RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "58118-0814-8",
      "PackageDescription": "30 CAPSULE in 1 BLISTER PACK (58118-0814-8)",
      "NDC11Code": "58118-0814-08",
      "ProductNDC": "58118-0814",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Gabapentin",
      "NonProprietaryName": "Gabapentin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170727",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090705",
      "LabelerName": "Clinical Solutions Wholesale, LLC",
      "SubstanceName": "GABAPENTIN",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2018-11-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "60905-0814-0",
      "PackageDescription": "8.8 mL in 1 BOTTLE (60905-0814-0) ",
      "NDC11Code": "60905-0814-00",
      "ProductNDC": "60905-0814",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Teint Couture Everwear 24h Wear Satin Finish Full Coverage And Comfort Broad Spectrum Spf 20 Y300",
      "NonProprietaryName": "Octinoxate, Titanium Dioxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20190401",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "LVMH Fragrance Brands",
      "SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
      "StrengthNumber": "30; 17.5",
      "StrengthUnit": "mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-10-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20190401",
      "SamplePackage": "Y",
      "IndicationAndUsage": "helps prevent sunburn if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions."
    },
    {
      "NDCCode": "71335-0814-8",
      "PackageDescription": "10 TABLET in 1 BOTTLE (71335-0814-8) ",
      "NDC11Code": "71335-0814-08",
      "ProductNDC": "71335-0814",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Meclizine Hydrochloride",
      "NonProprietaryName": "Meclizine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100212",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA201451",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "MECLIZINE HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antiemetic [EPC], Emesis Suppression [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2022-02-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20140829",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "25021-814-30",
      "PackageDescription": "1 VIAL in 1 CARTON (25021-814-30)  / 10 mL in 1 VIAL",
      "NDC11Code": "25021-0814-30",
      "ProductNDC": "25021-814",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Leucovorin Calcium",
      "NonProprietaryName": "Leucovorin Calcium",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20120915",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA200753",
      "LabelerName": "Sagent Pharmaceuticals",
      "SubstanceName": "LEUCOVORIN CALCIUM",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/10mL",
      "Pharm_Classes": "Folate Analog [EPC], Folic Acid [CS]",
      "Status": "Active",
      "LastUpdate": "2026-07-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20120915",
      "SamplePackage": "N",
      "IndicationAndUsage": "Leucovorin rescue is indicated after high dose methotrexate therapy in osteosarcoma. Leucovorin Calcium for Injection is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosages of folic acid antagonists. Leucovorin Calcium for Injection is indicated in the treatment of megaloblastic anemias due to folic acid deficiency when oral therapy is not feasible. Leucovorin Calcium for Injection is also indicated for use in combination with 5-fluorouracil to prolong survival in the palliative treatment of patients with advanced colorectal cancer. Leucovorin Calcium for Injection should not be mixed in the same infusion as 5-fluorouracil because a precipitate may form.",
      "Description": "Leucovorin is one of several active, chemically reduced derivatives of folic acid. It is useful as an antidote to drugs which act as folic acid antagonists. Also known as folinic acid, Citrovorum factor, or 5-formyl-5,6,7,8-tetrahydrofolic acid, this compound has the chemical designation of Calcium N-[p-[[[(6RS)-2-amino-5-formyl-5,6,7,8-tetrahydro-4-hydroxy-6-pteridinyl]methyl]amino]benzoyl]-L-glutamate (1:1). The structural formula of leucovorin calcium is:. Leucovorin Calcium for Injection, USP is a sterile product indicated for intramuscular (IM) or intravenous (IV) administration and is supplied in 50 mg, 100 mg, 200 mg, and 350 mg vials. Each 50 mg vial of Leucovorin Calcium for Injection, USP, when reconstituted with 5 mL of sterile diluent, contains leucovorin (as the calcium salt) 10 mg per mL. Each 100 mg vial of Leucovorin Calcium for Injection, USP, when reconstituted with 10 mL of sterile diluent, contains leucovorin (as the calcium salt) 10 mg per mL. Each 200 mg vial of Leucovorin Calcium for Injection, USP, when reconstituted with 20 mL of sterile diluent, contains leucovorin (as the calcium salt) 10 mg per mL. Each 350 mg vial of Leucovorin Calcium for Injection, USP, when reconstituted with 17.5 mL of sterile diluent, contains leucovorin (as the calcium salt) 20 mg per mL. In each dosage form, one milligram of leucovorin calcium contains 0.002 mmol of leucovorin and 0.002 mmol of calcium. These lyophilized products contain no preservative. The inactive ingredient is Sodium Chloride, USP, added to adjust tonicity. Sodium hydroxide and / or hydrochloric acid may be used to adjust the pH. The pH is between 6.5 and 8.5. Reconstitute with Bacteriostatic Water for Injection, USP, which contains benzyl alcohol (see WARNINGS section), or with Sterile Water for Injection, USP."
    },
    {
      "NDCCode": "33261-814-30",
      "PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (33261-814-30)",
      "NDC11Code": "33261-0814-30",
      "ProductNDC": "33261-814",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Venlafaxine Hydrochloride",
      "NonProprietaryName": "Venlafaxine Hydrochloride",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100701",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076565",
      "LabelerName": "Aidarex Pharmaceuticals LLC",
      "SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "Venlafaxine Hydrochloride Extended-Release Capsules USP are indicated for the treatment of major depressive disorder. The efficacy of Venlafaxine Hydrochloride Extended-Release Capsules USP in the treatment of major depressive disorder was established in 8 and 12 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III-R or DSM-IV category of major depressive disorder (see Clinical Trials). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two-week period: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The efficacy of Venlafaxine Hydrochloride Tablets USP (immediate release) in the treatment of major depressive disorder in adult inpatients meeting diagnostic criteria for major depressive disorder with melancholia was established in a 4 week controlled trial (see Clinical Trials). The safety and efficacy of Venlafaxine Hydrochloride Extended-Release Capsules USP in hospitalized depressed patients have not been adequately studied. The efficacy of Venlafaxine Hydrochloride Extended-Release Capsules USP in maintaining a response in major depressive disorder for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of Venlafaxine Hydrochloride Tablets USP (immediate release) in maintaining a response in patients with recurrent major depressive disorder who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see Clinical Trials). Nevertheless, the physician who elects to use Venlafaxine Hydrochloride Tablets USP/Venlafaxine Hydrochloride Extended-Release Capsules USP for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).",
      "Description": "Venlafaxine Hydrochloride Extended-Release Capsules USP for oral administration contain venlafaxine hydrochloride, USP a structurally novel antidepressant. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride. The structural formula is shown below. C17H27NO2HCl M.W. 313.87. Venlafaxine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Venlafaxine Hydrochloride Extended-Release Capsules USP are formulated as an extended-release capsule for once-a-day oral administration. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH dependent. Capsules contain venlafaxine hydrochloride, USP equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of black iron oxide, dibutyl sebacate, ethylcellulose, gelatin, polyethylene glycol, povidone, propylene glycol, shellac, sugar spheres (which contain sucrose and corn starch), sunset yellow FCF FD&C yellow 6, talc, and titanium dioxide. The 37.5 mg capsules also contain D&C yellow 10 and potassium hydroxide, the 75 mg capsules also contain D&C yellow 10 and may contain potassium hydroxide, and the 150 mg capsules also contain potassium hydroxide."
    },
    {
      "NDCCode": "33261-814-60",
      "PackageDescription": "60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (33261-814-60)",
      "NDC11Code": "33261-0814-60",
      "ProductNDC": "33261-814",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Venlafaxine Hydrochloride",
      "NonProprietaryName": "Venlafaxine Hydrochloride",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100701",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076565",
      "LabelerName": "Aidarex Pharmaceuticals LLC",
      "SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "Venlafaxine Hydrochloride Extended-Release Capsules USP are indicated for the treatment of major depressive disorder. The efficacy of Venlafaxine Hydrochloride Extended-Release Capsules USP in the treatment of major depressive disorder was established in 8 and 12 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III-R or DSM-IV category of major depressive disorder (see Clinical Trials). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two-week period: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The efficacy of Venlafaxine Hydrochloride Tablets USP (immediate release) in the treatment of major depressive disorder in adult inpatients meeting diagnostic criteria for major depressive disorder with melancholia was established in a 4 week controlled trial (see Clinical Trials). The safety and efficacy of Venlafaxine Hydrochloride Extended-Release Capsules USP in hospitalized depressed patients have not been adequately studied. The efficacy of Venlafaxine Hydrochloride Extended-Release Capsules USP in maintaining a response in major depressive disorder for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of Venlafaxine Hydrochloride Tablets USP (immediate release) in maintaining a response in patients with recurrent major depressive disorder who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see Clinical Trials). Nevertheless, the physician who elects to use Venlafaxine Hydrochloride Tablets USP/Venlafaxine Hydrochloride Extended-Release Capsules USP for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).",
      "Description": "Venlafaxine Hydrochloride Extended-Release Capsules USP for oral administration contain venlafaxine hydrochloride, USP a structurally novel antidepressant. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride. The structural formula is shown below. C17H27NO2HCl M.W. 313.87. Venlafaxine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Venlafaxine Hydrochloride Extended-Release Capsules USP are formulated as an extended-release capsule for once-a-day oral administration. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH dependent. Capsules contain venlafaxine hydrochloride, USP equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of black iron oxide, dibutyl sebacate, ethylcellulose, gelatin, polyethylene glycol, povidone, propylene glycol, shellac, sugar spheres (which contain sucrose and corn starch), sunset yellow FCF FD&C yellow 6, talc, and titanium dioxide. The 37.5 mg capsules also contain D&C yellow 10 and potassium hydroxide, the 75 mg capsules also contain D&C yellow 10 and may contain potassium hydroxide, and the 150 mg capsules also contain potassium hydroxide."
    },
    {
      "NDCCode": "33261-814-90",
      "PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (33261-814-90)",
      "NDC11Code": "33261-0814-90",
      "ProductNDC": "33261-814",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Venlafaxine Hydrochloride",
      "NonProprietaryName": "Venlafaxine Hydrochloride",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100701",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076565",
      "LabelerName": "Aidarex Pharmaceuticals LLC",
      "SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "Venlafaxine Hydrochloride Extended-Release Capsules USP are indicated for the treatment of major depressive disorder. The efficacy of Venlafaxine Hydrochloride Extended-Release Capsules USP in the treatment of major depressive disorder was established in 8 and 12 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III-R or DSM-IV category of major depressive disorder (see Clinical Trials). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two-week period: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The efficacy of Venlafaxine Hydrochloride Tablets USP (immediate release) in the treatment of major depressive disorder in adult inpatients meeting diagnostic criteria for major depressive disorder with melancholia was established in a 4 week controlled trial (see Clinical Trials). The safety and efficacy of Venlafaxine Hydrochloride Extended-Release Capsules USP in hospitalized depressed patients have not been adequately studied. The efficacy of Venlafaxine Hydrochloride Extended-Release Capsules USP in maintaining a response in major depressive disorder for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of Venlafaxine Hydrochloride Tablets USP (immediate release) in maintaining a response in patients with recurrent major depressive disorder who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see Clinical Trials). Nevertheless, the physician who elects to use Venlafaxine Hydrochloride Tablets USP/Venlafaxine Hydrochloride Extended-Release Capsules USP for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).",
      "Description": "Venlafaxine Hydrochloride Extended-Release Capsules USP for oral administration contain venlafaxine hydrochloride, USP a structurally novel antidepressant. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride. The structural formula is shown below. C17H27NO2HCl M.W. 313.87. Venlafaxine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Venlafaxine Hydrochloride Extended-Release Capsules USP are formulated as an extended-release capsule for once-a-day oral administration. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH dependent. Capsules contain venlafaxine hydrochloride, USP equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of black iron oxide, dibutyl sebacate, ethylcellulose, gelatin, polyethylene glycol, povidone, propylene glycol, shellac, sugar spheres (which contain sucrose and corn starch), sunset yellow FCF FD&C yellow 6, talc, and titanium dioxide. The 37.5 mg capsules also contain D&C yellow 10 and potassium hydroxide, the 75 mg capsules also contain D&C yellow 10 and may contain potassium hydroxide, and the 150 mg capsules also contain potassium hydroxide."
    },
    {
      "NDCCode": "35356-814-01",
      "PackageDescription": "120 TABLET in 1 BOTTLE, PLASTIC (35356-814-01) ",
      "NDC11Code": "35356-0814-01",
      "ProductNDC": "35356-814",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydromorphone Hydrochloride",
      "NonProprietaryName": "Hydromorphone Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20091209",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077471",
      "LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
      "SubstanceName": "HYDROMORPHONE HYDROCHLORIDE",
      "StrengthNumber": "8",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2019-06-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20091209",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "35356-814-30",
      "PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (35356-814-30) ",
      "NDC11Code": "35356-0814-30",
      "ProductNDC": "35356-814",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydromorphone Hydrochloride",
      "NonProprietaryName": "Hydromorphone Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20091209",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077471",
      "LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
      "SubstanceName": "HYDROMORPHONE HYDROCHLORIDE",
      "StrengthNumber": "8",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2019-06-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20091209",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "35356-814-60",
      "PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (35356-814-60) ",
      "NDC11Code": "35356-0814-60",
      "ProductNDC": "35356-814",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydromorphone Hydrochloride",
      "NonProprietaryName": "Hydromorphone Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20091209",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077471",
      "LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
      "SubstanceName": "HYDROMORPHONE HYDROCHLORIDE",
      "StrengthNumber": "8",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20091209",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "35356-814-90",
      "PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (35356-814-90) ",
      "NDC11Code": "35356-0814-90",
      "ProductNDC": "35356-814",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydromorphone Hydrochloride",
      "NonProprietaryName": "Hydromorphone Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20091209",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077471",
      "LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
      "SubstanceName": "HYDROMORPHONE HYDROCHLORIDE",
      "StrengthNumber": "8",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2019-06-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20091209",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "45865-814-49",
      "PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (45865-814-49) ",
      "NDC11Code": "45865-0814-49",
      "ProductNDC": "45865-814",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metoprolol Succinate",
      "NonProprietaryName": "Metoprolol Succinate",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120910",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090617",
      "LabelerName": "medsource pharmaceuticals",
      "SubstanceName": "METOPROLOL SUCCINATE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20180601",
      "SamplePackage": "N",
      "Description": "Metoprolol succinate, is a beta 1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended release tablets. Metoprolol succinate extended-release tablets USP, have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75 mg and 47.5 mg of metoprolol succinate equivalent to 25 mg and 50 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±) 1-(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate USP, is a white to off white powder with a molecular weight of 652.8. It is freely soluble in water and soluble in methanol. Inactive ingredients: acetyl tributyl citrate, colloidal silicon dioxide, croscarmellose sodium,   ethyl cellulose, hydrogenated vegetable oil, hydroxypropyl cellulose, hypromellose, methylene chloride,   microcrystalline cellulose, polyethylene glycol 6000, prosolv, sodium stearyl fumarate, talc and titanium dioxide."
    },
    {
      "NDCCode": "49884-814-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE (49884-814-01) ",
      "NDC11Code": "49884-0814-01",
      "ProductNDC": "49884-814",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Midodrine Hydrochloride",
      "NonProprietaryName": "Midodrine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20181029",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207169",
      "LabelerName": "Par Health USA, LLC",
      "SubstanceName": "MIDODRINE HYDROCHLORIDE",
      "StrengthNumber": "2.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-09-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20181029",
      "SamplePackage": "N",
      "IndicationAndUsage": "Midodrine hydrochloride tablets, USP are indicated for the treatment of symptomatic orthostatic hypotension (OH). Because midodrine hydrochloride tablets, USP can cause marked elevation of supine blood pressure (BP > 200 mmHg systolic), it should be used in patients whose lives are considerably impaired despite standard clinical care, including non-pharmacologic treatment (such as support stockings), fluid expansion, and lifestyle alterations. The indication is based on midodrine hydrochloride tablets, USP effect on increases in 1-minute standing systolic blood pressure, a surrogate marker considered likely to correspond to a clinical benefit. At present, however, clinical benefits of midodrine hydrochloride tablets, USP principally improved ability to perform life activities, have not been established. Further clinical trials are underway to verify and describe the clinical benefits of midodrine hydrochloride tablets, USP. After initiation of treatment, midodrine hydrochloride tablets, USP should be continued only for patients who report significant symptomatic improvement.",
      "Description": "Midodrine hydrochloride is a vasopressor/antihypotensive. The chemical name for midodrine hydrochloride is acetamide, 2-amino-N-[2-(2,5-dimethoxyphenyl)-2-hydroxyethyl]-, monohydrochloride, (±)-. The molecular weight of midodrine hydrochloride is 290.7. Its structural formula and molecular formula are. Midodrine hydrochloride, USP is an odorless, white, crystalline powder. It is soluble in water and sparingly soluble in methanol and has a pKa of 7.8 (0.3% aqueous solution) and a pH of 3.5 to 5.5 (5% aqueous solution). It has a melting range of 200° to 203°C. Each midodrine hydrochloride tablet, USP for oral administration contains 2.5 mg, 5 mg or 10 mg of midodrine hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, pregelatinized starch (maize) and stear-o-wet M (magnesium stearate and sodium lauryl sulphate)."
    },
    {
      "NDCCode": "49884-814-05",
      "PackageDescription": "500 TABLET in 1 BOTTLE (49884-814-05) ",
      "NDC11Code": "49884-0814-05",
      "ProductNDC": "49884-814",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Midodrine Hydrochloride",
      "NonProprietaryName": "Midodrine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20181029",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207169",
      "LabelerName": "Par Pharmaceutical, Inc.",
      "SubstanceName": "MIDODRINE HYDROCHLORIDE",
      "StrengthNumber": "2.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-12-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20181029",
      "SamplePackage": "N",
      "IndicationAndUsage": "Midodrine hydrochloride tablets, USP are indicated for the treatment of symptomatic orthostatic hypotension (OH). Because midodrine hydrochloride tablets, USP can cause marked elevation of supine blood pressure (BP > 200 mmHg systolic), it should be used in patients whose lives are considerably impaired despite standard clinical care, including non-pharmacologic treatment (such as support stockings), fluid expansion, and lifestyle alterations. The indication is based on midodrine hydrochloride tablets, USP effect on increases in 1-minute standing systolic blood pressure, a surrogate marker considered likely to correspond to a clinical benefit. At present, however, clinical benefits of midodrine hydrochloride tablets, USP principally improved ability to perform life activities, have not been established. Further clinical trials are underway to verify and describe the clinical benefits of midodrine hydrochloride tablets, USP. After initiation of treatment, midodrine hydrochloride tablets, USP should be continued only for patients who report significant symptomatic improvement.",
      "Description": "Midodrine hydrochloride is a vasopressor/antihypotensive. The chemical name for midodrine hydrochloride is acetamide, 2-amino-N-[2-(2,5-dimethoxyphenyl)-2-hydroxyethyl]-, monohydrochloride, (±)-. The molecular weight of midodrine hydrochloride is 290.7. Its structural formula and molecular formula are. Midodrine hydrochloride, USP is an odorless, white, crystalline powder. It is soluble in water and sparingly soluble in methanol and has a pKa of 7.8 (0.3% aqueous solution) and a pH of 3.5 to 5.5 (5% aqueous solution). It has a melting range of 200° to 203°C. Each midodrine hydrochloride tablet, USP for oral administration contains 2.5 mg, 5 mg or 10 mg of midodrine hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, pregelatinized starch (maize) and stear-o-wet M (magnesium stearate and sodium lauryl sulphate)."
    },
    {
      "NDCCode": "51991-814-03",
      "PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (51991-814-03)  > 30 mL in 1 BOTTLE, SPRAY",
      "NDC11Code": "51991-0814-03",
      "ProductNDC": "51991-814",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Azelastine Hydrochloride",
      "NonProprietaryName": "Azelastine Hydrochloride",
      "DosageFormName": "SPRAY, METERED",
      "RouteName": "NASAL",
      "StartMarketingDate": "20150729",
      "EndMarketingDate": "20241231",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090176",
      "LabelerName": "Breckenridge Pharmaceutical, Inc.",
      "SubstanceName": "AZELASTINE HYDROCHLORIDE",
      "StrengthNumber": "137",
      "StrengthUnit": "ug/.137mL",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20150729",
      "EndMarketingDatePackage": "20241231",
      "SamplePackage": "N",
      "IndicationAndUsage": "Azelastine Hydrochloride Nasal Spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older.",
      "Description": "Azelastine Hydrochloride Nasal Spray, 0.1% (137 micrograms (mcg) per spray), is an antihistamine formulated as a metered-spray solution for intranasal administration. Azelastine hydrochloride occurs as a white, almost odorless, crystalline powder with a bitter taste. It has a molecular weight of 418.37. It is sparingly soluble in water, methanol, and propylene glycol and slightly soluble in ethanol, octanol, and glycerine. It has a melting point of about 225°C and the pH of a saturated solution is between 5.0 and 5.4. Its chemical name is (±)-1-(2H)-phthalazinone, 4-[(4-chlorophenyl) methyl]-2-(hexahydro-1-methyl-1H-azepin-4-yl)-, monohydrochloride. Its molecular formula is C22H24ClN3O∙HCl with the following chemical structure. Azelastine Hydrochloride Nasal Spray contains 0.1% azelastine hydrochloride in an aqueous solution at pH 6.8 ± 0.3. It also contains benzalkonium chloride (125 mcg/mL), edetate disodium, hypromellose, citric acid, dibasic sodium phosphate heptahydrate, sodium chloride, and purified water. After priming [see Dosage and Administration (2.3)], each metered spray delivers a 0.137 mL mean volume containing 137 mcg of azelastine hydrochloride (equivalent to 125 mcg of azelastine base). The bottle can deliver 200 metered sprays."
    },
    {
      "NDCCode": "60687-814-65",
      "PackageDescription": "50 BLISTER PACK in 1 CARTON (60687-814-65)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-814-11) ",
      "NDC11Code": "60687-0814-65",
      "ProductNDC": "60687-814",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prochlorperazine Maleate",
      "NonProprietaryName": "Prochlorperazine Maleate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20241014",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA216598",
      "LabelerName": "American Health Packaging",
      "SubstanceName": "PROCHLORPERAZINE MALEATE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
      "Status": "Active",
      "LastUpdate": "2026-09-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20241014",
      "SamplePackage": "N",
      "IndicationAndUsage": "For control of severe nausea and vomiting. For the treatment of schizophrenia. Prochlorperazine maleate tablets are effective for the short-term treatment of generalized non-psychotic anxiety. However, prochlorperazine maleate tablets are not the first drug to be used in therapy for most patients with non-psychotic anxiety, because certain risks associated with its use are not shared by common alternative treatments (e.g., benzodiazepines). When used in the treatment of non-psychotic anxiety, prochlorperazine maleate tablets should not be administered at doses of more than 20 mg per day or for longer than 12 weeks, because the use of prochlorperazine maleate tablets at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see WARNINGS). The effectiveness of prochlorperazine maleate tablets as treatment for non-psychotic anxiety was established in 4-week clinical studies of outpatients with generalized anxiety disorder. This evidence does not predict that prochlorperazine maleate tablets will be useful in patients with other non-psychotic conditions in which anxiety, or signs that mimic anxiety, are found (e.g., physical illness, organic mental conditions, agitated depression, character pathologies, etc.). Prochlorperazine maleate tablets have not been shown effective in the management of behavioral complications in patients with mental retardation.",
      "Description": "Prochlorperazine, USP is a phenothiazine derivative, present in prochlorperazine maleate tablets, USP as the maleate. Prochlorperazine maleate is designated chemically as 10H-phenothiazine, 2-chloro-10-[3-(4-methyl-1-piperazinyl)propyl]-, (Z)-2-butenedioate (1:2) and has the following structure. Molecular formula: C 20H 24CIN 3S2C 4H 4O 4 Molecular weight: 606.09 g/mol. Prochlorperazine maleate is classified as an anti-emetic and antipsychotic agent. Prochlorperazine maleate, USP is a white to pale yellow color powder. It is sparingly soluble in dimethyl sulfoxide, practically insoluble in water and in alcohol. Each film-coated tablet contains prochlorperazine maleate USP, 8.104 mg or 16.208 mg equivalent to prochlorperazine USP, 5 mg or 10 mg respectively. In addition, each tablet contains the following inactive ingredients: D&C yellow # 10 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch and titanium dioxide."
    },
    {
      "NDCCode": "61047-814-75",
      "PackageDescription": "88 mL in 1 TUBE (61047-814-75)",
      "NDC11Code": "61047-0814-75",
      "ProductNDC": "61047-814",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Banana Boat Sport Performance",
      "NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20100322",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part348",
      "LabelerName": "KIK Custom Products",
      "SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
      "StrengthNumber": ".88; 8.8; 4.4; .7; 3.52",
      "StrengthUnit": "mL/88mL; mL/88mL; mL/88mL; mL/88mL; mL/88mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "62713-814-02",
      "PackageDescription": "60 mL in 1 BOTTLE, DROPPER (62713-814-02) ",
      "NDC11Code": "62713-0814-02",
      "ProductNDC": "62713-814",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Allergena Fragrance",
      "NonProprietaryName": "Allergena Fragrance",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120901",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Meditrend, Inc. DBA Progena Professional Formulations",
      "SubstanceName": "ACTIVATED CHARCOAL; ARNICA MONTANA; CICUTA VIROSA ROOT; EUPHORBIA RESINIFERA RESIN; GOLDENSEAL; KEROSENE; LEAD; LYCOPERDON UTRIFORME FRUITING BODY; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; SULFUR",
      "StrengthNumber": "8; 6; 6; 6; 4; 6; 8; 6; 8; 8; 30",
      "StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-02-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20120901",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "63187-814-30",
      "PackageDescription": "30 TABLET in 1 BOTTLE (63187-814-30) ",
      "NDC11Code": "63187-0814-30",
      "ProductNDC": "63187-814",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lovastatin",
      "NonProprietaryName": "Lovastatin",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20071101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078296",
      "LabelerName": "Proficient Rx LP",
      "SubstanceName": "LOVASTATIN",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2019-11-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20170201",
      "SamplePackage": "N",
      "IndicationAndUsage": "Therapy with lovastatin tablets USP should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. Lovastatin tablets USP should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-C and LDL-C to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk. Primary Prevention of Coronary Heart Disease. In individuals without symptomatic cardiovascular disease, average to moderately elevated total-C and LDL-C and below average HDL-C, lovastatin tablets USP are indicated to reduce the risk of:. -Myocardial infarction. -Unstable angina. -Coronary revascularization procedures. (See CLINICAL PHARMACOLOGY, Clinical Studies). Coronary Heart Disease. Lovastatin tablets USP are indicated to slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment strategy to lower total-C and LDL-C to target levels. Hypercholesterolemia. Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Lovastatin tablets USP are indicated as an adjunct to diet for the reduction of elevated total-C and LDL-C levels in patients with primary hypercholesterolemia (Types IIa and IIb2), when the response to diet restricted in saturated fat and cholesterol and to other nonpharmacological measures alone has been inadequate. Adolescent Patients with Heterozygous Familial Hypercholesterolemia. Lovastatin tablets USP are indicated as an adjunct to diet to reduce total-C, LDL-C and apolipoprotein B levels in adolescent boys and girls who are at least one year post-menarche, 10 to 17 years of age, with heFH if after an adequate trial of diet therapy the following findings are present. 1. LDL-C remains >189 mg/dL or. 2. LDL-C remains >160 mg/dL and: : 1 there is a positive family history of premature cardiovascular disease or , 2 two or more other CVD risk factors are present in the adolescent patient .",
      "Description": "Lovastatin is a cholesterol lowering agent isolated from a strain of Aspergillus terreus. After oral ingestion, lovastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is a principal metabolite and an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate limiting step in the biosynthesis of cholesterol. Lovastatin is [1S-[1α(R*),3α,7β,8β(2S*,4S*),8aβ]]-1,2,3,7, 8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)ethyl]-1-naphthalenyl 2-methylbutanoate. The empirical formula of lovastatin is C24H36O5 and its molecular weight is 404.55. Its structural formula is. Lovastatin is a white, nonhygroscopic crystalline powder that is insoluble in water and sparingly soluble in ethanol, methanol, and acetonitrile. Lovastatin tablets USP are supplied as 10 mg, 20 mg and 40 mg tablets for oral administration. In addition to the active ingredient lovastatin, each tablet contains the following inactive ingredients: D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, lactose anhydrous, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch. Butylated hydroxyanisole (BHA) is added as a preservative."
    },
    {
      "NDCCode": "63187-814-60",
      "PackageDescription": "60 TABLET in 1 BOTTLE (63187-814-60) ",
      "NDC11Code": "63187-0814-60",
      "ProductNDC": "63187-814",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lovastatin",
      "NonProprietaryName": "Lovastatin",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20071101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078296",
      "LabelerName": "Proficient Rx LP",
      "SubstanceName": "LOVASTATIN",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2019-11-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20170201",
      "SamplePackage": "N",
      "IndicationAndUsage": "Therapy with lovastatin tablets USP should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. Lovastatin tablets USP should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-C and LDL-C to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk. Primary Prevention of Coronary Heart Disease. In individuals without symptomatic cardiovascular disease, average to moderately elevated total-C and LDL-C and below average HDL-C, lovastatin tablets USP are indicated to reduce the risk of:. -Myocardial infarction. -Unstable angina. -Coronary revascularization procedures. (See CLINICAL PHARMACOLOGY, Clinical Studies). Coronary Heart Disease. Lovastatin tablets USP are indicated to slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment strategy to lower total-C and LDL-C to target levels. Hypercholesterolemia. Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Lovastatin tablets USP are indicated as an adjunct to diet for the reduction of elevated total-C and LDL-C levels in patients with primary hypercholesterolemia (Types IIa and IIb2), when the response to diet restricted in saturated fat and cholesterol and to other nonpharmacological measures alone has been inadequate. Adolescent Patients with Heterozygous Familial Hypercholesterolemia. Lovastatin tablets USP are indicated as an adjunct to diet to reduce total-C, LDL-C and apolipoprotein B levels in adolescent boys and girls who are at least one year post-menarche, 10 to 17 years of age, with heFH if after an adequate trial of diet therapy the following findings are present. 1. LDL-C remains >189 mg/dL or. 2. LDL-C remains >160 mg/dL and: : 1 there is a positive family history of premature cardiovascular disease or , 2 two or more other CVD risk factors are present in the adolescent patient .",
      "Description": "Lovastatin is a cholesterol lowering agent isolated from a strain of Aspergillus terreus. After oral ingestion, lovastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is a principal metabolite and an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate limiting step in the biosynthesis of cholesterol. Lovastatin is [1S-[1α(R*),3α,7β,8β(2S*,4S*),8aβ]]-1,2,3,7, 8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)ethyl]-1-naphthalenyl 2-methylbutanoate. The empirical formula of lovastatin is C24H36O5 and its molecular weight is 404.55. Its structural formula is. Lovastatin is a white, nonhygroscopic crystalline powder that is insoluble in water and sparingly soluble in ethanol, methanol, and acetonitrile. Lovastatin tablets USP are supplied as 10 mg, 20 mg and 40 mg tablets for oral administration. In addition to the active ingredient lovastatin, each tablet contains the following inactive ingredients: D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, lactose anhydrous, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch. Butylated hydroxyanisole (BHA) is added as a preservative."
    },
    {
      "NDCCode": "63187-814-90",
      "PackageDescription": "90 TABLET in 1 BOTTLE (63187-814-90) ",
      "NDC11Code": "63187-0814-90",
      "ProductNDC": "63187-814",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lovastatin",
      "NonProprietaryName": "Lovastatin",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20071101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078296",
      "LabelerName": "Proficient Rx LP",
      "SubstanceName": "LOVASTATIN",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2019-11-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20170201",
      "SamplePackage": "N",
      "IndicationAndUsage": "Therapy with lovastatin tablets USP should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. Lovastatin tablets USP should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-C and LDL-C to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk. Primary Prevention of Coronary Heart Disease. In individuals without symptomatic cardiovascular disease, average to moderately elevated total-C and LDL-C and below average HDL-C, lovastatin tablets USP are indicated to reduce the risk of:. -Myocardial infarction. -Unstable angina. -Coronary revascularization procedures. (See CLINICAL PHARMACOLOGY, Clinical Studies). Coronary Heart Disease. Lovastatin tablets USP are indicated to slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment strategy to lower total-C and LDL-C to target levels. Hypercholesterolemia. Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Lovastatin tablets USP are indicated as an adjunct to diet for the reduction of elevated total-C and LDL-C levels in patients with primary hypercholesterolemia (Types IIa and IIb2), when the response to diet restricted in saturated fat and cholesterol and to other nonpharmacological measures alone has been inadequate. Adolescent Patients with Heterozygous Familial Hypercholesterolemia. Lovastatin tablets USP are indicated as an adjunct to diet to reduce total-C, LDL-C and apolipoprotein B levels in adolescent boys and girls who are at least one year post-menarche, 10 to 17 years of age, with heFH if after an adequate trial of diet therapy the following findings are present. 1. LDL-C remains >189 mg/dL or. 2. LDL-C remains >160 mg/dL and: : 1 there is a positive family history of premature cardiovascular disease or , 2 two or more other CVD risk factors are present in the adolescent patient .",
      "Description": "Lovastatin is a cholesterol lowering agent isolated from a strain of Aspergillus terreus. After oral ingestion, lovastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is a principal metabolite and an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate limiting step in the biosynthesis of cholesterol. Lovastatin is [1S-[1α(R*),3α,7β,8β(2S*,4S*),8aβ]]-1,2,3,7, 8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)ethyl]-1-naphthalenyl 2-methylbutanoate. The empirical formula of lovastatin is C24H36O5 and its molecular weight is 404.55. Its structural formula is. Lovastatin is a white, nonhygroscopic crystalline powder that is insoluble in water and sparingly soluble in ethanol, methanol, and acetonitrile. Lovastatin tablets USP are supplied as 10 mg, 20 mg and 40 mg tablets for oral administration. In addition to the active ingredient lovastatin, each tablet contains the following inactive ingredients: D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, lactose anhydrous, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch. Butylated hydroxyanisole (BHA) is added as a preservative."
    },
    {
      "NDCCode": "65219-814-05",
      "PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (65219-814-05)  / 5 mL in 1 VIAL, SINGLE-DOSE (65219-814-01) ",
      "NDC11Code": "65219-0814-05",
      "ProductNDC": "65219-814",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Xylocaine",
      "ProprietaryNameSuffix": "Mpf",
      "NonProprietaryName": "Lidocaine Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL",
      "StartMarketingDate": "20201030",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA006488",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "LIDOCAINE HYDROCHLORIDE ANHYDROUS",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2024-03-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20201030",
      "SamplePackage": "N",
      "IndicationAndUsage": "Xylocaine (lidocaine HCl) Injections are indicated for production  of local or regional anesthesia by infiltration techniques such as  percutaneous injection and intravenous regional anesthesia by peripheral  nerve block techniques such as brachial plexus and intercostal and by  central neural techniques such as lumbar and caudal epidural blocks,  when the accepted procedures for these techniques as described in  standard textbooks are observed.",
      "Description": "Xylocaine (lidocaine HCl) Injections are sterile, nonpyrogenic, aqueous solutions that contain a local anesthetic agent with or without epinephrine and are administered parenterally by injection.  See INDICATIONS AND USAGE section for specific uses. Xylocaine solutions contain lidocaine HCl, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the molecular wt. 270.8.  Lidocaine HCl (C14H22N2O  HCl) has the following structural formula:. Epinephrine is (-) -3, 4-Dihydroxy-α-[(methylamino) methyl] benzyl alcohol and has the molecular wt. 183.21.  Epinephrine (C9H13NO3) has the following structural formula:. Dosage forms listed as Xylocaine-MPF indicate single dose solutions that are Methyl Paraben Free (MPF). Xylocaine MPF is a sterile, nonpyrogenic, isotonic solution containing sodium chloride.  Xylocaine in multiple dose vials:  Each mL also contains 1 mg methyl­paraben as antiseptic preservative.  The pH of these solutions is adjusted to approximately 6.5 (5.0 to 7.0) with sodium hydroxide and/or hydrochloric acid. Xylocaine MPF with Epinephrine is a sterile, nonpyrogenic, isotonic solution containing sodium chloride.  Each mL contains lidocaine hydrochloride and epinephrine, with 0.5 mg sodium metabisulfite as an antioxidant and 0.2 mg citric acid as a stabilizer.   Xylocaine with Epinephrine in multiple dose vials:  Each mL also contains 1 mg methylparaben as antiseptic preservative.  The pH of these solutions is adjusted to approximately 4.5 (3.3 to 5.5) with sodium hydroxide and/or hydrochloric acid.  Filled under nitrogen."
    },
    {
      "NDCCode": "65862-814-05",
      "PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (65862-814-05) ",
      "NDC11Code": "65862-0814-05",
      "ProductNDC": "65862-814",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pitavastatin",
      "NonProprietaryName": "Pitavastatin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20231102",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206015",
      "LabelerName": "Aurobindo Pharma Limited",
      "SubstanceName": "PITAVASTATIN CALCIUM",
      "StrengthNumber": "4",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-04-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20231102",
      "SamplePackage": "N",
      "IndicationAndUsage": "Pitavastatin tablets are  indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: : 1 Adults with primary hyperlipidemia., 2 Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).",
      "Description": "Pitavastatin tablets for oral use is an HMG-CoA reductase inhibitor. The chemical name for pitavastatin is (+)monocalcium bis{(3R, 5S, 6E)-7-[2-cyclopropyl-4-(4-fluorophenyl)-3-quinolyl]-3,5-dihydroxy-6-heptenoate}. The structural formula is. The molecular formula for pitavastatin is C50H46CaF2N2O8 and the molecular weight is 880.98. Pitavastatin is odorless and occurs as a white to pale yellow powder. It is freely soluble in pyridine, chloroform, dilute hydrochloric acid, and tetrahydrofuran, soluble in ethylene glycol, sparingly soluble in octanol, slightly soluble in methanol, very slightly soluble in water or ethanol, and practically insoluble in acetonitrile or diethyl ether. Pitavastatin is hygroscopic and slightly unstable in light. Each film-coated tablet of pitavastatin contains 1 mg, 2 mg, or 4 mg of pitavastatin, which is equivalent to 1.045 mg, 2.09 mg, or 4.18 mg, respectively, of pitavastatin calcium and the following inactive ingredients: hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium aluminometa silicate type I-B, magnesium stearate, silicon dioxide, titanium dioxide, and triethyl citrate."
    },
    {
      "NDCCode": "65862-814-90",
      "PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (65862-814-90) ",
      "NDC11Code": "65862-0814-90",
      "ProductNDC": "65862-814",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pitavastatin",
      "NonProprietaryName": "Pitavastatin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20231102",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206015",
      "LabelerName": "Aurobindo Pharma Limited",
      "SubstanceName": "PITAVASTATIN CALCIUM",
      "StrengthNumber": "4",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-04-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20231102",
      "SamplePackage": "N",
      "IndicationAndUsage": "Pitavastatin tablets are  indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: : 1 Adults with primary hyperlipidemia., 2 Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).",
      "Description": "Pitavastatin tablets for oral use is an HMG-CoA reductase inhibitor. The chemical name for pitavastatin is (+)monocalcium bis{(3R, 5S, 6E)-7-[2-cyclopropyl-4-(4-fluorophenyl)-3-quinolyl]-3,5-dihydroxy-6-heptenoate}. The structural formula is. The molecular formula for pitavastatin is C50H46CaF2N2O8 and the molecular weight is 880.98. Pitavastatin is odorless and occurs as a white to pale yellow powder. It is freely soluble in pyridine, chloroform, dilute hydrochloric acid, and tetrahydrofuran, soluble in ethylene glycol, sparingly soluble in octanol, slightly soluble in methanol, very slightly soluble in water or ethanol, and practically insoluble in acetonitrile or diethyl ether. Pitavastatin is hygroscopic and slightly unstable in light. Each film-coated tablet of pitavastatin contains 1 mg, 2 mg, or 4 mg of pitavastatin, which is equivalent to 1.045 mg, 2.09 mg, or 4.18 mg, respectively, of pitavastatin calcium and the following inactive ingredients: hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium aluminometa silicate type I-B, magnesium stearate, silicon dioxide, titanium dioxide, and triethyl citrate."
    },
    {
      "NDCCode": "65954-814-33",
      "PackageDescription": "1 TUBE in 1 CARTON (65954-814-33)  > 36.8 g in 1 TUBE",
      "NDC11Code": "65954-0814-33",
      "ProductNDC": "65954-814",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Colgate Optic White Stain Fighter Clean Mint",
      "NonProprietaryName": "Sodium Fluoride",
      "DosageFormName": "PASTE, DENTIFRICE",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20220601",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part355",
      "LabelerName": "Mission Hills, S.A. de C.V.",
      "SubstanceName": "SODIUM FLUORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20220601",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps protect against cavities."
    },
    {
      "NDCCode": "67457-814-02",
      "PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (67457-814-02)  > 2 mL in 1 VIAL, SINGLE-DOSE (67457-814-00) ",
      "NDC11Code": "67457-0814-02",
      "ProductNDC": "67457-814",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clindamycin",
      "NonProprietaryName": "Clindamycin",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20171129",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204748",
      "LabelerName": "Mylan Institutional LLC",
      "SubstanceName": "CLINDAMYCIN",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20171129",
      "SamplePackage": "N",
      "IndicationAndUsage": "Clindamycin injection is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin injection products are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of antibiotic-associated pseudomembranous colitis, as described in the BOXED WARNING, before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. Indicated surgical procedures should be performed in conjunction with antibiotic therapy. Clindamycin injection is indicated in the treatment of serious infections caused by susceptible strains of the designated organisms in the conditions listed below. Lower respiratory tract infections including pneumonia, empyema, and lung abscess caused by anaerobes, Streptococcus pneumoniae, other streptococci (except E. faecalis), and Staphylococcus aureus. Skin and skin structure infections caused by Streptococcus pyogenes, Staphylococcus aureus, and anaerobes. Gynecological infections including endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection caused by susceptible anaerobes. Intra-abdominal infections including peritonitis and intra-abdominal abscess caused by susceptible anaerobic organisms. Septicemia caused by Staphylococcus aureus, streptococci (except Enterococcus faecalis), and susceptible anaerobes. Bone and joint infections including acute hematogenous osteomyelitis caused by Staphylococcus aureus and as adjunctive therapy in the surgical treatment of chronic bone and joint infections due to susceptible organisms. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin injection and other antibacterial drugs, clindamycin injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
      "Description": "Clindamycin injection, USP, a clear colorless to pale yellow sterile solution, contains clindamycin phosphate, USP a water soluble ester of clindamycin and phosphoric acid. Each mL contains the equivalent of 150 mg clindamycin, 0.5 mg disodium edetate and 9.45 mg benzyl alcohol added as preservative in each mL. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH between 5.5 and 7.0. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. The chemical name of clindamycin phosphate is L-threo-α-D-galacto-Octopyranoside, methyl-7-chloro-6,7,8-trideoxy-6-[[(1-methyl-4-propyl-2-pyrrolidinyl)carbonyl]amino]-1-thio-, 2-(dihydrogen phosphate), (2S-trans)-. The molecular formula is C18H34ClN2O8PS and the molecular weight is 504.97. The structural formula is represented below."
    },
    {
      "NDCCode": "68428-814-30",
      "PackageDescription": "960 mL in 1 BOTTLE, PLASTIC (68428-814-30)",
      "NDC11Code": "68428-0814-30",
      "ProductNDC": "68428-814",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Bryonia Alba Root",
      "DosageFormName": "LIQUID",
      "StartMarketingDate": "20140305",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Washington Homeopathic Products",
      "SubstanceName": "BRYONIA ALBA ROOT",
      "StrengthNumber": "8",
      "StrengthUnit": "[hp_X]/mL",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "70069-814-10",
      "PackageDescription": "1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70069-814-10) ",
      "NDC11Code": "70069-0814-10",
      "ProductNDC": "70069-814",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Esomeprazole Magnesium",
      "NonProprietaryName": "Esomeprazole Magnesium",
      "DosageFormName": "CAPSULE, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230815",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA213859",
      "LabelerName": "Somerset Therapeutics, LLC",
      "SubstanceName": "ESOMEPRAZOLE MAGNESIUM",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-11-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230815",
      "SamplePackage": "N",
      "IndicationAndUsage": "Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the:.  Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age.  ( 1.1).  Maintenance of healing of EE in adults. ( 1.2).  Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age.  ( 1.3).  Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers.  ( 1.4).   Helicobacter pylorieradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin.  ( 1.5).  Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults.  ( 1.6).",
      "Description": "The active ingredient in Esomeprazole Magnesium Delayed-Release Capsules, USP for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5­-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole-1-yl) magnesium trihydrate, a PPI. Esomeprazole is the S- isomer of omeprazole, which is a mixture of the S- and R-isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C 17H 18N 3O 3S) 2Mg × 3 H 2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is:. The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium is supplied in delayed-release capsules. Each Esomeprazole Magnesium Delayed-Release Capsule, USP contains 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) or 40 mg of esomeprazole (equivalent to 44.5 mg esomeprazole magnesium trihydrate) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate, hypromellose, magnesium oxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate, sugar spheres (composed of corn starch and sucrose), talc, and triethyl citrate. The capsule shells have the following inactive ingredients: FD&C Blue 1, FD&C Red 3, ferrosoferric oxide, gelatin, potassium hydroxide, shellac, sodium lauryl sulfate and titanium dioxide. Esomeprazole Magnesium Delayed-Release Capsules, USP meets USP Dissolution Test 2."
    },
    {
      "NDCCode": "70069-814-30",
      "PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70069-814-30) ",
      "NDC11Code": "70069-0814-30",
      "ProductNDC": "70069-814",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Esomeprazole Magnesium",
      "NonProprietaryName": "Esomeprazole Magnesium",
      "DosageFormName": "CAPSULE, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230815",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA213859",
      "LabelerName": "Somerset Therapeutics, LLC",
      "SubstanceName": "ESOMEPRAZOLE MAGNESIUM",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-11-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230815",
      "SamplePackage": "N",
      "IndicationAndUsage": "Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the:.  Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age.  ( 1.1).  Maintenance of healing of EE in adults. ( 1.2).  Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age.  ( 1.3).  Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers.  ( 1.4).   Helicobacter pylorieradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin.  ( 1.5).  Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults.  ( 1.6).",
      "Description": "The active ingredient in Esomeprazole Magnesium Delayed-Release Capsules, USP for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5­-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole-1-yl) magnesium trihydrate, a PPI. Esomeprazole is the S- isomer of omeprazole, which is a mixture of the S- and R-isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C 17H 18N 3O 3S) 2Mg × 3 H 2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is:. The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium is supplied in delayed-release capsules. Each Esomeprazole Magnesium Delayed-Release Capsule, USP contains 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) or 40 mg of esomeprazole (equivalent to 44.5 mg esomeprazole magnesium trihydrate) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate, hypromellose, magnesium oxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate, sugar spheres (composed of corn starch and sucrose), talc, and triethyl citrate. The capsule shells have the following inactive ingredients: FD&C Blue 1, FD&C Red 3, ferrosoferric oxide, gelatin, potassium hydroxide, shellac, sodium lauryl sulfate and titanium dioxide. Esomeprazole Magnesium Delayed-Release Capsules, USP meets USP Dissolution Test 2."
    },
    {
      "NDCCode": "70069-814-90",
      "PackageDescription": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70069-814-90) ",
      "NDC11Code": "70069-0814-90",
      "ProductNDC": "70069-814",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Esomeprazole Magnesium",
      "NonProprietaryName": "Esomeprazole Magnesium",
      "DosageFormName": "CAPSULE, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230815",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA213859",
      "LabelerName": "Somerset Therapeutics, LLC",
      "SubstanceName": "ESOMEPRAZOLE MAGNESIUM",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-11-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230815",
      "SamplePackage": "N",
      "IndicationAndUsage": "Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the:.  Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age.  ( 1.1).  Maintenance of healing of EE in adults. ( 1.2).  Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age.  ( 1.3).  Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers.  ( 1.4).   Helicobacter pylorieradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin.  ( 1.5).  Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults.  ( 1.6).",
      "Description": "The active ingredient in Esomeprazole Magnesium Delayed-Release Capsules, USP for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5­-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole-1-yl) magnesium trihydrate, a PPI. Esomeprazole is the S- isomer of omeprazole, which is a mixture of the S- and R-isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C 17H 18N 3O 3S) 2Mg × 3 H 2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is:. The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium is supplied in delayed-release capsules. Each Esomeprazole Magnesium Delayed-Release Capsule, USP contains 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) or 40 mg of esomeprazole (equivalent to 44.5 mg esomeprazole magnesium trihydrate) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate, hypromellose, magnesium oxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate, sugar spheres (composed of corn starch and sucrose), talc, and triethyl citrate. The capsule shells have the following inactive ingredients: FD&C Blue 1, FD&C Red 3, ferrosoferric oxide, gelatin, potassium hydroxide, shellac, sodium lauryl sulfate and titanium dioxide. Esomeprazole Magnesium Delayed-Release Capsules, USP meets USP Dissolution Test 2."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"58118-0814-8","ProprietaryName":"Gabapentin","NonProprietaryName":"Gabapentin"},{"NDCCode":"60905-0814-0","ProprietaryName":"Teint Couture Everwear 24h Wear Satin Finish Full Coverage And Comfort Broad Spectrum Spf 20 Y300","NonProprietaryName":"Octinoxate, Titanium Dioxide"},{"NDCCode":"71335-0814-8","ProprietaryName":"Meclizine Hydrochloride","NonProprietaryName":"Meclizine Hydrochloride"},{"NDCCode":"25021-814-30","ProprietaryName":"Leucovorin Calcium","NonProprietaryName":"Leucovorin Calcium"},{"NDCCode":"33261-814-30","ProprietaryName":"Venlafaxine Hydrochloride","NonProprietaryName":"Venlafaxine Hydrochloride"},{"NDCCode":"33261-814-60","ProprietaryName":"Venlafaxine Hydrochloride","NonProprietaryName":"Venlafaxine Hydrochloride"},{"NDCCode":"33261-814-90","ProprietaryName":"Venlafaxine Hydrochloride","NonProprietaryName":"Venlafaxine Hydrochloride"},{"NDCCode":"35356-814-01","ProprietaryName":"Hydromorphone Hydrochloride","NonProprietaryName":"Hydromorphone Hydrochloride"},{"NDCCode":"35356-814-30","ProprietaryName":"Hydromorphone Hydrochloride","NonProprietaryName":"Hydromorphone Hydrochloride"},{"NDCCode":"35356-814-60","ProprietaryName":"Hydromorphone Hydrochloride","NonProprietaryName":"Hydromorphone Hydrochloride"},{"NDCCode":"35356-814-90","ProprietaryName":"Hydromorphone Hydrochloride","NonProprietaryName":"Hydromorphone Hydrochloride"},{"NDCCode":"45865-814-49","ProprietaryName":"Metoprolol Succinate","NonProprietaryName":"Metoprolol Succinate"},{"NDCCode":"49884-814-01","ProprietaryName":"Midodrine Hydrochloride","NonProprietaryName":"Midodrine Hydrochloride"},{"NDCCode":"49884-814-05","ProprietaryName":"Midodrine Hydrochloride","NonProprietaryName":"Midodrine Hydrochloride"},{"NDCCode":"51991-814-03","ProprietaryName":"Azelastine Hydrochloride","NonProprietaryName":"Azelastine Hydrochloride"},{"NDCCode":"60687-814-65","ProprietaryName":"Prochlorperazine Maleate","NonProprietaryName":"Prochlorperazine Maleate"},{"NDCCode":"61047-814-75","ProprietaryName":"Banana Boat Sport Performance","NonProprietaryName":"Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone"},{"NDCCode":"62713-814-02","ProprietaryName":"Allergena Fragrance","NonProprietaryName":"Allergena Fragrance"},{"NDCCode":"63187-814-30","ProprietaryName":"Lovastatin","NonProprietaryName":"Lovastatin"},{"NDCCode":"63187-814-60","ProprietaryName":"Lovastatin","NonProprietaryName":"Lovastatin"},{"NDCCode":"63187-814-90","ProprietaryName":"Lovastatin","NonProprietaryName":"Lovastatin"},{"NDCCode":"65219-814-05","ProprietaryName":"Xylocaine","NonProprietaryName":"Lidocaine Hydrochloride"},{"NDCCode":"65862-814-05","ProprietaryName":"Pitavastatin","NonProprietaryName":"Pitavastatin"},{"NDCCode":"65862-814-90","ProprietaryName":"Pitavastatin","NonProprietaryName":"Pitavastatin"},{"NDCCode":"65954-814-33","ProprietaryName":"Colgate Optic White Stain Fighter Clean Mint","NonProprietaryName":"Sodium Fluoride"},{"NDCCode":"67457-814-02","ProprietaryName":"Clindamycin","NonProprietaryName":"Clindamycin"},{"NDCCode":"68428-814-30","NonProprietaryName":"Bryonia Alba Root"},{"NDCCode":"70069-814-10","ProprietaryName":"Esomeprazole Magnesium","NonProprietaryName":"Esomeprazole Magnesium"},{"NDCCode":"70069-814-30","ProprietaryName":"Esomeprazole Magnesium","NonProprietaryName":"Esomeprazole Magnesium"},{"NDCCode":"70069-814-90","ProprietaryName":"Esomeprazole Magnesium","NonProprietaryName":"Esomeprazole Magnesium"}]}
                    

<NDCList><NDC><NDCCode>58118-0814-8</NDCCode><ProprietaryName>Gabapentin</ProprietaryName><NonProprietaryName>Gabapentin</NonProprietaryName></NDC><NDC><NDCCode>60905-0814-0</NDCCode><ProprietaryName>Teint Couture Everwear 24h Wear Satin Finish Full Coverage And Comfort Broad Spectrum Spf 20 Y300</ProprietaryName><NonProprietaryName>Octinoxate, Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>71335-0814-8</NDCCode><ProprietaryName>Meclizine Hydrochloride</ProprietaryName><NonProprietaryName>Meclizine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>25021-814-30</NDCCode><ProprietaryName>Leucovorin Calcium</ProprietaryName><NonProprietaryName>Leucovorin Calcium</NonProprietaryName></NDC><NDC><NDCCode>33261-814-30</NDCCode><ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName><NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>33261-814-60</NDCCode><ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName><NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>33261-814-90</NDCCode><ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName><NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>35356-814-01</NDCCode><ProprietaryName>Hydromorphone Hydrochloride</ProprietaryName><NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>35356-814-30</NDCCode><ProprietaryName>Hydromorphone Hydrochloride</ProprietaryName><NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>35356-814-60</NDCCode><ProprietaryName>Hydromorphone Hydrochloride</ProprietaryName><NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>35356-814-90</NDCCode><ProprietaryName>Hydromorphone Hydrochloride</ProprietaryName><NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>45865-814-49</NDCCode><ProprietaryName>Metoprolol Succinate</ProprietaryName><NonProprietaryName>Metoprolol Succinate</NonProprietaryName></NDC><NDC><NDCCode>49884-814-01</NDCCode><ProprietaryName>Midodrine Hydrochloride</ProprietaryName><NonProprietaryName>Midodrine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>49884-814-05</NDCCode><ProprietaryName>Midodrine Hydrochloride</ProprietaryName><NonProprietaryName>Midodrine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>51991-814-03</NDCCode><ProprietaryName>Azelastine Hydrochloride</ProprietaryName><NonProprietaryName>Azelastine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>60687-814-65</NDCCode><ProprietaryName>Prochlorperazine Maleate</ProprietaryName><NonProprietaryName>Prochlorperazine Maleate</NonProprietaryName></NDC><NDC><NDCCode>61047-814-75</NDCCode><ProprietaryName>Banana Boat Sport Performance</ProprietaryName><NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone</NonProprietaryName></NDC><NDC><NDCCode>62713-814-02</NDCCode><ProprietaryName>Allergena Fragrance</ProprietaryName><NonProprietaryName>Allergena Fragrance</NonProprietaryName></NDC><NDC><NDCCode>63187-814-30</NDCCode><ProprietaryName>Lovastatin</ProprietaryName><NonProprietaryName>Lovastatin</NonProprietaryName></NDC><NDC><NDCCode>63187-814-60</NDCCode><ProprietaryName>Lovastatin</ProprietaryName><NonProprietaryName>Lovastatin</NonProprietaryName></NDC><NDC><NDCCode>63187-814-90</NDCCode><ProprietaryName>Lovastatin</ProprietaryName><NonProprietaryName>Lovastatin</NonProprietaryName></NDC><NDC><NDCCode>65219-814-05</NDCCode><ProprietaryName>Xylocaine</ProprietaryName><NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>65862-814-05</NDCCode><ProprietaryName>Pitavastatin</ProprietaryName><NonProprietaryName>Pitavastatin</NonProprietaryName></NDC><NDC><NDCCode>65862-814-90</NDCCode><ProprietaryName>Pitavastatin</ProprietaryName><NonProprietaryName>Pitavastatin</NonProprietaryName></NDC><NDC><NDCCode>65954-814-33</NDCCode><ProprietaryName>Colgate Optic White Stain Fighter Clean Mint</ProprietaryName><NonProprietaryName>Sodium Fluoride</NonProprietaryName></NDC><NDC><NDCCode>67457-814-02</NDCCode><ProprietaryName>Clindamycin</ProprietaryName><NonProprietaryName>Clindamycin</NonProprietaryName></NDC><NDC><NDCCode>68428-814-30</NDCCode><NonProprietaryName>Bryonia Alba Root</NonProprietaryName></NDC><NDC><NDCCode>70069-814-10</NDCCode><ProprietaryName>Esomeprazole Magnesium</ProprietaryName><NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName></NDC><NDC><NDCCode>70069-814-30</NDCCode><ProprietaryName>Esomeprazole Magnesium</ProprietaryName><NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName></NDC><NDC><NDCCode>70069-814-90</NDCCode><ProprietaryName>Esomeprazole Magnesium</ProprietaryName><NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName></NDC></NDCList>