RESTful Lookup — Test-Drive (2007 – 2026)

Query complete (39 ms elapsed)

{
  "NDC": [
    {
      "NDCCode": "52183-278-20",
      "PackageDescription": "20 LOZENGE in 1 BOX (52183-278-20) ",
      "NDC11Code": "52183-0278-20",
      "ProductNDC": "52183-278",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ludens Menthol Throat Drops",
      "NonProprietaryName": "Menthol",
      "DosageFormName": "LOZENGE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140204",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part356",
      "LabelerName": "Prestige Brands Holdings, Inc.",
      "SubstanceName": "MENTHOL",
      "StrengthNumber": "2.5",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2020-07-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20140204",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "52183-101-01",
      "PackageDescription": "20 LOZENGE in 1 CARTON (52183-101-01) ",
      "NDC11Code": "52183-0101-01",
      "ProductNDC": "52183-101",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ludens Blue Raspberry Throat Drops",
      "NonProprietaryName": "Pectin",
      "DosageFormName": "LOZENGE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20091029",
      "EndMarketingDate": "20210831",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part356",
      "LabelerName": "Prestige Brands Holdings, Inc.",
      "SubstanceName": "PECTIN",
      "StrengthNumber": "1.7",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2021-09-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20091029",
      "EndMarketingDatePackage": "20210831",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "52183-102-01",
      "PackageDescription": "20 LOZENGE in 1 CARTON (52183-102-01) ",
      "NDC11Code": "52183-0102-01",
      "ProductNDC": "52183-102",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ludens Watermelon Throat Drops",
      "NonProprietaryName": "Pectin",
      "DosageFormName": "LOZENGE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20091029",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M022",
      "LabelerName": "Prestige Brands Holdings, Inc.",
      "SubstanceName": "PECTIN",
      "StrengthNumber": "1.7",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2026-08-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20091029",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "52183-205-20",
      "PackageDescription": "20 LOZENGE in 1 BAG (52183-205-20) ",
      "NDC11Code": "52183-0205-20",
      "ProductNDC": "52183-205",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ludens Kiwi-strawberry",
      "NonProprietaryName": "Pectin",
      "DosageFormName": "LOZENGE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120702",
      "EndMarketingDate": "20210531",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part356",
      "LabelerName": "Prestige Brands Holdings, Inc.",
      "SubstanceName": "PECTIN",
      "StrengthNumber": "2.8",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2021-06-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20120702",
      "EndMarketingDatePackage": "20210531",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "52183-208-20",
      "PackageDescription": "20 LOZENGE in 1 CARTON (52183-208-20) ",
      "NDC11Code": "52183-0208-20",
      "ProductNDC": "52183-208",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ludens Strawberry Banana Throat Drops",
      "NonProprietaryName": "Pectin",
      "DosageFormName": "LOZENGE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150701",
      "EndMarketingDate": "20210831",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part356",
      "LabelerName": "Prestige Brands Holdings, Inc.",
      "SubstanceName": "PECTIN",
      "StrengthNumber": "1.7",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2021-09-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20150701",
      "EndMarketingDatePackage": "20210831",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "52183-259-20",
      "PackageDescription": "20 LOZENGE in 1 BOX (52183-259-20) ",
      "NDC11Code": "52183-0259-20",
      "ProductNDC": "52183-259",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ludens Honey Licorice Throat Drops",
      "NonProprietaryName": "Menthol",
      "DosageFormName": "LOZENGE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20091029",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M022",
      "LabelerName": "Prestige Brands Holdings, Inc.",
      "SubstanceName": "MENTHOL",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2026-08-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20091029",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "52183-269-20",
      "PackageDescription": "20 LOZENGE in 1 BOX (52183-269-20) ",
      "NDC11Code": "52183-0269-20",
      "ProductNDC": "52183-269",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ludens Honey Lemon Throat Drops",
      "NonProprietaryName": "Menthol",
      "DosageFormName": "LOZENGE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20091029",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part356",
      "LabelerName": "Prestige Brands Holdings, Inc.",
      "SubstanceName": "MENTHOL",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2020-07-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20140204",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "52183-299-20",
      "PackageDescription": "20 LOZENGE in 1 BOX (52183-299-20) ",
      "NDC11Code": "52183-0299-20",
      "ProductNDC": "52183-299",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ludens Wild Cherry Throat Drops",
      "NonProprietaryName": "Pectin",
      "DosageFormName": "LOZENGE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20091029",
      "EndMarketingDate": "20260930",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M022",
      "LabelerName": "Prestige Brands Holdings, Inc.",
      "SubstanceName": "PECTIN",
      "StrengthNumber": "1.7",
      "StrengthUnit": "mg/1",
      "Status": "Active",
      "LastUpdate": "2026-08-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20091029",
      "EndMarketingDatePackage": "20260930",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "10544-278-20",
      "PackageDescription": "20 TABLET in 1 BOTTLE (10544-278-20)",
      "NDC11Code": "10544-0278-20",
      "ProductNDC": "10544-278",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Naproxen",
      "NonProprietaryName": "Naproxen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100317",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078250",
      "LabelerName": "Blenheim Pharmacal, Inc.",
      "SubstanceName": "NAPROXEN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Carefully consider the potential benefits and risks of naproxen, naproxen sodium and other treatment options before deciding to use naproxen and naproxen sodium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Naproxen as naproxen or naproxen sodium tablets are indicated: : 1 For the relief of the signs and symptoms of rheumatoid arthritis , 2 For the relief of the signs and symptoms of osteoarthritis , 3 For the relief of the signs and symptoms of ankylosing spondylitis , 4 For the relief of the signs and symptoms of juvenile arthritis.",
      "Description": "Naproxen USP is a proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen USP and naproxen sodium USP are (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid and (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen USP and naproxen sodium USP have the following structures, respectively:. Naproxen USP has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen sodium USP has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. Naproxen USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen USP at pH 7.4 is 1.6 to 1.8. Naproxen sodium USP is a white to creamy white, crystalline solid, freely soluble in water at neutral pH. Naproxen tablets USP are available as light orange colored tablets containing 250 mg of naproxen USP, light orange colored tablets containing 375 mg of naproxen USP and light orange colored tablets containing 500 mg of naproxen USP for oral administration. The inactive ingredients are microcrystalline cellulose, croscarmellose sodium, iron oxides, povidone and magnesium stearate. Naproxen sodium tablets USP are available as blue tablets containing 275 mg of naproxen sodium USP and as blue tablets containing 550 mg of naproxen sodium USP for oral administration. The inactive ingredients are croscarmellose sodium, colloidal silicon dioxide, povidone, magnesium stearate, microcrystalline cellulose and talc. The coating suspension for the naproxen sodium 275 mg tablet may contain Opadry blue 03F50544. The coating suspension for the naproxen sodium 550 mg tablet may contain Opadry blue 03F50544."
    },
    {
      "NDCCode": "43353-278-20",
      "PackageDescription": "20 TABLET in 1 BOTTLE, PLASTIC (43353-278-20)",
      "NDC11Code": "43353-0278-20",
      "ProductNDC": "43353-278",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Diazepam",
      "NonProprietaryName": "Diazepam",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160803",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA071135",
      "LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
      "SubstanceName": "DIAZEPAM",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
      "DEASchedule": "CIV",
      "Status": "Deprecated",
      "LastUpdate": "2025-06-10",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "IndicationAndUsage": "Diazepam Tablets USP are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma); spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia); athetosis; and stiff-man syndrome. Oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. The effectiveness of diazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.",
      "Description": "Diazepam is a benzodiazepine derivative. The chemical name of diazepam is 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. It is a colorless to light yellow crystalline compound, insoluble in water. The empirical formula is C16H13ClN2O and the molecular weight is 284.75. The structural formula is as follows. Diazepam is available for oral administration as tablets containing 2 mg, 5 mg or 10 mg diazepam. In addition to the active ingredient diazepam, each tablet contains the following inactive ingredients: anhydrous lactose, magnesium stearate and microcrystalline cellulose. Diazepam Tablets USP 5 mg also contain D&C Yellow No. 10. Diazepam Tablets USP 10 mg also contain FD&C Blue No. 1."
    },
    {
      "NDCCode": "51079-278-20",
      "PackageDescription": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-278-20)  > 1 TABLET in 1 BLISTER PACK (51079-278-01)",
      "NDC11Code": "51079-0278-20",
      "ProductNDC": "51079-278",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Propranolol Hydrochloride",
      "NonProprietaryName": "Propranolol Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19980901",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA070213",
      "LabelerName": "UDL Laboratories, Inc.",
      "SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2017-10-13"
    },
    {
      "NDCCode": "57687-278-20",
      "PackageDescription": "20 mL in 1 BOTTLE, DROPPER (57687-278-20) ",
      "NDC11Code": "57687-0278-20",
      "ProductNDC": "57687-278",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Bach Original Flower Remedies",
      "NonProprietaryName": "Ornithogalum Umbellatum",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20020101",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Nelson Bach USA Limited",
      "SubstanceName": "ORNITHOGALUM UMBELLATUM WHOLE",
      "StrengthNumber": "5",
      "StrengthUnit": "[hp_X]/.095mL",
      "Status": "Active",
      "LastUpdate": "2020-06-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20020101",
      "SamplePackage": "N",
      "IndicationAndUsage": "For relief of naturally occurring simple nervous tension."
    },
    {
      "NDCCode": "67046-278-20",
      "PackageDescription": "20 TABLET in 1 BLISTER PACK (67046-278-20) ",
      "NDC11Code": "67046-0278-20",
      "ProductNDC": "67046-278",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydrochlorothiazide",
      "NonProprietaryName": "Hydrochlorothiazide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170928",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202556",
      "LabelerName": "Contract Pharmacy Services-PA",
      "SubstanceName": "HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20170928",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.",
      "Description": "Hydrochlorothiazide is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. It is chemically designated as 6-chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide and has the following structural formula:. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder which is slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. Each tablet for oral administration contains 12.5 mg, 25 mg or 50 mg hydrochlorothiazide, USP. In addition, each tablet contains the following inactive ingredients: dibasic calcium phosphate dihydrate, FD & C yellow, lactose monohydrate, magnesium stearate, pregelatinized starch (starch 1500) and sodium starch glycolate."
    },
    {
      "NDCCode": "69452-278-20",
      "PackageDescription": "100 TABLET in 1 BOTTLE (69452-278-20) ",
      "NDC11Code": "69452-0278-20",
      "ProductNDC": "69452-278",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dexamethasone",
      "NonProprietaryName": "Dexamethasone",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230801",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217001",
      "LabelerName": "Bionpharma Inc.,",
      "SubstanceName": "DEXAMETHASONE",
      "StrengthNumber": "6",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-03-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230801",
      "SamplePackage": "N",
      "IndicationAndUsage": "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, perennial or seasonal allergic rhinitis, and serum sickness. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia. Miscellaneous: Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used 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, craniotomy, or head injury. Ophthalmic diseases: Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce a 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, polymyositis, and systemic lupus erythematosus.",
      "Description": "Dexamethasone tablets, USP, for oral administration, are supplied as 4 mg, and 6 mg. Inactive ingredients are corn starch, D&C yellow 10 (4 mg), FD&C blue 1 (6 mg), lactose monohydrate, and magnesium stearate. The molecular weight for dexamethasone is 392.5 g/mol. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione. The molecular formula is C 22H 29FO 5 and the structural formula is:. Dexamethasone, USP a synthetic adrenocortical steroid, is a white to almost-white, crystalline powder. It is stable in air. It is practically insoluble in water, very slightly soluble in ether, slightly soluble in methylene chloride and chloroform, and sparingly soluble in methanol, ethanol (96 %), acetone and 1,4 dioxane."
    },
    {
      "NDCCode": "76233-278-20",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (76233-278-20)  > 20 mL in 1 VIAL, SINGLE-DOSE (76233-278-00) ",
      "NDC11Code": "76233-0278-20",
      "ProductNDC": "76233-278",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Piperacillin And Tazobactam",
      "NonProprietaryName": "Piperacillin And Tazobactam",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20200724",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203768",
      "LabelerName": "Laboratorio Reig Jofre Sa.",
      "SubstanceName": "PIPERACILLIN SODIUM; TAZOBACTAM SODIUM",
      "StrengthNumber": "4; .5",
      "StrengthUnit": "g/20mL; g/20mL",
      "Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2021-07-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200724",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "76945-278-20",
      "PackageDescription": "20 L in 1 DRUM (76945-278-20) ",
      "NDC11Code": "76945-0278-20",
      "ProductNDC": "76945-278",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Tecnologia Y Soluciones En Alimentos S.a De C.v",
      "NonProprietaryName": "Tecnofood",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200510",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "Tecnologia y Soluciones en Alimentos S.A de C.V",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": "13",
      "StrengthUnit": "mg/100L",
      "Status": "Deprecated",
      "LastUpdate": "2022-08-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20200510",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "52183-353-01",
      "PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (52183-353-01)  > 30 mL in 1 BOTTLE, DROPPER",
      "NDC11Code": "52183-0353-01",
      "ProductNDC": "52183-353",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Pediacare Infants Gas Relief Dye Free",
      "NonProprietaryName": "Simethicone",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20101012",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part332",
      "LabelerName": "Blacksmith Brands, Inc.",
      "SubstanceName": "SILICON DIOXIDE; DIMETHICONE",
      "StrengthNumber": ".37; 6.3",
      "StrengthUnit": "mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2017-12-20",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "52183-363-01",
      "PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (52183-363-01)  > 30 mL in 1 BOTTLE, DROPPER",
      "NDC11Code": "52183-0363-01",
      "ProductNDC": "52183-363",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Pediacare Infants Gas Relief",
      "NonProprietaryName": "Simethicone",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20101012",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part332",
      "LabelerName": "Blacksmith Brands, Inc.",
      "SubstanceName": "DIMETHICONE; SILICON DIOXIDE",
      "StrengthNumber": "6.3; .37",
      "StrengthUnit": "mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2017-12-20",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "52183-369-04",
      "PackageDescription": "1 BOTTLE in 1 CARTON (52183-369-04)  > 118 mL in 1 BOTTLE",
      "NDC11Code": "52183-0369-04",
      "ProductNDC": "52183-369",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Pediacare Longacting Cough",
      "NonProprietaryName": "Dextromethorphan Hbr",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20091029",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "Blacksmith Brands, Inc.",
      "SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE",
      "StrengthNumber": "7.5",
      "StrengthUnit": "mg/5mL",
      "Status": "Deprecated",
      "LastUpdate": "2017-12-20",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "10702-278-03",
      "PackageDescription": "30 TABLET in 1 BOTTLE (10702-278-03) ",
      "NDC11Code": "10702-0278-03",
      "ProductNDC": "10702-278",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Leflunomide",
      "NonProprietaryName": "Leflunomide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200723",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212453",
      "LabelerName": "KVK-Tech, Inc.",
      "SubstanceName": "LEFLUNOMIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antirheumatic Agent [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-06-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200723",
      "SamplePackage": "N",
      "IndicationAndUsage": "Leflunomide tablets are indicated for the treatment of adults with active rheumatoid arthritis (RA).",
      "Description": "Leflunomide is a pyrimidine synthesis inhibitor. The chemical name for leflunomide is 4-Isoxazolecarboxamide, 5-methyl-N-[4-(trifluoromethyl)-phenyl]-. It has an empirical formula C12H9F3N2O2, a molecular weight of 270.21 and the following structural formula. Leflunomide tablets are available for oral administration as film coated tablets containing 10, or 20 mg of active drug. Combined with leflunomide are the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, corn starch, talc, titanium dioxide, and yellow ferric oxide (20 mg tablet only)."
    },
    {
      "NDCCode": "16729-278-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (16729-278-01) ",
      "NDC11Code": "16729-0278-01",
      "ProductNDC": "16729-278",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Aripiprazole",
      "NonProprietaryName": "Aripiprazole",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170215",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206251",
      "LabelerName": "Accord Healthcare, Inc.",
      "SubstanceName": "ARIPIPRAZOLE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-10-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20170215",
      "SamplePackage": "N",
      "IndicationAndUsage": "Aripiprazole tablets are indicated for the treatment of: 1 Schizophrenia, 2 Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder, 3 Adjunctive Treatment of Major Depressive Disorder, 4 Irritability Associated with Autistic Disorder, 5 Treatment of Tourette's Disorder.",
      "Description": "Aripiprazole is an atypical antipsychotic drug that is available as aripiprazole tablets, USP. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C 23H 27Cl 2N 3O 2and its molecular weight is 448.38. The chemical structure is:. Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, maize starch and microcrystalline cellulose. Colorants include ferric oxide red (10 mg and 30 mg), ferric oxide yellow (2 mg and 15 mg), and FD&C Blue No. 2 aluminum lake (2 mg and 5 mg)."
    },
    {
      "NDCCode": "16729-278-10",
      "PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (16729-278-10) ",
      "NDC11Code": "16729-0278-10",
      "ProductNDC": "16729-278",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Aripiprazole",
      "NonProprietaryName": "Aripiprazole",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170215",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206251",
      "LabelerName": "Accord Healthcare, Inc.",
      "SubstanceName": "ARIPIPRAZOLE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-10-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20170215",
      "SamplePackage": "N",
      "IndicationAndUsage": "Aripiprazole tablets are indicated for the treatment of: 1 Schizophrenia, 2 Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder, 3 Adjunctive Treatment of Major Depressive Disorder, 4 Irritability Associated with Autistic Disorder, 5 Treatment of Tourette's Disorder.",
      "Description": "Aripiprazole is an atypical antipsychotic drug that is available as aripiprazole tablets, USP. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C 23H 27Cl 2N 3O 2and its molecular weight is 448.38. The chemical structure is:. Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, maize starch and microcrystalline cellulose. Colorants include ferric oxide red (10 mg and 30 mg), ferric oxide yellow (2 mg and 15 mg), and FD&C Blue No. 2 aluminum lake (2 mg and 5 mg)."
    },
    {
      "NDCCode": "21695-278-30",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE (21695-278-30)",
      "NDC11Code": "21695-0278-30",
      "ProductNDC": "21695-278",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lyrica",
      "NonProprietaryName": "Pregabalin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20050610",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021724",
      "LabelerName": "Rebel Distributors Corp",
      "SubstanceName": "PREGABALIN",
      "StrengthNumber": "75",
      "StrengthUnit": "mg/1",
      "DEASchedule": "CV",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "LYRICA is indicated for.",
      "Description": "Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, cornstarch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain sodium lauryl sulfate and colloidal silicon dioxide. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide. LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with methylparaben, propylparaben, monobasic sodium phosphate anhydrous, dibasic sodium phosphate anhydrous, sucralose, artificial strawberry #11545 and purified water as inactive ingredients."
    },
    {
      "NDCCode": "21695-278-60",
      "PackageDescription": "60 CAPSULE in 1 BOTTLE (21695-278-60)",
      "NDC11Code": "21695-0278-60",
      "ProductNDC": "21695-278",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lyrica",
      "NonProprietaryName": "Pregabalin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20050610",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021724",
      "LabelerName": "Rebel Distributors Corp",
      "SubstanceName": "PREGABALIN",
      "StrengthNumber": "75",
      "StrengthUnit": "mg/1",
      "DEASchedule": "CV",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "LYRICA is indicated for.",
      "Description": "Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, cornstarch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain sodium lauryl sulfate and colloidal silicon dioxide. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide. LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with methylparaben, propylparaben, monobasic sodium phosphate anhydrous, dibasic sodium phosphate anhydrous, sucralose, artificial strawberry #11545 and purified water as inactive ingredients."
    },
    {
      "NDCCode": "21695-278-72",
      "PackageDescription": "120 CAPSULE in 1 BOTTLE (21695-278-72)",
      "NDC11Code": "21695-0278-72",
      "ProductNDC": "21695-278",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lyrica",
      "NonProprietaryName": "Pregabalin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20050610",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021724",
      "LabelerName": "Rebel Distributors Corp",
      "SubstanceName": "PREGABALIN",
      "StrengthNumber": "75",
      "StrengthUnit": "mg/1",
      "DEASchedule": "CV",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "LYRICA is indicated for.",
      "Description": "Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, cornstarch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain sodium lauryl sulfate and colloidal silicon dioxide. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide. LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with methylparaben, propylparaben, monobasic sodium phosphate anhydrous, dibasic sodium phosphate anhydrous, sucralose, artificial strawberry #11545 and purified water as inactive ingredients."
    },
    {
      "NDCCode": "21695-278-90",
      "PackageDescription": "90 CAPSULE in 1 BOTTLE (21695-278-90)",
      "NDC11Code": "21695-0278-90",
      "ProductNDC": "21695-278",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lyrica",
      "NonProprietaryName": "Pregabalin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20050610",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021724",
      "LabelerName": "Rebel Distributors Corp",
      "SubstanceName": "PREGABALIN",
      "StrengthNumber": "75",
      "StrengthUnit": "mg/1",
      "DEASchedule": "CV",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "LYRICA is indicated for.",
      "Description": "Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, cornstarch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain sodium lauryl sulfate and colloidal silicon dioxide. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide. LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with methylparaben, propylparaben, monobasic sodium phosphate anhydrous, dibasic sodium phosphate anhydrous, sucralose, artificial strawberry #11545 and purified water as inactive ingredients."
    },
    {
      "NDCCode": "33342-278-07",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (33342-278-07) ",
      "NDC11Code": "33342-0278-07",
      "ProductNDC": "33342-278",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tadalafil",
      "NonProprietaryName": "Tadalafil",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20191017",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207290",
      "LabelerName": "Macleods Pharmaceuticals Limited",
      "SubstanceName": "TADALAFIL",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2022-10-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20191030",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tadalafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class II – III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%). (1.1).",
      "Description": "Tadalafil tablets USP, an oral treatment for pulmonary arterial hypertension, are a selective inhibitor of cyclic guanosine monophosphate (cGMP)–specific phosphodiesterase type 5 (PDE5). Tadalafil USP has the empirical formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4–b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil tablets USP are available as yellow coloured, almond shaped, biconvex film coated tablets having ‘L64’ debossed on one side and plain on other side for oral administration. Each tablet contains 20 mg of tadalafil USP and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose 6 cPs, iron oxide yellow, lactose monohydrate, microcrystalline cellulose, povidone, sodium citrate dihydrate, sodium lauryl sulphate, sodium stearyl fumarate, talc, titanium dioxide, and triacetin."
    },
    {
      "NDCCode": "33342-278-09",
      "PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (33342-278-09) ",
      "NDC11Code": "33342-0278-09",
      "ProductNDC": "33342-278",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tadalafil",
      "NonProprietaryName": "Tadalafil",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20191017",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207290",
      "LabelerName": "Macleods Pharmaceuticals Limited",
      "SubstanceName": "TADALAFIL",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2022-10-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20191030",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tadalafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class II – III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%). (1.1).",
      "Description": "Tadalafil tablets USP, an oral treatment for pulmonary arterial hypertension, are a selective inhibitor of cyclic guanosine monophosphate (cGMP)–specific phosphodiesterase type 5 (PDE5). Tadalafil USP has the empirical formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4–b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil tablets USP are available as yellow coloured, almond shaped, biconvex film coated tablets having ‘L64’ debossed on one side and plain on other side for oral administration. Each tablet contains 20 mg of tadalafil USP and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose 6 cPs, iron oxide yellow, lactose monohydrate, microcrystalline cellulose, povidone, sodium citrate dihydrate, sodium lauryl sulphate, sodium stearyl fumarate, talc, titanium dioxide, and triacetin."
    },
    {
      "NDCCode": "40032-060-19",
      "PackageDescription": "278.26 g in 1 BOTTLE (40032-060-19)",
      "NDC11Code": "40032-0060-19",
      "ProductNDC": "40032-060",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Polyethylene Glycol-3350 And Electrolytes With Flavor Pack",
      "NonProprietaryName": "Polyethylene Glycol-3350 And Electrolytes With Flavor Pack",
      "DosageFormName": "POWDER, FOR SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090601",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090186",
      "LabelerName": "Novel Laboratories, Inc.",
      "SubstanceName": "POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE; SODIUM SULFATE ANHYDROUS",
      "StrengthNumber": "240; 5.84; 6.72; 2.98; 22.72",
      "StrengthUnit": "g/278.26g; g/278.26g; g/278.26g; g/278.26g; g/278.26g",
      "Pharm_Classes": "Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "PEG-3350 (240 g) and Electrolytes for Oral Solution, USP with flavor pack is indicated for bowel cleansing prior to colonoscopy or barium enema X-ray examination.",
      "Description": "PEG-3350 (240 g) and Electrolytes for Oral Solution, USP with flavor pack is a white, colon lavage preparation provided as water-soluble components for solution. In solution this preparation with lemon flavor pack added delivers the following, in grams per liter. Polyethylene glycol 3350 60.00. Sodium chloride 1.46. Potassium chloride 0.745. Sodium bicarbonate 1.68. Sodium sulfate 5.68. Flavor ingredients 0.500. When dissolved in sufficient water to make 4 liters, the final solution contains 125 mEq/L sodium, 10 mEq/L potassium, 20 mEq/L bicarbonate, 80 mEq/L sulfate, 35 mEq/L chloride and 18 mEq/L polyethylene glycol 3350. The reconstituted solution is an isosmotic solution, for oral administration, having mild salty taste. This preparation can be used without the lemon flavor pack and is administered orally or via nasogastric tube. Each lemon flavor pack (2 g) contains natural lemon flavor powder, saccharin sodium, maltodextrin."
    },
    {
      "NDCCode": "42546-190-30",
      "PackageDescription": "6 BLISTER PACK in 1 CARTON (42546-190-30)  > 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "42546-0190-30",
      "ProductNDC": "42546-190",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Moms Choice Rx",
      "NonProprietaryName": "Beta Carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Carbonate, Sodium Feredetate, Magnesium Oxide, Zinc Oxide, Cupric Oxide, Iron Sucrose, Iodine, Omega 3 Fatty Acids",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20130401",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "PruGen, Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "Description": "SUPPLEMENT FACTSServing Size 1 Tablet:VITAMINSA (beta carotene)  . . . . . . . . . . . . . . . . . . . . . . . . . . 2,840 IU    36% Daily ValueC (ascorbic acid)    . . . . . . . . . . . . . . . . . . . . . . . . . . 120 mg    200% Daily ValueD (cholecalciferol)    . . . . . . . . . . . . . . . . . . . . . . . . .840 IU    210% Daily ValueE (dl-alpha tocopheryl acetate)  . . . . . . . . . . . . . .2 mg    7% Daily ValueB1 (thiamine mononitrate)  . . . . . . . . . . . . . . . . . . .1.5 mg    88% Daily ValueB2 (riboflavin)   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4 mg    200% Daily ValueNiacinamide   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 mg    100% Daily ValueB6 (pyridoxine hydrochloride)  . . . . . . . . . . . . . . .50 mg    2000% Daily ValueFolic acid    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1 mg    125% Daily ValueB12 (cyanocobalamin)   . . . . . . . . . . . . . . . . . . . . . . 12 mcg    150% Daily ValueMINERALSCalcium (calcium carbonate)  . . . . . . . . . . . . . . . . 215 mg    17% Daily ValueIron (as sodium iron EDTA and polysaccharide iron complex) . . .26 mg    144% Daily Value. Iodine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 210 mcg  140% Daily ValueMagnesium (magnesium oxide)  . . . . . . . . . . . . . 25 mg    6% Daily ValueZinc (zinc oxide)  . . . . . . . . . . . . . . . . . . . . . . . . .  . . . 25 mg    167% Daily ValueCopper (cupric oxide)  . . . . . . . . . . . . . . . . . . . . . . . .2 mg    100% Daily ValueServing Size 1 Softgel:at least 278 mg purified omega-3 fatty acids (as DHA, EPA, ALA, and DPA)OTHER TABLET INGREDIENTS:Microcrystalline Cellulose, Hydroxypropyl Methylcellulose, Crospovidone, Maltodextrin, Acacia Gum, Silicon Dioxide, Triacetin, Magnesium Stearate, Titanium Dioxide, Polydextrose, Yellow #6 Lake, Blue #2 Lake, Red #40 Lake.OTHER SOFTGEL INGREDIENTS: Ammonium Hydroxide, Ethylcellulose, Gelatin, Glycerin, Medium Chain Triglycerides, Oleic Acid, Sodium Alginate, Stearic Acid, Vanillin.Softgel contains fish and soybeans."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"52183-278-20","ProprietaryName":"Ludens Menthol Throat Drops","NonProprietaryName":"Menthol"},{"NDCCode":"52183-101-01","ProprietaryName":"Ludens Blue Raspberry Throat Drops","NonProprietaryName":"Pectin"},{"NDCCode":"52183-102-01","ProprietaryName":"Ludens Watermelon Throat Drops","NonProprietaryName":"Pectin"},{"NDCCode":"52183-205-20","ProprietaryName":"Ludens Kiwi-strawberry","NonProprietaryName":"Pectin"},{"NDCCode":"52183-208-20","ProprietaryName":"Ludens Strawberry Banana Throat Drops","NonProprietaryName":"Pectin"},{"NDCCode":"52183-259-20","ProprietaryName":"Ludens Honey Licorice Throat Drops","NonProprietaryName":"Menthol"},{"NDCCode":"52183-269-20","ProprietaryName":"Ludens Honey Lemon Throat Drops","NonProprietaryName":"Menthol"},{"NDCCode":"52183-299-20","ProprietaryName":"Ludens Wild Cherry Throat Drops","NonProprietaryName":"Pectin"},{"NDCCode":"10544-278-20","ProprietaryName":"Naproxen","NonProprietaryName":"Naproxen"},{"NDCCode":"43353-278-20","ProprietaryName":"Diazepam","NonProprietaryName":"Diazepam"},{"NDCCode":"51079-278-20","ProprietaryName":"Propranolol Hydrochloride","NonProprietaryName":"Propranolol Hydrochloride"},{"NDCCode":"57687-278-20","ProprietaryName":"Bach Original Flower Remedies","NonProprietaryName":"Ornithogalum Umbellatum"},{"NDCCode":"67046-278-20","ProprietaryName":"Hydrochlorothiazide","NonProprietaryName":"Hydrochlorothiazide"},{"NDCCode":"69452-278-20","ProprietaryName":"Dexamethasone","NonProprietaryName":"Dexamethasone"},{"NDCCode":"76233-278-20","ProprietaryName":"Piperacillin And Tazobactam","NonProprietaryName":"Piperacillin And Tazobactam"},{"NDCCode":"76945-278-20","ProprietaryName":"Tecnologia Y Soluciones En Alimentos S.a De C.v","NonProprietaryName":"Tecnofood"},{"NDCCode":"52183-353-01","ProprietaryName":"Pediacare Infants Gas Relief Dye Free","NonProprietaryName":"Simethicone"},{"NDCCode":"52183-363-01","ProprietaryName":"Pediacare Infants Gas Relief","NonProprietaryName":"Simethicone"},{"NDCCode":"52183-369-04","ProprietaryName":"Pediacare Longacting Cough","NonProprietaryName":"Dextromethorphan Hbr"},{"NDCCode":"10702-278-03","ProprietaryName":"Leflunomide","NonProprietaryName":"Leflunomide"},{"NDCCode":"16729-278-01","ProprietaryName":"Aripiprazole","NonProprietaryName":"Aripiprazole"},{"NDCCode":"16729-278-10","ProprietaryName":"Aripiprazole","NonProprietaryName":"Aripiprazole"},{"NDCCode":"21695-278-30","ProprietaryName":"Lyrica","NonProprietaryName":"Pregabalin"},{"NDCCode":"21695-278-60","ProprietaryName":"Lyrica","NonProprietaryName":"Pregabalin"},{"NDCCode":"21695-278-72","ProprietaryName":"Lyrica","NonProprietaryName":"Pregabalin"},{"NDCCode":"21695-278-90","ProprietaryName":"Lyrica","NonProprietaryName":"Pregabalin"},{"NDCCode":"33342-278-07","ProprietaryName":"Tadalafil","NonProprietaryName":"Tadalafil"},{"NDCCode":"33342-278-09","ProprietaryName":"Tadalafil","NonProprietaryName":"Tadalafil"},{"NDCCode":"40032-060-19","ProprietaryName":"Polyethylene Glycol-3350 And Electrolytes With Flavor Pack","NonProprietaryName":"Polyethylene Glycol-3350 And Electrolytes With Flavor Pack"},{"NDCCode":"42546-190-30","ProprietaryName":"Moms Choice Rx","NonProprietaryName":"Beta Carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Carbonate, Sodium Feredetate, Magnesium Oxide, Zinc Oxide, Cupric Oxide, Iron Sucrose, Iodine, Omega 3 Fatty Acids"}]}
                    

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    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
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    <LabelerName>Prestige Brands Holdings, Inc.</LabelerName>
    <SubstanceName>MENTHOL</SubstanceName>
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    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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  <NDC>
    <NDCCode>52183-101-01</NDCCode>
    <PackageDescription>20 LOZENGE in 1 CARTON (52183-101-01) </PackageDescription>
    <NDC11Code>52183-0101-01</NDC11Code>
    <ProductNDC>52183-101</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ludens Blue Raspberry Throat Drops</ProprietaryName>
    <NonProprietaryName>Pectin</NonProprietaryName>
    <DosageFormName>LOZENGE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20091029</StartMarketingDate>
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    <LabelerName>Prestige Brands Holdings, Inc.</LabelerName>
    <SubstanceName>PECTIN</SubstanceName>
    <StrengthNumber>1.7</StrengthNumber>
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    <LastUpdate>2021-09-01</LastUpdate>
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    <NDC11Code>52183-0102-01</NDC11Code>
    <ProductNDC>52183-102</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ludens Watermelon Throat Drops</ProprietaryName>
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    <SubstanceName>PECTIN</SubstanceName>
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    <StrengthUnit>mg/1</StrengthUnit>
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    <LastUpdate>2026-08-31</LastUpdate>
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    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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    <NDCCode>52183-205-20</NDCCode>
    <PackageDescription>20 LOZENGE in 1 BAG (52183-205-20) </PackageDescription>
    <NDC11Code>52183-0205-20</NDC11Code>
    <ProductNDC>52183-205</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ludens Kiwi-strawberry</ProprietaryName>
    <NonProprietaryName>Pectin</NonProprietaryName>
    <DosageFormName>LOZENGE</DosageFormName>
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    <LabelerName>Prestige Brands Holdings, Inc.</LabelerName>
    <SubstanceName>PECTIN</SubstanceName>
    <StrengthNumber>2.8</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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    <NDC11Code>52183-0208-20</NDC11Code>
    <ProductNDC>52183-208</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ludens Strawberry Banana Throat Drops</ProprietaryName>
    <NonProprietaryName>Pectin</NonProprietaryName>
    <DosageFormName>LOZENGE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150701</StartMarketingDate>
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    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
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    <LabelerName>Prestige Brands Holdings, Inc.</LabelerName>
    <SubstanceName>PECTIN</SubstanceName>
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    <LastUpdate>2021-09-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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    <PackageDescription>20 LOZENGE in 1 BOX (52183-259-20) </PackageDescription>
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    <ProductNDC>52183-259</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ludens Honey Licorice Throat Drops</ProprietaryName>
    <NonProprietaryName>Menthol</NonProprietaryName>
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    <RouteName>ORAL</RouteName>
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    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M022</ApplicationNumber>
    <LabelerName>Prestige Brands Holdings, Inc.</LabelerName>
    <SubstanceName>MENTHOL</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-08-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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    <SamplePackage>N</SamplePackage>
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    <PackageDescription>20 LOZENGE in 1 BOX (52183-269-20) </PackageDescription>
    <NDC11Code>52183-0269-20</NDC11Code>
    <ProductNDC>52183-269</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ludens Honey Lemon Throat Drops</ProprietaryName>
    <NonProprietaryName>Menthol</NonProprietaryName>
    <DosageFormName>LOZENGE</DosageFormName>
    <RouteName>ORAL</RouteName>
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    <LabelerName>Prestige Brands Holdings, Inc.</LabelerName>
    <SubstanceName>MENTHOL</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-07-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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    <PackageDescription>20 LOZENGE in 1 BOX (52183-299-20) </PackageDescription>
    <NDC11Code>52183-0299-20</NDC11Code>
    <ProductNDC>52183-299</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ludens Wild Cherry Throat Drops</ProprietaryName>
    <NonProprietaryName>Pectin</NonProprietaryName>
    <DosageFormName>LOZENGE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20091029</StartMarketingDate>
    <EndMarketingDate>20260930</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M022</ApplicationNumber>
    <LabelerName>Prestige Brands Holdings, Inc.</LabelerName>
    <SubstanceName>PECTIN</SubstanceName>
    <StrengthNumber>1.7</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-08-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20091029</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260930</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>10544-278-20</NDCCode>
    <PackageDescription>20 TABLET in 1 BOTTLE (10544-278-20)</PackageDescription>
    <NDC11Code>10544-0278-20</NDC11Code>
    <ProductNDC>10544-278</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Naproxen</ProprietaryName>
    <NonProprietaryName>Naproxen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100317</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078250</ApplicationNumber>
    <LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
    <SubstanceName>NAPROXEN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of naproxen, naproxen sodium and other treatment options before deciding to use naproxen and naproxen sodium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Naproxen as naproxen or naproxen sodium tablets are indicated: : 1 For the relief of the signs and symptoms of rheumatoid arthritis , 2 For the relief of the signs and symptoms of osteoarthritis , 3 For the relief of the signs and symptoms of ankylosing spondylitis , 4 For the relief of the signs and symptoms of juvenile arthritis.</IndicationAndUsage>
    <Description>Naproxen USP is a proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen USP and naproxen sodium USP are (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid and (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen USP and naproxen sodium USP have the following structures, respectively:. Naproxen USP has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen sodium USP has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. Naproxen USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen USP at pH 7.4 is 1.6 to 1.8. Naproxen sodium USP is a white to creamy white, crystalline solid, freely soluble in water at neutral pH. Naproxen tablets USP are available as light orange colored tablets containing 250 mg of naproxen USP, light orange colored tablets containing 375 mg of naproxen USP and light orange colored tablets containing 500 mg of naproxen USP for oral administration. The inactive ingredients are microcrystalline cellulose, croscarmellose sodium, iron oxides, povidone and magnesium stearate. Naproxen sodium tablets USP are available as blue tablets containing 275 mg of naproxen sodium USP and as blue tablets containing 550 mg of naproxen sodium USP for oral administration. The inactive ingredients are croscarmellose sodium, colloidal silicon dioxide, povidone, magnesium stearate, microcrystalline cellulose and talc. The coating suspension for the naproxen sodium 275 mg tablet may contain Opadry blue 03F50544. The coating suspension for the naproxen sodium 550 mg tablet may contain Opadry blue 03F50544.</Description>
  </NDC>
  <NDC>
    <NDCCode>43353-278-20</NDCCode>
    <PackageDescription>20 TABLET in 1 BOTTLE, PLASTIC (43353-278-20)</PackageDescription>
    <NDC11Code>43353-0278-20</NDC11Code>
    <ProductNDC>43353-278</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diazepam</ProprietaryName>
    <NonProprietaryName>Diazepam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160803</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA071135</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>DIAZEPAM</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2025-06-10</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Diazepam Tablets USP are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma); spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia); athetosis; and stiff-man syndrome. Oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. The effectiveness of diazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Diazepam is a benzodiazepine derivative. The chemical name of diazepam is 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. It is a colorless to light yellow crystalline compound, insoluble in water. The empirical formula is C16H13ClN2O and the molecular weight is 284.75. The structural formula is as follows. Diazepam is available for oral administration as tablets containing 2 mg, 5 mg or 10 mg diazepam. In addition to the active ingredient diazepam, each tablet contains the following inactive ingredients: anhydrous lactose, magnesium stearate and microcrystalline cellulose. Diazepam Tablets USP 5 mg also contain D&amp;C Yellow No. 10. Diazepam Tablets USP 10 mg also contain FD&amp;C Blue No. 1.</Description>
  </NDC>
  <NDC>
    <NDCCode>51079-278-20</NDCCode>
    <PackageDescription>100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-278-20)  &gt; 1 TABLET in 1 BLISTER PACK (51079-278-01)</PackageDescription>
    <NDC11Code>51079-0278-20</NDC11Code>
    <ProductNDC>51079-278</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19980901</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA070213</ApplicationNumber>
    <LabelerName>UDL Laboratories, Inc.</LabelerName>
    <SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-10-13</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>57687-278-20</NDCCode>
    <PackageDescription>20 mL in 1 BOTTLE, DROPPER (57687-278-20) </PackageDescription>
    <NDC11Code>57687-0278-20</NDC11Code>
    <ProductNDC>57687-278</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Bach Original Flower Remedies</ProprietaryName>
    <NonProprietaryName>Ornithogalum Umbellatum</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20020101</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Nelson Bach USA Limited</LabelerName>
    <SubstanceName>ORNITHOGALUM UMBELLATUM WHOLE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>[hp_X]/.095mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2020-06-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20020101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For relief of naturally occurring simple nervous tension.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>67046-278-20</NDCCode>
    <PackageDescription>20 TABLET in 1 BLISTER PACK (67046-278-20) </PackageDescription>
    <NDC11Code>67046-0278-20</NDC11Code>
    <ProductNDC>67046-278</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydrochlorothiazide</ProprietaryName>
    <NonProprietaryName>Hydrochlorothiazide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170928</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202556</ApplicationNumber>
    <LabelerName>Contract Pharmacy Services-PA</LabelerName>
    <SubstanceName>HYDROCHLOROTHIAZIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170928</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.</IndicationAndUsage>
    <Description>Hydrochlorothiazide is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. It is chemically designated as 6-chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide and has the following structural formula:. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder which is slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. Each tablet for oral administration contains 12.5 mg, 25 mg or 50 mg hydrochlorothiazide, USP. In addition, each tablet contains the following inactive ingredients: dibasic calcium phosphate dihydrate, FD &amp; C yellow, lactose monohydrate, magnesium stearate, pregelatinized starch (starch 1500) and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>69452-278-20</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (69452-278-20) </PackageDescription>
    <NDC11Code>69452-0278-20</NDC11Code>
    <ProductNDC>69452-278</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dexamethasone</ProprietaryName>
    <NonProprietaryName>Dexamethasone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230801</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217001</ApplicationNumber>
    <LabelerName>Bionpharma Inc.,</LabelerName>
    <SubstanceName>DEXAMETHASONE</SubstanceName>
    <StrengthNumber>6</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230801</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>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, perennial or seasonal allergic rhinitis, and serum sickness. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia. Miscellaneous: Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used 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, craniotomy, or head injury. Ophthalmic diseases: Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce a 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, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
    <Description>Dexamethasone tablets, USP, for oral administration, are supplied as 4 mg, and 6 mg. Inactive ingredients are corn starch, D&amp;C yellow 10 (4 mg), FD&amp;C blue 1 (6 mg), lactose monohydrate, and magnesium stearate. The molecular weight for dexamethasone is 392.5 g/mol. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione. The molecular formula is C 22H 29FO 5 and the structural formula is:. Dexamethasone, USP a synthetic adrenocortical steroid, is a white to almost-white, crystalline powder. It is stable in air. It is practically insoluble in water, very slightly soluble in ether, slightly soluble in methylene chloride and chloroform, and sparingly soluble in methanol, ethanol (96 %), acetone and 1,4 dioxane.</Description>
  </NDC>
  <NDC>
    <NDCCode>76233-278-20</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (76233-278-20)  &gt; 20 mL in 1 VIAL, SINGLE-DOSE (76233-278-00) </PackageDescription>
    <NDC11Code>76233-0278-20</NDC11Code>
    <ProductNDC>76233-278</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Piperacillin And Tazobactam</ProprietaryName>
    <NonProprietaryName>Piperacillin And Tazobactam</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20200724</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203768</ApplicationNumber>
    <LabelerName>Laboratorio Reig Jofre Sa.</LabelerName>
    <SubstanceName>PIPERACILLIN SODIUM; TAZOBACTAM SODIUM</SubstanceName>
    <StrengthNumber>4; .5</StrengthNumber>
    <StrengthUnit>g/20mL; g/20mL</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-07-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200724</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>76945-278-20</NDCCode>
    <PackageDescription>20 L in 1 DRUM (76945-278-20) </PackageDescription>
    <NDC11Code>76945-0278-20</NDC11Code>
    <ProductNDC>76945-278</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Tecnologia Y Soluciones En Alimentos S.a De C.v</ProprietaryName>
    <NonProprietaryName>Tecnofood</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200510</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>Tecnologia y Soluciones en Alimentos S.A de C.V</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>13</StrengthNumber>
    <StrengthUnit>mg/100L</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-08-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200510</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>52183-353-01</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (52183-353-01)  &gt; 30 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>52183-0353-01</NDC11Code>
    <ProductNDC>52183-353</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Pediacare Infants Gas Relief Dye Free</ProprietaryName>
    <NonProprietaryName>Simethicone</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20101012</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part332</ApplicationNumber>
    <LabelerName>Blacksmith Brands, Inc.</LabelerName>
    <SubstanceName>SILICON DIOXIDE; DIMETHICONE</SubstanceName>
    <StrengthNumber>.37; 6.3</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-12-20</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>52183-363-01</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (52183-363-01)  &gt; 30 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>52183-0363-01</NDC11Code>
    <ProductNDC>52183-363</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Pediacare Infants Gas Relief</ProprietaryName>
    <NonProprietaryName>Simethicone</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20101012</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part332</ApplicationNumber>
    <LabelerName>Blacksmith Brands, Inc.</LabelerName>
    <SubstanceName>DIMETHICONE; SILICON DIOXIDE</SubstanceName>
    <StrengthNumber>6.3; .37</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-12-20</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>52183-369-04</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (52183-369-04)  &gt; 118 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>52183-0369-04</NDC11Code>
    <ProductNDC>52183-369</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Pediacare Longacting Cough</ProprietaryName>
    <NonProprietaryName>Dextromethorphan Hbr</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20091029</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>Blacksmith Brands, Inc.</LabelerName>
    <SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
    <StrengthNumber>7.5</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-12-20</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>10702-278-03</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (10702-278-03) </PackageDescription>
    <NDC11Code>10702-0278-03</NDC11Code>
    <ProductNDC>10702-278</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Leflunomide</ProprietaryName>
    <NonProprietaryName>Leflunomide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200723</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212453</ApplicationNumber>
    <LabelerName>KVK-Tech, Inc.</LabelerName>
    <SubstanceName>LEFLUNOMIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antirheumatic Agent [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200723</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Leflunomide tablets are indicated for the treatment of adults with active rheumatoid arthritis (RA).</IndicationAndUsage>
    <Description>Leflunomide is a pyrimidine synthesis inhibitor. The chemical name for leflunomide is 4-Isoxazolecarboxamide, 5-methyl-N-[4-(trifluoromethyl)-phenyl]-. It has an empirical formula C12H9F3N2O2, a molecular weight of 270.21 and the following structural formula. Leflunomide tablets are available for oral administration as film coated tablets containing 10, or 20 mg of active drug. Combined with leflunomide are the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, corn starch, talc, titanium dioxide, and yellow ferric oxide (20 mg tablet only).</Description>
  </NDC>
  <NDC>
    <NDCCode>16729-278-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (16729-278-01) </PackageDescription>
    <NDC11Code>16729-0278-01</NDC11Code>
    <ProductNDC>16729-278</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Aripiprazole</ProprietaryName>
    <NonProprietaryName>Aripiprazole</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170215</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206251</ApplicationNumber>
    <LabelerName>Accord Healthcare, Inc.</LabelerName>
    <SubstanceName>ARIPIPRAZOLE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170215</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Aripiprazole tablets are indicated for the treatment of: 1 Schizophrenia, 2 Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder, 3 Adjunctive Treatment of Major Depressive Disorder, 4 Irritability Associated with Autistic Disorder, 5 Treatment of Tourette's Disorder.</IndicationAndUsage>
    <Description>Aripiprazole is an atypical antipsychotic drug that is available as aripiprazole tablets, USP. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C 23H 27Cl 2N 3O 2and its molecular weight is 448.38. The chemical structure is:. Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, maize starch and microcrystalline cellulose. Colorants include ferric oxide red (10 mg and 30 mg), ferric oxide yellow (2 mg and 15 mg), and FD&amp;C Blue No. 2 aluminum lake (2 mg and 5 mg).</Description>
  </NDC>
  <NDC>
    <NDCCode>16729-278-10</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (16729-278-10) </PackageDescription>
    <NDC11Code>16729-0278-10</NDC11Code>
    <ProductNDC>16729-278</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Aripiprazole</ProprietaryName>
    <NonProprietaryName>Aripiprazole</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170215</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206251</ApplicationNumber>
    <LabelerName>Accord Healthcare, Inc.</LabelerName>
    <SubstanceName>ARIPIPRAZOLE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170215</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Aripiprazole tablets are indicated for the treatment of: 1 Schizophrenia, 2 Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder, 3 Adjunctive Treatment of Major Depressive Disorder, 4 Irritability Associated with Autistic Disorder, 5 Treatment of Tourette's Disorder.</IndicationAndUsage>
    <Description>Aripiprazole is an atypical antipsychotic drug that is available as aripiprazole tablets, USP. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C 23H 27Cl 2N 3O 2and its molecular weight is 448.38. The chemical structure is:. Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, maize starch and microcrystalline cellulose. Colorants include ferric oxide red (10 mg and 30 mg), ferric oxide yellow (2 mg and 15 mg), and FD&amp;C Blue No. 2 aluminum lake (2 mg and 5 mg).</Description>
  </NDC>
  <NDC>
    <NDCCode>21695-278-30</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (21695-278-30)</PackageDescription>
    <NDC11Code>21695-0278-30</NDC11Code>
    <ProductNDC>21695-278</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lyrica</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20050610</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021724</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>LYRICA is indicated for.</IndicationAndUsage>
    <Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, cornstarch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain sodium lauryl sulfate and colloidal silicon dioxide. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide. LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with methylparaben, propylparaben, monobasic sodium phosphate anhydrous, dibasic sodium phosphate anhydrous, sucralose, artificial strawberry #11545 and purified water as inactive ingredients.</Description>
  </NDC>
  <NDC>
    <NDCCode>21695-278-60</NDCCode>
    <PackageDescription>60 CAPSULE in 1 BOTTLE (21695-278-60)</PackageDescription>
    <NDC11Code>21695-0278-60</NDC11Code>
    <ProductNDC>21695-278</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lyrica</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20050610</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021724</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>LYRICA is indicated for.</IndicationAndUsage>
    <Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, cornstarch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain sodium lauryl sulfate and colloidal silicon dioxide. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide. LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with methylparaben, propylparaben, monobasic sodium phosphate anhydrous, dibasic sodium phosphate anhydrous, sucralose, artificial strawberry #11545 and purified water as inactive ingredients.</Description>
  </NDC>
  <NDC>
    <NDCCode>21695-278-72</NDCCode>
    <PackageDescription>120 CAPSULE in 1 BOTTLE (21695-278-72)</PackageDescription>
    <NDC11Code>21695-0278-72</NDC11Code>
    <ProductNDC>21695-278</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lyrica</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20050610</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021724</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>LYRICA is indicated for.</IndicationAndUsage>
    <Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, cornstarch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain sodium lauryl sulfate and colloidal silicon dioxide. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide. LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with methylparaben, propylparaben, monobasic sodium phosphate anhydrous, dibasic sodium phosphate anhydrous, sucralose, artificial strawberry #11545 and purified water as inactive ingredients.</Description>
  </NDC>
  <NDC>
    <NDCCode>21695-278-90</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (21695-278-90)</PackageDescription>
    <NDC11Code>21695-0278-90</NDC11Code>
    <ProductNDC>21695-278</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lyrica</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20050610</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021724</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>LYRICA is indicated for.</IndicationAndUsage>
    <Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, cornstarch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain sodium lauryl sulfate and colloidal silicon dioxide. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide. LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with methylparaben, propylparaben, monobasic sodium phosphate anhydrous, dibasic sodium phosphate anhydrous, sucralose, artificial strawberry #11545 and purified water as inactive ingredients.</Description>
  </NDC>
  <NDC>
    <NDCCode>33342-278-07</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (33342-278-07) </PackageDescription>
    <NDC11Code>33342-0278-07</NDC11Code>
    <ProductNDC>33342-278</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tadalafil</ProprietaryName>
    <NonProprietaryName>Tadalafil</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20191017</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207290</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>TADALAFIL</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-10-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191030</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tadalafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class II – III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%). (1.1).</IndicationAndUsage>
    <Description>Tadalafil tablets USP, an oral treatment for pulmonary arterial hypertension, are a selective inhibitor of cyclic guanosine monophosphate (cGMP)–specific phosphodiesterase type 5 (PDE5). Tadalafil USP has the empirical formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4–b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil tablets USP are available as yellow coloured, almond shaped, biconvex film coated tablets having ‘L64’ debossed on one side and plain on other side for oral administration. Each tablet contains 20 mg of tadalafil USP and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose 6 cPs, iron oxide yellow, lactose monohydrate, microcrystalline cellulose, povidone, sodium citrate dihydrate, sodium lauryl sulphate, sodium stearyl fumarate, talc, titanium dioxide, and triacetin.</Description>
  </NDC>
  <NDC>
    <NDCCode>33342-278-09</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (33342-278-09) </PackageDescription>
    <NDC11Code>33342-0278-09</NDC11Code>
    <ProductNDC>33342-278</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tadalafil</ProprietaryName>
    <NonProprietaryName>Tadalafil</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20191017</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207290</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>TADALAFIL</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-10-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191030</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tadalafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class II – III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%). (1.1).</IndicationAndUsage>
    <Description>Tadalafil tablets USP, an oral treatment for pulmonary arterial hypertension, are a selective inhibitor of cyclic guanosine monophosphate (cGMP)–specific phosphodiesterase type 5 (PDE5). Tadalafil USP has the empirical formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4–b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil tablets USP are available as yellow coloured, almond shaped, biconvex film coated tablets having ‘L64’ debossed on one side and plain on other side for oral administration. Each tablet contains 20 mg of tadalafil USP and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose 6 cPs, iron oxide yellow, lactose monohydrate, microcrystalline cellulose, povidone, sodium citrate dihydrate, sodium lauryl sulphate, sodium stearyl fumarate, talc, titanium dioxide, and triacetin.</Description>
  </NDC>
  <NDC>
    <NDCCode>40032-060-19</NDCCode>
    <PackageDescription>278.26 g in 1 BOTTLE (40032-060-19)</PackageDescription>
    <NDC11Code>40032-0060-19</NDC11Code>
    <ProductNDC>40032-060</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Polyethylene Glycol-3350 And Electrolytes With Flavor Pack</ProprietaryName>
    <NonProprietaryName>Polyethylene Glycol-3350 And Electrolytes With Flavor Pack</NonProprietaryName>
    <DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090601</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090186</ApplicationNumber>
    <LabelerName>Novel Laboratories, Inc.</LabelerName>
    <SubstanceName>POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE; SODIUM SULFATE ANHYDROUS</SubstanceName>
    <StrengthNumber>240; 5.84; 6.72; 2.98; 22.72</StrengthNumber>
    <StrengthUnit>g/278.26g; g/278.26g; g/278.26g; g/278.26g; g/278.26g</StrengthUnit>
    <Pharm_Classes>Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>PEG-3350 (240 g) and Electrolytes for Oral Solution, USP with flavor pack is indicated for bowel cleansing prior to colonoscopy or barium enema X-ray examination.</IndicationAndUsage>
    <Description>PEG-3350 (240 g) and Electrolytes for Oral Solution, USP with flavor pack is a white, colon lavage preparation provided as water-soluble components for solution. In solution this preparation with lemon flavor pack added delivers the following, in grams per liter. Polyethylene glycol 3350 60.00. Sodium chloride 1.46. Potassium chloride 0.745. Sodium bicarbonate 1.68. Sodium sulfate 5.68. Flavor ingredients 0.500. When dissolved in sufficient water to make 4 liters, the final solution contains 125 mEq/L sodium, 10 mEq/L potassium, 20 mEq/L bicarbonate, 80 mEq/L sulfate, 35 mEq/L chloride and 18 mEq/L polyethylene glycol 3350. The reconstituted solution is an isosmotic solution, for oral administration, having mild salty taste. This preparation can be used without the lemon flavor pack and is administered orally or via nasogastric tube. Each lemon flavor pack (2 g) contains natural lemon flavor powder, saccharin sodium, maltodextrin.</Description>
  </NDC>
  <NDC>
    <NDCCode>42546-190-30</NDCCode>
    <PackageDescription>6 BLISTER PACK in 1 CARTON (42546-190-30)  &gt; 1 KIT in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>42546-0190-30</NDC11Code>
    <ProductNDC>42546-190</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Moms Choice Rx</ProprietaryName>
    <NonProprietaryName>Beta Carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Carbonate, Sodium Feredetate, Magnesium Oxide, Zinc Oxide, Cupric Oxide, Iron Sucrose, Iodine, Omega 3 Fatty Acids</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20130401</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>PruGen, Inc.</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <Description>SUPPLEMENT FACTSServing Size 1 Tablet:VITAMINSA (beta carotene)  . . . . . . . . . . . . . . . . . . . . . . . . . . 2,840 IU    36% Daily ValueC (ascorbic acid)    . . . . . . . . . . . . . . . . . . . . . . . . . . 120 mg    200% Daily ValueD (cholecalciferol)    . . . . . . . . . . . . . . . . . . . . . . . . .840 IU    210% Daily ValueE (dl-alpha tocopheryl acetate)  . . . . . . . . . . . . . .2 mg    7% Daily ValueB1 (thiamine mononitrate)  . . . . . . . . . . . . . . . . . . .1.5 mg    88% Daily ValueB2 (riboflavin)   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4 mg    200% Daily ValueNiacinamide   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 mg    100% Daily ValueB6 (pyridoxine hydrochloride)  . . . . . . . . . . . . . . .50 mg    2000% Daily ValueFolic acid    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1 mg    125% Daily ValueB12 (cyanocobalamin)   . . . . . . . . . . . . . . . . . . . . . . 12 mcg    150% Daily ValueMINERALSCalcium (calcium carbonate)  . . . . . . . . . . . . . . . . 215 mg    17% Daily ValueIron (as sodium iron EDTA and polysaccharide iron complex) . . .26 mg    144% Daily Value. Iodine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 210 mcg  140% Daily ValueMagnesium (magnesium oxide)  . . . . . . . . . . . . . 25 mg    6% Daily ValueZinc (zinc oxide)  . . . . . . . . . . . . . . . . . . . . . . . . .  . . . 25 mg    167% Daily ValueCopper (cupric oxide)  . . . . . . . . . . . . . . . . . . . . . . . .2 mg    100% Daily ValueServing Size 1 Softgel:at least 278 mg purified omega-3 fatty acids (as DHA, EPA, ALA, and DPA)OTHER TABLET INGREDIENTS:Microcrystalline Cellulose, Hydroxypropyl Methylcellulose, Crospovidone, Maltodextrin, Acacia Gum, Silicon Dioxide, Triacetin, Magnesium Stearate, Titanium Dioxide, Polydextrose, Yellow #6 Lake, Blue #2 Lake, Red #40 Lake.OTHER SOFTGEL INGREDIENTS: Ammonium Hydroxide, Ethylcellulose, Gelatin, Glycerin, Medium Chain Triglycerides, Oleic Acid, Sodium Alginate, Stearic Acid, Vanillin.Softgel contains fish and soybeans.</Description>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>52183-278-20</NDCCode><ProprietaryName>Ludens Menthol Throat Drops</ProprietaryName><NonProprietaryName>Menthol</NonProprietaryName></NDC><NDC><NDCCode>52183-101-01</NDCCode><ProprietaryName>Ludens Blue Raspberry Throat Drops</ProprietaryName><NonProprietaryName>Pectin</NonProprietaryName></NDC><NDC><NDCCode>52183-102-01</NDCCode><ProprietaryName>Ludens Watermelon Throat Drops</ProprietaryName><NonProprietaryName>Pectin</NonProprietaryName></NDC><NDC><NDCCode>52183-205-20</NDCCode><ProprietaryName>Ludens Kiwi-strawberry</ProprietaryName><NonProprietaryName>Pectin</NonProprietaryName></NDC><NDC><NDCCode>52183-208-20</NDCCode><ProprietaryName>Ludens Strawberry Banana Throat Drops</ProprietaryName><NonProprietaryName>Pectin</NonProprietaryName></NDC><NDC><NDCCode>52183-259-20</NDCCode><ProprietaryName>Ludens Honey Licorice Throat Drops</ProprietaryName><NonProprietaryName>Menthol</NonProprietaryName></NDC><NDC><NDCCode>52183-269-20</NDCCode><ProprietaryName>Ludens Honey Lemon Throat Drops</ProprietaryName><NonProprietaryName>Menthol</NonProprietaryName></NDC><NDC><NDCCode>52183-299-20</NDCCode><ProprietaryName>Ludens Wild Cherry Throat Drops</ProprietaryName><NonProprietaryName>Pectin</NonProprietaryName></NDC><NDC><NDCCode>10544-278-20</NDCCode><ProprietaryName>Naproxen</ProprietaryName><NonProprietaryName>Naproxen</NonProprietaryName></NDC><NDC><NDCCode>43353-278-20</NDCCode><ProprietaryName>Diazepam</ProprietaryName><NonProprietaryName>Diazepam</NonProprietaryName></NDC><NDC><NDCCode>51079-278-20</NDCCode><ProprietaryName>Propranolol Hydrochloride</ProprietaryName><NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>57687-278-20</NDCCode><ProprietaryName>Bach Original Flower Remedies</ProprietaryName><NonProprietaryName>Ornithogalum Umbellatum</NonProprietaryName></NDC><NDC><NDCCode>67046-278-20</NDCCode><ProprietaryName>Hydrochlorothiazide</ProprietaryName><NonProprietaryName>Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>69452-278-20</NDCCode><ProprietaryName>Dexamethasone</ProprietaryName><NonProprietaryName>Dexamethasone</NonProprietaryName></NDC><NDC><NDCCode>76233-278-20</NDCCode><ProprietaryName>Piperacillin And Tazobactam</ProprietaryName><NonProprietaryName>Piperacillin And Tazobactam</NonProprietaryName></NDC><NDC><NDCCode>76945-278-20</NDCCode><ProprietaryName>Tecnologia Y Soluciones En Alimentos S.a De C.v</ProprietaryName><NonProprietaryName>Tecnofood</NonProprietaryName></NDC><NDC><NDCCode>52183-353-01</NDCCode><ProprietaryName>Pediacare Infants Gas Relief Dye Free</ProprietaryName><NonProprietaryName>Simethicone</NonProprietaryName></NDC><NDC><NDCCode>52183-363-01</NDCCode><ProprietaryName>Pediacare Infants Gas Relief</ProprietaryName><NonProprietaryName>Simethicone</NonProprietaryName></NDC><NDC><NDCCode>52183-369-04</NDCCode><ProprietaryName>Pediacare Longacting Cough</ProprietaryName><NonProprietaryName>Dextromethorphan Hbr</NonProprietaryName></NDC><NDC><NDCCode>10702-278-03</NDCCode><ProprietaryName>Leflunomide</ProprietaryName><NonProprietaryName>Leflunomide</NonProprietaryName></NDC><NDC><NDCCode>16729-278-01</NDCCode><ProprietaryName>Aripiprazole</ProprietaryName><NonProprietaryName>Aripiprazole</NonProprietaryName></NDC><NDC><NDCCode>16729-278-10</NDCCode><ProprietaryName>Aripiprazole</ProprietaryName><NonProprietaryName>Aripiprazole</NonProprietaryName></NDC><NDC><NDCCode>21695-278-30</NDCCode><ProprietaryName>Lyrica</ProprietaryName><NonProprietaryName>Pregabalin</NonProprietaryName></NDC><NDC><NDCCode>21695-278-60</NDCCode><ProprietaryName>Lyrica</ProprietaryName><NonProprietaryName>Pregabalin</NonProprietaryName></NDC><NDC><NDCCode>21695-278-72</NDCCode><ProprietaryName>Lyrica</ProprietaryName><NonProprietaryName>Pregabalin</NonProprietaryName></NDC><NDC><NDCCode>21695-278-90</NDCCode><ProprietaryName>Lyrica</ProprietaryName><NonProprietaryName>Pregabalin</NonProprietaryName></NDC><NDC><NDCCode>33342-278-07</NDCCode><ProprietaryName>Tadalafil</ProprietaryName><NonProprietaryName>Tadalafil</NonProprietaryName></NDC><NDC><NDCCode>33342-278-09</NDCCode><ProprietaryName>Tadalafil</ProprietaryName><NonProprietaryName>Tadalafil</NonProprietaryName></NDC><NDC><NDCCode>40032-060-19</NDCCode><ProprietaryName>Polyethylene Glycol-3350 And Electrolytes With Flavor Pack</ProprietaryName><NonProprietaryName>Polyethylene Glycol-3350 And Electrolytes With Flavor Pack</NonProprietaryName></NDC><NDC><NDCCode>42546-190-30</NDCCode><ProprietaryName>Moms Choice Rx</ProprietaryName><NonProprietaryName>Beta Carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Carbonate, Sodium Feredetate, Magnesium Oxide, Zinc Oxide, Cupric Oxide, Iron Sucrose, Iodine, Omega 3 Fatty Acids</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/04/2006",
      "LastUpdateDate": "12/11/2007",
      "AuthorizedOfficialLastName": "MONTECILLO",
      "AuthorizedOfficialFirstName": "RANIA",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-7363",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "801TX",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1346319878",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "REDMOND EYE CLINIC PLLC",
      "FirstLineMailingAddress": "16150 NE 85TH ST STE 206",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3543",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-3574",
      "MailingAddressFaxNumber": "425-881-0230",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "PracticeLocationAddressFaxNumber": "425-881-0230",
      "EnumerationDate": "11/07/2006",
      "LastUpdateDate": "07/08/2007",
      "AuthorizedOfficialLastName": "OTTEN",
      "AuthorizedOfficialFirstName": "LARRY",
      "AuthorizedOfficialMiddleName": "C",
      "AuthorizedOfficialTitle": "DR",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-3574",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "OD00001172",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
    },
    {
      "NPI": "1376755009",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "PERIMAN",
      "FirstName": "LAURA",
      "MiddleName": "MARIE",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "FirstLineMailingAddress": "623 W HIGHLAND DR",
      "MailingAddressCityName": "SEATTLE",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98119-3446",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "206-282-2716",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "SecondLinePracticeLocationAddress": "REDMOND EYE CLINIC",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "EnumerationDate": "05/04/2007",
      "LastUpdateDate": "07/08/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207W00000X",
      "Taxonomy1": "Ophthalmology",
      "LicenseNumber1": "MD00039796",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1659320539",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "MONTECILLO",
      "FirstName": "RANIA",
      "MiddleName": "B",
      "NamePrefix": "DR.",
      "Credential": "OD",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/09/2006",
      "LastUpdateDate": "12/19/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "3680",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1427560267",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ABOU SHADI",
      "FirstName": "RANIA",
      "NamePrefix": "MRS.",
      "Credential": "RPH",
      "FirstLineMailingAddress": "8862 161ST AVENUE NE",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-883-9532",
      "MailingAddressFaxNumber": "425-882-2743",
      "FirstLinePracticeLocationAddress": "8862 161ST AVENUE NE",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-883-9532",
      "PracticeLocationAddressFaxNumber": "425-882-2743",
      "EnumerationDate": "11/02/2017",
      "LastUpdateDate": "11/02/2017",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "3336C0003X",
      "Taxonomy1": "Community/Retail Pharmacy",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1528050523",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "DESCHUTES EYE CLINIC PC",
      "OtherOrgName": "THE EYE SURGERY INSTITUTE",
      "OtherOrgNameTypeCode": "3",
      "FirstLineMailingAddress": "813 SW HIGHLAND AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-3123",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-548-7170",
      "MailingAddressFaxNumber": "541-548-3842",
      "FirstLinePracticeLocationAddress": "813 SW HIGHLAND AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-3123",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-548-7170",
      "PracticeLocationAddressFaxNumber": "541-548-3842",
      "EnumerationDate": "08/17/2005",
      "LastUpdateDate": "12/01/2010",
      "AuthorizedOfficialLastName": "TRAUSTASON",
      "AuthorizedOfficialFirstName": "OLI",
      "AuthorizedOfficialMiddleName": "I",
      "AuthorizedOfficialTitle": "PRESIDENT",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "M.D.",
      "AuthorizedOfficialTelephoneNumber": "541-548-7170",
      "TaxonomyCode1": "207W00000X",
      "Taxonomy1": "Ophthalmology",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "053857000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierState1": "OR",
      "OtherIdentifierIssuer1": "REGENCE BCBS",
      "OtherIdentifier2": "CJ8770",
      "OtherIdentifierType2": "OTHER",
      "OtherIdentifierState2": "OR",
      "OtherIdentifierIssuer2": "RAILROAD MEDICARE",
      "OtherIdentifier3": "38080A",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierState3": "OR",
      "OtherIdentifierIssuer3": "CLEAR CHOICE",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1477596252",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "EYE CARE SPECIALISTS NORTHWEST PLLC",
      "OtherOrgName": "THE CHILDRENS EYE DOCTORS, THE FAMILY EYE DOCTORS, WOODLAWN OPTICAL",
      "OtherOrgNameTypeCode": "3",
      "FirstLineMailingAddress": "17130 AVONDALE WAY NE",
      "SecondLineMailingAddress": "SUITE 111",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-6600",
      "MailingAddressFaxNumber": "425-885-6580",
      "FirstLinePracticeLocationAddress": "17130 AVONDALE WAY NE",
      "SecondLinePracticeLocationAddress": "SUITE 111",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-6600",
      "PracticeLocationAddressFaxNumber": "425-885-6580",
      "EnumerationDate": "06/13/2006",
      "LastUpdateDate": "03/03/2008",
      "AuthorizedOfficialLastName": "LENART",
      "AuthorizedOfficialFirstName": "THOMAS",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "MD PHD",
      "AuthorizedOfficialTelephoneNumber": "425-885-6600",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "156FX1800X",
      "Taxonomy2": "Optician",
      "PrimaryTaxonomySwitch2": "N",
      "TaxonomyCode3": "207W00000X",
      "Taxonomy3": "Ophthalmology",
      "PrimaryTaxonomySwitch3": "Y",
      "OtherIdentifier1": "1568514032",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "NPI",
      "OtherIdentifier2": "1740297829",
      "OtherIdentifierType2": "OTHER",
      "OtherIdentifierIssuer2": "NPI",
      "OtherIdentifier3": "1205989522",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "NPI",
      "HealthcareProviderTaxonomyGroup1": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization.",
      "HealthcareProviderTaxonomyGroup2": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription2": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization.",
      "HealthcareProviderTaxonomyGroup3": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription3": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
    },
    {
      "NPI": "1215029343",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "EYE HEALTH PROFESSIONALS, P.C.",
      "FirstLineMailingAddress": "85 BARNES RD",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "WALLINGFORD",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06492-1832",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "203-284-9448",
      "MailingAddressFaxNumber": "203-269-1361",
      "FirstLinePracticeLocationAddress": "85 BARNES RD",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "WALLINGFORD",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06492-1832",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "203-284-9448",
      "PracticeLocationAddressFaxNumber": "203-269-1361",
      "EnumerationDate": "09/28/2006",
      "LastUpdateDate": "03/07/2008",
      "AuthorizedOfficialLastName": "REDMOND",
      "AuthorizedOfficialFirstName": "JOHN",
      "AuthorizedOfficialMiddleName": "W",
      "AuthorizedOfficialTitle": "PRESIDENT",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "M.D.",
      "AuthorizedOfficialTelephoneNumber": "203-284-9448",
      "TaxonomyCode1": "207W00000X",
      "Taxonomy1": "Ophthalmology",
      "PrimaryTaxonomySwitch1": "Y",
      "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": "1982789863",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "OVERLAKE EYE DESIGNS, P.C.",
      "FirstLineMailingAddress": "15230 NE 24TH ST STE Q",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-5540",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-562-2015",
      "MailingAddressFaxNumber": "425-562-2010",
      "FirstLinePracticeLocationAddress": "15230 NE 24TH ST STE Q",
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      "MailingAddressPostalCode": "34787-3546",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "407-905-8827",
      "MailingAddressFaxNumber": "407-645-4587",
      "FirstLinePracticeLocationAddress": "7900 FOREST CITY RD",
      "PracticeLocationAddressCityName": "ORLANDO",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "32810-3002",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "407-905-8827",
      "PracticeLocationAddressFaxNumber": "407-645-4587",
      "EnumerationDate": "02/28/2006",
      "LastUpdateDate": "07/28/2017",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1223G0001X",
      "Taxonomy1": "General Practice",
      "LicenseNumber1": "DN15582",
      "LicenseNumberStateCode1": "FL",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "122300000X",
      "Taxonomy2": "Dentist",
      "LicenseNumber2": "DN15582",
      "LicenseNumberStateCode2": "FL",
      "PrimaryTaxonomySwitch2": "Y",
      "OtherIdentifier1": "075156100",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "FL"
    },
    {
      "NPI": "1720032899",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ALBATAINEH",
      "FirstName": "RANIA",
      "MiddleName": "QASSIEM",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "11476 OKEECHOBEE BLVD",
      "MailingAddressCityName": "ROYAL PALM BEACH",
      "MailingAddressStateName": "FL",
      "MailingAddressPostalCode": "33411-8715",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "561-204-5111",
      "MailingAddressFaxNumber": "561-204-5150",
      "FirstLinePracticeLocationAddress": "11476 OKEECHOBEE BLVD",
      "PracticeLocationAddressCityName": "ROYAL PALM BEACH",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "33411-8715",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "561-204-5111",
      "PracticeLocationAddressFaxNumber": "561-204-5150",
      "EnumerationDate": "05/21/2006",
      "LastUpdateDate": "09/11/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "ME 79876",
      "LicenseNumberStateCode1": "FL",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1326095100",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ROSBOROUGH",
      "FirstName": "RANIA",
      "MiddleName": "BAJWA",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "3100 WYMAN PARK DR",
      "MailingAddressCityName": "BALTIMORE",
      "MailingAddressStateName": "MD",
      "MailingAddressPostalCode": "21211-2803",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "410-338-3500",
      "FirstLinePracticeLocationAddress": "3601 SW 160TH AVE",
      "SecondLinePracticeLocationAddress": "SUITE 250",
      "PracticeLocationAddressCityName": "MIRAMAR",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "33027-6308",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "877-866-7123",
      "EnumerationDate": "05/27/2006",
      "LastUpdateDate": "12/10/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "D0063732",
      "LicenseNumberStateCode1": "MD",
      "PrimaryTaxonomySwitch1": "Y",
      "TaxonomyCode2": "207Q00000X",
      "Taxonomy2": "Family Medicine",
      "LicenseNumber2": "0101257197",
      "LicenseNumberStateCode2": "VA",
      "PrimaryTaxonomySwitch2": "N"
    },
    {
      "NPI": "1528015310",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "HUSSEINI",
      "FirstName": "RANIA",
      "MiddleName": "I",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "111 CYPRESS ST",
      "MailingAddressCityName": "BROOKLINE",
      "MailingAddressStateName": "MA",
      "MailingAddressPostalCode": "02445-6002",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "508-718-4050",
      "FirstLinePracticeLocationAddress": "20 PATRIOT PL",
      "PracticeLocationAddressCityName": "FOXBORO",
      "PracticeLocationAddressStateName": "MA",
      "PracticeLocationAddressPostalCode": "02035-1375",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "508-718-4050",
      "EnumerationDate": "05/27/2006",
      "LastUpdateDate": "04/17/2012",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "209649",
      "LicenseNumberStateCode1": "MA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1760429591",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "RAYES-DANAN",
      "FirstName": "RANIA",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "OtherLastName": "RAYES",
      "OtherFirstName": "RANIA",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2500 METROHEALTH DR",
      "MailingAddressCityName": "CLEVELAND",
      "MailingAddressStateName": "OH",
      "MailingAddressPostalCode": "44109-1900",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "216-778-7800",
      "FirstLinePracticeLocationAddress": "2500 METROHEALTH DR",
      "PracticeLocationAddressCityName": "CLEVELAND",
      "PracticeLocationAddressStateName": "OH",
      "PracticeLocationAddressPostalCode": "44109-1900",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "216-778-7800",
      "EnumerationDate": "06/01/2006",
      "LastUpdateDate": "01/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207ZP0102X",
      "Taxonomy1": "Anatomic Pathology & Clinical Pathology",
      "LicenseNumber1": "35086346",
      "LicenseNumberStateCode1": "OH",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "2687703",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "OH"
    },
    {
      "NPI": "1699717660",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "AMPEY",
      "FirstName": "RANIA",
      "MiddleName": "L",
      "Credential": "LPC",
      "FirstLineMailingAddress": "5930 LOVERS LN",
      "SecondLineMailingAddress": "PREMIER NEUROPSYCHIATRY, PLC",
      "MailingAddressCityName": "PORTAGE",
      "MailingAddressStateName": "MI",
      "MailingAddressPostalCode": "49002-1673",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "269-873-1611",
      "FirstLinePracticeLocationAddress": "5930 LOVERS LN",
      "SecondLinePracticeLocationAddress": "PREMIER NEUROPSYCHIATRY, PLC",
      "PracticeLocationAddressCityName": "PORTAGE",
      "PracticeLocationAddressStateName": "MI",
      "PracticeLocationAddressPostalCode": "49002-1673",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "269-873-1611",
      "EnumerationDate": "06/12/2006",
      "LastUpdateDate": "12/30/2010",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional",
      "LicenseNumber1": "6401007658",
      "LicenseNumberStateCode1": "MI",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1801839667",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ABOUJAOUDE",
      "FirstName": "RANIA",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "PO BOX 1283",
      "MailingAddressCityName": "MEDFORD",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08055-6283",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "609-677-1046",
      "MailingAddressFaxNumber": "609-677-1306",
      "FirstLinePracticeLocationAddress": "200 TRENTON RD",
      "PracticeLocationAddressCityName": "BROWNS MILLS",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08015-1705",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "609-677-1046",
      "PracticeLocationAddressFaxNumber": "609-677-1306",
      "EnumerationDate": "06/13/2006",
      "LastUpdateDate": "09/15/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207RI0200X",
      "Taxonomy1": "Infectious Disease",
      "LicenseNumber1": "39215",
      "LicenseNumberStateCode1": "KY",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "207RI0200X",
      "Taxonomy2": "Infectious Disease",
      "LicenseNumber2": "25MA07672000",
      "LicenseNumberStateCode2": "NJ",
      "PrimaryTaxonomySwitch2": "Y"
    },
    {
      "NPI": "1184645301",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "BAIK",
      "FirstName": "RANIA",
      "Credential": "D.O.",
      "FirstLineMailingAddress": "602 ROUTE 169",
      "SecondLineMailingAddress": "PO BOX 865",
      "MailingAddressCityName": "WOODSTOCK",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06281-2225",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "860-821-3406",
      "MailingAddressFaxNumber": "860-821-3407",
      "FirstLinePracticeLocationAddress": "602 ROUTE 169",
      "PracticeLocationAddressCityName": "WOODSTOCK",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06281-2225",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "860-821-3406",
      "PracticeLocationAddressFaxNumber": "860-821-3407",
      "EnumerationDate": "07/22/2006",
      "LastUpdateDate": "01/14/2016",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "000260",
      "LicenseNumberStateCode1": "CT",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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