024-10-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190520",
      "SamplePackage": "N",
      "IndicationAndUsage": "▪for relief of occasional constipation (irregularity). ▪generally produces bowel movement in 12-72 hours."
    },
    {
      "NDCCode": "65734-270-72",
      "PackageDescription": "72 APPLICATOR in 1 PACKET (65734-270-72)  > .15 mL in 1 APPLICATOR (65734-270-00)",
      "NDC11Code": "65734-0270-72",
      "ProductNDC": "65734-270",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Antiseptic Formula Filled Swab",
      "NonProprietaryName": "Lidocaine Hydrochloride, Benzalkonium Chloride",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20030301",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part348",
      "LabelerName": "Swabplus Inc.",
      "SubstanceName": "LIDOCAINE HYDROCHLORIDE; BENZALKONIUM CHLORIDE",
      "StrengthNumber": "100; 11",
      "StrengthUnit": "mg/10mL; mg/10mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": ": 1 Hold the swan vertically, with the color tip upwards. Hold in the center of the tube with one hand and at the color ring with the other., 2 Gently snap the tip with the color ring. Formula inside the tube flows down and fills the opposite tip., 3 Apply the product to the affected area., 4 Discard swab after use."
    },
    {
      "NDCCode": "65734-317-72",
      "PackageDescription": "72 APPLICATOR in 1 PACKAGE (65734-317-72)  > .15 mL in 1 APPLICATOR (65734-317-00)",
      "NDC11Code": "65734-0317-72",
      "ProductNDC": "65734-317",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Iodine",
      "NonProprietaryName": "Povidone-iodine",
      "DosageFormName": "SOLUTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20030301",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part333C",
      "LabelerName": "Swabplus Inc.",
      "SubstanceName": "POVIDONE-IODINE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Hold the swab vertically, with the color ring tip upwards. Hold in the center of the tube with one hand at the color ring with the other. Gently snap the tip with the color ring. Formula inside the tube flows down and fills the opposite tip. Apply the product to the affected area. Discard swab after use."
    },
    {
      "NDCCode": "65734-501-72",
      "PackageDescription": "72 APPLICATOR in 1 CARTON (65734-501-72)  > .15 g in 1 APPLICATOR (65734-501-01) ",
      "NDC11Code": "65734-0501-72",
      "ProductNDC": "65734-501",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hurricaine",
      "NonProprietaryName": "Benzocaine",
      "DosageFormName": "LIQUID",
      "RouteName": "DENTAL; ORAL; PERIODONTAL",
      "StartMarketingDate": "20190101",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part356",
      "LabelerName": "Swabplus, L.P.",
      "SubstanceName": "BENZOCAINE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2021-05-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20190101",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "55301-511-14",
      "PackageDescription": "822 g in 1 BOTTLE, PLASTIC (55301-511-14) ",
      "NDC11Code": "55301-0511-14",
      "ProductNDC": "55301-511",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Multihealth Fiber Therapy",
      "ProprietaryNameSuffix": "Original Coarse",
      "NonProprietaryName": "Psyllium Husk",
      "DosageFormName": "POWDER",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190415",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part334",
      "LabelerName": "YOUR MILITARY EXCHANGE",
      "SubstanceName": "PSYLLIUM HUSK",
      "StrengthNumber": "3.4",
      "StrengthUnit": "g/7g",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20190415",
      "SamplePackage": "N",
      "IndicationAndUsage": "▪for relief of occasional constipation (irregularity). ▪generally produces bowel movement in 12-72 hours."
    },
    {
      "NDCCode": "63941-511-48",
      "PackageDescription": "368 g in 1 BOTTLE, PLASTIC (63941-511-48) ",
      "NDC11Code": "63941-0511-48",
      "ProductNDC": "63941-511",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Best Choice Fiber Therapy",
      "ProprietaryNameSuffix": "Original Coarse",
      "NonProprietaryName": "Psyllium Husk",
      "DosageFormName": "POWDER",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190514",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M007",
      "LabelerName": "BEST CHOICE (VALU MERCHANDISERS COMPANY)",
      "SubstanceName": "PSYLLIUM HUSK",
      "StrengthNumber": "3.4",
      "StrengthUnit": "g/7g",
      "Status": "Active",
      "LastUpdate": "2026-07-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190514",
      "SamplePackage": "N",
      "IndicationAndUsage": "▪for relief of occasional constipation (irregularity). ▪generally produces bowel movement in 12-72 hours."
    },
    {
      "NDCCode": "82449-511-10",
      "PackageDescription": "10 VIAL in 1 CARTON (82449-511-10)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL",
      "NDC11Code": "82449-0511-10",
      "ProductNDC": "82449-511",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ampicillin",
      "NonProprietaryName": "Ampicillin",
      "DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20230512",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA201025",
      "LabelerName": "Steriscience Specialties Private Limited",
      "SubstanceName": "AMPICILLIN SODIUM",
      "StrengthNumber": "1",
      "StrengthUnit": "g/1",
      "Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2026-05-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230512",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ampicillin for Injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions. Respiratory tract Infections caused by S. pneumoniae. Staphylococcus aureus (penicillinase and nonpenicillinase-producing), H. influenzae, and Group A beta-hemolytic Streptococci. Bacterial Meningitis caused by E. coli, Group B Streptococci, and other Gram-negative bacteria ( Listeria monocytogenes, N. meningitidis). The addition of an aminoglycoside with ampicillin may increase its effectiveness against Gram-negative bacteria. Septicemia and Endocarditis caused by susceptible Gram-positive organisms including Streptococcus spp., penicillin G-susceptible staphylococci, and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella spp. responds to ampicillin. Endocarditis due to enterococcal strains usually respond to intravenous therapy. The addition of an aminoglycoside may enhance the effectiveness of ampicillin when treating streptococcal endocarditis. Urinary Tract Infections caused by sensitive strains of E. coli and Proteus mirabilis. Gastrointestinal Infections caused by Salmonella typhi(typhoid fever), other Salmonella spp., and Shigella spp. (dysentery) usually respond to oral or intravenous therapy. Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Therapy may be instituted prior to obtaining results of susceptibility testing. It is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms. A change to oral ampicillin may be made as soon as appropriate. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin for Injection, USP and other antibacterial drugs, Ampicillin for Injection, 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. Indicated surgical procedures should be performed.",
      "Description": "Ampicillin for Injection, USP the monosodium salt of [2S-[2α,5α,6β(S*)]]-6-[(aminophenylacetyl)amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, is a synthetic penicillin. It is an antibacterial agent with a broad spectrum of bactericidal activity against both penicillin-susceptible Gram-positive organisms and many common Gram-negative pathogens. Ampicillin for Injection, USP is a white to off-white crystalline sterile powder and forms a clear colorless solution upon reconstitution with sterile water for injection, USP or Bacteriostatic water for injection, USP. Each vial of Ampicillin for Injection, USP contains ampicillin sodium equivalent to 250 mg, 500 mg, 1 gram or 2 gram ampicillin. The sodium content is 16.46 mg (0.71 mEq) per 250 mg, 32.91 mg (1.43 mEq) per 500 mg, 65.83 mg (2.86 mEq) per 1 g, 131.66 mg (5.72 mEq) per 2 g of ampicillin. It has the following molecular structure. The molecular formula is C 16H 18N 3NaO 4S, and the molecular weight is 371.39. The pH range of the reconstituted solution is 8 to 10."
    },
    {
      "NDCCode": "65734-000-23",
      "PackageDescription": "1 KIT in 1 CARTON (65734-000-23)  *  2 mL in 1 PACKET (65734-125-01)  *  2 mL in 1 PACKET (65734-119-01)",
      "NDC11Code": "65734-0000-23",
      "ProductNDC": "65734-000",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "3-step First Aid Kit",
      "NonProprietaryName": "Povidone-iodine, Lidocaine Hydrochloride, Benzalkonium Chloride",
      "DosageFormName": "KIT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20030301",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part333C",
      "LabelerName": "Swabplus Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Do not use if label seal is broken prior to purchase. Hold the swab vertically, with the color ring band tip upwards. Hold in the center of the stem with one hand and at the color band with the other. Bend the tip at the color band to one side until it snaps. Apply the product to the affected area. Discard swab after use."
    },
    {
      "NDCCode": "65734-001-24",
      "PackageDescription": "24 APPLICATOR in 1 PACKET (65734-001-24)  > .15 mL in 1 APPLICATOR (65734-001-00)",
      "NDC11Code": "65734-0001-24",
      "ProductNDC": "65734-001",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Isopropyl Alcohol",
      "NonProprietaryName": "Isopropyl Alcohol",
      "DosageFormName": "SOLUTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20151001",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Swabplus Inc.",
      "SubstanceName": "ISOPROPYL ALCOHOL",
      "StrengthNumber": ".105",
      "StrengthUnit": "mL/.15mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Hold the swan vertically, with the color tip upwards. Hold in the center of the tube with one hand and at the color ring with the other. Gently snap the tip with the color ring. Formula inside the tube flows down and fills the opposite tip. Apply the product to the affected area. Discard swab after use."
    },
    {
      "NDCCode": "65734-082-36",
      "PackageDescription": "1 PACKAGE in 1 CARTON (65734-082-36)  > 2 mL in 1 PACKAGE (65734-082-12)",
      "NDC11Code": "65734-0082-36",
      "ProductNDC": "65734-082",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "3-in-1 First Aid Povidone-iodine Swab",
      "NonProprietaryName": "Povidone-iodine",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20030301",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part333C",
      "LabelerName": "Swabplus Inc.",
      "SubstanceName": "POVIDONE-IODINE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2015-04-10"
    },
    {
      "NDCCode": "65734-101-24",
      "PackageDescription": "24 APPLICATOR in 1 PACKAGE (65734-101-24)  > .15 mL in 1 APPLICATOR (65734-101-00)",
      "NDC11Code": "65734-0101-24",
      "ProductNDC": "65734-101",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Isopropyl Alcohol",
      "NonProprietaryName": "Isopropyl Alcohol",
      "DosageFormName": "SOLUTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20151001",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Swabplus Inc.",
      "SubstanceName": "ISOPROPYL ALCOHOL",
      "StrengthNumber": ".105",
      "StrengthUnit": "mL/.15mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Hold the swan vertically, with the color tip upwards. Hold in the center of the tube with one hand and at the color ring with the other. Gently snap the tip with the color ring. Formula inside the tube flows down and fills the opposite tip. Apply the product to the affected area. Discard swab after use."
    },
    {
      "NDCCode": "65734-103-36",
      "PackageDescription": "5 mL in 1 PACKET (65734-103-36)",
      "NDC11Code": "65734-0103-36",
      "ProductNDC": "65734-103",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Insect Bite Relief",
      "NonProprietaryName": "Benzocaine",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20030301",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part346",
      "LabelerName": "Swabplus Inc.",
      "SubstanceName": "BENZOCAINE",
      "StrengthNumber": "15",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2015-03-06"
    },
    {
      "NDCCode": "65734-112-36",
      "PackageDescription": "1 PACKET in 1 CARTON (65734-112-36)  > 2 mL in 1 PACKET (65734-112-12)",
      "NDC11Code": "65734-0112-36",
      "ProductNDC": "65734-112",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "3 Step First Aid Kit",
      "NonProprietaryName": "Lidocaine Hydrochloride",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20030301",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part348",
      "LabelerName": "Swabplus Inc.",
      "SubstanceName": "BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE",
      "StrengthNumber": "1; 10",
      "StrengthUnit": "mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2015-04-10"
    },
    {
      "NDCCode": "65734-300-36",
      "PackageDescription": "36 APPLICATOR in 1 PACKAGE (65734-300-36)  > .15 mL in 1 APPLICATOR (65734-300-00)",
      "NDC11Code": "65734-0300-36",
      "ProductNDC": "65734-300",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Insect Bite Relief",
      "NonProprietaryName": "Benzocaine",
      "DosageFormName": "SOLUTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20030301",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part346",
      "LabelerName": "Swabplus Inc.",
      "SubstanceName": "BENZOCAINE",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "♦   Do not use if label seal is broken prior to purchase. Keep swabs in original container when not in use. ♦   Hold the swab vertically, with the color band tip upwards. hold in the center of the stem with one hand and at the color band with the other. ♦  Bend the tip at the color band to one side until it snaps. ♦  Apply the product to the affected area. ♦  Discard swab after use."
    },
    {
      "NDCCode": "65734-348-36",
      "PackageDescription": "36 APPLICATOR in 1 PACKAGE (65734-348-36)  > .15 mL in 1 APPLICATOR (65734-348-00)",
      "NDC11Code": "65734-0348-36",
      "ProductNDC": "65734-348",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Fungus Relief",
      "NonProprietaryName": "Tolnaftate",
      "DosageFormName": "SOLUTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20030301",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part333C",
      "LabelerName": "Swabplus Inc.",
      "SubstanceName": "TOLNAFTATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": ": 1 Do not use if label seal is broken prior to purchase., 2 Keep swabs in original container when not in use., 3 wash affected area and dry thoroughly., 4 Hold the swab vertically with the color band tip upwards., 5 Bend the tip at the color band to one side until it snaps., 6 Apply a thin layer over affected area twice daily (morning and night), 7 Discard swab after use., 8 For athlete's foot, apply once or twice daily, pay special attention to spaces between toes, wear shoes with good ventilation and change shoes and socks at least once daily., 9 Use daily for 4 weeks; if condition persists longer, ask a doctor., 10 This product is not effective on the scalp or nails."
    },
    {
      "NDCCode": "65734-501-01",
      "PackageDescription": ".15 g in 1 APPLICATOR (65734-501-01) ",
      "NDC11Code": "65734-0501-01",
      "ProductNDC": "65734-501",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hurricaine",
      "NonProprietaryName": "Benzocaine",
      "DosageFormName": "LIQUID",
      "RouteName": "DENTAL; ORAL; PERIODONTAL",
      "StartMarketingDate": "20190101",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part356",
      "LabelerName": "Swabplus, L.P.",
      "SubstanceName": "BENZOCAINE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2021-05-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20190101",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "65734-502-12",
      "PackageDescription": "12 APPLICATOR in 1 CARTON (65734-502-12)  > .15 g in 1 APPLICATOR",
      "NDC11Code": "65734-0502-12",
      "ProductNDC": "65734-502",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Orajel Instant Pain Relief Maximum Toothache Oral Pain Relief",
      "NonProprietaryName": "Benzocaine",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20190101",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part356",
      "LabelerName": "Swabplus, L.P.",
      "SubstanceName": "BENZOCAINE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2021-05-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20190101",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "65734-503-12",
      "PackageDescription": "12 APPLICATOR in 1 CARTON (65734-503-12)  > .15 g in 1 APPLICATOR",
      "NDC11Code": "65734-0503-12",
      "ProductNDC": "65734-503",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Orajel Instant Pain Relief For All Mouth Sores",
      "NonProprietaryName": "Benzocaine",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20190101",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part356",
      "LabelerName": "Swabplus, L.P.",
      "SubstanceName": "BENZOCAINE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2021-05-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20190101",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "65734-504-36",
      "PackageDescription": "36 APPLICATOR in 1 CASE (65734-504-36)  > .15 mL in 1 APPLICATOR",
      "NDC11Code": "65734-0504-36",
      "ProductNDC": "65734-504",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dr. Piercing Aftercare",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "SWAB",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210101",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Swabplus, L.P.",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": "1.1",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-07-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20210101",
      "SamplePackage": "N",
      "Description": "DISTRIBUTED BY: Broadway Products LLC, Sellersburg, Indiana. LEARN MORE: www.drpiercing.com. BARCODE XM001448MO3. Dr. Piercing Afterca...roduct, 36 Swab Pierce New."
    },
    {
      "NDCCode": "65734-740-00",
      "PackageDescription": "1 KIT in 1 CARTON (65734-740-00)  *  24 APPLICATOR in 1 PACKAGE (65734-741-24)  > .15 mL in 1 APPLICATOR (65734-741-00)  *  24 APPLICATOR in 1 PACKAGE (65734-742-24)  > .15 mL in 1 APPLICATOR (65734-742-00)",
      "NDC11Code": "65734-0740-00",
      "ProductNDC": "65734-740",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Advance Acne Care",
      "NonProprietaryName": "Salicylic Acid, Silver",
      "DosageFormName": "KIT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20080807",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part333D",
      "LabelerName": "Swabplus Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Do not use if label seal is broken prior to purchase.Keep swabs in original container when not in use. Treatment Swabs have a red color band. Use Cleansinh swab to cleanse the skin throughly before applying medication. Hold the swab vertically, with the color ring band tip upwards. . Bend the tip at the color band to one side until it snaps. Medicine will flow to theother end. Cover the entire affected area with a thin layer 1 to 3 times daily. Discard swab after use. Each swab can be used on multipe pimples. Because excesssive drying of the skin may occur start with1 application daiky then gradually increase to 2 or 3 times daily if needed, or as direcvted by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every othr day. ."
    },
    {
      "NDCCode": "65734-867-24",
      "PackageDescription": "3.6 mL in 1 PACKET (65734-867-24)",
      "NDC11Code": "65734-0867-24",
      "ProductNDC": "65734-867",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Mouth Sore Relief Applicator",
      "NonProprietaryName": "Benzocaine",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20050601",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part333B",
      "LabelerName": "Swabplus Inc.",
      "SubstanceName": "BENZOCAINE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Snap the tip at the color ring. Allow formula to flow down to the opposite tip. Apply formula with the saturated tip to affected area."
    },
    {
      "NDCCode": "0054-4496-13",
      "PackageDescription": "30 TABLET in 1 BOTTLE (0054-4496-13) ",
      "NDC11Code": "00054-4496-13",
      "ProductNDC": "0054-4496",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Leucovorin Calcium",
      "NonProprietaryName": "Leucovorin Calcium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19930222",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA072733",
      "LabelerName": "Hikma Pharmaceuticals USA Inc.",
      "SubstanceName": "LEUCOVORIN CALCIUM",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Folate Analog [EPC], Folic Acid [CS]",
      "Status": "Active",
      "LastUpdate": "2026-03-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19930322",
      "SamplePackage": "N",
      "IndicationAndUsage": "Leucovorin is a folate analog indicated: 1 To reduce the toxicity of:, 2 oMethotrexate in adult patients with impaired methotrexate elimination, and, 3 oFolic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients. (1.1) , 4 For the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD). (1.2), 5  Limitations of Use, 6  Leucovorin is not recommended for use in patients with a deficiency of methenyltetrahydrofolate synthetase (MTHFS) because MTHFS is a primary enzyme in the metabolism of leucovorin to 5-methenyltetrahydrofolate. (1.2).",
      "Description": "Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. C20H21CaN7O7 M.W. 511.51. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg, 10 mg, 15 mg or 25 mg leucovorin tablets are either equivalent to 5.4 mg, 10.8 mg, 16.21 mg or 27.01 mg of anhydrous leucovorin calcium, USP, respectively. In addition, each tablet contains the following inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 (15 mg and 25 mg), magnesium stearate, microcrystalline cellulose, povidone and pregelatinized starch."
    },
    {
      "NDCCode": "0054-4496-25",
      "PackageDescription": "100 TABLET in 1 BOTTLE (0054-4496-25) ",
      "NDC11Code": "00054-4496-25",
      "ProductNDC": "0054-4496",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Leucovorin Calcium",
      "NonProprietaryName": "Leucovorin Calcium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19930222",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA072733",
      "LabelerName": "Hikma Pharmaceuticals USA Inc.",
      "SubstanceName": "LEUCOVORIN CALCIUM",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Folate Analog [EPC], Folic Acid [CS]",
      "Status": "Active",
      "LastUpdate": "2026-03-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19930322",
      "SamplePackage": "N",
      "IndicationAndUsage": "Leucovorin is a folate analog indicated: 1 To reduce the toxicity of:, 2 oMethotrexate in adult patients with impaired methotrexate elimination, and, 3 oFolic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients. (1.1) , 4 For the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD). (1.2), 5  Limitations of Use, 6  Leucovorin is not recommended for use in patients with a deficiency of methenyltetrahydrofolate synthetase (MTHFS) because MTHFS is a primary enzyme in the metabolism of leucovorin to 5-methenyltetrahydrofolate. (1.2).",
      "Description": "Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. C20H21CaN7O7 M.W. 511.51. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg, 10 mg, 15 mg or 25 mg leucovorin tablets are either equivalent to 5.4 mg, 10.8 mg, 16.21 mg or 27.01 mg of anhydrous leucovorin calcium, USP, respectively. In addition, each tablet contains the following inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 (15 mg and 25 mg), magnesium stearate, microcrystalline cellulose, povidone and pregelatinized starch."
    },
    {
      "NDCCode": "0054-4497-05",
      "PackageDescription": "12 TABLET in 1 BOTTLE (0054-4497-05) ",
      "NDC11Code": "00054-4497-05",
      "ProductNDC": "0054-4497",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Leucovorin Calcium",
      "NonProprietaryName": "Leucovorin Calcium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19930222",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA072734",
      "LabelerName": "Hikma Pharmaceuticals USA Inc.",
      "SubstanceName": "LEUCOVORIN CALCIUM",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Folate Analog [EPC], Folic Acid [CS]",
      "Status": "Active",
      "LastUpdate": "2026-03-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19930322",
      "SamplePackage": "N",
      "IndicationAndUsage": "Leucovorin is a folate analog indicated: 1 To reduce the toxicity of:, 2 oMethotrexate in adult patients with impaired methotrexate elimination, and, 3 oFolic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients. (1.1) , 4 For the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD). (1.2), 5  Limitations of Use, 6  Leucovorin is not recommended for use in patients with a deficiency of methenyltetrahydrofolate synthetase (MTHFS) because MTHFS is a primary enzyme in the metabolism of leucovorin to 5-methenyltetrahydrofolate. (1.2).",
      "Description": "Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. C20H21CaN7O7 M.W. 511.51. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg, 10 mg, 15 mg or 25 mg leucovorin tablets are either equivalent to 5.4 mg, 10.8 mg, 16.21 mg or 27.01 mg of anhydrous leucovorin calcium, USP, respectively. In addition, each tablet contains the following inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 (15 mg and 25 mg), magnesium stearate, microcrystalline cellulose, povidone and pregelatinized starch."
    },
    {
      "NDCCode": "0054-4497-10",
      "PackageDescription": "24 TABLET in 1 BOTTLE (0054-4497-10) ",
      "NDC11Code": "00054-4497-10",
      "ProductNDC": "0054-4497",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Leucovorin Calcium",
      "NonProprietaryName": "Leucovorin Calcium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19930222",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA072734",
      "LabelerName": "Hikma Pharmaceuticals USA Inc.",
      "SubstanceName": "LEUCOVORIN CALCIUM",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Folate Analog [EPC], Folic Acid [CS]",
      "Status": "Active",
      "LastUpdate": "2026-03-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19930322",
      "SamplePackage": "N",
      "IndicationAndUsage": "Leucovorin is a folate analog indicated: 1 To reduce the toxicity of:, 2 oMethotrexate in adult patients with impaired methotrexate elimination, and, 3 oFolic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients. (1.1) , 4 For the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD). (1.2), 5  Limitations of Use, 6  Leucovorin is not recommended for use in patients with a deficiency of methenyltetrahydrofolate synthetase (MTHFS) because MTHFS is a primary enzyme in the metabolism of leucovorin to 5-methenyltetrahydrofolate. (1.2).",
      "Description": "Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. C20H21CaN7O7 M.W. 511.51. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg, 10 mg, 15 mg or 25 mg leucovorin tablets are either equivalent to 5.4 mg, 10.8 mg, 16.21 mg or 27.01 mg of anhydrous leucovorin calcium, USP, respectively. In addition, each tablet contains the following inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 (15 mg and 25 mg), magnesium stearate, microcrystalline cellulose, povidone and pregelatinized starch."
    },
    {
      "NDCCode": "0054-4498-10",
      "PackageDescription": "24 TABLET in 1 BOTTLE (0054-4498-10) ",
      "NDC11Code": "00054-4498-10",
      "ProductNDC": "0054-4498",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Leucovorin Calcium",
      "NonProprietaryName": "Leucovorin Calcium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19930222",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA072735",
      "LabelerName": "Hikma Pharmaceuticals USA Inc.",
      "SubstanceName": "LEUCOVORIN CALCIUM",
      "StrengthNumber": "15",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Folate Analog [EPC], Folic Acid [CS]",
      "Status": "Active",
      "LastUpdate": "2026-03-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19930322",
      "SamplePackage": "N",
      "IndicationAndUsage": "Leucovorin is a folate analog indicated: 1 To reduce the toxicity of:, 2 oMethotrexate in adult patients with impaired methotrexate elimination, and, 3 oFolic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients. (1.1) , 4 For the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD). (1.2), 5  Limitations of Use, 6  Leucovorin is not recommended for use in patients with a deficiency of methenyltetrahydrofolate synthetase (MTHFS) because MTHFS is a primary enzyme in the metabolism of leucovorin to 5-methenyltetrahydrofolate. (1.2).",
      "Description": "Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. C20H21CaN7O7 M.W. 511.51. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg, 10 mg, 15 mg or 25 mg leucovorin tablets are either equivalent to 5.4 mg, 10.8 mg, 16.21 mg or 27.01 mg of anhydrous leucovorin calcium, USP, respectively. In addition, each tablet contains the following inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 (15 mg and 25 mg), magnesium stearate, microcrystalline cellulose, povidone and pregelatinized starch."
    },
    {
      "NDCCode": "0054-4499-11",
      "PackageDescription": "25 TABLET in 1 BOTTLE (0054-4499-11) ",
      "NDC11Code": "00054-4499-11",
      "ProductNDC": "0054-4499",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Leucovorin Calcium",
      "NonProprietaryName": "Leucovorin Calcium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19930222",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA072736",
      "LabelerName": "Hikma Pharmaceuticals USA Inc.",
      "SubstanceName": "LEUCOVORIN CALCIUM",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Folate Analog [EPC], Folic Acid [CS]",
      "Status": "Active",
      "LastUpdate": "2026-03-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19930322",
      "SamplePackage": "N",
      "IndicationAndUsage": "Leucovorin is a folate analog indicated: 1 To reduce the toxicity of:, 2 oMethotrexate in adult patients with impaired methotrexate elimination, and, 3 oFolic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients. (1.1) , 4 For the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD). (1.2), 5  Limitations of Use, 6  Leucovorin is not recommended for use in patients with a deficiency of methenyltetrahydrofolate synthetase (MTHFS) because MTHFS is a primary enzyme in the metabolism of leucovorin to 5-methenyltetrahydrofolate. (1.2).",
      "Description": "Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. C20H21CaN7O7 M.W. 511.51. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg, 10 mg, 15 mg or 25 mg leucovorin tablets are either equivalent to 5.4 mg, 10.8 mg, 16.21 mg or 27.01 mg of anhydrous leucovorin calcium, USP, respectively. In addition, each tablet contains the following inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 (15 mg and 25 mg), magnesium stearate, microcrystalline cellulose, povidone and pregelatinized starch."
    },
    {
      "NDCCode": "0054-8496-19",
      "PackageDescription": "5 BLISTER PACK in 1 CARTON (0054-8496-19)  / 10 TABLET in 1 BLISTER PACK",
      "NDC11Code": "00054-8496-19",
      "ProductNDC": "0054-8496",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Leucovorin Calcium",
      "NonProprietaryName": "Leucovorin Calcium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19930222",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA072733",
      "LabelerName": "Hikma Pharmaceuticals USA Inc.",
      "SubstanceName": "LEUCOVORIN CALCIUM",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Folate Analog [EPC], Folic Acid [CS]",
      "Status": "Active",
      "LastUpdate": "2026-03-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19930322",
      "SamplePackage": "N",
      "IndicationAndUsage": "Leucovorin is a folate analog indicated: 1 To reduce the toxicity of:, 2 oMethotrexate in adult patients with impaired methotrexate elimination, and, 3 oFolic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients. (1.1) , 4 For the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD). (1.2), 5  Limitations of Use, 6  Leucovorin is not recommended for use in patients with a deficiency of methenyltetrahydrofolate synthetase (MTHFS) because MTHFS is a primary enzyme in the metabolism of leucovorin to 5-methenyltetrahydrofolate. (1.2).",
      "Description": "Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. C20H21CaN7O7 M.W. 511.51. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg, 10 mg, 15 mg or 25 mg leucovorin tablets are either equivalent to 5.4 mg, 10.8 mg, 16.21 mg or 27.01 mg of anhydrous leucovorin calcium, USP, respectively. In addition, each tablet contains the following inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 (15 mg and 25 mg), magnesium stearate, microcrystalline cellulose, povidone and pregelatinized starch."
    },
    {
      "NDCCode": "0143-9368-01",
      "PackageDescription": "1 VIAL in 1 BOX, UNIT-DOSE (0143-9368-01)  > 20 mL in 1 VIAL",
      "NDC11Code": "00143-9368-01",
      "ProductNDC": "0143-9368",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Leucovorin Calcium",
      "NonProprietaryName": "Leucovorin Calcium",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "19950523",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040056",
      "LabelerName": "Hikma Pharmaceuticals USA Inc.",
      "SubstanceName": "LEUCOVORIN CALCIUM",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/20mL",
      "Pharm_Classes": "Folate Analog [EPC], Folic Acid [CS]",
      "Status": "Active",
      "LastUpdate": "2022-06-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20191001",
      "SamplePackage": "N",
      "IndicationAndUsage": "Leucovorin calcium, USP rescue is indicated after high dose methotrexate therapy in osteosarcoma. Leucovorin calcium, USP is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosages of folic acid antagonists. Leucovorin calcium, USP is indicated in the treatment of megaloblastic anemias due to folic acid deficiency when oral therapy is not feasible. Leucovorin Calcium, USP is also indicated for use in combination with 5-fluorouracil to prolong survival in the palliative treatment of patients with advanced colorectal cancer. Leucovorin should not be mixed in the same infusion as 5-fluorouracil because a precipitate may form.",
      "Description": "Leucovorin is one of several active, chemically reduced derivatives of folic acid. It is useful as an antidote to drugs which act as folic acid antagonists. Also known as folinic acid, Citrovorum factor, or 5-formyl-5,6,7,8-tetrahydrofolic acid, this compound has the chemical designation of Calcium N-[p-[[[(6RS)-2-amino-5-formyl-5,6,7,8-tetrahydro-4-hydroxy-6-pteridinyl]methyl]amino]benzoyl]-L-glutamate (1:1). The structural formula of leucovorin calcium is. C20H21CaN7O7                                                                  M.W.=511.51. Leucovorin Calcium for Injection, USP is a sterile product indicated for intramuscular (IM) or intravenous (IV) administration and is supplied in 200 mg vials. Each 200 mg vial of Leucovorin Calcium for Injection, USP, when reconstituted with 20 mL of sterile diluent, contains leucovorin (as the calcium salt) 10 mg/mL. One milligram of leucovorin calcium, USP contains 0.002 mmol of leucovorin and 0.002 mmol of calcium. These lyophilized products contain no preservative. The inactive ingredient is Sodium Chloride, added to adjust tonicity. Sodium hydroxide and/or hydrochloric acid may be added for pH adjustment. pH adjusted to 7.0 to 8.5. Reconstitute with Bacteriostatic Water for Injection, which contains benzyl alcohol (see WARNINGS section), or with Sterile Water for Injection."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"65734-511-72","ProprietaryName":"Isodine Copitos","NonProprietaryName":"Povidone-iodine"},{"NDCCode":"68016-511-72","ProprietaryName":"Premier Value Fiber Therapy","NonProprietaryName":"Psyllium Husk"},{"NDCCode":"65734-270-72","ProprietaryName":"Antiseptic Formula Filled Swab","NonProprietaryName":"Lidocaine Hydrochloride, Benzalkonium Chloride"},{"NDCCode":"65734-317-72","ProprietaryName":"Iodine","NonProprietaryName":"Povidone-iodine"},{"NDCCode":"65734-501-72","ProprietaryName":"Hurricaine","NonProprietaryName":"Benzocaine"},{"NDCCode":"55301-511-14","ProprietaryName":"Multihealth Fiber Therapy","NonProprietaryName":"Psyllium Husk"},{"NDCCode":"63941-511-48","ProprietaryName":"Best Choice Fiber Therapy","NonProprietaryName":"Psyllium Husk"},{"NDCCode":"82449-511-10","ProprietaryName":"Ampicillin","NonProprietaryName":"Ampicillin"},{"NDCCode":"65734-000-23","ProprietaryName":"3-step First Aid Kit","NonProprietaryName":"Povidone-iodine, Lidocaine Hydrochloride, Benzalkonium Chloride"},{"NDCCode":"65734-001-24","ProprietaryName":"Isopropyl Alcohol","NonProprietaryName":"Isopropyl Alcohol"},{"NDCCode":"65734-082-36","ProprietaryName":"3-in-1 First Aid Povidone-iodine Swab","NonProprietaryName":"Povidone-iodine"},{"NDCCode":"65734-101-24","ProprietaryName":"Isopropyl Alcohol","NonProprietaryName":"Isopropyl Alcohol"},{"NDCCode":"65734-103-36","ProprietaryName":"Insect Bite Relief","NonProprietaryName":"Benzocaine"},{"NDCCode":"65734-112-36","ProprietaryName":"3 Step First Aid Kit","NonProprietaryName":"Lidocaine Hydrochloride"},{"NDCCode":"65734-300-36","ProprietaryName":"Insect Bite Relief","NonProprietaryName":"Benzocaine"},{"NDCCode":"65734-348-36","ProprietaryName":"Fungus Relief","NonProprietaryName":"Tolnaftate"},{"NDCCode":"65734-501-01","ProprietaryName":"Hurricaine","NonProprietaryName":"Benzocaine"},{"NDCCode":"65734-502-12","ProprietaryName":"Orajel Instant Pain Relief Maximum Toothache Oral Pain Relief","NonProprietaryName":"Benzocaine"},{"NDCCode":"65734-503-12","ProprietaryName":"Orajel Instant Pain Relief For All Mouth Sores","NonProprietaryName":"Benzocaine"},{"NDCCode":"65734-504-36","ProprietaryName":"Dr. Piercing Aftercare","NonProprietaryName":"Benzalkonium Chloride"},{"NDCCode":"65734-740-00","ProprietaryName":"Advance Acne Care","NonProprietaryName":"Salicylic Acid, Silver"},{"NDCCode":"65734-867-24","ProprietaryName":"Mouth Sore Relief Applicator","NonProprietaryName":"Benzocaine"},{"NDCCode":"0054-4496-13","ProprietaryName":"Leucovorin Calcium","NonProprietaryName":"Leucovorin Calcium"},{"NDCCode":"0054-4496-25","ProprietaryName":"Leucovorin Calcium","NonProprietaryName":"Leucovorin Calcium"},{"NDCCode":"0054-4497-05","ProprietaryName":"Leucovorin Calcium","NonProprietaryName":"Leucovorin Calcium"},{"NDCCode":"0054-4497-10","ProprietaryName":"Leucovorin Calcium","NonProprietaryName":"Leucovorin Calcium"},{"NDCCode":"0054-4498-10","ProprietaryName":"Leucovorin Calcium","NonProprietaryName":"Leucovorin Calcium"},{"NDCCode":"0054-4499-11","ProprietaryName":"Leucovorin Calcium","NonProprietaryName":"Leucovorin Calcium"},{"NDCCode":"0054-8496-19","ProprietaryName":"Leucovorin Calcium","NonProprietaryName":"Leucovorin Calcium"},{"NDCCode":"0143-9368-01","ProprietaryName":"Leucovorin Calcium","NonProprietaryName":"Leucovorin Calcium"}]}
                    

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<NDCList>
  <NDC>
    <NDCCode>65734-511-72</NDCCode>
    <PackageDescription>72 APPLICATOR in 1 PACKAGE (65734-511-72)  &gt; .15 mL in 1 APPLICATOR (65734-511-00)</PackageDescription>
    <NDC11Code>65734-0511-72</NDC11Code>
    <ProductNDC>65734-511</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Isodine Copitos</ProprietaryName>
    <NonProprietaryName>Povidone-iodine</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20080601</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part333C</ApplicationNumber>
    <LabelerName>Swabplus Inc.</LabelerName>
    <SubstanceName>POVIDONE-IODINE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Hold the swab vertically, with the color ring tip upwards, Hold n the center of the tube with one hand at the color ring with the other. Gently snap the tip with the color ring, Formula inside the tube flows down and fills the opposite tip. Apply the product to the affected area. Discard swab after use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>68016-511-72</NDCCode>
    <PackageDescription>538 g in 1 BOTTLE, PLASTIC (68016-511-72) </PackageDescription>
    <NDC11Code>68016-0511-72</NDC11Code>
    <ProductNDC>68016-511</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Premier Value Fiber Therapy</ProprietaryName>
    <ProprietaryNameSuffix>Original Coarse</ProprietaryNameSuffix>
    <NonProprietaryName>Psyllium Husk</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190520</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M007</ApplicationNumber>
    <LabelerName>PHARMACY VALUE ALLIANCE, LLC</LabelerName>
    <SubstanceName>PSYLLIUM HUSK</SubstanceName>
    <StrengthNumber>3.4</StrengthNumber>
    <StrengthUnit>g/7g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-10-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190520</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>▪for relief of occasional constipation (irregularity). ▪generally produces bowel movement in 12-72 hours.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>65734-270-72</NDCCode>
    <PackageDescription>72 APPLICATOR in 1 PACKET (65734-270-72)  &gt; .15 mL in 1 APPLICATOR (65734-270-00)</PackageDescription>
    <NDC11Code>65734-0270-72</NDC11Code>
    <ProductNDC>65734-270</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Antiseptic Formula Filled Swab</ProprietaryName>
    <NonProprietaryName>Lidocaine Hydrochloride, Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20030301</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part348</ApplicationNumber>
    <LabelerName>Swabplus Inc.</LabelerName>
    <SubstanceName>LIDOCAINE HYDROCHLORIDE; BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>100; 11</StrengthNumber>
    <StrengthUnit>mg/10mL; mg/10mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>: 1 Hold the swan vertically, with the color tip upwards. Hold in the center of the tube with one hand and at the color ring with the other., 2 Gently snap the tip with the color ring. Formula inside the tube flows down and fills the opposite tip., 3 Apply the product to the affected area., 4 Discard swab after use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>65734-317-72</NDCCode>
    <PackageDescription>72 APPLICATOR in 1 PACKAGE (65734-317-72)  &gt; .15 mL in 1 APPLICATOR (65734-317-00)</PackageDescription>
    <NDC11Code>65734-0317-72</NDC11Code>
    <ProductNDC>65734-317</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Iodine</ProprietaryName>
    <NonProprietaryName>Povidone-iodine</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20030301</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part333C</ApplicationNumber>
    <LabelerName>Swabplus Inc.</LabelerName>
    <SubstanceName>POVIDONE-IODINE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Hold the swab vertically, with the color ring tip upwards. Hold in the center of the tube with one hand at the color ring with the other. Gently snap the tip with the color ring. Formula inside the tube flows down and fills the opposite tip. Apply the product to the affected area. Discard swab after use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>65734-501-72</NDCCode>
    <PackageDescription>72 APPLICATOR in 1 CARTON (65734-501-72)  &gt; .15 g in 1 APPLICATOR (65734-501-01) </PackageDescription>
    <NDC11Code>65734-0501-72</NDC11Code>
    <ProductNDC>65734-501</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hurricaine</ProprietaryName>
    <NonProprietaryName>Benzocaine</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>DENTAL; ORAL; PERIODONTAL</RouteName>
    <StartMarketingDate>20190101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part356</ApplicationNumber>
    <LabelerName>Swabplus, L.P.</LabelerName>
    <SubstanceName>BENZOCAINE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-05-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>55301-511-14</NDCCode>
    <PackageDescription>822 g in 1 BOTTLE, PLASTIC (55301-511-14) </PackageDescription>
    <NDC11Code>55301-0511-14</NDC11Code>
    <ProductNDC>55301-511</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Multihealth Fiber Therapy</ProprietaryName>
    <ProprietaryNameSuffix>Original Coarse</ProprietaryNameSuffix>
    <NonProprietaryName>Psyllium Husk</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190415</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part334</ApplicationNumber>
    <LabelerName>YOUR MILITARY EXCHANGE</LabelerName>
    <SubstanceName>PSYLLIUM HUSK</SubstanceName>
    <StrengthNumber>3.4</StrengthNumber>
    <StrengthUnit>g/7g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190415</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>▪for relief of occasional constipation (irregularity). ▪generally produces bowel movement in 12-72 hours.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>63941-511-48</NDCCode>
    <PackageDescription>368 g in 1 BOTTLE, PLASTIC (63941-511-48) </PackageDescription>
    <NDC11Code>63941-0511-48</NDC11Code>
    <ProductNDC>63941-511</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Best Choice Fiber Therapy</ProprietaryName>
    <ProprietaryNameSuffix>Original Coarse</ProprietaryNameSuffix>
    <NonProprietaryName>Psyllium Husk</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190514</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M007</ApplicationNumber>
    <LabelerName>BEST CHOICE (VALU MERCHANDISERS COMPANY)</LabelerName>
    <SubstanceName>PSYLLIUM HUSK</SubstanceName>
    <StrengthNumber>3.4</StrengthNumber>
    <StrengthUnit>g/7g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-07-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190514</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>▪for relief of occasional constipation (irregularity). ▪generally produces bowel movement in 12-72 hours.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>82449-511-10</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (82449-511-10)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL</PackageDescription>
    <NDC11Code>82449-0511-10</NDC11Code>
    <ProductNDC>82449-511</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ampicillin</ProprietaryName>
    <NonProprietaryName>Ampicillin</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20230512</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA201025</ApplicationNumber>
    <LabelerName>Steriscience Specialties Private Limited</LabelerName>
    <SubstanceName>AMPICILLIN SODIUM</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/1</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-05-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230512</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ampicillin for Injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions. Respiratory tract Infections caused by S. pneumoniae. Staphylococcus aureus (penicillinase and nonpenicillinase-producing), H. influenzae, and Group A beta-hemolytic Streptococci. Bacterial Meningitis caused by E. coli, Group B Streptococci, and other Gram-negative bacteria ( Listeria monocytogenes, N. meningitidis). The addition of an aminoglycoside with ampicillin may increase its effectiveness against Gram-negative bacteria. Septicemia and Endocarditis caused by susceptible Gram-positive organisms including Streptococcus spp., penicillin G-susceptible staphylococci, and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella spp. responds to ampicillin. Endocarditis due to enterococcal strains usually respond to intravenous therapy. The addition of an aminoglycoside may enhance the effectiveness of ampicillin when treating streptococcal endocarditis. Urinary Tract Infections caused by sensitive strains of E. coli and Proteus mirabilis. Gastrointestinal Infections caused by Salmonella typhi(typhoid fever), other Salmonella spp., and Shigella spp. (dysentery) usually respond to oral or intravenous therapy. Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Therapy may be instituted prior to obtaining results of susceptibility testing. It is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms. A change to oral ampicillin may be made as soon as appropriate. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin for Injection, USP and other antibacterial drugs, Ampicillin for Injection, 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. Indicated surgical procedures should be performed.</IndicationAndUsage>
    <Description>Ampicillin for Injection, USP the monosodium salt of [2S-[2α,5α,6β(S*)]]-6-[(aminophenylacetyl)amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, is a synthetic penicillin. It is an antibacterial agent with a broad spectrum of bactericidal activity against both penicillin-susceptible Gram-positive organisms and many common Gram-negative pathogens. Ampicillin for Injection, USP is a white to off-white crystalline sterile powder and forms a clear colorless solution upon reconstitution with sterile water for injection, USP or Bacteriostatic water for injection, USP. Each vial of Ampicillin for Injection, USP contains ampicillin sodium equivalent to 250 mg, 500 mg, 1 gram or 2 gram ampicillin. The sodium content is 16.46 mg (0.71 mEq) per 250 mg, 32.91 mg (1.43 mEq) per 500 mg, 65.83 mg (2.86 mEq) per 1 g, 131.66 mg (5.72 mEq) per 2 g of ampicillin. It has the following molecular structure. The molecular formula is C 16H 18N 3NaO 4S, and the molecular weight is 371.39. The pH range of the reconstituted solution is 8 to 10.</Description>
  </NDC>
  <NDC>
    <NDCCode>65734-000-23</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (65734-000-23)  *  2 mL in 1 PACKET (65734-125-01)  *  2 mL in 1 PACKET (65734-119-01)</PackageDescription>
    <NDC11Code>65734-0000-23</NDC11Code>
    <ProductNDC>65734-000</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>3-step First Aid Kit</ProprietaryName>
    <NonProprietaryName>Povidone-iodine, Lidocaine Hydrochloride, Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20030301</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part333C</ApplicationNumber>
    <LabelerName>Swabplus Inc.</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Do not use if label seal is broken prior to purchase. Hold the swab vertically, with the color ring band tip upwards. Hold in the center of the stem with one hand and at the color band with the other. Bend the tip at the color band to one side until it snaps. Apply the product to the affected area. Discard swab after use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>65734-001-24</NDCCode>
    <PackageDescription>24 APPLICATOR in 1 PACKET (65734-001-24)  &gt; .15 mL in 1 APPLICATOR (65734-001-00)</PackageDescription>
    <NDC11Code>65734-0001-24</NDC11Code>
    <ProductNDC>65734-001</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Isopropyl Alcohol</ProprietaryName>
    <NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20151001</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Swabplus Inc.</LabelerName>
    <SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
    <StrengthNumber>.105</StrengthNumber>
    <StrengthUnit>mL/.15mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Hold the swan vertically, with the color tip upwards. Hold in the center of the tube with one hand and at the color ring with the other. Gently snap the tip with the color ring. Formula inside the tube flows down and fills the opposite tip. Apply the product to the affected area. Discard swab after use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>65734-082-36</NDCCode>
    <PackageDescription>1 PACKAGE in 1 CARTON (65734-082-36)  &gt; 2 mL in 1 PACKAGE (65734-082-12)</PackageDescription>
    <NDC11Code>65734-0082-36</NDC11Code>
    <ProductNDC>65734-082</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>3-in-1 First Aid Povidone-iodine Swab</ProprietaryName>
    <NonProprietaryName>Povidone-iodine</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20030301</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part333C</ApplicationNumber>
    <LabelerName>Swabplus Inc.</LabelerName>
    <SubstanceName>POVIDONE-IODINE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2015-04-10</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>65734-101-24</NDCCode>
    <PackageDescription>24 APPLICATOR in 1 PACKAGE (65734-101-24)  &gt; .15 mL in 1 APPLICATOR (65734-101-00)</PackageDescription>
    <NDC11Code>65734-0101-24</NDC11Code>
    <ProductNDC>65734-101</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Isopropyl Alcohol</ProprietaryName>
    <NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20151001</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Swabplus Inc.</LabelerName>
    <SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
    <StrengthNumber>.105</StrengthNumber>
    <StrengthUnit>mL/.15mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Hold the swan vertically, with the color tip upwards. Hold in the center of the tube with one hand and at the color ring with the other. Gently snap the tip with the color ring. Formula inside the tube flows down and fills the opposite tip. Apply the product to the affected area. Discard swab after use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>65734-103-36</NDCCode>
    <PackageDescription>5 mL in 1 PACKET (65734-103-36)</PackageDescription>
    <NDC11Code>65734-0103-36</NDC11Code>
    <ProductNDC>65734-103</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Insect Bite Relief</ProprietaryName>
    <NonProprietaryName>Benzocaine</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20030301</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part346</ApplicationNumber>
    <LabelerName>Swabplus Inc.</LabelerName>
    <SubstanceName>BENZOCAINE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2015-03-06</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>65734-112-36</NDCCode>
    <PackageDescription>1 PACKET in 1 CARTON (65734-112-36)  &gt; 2 mL in 1 PACKET (65734-112-12)</PackageDescription>
    <NDC11Code>65734-0112-36</NDC11Code>
    <ProductNDC>65734-112</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>3 Step First Aid Kit</ProprietaryName>
    <NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20030301</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part348</ApplicationNumber>
    <LabelerName>Swabplus Inc.</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1; 10</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2015-04-10</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>65734-300-36</NDCCode>
    <PackageDescription>36 APPLICATOR in 1 PACKAGE (65734-300-36)  &gt; .15 mL in 1 APPLICATOR (65734-300-00)</PackageDescription>
    <NDC11Code>65734-0300-36</NDC11Code>
    <ProductNDC>65734-300</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Insect Bite Relief</ProprietaryName>
    <NonProprietaryName>Benzocaine</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20030301</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part346</ApplicationNumber>
    <LabelerName>Swabplus Inc.</LabelerName>
    <SubstanceName>BENZOCAINE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>♦   Do not use if label seal is broken prior to purchase. Keep swabs in original container when not in use. ♦   Hold the swab vertically, with the color band tip upwards. hold in the center of the stem with one hand and at the color band with the other. ♦  Bend the tip at the color band to one side until it snaps. ♦  Apply the product to the affected area. ♦  Discard swab after use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>65734-348-36</NDCCode>
    <PackageDescription>36 APPLICATOR in 1 PACKAGE (65734-348-36)  &gt; .15 mL in 1 APPLICATOR (65734-348-00)</PackageDescription>
    <NDC11Code>65734-0348-36</NDC11Code>
    <ProductNDC>65734-348</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Fungus Relief</ProprietaryName>
    <NonProprietaryName>Tolnaftate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20030301</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part333C</ApplicationNumber>
    <LabelerName>Swabplus Inc.</LabelerName>
    <SubstanceName>TOLNAFTATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>: 1 Do not use if label seal is broken prior to purchase., 2 Keep swabs in original container when not in use., 3 wash affected area and dry thoroughly., 4 Hold the swab vertically with the color band tip upwards., 5 Bend the tip at the color band to one side until it snaps., 6 Apply a thin layer over affected area twice daily (morning and night), 7 Discard swab after use., 8 For athlete's foot, apply once or twice daily, pay special attention to spaces between toes, wear shoes with good ventilation and change shoes and socks at least once daily., 9 Use daily for 4 weeks; if condition persists longer, ask a doctor., 10 This product is not effective on the scalp or nails.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>65734-501-01</NDCCode>
    <PackageDescription>.15 g in 1 APPLICATOR (65734-501-01) </PackageDescription>
    <NDC11Code>65734-0501-01</NDC11Code>
    <ProductNDC>65734-501</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hurricaine</ProprietaryName>
    <NonProprietaryName>Benzocaine</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>DENTAL; ORAL; PERIODONTAL</RouteName>
    <StartMarketingDate>20190101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part356</ApplicationNumber>
    <LabelerName>Swabplus, L.P.</LabelerName>
    <SubstanceName>BENZOCAINE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-05-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>65734-502-12</NDCCode>
    <PackageDescription>12 APPLICATOR in 1 CARTON (65734-502-12)  &gt; .15 g in 1 APPLICATOR</PackageDescription>
    <NDC11Code>65734-0502-12</NDC11Code>
    <ProductNDC>65734-502</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Orajel Instant Pain Relief Maximum Toothache Oral Pain Relief</ProprietaryName>
    <NonProprietaryName>Benzocaine</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20190101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part356</ApplicationNumber>
    <LabelerName>Swabplus, L.P.</LabelerName>
    <SubstanceName>BENZOCAINE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-05-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>65734-503-12</NDCCode>
    <PackageDescription>12 APPLICATOR in 1 CARTON (65734-503-12)  &gt; .15 g in 1 APPLICATOR</PackageDescription>
    <NDC11Code>65734-0503-12</NDC11Code>
    <ProductNDC>65734-503</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Orajel Instant Pain Relief For All Mouth Sores</ProprietaryName>
    <NonProprietaryName>Benzocaine</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20190101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part356</ApplicationNumber>
    <LabelerName>Swabplus, L.P.</LabelerName>
    <SubstanceName>BENZOCAINE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-05-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>65734-504-36</NDCCode>
    <PackageDescription>36 APPLICATOR in 1 CASE (65734-504-36)  &gt; .15 mL in 1 APPLICATOR</PackageDescription>
    <NDC11Code>65734-0504-36</NDC11Code>
    <ProductNDC>65734-504</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dr. Piercing Aftercare</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>SWAB</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Swabplus, L.P.</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>1.1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>DISTRIBUTED BY: Broadway Products LLC, Sellersburg, Indiana. LEARN MORE: www.drpiercing.com. BARCODE XM001448MO3. Dr. Piercing Afterca...roduct, 36 Swab Pierce New.</Description>
  </NDC>
  <NDC>
    <NDCCode>65734-740-00</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (65734-740-00)  *  24 APPLICATOR in 1 PACKAGE (65734-741-24)  &gt; .15 mL in 1 APPLICATOR (65734-741-00)  *  24 APPLICATOR in 1 PACKAGE (65734-742-24)  &gt; .15 mL in 1 APPLICATOR (65734-742-00)</PackageDescription>
    <NDC11Code>65734-0740-00</NDC11Code>
    <ProductNDC>65734-740</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Advance Acne Care</ProprietaryName>
    <NonProprietaryName>Salicylic Acid, Silver</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20080807</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part333D</ApplicationNumber>
    <LabelerName>Swabplus Inc.</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Do not use if label seal is broken prior to purchase.Keep swabs in original container when not in use. Treatment Swabs have a red color band. Use Cleansinh swab to cleanse the skin throughly before applying medication. Hold the swab vertically, with the color ring band tip upwards. . Bend the tip at the color band to one side until it snaps. Medicine will flow to theother end. Cover the entire affected area with a thin layer 1 to 3 times daily. Discard swab after use. Each swab can be used on multipe pimples. Because excesssive drying of the skin may occur start with1 application daiky then gradually increase to 2 or 3 times daily if needed, or as direcvted by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every othr day. .</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>65734-867-24</NDCCode>
    <PackageDescription>3.6 mL in 1 PACKET (65734-867-24)</PackageDescription>
    <NDC11Code>65734-0867-24</NDC11Code>
    <ProductNDC>65734-867</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Mouth Sore Relief Applicator</ProprietaryName>
    <NonProprietaryName>Benzocaine</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20050601</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part333B</ApplicationNumber>
    <LabelerName>Swabplus Inc.</LabelerName>
    <SubstanceName>BENZOCAINE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Snap the tip at the color ring. Allow formula to flow down to the opposite tip. Apply formula with the saturated tip to affected area.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0054-4496-13</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (0054-4496-13) </PackageDescription>
    <NDC11Code>00054-4496-13</NDC11Code>
    <ProductNDC>0054-4496</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Leucovorin Calcium</ProprietaryName>
    <NonProprietaryName>Leucovorin Calcium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19930222</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA072733</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>LEUCOVORIN CALCIUM</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Folate Analog [EPC], Folic Acid [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19930322</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Leucovorin is a folate analog indicated: 1 To reduce the toxicity of:, 2 oMethotrexate in adult patients with impaired methotrexate elimination, and, 3 oFolic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients. (1.1) , 4 For the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD). (1.2), 5  Limitations of Use, 6  Leucovorin is not recommended for use in patients with a deficiency of methenyltetrahydrofolate synthetase (MTHFS) because MTHFS is a primary enzyme in the metabolism of leucovorin to 5-methenyltetrahydrofolate. (1.2).</IndicationAndUsage>
    <Description>Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. C20H21CaN7O7 M.W. 511.51. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg, 10 mg, 15 mg or 25 mg leucovorin tablets are either equivalent to 5.4 mg, 10.8 mg, 16.21 mg or 27.01 mg of anhydrous leucovorin calcium, USP, respectively. In addition, each tablet contains the following inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&amp;C yellow #10 (15 mg and 25 mg), magnesium stearate, microcrystalline cellulose, povidone and pregelatinized starch.</Description>
  </NDC>
  <NDC>
    <NDCCode>0054-4496-25</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (0054-4496-25) </PackageDescription>
    <NDC11Code>00054-4496-25</NDC11Code>
    <ProductNDC>0054-4496</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Leucovorin Calcium</ProprietaryName>
    <NonProprietaryName>Leucovorin Calcium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19930222</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA072733</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>LEUCOVORIN CALCIUM</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Folate Analog [EPC], Folic Acid [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19930322</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Leucovorin is a folate analog indicated: 1 To reduce the toxicity of:, 2 oMethotrexate in adult patients with impaired methotrexate elimination, and, 3 oFolic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients. (1.1) , 4 For the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD). (1.2), 5  Limitations of Use, 6  Leucovorin is not recommended for use in patients with a deficiency of methenyltetrahydrofolate synthetase (MTHFS) because MTHFS is a primary enzyme in the metabolism of leucovorin to 5-methenyltetrahydrofolate. (1.2).</IndicationAndUsage>
    <Description>Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. C20H21CaN7O7 M.W. 511.51. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg, 10 mg, 15 mg or 25 mg leucovorin tablets are either equivalent to 5.4 mg, 10.8 mg, 16.21 mg or 27.01 mg of anhydrous leucovorin calcium, USP, respectively. In addition, each tablet contains the following inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&amp;C yellow #10 (15 mg and 25 mg), magnesium stearate, microcrystalline cellulose, povidone and pregelatinized starch.</Description>
  </NDC>
  <NDC>
    <NDCCode>0054-4497-05</NDCCode>
    <PackageDescription>12 TABLET in 1 BOTTLE (0054-4497-05) </PackageDescription>
    <NDC11Code>00054-4497-05</NDC11Code>
    <ProductNDC>0054-4497</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Leucovorin Calcium</ProprietaryName>
    <NonProprietaryName>Leucovorin Calcium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19930222</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA072734</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>LEUCOVORIN CALCIUM</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Folate Analog [EPC], Folic Acid [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19930322</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Leucovorin is a folate analog indicated: 1 To reduce the toxicity of:, 2 oMethotrexate in adult patients with impaired methotrexate elimination, and, 3 oFolic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients. (1.1) , 4 For the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD). (1.2), 5  Limitations of Use, 6  Leucovorin is not recommended for use in patients with a deficiency of methenyltetrahydrofolate synthetase (MTHFS) because MTHFS is a primary enzyme in the metabolism of leucovorin to 5-methenyltetrahydrofolate. (1.2).</IndicationAndUsage>
    <Description>Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. C20H21CaN7O7 M.W. 511.51. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg, 10 mg, 15 mg or 25 mg leucovorin tablets are either equivalent to 5.4 mg, 10.8 mg, 16.21 mg or 27.01 mg of anhydrous leucovorin calcium, USP, respectively. In addition, each tablet contains the following inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&amp;C yellow #10 (15 mg and 25 mg), magnesium stearate, microcrystalline cellulose, povidone and pregelatinized starch.</Description>
  </NDC>
  <NDC>
    <NDCCode>0054-4497-10</NDCCode>
    <PackageDescription>24 TABLET in 1 BOTTLE (0054-4497-10) </PackageDescription>
    <NDC11Code>00054-4497-10</NDC11Code>
    <ProductNDC>0054-4497</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Leucovorin Calcium</ProprietaryName>
    <NonProprietaryName>Leucovorin Calcium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19930222</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA072734</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>LEUCOVORIN CALCIUM</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Folate Analog [EPC], Folic Acid [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19930322</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Leucovorin is a folate analog indicated: 1 To reduce the toxicity of:, 2 oMethotrexate in adult patients with impaired methotrexate elimination, and, 3 oFolic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients. (1.1) , 4 For the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD). (1.2), 5  Limitations of Use, 6  Leucovorin is not recommended for use in patients with a deficiency of methenyltetrahydrofolate synthetase (MTHFS) because MTHFS is a primary enzyme in the metabolism of leucovorin to 5-methenyltetrahydrofolate. (1.2).</IndicationAndUsage>
    <Description>Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. C20H21CaN7O7 M.W. 511.51. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg, 10 mg, 15 mg or 25 mg leucovorin tablets are either equivalent to 5.4 mg, 10.8 mg, 16.21 mg or 27.01 mg of anhydrous leucovorin calcium, USP, respectively. In addition, each tablet contains the following inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&amp;C yellow #10 (15 mg and 25 mg), magnesium stearate, microcrystalline cellulose, povidone and pregelatinized starch.</Description>
  </NDC>
  <NDC>
    <NDCCode>0054-4498-10</NDCCode>
    <PackageDescription>24 TABLET in 1 BOTTLE (0054-4498-10) </PackageDescription>
    <NDC11Code>00054-4498-10</NDC11Code>
    <ProductNDC>0054-4498</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Leucovorin Calcium</ProprietaryName>
    <NonProprietaryName>Leucovorin Calcium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19930222</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA072735</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>LEUCOVORIN CALCIUM</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Folate Analog [EPC], Folic Acid [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19930322</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Leucovorin is a folate analog indicated: 1 To reduce the toxicity of:, 2 oMethotrexate in adult patients with impaired methotrexate elimination, and, 3 oFolic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients. (1.1) , 4 For the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD). (1.2), 5  Limitations of Use, 6  Leucovorin is not recommended for use in patients with a deficiency of methenyltetrahydrofolate synthetase (MTHFS) because MTHFS is a primary enzyme in the metabolism of leucovorin to 5-methenyltetrahydrofolate. (1.2).</IndicationAndUsage>
    <Description>Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. C20H21CaN7O7 M.W. 511.51. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg, 10 mg, 15 mg or 25 mg leucovorin tablets are either equivalent to 5.4 mg, 10.8 mg, 16.21 mg or 27.01 mg of anhydrous leucovorin calcium, USP, respectively. In addition, each tablet contains the following inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&amp;C yellow #10 (15 mg and 25 mg), magnesium stearate, microcrystalline cellulose, povidone and pregelatinized starch.</Description>
  </NDC>
  <NDC>
    <NDCCode>0054-4499-11</NDCCode>
    <PackageDescription>25 TABLET in 1 BOTTLE (0054-4499-11) </PackageDescription>
    <NDC11Code>00054-4499-11</NDC11Code>
    <ProductNDC>0054-4499</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Leucovorin Calcium</ProprietaryName>
    <NonProprietaryName>Leucovorin Calcium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19930222</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA072736</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>LEUCOVORIN CALCIUM</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Folate Analog [EPC], Folic Acid [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19930322</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Leucovorin is a folate analog indicated: 1 To reduce the toxicity of:, 2 oMethotrexate in adult patients with impaired methotrexate elimination, and, 3 oFolic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients. (1.1) , 4 For the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD). (1.2), 5  Limitations of Use, 6  Leucovorin is not recommended for use in patients with a deficiency of methenyltetrahydrofolate synthetase (MTHFS) because MTHFS is a primary enzyme in the metabolism of leucovorin to 5-methenyltetrahydrofolate. (1.2).</IndicationAndUsage>
    <Description>Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. C20H21CaN7O7 M.W. 511.51. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg, 10 mg, 15 mg or 25 mg leucovorin tablets are either equivalent to 5.4 mg, 10.8 mg, 16.21 mg or 27.01 mg of anhydrous leucovorin calcium, USP, respectively. In addition, each tablet contains the following inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&amp;C yellow #10 (15 mg and 25 mg), magnesium stearate, microcrystalline cellulose, povidone and pregelatinized starch.</Description>
  </NDC>
  <NDC>
    <NDCCode>0054-8496-19</NDCCode>
    <PackageDescription>5 BLISTER PACK in 1 CARTON (0054-8496-19)  / 10 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00054-8496-19</NDC11Code>
    <ProductNDC>0054-8496</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Leucovorin Calcium</ProprietaryName>
    <NonProprietaryName>Leucovorin Calcium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19930222</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA072733</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>LEUCOVORIN CALCIUM</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Folate Analog [EPC], Folic Acid [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19930322</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Leucovorin is a folate analog indicated: 1 To reduce the toxicity of:, 2 oMethotrexate in adult patients with impaired methotrexate elimination, and, 3 oFolic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients. (1.1) , 4 For the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD). (1.2), 5  Limitations of Use, 6  Leucovorin is not recommended for use in patients with a deficiency of methenyltetrahydrofolate synthetase (MTHFS) because MTHFS is a primary enzyme in the metabolism of leucovorin to 5-methenyltetrahydrofolate. (1.2).</IndicationAndUsage>
    <Description>Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. C20H21CaN7O7 M.W. 511.51. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg, 10 mg, 15 mg or 25 mg leucovorin tablets are either equivalent to 5.4 mg, 10.8 mg, 16.21 mg or 27.01 mg of anhydrous leucovorin calcium, USP, respectively. In addition, each tablet contains the following inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&amp;C yellow #10 (15 mg and 25 mg), magnesium stearate, microcrystalline cellulose, povidone and pregelatinized starch.</Description>
  </NDC>
  <NDC>
    <NDCCode>0143-9368-01</NDCCode>
    <PackageDescription>1 VIAL in 1 BOX, UNIT-DOSE (0143-9368-01)  &gt; 20 mL in 1 VIAL</PackageDescription>
    <NDC11Code>00143-9368-01</NDC11Code>
    <ProductNDC>0143-9368</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Leucovorin Calcium</ProprietaryName>
    <NonProprietaryName>Leucovorin Calcium</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>19950523</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040056</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>LEUCOVORIN CALCIUM</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/20mL</StrengthUnit>
    <Pharm_Classes>Folate Analog [EPC], Folic Acid [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-06-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Leucovorin calcium, USP rescue is indicated after high dose methotrexate therapy in osteosarcoma. Leucovorin calcium, USP is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosages of folic acid antagonists. Leucovorin calcium, USP is indicated in the treatment of megaloblastic anemias due to folic acid deficiency when oral therapy is not feasible. Leucovorin Calcium, USP is also indicated for use in combination with 5-fluorouracil to prolong survival in the palliative treatment of patients with advanced colorectal cancer. Leucovorin should not be mixed in the same infusion as 5-fluorouracil because a precipitate may form.</IndicationAndUsage>
    <Description>Leucovorin is one of several active, chemically reduced derivatives of folic acid. It is useful as an antidote to drugs which act as folic acid antagonists. Also known as folinic acid, Citrovorum factor, or 5-formyl-5,6,7,8-tetrahydrofolic acid, this compound has the chemical designation of Calcium N-[p-[[[(6RS)-2-amino-5-formyl-5,6,7,8-tetrahydro-4-hydroxy-6-pteridinyl]methyl]amino]benzoyl]-L-glutamate (1:1). The structural formula of leucovorin calcium is. C20H21CaN7O7                                                                  M.W.=511.51. Leucovorin Calcium for Injection, USP is a sterile product indicated for intramuscular (IM) or intravenous (IV) administration and is supplied in 200 mg vials. Each 200 mg vial of Leucovorin Calcium for Injection, USP, when reconstituted with 20 mL of sterile diluent, contains leucovorin (as the calcium salt) 10 mg/mL. One milligram of leucovorin calcium, USP contains 0.002 mmol of leucovorin and 0.002 mmol of calcium. These lyophilized products contain no preservative. The inactive ingredient is Sodium Chloride, added to adjust tonicity. Sodium hydroxide and/or hydrochloric acid may be added for pH adjustment. pH adjusted to 7.0 to 8.5. Reconstitute with Bacteriostatic Water for Injection, which contains benzyl alcohol (see WARNINGS section), or with Sterile Water for Injection.</Description>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>65734-511-72</NDCCode><ProprietaryName>Isodine Copitos</ProprietaryName><NonProprietaryName>Povidone-iodine</NonProprietaryName></NDC><NDC><NDCCode>68016-511-72</NDCCode><ProprietaryName>Premier Value Fiber Therapy</ProprietaryName><NonProprietaryName>Psyllium Husk</NonProprietaryName></NDC><NDC><NDCCode>65734-270-72</NDCCode><ProprietaryName>Antiseptic Formula Filled Swab</ProprietaryName><NonProprietaryName>Lidocaine Hydrochloride, Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>65734-317-72</NDCCode><ProprietaryName>Iodine</ProprietaryName><NonProprietaryName>Povidone-iodine</NonProprietaryName></NDC><NDC><NDCCode>65734-501-72</NDCCode><ProprietaryName>Hurricaine</ProprietaryName><NonProprietaryName>Benzocaine</NonProprietaryName></NDC><NDC><NDCCode>55301-511-14</NDCCode><ProprietaryName>Multihealth Fiber Therapy</ProprietaryName><NonProprietaryName>Psyllium Husk</NonProprietaryName></NDC><NDC><NDCCode>63941-511-48</NDCCode><ProprietaryName>Best Choice Fiber Therapy</ProprietaryName><NonProprietaryName>Psyllium Husk</NonProprietaryName></NDC><NDC><NDCCode>82449-511-10</NDCCode><ProprietaryName>Ampicillin</ProprietaryName><NonProprietaryName>Ampicillin</NonProprietaryName></NDC><NDC><NDCCode>65734-000-23</NDCCode><ProprietaryName>3-step First Aid Kit</ProprietaryName><NonProprietaryName>Povidone-iodine, Lidocaine Hydrochloride, Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>65734-001-24</NDCCode><ProprietaryName>Isopropyl Alcohol</ProprietaryName><NonProprietaryName>Isopropyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>65734-082-36</NDCCode><ProprietaryName>3-in-1 First Aid Povidone-iodine Swab</ProprietaryName><NonProprietaryName>Povidone-iodine</NonProprietaryName></NDC><NDC><NDCCode>65734-101-24</NDCCode><ProprietaryName>Isopropyl Alcohol</ProprietaryName><NonProprietaryName>Isopropyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>65734-103-36</NDCCode><ProprietaryName>Insect Bite Relief</ProprietaryName><NonProprietaryName>Benzocaine</NonProprietaryName></NDC><NDC><NDCCode>65734-112-36</NDCCode><ProprietaryName>3 Step First Aid Kit</ProprietaryName><NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>65734-300-36</NDCCode><ProprietaryName>Insect Bite Relief</ProprietaryName><NonProprietaryName>Benzocaine</NonProprietaryName></NDC><NDC><NDCCode>65734-348-36</NDCCode><ProprietaryName>Fungus Relief</ProprietaryName><NonProprietaryName>Tolnaftate</NonProprietaryName></NDC><NDC><NDCCode>65734-501-01</NDCCode><ProprietaryName>Hurricaine</ProprietaryName><NonProprietaryName>Benzocaine</NonProprietaryName></NDC><NDC><NDCCode>65734-502-12</NDCCode><ProprietaryName>Orajel Instant Pain Relief Maximum Toothache Oral Pain Relief</ProprietaryName><NonProprietaryName>Benzocaine</NonProprietaryName></NDC><NDC><NDCCode>65734-503-12</NDCCode><ProprietaryName>Orajel Instant Pain Relief For All Mouth Sores</ProprietaryName><NonProprietaryName>Benzocaine</NonProprietaryName></NDC><NDC><NDCCode>65734-504-36</NDCCode><ProprietaryName>Dr. Piercing Aftercare</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>65734-740-00</NDCCode><ProprietaryName>Advance Acne Care</ProprietaryName><NonProprietaryName>Salicylic Acid, Silver</NonProprietaryName></NDC><NDC><NDCCode>65734-867-24</NDCCode><ProprietaryName>Mouth Sore Relief Applicator</ProprietaryName><NonProprietaryName>Benzocaine</NonProprietaryName></NDC><NDC><NDCCode>0054-4496-13</NDCCode><ProprietaryName>Leucovorin Calcium</ProprietaryName><NonProprietaryName>Leucovorin Calcium</NonProprietaryName></NDC><NDC><NDCCode>0054-4496-25</NDCCode><ProprietaryName>Leucovorin Calcium</ProprietaryName><NonProprietaryName>Leucovorin Calcium</NonProprietaryName></NDC><NDC><NDCCode>0054-4497-05</NDCCode><ProprietaryName>Leucovorin Calcium</ProprietaryName><NonProprietaryName>Leucovorin Calcium</NonProprietaryName></NDC><NDC><NDCCode>0054-4497-10</NDCCode><ProprietaryName>Leucovorin Calcium</ProprietaryName><NonProprietaryName>Leucovorin Calcium</NonProprietaryName></NDC><NDC><NDCCode>0054-4498-10</NDCCode><ProprietaryName>Leucovorin Calcium</ProprietaryName><NonProprietaryName>Leucovorin Calcium</NonProprietaryName></NDC><NDC><NDCCode>0054-4499-11</NDCCode><ProprietaryName>Leucovorin Calcium</ProprietaryName><NonProprietaryName>Leucovorin Calcium</NonProprietaryName></NDC><NDC><NDCCode>0054-8496-19</NDCCode><ProprietaryName>Leucovorin Calcium</ProprietaryName><NonProprietaryName>Leucovorin Calcium</NonProprietaryName></NDC><NDC><NDCCode>0143-9368-01</NDCCode><ProprietaryName>Leucovorin Calcium</ProprietaryName><NonProprietaryName>Leucovorin Calcium</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
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      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06281-2225",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "860-821-3406",
      "MailingAddressFaxNumber": "860-821-3407",
      "FirstLinePracticeLocationAddress": "602 ROUTE 169",
      "PracticeLocationAddressCityName": "WOODSTOCK",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06281-2225",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "860-821-3406",
      "PracticeLocationAddressFaxNumber": "860-821-3407",
      "EnumerationDate": "07/22/2006",
      "LastUpdateDate": "01/14/2016",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "000260",
      "LicenseNumberStateCode1": "CT",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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