RESTful Lookup — Test-Drive (2007 – 2026)

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{
  "NDC": [
    {
      "NDCCode": "66993-902-06",
      "PackageDescription": "170.3 g in 1 BOTTLE (66993-902-06)",
      "NDC11Code": "66993-0902-06",
      "ProductNDC": "66993-902",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prascion",
      "ProprietaryNameSuffix": "Cleanser",
      "NonProprietaryName": "Sodium Sulfacetamide And Sulfur",
      "DosageFormName": "SOAP",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110805",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Prasco Laboratories",
      "SubstanceName": "SULFACETAMIDE SODIUM; SULFUR",
      "StrengthNumber": "100; 50",
      "StrengthUnit": "mg/g; mg/g",
      "Pharm_Classes": "Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "66993-902-12",
      "PackageDescription": "340.2 g in 1 BOTTLE (66993-902-12)",
      "NDC11Code": "66993-0902-12",
      "ProductNDC": "66993-902",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prascion",
      "ProprietaryNameSuffix": "Cleanser",
      "NonProprietaryName": "Sodium Sulfacetamide And Sulfur",
      "DosageFormName": "SOAP",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110805",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Prasco Laboratories",
      "SubstanceName": "SULFACETAMIDE SODIUM; SULFUR",
      "StrengthNumber": "100; 50",
      "StrengthUnit": "mg/g; mg/g",
      "Pharm_Classes": "Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "66993-100-06",
      "PackageDescription": "6 BLISTER PACK in 1 CARTON (66993-100-06)  / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (66993-100-51) ",
      "NDC11Code": "66993-0100-06",
      "ProductNDC": "66993-100",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levetiracetam",
      "NonProprietaryName": "Levetiracetam",
      "DosageFormName": "TABLET, FOR SUSPENSION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250120",
      "MarketingCategoryName": "NDA AUTHORIZED GENERIC",
      "ApplicationNumber": "NDA207958",
      "LabelerName": "Prasco Laboratories",
      "SubstanceName": "LEVETIRACETAM",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2026-01-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250120",
      "SamplePackage": "N",
      "IndicationAndUsage": "Levetiracetam tablets for oral suspension are indicated for the treatment of partial-onset seizures in patients 4 years of age and older weighing more than 20 kg (1.1). Levetiracetam tablets for oral suspension are indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).",
      "Description": "Levetiracetam tablets for oral suspension are an antiepileptic drug available as 250 mg and 500 mg, round, white to off-white, spearmint-flavored tablets for oral suspension. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent). Levetiracetam tablets for oral suspension contain 250 mg and 500 mg levetiracetam. Each tablet also contains the following inactive ingredients: colloidal silicon dioxide, glycerin, mannitol, microcrystalline cellulose, polysorbate 20, povidone, sucralose, butylated hydroxyanisole, and natural and artificial spearmint flavor. Levetiracetam tablets for oral suspension are unitary porous structures produced by a three-dimensional printing process that binds the powders without compression. Levetiracetam tablets for oral suspension disintegrate in a mean time of 11 seconds (ranging from 2 to 27 seconds) in the mouth, when taken with a sip of liquid, to produce small particles that may be swallowed."
    },
    {
      "NDCCode": "66993-926-06",
      "PackageDescription": "170.1 g in 1 TUBE (66993-926-06)",
      "NDC11Code": "66993-0926-06",
      "ProductNDC": "66993-926",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lavoclen",
      "ProprietaryNameSuffix": "4",
      "NonProprietaryName": "Benzoyl Peroxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20090701",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Prasco Laboratories",
      "SubstanceName": "BENZOYL PEROXIDE",
      "StrengthNumber": "6.8",
      "StrengthUnit": "g/170.1g",
      "Status": "Deprecated",
      "LastUpdate": "2014-03-12"
    },
    {
      "NDCCode": "66993-927-06",
      "PackageDescription": "170.1 g in 1 TUBE (66993-927-06)",
      "NDC11Code": "66993-0927-06",
      "ProductNDC": "66993-927",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lavoclen",
      "ProprietaryNameSuffix": "8",
      "NonProprietaryName": "Benzoyl Peroxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20090701",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Prasco Laboratories",
      "SubstanceName": "BENZOYL PEROXIDE",
      "StrengthNumber": "13.6",
      "StrengthUnit": "g/170.1g",
      "Status": "Deprecated",
      "LastUpdate": "2014-03-12"
    },
    {
      "NDCCode": "41250-902-06",
      "PackageDescription": "296 mL in 1 BOTTLE (41250-902-06) ",
      "NDC11Code": "41250-0902-06",
      "ProductNDC": "41250-902",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Baby Sunscreen Spf 50",
      "NonProprietaryName": "Titanium Dioxide 3.1% Zinc Oxide 4.0%",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20170314",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Meijer",
      "SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": "3.1; 4",
      "StrengthUnit": "g/100mL; g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20170314",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses  helps prevent sunburn."
    },
    {
      "NDCCode": "42385-902-06",
      "PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (42385-902-06) ",
      "NDC11Code": "42385-0902-06",
      "ProductNDC": "42385-902",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metformin Hydrochloride",
      "NonProprietaryName": "Metformin Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190115",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209882",
      "LabelerName": "Laurus Labs Limited",
      "SubstanceName": "METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "1000",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2022-12-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20190115",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "51316-902-06",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (51316-902-06)  / 60 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC",
      "NDC11Code": "51316-0902-06",
      "ProductNDC": "51316-902",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cvs Health Senna Plus Stool Softener Laxative Softgel",
      "NonProprietaryName": "Docusate Sodium, Sennosides",
      "DosageFormName": "CAPSULE, LIQUID FILLED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240117",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M007",
      "LabelerName": "CVS Pharmacy, Inc.",
      "SubstanceName": "DOCUSATE SODIUM; SENNOSIDES",
      "StrengthNumber": "50; 8.6",
      "StrengthUnit": "mg/1; mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20240117",
      "SamplePackage": "N",
      "IndicationAndUsage": " relieves occasional constipation (irregularity) generally produces a bowel movement in 6-12 hours."
    },
    {
      "NDCCode": "52862-902-06",
      "PackageDescription": "170 g in 1 BOTTLE, PLASTIC (52862-902-06) ",
      "NDC11Code": "52862-0902-06",
      "ProductNDC": "52862-902",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Health Smart Vaporizing Chest Rub",
      "NonProprietaryName": "Menthol And Camphor And Eucalyptus Oil",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20131001",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "International Wholesale Inc",
      "SubstanceName": "CAMPHOR (SYNTHETIC); MENTHOL; EUCALYPTUS OIL",
      "StrengthNumber": "4.7; 1; 1",
      "StrengthUnit": "g/100g; g/100g; g/100g",
      "Status": "Active",
      "LastUpdate": "2025-07-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20220214",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses: 1 On chest and throat, helps temporarily relieve cough as may occur with common cold and minor bronchial irritation., 2 For the temporary relief of pain associated with minor skin irritation."
    },
    {
      "NDCCode": "54257-902-06",
      "PackageDescription": "1000 CAPSULE, GELATIN COATED in 1 BOTTLE (54257-902-06) ",
      "NDC11Code": "54257-0902-06",
      "ProductNDC": "54257-902",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Stool Softener Docusate Sodium",
      "NonProprietaryName": "Docusate Sodium",
      "DosageFormName": "CAPSULE, GELATIN COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170404",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M007",
      "LabelerName": "Magno-Humphries, Inc.",
      "SubstanceName": "DOCUSATE SODIUM",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Status": "Active",
      "LastUpdate": "2023-10-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20170404",
      "SamplePackage": "N",
      "IndicationAndUsage": "relieves occasional constipation (irregularity). generally produces a bowel movement in 12-72 hours."
    },
    {
      "NDCCode": "59735-902-06",
      "PackageDescription": "1 TUBE in 1 CARTON (59735-902-06)  / 50 mL in 1 TUBE (59735-902-05) ",
      "NDC11Code": "59735-0902-06",
      "ProductNDC": "59735-902",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Amazonian Clay Bb Tinted Moisturizer Broad Spectrum Spf 20 Sunscreen",
      "ProprietaryNameSuffix": "Light-medium",
      "NonProprietaryName": "Titanium Dioxide And Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20040501",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "PML NYC, LLC",
      "SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": "50; 50",
      "StrengthUnit": "mg/mL; mg/mL",
      "Status": "Active",
      "LastUpdate": "2026-04-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20040501",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
    },
    {
      "NDCCode": "64380-902-06",
      "PackageDescription": "100 TABLET in 1 BOTTLE (64380-902-06) ",
      "NDC11Code": "64380-0902-06",
      "ProductNDC": "64380-902",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fluoxetine",
      "NonProprietaryName": "Fluoxetine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240812",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212684",
      "LabelerName": "Strides Pharma Science Limited",
      "SubstanceName": "FLUOXETINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-02-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240812",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fluoxetine is a selective serotonin reuptake inhibitor indicated for: 1   Acute and maintenance treatment of Major Depressive Disorder (MDD) in adult and pediatric patients aged 8 to 18 years (1.1), 2   Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) in adults and pediatric patients aged 7 to 17 years (1.2), 3   Acute and maintenance treatment of Bulimia Nervosa in adult patients (1.3), 4   Acute treatment of Panic Disorder, with or without agoraphobia, in adult patients (1.4).",
      "Description": "Fluoxetine is a selective serotonin reuptake inhibitor for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the molecular formula of C17 H18 F3NO.HCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each tablet contains fluoxetine hydrochloride equivalent to 10 mg (32.3 µmol) or 20 mg (64.7 µmol) of fluoxetine. In addition, each tablet also contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, Pre-gelatinized Starch and titanium dioxide."
    },
    {
      "NDCCode": "68428-902-06",
      "PackageDescription": "1200 PELLET in 1 BOTTLE, GLASS (68428-902-06)",
      "NDC11Code": "68428-0902-06",
      "ProductNDC": "68428-902",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cadmium Metallicum",
      "NonProprietaryName": "Cadmium",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110404",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Washington Homeopathic Products",
      "SubstanceName": "CADMIUM",
      "StrengthNumber": "30",
      "StrengthUnit": "[hp_C]/1",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "IndicationAndUsage": "Indications. CADMIUM MET   Fatigue."
    },
    {
      "NDCCode": "78870-902-06",
      "PackageDescription": "40 POUCH in 1 BAG (78870-902-06)  > .0037 g in 1 POUCH",
      "NDC11Code": "78870-0902-06",
      "ProductNDC": "78870-902",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Safeact Claening Wipes",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "CLOTH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200704",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "AMERICAN EXCHANGE TIME LLC",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": ".13",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200704",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hand sanitizer to help reduce bacteria that potentially cause disease. For use when soap and water are not available."
    },
    {
      "NDCCode": "66993-115-60",
      "PackageDescription": "60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66993-115-60) ",
      "NDC11Code": "66993-0115-60",
      "ProductNDC": "66993-115",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Propafenone Hydrochloride",
      "ProprietaryNameSuffix": "Sr",
      "NonProprietaryName": "Propafenone Hydrochloride",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20141022",
      "EndMarketingDate": "20220531",
      "MarketingCategoryName": "NDA AUTHORIZED GENERIC",
      "ApplicationNumber": "NDA021416",
      "LabelerName": "Prasco Laboratories",
      "SubstanceName": "PROPAFENONE HYDROCHLORIDE",
      "StrengthNumber": "325",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antiarrhythmic [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2022-06-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20141022",
      "EndMarketingDatePackage": "20220531",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "66993-135-97",
      "PackageDescription": "1 TRAY in 1 CARTON (66993-135-97)  / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER",
      "NDC11Code": "66993-0135-97",
      "ProductNDC": "66993-135",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fluticasone Furoate And Vilanterol",
      "NonProprietaryName": "Fluticasone Furoate And Vilanterol",
      "DosageFormName": "POWDER",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20220523",
      "MarketingCategoryName": "NDA AUTHORIZED GENERIC",
      "ApplicationNumber": "NDA204275",
      "LabelerName": "Prasco Laboratories",
      "SubstanceName": "FLUTICASONE FUROATE; VILANTEROL TRIFENATATE",
      "StrengthNumber": "100; 25",
      "StrengthUnit": "ug/1; ug/1",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-06-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20220523",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fluticasone Furoate/Vilanterol ELLIPTA is a combination of fluticasone furoate, a corticosteroid, and vilanterol, a long‑acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 5 years and older. (1.2).",
      "Description": "Fluticasone Furoate/Vilanterol ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS) and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. Fluticasone furoate/vilanterol ELLIPTA is a light grey and pale blue plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (50, 100 or 200 mcg) and lactose monohydrate (12.5, 12.4 or 12.3 mg, respectively), and each blister on the other strip contains a white powder blend of micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (125 mcg), and lactose monohydrate (12.34 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, fluticasone furoate/vilanterol ELLIPTA delivers 46, 92 or 184 mcg of fluticasone furoate and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult patients with obstructive lung disease and severely compromised lung function (COPD with FEV1/FVC <70% and FEV1 <30% predicted or FEV1 <50% predicted plus chronic respiratory failure), mean peak inspiratory flow through the ELLIPTA inhaler was 66.5 L/min (range: 43.5 to 81.0 L/min). In adult patients with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). In pediatric patients with asthma aged 5 to 11 years, mean peak inspiratory flow through the ELLIPTA inhaler was 60.6 L/min (range: 36.3 to 82.5 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
    },
    {
      "NDCCode": "66993-136-97",
      "PackageDescription": "1 TRAY in 1 CARTON (66993-136-97)  / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER",
      "NDC11Code": "66993-0136-97",
      "ProductNDC": "66993-136",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fluticasone Furoate And Vilanterol",
      "NonProprietaryName": "Fluticasone Furoate And Vilanterol",
      "DosageFormName": "POWDER",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20220523",
      "MarketingCategoryName": "NDA AUTHORIZED GENERIC",
      "ApplicationNumber": "NDA204275",
      "LabelerName": "Prasco Laboratories",
      "SubstanceName": "FLUTICASONE FUROATE; VILANTEROL TRIFENATATE",
      "StrengthNumber": "200; 25",
      "StrengthUnit": "ug/1; ug/1",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-06-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20220523",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fluticasone Furoate/Vilanterol ELLIPTA is a combination of fluticasone furoate, a corticosteroid, and vilanterol, a long‑acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 5 years and older. (1.2).",
      "Description": "Fluticasone Furoate/Vilanterol ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS) and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. Fluticasone furoate/vilanterol ELLIPTA is a light grey and pale blue plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (50, 100 or 200 mcg) and lactose monohydrate (12.5, 12.4 or 12.3 mg, respectively), and each blister on the other strip contains a white powder blend of micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (125 mcg), and lactose monohydrate (12.34 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, fluticasone furoate/vilanterol ELLIPTA delivers 46, 92 or 184 mcg of fluticasone furoate and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult patients with obstructive lung disease and severely compromised lung function (COPD with FEV1/FVC <70% and FEV1 <30% predicted or FEV1 <50% predicted plus chronic respiratory failure), mean peak inspiratory flow through the ELLIPTA inhaler was 66.5 L/min (range: 43.5 to 81.0 L/min). In adult patients with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). In pediatric patients with asthma aged 5 to 11 years, mean peak inspiratory flow through the ELLIPTA inhaler was 60.6 L/min (range: 36.3 to 82.5 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
    },
    {
      "NDCCode": "66993-343-30",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (66993-343-30) ",
      "NDC11Code": "66993-0343-30",
      "ProductNDC": "66993-343",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Eplerenone",
      "NonProprietaryName": "Eplerenone",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210601",
      "EndMarketingDate": "20250531",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203896",
      "LabelerName": "Prasco Laboratories",
      "SubstanceName": "EPLERENONE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2025-06-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20210601",
      "EndMarketingDatePackage": "20250531",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "66993-343-85",
      "PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (66993-343-85) ",
      "NDC11Code": "66993-0343-85",
      "ProductNDC": "66993-343",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Eplerenone",
      "NonProprietaryName": "Eplerenone",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210601",
      "EndMarketingDate": "20250531",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203896",
      "LabelerName": "Prasco Laboratories",
      "SubstanceName": "EPLERENONE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2025-06-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20210601",
      "EndMarketingDatePackage": "20250531",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "66993-344-85",
      "PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (66993-344-85) ",
      "NDC11Code": "66993-0344-85",
      "ProductNDC": "66993-344",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Eplerenone",
      "NonProprietaryName": "Eplerenone",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210601",
      "EndMarketingDate": "20250531",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203896",
      "LabelerName": "Prasco Laboratories",
      "SubstanceName": "EPLERENONE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2025-06-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20210601",
      "EndMarketingDatePackage": "20250531",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "66993-350-80",
      "PackageDescription": "10 BLISTER PACK in 1 CARTON (66993-350-80)  > 10 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK (66993-350-51)",
      "NDC11Code": "66993-0350-80",
      "ProductNDC": "66993-350",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lansoprazole Delayed-release Orally Disintegrating",
      "NonProprietaryName": "Lansoprazole",
      "DosageFormName": "TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20020830",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021428",
      "LabelerName": "Prasco Laboratories",
      "SubstanceName": "LANSOPRAZOLE",
      "StrengthNumber": "15",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2015-06-05"
    },
    {
      "NDCCode": "66993-351-80",
      "PackageDescription": "10 BLISTER PACK in 1 CARTON (66993-351-80)  > 10 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK (66993-351-51)",
      "NDC11Code": "66993-0351-80",
      "ProductNDC": "66993-351",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lansoprazole Delayed-release Orally Disintegrating",
      "NonProprietaryName": "Lansoprazole",
      "DosageFormName": "TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20020830",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021428",
      "LabelerName": "Prasco Laboratories",
      "SubstanceName": "LANSOPRAZOLE",
      "StrengthNumber": "30",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2015-06-05"
    },
    {
      "NDCCode": "66993-361-60",
      "PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (66993-361-60) ",
      "NDC11Code": "66993-0361-60",
      "ProductNDC": "66993-361",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dapagliflozin And Metformin Hydrochloride",
      "NonProprietaryName": "Dapagliflozin And Metformin Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240103",
      "MarketingCategoryName": "NDA AUTHORIZED GENERIC",
      "ApplicationNumber": "NDA205649",
      "LabelerName": "Prasco Laboratories",
      "SubstanceName": "DAPAGLIFLOZIN PROPANEDIOL; METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "5; 1000",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-06-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240103",
      "SamplePackage": "N",
      "IndicationAndUsage": "Dapagliflozin and Metformin HCl extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. Dapagliflozin, when used as a component of Dapagliflozin and Metformin HCl extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: 1 Sustained eGFR decline, end stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure., 3 Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.",
      "Description": "Dapagliflozin and Metformin HCl extended-release tablets contain: dapagliflozin, a SGLT2 inhibitor, and metformin HCl, a biguanide."
    },
    {
      "NDCCode": "66993-362-30",
      "PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (66993-362-30) ",
      "NDC11Code": "66993-0362-30",
      "ProductNDC": "66993-362",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dapagliflozin And Metformin Hydrochloride",
      "NonProprietaryName": "Dapagliflozin And Metformin Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240103",
      "MarketingCategoryName": "NDA AUTHORIZED GENERIC",
      "ApplicationNumber": "NDA205649",
      "LabelerName": "Prasco Laboratories",
      "SubstanceName": "DAPAGLIFLOZIN PROPANEDIOL; METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "10; 1000",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-06-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240103",
      "SamplePackage": "N",
      "IndicationAndUsage": "Dapagliflozin and Metformin HCl extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. Dapagliflozin, when used as a component of Dapagliflozin and Metformin HCl extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: 1 Sustained eGFR decline, end stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure., 3 Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.",
      "Description": "Dapagliflozin and Metformin HCl extended-release tablets contain: dapagliflozin, a SGLT2 inhibitor, and metformin HCl, a biguanide."
    },
    {
      "NDCCode": "66993-372-02",
      "PackageDescription": "100 TABLET, CHEWABLE in 1 BOTTLE (66993-372-02) ",
      "NDC11Code": "66993-0372-02",
      "ProductNDC": "66993-372",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Phenytoin Infatabs",
      "NonProprietaryName": "Phenytoin",
      "DosageFormName": "TABLET, CHEWABLE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20211123",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA084427",
      "LabelerName": "Prasco Laboratories",
      "SubstanceName": "PHENYTOIN",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2026-06-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20211123",
      "SamplePackage": "N",
      "IndicationAndUsage": "Phenytoin Infatabs are indicated for the treatment of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery.",
      "Description": "Phenytoin is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is 5,5-diphenyl-2,4 imidazolidinedione, having the following structural formula:. Each Phenytoin Infatab, chewable tablet for oral administration, contains 50 mg phenytoin, USP. Also contains: D&C yellow No. 10, Aluminum Lake; FD&C yellow No. 6, Aluminum Lake; flavor; saccharin sodium, USP; confectioner's sugar, NF; talc, USP; magnesium stearate, NF; and purified water, USP."
    },
    {
      "NDCCode": "66993-407-32",
      "PackageDescription": "120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66993-407-32) ",
      "NDC11Code": "66993-0407-32",
      "ProductNDC": "66993-407",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Carbamazepine",
      "NonProprietaryName": "Carbamazepine",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20111215",
      "MarketingCategoryName": "NDA AUTHORIZED GENERIC",
      "ApplicationNumber": "NDA020712",
      "LabelerName": "Prasco Laboratories",
      "SubstanceName": "CARBAMAZEPINE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-06-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20111215",
      "SamplePackage": "N",
      "IndicationAndUsage": "Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: 1 Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvements than those with other types., 2 Generalized tonic-clonic seizures (grand mal)., 3 Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see PRECAUTIONS, General).",
      "Description": "Carbamazepine is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as 100 mg, 200 mg and 300 mg extended-release capsules of Carbamazepine, USP. Carbamazepine is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27. Its chemical name is 5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula is. Carbamazepine is a multi-component capsule formulation consisting of three different types of beads: immediate-release beads, extended-release beads, and enteric-release beads. The three bead types are combined in a specific ratio to provide twice daily dosing of carbamazepine. Inactive ingredients: citric acid, colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, povidone, sodium lauryl sulfate, talc, triethyl citrate and other ingredients. The 100 mg capsule shells contain gelatin-NF, FD&C Blue #2, Yellow Iron Oxide, and titanium dioxide and are imprinted with white ink; the 200 mg capsule shells contain gelatin-NF, FD&C Red #3, FD&C Yellow #6, Yellow Iron Oxide, FD&C Blue #2, and titanium dioxide, and are imprinted with white ink; and the 300 mg capsule shells contain gelatin-NF, FD&C Blue #2, FD&C Yellow #6, Red Iron Oxide, Yellow Iron Oxide, and titanium dioxide, and are imprinted with white ink."
    },
    {
      "NDCCode": "66993-408-32",
      "PackageDescription": "120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66993-408-32) ",
      "NDC11Code": "66993-0408-32",
      "ProductNDC": "66993-408",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Carbamazepine",
      "NonProprietaryName": "Carbamazepine",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20111215",
      "MarketingCategoryName": "NDA AUTHORIZED GENERIC",
      "ApplicationNumber": "NDA020712",
      "LabelerName": "Prasco Laboratories",
      "SubstanceName": "CARBAMAZEPINE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-06-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20111215",
      "SamplePackage": "N",
      "IndicationAndUsage": "Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: 1 Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvements than those with other types., 2 Generalized tonic-clonic seizures (grand mal)., 3 Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see PRECAUTIONS, General).",
      "Description": "Carbamazepine is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as 100 mg, 200 mg and 300 mg extended-release capsules of Carbamazepine, USP. Carbamazepine is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27. Its chemical name is 5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula is. Carbamazepine is a multi-component capsule formulation consisting of three different types of beads: immediate-release beads, extended-release beads, and enteric-release beads. The three bead types are combined in a specific ratio to provide twice daily dosing of carbamazepine. Inactive ingredients: citric acid, colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, povidone, sodium lauryl sulfate, talc, triethyl citrate and other ingredients. The 100 mg capsule shells contain gelatin-NF, FD&C Blue #2, Yellow Iron Oxide, and titanium dioxide and are imprinted with white ink; the 200 mg capsule shells contain gelatin-NF, FD&C Red #3, FD&C Yellow #6, Yellow Iron Oxide, FD&C Blue #2, and titanium dioxide, and are imprinted with white ink; and the 300 mg capsule shells contain gelatin-NF, FD&C Blue #2, FD&C Yellow #6, Red Iron Oxide, Yellow Iron Oxide, and titanium dioxide, and are imprinted with white ink."
    },
    {
      "NDCCode": "66993-409-32",
      "PackageDescription": "120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66993-409-32) ",
      "NDC11Code": "66993-0409-32",
      "ProductNDC": "66993-409",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Carbamazepine",
      "NonProprietaryName": "Carbamazepine",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20111215",
      "EndMarketingDate": "20250630",
      "MarketingCategoryName": "NDA AUTHORIZED GENERIC",
      "ApplicationNumber": "NDA020712",
      "LabelerName": "Prasco Laboratories",
      "SubstanceName": "CARBAMAZEPINE",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-06-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20111215",
      "EndMarketingDatePackage": "20250630",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "66993-571-64",
      "PackageDescription": "1 INHALER in 1 CARTON (66993-571-64)  > 60 AEROSOL, METERED in 1 INHALER",
      "NDC11Code": "66993-0571-64",
      "ProductNDC": "66993-571",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ciclesonide",
      "NonProprietaryName": "Ciclesonide",
      "DosageFormName": "AEROSOL, METERED",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20210501",
      "MarketingCategoryName": "NDA AUTHORIZED GENERIC",
      "ApplicationNumber": "NDA021658",
      "LabelerName": "Prasco Laboratories",
      "SubstanceName": "CICLESONIDE",
      "StrengthNumber": "80",
      "StrengthUnit": "ug/1",
      "Status": "Deprecated",
      "LastUpdate": "2021-05-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20210501",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "66993-572-64",
      "PackageDescription": "1 INHALER in 1 CARTON (66993-572-64)  > 60 AEROSOL, METERED in 1 INHALER",
      "NDC11Code": "66993-0572-64",
      "ProductNDC": "66993-572",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ciclesonide",
      "NonProprietaryName": "Ciclesonide",
      "DosageFormName": "AEROSOL, METERED",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20210501",
      "MarketingCategoryName": "NDA AUTHORIZED GENERIC",
      "ApplicationNumber": "NDA021658",
      "LabelerName": "Prasco Laboratories",
      "SubstanceName": "CICLESONIDE",
      "StrengthNumber": "160",
      "StrengthUnit": "ug/1",
      "Status": "Deprecated",
      "LastUpdate": "2021-05-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20210501",
      "SamplePackage": "N"
    }
  ]
}
                    

{"NDC":[{"NDCCode":"66993-902-06","ProprietaryName":"Prascion","NonProprietaryName":"Sodium Sulfacetamide And Sulfur"},{"NDCCode":"66993-902-12","ProprietaryName":"Prascion","NonProprietaryName":"Sodium Sulfacetamide And Sulfur"},{"NDCCode":"66993-100-06","ProprietaryName":"Levetiracetam","NonProprietaryName":"Levetiracetam"},{"NDCCode":"66993-926-06","ProprietaryName":"Lavoclen","NonProprietaryName":"Benzoyl Peroxide"},{"NDCCode":"66993-927-06","ProprietaryName":"Lavoclen","NonProprietaryName":"Benzoyl Peroxide"},{"NDCCode":"41250-902-06","ProprietaryName":"Baby Sunscreen Spf 50","NonProprietaryName":"Titanium Dioxide 3.1% Zinc Oxide 4.0%"},{"NDCCode":"42385-902-06","ProprietaryName":"Metformin Hydrochloride","NonProprietaryName":"Metformin Hydrochloride"},{"NDCCode":"51316-902-06","ProprietaryName":"Cvs Health Senna Plus Stool Softener Laxative Softgel","NonProprietaryName":"Docusate Sodium, Sennosides"},{"NDCCode":"52862-902-06","ProprietaryName":"Health Smart Vaporizing Chest Rub","NonProprietaryName":"Menthol And Camphor And Eucalyptus Oil"},{"NDCCode":"54257-902-06","ProprietaryName":"Stool Softener Docusate Sodium","NonProprietaryName":"Docusate Sodium"},{"NDCCode":"59735-902-06","ProprietaryName":"Amazonian Clay Bb Tinted Moisturizer Broad Spectrum Spf 20 Sunscreen","NonProprietaryName":"Titanium Dioxide And Zinc Oxide"},{"NDCCode":"64380-902-06","ProprietaryName":"Fluoxetine","NonProprietaryName":"Fluoxetine"},{"NDCCode":"68428-902-06","ProprietaryName":"Cadmium Metallicum","NonProprietaryName":"Cadmium"},{"NDCCode":"78870-902-06","ProprietaryName":"Safeact Claening Wipes","NonProprietaryName":"Benzalkonium Chloride"},{"NDCCode":"66993-115-60","ProprietaryName":"Propafenone Hydrochloride","NonProprietaryName":"Propafenone Hydrochloride"},{"NDCCode":"66993-135-97","ProprietaryName":"Fluticasone Furoate And Vilanterol","NonProprietaryName":"Fluticasone Furoate And Vilanterol"},{"NDCCode":"66993-136-97","ProprietaryName":"Fluticasone Furoate And Vilanterol","NonProprietaryName":"Fluticasone Furoate And Vilanterol"},{"NDCCode":"66993-343-30","ProprietaryName":"Eplerenone","NonProprietaryName":"Eplerenone"},{"NDCCode":"66993-343-85","ProprietaryName":"Eplerenone","NonProprietaryName":"Eplerenone"},{"NDCCode":"66993-344-85","ProprietaryName":"Eplerenone","NonProprietaryName":"Eplerenone"},{"NDCCode":"66993-350-80","ProprietaryName":"Lansoprazole Delayed-release Orally Disintegrating","NonProprietaryName":"Lansoprazole"},{"NDCCode":"66993-351-80","ProprietaryName":"Lansoprazole Delayed-release Orally Disintegrating","NonProprietaryName":"Lansoprazole"},{"NDCCode":"66993-361-60","ProprietaryName":"Dapagliflozin And Metformin Hydrochloride","NonProprietaryName":"Dapagliflozin And Metformin Hydrochloride"},{"NDCCode":"66993-362-30","ProprietaryName":"Dapagliflozin And Metformin Hydrochloride","NonProprietaryName":"Dapagliflozin And Metformin Hydrochloride"},{"NDCCode":"66993-372-02","ProprietaryName":"Phenytoin Infatabs","NonProprietaryName":"Phenytoin"},{"NDCCode":"66993-407-32","ProprietaryName":"Carbamazepine","NonProprietaryName":"Carbamazepine"},{"NDCCode":"66993-408-32","ProprietaryName":"Carbamazepine","NonProprietaryName":"Carbamazepine"},{"NDCCode":"66993-409-32","ProprietaryName":"Carbamazepine","NonProprietaryName":"Carbamazepine"},{"NDCCode":"66993-571-64","ProprietaryName":"Ciclesonide","NonProprietaryName":"Ciclesonide"},{"NDCCode":"66993-572-64","ProprietaryName":"Ciclesonide","NonProprietaryName":"Ciclesonide"}]}
                    

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<NDCList>
  <NDC>
    <NDCCode>66993-902-06</NDCCode>
    <PackageDescription>170.3 g in 1 BOTTLE (66993-902-06)</PackageDescription>
    <NDC11Code>66993-0902-06</NDC11Code>
    <ProductNDC>66993-902</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prascion</ProprietaryName>
    <ProprietaryNameSuffix>Cleanser</ProprietaryNameSuffix>
    <NonProprietaryName>Sodium Sulfacetamide And Sulfur</NonProprietaryName>
    <DosageFormName>SOAP</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110805</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Prasco Laboratories</LabelerName>
    <SubstanceName>SULFACETAMIDE SODIUM; SULFUR</SubstanceName>
    <StrengthNumber>100; 50</StrengthNumber>
    <StrengthUnit>mg/g; mg/g</StrengthUnit>
    <Pharm_Classes>Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>66993-902-12</NDCCode>
    <PackageDescription>340.2 g in 1 BOTTLE (66993-902-12)</PackageDescription>
    <NDC11Code>66993-0902-12</NDC11Code>
    <ProductNDC>66993-902</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prascion</ProprietaryName>
    <ProprietaryNameSuffix>Cleanser</ProprietaryNameSuffix>
    <NonProprietaryName>Sodium Sulfacetamide And Sulfur</NonProprietaryName>
    <DosageFormName>SOAP</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110805</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Prasco Laboratories</LabelerName>
    <SubstanceName>SULFACETAMIDE SODIUM; SULFUR</SubstanceName>
    <StrengthNumber>100; 50</StrengthNumber>
    <StrengthUnit>mg/g; mg/g</StrengthUnit>
    <Pharm_Classes>Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>66993-100-06</NDCCode>
    <PackageDescription>6 BLISTER PACK in 1 CARTON (66993-100-06)  / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (66993-100-51) </PackageDescription>
    <NDC11Code>66993-0100-06</NDC11Code>
    <ProductNDC>66993-100</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levetiracetam</ProprietaryName>
    <NonProprietaryName>Levetiracetam</NonProprietaryName>
    <DosageFormName>TABLET, FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250120</StartMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA207958</ApplicationNumber>
    <LabelerName>Prasco Laboratories</LabelerName>
    <SubstanceName>LEVETIRACETAM</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250120</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Levetiracetam tablets for oral suspension are indicated for the treatment of partial-onset seizures in patients 4 years of age and older weighing more than 20 kg (1.1). Levetiracetam tablets for oral suspension are indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).</IndicationAndUsage>
    <Description>Levetiracetam tablets for oral suspension are an antiepileptic drug available as 250 mg and 500 mg, round, white to off-white, spearmint-flavored tablets for oral suspension. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent). Levetiracetam tablets for oral suspension contain 250 mg and 500 mg levetiracetam. Each tablet also contains the following inactive ingredients: colloidal silicon dioxide, glycerin, mannitol, microcrystalline cellulose, polysorbate 20, povidone, sucralose, butylated hydroxyanisole, and natural and artificial spearmint flavor. Levetiracetam tablets for oral suspension are unitary porous structures produced by a three-dimensional printing process that binds the powders without compression. Levetiracetam tablets for oral suspension disintegrate in a mean time of 11 seconds (ranging from 2 to 27 seconds) in the mouth, when taken with a sip of liquid, to produce small particles that may be swallowed.</Description>
  </NDC>
  <NDC>
    <NDCCode>66993-926-06</NDCCode>
    <PackageDescription>170.1 g in 1 TUBE (66993-926-06)</PackageDescription>
    <NDC11Code>66993-0926-06</NDC11Code>
    <ProductNDC>66993-926</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lavoclen</ProprietaryName>
    <ProprietaryNameSuffix>4</ProprietaryNameSuffix>
    <NonProprietaryName>Benzoyl Peroxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20090701</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Prasco Laboratories</LabelerName>
    <SubstanceName>BENZOYL PEROXIDE</SubstanceName>
    <StrengthNumber>6.8</StrengthNumber>
    <StrengthUnit>g/170.1g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-03-12</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>66993-927-06</NDCCode>
    <PackageDescription>170.1 g in 1 TUBE (66993-927-06)</PackageDescription>
    <NDC11Code>66993-0927-06</NDC11Code>
    <ProductNDC>66993-927</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lavoclen</ProprietaryName>
    <ProprietaryNameSuffix>8</ProprietaryNameSuffix>
    <NonProprietaryName>Benzoyl Peroxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20090701</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Prasco Laboratories</LabelerName>
    <SubstanceName>BENZOYL PEROXIDE</SubstanceName>
    <StrengthNumber>13.6</StrengthNumber>
    <StrengthUnit>g/170.1g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-03-12</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>41250-902-06</NDCCode>
    <PackageDescription>296 mL in 1 BOTTLE (41250-902-06) </PackageDescription>
    <NDC11Code>41250-0902-06</NDC11Code>
    <ProductNDC>41250-902</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Baby Sunscreen Spf 50</ProprietaryName>
    <NonProprietaryName>Titanium Dioxide 3.1% Zinc Oxide 4.0%</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20170314</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Meijer</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>3.1; 4</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170314</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses  helps prevent sunburn.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>42385-902-06</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (42385-902-06) </PackageDescription>
    <NDC11Code>42385-0902-06</NDC11Code>
    <ProductNDC>42385-902</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metformin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190115</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209882</ApplicationNumber>
    <LabelerName>Laurus Labs Limited</LabelerName>
    <SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1000</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-12-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>51316-902-06</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (51316-902-06)  / 60 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>51316-0902-06</NDC11Code>
    <ProductNDC>51316-902</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cvs Health Senna Plus Stool Softener Laxative Softgel</ProprietaryName>
    <NonProprietaryName>Docusate Sodium, Sennosides</NonProprietaryName>
    <DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240117</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M007</ApplicationNumber>
    <LabelerName>CVS Pharmacy, Inc.</LabelerName>
    <SubstanceName>DOCUSATE SODIUM; SENNOSIDES</SubstanceName>
    <StrengthNumber>50; 8.6</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240117</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage> relieves occasional constipation (irregularity) generally produces a bowel movement in 6-12 hours.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>52862-902-06</NDCCode>
    <PackageDescription>170 g in 1 BOTTLE, PLASTIC (52862-902-06) </PackageDescription>
    <NDC11Code>52862-0902-06</NDC11Code>
    <ProductNDC>52862-902</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Health Smart Vaporizing Chest Rub</ProprietaryName>
    <NonProprietaryName>Menthol And Camphor And Eucalyptus Oil</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20131001</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>International Wholesale Inc</LabelerName>
    <SubstanceName>CAMPHOR (SYNTHETIC); MENTHOL; EUCALYPTUS OIL</SubstanceName>
    <StrengthNumber>4.7; 1; 1</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-07-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220214</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses: 1 On chest and throat, helps temporarily relieve cough as may occur with common cold and minor bronchial irritation., 2 For the temporary relief of pain associated with minor skin irritation.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>54257-902-06</NDCCode>
    <PackageDescription>1000 CAPSULE, GELATIN COATED in 1 BOTTLE (54257-902-06) </PackageDescription>
    <NDC11Code>54257-0902-06</NDC11Code>
    <ProductNDC>54257-902</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Stool Softener Docusate Sodium</ProprietaryName>
    <NonProprietaryName>Docusate Sodium</NonProprietaryName>
    <DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170404</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M007</ApplicationNumber>
    <LabelerName>Magno-Humphries, Inc.</LabelerName>
    <SubstanceName>DOCUSATE SODIUM</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2023-10-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170404</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>relieves occasional constipation (irregularity). generally produces a bowel movement in 12-72 hours.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>59735-902-06</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (59735-902-06)  / 50 mL in 1 TUBE (59735-902-05) </PackageDescription>
    <NDC11Code>59735-0902-06</NDC11Code>
    <ProductNDC>59735-902</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Amazonian Clay Bb Tinted Moisturizer Broad Spectrum Spf 20 Sunscreen</ProprietaryName>
    <ProprietaryNameSuffix>Light-medium</ProprietaryNameSuffix>
    <NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20040501</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>PML NYC, LLC</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>50; 50</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-04-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20040501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>64380-902-06</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (64380-902-06) </PackageDescription>
    <NDC11Code>64380-0902-06</NDC11Code>
    <ProductNDC>64380-902</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluoxetine</ProprietaryName>
    <NonProprietaryName>Fluoxetine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240812</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212684</ApplicationNumber>
    <LabelerName>Strides Pharma Science Limited</LabelerName>
    <SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240812</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluoxetine is a selective serotonin reuptake inhibitor indicated for: 1   Acute and maintenance treatment of Major Depressive Disorder (MDD) in adult and pediatric patients aged 8 to 18 years (1.1), 2   Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) in adults and pediatric patients aged 7 to 17 years (1.2), 3   Acute and maintenance treatment of Bulimia Nervosa in adult patients (1.3), 4   Acute treatment of Panic Disorder, with or without agoraphobia, in adult patients (1.4).</IndicationAndUsage>
    <Description>Fluoxetine is a selective serotonin reuptake inhibitor for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the molecular formula of C17 H18 F3NO.HCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each tablet contains fluoxetine hydrochloride equivalent to 10 mg (32.3 µmol) or 20 mg (64.7 µmol) of fluoxetine. In addition, each tablet also contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, Pre-gelatinized Starch and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>68428-902-06</NDCCode>
    <PackageDescription>1200 PELLET in 1 BOTTLE, GLASS (68428-902-06)</PackageDescription>
    <NDC11Code>68428-0902-06</NDC11Code>
    <ProductNDC>68428-902</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cadmium Metallicum</ProprietaryName>
    <NonProprietaryName>Cadmium</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110404</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Washington Homeopathic Products</LabelerName>
    <SubstanceName>CADMIUM</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>[hp_C]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Indications. CADMIUM MET   Fatigue.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>78870-902-06</NDCCode>
    <PackageDescription>40 POUCH in 1 BAG (78870-902-06)  &gt; .0037 g in 1 POUCH</PackageDescription>
    <NDC11Code>78870-0902-06</NDC11Code>
    <ProductNDC>78870-902</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Safeact Claening Wipes</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200704</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>AMERICAN EXCHANGE TIME LLC</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>.13</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200704</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hand sanitizer to help reduce bacteria that potentially cause disease. For use when soap and water are not available.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>66993-115-60</NDCCode>
    <PackageDescription>60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66993-115-60) </PackageDescription>
    <NDC11Code>66993-0115-60</NDC11Code>
    <ProductNDC>66993-115</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Propafenone Hydrochloride</ProprietaryName>
    <ProprietaryNameSuffix>Sr</ProprietaryNameSuffix>
    <NonProprietaryName>Propafenone Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20141022</StartMarketingDate>
    <EndMarketingDate>20220531</EndMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA021416</ApplicationNumber>
    <LabelerName>Prasco Laboratories</LabelerName>
    <SubstanceName>PROPAFENONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>325</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-06-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20141022</StartMarketingDatePackage>
    <EndMarketingDatePackage>20220531</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>66993-135-97</NDCCode>
    <PackageDescription>1 TRAY in 1 CARTON (66993-135-97)  / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER</PackageDescription>
    <NDC11Code>66993-0135-97</NDC11Code>
    <ProductNDC>66993-135</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluticasone Furoate And Vilanterol</ProprietaryName>
    <NonProprietaryName>Fluticasone Furoate And Vilanterol</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20220523</StartMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA204275</ApplicationNumber>
    <LabelerName>Prasco Laboratories</LabelerName>
    <SubstanceName>FLUTICASONE FUROATE; VILANTEROL TRIFENATATE</SubstanceName>
    <StrengthNumber>100; 25</StrengthNumber>
    <StrengthUnit>ug/1; ug/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220523</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluticasone Furoate/Vilanterol ELLIPTA is a combination of fluticasone furoate, a corticosteroid, and vilanterol, a long‑acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 5 years and older. (1.2).</IndicationAndUsage>
    <Description>Fluticasone Furoate/Vilanterol ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS) and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. Fluticasone furoate/vilanterol ELLIPTA is a light grey and pale blue plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (50, 100 or 200 mcg) and lactose monohydrate (12.5, 12.4 or 12.3 mg, respectively), and each blister on the other strip contains a white powder blend of micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (125 mcg), and lactose monohydrate (12.34 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, fluticasone furoate/vilanterol ELLIPTA delivers 46, 92 or 184 mcg of fluticasone furoate and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult patients with obstructive lung disease and severely compromised lung function (COPD with FEV1/FVC &lt;70% and FEV1 &lt;30% predicted or FEV1 &lt;50% predicted plus chronic respiratory failure), mean peak inspiratory flow through the ELLIPTA inhaler was 66.5 L/min (range: 43.5 to 81.0 L/min). In adult patients with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). In pediatric patients with asthma aged 5 to 11 years, mean peak inspiratory flow through the ELLIPTA inhaler was 60.6 L/min (range: 36.3 to 82.5 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.</Description>
  </NDC>
  <NDC>
    <NDCCode>66993-136-97</NDCCode>
    <PackageDescription>1 TRAY in 1 CARTON (66993-136-97)  / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER</PackageDescription>
    <NDC11Code>66993-0136-97</NDC11Code>
    <ProductNDC>66993-136</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluticasone Furoate And Vilanterol</ProprietaryName>
    <NonProprietaryName>Fluticasone Furoate And Vilanterol</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20220523</StartMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA204275</ApplicationNumber>
    <LabelerName>Prasco Laboratories</LabelerName>
    <SubstanceName>FLUTICASONE FUROATE; VILANTEROL TRIFENATATE</SubstanceName>
    <StrengthNumber>200; 25</StrengthNumber>
    <StrengthUnit>ug/1; ug/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220523</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluticasone Furoate/Vilanterol ELLIPTA is a combination of fluticasone furoate, a corticosteroid, and vilanterol, a long‑acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 5 years and older. (1.2).</IndicationAndUsage>
    <Description>Fluticasone Furoate/Vilanterol ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS) and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. Fluticasone furoate/vilanterol ELLIPTA is a light grey and pale blue plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (50, 100 or 200 mcg) and lactose monohydrate (12.5, 12.4 or 12.3 mg, respectively), and each blister on the other strip contains a white powder blend of micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (125 mcg), and lactose monohydrate (12.34 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, fluticasone furoate/vilanterol ELLIPTA delivers 46, 92 or 184 mcg of fluticasone furoate and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult patients with obstructive lung disease and severely compromised lung function (COPD with FEV1/FVC &lt;70% and FEV1 &lt;30% predicted or FEV1 &lt;50% predicted plus chronic respiratory failure), mean peak inspiratory flow through the ELLIPTA inhaler was 66.5 L/min (range: 43.5 to 81.0 L/min). In adult patients with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). In pediatric patients with asthma aged 5 to 11 years, mean peak inspiratory flow through the ELLIPTA inhaler was 60.6 L/min (range: 36.3 to 82.5 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.</Description>
  </NDC>
  <NDC>
    <NDCCode>66993-343-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (66993-343-30) </PackageDescription>
    <NDC11Code>66993-0343-30</NDC11Code>
    <ProductNDC>66993-343</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Eplerenone</ProprietaryName>
    <NonProprietaryName>Eplerenone</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210601</StartMarketingDate>
    <EndMarketingDate>20250531</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203896</ApplicationNumber>
    <LabelerName>Prasco Laboratories</LabelerName>
    <SubstanceName>EPLERENONE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20210601</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250531</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>66993-343-85</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (66993-343-85) </PackageDescription>
    <NDC11Code>66993-0343-85</NDC11Code>
    <ProductNDC>66993-343</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Eplerenone</ProprietaryName>
    <NonProprietaryName>Eplerenone</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210601</StartMarketingDate>
    <EndMarketingDate>20250531</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203896</ApplicationNumber>
    <LabelerName>Prasco Laboratories</LabelerName>
    <SubstanceName>EPLERENONE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20210601</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250531</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>66993-344-85</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (66993-344-85) </PackageDescription>
    <NDC11Code>66993-0344-85</NDC11Code>
    <ProductNDC>66993-344</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Eplerenone</ProprietaryName>
    <NonProprietaryName>Eplerenone</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210601</StartMarketingDate>
    <EndMarketingDate>20250531</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203896</ApplicationNumber>
    <LabelerName>Prasco Laboratories</LabelerName>
    <SubstanceName>EPLERENONE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20210601</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250531</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>66993-350-80</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (66993-350-80)  &gt; 10 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK (66993-350-51)</PackageDescription>
    <NDC11Code>66993-0350-80</NDC11Code>
    <ProductNDC>66993-350</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lansoprazole Delayed-release Orally Disintegrating</ProprietaryName>
    <NonProprietaryName>Lansoprazole</NonProprietaryName>
    <DosageFormName>TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20020830</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021428</ApplicationNumber>
    <LabelerName>Prasco Laboratories</LabelerName>
    <SubstanceName>LANSOPRAZOLE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2015-06-05</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>66993-351-80</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (66993-351-80)  &gt; 10 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK (66993-351-51)</PackageDescription>
    <NDC11Code>66993-0351-80</NDC11Code>
    <ProductNDC>66993-351</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lansoprazole Delayed-release Orally Disintegrating</ProprietaryName>
    <NonProprietaryName>Lansoprazole</NonProprietaryName>
    <DosageFormName>TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20020830</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021428</ApplicationNumber>
    <LabelerName>Prasco Laboratories</LabelerName>
    <SubstanceName>LANSOPRAZOLE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2015-06-05</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>66993-361-60</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (66993-361-60) </PackageDescription>
    <NDC11Code>66993-0361-60</NDC11Code>
    <ProductNDC>66993-361</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dapagliflozin And Metformin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Dapagliflozin And Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240103</StartMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA205649</ApplicationNumber>
    <LabelerName>Prasco Laboratories</LabelerName>
    <SubstanceName>DAPAGLIFLOZIN PROPANEDIOL; METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5; 1000</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240103</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dapagliflozin and Metformin HCl extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. Dapagliflozin, when used as a component of Dapagliflozin and Metformin HCl extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: 1 Sustained eGFR decline, end stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure., 3 Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.</IndicationAndUsage>
    <Description>Dapagliflozin and Metformin HCl extended-release tablets contain: dapagliflozin, a SGLT2 inhibitor, and metformin HCl, a biguanide.</Description>
  </NDC>
  <NDC>
    <NDCCode>66993-362-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (66993-362-30) </PackageDescription>
    <NDC11Code>66993-0362-30</NDC11Code>
    <ProductNDC>66993-362</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dapagliflozin And Metformin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Dapagliflozin And Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240103</StartMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA205649</ApplicationNumber>
    <LabelerName>Prasco Laboratories</LabelerName>
    <SubstanceName>DAPAGLIFLOZIN PROPANEDIOL; METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10; 1000</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240103</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dapagliflozin and Metformin HCl extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. Dapagliflozin, when used as a component of Dapagliflozin and Metformin HCl extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: 1 Sustained eGFR decline, end stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure., 3 Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.</IndicationAndUsage>
    <Description>Dapagliflozin and Metformin HCl extended-release tablets contain: dapagliflozin, a SGLT2 inhibitor, and metformin HCl, a biguanide.</Description>
  </NDC>
  <NDC>
    <NDCCode>66993-372-02</NDCCode>
    <PackageDescription>100 TABLET, CHEWABLE in 1 BOTTLE (66993-372-02) </PackageDescription>
    <NDC11Code>66993-0372-02</NDC11Code>
    <ProductNDC>66993-372</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phenytoin Infatabs</ProprietaryName>
    <NonProprietaryName>Phenytoin</NonProprietaryName>
    <DosageFormName>TABLET, CHEWABLE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20211123</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA084427</ApplicationNumber>
    <LabelerName>Prasco Laboratories</LabelerName>
    <SubstanceName>PHENYTOIN</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211123</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Phenytoin Infatabs are indicated for the treatment of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery.</IndicationAndUsage>
    <Description>Phenytoin is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is 5,5-diphenyl-2,4 imidazolidinedione, having the following structural formula:. Each Phenytoin Infatab, chewable tablet for oral administration, contains 50 mg phenytoin, USP. Also contains: D&amp;C yellow No. 10, Aluminum Lake; FD&amp;C yellow No. 6, Aluminum Lake; flavor; saccharin sodium, USP; confectioner's sugar, NF; talc, USP; magnesium stearate, NF; and purified water, USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>66993-407-32</NDCCode>
    <PackageDescription>120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66993-407-32) </PackageDescription>
    <NDC11Code>66993-0407-32</NDC11Code>
    <ProductNDC>66993-407</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carbamazepine</ProprietaryName>
    <NonProprietaryName>Carbamazepine</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20111215</StartMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA020712</ApplicationNumber>
    <LabelerName>Prasco Laboratories</LabelerName>
    <SubstanceName>CARBAMAZEPINE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-06-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20111215</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: 1 Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvements than those with other types., 2 Generalized tonic-clonic seizures (grand mal)., 3 Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see PRECAUTIONS, General).</IndicationAndUsage>
    <Description>Carbamazepine is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as 100 mg, 200 mg and 300 mg extended-release capsules of Carbamazepine, USP. Carbamazepine is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27. Its chemical name is 5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula is. Carbamazepine is a multi-component capsule formulation consisting of three different types of beads: immediate-release beads, extended-release beads, and enteric-release beads. The three bead types are combined in a specific ratio to provide twice daily dosing of carbamazepine. Inactive ingredients: citric acid, colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, povidone, sodium lauryl sulfate, talc, triethyl citrate and other ingredients. The 100 mg capsule shells contain gelatin-NF, FD&amp;C Blue #2, Yellow Iron Oxide, and titanium dioxide and are imprinted with white ink; the 200 mg capsule shells contain gelatin-NF, FD&amp;C Red #3, FD&amp;C Yellow #6, Yellow Iron Oxide, FD&amp;C Blue #2, and titanium dioxide, and are imprinted with white ink; and the 300 mg capsule shells contain gelatin-NF, FD&amp;C Blue #2, FD&amp;C Yellow #6, Red Iron Oxide, Yellow Iron Oxide, and titanium dioxide, and are imprinted with white ink.</Description>
  </NDC>
  <NDC>
    <NDCCode>66993-408-32</NDCCode>
    <PackageDescription>120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66993-408-32) </PackageDescription>
    <NDC11Code>66993-0408-32</NDC11Code>
    <ProductNDC>66993-408</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carbamazepine</ProprietaryName>
    <NonProprietaryName>Carbamazepine</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20111215</StartMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA020712</ApplicationNumber>
    <LabelerName>Prasco Laboratories</LabelerName>
    <SubstanceName>CARBAMAZEPINE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-06-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20111215</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: 1 Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvements than those with other types., 2 Generalized tonic-clonic seizures (grand mal)., 3 Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see PRECAUTIONS, General).</IndicationAndUsage>
    <Description>Carbamazepine is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as 100 mg, 200 mg and 300 mg extended-release capsules of Carbamazepine, USP. Carbamazepine is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27. Its chemical name is 5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula is. Carbamazepine is a multi-component capsule formulation consisting of three different types of beads: immediate-release beads, extended-release beads, and enteric-release beads. The three bead types are combined in a specific ratio to provide twice daily dosing of carbamazepine. Inactive ingredients: citric acid, colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, povidone, sodium lauryl sulfate, talc, triethyl citrate and other ingredients. The 100 mg capsule shells contain gelatin-NF, FD&amp;C Blue #2, Yellow Iron Oxide, and titanium dioxide and are imprinted with white ink; the 200 mg capsule shells contain gelatin-NF, FD&amp;C Red #3, FD&amp;C Yellow #6, Yellow Iron Oxide, FD&amp;C Blue #2, and titanium dioxide, and are imprinted with white ink; and the 300 mg capsule shells contain gelatin-NF, FD&amp;C Blue #2, FD&amp;C Yellow #6, Red Iron Oxide, Yellow Iron Oxide, and titanium dioxide, and are imprinted with white ink.</Description>
  </NDC>
  <NDC>
    <NDCCode>66993-409-32</NDCCode>
    <PackageDescription>120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66993-409-32) </PackageDescription>
    <NDC11Code>66993-0409-32</NDC11Code>
    <ProductNDC>66993-409</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carbamazepine</ProprietaryName>
    <NonProprietaryName>Carbamazepine</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20111215</StartMarketingDate>
    <EndMarketingDate>20250630</EndMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA020712</ApplicationNumber>
    <LabelerName>Prasco Laboratories</LabelerName>
    <SubstanceName>CARBAMAZEPINE</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-06-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20111215</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250630</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>66993-571-64</NDCCode>
    <PackageDescription>1 INHALER in 1 CARTON (66993-571-64)  &gt; 60 AEROSOL, METERED in 1 INHALER</PackageDescription>
    <NDC11Code>66993-0571-64</NDC11Code>
    <ProductNDC>66993-571</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ciclesonide</ProprietaryName>
    <NonProprietaryName>Ciclesonide</NonProprietaryName>
    <DosageFormName>AEROSOL, METERED</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20210501</StartMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA021658</ApplicationNumber>
    <LabelerName>Prasco Laboratories</LabelerName>
    <SubstanceName>CICLESONIDE</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>ug/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-05-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>66993-572-64</NDCCode>
    <PackageDescription>1 INHALER in 1 CARTON (66993-572-64)  &gt; 60 AEROSOL, METERED in 1 INHALER</PackageDescription>
    <NDC11Code>66993-0572-64</NDC11Code>
    <ProductNDC>66993-572</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ciclesonide</ProprietaryName>
    <NonProprietaryName>Ciclesonide</NonProprietaryName>
    <DosageFormName>AEROSOL, METERED</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20210501</StartMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA021658</ApplicationNumber>
    <LabelerName>Prasco Laboratories</LabelerName>
    <SubstanceName>CICLESONIDE</SubstanceName>
    <StrengthNumber>160</StrengthNumber>
    <StrengthUnit>ug/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-05-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>66993-902-06</NDCCode><ProprietaryName>Prascion</ProprietaryName><NonProprietaryName>Sodium Sulfacetamide And Sulfur</NonProprietaryName></NDC><NDC><NDCCode>66993-902-12</NDCCode><ProprietaryName>Prascion</ProprietaryName><NonProprietaryName>Sodium Sulfacetamide And Sulfur</NonProprietaryName></NDC><NDC><NDCCode>66993-100-06</NDCCode><ProprietaryName>Levetiracetam</ProprietaryName><NonProprietaryName>Levetiracetam</NonProprietaryName></NDC><NDC><NDCCode>66993-926-06</NDCCode><ProprietaryName>Lavoclen</ProprietaryName><NonProprietaryName>Benzoyl Peroxide</NonProprietaryName></NDC><NDC><NDCCode>66993-927-06</NDCCode><ProprietaryName>Lavoclen</ProprietaryName><NonProprietaryName>Benzoyl Peroxide</NonProprietaryName></NDC><NDC><NDCCode>41250-902-06</NDCCode><ProprietaryName>Baby Sunscreen Spf 50</ProprietaryName><NonProprietaryName>Titanium Dioxide 3.1% Zinc Oxide 4.0%</NonProprietaryName></NDC><NDC><NDCCode>42385-902-06</NDCCode><ProprietaryName>Metformin Hydrochloride</ProprietaryName><NonProprietaryName>Metformin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>51316-902-06</NDCCode><ProprietaryName>Cvs Health Senna Plus Stool Softener Laxative Softgel</ProprietaryName><NonProprietaryName>Docusate Sodium, Sennosides</NonProprietaryName></NDC><NDC><NDCCode>52862-902-06</NDCCode><ProprietaryName>Health Smart Vaporizing Chest Rub</ProprietaryName><NonProprietaryName>Menthol And Camphor And Eucalyptus Oil</NonProprietaryName></NDC><NDC><NDCCode>54257-902-06</NDCCode><ProprietaryName>Stool Softener Docusate Sodium</ProprietaryName><NonProprietaryName>Docusate Sodium</NonProprietaryName></NDC><NDC><NDCCode>59735-902-06</NDCCode><ProprietaryName>Amazonian Clay Bb Tinted Moisturizer Broad Spectrum Spf 20 Sunscreen</ProprietaryName><NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>64380-902-06</NDCCode><ProprietaryName>Fluoxetine</ProprietaryName><NonProprietaryName>Fluoxetine</NonProprietaryName></NDC><NDC><NDCCode>68428-902-06</NDCCode><ProprietaryName>Cadmium Metallicum</ProprietaryName><NonProprietaryName>Cadmium</NonProprietaryName></NDC><NDC><NDCCode>78870-902-06</NDCCode><ProprietaryName>Safeact Claening Wipes</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>66993-115-60</NDCCode><ProprietaryName>Propafenone Hydrochloride</ProprietaryName><NonProprietaryName>Propafenone Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>66993-135-97</NDCCode><ProprietaryName>Fluticasone Furoate And Vilanterol</ProprietaryName><NonProprietaryName>Fluticasone Furoate And Vilanterol</NonProprietaryName></NDC><NDC><NDCCode>66993-136-97</NDCCode><ProprietaryName>Fluticasone Furoate And Vilanterol</ProprietaryName><NonProprietaryName>Fluticasone Furoate And Vilanterol</NonProprietaryName></NDC><NDC><NDCCode>66993-343-30</NDCCode><ProprietaryName>Eplerenone</ProprietaryName><NonProprietaryName>Eplerenone</NonProprietaryName></NDC><NDC><NDCCode>66993-343-85</NDCCode><ProprietaryName>Eplerenone</ProprietaryName><NonProprietaryName>Eplerenone</NonProprietaryName></NDC><NDC><NDCCode>66993-344-85</NDCCode><ProprietaryName>Eplerenone</ProprietaryName><NonProprietaryName>Eplerenone</NonProprietaryName></NDC><NDC><NDCCode>66993-350-80</NDCCode><ProprietaryName>Lansoprazole Delayed-release Orally Disintegrating</ProprietaryName><NonProprietaryName>Lansoprazole</NonProprietaryName></NDC><NDC><NDCCode>66993-351-80</NDCCode><ProprietaryName>Lansoprazole Delayed-release Orally Disintegrating</ProprietaryName><NonProprietaryName>Lansoprazole</NonProprietaryName></NDC><NDC><NDCCode>66993-361-60</NDCCode><ProprietaryName>Dapagliflozin And Metformin Hydrochloride</ProprietaryName><NonProprietaryName>Dapagliflozin And Metformin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>66993-362-30</NDCCode><ProprietaryName>Dapagliflozin And Metformin Hydrochloride</ProprietaryName><NonProprietaryName>Dapagliflozin And Metformin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>66993-372-02</NDCCode><ProprietaryName>Phenytoin Infatabs</ProprietaryName><NonProprietaryName>Phenytoin</NonProprietaryName></NDC><NDC><NDCCode>66993-407-32</NDCCode><ProprietaryName>Carbamazepine</ProprietaryName><NonProprietaryName>Carbamazepine</NonProprietaryName></NDC><NDC><NDCCode>66993-408-32</NDCCode><ProprietaryName>Carbamazepine</ProprietaryName><NonProprietaryName>Carbamazepine</NonProprietaryName></NDC><NDC><NDCCode>66993-409-32</NDCCode><ProprietaryName>Carbamazepine</ProprietaryName><NonProprietaryName>Carbamazepine</NonProprietaryName></NDC><NDC><NDCCode>66993-571-64</NDCCode><ProprietaryName>Ciclesonide</ProprietaryName><NonProprietaryName>Ciclesonide</NonProprietaryName></NDC><NDC><NDCCode>66993-572-64</NDCCode><ProprietaryName>Ciclesonide</ProprietaryName><NonProprietaryName>Ciclesonide</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/04/2006",
      "LastUpdateDate": "12/11/2007",
      "AuthorizedOfficialLastName": "MONTECILLO",
      "AuthorizedOfficialFirstName": "RANIA",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-7363",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "801TX",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1346319878",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "REDMOND EYE CLINIC PLLC",
      "FirstLineMailingAddress": "16150 NE 85TH ST STE 206",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3543",
      "MailingAddressCountryCode": "US",
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      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

                
{
  "NPI": [
    {
      "NPI": "1083349906",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "STAFFORD",
      "FirstName": "KADY",
      "NamePrefix": "MS.",
      "Credential": "LPC",
      "FirstLineMailingAddress": "13574 SW HIGHWAY 126",
      "MailingAddressCityName": "POWELL BUTTE",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97753-1541",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-480-6360",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-203-0307",
      "EnumerationDate": "07/24/2022",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional Counselor",
      "LicenseNumber1": "LPC6225",
      "LicenseNumberStateCode1": "ID",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C9084",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1215724679",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "SCHAY",
      "FirstName": "ANGELICA",
      "MiddleName": "NICOLE",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1841",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1841",
      "EnumerationDate": "04/21/2025",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101Y00000X",
      "Taxonomy1": "Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101Y00000X",
      "PrimaryTaxonomy": "Counselor"
    },
    {
      "NPI": "1013556505",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "IVENS",
      "FirstName": "KRYSTA",
      "FirstLineMailingAddress": "743 NW QUINCE AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-1250",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "360-526-1448",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "971-217-6150",
      "EnumerationDate": "12/31/2019",
      "LastUpdateDate": "02/15/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C7963",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "02/15/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1497336275",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ARANT",
      "FirstName": "ERIN",
      "MiddleName": "HENNESSEY",
      "FirstLineMailingAddress": "4639 SW 37TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-6776",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "04/14/2021",
      "LastUpdateDate": "04/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "225X00000X",
      "Taxonomy1": "Occupational Therapist",
      "LicenseNumber1": "390047",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/14/2021",
      "PrimaryTaxonomyCode": "225X00000X",
      "PrimaryTaxonomy": "Occupational Therapist"
    },
    {
      "NPI": "1174191407",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "GRIMALT",
      "FirstName": "EUGENIA",
      "MiddleName": "N",
      "Credential": "PT",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "06/14/2021",
      "LastUpdateDate": "06/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "2251P0200X",
      "Taxonomy1": "Pediatric Physical Therapist",
      "LicenseNumber1": "63979",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization.",
      "CertificationDate": "06/14/2021",
      "PrimaryTaxonomyCode": "2251P0200X",
      "PrimaryTaxonomy": "Pediatric Physical Therapist"
    },
    {
      "NPI": "1912604117",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "PAINTER",
      "FirstName": "JENNIFER",
      "FirstLineMailingAddress": "20080 DOANNA WAY UNIT 3",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-2931",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "209-743-9813",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/08/2023",
      "LastUpdateDate": "02/08/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/08/2023",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1396434700",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "GROVE",
      "FirstName": "JENNIFER",
      "MiddleName": "RHEA",
      "FirstLineMailingAddress": "303 NW BROADWAY ST",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97703-2658",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "801-573-6047",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "801-573-6047",
      "EnumerationDate": "05/02/2023",
      "LastUpdateDate": "05/02/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1041C0700X",
      "Taxonomy1": "Clinical Social Worker",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "05/02/2023",
      "PrimaryTaxonomyCode": "1041C0700X",
      "PrimaryTaxonomy": "Clinical Social Worker"
    },
    {
      "NPI": "1407698970",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "REDDEN",
      "FirstName": "SHANNON",
      "Credential": "CHW",
      "OtherLastName": "MCDOUGALL",
      "OtherFirstName": "SHANNON",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2312 NE 5TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8488",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-460-2192",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "PracticeLocationAddressFaxNumber": "541-550-7956",
      "EnumerationDate": "06/06/2024",
      "LastUpdateDate": "06/06/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "172V00000X",
      "Taxonomy1": "Community Health Worker",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "06/06/2024",
      "PrimaryTaxonomyCode": "172V00000X",
      "PrimaryTaxonomy": "Community Health Worker"
    },
    {
      "NPI": "1942022256",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "JACQUOT",
      "FirstName": "SHAYLA",
      "FirstLineMailingAddress": "PO BOX 1397",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97709-1397",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "10/28/2024",
      "LastUpdateDate": "10/28/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "10/26/2024",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1912723131",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "WEIMER",
      "FirstName": "ALAYNA",
      "FirstLineMailingAddress": "2748 NW 19TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-7766",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-499-8292",
      "EnumerationDate": "12/03/2024",
      "LastUpdateDate": "12/03/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "171M00000X",
      "Taxonomy1": "Case Manager/Care Coordinator",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/03/2024",
      "PrimaryTaxonomyCode": "171M00000X",
      "PrimaryTaxonomy": "Case Manager/Care Coordinator"
    },
    {
      "NPI": "1790594125",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "WIDDER",
      "FirstName": "JENNIFER",
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      "Gender": "Female",
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      "PrimaryTaxonomy": "Peer Specialist"
    },
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      "NPI": "1538965306",
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      "FirstLineMailingAddress": "2821 SW 28TH ST",
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      "MailingAddressCountryCode": "US",
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      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/21/2025",
      "LastUpdateDate": "02/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "175T00000X",
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      "CertificationDate": "02/21/2025",
      "PrimaryTaxonomyCode": "175T00000X",
      "PrimaryTaxonomy": "Peer Specialist"
    }
  ]
}
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