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How to Find 49967-089-01 NDC Data Using DataLabs API

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{
  "NDC": [
    {
      "NDCCode": "49967-089-01",
      "PackageDescription": "1 TUBE in 1 CARTON (49967-089-01)  > 150 mL in 1 TUBE",
      "NDC11Code": "49967-0089-01",
      "ProductNDC": "49967-089",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Vichy Laboratoire",
      "ProprietaryNameSuffix": "Capital Soleil Spf 30 Soft Sheer Sunscreen",
      "NonProprietaryName": "Avobenzone Homosalate Octisalate Octocrylene Oxybenzone",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110421",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "L'Oreal USA Products Inc",
      "SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
      "StrengthNumber": "4.5; 7.5; 7.5; 10.5; 9",
      "StrengthUnit": "mL/150mL; mL/150mL; mL/150mL; mL/150mL; mL/150mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-18",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "11489-089-01",
      "PackageDescription": "1 JAR in 1 CARTON (11489-089-01)  > 50 g in 1 JAR",
      "NDC11Code": "11489-0089-01",
      "ProductNDC": "11489-089",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Botanics Hydrating Day All Bright Sunscreen Broad Spectrum Spf 15",
      "NonProprietaryName": "Avobenzone, Octisalate, Octocrylene",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20141013",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "BCM Ltd",
      "SubstanceName": "AVOBENZONE; OCTISALATE; OCTOCRYLENE",
      "StrengthNumber": "1.5; 1.5; 2.5",
      "StrengthUnit": "g/50g; g/50g; g/50g",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "Directions for sunscreen use. apply liberally 15 minutes before sun exposure. reapply at least every 2 hours. use a water resistant sunscreen if swimming or sweating. children under 6 months of age: Ask a doctor. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including. limit time in the sun, especially from 10 a.m. – 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses."
    },
    {
      "NDCCode": "13107-089-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE (13107-089-01) ",
      "NDC11Code": "13107-0089-01",
      "ProductNDC": "13107-089",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Methadone Hydrochloride",
      "NonProprietaryName": "Methadone Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150915",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203502",
      "LabelerName": "Aurolife Pharma, LLC",
      "SubstanceName": "METHADONE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2025-12-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20150915",
      "SamplePackage": "N",
      "IndicationAndUsage": "Methadone Hydrochloride Tablets are indicated forthe:  1.      Management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.  2.Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse overdose, and death, which can occur at any dosage or duration  and persist over the course of therapy[See Warnings and Precautions (5.1)], reserve opioid analgesics, including Methadone Hydrochloride Tablets, for use in patients for whom alternative analgesic treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Methadone Hydrochloride Tablets is not indicated asanas-needed(prn)analgesic. (1).",
      "Description": "Methadone Hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-hepatanone hydrochloride. Methadone Hydrochloride USP is a white powder. Its molecular formula is C21H27 NO HCl and it has a molecular weight of 345.91. Methadone Hydrochloride has a melting point of 235°C, and a pKa of 8.25 in water at 20°C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5. It has the following structural formula. Methadone Hydrochloride Tablets are available for oral administration containing either 5 mg or 10 mg of Methadone Hydrochloride USP. Each tablet contains the following inactive ingredients: Colloidal silicon dioxide, Lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch."
    },
    {
      "NDCCode": "14141-089-02",
      "PackageDescription": "1 TUBE in 1 BOX (14141-089-02)  > 35 g in 1 TUBE (14141-089-01) ",
      "NDC11Code": "14141-0089-02",
      "ProductNDC": "14141-089",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lbel Libertage Cc Matte Perfectioning-effect Moisturizing Face Spf 30",
      "NonProprietaryName": "Octinoxate And Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20180808",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Bel Star S.A. (Colombia)",
      "SubstanceName": "OCTINOXATE; ZINC OXIDE",
      "StrengthNumber": ".07; .06",
      "StrengthUnit": "g/g; g/g",
      "Status": "Deprecated",
      "LastUpdate": "2023-12-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20180808",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "14783-089-02",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (14783-089-02)  > 27 mL in 1 BOTTLE, PLASTIC (14783-089-01) ",
      "NDC11Code": "14783-0089-02",
      "ProductNDC": "14783-089",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lbel Concentre Total Base Serum Ultra-fluid Foundation Spf 25",
      "ProprietaryNameSuffix": "Medium 7 - Beige",
      "NonProprietaryName": "Octinoxate And Zinc Oxide",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20170127",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Ventura International LTD",
      "SubstanceName": "OCTINOXATE; ZINC OXIDE",
      "StrengthNumber": ".07; .072",
      "StrengthUnit": "g/mL; g/mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20170127",
      "SamplePackage": "N",
      "IndicationAndUsage": "Helps prevent sunburn."
    },
    {
      "NDCCode": "16714-089-01",
      "PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (16714-089-01)  > 5 mL in 1 VIAL, MULTI-DOSE",
      "NDC11Code": "16714-0089-01",
      "ProductNDC": "16714-089",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Methylprednisolone Acetate",
      "NonProprietaryName": "Methylprednisolone Acetate",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE",
      "StartMarketingDate": "20210525",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040620",
      "LabelerName": "Northstar RxLLC",
      "SubstanceName": "METHYLPREDNISOLONE ACETATE",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-05-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20210525",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "20151-089-02",
      "PackageDescription": "1 BOTTLE, DISPENSING in 1 BOTTLE, DISPENSING (20151-089-02)  > 50 mL in 1 BOTTLE, DISPENSING (20151-089-01)",
      "NDC11Code": "20151-0089-02",
      "ProductNDC": "20151-089",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Vitalizing Energizing Moisturizing Cream",
      "NonProprietaryName": "Glycerin, Dimethicone",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20170223",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part347",
      "LabelerName": "Casmara Cosmetics, SA",
      "SubstanceName": "GLYCERIN; DIMETHICONE",
      "StrengthNumber": "3; .4",
      "StrengthUnit": "mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "provides an intensive dose of hydration and energy."
    },
    {
      "NDCCode": "21130-089-01",
      "PackageDescription": "1 BOTTLE in 1 CARTON (21130-089-01)  > 120 SPRAY, METERED in 1 BOTTLE",
      "NDC11Code": "21130-0089-01",
      "ProductNDC": "21130-089",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Signature Care Allergy Relief",
      "NonProprietaryName": "Fluticasone Propionate",
      "DosageFormName": "SPRAY, METERED",
      "RouteName": "NASAL",
      "StartMarketingDate": "20160531",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207957",
      "LabelerName": "Safeway",
      "SubstanceName": "FLUTICASONE PROPIONATE",
      "StrengthNumber": "50",
      "StrengthUnit": "ug/1",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160531",
      "EndMarketingDatePackage": "20230101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: 1 nasal congestion, 2 runny nose, 3 sneezing, 4 itchy nose , 5 itchy, watery eyes."
    },
    {
      "NDCCode": "27808-089-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (27808-089-01) ",
      "NDC11Code": "27808-0089-01",
      "ProductNDC": "27808-089",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dextroamphetamine Sulfate",
      "NonProprietaryName": "Dextroamphetamine Sulfate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220820",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206095",
      "LabelerName": "Cranbury Pharmaceuticals, LLC",
      "SubstanceName": "DEXTROAMPHETAMINE SULFATE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2025-06-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230228",
      "SamplePackage": "N",
      "IndicationAndUsage": "Dextroamphetamine Sulfate Tablets, USP are indicated for: 1 Narcolepsy., 2 Attention Deficit Disorder with Hyperactivity, as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.",
      "Description": "Dextroamphetamine sulfate, USP is the dextro isomer of the compound d,l-amphetamine sulfate, a sympathomimetic amine of the amphetamine group. Chemically, dextroamphetamine is d-alpha-methylphenethylamine, and is present in all forms of dextroamphetamine sulfate, USP as the neutral sulfate. The structural formula is as follows. (C9H13N)2  H2SO4 Molecular Weight: 368.49. Inactive Ingredients. Each tablet, for oral administration, contains dextroamphetamine sulfate, USP, 5 mg or 10 mg. Each tablet also contains the following inactive ingredients: dibasic calcium phosphate dihydrate, compressible sugar, magnesium stearate, microcrystalline cellulose, and sodium glycolate starch. The 5 mg also contains D&C yellow no. 10 aluminum lake and FD&C red no. 40 aluminum lake. The 10 mg also contains FD&C red no. 40 aluminum lake and FD&C yellow no. 6 aluminum lake."
    },
    {
      "NDCCode": "41366-089-01",
      "PackageDescription": "45 mL in 1 BOTTLE (41366-089-01) ",
      "NDC11Code": "41366-0089-01",
      "ProductNDC": "41366-089",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cashmere Woods Hand Sanitizer",
      "NonProprietaryName": "Cashmere Woods Hand Sanitizer",
      "DosageFormName": "LIQUID",
      "RouteName": "EXTRACORPOREAL",
      "StartMarketingDate": "20250610",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M003",
      "LabelerName": "Zhejiang Meimi Technology Co., Ltd.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-10-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250610",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hand sanitizer to help reduce bacteria on the skin that may cause disease."
    },
    {
      "NDCCode": "42291-089-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE (42291-089-01) ",
      "NDC11Code": "42291-0089-01",
      "ProductNDC": "42291-089",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Acetazolamide",
      "NonProprietaryName": "Acetazolamide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170518",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA205530",
      "LabelerName": "AvKARE",
      "SubstanceName": "ACETAZOLAMIDE",
      "StrengthNumber": "125",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], Sulfonamides [CS]",
      "Status": "Active",
      "LastUpdate": "2026-02-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20170518",
      "SamplePackage": "N",
      "IndicationAndUsage": "For adjunctive treatment of: edema due to congestive heart failure; drug-induced edema; centrencephalic epilepsies (petit mal, unlocalized seizures); chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where delay of surgery is desired in order to lower intraocular pressure. Acetazolamide Tablets are also indicated for the prevention or amelioration of symptoms associated with acute mountain sickness in climbers attempting rapid ascent and in those who are very susceptible to acute mountain sickness despite gradual ascent.",
      "Description": "Acetazolamide, an inhibitor of the enzyme carbonic anhydrase is a white to faintly yellowish white crystalline, odorless powder, weakly acidic, very slightly soluble in water and slightly soluble in alcohol. The chemical name for acetazolamide is N-(5-Sulfamoyl-1,3,4-thiadiazol-2-yl)-acetamide and has the following chemical structure:. Molecular Weight: 222.25. Molecular Formula: C 4H 6N 4 O 3S 2. Acetazolamide tablets, USP are available for oral administration each containing 125 mg and 250 mg of acetazolamide respectively. Additionally, they contain the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium lauryl sulfate, and sodium starch glycolate."
    },
    {
      "NDCCode": "42806-089-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE (42806-089-01) ",
      "NDC11Code": "42806-0089-01",
      "ProductNDC": "42806-089",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Estradiol",
      "NonProprietaryName": "Estradiol",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170410",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040275",
      "LabelerName": "EPIC PHARMA, LLC",
      "SubstanceName": "ESTRADIOL",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-01-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20170410",
      "SamplePackage": "N",
      "IndicationAndUsage": "Estradiol tablets are indicated in the: 1 Treatment of moderate to severe vasomotor symptoms associated with the menopause., 2 Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered., 3 Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure., 4 Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease., 5 Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only)., 6 Prevention of osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate (See CLINICAL PHARMACOLOGY, Clinical Studies). .",
      "Description": "Estradiol tablets, USP for oral administration contains 0.5, 1 or 2 mg of micronized estradiol, USP per tablet. Estradiol, USP (17β-estradiol) is a white, crystalline solid, chemically described as estra-1,3,5,(10)-triene-3, 17β-diol. The structural formula is. In addition, each tablet for oral administration contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate."
    },
    {
      "NDCCode": "42931-089-01",
      "PackageDescription": "25 kg in 1 DRUM (42931-089-01) ",
      "NDC11Code": "42931-0089-01",
      "ProductNDC": "42931-089",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Oseltamivir Phosphate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20220221",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Shanghai Desano Chemical Pharmaceutical Co., Ltd.",
      "SubstanceName": "OSELTAMIVIR PHOSPHATE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2022-02-23",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "21-FEB-22"
    },
    {
      "NDCCode": "43473-089-01",
      "PackageDescription": ".9 mL in 1 PACKET (43473-089-01) ",
      "NDC11Code": "43473-0089-01",
      "ProductNDC": "43473-089",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Everlit Care Hand Sanitizer",
      "NonProprietaryName": "Ethyl Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20251025",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M005",
      "LabelerName": "Nantong Health & Beyond Hygienic Products Inc.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "62",
      "StrengthUnit": "mL/100mL",
      "Status": "Active",
      "LastUpdate": "2025-10-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20251025",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses. Kill germs and bacteria on skin to help reducing risk of infections."
    },
    {
      "NDCCode": "44717-089-02",
      "PackageDescription": "1 BOTTLE in 1 CARTON (44717-089-02)  / 5 g in 1 BOTTLE (44717-089-01) ",
      "NDC11Code": "44717-0089-02",
      "ProductNDC": "44717-089",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Perfecting Blendrops Broad Spectrum Spf 46",
      "NonProprietaryName": "Homosalate, Octisalate, Zinc Oxide",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240214",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Wasatch Product Development, LLC",
      "SubstanceName": "ZINC OXIDE; HOMOSALATE; OCTISALATE",
      "StrengthNumber": "12; 6; 5",
      "StrengthUnit": "g/100g; g/100g; g/100g",
      "Status": "Active",
      "LastUpdate": "2025-11-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240214",
      "SamplePackage": "N",
      "IndicationAndUsage": "Stop use and ask a doctor if rash occurs."
    },
    {
      "NDCCode": "45629-089-01",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 BAG (45629-089-01)  / 21 CAPSULE in 1 BOTTLE, PLASTIC",
      "NDC11Code": "45629-0089-01",
      "ProductNDC": "45629-089",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fotivda",
      "NonProprietaryName": "Tivozanib",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210310",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA212904",
      "LabelerName": "AVEO Pharmaceuticals, Inc.",
      "SubstanceName": "TIVOZANIB HYDROCHLORIDE",
      "StrengthNumber": ".89",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Kinase Inhibitor [EPC], Tyrosine Kinase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-10-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210310",
      "SamplePackage": "N",
      "IndicationAndUsage": "FOTIVDA is indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.",
      "Description": "Tivozanib is a kinase inhibitor. Tivozanib hydrochloride, the active ingredient, has the chemical name 1-{2-chloro-4-[(6,7-dimethoxyquinolin-4-yl)oxy]phenyl}-3-(5-methylisoxazol-3-yl)urea hydrochloride hydrate. The molecular formula is C 22H 19ClN 4O 5∙ HCl ∙ H 2O and the molecular weight is 509.34 Daltons. The chemical structure is:. Tivozanib hydrochloride is a white to light brown crystalline powder that is practically insoluble in water (0.09 mg/mL). FOTIVDA 1.34 mg capsule contains 1.5 mg of tivozanib hydrochloride (equivalent to 1.34 mg tivozanib) with inactive ingredients: mannitol and magnesium stearate. Capsule composition: gelatin, titanium dioxide, FDA yellow iron oxide, and Blue SB-6018 (ink). FOTIVDA 0.89 mg capsule contains 1.0 mg of tivozanib hydrochloride (equivalent to 0.89 mg tivozanib) with inactive ingredients: mannitol and magnesium stearate. Capsule composition: gelatin, titanium dioxide, FDA yellow iron oxide, FD&C Blue #2, Blue SB-6018 (ink) and Yellow SB-3017 (ink). The Yellow SB-3017 ink contains FD&C Yellow No.5 (tartrazine)."
    },
    {
      "NDCCode": "45802-089-02",
      "PackageDescription": "3 CONTAINER in 1 CARTON (45802-089-02)  / 27 LOZENGE in 1 CONTAINER (45802-089-01) ",
      "NDC11Code": "45802-0089-02",
      "ProductNDC": "45802-089",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Nicotine Polacrilex",
      "NonProprietaryName": "Nicotine Polacrilex",
      "DosageFormName": "LOZENGE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160708",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203690",
      "LabelerName": "Padagis Israel Pharmaceuticals Ltd",
      "SubstanceName": "NICOTINE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
      "Status": "Active",
      "LastUpdate": "2026-05-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20160708",
      "SamplePackage": "N",
      "IndicationAndUsage": "reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
    },
    {
      "NDCCode": "48433-089-08",
      "PackageDescription": "80 BLISTER PACK in 1 CARTON (48433-089-08)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (48433-089-01) ",
      "NDC11Code": "48433-0089-08",
      "ProductNDC": "48433-089",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Spironolactone",
      "NonProprietaryName": "Spironolactone",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260505",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040424",
      "LabelerName": "Safecor Health LLC",
      "SubstanceName": "SPIRONOLACTONE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-07-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260505",
      "SamplePackage": "N",
      "IndicationAndUsage": "Spironolactone tablets are an aldosterone antagonist indicated for: 1 The treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure ( 1.1). , 2 Use as an add-on therapy for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1.2). , 3 The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response ( 1.3). , 4 Treatment of primary hyperaldosteronism for: ( 1.4) Short-term preoperative treatmentLong-term maintenance for patients with discrete aldosterone-producing adrenal adenomas who are not candidates for surgery and patients with bilateral micro or macronodular adrenal hyperplasia.",
      "Description": "Spironolactone oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula. Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Inactive ingredients include calcium sulfate dihydrate, colloidal silicon dioxide, croscarmellose sodium, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, peppermint flavor, polydextrose, polyethethylene glycol, povidone, pregelatinized starch (corn), sodium lauryl sulfate, titanium dioxide and triacetin."
    },
    {
      "NDCCode": "50242-089-01",
      "PackageDescription": "120 L in 1 TANK (50242-089-01)",
      "NDC11Code": "50242-0089-01",
      "ProductNDC": "50242-089",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Ado-trastuzumab Emtansine",
      "DosageFormName": "LIQUID",
      "StartMarketingDate": "20130222",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Genentech, Inc. (SSF)",
      "SubstanceName": "ADO-TRASTUZUMAB EMTANSINE",
      "StrengthNumber": "20",
      "StrengthUnit": "g/L",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "51060-089-01",
      "PackageDescription": "1 BOTTLE in 1 CARTON (51060-089-01)  > 30 mL in 1 BOTTLE",
      "NDC11Code": "51060-0089-01",
      "ProductNDC": "51060-089",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Rainforest Of The Sea Water Foundation Broad Spectrum Spf 15 Sunscreen",
      "ProprietaryNameSuffix": "Light Neutral",
      "NonProprietaryName": "Titanium Dioxide And Zinc Oxide",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20150901",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Tarte, Inc",
      "SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": "62.3; 38.4",
      "StrengthUnit": "mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "51079-089-20",
      "PackageDescription": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-089-20)  > 1 TABLET in 1 BLISTER PACK (51079-089-01)",
      "NDC11Code": "51079-0089-20",
      "ProductNDC": "51079-089",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Meclizine Hydrochloride",
      "NonProprietaryName": "Meclizine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110513",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA087127",
      "LabelerName": "UDL Laboratories, Inc.",
      "SubstanceName": "MECLIZINE HYDROCHLORIDE",
      "StrengthNumber": "12.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antiemetic [EPC],Emesis Suppression [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2017-01-18"
    },
    {
      "NDCCode": "51346-089-01",
      "PackageDescription": "50 mL in 1 CARTON (51346-089-01)",
      "NDC11Code": "51346-0089-01",
      "ProductNDC": "51346-089",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Solie Essence",
      "NonProprietaryName": "Glycerin",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110601",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part347",
      "LabelerName": "NATURE REPUBLIC CO., LTD.",
      "SubstanceName": "GLYCERIN",
      "StrengthNumber": "10",
      "StrengthUnit": "g/50mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "51407-089-01",
      "PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (51407-089-01) ",
      "NDC11Code": "51407-0089-01",
      "ProductNDC": "51407-089",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Felodipine",
      "NonProprietaryName": "Felodipine",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190429",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204800",
      "LabelerName": "Golden State Medical Supply, Inc.",
      "SubstanceName": "FELODIPINE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
      "Status": "Active",
      "LastUpdate": "2025-04-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200313",
      "SamplePackage": "N",
      "IndicationAndUsage": "Felodipine extended-release tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including felodipine. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure or diabetic kidney disease). These considerations may guide selection of therapy. Felodipine extended-release tablets, USP may be administered with other antihypertensive agents.",
      "Description": "Felodipine is a calcium antagonist (calcium channel blocker). Felodipine is a dihydropyridine derivative that is chemically described as ± ethyl methyl 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylate. Its molecular formula is C 18H 19Cl 2NO 4and its structural formula is:. Felodipine, USP is a light yellow to yellow crystalline powder with a molecular weight of 384.26. It is insoluble in water and is freely soluble in acetone and in methanol; very slightly soluble in heptane. Felodipine is a racemic mixture. Felodipine extended-release tablets, USP provide extended release of felodipine. They are available as tablets containing 2.5 mg, 5 mg or 10 mg of felodipine, USP for oral administration. Inactive ingredients are: lactose monohydrate, hydroxypropyl cellulose, silicon dioxide colloidal, hypromellose, magnesium stearate, calcium phosphate dibasic, butylated hydroxyanisole, polyethylene glycol, titanuium dioxide. In addition, the 5 mg and the 10 mg tablet strength contain FD&C Red No. 40 powder, FD&C Yellow No. 6 Aluminum Lake. Meets USP Dissolution Test 3."
    },
    {
      "NDCCode": "51621-089-01",
      "PackageDescription": "45 mL in 1 TUBE (51621-089-01) ",
      "NDC11Code": "51621-0089-01",
      "ProductNDC": "51621-089",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Derma Dr. Lab Hydromoist Cover Bb",
      "NonProprietaryName": "Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20180102",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part347",
      "LabelerName": "GOWOONSESANG COSMETICS CO., LTD.",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": ".9",
      "StrengthUnit": "g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2018-03-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20180102",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "52584-089-01",
      "PackageDescription": "1 VIAL, MULTI-DOSE in 1 BAG (52584-089-01)  > 10 mL in 1 VIAL, MULTI-DOSE",
      "NDC11Code": "52584-0089-01",
      "ProductNDC": "52584-089",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Flumazenil",
      "NonProprietaryName": "Flumazenil",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20190524",
      "EndMarketingDate": "20240131",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076755",
      "LabelerName": "General Injectables and Vaccines, Inc.",
      "SubstanceName": "FLUMAZENIL",
      "StrengthNumber": ".1",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Benzodiazepine Antagonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-02-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20190524",
      "EndMarketingDatePackage": "20240131",
      "SamplePackage": "N",
      "IndicationAndUsage": "Adult Patients:Flumazenil injection is indicated for the complete or partial reversal of the sedative effects of benzodiazepines in cases where general anesthesia has been induced and/or maintained with benzodiazepines, where sedation has been produced with benzodiazepines for diagnostic and therapeutic procedures, and for the management of benzodiazepine overdose. Pediatric Patients (aged 1 to 17):Flumazenil injection is indicated for the reversal of conscious sedation induced with benzodiazepines (see PRECAUTIONS: PEDIATRIC USE).",
      "Description": "Flumazenil Injection, USP is a benzodiazepine receptor antagonist. Chemically, flumazenil is ethyl 8-fluoro-5,6-dihydro-5-methyl-6-oxo-4H-imidazo [1,5-a](1,4) benzodiazepine-3-carboxylate. Flumazenil has an imidazobenzodiazepine structure a calculated molecular weight of 303.3 and the following structural formula. Flumazenil is a white to off-white crystalline compound with an octanol:buffer partition coefficient of 14 to 1 at pH 7.4. It is insoluble in water but slightly soluble in acidic aqueous solutions. Flumazenil is available as a sterile parenteral dosage form for intravenous administration. Each mL contains 0.1 mg of Flumazenil compounded with 1.8 mg of Methylparaben , 0.2 mg of Propylparaben , 0.9% mg Sodium Chloride , 0.01% Edetate Disodium Dihydrate , and 0.1 mg Glacial Acetic Acid ; the pH is adjusted to 3.4 to 4.6 with Hydrochloric Acid and/or, if necessary, Sodium Hydroxide and Water for Injection q.s. to 1 mL."
    },
    {
      "NDCCode": "53329-089-01",
      "PackageDescription": "1 TUBE in 1 BOX (53329-089-01)  / 28.4 g in 1 TUBE",
      "NDC11Code": "53329-0089-01",
      "ProductNDC": "53329-089",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "First Aid Antibiotic",
      "NonProprietaryName": "Bacitracin Zinc",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20100301",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M004",
      "LabelerName": "Medline Industries, LP",
      "SubstanceName": "BACITRACIN ZINC",
      "StrengthNumber": "500",
      "StrengthUnit": "[USP'U]/g",
      "Pharm_Classes": "Decreased Cell Wall Synthesis & Repair [PE]",
      "Status": "Active",
      "LastUpdate": "2025-10-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20100301",
      "SamplePackage": "N",
      "IndicationAndUsage": "First aid to help prevent infection in: 1 minor cuts, 2 scrapes, 3 burns."
    },
    {
      "NDCCode": "54860-089-01",
      "PackageDescription": "30 mL in 1 BOTTLE (54860-089-01) ",
      "NDC11Code": "54860-0089-01",
      "ProductNDC": "54860-089",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Vanilla Hand Sanitizer",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20180130",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "Shenzhen Lantern Science Co., Ltd.",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": ".1",
      "StrengthUnit": "g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20180130",
      "SamplePackage": "N",
      "IndicationAndUsage": "To decrease bacteria on hands."
    },
    {
      "NDCCode": "55319-089-01",
      "PackageDescription": "1000 mL in 1 BOTTLE, PLASTIC (55319-089-01) ",
      "NDC11Code": "55319-0089-01",
      "ProductNDC": "55319-089",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Antiseptic",
      "NonProprietaryName": "Eucalyptol, Menthol, Methyl Salicylate, Thymol",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250701",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M022",
      "LabelerName": "Family Dollar (FAMILY WELLNESS)",
      "SubstanceName": "EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL",
      "StrengthNumber": ".92; .42; .6; .64",
      "StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
      "Status": "Active",
      "LastUpdate": "2026-04-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250701",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps prevent and reduce: 1 plaque, 2 gingivitis."
    },
    {
      "NDCCode": "56136-089-01",
      "PackageDescription": "236 mL in 1 BOTTLE (56136-089-01) ",
      "NDC11Code": "56136-0089-01",
      "ProductNDC": "56136-089",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Follow The Rainbow Antibacterial Hand Sanitizer Watermelon Ice Pop Scented",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200730",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "Ganzhou Olivee Cosmetic Co., Ltd.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "65",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20200730",
      "SamplePackage": "N",
      "IndicationAndUsage": "Decrease bacteria on hands."
    },
    {
      "NDCCode": "57237-089-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE (57237-089-01) ",
      "NDC11Code": "57237-0089-01",
      "ProductNDC": "57237-089",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Trandolapril",
      "NonProprietaryName": "Trandolapril",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20070612",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078438",
      "LabelerName": "Rising Pharma Holdings, Inc.",
      "SubstanceName": "TRANDOLAPRIL",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-04-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20070612",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hypertension. Trandolapril tablets USP are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive medication such as hydrochlorothiazide. Heart Failure Post Myocardial Infarction or Left-Ventricular Dysfunction Post Myocardial Infarction. Trandolapril tablets USP are indicated in stable patients who have evidence of left-ventricular systolic dysfunction (identified by wall motion abnormalities) or who are symptomatic from congestive heart failure within the first few days after sustaining acute myocardial infarction. Administration of trandolapril to Caucasian patients has been shown to decrease the risk of death (principally cardiovascular death) and to decrease the risk of heart failure-related hospitalization (see CLINICAL PHARMACOLOGY-Heart Failure or Left-Ventricular Dysfunction Post Myocardial Infarction for details of the survival trial).",
      "Description": "Trandolapril is the ethyl ester prodrug of a nonsulfhydryl angiotensin converting enzyme (ACE) inhibitor, trandolaprilat. Trandolapril is chemically described as (2S,3aR,7aS)-1-[(S)-N-[(S)-1-Carboxy-3-phenylpropyl]alanyl] hexahydro-2-indolinecarboxylic acid, 1-ethyl ester. Its molecular formula is C24H34N2O5 and its structural formula is. M.W. = 430.54Melting Point = 125°CTrandolapril USP is a white or almost white powder that is soluble (>100 mg/mL) in chloroform, dichloromethane, and methanol. Trandolapril tablets USP contain 1 mg, 2 mg, or 4 mg of trandolapril USP for oral administration. Each tablet also contains lactose monohydrate, corn starch, croscarmellose sodium, hypromellose, povidone, and sodium stearyl fumarate. In addition 1 mg and 4 mg tablet also contains ferric oxide red and 2 mg tablet contains ferric oxide yellow."
    }
  ]
}
                    
{"NDC":[{"NDCCode":"49967-089-01","ProprietaryName":"Vichy Laboratoire","NonProprietaryName":"Avobenzone Homosalate Octisalate Octocrylene Oxybenzone"},{"NDCCode":"11489-089-01","ProprietaryName":"Botanics Hydrating Day All Bright Sunscreen Broad Spectrum Spf 15","NonProprietaryName":"Avobenzone, Octisalate, Octocrylene"},{"NDCCode":"13107-089-01","ProprietaryName":"Methadone Hydrochloride","NonProprietaryName":"Methadone Hydrochloride"},{"NDCCode":"14141-089-02","ProprietaryName":"Lbel Libertage Cc Matte Perfectioning-effect Moisturizing Face Spf 30","NonProprietaryName":"Octinoxate And Zinc Oxide"},{"NDCCode":"14783-089-02","ProprietaryName":"Lbel Concentre Total Base Serum Ultra-fluid Foundation Spf 25","NonProprietaryName":"Octinoxate And Zinc Oxide"},{"NDCCode":"16714-089-01","ProprietaryName":"Methylprednisolone Acetate","NonProprietaryName":"Methylprednisolone Acetate"},{"NDCCode":"20151-089-02","ProprietaryName":"Vitalizing Energizing Moisturizing Cream","NonProprietaryName":"Glycerin, Dimethicone"},{"NDCCode":"21130-089-01","ProprietaryName":"Signature Care Allergy Relief","NonProprietaryName":"Fluticasone Propionate"},{"NDCCode":"27808-089-01","ProprietaryName":"Dextroamphetamine Sulfate","NonProprietaryName":"Dextroamphetamine Sulfate"},{"NDCCode":"41366-089-01","ProprietaryName":"Cashmere Woods Hand Sanitizer","NonProprietaryName":"Cashmere Woods Hand Sanitizer"},{"NDCCode":"42291-089-01","ProprietaryName":"Acetazolamide","NonProprietaryName":"Acetazolamide"},{"NDCCode":"42806-089-01","ProprietaryName":"Estradiol","NonProprietaryName":"Estradiol"},{"NDCCode":"42931-089-01","NonProprietaryName":"Oseltamivir Phosphate"},{"NDCCode":"43473-089-01","ProprietaryName":"Everlit Care Hand Sanitizer","NonProprietaryName":"Ethyl Alcohol"},{"NDCCode":"44717-089-02","ProprietaryName":"Perfecting Blendrops Broad Spectrum Spf 46","NonProprietaryName":"Homosalate, Octisalate, Zinc Oxide"},{"NDCCode":"45629-089-01","ProprietaryName":"Fotivda","NonProprietaryName":"Tivozanib"},{"NDCCode":"45802-089-02","ProprietaryName":"Nicotine Polacrilex","NonProprietaryName":"Nicotine Polacrilex"},{"NDCCode":"48433-089-08","ProprietaryName":"Spironolactone","NonProprietaryName":"Spironolactone"},{"NDCCode":"50242-089-01","NonProprietaryName":"Ado-trastuzumab Emtansine"},{"NDCCode":"51060-089-01","ProprietaryName":"Rainforest Of The Sea Water Foundation Broad Spectrum Spf 15 Sunscreen","NonProprietaryName":"Titanium Dioxide And Zinc Oxide"},{"NDCCode":"51079-089-20","ProprietaryName":"Meclizine Hydrochloride","NonProprietaryName":"Meclizine Hydrochloride"},{"NDCCode":"51346-089-01","ProprietaryName":"Solie Essence","NonProprietaryName":"Glycerin"},{"NDCCode":"51407-089-01","ProprietaryName":"Felodipine","NonProprietaryName":"Felodipine"},{"NDCCode":"51621-089-01","ProprietaryName":"Derma Dr. Lab Hydromoist Cover Bb","NonProprietaryName":"Zinc Oxide"},{"NDCCode":"52584-089-01","ProprietaryName":"Flumazenil","NonProprietaryName":"Flumazenil"},{"NDCCode":"53329-089-01","ProprietaryName":"First Aid Antibiotic","NonProprietaryName":"Bacitracin Zinc"},{"NDCCode":"54860-089-01","ProprietaryName":"Vanilla Hand Sanitizer","NonProprietaryName":"Benzalkonium Chloride"},{"NDCCode":"55319-089-01","ProprietaryName":"Antiseptic","NonProprietaryName":"Eucalyptol, Menthol, Methyl Salicylate, Thymol"},{"NDCCode":"56136-089-01","ProprietaryName":"Follow The Rainbow Antibacterial Hand Sanitizer Watermelon Ice Pop Scented","NonProprietaryName":"Alcohol"},{"NDCCode":"57237-089-01","ProprietaryName":"Trandolapril","NonProprietaryName":"Trandolapril"}]}
                    
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    <NDCCode>49967-089-01</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (49967-089-01)  &gt; 150 mL in 1 TUBE</PackageDescription>
    <NDC11Code>49967-0089-01</NDC11Code>
    <ProductNDC>49967-089</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Vichy Laboratoire</ProprietaryName>
    <ProprietaryNameSuffix>Capital Soleil Spf 30 Soft Sheer Sunscreen</ProprietaryNameSuffix>
    <NonProprietaryName>Avobenzone Homosalate Octisalate Octocrylene Oxybenzone</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110421</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>L'Oreal USA Products Inc</LabelerName>
    <SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
    <StrengthNumber>4.5; 7.5; 7.5; 10.5; 9</StrengthNumber>
    <StrengthUnit>mL/150mL; mL/150mL; mL/150mL; mL/150mL; mL/150mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-18</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>11489-089-01</NDCCode>
    <PackageDescription>1 JAR in 1 CARTON (11489-089-01)  &gt; 50 g in 1 JAR</PackageDescription>
    <NDC11Code>11489-0089-01</NDC11Code>
    <ProductNDC>11489-089</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Botanics Hydrating Day All Bright Sunscreen Broad Spectrum Spf 15</ProprietaryName>
    <NonProprietaryName>Avobenzone, Octisalate, Octocrylene</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20141013</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>BCM Ltd</LabelerName>
    <SubstanceName>AVOBENZONE; OCTISALATE; OCTOCRYLENE</SubstanceName>
    <StrengthNumber>1.5; 1.5; 2.5</StrengthNumber>
    <StrengthUnit>g/50g; g/50g; g/50g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Directions for sunscreen use. apply liberally 15 minutes before sun exposure. reapply at least every 2 hours. use a water resistant sunscreen if swimming or sweating. children under 6 months of age: Ask a doctor. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including. limit time in the sun, especially from 10 a.m. – 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>13107-089-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (13107-089-01) </PackageDescription>
    <NDC11Code>13107-0089-01</NDC11Code>
    <ProductNDC>13107-089</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methadone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Methadone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150915</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203502</ApplicationNumber>
    <LabelerName>Aurolife Pharma, LLC</LabelerName>
    <SubstanceName>METHADONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-12-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Methadone Hydrochloride Tablets are indicated forthe:  1.      Management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.  2.Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse overdose, and death, which can occur at any dosage or duration  and persist over the course of therapy[See Warnings and Precautions (5.1)], reserve opioid analgesics, including Methadone Hydrochloride Tablets, for use in patients for whom alternative analgesic treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Methadone Hydrochloride Tablets is not indicated asanas-needed(prn)analgesic. (1).</IndicationAndUsage>
    <Description>Methadone Hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-hepatanone hydrochloride. Methadone Hydrochloride USP is a white powder. Its molecular formula is C21H27 NO HCl and it has a molecular weight of 345.91. Methadone Hydrochloride has a melting point of 235°C, and a pKa of 8.25 in water at 20°C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5. It has the following structural formula. Methadone Hydrochloride Tablets are available for oral administration containing either 5 mg or 10 mg of Methadone Hydrochloride USP. Each tablet contains the following inactive ingredients: Colloidal silicon dioxide, Lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch.</Description>
  </NDC>
  <NDC>
    <NDCCode>14141-089-02</NDCCode>
    <PackageDescription>1 TUBE in 1 BOX (14141-089-02)  &gt; 35 g in 1 TUBE (14141-089-01) </PackageDescription>
    <NDC11Code>14141-0089-02</NDC11Code>
    <ProductNDC>14141-089</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lbel Libertage Cc Matte Perfectioning-effect Moisturizing Face Spf 30</ProprietaryName>
    <NonProprietaryName>Octinoxate And Zinc Oxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20180808</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Bel Star S.A. (Colombia)</LabelerName>
    <SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>.07; .06</StrengthNumber>
    <StrengthUnit>g/g; g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-12-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180808</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>14783-089-02</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (14783-089-02)  &gt; 27 mL in 1 BOTTLE, PLASTIC (14783-089-01) </PackageDescription>
    <NDC11Code>14783-0089-02</NDC11Code>
    <ProductNDC>14783-089</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lbel Concentre Total Base Serum Ultra-fluid Foundation Spf 25</ProprietaryName>
    <ProprietaryNameSuffix>Medium 7 - Beige</ProprietaryNameSuffix>
    <NonProprietaryName>Octinoxate And Zinc Oxide</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20170127</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Ventura International LTD</LabelerName>
    <SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>.07; .072</StrengthNumber>
    <StrengthUnit>g/mL; g/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170127</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>16714-089-01</NDCCode>
    <PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (16714-089-01)  &gt; 5 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
    <NDC11Code>16714-0089-01</NDC11Code>
    <ProductNDC>16714-089</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methylprednisolone Acetate</ProprietaryName>
    <NonProprietaryName>Methylprednisolone Acetate</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE</RouteName>
    <StartMarketingDate>20210525</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040620</ApplicationNumber>
    <LabelerName>Northstar RxLLC</LabelerName>
    <SubstanceName>METHYLPREDNISOLONE ACETATE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-05-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210525</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>20151-089-02</NDCCode>
    <PackageDescription>1 BOTTLE, DISPENSING in 1 BOTTLE, DISPENSING (20151-089-02)  &gt; 50 mL in 1 BOTTLE, DISPENSING (20151-089-01)</PackageDescription>
    <NDC11Code>20151-0089-02</NDC11Code>
    <ProductNDC>20151-089</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Vitalizing Energizing Moisturizing Cream</ProprietaryName>
    <NonProprietaryName>Glycerin, Dimethicone</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20170223</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part347</ApplicationNumber>
    <LabelerName>Casmara Cosmetics, SA</LabelerName>
    <SubstanceName>GLYCERIN; DIMETHICONE</SubstanceName>
    <StrengthNumber>3; .4</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>provides an intensive dose of hydration and energy.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>21130-089-01</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (21130-089-01)  &gt; 120 SPRAY, METERED in 1 BOTTLE</PackageDescription>
    <NDC11Code>21130-0089-01</NDC11Code>
    <ProductNDC>21130-089</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Signature Care Allergy Relief</ProprietaryName>
    <NonProprietaryName>Fluticasone Propionate</NonProprietaryName>
    <DosageFormName>SPRAY, METERED</DosageFormName>
    <RouteName>NASAL</RouteName>
    <StartMarketingDate>20160531</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207957</ApplicationNumber>
    <LabelerName>Safeway</LabelerName>
    <SubstanceName>FLUTICASONE PROPIONATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>ug/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160531</StartMarketingDatePackage>
    <EndMarketingDatePackage>20230101</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: 1 nasal congestion, 2 runny nose, 3 sneezing, 4 itchy nose , 5 itchy, watery eyes.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>27808-089-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (27808-089-01) </PackageDescription>
    <NDC11Code>27808-0089-01</NDC11Code>
    <ProductNDC>27808-089</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dextroamphetamine Sulfate</ProprietaryName>
    <NonProprietaryName>Dextroamphetamine Sulfate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220820</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206095</ApplicationNumber>
    <LabelerName>Cranbury Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>DEXTROAMPHETAMINE SULFATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-06-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230228</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dextroamphetamine Sulfate Tablets, USP are indicated for: 1 Narcolepsy., 2 Attention Deficit Disorder with Hyperactivity, as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.</IndicationAndUsage>
    <Description>Dextroamphetamine sulfate, USP is the dextro isomer of the compound d,l-amphetamine sulfate, a sympathomimetic amine of the amphetamine group. Chemically, dextroamphetamine is d-alpha-methylphenethylamine, and is present in all forms of dextroamphetamine sulfate, USP as the neutral sulfate. The structural formula is as follows. (C9H13N)2  H2SO4 Molecular Weight: 368.49. Inactive Ingredients. Each tablet, for oral administration, contains dextroamphetamine sulfate, USP, 5 mg or 10 mg. Each tablet also contains the following inactive ingredients: dibasic calcium phosphate dihydrate, compressible sugar, magnesium stearate, microcrystalline cellulose, and sodium glycolate starch. The 5 mg also contains D&amp;C yellow no. 10 aluminum lake and FD&amp;C red no. 40 aluminum lake. The 10 mg also contains FD&amp;C red no. 40 aluminum lake and FD&amp;C yellow no. 6 aluminum lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>41366-089-01</NDCCode>
    <PackageDescription>45 mL in 1 BOTTLE (41366-089-01) </PackageDescription>
    <NDC11Code>41366-0089-01</NDC11Code>
    <ProductNDC>41366-089</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cashmere Woods Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Cashmere Woods Hand Sanitizer</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>EXTRACORPOREAL</RouteName>
    <StartMarketingDate>20250610</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M003</ApplicationNumber>
    <LabelerName>Zhejiang Meimi Technology Co., Ltd.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-10-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250610</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hand sanitizer to help reduce bacteria on the skin that may cause disease.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>42291-089-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (42291-089-01) </PackageDescription>
    <NDC11Code>42291-0089-01</NDC11Code>
    <ProductNDC>42291-089</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Acetazolamide</ProprietaryName>
    <NonProprietaryName>Acetazolamide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170518</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205530</ApplicationNumber>
    <LabelerName>AvKARE</LabelerName>
    <SubstanceName>ACETAZOLAMIDE</SubstanceName>
    <StrengthNumber>125</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], Sulfonamides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170518</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For adjunctive treatment of: edema due to congestive heart failure; drug-induced edema; centrencephalic epilepsies (petit mal, unlocalized seizures); chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where delay of surgery is desired in order to lower intraocular pressure. Acetazolamide Tablets are also indicated for the prevention or amelioration of symptoms associated with acute mountain sickness in climbers attempting rapid ascent and in those who are very susceptible to acute mountain sickness despite gradual ascent.</IndicationAndUsage>
    <Description>Acetazolamide, an inhibitor of the enzyme carbonic anhydrase is a white to faintly yellowish white crystalline, odorless powder, weakly acidic, very slightly soluble in water and slightly soluble in alcohol. The chemical name for acetazolamide is N-(5-Sulfamoyl-1,3,4-thiadiazol-2-yl)-acetamide and has the following chemical structure:. Molecular Weight: 222.25. Molecular Formula: C 4H 6N 4 O 3S 2. Acetazolamide tablets, USP are available for oral administration each containing 125 mg and 250 mg of acetazolamide respectively. Additionally, they contain the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium lauryl sulfate, and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>42806-089-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (42806-089-01) </PackageDescription>
    <NDC11Code>42806-0089-01</NDC11Code>
    <ProductNDC>42806-089</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Estradiol</ProprietaryName>
    <NonProprietaryName>Estradiol</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170410</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040275</ApplicationNumber>
    <LabelerName>EPIC PHARMA, LLC</LabelerName>
    <SubstanceName>ESTRADIOL</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-01-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170410</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Estradiol tablets are indicated in the: 1 Treatment of moderate to severe vasomotor symptoms associated with the menopause., 2 Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered., 3 Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure., 4 Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease., 5 Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only)., 6 Prevention of osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate (See CLINICAL PHARMACOLOGY, Clinical Studies). .</IndicationAndUsage>
    <Description>Estradiol tablets, USP for oral administration contains 0.5, 1 or 2 mg of micronized estradiol, USP per tablet. Estradiol, USP (17β-estradiol) is a white, crystalline solid, chemically described as estra-1,3,5,(10)-triene-3, 17β-diol. The structural formula is. In addition, each tablet for oral administration contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>42931-089-01</NDCCode>
    <PackageDescription>25 kg in 1 DRUM (42931-089-01) </PackageDescription>
    <NDC11Code>42931-0089-01</NDC11Code>
    <ProductNDC>42931-089</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Oseltamivir Phosphate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20220221</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Shanghai Desano Chemical Pharmaceutical Co., Ltd.</LabelerName>
    <SubstanceName>OSELTAMIVIR PHOSPHATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2022-02-23</LastUpdate>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>21-FEB-22</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>43473-089-01</NDCCode>
    <PackageDescription>.9 mL in 1 PACKET (43473-089-01) </PackageDescription>
    <NDC11Code>43473-0089-01</NDC11Code>
    <ProductNDC>43473-089</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Everlit Care Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20251025</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M005</ApplicationNumber>
    <LabelerName>Nantong Health &amp; Beyond Hygienic Products Inc.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>62</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-10-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251025</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses. Kill germs and bacteria on skin to help reducing risk of infections.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>44717-089-02</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (44717-089-02)  / 5 g in 1 BOTTLE (44717-089-01) </PackageDescription>
    <NDC11Code>44717-0089-02</NDC11Code>
    <ProductNDC>44717-089</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Perfecting Blendrops Broad Spectrum Spf 46</ProprietaryName>
    <NonProprietaryName>Homosalate, Octisalate, Zinc Oxide</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240214</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Wasatch Product Development, LLC</LabelerName>
    <SubstanceName>ZINC OXIDE; HOMOSALATE; OCTISALATE</SubstanceName>
    <StrengthNumber>12; 6; 5</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-11-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240214</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Stop use and ask a doctor if rash occurs.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>45629-089-01</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 BAG (45629-089-01)  / 21 CAPSULE in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>45629-0089-01</NDC11Code>
    <ProductNDC>45629-089</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fotivda</ProprietaryName>
    <NonProprietaryName>Tivozanib</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210310</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA212904</ApplicationNumber>
    <LabelerName>AVEO Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>TIVOZANIB HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>.89</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Kinase Inhibitor [EPC], Tyrosine Kinase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210310</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>FOTIVDA is indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.</IndicationAndUsage>
    <Description>Tivozanib is a kinase inhibitor. Tivozanib hydrochloride, the active ingredient, has the chemical name 1-{2-chloro-4-[(6,7-dimethoxyquinolin-4-yl)oxy]phenyl}-3-(5-methylisoxazol-3-yl)urea hydrochloride hydrate. The molecular formula is C 22H 19ClN 4O 5∙ HCl ∙ H 2O and the molecular weight is 509.34 Daltons. The chemical structure is:. Tivozanib hydrochloride is a white to light brown crystalline powder that is practically insoluble in water (0.09 mg/mL). FOTIVDA 1.34 mg capsule contains 1.5 mg of tivozanib hydrochloride (equivalent to 1.34 mg tivozanib) with inactive ingredients: mannitol and magnesium stearate. Capsule composition: gelatin, titanium dioxide, FDA yellow iron oxide, and Blue SB-6018 (ink). FOTIVDA 0.89 mg capsule contains 1.0 mg of tivozanib hydrochloride (equivalent to 0.89 mg tivozanib) with inactive ingredients: mannitol and magnesium stearate. Capsule composition: gelatin, titanium dioxide, FDA yellow iron oxide, FD&amp;C Blue #2, Blue SB-6018 (ink) and Yellow SB-3017 (ink). The Yellow SB-3017 ink contains FD&amp;C Yellow No.5 (tartrazine).</Description>
  </NDC>
  <NDC>
    <NDCCode>45802-089-02</NDCCode>
    <PackageDescription>3 CONTAINER in 1 CARTON (45802-089-02)  / 27 LOZENGE in 1 CONTAINER (45802-089-01) </PackageDescription>
    <NDC11Code>45802-0089-02</NDC11Code>
    <ProductNDC>45802-089</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Nicotine Polacrilex</ProprietaryName>
    <NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
    <DosageFormName>LOZENGE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160708</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203690</ApplicationNumber>
    <LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
    <SubstanceName>NICOTINE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160708</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>48433-089-08</NDCCode>
    <PackageDescription>80 BLISTER PACK in 1 CARTON (48433-089-08)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (48433-089-01) </PackageDescription>
    <NDC11Code>48433-0089-08</NDC11Code>
    <ProductNDC>48433-089</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Spironolactone</ProprietaryName>
    <NonProprietaryName>Spironolactone</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260505</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040424</ApplicationNumber>
    <LabelerName>Safecor Health LLC</LabelerName>
    <SubstanceName>SPIRONOLACTONE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260505</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Spironolactone tablets are an aldosterone antagonist indicated for: 1 The treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure ( 1.1). , 2 Use as an add-on therapy for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1.2). , 3 The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response ( 1.3). , 4 Treatment of primary hyperaldosteronism for: ( 1.4) Short-term preoperative treatmentLong-term maintenance for patients with discrete aldosterone-producing adrenal adenomas who are not candidates for surgery and patients with bilateral micro or macronodular adrenal hyperplasia.</IndicationAndUsage>
    <Description>Spironolactone oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula. Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Inactive ingredients include calcium sulfate dihydrate, colloidal silicon dioxide, croscarmellose sodium, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, peppermint flavor, polydextrose, polyethethylene glycol, povidone, pregelatinized starch (corn), sodium lauryl sulfate, titanium dioxide and triacetin.</Description>
  </NDC>
  <NDC>
    <NDCCode>50242-089-01</NDCCode>
    <PackageDescription>120 L in 1 TANK (50242-089-01)</PackageDescription>
    <NDC11Code>50242-0089-01</NDC11Code>
    <ProductNDC>50242-089</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Ado-trastuzumab Emtansine</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <StartMarketingDate>20130222</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Genentech, Inc. (SSF)</LabelerName>
    <SubstanceName>ADO-TRASTUZUMAB EMTANSINE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>g/L</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>51060-089-01</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (51060-089-01)  &gt; 30 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>51060-0089-01</NDC11Code>
    <ProductNDC>51060-089</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Rainforest Of The Sea Water Foundation Broad Spectrum Spf 15 Sunscreen</ProprietaryName>
    <ProprietaryNameSuffix>Light Neutral</ProprietaryNameSuffix>
    <NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20150901</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Tarte, Inc</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>62.3; 38.4</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>51079-089-20</NDCCode>
    <PackageDescription>100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-089-20)  &gt; 1 TABLET in 1 BLISTER PACK (51079-089-01)</PackageDescription>
    <NDC11Code>51079-0089-20</NDC11Code>
    <ProductNDC>51079-089</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Meclizine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Meclizine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110513</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA087127</ApplicationNumber>
    <LabelerName>UDL Laboratories, Inc.</LabelerName>
    <SubstanceName>MECLIZINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>12.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antiemetic [EPC],Emesis Suppression [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-01-18</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>51346-089-01</NDCCode>
    <PackageDescription>50 mL in 1 CARTON (51346-089-01)</PackageDescription>
    <NDC11Code>51346-0089-01</NDC11Code>
    <ProductNDC>51346-089</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Solie Essence</ProprietaryName>
    <NonProprietaryName>Glycerin</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110601</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part347</ApplicationNumber>
    <LabelerName>NATURE REPUBLIC CO., LTD.</LabelerName>
    <SubstanceName>GLYCERIN</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>g/50mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>51407-089-01</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (51407-089-01) </PackageDescription>
    <NDC11Code>51407-0089-01</NDC11Code>
    <ProductNDC>51407-089</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Felodipine</ProprietaryName>
    <NonProprietaryName>Felodipine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190429</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204800</ApplicationNumber>
    <LabelerName>Golden State Medical Supply, Inc.</LabelerName>
    <SubstanceName>FELODIPINE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200313</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Felodipine extended-release tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including felodipine. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure or diabetic kidney disease). These considerations may guide selection of therapy. Felodipine extended-release tablets, USP may be administered with other antihypertensive agents.</IndicationAndUsage>
    <Description>Felodipine is a calcium antagonist (calcium channel blocker). Felodipine is a dihydropyridine derivative that is chemically described as ± ethyl methyl 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylate. Its molecular formula is C 18H 19Cl 2NO 4and its structural formula is:. Felodipine, USP is a light yellow to yellow crystalline powder with a molecular weight of 384.26. It is insoluble in water and is freely soluble in acetone and in methanol; very slightly soluble in heptane. Felodipine is a racemic mixture. Felodipine extended-release tablets, USP provide extended release of felodipine. They are available as tablets containing 2.5 mg, 5 mg or 10 mg of felodipine, USP for oral administration. Inactive ingredients are: lactose monohydrate, hydroxypropyl cellulose, silicon dioxide colloidal, hypromellose, magnesium stearate, calcium phosphate dibasic, butylated hydroxyanisole, polyethylene glycol, titanuium dioxide. In addition, the 5 mg and the 10 mg tablet strength contain FD&amp;C Red No. 40 powder, FD&amp;C Yellow No. 6 Aluminum Lake. Meets USP Dissolution Test 3.</Description>
  </NDC>
  <NDC>
    <NDCCode>51621-089-01</NDCCode>
    <PackageDescription>45 mL in 1 TUBE (51621-089-01) </PackageDescription>
    <NDC11Code>51621-0089-01</NDC11Code>
    <ProductNDC>51621-089</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Derma Dr. Lab Hydromoist Cover Bb</ProprietaryName>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20180102</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part347</ApplicationNumber>
    <LabelerName>GOWOONSESANG COSMETICS CO., LTD.</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>.9</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-03-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180102</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>52584-089-01</NDCCode>
    <PackageDescription>1 VIAL, MULTI-DOSE in 1 BAG (52584-089-01)  &gt; 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
    <NDC11Code>52584-0089-01</NDC11Code>
    <ProductNDC>52584-089</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Flumazenil</ProprietaryName>
    <NonProprietaryName>Flumazenil</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20190524</StartMarketingDate>
    <EndMarketingDate>20240131</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076755</ApplicationNumber>
    <LabelerName>General Injectables and Vaccines, Inc.</LabelerName>
    <SubstanceName>FLUMAZENIL</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Benzodiazepine Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-02-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20190524</StartMarketingDatePackage>
    <EndMarketingDatePackage>20240131</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Adult Patients:Flumazenil injection is indicated for the complete or partial reversal of the sedative effects of benzodiazepines in cases where general anesthesia has been induced and/or maintained with benzodiazepines, where sedation has been produced with benzodiazepines for diagnostic and therapeutic procedures, and for the management of benzodiazepine overdose. Pediatric Patients (aged 1 to 17):Flumazenil injection is indicated for the reversal of conscious sedation induced with benzodiazepines (see PRECAUTIONS: PEDIATRIC USE).</IndicationAndUsage>
    <Description>Flumazenil Injection, USP is a benzodiazepine receptor antagonist. Chemically, flumazenil is ethyl 8-fluoro-5,6-dihydro-5-methyl-6-oxo-4H-imidazo [1,5-a](1,4) benzodiazepine-3-carboxylate. Flumazenil has an imidazobenzodiazepine structure a calculated molecular weight of 303.3 and the following structural formula. Flumazenil is a white to off-white crystalline compound with an octanol:buffer partition coefficient of 14 to 1 at pH 7.4. It is insoluble in water but slightly soluble in acidic aqueous solutions. Flumazenil is available as a sterile parenteral dosage form for intravenous administration. Each mL contains 0.1 mg of Flumazenil compounded with 1.8 mg of Methylparaben , 0.2 mg of Propylparaben , 0.9% mg Sodium Chloride , 0.01% Edetate Disodium Dihydrate , and 0.1 mg Glacial Acetic Acid ; the pH is adjusted to 3.4 to 4.6 with Hydrochloric Acid and/or, if necessary, Sodium Hydroxide and Water for Injection q.s. to 1 mL.</Description>
  </NDC>
  <NDC>
    <NDCCode>53329-089-01</NDCCode>
    <PackageDescription>1 TUBE in 1 BOX (53329-089-01)  / 28.4 g in 1 TUBE</PackageDescription>
    <NDC11Code>53329-0089-01</NDC11Code>
    <ProductNDC>53329-089</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>First Aid Antibiotic</ProprietaryName>
    <NonProprietaryName>Bacitracin Zinc</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20100301</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M004</ApplicationNumber>
    <LabelerName>Medline Industries, LP</LabelerName>
    <SubstanceName>BACITRACIN ZINC</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>[USP'U]/g</StrengthUnit>
    <Pharm_Classes>Decreased Cell Wall Synthesis &amp; Repair [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100301</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>First aid to help prevent infection in: 1 minor cuts, 2 scrapes, 3 burns.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>54860-089-01</NDCCode>
    <PackageDescription>30 mL in 1 BOTTLE (54860-089-01) </PackageDescription>
    <NDC11Code>54860-0089-01</NDC11Code>
    <ProductNDC>54860-089</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Vanilla Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20180130</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>Shenzhen Lantern Science Co., Ltd.</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180130</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To decrease bacteria on hands.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>55319-089-01</NDCCode>
    <PackageDescription>1000 mL in 1 BOTTLE, PLASTIC (55319-089-01) </PackageDescription>
    <NDC11Code>55319-0089-01</NDC11Code>
    <ProductNDC>55319-089</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Antiseptic</ProprietaryName>
    <NonProprietaryName>Eucalyptol, Menthol, Methyl Salicylate, Thymol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250701</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M022</ApplicationNumber>
    <LabelerName>Family Dollar (FAMILY WELLNESS)</LabelerName>
    <SubstanceName>EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL</SubstanceName>
    <StrengthNumber>.92; .42; .6; .64</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-04-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250701</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps prevent and reduce: 1 plaque, 2 gingivitis.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>56136-089-01</NDCCode>
    <PackageDescription>236 mL in 1 BOTTLE (56136-089-01) </PackageDescription>
    <NDC11Code>56136-0089-01</NDC11Code>
    <ProductNDC>56136-089</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Follow The Rainbow Antibacterial Hand Sanitizer Watermelon Ice Pop Scented</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200730</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>Ganzhou Olivee Cosmetic Co., Ltd.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>65</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200730</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Decrease bacteria on hands.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>57237-089-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (57237-089-01) </PackageDescription>
    <NDC11Code>57237-0089-01</NDC11Code>
    <ProductNDC>57237-089</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Trandolapril</ProprietaryName>
    <NonProprietaryName>Trandolapril</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070612</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078438</ApplicationNumber>
    <LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
    <SubstanceName>TRANDOLAPRIL</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-04-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20070612</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hypertension. Trandolapril tablets USP are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive medication such as hydrochlorothiazide. Heart Failure Post Myocardial Infarction or Left-Ventricular Dysfunction Post Myocardial Infarction. Trandolapril tablets USP are indicated in stable patients who have evidence of left-ventricular systolic dysfunction (identified by wall motion abnormalities) or who are symptomatic from congestive heart failure within the first few days after sustaining acute myocardial infarction. Administration of trandolapril to Caucasian patients has been shown to decrease the risk of death (principally cardiovascular death) and to decrease the risk of heart failure-related hospitalization (see CLINICAL PHARMACOLOGY-Heart Failure or Left-Ventricular Dysfunction Post Myocardial Infarction for details of the survival trial).</IndicationAndUsage>
    <Description>Trandolapril is the ethyl ester prodrug of a nonsulfhydryl angiotensin converting enzyme (ACE) inhibitor, trandolaprilat. Trandolapril is chemically described as (2S,3aR,7aS)-1-[(S)-N-[(S)-1-Carboxy-3-phenylpropyl]alanyl] hexahydro-2-indolinecarboxylic acid, 1-ethyl ester. Its molecular formula is C24H34N2O5 and its structural formula is. M.W. = 430.54Melting Point = 125°CTrandolapril USP is a white or almost white powder that is soluble (&gt;100 mg/mL) in chloroform, dichloromethane, and methanol. Trandolapril tablets USP contain 1 mg, 2 mg, or 4 mg of trandolapril USP for oral administration. Each tablet also contains lactose monohydrate, corn starch, croscarmellose sodium, hypromellose, povidone, and sodium stearyl fumarate. In addition 1 mg and 4 mg tablet also contains ferric oxide red and 2 mg tablet contains ferric oxide yellow.</Description>
  </NDC>
</NDCList>
                    
<NDCList><NDC><NDCCode>49967-089-01</NDCCode><ProprietaryName>Vichy Laboratoire</ProprietaryName><NonProprietaryName>Avobenzone Homosalate Octisalate Octocrylene Oxybenzone</NonProprietaryName></NDC><NDC><NDCCode>11489-089-01</NDCCode><ProprietaryName>Botanics Hydrating Day All Bright Sunscreen Broad Spectrum Spf 15</ProprietaryName><NonProprietaryName>Avobenzone, Octisalate, Octocrylene</NonProprietaryName></NDC><NDC><NDCCode>13107-089-01</NDCCode><ProprietaryName>Methadone Hydrochloride</ProprietaryName><NonProprietaryName>Methadone Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>14141-089-02</NDCCode><ProprietaryName>Lbel Libertage Cc Matte Perfectioning-effect Moisturizing Face Spf 30</ProprietaryName><NonProprietaryName>Octinoxate And Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>14783-089-02</NDCCode><ProprietaryName>Lbel Concentre Total Base Serum Ultra-fluid Foundation Spf 25</ProprietaryName><NonProprietaryName>Octinoxate And Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>16714-089-01</NDCCode><ProprietaryName>Methylprednisolone Acetate</ProprietaryName><NonProprietaryName>Methylprednisolone Acetate</NonProprietaryName></NDC><NDC><NDCCode>20151-089-02</NDCCode><ProprietaryName>Vitalizing Energizing Moisturizing Cream</ProprietaryName><NonProprietaryName>Glycerin, Dimethicone</NonProprietaryName></NDC><NDC><NDCCode>21130-089-01</NDCCode><ProprietaryName>Signature Care Allergy Relief</ProprietaryName><NonProprietaryName>Fluticasone Propionate</NonProprietaryName></NDC><NDC><NDCCode>27808-089-01</NDCCode><ProprietaryName>Dextroamphetamine Sulfate</ProprietaryName><NonProprietaryName>Dextroamphetamine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>41366-089-01</NDCCode><ProprietaryName>Cashmere Woods Hand Sanitizer</ProprietaryName><NonProprietaryName>Cashmere Woods Hand Sanitizer</NonProprietaryName></NDC><NDC><NDCCode>42291-089-01</NDCCode><ProprietaryName>Acetazolamide</ProprietaryName><NonProprietaryName>Acetazolamide</NonProprietaryName></NDC><NDC><NDCCode>42806-089-01</NDCCode><ProprietaryName>Estradiol</ProprietaryName><NonProprietaryName>Estradiol</NonProprietaryName></NDC><NDC><NDCCode>42931-089-01</NDCCode><NonProprietaryName>Oseltamivir Phosphate</NonProprietaryName></NDC><NDC><NDCCode>43473-089-01</NDCCode><ProprietaryName>Everlit Care Hand Sanitizer</ProprietaryName><NonProprietaryName>Ethyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>44717-089-02</NDCCode><ProprietaryName>Perfecting Blendrops Broad Spectrum Spf 46</ProprietaryName><NonProprietaryName>Homosalate, Octisalate, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>45629-089-01</NDCCode><ProprietaryName>Fotivda</ProprietaryName><NonProprietaryName>Tivozanib</NonProprietaryName></NDC><NDC><NDCCode>45802-089-02</NDCCode><ProprietaryName>Nicotine Polacrilex</ProprietaryName><NonProprietaryName>Nicotine Polacrilex</NonProprietaryName></NDC><NDC><NDCCode>48433-089-08</NDCCode><ProprietaryName>Spironolactone</ProprietaryName><NonProprietaryName>Spironolactone</NonProprietaryName></NDC><NDC><NDCCode>50242-089-01</NDCCode><NonProprietaryName>Ado-trastuzumab Emtansine</NonProprietaryName></NDC><NDC><NDCCode>51060-089-01</NDCCode><ProprietaryName>Rainforest Of The Sea Water Foundation Broad Spectrum Spf 15 Sunscreen</ProprietaryName><NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>51079-089-20</NDCCode><ProprietaryName>Meclizine Hydrochloride</ProprietaryName><NonProprietaryName>Meclizine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>51346-089-01</NDCCode><ProprietaryName>Solie Essence</ProprietaryName><NonProprietaryName>Glycerin</NonProprietaryName></NDC><NDC><NDCCode>51407-089-01</NDCCode><ProprietaryName>Felodipine</ProprietaryName><NonProprietaryName>Felodipine</NonProprietaryName></NDC><NDC><NDCCode>51621-089-01</NDCCode><ProprietaryName>Derma Dr. Lab Hydromoist Cover Bb</ProprietaryName><NonProprietaryName>Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>52584-089-01</NDCCode><ProprietaryName>Flumazenil</ProprietaryName><NonProprietaryName>Flumazenil</NonProprietaryName></NDC><NDC><NDCCode>53329-089-01</NDCCode><ProprietaryName>First Aid Antibiotic</ProprietaryName><NonProprietaryName>Bacitracin Zinc</NonProprietaryName></NDC><NDC><NDCCode>54860-089-01</NDCCode><ProprietaryName>Vanilla Hand Sanitizer</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>55319-089-01</NDCCode><ProprietaryName>Antiseptic</ProprietaryName><NonProprietaryName>Eucalyptol, Menthol, Methyl Salicylate, Thymol</NonProprietaryName></NDC><NDC><NDCCode>56136-089-01</NDCCode><ProprietaryName>Follow The Rainbow Antibacterial Hand Sanitizer Watermelon Ice Pop Scented</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>57237-089-01</NDCCode><ProprietaryName>Trandolapril</ProprietaryName><NonProprietaryName>Trandolapril</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.

Parameter Meaning Notes
domain Domain
  • Currently following data domains are supported:
    • NPI - NPI Number Lookup
    • HCPCS - Healthcare Provider Procedure Coding System Lookup
    • NDC - National Drug Code Lookup
    • NDCA - Animal Drug Product Listing Directory Lookup
    • CLIA - Clinical Laboratory Improvement Amendments
    • HPTC - Healthcare Provider Taxonomy Code Lookup
    • NAICS - North American Industry Classification System Lookup
    • LOINC - Logical Observation Identifiers Names and Codes (LOINC®) Lookup
    • DRG - Diagnosis-Related Group Lookup
    • ICD9 - Ninth Revision of the International Classification of Diseases Lookup
    • ICD10 - Tenth Revision of the International Classification of Diseases Lookup
    • ICD10DRUGS - ICD-10-CM Table Of Drugs And Chemicals Lookup
    • ZIP - Postal Codes used by the United States Postal Service
operation Operation
  • Generic operations:
    • check_status - this method allows to get current code status.
    • search - allows retrieval of set of items (up to 30) 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.
    • 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.
  • 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.
q Query
  • The search expression. May vary depending on the operation.
    • Free form text like: “q=blood glucose monitor” (search operation)
    • Exact code value : “q=1285636522” (getcode operation)
    • List of codes : “q=1285636522,1730198755,1427145176,1487730636” (getcodes operation)
zipcode Query for NPI by Zip code/radius Lookup
  • The search expression for zip code.
    • Exact code value : “zipcode=98052” (search operation)
radius Query for NPI by Zip code/radius Lookup
  • The search expression for radius.
    • Exact code value : “radius=20” (search operation)
fromdate Query for Deactivated NPI
  • The search expression for fromdate.
    • Exact code value : “fromdate=05/01/2023” (search operation - format MM/DD/YYYY)
todate Query for Deactivated NPI
  • The search expression for tomdate.
    • Exact code value : “todate=05/31/2023” (search operation - format MM/DD/YYYY)
tin Query for IRS Lookup
  • The search expression for tin number.
    • Exact code value : “tin=942404110” (search operation)
tinname Query for IRS Lookup
  • The search expression for tin name.
    • Free form text like: “tinname=apple inc.” (search operation)
rt Data format
  • If you don't specify an rt parameter, the API returns data in the JSON format. This is equivalent to rt=json.
  • Accepted values are:
    • json
    • minjson (minified json)
    • xml
    • minxml (minified xml)
token Your API key
num Number of search results to return
  • You can specify the how many results to return for the current search.
  • Valid values are integers between 1 and 100, inclusive.
  • If num is not used, a value of 30 is assumed.
friendlyprint Returns a response with indentations and line breaks
  • If friendlyprint is not used, a “true” value is assumed. This is equivalent to friendlyprint=true.
  • Accepted values are:
    • true - the results returned by the server will be more “human readable”.
    • false - the results returned by the server will not have indentations and line breaks.
ICD9/ICD10 Parameters
codeType Specifies whether ICD code is "dx"(Diagnosis) or "pcs"(Procedure).
  • Required for ICD only.
  • If you don't specify an codeType parameter this is equivalent to codeType=dx.
  • Accepted values are:
    • dx (diagnosis)
    • pcs (procedure)
qf Specifies predicate in form of tuple "qf=City:true:Phoenix".
  • Expected to be one or many "qf" parameters in request.
  • Required for following operations:
    • validate
    • paginate_with_predicates
    • search_with_predicates
  • Tuple values are (order based):
    • NPI Field Name
      • NPI
      • Phone
      • Fax
      • FirstName
      • LastName
      • OrganizationName
      • OtherOrganizationName
      • Address1
      • Address2
      • Zip
      • City
      • State
      • IndividualOrganizationCode
    • Exact Match
      • true
      • false
    • Expected Field Value
orderField Sort order field name
  • Expected to be one "orderField" parameter in request.
  • Required for following operations:
    • paginate_with_predicates
  • Values are:
    • NPI
    • Phone
    • Fax
    • FirstName
    • LastName
    • OrganizationName
    • OtherOrganizationName
    • Address1
    • Address2
    • Zip
    • City
    • State
    • IndividualOrganizationCode
pageNo Page Number
  • Ordinal page number.
  • Required for following operations:
    • paginate_with_predicates
    • zipradius
    • npideactivated
pageSize Page Size
  • Expected page size.
  • Required for following operations:
    • paginate_with_predicates

DataLabs Coding Library - Quering NPI Registry - REST API Examples

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();
    }
}
            
        

Output

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
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      "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 ...
            
        

Full Text Search Fundamentals

Facts

Everybody uses full text search. Full-text search is the most common technique used in search engines. The amount of information has just become too much to access it using navigation and categories alone. Full-text search reduces the hassle of searching for a keyword in huge amounts of metadata, such as the World Wide Web and commercial-scale databases. Full-text search became popular in late 1990s, when the Internet and Big Data began to became a part of everyday life.

How does it work

Users only provide keywords and expect the search engine to provide good results. Relevancy of documents is expected to be good and users want the results they are looking to be present in the top ten. How relevant a document is search engine decides based on scientifically proven algorithms. Besides getting the best results the user wants to be supported during the search process. Features like suggestions and highlighting on the result excerpt can help with this.

Full Text Search & DataLabs REST API

DataLabs REST API allows you to search the full text of healthcare providers database (NPI Registry). To find the information you need and make your search easy, please use our REST API for automation, or visit our NPI Lookup page for manual search ( NPI Number Lookup). We are still improving and enhancing Full Text NPI Search based on users feedbacks. Please email your comments and suggestions for improvement using our feedback page.

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();
        }
    }
                
            

Output

                
    {
      "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();
        }
    }
                
            

Output

                
    {
      "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();
        }
    }
                
            

Output

                
    {
      "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();
        }
    }
                
            

Output

                
{
  "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",
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}
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