RESTful Lookup — Test-Drive (2007 – 2026)

Query complete (18 ms elapsed)

{
  "NDC": [
    {
      "NDCCode": "73473-303-70",
      "PackageDescription": "1 TUBE, WITH APPLICATOR in 1 CARTON (73473-303-70)  / 70 g in 1 TUBE, WITH APPLICATOR",
      "NDC11Code": "73473-0303-70",
      "ProductNDC": "73473-303",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metronidazole",
      "NonProprietaryName": "Metronidazole",
      "DosageFormName": "GEL",
      "RouteName": "VAGINAL",
      "StartMarketingDate": "20260108",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA213648",
      "LabelerName": "Solaris Pharma Corporation",
      "SubstanceName": "METRONIDAZOLE",
      "StrengthNumber": "7.5",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]",
      "Status": "Active",
      "LastUpdate": "2026-01-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260108",
      "SamplePackage": "N",
      "IndicationAndUsage": "Metronidazole vaginal gel is indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis). NOTE: For purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a “fishy” amine odor when mixed with a 10% KOH solution, and (c) contains clue cells on microscopic examination. Gram’s stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent Lactobacillus morphology, (b) predominance of Gardnerella morphotype, and (c) absent or few white blood cells. Other pathogens commonly associated with vulvovaginitis, e.g., Trichomonas vaginalis, Chlamydia trachomatis, N. gonorrhoeae, Candida albicans, and Herpes simplex virus should be ruled out.",
      "Description": "Metronidazole vaginal gel, 0.75% is the intravaginal dosage form of the synthetic antibacterial agent, metronidazole, USP at a concentration of 0.75%. Metronidazole is a member of the imidazole class of antibacterial agents and is classified therapeutically as an antiprotozoal and antibacterial agent. Chemically, metronidazole is a 2-methyl-5-nitroimidazole-1-ethanol. It has a chemical formula of C6H9N3O3, a molecular weight of 171.16, and has the following structure. Metronidazole vaginal gel, 0.75% is a gelled, purified water solution, containing metronidazole at a concentration of 7.5 mg/g (0.75%). The gel is formulated at pH 4.0. The gel also contains carbomer 974P , edetate disodium, methyl paraben, propyl paraben, propylene glycol, and sodium hydroxide. Each applicator full of 5 grams of vaginal gel contains approximately 37.5 mg of metronidazole."
    },
    {
      "NDCCode": "42858-150-70",
      "PackageDescription": "24 POUCH in 1 BOX (42858-150-70)  / 1 PATCH in 1 POUCH / 3 d in 1 PATCH",
      "NDC11Code": "42858-0150-70",
      "ProductNDC": "42858-150",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Scopolamine",
      "NonProprietaryName": "Scopolamine",
      "DosageFormName": "PATCH, EXTENDED RELEASE",
      "RouteName": "TRANSDERMAL",
      "StartMarketingDate": "20241101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215329",
      "LabelerName": "Rhodes Pharmaceuticals LLC",
      "SubstanceName": "SCOPOLAMINE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/3d",
      "Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-05-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20241101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Scopolamine Transdermal System is indicated in adults for the prevention of: 1 nausea and vomiting associated with motion sickness., 2 post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery. .",
      "Description": "Scopolamine transdermal system is designed for continuous release of scopolamine following application to an area of intact skin on the head, behind the ear. Each system contains 1.3 mg of scopolamine base. Scopolamine is (9-methyl-3-oxa-9-azatricyclo [3.3.1.02,4]nonan-7-yl) 3-hydroxy-2-phenylpropanoate. The empirical formula is C17H21NO4 and its structural formula is. Scopolamine has a molecular weight of 303.35 and a pKa of 7.55 to 7.81. The scopolamine transdermal system is a circular, 0.28 mm thick, 2.5 cm2 film with four layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are: (1) a backing membrane of tan-colored, aluminized, polyester film; (2) a drug layer of scopolamine, light mineral oil, isopropyl palmitate, crospovidone, and polyisobutylene; (3) a microporous polypropylene membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) a contact layer formulation of mineral oil, polyisobutylene, isopropyl palmitate, crospovidone, and scopolamine. A release liner of siliconized polyester, which covers the adhesive layer, is removed before the system is used. Cross section of the system."
    },
    {
      "NDCCode": "50518-303-11",
      "PackageDescription": "30 mL in 1 BOTTLE (50518-303-11) ",
      "NDC11Code": "50518-0303-11",
      "ProductNDC": "50518-303",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hand Sanitizer",
      "NonProprietaryName": "Ethyl Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200525",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "CUSTOM RESEARCH LABS INC",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20200525",
      "SamplePackage": "N",
      "IndicationAndUsage": "TO DECREASE BACTERIA ON THE SKIN THAT COULD CAUSE DISEASE. RECOMMENDED FOR REPEATED USE."
    },
    {
      "NDCCode": "50518-303-12",
      "PackageDescription": "30 mL in 1 TUBE (50518-303-12) ",
      "NDC11Code": "50518-0303-12",
      "ProductNDC": "50518-303",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hand Sanitizer",
      "NonProprietaryName": "Ethyl Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200525",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "CUSTOM RESEARCH LABS INC",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20200525",
      "SamplePackage": "N",
      "IndicationAndUsage": "TO DECREASE BACTERIA ON THE SKIN THAT COULD CAUSE DISEASE. RECOMMENDED FOR REPEATED USE."
    },
    {
      "NDCCode": "51706-303-02",
      "PackageDescription": "1 BOTTLE in 1 PACKAGE (51706-303-02)  > 55 mL in 1 BOTTLE (51706-303-01)",
      "NDC11Code": "51706-0303-02",
      "ProductNDC": "51706-303",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Bodycology",
      "ProprietaryNameSuffix": "Moisturizing Hand Sanitizer Cucumber Melon",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20100101",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333",
      "LabelerName": "Landy International",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Directions:. -Wet hands with product and allow to dry without wiping. -For children under 6, use only under adult supervision. -Not recommended for infants."
    },
    {
      "NDCCode": "60289-303-24",
      "PackageDescription": "1 JAR in 1 CARTON (60289-303-24)  / 50 mL in 1 JAR",
      "NDC11Code": "60289-0303-24",
      "ProductNDC": "60289-303",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ahava",
      "ProprietaryNameSuffix": "Brightening Broad Spectrum Spf 20",
      "NonProprietaryName": "Avobenzone, Homosalate, Octisalate, And Octocrylene",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240212",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "AHAVA - Dead Sea Laboratories Ltd",
      "SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
      "StrengthNumber": "30; 70; 50; 27.4",
      "StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
      "Status": "Active",
      "LastUpdate": "2024-12-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240212",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps prevent sunburn."
    },
    {
      "NDCCode": "61380-303-27",
      "PackageDescription": "118 mL in 1 TUBE (61380-303-27)",
      "NDC11Code": "61380-0303-27",
      "ProductNDC": "61380-303",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Natures Gate Face Broad Spectrum Sunscreen Spf 25",
      "NonProprietaryName": "Octinoxate, Octocrylene, And Zinc Oxide",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20121120",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Levlad, LLC",
      "SubstanceName": "OCTINOXATE; OCTOCRYLENE; ZINC OXIDE",
      "StrengthNumber": "75; 70; 69",
      "StrengthUnit": "mg/mL; mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-02-07",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "63323-572-70",
      "PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (63323-572-70)  > 20 mL in 1 VIAL, SINGLE-USE",
      "NDC11Code": "63323-0572-70",
      "ProductNDC": "63323-572",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clofarabine",
      "NonProprietaryName": "Clofarabine",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20170510",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204029",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "CLOFARABINE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
      "Status": "Active",
      "LastUpdate": "2020-07-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20170510",
      "SamplePackage": "N",
      "IndicationAndUsage": "Clofarabine Injection is indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. This indication is based upon response rate. There are no trials verifying an improvement in disease-related symptoms or increased survival with Clofarabine Injection.",
      "Description": "Clofarabine Injection contains clofarabine, a purine nucleoside metabolic inhibitor. The chemical name of clofarabine is 2-chloro-9-(2-deoxy-2-fluoro-β-D-arabinofuranosyl)-9H-purin-6-amine. Its molecular formula is C10H11ClFN5O3 with a molecular weight of 303.68 Daltons. The molecular structure of clofarabine is. Clofarabine Injection (1 mg/mL) is supplied in a 20 mL, single-dose vial. The 20 mL vial contains 20 mg clofarabine formulated in 20 mL unbuffered normal saline (comprised of Water for Injection, USP, and Sodium Chloride, USP). The pH range of the solution is 4.5 to 7.5. The solution is sterile, clear and practically colorless, and is preservative-free."
    },
    {
      "NDCCode": "69730-303-12",
      "PackageDescription": "355 mL in 1 BOTTLE (69730-303-12)",
      "NDC11Code": "69730-0303-12",
      "ProductNDC": "69730-303",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Rubbing Alcohol",
      "ProprietaryNameSuffix": "70 Percent",
      "NonProprietaryName": "Isopropyl Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20141203",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "SAGE OIL LLC",
      "SubstanceName": "ISOPROPYL ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "FIRST AID TO HELP THE RISK OF INFECTION IN MINOR CUTS AND SCRAPES."
    },
    {
      "NDCCode": "70108-303-01",
      "PackageDescription": "1 BOTTLE, SPRAY in 1 POUCH (70108-303-01)  / 40 mL in 1 BOTTLE, SPRAY",
      "NDC11Code": "70108-0303-01",
      "ProductNDC": "70108-303",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Smart Care Jasmine Jewel Hand Sanitizer",
      "NonProprietaryName": "Ethyl Alcohol",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20260115",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "Ashtel Studios, Inc.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Active",
      "LastUpdate": "2026-01-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260115",
      "SamplePackage": "N",
      "IndicationAndUsage": "Decreases bacteria on skin."
    },
    {
      "NDCCode": "71611-303-12",
      "PackageDescription": "355 mL in 1 BOTTLE (71611-303-12) ",
      "NDC11Code": "71611-0303-12",
      "ProductNDC": "71611-303",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Rubbing Alcohol",
      "ProprietaryNameSuffix": "70 Percent",
      "NonProprietaryName": "Isopropyl Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20180222",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "MY Sales LLC dba Click Products LLC",
      "SubstanceName": "ISOPROPYL ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20180222",
      "SamplePackage": "N",
      "IndicationAndUsage": "FIRST AID TO HELP PREVENT THE RISK IN: 1 MINOR CUTS, 2 SCRAPES, 3 BURNS."
    },
    {
      "NDCCode": "71611-303-16",
      "PackageDescription": "475 mL in 1 BOTTLE (71611-303-16) ",
      "NDC11Code": "71611-0303-16",
      "ProductNDC": "71611-303",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Rubbing Alcohol",
      "ProprietaryNameSuffix": "70 Percent",
      "NonProprietaryName": "Isopropyl Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20180222",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "MY Sales LLC dba Click Products LLC",
      "SubstanceName": "ISOPROPYL ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20180222",
      "SamplePackage": "N",
      "IndicationAndUsage": "FIRST AID TO HELP PREVENT THE RISK IN: 1 MINOR CUTS, 2 SCRAPES, 3 BURNS."
    },
    {
      "NDCCode": "73717-303-04",
      "PackageDescription": "60 mL in 1 BOTTLE, SPRAY (73717-303-04) ",
      "NDC11Code": "73717-0303-04",
      "ProductNDC": "73717-303",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Herbal Scent Aromar Hand Sanitizer",
      "NonProprietaryName": "Isopropyl Alcohol",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200323",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Mar Company Distributors, LLC",
      "SubstanceName": "ISOPROPYL ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20200323",
      "SamplePackage": "N",
      "IndicationAndUsage": "to decrease bacteria on skin that could cause disease. recommended for repeated use."
    },
    {
      "NDCCode": "76436-303-12",
      "PackageDescription": "355 mL in 1 BOTTLE (76436-303-12)",
      "NDC11Code": "76436-0303-12",
      "ProductNDC": "76436-303",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Rubbing Alcohol",
      "ProprietaryNameSuffix": "70 Percent",
      "NonProprietaryName": "Isopropyl Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20141203",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Viny Health and Beauty Products Inc",
      "SubstanceName": "ISOPROPYL ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2017-12-07"
    },
    {
      "NDCCode": "76436-303-16",
      "PackageDescription": "475 mL in 1 BOTTLE (76436-303-16)",
      "NDC11Code": "76436-0303-16",
      "ProductNDC": "76436-303",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Rubbing Alcohol",
      "ProprietaryNameSuffix": "70 Percent",
      "NonProprietaryName": "Isopropyl Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20141203",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Viny Health and Beauty Products Inc",
      "SubstanceName": "ISOPROPYL ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2017-12-07"
    },
    {
      "NDCCode": "77118-303-10",
      "PackageDescription": "100 mL in 1 BOTTLE, SPRAY (77118-303-10) ",
      "NDC11Code": "77118-0303-10",
      "ProductNDC": "77118-303",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hand Sanitizer",
      "ProprietaryNameSuffix": "100",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200330",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "ABC INTERNATIONAL LTD",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20200330",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
    },
    {
      "NDCCode": "78280-303-02",
      "PackageDescription": "55 mL in 1 BOTTLE, SPRAY (78280-303-02) ",
      "NDC11Code": "78280-0303-02",
      "ProductNDC": "78280-303",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Kericure Hand Sanitizer",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200410",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "Kericure Inc.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Active",
      "LastUpdate": "2025-02-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200410",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses  to decrease bacteria on the skin that could cause disease  recommended for repeated use."
    },
    {
      "NDCCode": "78280-303-08",
      "PackageDescription": "230 mL in 1 BOTTLE, SPRAY (78280-303-08) ",
      "NDC11Code": "78280-0303-08",
      "ProductNDC": "78280-303",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Kericure Hand Sanitizer",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200410",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Kericure Inc.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20200410",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses  to decrease bacteria on the skin that could cause disease  recommended for repeated use."
    },
    {
      "NDCCode": "79633-303-59",
      "PackageDescription": "59 mL in 1 BOTTLE, SPRAY (79633-303-59) ",
      "NDC11Code": "79633-0303-59",
      "ProductNDC": "79633-303",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Shield Dr.",
      "NonProprietaryName": "Hand Sanitizer Liquid Spray With Peppermint And Citrus, 70% Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200819",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "MEDIPHARCO PHARMACEUTICAL JOINT STOCK COMPANY",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200819",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hand sanitizer to help reduce bacteria on the skin it could cause disease."
    },
    {
      "NDCCode": "73473-300-30",
      "PackageDescription": "1 TUBE in 1 CARTON (73473-300-30)  / 30 g in 1 TUBE",
      "NDC11Code": "73473-0300-30",
      "ProductNDC": "73473-300",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clindamycin Phosphate",
      "NonProprietaryName": "Clindamycin Phosphate",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250103",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211872",
      "LabelerName": "Solaris Pharma Corporation",
      "SubstanceName": "CLINDAMYCIN PHOSPHATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
      "Status": "Active",
      "LastUpdate": "2025-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250103",
      "SamplePackage": "N",
      "IndicationAndUsage": "Clindamycin phosphate gel, 1% is indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate (see CONTRAINDICATIONS, WARNINGS and ADVERSE REACTIONS).",
      "Description": "Clindamycin phosphate gel USP, 1% contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per gram. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The gel contains allantoin, carbomer 974P, methylparaben, polyethylene glycol 400, propylene glycol, sodium hydroxide, and purified water. The structural formula is represented below: The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate)."
    },
    {
      "NDCCode": "73473-300-60",
      "PackageDescription": "1 TUBE in 1 CARTON (73473-300-60)  / 60 g in 1 TUBE",
      "NDC11Code": "73473-0300-60",
      "ProductNDC": "73473-300",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clindamycin Phosphate",
      "NonProprietaryName": "Clindamycin Phosphate",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250103",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211872",
      "LabelerName": "Solaris Pharma Corporation",
      "SubstanceName": "CLINDAMYCIN PHOSPHATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
      "Status": "Active",
      "LastUpdate": "2025-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250103",
      "SamplePackage": "N",
      "IndicationAndUsage": "Clindamycin phosphate gel, 1% is indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate (see CONTRAINDICATIONS, WARNINGS and ADVERSE REACTIONS).",
      "Description": "Clindamycin phosphate gel USP, 1% contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per gram. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The gel contains allantoin, carbomer 974P, methylparaben, polyethylene glycol 400, propylene glycol, sodium hydroxide, and purified water. The structural formula is represented below: The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate)."
    },
    {
      "NDCCode": "73473-302-75",
      "PackageDescription": "1 BOTTLE in 1 CARTON (73473-302-75)  / 75 mL in 1 BOTTLE",
      "NDC11Code": "73473-0302-75",
      "ProductNDC": "73473-302",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clindamycin Phosphate",
      "NonProprietaryName": "Clindamycin Phosphate",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240915",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212842",
      "LabelerName": "Solaris Pharma Corporation",
      "SubstanceName": "CLINDAMYCIN PHOSPHATE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/10mL",
      "Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
      "Status": "Active",
      "LastUpdate": "2024-09-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240915",
      "SamplePackage": "N",
      "IndicationAndUsage": "Clindamycin phosphate gel, 1% is indicated for topical application in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea, and pseudomembranous colitis, the physician should consider whether other agents are more appropriate. (See CONTRAINDICATIONS, WARNINGS, and ADVERSE REACTIONS.).",
      "Description": "Clindamycin phosphate gel USP, 1%, a topical antibiotic, contains clindamycin phosphate, at a concentration equivalent to 10 mg clindamycin per gram in a gel vehicle consisting of carbomer 981, methylparaben, polyethylene glycol 400, propylene glycol, purified water, and sodium hydroxide. Chemically, clindamycin phosphate is a water-soluble ester of the semi-synthetic antibiotic produced by a 7 (S)-chlorosubstitution of the 7 (R)-hydroxyl group of the parent antibiotic, lincomycin, and has the structural formula represented below. The chemical name for clindamycin phosphate is methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-a-D-galacto-octopyranoside 2-(dihydrogen phosphate)."
    },
    {
      "NDCCode": "73473-306-30",
      "PackageDescription": "1 TUBE in 1 CARTON (73473-306-30)  / 30 g in 1 TUBE",
      "NDC11Code": "73473-0306-30",
      "ProductNDC": "73473-306",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clindamycin Phosphate And Tretinoin",
      "NonProprietaryName": "Clindamycin Phosphate And Tretinoin",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250103",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212845",
      "LabelerName": "Solaris Pharma Corporation",
      "SubstanceName": "CLINDAMYCIN PHOSPHATE; TRETINOIN",
      "StrengthNumber": "10; .25",
      "StrengthUnit": "mg/g; mg/g",
      "Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE], Retinoid [EPC], Retinoids [CS]",
      "Status": "Active",
      "LastUpdate": "2025-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250103",
      "SamplePackage": "N",
      "IndicationAndUsage": "Clindamycin phosphate and tretinoin gel is indicated for the topical treatment of acne vulgaris in patients 12 years and older.",
      "Description": "Clindamycin phosphate and tretinoin gel, 1.2%/0.025%, is a fixed combination of 2 solubilized active ingredients in an aqueous-based gel. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate is methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below. Molecular Formula: C18H34ClN2O8PS. Molecular Weight: 504.97. The chemical name for tretinoin is all-trans 3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. It is a member of the retinoid family of compounds. The structural formula for tretinoin is represented below. Molecular Formula: C20H28O2. Molecular Weight: 300.44. Clindamycin phosphate and tretinoin gel contains the following inactive ingredients: anhydrous citric acid, butylated hydroxytoluene, carbomer homopolymer (type C), edetate disodium, laureth 4, methylparaben, propylene glycol, purified water, and tromethamine."
    },
    {
      "NDCCode": "73473-306-60",
      "PackageDescription": "1 TUBE in 1 CARTON (73473-306-60)  / 60 g in 1 TUBE",
      "NDC11Code": "73473-0306-60",
      "ProductNDC": "73473-306",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clindamycin Phosphate And Tretinoin",
      "NonProprietaryName": "Clindamycin Phosphate And Tretinoin",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250103",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212845",
      "LabelerName": "Solaris Pharma Corporation",
      "SubstanceName": "CLINDAMYCIN PHOSPHATE; TRETINOIN",
      "StrengthNumber": "10; .25",
      "StrengthUnit": "mg/g; mg/g",
      "Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE], Retinoid [EPC], Retinoids [CS]",
      "Status": "Active",
      "LastUpdate": "2025-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250103",
      "SamplePackage": "N",
      "IndicationAndUsage": "Clindamycin phosphate and tretinoin gel is indicated for the topical treatment of acne vulgaris in patients 12 years and older.",
      "Description": "Clindamycin phosphate and tretinoin gel, 1.2%/0.025%, is a fixed combination of 2 solubilized active ingredients in an aqueous-based gel. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate is methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below. Molecular Formula: C18H34ClN2O8PS. Molecular Weight: 504.97. The chemical name for tretinoin is all-trans 3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. It is a member of the retinoid family of compounds. The structural formula for tretinoin is represented below. Molecular Formula: C20H28O2. Molecular Weight: 300.44. Clindamycin phosphate and tretinoin gel contains the following inactive ingredients: anhydrous citric acid, butylated hydroxytoluene, carbomer homopolymer (type C), edetate disodium, laureth 4, methylparaben, propylene glycol, purified water, and tromethamine."
    },
    {
      "NDCCode": "73473-308-50",
      "PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (73473-308-50)  / 50 g in 1 BOTTLE, PUMP",
      "NDC11Code": "73473-0308-50",
      "ProductNDC": "73473-308",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Estradiol",
      "NonProprietaryName": "Estradiol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20260128",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA216160",
      "LabelerName": "Solaris Pharma Corporation",
      "SubstanceName": "ESTRADIOL",
      "StrengthNumber": ".75",
      "StrengthUnit": "mg/1.25g",
      "Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-01-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260128",
      "SamplePackage": "N",
      "IndicationAndUsage": "Estradiol gel, 0.06% is an estrogen indicated for: 1 Treatment of moderate to severe vasomotor symptoms due to menopause (1.1), 2 Treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause (1.2).",
      "Description": "Estradiol gel contains 0.06 percent estradiol in an absorptive hydroalcoholic gel base for topical application. It is a clear, colorless gel, which is odorless when dry. One pump depression of estradiol gel, 0.06% delivers 1.25 g of gel containing 0.75 mg estradiol. Estradiol is a white crystalline powder, chemically described as estra-1,3,5(10)-triene-3,17β-diol. It has an empirical formula of C18H24O2 and molecular weight of 272.39. The structural formula is. The active component of the gel is estradiol. The remaining components of the gel (purified water, alcohol (44.89% v/v), triethanolamine and carbomer 974P) are pharmacologically inactive."
    },
    {
      "NDCCode": "73473-309-10",
      "PackageDescription": "1 TUBE in 1 CARTON (73473-309-10)  / 100 g in 1 TUBE",
      "NDC11Code": "73473-0309-10",
      "ProductNDC": "73473-309",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tazarotene",
      "NonProprietaryName": "Tazarotene",
      "DosageFormName": "GEL",
      "RouteName": "CUTANEOUS",
      "StartMarketingDate": "20250103",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA213644",
      "LabelerName": "Solaris Pharma Corporation",
      "SubstanceName": "TAZAROTENE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
      "Status": "Active",
      "LastUpdate": "2025-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250103",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tazarotene gel, 0.05% and 0.1% is a retinoid indicated for the topical treatment of plaque psoriasis of up to 20% body surface area involvement. (1.1). Tazarotene gel, 0.1% is indicated for the topical treatment of mild to moderate facial acne vulgaris. (1.2).",
      "Description": "Tazarotene gel, 0.05% and 0.1% is for topical use and contains the active ingredient, tazarotene. Each gram of tazarotene gel, 0.05% and 0.1% contains 0.5 and 1 mg of tazarotene, respectively in a translucent, aqueous gel. Tazarotene is a member of the acetylenic class of retinoids. Chemically, tazarotene is ethyl 6-[(4,4-dimethylthiochroman-6-yl)ethynyl]nicotinate. The compound has an empirical formula of C21H21NO2S and molecular weight of 351.46. The structural formula is shown below. Tazarotene gel, 0.05% and 0.1% contains the following inactive ingredients: benzyl alcohol 1%; ascorbic acid; butylated hydroxyanisole; butylated hydroxytoluene; carbomer homopolymer type B; edetate disodium; hexylene glycol; poloxamer 407; polyethylene glycol 400; polysorbate 40; purified water; and tromethamine."
    },
    {
      "NDCCode": "73473-309-30",
      "PackageDescription": "1 TUBE in 1 CARTON (73473-309-30)  / 30 g in 1 TUBE",
      "NDC11Code": "73473-0309-30",
      "ProductNDC": "73473-309",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tazarotene",
      "NonProprietaryName": "Tazarotene",
      "DosageFormName": "GEL",
      "RouteName": "CUTANEOUS",
      "StartMarketingDate": "20250103",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA213644",
      "LabelerName": "Solaris Pharma Corporation",
      "SubstanceName": "TAZAROTENE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
      "Status": "Active",
      "LastUpdate": "2025-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250103",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tazarotene gel, 0.05% and 0.1% is a retinoid indicated for the topical treatment of plaque psoriasis of up to 20% body surface area involvement. (1.1). Tazarotene gel, 0.1% is indicated for the topical treatment of mild to moderate facial acne vulgaris. (1.2).",
      "Description": "Tazarotene gel, 0.05% and 0.1% is for topical use and contains the active ingredient, tazarotene. Each gram of tazarotene gel, 0.05% and 0.1% contains 0.5 and 1 mg of tazarotene, respectively in a translucent, aqueous gel. Tazarotene is a member of the acetylenic class of retinoids. Chemically, tazarotene is ethyl 6-[(4,4-dimethylthiochroman-6-yl)ethynyl]nicotinate. The compound has an empirical formula of C21H21NO2S and molecular weight of 351.46. The structural formula is shown below. Tazarotene gel, 0.05% and 0.1% contains the following inactive ingredients: benzyl alcohol 1%; ascorbic acid; butylated hydroxyanisole; butylated hydroxytoluene; carbomer homopolymer type B; edetate disodium; hexylene glycol; poloxamer 407; polyethylene glycol 400; polysorbate 40; purified water; and tromethamine."
    },
    {
      "NDCCode": "73473-310-10",
      "PackageDescription": "1 TUBE in 1 CARTON (73473-310-10)  / 100 g in 1 TUBE",
      "NDC11Code": "73473-0310-10",
      "ProductNDC": "73473-310",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tazarotene",
      "NonProprietaryName": "Tazarotene",
      "DosageFormName": "GEL",
      "RouteName": "CUTANEOUS",
      "StartMarketingDate": "20250103",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA213644",
      "LabelerName": "Solaris Pharma Corporation",
      "SubstanceName": "TAZAROTENE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
      "Status": "Active",
      "LastUpdate": "2025-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250103",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tazarotene gel, 0.05% and 0.1% is a retinoid indicated for the topical treatment of plaque psoriasis of up to 20% body surface area involvement. (1.1). Tazarotene gel, 0.1% is indicated for the topical treatment of mild to moderate facial acne vulgaris. (1.2).",
      "Description": "Tazarotene gel, 0.05% and 0.1% is for topical use and contains the active ingredient, tazarotene. Each gram of tazarotene gel, 0.05% and 0.1% contains 0.5 and 1 mg of tazarotene, respectively in a translucent, aqueous gel. Tazarotene is a member of the acetylenic class of retinoids. Chemically, tazarotene is ethyl 6-[(4,4-dimethylthiochroman-6-yl)ethynyl]nicotinate. The compound has an empirical formula of C21H21NO2S and molecular weight of 351.46. The structural formula is shown below. Tazarotene gel, 0.05% and 0.1% contains the following inactive ingredients: benzyl alcohol 1%; ascorbic acid; butylated hydroxyanisole; butylated hydroxytoluene; carbomer homopolymer type B; edetate disodium; hexylene glycol; poloxamer 407; polyethylene glycol 400; polysorbate 40; purified water; and tromethamine."
    },
    {
      "NDCCode": "73473-310-30",
      "PackageDescription": "1 TUBE in 1 CARTON (73473-310-30)  / 30 g in 1 TUBE",
      "NDC11Code": "73473-0310-30",
      "ProductNDC": "73473-310",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tazarotene",
      "NonProprietaryName": "Tazarotene",
      "DosageFormName": "GEL",
      "RouteName": "CUTANEOUS",
      "StartMarketingDate": "20250103",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA213644",
      "LabelerName": "Solaris Pharma Corporation",
      "SubstanceName": "TAZAROTENE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
      "Status": "Active",
      "LastUpdate": "2025-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250103",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tazarotene gel, 0.05% and 0.1% is a retinoid indicated for the topical treatment of plaque psoriasis of up to 20% body surface area involvement. (1.1). Tazarotene gel, 0.1% is indicated for the topical treatment of mild to moderate facial acne vulgaris. (1.2).",
      "Description": "Tazarotene gel, 0.05% and 0.1% is for topical use and contains the active ingredient, tazarotene. Each gram of tazarotene gel, 0.05% and 0.1% contains 0.5 and 1 mg of tazarotene, respectively in a translucent, aqueous gel. Tazarotene is a member of the acetylenic class of retinoids. Chemically, tazarotene is ethyl 6-[(4,4-dimethylthiochroman-6-yl)ethynyl]nicotinate. The compound has an empirical formula of C21H21NO2S and molecular weight of 351.46. The structural formula is shown below. Tazarotene gel, 0.05% and 0.1% contains the following inactive ingredients: benzyl alcohol 1%; ascorbic acid; butylated hydroxyanisole; butylated hydroxytoluene; carbomer homopolymer type B; edetate disodium; hexylene glycol; poloxamer 407; polyethylene glycol 400; polysorbate 40; purified water; and tromethamine."
    },
    {
      "NDCCode": "73473-500-30",
      "PackageDescription": "30 g in 1 TUBE (73473-500-30) ",
      "NDC11Code": "73473-0500-30",
      "ProductNDC": "73473-500",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Nitroglycerin",
      "NonProprietaryName": "Nitroglycerin",
      "DosageFormName": "OINTMENT",
      "RouteName": "RECTAL",
      "StartMarketingDate": "20260108",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA218756",
      "LabelerName": "Solaris Pharma Corporation",
      "SubstanceName": "NITROGLYCERIN",
      "StrengthNumber": "4",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
      "Status": "Active",
      "LastUpdate": "2026-01-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260108",
      "SamplePackage": "N",
      "IndicationAndUsage": "Nitroglycerin Ointment 0.4% is indicated for the treatment of moderate to severe pain associated with chronic anal fissure.",
      "Description": "Nitroglycerin is 1,2,3,-propanetriol trinitrate, an organic nitrate whose structural formula is as follows. and whose molecular weight is 227.09. Nitroglycerin Ointment, USP 0.4% contains 0.4% nitroglycerin w/w (4 mg nitroglycerin/1 g ointment), propylene glycol, lanolin, sorbitan sesquioleate, paraffin, and white petrolatum. Nitroglycerin Ointment, USP 0.4% is available in tubes with a one-inch dosing line on the carton allowing the measurement of approximately 375 mg of nitroglycerin ointment 0.4% (1.5 mg nitroglycerin) for application."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"73473-303-70","ProprietaryName":"Metronidazole","NonProprietaryName":"Metronidazole"},{"NDCCode":"42858-150-70","ProprietaryName":"Scopolamine","NonProprietaryName":"Scopolamine"},{"NDCCode":"50518-303-11","ProprietaryName":"Hand Sanitizer","NonProprietaryName":"Ethyl Alcohol"},{"NDCCode":"50518-303-12","ProprietaryName":"Hand Sanitizer","NonProprietaryName":"Ethyl Alcohol"},{"NDCCode":"51706-303-02","ProprietaryName":"Bodycology","NonProprietaryName":"Alcohol"},{"NDCCode":"60289-303-24","ProprietaryName":"Ahava","NonProprietaryName":"Avobenzone, Homosalate, Octisalate, And Octocrylene"},{"NDCCode":"61380-303-27","ProprietaryName":"Natures Gate Face Broad Spectrum Sunscreen Spf 25","NonProprietaryName":"Octinoxate, Octocrylene, And Zinc Oxide"},{"NDCCode":"63323-572-70","ProprietaryName":"Clofarabine","NonProprietaryName":"Clofarabine"},{"NDCCode":"69730-303-12","ProprietaryName":"Rubbing Alcohol","NonProprietaryName":"Isopropyl Alcohol"},{"NDCCode":"70108-303-01","ProprietaryName":"Smart Care Jasmine Jewel Hand Sanitizer","NonProprietaryName":"Ethyl Alcohol"},{"NDCCode":"71611-303-12","ProprietaryName":"Rubbing Alcohol","NonProprietaryName":"Isopropyl Alcohol"},{"NDCCode":"71611-303-16","ProprietaryName":"Rubbing Alcohol","NonProprietaryName":"Isopropyl Alcohol"},{"NDCCode":"73717-303-04","ProprietaryName":"Herbal Scent Aromar Hand Sanitizer","NonProprietaryName":"Isopropyl Alcohol"},{"NDCCode":"76436-303-12","ProprietaryName":"Rubbing Alcohol","NonProprietaryName":"Isopropyl Alcohol"},{"NDCCode":"76436-303-16","ProprietaryName":"Rubbing Alcohol","NonProprietaryName":"Isopropyl Alcohol"},{"NDCCode":"77118-303-10","ProprietaryName":"Hand Sanitizer","NonProprietaryName":"Alcohol"},{"NDCCode":"78280-303-02","ProprietaryName":"Kericure Hand Sanitizer","NonProprietaryName":"Alcohol"},{"NDCCode":"78280-303-08","ProprietaryName":"Kericure Hand Sanitizer","NonProprietaryName":"Alcohol"},{"NDCCode":"79633-303-59","ProprietaryName":"Shield Dr.","NonProprietaryName":"Hand Sanitizer Liquid Spray With Peppermint And Citrus, 70% Alcohol"},{"NDCCode":"73473-300-30","ProprietaryName":"Clindamycin Phosphate","NonProprietaryName":"Clindamycin Phosphate"},{"NDCCode":"73473-300-60","ProprietaryName":"Clindamycin Phosphate","NonProprietaryName":"Clindamycin Phosphate"},{"NDCCode":"73473-302-75","ProprietaryName":"Clindamycin Phosphate","NonProprietaryName":"Clindamycin Phosphate"},{"NDCCode":"73473-306-30","ProprietaryName":"Clindamycin Phosphate And Tretinoin","NonProprietaryName":"Clindamycin Phosphate And Tretinoin"},{"NDCCode":"73473-306-60","ProprietaryName":"Clindamycin Phosphate And Tretinoin","NonProprietaryName":"Clindamycin Phosphate And Tretinoin"},{"NDCCode":"73473-308-50","ProprietaryName":"Estradiol","NonProprietaryName":"Estradiol"},{"NDCCode":"73473-309-10","ProprietaryName":"Tazarotene","NonProprietaryName":"Tazarotene"},{"NDCCode":"73473-309-30","ProprietaryName":"Tazarotene","NonProprietaryName":"Tazarotene"},{"NDCCode":"73473-310-10","ProprietaryName":"Tazarotene","NonProprietaryName":"Tazarotene"},{"NDCCode":"73473-310-30","ProprietaryName":"Tazarotene","NonProprietaryName":"Tazarotene"},{"NDCCode":"73473-500-30","ProprietaryName":"Nitroglycerin","NonProprietaryName":"Nitroglycerin"}]}
                    

<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>73473-303-70</NDCCode>
    <PackageDescription>1 TUBE, WITH APPLICATOR in 1 CARTON (73473-303-70)  / 70 g in 1 TUBE, WITH APPLICATOR</PackageDescription>
    <NDC11Code>73473-0303-70</NDC11Code>
    <ProductNDC>73473-303</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metronidazole</ProprietaryName>
    <NonProprietaryName>Metronidazole</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>VAGINAL</RouteName>
    <StartMarketingDate>20260108</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213648</ApplicationNumber>
    <LabelerName>Solaris Pharma Corporation</LabelerName>
    <SubstanceName>METRONIDAZOLE</SubstanceName>
    <StrengthNumber>7.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260108</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Metronidazole vaginal gel is indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis). NOTE: For purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a “fishy” amine odor when mixed with a 10% KOH solution, and (c) contains clue cells on microscopic examination. Gram’s stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent Lactobacillus morphology, (b) predominance of Gardnerella morphotype, and (c) absent or few white blood cells. Other pathogens commonly associated with vulvovaginitis, e.g., Trichomonas vaginalis, Chlamydia trachomatis, N. gonorrhoeae, Candida albicans, and Herpes simplex virus should be ruled out.</IndicationAndUsage>
    <Description>Metronidazole vaginal gel, 0.75% is the intravaginal dosage form of the synthetic antibacterial agent, metronidazole, USP at a concentration of 0.75%. Metronidazole is a member of the imidazole class of antibacterial agents and is classified therapeutically as an antiprotozoal and antibacterial agent. Chemically, metronidazole is a 2-methyl-5-nitroimidazole-1-ethanol. It has a chemical formula of C6H9N3O3, a molecular weight of 171.16, and has the following structure. Metronidazole vaginal gel, 0.75% is a gelled, purified water solution, containing metronidazole at a concentration of 7.5 mg/g (0.75%). The gel is formulated at pH 4.0. The gel also contains carbomer 974P , edetate disodium, methyl paraben, propyl paraben, propylene glycol, and sodium hydroxide. Each applicator full of 5 grams of vaginal gel contains approximately 37.5 mg of metronidazole.</Description>
  </NDC>
  <NDC>
    <NDCCode>42858-150-70</NDCCode>
    <PackageDescription>24 POUCH in 1 BOX (42858-150-70)  / 1 PATCH in 1 POUCH / 3 d in 1 PATCH</PackageDescription>
    <NDC11Code>42858-0150-70</NDC11Code>
    <ProductNDC>42858-150</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Scopolamine</ProprietaryName>
    <NonProprietaryName>Scopolamine</NonProprietaryName>
    <DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
    <RouteName>TRANSDERMAL</RouteName>
    <StartMarketingDate>20241101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215329</ApplicationNumber>
    <LabelerName>Rhodes Pharmaceuticals LLC</LabelerName>
    <SubstanceName>SCOPOLAMINE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/3d</StrengthUnit>
    <Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Scopolamine Transdermal System is indicated in adults for the prevention of: 1 nausea and vomiting associated with motion sickness., 2 post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery. .</IndicationAndUsage>
    <Description>Scopolamine transdermal system is designed for continuous release of scopolamine following application to an area of intact skin on the head, behind the ear. Each system contains 1.3 mg of scopolamine base. Scopolamine is (9-methyl-3-oxa-9-azatricyclo [3.3.1.02,4]nonan-7-yl) 3-hydroxy-2-phenylpropanoate. The empirical formula is C17H21NO4 and its structural formula is. Scopolamine has a molecular weight of 303.35 and a pKa of 7.55 to 7.81. The scopolamine transdermal system is a circular, 0.28 mm thick, 2.5 cm2 film with four layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are: (1) a backing membrane of tan-colored, aluminized, polyester film; (2) a drug layer of scopolamine, light mineral oil, isopropyl palmitate, crospovidone, and polyisobutylene; (3) a microporous polypropylene membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) a contact layer formulation of mineral oil, polyisobutylene, isopropyl palmitate, crospovidone, and scopolamine. A release liner of siliconized polyester, which covers the adhesive layer, is removed before the system is used. Cross section of the system.</Description>
  </NDC>
  <NDC>
    <NDCCode>50518-303-11</NDCCode>
    <PackageDescription>30 mL in 1 BOTTLE (50518-303-11) </PackageDescription>
    <NDC11Code>50518-0303-11</NDC11Code>
    <ProductNDC>50518-303</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200525</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>CUSTOM RESEARCH LABS INC</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200525</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>TO DECREASE BACTERIA ON THE SKIN THAT COULD CAUSE DISEASE. RECOMMENDED FOR REPEATED USE.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>50518-303-12</NDCCode>
    <PackageDescription>30 mL in 1 TUBE (50518-303-12) </PackageDescription>
    <NDC11Code>50518-0303-12</NDC11Code>
    <ProductNDC>50518-303</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200525</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>CUSTOM RESEARCH LABS INC</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200525</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>TO DECREASE BACTERIA ON THE SKIN THAT COULD CAUSE DISEASE. RECOMMENDED FOR REPEATED USE.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>51706-303-02</NDCCode>
    <PackageDescription>1 BOTTLE in 1 PACKAGE (51706-303-02)  &gt; 55 mL in 1 BOTTLE (51706-303-01)</PackageDescription>
    <NDC11Code>51706-0303-02</NDC11Code>
    <ProductNDC>51706-303</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Bodycology</ProprietaryName>
    <ProprietaryNameSuffix>Moisturizing Hand Sanitizer Cucumber Melon</ProprietaryNameSuffix>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20100101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333</ApplicationNumber>
    <LabelerName>Landy International</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Directions:. -Wet hands with product and allow to dry without wiping. -For children under 6, use only under adult supervision. -Not recommended for infants.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>60289-303-24</NDCCode>
    <PackageDescription>1 JAR in 1 CARTON (60289-303-24)  / 50 mL in 1 JAR</PackageDescription>
    <NDC11Code>60289-0303-24</NDC11Code>
    <ProductNDC>60289-303</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ahava</ProprietaryName>
    <ProprietaryNameSuffix>Brightening Broad Spectrum Spf 20</ProprietaryNameSuffix>
    <NonProprietaryName>Avobenzone, Homosalate, Octisalate, And Octocrylene</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240212</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>AHAVA - Dead Sea Laboratories Ltd</LabelerName>
    <SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
    <StrengthNumber>30; 70; 50; 27.4</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-12-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240212</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps prevent sunburn.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>61380-303-27</NDCCode>
    <PackageDescription>118 mL in 1 TUBE (61380-303-27)</PackageDescription>
    <NDC11Code>61380-0303-27</NDC11Code>
    <ProductNDC>61380-303</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Natures Gate Face Broad Spectrum Sunscreen Spf 25</ProprietaryName>
    <NonProprietaryName>Octinoxate, Octocrylene, And Zinc Oxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20121120</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Levlad, LLC</LabelerName>
    <SubstanceName>OCTINOXATE; OCTOCRYLENE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>75; 70; 69</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-02-07</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>63323-572-70</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (63323-572-70)  &gt; 20 mL in 1 VIAL, SINGLE-USE</PackageDescription>
    <NDC11Code>63323-0572-70</NDC11Code>
    <ProductNDC>63323-572</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clofarabine</ProprietaryName>
    <NonProprietaryName>Clofarabine</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20170510</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204029</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>CLOFARABINE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2020-07-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170510</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Clofarabine Injection is indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. This indication is based upon response rate. There are no trials verifying an improvement in disease-related symptoms or increased survival with Clofarabine Injection.</IndicationAndUsage>
    <Description>Clofarabine Injection contains clofarabine, a purine nucleoside metabolic inhibitor. The chemical name of clofarabine is 2-chloro-9-(2-deoxy-2-fluoro-β-D-arabinofuranosyl)-9H-purin-6-amine. Its molecular formula is C10H11ClFN5O3 with a molecular weight of 303.68 Daltons. The molecular structure of clofarabine is. Clofarabine Injection (1 mg/mL) is supplied in a 20 mL, single-dose vial. The 20 mL vial contains 20 mg clofarabine formulated in 20 mL unbuffered normal saline (comprised of Water for Injection, USP, and Sodium Chloride, USP). The pH range of the solution is 4.5 to 7.5. The solution is sterile, clear and practically colorless, and is preservative-free.</Description>
  </NDC>
  <NDC>
    <NDCCode>69730-303-12</NDCCode>
    <PackageDescription>355 mL in 1 BOTTLE (69730-303-12)</PackageDescription>
    <NDC11Code>69730-0303-12</NDC11Code>
    <ProductNDC>69730-303</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Rubbing Alcohol</ProprietaryName>
    <ProprietaryNameSuffix>70 Percent</ProprietaryNameSuffix>
    <NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20141203</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>SAGE OIL LLC</LabelerName>
    <SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>FIRST AID TO HELP THE RISK OF INFECTION IN MINOR CUTS AND SCRAPES.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>70108-303-01</NDCCode>
    <PackageDescription>1 BOTTLE, SPRAY in 1 POUCH (70108-303-01)  / 40 mL in 1 BOTTLE, SPRAY</PackageDescription>
    <NDC11Code>70108-0303-01</NDC11Code>
    <ProductNDC>70108-303</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Smart Care Jasmine Jewel Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20260115</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>505G(a)(3)</ApplicationNumber>
    <LabelerName>Ashtel Studios, Inc.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-01-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Decreases bacteria on skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>71611-303-12</NDCCode>
    <PackageDescription>355 mL in 1 BOTTLE (71611-303-12) </PackageDescription>
    <NDC11Code>71611-0303-12</NDC11Code>
    <ProductNDC>71611-303</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Rubbing Alcohol</ProprietaryName>
    <ProprietaryNameSuffix>70 Percent</ProprietaryNameSuffix>
    <NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20180222</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>MY Sales LLC dba Click Products LLC</LabelerName>
    <SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180222</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>FIRST AID TO HELP PREVENT THE RISK IN: 1 MINOR CUTS, 2 SCRAPES, 3 BURNS.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>71611-303-16</NDCCode>
    <PackageDescription>475 mL in 1 BOTTLE (71611-303-16) </PackageDescription>
    <NDC11Code>71611-0303-16</NDC11Code>
    <ProductNDC>71611-303</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Rubbing Alcohol</ProprietaryName>
    <ProprietaryNameSuffix>70 Percent</ProprietaryNameSuffix>
    <NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20180222</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>MY Sales LLC dba Click Products LLC</LabelerName>
    <SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180222</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>FIRST AID TO HELP PREVENT THE RISK IN: 1 MINOR CUTS, 2 SCRAPES, 3 BURNS.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>73717-303-04</NDCCode>
    <PackageDescription>60 mL in 1 BOTTLE, SPRAY (73717-303-04) </PackageDescription>
    <NDC11Code>73717-0303-04</NDC11Code>
    <ProductNDC>73717-303</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Herbal Scent Aromar Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200323</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Mar Company Distributors, LLC</LabelerName>
    <SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200323</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>to decrease bacteria on skin that could cause disease. recommended for repeated use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>76436-303-12</NDCCode>
    <PackageDescription>355 mL in 1 BOTTLE (76436-303-12)</PackageDescription>
    <NDC11Code>76436-0303-12</NDC11Code>
    <ProductNDC>76436-303</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Rubbing Alcohol</ProprietaryName>
    <ProprietaryNameSuffix>70 Percent</ProprietaryNameSuffix>
    <NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20141203</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Viny Health and Beauty Products Inc</LabelerName>
    <SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-12-07</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>76436-303-16</NDCCode>
    <PackageDescription>475 mL in 1 BOTTLE (76436-303-16)</PackageDescription>
    <NDC11Code>76436-0303-16</NDC11Code>
    <ProductNDC>76436-303</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Rubbing Alcohol</ProprietaryName>
    <ProprietaryNameSuffix>70 Percent</ProprietaryNameSuffix>
    <NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20141203</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Viny Health and Beauty Products Inc</LabelerName>
    <SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-12-07</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>77118-303-10</NDCCode>
    <PackageDescription>100 mL in 1 BOTTLE, SPRAY (77118-303-10) </PackageDescription>
    <NDC11Code>77118-0303-10</NDC11Code>
    <ProductNDC>77118-303</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizer</ProprietaryName>
    <ProprietaryNameSuffix>100</ProprietaryNameSuffix>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200330</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>ABC INTERNATIONAL LTD</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200330</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>78280-303-02</NDCCode>
    <PackageDescription>55 mL in 1 BOTTLE, SPRAY (78280-303-02) </PackageDescription>
    <NDC11Code>78280-0303-02</NDC11Code>
    <ProductNDC>78280-303</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Kericure Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200410</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>505G(a)(3)</ApplicationNumber>
    <LabelerName>Kericure Inc.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-02-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200410</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses  to decrease bacteria on the skin that could cause disease  recommended for repeated use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>78280-303-08</NDCCode>
    <PackageDescription>230 mL in 1 BOTTLE, SPRAY (78280-303-08) </PackageDescription>
    <NDC11Code>78280-0303-08</NDC11Code>
    <ProductNDC>78280-303</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Kericure Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200410</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Kericure Inc.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200410</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses  to decrease bacteria on the skin that could cause disease  recommended for repeated use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>79633-303-59</NDCCode>
    <PackageDescription>59 mL in 1 BOTTLE, SPRAY (79633-303-59) </PackageDescription>
    <NDC11Code>79633-0303-59</NDC11Code>
    <ProductNDC>79633-303</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Shield Dr.</ProprietaryName>
    <NonProprietaryName>Hand Sanitizer Liquid Spray With Peppermint And Citrus, 70% Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200819</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>MEDIPHARCO PHARMACEUTICAL JOINT STOCK COMPANY</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200819</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hand sanitizer to help reduce bacteria on the skin it could cause disease.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>73473-300-30</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (73473-300-30)  / 30 g in 1 TUBE</PackageDescription>
    <NDC11Code>73473-0300-30</NDC11Code>
    <ProductNDC>73473-300</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clindamycin Phosphate</ProprietaryName>
    <NonProprietaryName>Clindamycin Phosphate</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20250103</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211872</ApplicationNumber>
    <LabelerName>Solaris Pharma Corporation</LabelerName>
    <SubstanceName>CLINDAMYCIN PHOSPHATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250103</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Clindamycin phosphate gel, 1% is indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate (see CONTRAINDICATIONS, WARNINGS and ADVERSE REACTIONS).</IndicationAndUsage>
    <Description>Clindamycin phosphate gel USP, 1% contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per gram. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The gel contains allantoin, carbomer 974P, methylparaben, polyethylene glycol 400, propylene glycol, sodium hydroxide, and purified water. The structural formula is represented below: The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate).</Description>
  </NDC>
  <NDC>
    <NDCCode>73473-300-60</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (73473-300-60)  / 60 g in 1 TUBE</PackageDescription>
    <NDC11Code>73473-0300-60</NDC11Code>
    <ProductNDC>73473-300</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clindamycin Phosphate</ProprietaryName>
    <NonProprietaryName>Clindamycin Phosphate</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20250103</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211872</ApplicationNumber>
    <LabelerName>Solaris Pharma Corporation</LabelerName>
    <SubstanceName>CLINDAMYCIN PHOSPHATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250103</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Clindamycin phosphate gel, 1% is indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate (see CONTRAINDICATIONS, WARNINGS and ADVERSE REACTIONS).</IndicationAndUsage>
    <Description>Clindamycin phosphate gel USP, 1% contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per gram. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The gel contains allantoin, carbomer 974P, methylparaben, polyethylene glycol 400, propylene glycol, sodium hydroxide, and purified water. The structural formula is represented below: The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate).</Description>
  </NDC>
  <NDC>
    <NDCCode>73473-302-75</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (73473-302-75)  / 75 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>73473-0302-75</NDC11Code>
    <ProductNDC>73473-302</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clindamycin Phosphate</ProprietaryName>
    <NonProprietaryName>Clindamycin Phosphate</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240915</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212842</ApplicationNumber>
    <LabelerName>Solaris Pharma Corporation</LabelerName>
    <SubstanceName>CLINDAMYCIN PHOSPHATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/10mL</StrengthUnit>
    <Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-09-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Clindamycin phosphate gel, 1% is indicated for topical application in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea, and pseudomembranous colitis, the physician should consider whether other agents are more appropriate. (See CONTRAINDICATIONS, WARNINGS, and ADVERSE REACTIONS.).</IndicationAndUsage>
    <Description>Clindamycin phosphate gel USP, 1%, a topical antibiotic, contains clindamycin phosphate, at a concentration equivalent to 10 mg clindamycin per gram in a gel vehicle consisting of carbomer 981, methylparaben, polyethylene glycol 400, propylene glycol, purified water, and sodium hydroxide. Chemically, clindamycin phosphate is a water-soluble ester of the semi-synthetic antibiotic produced by a 7 (S)-chlorosubstitution of the 7 (R)-hydroxyl group of the parent antibiotic, lincomycin, and has the structural formula represented below. The chemical name for clindamycin phosphate is methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-a-D-galacto-octopyranoside 2-(dihydrogen phosphate).</Description>
  </NDC>
  <NDC>
    <NDCCode>73473-306-30</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (73473-306-30)  / 30 g in 1 TUBE</PackageDescription>
    <NDC11Code>73473-0306-30</NDC11Code>
    <ProductNDC>73473-306</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clindamycin Phosphate And Tretinoin</ProprietaryName>
    <NonProprietaryName>Clindamycin Phosphate And Tretinoin</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20250103</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212845</ApplicationNumber>
    <LabelerName>Solaris Pharma Corporation</LabelerName>
    <SubstanceName>CLINDAMYCIN PHOSPHATE; TRETINOIN</SubstanceName>
    <StrengthNumber>10; .25</StrengthNumber>
    <StrengthUnit>mg/g; mg/g</StrengthUnit>
    <Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE], Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250103</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Clindamycin phosphate and tretinoin gel is indicated for the topical treatment of acne vulgaris in patients 12 years and older.</IndicationAndUsage>
    <Description>Clindamycin phosphate and tretinoin gel, 1.2%/0.025%, is a fixed combination of 2 solubilized active ingredients in an aqueous-based gel. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate is methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below. Molecular Formula: C18H34ClN2O8PS. Molecular Weight: 504.97. The chemical name for tretinoin is all-trans 3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. It is a member of the retinoid family of compounds. The structural formula for tretinoin is represented below. Molecular Formula: C20H28O2. Molecular Weight: 300.44. Clindamycin phosphate and tretinoin gel contains the following inactive ingredients: anhydrous citric acid, butylated hydroxytoluene, carbomer homopolymer (type C), edetate disodium, laureth 4, methylparaben, propylene glycol, purified water, and tromethamine.</Description>
  </NDC>
  <NDC>
    <NDCCode>73473-306-60</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (73473-306-60)  / 60 g in 1 TUBE</PackageDescription>
    <NDC11Code>73473-0306-60</NDC11Code>
    <ProductNDC>73473-306</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clindamycin Phosphate And Tretinoin</ProprietaryName>
    <NonProprietaryName>Clindamycin Phosphate And Tretinoin</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20250103</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212845</ApplicationNumber>
    <LabelerName>Solaris Pharma Corporation</LabelerName>
    <SubstanceName>CLINDAMYCIN PHOSPHATE; TRETINOIN</SubstanceName>
    <StrengthNumber>10; .25</StrengthNumber>
    <StrengthUnit>mg/g; mg/g</StrengthUnit>
    <Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE], Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250103</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Clindamycin phosphate and tretinoin gel is indicated for the topical treatment of acne vulgaris in patients 12 years and older.</IndicationAndUsage>
    <Description>Clindamycin phosphate and tretinoin gel, 1.2%/0.025%, is a fixed combination of 2 solubilized active ingredients in an aqueous-based gel. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate is methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below. Molecular Formula: C18H34ClN2O8PS. Molecular Weight: 504.97. The chemical name for tretinoin is all-trans 3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. It is a member of the retinoid family of compounds. The structural formula for tretinoin is represented below. Molecular Formula: C20H28O2. Molecular Weight: 300.44. Clindamycin phosphate and tretinoin gel contains the following inactive ingredients: anhydrous citric acid, butylated hydroxytoluene, carbomer homopolymer (type C), edetate disodium, laureth 4, methylparaben, propylene glycol, purified water, and tromethamine.</Description>
  </NDC>
  <NDC>
    <NDCCode>73473-308-50</NDCCode>
    <PackageDescription>1 BOTTLE, PUMP in 1 CARTON (73473-308-50)  / 50 g in 1 BOTTLE, PUMP</PackageDescription>
    <NDC11Code>73473-0308-50</NDC11Code>
    <ProductNDC>73473-308</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Estradiol</ProprietaryName>
    <NonProprietaryName>Estradiol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20260128</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216160</ApplicationNumber>
    <LabelerName>Solaris Pharma Corporation</LabelerName>
    <SubstanceName>ESTRADIOL</SubstanceName>
    <StrengthNumber>.75</StrengthNumber>
    <StrengthUnit>mg/1.25g</StrengthUnit>
    <Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260128</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Estradiol gel, 0.06% is an estrogen indicated for: 1 Treatment of moderate to severe vasomotor symptoms due to menopause (1.1), 2 Treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause (1.2).</IndicationAndUsage>
    <Description>Estradiol gel contains 0.06 percent estradiol in an absorptive hydroalcoholic gel base for topical application. It is a clear, colorless gel, which is odorless when dry. One pump depression of estradiol gel, 0.06% delivers 1.25 g of gel containing 0.75 mg estradiol. Estradiol is a white crystalline powder, chemically described as estra-1,3,5(10)-triene-3,17β-diol. It has an empirical formula of C18H24O2 and molecular weight of 272.39. The structural formula is. The active component of the gel is estradiol. The remaining components of the gel (purified water, alcohol (44.89% v/v), triethanolamine and carbomer 974P) are pharmacologically inactive.</Description>
  </NDC>
  <NDC>
    <NDCCode>73473-309-10</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (73473-309-10)  / 100 g in 1 TUBE</PackageDescription>
    <NDC11Code>73473-0309-10</NDC11Code>
    <ProductNDC>73473-309</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tazarotene</ProprietaryName>
    <NonProprietaryName>Tazarotene</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>CUTANEOUS</RouteName>
    <StartMarketingDate>20250103</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213644</ApplicationNumber>
    <LabelerName>Solaris Pharma Corporation</LabelerName>
    <SubstanceName>TAZAROTENE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250103</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tazarotene gel, 0.05% and 0.1% is a retinoid indicated for the topical treatment of plaque psoriasis of up to 20% body surface area involvement. (1.1). Tazarotene gel, 0.1% is indicated for the topical treatment of mild to moderate facial acne vulgaris. (1.2).</IndicationAndUsage>
    <Description>Tazarotene gel, 0.05% and 0.1% is for topical use and contains the active ingredient, tazarotene. Each gram of tazarotene gel, 0.05% and 0.1% contains 0.5 and 1 mg of tazarotene, respectively in a translucent, aqueous gel. Tazarotene is a member of the acetylenic class of retinoids. Chemically, tazarotene is ethyl 6-[(4,4-dimethylthiochroman-6-yl)ethynyl]nicotinate. The compound has an empirical formula of C21H21NO2S and molecular weight of 351.46. The structural formula is shown below. Tazarotene gel, 0.05% and 0.1% contains the following inactive ingredients: benzyl alcohol 1%; ascorbic acid; butylated hydroxyanisole; butylated hydroxytoluene; carbomer homopolymer type B; edetate disodium; hexylene glycol; poloxamer 407; polyethylene glycol 400; polysorbate 40; purified water; and tromethamine.</Description>
  </NDC>
  <NDC>
    <NDCCode>73473-309-30</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (73473-309-30)  / 30 g in 1 TUBE</PackageDescription>
    <NDC11Code>73473-0309-30</NDC11Code>
    <ProductNDC>73473-309</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tazarotene</ProprietaryName>
    <NonProprietaryName>Tazarotene</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>CUTANEOUS</RouteName>
    <StartMarketingDate>20250103</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213644</ApplicationNumber>
    <LabelerName>Solaris Pharma Corporation</LabelerName>
    <SubstanceName>TAZAROTENE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250103</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tazarotene gel, 0.05% and 0.1% is a retinoid indicated for the topical treatment of plaque psoriasis of up to 20% body surface area involvement. (1.1). Tazarotene gel, 0.1% is indicated for the topical treatment of mild to moderate facial acne vulgaris. (1.2).</IndicationAndUsage>
    <Description>Tazarotene gel, 0.05% and 0.1% is for topical use and contains the active ingredient, tazarotene. Each gram of tazarotene gel, 0.05% and 0.1% contains 0.5 and 1 mg of tazarotene, respectively in a translucent, aqueous gel. Tazarotene is a member of the acetylenic class of retinoids. Chemically, tazarotene is ethyl 6-[(4,4-dimethylthiochroman-6-yl)ethynyl]nicotinate. The compound has an empirical formula of C21H21NO2S and molecular weight of 351.46. The structural formula is shown below. Tazarotene gel, 0.05% and 0.1% contains the following inactive ingredients: benzyl alcohol 1%; ascorbic acid; butylated hydroxyanisole; butylated hydroxytoluene; carbomer homopolymer type B; edetate disodium; hexylene glycol; poloxamer 407; polyethylene glycol 400; polysorbate 40; purified water; and tromethamine.</Description>
  </NDC>
  <NDC>
    <NDCCode>73473-310-10</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (73473-310-10)  / 100 g in 1 TUBE</PackageDescription>
    <NDC11Code>73473-0310-10</NDC11Code>
    <ProductNDC>73473-310</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tazarotene</ProprietaryName>
    <NonProprietaryName>Tazarotene</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>CUTANEOUS</RouteName>
    <StartMarketingDate>20250103</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213644</ApplicationNumber>
    <LabelerName>Solaris Pharma Corporation</LabelerName>
    <SubstanceName>TAZAROTENE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250103</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tazarotene gel, 0.05% and 0.1% is a retinoid indicated for the topical treatment of plaque psoriasis of up to 20% body surface area involvement. (1.1). Tazarotene gel, 0.1% is indicated for the topical treatment of mild to moderate facial acne vulgaris. (1.2).</IndicationAndUsage>
    <Description>Tazarotene gel, 0.05% and 0.1% is for topical use and contains the active ingredient, tazarotene. Each gram of tazarotene gel, 0.05% and 0.1% contains 0.5 and 1 mg of tazarotene, respectively in a translucent, aqueous gel. Tazarotene is a member of the acetylenic class of retinoids. Chemically, tazarotene is ethyl 6-[(4,4-dimethylthiochroman-6-yl)ethynyl]nicotinate. The compound has an empirical formula of C21H21NO2S and molecular weight of 351.46. The structural formula is shown below. Tazarotene gel, 0.05% and 0.1% contains the following inactive ingredients: benzyl alcohol 1%; ascorbic acid; butylated hydroxyanisole; butylated hydroxytoluene; carbomer homopolymer type B; edetate disodium; hexylene glycol; poloxamer 407; polyethylene glycol 400; polysorbate 40; purified water; and tromethamine.</Description>
  </NDC>
  <NDC>
    <NDCCode>73473-310-30</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (73473-310-30)  / 30 g in 1 TUBE</PackageDescription>
    <NDC11Code>73473-0310-30</NDC11Code>
    <ProductNDC>73473-310</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tazarotene</ProprietaryName>
    <NonProprietaryName>Tazarotene</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>CUTANEOUS</RouteName>
    <StartMarketingDate>20250103</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213644</ApplicationNumber>
    <LabelerName>Solaris Pharma Corporation</LabelerName>
    <SubstanceName>TAZAROTENE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250103</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tazarotene gel, 0.05% and 0.1% is a retinoid indicated for the topical treatment of plaque psoriasis of up to 20% body surface area involvement. (1.1). Tazarotene gel, 0.1% is indicated for the topical treatment of mild to moderate facial acne vulgaris. (1.2).</IndicationAndUsage>
    <Description>Tazarotene gel, 0.05% and 0.1% is for topical use and contains the active ingredient, tazarotene. Each gram of tazarotene gel, 0.05% and 0.1% contains 0.5 and 1 mg of tazarotene, respectively in a translucent, aqueous gel. Tazarotene is a member of the acetylenic class of retinoids. Chemically, tazarotene is ethyl 6-[(4,4-dimethylthiochroman-6-yl)ethynyl]nicotinate. The compound has an empirical formula of C21H21NO2S and molecular weight of 351.46. The structural formula is shown below. Tazarotene gel, 0.05% and 0.1% contains the following inactive ingredients: benzyl alcohol 1%; ascorbic acid; butylated hydroxyanisole; butylated hydroxytoluene; carbomer homopolymer type B; edetate disodium; hexylene glycol; poloxamer 407; polyethylene glycol 400; polysorbate 40; purified water; and tromethamine.</Description>
  </NDC>
  <NDC>
    <NDCCode>73473-500-30</NDCCode>
    <PackageDescription>30 g in 1 TUBE (73473-500-30) </PackageDescription>
    <NDC11Code>73473-0500-30</NDC11Code>
    <ProductNDC>73473-500</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nitroglycerin</ProprietaryName>
    <NonProprietaryName>Nitroglycerin</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>RECTAL</RouteName>
    <StartMarketingDate>20260108</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218756</ApplicationNumber>
    <LabelerName>Solaris Pharma Corporation</LabelerName>
    <SubstanceName>NITROGLYCERIN</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260108</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Nitroglycerin Ointment 0.4% is indicated for the treatment of moderate to severe pain associated with chronic anal fissure.</IndicationAndUsage>
    <Description>Nitroglycerin is 1,2,3,-propanetriol trinitrate, an organic nitrate whose structural formula is as follows. and whose molecular weight is 227.09. Nitroglycerin Ointment, USP 0.4% contains 0.4% nitroglycerin w/w (4 mg nitroglycerin/1 g ointment), propylene glycol, lanolin, sorbitan sesquioleate, paraffin, and white petrolatum. Nitroglycerin Ointment, USP 0.4% is available in tubes with a one-inch dosing line on the carton allowing the measurement of approximately 375 mg of nitroglycerin ointment 0.4% (1.5 mg nitroglycerin) for application.</Description>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>73473-303-70</NDCCode><ProprietaryName>Metronidazole</ProprietaryName><NonProprietaryName>Metronidazole</NonProprietaryName></NDC><NDC><NDCCode>42858-150-70</NDCCode><ProprietaryName>Scopolamine</ProprietaryName><NonProprietaryName>Scopolamine</NonProprietaryName></NDC><NDC><NDCCode>50518-303-11</NDCCode><ProprietaryName>Hand Sanitizer</ProprietaryName><NonProprietaryName>Ethyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>50518-303-12</NDCCode><ProprietaryName>Hand Sanitizer</ProprietaryName><NonProprietaryName>Ethyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>51706-303-02</NDCCode><ProprietaryName>Bodycology</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>60289-303-24</NDCCode><ProprietaryName>Ahava</ProprietaryName><NonProprietaryName>Avobenzone, Homosalate, Octisalate, And Octocrylene</NonProprietaryName></NDC><NDC><NDCCode>61380-303-27</NDCCode><ProprietaryName>Natures Gate Face Broad Spectrum Sunscreen Spf 25</ProprietaryName><NonProprietaryName>Octinoxate, Octocrylene, And Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>63323-572-70</NDCCode><ProprietaryName>Clofarabine</ProprietaryName><NonProprietaryName>Clofarabine</NonProprietaryName></NDC><NDC><NDCCode>69730-303-12</NDCCode><ProprietaryName>Rubbing Alcohol</ProprietaryName><NonProprietaryName>Isopropyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>70108-303-01</NDCCode><ProprietaryName>Smart Care Jasmine Jewel Hand Sanitizer</ProprietaryName><NonProprietaryName>Ethyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>71611-303-12</NDCCode><ProprietaryName>Rubbing Alcohol</ProprietaryName><NonProprietaryName>Isopropyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>71611-303-16</NDCCode><ProprietaryName>Rubbing Alcohol</ProprietaryName><NonProprietaryName>Isopropyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>73717-303-04</NDCCode><ProprietaryName>Herbal Scent Aromar Hand Sanitizer</ProprietaryName><NonProprietaryName>Isopropyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>76436-303-12</NDCCode><ProprietaryName>Rubbing Alcohol</ProprietaryName><NonProprietaryName>Isopropyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>76436-303-16</NDCCode><ProprietaryName>Rubbing Alcohol</ProprietaryName><NonProprietaryName>Isopropyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>77118-303-10</NDCCode><ProprietaryName>Hand Sanitizer</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>78280-303-02</NDCCode><ProprietaryName>Kericure Hand Sanitizer</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>78280-303-08</NDCCode><ProprietaryName>Kericure Hand Sanitizer</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>79633-303-59</NDCCode><ProprietaryName>Shield Dr.</ProprietaryName><NonProprietaryName>Hand Sanitizer Liquid Spray With Peppermint And Citrus, 70% Alcohol</NonProprietaryName></NDC><NDC><NDCCode>73473-300-30</NDCCode><ProprietaryName>Clindamycin Phosphate</ProprietaryName><NonProprietaryName>Clindamycin Phosphate</NonProprietaryName></NDC><NDC><NDCCode>73473-300-60</NDCCode><ProprietaryName>Clindamycin Phosphate</ProprietaryName><NonProprietaryName>Clindamycin Phosphate</NonProprietaryName></NDC><NDC><NDCCode>73473-302-75</NDCCode><ProprietaryName>Clindamycin Phosphate</ProprietaryName><NonProprietaryName>Clindamycin Phosphate</NonProprietaryName></NDC><NDC><NDCCode>73473-306-30</NDCCode><ProprietaryName>Clindamycin Phosphate And Tretinoin</ProprietaryName><NonProprietaryName>Clindamycin Phosphate And Tretinoin</NonProprietaryName></NDC><NDC><NDCCode>73473-306-60</NDCCode><ProprietaryName>Clindamycin Phosphate And Tretinoin</ProprietaryName><NonProprietaryName>Clindamycin Phosphate And Tretinoin</NonProprietaryName></NDC><NDC><NDCCode>73473-308-50</NDCCode><ProprietaryName>Estradiol</ProprietaryName><NonProprietaryName>Estradiol</NonProprietaryName></NDC><NDC><NDCCode>73473-309-10</NDCCode><ProprietaryName>Tazarotene</ProprietaryName><NonProprietaryName>Tazarotene</NonProprietaryName></NDC><NDC><NDCCode>73473-309-30</NDCCode><ProprietaryName>Tazarotene</ProprietaryName><NonProprietaryName>Tazarotene</NonProprietaryName></NDC><NDC><NDCCode>73473-310-10</NDCCode><ProprietaryName>Tazarotene</ProprietaryName><NonProprietaryName>Tazarotene</NonProprietaryName></NDC><NDC><NDCCode>73473-310-30</NDCCode><ProprietaryName>Tazarotene</ProprietaryName><NonProprietaryName>Tazarotene</NonProprietaryName></NDC><NDC><NDCCode>73473-500-30</NDCCode><ProprietaryName>Nitroglycerin</ProprietaryName><NonProprietaryName>Nitroglycerin</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/04/2006",
      "LastUpdateDate": "12/11/2007",
      "AuthorizedOfficialLastName": "MONTECILLO",
      "AuthorizedOfficialFirstName": "RANIA",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-7363",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "801TX",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1346319878",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "REDMOND EYE CLINIC PLLC",
      "FirstLineMailingAddress": "16150 NE 85TH ST STE 206",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3543",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-3574",
      "MailingAddressFaxNumber": "425-881-0230",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "PracticeLocationAddressFaxNumber": "425-881-0230",
      "EnumerationDate": "11/07/2006",
      "LastUpdateDate": "07/08/2007",
      "AuthorizedOfficialLastName": "OTTEN",
      "AuthorizedOfficialFirstName": "LARRY",
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      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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