RESTful Lookup — Test-Drive (2007 – 2026)

Query complete (28 ms elapsed)

{
  "NDC": [
    {
      "NDCCode": "51660-333-24",
      "PackageDescription": "1 BOTTLE in 1 CARTON (51660-333-24)  / 24 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE",
      "NDC11Code": "51660-0333-24",
      "ProductNDC": "51660-333",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Arthritis Pain Reliever",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20020430",
      "EndMarketingDate": "20251231",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076200",
      "LabelerName": "Ohm Laboratories Inc.",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "650",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20210903",
      "EndMarketingDatePackage": "20251231",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves minor aches and pains due to: minor pain of arthritismuscular achesbackachepremenstrual and menstrual crampsthe common coldheadachetoothache. temporarily reduces fever."
    },
    {
      "NDCCode": "51660-333-01",
      "PackageDescription": "1 BOTTLE in 1 CARTON (51660-333-01)  / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE",
      "NDC11Code": "51660-0333-01",
      "ProductNDC": "51660-333",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Arthritis Pain Reliever",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20020430",
      "EndMarketingDate": "20251231",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076200",
      "LabelerName": "Ohm Laboratories Inc.",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "650",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20020430",
      "EndMarketingDatePackage": "20251231",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves minor aches and pains due to: minor pain of arthritismuscular achesbackachepremenstrual and menstrual crampsthe common coldheadachetoothache. temporarily reduces fever."
    },
    {
      "NDCCode": "51660-333-50",
      "PackageDescription": "1 BOTTLE in 1 CARTON (51660-333-50)  / 50 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE",
      "NDC11Code": "51660-0333-50",
      "ProductNDC": "51660-333",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Arthritis Pain Reliever",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20020430",
      "EndMarketingDate": "20251231",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076200",
      "LabelerName": "Ohm Laboratories Inc.",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "650",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20020430",
      "EndMarketingDatePackage": "20251231",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves minor aches and pains due to: minor pain of arthritismuscular achesbackachepremenstrual and menstrual crampsthe common coldheadachetoothache. temporarily reduces fever."
    },
    {
      "NDCCode": "51660-069-24",
      "PackageDescription": "4 BLISTER PACK in 1 CARTON (51660-069-24)  > 6 TABLET in 1 BLISTER PACK",
      "NDC11Code": "51660-0069-24",
      "ProductNDC": "51660-069",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Loperamide Hcl And Simethicone",
      "NonProprietaryName": "Loperamide Hcl And Simethicone",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220113",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077500",
      "LabelerName": "Ohm Laboratories Inc.",
      "SubstanceName": "LOPERAMIDE HYDROCHLORIDE; DIMETHICONE",
      "StrengthNumber": "2; 125",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA], Skin Barrier Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2022-09-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220113",
      "SamplePackage": "N",
      "IndicationAndUsage": "relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas."
    },
    {
      "NDCCode": "51660-123-24",
      "PackageDescription": "4 BLISTER PACK in 1 CARTON (51660-123-24)  / 6 TABLET in 1 BLISTER PACK",
      "NDC11Code": "51660-0123-24",
      "ProductNDC": "51660-123",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Loperamide Hydrochloride",
      "NonProprietaryName": "Loperamide Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19930201",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074091",
      "LabelerName": "Ohm Laboratories Inc.",
      "SubstanceName": "LOPERAMIDE HYDROCHLORIDE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-01-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19930201",
      "SamplePackage": "N",
      "IndicationAndUsage": "controls symptoms of diarrhea, including Travelers' Diarrhea."
    },
    {
      "NDCCode": "51660-351-24",
      "PackageDescription": "24 BLISTER PACK in 1 CARTON (51660-351-24)  > 1 TABLET in 1 BLISTER PACK",
      "NDC11Code": "51660-0351-24",
      "ProductNDC": "51660-351",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Acid Reducer",
      "NonProprietaryName": "Ranitidine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110628",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA200536",
      "LabelerName": "Ohm Laboratories Inc.",
      "SubstanceName": "RANITIDINE HYDROCHLORIDE",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-13",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "51660-940-24",
      "PackageDescription": "4 BLISTER PACK in 1 CARTON (51660-940-24)  / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK",
      "NDC11Code": "51660-0940-24",
      "ProductNDC": "51660-940",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Allergy Relief-d",
      "NonProprietaryName": "Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170502",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090922",
      "LabelerName": "Ohm Laboratories Inc.",
      "SubstanceName": "CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE",
      "StrengthNumber": "5; 120",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20170502",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:runny nosesneezingitchy, watery eyesitching of the nose or throatnasal congestion. reduces swelling of nasal passages. temporarily relieves sinus congestion and pressure. temporarily restores freer breathing through the nose."
    },
    {
      "NDCCode": "10956-333-24",
      "PackageDescription": "2 BLISTER PACK in 1 CARTON (10956-333-24)  > 12 TABLET in 1 BLISTER PACK",
      "NDC11Code": "10956-0333-24",
      "ProductNDC": "10956-333",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Preferred Maximum Strength Urinary Pain Relief",
      "NonProprietaryName": "Phenazopyridine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150115",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Reese Pharmaceutical Co",
      "SubstanceName": "PHENAZOPYRIDINE HYDROCHLORIDE",
      "StrengthNumber": "97.5",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2021-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20150115",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fast relief from urinary pain, burning, urgency and frequency associated with urinary tractinfections."
    },
    {
      "NDCCode": "25113-333-24",
      "PackageDescription": "769 g in 1 BOTTLE (25113-333-24)",
      "NDC11Code": "25113-0333-24",
      "ProductNDC": "25113-333",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Germasidol",
      "NonProprietaryName": "Triclosan",
      "DosageFormName": "SOAP",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140429",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "The Dodge Company Inc.",
      "SubstanceName": "TRICLOSAN",
      "StrengthNumber": ".0057",
      "StrengthUnit": "g/g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Antiseptic handwash for handwashing to decrease baceria on the skin."
    },
    {
      "NDCCode": "55319-333-23",
      "PackageDescription": "24 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55319-333-23) ",
      "NDC11Code": "55319-0333-23",
      "ProductNDC": "55319-333",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Acetaminophen",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170901",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076200",
      "LabelerName": "Family Dollar Services, Inc.",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "650",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20170901",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves minor aches and pains due to:minor pain of arthritismuscular achesbackachepremenstrual and menstrual crampsthe common coldheadachetoothache. temporarily reduces fever."
    },
    {
      "NDCCode": "63868-333-24",
      "PackageDescription": "2 BLISTER PACK in 1 CARTON (63868-333-24)  / 12 TABLET in 1 BLISTER PACK",
      "NDC11Code": "63868-0333-24",
      "ProductNDC": "63868-333",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Allergy Relief",
      "NonProprietaryName": "Chlorpheniramine Maleate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210708",
      "EndMarketingDate": "20270531",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "CHAIN DRUG MARKETING ASSOCIATION INC",
      "SubstanceName": "CHLORPHENIRAMINE MALEATE",
      "StrengthNumber": "4",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20210708",
      "EndMarketingDatePackage": "20270531",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 itchy, watery eyes, 3 sneezing, 4 itching of the nose or throat."
    },
    {
      "NDCCode": "71571-333-24",
      "PackageDescription": "2.4 mL in 1 BOTTLE, DROPPER (71571-333-24) ",
      "NDC11Code": "71571-0333-24",
      "ProductNDC": "71571-333",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Eysuvis",
      "NonProprietaryName": "Loteprednol Etabonate",
      "DosageFormName": "SUSPENSION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20201118",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA210933",
      "LabelerName": "ALCON LABORATORIES, INC.",
      "SubstanceName": "LOTEPREDNOL ETABONATE",
      "StrengthNumber": "2.5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-03-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201118",
      "SamplePackage": "Y",
      "IndicationAndUsage": "EYSUVIS is a corticosteroid indicated for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease.",
      "Description": "Loteprednol etabonate is a corticosteroid. Its chemical name is chloromethyl 17α-[(ethoxycarbonyl)oxy]-11β-hydroxy-3-oxoandrosta-1,4-diene-17β-carboxylate. Its molecular formula is C24H31ClO7 and its chemical structure is. C24H31ClO7Mol. Wt. 467.0. EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25% contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. Each mL contains: 1 ACTIVE: loteprednol etabonate 2.5 mg (0.25%), 2 INACTIVES: glycerin, sodium citrate dihydrate, sodium chloride, Poloxamer 407, edetate disodium dihydrate, citric acid, and water for injection., 3 PRESERVATIVE: benzalkonium chloride 0.01%."
    },
    {
      "NDCCode": "51660-027-14",
      "PackageDescription": "1 BOTTLE in 1 CARTON (51660-027-14)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE",
      "NDC11Code": "51660-0027-14",
      "ProductNDC": "51660-027",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Esomeprazole",
      "NonProprietaryName": "Esomeprazole Magnesium",
      "DosageFormName": "CAPSULE, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200814",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212866",
      "LabelerName": "Ohm Laboratories Inc.",
      "SubstanceName": "ESOMEPRAZOLE MAGNESIUM",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-06-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20200814",
      "SamplePackage": "N",
      "IndicationAndUsage": "treats frequent heartburn (occurs 2 or moredays a week) . not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect."
    },
    {
      "NDCCode": "51660-027-27",
      "PackageDescription": "2 BOTTLE in 1 CARTON (51660-027-27)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE",
      "NDC11Code": "51660-0027-27",
      "ProductNDC": "51660-027",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Esomeprazole",
      "NonProprietaryName": "Esomeprazole Magnesium",
      "DosageFormName": "CAPSULE, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200814",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212866",
      "LabelerName": "Ohm Laboratories Inc.",
      "SubstanceName": "ESOMEPRAZOLE MAGNESIUM",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-06-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20200814",
      "SamplePackage": "N",
      "IndicationAndUsage": "treats frequent heartburn (occurs 2 or moredays a week) . not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect."
    },
    {
      "NDCCode": "51660-027-44",
      "PackageDescription": "3 BOTTLE in 1 CARTON (51660-027-44)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE",
      "NDC11Code": "51660-0027-44",
      "ProductNDC": "51660-027",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Esomeprazole",
      "NonProprietaryName": "Esomeprazole Magnesium",
      "DosageFormName": "CAPSULE, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200814",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212866",
      "LabelerName": "Ohm Laboratories Inc.",
      "SubstanceName": "ESOMEPRAZOLE MAGNESIUM",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-06-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20200814",
      "SamplePackage": "N",
      "IndicationAndUsage": "treats frequent heartburn (occurs 2 or moredays a week) . not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect."
    },
    {
      "NDCCode": "51660-301-21",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (51660-301-21)  / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
      "NDC11Code": "51660-0301-21",
      "ProductNDC": "51660-301",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Guaifenesin And Dextromethorphan Hbr",
      "NonProprietaryName": "Guaifenesin And Dextromethorphan Hbr",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210701",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA214781",
      "LabelerName": "OHM LABORATORIES INC",
      "SubstanceName": "GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE",
      "StrengthNumber": "600; 30",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-04-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20210701",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritantsthe intensity of coughingthe impulse to cough to help you get to sleep."
    },
    {
      "NDCCode": "51660-301-41",
      "PackageDescription": "2 BLISTER PACK in 1 CARTON (51660-301-41)  / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
      "NDC11Code": "51660-0301-41",
      "ProductNDC": "51660-301",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Guaifenesin And Dextromethorphan Hbr",
      "NonProprietaryName": "Guaifenesin And Dextromethorphan Hbr",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210701",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA214781",
      "LabelerName": "OHM LABORATORIES INC",
      "SubstanceName": "GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE",
      "StrengthNumber": "600; 30",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-04-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20210701",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritantsthe intensity of coughingthe impulse to cough to help you get to sleep."
    },
    {
      "NDCCode": "51660-526-03",
      "PackageDescription": "5000 TABLET in 1 BAG (51660-526-03) ",
      "NDC11Code": "51660-0526-03",
      "ProductNDC": "51660-526",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Loratadine",
      "DosageFormName": "TABLET",
      "StartMarketingDate": "20241128",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "OHM LABORATORIES INC",
      "SubstanceName": "LORATADINE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Status": "Unfinished",
      "LastUpdate": "2025-08-28",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "28-NOV-24"
    },
    {
      "NDCCode": "51660-939-04",
      "PackageDescription": "5000 TABLET in 1 BAG (51660-939-04) ",
      "NDC11Code": "51660-0939-04",
      "ProductNDC": "51660-939",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Cetirizine Hydrochloride",
      "DosageFormName": "TABLET",
      "StartMarketingDate": "20241128",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Ohm Laboratories Inc",
      "SubstanceName": "CETIRIZINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Status": "Unfinished",
      "LastUpdate": "2025-08-28",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "28-NOV-24"
    },
    {
      "NDCCode": "0362-9048-02",
      "PackageDescription": "50 CARTRIDGE in 1 CARTON (0362-9048-02)  / 1.7 mL in 1 CARTRIDGE",
      "NDC11Code": "00362-9048-02",
      "ProductNDC": "0362-9048",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Septocaine And Epinephrine",
      "NonProprietaryName": "Articaine Hydrochloride And Epinephrine Bitartrate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBMUCOSAL",
      "StartMarketingDate": "20110112",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020971",
      "LabelerName": "Septodont Inc.",
      "SubstanceName": "ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE",
      "StrengthNumber": "40; .005",
      "StrengthUnit": "mg/mL; mg/mL",
      "Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-10-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20110112",
      "SamplePackage": "N",
      "IndicationAndUsage": "SEPTOCAINE is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older.",
      "Description": "SEPTOCAINE (articaine hydrochloride and epinephrine injection), for intraoral submucosal infiltration use, is a sterile, aqueous solution that contains articaine HCl 4% (68 mg/1.7mL) (40 mg/mL) and epinephrine bitartrate in an epinephrine 1:200,000 or epinephrine 1:100,000 strength.Articaine HCl is an amino amide local anesthetic, chemically designated as 4-methyl-3-[2-(propylamino)-propionamido]-2-thiophene-carboxylic acid, methyl ester hydrochloride and is a racemic mixture. Articaine HCl has a molecular weight of 320.84 and the following structural formula. Articaine HCl has a partition coefficient in n-octanol/Soerensen buffer (pH 7.35) of 17 and a pKa of 7.8. Epinephrine bitartrate, (-)-1-(3,4-Dihydroxyphenyl)-2-methylamino-ethanol (+) tartrate (1:1) salt, is a vasoconstrictor with a concentration of 1:200,000 or 1:100,000 (expressed as free base). It has a molecular weight of 333.3 and the following structural formula. SEPTOCAINE contains the following inactive ingredients: sodium chloride (1.6 mg/mL) and sodium metabisulfite (0.5 mg/mL). The product is formulated with a 15% overage of epinephrine. The pH is adjusted with sodium hydroxide."
    },
    {
      "NDCCode": "0362-9049-02",
      "PackageDescription": "50 CARTRIDGE in 1 CARTON (0362-9049-02)  / 1.7 mL in 1 CARTRIDGE",
      "NDC11Code": "00362-9049-02",
      "ProductNDC": "0362-9049",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Septocaine And Epinephrine",
      "NonProprietaryName": "Articaine Hydrochloride And Epinephrine Bitartrate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBMUCOSAL",
      "StartMarketingDate": "20110112",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020971",
      "LabelerName": "Septodont Inc.",
      "SubstanceName": "ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE",
      "StrengthNumber": "40; .01",
      "StrengthUnit": "mg/mL; mg/mL",
      "Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-10-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20110112",
      "SamplePackage": "N",
      "IndicationAndUsage": "SEPTOCAINE is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older.",
      "Description": "SEPTOCAINE (articaine hydrochloride and epinephrine injection), for intraoral submucosal infiltration use, is a sterile, aqueous solution that contains articaine HCl 4% (68 mg/1.7mL) (40 mg/mL) and epinephrine bitartrate in an epinephrine 1:200,000 or epinephrine 1:100,000 strength.Articaine HCl is an amino amide local anesthetic, chemically designated as 4-methyl-3-[2-(propylamino)-propionamido]-2-thiophene-carboxylic acid, methyl ester hydrochloride and is a racemic mixture. Articaine HCl has a molecular weight of 320.84 and the following structural formula. Articaine HCl has a partition coefficient in n-octanol/Soerensen buffer (pH 7.35) of 17 and a pKa of 7.8. Epinephrine bitartrate, (-)-1-(3,4-Dihydroxyphenyl)-2-methylamino-ethanol (+) tartrate (1:1) salt, is a vasoconstrictor with a concentration of 1:200,000 or 1:100,000 (expressed as free base). It has a molecular weight of 333.3 and the following structural formula. SEPTOCAINE contains the following inactive ingredients: sodium chloride (1.6 mg/mL) and sodium metabisulfite (0.5 mg/mL). The product is formulated with a 15% overage of epinephrine. The pH is adjusted with sodium hydroxide."
    },
    {
      "NDCCode": "43063-536-24",
      "PackageDescription": "24 CAPSULE in 1 BOTTLE, PLASTIC (43063-536-24) ",
      "NDC11Code": "43063-0536-24",
      "ProductNDC": "43063-536",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cephalexin",
      "NonProprietaryName": "Cephalexin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110119",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090836",
      "LabelerName": "PD-Rx Pharmaceuticals, Inc.",
      "SubstanceName": "CEPHALEXIN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2026-03-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20140206",
      "SamplePackage": "N",
      "IndicationAndUsage": "Cephalexin is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria.  To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, Cephalexin should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (1.6).",
      "Description": "Cephalexin capsules, USP is a semisynthetic cephalosporin antibacterial drug intended for oral administration. It is 7-(D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C 16H 17N 3O 4SH 2O and the molecular weight is 365.41. Cephalexin has the following structural formula:. Each capsule contains cephalexin monohydrate equivalent to 250 mg, 333 mg, 500 mg, or 750 mg of cephalexin. The 250 mg, 333 mg, 500 mg and 750 mg capsules contain anhydrous lactose, colloidal silicon dioxide, magnesium stearate, FD & C Blue No. 1, D & C Yellow No. 10, gelatin, sodium lauryl sulphate, titanium dioxide. In addition, the 250 mg capsule contains FD & C Red No. 40; 333 mg and 750 mg Capsules contains FD & C Yellow No. 6. The imprinting ink contains; shellac, propylene glycol, strong ammonia solution and potassium hydroxide. Also black Iron oxide is used in 250mg, 333mg and 500mg and titanium dioxide is used in 750mg."
    },
    {
      "NDCCode": "46708-333-30",
      "PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-333-30) ",
      "NDC11Code": "46708-0333-30",
      "ProductNDC": "46708-333",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Carbidopa And Levodopa",
      "NonProprietaryName": "Carbidopa And Levodopa",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190606",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210341",
      "LabelerName": "Alembic Pharmaceuticals Limited",
      "SubstanceName": "CARBIDOPA; LEVODOPA",
      "StrengthNumber": "50; 200",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]",
      "Status": "Active",
      "LastUpdate": "2019-06-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190606",
      "SamplePackage": "N",
      "IndicationAndUsage": "Carbidopa and levodopa extended-release tablets, USP are indicated  in  the  treatment  of  Parkinson’s  disease,  post-encephalitic  parkinsonism,  and  symptomatic  parkinsonism  that  may  follow  carbon  monoxide  intoxication  or  manganese  intoxication.",
      "Description": "Carbidopa and levodopa extended-release tablets, USP are an extended-release  combination  of  carbidopa  and  levodopa  for  the treatment of Parkinson’s disease and  syndrome. Carbidopa, USP , an  inhibitor  of  aromatic  amino  acid  decarboxylation,  is  a  white to creamy white,  odorless or practically odorless powder,  freely soluble in 3N hydrochloric acid, slightly soluble in water and in methanol, practically insoluble in alcohol, in acetone, in chloroform and in ether, with a molecular weight of 244.24. It is designated chemically as  (-)-L-α­hydrazino-α-methyl-β-(3,4-dihydroxybenzene)  propanoic  acid  monohydrate. Its empirical formula  is C10H14N2O4H2O, and its structural formula  is.   Tablet  content  is  expressed  in  terms  of  anhydrous  carbidopa,  which  has  a  molecular  weight  of  226.24. Levodopa, USP, an  aromatic  amino  acid,  is  a  white to off-white, odorless , crystalline  powder,  slightly  soluble  in  water, freely soluble in 3N hydrochloric acid and insoluble in alcohol  with  a molecular weight of 197.19. It is designated chemically as  (-)-L-α-amino-β-(3,4-dihydroxybenzene)  propanoic  acid.  Its  empirical  formula  is  C9H11NO4,  and  its  structural  formula  is. Carbidopa and levodopa extended-release tablets, USP are supplied as extended-release tablets containing either 25 mg of carbidopa and 100 mg of levodopa, or 50 mg of carbidopa  and  200 mg of levodopa. Inactive ingredients  are hydroxypropyl  cellulose,  magnesium  stearate, and hypromellose. Carbidopa and levodopa extended-release tablets USP, 25 mg/100 mg and carbidopa and levodopa extended-release tablets USP, 50 mg/200 mg also contain FD&C  Blue  #2 Aluminium Lake  and  FD&C  Red  #40 Aluminium Lake. The  25 mg/100 mg  tablet  is  supplied  as  an  oval shaped  mottled  tablet  that  is  dappled-purple  in  color  and  is debossed with  “L519”  on  one  side  and  plain  on  the  other.  The  50 mg/200 mg  tablet  is  supplied  as  an  oval shaped  mottled  tablet  that  is  dappled-purple  in  color  and  is debossed with  “L520”  on  one  side  and  plain  on  the  other.  Carbidopa and levodopa extended-release tablets, USP are polymeric-based drug delivery system that controls the release of carbidopa and  levodopa  as  it  slowly  erodes.  Carbidopa and levodopa extended-release tablet 25 mg/100 mg  is  available  to  facilitate  titration  when  100  mg  steps  are  required. FDA approved dissolution specifications differs from the USP dissolution specifications."
    },
    {
      "NDCCode": "46708-333-31",
      "PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-333-31) ",
      "NDC11Code": "46708-0333-31",
      "ProductNDC": "46708-333",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Carbidopa And Levodopa",
      "NonProprietaryName": "Carbidopa And Levodopa",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190606",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210341",
      "LabelerName": "Alembic Pharmaceuticals Limited",
      "SubstanceName": "CARBIDOPA; LEVODOPA",
      "StrengthNumber": "50; 200",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]",
      "Status": "Active",
      "LastUpdate": "2019-06-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190606",
      "SamplePackage": "N",
      "IndicationAndUsage": "Carbidopa and levodopa extended-release tablets, USP are indicated  in  the  treatment  of  Parkinson’s  disease,  post-encephalitic  parkinsonism,  and  symptomatic  parkinsonism  that  may  follow  carbon  monoxide  intoxication  or  manganese  intoxication.",
      "Description": "Carbidopa and levodopa extended-release tablets, USP are an extended-release  combination  of  carbidopa  and  levodopa  for  the treatment of Parkinson’s disease and  syndrome. Carbidopa, USP , an  inhibitor  of  aromatic  amino  acid  decarboxylation,  is  a  white to creamy white,  odorless or practically odorless powder,  freely soluble in 3N hydrochloric acid, slightly soluble in water and in methanol, practically insoluble in alcohol, in acetone, in chloroform and in ether, with a molecular weight of 244.24. It is designated chemically as  (-)-L-α­hydrazino-α-methyl-β-(3,4-dihydroxybenzene)  propanoic  acid  monohydrate. Its empirical formula  is C10H14N2O4H2O, and its structural formula  is.   Tablet  content  is  expressed  in  terms  of  anhydrous  carbidopa,  which  has  a  molecular  weight  of  226.24. Levodopa, USP, an  aromatic  amino  acid,  is  a  white to off-white, odorless , crystalline  powder,  slightly  soluble  in  water, freely soluble in 3N hydrochloric acid and insoluble in alcohol  with  a molecular weight of 197.19. It is designated chemically as  (-)-L-α-amino-β-(3,4-dihydroxybenzene)  propanoic  acid.  Its  empirical  formula  is  C9H11NO4,  and  its  structural  formula  is. Carbidopa and levodopa extended-release tablets, USP are supplied as extended-release tablets containing either 25 mg of carbidopa and 100 mg of levodopa, or 50 mg of carbidopa  and  200 mg of levodopa. Inactive ingredients  are hydroxypropyl  cellulose,  magnesium  stearate, and hypromellose. Carbidopa and levodopa extended-release tablets USP, 25 mg/100 mg and carbidopa and levodopa extended-release tablets USP, 50 mg/200 mg also contain FD&C  Blue  #2 Aluminium Lake  and  FD&C  Red  #40 Aluminium Lake. The  25 mg/100 mg  tablet  is  supplied  as  an  oval shaped  mottled  tablet  that  is  dappled-purple  in  color  and  is debossed with  “L519”  on  one  side  and  plain  on  the  other.  The  50 mg/200 mg  tablet  is  supplied  as  an  oval shaped  mottled  tablet  that  is  dappled-purple  in  color  and  is debossed with  “L520”  on  one  side  and  plain  on  the  other.  Carbidopa and levodopa extended-release tablets, USP are polymeric-based drug delivery system that controls the release of carbidopa and  levodopa  as  it  slowly  erodes.  Carbidopa and levodopa extended-release tablet 25 mg/100 mg  is  available  to  facilitate  titration  when  100  mg  steps  are  required. FDA approved dissolution specifications differs from the USP dissolution specifications."
    },
    {
      "NDCCode": "46708-333-91",
      "PackageDescription": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-333-91) ",
      "NDC11Code": "46708-0333-91",
      "ProductNDC": "46708-333",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Carbidopa And Levodopa",
      "NonProprietaryName": "Carbidopa And Levodopa",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190606",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210341",
      "LabelerName": "Alembic Pharmaceuticals Limited",
      "SubstanceName": "CARBIDOPA; LEVODOPA",
      "StrengthNumber": "50; 200",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]",
      "Status": "Active",
      "LastUpdate": "2019-06-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190606",
      "SamplePackage": "N",
      "IndicationAndUsage": "Carbidopa and levodopa extended-release tablets, USP are indicated  in  the  treatment  of  Parkinson’s  disease,  post-encephalitic  parkinsonism,  and  symptomatic  parkinsonism  that  may  follow  carbon  monoxide  intoxication  or  manganese  intoxication.",
      "Description": "Carbidopa and levodopa extended-release tablets, USP are an extended-release  combination  of  carbidopa  and  levodopa  for  the treatment of Parkinson’s disease and  syndrome. Carbidopa, USP , an  inhibitor  of  aromatic  amino  acid  decarboxylation,  is  a  white to creamy white,  odorless or practically odorless powder,  freely soluble in 3N hydrochloric acid, slightly soluble in water and in methanol, practically insoluble in alcohol, in acetone, in chloroform and in ether, with a molecular weight of 244.24. It is designated chemically as  (-)-L-α­hydrazino-α-methyl-β-(3,4-dihydroxybenzene)  propanoic  acid  monohydrate. Its empirical formula  is C10H14N2O4H2O, and its structural formula  is.   Tablet  content  is  expressed  in  terms  of  anhydrous  carbidopa,  which  has  a  molecular  weight  of  226.24. Levodopa, USP, an  aromatic  amino  acid,  is  a  white to off-white, odorless , crystalline  powder,  slightly  soluble  in  water, freely soluble in 3N hydrochloric acid and insoluble in alcohol  with  a molecular weight of 197.19. It is designated chemically as  (-)-L-α-amino-β-(3,4-dihydroxybenzene)  propanoic  acid.  Its  empirical  formula  is  C9H11NO4,  and  its  structural  formula  is. Carbidopa and levodopa extended-release tablets, USP are supplied as extended-release tablets containing either 25 mg of carbidopa and 100 mg of levodopa, or 50 mg of carbidopa  and  200 mg of levodopa. Inactive ingredients  are hydroxypropyl  cellulose,  magnesium  stearate, and hypromellose. Carbidopa and levodopa extended-release tablets USP, 25 mg/100 mg and carbidopa and levodopa extended-release tablets USP, 50 mg/200 mg also contain FD&C  Blue  #2 Aluminium Lake  and  FD&C  Red  #40 Aluminium Lake. The  25 mg/100 mg  tablet  is  supplied  as  an  oval shaped  mottled  tablet  that  is  dappled-purple  in  color  and  is debossed with  “L519”  on  one  side  and  plain  on  the  other.  The  50 mg/200 mg  tablet  is  supplied  as  an  oval shaped  mottled  tablet  that  is  dappled-purple  in  color  and  is debossed with  “L520”  on  one  side  and  plain  on  the  other.  Carbidopa and levodopa extended-release tablets, USP are polymeric-based drug delivery system that controls the release of carbidopa and  levodopa  as  it  slowly  erodes.  Carbidopa and levodopa extended-release tablet 25 mg/100 mg  is  available  to  facilitate  titration  when  100  mg  steps  are  required. FDA approved dissolution specifications differs from the USP dissolution specifications."
    },
    {
      "NDCCode": "49884-333-01",
      "PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (49884-333-01) ",
      "NDC11Code": "49884-0333-01",
      "ProductNDC": "49884-333",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dexmethylphenidate Hydrochloride",
      "NonProprietaryName": "Dexmethylphenidate Hydrochloride",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170105",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202842",
      "LabelerName": "Par Health USA, LLC",
      "SubstanceName": "DEXMETHYLPHENIDATE HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2025-12-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20170105",
      "SamplePackage": "N",
      "IndicationAndUsage": "Dexmethylphenidate hydrochloride extended-release is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)].",
      "Description": "Dexmethylphenidate hydrochloride extended-release contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Dexmethylphenidate hydrochloride extended-release is an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each bead-filled dexmethylphenidate hydrochloride extended-release capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a delayed release of dexmethylphenidate. Dexmethylphenidate hydrochloride extended-release is intended for oral administration and is available as 5 mg, 10 mg, 20 mg, 25 mg, 35 mg, and 40 mg extended-release capsules. Chemically, dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C14H19NO2HCl. Its structural formula is. Note* = asymmetric carbon center. Dexmethylphenidate hydrochloride is a white to off-white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients: methacrylic acid copolymer, amino methacrylate copolymer, triethyl citrate, talc, sugar spheres, polyethylene glycol, gelatin, titanium dioxide and black ink. The black ink contains shellac glaze, iron oxide black, n-butyl alcohol, propylene glycol, FD&C Blue #1, FD&C Blue #2, FD&C Red #40 and D&C Yellow #10. The 5 mg also contains FD& C Blue #1 and FD&C Red #3. The 10 mg contains FD&C Yellow #6. The 25 mg, 35 mg and 40 mg contains yellow iron oxide."
    },
    {
      "NDCCode": "50090-5940-0",
      "PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-5940-0) ",
      "NDC11Code": "50090-5940-00",
      "ProductNDC": "50090-5940",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Duloxetine",
      "NonProprietaryName": "Duloxetine",
      "DosageFormName": "CAPSULE, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170316",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208706",
      "LabelerName": "A-S Medication Solutions",
      "SubstanceName": "DULOXETINE HYDROCHLORIDE",
      "StrengthNumber": "60",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-11-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220314",
      "SamplePackage": "N",
      "IndicationAndUsage": "Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major depressive disorder in adults, 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults and pediatric patients 13 years of age and older, 5 Chronic musculoskeletal pain in adults.",
      "Description": "Duloxetine hydrochloride USP is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride USP is a white to brownish-white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20 mg, 30 mg, 40 mg or 60 mg of duloxetine hydrochloride USP (equivalent to 22.4 mg, 33.7 mg, 44.9 mg or 67.3 mg of duloxetine, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include sugar spheres, hypromellose, sucrose, talc, methacrylic acid copolymer dispersion, and triethyl citrate. The capsule shell contains gelatin, FD&C Red No. 3 (40 mg), FD&C Blue No. 1 (40 mg), FD&C Blue No. 2 (20 mg, 30 mg, 60 mg), titanium dioxide, and sodium lauryl sulfate. For 20 mg, 30 mg, 40 mg (body & cap) and 60 mg (body only) strengths, imprinting black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide and purified water. For 60 mg (cap only) strength, imprinting white ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, purified water, potassium hydroxide, and titanium dioxide. USP Assay & Organic Impurities test pending."
    },
    {
      "NDCCode": "50090-5940-1",
      "PackageDescription": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-5940-1) ",
      "NDC11Code": "50090-5940-01",
      "ProductNDC": "50090-5940",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Duloxetine",
      "NonProprietaryName": "Duloxetine",
      "DosageFormName": "CAPSULE, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170316",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208706",
      "LabelerName": "A-S Medication Solutions",
      "SubstanceName": "DULOXETINE HYDROCHLORIDE",
      "StrengthNumber": "60",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-11-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220314",
      "SamplePackage": "N",
      "IndicationAndUsage": "Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major depressive disorder in adults, 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults and pediatric patients 13 years of age and older, 5 Chronic musculoskeletal pain in adults.",
      "Description": "Duloxetine hydrochloride USP is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride USP is a white to brownish-white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20 mg, 30 mg, 40 mg or 60 mg of duloxetine hydrochloride USP (equivalent to 22.4 mg, 33.7 mg, 44.9 mg or 67.3 mg of duloxetine, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include sugar spheres, hypromellose, sucrose, talc, methacrylic acid copolymer dispersion, and triethyl citrate. The capsule shell contains gelatin, FD&C Red No. 3 (40 mg), FD&C Blue No. 1 (40 mg), FD&C Blue No. 2 (20 mg, 30 mg, 60 mg), titanium dioxide, and sodium lauryl sulfate. For 20 mg, 30 mg, 40 mg (body & cap) and 60 mg (body only) strengths, imprinting black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide and purified water. For 60 mg (cap only) strength, imprinting white ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, purified water, potassium hydroxide, and titanium dioxide. USP Assay & Organic Impurities test pending."
    },
    {
      "NDCCode": "53145-333-15",
      "PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (53145-333-15)  / 30 mL in 1 BOTTLE, DROPPER",
      "NDC11Code": "53145-0333-15",
      "ProductNDC": "53145-333",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Defensol-ito",
      "NonProprietaryName": "Dextromethorphan, Guiafenesin, Phenylephrine",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140101",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "Menper Distributors, Inc",
      "SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "4; 50; 2.5",
      "StrengthUnit": "mg/mL; mg/mL; mg/mL",
      "Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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": "2025-07-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20140101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses temporarily relives these symptoms occuring with cold: : 1 nasal congestion, 2 cough due to minor throat and bronchial irriatation, 3 helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes."
    },
    {
      "NDCCode": "54868-0840-0",
      "PackageDescription": "20 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (54868-0840-0)",
      "NDC11Code": "54868-0840-00",
      "ProductNDC": "54868-0840",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ery-tab",
      "NonProprietaryName": "Erythromycin",
      "DosageFormName": "TABLET, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19990928",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA062298",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "ERYTHROMYCIN",
      "StrengthNumber": "333",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of ERY-TAB and other antibacterial drugs, ERY-TAB should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. ERY-TAB tablets are indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes; Streptococcus pneumoniae; Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower respiratory tract infections of mild to moderate severity caused by Streptococcus pyogenes or Streptococcus pneumoniae. Listeriosis caused by Listeria monocytogenes. Respiratory tract infections due to Mycoplasma pneumoniae. Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals, rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Diphtheria: Infections due to Corynebacterium diphtheriae, as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma - In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: Erythrocin® Lactobionate-I.V. (erythromycin lactobionate for injection, USP) followed by erythromycin base orally, as an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Erythromycins are indicated for treatment of the following infections caused by Chlamydia trachomatis: conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis . When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Primary syphilis caused by Treponema pallidum. Erythromycin (oral forms only) is an alternative choice of treatment for primary syphilis in patients allergic to the penicillins. In treatment of primary syphilis, spinal fluid should be examined before treatment and as part of the follow-up after therapy. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease. Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract e.g., tonsillitis, or pharyngitis).3 Erythromycin is indicated for the treatment of penicillin-allergic patients. The therapeutic dose should be administered for ten days. Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).3.",
      "Description": "ERY-TAB (erythromycin delayed-release tablets) is an antibacterial product containing erythromycin base in a specially enteric-coated tablet to protect it from the inactivating effects of gastric acidity and to permit efficient absorption of the antibiotic in the small intestine. ERY-TAB tablets for oral administration are available in three dosage strengths, each white oval tablet containing either 250 mg, 333 mg, or 500 mg of erythromycin as the free base. ERY-TAB tablets comply with USP Drug Release Test 1. Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. Erythromycin is a white to off-white powder, slightly soluble in water, and soluble in alcohol, chloroform, and ether. Erythromycin is known chemically as (3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*)-4-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione. The molecular formula is C37H67NO13, and the molecular weight is 733.94. The structural formula is. Ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, crospovidone, diacetylated monoglycerides, hydroxypropyl cellulose, hypromellose, hypromellose phthalate, magnesium stearate, microcrystalline cellulose, povidone, propylene glycol, sodium citrate, sorbitan monooleate, talc, and titanium dioxide."
    }
  ]
}
                    

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    <LabelerName>Ohm Laboratories Inc.</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
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    <StartMarketingDatePackage>20210903</StartMarketingDatePackage>
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    <IndicationAndUsage>temporarily relieves minor aches and pains due to: minor pain of arthritismuscular achesbackachepremenstrual and menstrual crampsthe common coldheadachetoothache. temporarily reduces fever.</IndicationAndUsage>
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    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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    <PackageDescription>4 BLISTER PACK in 1 CARTON (51660-069-24)  &gt; 6 TABLET in 1 BLISTER PACK</PackageDescription>
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    <Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA], Skin Barrier Activity [PE]</Pharm_Classes>
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    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas.</IndicationAndUsage>
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    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19930201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>controls symptoms of diarrhea, including Travelers' Diarrhea.</IndicationAndUsage>
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    <NDC11Code>51660-0351-24</NDC11Code>
    <ProductNDC>51660-351</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Acid Reducer</ProprietaryName>
    <NonProprietaryName>Ranitidine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110628</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA200536</ApplicationNumber>
    <LabelerName>Ohm Laboratories Inc.</LabelerName>
    <SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-13</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>51660-940-24</NDCCode>
    <PackageDescription>4 BLISTER PACK in 1 CARTON (51660-940-24)  / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>51660-0940-24</NDC11Code>
    <ProductNDC>51660-940</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Allergy Relief-d</ProprietaryName>
    <NonProprietaryName>Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170502</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090922</ApplicationNumber>
    <LabelerName>Ohm Laboratories Inc.</LabelerName>
    <SubstanceName>CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5; 120</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170502</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:runny nosesneezingitchy, watery eyesitching of the nose or throatnasal congestion. reduces swelling of nasal passages. temporarily relieves sinus congestion and pressure. temporarily restores freer breathing through the nose.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10956-333-24</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 CARTON (10956-333-24)  &gt; 12 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>10956-0333-24</NDC11Code>
    <ProductNDC>10956-333</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Preferred Maximum Strength Urinary Pain Relief</ProprietaryName>
    <NonProprietaryName>Phenazopyridine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150115</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Reese Pharmaceutical Co</LabelerName>
    <SubstanceName>PHENAZOPYRIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>97.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fast relief from urinary pain, burning, urgency and frequency associated with urinary tractinfections.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>25113-333-24</NDCCode>
    <PackageDescription>769 g in 1 BOTTLE (25113-333-24)</PackageDescription>
    <NDC11Code>25113-0333-24</NDC11Code>
    <ProductNDC>25113-333</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Germasidol</ProprietaryName>
    <NonProprietaryName>Triclosan</NonProprietaryName>
    <DosageFormName>SOAP</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20140429</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>The Dodge Company Inc.</LabelerName>
    <SubstanceName>TRICLOSAN</SubstanceName>
    <StrengthNumber>.0057</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Antiseptic handwash for handwashing to decrease baceria on the skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>55319-333-23</NDCCode>
    <PackageDescription>24 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55319-333-23) </PackageDescription>
    <NDC11Code>55319-0333-23</NDC11Code>
    <ProductNDC>55319-333</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Acetaminophen</ProprietaryName>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170901</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076200</ApplicationNumber>
    <LabelerName>Family Dollar Services, Inc.</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>650</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves minor aches and pains due to:minor pain of arthritismuscular achesbackachepremenstrual and menstrual crampsthe common coldheadachetoothache. temporarily reduces fever.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>63868-333-24</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 CARTON (63868-333-24)  / 12 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>63868-0333-24</NDC11Code>
    <ProductNDC>63868-333</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Allergy Relief</ProprietaryName>
    <NonProprietaryName>Chlorpheniramine Maleate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210708</StartMarketingDate>
    <EndMarketingDate>20270531</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>CHAIN DRUG MARKETING ASSOCIATION INC</LabelerName>
    <SubstanceName>CHLORPHENIRAMINE MALEATE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20210708</StartMarketingDatePackage>
    <EndMarketingDatePackage>20270531</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 itchy, watery eyes, 3 sneezing, 4 itching of the nose or throat.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>71571-333-24</NDCCode>
    <PackageDescription>2.4 mL in 1 BOTTLE, DROPPER (71571-333-24) </PackageDescription>
    <NDC11Code>71571-0333-24</NDC11Code>
    <ProductNDC>71571-333</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Eysuvis</ProprietaryName>
    <NonProprietaryName>Loteprednol Etabonate</NonProprietaryName>
    <DosageFormName>SUSPENSION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20201118</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA210933</ApplicationNumber>
    <LabelerName>ALCON LABORATORIES, INC.</LabelerName>
    <SubstanceName>LOTEPREDNOL ETABONATE</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201118</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>EYSUVIS is a corticosteroid indicated for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease.</IndicationAndUsage>
    <Description>Loteprednol etabonate is a corticosteroid. Its chemical name is chloromethyl 17α-[(ethoxycarbonyl)oxy]-11β-hydroxy-3-oxoandrosta-1,4-diene-17β-carboxylate. Its molecular formula is C24H31ClO7 and its chemical structure is. C24H31ClO7Mol. Wt. 467.0. EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25% contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. Each mL contains: 1 ACTIVE: loteprednol etabonate 2.5 mg (0.25%), 2 INACTIVES: glycerin, sodium citrate dihydrate, sodium chloride, Poloxamer 407, edetate disodium dihydrate, citric acid, and water for injection., 3 PRESERVATIVE: benzalkonium chloride 0.01%.</Description>
  </NDC>
  <NDC>
    <NDCCode>51660-027-14</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (51660-027-14)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE</PackageDescription>
    <NDC11Code>51660-0027-14</NDC11Code>
    <ProductNDC>51660-027</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Esomeprazole</ProprietaryName>
    <NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200814</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212866</ApplicationNumber>
    <LabelerName>Ohm Laboratories Inc.</LabelerName>
    <SubstanceName>ESOMEPRAZOLE MAGNESIUM</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200814</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>treats frequent heartburn (occurs 2 or moredays a week) . not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>51660-027-27</NDCCode>
    <PackageDescription>2 BOTTLE in 1 CARTON (51660-027-27)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE</PackageDescription>
    <NDC11Code>51660-0027-27</NDC11Code>
    <ProductNDC>51660-027</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Esomeprazole</ProprietaryName>
    <NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200814</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212866</ApplicationNumber>
    <LabelerName>Ohm Laboratories Inc.</LabelerName>
    <SubstanceName>ESOMEPRAZOLE MAGNESIUM</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200814</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>treats frequent heartburn (occurs 2 or moredays a week) . not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>51660-027-44</NDCCode>
    <PackageDescription>3 BOTTLE in 1 CARTON (51660-027-44)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE</PackageDescription>
    <NDC11Code>51660-0027-44</NDC11Code>
    <ProductNDC>51660-027</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Esomeprazole</ProprietaryName>
    <NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200814</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212866</ApplicationNumber>
    <LabelerName>Ohm Laboratories Inc.</LabelerName>
    <SubstanceName>ESOMEPRAZOLE MAGNESIUM</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200814</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>treats frequent heartburn (occurs 2 or moredays a week) . not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>51660-301-21</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (51660-301-21)  / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>51660-0301-21</NDC11Code>
    <ProductNDC>51660-301</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Guaifenesin And Dextromethorphan Hbr</ProprietaryName>
    <NonProprietaryName>Guaifenesin And Dextromethorphan Hbr</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210701</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214781</ApplicationNumber>
    <LabelerName>OHM LABORATORIES INC</LabelerName>
    <SubstanceName>GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
    <StrengthNumber>600; 30</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210701</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritantsthe intensity of coughingthe impulse to cough to help you get to sleep.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>51660-301-41</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 CARTON (51660-301-41)  / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>51660-0301-41</NDC11Code>
    <ProductNDC>51660-301</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Guaifenesin And Dextromethorphan Hbr</ProprietaryName>
    <NonProprietaryName>Guaifenesin And Dextromethorphan Hbr</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210701</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214781</ApplicationNumber>
    <LabelerName>OHM LABORATORIES INC</LabelerName>
    <SubstanceName>GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
    <StrengthNumber>600; 30</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210701</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritantsthe intensity of coughingthe impulse to cough to help you get to sleep.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>51660-526-03</NDCCode>
    <PackageDescription>5000 TABLET in 1 BAG (51660-526-03) </PackageDescription>
    <NDC11Code>51660-0526-03</NDC11Code>
    <ProductNDC>51660-526</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Loratadine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <StartMarketingDate>20241128</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>OHM LABORATORIES INC</LabelerName>
    <SubstanceName>LORATADINE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-08-28</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>28-NOV-24</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>51660-939-04</NDCCode>
    <PackageDescription>5000 TABLET in 1 BAG (51660-939-04) </PackageDescription>
    <NDC11Code>51660-0939-04</NDC11Code>
    <ProductNDC>51660-939</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <StartMarketingDate>20241128</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Ohm Laboratories Inc</LabelerName>
    <SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-08-28</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>28-NOV-24</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>0362-9048-02</NDCCode>
    <PackageDescription>50 CARTRIDGE in 1 CARTON (0362-9048-02)  / 1.7 mL in 1 CARTRIDGE</PackageDescription>
    <NDC11Code>00362-9048-02</NDC11Code>
    <ProductNDC>0362-9048</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Septocaine And Epinephrine</ProprietaryName>
    <NonProprietaryName>Articaine Hydrochloride And Epinephrine Bitartrate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBMUCOSAL</RouteName>
    <StartMarketingDate>20110112</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020971</ApplicationNumber>
    <LabelerName>Septodont Inc.</LabelerName>
    <SubstanceName>ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE</SubstanceName>
    <StrengthNumber>40; .005</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-10-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110112</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>SEPTOCAINE is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older.</IndicationAndUsage>
    <Description>SEPTOCAINE (articaine hydrochloride and epinephrine injection), for intraoral submucosal infiltration use, is a sterile, aqueous solution that contains articaine HCl 4% (68 mg/1.7mL) (40 mg/mL) and epinephrine bitartrate in an epinephrine 1:200,000 or epinephrine 1:100,000 strength.Articaine HCl is an amino amide local anesthetic, chemically designated as 4-methyl-3-[2-(propylamino)-propionamido]-2-thiophene-carboxylic acid, methyl ester hydrochloride and is a racemic mixture. Articaine HCl has a molecular weight of 320.84 and the following structural formula. Articaine HCl has a partition coefficient in n-octanol/Soerensen buffer (pH 7.35) of 17 and a pKa of 7.8. Epinephrine bitartrate, (-)-1-(3,4-Dihydroxyphenyl)-2-methylamino-ethanol (+) tartrate (1:1) salt, is a vasoconstrictor with a concentration of 1:200,000 or 1:100,000 (expressed as free base). It has a molecular weight of 333.3 and the following structural formula. SEPTOCAINE contains the following inactive ingredients: sodium chloride (1.6 mg/mL) and sodium metabisulfite (0.5 mg/mL). The product is formulated with a 15% overage of epinephrine. The pH is adjusted with sodium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0362-9049-02</NDCCode>
    <PackageDescription>50 CARTRIDGE in 1 CARTON (0362-9049-02)  / 1.7 mL in 1 CARTRIDGE</PackageDescription>
    <NDC11Code>00362-9049-02</NDC11Code>
    <ProductNDC>0362-9049</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Septocaine And Epinephrine</ProprietaryName>
    <NonProprietaryName>Articaine Hydrochloride And Epinephrine Bitartrate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBMUCOSAL</RouteName>
    <StartMarketingDate>20110112</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020971</ApplicationNumber>
    <LabelerName>Septodont Inc.</LabelerName>
    <SubstanceName>ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE</SubstanceName>
    <StrengthNumber>40; .01</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-10-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110112</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>SEPTOCAINE is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older.</IndicationAndUsage>
    <Description>SEPTOCAINE (articaine hydrochloride and epinephrine injection), for intraoral submucosal infiltration use, is a sterile, aqueous solution that contains articaine HCl 4% (68 mg/1.7mL) (40 mg/mL) and epinephrine bitartrate in an epinephrine 1:200,000 or epinephrine 1:100,000 strength.Articaine HCl is an amino amide local anesthetic, chemically designated as 4-methyl-3-[2-(propylamino)-propionamido]-2-thiophene-carboxylic acid, methyl ester hydrochloride and is a racemic mixture. Articaine HCl has a molecular weight of 320.84 and the following structural formula. Articaine HCl has a partition coefficient in n-octanol/Soerensen buffer (pH 7.35) of 17 and a pKa of 7.8. Epinephrine bitartrate, (-)-1-(3,4-Dihydroxyphenyl)-2-methylamino-ethanol (+) tartrate (1:1) salt, is a vasoconstrictor with a concentration of 1:200,000 or 1:100,000 (expressed as free base). It has a molecular weight of 333.3 and the following structural formula. SEPTOCAINE contains the following inactive ingredients: sodium chloride (1.6 mg/mL) and sodium metabisulfite (0.5 mg/mL). The product is formulated with a 15% overage of epinephrine. The pH is adjusted with sodium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>43063-536-24</NDCCode>
    <PackageDescription>24 CAPSULE in 1 BOTTLE, PLASTIC (43063-536-24) </PackageDescription>
    <NDC11Code>43063-0536-24</NDC11Code>
    <ProductNDC>43063-536</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cephalexin</ProprietaryName>
    <NonProprietaryName>Cephalexin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110119</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090836</ApplicationNumber>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>CEPHALEXIN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-03-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140206</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cephalexin is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria.  To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, Cephalexin should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (1.6).</IndicationAndUsage>
    <Description>Cephalexin capsules, USP is a semisynthetic cephalosporin antibacterial drug intended for oral administration. It is 7-(D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C 16H 17N 3O 4SH 2O and the molecular weight is 365.41. Cephalexin has the following structural formula:. Each capsule contains cephalexin monohydrate equivalent to 250 mg, 333 mg, 500 mg, or 750 mg of cephalexin. The 250 mg, 333 mg, 500 mg and 750 mg capsules contain anhydrous lactose, colloidal silicon dioxide, magnesium stearate, FD &amp; C Blue No. 1, D &amp; C Yellow No. 10, gelatin, sodium lauryl sulphate, titanium dioxide. In addition, the 250 mg capsule contains FD &amp; C Red No. 40; 333 mg and 750 mg Capsules contains FD &amp; C Yellow No. 6. The imprinting ink contains; shellac, propylene glycol, strong ammonia solution and potassium hydroxide. Also black Iron oxide is used in 250mg, 333mg and 500mg and titanium dioxide is used in 750mg.</Description>
  </NDC>
  <NDC>
    <NDCCode>46708-333-30</NDCCode>
    <PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-333-30) </PackageDescription>
    <NDC11Code>46708-0333-30</NDC11Code>
    <ProductNDC>46708-333</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carbidopa And Levodopa</ProprietaryName>
    <NonProprietaryName>Carbidopa And Levodopa</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190606</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210341</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
    <SubstanceName>CARBIDOPA; LEVODOPA</SubstanceName>
    <StrengthNumber>50; 200</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2019-06-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190606</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carbidopa and levodopa extended-release tablets, USP are indicated  in  the  treatment  of  Parkinson’s  disease,  post-encephalitic  parkinsonism,  and  symptomatic  parkinsonism  that  may  follow  carbon  monoxide  intoxication  or  manganese  intoxication.</IndicationAndUsage>
    <Description>Carbidopa and levodopa extended-release tablets, USP are an extended-release  combination  of  carbidopa  and  levodopa  for  the treatment of Parkinson’s disease and  syndrome. Carbidopa, USP , an  inhibitor  of  aromatic  amino  acid  decarboxylation,  is  a  white to creamy white,  odorless or practically odorless powder,  freely soluble in 3N hydrochloric acid, slightly soluble in water and in methanol, practically insoluble in alcohol, in acetone, in chloroform and in ether, with a molecular weight of 244.24. It is designated chemically as  (-)-L-α­hydrazino-α-methyl-β-(3,4-dihydroxybenzene)  propanoic  acid  monohydrate. Its empirical formula  is C10H14N2O4H2O, and its structural formula  is.   Tablet  content  is  expressed  in  terms  of  anhydrous  carbidopa,  which  has  a  molecular  weight  of  226.24. Levodopa, USP, an  aromatic  amino  acid,  is  a  white to off-white, odorless , crystalline  powder,  slightly  soluble  in  water, freely soluble in 3N hydrochloric acid and insoluble in alcohol  with  a molecular weight of 197.19. It is designated chemically as  (-)-L-α-amino-β-(3,4-dihydroxybenzene)  propanoic  acid.  Its  empirical  formula  is  C9H11NO4,  and  its  structural  formula  is. Carbidopa and levodopa extended-release tablets, USP are supplied as extended-release tablets containing either 25 mg of carbidopa and 100 mg of levodopa, or 50 mg of carbidopa  and  200 mg of levodopa. Inactive ingredients  are hydroxypropyl  cellulose,  magnesium  stearate, and hypromellose. Carbidopa and levodopa extended-release tablets USP, 25 mg/100 mg and carbidopa and levodopa extended-release tablets USP, 50 mg/200 mg also contain FD&amp;C  Blue  #2 Aluminium Lake  and  FD&amp;C  Red  #40 Aluminium Lake. The  25 mg/100 mg  tablet  is  supplied  as  an  oval shaped  mottled  tablet  that  is  dappled-purple  in  color  and  is debossed with  “L519”  on  one  side  and  plain  on  the  other.  The  50 mg/200 mg  tablet  is  supplied  as  an  oval shaped  mottled  tablet  that  is  dappled-purple  in  color  and  is debossed with  “L520”  on  one  side  and  plain  on  the  other.  Carbidopa and levodopa extended-release tablets, USP are polymeric-based drug delivery system that controls the release of carbidopa and  levodopa  as  it  slowly  erodes.  Carbidopa and levodopa extended-release tablet 25 mg/100 mg  is  available  to  facilitate  titration  when  100  mg  steps  are  required. FDA approved dissolution specifications differs from the USP dissolution specifications.</Description>
  </NDC>
  <NDC>
    <NDCCode>46708-333-31</NDCCode>
    <PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-333-31) </PackageDescription>
    <NDC11Code>46708-0333-31</NDC11Code>
    <ProductNDC>46708-333</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carbidopa And Levodopa</ProprietaryName>
    <NonProprietaryName>Carbidopa And Levodopa</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190606</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210341</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
    <SubstanceName>CARBIDOPA; LEVODOPA</SubstanceName>
    <StrengthNumber>50; 200</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2019-06-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190606</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carbidopa and levodopa extended-release tablets, USP are indicated  in  the  treatment  of  Parkinson’s  disease,  post-encephalitic  parkinsonism,  and  symptomatic  parkinsonism  that  may  follow  carbon  monoxide  intoxication  or  manganese  intoxication.</IndicationAndUsage>
    <Description>Carbidopa and levodopa extended-release tablets, USP are an extended-release  combination  of  carbidopa  and  levodopa  for  the treatment of Parkinson’s disease and  syndrome. Carbidopa, USP , an  inhibitor  of  aromatic  amino  acid  decarboxylation,  is  a  white to creamy white,  odorless or practically odorless powder,  freely soluble in 3N hydrochloric acid, slightly soluble in water and in methanol, practically insoluble in alcohol, in acetone, in chloroform and in ether, with a molecular weight of 244.24. It is designated chemically as  (-)-L-α­hydrazino-α-methyl-β-(3,4-dihydroxybenzene)  propanoic  acid  monohydrate. Its empirical formula  is C10H14N2O4H2O, and its structural formula  is.   Tablet  content  is  expressed  in  terms  of  anhydrous  carbidopa,  which  has  a  molecular  weight  of  226.24. Levodopa, USP, an  aromatic  amino  acid,  is  a  white to off-white, odorless , crystalline  powder,  slightly  soluble  in  water, freely soluble in 3N hydrochloric acid and insoluble in alcohol  with  a molecular weight of 197.19. It is designated chemically as  (-)-L-α-amino-β-(3,4-dihydroxybenzene)  propanoic  acid.  Its  empirical  formula  is  C9H11NO4,  and  its  structural  formula  is. Carbidopa and levodopa extended-release tablets, USP are supplied as extended-release tablets containing either 25 mg of carbidopa and 100 mg of levodopa, or 50 mg of carbidopa  and  200 mg of levodopa. Inactive ingredients  are hydroxypropyl  cellulose,  magnesium  stearate, and hypromellose. Carbidopa and levodopa extended-release tablets USP, 25 mg/100 mg and carbidopa and levodopa extended-release tablets USP, 50 mg/200 mg also contain FD&amp;C  Blue  #2 Aluminium Lake  and  FD&amp;C  Red  #40 Aluminium Lake. The  25 mg/100 mg  tablet  is  supplied  as  an  oval shaped  mottled  tablet  that  is  dappled-purple  in  color  and  is debossed with  “L519”  on  one  side  and  plain  on  the  other.  The  50 mg/200 mg  tablet  is  supplied  as  an  oval shaped  mottled  tablet  that  is  dappled-purple  in  color  and  is debossed with  “L520”  on  one  side  and  plain  on  the  other.  Carbidopa and levodopa extended-release tablets, USP are polymeric-based drug delivery system that controls the release of carbidopa and  levodopa  as  it  slowly  erodes.  Carbidopa and levodopa extended-release tablet 25 mg/100 mg  is  available  to  facilitate  titration  when  100  mg  steps  are  required. FDA approved dissolution specifications differs from the USP dissolution specifications.</Description>
  </NDC>
  <NDC>
    <NDCCode>46708-333-91</NDCCode>
    <PackageDescription>1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-333-91) </PackageDescription>
    <NDC11Code>46708-0333-91</NDC11Code>
    <ProductNDC>46708-333</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carbidopa And Levodopa</ProprietaryName>
    <NonProprietaryName>Carbidopa And Levodopa</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190606</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210341</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
    <SubstanceName>CARBIDOPA; LEVODOPA</SubstanceName>
    <StrengthNumber>50; 200</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2019-06-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190606</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carbidopa and levodopa extended-release tablets, USP are indicated  in  the  treatment  of  Parkinson’s  disease,  post-encephalitic  parkinsonism,  and  symptomatic  parkinsonism  that  may  follow  carbon  monoxide  intoxication  or  manganese  intoxication.</IndicationAndUsage>
    <Description>Carbidopa and levodopa extended-release tablets, USP are an extended-release  combination  of  carbidopa  and  levodopa  for  the treatment of Parkinson’s disease and  syndrome. Carbidopa, USP , an  inhibitor  of  aromatic  amino  acid  decarboxylation,  is  a  white to creamy white,  odorless or practically odorless powder,  freely soluble in 3N hydrochloric acid, slightly soluble in water and in methanol, practically insoluble in alcohol, in acetone, in chloroform and in ether, with a molecular weight of 244.24. It is designated chemically as  (-)-L-α­hydrazino-α-methyl-β-(3,4-dihydroxybenzene)  propanoic  acid  monohydrate. Its empirical formula  is C10H14N2O4H2O, and its structural formula  is.   Tablet  content  is  expressed  in  terms  of  anhydrous  carbidopa,  which  has  a  molecular  weight  of  226.24. Levodopa, USP, an  aromatic  amino  acid,  is  a  white to off-white, odorless , crystalline  powder,  slightly  soluble  in  water, freely soluble in 3N hydrochloric acid and insoluble in alcohol  with  a molecular weight of 197.19. It is designated chemically as  (-)-L-α-amino-β-(3,4-dihydroxybenzene)  propanoic  acid.  Its  empirical  formula  is  C9H11NO4,  and  its  structural  formula  is. Carbidopa and levodopa extended-release tablets, USP are supplied as extended-release tablets containing either 25 mg of carbidopa and 100 mg of levodopa, or 50 mg of carbidopa  and  200 mg of levodopa. Inactive ingredients  are hydroxypropyl  cellulose,  magnesium  stearate, and hypromellose. Carbidopa and levodopa extended-release tablets USP, 25 mg/100 mg and carbidopa and levodopa extended-release tablets USP, 50 mg/200 mg also contain FD&amp;C  Blue  #2 Aluminium Lake  and  FD&amp;C  Red  #40 Aluminium Lake. The  25 mg/100 mg  tablet  is  supplied  as  an  oval shaped  mottled  tablet  that  is  dappled-purple  in  color  and  is debossed with  “L519”  on  one  side  and  plain  on  the  other.  The  50 mg/200 mg  tablet  is  supplied  as  an  oval shaped  mottled  tablet  that  is  dappled-purple  in  color  and  is debossed with  “L520”  on  one  side  and  plain  on  the  other.  Carbidopa and levodopa extended-release tablets, USP are polymeric-based drug delivery system that controls the release of carbidopa and  levodopa  as  it  slowly  erodes.  Carbidopa and levodopa extended-release tablet 25 mg/100 mg  is  available  to  facilitate  titration  when  100  mg  steps  are  required. FDA approved dissolution specifications differs from the USP dissolution specifications.</Description>
  </NDC>
  <NDC>
    <NDCCode>49884-333-01</NDCCode>
    <PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (49884-333-01) </PackageDescription>
    <NDC11Code>49884-0333-01</NDC11Code>
    <ProductNDC>49884-333</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dexmethylphenidate Hydrochloride</ProprietaryName>
    <NonProprietaryName>Dexmethylphenidate Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170105</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202842</ApplicationNumber>
    <LabelerName>Par Health USA, LLC</LabelerName>
    <SubstanceName>DEXMETHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-12-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170105</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dexmethylphenidate hydrochloride extended-release is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)].</IndicationAndUsage>
    <Description>Dexmethylphenidate hydrochloride extended-release contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Dexmethylphenidate hydrochloride extended-release is an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each bead-filled dexmethylphenidate hydrochloride extended-release capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a delayed release of dexmethylphenidate. Dexmethylphenidate hydrochloride extended-release is intended for oral administration and is available as 5 mg, 10 mg, 20 mg, 25 mg, 35 mg, and 40 mg extended-release capsules. Chemically, dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C14H19NO2HCl. Its structural formula is. Note* = asymmetric carbon center. Dexmethylphenidate hydrochloride is a white to off-white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients: methacrylic acid copolymer, amino methacrylate copolymer, triethyl citrate, talc, sugar spheres, polyethylene glycol, gelatin, titanium dioxide and black ink. The black ink contains shellac glaze, iron oxide black, n-butyl alcohol, propylene glycol, FD&amp;C Blue #1, FD&amp;C Blue #2, FD&amp;C Red #40 and D&amp;C Yellow #10. The 5 mg also contains FD&amp; C Blue #1 and FD&amp;C Red #3. The 10 mg contains FD&amp;C Yellow #6. The 25 mg, 35 mg and 40 mg contains yellow iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>50090-5940-0</NDCCode>
    <PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-5940-0) </PackageDescription>
    <NDC11Code>50090-5940-00</NDC11Code>
    <ProductNDC>50090-5940</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Duloxetine</ProprietaryName>
    <NonProprietaryName>Duloxetine</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170316</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208706</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-11-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220314</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major depressive disorder in adults, 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults and pediatric patients 13 years of age and older, 5 Chronic musculoskeletal pain in adults.</IndicationAndUsage>
    <Description>Duloxetine hydrochloride USP is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride USP is a white to brownish-white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20 mg, 30 mg, 40 mg or 60 mg of duloxetine hydrochloride USP (equivalent to 22.4 mg, 33.7 mg, 44.9 mg or 67.3 mg of duloxetine, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include sugar spheres, hypromellose, sucrose, talc, methacrylic acid copolymer dispersion, and triethyl citrate. The capsule shell contains gelatin, FD&amp;C Red No. 3 (40 mg), FD&amp;C Blue No. 1 (40 mg), FD&amp;C Blue No. 2 (20 mg, 30 mg, 60 mg), titanium dioxide, and sodium lauryl sulfate. For 20 mg, 30 mg, 40 mg (body &amp; cap) and 60 mg (body only) strengths, imprinting black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide and purified water. For 60 mg (cap only) strength, imprinting white ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, purified water, potassium hydroxide, and titanium dioxide. USP Assay &amp; Organic Impurities test pending.</Description>
  </NDC>
  <NDC>
    <NDCCode>50090-5940-1</NDCCode>
    <PackageDescription>90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-5940-1) </PackageDescription>
    <NDC11Code>50090-5940-01</NDC11Code>
    <ProductNDC>50090-5940</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Duloxetine</ProprietaryName>
    <NonProprietaryName>Duloxetine</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170316</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208706</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-11-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220314</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major depressive disorder in adults, 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults and pediatric patients 13 years of age and older, 5 Chronic musculoskeletal pain in adults.</IndicationAndUsage>
    <Description>Duloxetine hydrochloride USP is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride USP is a white to brownish-white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20 mg, 30 mg, 40 mg or 60 mg of duloxetine hydrochloride USP (equivalent to 22.4 mg, 33.7 mg, 44.9 mg or 67.3 mg of duloxetine, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include sugar spheres, hypromellose, sucrose, talc, methacrylic acid copolymer dispersion, and triethyl citrate. The capsule shell contains gelatin, FD&amp;C Red No. 3 (40 mg), FD&amp;C Blue No. 1 (40 mg), FD&amp;C Blue No. 2 (20 mg, 30 mg, 60 mg), titanium dioxide, and sodium lauryl sulfate. For 20 mg, 30 mg, 40 mg (body &amp; cap) and 60 mg (body only) strengths, imprinting black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide and purified water. For 60 mg (cap only) strength, imprinting white ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, purified water, potassium hydroxide, and titanium dioxide. USP Assay &amp; Organic Impurities test pending.</Description>
  </NDC>
  <NDC>
    <NDCCode>53145-333-15</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (53145-333-15)  / 30 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>53145-0333-15</NDC11Code>
    <ProductNDC>53145-333</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Defensol-ito</ProprietaryName>
    <NonProprietaryName>Dextromethorphan, Guiafenesin, Phenylephrine</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>Menper Distributors, Inc</LabelerName>
    <SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>4; 50; 2.5</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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>2025-07-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses temporarily relives these symptoms occuring with cold: : 1 nasal congestion, 2 cough due to minor throat and bronchial irriatation, 3 helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>54868-0840-0</NDCCode>
    <PackageDescription>20 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (54868-0840-0)</PackageDescription>
    <NDC11Code>54868-0840-00</NDC11Code>
    <ProductNDC>54868-0840</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ery-tab</ProprietaryName>
    <NonProprietaryName>Erythromycin</NonProprietaryName>
    <DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19990928</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA062298</ApplicationNumber>
    <LabelerName>Physicians Total Care, Inc.</LabelerName>
    <SubstanceName>ERYTHROMYCIN</SubstanceName>
    <StrengthNumber>333</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-07-24</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of ERY-TAB and other antibacterial drugs, ERY-TAB should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. ERY-TAB tablets are indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes; Streptococcus pneumoniae; Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower respiratory tract infections of mild to moderate severity caused by Streptococcus pyogenes or Streptococcus pneumoniae. Listeriosis caused by Listeria monocytogenes. Respiratory tract infections due to Mycoplasma pneumoniae. Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals, rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Diphtheria: Infections due to Corynebacterium diphtheriae, as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma - In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: Erythrocin® Lactobionate-I.V. (erythromycin lactobionate for injection, USP) followed by erythromycin base orally, as an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Erythromycins are indicated for treatment of the following infections caused by Chlamydia trachomatis: conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis . When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Primary syphilis caused by Treponema pallidum. Erythromycin (oral forms only) is an alternative choice of treatment for primary syphilis in patients allergic to the penicillins. In treatment of primary syphilis, spinal fluid should be examined before treatment and as part of the follow-up after therapy. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease. Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract e.g., tonsillitis, or pharyngitis).3 Erythromycin is indicated for the treatment of penicillin-allergic patients. The therapeutic dose should be administered for ten days. Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).3.</IndicationAndUsage>
    <Description>ERY-TAB (erythromycin delayed-release tablets) is an antibacterial product containing erythromycin base in a specially enteric-coated tablet to protect it from the inactivating effects of gastric acidity and to permit efficient absorption of the antibiotic in the small intestine. ERY-TAB tablets for oral administration are available in three dosage strengths, each white oval tablet containing either 250 mg, 333 mg, or 500 mg of erythromycin as the free base. ERY-TAB tablets comply with USP Drug Release Test 1. Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. Erythromycin is a white to off-white powder, slightly soluble in water, and soluble in alcohol, chloroform, and ether. Erythromycin is known chemically as (3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*)-4-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione. The molecular formula is C37H67NO13, and the molecular weight is 733.94. The structural formula is. Ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, crospovidone, diacetylated monoglycerides, hydroxypropyl cellulose, hypromellose, hypromellose phthalate, magnesium stearate, microcrystalline cellulose, povidone, propylene glycol, sodium citrate, sorbitan monooleate, talc, and titanium dioxide.</Description>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>51660-333-24</NDCCode><ProprietaryName>Arthritis Pain Reliever</ProprietaryName><NonProprietaryName>Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>51660-333-01</NDCCode><ProprietaryName>Arthritis Pain Reliever</ProprietaryName><NonProprietaryName>Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>51660-333-50</NDCCode><ProprietaryName>Arthritis Pain Reliever</ProprietaryName><NonProprietaryName>Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>51660-069-24</NDCCode><ProprietaryName>Loperamide Hcl And Simethicone</ProprietaryName><NonProprietaryName>Loperamide Hcl And Simethicone</NonProprietaryName></NDC><NDC><NDCCode>51660-123-24</NDCCode><ProprietaryName>Loperamide Hydrochloride</ProprietaryName><NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>51660-351-24</NDCCode><ProprietaryName>Acid Reducer</ProprietaryName><NonProprietaryName>Ranitidine</NonProprietaryName></NDC><NDC><NDCCode>51660-940-24</NDCCode><ProprietaryName>Allergy Relief-d</ProprietaryName><NonProprietaryName>Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>10956-333-24</NDCCode><ProprietaryName>Preferred Maximum Strength Urinary Pain Relief</ProprietaryName><NonProprietaryName>Phenazopyridine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>25113-333-24</NDCCode><ProprietaryName>Germasidol</ProprietaryName><NonProprietaryName>Triclosan</NonProprietaryName></NDC><NDC><NDCCode>55319-333-23</NDCCode><ProprietaryName>Acetaminophen</ProprietaryName><NonProprietaryName>Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>63868-333-24</NDCCode><ProprietaryName>Allergy Relief</ProprietaryName><NonProprietaryName>Chlorpheniramine Maleate</NonProprietaryName></NDC><NDC><NDCCode>71571-333-24</NDCCode><ProprietaryName>Eysuvis</ProprietaryName><NonProprietaryName>Loteprednol Etabonate</NonProprietaryName></NDC><NDC><NDCCode>51660-027-14</NDCCode><ProprietaryName>Esomeprazole</ProprietaryName><NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName></NDC><NDC><NDCCode>51660-027-27</NDCCode><ProprietaryName>Esomeprazole</ProprietaryName><NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName></NDC><NDC><NDCCode>51660-027-44</NDCCode><ProprietaryName>Esomeprazole</ProprietaryName><NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName></NDC><NDC><NDCCode>51660-301-21</NDCCode><ProprietaryName>Guaifenesin And Dextromethorphan Hbr</ProprietaryName><NonProprietaryName>Guaifenesin And Dextromethorphan Hbr</NonProprietaryName></NDC><NDC><NDCCode>51660-301-41</NDCCode><ProprietaryName>Guaifenesin And Dextromethorphan Hbr</ProprietaryName><NonProprietaryName>Guaifenesin And Dextromethorphan Hbr</NonProprietaryName></NDC><NDC><NDCCode>51660-526-03</NDCCode><NonProprietaryName>Loratadine</NonProprietaryName></NDC><NDC><NDCCode>51660-939-04</NDCCode><NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0362-9048-02</NDCCode><ProprietaryName>Septocaine And Epinephrine</ProprietaryName><NonProprietaryName>Articaine Hydrochloride And Epinephrine Bitartrate</NonProprietaryName></NDC><NDC><NDCCode>0362-9049-02</NDCCode><ProprietaryName>Septocaine And Epinephrine</ProprietaryName><NonProprietaryName>Articaine Hydrochloride And Epinephrine Bitartrate</NonProprietaryName></NDC><NDC><NDCCode>43063-536-24</NDCCode><ProprietaryName>Cephalexin</ProprietaryName><NonProprietaryName>Cephalexin</NonProprietaryName></NDC><NDC><NDCCode>46708-333-30</NDCCode><ProprietaryName>Carbidopa And Levodopa</ProprietaryName><NonProprietaryName>Carbidopa And Levodopa</NonProprietaryName></NDC><NDC><NDCCode>46708-333-31</NDCCode><ProprietaryName>Carbidopa And Levodopa</ProprietaryName><NonProprietaryName>Carbidopa And Levodopa</NonProprietaryName></NDC><NDC><NDCCode>46708-333-91</NDCCode><ProprietaryName>Carbidopa And Levodopa</ProprietaryName><NonProprietaryName>Carbidopa And Levodopa</NonProprietaryName></NDC><NDC><NDCCode>49884-333-01</NDCCode><ProprietaryName>Dexmethylphenidate Hydrochloride</ProprietaryName><NonProprietaryName>Dexmethylphenidate Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>50090-5940-0</NDCCode><ProprietaryName>Duloxetine</ProprietaryName><NonProprietaryName>Duloxetine</NonProprietaryName></NDC><NDC><NDCCode>50090-5940-1</NDCCode><ProprietaryName>Duloxetine</ProprietaryName><NonProprietaryName>Duloxetine</NonProprietaryName></NDC><NDC><NDCCode>53145-333-15</NDCCode><ProprietaryName>Defensol-ito</ProprietaryName><NonProprietaryName>Dextromethorphan, Guiafenesin, Phenylephrine</NonProprietaryName></NDC><NDC><NDCCode>54868-0840-0</NDCCode><ProprietaryName>Ery-tab</ProprietaryName><NonProprietaryName>Erythromycin</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",
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      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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