RESTful Lookup — Test-Drive (2007 – 2026)

Query complete (39 ms elapsed)

{
  "NDC": [
    {
      "NDCCode": "0799-0001-06",
      "PackageDescription": "20 g in 1 TUBE (0799-0001-06) ",
      "NDC11Code": "00799-0001-06",
      "ProductNDC": "0799-0001",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Calmoseptine",
      "NonProprietaryName": "Anorectal Ointment",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "19500801",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M015",
      "LabelerName": "Calmoseptine Inc.",
      "SubstanceName": "LANOLIN; MENTHOL; PETROLATUM; ZINC OXIDE",
      "StrengthNumber": "15.7; .44; 24; 20.6",
      "StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
      "Status": "Active",
      "LastUpdate": "2025-01-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20170703",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporarily protects irritated areas. For the temporary relief of:.   local itching and discomfort in the perianal area.   pain or burning.   skin irritations."
    },
    {
      "NDCCode": "53329-799-06",
      "PackageDescription": "473 mL in 1 BOTTLE (53329-799-06) ",
      "NDC11Code": "53329-0799-06",
      "ProductNDC": "53329-799",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Isopropyl Alcohol",
      "NonProprietaryName": "Isopropyl Alcohol",
      "DosageFormName": "SOLUTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20150806",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M003",
      "LabelerName": "Medline Industries, LP",
      "SubstanceName": "ISOPROPYL ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Active",
      "LastUpdate": "2026-02-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20150806",
      "SamplePackage": "N",
      "IndicationAndUsage": "first aid to help prevent the risk of infection in. : 1 minor cuts, 2 scrapes, 3 burns."
    },
    {
      "NDCCode": "64380-799-06",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE (64380-799-06) ",
      "NDC11Code": "64380-0799-06",
      "ProductNDC": "64380-799",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oseltamivir Phosphate",
      "NonProprietaryName": "Oseltamivir Phosphate",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20181005",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209421",
      "LabelerName": "Strides Pharma Science Limited",
      "SubstanceName": "OSELTAMIVIR PHOSPHATE",
      "StrengthNumber": "75",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Neuraminidase Inhibitor [EPC], Neuraminidase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-09-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20211130",
      "SamplePackage": "N",
      "IndicationAndUsage": "Oseltamivir Phosphate capsule is an influenza neuraminidase inhibitor (NAI) indicated for: 1 Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. (1.1), 2 Prophylaxis of influenza A and B in patients 1 year and older. (1.2).",
      "Description": "Oseltamivir phosphate, an influenza neuraminidase inhibitor (NAI) is available as capsules containing 30 mg, 45 mg, or 75 mg oseltamivir for oral use, in the form of oseltamivir phosphate USP. In addition to the active ingredient, each capsule contains pregelatinized starch, talc, povidone, croscarmellose sodium, and sodium stearyl fumarate.The 30 mg capsule shell contains gelatin, titanium dioxide, water and iron oxide yellow. The 45 mg capsule shell contains gelatin, titanium dioxide, water and iron oxide black. The 75 mg capsule shell contains gelatin, titanium dioxide, water, Iron oxide yellow, Iron oxide red and Sodium lauryl sulfate. Imprinting ink contains shellac, black iron oxide, potassium hydroxide. Oseltamivir phosphate is a White to off-white powder with the chemical name (3R, 4R, 5S) -4-acetylamino-5amino-3(1-ethylpropoxy)-1-cyclohexene-1-carboxylic acid, ethyl ester, phosphate (1:1). The chemical formula is C16H28N2O4 (free base). The molecular weight is 312.4 for oseltamivir free base and 410.4 for oseltamivir phosphate salt. The structural formula is as follows."
    },
    {
      "NDCCode": "65841-799-06",
      "PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-799-06) ",
      "NDC11Code": "65841-0799-06",
      "ProductNDC": "65841-799",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Duloxetine",
      "NonProprietaryName": "Duloxetine",
      "DosageFormName": "CAPSULE, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140527",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090739",
      "LabelerName": "Zydus Lifesciences Limited",
      "SubstanceName": "DULOXETINE HYDROCHLORIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-12-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20140527",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "68382-799-06",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (68382-799-06) ",
      "NDC11Code": "68382-0799-06",
      "ProductNDC": "68382-799",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Labetalol Hydrochloride",
      "NonProprietaryName": "Labetalol Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20171205",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207743",
      "LabelerName": "Zydus Pharmaceuticals USA Inc.",
      "SubstanceName": "LABETALOL HYDROCHLORIDE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-03-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20171205",
      "SamplePackage": "N",
      "IndicationAndUsage": "Labetalol hydrochloride tablets, USP are indicated in the management of hypertension. Labetalol hydrochloride tablets USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.",
      "Description": "Labetalol hydrochloride tablets, USP are an adrenergic receptor blocking agent that has both selective Alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl- 3-phenylpropyl)amino]ethyl]benzamide mono hydrochloride and it has the following structure. Labetalol hydrochloride has the molecular formula C19 H24 N2 O3 HCl and a molecular weight of 364.87. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R' stereoisomer, makes up 25% of racemic labetalol. Labetalol hydrochloride, USP is a white or almost white powder. It is sparingly soluble in water and in ethanol (96%), practically insoluble in ether and in methylene chloride. Labetalol hydrochloride tablet, USP for oral administration contain 100 mg, 200 mg or 300 mg labetalol hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sodium starch glycolate (botanical source: potato) and titanium dioxide. Additionally, 100 mg tablets contain D&C yellow #10 Aluminum lake, iron oxide yellow, iron oxide red and talc. 300 mg tablets contain FD&C blue #1 Aluminum lake, iron oxide yellow and talc."
    },
    {
      "NDCCode": "71335-0799-6",
      "PackageDescription": "800 TABLET in 1 BOTTLE (71335-0799-6) ",
      "NDC11Code": "71335-0799-06",
      "ProductNDC": "71335-0799",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amlodipine Besylate",
      "NonProprietaryName": "Amlodipine Besylate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140303",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203245",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "AMLODIPINE BESYLATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2023-03-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20220209",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0799-0001-02",
      "PackageDescription": "71 g in 1 TUBE (0799-0001-02) ",
      "NDC11Code": "00799-0001-02",
      "ProductNDC": "0799-0001",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Calmoseptine",
      "NonProprietaryName": "Anorectal Ointment",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "19500801",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M015",
      "LabelerName": "Calmoseptine Inc.",
      "SubstanceName": "LANOLIN; MENTHOL; PETROLATUM; ZINC OXIDE",
      "StrengthNumber": "15.7; .44; 24; 20.6",
      "StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
      "Status": "Active",
      "LastUpdate": "2025-01-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19990104",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporarily protects irritated areas. For the temporary relief of:.   local itching and discomfort in the perianal area.   pain or burning.   skin irritations."
    },
    {
      "NDCCode": "0799-0001-03",
      "PackageDescription": "71 g in 1 JAR (0799-0001-03) ",
      "NDC11Code": "00799-0001-03",
      "ProductNDC": "0799-0001",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Calmoseptine",
      "NonProprietaryName": "Anorectal Ointment",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "19500801",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M015",
      "LabelerName": "Calmoseptine Inc.",
      "SubstanceName": "LANOLIN; MENTHOL; PETROLATUM; ZINC OXIDE",
      "StrengthNumber": "15.7; .44; 24; 20.6",
      "StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
      "Status": "Active",
      "LastUpdate": "2025-01-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19500801",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporarily protects irritated areas. For the temporary relief of:.   local itching and discomfort in the perianal area.   pain or burning.   skin irritations."
    },
    {
      "NDCCode": "0799-0001-04",
      "PackageDescription": "113 g in 1 TUBE (0799-0001-04) ",
      "NDC11Code": "00799-0001-04",
      "ProductNDC": "0799-0001",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Calmoseptine",
      "NonProprietaryName": "Anorectal Ointment",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "19500801",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M015",
      "LabelerName": "Calmoseptine Inc.",
      "SubstanceName": "LANOLIN; MENTHOL; PETROLATUM; ZINC OXIDE",
      "StrengthNumber": "15.7; .44; 24; 20.6",
      "StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
      "Status": "Active",
      "LastUpdate": "2025-01-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19880801",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporarily protects irritated areas. For the temporary relief of:.   local itching and discomfort in the perianal area.   pain or burning.   skin irritations."
    },
    {
      "NDCCode": "0799-0001-05",
      "PackageDescription": "3.5 g in 1 PACKET (0799-0001-05) ",
      "NDC11Code": "00799-0001-05",
      "ProductNDC": "0799-0001",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Calmoseptine",
      "NonProprietaryName": "Anorectal Ointment",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "19500801",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M015",
      "LabelerName": "Calmoseptine Inc.",
      "SubstanceName": "LANOLIN; MENTHOL; PETROLATUM; ZINC OXIDE",
      "StrengthNumber": "15.7; .44; 24; 20.6",
      "StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
      "Status": "Active",
      "LastUpdate": "2025-01-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20010601",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporarily protects irritated areas. For the temporary relief of:.   local itching and discomfort in the perianal area.   pain or burning.   skin irritations."
    },
    {
      "NDCCode": "63307-611-99",
      "PackageDescription": "1 KIT in 1 CARTON (63307-611-99)  *  20 g in 1 TUBE *  1  in 1 BOX (30707387763658)  *  113 g in 1 TUBE (0799-0001-04)",
      "NDC11Code": "63307-0611-99",
      "ProductNDC": "63307-611",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dermapak Plus",
      "NonProprietaryName": "Zinc Oxide, Menthol, Unspecified Form, And Tretinoin",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20150908",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Total Pharmacy Supply, Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2016-02-05"
    },
    {
      "NDCCode": "69329-600-30",
      "PackageDescription": "1 KIT in 1 CARTON (69329-600-30)  *  113 g in 1 TUBE (0799-0001-04)  *  20 g in 1 TUBE",
      "NDC11Code": "69329-0600-30",
      "ProductNDC": "69329-600",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dermawerx Zmt Pak",
      "NonProprietaryName": "Zinc Oxide, Menthol, Unspecified Form, And Tretinoin",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20150908",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075264",
      "LabelerName": "Patchwerx Labs, Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "Description": "Tretinoin Gel, USP and Tretinoin Cream, USP are used for the topical treatment of acne vulgaris. Each gram of tretinoin gel contains tretinoin in either of two strengths, 0.025% (0.25 mg) or 0.01% (0.1 mg) in a gel vehicle of hydroxypropyl cellulose, butylated hydroxytoluene, and alcohol (denatured with tert-butyl alcohol and brucine sulfate) 90% w/w. Each gram of tretinoin cream contains tretinoin in either of three strengths, 0.1% (1 mg), 0.05% (0.5 mg), or 0.025% (0.25 mg) in a hydrophilic cream vehicle of: stearic acid, isopropyl myristate, polyoxyl 40 stearate, stearyl alcohol, xanthan gum, sorbic acid, butylated hydroxytoluene, and purified water. Chemically, tretinoin is all-trans-retinoic acid. It has a molecular weight of 300.44 and has the following structural formula:."
    },
    {
      "NDCCode": "0185-0799-05",
      "PackageDescription": "500 CAPSULE in 1 BOTTLE (0185-0799-05) ",
      "NDC11Code": "00185-0799-05",
      "ProductNDC": "0185-0799",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Rifampin",
      "NonProprietaryName": "Rifampin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19970528",
      "EndMarketingDate": "20250630",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA064150",
      "LabelerName": "Eon Labs, Inc.",
      "SubstanceName": "RIFAMPIN",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Rifamycin Antibacterial [EPC], Rifamycins [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2025-06-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "19970528",
      "EndMarketingDatePackage": "20250531",
      "SamplePackage": "N",
      "IndicationAndUsage": "In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.",
      "Description": "Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either:. 3-[[(4-methyl-1-piperazinyl)imino]methyl]rifamycin. or. 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18, 20,22-. heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca. [1,11,13]trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is. Rifampin capsules, USP for oral administration, contain 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, D&C Yellow #10 aluminum lake, docusate sodium, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40, FD&C red #40 aluminum lake, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac glaze, sodium benzoate, black iron oxide, talc, and titanium dioxide. The 150 mg capsules also contain D&C yellow #10, and D&C Red #28."
    },
    {
      "NDCCode": "0813-0799-55",
      "PackageDescription": "50 g in 1 TUBE (0813-0799-55) ",
      "NDC11Code": "00813-0799-55",
      "ProductNDC": "0813-0799",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fem Ph",
      "NonProprietaryName": "Acetic Acid And Oxyquinoline Sulfate",
      "DosageFormName": "JELLY",
      "RouteName": "VAGINAL",
      "StartMarketingDate": "19990715",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Pharmics, Inc.",
      "SubstanceName": "ACETIC ACID; OXYQUINOLINE SULFATE",
      "StrengthNumber": ".009; .00025",
      "StrengthUnit": "g/g; g/g",
      "Status": "Deprecated",
      "LastUpdate": "2024-06-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "19990715",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fem pH is indicated as adjunctive therapy in those cases where restoration and maintenance of vaginal acidity is desirable.",
      "Description": "Fem pH Vaginal Jelly is a bland, non-irritating water dispersible, buffered acid jelly for intravaginal use.  Fem pH is classified as a Vaginal Therapeutic Jelly.  Fem pH contains 0.9% glacial acetic acid (C2H402) and 0.025% oxyquinoline sulfate (C18H16N206S) compounded with glycerin, lactic acid, poly ethylene glycol 4500 and purified water.  Fem pH is formulated to pH 3.8-4.3 and is adjusted using 1 N potassium hydroxide."
    },
    {
      "NDCCode": "16714-799-01",
      "PackageDescription": "30 TABLET in 1 BOTTLE (16714-799-01) ",
      "NDC11Code": "16714-0799-01",
      "ProductNDC": "16714-799",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cetirizine Hydrochloride (allergy)",
      "NonProprietaryName": "Cetirizine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150805",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090760",
      "LabelerName": "NorthStar Rx LLC",
      "SubstanceName": "CETIRIZINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-06-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20150805",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies."
    },
    {
      "NDCCode": "16714-799-02",
      "PackageDescription": "100 TABLET in 1 BOTTLE (16714-799-02) ",
      "NDC11Code": "16714-0799-02",
      "ProductNDC": "16714-799",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cetirizine Hydrochloride (allergy)",
      "NonProprietaryName": "Cetirizine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150805",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090760",
      "LabelerName": "NorthStar Rx LLC",
      "SubstanceName": "CETIRIZINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-06-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20150805",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies."
    },
    {
      "NDCCode": "16714-799-03",
      "PackageDescription": "300 TABLET in 1 BOTTLE (16714-799-03) ",
      "NDC11Code": "16714-0799-03",
      "ProductNDC": "16714-799",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cetirizine Hydrochloride (allergy)",
      "NonProprietaryName": "Cetirizine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150805",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090760",
      "LabelerName": "NorthStar Rx LLC",
      "SubstanceName": "CETIRIZINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-06-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20150805",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies."
    },
    {
      "NDCCode": "16714-799-04",
      "PackageDescription": "500 TABLET in 1 BOTTLE (16714-799-04) ",
      "NDC11Code": "16714-0799-04",
      "ProductNDC": "16714-799",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cetirizine Hydrochloride (allergy)",
      "NonProprietaryName": "Cetirizine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150805",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090760",
      "LabelerName": "NorthStar Rx LLC",
      "SubstanceName": "CETIRIZINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-06-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20150805",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies."
    },
    {
      "NDCCode": "54766-799-64",
      "PackageDescription": "30 TUBE, WITH APPLICATOR in 1 CARTON (54766-799-64)  / 4 g in 1 TUBE, WITH APPLICATOR (54766-799-36) ",
      "NDC11Code": "54766-0799-64",
      "ProductNDC": "54766-799",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Analpram Hc",
      "NonProprietaryName": "Hydrocortisone Acetate And Pramoxine Hydrochloride",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20150807",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Sebela Pharmaceuticals Inc.",
      "SubstanceName": "HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE",
      "StrengthNumber": "25; 10",
      "StrengthUnit": "mg/g; mg/g",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-06-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20150807",
      "EndMarketingDatePackage": "20250531",
      "SamplePackage": "N",
      "IndicationAndUsage": "INIDCATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
      "Description": "DESCRIPTION: Analpram HC® Cream 2.5% is a topical preparation containing hydrocortisone acetate 2.5% w/w and pramoxine hydrochloride 1% w/w in a hydrolipid base containing stearic acid, cetyl alcohol, Aquaphor ®, isopropyl palmitate, polyoxyl 40 stearate, propylene glycol, potassium sorbate, sorbic acid, triethanolamine lauryl sulfate, and purified water. Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for active ingredients are presented below. hydrocortisone acetate Pregn-4-ene-3,20-dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11-beta)- C 23H 32O 6; mol. wt.: 404.50. pramoxine hydrochloride  4-(3-(p-butoxyphenoxy)propyl)morpholine hydrochloride  C  17H  27NO  3.HCl; mol. wt.: 329.87."
    },
    {
      "NDCCode": "55111-799-04",
      "PackageDescription": "4 BLISTER PACK in 1 CARTON (55111-799-04)  / 6 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (55111-799-06) ",
      "NDC11Code": "55111-0799-04",
      "ProductNDC": "55111-799",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Guaifenesin And Pseudoephedrine Hcl",
      "NonProprietaryName": "Guaifenesin And Pseudoephedrine Hcl",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20171229",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208369",
      "LabelerName": "Dr. Reddys Laboratories Limited",
      "SubstanceName": "GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE",
      "StrengthNumber": "1200; 120",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-11-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20171229",
      "SamplePackage": "N",
      "IndicationAndUsage": "■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bother some mucus and make coughs more productive. ■ temporarily relieves nasal congestion due to:. ■ common cold. ■ hay fever. ■ upper respiratory allergies. ■ temporarily restores freer breathing through the nose. ■ promotes nasal and/or sinus drainage. ■ temporarily relieves sinus congestion and pressure."
    },
    {
      "NDCCode": "62332-799-31",
      "PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (62332-799-31) ",
      "NDC11Code": "62332-0799-31",
      "ProductNDC": "62332-799",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Carbidopa, Levodopa And Entacapone",
      "NonProprietaryName": "Carbidopa, Levodopa And Entacapone",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260212",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA218535",
      "LabelerName": "Alembic Pharmaceuticals Inc.",
      "SubstanceName": "CARBIDOPA; LEVODOPA; ENTACAPONE",
      "StrengthNumber": "37.5; 150; 200",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC], Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-06-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260212",
      "SamplePackage": "N",
      "IndicationAndUsage": "Carbidopa, levodopa and entacapone tablets are indicated for the treatment of Parkinson’s disease. Carbidopa, levodopa and entacapone tablets can be used:   To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products.   To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose “wearing-off” and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias.",
      "Description": "Carbidopa, levodopa and entacapone tablets are a combination of carbidopa, levodopa, and entacapone for the treatment of Parkinson’s disease. Carbidopa USP, an inhibitor of aromatic amino acid decarboxylation, is a white to creamy white powder, freely soluble in 3 N hydrochloric acid; slightly soluble in water and in methanol; practically insoluble in alcohol, in acetone, in chloroform and in ether, with a molecular weight of 244.3. It is designated chemically as (-)-L-(α-hydrazino-(α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its empirical formula is C10H14N2O4H2O, and its structural formula is:. Tablet content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.3. Levodopa USP, an aromatic amino acid, is a white to off-white, crystalline powder, slightly soluble in water, freely soluble in 3 N hydrochloric acid and insoluble in alcohol, with a molecular weight of 197.2. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its empirical formula is C9H11NO4, and its structural formula is:. Entacapone USP, a COMT inhibitor, is a nitro-catechol-structured compound with a molecular weight of 305.3. The chemical name of entacapone is (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide. Its empirical formula is C14H15N3O5 and its structural formula is. Carbidopa, levodopa and entacapone is supplied as tablets in 6 strengths: Carbidopa, levodopa and entacapone tablets 12.5 mg/50 mg/200 mg: 12.5 mg of carbidopa USP, 50 mg of levodopa USP and 200 mg of entacapone USP. Carbidopa, levodopa and entacapone tablets 18.75 mg/75 mg/200 mg: 18.75 mg of carbidopa USP, 75 mg of levodopa USP and 200 mg of entacapone USP. Carbidopa, levodopa and entacapone tablets 25 mg/100 mg/200 mg: 25 mg of carbidopa USP, 100 mg of levodopa USP and 200 mg of entacapone USP. Carbidopa, levodopa and entacapone tablets 31.25 mg/125 mg/200 mg: 31.25 mg of carbidopa USP, 125 mg of levodopa USP and 200 mg of entacapone USP. Carbidopa, levodopa and entacapone tablets 37.5 mg/150 mg/200 mg: 37.5 mg of carbidopa USP, 150 mg of levodopa USP and 200 mg of entacapone USP. Carbidopa, levodopa and entacapone tablets 50 mg/200 mg/200 mg: 50 mg of carbidopa USP, 200 mg of levodopa USP and 200 mg of entacapone USP. Inactive Ingredients: Mannitol, corn starch, croscarmellose sodium, povidone (K-30), colloidal silicon dioxide, magnesium stearate, hypromellose, glycerin, titanium dioxide, iron oxide red, sucrose, polysorbate 80. Carbidopa, levodopa and entacapone tablets 12.5 mg/50 mg/200 mg, 25 mg/100 mg/200 mg, 31.25 mg/125 mg/200 mg and 37.5 mg/150 mg/200 mg also contain yellow iron oxide."
    },
    {
      "NDCCode": "62332-799-91",
      "PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (62332-799-91) ",
      "NDC11Code": "62332-0799-91",
      "ProductNDC": "62332-799",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Carbidopa, Levodopa And Entacapone",
      "NonProprietaryName": "Carbidopa, Levodopa And Entacapone",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260212",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA218535",
      "LabelerName": "Alembic Pharmaceuticals Inc.",
      "SubstanceName": "CARBIDOPA; LEVODOPA; ENTACAPONE",
      "StrengthNumber": "37.5; 150; 200",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC], Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-06-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260212",
      "SamplePackage": "N",
      "IndicationAndUsage": "Carbidopa, levodopa and entacapone tablets are indicated for the treatment of Parkinson’s disease. Carbidopa, levodopa and entacapone tablets can be used:   To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products.   To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose “wearing-off” and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias.",
      "Description": "Carbidopa, levodopa and entacapone tablets are a combination of carbidopa, levodopa, and entacapone for the treatment of Parkinson’s disease. Carbidopa USP, an inhibitor of aromatic amino acid decarboxylation, is a white to creamy white powder, freely soluble in 3 N hydrochloric acid; slightly soluble in water and in methanol; practically insoluble in alcohol, in acetone, in chloroform and in ether, with a molecular weight of 244.3. It is designated chemically as (-)-L-(α-hydrazino-(α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its empirical formula is C10H14N2O4H2O, and its structural formula is:. Tablet content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.3. Levodopa USP, an aromatic amino acid, is a white to off-white, crystalline powder, slightly soluble in water, freely soluble in 3 N hydrochloric acid and insoluble in alcohol, with a molecular weight of 197.2. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its empirical formula is C9H11NO4, and its structural formula is:. Entacapone USP, a COMT inhibitor, is a nitro-catechol-structured compound with a molecular weight of 305.3. The chemical name of entacapone is (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide. Its empirical formula is C14H15N3O5 and its structural formula is. Carbidopa, levodopa and entacapone is supplied as tablets in 6 strengths: Carbidopa, levodopa and entacapone tablets 12.5 mg/50 mg/200 mg: 12.5 mg of carbidopa USP, 50 mg of levodopa USP and 200 mg of entacapone USP. Carbidopa, levodopa and entacapone tablets 18.75 mg/75 mg/200 mg: 18.75 mg of carbidopa USP, 75 mg of levodopa USP and 200 mg of entacapone USP. Carbidopa, levodopa and entacapone tablets 25 mg/100 mg/200 mg: 25 mg of carbidopa USP, 100 mg of levodopa USP and 200 mg of entacapone USP. Carbidopa, levodopa and entacapone tablets 31.25 mg/125 mg/200 mg: 31.25 mg of carbidopa USP, 125 mg of levodopa USP and 200 mg of entacapone USP. Carbidopa, levodopa and entacapone tablets 37.5 mg/150 mg/200 mg: 37.5 mg of carbidopa USP, 150 mg of levodopa USP and 200 mg of entacapone USP. Carbidopa, levodopa and entacapone tablets 50 mg/200 mg/200 mg: 50 mg of carbidopa USP, 200 mg of levodopa USP and 200 mg of entacapone USP. Inactive Ingredients: Mannitol, corn starch, croscarmellose sodium, povidone (K-30), colloidal silicon dioxide, magnesium stearate, hypromellose, glycerin, titanium dioxide, iron oxide red, sucrose, polysorbate 80. Carbidopa, levodopa and entacapone tablets 12.5 mg/50 mg/200 mg, 25 mg/100 mg/200 mg, 31.25 mg/125 mg/200 mg and 37.5 mg/150 mg/200 mg also contain yellow iron oxide."
    },
    {
      "NDCCode": "63981-799-05",
      "PackageDescription": "3 TUBE in 1 CARTON (63981-799-05)  / 150 g in 1 TUBE (63981-799-03) ",
      "NDC11Code": "63981-0799-05",
      "ProductNDC": "63981-799",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Kirkland Signature Arthritis Pain Relief",
      "NonProprietaryName": "Diclofenac Sodium",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250610",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211253",
      "LabelerName": "Costco Wholesale Company",
      "SubstanceName": "DICLOFENAC SODIUM",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-06-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250610",
      "SamplePackage": "N",
      "IndicationAndUsage": "for the temporary relief of arthritis pain ONLY in the following areas: hand, wrist, elbow (upper body areas)foot, ankle, knee (lower body areas). this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use. ."
    },
    {
      "NDCCode": "64455-799-42",
      "PackageDescription": "90 CAPSULE in 1 BOTTLE, PLASTIC (64455-799-42)",
      "NDC11Code": "64455-0799-42",
      "ProductNDC": "64455-799",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cardizem Cd",
      "NonProprietaryName": "Diltiazem Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20010411",
      "EndMarketingDate": "20150531",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020062",
      "LabelerName": "BTA Pharmaceuticals Inc.",
      "SubstanceName": "DILTIAZEM HYDROCHLORIDE",
      "StrengthNumber": "360",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2015-06-05"
    },
    {
      "NDCCode": "67457-799-99",
      "PackageDescription": "10 POUCH in 1 CARTON (67457-799-99)  / 1 BAG in 1 POUCH (67457-799-20)  / 200 mL in 1 BAG",
      "NDC11Code": "67457-0799-99",
      "ProductNDC": "67457-799",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ropivacaine Hydrochloride",
      "NonProprietaryName": "Ropivacaine Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "EPIDURAL; INFILTRATION; PERINEURAL",
      "StartMarketingDate": "20240318",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206091",
      "LabelerName": "Mylan Institutional LLC",
      "SubstanceName": "ROPIVACAINE HYDROCHLORIDE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2026-06-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240318",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ropivacaine hydrochloride injection is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration.",
      "Description": "Ropivacaine hydrochloride injection, USP is a sterile, isotonic solution that contains ropivacaine hydrochloride as the active pharmaceutical ingredient. Ropivacaine hydrochloride is a member of the amino amide class of local anesthetics. Ropivacaine hydrochloride injection, USP is administered parenterally by for infiltration, epidural, and nerve block. Ropivacaine hydrochloride is chemically described as S-(-)-1-propyl-2',6'-pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder, with the following structural formula. At 25°C ropivacaine hydrochloride has a solubility of 53.8 mg/mL in water, a distribution ratio between n-octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine. Ropivacaine hydrochloride injection, USP is a clear, colorless, and preservative-free solution. Each mL contains 2.1 mg ropivacaine hydrochloride monohydrate (equivalent to 2 mg of ropivacaine hydrochloride anhydrous), and 8.6 mg of sodium chloride; and sodium hydroxide and hydrochloric acid as pH adjusters, in water for injection. The pH is adjusted between 4.0 to 6.0 with. The specific gravity of ropivacaine hydrochloride injection, USP solutions range from 1.002 to 1.009 at 25°C."
    },
    {
      "NDCCode": "68382-799-01",
      "PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (68382-799-01) ",
      "NDC11Code": "68382-0799-01",
      "ProductNDC": "68382-799",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Labetalol Hydrochloride",
      "NonProprietaryName": "Labetalol Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20171205",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207743",
      "LabelerName": "Zydus Pharmaceuticals USA Inc.",
      "SubstanceName": "LABETALOL HYDROCHLORIDE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-03-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20171205",
      "SamplePackage": "N",
      "IndicationAndUsage": "Labetalol hydrochloride tablets, USP are indicated in the management of hypertension. Labetalol hydrochloride tablets USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.",
      "Description": "Labetalol hydrochloride tablets, USP are an adrenergic receptor blocking agent that has both selective Alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl- 3-phenylpropyl)amino]ethyl]benzamide mono hydrochloride and it has the following structure. Labetalol hydrochloride has the molecular formula C19 H24 N2 O3 HCl and a molecular weight of 364.87. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R' stereoisomer, makes up 25% of racemic labetalol. Labetalol hydrochloride, USP is a white or almost white powder. It is sparingly soluble in water and in ethanol (96%), practically insoluble in ether and in methylene chloride. Labetalol hydrochloride tablet, USP for oral administration contain 100 mg, 200 mg or 300 mg labetalol hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sodium starch glycolate (botanical source: potato) and titanium dioxide. Additionally, 100 mg tablets contain D&C yellow #10 Aluminum lake, iron oxide yellow, iron oxide red and talc. 300 mg tablets contain FD&C blue #1 Aluminum lake, iron oxide yellow and talc."
    },
    {
      "NDCCode": "68382-799-05",
      "PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (68382-799-05) ",
      "NDC11Code": "68382-0799-05",
      "ProductNDC": "68382-799",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Labetalol Hydrochloride",
      "NonProprietaryName": "Labetalol Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20171205",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207743",
      "LabelerName": "Zydus Pharmaceuticals USA Inc.",
      "SubstanceName": "LABETALOL HYDROCHLORIDE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-03-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20171205",
      "SamplePackage": "N",
      "IndicationAndUsage": "Labetalol hydrochloride tablets, USP are indicated in the management of hypertension. Labetalol hydrochloride tablets USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.",
      "Description": "Labetalol hydrochloride tablets, USP are an adrenergic receptor blocking agent that has both selective Alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl- 3-phenylpropyl)amino]ethyl]benzamide mono hydrochloride and it has the following structure. Labetalol hydrochloride has the molecular formula C19 H24 N2 O3 HCl and a molecular weight of 364.87. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R' stereoisomer, makes up 25% of racemic labetalol. Labetalol hydrochloride, USP is a white or almost white powder. It is sparingly soluble in water and in ethanol (96%), practically insoluble in ether and in methylene chloride. Labetalol hydrochloride tablet, USP for oral administration contain 100 mg, 200 mg or 300 mg labetalol hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sodium starch glycolate (botanical source: potato) and titanium dioxide. Additionally, 100 mg tablets contain D&C yellow #10 Aluminum lake, iron oxide yellow, iron oxide red and talc. 300 mg tablets contain FD&C blue #1 Aluminum lake, iron oxide yellow and talc."
    },
    {
      "NDCCode": "68382-799-16",
      "PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (68382-799-16) ",
      "NDC11Code": "68382-0799-16",
      "ProductNDC": "68382-799",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Labetalol Hydrochloride",
      "NonProprietaryName": "Labetalol Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20171205",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207743",
      "LabelerName": "Zydus Pharmaceuticals USA Inc.",
      "SubstanceName": "LABETALOL HYDROCHLORIDE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-03-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20171205",
      "SamplePackage": "N",
      "IndicationAndUsage": "Labetalol hydrochloride tablets, USP are indicated in the management of hypertension. Labetalol hydrochloride tablets USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.",
      "Description": "Labetalol hydrochloride tablets, USP are an adrenergic receptor blocking agent that has both selective Alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl- 3-phenylpropyl)amino]ethyl]benzamide mono hydrochloride and it has the following structure. Labetalol hydrochloride has the molecular formula C19 H24 N2 O3 HCl and a molecular weight of 364.87. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R' stereoisomer, makes up 25% of racemic labetalol. Labetalol hydrochloride, USP is a white or almost white powder. It is sparingly soluble in water and in ethanol (96%), practically insoluble in ether and in methylene chloride. Labetalol hydrochloride tablet, USP for oral administration contain 100 mg, 200 mg or 300 mg labetalol hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sodium starch glycolate (botanical source: potato) and titanium dioxide. Additionally, 100 mg tablets contain D&C yellow #10 Aluminum lake, iron oxide yellow, iron oxide red and talc. 300 mg tablets contain FD&C blue #1 Aluminum lake, iron oxide yellow and talc."
    },
    {
      "NDCCode": "70518-0799-0",
      "PackageDescription": "30 CAPSULE in 1 BLISTER PACK (70518-0799-0) ",
      "NDC11Code": "70518-0799-00",
      "ProductNDC": "70518-0799",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Nitrofurantoin",
      "ProprietaryNameSuffix": "(monohydrate/macrocrystals)",
      "NonProprietaryName": "Nitrofurantoin Monohydrate/macrocrystals",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20171019",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207372",
      "LabelerName": "REMEDYREPACK INC.",
      "SubstanceName": "NITROFURANTOIN MONOHYDRATE; NITROFURANTOIN",
      "StrengthNumber": "75; 25",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Nitrofurans [CS],Nitrofuran Antibacterial [EPC],Nitrofurans [CS],Nitrofuran Antibacterial [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2020-05-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20171019",
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    {
      "NDCCode": "70518-0799-1",
      "PackageDescription": "14 CAPSULE in 1 BLISTER PACK (70518-0799-1) ",
      "NDC11Code": "70518-0799-01",
      "ProductNDC": "70518-0799",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Nitrofurantoin",
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      "NonProprietaryName": "Nitrofurantoin Monohydrate/macrocrystals",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20171019",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207372",
      "LabelerName": "REMEDYREPACK INC.",
      "SubstanceName": "NITROFURANTOIN MONOHYDRATE; NITROFURANTOIN",
      "StrengthNumber": "75; 25",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Nitrofurans [CS],Nitrofuran Antibacterial [EPC],Nitrofurans [CS],Nitrofuran Antibacterial [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2020-05-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20180511",
      "SamplePackage": "N"
    }
  ]
}
                    

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    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Calmoseptine</ProprietaryName>
    <NonProprietaryName>Anorectal Ointment</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
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    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M015</ApplicationNumber>
    <LabelerName>Calmoseptine Inc.</LabelerName>
    <SubstanceName>LANOLIN; MENTHOL; PETROLATUM; ZINC OXIDE</SubstanceName>
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    <StrengthUnit>g/100g; g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-01-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170703</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temporarily protects irritated areas. For the temporary relief of:.   local itching and discomfort in the perianal area.   pain or burning.   skin irritations.</IndicationAndUsage>
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  <NDC>
    <NDCCode>53329-799-06</NDCCode>
    <PackageDescription>473 mL in 1 BOTTLE (53329-799-06) </PackageDescription>
    <NDC11Code>53329-0799-06</NDC11Code>
    <ProductNDC>53329-799</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Isopropyl Alcohol</ProprietaryName>
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    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20150806</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M003</ApplicationNumber>
    <LabelerName>Medline Industries, LP</LabelerName>
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    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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    <IndicationAndUsage>first aid to help prevent the risk of infection in. : 1 minor cuts, 2 scrapes, 3 burns.</IndicationAndUsage>
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  <NDC>
    <NDCCode>64380-799-06</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (64380-799-06) </PackageDescription>
    <NDC11Code>64380-0799-06</NDC11Code>
    <ProductNDC>64380-799</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oseltamivir Phosphate</ProprietaryName>
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    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209421</ApplicationNumber>
    <LabelerName>Strides Pharma Science Limited</LabelerName>
    <SubstanceName>OSELTAMIVIR PHOSPHATE</SubstanceName>
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    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Neuraminidase Inhibitor [EPC], Neuraminidase Inhibitors [MoA]</Pharm_Classes>
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    <LastUpdate>2026-09-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Oseltamivir Phosphate capsule is an influenza neuraminidase inhibitor (NAI) indicated for: 1 Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. (1.1), 2 Prophylaxis of influenza A and B in patients 1 year and older. (1.2).</IndicationAndUsage>
    <Description>Oseltamivir phosphate, an influenza neuraminidase inhibitor (NAI) is available as capsules containing 30 mg, 45 mg, or 75 mg oseltamivir for oral use, in the form of oseltamivir phosphate USP. In addition to the active ingredient, each capsule contains pregelatinized starch, talc, povidone, croscarmellose sodium, and sodium stearyl fumarate.The 30 mg capsule shell contains gelatin, titanium dioxide, water and iron oxide yellow. The 45 mg capsule shell contains gelatin, titanium dioxide, water and iron oxide black. The 75 mg capsule shell contains gelatin, titanium dioxide, water, Iron oxide yellow, Iron oxide red and Sodium lauryl sulfate. Imprinting ink contains shellac, black iron oxide, potassium hydroxide. Oseltamivir phosphate is a White to off-white powder with the chemical name (3R, 4R, 5S) -4-acetylamino-5amino-3(1-ethylpropoxy)-1-cyclohexene-1-carboxylic acid, ethyl ester, phosphate (1:1). The chemical formula is C16H28N2O4 (free base). The molecular weight is 312.4 for oseltamivir free base and 410.4 for oseltamivir phosphate salt. The structural formula is as follows.</Description>
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    <NDCCode>65841-799-06</NDCCode>
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    <NDC11Code>65841-0799-06</NDC11Code>
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    <ProprietaryName>Duloxetine</ProprietaryName>
    <NonProprietaryName>Duloxetine</NonProprietaryName>
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    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090739</ApplicationNumber>
    <LabelerName>Zydus Lifesciences Limited</LabelerName>
    <SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
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    <LastUpdate>2024-12-03</LastUpdate>
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    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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    <SamplePackage>N</SamplePackage>
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    <LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
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    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
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    <LastUpdate>2026-03-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Labetalol hydrochloride tablets, USP are indicated in the management of hypertension. Labetalol hydrochloride tablets USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.</IndicationAndUsage>
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  <NDC>
    <NDCCode>71335-0799-6</NDCCode>
    <PackageDescription>800 TABLET in 1 BOTTLE (71335-0799-6) </PackageDescription>
    <NDC11Code>71335-0799-06</NDC11Code>
    <ProductNDC>71335-0799</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amlodipine Besylate</ProprietaryName>
    <NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140303</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203245</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-03-22</LastUpdate>
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    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220209</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
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    <PackageDescription>71 g in 1 TUBE (0799-0001-02) </PackageDescription>
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    <ProductNDC>0799-0001</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Calmoseptine</ProprietaryName>
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    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
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    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M015</ApplicationNumber>
    <LabelerName>Calmoseptine Inc.</LabelerName>
    <SubstanceName>LANOLIN; MENTHOL; PETROLATUM; ZINC OXIDE</SubstanceName>
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    <StrengthUnit>g/100g; g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-01-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19990104</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temporarily protects irritated areas. For the temporary relief of:.   local itching and discomfort in the perianal area.   pain or burning.   skin irritations.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0799-0001-03</NDCCode>
    <PackageDescription>71 g in 1 JAR (0799-0001-03) </PackageDescription>
    <NDC11Code>00799-0001-03</NDC11Code>
    <ProductNDC>0799-0001</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Calmoseptine</ProprietaryName>
    <NonProprietaryName>Anorectal Ointment</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>19500801</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M015</ApplicationNumber>
    <LabelerName>Calmoseptine Inc.</LabelerName>
    <SubstanceName>LANOLIN; MENTHOL; PETROLATUM; ZINC OXIDE</SubstanceName>
    <StrengthNumber>15.7; .44; 24; 20.6</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-01-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19500801</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temporarily protects irritated areas. For the temporary relief of:.   local itching and discomfort in the perianal area.   pain or burning.   skin irritations.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0799-0001-04</NDCCode>
    <PackageDescription>113 g in 1 TUBE (0799-0001-04) </PackageDescription>
    <NDC11Code>00799-0001-04</NDC11Code>
    <ProductNDC>0799-0001</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Calmoseptine</ProprietaryName>
    <NonProprietaryName>Anorectal Ointment</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>19500801</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M015</ApplicationNumber>
    <LabelerName>Calmoseptine Inc.</LabelerName>
    <SubstanceName>LANOLIN; MENTHOL; PETROLATUM; ZINC OXIDE</SubstanceName>
    <StrengthNumber>15.7; .44; 24; 20.6</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-01-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19880801</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temporarily protects irritated areas. For the temporary relief of:.   local itching and discomfort in the perianal area.   pain or burning.   skin irritations.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0799-0001-05</NDCCode>
    <PackageDescription>3.5 g in 1 PACKET (0799-0001-05) </PackageDescription>
    <NDC11Code>00799-0001-05</NDC11Code>
    <ProductNDC>0799-0001</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Calmoseptine</ProprietaryName>
    <NonProprietaryName>Anorectal Ointment</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>19500801</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M015</ApplicationNumber>
    <LabelerName>Calmoseptine Inc.</LabelerName>
    <SubstanceName>LANOLIN; MENTHOL; PETROLATUM; ZINC OXIDE</SubstanceName>
    <StrengthNumber>15.7; .44; 24; 20.6</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-01-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20010601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temporarily protects irritated areas. For the temporary relief of:.   local itching and discomfort in the perianal area.   pain or burning.   skin irritations.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>63307-611-99</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (63307-611-99)  *  20 g in 1 TUBE *  1  in 1 BOX (30707387763658)  *  113 g in 1 TUBE (0799-0001-04)</PackageDescription>
    <NDC11Code>63307-0611-99</NDC11Code>
    <ProductNDC>63307-611</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dermapak Plus</ProprietaryName>
    <NonProprietaryName>Zinc Oxide, Menthol, Unspecified Form, And Tretinoin</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20150908</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Total Pharmacy Supply, Inc.</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2016-02-05</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>69329-600-30</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (69329-600-30)  *  113 g in 1 TUBE (0799-0001-04)  *  20 g in 1 TUBE</PackageDescription>
    <NDC11Code>69329-0600-30</NDC11Code>
    <ProductNDC>69329-600</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dermawerx Zmt Pak</ProprietaryName>
    <NonProprietaryName>Zinc Oxide, Menthol, Unspecified Form, And Tretinoin</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20150908</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075264</ApplicationNumber>
    <LabelerName>Patchwerx Labs, Inc.</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <Description>Tretinoin Gel, USP and Tretinoin Cream, USP are used for the topical treatment of acne vulgaris. Each gram of tretinoin gel contains tretinoin in either of two strengths, 0.025% (0.25 mg) or 0.01% (0.1 mg) in a gel vehicle of hydroxypropyl cellulose, butylated hydroxytoluene, and alcohol (denatured with tert-butyl alcohol and brucine sulfate) 90% w/w. Each gram of tretinoin cream contains tretinoin in either of three strengths, 0.1% (1 mg), 0.05% (0.5 mg), or 0.025% (0.25 mg) in a hydrophilic cream vehicle of: stearic acid, isopropyl myristate, polyoxyl 40 stearate, stearyl alcohol, xanthan gum, sorbic acid, butylated hydroxytoluene, and purified water. Chemically, tretinoin is all-trans-retinoic acid. It has a molecular weight of 300.44 and has the following structural formula:.</Description>
  </NDC>
  <NDC>
    <NDCCode>0185-0799-05</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (0185-0799-05) </PackageDescription>
    <NDC11Code>00185-0799-05</NDC11Code>
    <ProductNDC>0185-0799</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rifampin</ProprietaryName>
    <NonProprietaryName>Rifampin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19970528</StartMarketingDate>
    <EndMarketingDate>20250630</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA064150</ApplicationNumber>
    <LabelerName>Eon Labs, Inc.</LabelerName>
    <SubstanceName>RIFAMPIN</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Rifamycin Antibacterial [EPC], Rifamycins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>19970528</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250531</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.</IndicationAndUsage>
    <Description>Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either:. 3-[[(4-methyl-1-piperazinyl)imino]methyl]rifamycin. or. 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18, 20,22-. heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca. [1,11,13]trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is. Rifampin capsules, USP for oral administration, contain 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, D&amp;C Yellow #10 aluminum lake, docusate sodium, FD&amp;C blue #1, FD&amp;C blue #1 aluminum lake, FD&amp;C blue #2 aluminum lake, FD&amp;C red #40, FD&amp;C red #40 aluminum lake, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac glaze, sodium benzoate, black iron oxide, talc, and titanium dioxide. The 150 mg capsules also contain D&amp;C yellow #10, and D&amp;C Red #28.</Description>
  </NDC>
  <NDC>
    <NDCCode>0813-0799-55</NDCCode>
    <PackageDescription>50 g in 1 TUBE (0813-0799-55) </PackageDescription>
    <NDC11Code>00813-0799-55</NDC11Code>
    <ProductNDC>0813-0799</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fem Ph</ProprietaryName>
    <NonProprietaryName>Acetic Acid And Oxyquinoline Sulfate</NonProprietaryName>
    <DosageFormName>JELLY</DosageFormName>
    <RouteName>VAGINAL</RouteName>
    <StartMarketingDate>19990715</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Pharmics, Inc.</LabelerName>
    <SubstanceName>ACETIC ACID; OXYQUINOLINE SULFATE</SubstanceName>
    <StrengthNumber>.009; .00025</StrengthNumber>
    <StrengthUnit>g/g; g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-06-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19990715</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fem pH is indicated as adjunctive therapy in those cases where restoration and maintenance of vaginal acidity is desirable.</IndicationAndUsage>
    <Description>Fem pH Vaginal Jelly is a bland, non-irritating water dispersible, buffered acid jelly for intravaginal use.  Fem pH is classified as a Vaginal Therapeutic Jelly.  Fem pH contains 0.9% glacial acetic acid (C2H402) and 0.025% oxyquinoline sulfate (C18H16N206S) compounded with glycerin, lactic acid, poly ethylene glycol 4500 and purified water.  Fem pH is formulated to pH 3.8-4.3 and is adjusted using 1 N potassium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>16714-799-01</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (16714-799-01) </PackageDescription>
    <NDC11Code>16714-0799-01</NDC11Code>
    <ProductNDC>16714-799</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cetirizine Hydrochloride (allergy)</ProprietaryName>
    <NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150805</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090760</ApplicationNumber>
    <LabelerName>NorthStar Rx LLC</LabelerName>
    <SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-06-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150805</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>16714-799-02</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (16714-799-02) </PackageDescription>
    <NDC11Code>16714-0799-02</NDC11Code>
    <ProductNDC>16714-799</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cetirizine Hydrochloride (allergy)</ProprietaryName>
    <NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150805</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090760</ApplicationNumber>
    <LabelerName>NorthStar Rx LLC</LabelerName>
    <SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-06-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150805</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>16714-799-03</NDCCode>
    <PackageDescription>300 TABLET in 1 BOTTLE (16714-799-03) </PackageDescription>
    <NDC11Code>16714-0799-03</NDC11Code>
    <ProductNDC>16714-799</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cetirizine Hydrochloride (allergy)</ProprietaryName>
    <NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150805</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090760</ApplicationNumber>
    <LabelerName>NorthStar Rx LLC</LabelerName>
    <SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-06-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150805</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>16714-799-04</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (16714-799-04) </PackageDescription>
    <NDC11Code>16714-0799-04</NDC11Code>
    <ProductNDC>16714-799</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cetirizine Hydrochloride (allergy)</ProprietaryName>
    <NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150805</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090760</ApplicationNumber>
    <LabelerName>NorthStar Rx LLC</LabelerName>
    <SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-06-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150805</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>54766-799-64</NDCCode>
    <PackageDescription>30 TUBE, WITH APPLICATOR in 1 CARTON (54766-799-64)  / 4 g in 1 TUBE, WITH APPLICATOR (54766-799-36) </PackageDescription>
    <NDC11Code>54766-0799-64</NDC11Code>
    <ProductNDC>54766-799</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Analpram Hc</ProprietaryName>
    <NonProprietaryName>Hydrocortisone Acetate And Pramoxine Hydrochloride</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20150807</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Sebela Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25; 10</StrengthNumber>
    <StrengthUnit>mg/g; mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150807</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250531</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>INIDCATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
    <Description>DESCRIPTION: Analpram HC® Cream 2.5% is a topical preparation containing hydrocortisone acetate 2.5% w/w and pramoxine hydrochloride 1% w/w in a hydrolipid base containing stearic acid, cetyl alcohol, Aquaphor ®, isopropyl palmitate, polyoxyl 40 stearate, propylene glycol, potassium sorbate, sorbic acid, triethanolamine lauryl sulfate, and purified water. Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for active ingredients are presented below. hydrocortisone acetate Pregn-4-ene-3,20-dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11-beta)- C 23H 32O 6; mol. wt.: 404.50. pramoxine hydrochloride  4-(3-(p-butoxyphenoxy)propyl)morpholine hydrochloride  C  17H  27NO  3.HCl; mol. wt.: 329.87.</Description>
  </NDC>
  <NDC>
    <NDCCode>55111-799-04</NDCCode>
    <PackageDescription>4 BLISTER PACK in 1 CARTON (55111-799-04)  / 6 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (55111-799-06) </PackageDescription>
    <NDC11Code>55111-0799-04</NDC11Code>
    <ProductNDC>55111-799</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Guaifenesin And Pseudoephedrine Hcl</ProprietaryName>
    <NonProprietaryName>Guaifenesin And Pseudoephedrine Hcl</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171229</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208369</ApplicationNumber>
    <LabelerName>Dr. Reddys Laboratories Limited</LabelerName>
    <SubstanceName>GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1200; 120</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171229</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bother some mucus and make coughs more productive. ■ temporarily relieves nasal congestion due to:. ■ common cold. ■ hay fever. ■ upper respiratory allergies. ■ temporarily restores freer breathing through the nose. ■ promotes nasal and/or sinus drainage. ■ temporarily relieves sinus congestion and pressure.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>62332-799-31</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (62332-799-31) </PackageDescription>
    <NDC11Code>62332-0799-31</NDC11Code>
    <ProductNDC>62332-799</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carbidopa, Levodopa And Entacapone</ProprietaryName>
    <NonProprietaryName>Carbidopa, Levodopa And Entacapone</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260212</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218535</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>CARBIDOPA; LEVODOPA; ENTACAPONE</SubstanceName>
    <StrengthNumber>37.5; 150; 200</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC], Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260212</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carbidopa, levodopa and entacapone tablets are indicated for the treatment of Parkinson’s disease. Carbidopa, levodopa and entacapone tablets can be used:   To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products.   To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose “wearing-off” and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias.</IndicationAndUsage>
    <Description>Carbidopa, levodopa and entacapone tablets are a combination of carbidopa, levodopa, and entacapone for the treatment of Parkinson’s disease. Carbidopa USP, an inhibitor of aromatic amino acid decarboxylation, is a white to creamy white powder, freely soluble in 3 N hydrochloric acid; slightly soluble in water and in methanol; practically insoluble in alcohol, in acetone, in chloroform and in ether, with a molecular weight of 244.3. It is designated chemically as (-)-L-(α-hydrazino-(α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its empirical formula is C10H14N2O4H2O, and its structural formula is:. Tablet content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.3. Levodopa USP, an aromatic amino acid, is a white to off-white, crystalline powder, slightly soluble in water, freely soluble in 3 N hydrochloric acid and insoluble in alcohol, with a molecular weight of 197.2. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its empirical formula is C9H11NO4, and its structural formula is:. Entacapone USP, a COMT inhibitor, is a nitro-catechol-structured compound with a molecular weight of 305.3. The chemical name of entacapone is (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide. Its empirical formula is C14H15N3O5 and its structural formula is. Carbidopa, levodopa and entacapone is supplied as tablets in 6 strengths: Carbidopa, levodopa and entacapone tablets 12.5 mg/50 mg/200 mg: 12.5 mg of carbidopa USP, 50 mg of levodopa USP and 200 mg of entacapone USP. Carbidopa, levodopa and entacapone tablets 18.75 mg/75 mg/200 mg: 18.75 mg of carbidopa USP, 75 mg of levodopa USP and 200 mg of entacapone USP. Carbidopa, levodopa and entacapone tablets 25 mg/100 mg/200 mg: 25 mg of carbidopa USP, 100 mg of levodopa USP and 200 mg of entacapone USP. Carbidopa, levodopa and entacapone tablets 31.25 mg/125 mg/200 mg: 31.25 mg of carbidopa USP, 125 mg of levodopa USP and 200 mg of entacapone USP. Carbidopa, levodopa and entacapone tablets 37.5 mg/150 mg/200 mg: 37.5 mg of carbidopa USP, 150 mg of levodopa USP and 200 mg of entacapone USP. Carbidopa, levodopa and entacapone tablets 50 mg/200 mg/200 mg: 50 mg of carbidopa USP, 200 mg of levodopa USP and 200 mg of entacapone USP. Inactive Ingredients: Mannitol, corn starch, croscarmellose sodium, povidone (K-30), colloidal silicon dioxide, magnesium stearate, hypromellose, glycerin, titanium dioxide, iron oxide red, sucrose, polysorbate 80. Carbidopa, levodopa and entacapone tablets 12.5 mg/50 mg/200 mg, 25 mg/100 mg/200 mg, 31.25 mg/125 mg/200 mg and 37.5 mg/150 mg/200 mg also contain yellow iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-799-91</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (62332-799-91) </PackageDescription>
    <NDC11Code>62332-0799-91</NDC11Code>
    <ProductNDC>62332-799</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carbidopa, Levodopa And Entacapone</ProprietaryName>
    <NonProprietaryName>Carbidopa, Levodopa And Entacapone</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260212</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218535</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>CARBIDOPA; LEVODOPA; ENTACAPONE</SubstanceName>
    <StrengthNumber>37.5; 150; 200</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC], Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260212</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carbidopa, levodopa and entacapone tablets are indicated for the treatment of Parkinson’s disease. Carbidopa, levodopa and entacapone tablets can be used:   To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products.   To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose “wearing-off” and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias.</IndicationAndUsage>
    <Description>Carbidopa, levodopa and entacapone tablets are a combination of carbidopa, levodopa, and entacapone for the treatment of Parkinson’s disease. Carbidopa USP, an inhibitor of aromatic amino acid decarboxylation, is a white to creamy white powder, freely soluble in 3 N hydrochloric acid; slightly soluble in water and in methanol; practically insoluble in alcohol, in acetone, in chloroform and in ether, with a molecular weight of 244.3. It is designated chemically as (-)-L-(α-hydrazino-(α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its empirical formula is C10H14N2O4H2O, and its structural formula is:. Tablet content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.3. Levodopa USP, an aromatic amino acid, is a white to off-white, crystalline powder, slightly soluble in water, freely soluble in 3 N hydrochloric acid and insoluble in alcohol, with a molecular weight of 197.2. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its empirical formula is C9H11NO4, and its structural formula is:. Entacapone USP, a COMT inhibitor, is a nitro-catechol-structured compound with a molecular weight of 305.3. The chemical name of entacapone is (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide. Its empirical formula is C14H15N3O5 and its structural formula is. Carbidopa, levodopa and entacapone is supplied as tablets in 6 strengths: Carbidopa, levodopa and entacapone tablets 12.5 mg/50 mg/200 mg: 12.5 mg of carbidopa USP, 50 mg of levodopa USP and 200 mg of entacapone USP. Carbidopa, levodopa and entacapone tablets 18.75 mg/75 mg/200 mg: 18.75 mg of carbidopa USP, 75 mg of levodopa USP and 200 mg of entacapone USP. Carbidopa, levodopa and entacapone tablets 25 mg/100 mg/200 mg: 25 mg of carbidopa USP, 100 mg of levodopa USP and 200 mg of entacapone USP. Carbidopa, levodopa and entacapone tablets 31.25 mg/125 mg/200 mg: 31.25 mg of carbidopa USP, 125 mg of levodopa USP and 200 mg of entacapone USP. Carbidopa, levodopa and entacapone tablets 37.5 mg/150 mg/200 mg: 37.5 mg of carbidopa USP, 150 mg of levodopa USP and 200 mg of entacapone USP. Carbidopa, levodopa and entacapone tablets 50 mg/200 mg/200 mg: 50 mg of carbidopa USP, 200 mg of levodopa USP and 200 mg of entacapone USP. Inactive Ingredients: Mannitol, corn starch, croscarmellose sodium, povidone (K-30), colloidal silicon dioxide, magnesium stearate, hypromellose, glycerin, titanium dioxide, iron oxide red, sucrose, polysorbate 80. Carbidopa, levodopa and entacapone tablets 12.5 mg/50 mg/200 mg, 25 mg/100 mg/200 mg, 31.25 mg/125 mg/200 mg and 37.5 mg/150 mg/200 mg also contain yellow iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>63981-799-05</NDCCode>
    <PackageDescription>3 TUBE in 1 CARTON (63981-799-05)  / 150 g in 1 TUBE (63981-799-03) </PackageDescription>
    <NDC11Code>63981-0799-05</NDC11Code>
    <ProductNDC>63981-799</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Kirkland Signature Arthritis Pain Relief</ProprietaryName>
    <NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20250610</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211253</ApplicationNumber>
    <LabelerName>Costco Wholesale Company</LabelerName>
    <SubstanceName>DICLOFENAC SODIUM</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250610</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for the temporary relief of arthritis pain ONLY in the following areas: hand, wrist, elbow (upper body areas)foot, ankle, knee (lower body areas). this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use. .</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>64455-799-42</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE, PLASTIC (64455-799-42)</PackageDescription>
    <NDC11Code>64455-0799-42</NDC11Code>
    <ProductNDC>64455-799</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cardizem Cd</ProprietaryName>
    <NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20010411</StartMarketingDate>
    <EndMarketingDate>20150531</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020062</ApplicationNumber>
    <LabelerName>BTA Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>360</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2015-06-05</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>67457-799-99</NDCCode>
    <PackageDescription>10 POUCH in 1 CARTON (67457-799-99)  / 1 BAG in 1 POUCH (67457-799-20)  / 200 mL in 1 BAG</PackageDescription>
    <NDC11Code>67457-0799-99</NDC11Code>
    <ProductNDC>67457-799</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ropivacaine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Ropivacaine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>EPIDURAL; INFILTRATION; PERINEURAL</RouteName>
    <StartMarketingDate>20240318</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206091</ApplicationNumber>
    <LabelerName>Mylan Institutional LLC</LabelerName>
    <SubstanceName>ROPIVACAINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240318</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ropivacaine hydrochloride injection is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration.</IndicationAndUsage>
    <Description>Ropivacaine hydrochloride injection, USP is a sterile, isotonic solution that contains ropivacaine hydrochloride as the active pharmaceutical ingredient. Ropivacaine hydrochloride is a member of the amino amide class of local anesthetics. Ropivacaine hydrochloride injection, USP is administered parenterally by for infiltration, epidural, and nerve block. Ropivacaine hydrochloride is chemically described as S-(-)-1-propyl-2',6'-pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder, with the following structural formula. At 25°C ropivacaine hydrochloride has a solubility of 53.8 mg/mL in water, a distribution ratio between n-octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine. Ropivacaine hydrochloride injection, USP is a clear, colorless, and preservative-free solution. Each mL contains 2.1 mg ropivacaine hydrochloride monohydrate (equivalent to 2 mg of ropivacaine hydrochloride anhydrous), and 8.6 mg of sodium chloride; and sodium hydroxide and hydrochloric acid as pH adjusters, in water for injection. The pH is adjusted between 4.0 to 6.0 with. The specific gravity of ropivacaine hydrochloride injection, USP solutions range from 1.002 to 1.009 at 25°C.</Description>
  </NDC>
  <NDC>
    <NDCCode>68382-799-01</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (68382-799-01) </PackageDescription>
    <NDC11Code>68382-0799-01</NDC11Code>
    <ProductNDC>68382-799</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Labetalol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Labetalol Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171205</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207743</ApplicationNumber>
    <LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>LABETALOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171205</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Labetalol hydrochloride tablets, USP are indicated in the management of hypertension. Labetalol hydrochloride tablets USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.</IndicationAndUsage>
    <Description>Labetalol hydrochloride tablets, USP are an adrenergic receptor blocking agent that has both selective Alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl- 3-phenylpropyl)amino]ethyl]benzamide mono hydrochloride and it has the following structure. Labetalol hydrochloride has the molecular formula C19 H24 N2 O3 HCl and a molecular weight of 364.87. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R' stereoisomer, makes up 25% of racemic labetalol. Labetalol hydrochloride, USP is a white or almost white powder. It is sparingly soluble in water and in ethanol (96%), practically insoluble in ether and in methylene chloride. Labetalol hydrochloride tablet, USP for oral administration contain 100 mg, 200 mg or 300 mg labetalol hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sodium starch glycolate (botanical source: potato) and titanium dioxide. Additionally, 100 mg tablets contain D&amp;C yellow #10 Aluminum lake, iron oxide yellow, iron oxide red and talc. 300 mg tablets contain FD&amp;C blue #1 Aluminum lake, iron oxide yellow and talc.</Description>
  </NDC>
  <NDC>
    <NDCCode>68382-799-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (68382-799-05) </PackageDescription>
    <NDC11Code>68382-0799-05</NDC11Code>
    <ProductNDC>68382-799</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Labetalol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Labetalol Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171205</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207743</ApplicationNumber>
    <LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>LABETALOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171205</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Labetalol hydrochloride tablets, USP are indicated in the management of hypertension. Labetalol hydrochloride tablets USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.</IndicationAndUsage>
    <Description>Labetalol hydrochloride tablets, USP are an adrenergic receptor blocking agent that has both selective Alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl- 3-phenylpropyl)amino]ethyl]benzamide mono hydrochloride and it has the following structure. Labetalol hydrochloride has the molecular formula C19 H24 N2 O3 HCl and a molecular weight of 364.87. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R' stereoisomer, makes up 25% of racemic labetalol. Labetalol hydrochloride, USP is a white or almost white powder. It is sparingly soluble in water and in ethanol (96%), practically insoluble in ether and in methylene chloride. Labetalol hydrochloride tablet, USP for oral administration contain 100 mg, 200 mg or 300 mg labetalol hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sodium starch glycolate (botanical source: potato) and titanium dioxide. Additionally, 100 mg tablets contain D&amp;C yellow #10 Aluminum lake, iron oxide yellow, iron oxide red and talc. 300 mg tablets contain FD&amp;C blue #1 Aluminum lake, iron oxide yellow and talc.</Description>
  </NDC>
  <NDC>
    <NDCCode>68382-799-16</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (68382-799-16) </PackageDescription>
    <NDC11Code>68382-0799-16</NDC11Code>
    <ProductNDC>68382-799</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Labetalol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Labetalol Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171205</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207743</ApplicationNumber>
    <LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>LABETALOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171205</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Labetalol hydrochloride tablets, USP are indicated in the management of hypertension. Labetalol hydrochloride tablets USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.</IndicationAndUsage>
    <Description>Labetalol hydrochloride tablets, USP are an adrenergic receptor blocking agent that has both selective Alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl- 3-phenylpropyl)amino]ethyl]benzamide mono hydrochloride and it has the following structure. Labetalol hydrochloride has the molecular formula C19 H24 N2 O3 HCl and a molecular weight of 364.87. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R' stereoisomer, makes up 25% of racemic labetalol. Labetalol hydrochloride, USP is a white or almost white powder. It is sparingly soluble in water and in ethanol (96%), practically insoluble in ether and in methylene chloride. Labetalol hydrochloride tablet, USP for oral administration contain 100 mg, 200 mg or 300 mg labetalol hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sodium starch glycolate (botanical source: potato) and titanium dioxide. Additionally, 100 mg tablets contain D&amp;C yellow #10 Aluminum lake, iron oxide yellow, iron oxide red and talc. 300 mg tablets contain FD&amp;C blue #1 Aluminum lake, iron oxide yellow and talc.</Description>
  </NDC>
  <NDC>
    <NDCCode>70518-0799-0</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BLISTER PACK (70518-0799-0) </PackageDescription>
    <NDC11Code>70518-0799-00</NDC11Code>
    <ProductNDC>70518-0799</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nitrofurantoin</ProprietaryName>
    <ProprietaryNameSuffix>(monohydrate/macrocrystals)</ProprietaryNameSuffix>
    <NonProprietaryName>Nitrofurantoin Monohydrate/macrocrystals</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171019</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207372</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</LabelerName>
    <SubstanceName>NITROFURANTOIN MONOHYDRATE; NITROFURANTOIN</SubstanceName>
    <StrengthNumber>75; 25</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Nitrofurans [CS],Nitrofuran Antibacterial [EPC],Nitrofurans [CS],Nitrofuran Antibacterial [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-05-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171019</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>70518-0799-1</NDCCode>
    <PackageDescription>14 CAPSULE in 1 BLISTER PACK (70518-0799-1) </PackageDescription>
    <NDC11Code>70518-0799-01</NDC11Code>
    <ProductNDC>70518-0799</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nitrofurantoin</ProprietaryName>
    <ProprietaryNameSuffix>(monohydrate/macrocrystals)</ProprietaryNameSuffix>
    <NonProprietaryName>Nitrofurantoin Monohydrate/macrocrystals</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171019</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207372</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</LabelerName>
    <SubstanceName>NITROFURANTOIN MONOHYDRATE; NITROFURANTOIN</SubstanceName>
    <StrengthNumber>75; 25</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Nitrofurans [CS],Nitrofuran Antibacterial [EPC],Nitrofurans [CS],Nitrofuran Antibacterial [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-05-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180511</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>0799-0001-06</NDCCode><ProprietaryName>Calmoseptine</ProprietaryName><NonProprietaryName>Anorectal Ointment</NonProprietaryName></NDC><NDC><NDCCode>53329-799-06</NDCCode><ProprietaryName>Isopropyl Alcohol</ProprietaryName><NonProprietaryName>Isopropyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>64380-799-06</NDCCode><ProprietaryName>Oseltamivir Phosphate</ProprietaryName><NonProprietaryName>Oseltamivir Phosphate</NonProprietaryName></NDC><NDC><NDCCode>65841-799-06</NDCCode><ProprietaryName>Duloxetine</ProprietaryName><NonProprietaryName>Duloxetine</NonProprietaryName></NDC><NDC><NDCCode>68382-799-06</NDCCode><ProprietaryName>Labetalol Hydrochloride</ProprietaryName><NonProprietaryName>Labetalol Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>71335-0799-6</NDCCode><ProprietaryName>Amlodipine Besylate</ProprietaryName><NonProprietaryName>Amlodipine Besylate</NonProprietaryName></NDC><NDC><NDCCode>0799-0001-02</NDCCode><ProprietaryName>Calmoseptine</ProprietaryName><NonProprietaryName>Anorectal Ointment</NonProprietaryName></NDC><NDC><NDCCode>0799-0001-03</NDCCode><ProprietaryName>Calmoseptine</ProprietaryName><NonProprietaryName>Anorectal Ointment</NonProprietaryName></NDC><NDC><NDCCode>0799-0001-04</NDCCode><ProprietaryName>Calmoseptine</ProprietaryName><NonProprietaryName>Anorectal Ointment</NonProprietaryName></NDC><NDC><NDCCode>0799-0001-05</NDCCode><ProprietaryName>Calmoseptine</ProprietaryName><NonProprietaryName>Anorectal Ointment</NonProprietaryName></NDC><NDC><NDCCode>63307-611-99</NDCCode><ProprietaryName>Dermapak Plus</ProprietaryName><NonProprietaryName>Zinc Oxide, Menthol, Unspecified Form, And Tretinoin</NonProprietaryName></NDC><NDC><NDCCode>69329-600-30</NDCCode><ProprietaryName>Dermawerx Zmt Pak</ProprietaryName><NonProprietaryName>Zinc Oxide, Menthol, Unspecified Form, And Tretinoin</NonProprietaryName></NDC><NDC><NDCCode>0185-0799-05</NDCCode><ProprietaryName>Rifampin</ProprietaryName><NonProprietaryName>Rifampin</NonProprietaryName></NDC><NDC><NDCCode>0813-0799-55</NDCCode><ProprietaryName>Fem Ph</ProprietaryName><NonProprietaryName>Acetic Acid And Oxyquinoline Sulfate</NonProprietaryName></NDC><NDC><NDCCode>16714-799-01</NDCCode><ProprietaryName>Cetirizine Hydrochloride (allergy)</ProprietaryName><NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>16714-799-02</NDCCode><ProprietaryName>Cetirizine Hydrochloride (allergy)</ProprietaryName><NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>16714-799-03</NDCCode><ProprietaryName>Cetirizine Hydrochloride (allergy)</ProprietaryName><NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>16714-799-04</NDCCode><ProprietaryName>Cetirizine Hydrochloride (allergy)</ProprietaryName><NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>54766-799-64</NDCCode><ProprietaryName>Analpram Hc</ProprietaryName><NonProprietaryName>Hydrocortisone Acetate And Pramoxine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>55111-799-04</NDCCode><ProprietaryName>Guaifenesin And Pseudoephedrine Hcl</ProprietaryName><NonProprietaryName>Guaifenesin And Pseudoephedrine Hcl</NonProprietaryName></NDC><NDC><NDCCode>62332-799-31</NDCCode><ProprietaryName>Carbidopa, Levodopa And Entacapone</ProprietaryName><NonProprietaryName>Carbidopa, Levodopa And Entacapone</NonProprietaryName></NDC><NDC><NDCCode>62332-799-91</NDCCode><ProprietaryName>Carbidopa, Levodopa And Entacapone</ProprietaryName><NonProprietaryName>Carbidopa, Levodopa And Entacapone</NonProprietaryName></NDC><NDC><NDCCode>63981-799-05</NDCCode><ProprietaryName>Kirkland Signature Arthritis Pain Relief</ProprietaryName><NonProprietaryName>Diclofenac Sodium</NonProprietaryName></NDC><NDC><NDCCode>64455-799-42</NDCCode><ProprietaryName>Cardizem Cd</ProprietaryName><NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>67457-799-99</NDCCode><ProprietaryName>Ropivacaine Hydrochloride</ProprietaryName><NonProprietaryName>Ropivacaine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>68382-799-01</NDCCode><ProprietaryName>Labetalol Hydrochloride</ProprietaryName><NonProprietaryName>Labetalol Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>68382-799-05</NDCCode><ProprietaryName>Labetalol Hydrochloride</ProprietaryName><NonProprietaryName>Labetalol Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>68382-799-16</NDCCode><ProprietaryName>Labetalol Hydrochloride</ProprietaryName><NonProprietaryName>Labetalol Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>70518-0799-0</NDCCode><ProprietaryName>Nitrofurantoin</ProprietaryName><NonProprietaryName>Nitrofurantoin Monohydrate/macrocrystals</NonProprietaryName></NDC><NDC><NDCCode>70518-0799-1</NDCCode><ProprietaryName>Nitrofurantoin</ProprietaryName><NonProprietaryName>Nitrofurantoin Monohydrate/macrocrystals</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",
      "MailingAddressTelephoneNumber": "425-885-3574",
      "MailingAddressFaxNumber": "425-881-0230",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "PracticeLocationAddressFaxNumber": "425-881-0230",
      "EnumerationDate": "11/07/2006",
      "LastUpdateDate": "07/08/2007",
      "AuthorizedOfficialLastName": "OTTEN",
      "AuthorizedOfficialFirstName": "LARRY",
      "AuthorizedOfficialMiddleName": "C",
      "AuthorizedOfficialTitle": "DR",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-3574",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "OD00001172",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "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."
    },
    {
      "NPI": "1376755009",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "PERIMAN",
      "FirstName": "LAURA",
      "MiddleName": "MARIE",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "FirstLineMailingAddress": "623 W HIGHLAND DR",
      "MailingAddressCityName": "SEATTLE",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98119-3446",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "206-282-2716",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "SecondLinePracticeLocationAddress": "REDMOND EYE CLINIC",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "EnumerationDate": "05/04/2007",
      "LastUpdateDate": "07/08/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207W00000X",
      "Taxonomy1": "Ophthalmology",
      "LicenseNumber1": "MD00039796",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1659320539",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "MONTECILLO",
      "FirstName": "RANIA",
      "MiddleName": "B",
      "NamePrefix": "DR.",
      "Credential": "OD",
      "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": "05/09/2006",
      "LastUpdateDate": "12/19/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "3680",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1427560267",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ABOU SHADI",
      "FirstName": "RANIA",
      "NamePrefix": "MRS.",
      "Credential": "RPH",
      "FirstLineMailingAddress": "8862 161ST AVENUE NE",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-883-9532",
      "MailingAddressFaxNumber": "425-882-2743",
      "FirstLinePracticeLocationAddress": "8862 161ST AVENUE NE",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-883-9532",
      "PracticeLocationAddressFaxNumber": "425-882-2743",
      "EnumerationDate": "11/02/2017",
      "LastUpdateDate": "11/02/2017",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "3336C0003X",
      "Taxonomy1": "Community/Retail Pharmacy",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1528050523",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "DESCHUTES EYE CLINIC PC",
      "OtherOrgName": "THE EYE SURGERY INSTITUTE",
      "OtherOrgNameTypeCode": "3",
      "FirstLineMailingAddress": "813 SW HIGHLAND AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-3123",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-548-7170",
      "MailingAddressFaxNumber": "541-548-3842",
      "FirstLinePracticeLocationAddress": "813 SW HIGHLAND AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-3123",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-548-7170",
      "PracticeLocationAddressFaxNumber": "541-548-3842",
      "EnumerationDate": "08/17/2005",
      "LastUpdateDate": "12/01/2010",
      "AuthorizedOfficialLastName": "TRAUSTASON",
      "AuthorizedOfficialFirstName": "OLI",
      "AuthorizedOfficialMiddleName": "I",
      "AuthorizedOfficialTitle": "PRESIDENT",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "M.D.",
      "AuthorizedOfficialTelephoneNumber": "541-548-7170",
      "TaxonomyCode1": "207W00000X",
      "Taxonomy1": "Ophthalmology",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "053857000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierState1": "OR",
      "OtherIdentifierIssuer1": "REGENCE BCBS",
      "OtherIdentifier2": "CJ8770",
      "OtherIdentifierType2": "OTHER",
      "OtherIdentifierState2": "OR",
      "OtherIdentifierIssuer2": "RAILROAD MEDICARE",
      "OtherIdentifier3": "38080A",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierState3": "OR",
      "OtherIdentifierIssuer3": "CLEAR CHOICE",
      "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": "1477596252",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "EYE CARE SPECIALISTS NORTHWEST PLLC",
      "OtherOrgName": "THE CHILDRENS EYE DOCTORS, THE FAMILY EYE DOCTORS, WOODLAWN OPTICAL",
      "OtherOrgNameTypeCode": "3",
      "FirstLineMailingAddress": "17130 AVONDALE WAY NE",
      "SecondLineMailingAddress": "SUITE 111",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-6600",
      "MailingAddressFaxNumber": "425-885-6580",
      "FirstLinePracticeLocationAddress": "17130 AVONDALE WAY NE",
      "SecondLinePracticeLocationAddress": "SUITE 111",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-6600",
      "PracticeLocationAddressFaxNumber": "425-885-6580",
      "EnumerationDate": "06/13/2006",
      "LastUpdateDate": "03/03/2008",
      "AuthorizedOfficialLastName": "LENART",
      "AuthorizedOfficialFirstName": "THOMAS",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "MD PHD",
      "AuthorizedOfficialTelephoneNumber": "425-885-6600",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "156FX1800X",
      "Taxonomy2": "Optician",
      "PrimaryTaxonomySwitch2": "N",
      "TaxonomyCode3": "207W00000X",
      "Taxonomy3": "Ophthalmology",
      "PrimaryTaxonomySwitch3": "Y",
      "OtherIdentifier1": "1568514032",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "NPI",
      "OtherIdentifier2": "1740297829",
      "OtherIdentifierType2": "OTHER",
      "OtherIdentifierIssuer2": "NPI",
      "OtherIdentifier3": "1205989522",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "NPI",
      "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.",
      "HealthcareProviderTaxonomyGroup2": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription2": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization.",
      "HealthcareProviderTaxonomyGroup3": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription3": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
    },
    {
      "NPI": "1215029343",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "EYE HEALTH PROFESSIONALS, P.C.",
      "FirstLineMailingAddress": "85 BARNES RD",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "WALLINGFORD",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06492-1832",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "203-284-9448",
      "MailingAddressFaxNumber": "203-269-1361",
      "FirstLinePracticeLocationAddress": "85 BARNES RD",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "WALLINGFORD",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06492-1832",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "203-284-9448",
      "PracticeLocationAddressFaxNumber": "203-269-1361",
      "EnumerationDate": "09/28/2006",
      "LastUpdateDate": "03/07/2008",
      "AuthorizedOfficialLastName": "REDMOND",
      "AuthorizedOfficialFirstName": "JOHN",
      "AuthorizedOfficialMiddleName": "W",
      "AuthorizedOfficialTitle": "PRESIDENT",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "M.D.",
      "AuthorizedOfficialTelephoneNumber": "203-284-9448",
      "TaxonomyCode1": "207W00000X",
      "Taxonomy1": "Ophthalmology",
      "PrimaryTaxonomySwitch1": "Y",
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      "OtherIdentifier1": "2621621",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "OH",
      "OtherIdentifier2": "P00401238",
      "OtherIdentifierType2": "OTHER",
      "OtherIdentifierState2": "OH",
      "OtherIdentifierIssuer2": "RAILROAD MEDICARE"
    },
    {
      "NPI": "1033186986",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "NICOLA",
      "FirstName": "RANIA",
      "MiddleName": "SOLIMAN",
      "NamePrefix": "DR.",
      "Credential": "DDS",
      "FirstLineMailingAddress": "110 S WOODLAND ST",
      "MailingAddressCityName": "WINTER GARDEN",
      "MailingAddressStateName": "FL",
      "MailingAddressPostalCode": "34787-3546",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "407-905-8827",
      "MailingAddressFaxNumber": "407-645-4587",
      "FirstLinePracticeLocationAddress": "7900 FOREST CITY RD",
      "PracticeLocationAddressCityName": "ORLANDO",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "32810-3002",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "407-905-8827",
      "PracticeLocationAddressFaxNumber": "407-645-4587",
      "EnumerationDate": "02/28/2006",
      "LastUpdateDate": "07/28/2017",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1223G0001X",
      "Taxonomy1": "General Practice",
      "LicenseNumber1": "DN15582",
      "LicenseNumberStateCode1": "FL",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "122300000X",
      "Taxonomy2": "Dentist",
      "LicenseNumber2": "DN15582",
      "LicenseNumberStateCode2": "FL",
      "PrimaryTaxonomySwitch2": "Y",
      "OtherIdentifier1": "075156100",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "FL"
    },
    {
      "NPI": "1720032899",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ALBATAINEH",
      "FirstName": "RANIA",
      "MiddleName": "QASSIEM",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "11476 OKEECHOBEE BLVD",
      "MailingAddressCityName": "ROYAL PALM BEACH",
      "MailingAddressStateName": "FL",
      "MailingAddressPostalCode": "33411-8715",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "561-204-5111",
      "MailingAddressFaxNumber": "561-204-5150",
      "FirstLinePracticeLocationAddress": "11476 OKEECHOBEE BLVD",
      "PracticeLocationAddressCityName": "ROYAL PALM BEACH",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "33411-8715",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "561-204-5111",
      "PracticeLocationAddressFaxNumber": "561-204-5150",
      "EnumerationDate": "05/21/2006",
      "LastUpdateDate": "09/11/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "ME 79876",
      "LicenseNumberStateCode1": "FL",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1326095100",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ROSBOROUGH",
      "FirstName": "RANIA",
      "MiddleName": "BAJWA",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "3100 WYMAN PARK DR",
      "MailingAddressCityName": "BALTIMORE",
      "MailingAddressStateName": "MD",
      "MailingAddressPostalCode": "21211-2803",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "410-338-3500",
      "FirstLinePracticeLocationAddress": "3601 SW 160TH AVE",
      "SecondLinePracticeLocationAddress": "SUITE 250",
      "PracticeLocationAddressCityName": "MIRAMAR",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "33027-6308",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "877-866-7123",
      "EnumerationDate": "05/27/2006",
      "LastUpdateDate": "12/10/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "D0063732",
      "LicenseNumberStateCode1": "MD",
      "PrimaryTaxonomySwitch1": "Y",
      "TaxonomyCode2": "207Q00000X",
      "Taxonomy2": "Family Medicine",
      "LicenseNumber2": "0101257197",
      "LicenseNumberStateCode2": "VA",
      "PrimaryTaxonomySwitch2": "N"
    },
    {
      "NPI": "1528015310",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "HUSSEINI",
      "FirstName": "RANIA",
      "MiddleName": "I",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "111 CYPRESS ST",
      "MailingAddressCityName": "BROOKLINE",
      "MailingAddressStateName": "MA",
      "MailingAddressPostalCode": "02445-6002",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "508-718-4050",
      "FirstLinePracticeLocationAddress": "20 PATRIOT PL",
      "PracticeLocationAddressCityName": "FOXBORO",
      "PracticeLocationAddressStateName": "MA",
      "PracticeLocationAddressPostalCode": "02035-1375",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "508-718-4050",
      "EnumerationDate": "05/27/2006",
      "LastUpdateDate": "04/17/2012",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "209649",
      "LicenseNumberStateCode1": "MA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1760429591",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "RAYES-DANAN",
      "FirstName": "RANIA",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "OtherLastName": "RAYES",
      "OtherFirstName": "RANIA",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2500 METROHEALTH DR",
      "MailingAddressCityName": "CLEVELAND",
      "MailingAddressStateName": "OH",
      "MailingAddressPostalCode": "44109-1900",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "216-778-7800",
      "FirstLinePracticeLocationAddress": "2500 METROHEALTH DR",
      "PracticeLocationAddressCityName": "CLEVELAND",
      "PracticeLocationAddressStateName": "OH",
      "PracticeLocationAddressPostalCode": "44109-1900",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "216-778-7800",
      "EnumerationDate": "06/01/2006",
      "LastUpdateDate": "01/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207ZP0102X",
      "Taxonomy1": "Anatomic Pathology & Clinical Pathology",
      "LicenseNumber1": "35086346",
      "LicenseNumberStateCode1": "OH",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "2687703",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "OH"
    },
    {
      "NPI": "1699717660",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "AMPEY",
      "FirstName": "RANIA",
      "MiddleName": "L",
      "Credential": "LPC",
      "FirstLineMailingAddress": "5930 LOVERS LN",
      "SecondLineMailingAddress": "PREMIER NEUROPSYCHIATRY, PLC",
      "MailingAddressCityName": "PORTAGE",
      "MailingAddressStateName": "MI",
      "MailingAddressPostalCode": "49002-1673",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "269-873-1611",
      "FirstLinePracticeLocationAddress": "5930 LOVERS LN",
      "SecondLinePracticeLocationAddress": "PREMIER NEUROPSYCHIATRY, PLC",
      "PracticeLocationAddressCityName": "PORTAGE",
      "PracticeLocationAddressStateName": "MI",
      "PracticeLocationAddressPostalCode": "49002-1673",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "269-873-1611",
      "EnumerationDate": "06/12/2006",
      "LastUpdateDate": "12/30/2010",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional",
      "LicenseNumber1": "6401007658",
      "LicenseNumberStateCode1": "MI",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1801839667",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ABOUJAOUDE",
      "FirstName": "RANIA",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "PO BOX 1283",
      "MailingAddressCityName": "MEDFORD",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08055-6283",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "609-677-1046",
      "MailingAddressFaxNumber": "609-677-1306",
      "FirstLinePracticeLocationAddress": "200 TRENTON RD",
      "PracticeLocationAddressCityName": "BROWNS MILLS",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08015-1705",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "609-677-1046",
      "PracticeLocationAddressFaxNumber": "609-677-1306",
      "EnumerationDate": "06/13/2006",
      "LastUpdateDate": "09/15/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207RI0200X",
      "Taxonomy1": "Infectious Disease",
      "LicenseNumber1": "39215",
      "LicenseNumberStateCode1": "KY",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "207RI0200X",
      "Taxonomy2": "Infectious Disease",
      "LicenseNumber2": "25MA07672000",
      "LicenseNumberStateCode2": "NJ",
      "PrimaryTaxonomySwitch2": "Y"
    },
    {
      "NPI": "1184645301",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "BAIK",
      "FirstName": "RANIA",
      "Credential": "D.O.",
      "FirstLineMailingAddress": "602 ROUTE 169",
      "SecondLineMailingAddress": "PO BOX 865",
      "MailingAddressCityName": "WOODSTOCK",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06281-2225",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "860-821-3406",
      "MailingAddressFaxNumber": "860-821-3407",
      "FirstLinePracticeLocationAddress": "602 ROUTE 169",
      "PracticeLocationAddressCityName": "WOODSTOCK",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06281-2225",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "860-821-3406",
      "PracticeLocationAddressFaxNumber": "860-821-3407",
      "EnumerationDate": "07/22/2006",
      "LastUpdateDate": "01/14/2016",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "000260",
      "LicenseNumberStateCode1": "CT",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

                
{
  "NPI": [
    {
      "NPI": "1083349906",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "STAFFORD",
      "FirstName": "KADY",
      "NamePrefix": "MS.",
      "Credential": "LPC",
      "FirstLineMailingAddress": "13574 SW HIGHWAY 126",
      "MailingAddressCityName": "POWELL BUTTE",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97753-1541",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-480-6360",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-203-0307",
      "EnumerationDate": "07/24/2022",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional Counselor",
      "LicenseNumber1": "LPC6225",
      "LicenseNumberStateCode1": "ID",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C9084",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "04/21/2025",
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}
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