RESTful Lookup — Test-Drive (2007 – 2026)

Query complete (35 ms elapsed)

{
  "NDC": [
    {
      "NDCCode": "0054-0639-03",
      "PackageDescription": "7 TABLET in 1 BOTTLE (0054-0639-03) ",
      "NDC11Code": "00054-0639-03",
      "ProductNDC": "0054-0639",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Methylergonovine Maleate",
      "NonProprietaryName": "Methylergonovine Maleate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180703",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210424",
      "LabelerName": "West-Ward Pharmaceuticals Corp",
      "SubstanceName": "METHYLERGONOVINE MALEATE",
      "StrengthNumber": ".2",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Ergolines [CS], Ergot Derivative [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-12-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20180703",
      "SamplePackage": "N",
      "IndicationAndUsage": "Following delivery of placenta, for routine management of uterine atony, hemorrhage and subinvolution of the uterus. For control of uterine hemorrhage in the second stage of labor following delivery of the anterior shoulder.",
      "Description": "Methylergonovine Maleate Tablets, USP is a semi-synthetic ergot alkaloid used for the prevention and control of postpartum hemorrhage.  Methylergonovine Maleate Tablets, USP is available in tablets for oral ingestion containing 0.2 mg methylergonovine maleate. Tablets Active ingredient: Methylergonovine maleate, USP, 0.2 mg. Inactive ingredients: acacia, corn starch, gelatin, lactose monohydrate, methylparaben, microcrystalline cellulose, povidone, propylparaben, stearic acid, and tartaric acid. Chemically, methylergonovine maleate is designated as ergoline-8-carboxamide, 9, 10-didehydro-N-[1-(hydroxymethyl) propyl]-6-methyl-, [8β(S)]-, (Z)-2-butenedioate (1:1) (salt). Its structural formula is:. C  20H  25N  3O  2C  4H  4O  4                Mol Wt:  455.51."
    },
    {
      "NDCCode": "0054-0639-05",
      "PackageDescription": "12 TABLET in 1 BOTTLE (0054-0639-05) ",
      "NDC11Code": "00054-0639-05",
      "ProductNDC": "0054-0639",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Methylergonovine Maleate",
      "NonProprietaryName": "Methylergonovine Maleate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180703",
      "EndMarketingDate": "20241231",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210424",
      "LabelerName": "West-Ward Pharmaceuticals Corp",
      "SubstanceName": "METHYLERGONOVINE MALEATE",
      "StrengthNumber": ".2",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Ergolines [CS], Ergot Derivative [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20180703",
      "EndMarketingDatePackage": "20241231",
      "SamplePackage": "N",
      "IndicationAndUsage": "Following delivery of placenta, for routine management of uterine atony, hemorrhage and subinvolution of the uterus. For control of uterine hemorrhage in the second stage of labor following delivery of the anterior shoulder.",
      "Description": "Methylergonovine Maleate Tablets, USP is a semi-synthetic ergot alkaloid used for the prevention and control of postpartum hemorrhage. Methylergonovine Maleate Tablets, USP is available in tablets for oral ingestion containing 0.2 mg methylergonovine maleate. Tablets. Active ingredient: Methylergonovine maleate, USP, 0.2 mg. Inactive ingredients: acacia, corn starch, gelatin, lactose monohydrate, methylparaben, microcrystalline cellulose, povidone, propylparaben, stearic acid, and tartaric acid. Chemically, methylergonovine maleate is designated as ergoline-8-carboxamide, 9, 10-didehydro-N-[1-(hydroxymethyl) propyl]-6-methyl-, [8β(S)]-, (Z)-2-butenedioate (1:1) (salt). Its structural formula is:. C20H25N3O2C4H4O4                Mol Wt:  455.51."
    },
    {
      "NDCCode": "0054-0639-13",
      "PackageDescription": "28 TABLET in 1 BOTTLE (0054-0639-13) ",
      "NDC11Code": "00054-0639-13",
      "ProductNDC": "0054-0639",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Methylergonovine Maleate",
      "NonProprietaryName": "Methylergonovine Maleate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180703",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210424",
      "LabelerName": "West-Ward Pharmaceuticals Corp",
      "SubstanceName": "METHYLERGONOVINE MALEATE",
      "StrengthNumber": ".2",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Ergolines [CS], Ergot Derivative [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-12-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20180703",
      "SamplePackage": "N",
      "IndicationAndUsage": "Following delivery of placenta, for routine management of uterine atony, hemorrhage and subinvolution of the uterus. For control of uterine hemorrhage in the second stage of labor following delivery of the anterior shoulder.",
      "Description": "Methylergonovine Maleate Tablets, USP is a semi-synthetic ergot alkaloid used for the prevention and control of postpartum hemorrhage.  Methylergonovine Maleate Tablets, USP is available in tablets for oral ingestion containing 0.2 mg methylergonovine maleate. Tablets Active ingredient: Methylergonovine maleate, USP, 0.2 mg. Inactive ingredients: acacia, corn starch, gelatin, lactose monohydrate, methylparaben, microcrystalline cellulose, povidone, propylparaben, stearic acid, and tartaric acid. Chemically, methylergonovine maleate is designated as ergoline-8-carboxamide, 9, 10-didehydro-N-[1-(hydroxymethyl) propyl]-6-methyl-, [8β(S)]-, (Z)-2-butenedioate (1:1) (salt). Its structural formula is:. C  20H  25N  3O  2C  4H  4O  4                Mol Wt:  455.51."
    },
    {
      "NDCCode": "0054-0639-25",
      "PackageDescription": "100 TABLET in 1 BOTTLE (0054-0639-25) ",
      "NDC11Code": "00054-0639-25",
      "ProductNDC": "0054-0639",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Methylergonovine Maleate",
      "NonProprietaryName": "Methylergonovine Maleate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180703",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210424",
      "LabelerName": "West-Ward Pharmaceuticals Corp",
      "SubstanceName": "METHYLERGONOVINE MALEATE",
      "StrengthNumber": ".2",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Ergolines [CS], Ergot Derivative [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-12-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20180703",
      "SamplePackage": "N",
      "IndicationAndUsage": "Following delivery of placenta, for routine management of uterine atony, hemorrhage and subinvolution of the uterus. For control of uterine hemorrhage in the second stage of labor following delivery of the anterior shoulder.",
      "Description": "Methylergonovine Maleate Tablets, USP is a semi-synthetic ergot alkaloid used for the prevention and control of postpartum hemorrhage.  Methylergonovine Maleate Tablets, USP is available in tablets for oral ingestion containing 0.2 mg methylergonovine maleate. Tablets Active ingredient: Methylergonovine maleate, USP, 0.2 mg. Inactive ingredients: acacia, corn starch, gelatin, lactose monohydrate, methylparaben, microcrystalline cellulose, povidone, propylparaben, stearic acid, and tartaric acid. Chemically, methylergonovine maleate is designated as ergoline-8-carboxamide, 9, 10-didehydro-N-[1-(hydroxymethyl) propyl]-6-methyl-, [8β(S)]-, (Z)-2-butenedioate (1:1) (salt). Its structural formula is:. C  20H  25N  3O  2C  4H  4O  4                Mol Wt:  455.51."
    },
    {
      "NDCCode": "0363-0639-03",
      "PackageDescription": "1 TUBE in 1 CARTON (0363-0639-03)  > 56 g in 1 TUBE (0363-0639-01) ",
      "NDC11Code": "00363-0639-03",
      "ProductNDC": "0363-0639",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Regular Strength Hydrocortisone Cream",
      "NonProprietaryName": "Hydrocortisone Cream",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160607",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part348",
      "LabelerName": "Walgreens",
      "SubstanceName": "HYDROCORTISONE",
      "StrengthNumber": ".51",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20160607",
      "SamplePackage": "N",
      "IndicationAndUsage": "for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to: eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, jewelry, detergents, cosmetics, psoriasis, seborrheic dermatitis, for external genital, feminine and anal itching, other uses of this product should be only under the advice and supervision of a doctor."
    },
    {
      "NDCCode": "11822-0639-3",
      "PackageDescription": "85 g in 1 CAN (11822-0639-3) ",
      "NDC11Code": "11822-0639-03",
      "ProductNDC": "11822-0639",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Rite Aid Cooling Pain Relief",
      "NonProprietaryName": "Menthol 10.5%",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210331",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "Rite Aid",
      "SubstanceName": "MENTHOL",
      "StrengthNumber": "10.5",
      "StrengthUnit": "g/100g",
      "Status": "Active",
      "LastUpdate": "2024-12-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210331",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the temporary relief of minor pain associated with arthritis, simple backache, muscle strains, sprains, and bruises."
    },
    {
      "NDCCode": "15631-0639-3",
      "PackageDescription": "100 TABLET in 1 CONTAINER (15631-0639-3)",
      "NDC11Code": "15631-0639-03",
      "ProductNDC": "15631-0639",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Natrum Muriaticum",
      "NonProprietaryName": "Natrum Muriaticum",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20151207",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
      "SubstanceName": "SODIUM CHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "[hp_X]/1",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Condition listed above or as directed by the physician."
    },
    {
      "NDCCode": "37662-0639-3",
      "PackageDescription": "3000 PELLET in 1 BOTTLE, GLASS (37662-0639-3) ",
      "NDC11Code": "37662-0639-03",
      "ProductNDC": "37662-0639",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dolichos Pruriens",
      "NonProprietaryName": "Dolichos Pruriens",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220620",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Hahnemann Laboratories, INC.",
      "SubstanceName": "MUCUNA PRURIENS FRUIT TRICHOME",
      "StrengthNumber": "500",
      "StrengthUnit": "[hp_C]/1",
      "Status": "Active",
      "LastUpdate": "2022-06-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220620",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "49288-0639-3",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (49288-0639-3)",
      "NDC11Code": "49288-0639-03",
      "ProductNDC": "49288-0639",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Neurospora Crassa",
      "NonProprietaryName": "Neurospora Crassa",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "NEUROSPORA CRASSA",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
    },
    {
      "NDCCode": "52125-639-03",
      "PackageDescription": "20 TABLET in 1 BOTTLE (52125-639-03)",
      "NDC11Code": "52125-0639-03",
      "ProductNDC": "52125-639",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Promethazine Hydrochloride",
      "NonProprietaryName": "Promethazine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20131205",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA083426",
      "LabelerName": "REMEDYREPACK INC.",
      "SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2017-01-05"
    },
    {
      "NDCCode": "53041-639-03",
      "PackageDescription": "1 BOTTLE in 1 CARTON (53041-639-03)  > 120 mL in 1 BOTTLE",
      "NDC11Code": "53041-0639-03",
      "ProductNDC": "53041-639",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Childrens Ibuprofen Grape",
      "NonProprietaryName": "Ibuprofen",
      "DosageFormName": "SUSPENSION/ DROPS",
      "RouteName": "ORAL",
      "StartMarketingDate": "20211013",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210149",
      "LabelerName": "Guardian Drug Company",
      "SubstanceName": "IBUPROFEN",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2021-10-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20211013",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily."
    },
    {
      "NDCCode": "58443-0639-3",
      "PackageDescription": "59 mL in 1 TUBE (58443-0639-3) ",
      "NDC11Code": "58443-0639-03",
      "ProductNDC": "58443-0639",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Black Girl Sunscreen",
      "ProprietaryNameSuffix": "Sunscreen Spf 30 Broad Spectrum",
      "NonProprietaryName": "Avobenzone, Homosalate, Octisalate, And Octocrylene",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20230804",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "M020",
      "LabelerName": "Prime Enterprises Inc.",
      "SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
      "StrengthNumber": "29.4; 98; 49; 26.95",
      "StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-09-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20230804",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreses the risk of skin cancer and early skin aging caused by the sun ."
    },
    {
      "NDCCode": "62257-639-03",
      "PackageDescription": "350 mL in 1 CARTRIDGE (62257-639-03)",
      "NDC11Code": "62257-0639-03",
      "ProductNDC": "62257-639",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Clean All",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20101101",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "ABC Compounding Co., Inc.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": ".62",
      "StrengthUnit": "mL/mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "for hand-washing to decrease bacteria on the skin, only when water is not available."
    },
    {
      "NDCCode": "63545-639-03",
      "PackageDescription": "3650 PELLET in 1 BOTTLE (63545-639-03)",
      "NDC11Code": "63545-0639-03",
      "ProductNDC": "63545-639",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hahnemann Fever",
      "NonProprietaryName": "Peridot",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20101231",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals",
      "SubstanceName": "OLIVINE",
      "StrengthNumber": "200",
      "StrengthUnit": "[hp_C]/1",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "USE according to standard Homeopathic indications for self-limiting conditions, such as listed above. FEVER."
    },
    {
      "NDCCode": "64980-639-03",
      "PackageDescription": "30 POUCH in 1 CARTON (64980-639-03)  / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE",
      "NDC11Code": "64980-0639-03",
      "ProductNDC": "64980-639",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Budesonide",
      "NonProprietaryName": "Budesonide",
      "DosageFormName": "INHALANT",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20250314",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078202",
      "LabelerName": "Rising Pharma Holdings, Inc.",
      "SubstanceName": "BUDESONIDE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/2mL",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-07-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250314",
      "SamplePackage": "N",
      "IndicationAndUsage": "Budesonide inhalation suspension is an inhaled corticosteroid indicated for: 1 Maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age ( 1) .",
      "Description": "Budesonide, the active component of budesonide inhalation suspension, is a corticosteroid designated chemically as (RS)-11β, 16α, 17, 21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C 25H 34O 6and its molecular weight is 430.5. Its structural formula is:. Budesonide is a white to off-white, tasteless, odorless powder that is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coeffecient between octanol and water at pH 7.4 is 1.6 x 10 3. Budesonide inhalation suspension is a sterile suspension for inhalation via jet nebulizer and contains the active ingredient budesonide (micronized), and the inactive ingredients citric acid, edetate disodium dihydrate, polysorbate 80, sodium chloride, sodium citrate, and water for injection. Two dose strengths are available in single-dose ampules: 0.25 mg and 0.5 mg per 2 mL ampule. For budesonide inhalation suspension, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari-LC-Jet Plus Nebulizer/Pari Master compressor system, under in vitroconditions, the mean delivered dose at the mouthpiece (% nominal dose) was approximately 17% at a mean flow rate of 5.5 L/min. The mean nebulization time was 5 minutes or less. Budesonide inhalation suspension should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces [see Dosage and Administration (2)]."
    },
    {
      "NDCCode": "68428-639-03",
      "PackageDescription": "75 PELLET in 1 VIAL, GLASS (68428-639-03) ",
      "NDC11Code": "68428-0639-03",
      "ProductNDC": "68428-639",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sinapis Nigra",
      "NonProprietaryName": "Black Mustard Seed",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20091028",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Washington Homeopathic Products",
      "SubstanceName": "BLACK MUSTARD SEED",
      "StrengthNumber": "30",
      "StrengthUnit": "[hp_C]/1",
      "Status": "Deprecated",
      "LastUpdate": "2022-04-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20091028",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "69097-639-03",
      "PackageDescription": "60 CAPSULE in 1 BOTTLE (69097-639-03) ",
      "NDC11Code": "69097-0639-03",
      "ProductNDC": "69097-639",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Nintedanib",
      "NonProprietaryName": "Nintedanib",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260402",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212609",
      "LabelerName": "Cipla USA Inc.",
      "SubstanceName": "NINTEDANIB ESYLATE",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-04-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260402",
      "SamplePackage": "N",
      "IndicationAndUsage": "Nintedanib is a kinase inhibitor indicated in adults for: : 1 Treatment of idiopathic pulmonary fibrosis (IPF). (1.1), 2 Treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype. (1.2), 3 Slowing the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). (1.3).",
      "Description": "Nintedanib capsules contain nintedanib, a kinase inhibitor [see Mechanism of Action (12.1)]. Nintedanib is presented as the ethanesulfonate salt (esylate), with the chemical name 1H-Indole-6-carboxylic acid, 2,3-dihydro-3-[[[4-[methyl[(4-methyl-1-piperazinyl)acetyl]amino]phenyl]amino]phenylmethylene]-2-oxo-,methyl ester, (3Z)-, ethanesulfonate (1:1). Its structural formula is:. Nintedanib esylate is a pale yellow to yellow colored powder with an empirical formula of C31H33N5O4·C2H6O3S and a molecular weight of 649.76 g/mol. Nintedanib capsules for oral administration are available in 2 dose strengths containing 100 mg or 150 mg of nintedanib (equivalent to 120.40 mg or 180.60 mg nintedanib ethanesulfonate, respectively). The inactive ingredients of nintedanib capsule are the following: Fill Material: medium chain triglyceride, hard fat, lecithin. Capsule Shell: gelatin, glycerin, titanium dioxide, red ferric oxide, yellow ferric oxide."
    },
    {
      "NDCCode": "71335-0639-3",
      "PackageDescription": "4 TABLET, FILM COATED in 1 BOTTLE (71335-0639-3) ",
      "NDC11Code": "71335-0639-03",
      "ProductNDC": "71335-0639",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lamivudine And Zidovudine",
      "NonProprietaryName": "Lamivudine And Zidovudine",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150918",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA079124",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "LAMIVUDINE; ZIDOVUDINE",
      "StrengthNumber": "150; 300",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2023-03-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20211227",
      "SamplePackage": "N",
      "IndicationAndUsage": "Lamivudine and zidovudine tablets a combination of 2 nucleoside analogues, are indicated in combination with other antiretrovirals for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.",
      "Description": "Lamivudine and Zidovudine tablets, USP are combination tablets containing lamivudine and zidovudine. Lamivudine (EPIVIR) and zidovudine (RETROVIR, azidothymidine, AZT, or ZDV) are synthetic nucleoside analogues with activity against HIV-1. Lamivudine and Zidovudine tablets, USP are for oral administration. Each film-coated tablet contains 150 mg of lamivudine, USP, 300 mg of zidovudine, USP, and the inactive ingredients microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate and opadry white (hypromellose, polyethylene glycol, polysorbate 80 and titanium dioxide).Lamivudine The chemical name of lamivudine is (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidine-2-one. Lamivudine is the (-) enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2',3'-dideoxy, 3'-thiacytidine. It has a molecular formula of C8H11N303S and a molecular weight of 229.26. It has the following structural formula. Lamivudine USP is a white to off-white crystalline solid with a solubility of approximately 70 mg/mL in water at 20°C. Zidovudine The chemical name of zidovudine is 3'-azido-3'-deoxythymidine. It has a molecular formula of C10H13N5O4 and a molecular weight of 267.24. It has the following structural formula. Zidovudine USP is a white to beige, odorless, crystalline solid with a solubility of 20.1 mg/mL in water at 25°C. Meets USP Dissolution Test 2."
    },
    {
      "NDCCode": "72839-639-03",
      "PackageDescription": "85 g in 1 CAN (72839-639-03) ",
      "NDC11Code": "72839-0639-03",
      "ProductNDC": "72839-639",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dch Cooling Pain Relief",
      "NonProprietaryName": "Menthol 10.5%",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210524",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "Derma Care Research Labs, LLC",
      "SubstanceName": "MENTHOL",
      "StrengthNumber": "10.5",
      "StrengthUnit": "g/100g",
      "Status": "Active",
      "LastUpdate": "2024-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210524",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the temporary relief of minor aches and pain associated with arthritis, simple backache, muscle strains, bruises, sprains, and cramps."
    },
    {
      "NDCCode": "75936-639-03",
      "PackageDescription": "10 mL in 1 TUBE (75936-639-03) ",
      "NDC11Code": "75936-0639-03",
      "ProductNDC": "75936-639",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Mineral Glowscreen Soft-radiance Drops Golden Hour",
      "NonProprietaryName": "Zinc Oxide",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240807",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Supergoop LLC",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "15.11",
      "StrengthUnit": "g/100mL",
      "Status": "Active",
      "LastUpdate": "2026-06-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240807",
      "SamplePackage": "Y",
      "IndicationAndUsage": "Stop use and ask a doctor if rash occurs."
    },
    {
      "NDCCode": "79481-0639-3",
      "PackageDescription": "85 g in 1 CAN (79481-0639-3) ",
      "NDC11Code": "79481-0639-03",
      "ProductNDC": "79481-0639",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Meijer Pain Relief",
      "NonProprietaryName": "Menthol 10.5%",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210331",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "Meijer",
      "SubstanceName": "MENTHOL",
      "StrengthNumber": "10.5",
      "StrengthUnit": "g/100g",
      "Status": "Active",
      "LastUpdate": "2024-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210331",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the temporary relief of minor pain associated with arthritis, simple backache, muscle strains, sprains, and bruises."
    },
    {
      "NDCCode": "0054-0278-03",
      "PackageDescription": "9 TABLET in 1 BOTTLE (0054-0278-03) ",
      "NDC11Code": "00054-0278-03",
      "ProductNDC": "0054-0278",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Naratriptan",
      "NonProprietaryName": "Naratriptan",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100707",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090381",
      "LabelerName": "Hikma Pharmaceuticals USA Inc.",
      "SubstanceName": "NARATRIPTAN HYDROCHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-07-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20101007",
      "SamplePackage": "N",
      "IndicationAndUsage": "Naratriptan is indicated for the acute treatment of migraine attacks with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan, reconsider the diagnosis of migraine before naratriptan is administered to treat any subsequent attacks., 2 Naratriptan is not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of naratriptan have not been established for cluster headache. .",
      "Description": "Naratriptan Tablets, USP contains naratriptan hydrochloride, USP, a selective 5-HT1B/1D receptor agonist. Naratriptan hydrochloride is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure. The empirical formula is C17H25N3O2SHCl, representing a molecular weight of 371.93. Naratriptan hydrochloride, USP is a white to pale yellow crystalline powder that is readily soluble in water. Each naratriptan tablet for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride, USP, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose (anhydrous), magnesium stearate, and microcrystalline cellulose."
    },
    {
      "NDCCode": "0054-0279-03",
      "PackageDescription": "9 TABLET in 1 BOTTLE (0054-0279-03) ",
      "NDC11Code": "00054-0279-03",
      "ProductNDC": "0054-0279",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Naratriptan",
      "NonProprietaryName": "Naratriptan",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100707",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090381",
      "LabelerName": "Hikma Pharmaceuticals USA Inc.",
      "SubstanceName": "NARATRIPTAN HYDROCHLORIDE",
      "StrengthNumber": "2.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-07-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20101007",
      "SamplePackage": "N",
      "IndicationAndUsage": "Naratriptan is indicated for the acute treatment of migraine attacks with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan, reconsider the diagnosis of migraine before naratriptan is administered to treat any subsequent attacks., 2 Naratriptan is not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of naratriptan have not been established for cluster headache. .",
      "Description": "Naratriptan Tablets, USP contains naratriptan hydrochloride, USP, a selective 5-HT1B/1D receptor agonist. Naratriptan hydrochloride is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure. The empirical formula is C17H25N3O2SHCl, representing a molecular weight of 371.93. Naratriptan hydrochloride, USP is a white to pale yellow crystalline powder that is readily soluble in water. Each naratriptan tablet for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride, USP, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose (anhydrous), magnesium stearate, and microcrystalline cellulose."
    },
    {
      "NDCCode": "0338-0054-03",
      "PackageDescription": "24 BAG in 1 CARTON (0338-0054-03)  / 500 mL in 1 BAG",
      "NDC11Code": "00338-0054-03",
      "ProductNDC": "0338-0054",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Chloride",
      "NonProprietaryName": "Sodium Chloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19831101",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019022",
      "LabelerName": "Baxter Healthcare Corporation",
      "SubstanceName": "SODIUM CHLORIDE",
      "StrengthNumber": "3",
      "StrengthUnit": "g/100mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-03-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19831101",
      "SamplePackage": "N",
      "IndicationAndUsage": "3% and 5% Sodium Chloride Injection, USP is indicated as a source of water and electrolytes.",
      "Description": "3% and 5% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, hypertonic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. The pH may have been adjusted with hydrochloric acid. It contains no antimicrobial agents. Composition, ionic concentration, osmolarity, and pH are shown in Table 1. The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies."
    },
    {
      "NDCCode": "15631-0054-3",
      "PackageDescription": "750 PELLET in 1 PACKAGE (15631-0054-3) ",
      "NDC11Code": "15631-0054-03",
      "ProductNDC": "15631-0054",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Arsenicum Sulphuratum Flavum",
      "NonProprietaryName": "Arsenicum Sulphuratum Flavum",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150911",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
      "SubstanceName": "ARSENIC TRISULFIDE",
      "StrengthNumber": "6",
      "StrengthUnit": "[hp_X]/1",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20180101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Condition listed above or as directed by the physician."
    },
    {
      "NDCCode": "23155-054-03",
      "PackageDescription": "30 TABLET in 1 BOTTLE (23155-054-03) ",
      "NDC11Code": "23155-0054-03",
      "ProductNDC": "23155-054",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Naratriptan",
      "NonProprietaryName": "Naratriptan",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110315",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA200502",
      "LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
      "SubstanceName": "NARATRIPTAN HYDROCHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-11-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20110315",
      "SamplePackage": "N",
      "IndicationAndUsage": "Naratriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan tablets reconsider the diagnosis of migraine before naratriptan tablets are administered to treat any subsequent attacks., 2 Naratriptan tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of naratriptan tablets have not been established for cluster headache.",
      "Description": "Naratriptan tablets, USP contains naratriptan hydrochloride, a selective 5-HT1B/1D receptor agonist. Naratriptan hydrochloride is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure. The empirical formula is C17 H25 N3 O2 SHCl, representing a molecular weight of 371.93. Naratriptan hydrochloride is a white to pale yellow powder that is readily soluble in water. Each naratriptan tablets, USP for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, magnesium stearate. 1 mg tablet additionally contains opadry yellow, which contains: hypromellose 2910, titanium dioxide, polyethylene glycol 400 and iron oxide yellow. 2.5 mg tablet additionally contains opadry white, which contains: hypromellose 2910, talc, polyethylene glycol 8000 and titanium dioxide."
    },
    {
      "NDCCode": "27241-054-03",
      "PackageDescription": "30 TABLET in 1 BOTTLE (27241-054-03) ",
      "NDC11Code": "27241-0054-03",
      "ProductNDC": "27241-054",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Aripiprazole",
      "NonProprietaryName": "Aripiprazole",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170530",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206174",
      "LabelerName": "Ajanta Pharma USA Inc.",
      "SubstanceName": "ARIPIPRAZOLE",
      "StrengthNumber": "15",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20170530",
      "SamplePackage": "N",
      "IndicationAndUsage": "Aripiprazole Tablets are indicated for the treatment of: 1 Schizophrenia, 2 Irritability Associated with Autistic Disorder, 3 Treatment of Tourette’s Disorder.",
      "Description": "Aripiprazole is an atypical antipsychotic drug that is available as aripiprazole tablets, USP. Aripiprazole USP is 7-[4-[4-(2,3-dichlorophenyl)-1- piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include lactose monohydrate, magnesium stearate, microcrystalline cellulose, corn starch, hydroxypropyl cellulose and low-substituted hydroxypropyl cellulose. The 5 mg tablet also contains ferric oxide yellow. The 10 mg tablet, 15 mg tablet, 20 mg tablet, and 30 mg tablet also contains ferric oxide red. Aripiprazole tablets meets USP Dissolution Test 2."
    },
    {
      "NDCCode": "37662-0054-3",
      "PackageDescription": "3000 PELLET in 1 BOTTLE, GLASS (37662-0054-3) ",
      "NDC11Code": "37662-0054-03",
      "ProductNDC": "37662-0054",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Calcarea Bromata",
      "NonProprietaryName": "Calcarea Bromata",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220517",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Hahnemann Laboratories, INC.",
      "SubstanceName": "CALCIUM BROMATE",
      "StrengthNumber": "500",
      "StrengthUnit": "[hp_C]/1",
      "Status": "Active",
      "LastUpdate": "2022-05-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220517",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "42292-054-03",
      "PackageDescription": "30 BLISTER PACK in 1 CARTON (42292-054-03)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (42292-054-01) ",
      "NDC11Code": "42292-0054-03",
      "ProductNDC": "42292-054",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Colchicine",
      "NonProprietaryName": "Colchicine",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200430",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209470",
      "LabelerName": "Mylan Institutional Inc.",
      "SubstanceName": "COLCHICINE",
      "StrengthNumber": ".6",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Alkaloid [EPC], Alkaloids [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2025-07-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20200430",
      "SamplePackage": "N",
      "IndicationAndUsage": "Colchicine tablets are an alkaloid indicated for: 1 Prophylaxis and treatment of gout flares in adults (1.1). , 2 Familial Mediterranean fever (FMF) in adults and children 4 years or older (1.2). .",
      "Description": "Colchicine is an alkaloid chemically described as Acetamide, N-(5,6,7,9-tetrahydro-1,2,3,10-tetramethoxy-9-oxobenzo[a]heptalen-7-yl)-, (S)- with a molecular formula of C22H25NO6 and a molecular weight of 399.44. The structural formula of colchicine is given below. Colchicine, USP occurs as a white to pale yellow powder that is soluble in water. Colchicine tablets, USP are supplied for oral administration as red, film-coated, oval, scored tablets (0.1770” × 0.3240”), debossed with M on one side of the tablet and CC to the left of the score and 2 to the right of the score on the other side, containing 0.6 mg of the active ingredient colchicine, USP. Inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), polydextrose, polyethylene glycol, red iron oxide, sodium starch glycolate (potato), titanium dioxide and yellow iron oxide."
    },
    {
      "NDCCode": "42961-054-03",
      "PackageDescription": "50 CARTON in 1 CARTON (42961-054-03)  > 125 PACKET in 1 CARTON (42961-054-02)  > 2 TABLET in 1 PACKET (42961-054-01) ",
      "NDC11Code": "42961-0054-03",
      "ProductNDC": "42961-054",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Congestaid Ii",
      "NonProprietaryName": "Phenylephrine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210107",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "Cintas Corporation",
      "SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20210107",
      "SamplePackage": "N"
    }
  ]
}
                    

{"NDC":[{"NDCCode":"0054-0639-03","ProprietaryName":"Methylergonovine Maleate","NonProprietaryName":"Methylergonovine Maleate"},{"NDCCode":"0054-0639-05","ProprietaryName":"Methylergonovine Maleate","NonProprietaryName":"Methylergonovine Maleate"},{"NDCCode":"0054-0639-13","ProprietaryName":"Methylergonovine Maleate","NonProprietaryName":"Methylergonovine Maleate"},{"NDCCode":"0054-0639-25","ProprietaryName":"Methylergonovine Maleate","NonProprietaryName":"Methylergonovine Maleate"},{"NDCCode":"0363-0639-03","ProprietaryName":"Regular Strength Hydrocortisone Cream","NonProprietaryName":"Hydrocortisone Cream"},{"NDCCode":"11822-0639-3","ProprietaryName":"Rite Aid Cooling Pain Relief","NonProprietaryName":"Menthol 10.5%"},{"NDCCode":"15631-0639-3","ProprietaryName":"Natrum Muriaticum","NonProprietaryName":"Natrum Muriaticum"},{"NDCCode":"37662-0639-3","ProprietaryName":"Dolichos Pruriens","NonProprietaryName":"Dolichos Pruriens"},{"NDCCode":"49288-0639-3","ProprietaryName":"Neurospora Crassa","NonProprietaryName":"Neurospora Crassa"},{"NDCCode":"52125-639-03","ProprietaryName":"Promethazine Hydrochloride","NonProprietaryName":"Promethazine Hydrochloride"},{"NDCCode":"53041-639-03","ProprietaryName":"Childrens Ibuprofen Grape","NonProprietaryName":"Ibuprofen"},{"NDCCode":"58443-0639-3","ProprietaryName":"Black Girl Sunscreen","NonProprietaryName":"Avobenzone, Homosalate, Octisalate, And Octocrylene"},{"NDCCode":"62257-639-03","ProprietaryName":"Clean All","NonProprietaryName":"Alcohol"},{"NDCCode":"63545-639-03","ProprietaryName":"Hahnemann Fever","NonProprietaryName":"Peridot"},{"NDCCode":"64980-639-03","ProprietaryName":"Budesonide","NonProprietaryName":"Budesonide"},{"NDCCode":"68428-639-03","ProprietaryName":"Sinapis Nigra","NonProprietaryName":"Black Mustard Seed"},{"NDCCode":"69097-639-03","ProprietaryName":"Nintedanib","NonProprietaryName":"Nintedanib"},{"NDCCode":"71335-0639-3","ProprietaryName":"Lamivudine And Zidovudine","NonProprietaryName":"Lamivudine And Zidovudine"},{"NDCCode":"72839-639-03","ProprietaryName":"Dch Cooling Pain Relief","NonProprietaryName":"Menthol 10.5%"},{"NDCCode":"75936-639-03","ProprietaryName":"Mineral Glowscreen Soft-radiance Drops Golden Hour","NonProprietaryName":"Zinc Oxide"},{"NDCCode":"79481-0639-3","ProprietaryName":"Meijer Pain Relief","NonProprietaryName":"Menthol 10.5%"},{"NDCCode":"0054-0278-03","ProprietaryName":"Naratriptan","NonProprietaryName":"Naratriptan"},{"NDCCode":"0054-0279-03","ProprietaryName":"Naratriptan","NonProprietaryName":"Naratriptan"},{"NDCCode":"0338-0054-03","ProprietaryName":"Sodium Chloride","NonProprietaryName":"Sodium Chloride"},{"NDCCode":"15631-0054-3","ProprietaryName":"Arsenicum Sulphuratum Flavum","NonProprietaryName":"Arsenicum Sulphuratum Flavum"},{"NDCCode":"23155-054-03","ProprietaryName":"Naratriptan","NonProprietaryName":"Naratriptan"},{"NDCCode":"27241-054-03","ProprietaryName":"Aripiprazole","NonProprietaryName":"Aripiprazole"},{"NDCCode":"37662-0054-3","ProprietaryName":"Calcarea Bromata","NonProprietaryName":"Calcarea Bromata"},{"NDCCode":"42292-054-03","ProprietaryName":"Colchicine","NonProprietaryName":"Colchicine"},{"NDCCode":"42961-054-03","ProprietaryName":"Congestaid Ii","NonProprietaryName":"Phenylephrine Hydrochloride"}]}
                    

<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>0054-0639-03</NDCCode>
    <PackageDescription>7 TABLET in 1 BOTTLE (0054-0639-03) </PackageDescription>
    <NDC11Code>00054-0639-03</NDC11Code>
    <ProductNDC>0054-0639</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methylergonovine Maleate</ProprietaryName>
    <NonProprietaryName>Methylergonovine Maleate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180703</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210424</ApplicationNumber>
    <LabelerName>West-Ward Pharmaceuticals Corp</LabelerName>
    <SubstanceName>METHYLERGONOVINE MALEATE</SubstanceName>
    <StrengthNumber>.2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Ergolines [CS], Ergot Derivative [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180703</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Following delivery of placenta, for routine management of uterine atony, hemorrhage and subinvolution of the uterus. For control of uterine hemorrhage in the second stage of labor following delivery of the anterior shoulder.</IndicationAndUsage>
    <Description>Methylergonovine Maleate Tablets, USP is a semi-synthetic ergot alkaloid used for the prevention and control of postpartum hemorrhage.  Methylergonovine Maleate Tablets, USP is available in tablets for oral ingestion containing 0.2 mg methylergonovine maleate. Tablets Active ingredient: Methylergonovine maleate, USP, 0.2 mg. Inactive ingredients: acacia, corn starch, gelatin, lactose monohydrate, methylparaben, microcrystalline cellulose, povidone, propylparaben, stearic acid, and tartaric acid. Chemically, methylergonovine maleate is designated as ergoline-8-carboxamide, 9, 10-didehydro-N-[1-(hydroxymethyl) propyl]-6-methyl-, [8β(S)]-, (Z)-2-butenedioate (1:1) (salt). Its structural formula is:. C  20H  25N  3O  2C  4H  4O  4                Mol Wt:  455.51.</Description>
  </NDC>
  <NDC>
    <NDCCode>0054-0639-05</NDCCode>
    <PackageDescription>12 TABLET in 1 BOTTLE (0054-0639-05) </PackageDescription>
    <NDC11Code>00054-0639-05</NDC11Code>
    <ProductNDC>0054-0639</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methylergonovine Maleate</ProprietaryName>
    <NonProprietaryName>Methylergonovine Maleate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180703</StartMarketingDate>
    <EndMarketingDate>20241231</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210424</ApplicationNumber>
    <LabelerName>West-Ward Pharmaceuticals Corp</LabelerName>
    <SubstanceName>METHYLERGONOVINE MALEATE</SubstanceName>
    <StrengthNumber>.2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Ergolines [CS], Ergot Derivative [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20180703</StartMarketingDatePackage>
    <EndMarketingDatePackage>20241231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Following delivery of placenta, for routine management of uterine atony, hemorrhage and subinvolution of the uterus. For control of uterine hemorrhage in the second stage of labor following delivery of the anterior shoulder.</IndicationAndUsage>
    <Description>Methylergonovine Maleate Tablets, USP is a semi-synthetic ergot alkaloid used for the prevention and control of postpartum hemorrhage. Methylergonovine Maleate Tablets, USP is available in tablets for oral ingestion containing 0.2 mg methylergonovine maleate. Tablets. Active ingredient: Methylergonovine maleate, USP, 0.2 mg. Inactive ingredients: acacia, corn starch, gelatin, lactose monohydrate, methylparaben, microcrystalline cellulose, povidone, propylparaben, stearic acid, and tartaric acid. Chemically, methylergonovine maleate is designated as ergoline-8-carboxamide, 9, 10-didehydro-N-[1-(hydroxymethyl) propyl]-6-methyl-, [8β(S)]-, (Z)-2-butenedioate (1:1) (salt). Its structural formula is:. C20H25N3O2C4H4O4                Mol Wt:  455.51.</Description>
  </NDC>
  <NDC>
    <NDCCode>0054-0639-13</NDCCode>
    <PackageDescription>28 TABLET in 1 BOTTLE (0054-0639-13) </PackageDescription>
    <NDC11Code>00054-0639-13</NDC11Code>
    <ProductNDC>0054-0639</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methylergonovine Maleate</ProprietaryName>
    <NonProprietaryName>Methylergonovine Maleate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180703</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210424</ApplicationNumber>
    <LabelerName>West-Ward Pharmaceuticals Corp</LabelerName>
    <SubstanceName>METHYLERGONOVINE MALEATE</SubstanceName>
    <StrengthNumber>.2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Ergolines [CS], Ergot Derivative [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180703</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Following delivery of placenta, for routine management of uterine atony, hemorrhage and subinvolution of the uterus. For control of uterine hemorrhage in the second stage of labor following delivery of the anterior shoulder.</IndicationAndUsage>
    <Description>Methylergonovine Maleate Tablets, USP is a semi-synthetic ergot alkaloid used for the prevention and control of postpartum hemorrhage.  Methylergonovine Maleate Tablets, USP is available in tablets for oral ingestion containing 0.2 mg methylergonovine maleate. Tablets Active ingredient: Methylergonovine maleate, USP, 0.2 mg. Inactive ingredients: acacia, corn starch, gelatin, lactose monohydrate, methylparaben, microcrystalline cellulose, povidone, propylparaben, stearic acid, and tartaric acid. Chemically, methylergonovine maleate is designated as ergoline-8-carboxamide, 9, 10-didehydro-N-[1-(hydroxymethyl) propyl]-6-methyl-, [8β(S)]-, (Z)-2-butenedioate (1:1) (salt). Its structural formula is:. C  20H  25N  3O  2C  4H  4O  4                Mol Wt:  455.51.</Description>
  </NDC>
  <NDC>
    <NDCCode>0054-0639-25</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (0054-0639-25) </PackageDescription>
    <NDC11Code>00054-0639-25</NDC11Code>
    <ProductNDC>0054-0639</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methylergonovine Maleate</ProprietaryName>
    <NonProprietaryName>Methylergonovine Maleate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180703</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210424</ApplicationNumber>
    <LabelerName>West-Ward Pharmaceuticals Corp</LabelerName>
    <SubstanceName>METHYLERGONOVINE MALEATE</SubstanceName>
    <StrengthNumber>.2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Ergolines [CS], Ergot Derivative [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180703</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Following delivery of placenta, for routine management of uterine atony, hemorrhage and subinvolution of the uterus. For control of uterine hemorrhage in the second stage of labor following delivery of the anterior shoulder.</IndicationAndUsage>
    <Description>Methylergonovine Maleate Tablets, USP is a semi-synthetic ergot alkaloid used for the prevention and control of postpartum hemorrhage.  Methylergonovine Maleate Tablets, USP is available in tablets for oral ingestion containing 0.2 mg methylergonovine maleate. Tablets Active ingredient: Methylergonovine maleate, USP, 0.2 mg. Inactive ingredients: acacia, corn starch, gelatin, lactose monohydrate, methylparaben, microcrystalline cellulose, povidone, propylparaben, stearic acid, and tartaric acid. Chemically, methylergonovine maleate is designated as ergoline-8-carboxamide, 9, 10-didehydro-N-[1-(hydroxymethyl) propyl]-6-methyl-, [8β(S)]-, (Z)-2-butenedioate (1:1) (salt). Its structural formula is:. C  20H  25N  3O  2C  4H  4O  4                Mol Wt:  455.51.</Description>
  </NDC>
  <NDC>
    <NDCCode>0363-0639-03</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (0363-0639-03)  &gt; 56 g in 1 TUBE (0363-0639-01) </PackageDescription>
    <NDC11Code>00363-0639-03</NDC11Code>
    <ProductNDC>0363-0639</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Regular Strength Hydrocortisone Cream</ProprietaryName>
    <NonProprietaryName>Hydrocortisone Cream</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20160607</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part348</ApplicationNumber>
    <LabelerName>Walgreens</LabelerName>
    <SubstanceName>HYDROCORTISONE</SubstanceName>
    <StrengthNumber>.51</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160607</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to: eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, jewelry, detergents, cosmetics, psoriasis, seborrheic dermatitis, for external genital, feminine and anal itching, other uses of this product should be only under the advice and supervision of a doctor.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>11822-0639-3</NDCCode>
    <PackageDescription>85 g in 1 CAN (11822-0639-3) </PackageDescription>
    <NDC11Code>11822-0639-03</NDC11Code>
    <ProductNDC>11822-0639</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Rite Aid Cooling Pain Relief</ProprietaryName>
    <NonProprietaryName>Menthol 10.5%</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210331</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>Rite Aid</LabelerName>
    <SubstanceName>MENTHOL</SubstanceName>
    <StrengthNumber>10.5</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-12-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210331</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the temporary relief of minor pain associated with arthritis, simple backache, muscle strains, sprains, and bruises.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>15631-0639-3</NDCCode>
    <PackageDescription>100 TABLET in 1 CONTAINER (15631-0639-3)</PackageDescription>
    <NDC11Code>15631-0639-03</NDC11Code>
    <ProductNDC>15631-0639</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Natrum Muriaticum</ProprietaryName>
    <NonProprietaryName>Natrum Muriaticum</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20151207</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
    <SubstanceName>SODIUM CHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>[hp_X]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>37662-0639-3</NDCCode>
    <PackageDescription>3000 PELLET in 1 BOTTLE, GLASS (37662-0639-3) </PackageDescription>
    <NDC11Code>37662-0639-03</NDC11Code>
    <ProductNDC>37662-0639</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dolichos Pruriens</ProprietaryName>
    <NonProprietaryName>Dolichos Pruriens</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220620</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Hahnemann Laboratories, INC.</LabelerName>
    <SubstanceName>MUCUNA PRURIENS FRUIT TRICHOME</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>[hp_C]/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2022-06-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220620</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>49288-0639-3</NDCCode>
    <PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (49288-0639-3)</PackageDescription>
    <NDC11Code>49288-0639-03</NDC11Code>
    <ProductNDC>49288-0639</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Neurospora Crassa</ProprietaryName>
    <NonProprietaryName>Neurospora Crassa</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19740323</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102223</ApplicationNumber>
    <LabelerName>Antigen Laboratories, Inc.</LabelerName>
    <SubstanceName>NEUROSPORA CRASSA</SubstanceName>
    <StrengthNumber>.05</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
    <Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
  </NDC>
  <NDC>
    <NDCCode>52125-639-03</NDCCode>
    <PackageDescription>20 TABLET in 1 BOTTLE (52125-639-03)</PackageDescription>
    <NDC11Code>52125-0639-03</NDC11Code>
    <ProductNDC>52125-639</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Promethazine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Promethazine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20131205</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA083426</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</LabelerName>
    <SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-01-05</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>53041-639-03</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (53041-639-03)  &gt; 120 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>53041-0639-03</NDC11Code>
    <ProductNDC>53041-639</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Childrens Ibuprofen Grape</ProprietaryName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>SUSPENSION/ DROPS</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20211013</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210149</ApplicationNumber>
    <LabelerName>Guardian Drug Company</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2021-10-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211013</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>58443-0639-3</NDCCode>
    <PackageDescription>59 mL in 1 TUBE (58443-0639-3) </PackageDescription>
    <NDC11Code>58443-0639-03</NDC11Code>
    <ProductNDC>58443-0639</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Black Girl Sunscreen</ProprietaryName>
    <ProprietaryNameSuffix>Sunscreen Spf 30 Broad Spectrum</ProprietaryNameSuffix>
    <NonProprietaryName>Avobenzone, Homosalate, Octisalate, And Octocrylene</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20230804</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Prime Enterprises Inc.</LabelerName>
    <SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
    <StrengthNumber>29.4; 98; 49; 26.95</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-09-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230804</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreses the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>62257-639-03</NDCCode>
    <PackageDescription>350 mL in 1 CARTRIDGE (62257-639-03)</PackageDescription>
    <NDC11Code>62257-0639-03</NDC11Code>
    <ProductNDC>62257-639</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Clean All</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20101101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>ABC Compounding Co., Inc.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>.62</StrengthNumber>
    <StrengthUnit>mL/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>for hand-washing to decrease bacteria on the skin, only when water is not available.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>63545-639-03</NDCCode>
    <PackageDescription>3650 PELLET in 1 BOTTLE (63545-639-03)</PackageDescription>
    <NDC11Code>63545-0639-03</NDC11Code>
    <ProductNDC>63545-639</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hahnemann Fever</ProprietaryName>
    <NonProprietaryName>Peridot</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20101231</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals</LabelerName>
    <SubstanceName>OLIVINE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>[hp_C]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>USE according to standard Homeopathic indications for self-limiting conditions, such as listed above. FEVER.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>64980-639-03</NDCCode>
    <PackageDescription>30 POUCH in 1 CARTON (64980-639-03)  / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE</PackageDescription>
    <NDC11Code>64980-0639-03</NDC11Code>
    <ProductNDC>64980-639</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Budesonide</ProprietaryName>
    <NonProprietaryName>Budesonide</NonProprietaryName>
    <DosageFormName>INHALANT</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20250314</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078202</ApplicationNumber>
    <LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
    <SubstanceName>BUDESONIDE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/2mL</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250314</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Budesonide inhalation suspension is an inhaled corticosteroid indicated for: 1 Maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age ( 1) .</IndicationAndUsage>
    <Description>Budesonide, the active component of budesonide inhalation suspension, is a corticosteroid designated chemically as (RS)-11β, 16α, 17, 21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C 25H 34O 6and its molecular weight is 430.5. Its structural formula is:. Budesonide is a white to off-white, tasteless, odorless powder that is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coeffecient between octanol and water at pH 7.4 is 1.6 x 10 3. Budesonide inhalation suspension is a sterile suspension for inhalation via jet nebulizer and contains the active ingredient budesonide (micronized), and the inactive ingredients citric acid, edetate disodium dihydrate, polysorbate 80, sodium chloride, sodium citrate, and water for injection. Two dose strengths are available in single-dose ampules: 0.25 mg and 0.5 mg per 2 mL ampule. For budesonide inhalation suspension, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari-LC-Jet Plus Nebulizer/Pari Master compressor system, under in vitroconditions, the mean delivered dose at the mouthpiece (% nominal dose) was approximately 17% at a mean flow rate of 5.5 L/min. The mean nebulization time was 5 minutes or less. Budesonide inhalation suspension should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces [see Dosage and Administration (2)].</Description>
  </NDC>
  <NDC>
    <NDCCode>68428-639-03</NDCCode>
    <PackageDescription>75 PELLET in 1 VIAL, GLASS (68428-639-03) </PackageDescription>
    <NDC11Code>68428-0639-03</NDC11Code>
    <ProductNDC>68428-639</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sinapis Nigra</ProprietaryName>
    <NonProprietaryName>Black Mustard Seed</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20091028</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Washington Homeopathic Products</LabelerName>
    <SubstanceName>BLACK MUSTARD SEED</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>[hp_C]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-04-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20091028</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>69097-639-03</NDCCode>
    <PackageDescription>60 CAPSULE in 1 BOTTLE (69097-639-03) </PackageDescription>
    <NDC11Code>69097-0639-03</NDC11Code>
    <ProductNDC>69097-639</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nintedanib</ProprietaryName>
    <NonProprietaryName>Nintedanib</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260402</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212609</ApplicationNumber>
    <LabelerName>Cipla USA Inc.</LabelerName>
    <SubstanceName>NINTEDANIB ESYLATE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260402</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Nintedanib is a kinase inhibitor indicated in adults for: : 1 Treatment of idiopathic pulmonary fibrosis (IPF). (1.1), 2 Treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype. (1.2), 3 Slowing the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). (1.3).</IndicationAndUsage>
    <Description>Nintedanib capsules contain nintedanib, a kinase inhibitor [see Mechanism of Action (12.1)]. Nintedanib is presented as the ethanesulfonate salt (esylate), with the chemical name 1H-Indole-6-carboxylic acid, 2,3-dihydro-3-[[[4-[methyl[(4-methyl-1-piperazinyl)acetyl]amino]phenyl]amino]phenylmethylene]-2-oxo-,methyl ester, (3Z)-, ethanesulfonate (1:1). Its structural formula is:. Nintedanib esylate is a pale yellow to yellow colored powder with an empirical formula of C31H33N5O4·C2H6O3S and a molecular weight of 649.76 g/mol. Nintedanib capsules for oral administration are available in 2 dose strengths containing 100 mg or 150 mg of nintedanib (equivalent to 120.40 mg or 180.60 mg nintedanib ethanesulfonate, respectively). The inactive ingredients of nintedanib capsule are the following: Fill Material: medium chain triglyceride, hard fat, lecithin. Capsule Shell: gelatin, glycerin, titanium dioxide, red ferric oxide, yellow ferric oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>71335-0639-3</NDCCode>
    <PackageDescription>4 TABLET, FILM COATED in 1 BOTTLE (71335-0639-3) </PackageDescription>
    <NDC11Code>71335-0639-03</NDC11Code>
    <ProductNDC>71335-0639</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lamivudine And Zidovudine</ProprietaryName>
    <NonProprietaryName>Lamivudine And Zidovudine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150918</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA079124</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>LAMIVUDINE; ZIDOVUDINE</SubstanceName>
    <StrengthNumber>150; 300</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-03-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211227</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lamivudine and zidovudine tablets a combination of 2 nucleoside analogues, are indicated in combination with other antiretrovirals for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.</IndicationAndUsage>
    <Description>Lamivudine and Zidovudine tablets, USP are combination tablets containing lamivudine and zidovudine. Lamivudine (EPIVIR) and zidovudine (RETROVIR, azidothymidine, AZT, or ZDV) are synthetic nucleoside analogues with activity against HIV-1. Lamivudine and Zidovudine tablets, USP are for oral administration. Each film-coated tablet contains 150 mg of lamivudine, USP, 300 mg of zidovudine, USP, and the inactive ingredients microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate and opadry white (hypromellose, polyethylene glycol, polysorbate 80 and titanium dioxide).Lamivudine The chemical name of lamivudine is (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidine-2-one. Lamivudine is the (-) enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2',3'-dideoxy, 3'-thiacytidine. It has a molecular formula of C8H11N303S and a molecular weight of 229.26. It has the following structural formula. Lamivudine USP is a white to off-white crystalline solid with a solubility of approximately 70 mg/mL in water at 20°C. Zidovudine The chemical name of zidovudine is 3'-azido-3'-deoxythymidine. It has a molecular formula of C10H13N5O4 and a molecular weight of 267.24. It has the following structural formula. Zidovudine USP is a white to beige, odorless, crystalline solid with a solubility of 20.1 mg/mL in water at 25°C. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>72839-639-03</NDCCode>
    <PackageDescription>85 g in 1 CAN (72839-639-03) </PackageDescription>
    <NDC11Code>72839-0639-03</NDC11Code>
    <ProductNDC>72839-639</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dch Cooling Pain Relief</ProprietaryName>
    <NonProprietaryName>Menthol 10.5%</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210524</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>Derma Care Research Labs, LLC</LabelerName>
    <SubstanceName>MENTHOL</SubstanceName>
    <StrengthNumber>10.5</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210524</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the temporary relief of minor aches and pain associated with arthritis, simple backache, muscle strains, bruises, sprains, and cramps.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>75936-639-03</NDCCode>
    <PackageDescription>10 mL in 1 TUBE (75936-639-03) </PackageDescription>
    <NDC11Code>75936-0639-03</NDC11Code>
    <ProductNDC>75936-639</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Mineral Glowscreen Soft-radiance Drops Golden Hour</ProprietaryName>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240807</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Supergoop LLC</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>15.11</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-06-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240807</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>Stop use and ask a doctor if rash occurs.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>79481-0639-3</NDCCode>
    <PackageDescription>85 g in 1 CAN (79481-0639-3) </PackageDescription>
    <NDC11Code>79481-0639-03</NDC11Code>
    <ProductNDC>79481-0639</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Meijer Pain Relief</ProprietaryName>
    <NonProprietaryName>Menthol 10.5%</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210331</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>Meijer</LabelerName>
    <SubstanceName>MENTHOL</SubstanceName>
    <StrengthNumber>10.5</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210331</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the temporary relief of minor pain associated with arthritis, simple backache, muscle strains, sprains, and bruises.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0054-0278-03</NDCCode>
    <PackageDescription>9 TABLET in 1 BOTTLE (0054-0278-03) </PackageDescription>
    <NDC11Code>00054-0278-03</NDC11Code>
    <ProductNDC>0054-0278</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Naratriptan</ProprietaryName>
    <NonProprietaryName>Naratriptan</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100707</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090381</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>NARATRIPTAN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-07-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20101007</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Naratriptan is indicated for the acute treatment of migraine attacks with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan, reconsider the diagnosis of migraine before naratriptan is administered to treat any subsequent attacks., 2 Naratriptan is not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of naratriptan have not been established for cluster headache. .</IndicationAndUsage>
    <Description>Naratriptan Tablets, USP contains naratriptan hydrochloride, USP, a selective 5-HT1B/1D receptor agonist. Naratriptan hydrochloride is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure. The empirical formula is C17H25N3O2SHCl, representing a molecular weight of 371.93. Naratriptan hydrochloride, USP is a white to pale yellow crystalline powder that is readily soluble in water. Each naratriptan tablet for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride, USP, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose (anhydrous), magnesium stearate, and microcrystalline cellulose.</Description>
  </NDC>
  <NDC>
    <NDCCode>0054-0279-03</NDCCode>
    <PackageDescription>9 TABLET in 1 BOTTLE (0054-0279-03) </PackageDescription>
    <NDC11Code>00054-0279-03</NDC11Code>
    <ProductNDC>0054-0279</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Naratriptan</ProprietaryName>
    <NonProprietaryName>Naratriptan</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100707</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090381</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>NARATRIPTAN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-07-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20101007</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Naratriptan is indicated for the acute treatment of migraine attacks with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan, reconsider the diagnosis of migraine before naratriptan is administered to treat any subsequent attacks., 2 Naratriptan is not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of naratriptan have not been established for cluster headache. .</IndicationAndUsage>
    <Description>Naratriptan Tablets, USP contains naratriptan hydrochloride, USP, a selective 5-HT1B/1D receptor agonist. Naratriptan hydrochloride is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure. The empirical formula is C17H25N3O2SHCl, representing a molecular weight of 371.93. Naratriptan hydrochloride, USP is a white to pale yellow crystalline powder that is readily soluble in water. Each naratriptan tablet for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride, USP, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose (anhydrous), magnesium stearate, and microcrystalline cellulose.</Description>
  </NDC>
  <NDC>
    <NDCCode>0338-0054-03</NDCCode>
    <PackageDescription>24 BAG in 1 CARTON (0338-0054-03)  / 500 mL in 1 BAG</PackageDescription>
    <NDC11Code>00338-0054-03</NDC11Code>
    <ProductNDC>0338-0054</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Chloride</ProprietaryName>
    <NonProprietaryName>Sodium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19831101</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019022</ApplicationNumber>
    <LabelerName>Baxter Healthcare Corporation</LabelerName>
    <SubstanceName>SODIUM CHLORIDE</SubstanceName>
    <StrengthNumber>3</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19831101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>3% and 5% Sodium Chloride Injection, USP is indicated as a source of water and electrolytes.</IndicationAndUsage>
    <Description>3% and 5% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, hypertonic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. The pH may have been adjusted with hydrochloric acid. It contains no antimicrobial agents. Composition, ionic concentration, osmolarity, and pH are shown in Table 1. The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.</Description>
  </NDC>
  <NDC>
    <NDCCode>15631-0054-3</NDCCode>
    <PackageDescription>750 PELLET in 1 PACKAGE (15631-0054-3) </PackageDescription>
    <NDC11Code>15631-0054-03</NDC11Code>
    <ProductNDC>15631-0054</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Arsenicum Sulphuratum Flavum</ProprietaryName>
    <NonProprietaryName>Arsenicum Sulphuratum Flavum</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150911</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
    <SubstanceName>ARSENIC TRISULFIDE</SubstanceName>
    <StrengthNumber>6</StrengthNumber>
    <StrengthUnit>[hp_X]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>23155-054-03</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (23155-054-03) </PackageDescription>
    <NDC11Code>23155-0054-03</NDC11Code>
    <ProductNDC>23155-054</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Naratriptan</ProprietaryName>
    <NonProprietaryName>Naratriptan</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110315</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA200502</ApplicationNumber>
    <LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>NARATRIPTAN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110315</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Naratriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan tablets reconsider the diagnosis of migraine before naratriptan tablets are administered to treat any subsequent attacks., 2 Naratriptan tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of naratriptan tablets have not been established for cluster headache.</IndicationAndUsage>
    <Description>Naratriptan tablets, USP contains naratriptan hydrochloride, a selective 5-HT1B/1D receptor agonist. Naratriptan hydrochloride is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure. The empirical formula is C17 H25 N3 O2 SHCl, representing a molecular weight of 371.93. Naratriptan hydrochloride is a white to pale yellow powder that is readily soluble in water. Each naratriptan tablets, USP for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, magnesium stearate. 1 mg tablet additionally contains opadry yellow, which contains: hypromellose 2910, titanium dioxide, polyethylene glycol 400 and iron oxide yellow. 2.5 mg tablet additionally contains opadry white, which contains: hypromellose 2910, talc, polyethylene glycol 8000 and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>27241-054-03</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (27241-054-03) </PackageDescription>
    <NDC11Code>27241-0054-03</NDC11Code>
    <ProductNDC>27241-054</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Aripiprazole</ProprietaryName>
    <NonProprietaryName>Aripiprazole</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170530</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206174</ApplicationNumber>
    <LabelerName>Ajanta Pharma USA Inc.</LabelerName>
    <SubstanceName>ARIPIPRAZOLE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170530</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Aripiprazole Tablets are indicated for the treatment of: 1 Schizophrenia, 2 Irritability Associated with Autistic Disorder, 3 Treatment of Tourette’s Disorder.</IndicationAndUsage>
    <Description>Aripiprazole is an atypical antipsychotic drug that is available as aripiprazole tablets, USP. Aripiprazole USP is 7-[4-[4-(2,3-dichlorophenyl)-1- piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include lactose monohydrate, magnesium stearate, microcrystalline cellulose, corn starch, hydroxypropyl cellulose and low-substituted hydroxypropyl cellulose. The 5 mg tablet also contains ferric oxide yellow. The 10 mg tablet, 15 mg tablet, 20 mg tablet, and 30 mg tablet also contains ferric oxide red. Aripiprazole tablets meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>37662-0054-3</NDCCode>
    <PackageDescription>3000 PELLET in 1 BOTTLE, GLASS (37662-0054-3) </PackageDescription>
    <NDC11Code>37662-0054-03</NDC11Code>
    <ProductNDC>37662-0054</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Calcarea Bromata</ProprietaryName>
    <NonProprietaryName>Calcarea Bromata</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220517</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Hahnemann Laboratories, INC.</LabelerName>
    <SubstanceName>CALCIUM BROMATE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>[hp_C]/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2022-05-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220517</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>42292-054-03</NDCCode>
    <PackageDescription>30 BLISTER PACK in 1 CARTON (42292-054-03)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (42292-054-01) </PackageDescription>
    <NDC11Code>42292-0054-03</NDC11Code>
    <ProductNDC>42292-054</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Colchicine</ProprietaryName>
    <NonProprietaryName>Colchicine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200430</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209470</ApplicationNumber>
    <LabelerName>Mylan Institutional Inc.</LabelerName>
    <SubstanceName>COLCHICINE</SubstanceName>
    <StrengthNumber>.6</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Alkaloid [EPC], Alkaloids [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-07-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200430</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Colchicine tablets are an alkaloid indicated for: 1 Prophylaxis and treatment of gout flares in adults (1.1). , 2 Familial Mediterranean fever (FMF) in adults and children 4 years or older (1.2). .</IndicationAndUsage>
    <Description>Colchicine is an alkaloid chemically described as Acetamide, N-(5,6,7,9-tetrahydro-1,2,3,10-tetramethoxy-9-oxobenzo[a]heptalen-7-yl)-, (S)- with a molecular formula of C22H25NO6 and a molecular weight of 399.44. The structural formula of colchicine is given below. Colchicine, USP occurs as a white to pale yellow powder that is soluble in water. Colchicine tablets, USP are supplied for oral administration as red, film-coated, oval, scored tablets (0.1770” × 0.3240”), debossed with M on one side of the tablet and CC to the left of the score and 2 to the right of the score on the other side, containing 0.6 mg of the active ingredient colchicine, USP. Inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), polydextrose, polyethylene glycol, red iron oxide, sodium starch glycolate (potato), titanium dioxide and yellow iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>42961-054-03</NDCCode>
    <PackageDescription>50 CARTON in 1 CARTON (42961-054-03)  &gt; 125 PACKET in 1 CARTON (42961-054-02)  &gt; 2 TABLET in 1 PACKET (42961-054-01) </PackageDescription>
    <NDC11Code>42961-0054-03</NDC11Code>
    <ProductNDC>42961-054</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Congestaid Ii</ProprietaryName>
    <NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210107</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>Cintas Corporation</LabelerName>
    <SubstanceName>PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210107</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>0054-0639-03</NDCCode><ProprietaryName>Methylergonovine Maleate</ProprietaryName><NonProprietaryName>Methylergonovine Maleate</NonProprietaryName></NDC><NDC><NDCCode>0054-0639-05</NDCCode><ProprietaryName>Methylergonovine Maleate</ProprietaryName><NonProprietaryName>Methylergonovine Maleate</NonProprietaryName></NDC><NDC><NDCCode>0054-0639-13</NDCCode><ProprietaryName>Methylergonovine Maleate</ProprietaryName><NonProprietaryName>Methylergonovine Maleate</NonProprietaryName></NDC><NDC><NDCCode>0054-0639-25</NDCCode><ProprietaryName>Methylergonovine Maleate</ProprietaryName><NonProprietaryName>Methylergonovine Maleate</NonProprietaryName></NDC><NDC><NDCCode>0363-0639-03</NDCCode><ProprietaryName>Regular Strength Hydrocortisone Cream</ProprietaryName><NonProprietaryName>Hydrocortisone Cream</NonProprietaryName></NDC><NDC><NDCCode>11822-0639-3</NDCCode><ProprietaryName>Rite Aid Cooling Pain Relief</ProprietaryName><NonProprietaryName>Menthol 10.5%</NonProprietaryName></NDC><NDC><NDCCode>15631-0639-3</NDCCode><ProprietaryName>Natrum Muriaticum</ProprietaryName><NonProprietaryName>Natrum Muriaticum</NonProprietaryName></NDC><NDC><NDCCode>37662-0639-3</NDCCode><ProprietaryName>Dolichos Pruriens</ProprietaryName><NonProprietaryName>Dolichos Pruriens</NonProprietaryName></NDC><NDC><NDCCode>49288-0639-3</NDCCode><ProprietaryName>Neurospora Crassa</ProprietaryName><NonProprietaryName>Neurospora Crassa</NonProprietaryName></NDC><NDC><NDCCode>52125-639-03</NDCCode><ProprietaryName>Promethazine Hydrochloride</ProprietaryName><NonProprietaryName>Promethazine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>53041-639-03</NDCCode><ProprietaryName>Childrens Ibuprofen Grape</ProprietaryName><NonProprietaryName>Ibuprofen</NonProprietaryName></NDC><NDC><NDCCode>58443-0639-3</NDCCode><ProprietaryName>Black Girl Sunscreen</ProprietaryName><NonProprietaryName>Avobenzone, Homosalate, Octisalate, And Octocrylene</NonProprietaryName></NDC><NDC><NDCCode>62257-639-03</NDCCode><ProprietaryName>Clean All</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>63545-639-03</NDCCode><ProprietaryName>Hahnemann Fever</ProprietaryName><NonProprietaryName>Peridot</NonProprietaryName></NDC><NDC><NDCCode>64980-639-03</NDCCode><ProprietaryName>Budesonide</ProprietaryName><NonProprietaryName>Budesonide</NonProprietaryName></NDC><NDC><NDCCode>68428-639-03</NDCCode><ProprietaryName>Sinapis Nigra</ProprietaryName><NonProprietaryName>Black Mustard Seed</NonProprietaryName></NDC><NDC><NDCCode>69097-639-03</NDCCode><ProprietaryName>Nintedanib</ProprietaryName><NonProprietaryName>Nintedanib</NonProprietaryName></NDC><NDC><NDCCode>71335-0639-3</NDCCode><ProprietaryName>Lamivudine And Zidovudine</ProprietaryName><NonProprietaryName>Lamivudine And Zidovudine</NonProprietaryName></NDC><NDC><NDCCode>72839-639-03</NDCCode><ProprietaryName>Dch Cooling Pain Relief</ProprietaryName><NonProprietaryName>Menthol 10.5%</NonProprietaryName></NDC><NDC><NDCCode>75936-639-03</NDCCode><ProprietaryName>Mineral Glowscreen Soft-radiance Drops Golden Hour</ProprietaryName><NonProprietaryName>Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>79481-0639-3</NDCCode><ProprietaryName>Meijer Pain Relief</ProprietaryName><NonProprietaryName>Menthol 10.5%</NonProprietaryName></NDC><NDC><NDCCode>0054-0278-03</NDCCode><ProprietaryName>Naratriptan</ProprietaryName><NonProprietaryName>Naratriptan</NonProprietaryName></NDC><NDC><NDCCode>0054-0279-03</NDCCode><ProprietaryName>Naratriptan</ProprietaryName><NonProprietaryName>Naratriptan</NonProprietaryName></NDC><NDC><NDCCode>0338-0054-03</NDCCode><ProprietaryName>Sodium Chloride</ProprietaryName><NonProprietaryName>Sodium Chloride</NonProprietaryName></NDC><NDC><NDCCode>15631-0054-3</NDCCode><ProprietaryName>Arsenicum Sulphuratum Flavum</ProprietaryName><NonProprietaryName>Arsenicum Sulphuratum Flavum</NonProprietaryName></NDC><NDC><NDCCode>23155-054-03</NDCCode><ProprietaryName>Naratriptan</ProprietaryName><NonProprietaryName>Naratriptan</NonProprietaryName></NDC><NDC><NDCCode>27241-054-03</NDCCode><ProprietaryName>Aripiprazole</ProprietaryName><NonProprietaryName>Aripiprazole</NonProprietaryName></NDC><NDC><NDCCode>37662-0054-3</NDCCode><ProprietaryName>Calcarea Bromata</ProprietaryName><NonProprietaryName>Calcarea Bromata</NonProprietaryName></NDC><NDC><NDCCode>42292-054-03</NDCCode><ProprietaryName>Colchicine</ProprietaryName><NonProprietaryName>Colchicine</NonProprietaryName></NDC><NDC><NDCCode>42961-054-03</NDCCode><ProprietaryName>Congestaid Ii</ProprietaryName><NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

            
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      "LicenseNumberStateCode1": "KY",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "207RI0200X",
      "Taxonomy2": "Infectious Disease",
      "LicenseNumber2": "25MA07672000",
      "LicenseNumberStateCode2": "NJ",
      "PrimaryTaxonomySwitch2": "Y"
    },
    {
      "NPI": "1184645301",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "BAIK",
      "FirstName": "RANIA",
      "Credential": "D.O.",
      "FirstLineMailingAddress": "602 ROUTE 169",
      "SecondLineMailingAddress": "PO BOX 865",
      "MailingAddressCityName": "WOODSTOCK",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06281-2225",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "860-821-3406",
      "MailingAddressFaxNumber": "860-821-3407",
      "FirstLinePracticeLocationAddress": "602 ROUTE 169",
      "PracticeLocationAddressCityName": "WOODSTOCK",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06281-2225",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "860-821-3406",
      "PracticeLocationAddressFaxNumber": "860-821-3407",
      "EnumerationDate": "07/22/2006",
      "LastUpdateDate": "01/14/2016",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "000260",
      "LicenseNumberStateCode1": "CT",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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