RESTful Lookup — Test-Drive (2007 – 2026)

Query complete (35 ms elapsed)

{
  "NDC": [
    {
      "NDCCode": "65923-831-30",
      "PackageDescription": "30 SOLUTION in 1 POUCH (65923-831-30) ",
      "NDC11Code": "65923-0831-30",
      "ProductNDC": "65923-831",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Coralite Antibacterial Moist",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130926",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M003",
      "LabelerName": "United Exchange Corp.",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": ".115",
      "StrengthUnit": "g/1",
      "Status": "Active",
      "LastUpdate": "2025-11-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20130926",
      "SamplePackage": "N",
      "IndicationAndUsage": "Directions."
    },
    {
      "NDCCode": "65923-001-00",
      "PackageDescription": "30 PATCH in 1 PACKAGE (65923-001-00)  > .048 mg in 1 PATCH",
      "NDC11Code": "65923-0001-00",
      "ProductNDC": "65923-001",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Coralite Antibacterial Bandage",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "PATCH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140219",
      "EndMarketingDate": "20200930",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "UNITED EXCHANGE CORP",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": ".12",
      "StrengthUnit": "mg/100mg",
      "Status": "Deprecated",
      "LastUpdate": "2020-10-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20140219",
      "EndMarketingDatePackage": "20200930",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "65923-002-01",
      "PackageDescription": "30 PACKET in 1 CARTON (65923-002-01)  > .6 mg in 1 PACKET",
      "NDC11Code": "65923-0002-01",
      "ProductNDC": "65923-002",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Coralite Alcohol Pads",
      "NonProprietaryName": "Isopropyl Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20120114",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "UNITED EXCHANGE CORP.",
      "SubstanceName": "ISOPROPYL ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mg/100mg",
      "Status": "Deprecated",
      "LastUpdate": "2017-05-09"
    },
    {
      "NDCCode": "65923-011-30",
      "PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (65923-011-30)  > 30 mL in 1 BOTTLE, SPRAY",
      "NDC11Code": "65923-0011-30",
      "ProductNDC": "65923-011",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Family Care Nasal Relief",
      "NonProprietaryName": "Oxymetazoline Hydrochloride",
      "DosageFormName": "SPRAY",
      "RouteName": "NASAL",
      "StartMarketingDate": "20130531",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "United Exchange Corp",
      "SubstanceName": "OXYMETAZOLINE HYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2021-08-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20161104",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "65923-077-30",
      "PackageDescription": "1 BOTTLE in 1 CARTON (65923-077-30)  > 30 mL in 1 BOTTLE",
      "NDC11Code": "65923-0077-30",
      "ProductNDC": "65923-077",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Shopko Original Nasal",
      "NonProprietaryName": "Oxymetazoline Hydrochloride",
      "DosageFormName": "SPRAY",
      "RouteName": "NASAL",
      "StartMarketingDate": "20120301",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "UNITED EXCHANGE CORP.",
      "SubstanceName": "OXYMETAZOLINE HYDROCHLORIDE",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Directions: 1 adults and children 6 to 12 years of age (with adult supervision) 2 or 3 sprays in each nostril not more often than every 10 to 12 hours.  Do not exceed 2 doses in any 24-hour period. , 2 children under 6 years of age: ask a doctor. , 3 To spray, hold bottle with thumb at base and nozzle between first and second fingers.  Without tilting head, insert nozzle into nostril  Fully depress rim with a firm, even stroke and sniff deeply.  Wipe nozzle clean after use."
    },
    {
      "NDCCode": "65923-551-30",
      "PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (65923-551-30)  > 15 mL in 1 BOTTLE, PUMP",
      "NDC11Code": "65923-0551-30",
      "ProductNDC": "65923-551",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Family Care Nasal Relief",
      "NonProprietaryName": "Oxymetazoline Hydrochloride",
      "DosageFormName": "SPRAY",
      "RouteName": "NASAL",
      "StartMarketingDate": "20130630",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "United Exchange Corp",
      "SubstanceName": "OXYMETAZOLINE HYDROCHLORIDE",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2021-08-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20161102",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "65923-576-30",
      "PackageDescription": "30 VIAL, SINGLE-DOSE in 1 BOX (65923-576-30)  / 5 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "65923-0576-30",
      "ProductNDC": "65923-576",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Family Care Single Use Lubricant Eye Drop 0.4ml 30ct",
      "NonProprietaryName": "Carboxymethyl Cellulose 0.5%",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20260116",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M018",
      "LabelerName": "United Exchange Corp",
      "SubstanceName": "CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2026-01-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260116",
      "SamplePackage": "N",
      "IndicationAndUsage": "Directions  Instill 1 or 2 drops in the affected eye(s) as needed and discard container."
    },
    {
      "NDCCode": "65923-583-30",
      "PackageDescription": "30 VIAL, SINGLE-USE in 1 BOX (65923-583-30)  > .4 mL in 1 VIAL, SINGLE-USE",
      "NDC11Code": "65923-0583-30",
      "ProductNDC": "65923-583",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Family Care Single-use Eye",
      "NonProprietaryName": "Carboxymethylcellulose Sodium",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20160328",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part349",
      "LabelerName": "United Exchange Corp.",
      "SubstanceName": "CARBOXYMETHYLCELLULOSE SODIUM",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2021-11-19",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231"
    },
    {
      "NDCCode": "65923-584-25",
      "PackageDescription": "30 VIAL, SINGLE-USE in 1 BOX (65923-584-25)  > .4 mL in 1 VIAL, SINGLE-USE",
      "NDC11Code": "65923-0584-25",
      "ProductNDC": "65923-584",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Family Care Single-use Eye",
      "NonProprietaryName": "Polyethylene Glycol 400, And Propylene Glycol",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20160328",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part349",
      "LabelerName": "United Exchange Corp.",
      "SubstanceName": "POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL",
      "StrengthNumber": "4; 3",
      "StrengthUnit": "mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2021-11-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231"
    },
    {
      "NDCCode": "65923-655-30",
      "PackageDescription": "30 VIAL, SINGLE-USE in 1 CARTON (65923-655-30)  > .4 mL in 1 VIAL, SINGLE-USE",
      "NDC11Code": "65923-0655-30",
      "ProductNDC": "65923-655",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cvs Single Use Lubricant Eye Drops",
      "NonProprietaryName": "Polyethylene Glycol 400, And Propylene Glycol",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20160121",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part349",
      "LabelerName": "United Exchange Corp.",
      "SubstanceName": "POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL",
      "StrengthNumber": "4; 3",
      "StrengthUnit": "mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2021-11-13",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231"
    },
    {
      "NDCCode": "65923-977-30",
      "PackageDescription": "1 BOTTLE in 1 CARTON (65923-977-30)  > 30 mL in 1 BOTTLE",
      "NDC11Code": "65923-0977-30",
      "ProductNDC": "65923-977",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Shopko Extra Moisturizing Nasal",
      "NonProprietaryName": "Oxymetazoline Hydrochloride",
      "DosageFormName": "SPRAY",
      "RouteName": "NASAL",
      "StartMarketingDate": "20120301",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "UNITED EXCHANGE CORP.",
      "SubstanceName": "OXYMETAZOLINE HYDROCHLORIDE",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Directions: 1 adults and children 6 to 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours.  Do not exceed 2 doses in any 24 hour period. , 2 children under 6 years of age: ask a doctor ."
    },
    {
      "NDCCode": "65923-978-30",
      "PackageDescription": "1 BOTTLE in 1 CARTON (65923-978-30)  > 30 mL in 1 BOTTLE",
      "NDC11Code": "65923-0978-30",
      "ProductNDC": "65923-978",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Shopko Severe Congestion Nasal",
      "NonProprietaryName": "Oxymetazoline Hcl",
      "DosageFormName": "SPRAY",
      "RouteName": "NASAL",
      "StartMarketingDate": "20120301",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "UNITED EXCHANGE CORP.",
      "SubstanceName": "OXYMETAZOLINE HYDROCHLORIDE",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Directions: 1 adults and children 6 to 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours.  Don not exceed 2 doses in any 24-hour period. , 2 children under 6 years of age : ask a doctor.  To spray, hold bottle with thumb at base and nozzle between first and second fingers.  Without tilting head, insert nozzle into nostril.  Fully depress rim with a firm, even stroke and sniff deeply.  Wipe nozzle clean after use. ."
    },
    {
      "NDCCode": "10370-831-11",
      "PackageDescription": "30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (10370-831-11) ",
      "NDC11Code": "10370-0831-11",
      "ProductNDC": "10370-831",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Diltiazem Hydrochloride",
      "ProprietaryNameSuffix": "Extended-release",
      "NonProprietaryName": "Diltiazem Hydrochloride",
      "DosageFormName": "CAPSULE, COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20151001",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074984",
      "LabelerName": "Endo USA, Inc.",
      "SubstanceName": "DILTIAZEM HYDROCHLORIDE",
      "StrengthNumber": "240",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2026-08-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20170213",
      "SamplePackage": "N",
      "IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules, USP is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP is indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
      "Description": "Diltiazem Hydrochloride Extended-Release Capsules, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-­4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem Hydrochloride Extended-Release Capsules, USP is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem) or 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem). Each diltiazem hydrochloride extended-release capsule, contains the following inactive ingredients: ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, gelatin, hydroxypropyl cellulose, propylene glycol, shellac, sodium lauryl sulfate, sucrose, corn starch, talc, titanium dioxide, triethyl citrate and black iron oxide. In addition, the 180 mg capsules contains D&C yellow #10, FD&C blue #1, FD&C green #3, 240 mg capsules contains D&C yellow #10, FD&C green #3 and 300 mg capsules contains black iron oxide, D&C yellow #10, FD&C green #3. For oral administration. This drug product conforms to USP Drug release test #11."
    },
    {
      "NDCCode": "24236-831-02",
      "PackageDescription": "30 CAPSULE in 1 BLISTER PACK (24236-831-02)",
      "NDC11Code": "24236-0831-02",
      "ProductNDC": "24236-831",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lyrica",
      "NonProprietaryName": "Pregabalin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20080926",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021446",
      "LabelerName": "REMEDYREPACK INC.",
      "SubstanceName": "PREGABALIN",
      "StrengthNumber": "75",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2017-07-25"
    },
    {
      "NDCCode": "41520-831-10",
      "PackageDescription": "1 BOTTLE in 1 CARTON (41520-831-10)  > 30 mL in 1 BOTTLE",
      "NDC11Code": "41520-0831-10",
      "ProductNDC": "41520-831",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Careone Cold And Sinus",
      "NonProprietaryName": "Phenylephrine Hydrochloride",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "NASAL",
      "StartMarketingDate": "20161020",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "American Sales Company",
      "SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/100mL",
      "Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-10-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20161020",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves nasal congestion due to:. common cold. hay fever. upper respiratory allergies. temporarily relieves sinus congestion and pressure. shrinks swollen membranes so you can breathe more freely. temporarily restores freer breathing through the nose."
    },
    {
      "NDCCode": "42291-831-30",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (42291-831-30) ",
      "NDC11Code": "42291-0831-30",
      "ProductNDC": "42291-831",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Teriflunomide",
      "NonProprietaryName": "Teriflunomide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230420",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209700",
      "LabelerName": "AvKARE",
      "SubstanceName": "TERIFLUNOMIDE",
      "StrengthNumber": "14",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-01-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230420",
      "SamplePackage": "N",
      "IndicationAndUsage": "Teriflunomide tablets are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.",
      "Description": "Teriflunomide is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-cyano-3-hydroxy-N-(4-(trifluoromethyl)phenyl)but-2-enamide. Its molecular weight is 270.21, and the molecular formula is C 12H 9F 3N 2O 2 with the following chemical structure:. Teriflunomide is a white crystalline powder that is sparingly soluble in acetone and ethyl acetate, slightly soluble in polyethylene glycol and ethanol, very slightly soluble in isopropanol and methanol and practically insoluble in water. Teriflunomide is formulated as film-coated tablets for oral administration. Teriflunomide tablets contain 7 mg or 14 mg of teriflunomide and the following inactive ingredients: colloidal silicon dioxide, FD&C Blue #2/Indigo Carmine Aluminum Lake, hydroxypropyl cellulose, hypromellose 2910, lactose monohydrate, maize starch, microcrystalline cellulose, polyethylene glycol 8000, sodium starch glycolate, sodium stearyl fumarate, talc, and titanium dioxide. In addition, the 7 mg tablet contains FD&C Blue #1/Brilliant Blue FCF Aluminum Lake and iron oxide yellow."
    },
    {
      "NDCCode": "43063-831-30",
      "PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (43063-831-30) ",
      "NDC11Code": "43063-0831-30",
      "ProductNDC": "43063-831",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levocetirizine Dihydrochloride",
      "NonProprietaryName": "Levocetirizine Dihydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150213",
      "EndMarketingDate": "20210301",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203027",
      "LabelerName": "PD-Rx Pharmaceuticals, Inc.",
      "SubstanceName": "LEVOCETIRIZINE DIHYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2021-03-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20180129",
      "EndMarketingDatePackage": "20210301",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "43353-831-30",
      "PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (43353-831-30)",
      "NDC11Code": "43353-0831-30",
      "ProductNDC": "43353-831",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Modafinil",
      "NonProprietaryName": "Modafinil",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120810",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076594",
      "LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
      "SubstanceName": "MODAFINIL",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC]",
      "DEASchedule": "CIV",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "Modafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea, and shift work disorder. In OSA, modafinil tablets are indicated as an adjunct to standard treatment(s) for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating modafinil tablets. If modafinil tablets are used adjunctively with CPAP, the encouragement of and periodic assessment of CPAP compliance is necessary. In all cases, careful attention to the diagnosis and treatment of the underlying sleep disorder(s) is of utmost importance. Prescribers should be aware that some patients may have more than one sleep disorder contributing to their excessive sleepiness. The effectiveness of modafinil in long-term use (greater than 9 weeks in Narcolepsy clinical trials and 12 weeks in OSA and SWD clinical trials) has not been systematically evaluated in placebo-controlled trials. The physician who elects to prescribe modafinil tablets for an extended time in patients with Narcolepsy, OSA, or SWD should periodically reevaluate long-term usefulness for the individual patient.",
      "Description": "Modafinil is a wakefulness-promoting agent for oral administration. Modafinil is a racemic compound. The chemical name for modafinil is 2-[(diphenylmethyl) sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.36. The chemical structure is:. Modafinil, USP is a white to off-white, crystalline powder that is practically insoluble in water and cyclohexane. It is sparingly to slightly soluble in methanol and acetone. Modafinil tablets contain 100 mg or 200 mg of modafinil and the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate (anhydrous), lactose monohydrate, magnesium stearate, microcrystalline cellulose and povidone. Meets USP Dissolution Test 2."
    },
    {
      "NDCCode": "49035-831-30",
      "PackageDescription": "30 mL in 1 BOTTLE, PLASTIC (49035-831-30)",
      "NDC11Code": "49035-0831-30",
      "ProductNDC": "49035-831",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Equate Anti Bacterial",
      "ProprietaryNameSuffix": "Hand Sanitizer Coconut",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20161101",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Wal-Mart Stores Inc",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "62",
      "StrengthUnit": "g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2021-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "IndicationAndUsage": "■ For handwashing to decrease bacteria on the skin. ■ Recommended for repeated use."
    },
    {
      "NDCCode": "49349-831-02",
      "PackageDescription": "30 TABLET in 1 BLISTER PACK (49349-831-02)",
      "NDC11Code": "49349-0831-02",
      "ProductNDC": "49349-831",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metoprolol Tartrate",
      "NonProprietaryName": "Metoprolol Tartrate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20111201",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074644",
      "LabelerName": "REMEDYREPACK INC.",
      "SubstanceName": "METOPROLOL TARTRATE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2017-02-20"
    },
    {
      "NDCCode": "49884-831-11",
      "PackageDescription": "30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (49884-831-11)",
      "NDC11Code": "49884-0831-11",
      "ProductNDC": "49884-831",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Diltiazem Hydrochloride",
      "ProprietaryNameSuffix": "Extended Release",
      "NonProprietaryName": "Diltiazem Hydrochloride",
      "DosageFormName": "CAPSULE, COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19991220",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074984",
      "LabelerName": "Par Pharmaceutical, Inc.",
      "SubstanceName": "DILTIAZEM HYDROCHLORIDE",
      "StrengthNumber": "240",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-12-28",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "51655-831-52",
      "PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (51655-831-52) ",
      "NDC11Code": "51655-0831-52",
      "ProductNDC": "51655-831",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydrochlorothiazide",
      "NonProprietaryName": "Hydrochlorothiazide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230203",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA083177",
      "LabelerName": "Northwind Health Company, LLC",
      "SubstanceName": "HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Active",
      "LastUpdate": "2026-02-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230306",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.",
      "Description": "Hydrochlorothiazide, USP is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. It is chemically designated as 6-chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide and has the following structural formula:. C 7H 8ClN 3O 4S 2              M.W. 297.74. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder which is slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. Each tablet for oral administration contains 12.5 mg, 25 mg or 50 mg hydrochlorothiazide, USP. In addition, each tablet contains the following inactive ingredients: corn starch, dibasic calcium phosphate dihydrate, FD&C Yellow No. 6 Aluminum Lake, lactose monohydrate and magnesium stearate."
    },
    {
      "NDCCode": "55700-831-30",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE (55700-831-30) ",
      "NDC11Code": "55700-0831-30",
      "ProductNDC": "55700-831",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Doxepin Hydrochloride",
      "NonProprietaryName": "Doxepin Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20191223",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211603",
      "LabelerName": "Quality Care Products, LLC",
      "SubstanceName": "DOXEPIN HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tricyclic Antidepressant [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20191223",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "61919-831-30",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (61919-831-30)",
      "NDC11Code": "61919-0831-30",
      "ProductNDC": "61919-831",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fenofibrate",
      "NonProprietaryName": "Fenofibrate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076635",
      "LabelerName": "DirectRX",
      "SubstanceName": "FENOFIBRATE",
      "StrengthNumber": "160",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Treatment of HypercholesterolemiaFenofibrate tablets, USP are indicated as adjunctive therapy to diet to reduce elevated LDL-C, Total-C, Triglycerides and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (See National Cholesterol Education Program [NCEP] Treatment Guidelines, below).Treatment of HypertriglyceridemiaFenofibrate tablets, USP are also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (Fredrickson Types IV and V hyperlipidemia). Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention.Markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate tablet, USP therapy on reducing this risk has not been adequately studied.Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV and V hyperlipoproteinemia2.The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, thiazide diuretics and beta-blockers, are sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia.The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with non-drug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet. (See WARNINGS and PRECAUTIONS).Fredrickson Classification of HyperlipoproteinemiasC = cholesterolTG = triglyceridesLDL = low density lipoproteinVLDL = very low density lipoproteinIDL = intermediate density lipoproteinLipid Elevation TypeLipoprotein ElevatedMajorMinorI (rare)chylomicronsTG↑↔CIIaLDLC-IIbLDL, VLDLCTGIII (rare)IDLC, TG-IVVLDLTG↑↔CV (rare)chylomicrons, VLDLTG↑↔NCEP Treatment Guidelines: LDL-C Goals and Cutpoints for Therapeutic Lifestyle Changes and Drug Therapy in Different Risk Categories†CHD = coronary heart disease††Some authorities recommend use of LDL-lowering drugs in this category if an LDL-C level of < 100 mg/dL cannot be achieved by therapeutic lifestyle changes. Others prefer use of drugs that primarily modify triglycerides and HDL-C, e.g., nicotinic acid or fibrate. Clinical judgment also may call for deferring drug therapy in this subcategory.†††Almost all people with 0 to 1 risk factor have 10-year risk < 10%; thus, 10-year risk assessment in people with 0 to 1 risk factor is not necessary.Risk CategoryLDL Goal (mg/dL)LDL Level at Which to Initiate Therapeutic Lifestyle Changes (mg/dL)LDL Level at Which to Consider Drug Therapy (mg/dL)CHD† or CHD risk equivalents (10-years risk > 20%)< 100≥ 100≥ 130 (100 to 129: drug optional)††2+ Risk Factors (10-year risk ≤ 20%)< 130≥ 13010-year risk 10% to 20%: ≥ 130 10-year risk < 10%: ≥ 1600 to 1 Risk Factor†††< 160≥ 160≥ 190 (160 to 189: LDL- lowering drug optional)After the LDL-C goal has been achieved, if the TG is still ≥ 200 mg/dL, non HDL-C (total-C minus HDL-C) becomes a secondary target of therapy. Non-HDL-C goals are set 30 mg/dL higher than LDL-C goals for each risk category.",
      "Description": "Fenofibrate tablets, USP is a lipid regulating agent available as tablets for oral administration. Each tablet contains 54 mg or 160 mg of fenofibrate, USP. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following molecular structure. structure. The molecular formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate, USP is very soluble in methylene chloride, slightly soluble in alcohal and prectically insoluble in water. The melting point is 79 - 82° C. Fenofibrate, USP is a white or almost white crystalline powder. Inactive Ingredients: Each tablet contains colloidal silicon dioxide, crospovidone, lecithin (soya), microcrystalline cellulose, polyvinyl alcohol, povidone, pregelatinized starch, sodium lauryl sulfate, sodium stearyl fumarate, talc, titanium dioxide and xanthan gum. Meets USP Dissolution Test 2."
    },
    {
      "NDCCode": "62856-831-30",
      "PackageDescription": "3 BLISTER PACK in 1 CARTON (62856-831-30)  > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
      "NDC11Code": "62856-0831-30",
      "ProductNDC": "62856-831",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Aricept",
      "ProprietaryNameSuffix": "Odt",
      "NonProprietaryName": "Donepezil Hydrochloride",
      "DosageFormName": "TABLET, ORALLY DISINTEGRATING",
      "RouteName": "ORAL",
      "StartMarketingDate": "20041018",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021720",
      "LabelerName": "Eisai Inc.",
      "SubstanceName": "DONEPEZIL HYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2017-02-13"
    },
    {
      "NDCCode": "63187-831-30",
      "PackageDescription": "30 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-831-30) ",
      "NDC11Code": "63187-0831-30",
      "ProductNDC": "63187-831",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pantoprazole Sodium",
      "NonProprietaryName": "Pantoprazole",
      "DosageFormName": "TABLET, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140910",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202882",
      "LabelerName": "Proficient Rx LP",
      "SubstanceName": "PANTOPRAZOLE SODIUM",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2019-11-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20170403",
      "SamplePackage": "N",
      "IndicationAndUsage": "Pantoprazole Sodium Delayed-Release Tablets, USP are indicated for:.",
      "Description": "The active ingredient in Pantoprazole Sodium Delayed-Release Tablets, USP is a substituted benzimidazole, 5-(Difluoromethoxy) -2- [[(3,4 dimethoxy-2- pyridyl)methyl] sulfinyl]benzimidazole, sodium salt, sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S . 1.5 H2O, with a molecular weight of 432.4. The structural formula is. Pantoprazole sodium sesquihydrate, USP is a white to off-white powder. Pantoprazole sodium sesquihydrate, USP is freely soluble in water, in methanol, in dehydrated alcohol, practically insoluble in hexane and dichloromethane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole Sodium is supplied as a Delayed-Release Tablet, available in two strengths (20 mg and 40 mg). Each Pantoprazole Sodium Delayed-Release Tablet, USP contains 45.11 mg or 22.55 mg of pantoprazole sodium sesquihydrate, USP (equivalent to 40 mg or 20 mg pantoprazole, respectively) with the following inactive ingredients: calcium stearate, ferric oxide yellow, hydroxy propyl cellulose, hypromellose, lactose monohydrate, methacrylic acid copolymer, polysorbate 80, propylene glycol, sodium carbonate anhydrous, sodium lauryl sulfate, titanium dioxide and triethyl citrate. The tablets are imprinted with opacode black containing ammonium hydroxide, iron oxide black, propylene glycol and shellac. Pantoprazole Sodium Delayed-Release Tablets, (40 mg and 20 mg) complies with USP dissolution test 2."
    },
    {
      "NDCCode": "64380-831-04",
      "PackageDescription": "30 TABLET in 1 BOTTLE (64380-831-04) ",
      "NDC11Code": "64380-0831-04",
      "ProductNDC": "64380-831",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Gabapentin",
      "NonProprietaryName": "Gabapentin",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260304",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211313",
      "LabelerName": "Strides Pharma Science Limited",
      "SubstanceName": "GABAPENTIN",
      "StrengthNumber": "600",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2026-03-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20260304",
      "SamplePackage": "N",
      "IndicationAndUsage": "Gabapentin tablets is indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.",
      "Description": "The active ingredient in gabapentin tablets, USP is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9 H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin, USP is a white to off-white crystalline powder with a pH of 6.5 – 7.5. It is freely soluble in water and sparingly soluble in methanol. Each gabapentin tablet contains 600 mg or 800 mg of gabapentin and the following inactive ingredients. Corn (maize) Starch, Mannitol, Crospovidone, Copovidone, Talc, Magnesium Stearate 50%, Colloidal Silicon Dioxide, Hydroxypropyl Cellulose, Isopropyl alcohol."
    },
    {
      "NDCCode": "65841-831-06",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (65841-831-06) ",
      "NDC11Code": "65841-0831-06",
      "ProductNDC": "65841-831",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Voriconazole",
      "NonProprietaryName": "Voriconazole",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160525",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206747",
      "LabelerName": "Zydus Lifesciences Limited",
      "SubstanceName": "VORICONAZOLE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-03-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20160525",
      "SamplePackage": "N",
      "IndicationAndUsage": "Voriconazole is an azole antifungal indicated for the treatment of adults and pediatric patients aged 2 years of age and older with: 1 Invasive aspergillosis (1.1), 2 Candidemia in non-neutropenics and other deep tissue Candida infections (1.2), 3 Esophageal candidiasis (1.3), 4 Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani , in patients intolerant of, or refractory to, other therapy (1.4).",
      "Description": "Voriconazole, an azole antifungal agent is available as film-coated tablets for oral administration. The structural formula is. Voriconazole is designated chemically as (2R,3S)-2-(2,4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4-triazol-1-yl)-2-butanol with an molecular formula of C16H14F3N5O and a molecular weight of 349.3. Voriconazole drug substance is a white to almost white powder. Each voriconazole tablet intended for oral administration contains 50 mg or 200 mg of voriconazole. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone and pregelatinized starch. Additionally, each voriconazole tablets contain opadry II white 33F28398 which contains hypromellose, lactose monohydrate, polyethylene glycol, talc and titanium dioxide."
    },
    {
      "NDCCode": "65841-831-77",
      "PackageDescription": "10 BLISTER PACK in 1 CARTON (65841-831-77)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (65841-831-30) ",
      "NDC11Code": "65841-0831-77",
      "ProductNDC": "65841-831",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Voriconazole",
      "NonProprietaryName": "Voriconazole",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160525",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206747",
      "LabelerName": "Zydus Lifesciences Limited",
      "SubstanceName": "VORICONAZOLE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-03-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20160525",
      "SamplePackage": "N",
      "IndicationAndUsage": "Voriconazole is an azole antifungal indicated for the treatment of adults and pediatric patients aged 2 years of age and older with: 1 Invasive aspergillosis (1.1), 2 Candidemia in non-neutropenics and other deep tissue Candida infections (1.2), 3 Esophageal candidiasis (1.3), 4 Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani , in patients intolerant of, or refractory to, other therapy (1.4).",
      "Description": "Voriconazole, an azole antifungal agent is available as film-coated tablets for oral administration. The structural formula is. Voriconazole is designated chemically as (2R,3S)-2-(2,4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4-triazol-1-yl)-2-butanol with an molecular formula of C16H14F3N5O and a molecular weight of 349.3. Voriconazole drug substance is a white to almost white powder. Each voriconazole tablet intended for oral administration contains 50 mg or 200 mg of voriconazole. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone and pregelatinized starch. Additionally, each voriconazole tablets contain opadry II white 33F28398 which contains hypromellose, lactose monohydrate, polyethylene glycol, talc and titanium dioxide."
    },
    {
      "NDCCode": "65862-831-30",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (65862-831-30) ",
      "NDC11Code": "65862-0831-30",
      "ProductNDC": "65862-831",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cinacalcet",
      "NonProprietaryName": "Cinacalcet",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190625",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206125",
      "LabelerName": "Aurobindo Pharma Limited",
      "SubstanceName": "CINACALCET HYDROCHLORIDE",
      "StrengthNumber": "30",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2026-07-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190625",
      "SamplePackage": "N",
      "IndicationAndUsage": "Cinacalcet is a positive modulator of the calcium sensing receptor indicated for: 1 Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (1.1).",
      "Description": "Cinacalcet tablets contain the hydrochloride salt of the active ingredient cinacalcet, a positive modulator of the calcium sensing receptor. The molecular formula for cinacalcet is C22H22F3N⋅HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white powder that is soluble in methanol or 95% ethanol and slightly soluble in water. The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula: Cinacalcet tablets are formulated as light green, film-coated, oval shaped tablets for oral administration in strengths of 30 mg, 60 mg, and 90 mg of cinacalcet as the free base equivalent (33 mg, 66 mg, and 99 mg as the hydrochloride salt, respectively). Inactive Ingredients. The following are the inactive ingredients in cinacalcet tablets: colloidal silicon dioxide, crospovidone, FD&C blue #2/indigo carmine aluminum lake, hypromellose, iron oxide yellow, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (maize), sodium stearyl fumarate, titanium dioxide and triacetin."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"65923-831-30","ProprietaryName":"Coralite Antibacterial Moist","NonProprietaryName":"Benzalkonium Chloride"},{"NDCCode":"65923-001-00","ProprietaryName":"Coralite Antibacterial Bandage","NonProprietaryName":"Benzalkonium Chloride"},{"NDCCode":"65923-002-01","ProprietaryName":"Coralite Alcohol Pads","NonProprietaryName":"Isopropyl Alcohol"},{"NDCCode":"65923-011-30","ProprietaryName":"Family Care Nasal Relief","NonProprietaryName":"Oxymetazoline Hydrochloride"},{"NDCCode":"65923-077-30","ProprietaryName":"Shopko Original Nasal","NonProprietaryName":"Oxymetazoline Hydrochloride"},{"NDCCode":"65923-551-30","ProprietaryName":"Family Care Nasal Relief","NonProprietaryName":"Oxymetazoline Hydrochloride"},{"NDCCode":"65923-576-30","ProprietaryName":"Family Care Single Use Lubricant Eye Drop 0.4ml 30ct","NonProprietaryName":"Carboxymethyl Cellulose 0.5%"},{"NDCCode":"65923-583-30","ProprietaryName":"Family Care Single-use Eye","NonProprietaryName":"Carboxymethylcellulose Sodium"},{"NDCCode":"65923-584-25","ProprietaryName":"Family Care Single-use Eye","NonProprietaryName":"Polyethylene Glycol 400, And Propylene Glycol"},{"NDCCode":"65923-655-30","ProprietaryName":"Cvs Single Use Lubricant Eye Drops","NonProprietaryName":"Polyethylene Glycol 400, And Propylene Glycol"},{"NDCCode":"65923-977-30","ProprietaryName":"Shopko Extra Moisturizing Nasal","NonProprietaryName":"Oxymetazoline Hydrochloride"},{"NDCCode":"65923-978-30","ProprietaryName":"Shopko Severe Congestion Nasal","NonProprietaryName":"Oxymetazoline Hcl"},{"NDCCode":"10370-831-11","ProprietaryName":"Diltiazem Hydrochloride","NonProprietaryName":"Diltiazem Hydrochloride"},{"NDCCode":"24236-831-02","ProprietaryName":"Lyrica","NonProprietaryName":"Pregabalin"},{"NDCCode":"41520-831-10","ProprietaryName":"Careone Cold And Sinus","NonProprietaryName":"Phenylephrine Hydrochloride"},{"NDCCode":"42291-831-30","ProprietaryName":"Teriflunomide","NonProprietaryName":"Teriflunomide"},{"NDCCode":"43063-831-30","ProprietaryName":"Levocetirizine Dihydrochloride","NonProprietaryName":"Levocetirizine Dihydrochloride"},{"NDCCode":"43353-831-30","ProprietaryName":"Modafinil","NonProprietaryName":"Modafinil"},{"NDCCode":"49035-831-30","ProprietaryName":"Equate Anti Bacterial","NonProprietaryName":"Alcohol"},{"NDCCode":"49349-831-02","ProprietaryName":"Metoprolol Tartrate","NonProprietaryName":"Metoprolol Tartrate"},{"NDCCode":"49884-831-11","ProprietaryName":"Diltiazem Hydrochloride","NonProprietaryName":"Diltiazem Hydrochloride"},{"NDCCode":"51655-831-52","ProprietaryName":"Hydrochlorothiazide","NonProprietaryName":"Hydrochlorothiazide"},{"NDCCode":"55700-831-30","ProprietaryName":"Doxepin Hydrochloride","NonProprietaryName":"Doxepin Hydrochloride"},{"NDCCode":"61919-831-30","ProprietaryName":"Fenofibrate","NonProprietaryName":"Fenofibrate"},{"NDCCode":"62856-831-30","ProprietaryName":"Aricept","NonProprietaryName":"Donepezil Hydrochloride"},{"NDCCode":"63187-831-30","ProprietaryName":"Pantoprazole Sodium","NonProprietaryName":"Pantoprazole"},{"NDCCode":"64380-831-04","ProprietaryName":"Gabapentin","NonProprietaryName":"Gabapentin"},{"NDCCode":"65841-831-06","ProprietaryName":"Voriconazole","NonProprietaryName":"Voriconazole"},{"NDCCode":"65841-831-77","ProprietaryName":"Voriconazole","NonProprietaryName":"Voriconazole"},{"NDCCode":"65862-831-30","ProprietaryName":"Cinacalcet","NonProprietaryName":"Cinacalcet"}]}
                    

<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>65923-831-30</NDCCode>
    <PackageDescription>30 SOLUTION in 1 POUCH (65923-831-30) </PackageDescription>
    <NDC11Code>65923-0831-30</NDC11Code>
    <ProductNDC>65923-831</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Coralite Antibacterial Moist</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130926</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M003</ApplicationNumber>
    <LabelerName>United Exchange Corp.</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>.115</StrengthNumber>
    <StrengthUnit>g/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-11-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130926</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Directions.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>65923-001-00</NDCCode>
    <PackageDescription>30 PATCH in 1 PACKAGE (65923-001-00)  &gt; .048 mg in 1 PATCH</PackageDescription>
    <NDC11Code>65923-0001-00</NDC11Code>
    <ProductNDC>65923-001</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Coralite Antibacterial Bandage</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20140219</StartMarketingDate>
    <EndMarketingDate>20200930</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>UNITED EXCHANGE CORP</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>.12</StrengthNumber>
    <StrengthUnit>mg/100mg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-10-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20140219</StartMarketingDatePackage>
    <EndMarketingDatePackage>20200930</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>65923-002-01</NDCCode>
    <PackageDescription>30 PACKET in 1 CARTON (65923-002-01)  &gt; .6 mg in 1 PACKET</PackageDescription>
    <NDC11Code>65923-0002-01</NDC11Code>
    <ProductNDC>65923-002</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Coralite Alcohol Pads</ProprietaryName>
    <NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20120114</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>UNITED EXCHANGE CORP.</LabelerName>
    <SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mg/100mg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-05-09</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>65923-011-30</NDCCode>
    <PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (65923-011-30)  &gt; 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
    <NDC11Code>65923-0011-30</NDC11Code>
    <ProductNDC>65923-011</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Family Care Nasal Relief</ProprietaryName>
    <NonProprietaryName>Oxymetazoline Hydrochloride</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>NASAL</RouteName>
    <StartMarketingDate>20130531</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>United Exchange Corp</LabelerName>
    <SubstanceName>OXYMETAZOLINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-08-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161104</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>65923-077-30</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (65923-077-30)  &gt; 30 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>65923-0077-30</NDC11Code>
    <ProductNDC>65923-077</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Shopko Original Nasal</ProprietaryName>
    <NonProprietaryName>Oxymetazoline Hydrochloride</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>NASAL</RouteName>
    <StartMarketingDate>20120301</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>UNITED EXCHANGE CORP.</LabelerName>
    <SubstanceName>OXYMETAZOLINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>.05</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Directions: 1 adults and children 6 to 12 years of age (with adult supervision) 2 or 3 sprays in each nostril not more often than every 10 to 12 hours.  Do not exceed 2 doses in any 24-hour period. , 2 children under 6 years of age: ask a doctor. , 3 To spray, hold bottle with thumb at base and nozzle between first and second fingers.  Without tilting head, insert nozzle into nostril  Fully depress rim with a firm, even stroke and sniff deeply.  Wipe nozzle clean after use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>65923-551-30</NDCCode>
    <PackageDescription>1 BOTTLE, PUMP in 1 CARTON (65923-551-30)  &gt; 15 mL in 1 BOTTLE, PUMP</PackageDescription>
    <NDC11Code>65923-0551-30</NDC11Code>
    <ProductNDC>65923-551</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Family Care Nasal Relief</ProprietaryName>
    <NonProprietaryName>Oxymetazoline Hydrochloride</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>NASAL</RouteName>
    <StartMarketingDate>20130630</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>United Exchange Corp</LabelerName>
    <SubstanceName>OXYMETAZOLINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>.05</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-08-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161102</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>65923-576-30</NDCCode>
    <PackageDescription>30 VIAL, SINGLE-DOSE in 1 BOX (65923-576-30)  / 5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>65923-0576-30</NDC11Code>
    <ProductNDC>65923-576</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Family Care Single Use Lubricant Eye Drop 0.4ml 30ct</ProprietaryName>
    <NonProprietaryName>Carboxymethyl Cellulose 0.5%</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20260116</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M018</ApplicationNumber>
    <LabelerName>United Exchange Corp</LabelerName>
    <SubstanceName>CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-01-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260116</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Directions  Instill 1 or 2 drops in the affected eye(s) as needed and discard container.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>65923-583-30</NDCCode>
    <PackageDescription>30 VIAL, SINGLE-USE in 1 BOX (65923-583-30)  &gt; .4 mL in 1 VIAL, SINGLE-USE</PackageDescription>
    <NDC11Code>65923-0583-30</NDC11Code>
    <ProductNDC>65923-583</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Family Care Single-use Eye</ProprietaryName>
    <NonProprietaryName>Carboxymethylcellulose Sodium</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20160328</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part349</ApplicationNumber>
    <LabelerName>United Exchange Corp.</LabelerName>
    <SubstanceName>CARBOXYMETHYLCELLULOSE SODIUM</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-11-19</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>65923-584-25</NDCCode>
    <PackageDescription>30 VIAL, SINGLE-USE in 1 BOX (65923-584-25)  &gt; .4 mL in 1 VIAL, SINGLE-USE</PackageDescription>
    <NDC11Code>65923-0584-25</NDC11Code>
    <ProductNDC>65923-584</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Family Care Single-use Eye</ProprietaryName>
    <NonProprietaryName>Polyethylene Glycol 400, And Propylene Glycol</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20160328</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part349</ApplicationNumber>
    <LabelerName>United Exchange Corp.</LabelerName>
    <SubstanceName>POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL</SubstanceName>
    <StrengthNumber>4; 3</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-11-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>65923-655-30</NDCCode>
    <PackageDescription>30 VIAL, SINGLE-USE in 1 CARTON (65923-655-30)  &gt; .4 mL in 1 VIAL, SINGLE-USE</PackageDescription>
    <NDC11Code>65923-0655-30</NDC11Code>
    <ProductNDC>65923-655</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cvs Single Use Lubricant Eye Drops</ProprietaryName>
    <NonProprietaryName>Polyethylene Glycol 400, And Propylene Glycol</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20160121</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part349</ApplicationNumber>
    <LabelerName>United Exchange Corp.</LabelerName>
    <SubstanceName>POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL</SubstanceName>
    <StrengthNumber>4; 3</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-11-13</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>65923-977-30</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (65923-977-30)  &gt; 30 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>65923-0977-30</NDC11Code>
    <ProductNDC>65923-977</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Shopko Extra Moisturizing Nasal</ProprietaryName>
    <NonProprietaryName>Oxymetazoline Hydrochloride</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>NASAL</RouteName>
    <StartMarketingDate>20120301</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>UNITED EXCHANGE CORP.</LabelerName>
    <SubstanceName>OXYMETAZOLINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>.05</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Directions: 1 adults and children 6 to 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours.  Do not exceed 2 doses in any 24 hour period. , 2 children under 6 years of age: ask a doctor .</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>65923-978-30</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (65923-978-30)  &gt; 30 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>65923-0978-30</NDC11Code>
    <ProductNDC>65923-978</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Shopko Severe Congestion Nasal</ProprietaryName>
    <NonProprietaryName>Oxymetazoline Hcl</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>NASAL</RouteName>
    <StartMarketingDate>20120301</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>UNITED EXCHANGE CORP.</LabelerName>
    <SubstanceName>OXYMETAZOLINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>.05</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Directions: 1 adults and children 6 to 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours.  Don not exceed 2 doses in any 24-hour period. , 2 children under 6 years of age : ask a doctor.  To spray, hold bottle with thumb at base and nozzle between first and second fingers.  Without tilting head, insert nozzle into nostril.  Fully depress rim with a firm, even stroke and sniff deeply.  Wipe nozzle clean after use. .</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10370-831-11</NDCCode>
    <PackageDescription>30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (10370-831-11) </PackageDescription>
    <NDC11Code>10370-0831-11</NDC11Code>
    <ProductNDC>10370-831</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
    <ProprietaryNameSuffix>Extended-release</ProprietaryNameSuffix>
    <NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE, COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20151001</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074984</ApplicationNumber>
    <LabelerName>Endo USA, Inc.</LabelerName>
    <SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>240</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-08-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170213</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Diltiazem hydrochloride extended-release capsules, USP is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP is indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
    <Description>Diltiazem Hydrochloride Extended-Release Capsules, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-­4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem Hydrochloride Extended-Release Capsules, USP is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem) or 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem). Each diltiazem hydrochloride extended-release capsule, contains the following inactive ingredients: ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, gelatin, hydroxypropyl cellulose, propylene glycol, shellac, sodium lauryl sulfate, sucrose, corn starch, talc, titanium dioxide, triethyl citrate and black iron oxide. In addition, the 180 mg capsules contains D&amp;C yellow #10, FD&amp;C blue #1, FD&amp;C green #3, 240 mg capsules contains D&amp;C yellow #10, FD&amp;C green #3 and 300 mg capsules contains black iron oxide, D&amp;C yellow #10, FD&amp;C green #3. For oral administration. This drug product conforms to USP Drug release test #11.</Description>
  </NDC>
  <NDC>
    <NDCCode>24236-831-02</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BLISTER PACK (24236-831-02)</PackageDescription>
    <NDC11Code>24236-0831-02</NDC11Code>
    <ProductNDC>24236-831</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lyrica</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080926</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021446</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-07-25</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>41520-831-10</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (41520-831-10)  &gt; 30 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>41520-0831-10</NDC11Code>
    <ProductNDC>41520-831</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Careone Cold And Sinus</ProprietaryName>
    <NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>NASAL</RouteName>
    <StartMarketingDate>20161020</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>American Sales Company</LabelerName>
    <SubstanceName>PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-10-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161020</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves nasal congestion due to:. common cold. hay fever. upper respiratory allergies. temporarily relieves sinus congestion and pressure. shrinks swollen membranes so you can breathe more freely. temporarily restores freer breathing through the nose.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>42291-831-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (42291-831-30) </PackageDescription>
    <NDC11Code>42291-0831-30</NDC11Code>
    <ProductNDC>42291-831</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Teriflunomide</ProprietaryName>
    <NonProprietaryName>Teriflunomide</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230420</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209700</ApplicationNumber>
    <LabelerName>AvKARE</LabelerName>
    <SubstanceName>TERIFLUNOMIDE</SubstanceName>
    <StrengthNumber>14</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230420</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Teriflunomide tablets are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
    <Description>Teriflunomide is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-cyano-3-hydroxy-N-(4-(trifluoromethyl)phenyl)but-2-enamide. Its molecular weight is 270.21, and the molecular formula is C 12H 9F 3N 2O 2 with the following chemical structure:. Teriflunomide is a white crystalline powder that is sparingly soluble in acetone and ethyl acetate, slightly soluble in polyethylene glycol and ethanol, very slightly soluble in isopropanol and methanol and practically insoluble in water. Teriflunomide is formulated as film-coated tablets for oral administration. Teriflunomide tablets contain 7 mg or 14 mg of teriflunomide and the following inactive ingredients: colloidal silicon dioxide, FD&amp;C Blue #2/Indigo Carmine Aluminum Lake, hydroxypropyl cellulose, hypromellose 2910, lactose monohydrate, maize starch, microcrystalline cellulose, polyethylene glycol 8000, sodium starch glycolate, sodium stearyl fumarate, talc, and titanium dioxide. In addition, the 7 mg tablet contains FD&amp;C Blue #1/Brilliant Blue FCF Aluminum Lake and iron oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>43063-831-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (43063-831-30) </PackageDescription>
    <NDC11Code>43063-0831-30</NDC11Code>
    <ProductNDC>43063-831</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levocetirizine Dihydrochloride</ProprietaryName>
    <NonProprietaryName>Levocetirizine Dihydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150213</StartMarketingDate>
    <EndMarketingDate>20210301</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203027</ApplicationNumber>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>LEVOCETIRIZINE DIHYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-03-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20180129</StartMarketingDatePackage>
    <EndMarketingDatePackage>20210301</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>43353-831-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (43353-831-30)</PackageDescription>
    <NDC11Code>43353-0831-30</NDC11Code>
    <ProductNDC>43353-831</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Modafinil</ProprietaryName>
    <NonProprietaryName>Modafinil</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120810</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076594</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>MODAFINIL</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Modafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea, and shift work disorder. In OSA, modafinil tablets are indicated as an adjunct to standard treatment(s) for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating modafinil tablets. If modafinil tablets are used adjunctively with CPAP, the encouragement of and periodic assessment of CPAP compliance is necessary. In all cases, careful attention to the diagnosis and treatment of the underlying sleep disorder(s) is of utmost importance. Prescribers should be aware that some patients may have more than one sleep disorder contributing to their excessive sleepiness. The effectiveness of modafinil in long-term use (greater than 9 weeks in Narcolepsy clinical trials and 12 weeks in OSA and SWD clinical trials) has not been systematically evaluated in placebo-controlled trials. The physician who elects to prescribe modafinil tablets for an extended time in patients with Narcolepsy, OSA, or SWD should periodically reevaluate long-term usefulness for the individual patient.</IndicationAndUsage>
    <Description>Modafinil is a wakefulness-promoting agent for oral administration. Modafinil is a racemic compound. The chemical name for modafinil is 2-[(diphenylmethyl) sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.36. The chemical structure is:. Modafinil, USP is a white to off-white, crystalline powder that is practically insoluble in water and cyclohexane. It is sparingly to slightly soluble in methanol and acetone. Modafinil tablets contain 100 mg or 200 mg of modafinil and the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate (anhydrous), lactose monohydrate, magnesium stearate, microcrystalline cellulose and povidone. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>49035-831-30</NDCCode>
    <PackageDescription>30 mL in 1 BOTTLE, PLASTIC (49035-831-30)</PackageDescription>
    <NDC11Code>49035-0831-30</NDC11Code>
    <ProductNDC>49035-831</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Equate Anti Bacterial</ProprietaryName>
    <ProprietaryNameSuffix>Hand Sanitizer Coconut</ProprietaryNameSuffix>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20161101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Wal-Mart Stores Inc</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>62</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>■ For handwashing to decrease bacteria on the skin. ■ Recommended for repeated use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>49349-831-02</NDCCode>
    <PackageDescription>30 TABLET in 1 BLISTER PACK (49349-831-02)</PackageDescription>
    <NDC11Code>49349-0831-02</NDC11Code>
    <ProductNDC>49349-831</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metoprolol Tartrate</ProprietaryName>
    <NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20111201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074644</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</LabelerName>
    <SubstanceName>METOPROLOL TARTRATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-02-20</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>49884-831-11</NDCCode>
    <PackageDescription>30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (49884-831-11)</PackageDescription>
    <NDC11Code>49884-0831-11</NDC11Code>
    <ProductNDC>49884-831</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
    <ProprietaryNameSuffix>Extended Release</ProprietaryNameSuffix>
    <NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE, COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19991220</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074984</ApplicationNumber>
    <LabelerName>Par Pharmaceutical, Inc.</LabelerName>
    <SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>240</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-12-28</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>51655-831-52</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (51655-831-52) </PackageDescription>
    <NDC11Code>51655-0831-52</NDC11Code>
    <ProductNDC>51655-831</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydrochlorothiazide</ProprietaryName>
    <NonProprietaryName>Hydrochlorothiazide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230203</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA083177</ApplicationNumber>
    <LabelerName>Northwind Health Company, LLC</LabelerName>
    <SubstanceName>HYDROCHLOROTHIAZIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230306</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.</IndicationAndUsage>
    <Description>Hydrochlorothiazide, USP is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. It is chemically designated as 6-chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide and has the following structural formula:. C 7H 8ClN 3O 4S 2              M.W. 297.74. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder which is slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. Each tablet for oral administration contains 12.5 mg, 25 mg or 50 mg hydrochlorothiazide, USP. In addition, each tablet contains the following inactive ingredients: corn starch, dibasic calcium phosphate dihydrate, FD&amp;C Yellow No. 6 Aluminum Lake, lactose monohydrate and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>55700-831-30</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (55700-831-30) </PackageDescription>
    <NDC11Code>55700-0831-30</NDC11Code>
    <ProductNDC>55700-831</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20191223</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211603</ApplicationNumber>
    <LabelerName>Quality Care Products, LLC</LabelerName>
    <SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191223</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>61919-831-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (61919-831-30)</PackageDescription>
    <NDC11Code>61919-0831-30</NDC11Code>
    <ProductNDC>61919-831</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fenofibrate</ProprietaryName>
    <NonProprietaryName>Fenofibrate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076635</ApplicationNumber>
    <LabelerName>DirectRX</LabelerName>
    <SubstanceName>FENOFIBRATE</SubstanceName>
    <StrengthNumber>160</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Treatment of HypercholesterolemiaFenofibrate tablets, USP are indicated as adjunctive therapy to diet to reduce elevated LDL-C, Total-C, Triglycerides and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (See National Cholesterol Education Program [NCEP] Treatment Guidelines, below).Treatment of HypertriglyceridemiaFenofibrate tablets, USP are also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (Fredrickson Types IV and V hyperlipidemia). Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention.Markedly elevated levels of serum triglycerides (e.g. &gt; 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate tablet, USP therapy on reducing this risk has not been adequately studied.Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV and V hyperlipoproteinemia2.The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, thiazide diuretics and beta-blockers, are sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia.The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with non-drug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet. (See WARNINGS and PRECAUTIONS).Fredrickson Classification of HyperlipoproteinemiasC = cholesterolTG = triglyceridesLDL = low density lipoproteinVLDL = very low density lipoproteinIDL = intermediate density lipoproteinLipid Elevation TypeLipoprotein ElevatedMajorMinorI (rare)chylomicronsTG↑↔CIIaLDLC-IIbLDL, VLDLCTGIII (rare)IDLC, TG-IVVLDLTG↑↔CV (rare)chylomicrons, VLDLTG↑↔NCEP Treatment Guidelines: LDL-C Goals and Cutpoints for Therapeutic Lifestyle Changes and Drug Therapy in Different Risk Categories†CHD = coronary heart disease††Some authorities recommend use of LDL-lowering drugs in this category if an LDL-C level of &lt; 100 mg/dL cannot be achieved by therapeutic lifestyle changes. Others prefer use of drugs that primarily modify triglycerides and HDL-C, e.g., nicotinic acid or fibrate. Clinical judgment also may call for deferring drug therapy in this subcategory.†††Almost all people with 0 to 1 risk factor have 10-year risk &lt; 10%; thus, 10-year risk assessment in people with 0 to 1 risk factor is not necessary.Risk CategoryLDL Goal (mg/dL)LDL Level at Which to Initiate Therapeutic Lifestyle Changes (mg/dL)LDL Level at Which to Consider Drug Therapy (mg/dL)CHD† or CHD risk equivalents (10-years risk &gt; 20%)&lt; 100≥ 100≥ 130 (100 to 129: drug optional)††2+ Risk Factors (10-year risk ≤ 20%)&lt; 130≥ 13010-year risk 10% to 20%: ≥ 130 10-year risk &lt; 10%: ≥ 1600 to 1 Risk Factor†††&lt; 160≥ 160≥ 190 (160 to 189: LDL- lowering drug optional)After the LDL-C goal has been achieved, if the TG is still ≥ 200 mg/dL, non HDL-C (total-C minus HDL-C) becomes a secondary target of therapy. Non-HDL-C goals are set 30 mg/dL higher than LDL-C goals for each risk category.</IndicationAndUsage>
    <Description>Fenofibrate tablets, USP is a lipid regulating agent available as tablets for oral administration. Each tablet contains 54 mg or 160 mg of fenofibrate, USP. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following molecular structure. structure. The molecular formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate, USP is very soluble in methylene chloride, slightly soluble in alcohal and prectically insoluble in water. The melting point is 79 - 82° C. Fenofibrate, USP is a white or almost white crystalline powder. Inactive Ingredients: Each tablet contains colloidal silicon dioxide, crospovidone, lecithin (soya), microcrystalline cellulose, polyvinyl alcohol, povidone, pregelatinized starch, sodium lauryl sulfate, sodium stearyl fumarate, talc, titanium dioxide and xanthan gum. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>62856-831-30</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (62856-831-30)  &gt; 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>62856-0831-30</NDC11Code>
    <ProductNDC>62856-831</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Aricept</ProprietaryName>
    <ProprietaryNameSuffix>Odt</ProprietaryNameSuffix>
    <NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20041018</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021720</ApplicationNumber>
    <LabelerName>Eisai Inc.</LabelerName>
    <SubstanceName>DONEPEZIL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-02-13</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>63187-831-30</NDCCode>
    <PackageDescription>30 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-831-30) </PackageDescription>
    <NDC11Code>63187-0831-30</NDC11Code>
    <ProductNDC>63187-831</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pantoprazole Sodium</ProprietaryName>
    <NonProprietaryName>Pantoprazole</NonProprietaryName>
    <DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140910</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202882</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2019-11-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170403</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pantoprazole Sodium Delayed-Release Tablets, USP are indicated for:.</IndicationAndUsage>
    <Description>The active ingredient in Pantoprazole Sodium Delayed-Release Tablets, USP is a substituted benzimidazole, 5-(Difluoromethoxy) -2- [[(3,4 dimethoxy-2- pyridyl)methyl] sulfinyl]benzimidazole, sodium salt, sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S . 1.5 H2O, with a molecular weight of 432.4. The structural formula is. Pantoprazole sodium sesquihydrate, USP is a white to off-white powder. Pantoprazole sodium sesquihydrate, USP is freely soluble in water, in methanol, in dehydrated alcohol, practically insoluble in hexane and dichloromethane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole Sodium is supplied as a Delayed-Release Tablet, available in two strengths (20 mg and 40 mg). Each Pantoprazole Sodium Delayed-Release Tablet, USP contains 45.11 mg or 22.55 mg of pantoprazole sodium sesquihydrate, USP (equivalent to 40 mg or 20 mg pantoprazole, respectively) with the following inactive ingredients: calcium stearate, ferric oxide yellow, hydroxy propyl cellulose, hypromellose, lactose monohydrate, methacrylic acid copolymer, polysorbate 80, propylene glycol, sodium carbonate anhydrous, sodium lauryl sulfate, titanium dioxide and triethyl citrate. The tablets are imprinted with opacode black containing ammonium hydroxide, iron oxide black, propylene glycol and shellac. Pantoprazole Sodium Delayed-Release Tablets, (40 mg and 20 mg) complies with USP dissolution test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>64380-831-04</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (64380-831-04) </PackageDescription>
    <NDC11Code>64380-0831-04</NDC11Code>
    <ProductNDC>64380-831</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Gabapentin</ProprietaryName>
    <NonProprietaryName>Gabapentin</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260304</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211313</ApplicationNumber>
    <LabelerName>Strides Pharma Science Limited</LabelerName>
    <SubstanceName>GABAPENTIN</SubstanceName>
    <StrengthNumber>600</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-03-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20260304</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Gabapentin tablets is indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.</IndicationAndUsage>
    <Description>The active ingredient in gabapentin tablets, USP is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9 H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin, USP is a white to off-white crystalline powder with a pH of 6.5 – 7.5. It is freely soluble in water and sparingly soluble in methanol. Each gabapentin tablet contains 600 mg or 800 mg of gabapentin and the following inactive ingredients. Corn (maize) Starch, Mannitol, Crospovidone, Copovidone, Talc, Magnesium Stearate 50%, Colloidal Silicon Dioxide, Hydroxypropyl Cellulose, Isopropyl alcohol.</Description>
  </NDC>
  <NDC>
    <NDCCode>65841-831-06</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (65841-831-06) </PackageDescription>
    <NDC11Code>65841-0831-06</NDC11Code>
    <ProductNDC>65841-831</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Voriconazole</ProprietaryName>
    <NonProprietaryName>Voriconazole</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160525</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206747</ApplicationNumber>
    <LabelerName>Zydus Lifesciences Limited</LabelerName>
    <SubstanceName>VORICONAZOLE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160525</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Voriconazole is an azole antifungal indicated for the treatment of adults and pediatric patients aged 2 years of age and older with: 1 Invasive aspergillosis (1.1), 2 Candidemia in non-neutropenics and other deep tissue Candida infections (1.2), 3 Esophageal candidiasis (1.3), 4 Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani , in patients intolerant of, or refractory to, other therapy (1.4).</IndicationAndUsage>
    <Description>Voriconazole, an azole antifungal agent is available as film-coated tablets for oral administration. The structural formula is. Voriconazole is designated chemically as (2R,3S)-2-(2,4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4-triazol-1-yl)-2-butanol with an molecular formula of C16H14F3N5O and a molecular weight of 349.3. Voriconazole drug substance is a white to almost white powder. Each voriconazole tablet intended for oral administration contains 50 mg or 200 mg of voriconazole. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone and pregelatinized starch. Additionally, each voriconazole tablets contain opadry II white 33F28398 which contains hypromellose, lactose monohydrate, polyethylene glycol, talc and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>65841-831-77</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (65841-831-77)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (65841-831-30) </PackageDescription>
    <NDC11Code>65841-0831-77</NDC11Code>
    <ProductNDC>65841-831</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Voriconazole</ProprietaryName>
    <NonProprietaryName>Voriconazole</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160525</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206747</ApplicationNumber>
    <LabelerName>Zydus Lifesciences Limited</LabelerName>
    <SubstanceName>VORICONAZOLE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160525</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Voriconazole is an azole antifungal indicated for the treatment of adults and pediatric patients aged 2 years of age and older with: 1 Invasive aspergillosis (1.1), 2 Candidemia in non-neutropenics and other deep tissue Candida infections (1.2), 3 Esophageal candidiasis (1.3), 4 Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani , in patients intolerant of, or refractory to, other therapy (1.4).</IndicationAndUsage>
    <Description>Voriconazole, an azole antifungal agent is available as film-coated tablets for oral administration. The structural formula is. Voriconazole is designated chemically as (2R,3S)-2-(2,4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4-triazol-1-yl)-2-butanol with an molecular formula of C16H14F3N5O and a molecular weight of 349.3. Voriconazole drug substance is a white to almost white powder. Each voriconazole tablet intended for oral administration contains 50 mg or 200 mg of voriconazole. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone and pregelatinized starch. Additionally, each voriconazole tablets contain opadry II white 33F28398 which contains hypromellose, lactose monohydrate, polyethylene glycol, talc and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>65862-831-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (65862-831-30) </PackageDescription>
    <NDC11Code>65862-0831-30</NDC11Code>
    <ProductNDC>65862-831</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cinacalcet</ProprietaryName>
    <NonProprietaryName>Cinacalcet</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190625</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206125</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>CINACALCET HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-07-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190625</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cinacalcet is a positive modulator of the calcium sensing receptor indicated for: 1 Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (1.1).</IndicationAndUsage>
    <Description>Cinacalcet tablets contain the hydrochloride salt of the active ingredient cinacalcet, a positive modulator of the calcium sensing receptor. The molecular formula for cinacalcet is C22H22F3N⋅HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white powder that is soluble in methanol or 95% ethanol and slightly soluble in water. The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula: Cinacalcet tablets are formulated as light green, film-coated, oval shaped tablets for oral administration in strengths of 30 mg, 60 mg, and 90 mg of cinacalcet as the free base equivalent (33 mg, 66 mg, and 99 mg as the hydrochloride salt, respectively). Inactive Ingredients. The following are the inactive ingredients in cinacalcet tablets: colloidal silicon dioxide, crospovidone, FD&amp;C blue #2/indigo carmine aluminum lake, hypromellose, iron oxide yellow, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (maize), sodium stearyl fumarate, titanium dioxide and triacetin.</Description>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>65923-831-30</NDCCode><ProprietaryName>Coralite Antibacterial Moist</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>65923-001-00</NDCCode><ProprietaryName>Coralite Antibacterial Bandage</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>65923-002-01</NDCCode><ProprietaryName>Coralite Alcohol Pads</ProprietaryName><NonProprietaryName>Isopropyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>65923-011-30</NDCCode><ProprietaryName>Family Care Nasal Relief</ProprietaryName><NonProprietaryName>Oxymetazoline Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>65923-077-30</NDCCode><ProprietaryName>Shopko Original Nasal</ProprietaryName><NonProprietaryName>Oxymetazoline Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>65923-551-30</NDCCode><ProprietaryName>Family Care Nasal Relief</ProprietaryName><NonProprietaryName>Oxymetazoline Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>65923-576-30</NDCCode><ProprietaryName>Family Care Single Use Lubricant Eye Drop 0.4ml 30ct</ProprietaryName><NonProprietaryName>Carboxymethyl Cellulose 0.5%</NonProprietaryName></NDC><NDC><NDCCode>65923-583-30</NDCCode><ProprietaryName>Family Care Single-use Eye</ProprietaryName><NonProprietaryName>Carboxymethylcellulose Sodium</NonProprietaryName></NDC><NDC><NDCCode>65923-584-25</NDCCode><ProprietaryName>Family Care Single-use Eye</ProprietaryName><NonProprietaryName>Polyethylene Glycol 400, And Propylene Glycol</NonProprietaryName></NDC><NDC><NDCCode>65923-655-30</NDCCode><ProprietaryName>Cvs Single Use Lubricant Eye Drops</ProprietaryName><NonProprietaryName>Polyethylene Glycol 400, And Propylene Glycol</NonProprietaryName></NDC><NDC><NDCCode>65923-977-30</NDCCode><ProprietaryName>Shopko Extra Moisturizing Nasal</ProprietaryName><NonProprietaryName>Oxymetazoline Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>65923-978-30</NDCCode><ProprietaryName>Shopko Severe Congestion Nasal</ProprietaryName><NonProprietaryName>Oxymetazoline Hcl</NonProprietaryName></NDC><NDC><NDCCode>10370-831-11</NDCCode><ProprietaryName>Diltiazem Hydrochloride</ProprietaryName><NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>24236-831-02</NDCCode><ProprietaryName>Lyrica</ProprietaryName><NonProprietaryName>Pregabalin</NonProprietaryName></NDC><NDC><NDCCode>41520-831-10</NDCCode><ProprietaryName>Careone Cold And Sinus</ProprietaryName><NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>42291-831-30</NDCCode><ProprietaryName>Teriflunomide</ProprietaryName><NonProprietaryName>Teriflunomide</NonProprietaryName></NDC><NDC><NDCCode>43063-831-30</NDCCode><ProprietaryName>Levocetirizine Dihydrochloride</ProprietaryName><NonProprietaryName>Levocetirizine Dihydrochloride</NonProprietaryName></NDC><NDC><NDCCode>43353-831-30</NDCCode><ProprietaryName>Modafinil</ProprietaryName><NonProprietaryName>Modafinil</NonProprietaryName></NDC><NDC><NDCCode>49035-831-30</NDCCode><ProprietaryName>Equate Anti Bacterial</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>49349-831-02</NDCCode><ProprietaryName>Metoprolol Tartrate</ProprietaryName><NonProprietaryName>Metoprolol Tartrate</NonProprietaryName></NDC><NDC><NDCCode>49884-831-11</NDCCode><ProprietaryName>Diltiazem Hydrochloride</ProprietaryName><NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>51655-831-52</NDCCode><ProprietaryName>Hydrochlorothiazide</ProprietaryName><NonProprietaryName>Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>55700-831-30</NDCCode><ProprietaryName>Doxepin Hydrochloride</ProprietaryName><NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>61919-831-30</NDCCode><ProprietaryName>Fenofibrate</ProprietaryName><NonProprietaryName>Fenofibrate</NonProprietaryName></NDC><NDC><NDCCode>62856-831-30</NDCCode><ProprietaryName>Aricept</ProprietaryName><NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>63187-831-30</NDCCode><ProprietaryName>Pantoprazole Sodium</ProprietaryName><NonProprietaryName>Pantoprazole</NonProprietaryName></NDC><NDC><NDCCode>64380-831-04</NDCCode><ProprietaryName>Gabapentin</ProprietaryName><NonProprietaryName>Gabapentin</NonProprietaryName></NDC><NDC><NDCCode>65841-831-06</NDCCode><ProprietaryName>Voriconazole</ProprietaryName><NonProprietaryName>Voriconazole</NonProprietaryName></NDC><NDC><NDCCode>65841-831-77</NDCCode><ProprietaryName>Voriconazole</ProprietaryName><NonProprietaryName>Voriconazole</NonProprietaryName></NDC><NDC><NDCCode>65862-831-30</NDCCode><ProprietaryName>Cinacalcet</ProprietaryName><NonProprietaryName>Cinacalcet</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",
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      "PracticeLocationAddressFaxNumber": "860-821-3407",
      "EnumerationDate": "07/22/2006",
      "LastUpdateDate": "01/14/2016",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "000260",
      "LicenseNumberStateCode1": "CT",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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