RESTful Lookup — Test-Drive (2007 – 2026)

Query complete (12 ms elapsed)

{
  "NDC": [
    {
      "NDCCode": "69269-108-36",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (69269-108-36)  > 57 mL in 1 BOTTLE, PLASTIC",
      "NDC11Code": "69269-0108-36",
      "ProductNDC": "69269-108",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Obagi",
      "NonProprietaryName": "Octisalate, Octinoxate, Oxybenzone",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20141001",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "YS PLUS CORPORATION",
      "SubstanceName": "OCTISALATE; OCTINOXATE; OXYBENZONE",
      "StrengthNumber": "50; 75; 40",
      "StrengthUnit": "mg/mL; mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2017-06-14"
    },
    {
      "NDCCode": "69269-100-36",
      "PackageDescription": "57 g in 1 BOTTLE, PLASTIC (69269-100-36)",
      "NDC11Code": "69269-0100-36",
      "ProductNDC": "69269-100",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Obagi Nu-derm",
      "NonProprietaryName": "Hydroquinone",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20141001",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "YS PLUS CORPORATION",
      "SubstanceName": "HYDROQUINONE",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2017-06-14"
    },
    {
      "NDCCode": "69269-101-36",
      "PackageDescription": "57 g in 1 BOTTLE, PLASTIC (69269-101-36)",
      "NDC11Code": "69269-0101-36",
      "ProductNDC": "69269-101",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Obagi Nu-derm",
      "NonProprietaryName": "Hydroquinone",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20141001",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "YS PLUS CORPORATION",
      "SubstanceName": "HYDROQUINONE",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2017-06-14"
    },
    {
      "NDCCode": "69269-105-36",
      "PackageDescription": "57 g in 1 BOTTLE, PLASTIC (69269-105-36)",
      "NDC11Code": "69269-0105-36",
      "ProductNDC": "69269-105",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Obagi - C",
      "NonProprietaryName": "Hydroquinone",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20141001",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "YS PLUS CORPORATION",
      "SubstanceName": "HYDROQUINONE",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2017-06-14"
    },
    {
      "NDCCode": "69269-116-36",
      "PackageDescription": "57 g in 1 BOTTLE, PLASTIC (69269-116-36)",
      "NDC11Code": "69269-0116-36",
      "ProductNDC": "69269-116",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Obagi Nu-derm Sunfader",
      "NonProprietaryName": "Hydroquinone, Octinoxate, Oxybenzone",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20141001",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "YS PLUS CORPORATION",
      "SubstanceName": "HYDROQUINONE; OCTINOXATE; OXYBENZONE",
      "StrengthNumber": "40; 75; 55",
      "StrengthUnit": "mg/g; mg/g; mg/g",
      "Pharm_Classes": "Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2017-06-14"
    },
    {
      "NDCCode": "69269-520-00",
      "PackageDescription": "1 KIT in 1 KIT (69269-520-00)  *  57 g in 1 BOTTLE, PLASTIC (69269-101-36)  *  85 g in 1 TUBE (69269-126-90)  *  57 g in 1 BOTTLE, PLASTIC (69269-100-36)",
      "NDC11Code": "69269-0520-00",
      "ProductNDC": "69269-520",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Obagi",
      "NonProprietaryName": "Hydroquinone, Octinoxate, Zinc Oxide",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20141001",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "YS PLUS CORPORATION",
      "Status": "Deprecated",
      "LastUpdate": "2017-06-14"
    },
    {
      "NDCCode": "69269-523-04",
      "PackageDescription": "1 KIT in 1 KIT (69269-523-04)  *  1 BOTTLE, GLASS in 1 CARTON (69269-122-10)  > 30 mL in 1 BOTTLE, GLASS *  85 g in 1 TUBE (69269-121-90)  *  57 g in 1 BOTTLE, PLASTIC (69269-105-36)",
      "NDC11Code": "69269-0523-04",
      "ProductNDC": "69269-523",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Obagi",
      "NonProprietaryName": "Hydroquinone, Octinoxate, Zinc Oxide",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20141001",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "YS PLUS CORPORATION",
      "Status": "Deprecated",
      "LastUpdate": "2017-06-14"
    },
    {
      "NDCCode": "69269-524-04",
      "PackageDescription": "1 KIT in 1 KIT (69269-524-04)  *  30 mL in 1 BOTTLE, GLASS (69269-106-10)  *  85 g in 1 TUBE (69269-121-90)  *  57 g in 1 BOTTLE, PLASTIC (69269-105-36)",
      "NDC11Code": "69269-0524-04",
      "ProductNDC": "69269-524",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Obagi",
      "NonProprietaryName": "Hydroquinone",
      "DosageFormName": "KIT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20141001",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "YS PLUS CORPORATION",
      "Status": "Deprecated",
      "LastUpdate": "2017-06-14"
    },
    {
      "NDCCode": "47682-108-36",
      "PackageDescription": "75 PACKET in 1 BOX (47682-108-36)  / 2 TABLET, FILM COATED in 1 PACKET",
      "NDC11Code": "47682-0108-36",
      "ProductNDC": "47682-108",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Medique Cold Cough Product",
      "NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl ,",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220926",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "Unifirst First Aid Corporation",
      "SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "10; 325; 5",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-09-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20221212",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses. temporarily relieves these common cold/flu symptoms: ■ minor aches and pains ■ headache ■ sore throat ■ nasal congestion ■ cough ■ sinus congestion and pressure ■ helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily reduces fever."
    },
    {
      "NDCCode": "62032-108-36",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (62032-108-36)  > 57 mL in 1 BOTTLE, PLASTIC",
      "NDC11Code": "62032-0108-36",
      "ProductNDC": "62032-108",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Obagi-c Rx System C-exfoliating Day",
      "ProprietaryNameSuffix": "With Vitamin C",
      "NonProprietaryName": "Octisalate, Octinoxate, And Oxybenzone",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20040101",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "OMP, INC.",
      "SubstanceName": "OCTISALATE; OCTINOXATE; OXYBENZONE",
      "StrengthNumber": "50; 75; 40",
      "StrengthUnit": "mg/mL; mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "65753-108-36",
      "PackageDescription": "24 APPLICATOR in 1 CONTAINER (65753-108-36)  / 4.44 mL in 1 APPLICATOR",
      "NDC11Code": "65753-0108-36",
      "ProductNDC": "65753-108",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sun X Spf 50 Broad Spectrum Sunscreen Lip Balm",
      "NonProprietaryName": "Avobenzone, Homosalate, Octinoxate, Octisalate, Petrolatum",
      "DosageFormName": "LIPSTICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20170101",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "CoreTex Products, INC",
      "SubstanceName": "PETROLATUM; OCTISALATE; OCTINOXATE; AVOBENZONE; HOMOSALATE",
      "StrengthNumber": "40; 5; 7.5; 3; 3",
      "StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL; g/100mL",
      "Status": "Active",
      "LastUpdate": "2023-12-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20211008",
      "SamplePackage": "N",
      "IndicationAndUsage": "Helps protect against sunburn and chapped lips."
    },
    {
      "NDCCode": "65753-514-36",
      "PackageDescription": "1 KIT in 1 KIT (65753-514-36)  *  4.44 mL in 1 APPLICATOR (65753-108-39)  *  1.1 mL in 1 POUCH *  1 mL in 1 POUCH (65753-400-39)  *  3.5 mL in 1 POUCH *  7 g in 1 POUCH (65753-109-39)  *  44 mL in 1 PACKET (65753-110-37) ",
      "NDC11Code": "65753-0514-36",
      "ProductNDC": "65753-514",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Coretex Professional Outdoor Skin Protection Wallet",
      "NonProprietaryName": "Coretex Professional Outdoor Skin Protection Wallet",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20230224",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "CoreTex Products Inc",
      "Status": "Active",
      "LastUpdate": "2025-10-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230224",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "65753-515-36",
      "PackageDescription": "1 KIT in 1 KIT (65753-515-36)  *  4.44 mL in 1 APPLICATOR (65753-108-39)  *  1.1 mL in 1 POUCH *  1 mL in 1 POUCH (65753-400-39)  *  3.5 mL in 1 POUCH *  7 g in 1 POUCH (65753-109-39)  *  44 mL in 1 PACKET (65753-110-37) ",
      "NDC11Code": "65753-0515-36",
      "ProductNDC": "65753-515",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Coretex Professional Outdoor Skin Protection Wallet Refill",
      "NonProprietaryName": "Coretex Professional Outdoor Skin Protection Wallet Refill",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20230224",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "CoreTex Products Inc",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20230224",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "67091-108-36",
      "PackageDescription": "18 POUCH in 1 CARTON (67091-108-36)  / 2 TABLET, EFFERVESCENT in 1 POUCH",
      "NDC11Code": "67091-0108-36",
      "ProductNDC": "67091-108",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Winco Foods Effervescent Antacid And Pain Relief",
      "NonProprietaryName": "Aspirin, Sodium Bicarbonate, Citric Acid Tablet",
      "DosageFormName": "TABLET, EFFERVESCENT",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150101",
      "EndMarketingDate": "20261231",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M013",
      "LabelerName": "WinCo Foods, LLC",
      "SubstanceName": "SODIUM BICARBONATE; ANHYDROUS CITRIC ACID; ASPIRIN",
      "StrengthNumber": "1916; 1000; 325",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Acidifying Activity [MoA], Alkalinizing Activity [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Cyclooxygenase Inhibitors [MoA], Decreased Coagulation Factor Activity [PE], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-12-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20150101",
      "EndMarketingDatePackage": "20261231",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses for the temporary relief of. ■ heartburn, acid indigestion and sour stomach when accompanied by headache or body aches and pains. ■ upset stomach with headache from overindulgence in food or drink. ■ pain alone (headaches or body aches and pains)."
    },
    {
      "NDCCode": "73069-108-36",
      "PackageDescription": "12 VIAL, MULTI-DOSE in 1 BOX (73069-108-36)  > 5 mL in 1 VIAL, MULTI-DOSE",
      "NDC11Code": "73069-0108-36",
      "ProductNDC": "73069-108",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Viatrexx-derma",
      "NonProprietaryName": "Anti-interleukin 1, Ankle Articulations, Beta Endorphin, Bfgf, Calcaneal Tendon, Hip Articulation, Knee Articulation, Liver, Transforming Growth Factor-1, Transforming Gf-beta",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
      "StartMarketingDate": "20190329",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "VIATREXX BIO INCORPORATED",
      "SubstanceName": "BASIC FIBROBLAST GROWTH FACTOR (HUMAN); CALCIUM GLUCONATE; CENTELLA ASIATICA; PORK COLLAGEN; HYALURONIDASE; MECASERMIN; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA",
      "StrengthNumber": "200; 30; 30; 200; 30; 200; 30; 30",
      "StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
      "Pharm_Classes": "Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS],Endoglycosidase [EPC],Glycoside Hydrolases [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2021-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20190506",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0004-0381-40",
      "PackageDescription": "1 KIT in 1 CARTON (0004-0381-40)  *  1 mL in 1 VIAL, SINGLE-USE *  1 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "00004-0381-40",
      "ProductNDC": "0004-0381",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fuzeon",
      "NonProprietaryName": "Enfuvirtide",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20120410",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021481",
      "LabelerName": "Genentech, Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2025-12-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20120410",
      "SamplePackage": "N",
      "IndicationAndUsage": "FUZEON® in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy.",
      "Description": "FUZEON (enfuvirtide) is an inhibitor of the fusion of HIV-1 with CD4 cells. Enfuvirtide is a linear 36-amino acid synthetic peptide with the N-terminus acetylated and the C-terminus is a carboxamide. It is composed of naturally occurring L-amino acid residues. Enfuvirtide is a white to off-white amorphous solid. It has negligible solubility in pure water and the solubility increases in aqueous buffers (pH 7.5) to 85-142 g/100 mL. The empirical formula of enfuvirtide is C204H301N51O64, and the molecular weight is 4492. It has the following primary amino acid sequence. CH3CO-Tyr-Thr-Ser-Leu-Ile-His-Ser-Leu-Ile-Glu-Glu-Ser-Gln-Asn-Gln-Gln-Glu-Lys-Asn-Glu-Gln-Glu-Leu-Leu-Glu-Leu-Asp-Lys-Trp-Ala-Ser-Leu-Trp-Asn-Trp-Phe-NH2 and the following structural formula. The drug product, FUZEON (enfuvirtide) for Injection, is a white to off-white, sterile, lyophilized powder. Each single-dose vial contains 108 mg of enfuvirtide for the delivery of 90 mg. Prior to subcutaneous administration, the contents of the vial are reconstituted with 1 mL of Sterile Water for Injection to provide the delivery of 1 mL of the solution. Each 1 mL of the reconstituted solution contains approximately 90 mg of enfuvirtide with approximate amounts of the following excipients: 22.55 mg of mannitol, 2.39 mg of sodium carbonate (anhydrous), and sodium hydroxide and hydrochloric acid for pH adjustment as needed. The reconstituted solution has an approximate pH of 9.0."
    },
    {
      "NDCCode": "0338-9051-12",
      "PackageDescription": "12 CARTON in 1 CARTON (0338-9051-12)  / 1 BAG in 1 CARTON (0338-9051-01)  / 50 mL in 1 BAG",
      "NDC11Code": "00338-9051-12",
      "ProductNDC": "0338-9051",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Micafungin In Sodium Chloride",
      "NonProprietaryName": "Micafungin In Sodium Chloride",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20230929",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA216142",
      "LabelerName": "Baxter Healthcare Corporation",
      "SubstanceName": "MICAFUNGIN SODIUM",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/50mL",
      "Pharm_Classes": "Echinocandin Antifungal [EPC], Lipopeptides [CS]",
      "Status": "Active",
      "LastUpdate": "2026-07-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230929",
      "SamplePackage": "N",
      "IndicationAndUsage": "Micafungin in Sodium Chloride Injection is indicated for: 1 Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older for whom appropriate dosing with this formulation can be achieved [see Clinical Studies (14.1) and Use in Specific Populations (8.4)]., 2 Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age for whom appropriate dosing with this formulation can be achieved [see Use in Specific Populations (8.4)]., 3 Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older for whom appropriate dosing with this formulation can be achieved [see Clinical Studies (14.2)]., 4 Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing hematopoietic stem cell transplantation for whom appropriate dosing with this formulation can be achieved [see Clinical Studies (14.3)].",
      "Description": "Micafungin in Sodium Chloride Injection is a premixed, iso-osmotic, sterile, nonpyrogenic solution for intravenous (IV) infusion that contains micafungin sodium. Micafungin sodium is a semisynthetic lipopeptide (echinocandin). Micafungin in Sodium Chloride Injection is supplied as a refrigerated 50 mL, 100 mL, or 150 mL single-dose GALAXY container in the following presentations. 50 mg/50 mL (1 mg/mL): containing 50 mg of micafungin (equivalent to 50.87 mg of micafungin sodium); 36 mg citric acid, anhydrous; 450 mg sodium chloride; 92 mg sodium citrate dihydrate;. 100 mg/100 mL (1 mg/mL): containing 100 mg of micafungin (equivalent to 101.73 mg of micafungin sodium); 72 mg citric acid, anhydrous; 900 mg sodium chloride; 184 mg sodium citrate dihydrate;. 150 mg/150 mL (1 mg/mL): containing 150 mg of micafungin (equivalent to 152.60 mg of micafungin sodium); 108 mg citric acid, anhydrous; 1350 mg sodium chloride; 276 mg sodium citrate dihydrate. : 1 Each 50 mg/50 mL Galaxy container of Micafungin in Sodium Chloride Injection contains 200 mg of sodium., 2 Each 100 mg/100 mL Galaxy container of Micafungin in Sodium Chloride Injection contains 400 mg of sodium., 3 Each 150 mg/150 mL Galaxy container of Micafungin in Sodium Chloride Injection contains 600 mg of sodium."
    },
    {
      "NDCCode": "0338-9053-12",
      "PackageDescription": "12 CARTON in 1 CARTON (0338-9053-12)  / 1 BAG in 1 CARTON (0338-9053-01)  / 100 mL in 1 BAG",
      "NDC11Code": "00338-9053-12",
      "ProductNDC": "0338-9053",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Micafungin In Sodium Chloride",
      "NonProprietaryName": "Micafungin In Sodium Chloride",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20230929",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA216142",
      "LabelerName": "Baxter Healthcare Corporation",
      "SubstanceName": "MICAFUNGIN SODIUM",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/100mL",
      "Pharm_Classes": "Echinocandin Antifungal [EPC], Lipopeptides [CS]",
      "Status": "Active",
      "LastUpdate": "2026-07-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230929",
      "SamplePackage": "N",
      "IndicationAndUsage": "Micafungin in Sodium Chloride Injection is indicated for: 1 Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older for whom appropriate dosing with this formulation can be achieved [see Clinical Studies (14.1) and Use in Specific Populations (8.4)]., 2 Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age for whom appropriate dosing with this formulation can be achieved [see Use in Specific Populations (8.4)]., 3 Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older for whom appropriate dosing with this formulation can be achieved [see Clinical Studies (14.2)]., 4 Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing hematopoietic stem cell transplantation for whom appropriate dosing with this formulation can be achieved [see Clinical Studies (14.3)].",
      "Description": "Micafungin in Sodium Chloride Injection is a premixed, iso-osmotic, sterile, nonpyrogenic solution for intravenous (IV) infusion that contains micafungin sodium. Micafungin sodium is a semisynthetic lipopeptide (echinocandin). Micafungin in Sodium Chloride Injection is supplied as a refrigerated 50 mL, 100 mL, or 150 mL single-dose GALAXY container in the following presentations. 50 mg/50 mL (1 mg/mL): containing 50 mg of micafungin (equivalent to 50.87 mg of micafungin sodium); 36 mg citric acid, anhydrous; 450 mg sodium chloride; 92 mg sodium citrate dihydrate;. 100 mg/100 mL (1 mg/mL): containing 100 mg of micafungin (equivalent to 101.73 mg of micafungin sodium); 72 mg citric acid, anhydrous; 900 mg sodium chloride; 184 mg sodium citrate dihydrate;. 150 mg/150 mL (1 mg/mL): containing 150 mg of micafungin (equivalent to 152.60 mg of micafungin sodium); 108 mg citric acid, anhydrous; 1350 mg sodium chloride; 276 mg sodium citrate dihydrate. : 1 Each 50 mg/50 mL Galaxy container of Micafungin in Sodium Chloride Injection contains 200 mg of sodium., 2 Each 100 mg/100 mL Galaxy container of Micafungin in Sodium Chloride Injection contains 400 mg of sodium., 3 Each 150 mg/150 mL Galaxy container of Micafungin in Sodium Chloride Injection contains 600 mg of sodium."
    },
    {
      "NDCCode": "0338-9055-10",
      "PackageDescription": "10 CARTON in 1 CARTON (0338-9055-10)  / 1 BAG in 1 CARTON (0338-9055-01)  / 150 mL in 1 BAG",
      "NDC11Code": "00338-9055-10",
      "ProductNDC": "0338-9055",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Micafungin In Sodium Chloride",
      "NonProprietaryName": "Micafungin In Sodium Chloride",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20230929",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA216142",
      "LabelerName": "Baxter Healthcare Corporation",
      "SubstanceName": "MICAFUNGIN SODIUM",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/150mL",
      "Pharm_Classes": "Echinocandin Antifungal [EPC], Lipopeptides [CS]",
      "Status": "Active",
      "LastUpdate": "2026-07-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230929",
      "SamplePackage": "N",
      "IndicationAndUsage": "Micafungin in Sodium Chloride Injection is indicated for: 1 Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older for whom appropriate dosing with this formulation can be achieved [see Clinical Studies (14.1) and Use in Specific Populations (8.4)]., 2 Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age for whom appropriate dosing with this formulation can be achieved [see Use in Specific Populations (8.4)]., 3 Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older for whom appropriate dosing with this formulation can be achieved [see Clinical Studies (14.2)]., 4 Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing hematopoietic stem cell transplantation for whom appropriate dosing with this formulation can be achieved [see Clinical Studies (14.3)].",
      "Description": "Micafungin in Sodium Chloride Injection is a premixed, iso-osmotic, sterile, nonpyrogenic solution for intravenous (IV) infusion that contains micafungin sodium. Micafungin sodium is a semisynthetic lipopeptide (echinocandin). Micafungin in Sodium Chloride Injection is supplied as a refrigerated 50 mL, 100 mL, or 150 mL single-dose GALAXY container in the following presentations. 50 mg/50 mL (1 mg/mL): containing 50 mg of micafungin (equivalent to 50.87 mg of micafungin sodium); 36 mg citric acid, anhydrous; 450 mg sodium chloride; 92 mg sodium citrate dihydrate;. 100 mg/100 mL (1 mg/mL): containing 100 mg of micafungin (equivalent to 101.73 mg of micafungin sodium); 72 mg citric acid, anhydrous; 900 mg sodium chloride; 184 mg sodium citrate dihydrate;. 150 mg/150 mL (1 mg/mL): containing 150 mg of micafungin (equivalent to 152.60 mg of micafungin sodium); 108 mg citric acid, anhydrous; 1350 mg sodium chloride; 276 mg sodium citrate dihydrate. : 1 Each 50 mg/50 mL Galaxy container of Micafungin in Sodium Chloride Injection contains 200 mg of sodium., 2 Each 100 mg/100 mL Galaxy container of Micafungin in Sodium Chloride Injection contains 400 mg of sodium., 3 Each 150 mg/150 mL Galaxy container of Micafungin in Sodium Chloride Injection contains 600 mg of sodium."
    },
    {
      "NDCCode": "59088-108-59",
      "PackageDescription": "100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-108-59) ",
      "NDC11Code": "59088-0108-59",
      "ProductNDC": "59088-108",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Multivitamin With Fluoride",
      "NonProprietaryName": "Sodium Fluoride",
      "DosageFormName": "TABLET, CHEWABLE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110601",
      "EndMarketingDate": "20250131",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "PureTek Corporation",
      "SubstanceName": ".ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM ASCORBATE; SODIUM FLUORIDE; THIAMINE MONONITRATE; VITAMIN A",
      "StrengthNumber": "10; 24; 10; 4.5; 300; 13.5; 1.05; 1.2; 36; .5; 1.05; 750",
      "StrengthUnit": "mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1",
      "Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Ascorbic Acid [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-02-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20110601",
      "EndMarketingDatePackage": "20250131",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "63323-300-36",
      "PackageDescription": "10 VIAL in 1 BOX (63323-300-36)  / 15 mL in 1 VIAL",
      "NDC11Code": "63323-0300-36",
      "ProductNDC": "63323-300",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Piperacillin And Tazobactam",
      "NonProprietaryName": "Piperacillin Sodium,tazobactam Sodium",
      "DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20091013",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065523",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "PIPERACILLIN SODIUM; TAZOBACTAM SODIUM",
      "StrengthNumber": "3; .375",
      "StrengthUnit": "g/15mL; g/15mL",
      "Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-10-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20091013",
      "SamplePackage": "N",
      "IndicationAndUsage": "Piperacillin and tazobactam for injection is a combination product consisting of a penicillin-class antibacterial, piperacillin, and a β-lactamase inhibitor, tazobactam, indicated for the treatment of patients with moderate to severe infections caused by susceptible isolates of the designated bacteria in the conditions listed below.",
      "Description": "Piperacillin and tazobactam for injection is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the β-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin.  The chemical name of piperacillin sodium is sodium (2 S,5 R,6 R)-6-[( R)-2-(4-ethyl-2,3-dioxo-1-piperazinecarboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate.  The chemical formula is C 23H 26N 5NaO 7S and the molecular weight is 539.5.  The chemical structure of piperacillin sodium is:. Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone.  Its chemical name is sodium (2 S,3 S,5 R)-3-methyl-7-oxo-3-(1 H-1,2,3-triazol-1-ylmethyl)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide.  The chemical formula is C 10H 11N 4NaO 5S and the molecular weight is 322.3.  The chemical structure of tazobactam sodium is:. Piperacillin and tazobactam for injection, piperacillin/tazobactam parenteral combination, is a white to off-white sterile, cryodesiccated powder consisting of piperacillin and tazobactam as their sodium salts packaged in glass vials.  The product does not contain excipients or preservatives. Each piperacillin and tazobactam for injection 2.25 g single dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 2 grams of piperacillin and tazobactam sodium equivalent to 0.25 g of tazobactam.  Each vial contains 4.7 mEq (108 mg) of sodium. Each piperacillin and tazobactam for injection 3.375 g single dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 3 grams of piperacillin and tazobactam sodium equivalent to 0.375 g of tazobactam.  Each vial contains 7.0 mEq (162 mg) of sodium. Each piperacillin and tazobactam for injection 4.5 g single dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 4 grams of piperacillin and tazobactam sodium equivalent to 0.5 g of tazobactam.  Each vial contains 9.4 mEq (216 mg) of sodium. Piperacillin and tazobactam for injection is a monosodium salt of piperacillin and a monosodium salt of tazobactam containing a total of 2.35 mEq (54 mg) of sodium (Na  +) per gram of piperacillin in the combination product."
    },
    {
      "NDCCode": "68462-108-05",
      "PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (68462-108-05) ",
      "NDC11Code": "68462-0108-05",
      "ProductNDC": "68462-108",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Topiramate",
      "NonProprietaryName": "Topiramate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090327",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077627",
      "LabelerName": "Glenmark Pharmaceuticals Inc., USA",
      "SubstanceName": "TOPIRAMATE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2026-04-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20200730",
      "SamplePackage": "N",
      "IndicationAndUsage": "Topiramate tablets are indicated for: : 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).",
      "Description": "Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate Tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate, USP is a white to off-white powder. It is freely soluble in dichloromethane. Topiramate, USP has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate, USP is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets, USP contain the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide. The 50 mg tablets also contain FD&C yellow# 6 and iron oxide yellow for color. The 100 mg and 200 mg tablets also contain iron oxide red and iron oxide yellow for color."
    },
    {
      "NDCCode": "68462-108-10",
      "PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (68462-108-10) ",
      "NDC11Code": "68462-0108-10",
      "ProductNDC": "68462-108",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Topiramate",
      "NonProprietaryName": "Topiramate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090327",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077627",
      "LabelerName": "Glenmark Pharmaceuticals Inc., USA",
      "SubstanceName": "TOPIRAMATE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2026-04-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20090327",
      "SamplePackage": "N",
      "IndicationAndUsage": "Topiramate tablets are indicated for: : 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).",
      "Description": "Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate Tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate, USP is a white to off-white powder. It is freely soluble in dichloromethane. Topiramate, USP has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate, USP is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets, USP contain the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide. The 50 mg tablets also contain FD&C yellow# 6 and iron oxide yellow for color. The 100 mg and 200 mg tablets also contain iron oxide red and iron oxide yellow for color."
    },
    {
      "NDCCode": "68462-108-60",
      "PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (68462-108-60) ",
      "NDC11Code": "68462-0108-60",
      "ProductNDC": "68462-108",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Topiramate",
      "NonProprietaryName": "Topiramate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090327",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077627",
      "LabelerName": "Glenmark Pharmaceuticals Inc., USA",
      "SubstanceName": "TOPIRAMATE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2026-04-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20090327",
      "SamplePackage": "N",
      "IndicationAndUsage": "Topiramate tablets are indicated for: : 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).",
      "Description": "Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate Tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate, USP is a white to off-white powder. It is freely soluble in dichloromethane. Topiramate, USP has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate, USP is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets, USP contain the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide. The 50 mg tablets also contain FD&C yellow# 6 and iron oxide yellow for color. The 100 mg and 200 mg tablets also contain iron oxide red and iron oxide yellow for color."
    },
    {
      "NDCCode": "69269-103-90",
      "PackageDescription": "88 mL in 1 BOTTLE, PLASTIC (69269-103-90)",
      "NDC11Code": "69269-0103-90",
      "ProductNDC": "69269-103",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Obagi",
      "NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20141014",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "YS PLUS CORPORATION",
      "SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": "20; 155",
      "StrengthUnit": "mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2017-06-14"
    },
    {
      "NDCCode": "69269-104-90",
      "PackageDescription": "85 g in 1 TUBE (69269-104-90)",
      "NDC11Code": "69269-0104-90",
      "ProductNDC": "69269-104",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Obagi",
      "NonProprietaryName": "Octinoxate, Zinc Oxide",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20141001",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "YS PLUS CORPORATION",
      "SubstanceName": "OCTINOXATE; ZINC OXIDE",
      "StrengthNumber": "75; 105",
      "StrengthUnit": "mg/g; mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2017-06-14"
    },
    {
      "NDCCode": "69269-106-10",
      "PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (69269-106-10)  > 30 mL in 1 BOTTLE, GLASS",
      "NDC11Code": "69269-0106-10",
      "ProductNDC": "69269-106",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Obagi - C",
      "NonProprietaryName": "Hydroquinone",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20141001",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "YS PLUS CORPORATION",
      "SubstanceName": "HYDROQUINONE",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "The gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles. senile lentigines, and other unwanted areas of melanin hyperpigmentation.",
      "Description": "Hydroquinone is 1,4 - bensenediol. Hydroquinone occurs as fine, white needles. The drug is freely. soluble in water and in alcohol. Chemically, hydroquinone is designated as p - dihydroxybenzene;. the empirical formula is C6H6O2; molecular weight is 110.11 g / moL."
    },
    {
      "NDCCode": "69269-107-90",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (69269-107-90)  > 90 mL in 1 BOTTLE, PLASTIC",
      "NDC11Code": "69269-0107-90",
      "ProductNDC": "69269-107",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Obagi",
      "NonProprietaryName": "Octinoxate, Zinc Oxide",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20141001",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "YS PLUS CORPORATION",
      "SubstanceName": "OCTINOXATE; ZINC OXIDE",
      "StrengthNumber": "75; 90",
      "StrengthUnit": "mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2017-06-14"
    },
    {
      "NDCCode": "69269-110-60",
      "PackageDescription": "118 mL in 1 BOTTLE, PLASTIC (69269-110-60)",
      "NDC11Code": "69269-0110-60",
      "ProductNDC": "69269-110",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Obagi",
      "NonProprietaryName": "Salicylic Acid",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20141015",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part333D",
      "LabelerName": "YS PLUS CORPORATION",
      "SubstanceName": "SALICYLIC ACID",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2017-06-14"
    },
    {
      "NDCCode": "69269-111-60",
      "PackageDescription": "118 mL in 1 BOTTLE, PLASTIC (69269-111-60)",
      "NDC11Code": "69269-0111-60",
      "ProductNDC": "69269-111",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Obagi",
      "NonProprietaryName": "Salicylic Acid",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20141015",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part333D",
      "LabelerName": "YS PLUS CORPORATION",
      "SubstanceName": "SALICYLIC ACID",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2017-06-14"
    }
  ]
}
                    

{"NDC":[{"NDCCode":"69269-108-36","ProprietaryName":"Obagi","NonProprietaryName":"Octisalate, Octinoxate, Oxybenzone"},{"NDCCode":"69269-100-36","ProprietaryName":"Obagi Nu-derm","NonProprietaryName":"Hydroquinone"},{"NDCCode":"69269-101-36","ProprietaryName":"Obagi Nu-derm","NonProprietaryName":"Hydroquinone"},{"NDCCode":"69269-105-36","ProprietaryName":"Obagi - C","NonProprietaryName":"Hydroquinone"},{"NDCCode":"69269-116-36","ProprietaryName":"Obagi Nu-derm Sunfader","NonProprietaryName":"Hydroquinone, Octinoxate, Oxybenzone"},{"NDCCode":"69269-520-00","ProprietaryName":"Obagi","NonProprietaryName":"Hydroquinone, Octinoxate, Zinc Oxide"},{"NDCCode":"69269-523-04","ProprietaryName":"Obagi","NonProprietaryName":"Hydroquinone, Octinoxate, Zinc Oxide"},{"NDCCode":"69269-524-04","ProprietaryName":"Obagi","NonProprietaryName":"Hydroquinone"},{"NDCCode":"47682-108-36","ProprietaryName":"Medique Cold Cough Product","NonProprietaryName":"Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl ,"},{"NDCCode":"62032-108-36","ProprietaryName":"Obagi-c Rx System C-exfoliating Day","NonProprietaryName":"Octisalate, Octinoxate, And Oxybenzone"},{"NDCCode":"65753-108-36","ProprietaryName":"Sun X Spf 50 Broad Spectrum Sunscreen Lip Balm","NonProprietaryName":"Avobenzone, Homosalate, Octinoxate, Octisalate, Petrolatum"},{"NDCCode":"65753-514-36","ProprietaryName":"Coretex Professional Outdoor Skin Protection Wallet","NonProprietaryName":"Coretex Professional Outdoor Skin Protection Wallet"},{"NDCCode":"65753-515-36","ProprietaryName":"Coretex Professional Outdoor Skin Protection Wallet Refill","NonProprietaryName":"Coretex Professional Outdoor Skin Protection Wallet Refill"},{"NDCCode":"67091-108-36","ProprietaryName":"Winco Foods Effervescent Antacid And Pain Relief","NonProprietaryName":"Aspirin, Sodium Bicarbonate, Citric Acid Tablet"},{"NDCCode":"73069-108-36","ProprietaryName":"Viatrexx-derma","NonProprietaryName":"Anti-interleukin 1, Ankle Articulations, Beta Endorphin, Bfgf, Calcaneal Tendon, Hip Articulation, Knee Articulation, Liver, Transforming Growth Factor-1, Transforming Gf-beta"},{"NDCCode":"0004-0381-40","ProprietaryName":"Fuzeon","NonProprietaryName":"Enfuvirtide"},{"NDCCode":"0338-9051-12","ProprietaryName":"Micafungin In Sodium Chloride","NonProprietaryName":"Micafungin In Sodium Chloride"},{"NDCCode":"0338-9053-12","ProprietaryName":"Micafungin In Sodium Chloride","NonProprietaryName":"Micafungin In Sodium Chloride"},{"NDCCode":"0338-9055-10","ProprietaryName":"Micafungin In Sodium Chloride","NonProprietaryName":"Micafungin In Sodium Chloride"},{"NDCCode":"59088-108-59","ProprietaryName":"Multivitamin With Fluoride","NonProprietaryName":"Sodium Fluoride"},{"NDCCode":"63323-300-36","ProprietaryName":"Piperacillin And Tazobactam","NonProprietaryName":"Piperacillin Sodium,tazobactam Sodium"},{"NDCCode":"68462-108-05","ProprietaryName":"Topiramate","NonProprietaryName":"Topiramate"},{"NDCCode":"68462-108-10","ProprietaryName":"Topiramate","NonProprietaryName":"Topiramate"},{"NDCCode":"68462-108-60","ProprietaryName":"Topiramate","NonProprietaryName":"Topiramate"},{"NDCCode":"69269-103-90","ProprietaryName":"Obagi","NonProprietaryName":"Titanium Dioxide, Zinc Oxide"},{"NDCCode":"69269-104-90","ProprietaryName":"Obagi","NonProprietaryName":"Octinoxate, Zinc Oxide"},{"NDCCode":"69269-106-10","ProprietaryName":"Obagi - C","NonProprietaryName":"Hydroquinone"},{"NDCCode":"69269-107-90","ProprietaryName":"Obagi","NonProprietaryName":"Octinoxate, Zinc Oxide"},{"NDCCode":"69269-110-60","ProprietaryName":"Obagi","NonProprietaryName":"Salicylic Acid"},{"NDCCode":"69269-111-60","ProprietaryName":"Obagi","NonProprietaryName":"Salicylic Acid"}]}
                    

<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>69269-108-36</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (69269-108-36)  &gt; 57 mL in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>69269-0108-36</NDC11Code>
    <ProductNDC>69269-108</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Obagi</ProprietaryName>
    <NonProprietaryName>Octisalate, Octinoxate, Oxybenzone</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20141001</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>YS PLUS CORPORATION</LabelerName>
    <SubstanceName>OCTISALATE; OCTINOXATE; OXYBENZONE</SubstanceName>
    <StrengthNumber>50; 75; 40</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-06-14</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>69269-100-36</NDCCode>
    <PackageDescription>57 g in 1 BOTTLE, PLASTIC (69269-100-36)</PackageDescription>
    <NDC11Code>69269-0100-36</NDC11Code>
    <ProductNDC>69269-100</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Obagi Nu-derm</ProprietaryName>
    <NonProprietaryName>Hydroquinone</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20141001</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>YS PLUS CORPORATION</LabelerName>
    <SubstanceName>HYDROQUINONE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-06-14</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>69269-101-36</NDCCode>
    <PackageDescription>57 g in 1 BOTTLE, PLASTIC (69269-101-36)</PackageDescription>
    <NDC11Code>69269-0101-36</NDC11Code>
    <ProductNDC>69269-101</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Obagi Nu-derm</ProprietaryName>
    <NonProprietaryName>Hydroquinone</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20141001</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>YS PLUS CORPORATION</LabelerName>
    <SubstanceName>HYDROQUINONE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-06-14</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>69269-105-36</NDCCode>
    <PackageDescription>57 g in 1 BOTTLE, PLASTIC (69269-105-36)</PackageDescription>
    <NDC11Code>69269-0105-36</NDC11Code>
    <ProductNDC>69269-105</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Obagi - C</ProprietaryName>
    <NonProprietaryName>Hydroquinone</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20141001</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>YS PLUS CORPORATION</LabelerName>
    <SubstanceName>HYDROQUINONE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-06-14</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>69269-116-36</NDCCode>
    <PackageDescription>57 g in 1 BOTTLE, PLASTIC (69269-116-36)</PackageDescription>
    <NDC11Code>69269-0116-36</NDC11Code>
    <ProductNDC>69269-116</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Obagi Nu-derm Sunfader</ProprietaryName>
    <NonProprietaryName>Hydroquinone, Octinoxate, Oxybenzone</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20141001</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>YS PLUS CORPORATION</LabelerName>
    <SubstanceName>HYDROQUINONE; OCTINOXATE; OXYBENZONE</SubstanceName>
    <StrengthNumber>40; 75; 55</StrengthNumber>
    <StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
    <Pharm_Classes>Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-06-14</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>69269-520-00</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (69269-520-00)  *  57 g in 1 BOTTLE, PLASTIC (69269-101-36)  *  85 g in 1 TUBE (69269-126-90)  *  57 g in 1 BOTTLE, PLASTIC (69269-100-36)</PackageDescription>
    <NDC11Code>69269-0520-00</NDC11Code>
    <ProductNDC>69269-520</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Obagi</ProprietaryName>
    <NonProprietaryName>Hydroquinone, Octinoxate, Zinc Oxide</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20141001</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>YS PLUS CORPORATION</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2017-06-14</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>69269-523-04</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (69269-523-04)  *  1 BOTTLE, GLASS in 1 CARTON (69269-122-10)  &gt; 30 mL in 1 BOTTLE, GLASS *  85 g in 1 TUBE (69269-121-90)  *  57 g in 1 BOTTLE, PLASTIC (69269-105-36)</PackageDescription>
    <NDC11Code>69269-0523-04</NDC11Code>
    <ProductNDC>69269-523</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Obagi</ProprietaryName>
    <NonProprietaryName>Hydroquinone, Octinoxate, Zinc Oxide</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20141001</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>YS PLUS CORPORATION</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2017-06-14</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>69269-524-04</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (69269-524-04)  *  30 mL in 1 BOTTLE, GLASS (69269-106-10)  *  85 g in 1 TUBE (69269-121-90)  *  57 g in 1 BOTTLE, PLASTIC (69269-105-36)</PackageDescription>
    <NDC11Code>69269-0524-04</NDC11Code>
    <ProductNDC>69269-524</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Obagi</ProprietaryName>
    <NonProprietaryName>Hydroquinone</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20141001</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>YS PLUS CORPORATION</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2017-06-14</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>47682-108-36</NDCCode>
    <PackageDescription>75 PACKET in 1 BOX (47682-108-36)  / 2 TABLET, FILM COATED in 1 PACKET</PackageDescription>
    <NDC11Code>47682-0108-36</NDC11Code>
    <ProductNDC>47682-108</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Medique Cold Cough Product</ProprietaryName>
    <NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl ,</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220926</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>Unifirst First Aid Corporation</LabelerName>
    <SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10; 325; 5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221212</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses. temporarily relieves these common cold/flu symptoms: ■ minor aches and pains ■ headache ■ sore throat ■ nasal congestion ■ cough ■ sinus congestion and pressure ■ helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily reduces fever.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>62032-108-36</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (62032-108-36)  &gt; 57 mL in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>62032-0108-36</NDC11Code>
    <ProductNDC>62032-108</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Obagi-c Rx System C-exfoliating Day</ProprietaryName>
    <ProprietaryNameSuffix>With Vitamin C</ProprietaryNameSuffix>
    <NonProprietaryName>Octisalate, Octinoxate, And Oxybenzone</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20040101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>OMP, INC.</LabelerName>
    <SubstanceName>OCTISALATE; OCTINOXATE; OXYBENZONE</SubstanceName>
    <StrengthNumber>50; 75; 40</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>65753-108-36</NDCCode>
    <PackageDescription>24 APPLICATOR in 1 CONTAINER (65753-108-36)  / 4.44 mL in 1 APPLICATOR</PackageDescription>
    <NDC11Code>65753-0108-36</NDC11Code>
    <ProductNDC>65753-108</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sun X Spf 50 Broad Spectrum Sunscreen Lip Balm</ProprietaryName>
    <NonProprietaryName>Avobenzone, Homosalate, Octinoxate, Octisalate, Petrolatum</NonProprietaryName>
    <DosageFormName>LIPSTICK</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20170101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>CoreTex Products, INC</LabelerName>
    <SubstanceName>PETROLATUM; OCTISALATE; OCTINOXATE; AVOBENZONE; HOMOSALATE</SubstanceName>
    <StrengthNumber>40; 5; 7.5; 3; 3</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2023-12-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211008</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Helps protect against sunburn and chapped lips.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>65753-514-36</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (65753-514-36)  *  4.44 mL in 1 APPLICATOR (65753-108-39)  *  1.1 mL in 1 POUCH *  1 mL in 1 POUCH (65753-400-39)  *  3.5 mL in 1 POUCH *  7 g in 1 POUCH (65753-109-39)  *  44 mL in 1 PACKET (65753-110-37) </PackageDescription>
    <NDC11Code>65753-0514-36</NDC11Code>
    <ProductNDC>65753-514</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Coretex Professional Outdoor Skin Protection Wallet</ProprietaryName>
    <NonProprietaryName>Coretex Professional Outdoor Skin Protection Wallet</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20230224</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>CoreTex Products Inc</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-10-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230224</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>65753-515-36</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (65753-515-36)  *  4.44 mL in 1 APPLICATOR (65753-108-39)  *  1.1 mL in 1 POUCH *  1 mL in 1 POUCH (65753-400-39)  *  3.5 mL in 1 POUCH *  7 g in 1 POUCH (65753-109-39)  *  44 mL in 1 PACKET (65753-110-37) </PackageDescription>
    <NDC11Code>65753-0515-36</NDC11Code>
    <ProductNDC>65753-515</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Coretex Professional Outdoor Skin Protection Wallet Refill</ProprietaryName>
    <NonProprietaryName>Coretex Professional Outdoor Skin Protection Wallet Refill</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20230224</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>CoreTex Products Inc</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230224</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>67091-108-36</NDCCode>
    <PackageDescription>18 POUCH in 1 CARTON (67091-108-36)  / 2 TABLET, EFFERVESCENT in 1 POUCH</PackageDescription>
    <NDC11Code>67091-0108-36</NDC11Code>
    <ProductNDC>67091-108</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Winco Foods Effervescent Antacid And Pain Relief</ProprietaryName>
    <NonProprietaryName>Aspirin, Sodium Bicarbonate, Citric Acid Tablet</NonProprietaryName>
    <DosageFormName>TABLET, EFFERVESCENT</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150101</StartMarketingDate>
    <EndMarketingDate>20261231</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M013</ApplicationNumber>
    <LabelerName>WinCo Foods, LLC</LabelerName>
    <SubstanceName>SODIUM BICARBONATE; ANHYDROUS CITRIC ACID; ASPIRIN</SubstanceName>
    <StrengthNumber>1916; 1000; 325</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Acidifying Activity [MoA], Alkalinizing Activity [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Cyclooxygenase Inhibitors [MoA], Decreased Coagulation Factor Activity [PE], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20150101</StartMarketingDatePackage>
    <EndMarketingDatePackage>20261231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses for the temporary relief of. ■ heartburn, acid indigestion and sour stomach when accompanied by headache or body aches and pains. ■ upset stomach with headache from overindulgence in food or drink. ■ pain alone (headaches or body aches and pains).</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>73069-108-36</NDCCode>
    <PackageDescription>12 VIAL, MULTI-DOSE in 1 BOX (73069-108-36)  &gt; 5 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
    <NDC11Code>73069-0108-36</NDC11Code>
    <ProductNDC>73069-108</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Viatrexx-derma</ProprietaryName>
    <NonProprietaryName>Anti-interleukin 1, Ankle Articulations, Beta Endorphin, Bfgf, Calcaneal Tendon, Hip Articulation, Knee Articulation, Liver, Transforming Growth Factor-1, Transforming Gf-beta</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20190329</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
    <SubstanceName>BASIC FIBROBLAST GROWTH FACTOR (HUMAN); CALCIUM GLUCONATE; CENTELLA ASIATICA; PORK COLLAGEN; HYALURONIDASE; MECASERMIN; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA</SubstanceName>
    <StrengthNumber>200; 30; 30; 200; 30; 200; 30; 30</StrengthNumber>
    <StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
    <Pharm_Classes>Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS],Endoglycosidase [EPC],Glycoside Hydrolases [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190506</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0004-0381-40</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (0004-0381-40)  *  1 mL in 1 VIAL, SINGLE-USE *  1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>00004-0381-40</NDC11Code>
    <ProductNDC>0004-0381</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fuzeon</ProprietaryName>
    <NonProprietaryName>Enfuvirtide</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20120410</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021481</ApplicationNumber>
    <LabelerName>Genentech, Inc.</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2025-12-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120410</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>FUZEON® in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy.</IndicationAndUsage>
    <Description>FUZEON (enfuvirtide) is an inhibitor of the fusion of HIV-1 with CD4 cells. Enfuvirtide is a linear 36-amino acid synthetic peptide with the N-terminus acetylated and the C-terminus is a carboxamide. It is composed of naturally occurring L-amino acid residues. Enfuvirtide is a white to off-white amorphous solid. It has negligible solubility in pure water and the solubility increases in aqueous buffers (pH 7.5) to 85-142 g/100 mL. The empirical formula of enfuvirtide is C204H301N51O64, and the molecular weight is 4492. It has the following primary amino acid sequence. CH3CO-Tyr-Thr-Ser-Leu-Ile-His-Ser-Leu-Ile-Glu-Glu-Ser-Gln-Asn-Gln-Gln-Glu-Lys-Asn-Glu-Gln-Glu-Leu-Leu-Glu-Leu-Asp-Lys-Trp-Ala-Ser-Leu-Trp-Asn-Trp-Phe-NH2 and the following structural formula. The drug product, FUZEON (enfuvirtide) for Injection, is a white to off-white, sterile, lyophilized powder. Each single-dose vial contains 108 mg of enfuvirtide for the delivery of 90 mg. Prior to subcutaneous administration, the contents of the vial are reconstituted with 1 mL of Sterile Water for Injection to provide the delivery of 1 mL of the solution. Each 1 mL of the reconstituted solution contains approximately 90 mg of enfuvirtide with approximate amounts of the following excipients: 22.55 mg of mannitol, 2.39 mg of sodium carbonate (anhydrous), and sodium hydroxide and hydrochloric acid for pH adjustment as needed. The reconstituted solution has an approximate pH of 9.0.</Description>
  </NDC>
  <NDC>
    <NDCCode>0338-9051-12</NDCCode>
    <PackageDescription>12 CARTON in 1 CARTON (0338-9051-12)  / 1 BAG in 1 CARTON (0338-9051-01)  / 50 mL in 1 BAG</PackageDescription>
    <NDC11Code>00338-9051-12</NDC11Code>
    <ProductNDC>0338-9051</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Micafungin In Sodium Chloride</ProprietaryName>
    <NonProprietaryName>Micafungin In Sodium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20230929</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA216142</ApplicationNumber>
    <LabelerName>Baxter Healthcare Corporation</LabelerName>
    <SubstanceName>MICAFUNGIN SODIUM</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/50mL</StrengthUnit>
    <Pharm_Classes>Echinocandin Antifungal [EPC], Lipopeptides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230929</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Micafungin in Sodium Chloride Injection is indicated for: 1 Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older for whom appropriate dosing with this formulation can be achieved [see Clinical Studies (14.1) and Use in Specific Populations (8.4)]., 2 Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age for whom appropriate dosing with this formulation can be achieved [see Use in Specific Populations (8.4)]., 3 Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older for whom appropriate dosing with this formulation can be achieved [see Clinical Studies (14.2)]., 4 Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing hematopoietic stem cell transplantation for whom appropriate dosing with this formulation can be achieved [see Clinical Studies (14.3)].</IndicationAndUsage>
    <Description>Micafungin in Sodium Chloride Injection is a premixed, iso-osmotic, sterile, nonpyrogenic solution for intravenous (IV) infusion that contains micafungin sodium. Micafungin sodium is a semisynthetic lipopeptide (echinocandin). Micafungin in Sodium Chloride Injection is supplied as a refrigerated 50 mL, 100 mL, or 150 mL single-dose GALAXY container in the following presentations. 50 mg/50 mL (1 mg/mL): containing 50 mg of micafungin (equivalent to 50.87 mg of micafungin sodium); 36 mg citric acid, anhydrous; 450 mg sodium chloride; 92 mg sodium citrate dihydrate;. 100 mg/100 mL (1 mg/mL): containing 100 mg of micafungin (equivalent to 101.73 mg of micafungin sodium); 72 mg citric acid, anhydrous; 900 mg sodium chloride; 184 mg sodium citrate dihydrate;. 150 mg/150 mL (1 mg/mL): containing 150 mg of micafungin (equivalent to 152.60 mg of micafungin sodium); 108 mg citric acid, anhydrous; 1350 mg sodium chloride; 276 mg sodium citrate dihydrate. : 1 Each 50 mg/50 mL Galaxy container of Micafungin in Sodium Chloride Injection contains 200 mg of sodium., 2 Each 100 mg/100 mL Galaxy container of Micafungin in Sodium Chloride Injection contains 400 mg of sodium., 3 Each 150 mg/150 mL Galaxy container of Micafungin in Sodium Chloride Injection contains 600 mg of sodium.</Description>
  </NDC>
  <NDC>
    <NDCCode>0338-9053-12</NDCCode>
    <PackageDescription>12 CARTON in 1 CARTON (0338-9053-12)  / 1 BAG in 1 CARTON (0338-9053-01)  / 100 mL in 1 BAG</PackageDescription>
    <NDC11Code>00338-9053-12</NDC11Code>
    <ProductNDC>0338-9053</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Micafungin In Sodium Chloride</ProprietaryName>
    <NonProprietaryName>Micafungin In Sodium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20230929</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA216142</ApplicationNumber>
    <LabelerName>Baxter Healthcare Corporation</LabelerName>
    <SubstanceName>MICAFUNGIN SODIUM</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/100mL</StrengthUnit>
    <Pharm_Classes>Echinocandin Antifungal [EPC], Lipopeptides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230929</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Micafungin in Sodium Chloride Injection is indicated for: 1 Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older for whom appropriate dosing with this formulation can be achieved [see Clinical Studies (14.1) and Use in Specific Populations (8.4)]., 2 Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age for whom appropriate dosing with this formulation can be achieved [see Use in Specific Populations (8.4)]., 3 Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older for whom appropriate dosing with this formulation can be achieved [see Clinical Studies (14.2)]., 4 Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing hematopoietic stem cell transplantation for whom appropriate dosing with this formulation can be achieved [see Clinical Studies (14.3)].</IndicationAndUsage>
    <Description>Micafungin in Sodium Chloride Injection is a premixed, iso-osmotic, sterile, nonpyrogenic solution for intravenous (IV) infusion that contains micafungin sodium. Micafungin sodium is a semisynthetic lipopeptide (echinocandin). Micafungin in Sodium Chloride Injection is supplied as a refrigerated 50 mL, 100 mL, or 150 mL single-dose GALAXY container in the following presentations. 50 mg/50 mL (1 mg/mL): containing 50 mg of micafungin (equivalent to 50.87 mg of micafungin sodium); 36 mg citric acid, anhydrous; 450 mg sodium chloride; 92 mg sodium citrate dihydrate;. 100 mg/100 mL (1 mg/mL): containing 100 mg of micafungin (equivalent to 101.73 mg of micafungin sodium); 72 mg citric acid, anhydrous; 900 mg sodium chloride; 184 mg sodium citrate dihydrate;. 150 mg/150 mL (1 mg/mL): containing 150 mg of micafungin (equivalent to 152.60 mg of micafungin sodium); 108 mg citric acid, anhydrous; 1350 mg sodium chloride; 276 mg sodium citrate dihydrate. : 1 Each 50 mg/50 mL Galaxy container of Micafungin in Sodium Chloride Injection contains 200 mg of sodium., 2 Each 100 mg/100 mL Galaxy container of Micafungin in Sodium Chloride Injection contains 400 mg of sodium., 3 Each 150 mg/150 mL Galaxy container of Micafungin in Sodium Chloride Injection contains 600 mg of sodium.</Description>
  </NDC>
  <NDC>
    <NDCCode>0338-9055-10</NDCCode>
    <PackageDescription>10 CARTON in 1 CARTON (0338-9055-10)  / 1 BAG in 1 CARTON (0338-9055-01)  / 150 mL in 1 BAG</PackageDescription>
    <NDC11Code>00338-9055-10</NDC11Code>
    <ProductNDC>0338-9055</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Micafungin In Sodium Chloride</ProprietaryName>
    <NonProprietaryName>Micafungin In Sodium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20230929</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA216142</ApplicationNumber>
    <LabelerName>Baxter Healthcare Corporation</LabelerName>
    <SubstanceName>MICAFUNGIN SODIUM</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/150mL</StrengthUnit>
    <Pharm_Classes>Echinocandin Antifungal [EPC], Lipopeptides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230929</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Micafungin in Sodium Chloride Injection is indicated for: 1 Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older for whom appropriate dosing with this formulation can be achieved [see Clinical Studies (14.1) and Use in Specific Populations (8.4)]., 2 Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age for whom appropriate dosing with this formulation can be achieved [see Use in Specific Populations (8.4)]., 3 Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older for whom appropriate dosing with this formulation can be achieved [see Clinical Studies (14.2)]., 4 Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing hematopoietic stem cell transplantation for whom appropriate dosing with this formulation can be achieved [see Clinical Studies (14.3)].</IndicationAndUsage>
    <Description>Micafungin in Sodium Chloride Injection is a premixed, iso-osmotic, sterile, nonpyrogenic solution for intravenous (IV) infusion that contains micafungin sodium. Micafungin sodium is a semisynthetic lipopeptide (echinocandin). Micafungin in Sodium Chloride Injection is supplied as a refrigerated 50 mL, 100 mL, or 150 mL single-dose GALAXY container in the following presentations. 50 mg/50 mL (1 mg/mL): containing 50 mg of micafungin (equivalent to 50.87 mg of micafungin sodium); 36 mg citric acid, anhydrous; 450 mg sodium chloride; 92 mg sodium citrate dihydrate;. 100 mg/100 mL (1 mg/mL): containing 100 mg of micafungin (equivalent to 101.73 mg of micafungin sodium); 72 mg citric acid, anhydrous; 900 mg sodium chloride; 184 mg sodium citrate dihydrate;. 150 mg/150 mL (1 mg/mL): containing 150 mg of micafungin (equivalent to 152.60 mg of micafungin sodium); 108 mg citric acid, anhydrous; 1350 mg sodium chloride; 276 mg sodium citrate dihydrate. : 1 Each 50 mg/50 mL Galaxy container of Micafungin in Sodium Chloride Injection contains 200 mg of sodium., 2 Each 100 mg/100 mL Galaxy container of Micafungin in Sodium Chloride Injection contains 400 mg of sodium., 3 Each 150 mg/150 mL Galaxy container of Micafungin in Sodium Chloride Injection contains 600 mg of sodium.</Description>
  </NDC>
  <NDC>
    <NDCCode>59088-108-59</NDCCode>
    <PackageDescription>100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-108-59) </PackageDescription>
    <NDC11Code>59088-0108-59</NDC11Code>
    <ProductNDC>59088-108</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Multivitamin With Fluoride</ProprietaryName>
    <NonProprietaryName>Sodium Fluoride</NonProprietaryName>
    <DosageFormName>TABLET, CHEWABLE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110601</StartMarketingDate>
    <EndMarketingDate>20250131</EndMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>PureTek Corporation</LabelerName>
    <SubstanceName>.ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM ASCORBATE; SODIUM FLUORIDE; THIAMINE MONONITRATE; VITAMIN A</SubstanceName>
    <StrengthNumber>10; 24; 10; 4.5; 300; 13.5; 1.05; 1.2; 36; .5; 1.05; 750</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1</StrengthUnit>
    <Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Ascorbic Acid [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-02-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20110601</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250131</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>63323-300-36</NDCCode>
    <PackageDescription>10 VIAL in 1 BOX (63323-300-36)  / 15 mL in 1 VIAL</PackageDescription>
    <NDC11Code>63323-0300-36</NDC11Code>
    <ProductNDC>63323-300</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Piperacillin And Tazobactam</ProprietaryName>
    <NonProprietaryName>Piperacillin Sodium,tazobactam Sodium</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20091013</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065523</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>PIPERACILLIN SODIUM; TAZOBACTAM SODIUM</SubstanceName>
    <StrengthNumber>3; .375</StrengthNumber>
    <StrengthUnit>g/15mL; g/15mL</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-10-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20091013</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Piperacillin and tazobactam for injection is a combination product consisting of a penicillin-class antibacterial, piperacillin, and a β-lactamase inhibitor, tazobactam, indicated for the treatment of patients with moderate to severe infections caused by susceptible isolates of the designated bacteria in the conditions listed below.</IndicationAndUsage>
    <Description>Piperacillin and tazobactam for injection is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the β-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin.  The chemical name of piperacillin sodium is sodium (2 S,5 R,6 R)-6-[( R)-2-(4-ethyl-2,3-dioxo-1-piperazinecarboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate.  The chemical formula is C 23H 26N 5NaO 7S and the molecular weight is 539.5.  The chemical structure of piperacillin sodium is:. Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone.  Its chemical name is sodium (2 S,3 S,5 R)-3-methyl-7-oxo-3-(1 H-1,2,3-triazol-1-ylmethyl)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide.  The chemical formula is C 10H 11N 4NaO 5S and the molecular weight is 322.3.  The chemical structure of tazobactam sodium is:. Piperacillin and tazobactam for injection, piperacillin/tazobactam parenteral combination, is a white to off-white sterile, cryodesiccated powder consisting of piperacillin and tazobactam as their sodium salts packaged in glass vials.  The product does not contain excipients or preservatives. Each piperacillin and tazobactam for injection 2.25 g single dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 2 grams of piperacillin and tazobactam sodium equivalent to 0.25 g of tazobactam.  Each vial contains 4.7 mEq (108 mg) of sodium. Each piperacillin and tazobactam for injection 3.375 g single dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 3 grams of piperacillin and tazobactam sodium equivalent to 0.375 g of tazobactam.  Each vial contains 7.0 mEq (162 mg) of sodium. Each piperacillin and tazobactam for injection 4.5 g single dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 4 grams of piperacillin and tazobactam sodium equivalent to 0.5 g of tazobactam.  Each vial contains 9.4 mEq (216 mg) of sodium. Piperacillin and tazobactam for injection is a monosodium salt of piperacillin and a monosodium salt of tazobactam containing a total of 2.35 mEq (54 mg) of sodium (Na  +) per gram of piperacillin in the combination product.</Description>
  </NDC>
  <NDC>
    <NDCCode>68462-108-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (68462-108-05) </PackageDescription>
    <NDC11Code>68462-0108-05</NDC11Code>
    <ProductNDC>68462-108</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Topiramate</ProprietaryName>
    <NonProprietaryName>Topiramate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090327</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077627</ApplicationNumber>
    <LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
    <SubstanceName>TOPIRAMATE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200730</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Topiramate tablets are indicated for: : 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).</IndicationAndUsage>
    <Description>Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate Tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate, USP is a white to off-white powder. It is freely soluble in dichloromethane. Topiramate, USP has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate, USP is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets, USP contain the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide. The 50 mg tablets also contain FD&amp;C yellow# 6 and iron oxide yellow for color. The 100 mg and 200 mg tablets also contain iron oxide red and iron oxide yellow for color.</Description>
  </NDC>
  <NDC>
    <NDCCode>68462-108-10</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (68462-108-10) </PackageDescription>
    <NDC11Code>68462-0108-10</NDC11Code>
    <ProductNDC>68462-108</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Topiramate</ProprietaryName>
    <NonProprietaryName>Topiramate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090327</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077627</ApplicationNumber>
    <LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
    <SubstanceName>TOPIRAMATE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090327</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Topiramate tablets are indicated for: : 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).</IndicationAndUsage>
    <Description>Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate Tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate, USP is a white to off-white powder. It is freely soluble in dichloromethane. Topiramate, USP has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate, USP is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets, USP contain the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide. The 50 mg tablets also contain FD&amp;C yellow# 6 and iron oxide yellow for color. The 100 mg and 200 mg tablets also contain iron oxide red and iron oxide yellow for color.</Description>
  </NDC>
  <NDC>
    <NDCCode>68462-108-60</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (68462-108-60) </PackageDescription>
    <NDC11Code>68462-0108-60</NDC11Code>
    <ProductNDC>68462-108</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Topiramate</ProprietaryName>
    <NonProprietaryName>Topiramate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090327</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077627</ApplicationNumber>
    <LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
    <SubstanceName>TOPIRAMATE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090327</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Topiramate tablets are indicated for: : 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).</IndicationAndUsage>
    <Description>Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate Tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate, USP is a white to off-white powder. It is freely soluble in dichloromethane. Topiramate, USP has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate, USP is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets, USP contain the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide. The 50 mg tablets also contain FD&amp;C yellow# 6 and iron oxide yellow for color. The 100 mg and 200 mg tablets also contain iron oxide red and iron oxide yellow for color.</Description>
  </NDC>
  <NDC>
    <NDCCode>69269-103-90</NDCCode>
    <PackageDescription>88 mL in 1 BOTTLE, PLASTIC (69269-103-90)</PackageDescription>
    <NDC11Code>69269-0103-90</NDC11Code>
    <ProductNDC>69269-103</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Obagi</ProprietaryName>
    <NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20141014</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>YS PLUS CORPORATION</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>20; 155</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-06-14</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>69269-104-90</NDCCode>
    <PackageDescription>85 g in 1 TUBE (69269-104-90)</PackageDescription>
    <NDC11Code>69269-0104-90</NDC11Code>
    <ProductNDC>69269-104</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Obagi</ProprietaryName>
    <NonProprietaryName>Octinoxate, Zinc Oxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20141001</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>YS PLUS CORPORATION</LabelerName>
    <SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>75; 105</StrengthNumber>
    <StrengthUnit>mg/g; mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-06-14</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>69269-106-10</NDCCode>
    <PackageDescription>1 BOTTLE, GLASS in 1 CARTON (69269-106-10)  &gt; 30 mL in 1 BOTTLE, GLASS</PackageDescription>
    <NDC11Code>69269-0106-10</NDC11Code>
    <ProductNDC>69269-106</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Obagi - C</ProprietaryName>
    <NonProprietaryName>Hydroquinone</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20141001</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>YS PLUS CORPORATION</LabelerName>
    <SubstanceName>HYDROQUINONE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>The gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles. senile lentigines, and other unwanted areas of melanin hyperpigmentation.</IndicationAndUsage>
    <Description>Hydroquinone is 1,4 - bensenediol. Hydroquinone occurs as fine, white needles. The drug is freely. soluble in water and in alcohol. Chemically, hydroquinone is designated as p - dihydroxybenzene;. the empirical formula is C6H6O2; molecular weight is 110.11 g / moL.</Description>
  </NDC>
  <NDC>
    <NDCCode>69269-107-90</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (69269-107-90)  &gt; 90 mL in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>69269-0107-90</NDC11Code>
    <ProductNDC>69269-107</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Obagi</ProprietaryName>
    <NonProprietaryName>Octinoxate, Zinc Oxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20141001</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>YS PLUS CORPORATION</LabelerName>
    <SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>75; 90</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-06-14</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>69269-110-60</NDCCode>
    <PackageDescription>118 mL in 1 BOTTLE, PLASTIC (69269-110-60)</PackageDescription>
    <NDC11Code>69269-0110-60</NDC11Code>
    <ProductNDC>69269-110</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Obagi</ProprietaryName>
    <NonProprietaryName>Salicylic Acid</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20141015</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part333D</ApplicationNumber>
    <LabelerName>YS PLUS CORPORATION</LabelerName>
    <SubstanceName>SALICYLIC ACID</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-06-14</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>69269-111-60</NDCCode>
    <PackageDescription>118 mL in 1 BOTTLE, PLASTIC (69269-111-60)</PackageDescription>
    <NDC11Code>69269-0111-60</NDC11Code>
    <ProductNDC>69269-111</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Obagi</ProprietaryName>
    <NonProprietaryName>Salicylic Acid</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20141015</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part333D</ApplicationNumber>
    <LabelerName>YS PLUS CORPORATION</LabelerName>
    <SubstanceName>SALICYLIC ACID</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-06-14</LastUpdate>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>69269-108-36</NDCCode><ProprietaryName>Obagi</ProprietaryName><NonProprietaryName>Octisalate, Octinoxate, Oxybenzone</NonProprietaryName></NDC><NDC><NDCCode>69269-100-36</NDCCode><ProprietaryName>Obagi Nu-derm</ProprietaryName><NonProprietaryName>Hydroquinone</NonProprietaryName></NDC><NDC><NDCCode>69269-101-36</NDCCode><ProprietaryName>Obagi Nu-derm</ProprietaryName><NonProprietaryName>Hydroquinone</NonProprietaryName></NDC><NDC><NDCCode>69269-105-36</NDCCode><ProprietaryName>Obagi - C</ProprietaryName><NonProprietaryName>Hydroquinone</NonProprietaryName></NDC><NDC><NDCCode>69269-116-36</NDCCode><ProprietaryName>Obagi Nu-derm Sunfader</ProprietaryName><NonProprietaryName>Hydroquinone, Octinoxate, Oxybenzone</NonProprietaryName></NDC><NDC><NDCCode>69269-520-00</NDCCode><ProprietaryName>Obagi</ProprietaryName><NonProprietaryName>Hydroquinone, Octinoxate, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>69269-523-04</NDCCode><ProprietaryName>Obagi</ProprietaryName><NonProprietaryName>Hydroquinone, Octinoxate, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>69269-524-04</NDCCode><ProprietaryName>Obagi</ProprietaryName><NonProprietaryName>Hydroquinone</NonProprietaryName></NDC><NDC><NDCCode>47682-108-36</NDCCode><ProprietaryName>Medique Cold Cough Product</ProprietaryName><NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl ,</NonProprietaryName></NDC><NDC><NDCCode>62032-108-36</NDCCode><ProprietaryName>Obagi-c Rx System C-exfoliating Day</ProprietaryName><NonProprietaryName>Octisalate, Octinoxate, And Oxybenzone</NonProprietaryName></NDC><NDC><NDCCode>65753-108-36</NDCCode><ProprietaryName>Sun X Spf 50 Broad Spectrum Sunscreen Lip Balm</ProprietaryName><NonProprietaryName>Avobenzone, Homosalate, Octinoxate, Octisalate, Petrolatum</NonProprietaryName></NDC><NDC><NDCCode>65753-514-36</NDCCode><ProprietaryName>Coretex Professional Outdoor Skin Protection Wallet</ProprietaryName><NonProprietaryName>Coretex Professional Outdoor Skin Protection Wallet</NonProprietaryName></NDC><NDC><NDCCode>65753-515-36</NDCCode><ProprietaryName>Coretex Professional Outdoor Skin Protection Wallet Refill</ProprietaryName><NonProprietaryName>Coretex Professional Outdoor Skin Protection Wallet Refill</NonProprietaryName></NDC><NDC><NDCCode>67091-108-36</NDCCode><ProprietaryName>Winco Foods Effervescent Antacid And Pain Relief</ProprietaryName><NonProprietaryName>Aspirin, Sodium Bicarbonate, Citric Acid Tablet</NonProprietaryName></NDC><NDC><NDCCode>73069-108-36</NDCCode><ProprietaryName>Viatrexx-derma</ProprietaryName><NonProprietaryName>Anti-interleukin 1, Ankle Articulations, Beta Endorphin, Bfgf, Calcaneal Tendon, Hip Articulation, Knee Articulation, Liver, Transforming Growth Factor-1, Transforming Gf-beta</NonProprietaryName></NDC><NDC><NDCCode>0004-0381-40</NDCCode><ProprietaryName>Fuzeon</ProprietaryName><NonProprietaryName>Enfuvirtide</NonProprietaryName></NDC><NDC><NDCCode>0338-9051-12</NDCCode><ProprietaryName>Micafungin In Sodium Chloride</ProprietaryName><NonProprietaryName>Micafungin In Sodium Chloride</NonProprietaryName></NDC><NDC><NDCCode>0338-9053-12</NDCCode><ProprietaryName>Micafungin In Sodium Chloride</ProprietaryName><NonProprietaryName>Micafungin In Sodium Chloride</NonProprietaryName></NDC><NDC><NDCCode>0338-9055-10</NDCCode><ProprietaryName>Micafungin In Sodium Chloride</ProprietaryName><NonProprietaryName>Micafungin In Sodium Chloride</NonProprietaryName></NDC><NDC><NDCCode>59088-108-59</NDCCode><ProprietaryName>Multivitamin With Fluoride</ProprietaryName><NonProprietaryName>Sodium Fluoride</NonProprietaryName></NDC><NDC><NDCCode>63323-300-36</NDCCode><ProprietaryName>Piperacillin And Tazobactam</ProprietaryName><NonProprietaryName>Piperacillin Sodium,tazobactam Sodium</NonProprietaryName></NDC><NDC><NDCCode>68462-108-05</NDCCode><ProprietaryName>Topiramate</ProprietaryName><NonProprietaryName>Topiramate</NonProprietaryName></NDC><NDC><NDCCode>68462-108-10</NDCCode><ProprietaryName>Topiramate</ProprietaryName><NonProprietaryName>Topiramate</NonProprietaryName></NDC><NDC><NDCCode>68462-108-60</NDCCode><ProprietaryName>Topiramate</ProprietaryName><NonProprietaryName>Topiramate</NonProprietaryName></NDC><NDC><NDCCode>69269-103-90</NDCCode><ProprietaryName>Obagi</ProprietaryName><NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>69269-104-90</NDCCode><ProprietaryName>Obagi</ProprietaryName><NonProprietaryName>Octinoxate, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>69269-106-10</NDCCode><ProprietaryName>Obagi - C</ProprietaryName><NonProprietaryName>Hydroquinone</NonProprietaryName></NDC><NDC><NDCCode>69269-107-90</NDCCode><ProprietaryName>Obagi</ProprietaryName><NonProprietaryName>Octinoxate, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>69269-110-60</NDCCode><ProprietaryName>Obagi</ProprietaryName><NonProprietaryName>Salicylic Acid</NonProprietaryName></NDC><NDC><NDCCode>69269-111-60</NDCCode><ProprietaryName>Obagi</ProprietaryName><NonProprietaryName>Salicylic Acid</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",
      "AuthorizedOfficialMiddleName": "C",
      "AuthorizedOfficialTitle": "DR",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-3574",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "OD00001172",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "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."
    },
    {
      "NPI": "1376755009",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "PERIMAN",
      "FirstName": "LAURA",
      "MiddleName": "MARIE",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "FirstLineMailingAddress": "623 W HIGHLAND DR",
      "MailingAddressCityName": "SEATTLE",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98119-3446",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "206-282-2716",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "SecondLinePracticeLocationAddress": "REDMOND EYE CLINIC",
      "PracticeLocationAddressCityName": "REDMOND",
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  ]
}

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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