RESTful Lookup — Test-Drive (2007 – 2026)

Query complete (43 ms elapsed)

{
  "NDC": [
    {
      "NDCCode": "0009-0850-01",
      "PackageDescription": "1 VIAL in 1 CARTON (0009-0850-01)  / 30.6 mL in 1 VIAL",
      "NDC11Code": "00009-0850-01",
      "ProductNDC": "0009-0850",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Solu-medrol",
      "NonProprietaryName": "Methylprednisolone Sodium Succinate",
      "DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "19590402",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA011856",
      "LabelerName": "Pharmacia & Upjohn Company LLC",
      "SubstanceName": "METHYLPREDNISOLONE SODIUM SUCCINATE",
      "StrengthNumber": "2",
      "StrengthUnit": "g/30.6mL",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-12-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20191206",
      "SamplePackage": "N",
      "IndicationAndUsage": "When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-MEDROL Sterile Powder is indicated as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.",
      "Description": "SOLU-MEDROL Sterile Powder is an anti-inflammatory glucocorticoid, which contains methylprednisolone sodium succinate as the active ingredient. Methylprednisolone sodium succinate, USP, is the sodium succinate ester of methylprednisolone, and it occurs as a white, or nearly white, odorless hygroscopic, amorphous solid. It is very soluble in water and in alcohol; it is insoluble in chloroform and is very slightly soluble in acetone. The chemical name for methylprednisolone sodium succinate is pregna-1,4-diene-3,20-dione,21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-6-methyl-monosodium salt, (6α, 11β), and the molecular weight is 496.53. The structural formula is represented below. Methylprednisolone sodium succinate is soluble in water; it may be administered in a small volume of diluent and is well suited for intravenous use in situations where high blood levels of methylprednisolone are required rapidly. SOLU-MEDROL is available in preservative and preservative-free formulations. When necessary, the pH of each formula was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7 to 8."
    },
    {
      "NDCCode": "11071-850-01",
      "PackageDescription": "40 kg in 1 DRUM (11071-850-01)",
      "NDC11Code": "11071-0850-01",
      "ProductNDC": "11071-850",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Rufinamide",
      "DosageFormName": "LIQUID",
      "StartMarketingDate": "20081114",
      "EndMarketingDate": "20161021",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Eisai Co., Ltd.",
      "SubstanceName": "RUFINAMIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20161021"
    },
    {
      "NDCCode": "12745-850-01",
      "PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (12745-850-01) ",
      "NDC11Code": "12745-0850-01",
      "ProductNDC": "12745-850",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Spectragenix Hand Sanitizer",
      "ProprietaryNameSuffix": "Antiseptic Hand Wash",
      "NonProprietaryName": "Ethyl Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20201023",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "Medical Chemical Corporation",
      "SubstanceName": "ALCOHOL; DIAZOLIDINYL UREA",
      "StrengthNumber": "55.34; .167",
      "StrengthUnit": "g/100mL; g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20201023",
      "SamplePackage": "N",
      "IndicationAndUsage": "Intended for use as a hand sanitizer to reduce pathogenic bacteria. Recommended for repeated use. For external use on the skin only. Not for use on the eyes."
    },
    {
      "NDCCode": "13537-850-01",
      "PackageDescription": "50 mL in 1 BOTTLE, PLASTIC (13537-850-01)",
      "NDC11Code": "13537-0850-01",
      "ProductNDC": "13537-850",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Esika Winner Black Antiperspirant Roll-on Deodorant",
      "NonProprietaryName": "Aluminum Sesquichlorohydrate",
      "DosageFormName": "EMULSION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20161209",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part350",
      "LabelerName": "Ventura Corporation LTD",
      "SubstanceName": "ALUMINUM SESQUICHLOROHYDRATE",
      "StrengthNumber": ".136",
      "StrengthUnit": "g/mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Reduces underarm perspiration."
    },
    {
      "NDCCode": "16714-850-01",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE (16714-850-01) ",
      "NDC11Code": "16714-0850-01",
      "ProductNDC": "16714-850",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clomipramine Hydrochloride",
      "NonProprietaryName": "Clomipramine Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180827",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208961",
      "LabelerName": "Northstar Rx LLC.",
      "SubstanceName": "CLOMIPRAMINE HYDROCHLORIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tricyclic Antidepressant [EPC]",
      "Status": "Active",
      "LastUpdate": "2022-11-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180827",
      "SamplePackage": "N",
      "IndicationAndUsage": "Clomipramine hydrochloride capsules, USP are indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly  interfere with  social  or  occupational  functioning,  in  order  to  meet  the DSM-III-R (circa 1,989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego  dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of clomipramine hydrochloride for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents. The effectiveness of clomipramine hydrochloride for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use clomipramine hydrochloride for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).",
      "Description": "Clomipramine hydrochloride capsules, USP are an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride is available as capsules of 25, 50, and 75 mg for oral administration. Clomipramine hydrochloride, USP is 3-chloro-5-[3-(dimethylamino) propyl]-10, 11-dihydro 5H-dibenz[b,f ] azepine monohydrochloride, and its structural formula is. Molecular Formula = C19H23ClN2.HCl. Molecular Weight = 351.31. Clomipramine hydrochloride, USP is a white or slightly yellow, crystalline powder, slightly hygroscopic. It is very soluble in water. Each capsule contains clomipramine hydrochloride USP, 25 mg or 50 mg or 75 mg and inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, magnesium stearate and pregelatinized starch. Additionally, hard gelatin capsule shell contains: D&C red 33, D&C yellow 10 (25 mg), D&C red 28 (25 mg and 75 mg), FD&C red 40, FD&C blue 1(25.mg and 75 mg), gelatin, iron oxide yellow (50 mg), sodium lauryl sulfate, titanium dioxide and water. Each capsule is imprinted with black pharmaceutical ink which contains ammonia solution, butyl alcohol, dehydrated alcohol, ferrosoferric oxide, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water and shellac. The Product meets USP Dissolution Test # 2."
    },
    {
      "NDCCode": "37000-850-01",
      "PackageDescription": "1 TUBE in 1 CARTON (37000-850-01)  > 24 g in 1 TUBE",
      "NDC11Code": "37000-0850-01",
      "ProductNDC": "37000-850",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Crest",
      "ProprietaryNameSuffix": "Sensi-relief",
      "NonProprietaryName": "Sodium Fluoride And Potassium Nitrate",
      "DosageFormName": "PASTE, DENTIFRICE",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20131113",
      "EndMarketingDate": "20170822",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part356",
      "LabelerName": "The Procter & Gamble Manufacturing Company",
      "SubstanceName": "SODIUM FLUORIDE; POTASSIUM NITRATE",
      "StrengthNumber": "1.4; 50",
      "StrengthUnit": "mg/g; mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2017-08-23"
    },
    {
      "NDCCode": "37662-0850-1",
      "PackageDescription": "10000 PELLET in 1 BOTTLE, GLASS (37662-0850-1) ",
      "NDC11Code": "37662-0850-01",
      "ProductNDC": "37662-0850",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ferrum Sulphuricum",
      "NonProprietaryName": "Ferrum Sulphuricum",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220712",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Hahnemann Laboratories, INC.",
      "SubstanceName": "FERROUS SULFATE",
      "StrengthNumber": "1",
      "StrengthUnit": "[hp_Q]/1",
      "Status": "Active",
      "LastUpdate": "2022-12-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220712",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "39892-0850-1",
      "PackageDescription": "118 mL in 1 PACKAGE (39892-0850-1) ",
      "NDC11Code": "39892-0850-01",
      "ProductNDC": "39892-0850",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Medichoice Pvp Scrub",
      "NonProprietaryName": "Povidone-iodine",
      "DosageFormName": "SOLUTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240125",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "O&M HALYARD, INC.",
      "SubstanceName": "POVIDONE-IODINE",
      "StrengthNumber": "75",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2025-10-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240125",
      "SamplePackage": "N",
      "IndicationAndUsage": "Healthcare antiseptic for preparation of the skin prior to surgery. First aid antiseptic to help prevent infection in minor cuts, scrapes and burns."
    },
    {
      "NDCCode": "41167-0850-1",
      "PackageDescription": "1 POUCH in 1 CARTON (41167-0850-1)  > 1 PATCH in 1 POUCH",
      "NDC11Code": "41167-0850-01",
      "ProductNDC": "41167-0850",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Icy Hot Medicated Roll Medium",
      "NonProprietaryName": "Menthol",
      "DosageFormName": "PATCH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20090401",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part348",
      "LabelerName": "Chattem, Inc.",
      "SubstanceName": "MENTHOL",
      "StrengthNumber": "787.5",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2017-11-29"
    },
    {
      "NDCCode": "43742-0850-1",
      "PackageDescription": "30 mL in 1 BOTTLE, DROPPER (43742-0850-1) ",
      "NDC11Code": "43742-0850-01",
      "ProductNDC": "43742-0850",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Gallbladder Liver Meridian Opener",
      "NonProprietaryName": "Arsenicum Album, Berberis Vulgaris, Bryonia (alba), Calcarea Carbonica, Carduus Marianus, Cinchona Officinalis, Kali Carbonicum, Lycopodium Clavatum, Natrum Sulphuricum, Nux Vomica, Phosphorus",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160915",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Deseret Biologicals, Inc.",
      "SubstanceName": "ARSENIC TRIOXIDE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; MILK THISTLE; CINCHONA OFFICINALIS BARK; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS",
      "StrengthNumber": "30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30",
      "StrengthUnit": "[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]",
      "Status": "Active",
      "LastUpdate": "2024-05-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160915",
      "SamplePackage": "N",
      "IndicationAndUsage": " For the temporary relief of symptoms including.  gallbladder support  liver support  menstrual support  headaches  leg pain.  bloating  vomiting  occasional diarrhea  abdominal pain   shoulder pain. These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration."
    },
    {
      "NDCCode": "49999-850-01",
      "PackageDescription": "120 TABLET in 1 BOTTLE (49999-850-01)",
      "NDC11Code": "49999-0850-01",
      "ProductNDC": "49999-850",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxycodone Hydrochloride",
      "NonProprietaryName": "Oxycodone Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120214",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076758",
      "LabelerName": "Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC",
      "SubstanceName": "OXYCODONE HYDROCHLORIDE",
      "StrengthNumber": "15",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2018-04-03",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "50090-0850-1",
      "PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (50090-0850-1) ",
      "NDC11Code": "50090-0850-01",
      "ProductNDC": "50090-0850",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Paroxetine",
      "NonProprietaryName": "Paroxetine",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20070413",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077584",
      "LabelerName": "A-S Medication Solutions",
      "SubstanceName": "PAROXETINE HYDROCHLORIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-02-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20141128",
      "SamplePackage": "N",
      "IndicationAndUsage": "Paroxetine tablets are indicated in adults for the treatment of: 1 Major depressive disorder (MDD), 2 Obsessive compulsive disorder (OCD), 3 Panic disorder (PD), 4 Social anxiety disorder (SAD), 5 Generalized anxiety disorder (GAD), 6 Posttraumatic stress disorder (PTSD).",
      "Description": "Paroxetine tablets, USP contains paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'- methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the molecular formula of C19H20FNO3HCl1/2H2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is. Paroxetine hydrochloride, USP is an odorless, white to off-white crystalline powder, having a melting point range of 120°C to 138°C. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in dichloromethane and slightly soluble in water. Paroxetine tablets are for oral administration. Each film-coated tablet contains 10 mg, 20 mg, 30 mg, or 40 mg of paroxetine equivalent to 11.1 mg, 22.2 mg, 33.3 mg or 44.4 mg of paroxetine hydrochloride, respectively. In addition, each tablet contains the following inactive ingredients: dibasic calcium phosphate anhydrous, hypromellose 6 cP, lactose anhydrous, magnesium stearate, polyethylene glycol 6000, povidone, sodium starch glycolate, talc, and titanium dioxide."
    },
    {
      "NDCCode": "50405-850-01",
      "PackageDescription": "170 g in 1 BOTTLE (50405-850-01) ",
      "NDC11Code": "50405-0850-01",
      "ProductNDC": "50405-850",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Sulfacetamide 10 % And Sulfur 5 % Cleanser",
      "NonProprietaryName": "Sodium Sulfacetamide And Sulfur",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20230430",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "SOHM, Inc",
      "SubstanceName": "SULFACETAMIDE SODIUM; SULFUR",
      "StrengthNumber": "100; 50",
      "StrengthUnit": "mg/g; mg/g",
      "Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
      "Status": "Active",
      "LastUpdate": "2023-05-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230430",
      "SamplePackage": "N",
      "IndicationAndUsage": "INDICATIONS: Sulfacetamide Sodium and Sulfur Cleanser is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.",
      "Description": "Sulfacetamide Sodium is a sulfonamide with antibacterial activity while Sulfur acts as a keratolytic agent. Chemically Sulfacetamide Sodium is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is. Each gram of Sodium Sulfacetamide 10% and Sulfur 5% Cleanser contains 100 mg of Sodium Sulfacetamide and 50 mg of sulfur in a formulation containing: Aloe Vera Leaf, Butylated Hydroxytoluene, Camellia 0leifera Leaf, Cetyl Alcohol, Disodium Oleamido Monoethanolamine Sulfosuccinate, Edetate Disodium, Glycerin, Glyceryl Monostearate, Magnesium Aluminum Silicate, Methylpara­ben, Peg-100 Stearate, Propylparaben, Sodium Cocoyl Isethionate, Sodium Methyl Cocoyl Taurate, Sodium Thiosulfate, Stearyl Alcohol, Water, Xanthan Gum."
    },
    {
      "NDCCode": "51316-850-01",
      "PackageDescription": "60 PASTILLE in 1 BAG (51316-850-01) ",
      "NDC11Code": "51316-0850-01",
      "ProductNDC": "51316-850",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Natural Herb Cough Drops",
      "NonProprietaryName": "Menthol Herb",
      "DosageFormName": "PASTILLE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230529",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "CVS Pharmacy",
      "SubstanceName": "MENTHOL",
      "StrengthNumber": "4.8",
      "StrengthUnit": "mg/1",
      "Status": "Active",
      "LastUpdate": "2024-10-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230529",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses temporarily relieves. cough as may occur with a cold ocassional minor irritation and sore throat."
    },
    {
      "NDCCode": "51531-0850-1",
      "PackageDescription": "1 TUBE in 1 CARTON (51531-0850-1)  / 29 mL in 1 TUBE",
      "NDC11Code": "51531-0850-01",
      "ProductNDC": "51531-0850",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Mary Kay Foundation Primer",
      "NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20120301",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Mary Kay Inc.",
      "SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
      "StrengthNumber": "2.5; 9; 5; 3",
      "StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL",
      "Status": "Active",
      "LastUpdate": "2024-12-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20120301",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
    },
    {
      "NDCCode": "51645-850-01",
      "PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51645-850-01) ",
      "NDC11Code": "51645-0850-01",
      "ProductNDC": "51645-850",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Plus Pharma Senna Plus",
      "ProprietaryNameSuffix": "Standardized Senna Concentrate 8.6 Mg And Docusate Sodium 50 Mg Each",
      "NonProprietaryName": "Docusate Sodium,sennosides",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20060327",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part334",
      "LabelerName": "Gemini Pharmaceuticals, Inc. dba Plus Pharma",
      "SubstanceName": "DOCUSATE SODIUM; SENNOSIDES",
      "StrengthNumber": "50; 8.6",
      "StrengthUnit": "mg/1; mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2020-11-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20060327",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "52372-0850-1",
      "PackageDescription": ".1 g in 1 CONTAINER (52372-0850-1)",
      "NDC11Code": "52372-0850-01",
      "ProductNDC": "52372-0850",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Fentanyl Citrate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20111001",
      "MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
      "LabelerName": "Freedom Pharmaceuticals, Inc.",
      "SubstanceName": "FENTANYL CITRATE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "52817-850-01",
      "PackageDescription": "1 POWDER, FOR SOLUTION in 1 POUCH (52817-850-01) ",
      "NDC11Code": "52817-0850-01",
      "ProductNDC": "52817-850",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sapropterin Dihydrochloride",
      "NonProprietaryName": "Sapropterin Dihydrochloride",
      "DosageFormName": "POWDER, FOR SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260130",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA216432",
      "LabelerName": "TRUPHARMA, LLC",
      "SubstanceName": "SAPROPTERIN DIHYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Phenylalanine Hydroxylase Activator [EPC], Phenylalanine Hydroxylase Activators [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-02-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260130",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sapropterin dihydrochloride powder for oral solution is indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). Sapropterin dihydrochloride powder for oral solution is to be used in conjunction with a Phe- restricted diet.",
      "Description": "Sapropterin dihydrochloride is an orally administered Phenylalanine Hydroxylase activator (or PAH activator). Sapropterin dihydrochloride, the active pharmaceutical ingredient in sapropterin dihydrochloride powder for oral solution, is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4). Sapropterin dihydrochloride is an off-white to pale yellow crystalline powder. The chemical name of sapropterin dihydrochloride is (6R)-2-amino-6-[(1R,2S)-1,2- dihydroxypropyl]-5,6,7,8-tetrahydro-4(1H)-pteridinone dihydrochloride and the molecular formula is C 9H 15N 5O 3·2HCl with a molecular weight of 314.17. Sapropterin dihydrochloride has the following structural formula. Sapropterin dihydrochloride is supplied as powder for oral solution containing 100 mg of sapropterin dihydrochloride (equivalent to 76.8 mg of sapropterin base). Sapropterin dihydrochloride is also supplied as powder for oral solution containing 500 mg of sapropterin dihydrochloride (equivalent to 384 mg of sapropterin base). Sapropterin dihydrochloride powder for oral solution is off-white to pale yellow in color. Each unit dose packet contains the following inactive ingredients: ascorbic acid, mannitol, potassium citrate and sucralose."
    },
    {
      "NDCCode": "53808-0850-1",
      "PackageDescription": "30 TABLET in 1 BLISTER PACK (53808-0850-1)",
      "NDC11Code": "53808-0850-01",
      "ProductNDC": "53808-0850",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Methimazole",
      "NonProprietaryName": "Methimazole",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040350",
      "LabelerName": "State of Florida DOH Central Pharmacy",
      "SubstanceName": "METHIMAZOLE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "Methimazole is indicated: 1 In patients with Graves’ disease with hyperthyroidism or toxic multinodular goiter for whom surgery or radioactive iodine therapy is not an appropriate treatment option, 2 To ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy.",
      "Description": "Methimazole (1-methylimidazole-2-thiol) is a white, crystalline substance that is freely soluble in water. It differs chemically from the drugs of the thiouracil series primarily because it has a 5- instead of a 6-membered ring. Each tablet contains 5 or 10 mg (43.8 or 87.6 μmol) methimazole, an orally administered antithyroid drug. Each tablet also contains lactose monohydrate, magnesium stearate, corn starch, and talc. The molecular weight is 114.17, and the molecular formula is C4H6N2S. The structural formula is as follows."
    },
    {
      "NDCCode": "55037-850-01",
      "PackageDescription": "6010 L in 1 CYLINDER (55037-850-01) ",
      "NDC11Code": "55037-0850-01",
      "ProductNDC": "55037-850",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxygen/nitrogen 26/74",
      "NonProprietaryName": "Oxygen/nitrogen 26/74",
      "DosageFormName": "GAS",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "19870101",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA205889",
      "LabelerName": "MATHESON TRI-GAS, INC.",
      "SubstanceName": "OXYGEN",
      "StrengthNumber": "260",
      "StrengthUnit": "mL/L",
      "Status": "Active",
      "LastUpdate": "2025-12-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19870101",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "57520-0850-1",
      "PackageDescription": "1000 mL in 1 BOTTLE (57520-0850-1)",
      "NDC11Code": "57520-0850-01",
      "ProductNDC": "57520-0850",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Cytomegalovirus,",
      "DosageFormName": "LIQUID",
      "StartMarketingDate": "20110914",
      "EndMarketingDate": "20160921",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Apotheca Company",
      "SubstanceName": "HUMAN HERPESVIRUS 5",
      "StrengthNumber": "90",
      "StrengthUnit": "[hp_X]/mL",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20160921"
    },
    {
      "NDCCode": "59735-850-01",
      "PackageDescription": "1 TUBE in 1 CARTON (59735-850-01)  / 30 mL in 1 TUBE",
      "NDC11Code": "59735-0850-01",
      "ProductNDC": "59735-850",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Young Clariti Mineral Brightening Sheer Tint Broad Spectrum Spf 20- Porcelain",
      "NonProprietaryName": "Young Clariti Mineral Brightening Sheer Tint - Porcelain",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20230228",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Mana Product, Inc",
      "SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": "5; 5",
      "StrengthUnit": "g/30mL; g/30mL",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20230228",
      "SamplePackage": "N",
      "IndicationAndUsage": "Stop use and ask a doctor if rash occurs."
    },
    {
      "NDCCode": "60258-850-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE (60258-850-01)",
      "NDC11Code": "60258-0850-01",
      "ProductNDC": "60258-850",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cyproheptadine Hydrochloride",
      "NonProprietaryName": "Cyproheptadine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100615",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040644",
      "LabelerName": "Cypress Pharmaceutical, Inc.",
      "SubstanceName": "CYPROHEPTADINE HYDROCHLORIDE",
      "StrengthNumber": "4",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2015-01-16"
    },
    {
      "NDCCode": "60687-850-01",
      "PackageDescription": "100 BLISTER PACK in 1 CARTON (60687-850-01)  / 1 CAPSULE in 1 BLISTER PACK (60687-850-11) ",
      "NDC11Code": "60687-0850-01",
      "ProductNDC": "60687-850",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Nitrofurantoin Macrocrystals",
      "NonProprietaryName": "Nitrofurantoin Macrocrystals",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240428",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217272",
      "LabelerName": "American Health Packaging",
      "SubstanceName": "NITROFURANTOIN",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Nitrofuran Antibacterial [EPC], Nitrofurans [CS]",
      "Status": "Active",
      "LastUpdate": "2024-04-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240428",
      "SamplePackage": "N",
      "IndicationAndUsage": "Nitrofurantoin capsules (macrocrystals) are specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain susceptible strains of Klebsiella and Enterobacter species. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin capsules (macrocrystals) and other antibacterial drugs, nitrofurantoin capsules (macrocrystals) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin capsules (macrocrystals) are predisposed to persistence or reappearance of bacteriuria. Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin capsules (macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin capsules (macrocrystals), lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.",
      "Description": "Nitrofurantoin capsules, USP (macrocrystals) are a synthetic chemical of controlled crystal size. It is a stable, lemon yellow, crystalline compound. Nitrofurantoin capsules, USP (macrocrystals) are an antibacterial agent for specific urinary tract infections. It is available in 25 mg, 50 mg, and 100 mg capsules for oral administration. Each capsule contains 25 mg, 50 mg, or 100 mg of nitrofurantoin, USP (macrocrystals). Molecular Formula: C 8H 6N 4O 5      Molecular Weight: 238.16 g/mole 1-[[(5-nitro-2-furanyl)methylene]amino]-2,4-imidazolidinedione. Inactive Ingredients: Each capsule contains: corn starch, gelatin, lactose monohydrate, talc and titanium dioxide. Additionally, each 50 mg and 100 mg capsule shell contains FD&C Blue no. 1 and FD&C Red no. 3. The capsule is printed with black pharmaceutical ink which contains ferrosoferric oxide, potassium hydroxide, and shellac."
    },
    {
      "NDCCode": "60793-850-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE (60793-850-01) ",
      "NDC11Code": "60793-0850-01",
      "ProductNDC": "60793-850",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levoxyl",
      "NonProprietaryName": "Levothyroxine Sodium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20010525",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021301",
      "LabelerName": "Pfizer Laboratories Div Pfizer Inc",
      "SubstanceName": "LEVOTHYROXINE SODIUM",
      "StrengthNumber": "25",
      "StrengthUnit": "ug/1",
      "Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
      "Status": "Active",
      "LastUpdate": "2020-12-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20010525",
      "SamplePackage": "N",
      "IndicationAndUsage": "LEVOXYL is L-thyroxine (T4) indicated in pediatric and adult patients for: 1 Hypothyroidism: As replacement in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. (1), 2 Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) suppression: As an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer. (1).",
      "Description": "LEVOXYL contains the active ingredient, levothyroxine, asynthetic crystalline levothyroxine (T4) in sodium salt form. It is chemically designated as L-3,3',5,5'-tetraiodothyronine monosodium hydrate. Synthetic T4 is identical in chemical structure to the T4 produced in the human thyroid gland. Levothyroxine sodium has an empirical formula of C15H10I4N NaO4 ∙ H2O, molecular weight of 798.85 g/mol (anhydrous), and structural formula as shown. LEVOXYL tablets for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, and 200 mcg."
    },
    {
      "NDCCode": "62157-850-01",
      "PackageDescription": "1 kg in 1 JAR (62157-850-01)",
      "NDC11Code": "62157-0850-01",
      "ProductNDC": "62157-850",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Trichlormethiazide",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20190605",
      "MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
      "LabelerName": "AX Pharmaceutical Corp",
      "SubstanceName": "TRICHLORMETHIAZIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20201231"
    },
    {
      "NDCCode": "63029-850-01",
      "PackageDescription": "75 SPRAY in 1 CANISTER (63029-850-01)",
      "NDC11Code": "63029-0850-01",
      "ProductNDC": "63029-850",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dermoplast Pain Relieving",
      "NonProprietaryName": "Benzocaine And Menthol",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140101",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part348",
      "LabelerName": "Medtech Products Inc.",
      "SubstanceName": "BENZOCAINE; MENTHOL",
      "StrengthNumber": "20; .5",
      "StrengthUnit": "g/1; g/1",
      "Status": "Deprecated",
      "LastUpdate": "2017-12-13",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "63545-850-01",
      "PackageDescription": "200 PELLET in 1 VIAL, GLASS (63545-850-01) ",
      "NDC11Code": "63545-0850-01",
      "ProductNDC": "63545-850",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Aluminium Fluoratum",
      "NonProprietaryName": "Aluminium Fluoratum",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200124",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Hahnemann Laboratories, Inc.",
      "SubstanceName": "ALUMINUM FLUORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "[hp_C]/1",
      "Status": "Deprecated",
      "LastUpdate": "2020-02-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200124",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "65044-0850-1",
      "PackageDescription": "5 mL in 1 VIAL (65044-0850-1) ",
      "NDC11Code": "65044-0850-01",
      "ProductNDC": "65044-0850",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Grass Pollen, Grass Mix 7",
      "NonProprietaryName": "Standardized Grass Pollen, Grass Mix 7",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19980115",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103873",
      "LabelerName": "Jubilant HollisterStier LLC",
      "SubstanceName": "POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; AGROSTIS GIGANTEA POLLEN; PHLEUM PRATENSE POLLEN; ANTHOXANTHUM ODORATUM POLLEN; FESTUCA PRATENSIS POLLEN; LOLIUM PERENNE POLLEN",
      "StrengthNumber": "1428; 1428; 1428; 1428; 1428; 1428; 1428",
      "StrengthUnit": "[BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL",
      "Pharm_Classes": "Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-11-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "19980115",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "67296-0850-1",
      "PackageDescription": "10 mL in 1 BOTTLE (67296-0850-1) ",
      "NDC11Code": "67296-0850-01",
      "ProductNDC": "67296-0850",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Polymyxin B Sulfate And Trimethoprim Sulfate",
      "NonProprietaryName": "Polymyxin B Sulfate, Trimethoprim Sulfate",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "19970429",
      "MarketingCategoryName": "NDA AUTHORIZED GENERIC",
      "ApplicationNumber": "NDA050567",
      "LabelerName": "RedPharm Drug",
      "SubstanceName": "POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE",
      "StrengthNumber": "10000; 1",
      "StrengthUnit": "[USP'U]/mL; mg/mL",
      "Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2025-07-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "19970429",
      "SamplePackage": "N",
      "IndicationAndUsage": "Polymyxin B sulfate and trimethoprim ophthalmic solution, USP is indicated in the treatment of surface ocular bacterial infections, including acute bacterial conjunctivitis, and blepharoconjunctivitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcusviridans,Haemophilusinfluenzae andPseudomonas aeruginosa.*. *Efficacy for this organism in this organ system was studied in fewer than 10 infections.",
      "Description": "Polymyxin B sulfate and trimethoprim ophthalmic solution, USP is a sterile antimicrobial solution for topical ophthalmic use. Chemical Names:Trimethoprim sulfate, 2,4-Diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine sulfate (2:1), is a white, odorless, crystalline powder with a molecular weight of 678.72 and the following structural formula:. Polymyxin B sulfate is the sulfate salt of polymyxin B 1and B 2which are produced by the growth of  Bacilluspolymyxa (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per mg, calculated on an anhydrous basis. The structural formulae are:. Contains: Actives:polymyxin B sulfate 10,000 units/mL; trimethoprim sulfate equivalent to 1 mg/mL. Preservative:benzalkonium chloride 0.04 mg/mL.  Inactives:purified water; sodium chloride; and sulfuric acid. May also contain sodium hydroxide for pH adjustment. It has pH of 4.0 to 6.2 and osmolality of 270 to 310 mOsm/kg."
    }
  ]
}
                    

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<NDCList>
  <NDC>
    <NDCCode>0009-0850-01</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (0009-0850-01)  / 30.6 mL in 1 VIAL</PackageDescription>
    <NDC11Code>00009-0850-01</NDC11Code>
    <ProductNDC>0009-0850</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Solu-medrol</ProprietaryName>
    <NonProprietaryName>Methylprednisolone Sodium Succinate</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>19590402</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA011856</ApplicationNumber>
    <LabelerName>Pharmacia &amp; Upjohn Company LLC</LabelerName>
    <SubstanceName>METHYLPREDNISOLONE SODIUM SUCCINATE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>g/30.6mL</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191206</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-MEDROL Sterile Powder is indicated as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
    <Description>SOLU-MEDROL Sterile Powder is an anti-inflammatory glucocorticoid, which contains methylprednisolone sodium succinate as the active ingredient. Methylprednisolone sodium succinate, USP, is the sodium succinate ester of methylprednisolone, and it occurs as a white, or nearly white, odorless hygroscopic, amorphous solid. It is very soluble in water and in alcohol; it is insoluble in chloroform and is very slightly soluble in acetone. The chemical name for methylprednisolone sodium succinate is pregna-1,4-diene-3,20-dione,21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-6-methyl-monosodium salt, (6α, 11β), and the molecular weight is 496.53. The structural formula is represented below. Methylprednisolone sodium succinate is soluble in water; it may be administered in a small volume of diluent and is well suited for intravenous use in situations where high blood levels of methylprednisolone are required rapidly. SOLU-MEDROL is available in preservative and preservative-free formulations. When necessary, the pH of each formula was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7 to 8.</Description>
  </NDC>
  <NDC>
    <NDCCode>11071-850-01</NDCCode>
    <PackageDescription>40 kg in 1 DRUM (11071-850-01)</PackageDescription>
    <NDC11Code>11071-0850-01</NDC11Code>
    <ProductNDC>11071-850</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Rufinamide</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <StartMarketingDate>20081114</StartMarketingDate>
    <EndMarketingDate>20161021</EndMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Eisai Co., Ltd.</LabelerName>
    <SubstanceName>RUFINAMIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20161021</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>12745-850-01</NDCCode>
    <PackageDescription>473 mL in 1 BOTTLE, PLASTIC (12745-850-01) </PackageDescription>
    <NDC11Code>12745-0850-01</NDC11Code>
    <ProductNDC>12745-850</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Spectragenix Hand Sanitizer</ProprietaryName>
    <ProprietaryNameSuffix>Antiseptic Hand Wash</ProprietaryNameSuffix>
    <NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20201023</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>Medical Chemical Corporation</LabelerName>
    <SubstanceName>ALCOHOL; DIAZOLIDINYL UREA</SubstanceName>
    <StrengthNumber>55.34; .167</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201023</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Intended for use as a hand sanitizer to reduce pathogenic bacteria. Recommended for repeated use. For external use on the skin only. Not for use on the eyes.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>13537-850-01</NDCCode>
    <PackageDescription>50 mL in 1 BOTTLE, PLASTIC (13537-850-01)</PackageDescription>
    <NDC11Code>13537-0850-01</NDC11Code>
    <ProductNDC>13537-850</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Esika Winner Black Antiperspirant Roll-on Deodorant</ProprietaryName>
    <NonProprietaryName>Aluminum Sesquichlorohydrate</NonProprietaryName>
    <DosageFormName>EMULSION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20161209</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part350</ApplicationNumber>
    <LabelerName>Ventura Corporation LTD</LabelerName>
    <SubstanceName>ALUMINUM SESQUICHLOROHYDRATE</SubstanceName>
    <StrengthNumber>.136</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Reduces underarm perspiration.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>16714-850-01</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (16714-850-01) </PackageDescription>
    <NDC11Code>16714-0850-01</NDC11Code>
    <ProductNDC>16714-850</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clomipramine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Clomipramine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180827</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208961</ApplicationNumber>
    <LabelerName>Northstar Rx LLC.</LabelerName>
    <SubstanceName>CLOMIPRAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-11-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180827</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Clomipramine hydrochloride capsules, USP are indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly  interfere with  social  or  occupational  functioning,  in  order  to  meet  the DSM-III-R (circa 1,989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego  dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of clomipramine hydrochloride for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents. The effectiveness of clomipramine hydrochloride for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use clomipramine hydrochloride for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
    <Description>Clomipramine hydrochloride capsules, USP are an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride is available as capsules of 25, 50, and 75 mg for oral administration. Clomipramine hydrochloride, USP is 3-chloro-5-[3-(dimethylamino) propyl]-10, 11-dihydro 5H-dibenz[b,f ] azepine monohydrochloride, and its structural formula is. Molecular Formula = C19H23ClN2.HCl. Molecular Weight = 351.31. Clomipramine hydrochloride, USP is a white or slightly yellow, crystalline powder, slightly hygroscopic. It is very soluble in water. Each capsule contains clomipramine hydrochloride USP, 25 mg or 50 mg or 75 mg and inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, magnesium stearate and pregelatinized starch. Additionally, hard gelatin capsule shell contains: D&amp;C red 33, D&amp;C yellow 10 (25 mg), D&amp;C red 28 (25 mg and 75 mg), FD&amp;C red 40, FD&amp;C blue 1(25.mg and 75 mg), gelatin, iron oxide yellow (50 mg), sodium lauryl sulfate, titanium dioxide and water. Each capsule is imprinted with black pharmaceutical ink which contains ammonia solution, butyl alcohol, dehydrated alcohol, ferrosoferric oxide, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water and shellac. The Product meets USP Dissolution Test # 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>37000-850-01</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (37000-850-01)  &gt; 24 g in 1 TUBE</PackageDescription>
    <NDC11Code>37000-0850-01</NDC11Code>
    <ProductNDC>37000-850</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Crest</ProprietaryName>
    <ProprietaryNameSuffix>Sensi-relief</ProprietaryNameSuffix>
    <NonProprietaryName>Sodium Fluoride And Potassium Nitrate</NonProprietaryName>
    <DosageFormName>PASTE, DENTIFRICE</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20131113</StartMarketingDate>
    <EndMarketingDate>20170822</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part356</ApplicationNumber>
    <LabelerName>The Procter &amp; Gamble Manufacturing Company</LabelerName>
    <SubstanceName>SODIUM FLUORIDE; POTASSIUM NITRATE</SubstanceName>
    <StrengthNumber>1.4; 50</StrengthNumber>
    <StrengthUnit>mg/g; mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-08-23</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>37662-0850-1</NDCCode>
    <PackageDescription>10000 PELLET in 1 BOTTLE, GLASS (37662-0850-1) </PackageDescription>
    <NDC11Code>37662-0850-01</NDC11Code>
    <ProductNDC>37662-0850</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ferrum Sulphuricum</ProprietaryName>
    <NonProprietaryName>Ferrum Sulphuricum</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220712</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Hahnemann Laboratories, INC.</LabelerName>
    <SubstanceName>FERROUS SULFATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>[hp_Q]/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2022-12-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220712</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
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  <NDC>
    <NDCCode>39892-0850-1</NDCCode>
    <PackageDescription>118 mL in 1 PACKAGE (39892-0850-1) </PackageDescription>
    <NDC11Code>39892-0850-01</NDC11Code>
    <ProductNDC>39892-0850</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Medichoice Pvp Scrub</ProprietaryName>
    <NonProprietaryName>Povidone-iodine</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240125</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>505G(a)(3)</ApplicationNumber>
    <LabelerName>O&amp;M HALYARD, INC.</LabelerName>
    <SubstanceName>POVIDONE-IODINE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-10-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240125</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Healthcare antiseptic for preparation of the skin prior to surgery. First aid antiseptic to help prevent infection in minor cuts, scrapes and burns.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>41167-0850-1</NDCCode>
    <PackageDescription>1 POUCH in 1 CARTON (41167-0850-1)  &gt; 1 PATCH in 1 POUCH</PackageDescription>
    <NDC11Code>41167-0850-01</NDC11Code>
    <ProductNDC>41167-0850</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Icy Hot Medicated Roll Medium</ProprietaryName>
    <NonProprietaryName>Menthol</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20090401</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part348</ApplicationNumber>
    <LabelerName>Chattem, Inc.</LabelerName>
    <SubstanceName>MENTHOL</SubstanceName>
    <StrengthNumber>787.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-11-29</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>43742-0850-1</NDCCode>
    <PackageDescription>30 mL in 1 BOTTLE, DROPPER (43742-0850-1) </PackageDescription>
    <NDC11Code>43742-0850-01</NDC11Code>
    <ProductNDC>43742-0850</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Gallbladder Liver Meridian Opener</ProprietaryName>
    <NonProprietaryName>Arsenicum Album, Berberis Vulgaris, Bryonia (alba), Calcarea Carbonica, Carduus Marianus, Cinchona Officinalis, Kali Carbonicum, Lycopodium Clavatum, Natrum Sulphuricum, Nux Vomica, Phosphorus</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160915</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Deseret Biologicals, Inc.</LabelerName>
    <SubstanceName>ARSENIC TRIOXIDE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; MILK THISTLE; CINCHONA OFFICINALIS BARK; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS</SubstanceName>
    <StrengthNumber>30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30</StrengthNumber>
    <StrengthUnit>[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-05-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage> For the temporary relief of symptoms including.  gallbladder support  liver support  menstrual support  headaches  leg pain.  bloating  vomiting  occasional diarrhea  abdominal pain   shoulder pain. These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>49999-850-01</NDCCode>
    <PackageDescription>120 TABLET in 1 BOTTLE (49999-850-01)</PackageDescription>
    <NDC11Code>49999-0850-01</NDC11Code>
    <ProductNDC>49999-850</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120214</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076758</ApplicationNumber>
    <LabelerName>Lake Erie Medical &amp; Surgical Supply DBA Quality Care Products LLC</LabelerName>
    <SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2018-04-03</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>50090-0850-1</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (50090-0850-1) </PackageDescription>
    <NDC11Code>50090-0850-01</NDC11Code>
    <ProductNDC>50090-0850</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Paroxetine</ProprietaryName>
    <NonProprietaryName>Paroxetine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070413</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077584</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>PAROXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20141128</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Paroxetine tablets are indicated in adults for the treatment of: 1 Major depressive disorder (MDD), 2 Obsessive compulsive disorder (OCD), 3 Panic disorder (PD), 4 Social anxiety disorder (SAD), 5 Generalized anxiety disorder (GAD), 6 Posttraumatic stress disorder (PTSD).</IndicationAndUsage>
    <Description>Paroxetine tablets, USP contains paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'- methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the molecular formula of C19H20FNO3HCl1/2H2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is. Paroxetine hydrochloride, USP is an odorless, white to off-white crystalline powder, having a melting point range of 120°C to 138°C. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in dichloromethane and slightly soluble in water. Paroxetine tablets are for oral administration. Each film-coated tablet contains 10 mg, 20 mg, 30 mg, or 40 mg of paroxetine equivalent to 11.1 mg, 22.2 mg, 33.3 mg or 44.4 mg of paroxetine hydrochloride, respectively. In addition, each tablet contains the following inactive ingredients: dibasic calcium phosphate anhydrous, hypromellose 6 cP, lactose anhydrous, magnesium stearate, polyethylene glycol 6000, povidone, sodium starch glycolate, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>50405-850-01</NDCCode>
    <PackageDescription>170 g in 1 BOTTLE (50405-850-01) </PackageDescription>
    <NDC11Code>50405-0850-01</NDC11Code>
    <ProductNDC>50405-850</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Sulfacetamide 10 % And Sulfur 5 % Cleanser</ProprietaryName>
    <NonProprietaryName>Sodium Sulfacetamide And Sulfur</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20230430</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>SOHM, Inc</LabelerName>
    <SubstanceName>SULFACETAMIDE SODIUM; SULFUR</SubstanceName>
    <StrengthNumber>100; 50</StrengthNumber>
    <StrengthUnit>mg/g; mg/g</StrengthUnit>
    <Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-05-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230430</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>INDICATIONS: Sulfacetamide Sodium and Sulfur Cleanser is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.</IndicationAndUsage>
    <Description>Sulfacetamide Sodium is a sulfonamide with antibacterial activity while Sulfur acts as a keratolytic agent. Chemically Sulfacetamide Sodium is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is. Each gram of Sodium Sulfacetamide 10% and Sulfur 5% Cleanser contains 100 mg of Sodium Sulfacetamide and 50 mg of sulfur in a formulation containing: Aloe Vera Leaf, Butylated Hydroxytoluene, Camellia 0leifera Leaf, Cetyl Alcohol, Disodium Oleamido Monoethanolamine Sulfosuccinate, Edetate Disodium, Glycerin, Glyceryl Monostearate, Magnesium Aluminum Silicate, Methylpara­ben, Peg-100 Stearate, Propylparaben, Sodium Cocoyl Isethionate, Sodium Methyl Cocoyl Taurate, Sodium Thiosulfate, Stearyl Alcohol, Water, Xanthan Gum.</Description>
  </NDC>
  <NDC>
    <NDCCode>51316-850-01</NDCCode>
    <PackageDescription>60 PASTILLE in 1 BAG (51316-850-01) </PackageDescription>
    <NDC11Code>51316-0850-01</NDC11Code>
    <ProductNDC>51316-850</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Natural Herb Cough Drops</ProprietaryName>
    <NonProprietaryName>Menthol Herb</NonProprietaryName>
    <DosageFormName>PASTILLE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230529</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>CVS Pharmacy</LabelerName>
    <SubstanceName>MENTHOL</SubstanceName>
    <StrengthNumber>4.8</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-10-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230529</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses temporarily relieves. cough as may occur with a cold ocassional minor irritation and sore throat.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>51531-0850-1</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (51531-0850-1)  / 29 mL in 1 TUBE</PackageDescription>
    <NDC11Code>51531-0850-01</NDC11Code>
    <ProductNDC>51531-0850</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Mary Kay Foundation Primer</ProprietaryName>
    <NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20120301</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Mary Kay Inc.</LabelerName>
    <SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
    <StrengthNumber>2.5; 9; 5; 3</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-12-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120301</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>51645-850-01</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51645-850-01) </PackageDescription>
    <NDC11Code>51645-0850-01</NDC11Code>
    <ProductNDC>51645-850</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Plus Pharma Senna Plus</ProprietaryName>
    <ProprietaryNameSuffix>Standardized Senna Concentrate 8.6 Mg And Docusate Sodium 50 Mg Each</ProprietaryNameSuffix>
    <NonProprietaryName>Docusate Sodium,sennosides</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20060327</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part334</ApplicationNumber>
    <LabelerName>Gemini Pharmaceuticals, Inc. dba Plus Pharma</LabelerName>
    <SubstanceName>DOCUSATE SODIUM; SENNOSIDES</SubstanceName>
    <StrengthNumber>50; 8.6</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-11-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20060327</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>52372-0850-1</NDCCode>
    <PackageDescription>.1 g in 1 CONTAINER (52372-0850-1)</PackageDescription>
    <NDC11Code>52372-0850-01</NDC11Code>
    <ProductNDC>52372-0850</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Fentanyl Citrate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20111001</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>Freedom Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>FENTANYL CITRATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>52817-850-01</NDCCode>
    <PackageDescription>1 POWDER, FOR SOLUTION in 1 POUCH (52817-850-01) </PackageDescription>
    <NDC11Code>52817-0850-01</NDC11Code>
    <ProductNDC>52817-850</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sapropterin Dihydrochloride</ProprietaryName>
    <NonProprietaryName>Sapropterin Dihydrochloride</NonProprietaryName>
    <DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260130</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216432</ApplicationNumber>
    <LabelerName>TRUPHARMA, LLC</LabelerName>
    <SubstanceName>SAPROPTERIN DIHYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Phenylalanine Hydroxylase Activator [EPC], Phenylalanine Hydroxylase Activators [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260130</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sapropterin dihydrochloride powder for oral solution is indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). Sapropterin dihydrochloride powder for oral solution is to be used in conjunction with a Phe- restricted diet.</IndicationAndUsage>
    <Description>Sapropterin dihydrochloride is an orally administered Phenylalanine Hydroxylase activator (or PAH activator). Sapropterin dihydrochloride, the active pharmaceutical ingredient in sapropterin dihydrochloride powder for oral solution, is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4). Sapropterin dihydrochloride is an off-white to pale yellow crystalline powder. The chemical name of sapropterin dihydrochloride is (6R)-2-amino-6-[(1R,2S)-1,2- dihydroxypropyl]-5,6,7,8-tetrahydro-4(1H)-pteridinone dihydrochloride and the molecular formula is C 9H 15N 5O 3·2HCl with a molecular weight of 314.17. Sapropterin dihydrochloride has the following structural formula. Sapropterin dihydrochloride is supplied as powder for oral solution containing 100 mg of sapropterin dihydrochloride (equivalent to 76.8 mg of sapropterin base). Sapropterin dihydrochloride is also supplied as powder for oral solution containing 500 mg of sapropterin dihydrochloride (equivalent to 384 mg of sapropterin base). Sapropterin dihydrochloride powder for oral solution is off-white to pale yellow in color. Each unit dose packet contains the following inactive ingredients: ascorbic acid, mannitol, potassium citrate and sucralose.</Description>
  </NDC>
  <NDC>
    <NDCCode>53808-0850-1</NDCCode>
    <PackageDescription>30 TABLET in 1 BLISTER PACK (53808-0850-1)</PackageDescription>
    <NDC11Code>53808-0850-01</NDC11Code>
    <ProductNDC>53808-0850</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methimazole</ProprietaryName>
    <NonProprietaryName>Methimazole</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040350</ApplicationNumber>
    <LabelerName>State of Florida DOH Central Pharmacy</LabelerName>
    <SubstanceName>METHIMAZOLE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Methimazole is indicated: 1 In patients with Graves’ disease with hyperthyroidism or toxic multinodular goiter for whom surgery or radioactive iodine therapy is not an appropriate treatment option, 2 To ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy.</IndicationAndUsage>
    <Description>Methimazole (1-methylimidazole-2-thiol) is a white, crystalline substance that is freely soluble in water. It differs chemically from the drugs of the thiouracil series primarily because it has a 5- instead of a 6-membered ring. Each tablet contains 5 or 10 mg (43.8 or 87.6 μmol) methimazole, an orally administered antithyroid drug. Each tablet also contains lactose monohydrate, magnesium stearate, corn starch, and talc. The molecular weight is 114.17, and the molecular formula is C4H6N2S. The structural formula is as follows.</Description>
  </NDC>
  <NDC>
    <NDCCode>55037-850-01</NDCCode>
    <PackageDescription>6010 L in 1 CYLINDER (55037-850-01) </PackageDescription>
    <NDC11Code>55037-0850-01</NDC11Code>
    <ProductNDC>55037-850</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxygen/nitrogen 26/74</ProprietaryName>
    <NonProprietaryName>Oxygen/nitrogen 26/74</NonProprietaryName>
    <DosageFormName>GAS</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>19870101</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA205889</ApplicationNumber>
    <LabelerName>MATHESON TRI-GAS, INC.</LabelerName>
    <SubstanceName>OXYGEN</SubstanceName>
    <StrengthNumber>260</StrengthNumber>
    <StrengthUnit>mL/L</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-12-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19870101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>57520-0850-1</NDCCode>
    <PackageDescription>1000 mL in 1 BOTTLE (57520-0850-1)</PackageDescription>
    <NDC11Code>57520-0850-01</NDC11Code>
    <ProductNDC>57520-0850</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Cytomegalovirus,</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <StartMarketingDate>20110914</StartMarketingDate>
    <EndMarketingDate>20160921</EndMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Apotheca Company</LabelerName>
    <SubstanceName>HUMAN HERPESVIRUS 5</SubstanceName>
    <StrengthNumber>90</StrengthNumber>
    <StrengthUnit>[hp_X]/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20160921</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>59735-850-01</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (59735-850-01)  / 30 mL in 1 TUBE</PackageDescription>
    <NDC11Code>59735-0850-01</NDC11Code>
    <ProductNDC>59735-850</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Young Clariti Mineral Brightening Sheer Tint Broad Spectrum Spf 20- Porcelain</ProprietaryName>
    <NonProprietaryName>Young Clariti Mineral Brightening Sheer Tint - Porcelain</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20230228</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Mana Product, Inc</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>5; 5</StrengthNumber>
    <StrengthUnit>g/30mL; g/30mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230228</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Stop use and ask a doctor if rash occurs.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>60258-850-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (60258-850-01)</PackageDescription>
    <NDC11Code>60258-0850-01</NDC11Code>
    <ProductNDC>60258-850</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cyproheptadine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Cyproheptadine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100615</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040644</ApplicationNumber>
    <LabelerName>Cypress Pharmaceutical, Inc.</LabelerName>
    <SubstanceName>CYPROHEPTADINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2015-01-16</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>60687-850-01</NDCCode>
    <PackageDescription>100 BLISTER PACK in 1 CARTON (60687-850-01)  / 1 CAPSULE in 1 BLISTER PACK (60687-850-11) </PackageDescription>
    <NDC11Code>60687-0850-01</NDC11Code>
    <ProductNDC>60687-850</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nitrofurantoin Macrocrystals</ProprietaryName>
    <NonProprietaryName>Nitrofurantoin Macrocrystals</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240428</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217272</ApplicationNumber>
    <LabelerName>American Health Packaging</LabelerName>
    <SubstanceName>NITROFURANTOIN</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Nitrofuran Antibacterial [EPC], Nitrofurans [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-04-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240428</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Nitrofurantoin capsules (macrocrystals) are specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain susceptible strains of Klebsiella and Enterobacter species. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin capsules (macrocrystals) and other antibacterial drugs, nitrofurantoin capsules (macrocrystals) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin capsules (macrocrystals) are predisposed to persistence or reappearance of bacteriuria. Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin capsules (macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin capsules (macrocrystals), lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.</IndicationAndUsage>
    <Description>Nitrofurantoin capsules, USP (macrocrystals) are a synthetic chemical of controlled crystal size. It is a stable, lemon yellow, crystalline compound. Nitrofurantoin capsules, USP (macrocrystals) are an antibacterial agent for specific urinary tract infections. It is available in 25 mg, 50 mg, and 100 mg capsules for oral administration. Each capsule contains 25 mg, 50 mg, or 100 mg of nitrofurantoin, USP (macrocrystals). Molecular Formula: C 8H 6N 4O 5      Molecular Weight: 238.16 g/mole 1-[[(5-nitro-2-furanyl)methylene]amino]-2,4-imidazolidinedione. Inactive Ingredients: Each capsule contains: corn starch, gelatin, lactose monohydrate, talc and titanium dioxide. Additionally, each 50 mg and 100 mg capsule shell contains FD&amp;C Blue no. 1 and FD&amp;C Red no. 3. The capsule is printed with black pharmaceutical ink which contains ferrosoferric oxide, potassium hydroxide, and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>60793-850-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (60793-850-01) </PackageDescription>
    <NDC11Code>60793-0850-01</NDC11Code>
    <ProductNDC>60793-850</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levoxyl</ProprietaryName>
    <NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20010525</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021301</ApplicationNumber>
    <LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
    <SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>ug/1</StrengthUnit>
    <Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2020-12-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20010525</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>LEVOXYL is L-thyroxine (T4) indicated in pediatric and adult patients for: 1 Hypothyroidism: As replacement in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. (1), 2 Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) suppression: As an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer. (1).</IndicationAndUsage>
    <Description>LEVOXYL contains the active ingredient, levothyroxine, asynthetic crystalline levothyroxine (T4) in sodium salt form. It is chemically designated as L-3,3',5,5'-tetraiodothyronine monosodium hydrate. Synthetic T4 is identical in chemical structure to the T4 produced in the human thyroid gland. Levothyroxine sodium has an empirical formula of C15H10I4N NaO4 ∙ H2O, molecular weight of 798.85 g/mol (anhydrous), and structural formula as shown. LEVOXYL tablets for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, and 200 mcg.</Description>
  </NDC>
  <NDC>
    <NDCCode>62157-850-01</NDCCode>
    <PackageDescription>1 kg in 1 JAR (62157-850-01)</PackageDescription>
    <NDC11Code>62157-0850-01</NDC11Code>
    <ProductNDC>62157-850</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Trichlormethiazide</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20190605</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>AX Pharmaceutical Corp</LabelerName>
    <SubstanceName>TRICHLORMETHIAZIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>63029-850-01</NDCCode>
    <PackageDescription>75 SPRAY in 1 CANISTER (63029-850-01)</PackageDescription>
    <NDC11Code>63029-0850-01</NDC11Code>
    <ProductNDC>63029-850</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dermoplast Pain Relieving</ProprietaryName>
    <NonProprietaryName>Benzocaine And Menthol</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20140101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part348</ApplicationNumber>
    <LabelerName>Medtech Products Inc.</LabelerName>
    <SubstanceName>BENZOCAINE; MENTHOL</SubstanceName>
    <StrengthNumber>20; .5</StrengthNumber>
    <StrengthUnit>g/1; g/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-12-13</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>63545-850-01</NDCCode>
    <PackageDescription>200 PELLET in 1 VIAL, GLASS (63545-850-01) </PackageDescription>
    <NDC11Code>63545-0850-01</NDC11Code>
    <ProductNDC>63545-850</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Aluminium Fluoratum</ProprietaryName>
    <NonProprietaryName>Aluminium Fluoratum</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200124</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Hahnemann Laboratories, Inc.</LabelerName>
    <SubstanceName>ALUMINUM FLUORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>[hp_C]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-02-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200124</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>65044-0850-1</NDCCode>
    <PackageDescription>5 mL in 1 VIAL (65044-0850-1) </PackageDescription>
    <NDC11Code>65044-0850-01</NDC11Code>
    <ProductNDC>65044-0850</ProductNDC>
    <ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
    <ProprietaryName>Standardized Grass Pollen, Grass Mix 7</ProprietaryName>
    <NonProprietaryName>Standardized Grass Pollen, Grass Mix 7</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19980115</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103873</ApplicationNumber>
    <LabelerName>Jubilant HollisterStier LLC</LabelerName>
    <SubstanceName>POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; AGROSTIS GIGANTEA POLLEN; PHLEUM PRATENSE POLLEN; ANTHOXANTHUM ODORATUM POLLEN; FESTUCA PRATENSIS POLLEN; LOLIUM PERENNE POLLEN</SubstanceName>
    <StrengthNumber>1428; 1428; 1428; 1428; 1428; 1428; 1428</StrengthNumber>
    <StrengthUnit>[BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL</StrengthUnit>
    <Pharm_Classes>Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-11-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19980115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>67296-0850-1</NDCCode>
    <PackageDescription>10 mL in 1 BOTTLE (67296-0850-1) </PackageDescription>
    <NDC11Code>67296-0850-01</NDC11Code>
    <ProductNDC>67296-0850</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Polymyxin B Sulfate And Trimethoprim Sulfate</ProprietaryName>
    <NonProprietaryName>Polymyxin B Sulfate, Trimethoprim Sulfate</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>19970429</StartMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA050567</ApplicationNumber>
    <LabelerName>RedPharm Drug</LabelerName>
    <SubstanceName>POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE</SubstanceName>
    <StrengthNumber>10000; 1</StrengthNumber>
    <StrengthUnit>[USP'U]/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-07-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19970429</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Polymyxin B sulfate and trimethoprim ophthalmic solution, USP is indicated in the treatment of surface ocular bacterial infections, including acute bacterial conjunctivitis, and blepharoconjunctivitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcusviridans,Haemophilusinfluenzae andPseudomonas aeruginosa.*. *Efficacy for this organism in this organ system was studied in fewer than 10 infections.</IndicationAndUsage>
    <Description>Polymyxin B sulfate and trimethoprim ophthalmic solution, USP is a sterile antimicrobial solution for topical ophthalmic use. Chemical Names:Trimethoprim sulfate, 2,4-Diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine sulfate (2:1), is a white, odorless, crystalline powder with a molecular weight of 678.72 and the following structural formula:. Polymyxin B sulfate is the sulfate salt of polymyxin B 1and B 2which are produced by the growth of  Bacilluspolymyxa (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per mg, calculated on an anhydrous basis. The structural formulae are:. Contains: Actives:polymyxin B sulfate 10,000 units/mL; trimethoprim sulfate equivalent to 1 mg/mL. Preservative:benzalkonium chloride 0.04 mg/mL.  Inactives:purified water; sodium chloride; and sulfuric acid. May also contain sodium hydroxide for pH adjustment. It has pH of 4.0 to 6.2 and osmolality of 270 to 310 mOsm/kg.</Description>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>0009-0850-01</NDCCode><ProprietaryName>Solu-medrol</ProprietaryName><NonProprietaryName>Methylprednisolone Sodium Succinate</NonProprietaryName></NDC><NDC><NDCCode>11071-850-01</NDCCode><NonProprietaryName>Rufinamide</NonProprietaryName></NDC><NDC><NDCCode>12745-850-01</NDCCode><ProprietaryName>Spectragenix Hand Sanitizer</ProprietaryName><NonProprietaryName>Ethyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>13537-850-01</NDCCode><ProprietaryName>Esika Winner Black Antiperspirant Roll-on Deodorant</ProprietaryName><NonProprietaryName>Aluminum Sesquichlorohydrate</NonProprietaryName></NDC><NDC><NDCCode>16714-850-01</NDCCode><ProprietaryName>Clomipramine Hydrochloride</ProprietaryName><NonProprietaryName>Clomipramine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>37000-850-01</NDCCode><ProprietaryName>Crest</ProprietaryName><NonProprietaryName>Sodium Fluoride And Potassium Nitrate</NonProprietaryName></NDC><NDC><NDCCode>37662-0850-1</NDCCode><ProprietaryName>Ferrum Sulphuricum</ProprietaryName><NonProprietaryName>Ferrum Sulphuricum</NonProprietaryName></NDC><NDC><NDCCode>39892-0850-1</NDCCode><ProprietaryName>Medichoice Pvp Scrub</ProprietaryName><NonProprietaryName>Povidone-iodine</NonProprietaryName></NDC><NDC><NDCCode>41167-0850-1</NDCCode><ProprietaryName>Icy Hot Medicated Roll Medium</ProprietaryName><NonProprietaryName>Menthol</NonProprietaryName></NDC><NDC><NDCCode>43742-0850-1</NDCCode><ProprietaryName>Gallbladder Liver Meridian Opener</ProprietaryName><NonProprietaryName>Arsenicum Album, Berberis Vulgaris, Bryonia (alba), Calcarea Carbonica, Carduus Marianus, Cinchona Officinalis, Kali Carbonicum, Lycopodium Clavatum, Natrum Sulphuricum, Nux Vomica, Phosphorus</NonProprietaryName></NDC><NDC><NDCCode>49999-850-01</NDCCode><ProprietaryName>Oxycodone Hydrochloride</ProprietaryName><NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>50090-0850-1</NDCCode><ProprietaryName>Paroxetine</ProprietaryName><NonProprietaryName>Paroxetine</NonProprietaryName></NDC><NDC><NDCCode>50405-850-01</NDCCode><ProprietaryName>Sodium Sulfacetamide 10 % And Sulfur 5 % Cleanser</ProprietaryName><NonProprietaryName>Sodium Sulfacetamide And Sulfur</NonProprietaryName></NDC><NDC><NDCCode>51316-850-01</NDCCode><ProprietaryName>Natural Herb Cough Drops</ProprietaryName><NonProprietaryName>Menthol Herb</NonProprietaryName></NDC><NDC><NDCCode>51531-0850-1</NDCCode><ProprietaryName>Mary Kay Foundation Primer</ProprietaryName><NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene</NonProprietaryName></NDC><NDC><NDCCode>51645-850-01</NDCCode><ProprietaryName>Plus Pharma Senna Plus</ProprietaryName><NonProprietaryName>Docusate Sodium,sennosides</NonProprietaryName></NDC><NDC><NDCCode>52372-0850-1</NDCCode><NonProprietaryName>Fentanyl Citrate</NonProprietaryName></NDC><NDC><NDCCode>52817-850-01</NDCCode><ProprietaryName>Sapropterin Dihydrochloride</ProprietaryName><NonProprietaryName>Sapropterin Dihydrochloride</NonProprietaryName></NDC><NDC><NDCCode>53808-0850-1</NDCCode><ProprietaryName>Methimazole</ProprietaryName><NonProprietaryName>Methimazole</NonProprietaryName></NDC><NDC><NDCCode>55037-850-01</NDCCode><ProprietaryName>Oxygen/nitrogen 26/74</ProprietaryName><NonProprietaryName>Oxygen/nitrogen 26/74</NonProprietaryName></NDC><NDC><NDCCode>57520-0850-1</NDCCode><NonProprietaryName>Cytomegalovirus,</NonProprietaryName></NDC><NDC><NDCCode>59735-850-01</NDCCode><ProprietaryName>Young Clariti Mineral Brightening Sheer Tint Broad Spectrum Spf 20- Porcelain</ProprietaryName><NonProprietaryName>Young Clariti Mineral Brightening Sheer Tint - Porcelain</NonProprietaryName></NDC><NDC><NDCCode>60258-850-01</NDCCode><ProprietaryName>Cyproheptadine Hydrochloride</ProprietaryName><NonProprietaryName>Cyproheptadine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>60687-850-01</NDCCode><ProprietaryName>Nitrofurantoin Macrocrystals</ProprietaryName><NonProprietaryName>Nitrofurantoin Macrocrystals</NonProprietaryName></NDC><NDC><NDCCode>60793-850-01</NDCCode><ProprietaryName>Levoxyl</ProprietaryName><NonProprietaryName>Levothyroxine Sodium</NonProprietaryName></NDC><NDC><NDCCode>62157-850-01</NDCCode><NonProprietaryName>Trichlormethiazide</NonProprietaryName></NDC><NDC><NDCCode>63029-850-01</NDCCode><ProprietaryName>Dermoplast Pain Relieving</ProprietaryName><NonProprietaryName>Benzocaine And Menthol</NonProprietaryName></NDC><NDC><NDCCode>63545-850-01</NDCCode><ProprietaryName>Aluminium Fluoratum</ProprietaryName><NonProprietaryName>Aluminium Fluoratum</NonProprietaryName></NDC><NDC><NDCCode>65044-0850-1</NDCCode><ProprietaryName>Standardized Grass Pollen, Grass Mix 7</ProprietaryName><NonProprietaryName>Standardized Grass Pollen, Grass Mix 7</NonProprietaryName></NDC><NDC><NDCCode>67296-0850-1</NDCCode><ProprietaryName>Polymyxin B Sulfate And Trimethoprim Sulfate</ProprietaryName><NonProprietaryName>Polymyxin B Sulfate, Trimethoprim Sulfate</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",
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      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

                
{
  "NPI": [
    {
      "NPI": "1083349906",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "STAFFORD",
      "FirstName": "KADY",
      "NamePrefix": "MS.",
      "Credential": "LPC",
      "FirstLineMailingAddress": "13574 SW HIGHWAY 126",
      "MailingAddressCityName": "POWELL BUTTE",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97753-1541",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-480-6360",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-203-0307",
      "EnumerationDate": "07/24/2022",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional Counselor",
      "LicenseNumber1": "LPC6225",
      "LicenseNumberStateCode1": "ID",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C9084",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1215724679",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "SCHAY",
      "FirstName": "ANGELICA",
      "MiddleName": "NICOLE",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1841",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1841",
      "EnumerationDate": "04/21/2025",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101Y00000X",
      "Taxonomy1": "Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101Y00000X",
      "PrimaryTaxonomy": "Counselor"
    },
    {
      "NPI": "1013556505",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "IVENS",
      "FirstName": "KRYSTA",
      "FirstLineMailingAddress": "743 NW QUINCE AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-1250",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "360-526-1448",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "971-217-6150",
      "EnumerationDate": "12/31/2019",
      "LastUpdateDate": "02/15/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C7963",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "02/15/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1497336275",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ARANT",
      "FirstName": "ERIN",
      "MiddleName": "HENNESSEY",
      "FirstLineMailingAddress": "4639 SW 37TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-6776",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "04/14/2021",
      "LastUpdateDate": "04/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "225X00000X",
      "Taxonomy1": "Occupational Therapist",
      "LicenseNumber1": "390047",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/14/2021",
      "PrimaryTaxonomyCode": "225X00000X",
      "PrimaryTaxonomy": "Occupational Therapist"
    },
    {
      "NPI": "1174191407",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "GRIMALT",
      "FirstName": "EUGENIA",
      "MiddleName": "N",
      "Credential": "PT",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "06/14/2021",
      "LastUpdateDate": "06/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "2251P0200X",
      "Taxonomy1": "Pediatric Physical Therapist",
      "LicenseNumber1": "63979",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization.",
      "CertificationDate": "06/14/2021",
      "PrimaryTaxonomyCode": "2251P0200X",
      "PrimaryTaxonomy": "Pediatric Physical Therapist"
    },
    {
      "NPI": "1912604117",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "PAINTER",
      "FirstName": "JENNIFER",
      "FirstLineMailingAddress": "20080 DOANNA WAY UNIT 3",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-2931",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "209-743-9813",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/08/2023",
      "LastUpdateDate": "02/08/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/08/2023",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1396434700",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "GROVE",
      "FirstName": "JENNIFER",
      "MiddleName": "RHEA",
      "FirstLineMailingAddress": "303 NW BROADWAY ST",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97703-2658",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "801-573-6047",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "801-573-6047",
      "EnumerationDate": "05/02/2023",
      "LastUpdateDate": "05/02/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1041C0700X",
      "Taxonomy1": "Clinical Social Worker",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "05/02/2023",
      "PrimaryTaxonomyCode": "1041C0700X",
      "PrimaryTaxonomy": "Clinical Social Worker"
    },
    {
      "NPI": "1407698970",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "REDDEN",
      "FirstName": "SHANNON",
      "Credential": "CHW",
      "OtherLastName": "MCDOUGALL",
      "OtherFirstName": "SHANNON",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2312 NE 5TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8488",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-460-2192",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "PracticeLocationAddressFaxNumber": "541-550-7956",
      "EnumerationDate": "06/06/2024",
      "LastUpdateDate": "06/06/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "172V00000X",
      "Taxonomy1": "Community Health Worker",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "06/06/2024",
      "PrimaryTaxonomyCode": "172V00000X",
      "PrimaryTaxonomy": "Community Health Worker"
    },
    {
      "NPI": "1942022256",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "JACQUOT",
      "FirstName": "SHAYLA",
      "FirstLineMailingAddress": "PO BOX 1397",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97709-1397",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "10/28/2024",
      "LastUpdateDate": "10/28/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "10/26/2024",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1912723131",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "WEIMER",
      "FirstName": "ALAYNA",
      "FirstLineMailingAddress": "2748 NW 19TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-7766",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-499-8292",
      "EnumerationDate": "12/03/2024",
      "LastUpdateDate": "12/03/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "171M00000X",
      "Taxonomy1": "Case Manager/Care Coordinator",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/03/2024",
      "PrimaryTaxonomyCode": "171M00000X",
      "PrimaryTaxonomy": "Case Manager/Care Coordinator"
    },
    {
      "NPI": "1790594125",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "WIDDER",
      "FirstName": "JENNIFER",
      "MiddleName": "LYNN",
      "FirstLineMailingAddress": "22350 CALGARY DR",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-9216",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-749-8895",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1858",
      "EnumerationDate": "12/31/2024",
      "LastUpdateDate": "12/31/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "175T00000X",
      "Taxonomy1": "Peer Specialist",
      "LicenseNumber1": "112910",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/31/2024",
      "PrimaryTaxonomyCode": "175T00000X",
      "PrimaryTaxonomy": "Peer Specialist"
    },
    {
      "NPI": "1538965306",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "PARSONS",
      "FirstName": "JEANINE",
      "MiddleName": "JEWELL",
      "FirstLineMailingAddress": "2821 SW 28TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8681",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "760-927-4761",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/21/2025",
      "LastUpdateDate": "02/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "175T00000X",
      "Taxonomy1": "Peer Specialist",
      "LicenseNumber1": "113398",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/21/2025",
      "PrimaryTaxonomyCode": "175T00000X",
      "PrimaryTaxonomy": "Peer Specialist"
    }
  ]
}
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