RESTful Lookup — Test-Drive (2007 – 2026)

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{
  "NDC": [
    {
      "NDCCode": "0268-0619-10",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (0268-0619-10) ",
      "NDC11Code": "00268-0619-10",
      "ProductNDC": "0268-0619",
      "ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Canis Lupus Familiaris Skin",
      "NonProprietaryName": "Dog Epithelia",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "19650101",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103753",
      "LabelerName": "ALK-Abello, Inc.",
      "SubstanceName": "CANIS LUPUS FAMILIARIS SKIN",
      "StrengthNumber": "10000",
      "StrengthUnit": "[PNU]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Cells, Epidermal [EXT], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Animal Skin Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-06-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19650101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust, molds, animal danders, various other inhalants, and in situations where the offending allergen cannot be avoided. Prior to initiation of therapy, the clinical sensitivity should be established by careful evaluation of the patient’s history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can easily be avoided.",
      "Description": "Sterile therapeutic extracts are supplied in either Phenol Saline Diluent or in Diluent containing Glycerin 50% (v/v) for subcutaneous injection. Inactive ingredients may include: Sodium Chloride for isotonicity, Glycerin, and Sodium Bicarbonate as buffering agents. These products are compounded and diluted on a w/v or PNU basis. Pollens are individually extracted from pure pollen extracted in a phenol-preserved sodium bicarbonate solution. Short Ragweed and Mixed (Tall and Short) Ragweed extracts are standardized by Antigen E content and so labeled. The Antigen E content of extracts containing Short Ragweed at a concentration more dilute than a weight/volume ratio of 1:10 are obtained by calculating the Antigen E content based on the assay value of more concentrated extract. Pollen extracts are filtered aseptically and, after final packaging, they are tested for sterility and safety. Molds are individually extracted from pure powdered inactivated mold source material extracted in phenol preserved saline. Mold extracts are filtered aseptically and after final packaging are tested for sterility and safety. Molds are present in all inhabited places at all seasons of the year; they are so ubiquitous that they are prevalent at times when common allergic pollens and other inhalants are not. In the home and surroundings, molds are found in upholstered furniture, mattresses, drapes, cellar and storage room dust, woolens, leather goods, fruits, meats, cheeses, garden soil and on plants. Spores, mycelial fragments and mold residues are thus inhaled, contacted and ingested continuously. Miscellaneous inhalants and epidermals are individually extracted in phenol preserved saline, filtered aseptically and after final packaging are tested for sterility and safety."
    },
    {
      "NDCCode": "0268-0619-50",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (0268-0619-50) ",
      "NDC11Code": "00268-0619-50",
      "ProductNDC": "0268-0619",
      "ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Canis Lupus Familiaris Skin",
      "NonProprietaryName": "Dog Epithelia",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "19650101",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103753",
      "LabelerName": "ALK-Abello, Inc.",
      "SubstanceName": "CANIS LUPUS FAMILIARIS SKIN",
      "StrengthNumber": "10000",
      "StrengthUnit": "[PNU]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Cells, Epidermal [EXT], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Animal Skin Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-06-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19650101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust, molds, animal danders, various other inhalants, and in situations where the offending allergen cannot be avoided. Prior to initiation of therapy, the clinical sensitivity should be established by careful evaluation of the patient’s history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can easily be avoided.",
      "Description": "Sterile therapeutic extracts are supplied in either Phenol Saline Diluent or in Diluent containing Glycerin 50% (v/v) for subcutaneous injection. Inactive ingredients may include: Sodium Chloride for isotonicity, Glycerin, and Sodium Bicarbonate as buffering agents. These products are compounded and diluted on a w/v or PNU basis. Pollens are individually extracted from pure pollen extracted in a phenol-preserved sodium bicarbonate solution. Short Ragweed and Mixed (Tall and Short) Ragweed extracts are standardized by Antigen E content and so labeled. The Antigen E content of extracts containing Short Ragweed at a concentration more dilute than a weight/volume ratio of 1:10 are obtained by calculating the Antigen E content based on the assay value of more concentrated extract. Pollen extracts are filtered aseptically and, after final packaging, they are tested for sterility and safety. Molds are individually extracted from pure powdered inactivated mold source material extracted in phenol preserved saline. Mold extracts are filtered aseptically and after final packaging are tested for sterility and safety. Molds are present in all inhabited places at all seasons of the year; they are so ubiquitous that they are prevalent at times when common allergic pollens and other inhalants are not. In the home and surroundings, molds are found in upholstered furniture, mattresses, drapes, cellar and storage room dust, woolens, leather goods, fruits, meats, cheeses, garden soil and on plants. Spores, mycelial fragments and mold residues are thus inhaled, contacted and ingested continuously. Miscellaneous inhalants and epidermals are individually extracted in phenol preserved saline, filtered aseptically and after final packaging are tested for sterility and safety."
    },
    {
      "NDCCode": "13811-619-10",
      "PackageDescription": "100 TABLET in 1 BOTTLE (13811-619-10) ",
      "NDC11Code": "13811-0619-10",
      "ProductNDC": "13811-619",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Timolol Maleate",
      "NonProprietaryName": "Timolol Maleate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190506",
      "EndMarketingDate": "20210131",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207556",
      "LabelerName": "TRIGEN LABORATORIES, LLC",
      "SubstanceName": "TIMOLOL MALEATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2021-02-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20190506",
      "EndMarketingDatePackage": "20210131",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "36998-0619-0",
      "PackageDescription": "10 kg in 1 DRUM (36998-0619-0)",
      "NDC11Code": "36998-0619-00",
      "ProductNDC": "36998-0619",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Meclizine Hydrochloride",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "19961213",
      "EndMarketingDate": "20041231",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "UCB Pharma SA",
      "SubstanceName": "MECLIZINE HYDROCHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20041231"
    },
    {
      "NDCCode": "42291-619-10",
      "PackageDescription": "1000 TABLET in 1 BOTTLE (42291-619-10)",
      "NDC11Code": "42291-0619-10",
      "ProductNDC": "42291-619",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Minoxidil",
      "NonProprietaryName": "Minoxidil",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130801",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA072709",
      "LabelerName": "AvKARE, Inc.",
      "SubstanceName": "MINOXIDIL",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "47335-619-10",
      "PackageDescription": "1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-619-10) ",
      "NDC11Code": "47335-0619-10",
      "ProductNDC": "47335-619",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Drizalma Sprinkle",
      "NonProprietaryName": "Duloxetine",
      "DosageFormName": "CAPSULE, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240610",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA212516",
      "LabelerName": "SUN PHARMACEUTICAL INDUSTRIES, INC.",
      "SubstanceName": "DULOXETINE HYDROCHLORIDE",
      "StrengthNumber": "60",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-06-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240610",
      "SamplePackage": "N",
      "IndicationAndUsage": "DRIZALMA SPRINKLE is indicated for the treatment of: 1 Major Depressive Disorder in adults , 2 Generalized Anxiety Disorder in adults and pediatric patients 7 years of age and older , 3 Diabetic Peripheral Neuropathy in adults , 4 Fibromyalgia in adults , 5 Chronic Musculoskeletal Pain in adults .",
      "Description": "Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). The chemical name of duloxetine hydrochloride is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride, USP is a white to off-white powder, which is freely soluble in methanol, soluble in dichloromethane, and slightly soluble in water. The molecular formula of duloxetine free base is C18H19NOS and its molecular weight is 297.38. Each DRIZALMA SPRINKLE (duloxetine delayed-release capsule) for oral administration contains enteric-coated pellets containing a total of 22.4 mg, 33.6 mg, 44.9 mg or 67.3 mg of duloxetine hydrochloride, equivalent to 20 mg, 30 mg, 40 mg or 60 mg of duloxetine free base, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients of the pellets include ascorbic acid, hypromellose, hypromellose phthalate, polyethylene glycol, starch, sucrose, sugar spheres, talc, titanium dioxide, and triethyl citrate. The capsule shell ingredients for 20 mg strength are D&C Yellow 10, FD &C Blue 1, FD &C Red 40, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell ingredients for 30 mg strength are FD &C Blue 1, FD &C Red 40 and FD &C Red 3 (present in cap), gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell ingredients for 40 mg strength are gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell ingredients for 60 mg strength are D&C Yellow 10 (present in body), FD &C Blue 1, FD &C Red 40, FD &C Red 3 (present in cap), gelatin, sodium lauryl sulfate and titanium dioxide. The imprinting ink for 20 mg, 30 mg, 40 mg, and 60 mg strength capsules was made of ammonia solution, black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol and shellac. DRIZALMA SPRINKLE does not comply with the USP dissolution test."
    },
    {
      "NDCCode": "49288-0619-3",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (49288-0619-3)",
      "NDC11Code": "49288-0619-03",
      "ProductNDC": "49288-0619",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Absidia Ramosa",
      "NonProprietaryName": "Absidia Ramosa",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "MYCOCLADUS CORYMBIFERUS",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
    },
    {
      "NDCCode": "60429-619-10",
      "PackageDescription": "10 mL in 1 BOTTLE, DROPPER (60429-619-10)",
      "NDC11Code": "60429-0619-10",
      "ProductNDC": "60429-619",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Antipyrine And Benzocaine",
      "NonProprietaryName": "Antipyrine And Benzocaine",
      "DosageFormName": "SOLUTION",
      "RouteName": "AURICULAR (OTIC)",
      "StartMarketingDate": "20090430",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Golden State Medical Supply, Inc.",
      "SubstanceName": "ANTIPYRINE; BENZOCAINE",
      "StrengthNumber": "54; 14",
      "StrengthUnit": "mg/mL; mg/mL",
      "Pharm_Classes": "Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "63187-619-10",
      "PackageDescription": "10 TABLET, FILM COATED in 1 BOTTLE (63187-619-10) ",
      "NDC11Code": "63187-0619-10",
      "ProductNDC": "63187-619",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sildenafil",
      "NonProprietaryName": "Sildenafil",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20141126",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203623",
      "LabelerName": "Proficient Rx LP",
      "SubstanceName": "SILDENAFIL CITRATE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2022-06-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20181201",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when sildenafil tablets were added to background epoprostenol therapy [see Clinical Studies (14)].Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class II to III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%).",
      "Description": "Sildenafil tablet, phosphodiesterase-5 (PDE-5) inhibitor, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE-5). Sildenafil is also marketed as VIAGRA® for erectile dysfunction. Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-Dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d] pyrimidin-5-yl)-4-ethoxyphenyl] sulfonyl]-4-methylpiperazine citrate and has the following structural formula. Sildenafil citrate, USP is a white to off white crystalline powder slightly soluble in methanol and a molecular weight of 666.70. Sildenafil tablets are formulated as white to off white, film coated, round tablets for oral administration. Each tablet contains sildenafil citrate, USP equivalent to 20 mg of sildenafil. In addition to the active ingredient, sildenafil citrate, USP, each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin."
    },
    {
      "NDCCode": "67296-0619-1",
      "PackageDescription": "10 TABLET in 1 BOTTLE (67296-0619-1)",
      "NDC11Code": "67296-0619-01",
      "ProductNDC": "67296-0619",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Zolpidem Tartrate",
      "NonProprietaryName": "Zolpidem Tartrate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20070905",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077903",
      "LabelerName": "RedPharm Drug Inc.",
      "SubstanceName": "ZOLPIDEM TARTRATE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE]",
      "DEASchedule": "CIV",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Zolpidem tartrate tablets, are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets, have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies (14)]. The clinical trials performed in support of efficacy were 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.",
      "Description": "Zolpidem tartrate is a non-benzodiazepine hypnotic of the imidazopyridine class and is available in 5 mg and 10 mg strength tablets for oral administration. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure. Zolpidem tartrate, USP is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. Each zolpidem tartrate tablet, USP includes the following inactive ingredients: hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, polyethylene glycol, sodium starch glycolate, titanium dioxide and ferric oxide red; the 10 mg tablet also contains ferric oxide yellow."
    },
    {
      "NDCCode": "67457-619-10",
      "PackageDescription": "1 VIAL in 1 CARTON (67457-619-10)  / 100 mL in 1 VIAL",
      "NDC11Code": "67457-0619-10",
      "ProductNDC": "67457-619",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Zoledronic Acid",
      "NonProprietaryName": "Zoledronic Acid",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20170519",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203841",
      "LabelerName": "Mylan Institutional LLC",
      "SubstanceName": "ZOLEDRONIC ACID",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/100mL",
      "Pharm_Classes": "Bisphosphonate [EPC], Diphosphonates [CS]",
      "Status": "Active",
      "LastUpdate": "2026-05-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20170519",
      "SamplePackage": "N",
      "IndicationAndUsage": "Zoledronic acid injection is a bisphosphonate indicated for: 1 Treatment and prevention of postmenopausal osteoporosis (1.1, 1.2), 2 Treatment to increase bone mass in men with osteoporosis (1.3), 3 Treatment and prevention of glucocorticoid-induced osteoporosis (1.4), 4 Treatment of Paget’s disease of bone in men and women (1.5).",
      "Description": "Zoledronic Acid Injection contains zoledronic acid, a bisphosphonic acid which is an inhibitor of osteoclastic bone resorption. Zoledronic acid, USP is designated chemically as (1-Hydroxy-2-imidazol-1-yl-ethylidene) diphosphonic acid, monohydrate and its structural formula is. Zoledronic acid monohydrate is a white crystalline powder. Its molecular formula is C5H10N2O7P2  H2O and a molar mass of 290.1 g/mol. Zoledronic acid monohydrate is highly soluble in 0.1N sodium hydroxide solution, sparingly soluble in water and 0.1N hydrochloric acid, and practically insoluble in organic solvents. The pH of the zoledronic acid injection solution for infusion is approximately 6.0-7.0. Zoledronic Acid Injection is available as a sterile solution in vials for intravenous infusion. One vial with 100 mL solution contains 5.330 mg of zoledronic acid monohydrate, equivalent to 5 mg zoledronic acid, USP on an anhydrous basis. Inactive Ingredients: 4950 mg of mannitol, USP; and 30 mg of sodium citrate, USP."
    },
    {
      "NDCCode": "68083-619-10",
      "PackageDescription": "10 POUCH in 1 CARTON (68083-619-10)  / 1 BAG in 1 POUCH / 100 mL in 1 BAG",
      "NDC11Code": "68083-0619-10",
      "ProductNDC": "68083-619",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Midazolam In Sodium Chloride",
      "NonProprietaryName": "Midazolam In Sodium Chloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20240812",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA218993",
      "LabelerName": "Gland Pharma Limited",
      "SubstanceName": "MIDAZOLAM HYDROCHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
      "DEASchedule": "CIV",
      "Status": "Active",
      "LastUpdate": "2024-08-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240812",
      "SamplePackage": "N",
      "IndicationAndUsage": "Midazolam in 0.9% Sodium Chloride Injection is indicated:  Continuous intravenous infusion for sedation of intubated and mechanically ventilated adult, pediatric, and neonatal patients as a component of         anesthesia or during treatment in a critical care setting.",
      "Description": "Midazolam in 0.9% Sodium Chloride Injection is a benzodiazepine available as a sterile, preservative-free, nonpyrogenic solution of midazolam and sodium chloride in water for injection for intravenous use. Each single-dose bag of Midazolam in 0.9% Sodium Chloride Injection contains either 50 mg/50 mL (1mg/mL) or 100 mg/100 mL (1 mg/mL) of midazolam and 9 mg/mL of sodium chloride in water for injection. Midazolam in 0.9% Sodium Chloride Injection may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. The pH is approximately 2.5-3.5. Midazolam is a white or yellowish powder, practically insoluble in water, Chemically, midazolam is 8-chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4]-benzodiazepine. Midazolam has the empirical formula C18H13ClFN3, a calculated molecular weight of 325.8 and the following structural formula:."
    },
    {
      "NDCCode": "68382-619-10",
      "PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (68382-619-10) ",
      "NDC11Code": "68382-0619-10",
      "ProductNDC": "68382-619",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Colesevelam",
      "NonProprietaryName": "Colesevelam",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20191011",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207765",
      "LabelerName": "Zydus Pharmaceuticals USA Inc.",
      "SubstanceName": "COLESEVELAM HYDROCHLORIDE",
      "StrengthNumber": "625",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-10-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20191011",
      "SamplePackage": "N",
      "IndicationAndUsage": "Colesevelam hydrochloride is a bile acid sequestrant indicated as an adjunct to diet and exercise to: 1 reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia (1.1)., 2 reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH), unable to reach LDL-C target levels despite an adequate trial of diet and lifestyle modification (1.1)., 3 improve glycemic control in adults with type 2 diabetes mellitus (1.2).",
      "Description": "Colesevelam hydrochloride is a non-absorbed, polymeric, lipid-lowering and glucose-lowering agent for oral administration. Colesevelam hydrochloride is a high-capacity bile acid-binding molecule. Colesevelam hydrochloride is a polymer with off-white to light yellow color powder, which is insoluble in water and any organic solvent. Colesevelam hydrochloride is poly (allylamine hydrochloride) cross-linked with epichlorohydrin and alkylated with 1-bromodecane and (6-bromohexyl)-trimethylammonium bromide. The chemical name (IUPAC) of colesevelam hydrochloride is allylamine polymer with 1-chloro-2,3-epoxypropane, [6-(allylamino)-hexyl]trimethylammonium chloride and N-allyldecylamine, hydrochloride. The chemical structure of colesevelam hydrochloride is represented by the following formula. wherein (a) represents allyl amine monomer units that have not been alkylated by either of the 1-bromodecane or (6-bromohexyl)-trimethylammonium bromide alkylating agents or cross-linked by epichlorohydrin; (b) represents allyl amine units that have undergone cross- linking with epichlorohydrin; (c) represents allyl amine units that have been alkylated with a decyl group; (d) represents allyl amine units that have been alkylated with a (6-trimethylammonium) hexyl group, and m represents a number ≥ 100 to indicate an extended polymer network. A small amount of the amines are dialkylated and are not depicted in the formula above. No regular order of the groups is implied by the structure; cross-linking and alkylation are expected to occur randomly along the polymer chains. A large amount of the amines are protonated. The polymer is depicted in the hydrochloride form; a small amount of the halides are bromide. Colesevelam hydrochloride is hydrophilic and insoluble in water. Colesevelam hydrochloride tablet contains 625 mg colesevelam hydrochloride. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide yellow, iron oxide red, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, povidone, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, sodium bicarbonate. The tablet is printed with black pharmaceutical ink which contains ammonium hydroxide, ferrosoferric oxide, propylene glycol and shellac (< 5 calories per 6 tablets)."
    },
    {
      "NDCCode": "70756-619-10",
      "PackageDescription": "10 VIAL in 1 CARTON (70756-619-10)  > 4 mL in 1 VIAL (70756-619-85) ",
      "NDC11Code": "70756-0619-10",
      "ProductNDC": "70756-619",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Furosemide",
      "NonProprietaryName": "Furosemide",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20221217",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA216860",
      "LabelerName": "Lifestar Pharma LLC",
      "SubstanceName": "FUROSEMIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
      "Status": "Active",
      "LastUpdate": "2022-12-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20221217",
      "SamplePackage": "N",
      "IndicationAndUsage": "Parenteral therapy should be reserved for patients unable to take oral medication or for patients in emergency clinical situations. Edema: Furosemide is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired. Furosemide is indicated as adjunctive therapy in acute pulmonary edema. The intravenous administration of furosemide is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema. If gastrointestinal absorption is impaired or oral medication is not practical for any reason, furosemide is indicated by the intravenous or intramuscular route. Parenteral use should be replaced with oral furosemide as soon as practical.",
      "Description": "Furosemide, USP is a diuretic which is an anthranilic acid derivative. Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide Injection, USP 10 mg/mL is a sterile, non-pyrogenic solution in vials for intravenous and intramuscular injection. Furosemide, USP is a white to slightly yellowish, odorless crystalline powder. It is freely soluble in acetone, in dimethylformamide, and in solutions of alkali hydroxides, soluble in methanol, sparingly soluble in alcohol, slightly soluble in ether, very slightly soluble in chloroform, practically insoluble in water. The structural formula is as follows. Molecular Formula: C12H11ClN2O5S. Molecular Weight: 330.74. Each mL contains: Furosemide, USP 10 mg, Water for Injection q.s., Sodium Chloride for isotonicity, Sodium  Hydroxide and, if necessary, Hydrochloric Acid to adjust pH between 8.0 and 9.3."
    },
    {
      "NDCCode": "71919-619-10",
      "PackageDescription": "100 mL in 1 BOTTLE, GLASS (71919-619-10) ",
      "NDC11Code": "71919-0619-10",
      "ProductNDC": "71919-619",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sedum Acre",
      "NonProprietaryName": "Sedum Acre",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20091210",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Washington Homeopathic Products",
      "SubstanceName": "SEDUM ACRE",
      "StrengthNumber": "30",
      "StrengthUnit": "[hp_C]/mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20091210",
      "SamplePackage": "N",
      "IndicationAndUsage": "Indications:. SEDUM   Hemorrhoids."
    },
    {
      "NDCCode": "0363-0619-44",
      "PackageDescription": "532 g in 1 BOTTLE, PLASTIC (0363-0619-44) ",
      "NDC11Code": "00363-0619-44",
      "ProductNDC": "0363-0619",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Daily Moisturizing",
      "NonProprietaryName": "Daily Moistruizing",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130206",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "Walgreen, Co.",
      "SubstanceName": "DIMETHICONE",
      "StrengthNumber": "13",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Skin Barrier Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2025-04-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20130206",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps prevent and temporarily protects chafed, chapped, or cracked skin. helps protect from the drying effects of wind and cold weather."
    },
    {
      "NDCCode": "21130-619-11",
      "PackageDescription": "325 mL in 1 BOTTLE, PLASTIC (21130-619-11)",
      "NDC11Code": "21130-0619-11",
      "ProductNDC": "21130-619",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Safeway Care",
      "ProprietaryNameSuffix": "Medicated Dandruff",
      "NonProprietaryName": "Selenium Sulfide",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140225",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part358H",
      "LabelerName": "SAFEWAY INC",
      "SubstanceName": "SELENIUM SULFIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "FOR RELIEF OF FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF AND SEBORRHEIC DERMATITIS AND TO HELP PREVENT THE CHANCE OF RECURRENCE."
    },
    {
      "NDCCode": "21695-619-40",
      "PackageDescription": "40 TABLET in 1 BOTTLE (21695-619-40)",
      "NDC11Code": "21695-0619-40",
      "ProductNDC": "21695-619",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxycodone And Acetaminophen",
      "NonProprietaryName": "Oxycodone And Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20071127",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040778",
      "LabelerName": "Rebel Distributors Corp",
      "SubstanceName": "OXYCODONE; ACETAMINOPHEN",
      "StrengthNumber": "10; 325",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Oxycodone and Acetaminophen Tablets, USP are indicated for the relief of moderate to moderately severe pain.",
      "Description": "Each tablet for oral administration contains. Oxycodone Hydrochloride, USP……………. 10 mg*. Acetaminophen, USP………………………325 mg. *10 mg oxycodone HCl is equivalent to 8.9637 mg of oxycodone. Oxycodone and Acetaminophen Tablets, USP also contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch and stearic acid. Oxycodone, 14-hydroxydihydrocodeinone, is a semisynthetic opioid analgesic which occurs as a white, odorless, crystalline powder having a saline, bitter taste. The molecular formula for oxycodone hydrochloride is C18H21NO4HCl and the molecular weight 351.82. It is derived from the opium alkaloid thebaine, and may be represented by the following structural formula. Acetaminophen, 4’-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.16. It may be represented by the following structural formula."
    },
    {
      "NDCCode": "21695-619-60",
      "PackageDescription": "60 TABLET in 1 BOTTLE (21695-619-60)",
      "NDC11Code": "21695-0619-60",
      "ProductNDC": "21695-619",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxycodone And Acetaminophen",
      "NonProprietaryName": "Oxycodone And Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20071127",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040778",
      "LabelerName": "Rebel Distributors Corp",
      "SubstanceName": "OXYCODONE; ACETAMINOPHEN",
      "StrengthNumber": "10; 325",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Oxycodone and Acetaminophen Tablets, USP are indicated for the relief of moderate to moderately severe pain.",
      "Description": "Each tablet for oral administration contains. Oxycodone Hydrochloride, USP……………. 10 mg*. Acetaminophen, USP………………………325 mg. *10 mg oxycodone HCl is equivalent to 8.9637 mg of oxycodone. Oxycodone and Acetaminophen Tablets, USP also contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch and stearic acid. Oxycodone, 14-hydroxydihydrocodeinone, is a semisynthetic opioid analgesic which occurs as a white, odorless, crystalline powder having a saline, bitter taste. The molecular formula for oxycodone hydrochloride is C18H21NO4HCl and the molecular weight 351.82. It is derived from the opium alkaloid thebaine, and may be represented by the following structural formula. Acetaminophen, 4’-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.16. It may be represented by the following structural formula."
    },
    {
      "NDCCode": "25021-619-02",
      "PackageDescription": "10 VIAL in 1 CARTON (25021-619-02)  / 2 mL in 1 VIAL",
      "NDC11Code": "25021-0619-02",
      "ProductNDC": "25021-619",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sugammadex",
      "NonProprietaryName": "Sugammadex Sodium",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20260701",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215575",
      "LabelerName": "Sagent Pharmaceuticals",
      "SubstanceName": "SUGAMMADEX SODIUM",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "gamma-Cyclodextrins [CS]",
      "Status": "Active",
      "LastUpdate": "2026-07-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260701",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sugammadex injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients aged 2 years and older undergoing surgery. Additional pediatric use information is approved for Merck Sharp & Dohme LLC's BRIDION® (sugammadex) injection. However, due to Merck Sharp & Dohme LLC's marketing exclusivity rights, this drug product is not labeled with that information.",
      "Description": "Sugammadex injection, for intravenous use, contains sugammadex sodium, a modified gamma cyclodextrin chemically designated as 6A,6B,6C,6D,6E,6F,6G,6H-Octakis-S-(2-carboxyethyl)-6A,6B,6C,6D,6E,6F,6G,6H-octathio-γ-cyclodextrin sodium salt (1:8) with a molecular weight of 2178.01. The structural formula is:. Sugammadex injection is supplied as a sterile, non-pyrogenic aqueous solution that is clear, colorless to slightly yellow-brown for intravenous injection only. Each mL contains 100 mg sugammadex, which is equivalent to 108.8 mg sugammadex sodium. The aqueous solution is adjusted to a pH of between 7 and 8 with hydrochloric acid and/or sodium hydroxide. The osmolality of the product is between 300 and 500 mOsmol/kg. Sugammadex injection may contain up to 7 mg per mL of the mono OH-derivative of sugammadex [see Clinical Pharmacology (12.2)]. This derivative is chemically designated as 6A,6B,6C,6D,6E,6F,6G-Heptakis-S-(2-carboxyethyl)-6A,6B,6C,6D,6E,6F,6G-heptathio-γ-cyclodextrin sodium salt (1:7) with a molecular weight of 2067.90. The structural formula is:."
    },
    {
      "NDCCode": "25021-619-05",
      "PackageDescription": "10 VIAL in 1 CARTON (25021-619-05)  / 5 mL in 1 VIAL",
      "NDC11Code": "25021-0619-05",
      "ProductNDC": "25021-619",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sugammadex",
      "NonProprietaryName": "Sugammadex Sodium",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20260701",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215575",
      "LabelerName": "Sagent Pharmaceuticals",
      "SubstanceName": "SUGAMMADEX SODIUM",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "gamma-Cyclodextrins [CS]",
      "Status": "Active",
      "LastUpdate": "2026-07-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260701",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sugammadex injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients aged 2 years and older undergoing surgery. Additional pediatric use information is approved for Merck Sharp & Dohme LLC's BRIDION® (sugammadex) injection. However, due to Merck Sharp & Dohme LLC's marketing exclusivity rights, this drug product is not labeled with that information.",
      "Description": "Sugammadex injection, for intravenous use, contains sugammadex sodium, a modified gamma cyclodextrin chemically designated as 6A,6B,6C,6D,6E,6F,6G,6H-Octakis-S-(2-carboxyethyl)-6A,6B,6C,6D,6E,6F,6G,6H-octathio-γ-cyclodextrin sodium salt (1:8) with a molecular weight of 2178.01. The structural formula is:. Sugammadex injection is supplied as a sterile, non-pyrogenic aqueous solution that is clear, colorless to slightly yellow-brown for intravenous injection only. Each mL contains 100 mg sugammadex, which is equivalent to 108.8 mg sugammadex sodium. The aqueous solution is adjusted to a pH of between 7 and 8 with hydrochloric acid and/or sodium hydroxide. The osmolality of the product is between 300 and 500 mOsmol/kg. Sugammadex injection may contain up to 7 mg per mL of the mono OH-derivative of sugammadex [see Clinical Pharmacology (12.2)]. This derivative is chemically designated as 6A,6B,6C,6D,6E,6F,6G-Heptakis-S-(2-carboxyethyl)-6A,6B,6C,6D,6E,6F,6G-heptathio-γ-cyclodextrin sodium salt (1:7) with a molecular weight of 2067.90. The structural formula is:."
    },
    {
      "NDCCode": "33992-0619-8",
      "PackageDescription": "8 BLISTER PACK in 1 CARTON (33992-0619-8)  > 1 CAPSULE in 1 BLISTER PACK",
      "NDC11Code": "33992-0619-08",
      "ProductNDC": "33992-0619",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Mucus Relief Cold, Flu, Sore Throat",
      "ProprietaryNameSuffix": "Maximum Strength",
      "NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180630",
      "EndMarketingDate": "20231231",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "ASSURED / DOLLAR TREE (Greenbrier International, Inc.)",
      "SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "325; 10; 200; 5",
      "StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
      "Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20180630",
      "EndMarketingDatePackage": "20231231",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "35356-619-30",
      "PackageDescription": "30 TABLET in 1 BOTTLE (35356-619-30) ",
      "NDC11Code": "35356-0619-30",
      "ProductNDC": "35356-619",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lamotrigine",
      "NonProprietaryName": "Lamotrigine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120309",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078525",
      "LabelerName": "Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC",
      "SubstanceName": "LAMOTRIGINE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-10-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20120309",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "35356-619-60",
      "PackageDescription": "60 TABLET in 1 BOTTLE (35356-619-60) ",
      "NDC11Code": "35356-0619-60",
      "ProductNDC": "35356-619",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lamotrigine",
      "NonProprietaryName": "Lamotrigine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120309",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078525",
      "LabelerName": "Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC",
      "SubstanceName": "LAMOTRIGINE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-10-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20180713",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "37808-619-91",
      "PackageDescription": "6 POWDER, FOR SOLUTION in 1 CARTON (37808-619-91) ",
      "NDC11Code": "37808-0619-91",
      "ProductNDC": "37808-619",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Severe Cold And Flu",
      "NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl",
      "DosageFormName": "POWDER, FOR SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180530",
      "EndMarketingDate": "20250101",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "H E B",
      "SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "500; 20; 10",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20180530",
      "EndMarketingDatePackage": "20250101",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these symptoms due to a cold:. minor aches and pains. minor sore throat pain. headache. nasal and sinus congestion. cough due to minor throat and bronchial irritation. temporarily reduces fever."
    },
    {
      "NDCCode": "41163-619-01",
      "PackageDescription": "3 BLISTER PACK in 1 CARTON (41163-619-01)  > 10 TABLET in 1 BLISTER PACK",
      "NDC11Code": "41163-0619-01",
      "ProductNDC": "41163-619",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Heartburn Relief",
      "NonProprietaryName": "Ranitidine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130615",
      "EndMarketingDate": "20180715",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA200536",
      "LabelerName": "SUPERVALU INC.",
      "SubstanceName": "RANITIDINE HYDROCHLORIDE",
      "StrengthNumber": "75",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-16",
      "ProductNdcExcludeFlag": "N"
    },
    {
      "NDCCode": "41190-619-40",
      "PackageDescription": "354 mL in 1 BOTTLE, PUMP (41190-619-40) ",
      "NDC11Code": "41190-0619-40",
      "ProductNDC": "41190-619",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Daily Moisturizing",
      "NonProprietaryName": "Dimethicone",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20100614",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "Wakefern Food Corp",
      "SubstanceName": "DIMETHICONE",
      "StrengthNumber": "1.3",
      "StrengthUnit": "kg/100mL",
      "Pharm_Classes": "Skin Barrier Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2024-10-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20100614",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps prevent and temporarily protects chafed, chapped, cracked skin. helps protect from the drying effects of wind and cold weather."
    },
    {
      "NDCCode": "42291-619-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE (42291-619-01) ",
      "NDC11Code": "42291-0619-01",
      "ProductNDC": "42291-619",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Minoxidil",
      "NonProprietaryName": "Minoxidil",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130801",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA072709",
      "LabelerName": "AvKARE",
      "SubstanceName": "MINOXIDIL",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20130801",
      "SamplePackage": "N",
      "IndicationAndUsage": "Because of the potential for serious adverse effects, minoxidil tablets are indicated only in the treatment of hypertension that is symptomatic or associated with target organ damage and is not manageable with maximum therapeutic doses of a diuretic plus two other antihypertensive drugs. At the present time use in milder degrees of hypertension is not recommended because the benefit-risk relationship in such patients has not been defined. Minoxidil reduced supine diastolic blood pressure by 20 mm Hg or to 90 mm Hg or less in approximately 75% of patients, most of who had hypertension that could not be controlled by other drugs.",
      "Description": "Minoxidil tablets contain minoxidil, an antihypertensive peripheral vasodilator. Minoxidil occurs as a white to off-white, crystalline powder, soluble in alcohol and propylene glycol; sparingly soluble in methanol; slightly soluble in water; practically insoluble in chloroform, acetone and ethyl acetate. The chemical name for minoxidil is 2,4-Pyrimidinediamine, 6-(1-piperidinyl)-, 3-oxide. The structural formula is represented below. Minoxidil tablets for oral administration contain either 2.5 mg or 10 mg of minoxidil. Inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate."
    },
    {
      "NDCCode": "42291-619-90",
      "PackageDescription": "90 TABLET in 1 BOTTLE (42291-619-90) ",
      "NDC11Code": "42291-0619-90",
      "ProductNDC": "42291-619",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Minoxidil",
      "NonProprietaryName": "Minoxidil",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130801",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA072709",
      "LabelerName": "AvKARE, Inc.",
      "SubstanceName": "MINOXIDIL",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-04-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20130801",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "42549-619-12",
      "PackageDescription": "120 TABLET, FILM COATED in 1 BOTTLE (42549-619-12)",
      "NDC11Code": "42549-0619-12",
      "ProductNDC": "42549-619",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Topiramate",
      "NonProprietaryName": "Topiramate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090327",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090278",
      "LabelerName": "STAT Rx USA LLC",
      "SubstanceName": "TOPIRAMATE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-07",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Topiramate tablets are indicated as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures. Effectiveness was demonstrated in a controlled trial in patients with epilepsy who had no more than 2 seizures in the 3 months prior to enrollment. Safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials.",
      "Description": "Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg circular tablets for oral administration. Topiramate is a white crystalline powder with a bitter taste. Topiramate USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.37. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets contain the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, magnesium stearate, purified water, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, individual tablets contain. 50 mg tablets: iron oxide yellow100 mg tablets: iron oxide yellow, and D&C Yellow # 10 Aluminum Lake200 mg tablets: iron oxide red, lecithin (soya), and iron oxide black."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"0268-0619-10","ProprietaryName":"Canis Lupus Familiaris Skin","NonProprietaryName":"Dog Epithelia"},{"NDCCode":"0268-0619-50","ProprietaryName":"Canis Lupus Familiaris Skin","NonProprietaryName":"Dog Epithelia"},{"NDCCode":"13811-619-10","ProprietaryName":"Timolol Maleate","NonProprietaryName":"Timolol Maleate"},{"NDCCode":"36998-0619-0","NonProprietaryName":"Meclizine Hydrochloride"},{"NDCCode":"42291-619-10","ProprietaryName":"Minoxidil","NonProprietaryName":"Minoxidil"},{"NDCCode":"47335-619-10","ProprietaryName":"Drizalma Sprinkle","NonProprietaryName":"Duloxetine"},{"NDCCode":"49288-0619-3","ProprietaryName":"Absidia Ramosa","NonProprietaryName":"Absidia Ramosa"},{"NDCCode":"60429-619-10","ProprietaryName":"Antipyrine And Benzocaine","NonProprietaryName":"Antipyrine And Benzocaine"},{"NDCCode":"63187-619-10","ProprietaryName":"Sildenafil","NonProprietaryName":"Sildenafil"},{"NDCCode":"67296-0619-1","ProprietaryName":"Zolpidem Tartrate","NonProprietaryName":"Zolpidem Tartrate"},{"NDCCode":"67457-619-10","ProprietaryName":"Zoledronic Acid","NonProprietaryName":"Zoledronic Acid"},{"NDCCode":"68083-619-10","ProprietaryName":"Midazolam In Sodium Chloride","NonProprietaryName":"Midazolam In Sodium Chloride"},{"NDCCode":"68382-619-10","ProprietaryName":"Colesevelam","NonProprietaryName":"Colesevelam"},{"NDCCode":"70756-619-10","ProprietaryName":"Furosemide","NonProprietaryName":"Furosemide"},{"NDCCode":"71919-619-10","ProprietaryName":"Sedum Acre","NonProprietaryName":"Sedum Acre"},{"NDCCode":"0363-0619-44","ProprietaryName":"Daily Moisturizing","NonProprietaryName":"Daily Moistruizing"},{"NDCCode":"21130-619-11","ProprietaryName":"Safeway Care","NonProprietaryName":"Selenium Sulfide"},{"NDCCode":"21695-619-40","ProprietaryName":"Oxycodone And Acetaminophen","NonProprietaryName":"Oxycodone And Acetaminophen"},{"NDCCode":"21695-619-60","ProprietaryName":"Oxycodone And Acetaminophen","NonProprietaryName":"Oxycodone And Acetaminophen"},{"NDCCode":"25021-619-02","ProprietaryName":"Sugammadex","NonProprietaryName":"Sugammadex Sodium"},{"NDCCode":"25021-619-05","ProprietaryName":"Sugammadex","NonProprietaryName":"Sugammadex Sodium"},{"NDCCode":"33992-0619-8","ProprietaryName":"Mucus Relief Cold, Flu, Sore Throat","NonProprietaryName":"Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl"},{"NDCCode":"35356-619-30","ProprietaryName":"Lamotrigine","NonProprietaryName":"Lamotrigine"},{"NDCCode":"35356-619-60","ProprietaryName":"Lamotrigine","NonProprietaryName":"Lamotrigine"},{"NDCCode":"37808-619-91","ProprietaryName":"Severe Cold And Flu","NonProprietaryName":"Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl"},{"NDCCode":"41163-619-01","ProprietaryName":"Heartburn Relief","NonProprietaryName":"Ranitidine"},{"NDCCode":"41190-619-40","ProprietaryName":"Daily Moisturizing","NonProprietaryName":"Dimethicone"},{"NDCCode":"42291-619-01","ProprietaryName":"Minoxidil","NonProprietaryName":"Minoxidil"},{"NDCCode":"42291-619-90","ProprietaryName":"Minoxidil","NonProprietaryName":"Minoxidil"},{"NDCCode":"42549-619-12","ProprietaryName":"Topiramate","NonProprietaryName":"Topiramate"}]}
                    

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<NDCList>
  <NDC>
    <NDCCode>0268-0619-10</NDCCode>
    <PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (0268-0619-10) </PackageDescription>
    <NDC11Code>00268-0619-10</NDC11Code>
    <ProductNDC>0268-0619</ProductNDC>
    <ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
    <ProprietaryName>Canis Lupus Familiaris Skin</ProprietaryName>
    <NonProprietaryName>Dog Epithelia</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19650101</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103753</ApplicationNumber>
    <LabelerName>ALK-Abello, Inc.</LabelerName>
    <SubstanceName>CANIS LUPUS FAMILIARIS SKIN</SubstanceName>
    <StrengthNumber>10000</StrengthNumber>
    <StrengthUnit>[PNU]/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Cells, Epidermal [EXT], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Animal Skin Allergenic Extract [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-06-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19650101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust, molds, animal danders, various other inhalants, and in situations where the offending allergen cannot be avoided. Prior to initiation of therapy, the clinical sensitivity should be established by careful evaluation of the patient’s history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can easily be avoided.</IndicationAndUsage>
    <Description>Sterile therapeutic extracts are supplied in either Phenol Saline Diluent or in Diluent containing Glycerin 50% (v/v) for subcutaneous injection. Inactive ingredients may include: Sodium Chloride for isotonicity, Glycerin, and Sodium Bicarbonate as buffering agents. These products are compounded and diluted on a w/v or PNU basis. Pollens are individually extracted from pure pollen extracted in a phenol-preserved sodium bicarbonate solution. Short Ragweed and Mixed (Tall and Short) Ragweed extracts are standardized by Antigen E content and so labeled. The Antigen E content of extracts containing Short Ragweed at a concentration more dilute than a weight/volume ratio of 1:10 are obtained by calculating the Antigen E content based on the assay value of more concentrated extract. Pollen extracts are filtered aseptically and, after final packaging, they are tested for sterility and safety. Molds are individually extracted from pure powdered inactivated mold source material extracted in phenol preserved saline. Mold extracts are filtered aseptically and after final packaging are tested for sterility and safety. Molds are present in all inhabited places at all seasons of the year; they are so ubiquitous that they are prevalent at times when common allergic pollens and other inhalants are not. In the home and surroundings, molds are found in upholstered furniture, mattresses, drapes, cellar and storage room dust, woolens, leather goods, fruits, meats, cheeses, garden soil and on plants. Spores, mycelial fragments and mold residues are thus inhaled, contacted and ingested continuously. Miscellaneous inhalants and epidermals are individually extracted in phenol preserved saline, filtered aseptically and after final packaging are tested for sterility and safety.</Description>
  </NDC>
  <NDC>
    <NDCCode>0268-0619-50</NDCCode>
    <PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (0268-0619-50) </PackageDescription>
    <NDC11Code>00268-0619-50</NDC11Code>
    <ProductNDC>0268-0619</ProductNDC>
    <ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
    <ProprietaryName>Canis Lupus Familiaris Skin</ProprietaryName>
    <NonProprietaryName>Dog Epithelia</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19650101</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103753</ApplicationNumber>
    <LabelerName>ALK-Abello, Inc.</LabelerName>
    <SubstanceName>CANIS LUPUS FAMILIARIS SKIN</SubstanceName>
    <StrengthNumber>10000</StrengthNumber>
    <StrengthUnit>[PNU]/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Cells, Epidermal [EXT], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Animal Skin Allergenic Extract [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-06-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19650101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust, molds, animal danders, various other inhalants, and in situations where the offending allergen cannot be avoided. Prior to initiation of therapy, the clinical sensitivity should be established by careful evaluation of the patient’s history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can easily be avoided.</IndicationAndUsage>
    <Description>Sterile therapeutic extracts are supplied in either Phenol Saline Diluent or in Diluent containing Glycerin 50% (v/v) for subcutaneous injection. Inactive ingredients may include: Sodium Chloride for isotonicity, Glycerin, and Sodium Bicarbonate as buffering agents. These products are compounded and diluted on a w/v or PNU basis. Pollens are individually extracted from pure pollen extracted in a phenol-preserved sodium bicarbonate solution. Short Ragweed and Mixed (Tall and Short) Ragweed extracts are standardized by Antigen E content and so labeled. The Antigen E content of extracts containing Short Ragweed at a concentration more dilute than a weight/volume ratio of 1:10 are obtained by calculating the Antigen E content based on the assay value of more concentrated extract. Pollen extracts are filtered aseptically and, after final packaging, they are tested for sterility and safety. Molds are individually extracted from pure powdered inactivated mold source material extracted in phenol preserved saline. Mold extracts are filtered aseptically and after final packaging are tested for sterility and safety. Molds are present in all inhabited places at all seasons of the year; they are so ubiquitous that they are prevalent at times when common allergic pollens and other inhalants are not. In the home and surroundings, molds are found in upholstered furniture, mattresses, drapes, cellar and storage room dust, woolens, leather goods, fruits, meats, cheeses, garden soil and on plants. Spores, mycelial fragments and mold residues are thus inhaled, contacted and ingested continuously. Miscellaneous inhalants and epidermals are individually extracted in phenol preserved saline, filtered aseptically and after final packaging are tested for sterility and safety.</Description>
  </NDC>
  <NDC>
    <NDCCode>13811-619-10</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (13811-619-10) </PackageDescription>
    <NDC11Code>13811-0619-10</NDC11Code>
    <ProductNDC>13811-619</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Timolol Maleate</ProprietaryName>
    <NonProprietaryName>Timolol Maleate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190506</StartMarketingDate>
    <EndMarketingDate>20210131</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207556</ApplicationNumber>
    <LabelerName>TRIGEN LABORATORIES, LLC</LabelerName>
    <SubstanceName>TIMOLOL MALEATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-02-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20190506</StartMarketingDatePackage>
    <EndMarketingDatePackage>20210131</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>36998-0619-0</NDCCode>
    <PackageDescription>10 kg in 1 DRUM (36998-0619-0)</PackageDescription>
    <NDC11Code>36998-0619-00</NDC11Code>
    <ProductNDC>36998-0619</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Meclizine Hydrochloride</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>19961213</StartMarketingDate>
    <EndMarketingDate>20041231</EndMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>UCB Pharma SA</LabelerName>
    <SubstanceName>MECLIZINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20041231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>42291-619-10</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (42291-619-10)</PackageDescription>
    <NDC11Code>42291-0619-10</NDC11Code>
    <ProductNDC>42291-619</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Minoxidil</ProprietaryName>
    <NonProprietaryName>Minoxidil</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130801</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA072709</ApplicationNumber>
    <LabelerName>AvKARE, Inc.</LabelerName>
    <SubstanceName>MINOXIDIL</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>47335-619-10</NDCCode>
    <PackageDescription>1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-619-10) </PackageDescription>
    <NDC11Code>47335-0619-10</NDC11Code>
    <ProductNDC>47335-619</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Drizalma Sprinkle</ProprietaryName>
    <NonProprietaryName>Duloxetine</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240610</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA212516</ApplicationNumber>
    <LabelerName>SUN PHARMACEUTICAL INDUSTRIES, INC.</LabelerName>
    <SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-06-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240610</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>DRIZALMA SPRINKLE is indicated for the treatment of: 1 Major Depressive Disorder in adults , 2 Generalized Anxiety Disorder in adults and pediatric patients 7 years of age and older , 3 Diabetic Peripheral Neuropathy in adults , 4 Fibromyalgia in adults , 5 Chronic Musculoskeletal Pain in adults .</IndicationAndUsage>
    <Description>Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). The chemical name of duloxetine hydrochloride is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride, USP is a white to off-white powder, which is freely soluble in methanol, soluble in dichloromethane, and slightly soluble in water. The molecular formula of duloxetine free base is C18H19NOS and its molecular weight is 297.38. Each DRIZALMA SPRINKLE (duloxetine delayed-release capsule) for oral administration contains enteric-coated pellets containing a total of 22.4 mg, 33.6 mg, 44.9 mg or 67.3 mg of duloxetine hydrochloride, equivalent to 20 mg, 30 mg, 40 mg or 60 mg of duloxetine free base, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients of the pellets include ascorbic acid, hypromellose, hypromellose phthalate, polyethylene glycol, starch, sucrose, sugar spheres, talc, titanium dioxide, and triethyl citrate. The capsule shell ingredients for 20 mg strength are D&amp;C Yellow 10, FD &amp;C Blue 1, FD &amp;C Red 40, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell ingredients for 30 mg strength are FD &amp;C Blue 1, FD &amp;C Red 40 and FD &amp;C Red 3 (present in cap), gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell ingredients for 40 mg strength are gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell ingredients for 60 mg strength are D&amp;C Yellow 10 (present in body), FD &amp;C Blue 1, FD &amp;C Red 40, FD &amp;C Red 3 (present in cap), gelatin, sodium lauryl sulfate and titanium dioxide. The imprinting ink for 20 mg, 30 mg, 40 mg, and 60 mg strength capsules was made of ammonia solution, black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol and shellac. DRIZALMA SPRINKLE does not comply with the USP dissolution test.</Description>
  </NDC>
  <NDC>
    <NDCCode>49288-0619-3</NDCCode>
    <PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (49288-0619-3)</PackageDescription>
    <NDC11Code>49288-0619-03</NDC11Code>
    <ProductNDC>49288-0619</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Absidia Ramosa</ProprietaryName>
    <NonProprietaryName>Absidia Ramosa</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19740323</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102223</ApplicationNumber>
    <LabelerName>Antigen Laboratories, Inc.</LabelerName>
    <SubstanceName>MYCOCLADUS CORYMBIFERUS</SubstanceName>
    <StrengthNumber>.05</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
    <Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
  </NDC>
  <NDC>
    <NDCCode>60429-619-10</NDCCode>
    <PackageDescription>10 mL in 1 BOTTLE, DROPPER (60429-619-10)</PackageDescription>
    <NDC11Code>60429-0619-10</NDC11Code>
    <ProductNDC>60429-619</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Antipyrine And Benzocaine</ProprietaryName>
    <NonProprietaryName>Antipyrine And Benzocaine</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>AURICULAR (OTIC)</RouteName>
    <StartMarketingDate>20090430</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Golden State Medical Supply, Inc.</LabelerName>
    <SubstanceName>ANTIPYRINE; BENZOCAINE</SubstanceName>
    <StrengthNumber>54; 14</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>63187-619-10</NDCCode>
    <PackageDescription>10 TABLET, FILM COATED in 1 BOTTLE (63187-619-10) </PackageDescription>
    <NDC11Code>63187-0619-10</NDC11Code>
    <ProductNDC>63187-619</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sildenafil</ProprietaryName>
    <NonProprietaryName>Sildenafil</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20141126</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203623</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>SILDENAFIL CITRATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-06-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when sildenafil tablets were added to background epoprostenol therapy [see Clinical Studies (14)].Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class II to III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%).</IndicationAndUsage>
    <Description>Sildenafil tablet, phosphodiesterase-5 (PDE-5) inhibitor, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE-5). Sildenafil is also marketed as VIAGRA® for erectile dysfunction. Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-Dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d] pyrimidin-5-yl)-4-ethoxyphenyl] sulfonyl]-4-methylpiperazine citrate and has the following structural formula. Sildenafil citrate, USP is a white to off white crystalline powder slightly soluble in methanol and a molecular weight of 666.70. Sildenafil tablets are formulated as white to off white, film coated, round tablets for oral administration. Each tablet contains sildenafil citrate, USP equivalent to 20 mg of sildenafil. In addition to the active ingredient, sildenafil citrate, USP, each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin.</Description>
  </NDC>
  <NDC>
    <NDCCode>67296-0619-1</NDCCode>
    <PackageDescription>10 TABLET in 1 BOTTLE (67296-0619-1)</PackageDescription>
    <NDC11Code>67296-0619-01</NDC11Code>
    <ProductNDC>67296-0619</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zolpidem Tartrate</ProprietaryName>
    <NonProprietaryName>Zolpidem Tartrate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070905</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077903</ApplicationNumber>
    <LabelerName>RedPharm Drug Inc.</LabelerName>
    <SubstanceName>ZOLPIDEM TARTRATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Zolpidem tartrate tablets, are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets, have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies (14)]. The clinical trials performed in support of efficacy were 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.</IndicationAndUsage>
    <Description>Zolpidem tartrate is a non-benzodiazepine hypnotic of the imidazopyridine class and is available in 5 mg and 10 mg strength tablets for oral administration. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure. Zolpidem tartrate, USP is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. Each zolpidem tartrate tablet, USP includes the following inactive ingredients: hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, polyethylene glycol, sodium starch glycolate, titanium dioxide and ferric oxide red; the 10 mg tablet also contains ferric oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>67457-619-10</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (67457-619-10)  / 100 mL in 1 VIAL</PackageDescription>
    <NDC11Code>67457-0619-10</NDC11Code>
    <ProductNDC>67457-619</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zoledronic Acid</ProprietaryName>
    <NonProprietaryName>Zoledronic Acid</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20170519</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203841</ApplicationNumber>
    <LabelerName>Mylan Institutional LLC</LabelerName>
    <SubstanceName>ZOLEDRONIC ACID</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/100mL</StrengthUnit>
    <Pharm_Classes>Bisphosphonate [EPC], Diphosphonates [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170519</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Zoledronic acid injection is a bisphosphonate indicated for: 1 Treatment and prevention of postmenopausal osteoporosis (1.1, 1.2), 2 Treatment to increase bone mass in men with osteoporosis (1.3), 3 Treatment and prevention of glucocorticoid-induced osteoporosis (1.4), 4 Treatment of Paget’s disease of bone in men and women (1.5).</IndicationAndUsage>
    <Description>Zoledronic Acid Injection contains zoledronic acid, a bisphosphonic acid which is an inhibitor of osteoclastic bone resorption. Zoledronic acid, USP is designated chemically as (1-Hydroxy-2-imidazol-1-yl-ethylidene) diphosphonic acid, monohydrate and its structural formula is. Zoledronic acid monohydrate is a white crystalline powder. Its molecular formula is C5H10N2O7P2  H2O and a molar mass of 290.1 g/mol. Zoledronic acid monohydrate is highly soluble in 0.1N sodium hydroxide solution, sparingly soluble in water and 0.1N hydrochloric acid, and practically insoluble in organic solvents. The pH of the zoledronic acid injection solution for infusion is approximately 6.0-7.0. Zoledronic Acid Injection is available as a sterile solution in vials for intravenous infusion. One vial with 100 mL solution contains 5.330 mg of zoledronic acid monohydrate, equivalent to 5 mg zoledronic acid, USP on an anhydrous basis. Inactive Ingredients: 4950 mg of mannitol, USP; and 30 mg of sodium citrate, USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>68083-619-10</NDCCode>
    <PackageDescription>10 POUCH in 1 CARTON (68083-619-10)  / 1 BAG in 1 POUCH / 100 mL in 1 BAG</PackageDescription>
    <NDC11Code>68083-0619-10</NDC11Code>
    <ProductNDC>68083-619</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Midazolam In Sodium Chloride</ProprietaryName>
    <NonProprietaryName>Midazolam In Sodium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20240812</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218993</ApplicationNumber>
    <LabelerName>Gland Pharma Limited</LabelerName>
    <SubstanceName>MIDAZOLAM HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2024-08-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240812</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Midazolam in 0.9% Sodium Chloride Injection is indicated:  Continuous intravenous infusion for sedation of intubated and mechanically ventilated adult, pediatric, and neonatal patients as a component of         anesthesia or during treatment in a critical care setting.</IndicationAndUsage>
    <Description>Midazolam in 0.9% Sodium Chloride Injection is a benzodiazepine available as a sterile, preservative-free, nonpyrogenic solution of midazolam and sodium chloride in water for injection for intravenous use. Each single-dose bag of Midazolam in 0.9% Sodium Chloride Injection contains either 50 mg/50 mL (1mg/mL) or 100 mg/100 mL (1 mg/mL) of midazolam and 9 mg/mL of sodium chloride in water for injection. Midazolam in 0.9% Sodium Chloride Injection may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. The pH is approximately 2.5-3.5. Midazolam is a white or yellowish powder, practically insoluble in water, Chemically, midazolam is 8-chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4]-benzodiazepine. Midazolam has the empirical formula C18H13ClFN3, a calculated molecular weight of 325.8 and the following structural formula:.</Description>
  </NDC>
  <NDC>
    <NDCCode>68382-619-10</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (68382-619-10) </PackageDescription>
    <NDC11Code>68382-0619-10</NDC11Code>
    <ProductNDC>68382-619</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Colesevelam</ProprietaryName>
    <NonProprietaryName>Colesevelam</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20191011</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207765</ApplicationNumber>
    <LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>COLESEVELAM HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>625</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191011</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Colesevelam hydrochloride is a bile acid sequestrant indicated as an adjunct to diet and exercise to: 1 reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia (1.1)., 2 reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH), unable to reach LDL-C target levels despite an adequate trial of diet and lifestyle modification (1.1)., 3 improve glycemic control in adults with type 2 diabetes mellitus (1.2).</IndicationAndUsage>
    <Description>Colesevelam hydrochloride is a non-absorbed, polymeric, lipid-lowering and glucose-lowering agent for oral administration. Colesevelam hydrochloride is a high-capacity bile acid-binding molecule. Colesevelam hydrochloride is a polymer with off-white to light yellow color powder, which is insoluble in water and any organic solvent. Colesevelam hydrochloride is poly (allylamine hydrochloride) cross-linked with epichlorohydrin and alkylated with 1-bromodecane and (6-bromohexyl)-trimethylammonium bromide. The chemical name (IUPAC) of colesevelam hydrochloride is allylamine polymer with 1-chloro-2,3-epoxypropane, [6-(allylamino)-hexyl]trimethylammonium chloride and N-allyldecylamine, hydrochloride. The chemical structure of colesevelam hydrochloride is represented by the following formula. wherein (a) represents allyl amine monomer units that have not been alkylated by either of the 1-bromodecane or (6-bromohexyl)-trimethylammonium bromide alkylating agents or cross-linked by epichlorohydrin; (b) represents allyl amine units that have undergone cross- linking with epichlorohydrin; (c) represents allyl amine units that have been alkylated with a decyl group; (d) represents allyl amine units that have been alkylated with a (6-trimethylammonium) hexyl group, and m represents a number ≥ 100 to indicate an extended polymer network. A small amount of the amines are dialkylated and are not depicted in the formula above. No regular order of the groups is implied by the structure; cross-linking and alkylation are expected to occur randomly along the polymer chains. A large amount of the amines are protonated. The polymer is depicted in the hydrochloride form; a small amount of the halides are bromide. Colesevelam hydrochloride is hydrophilic and insoluble in water. Colesevelam hydrochloride tablet contains 625 mg colesevelam hydrochloride. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide yellow, iron oxide red, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, povidone, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, sodium bicarbonate. The tablet is printed with black pharmaceutical ink which contains ammonium hydroxide, ferrosoferric oxide, propylene glycol and shellac (&lt; 5 calories per 6 tablets).</Description>
  </NDC>
  <NDC>
    <NDCCode>70756-619-10</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (70756-619-10)  &gt; 4 mL in 1 VIAL (70756-619-85) </PackageDescription>
    <NDC11Code>70756-0619-10</NDC11Code>
    <ProductNDC>70756-619</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Furosemide</ProprietaryName>
    <NonProprietaryName>Furosemide</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20221217</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216860</ApplicationNumber>
    <LabelerName>Lifestar Pharma LLC</LabelerName>
    <SubstanceName>FUROSEMIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-12-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221217</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Parenteral therapy should be reserved for patients unable to take oral medication or for patients in emergency clinical situations. Edema: Furosemide is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired. Furosemide is indicated as adjunctive therapy in acute pulmonary edema. The intravenous administration of furosemide is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema. If gastrointestinal absorption is impaired or oral medication is not practical for any reason, furosemide is indicated by the intravenous or intramuscular route. Parenteral use should be replaced with oral furosemide as soon as practical.</IndicationAndUsage>
    <Description>Furosemide, USP is a diuretic which is an anthranilic acid derivative. Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide Injection, USP 10 mg/mL is a sterile, non-pyrogenic solution in vials for intravenous and intramuscular injection. Furosemide, USP is a white to slightly yellowish, odorless crystalline powder. It is freely soluble in acetone, in dimethylformamide, and in solutions of alkali hydroxides, soluble in methanol, sparingly soluble in alcohol, slightly soluble in ether, very slightly soluble in chloroform, practically insoluble in water. The structural formula is as follows. Molecular Formula: C12H11ClN2O5S. Molecular Weight: 330.74. Each mL contains: Furosemide, USP 10 mg, Water for Injection q.s., Sodium Chloride for isotonicity, Sodium  Hydroxide and, if necessary, Hydrochloric Acid to adjust pH between 8.0 and 9.3.</Description>
  </NDC>
  <NDC>
    <NDCCode>71919-619-10</NDCCode>
    <PackageDescription>100 mL in 1 BOTTLE, GLASS (71919-619-10) </PackageDescription>
    <NDC11Code>71919-0619-10</NDC11Code>
    <ProductNDC>71919-619</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sedum Acre</ProprietaryName>
    <NonProprietaryName>Sedum Acre</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20091210</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Washington Homeopathic Products</LabelerName>
    <SubstanceName>SEDUM ACRE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>[hp_C]/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20091210</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Indications:. SEDUM   Hemorrhoids.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0363-0619-44</NDCCode>
    <PackageDescription>532 g in 1 BOTTLE, PLASTIC (0363-0619-44) </PackageDescription>
    <NDC11Code>00363-0619-44</NDC11Code>
    <ProductNDC>0363-0619</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Daily Moisturizing</ProprietaryName>
    <NonProprietaryName>Daily Moistruizing</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130206</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>Walgreen, Co.</LabelerName>
    <SubstanceName>DIMETHICONE</SubstanceName>
    <StrengthNumber>13</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-04-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130206</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps prevent and temporarily protects chafed, chapped, or cracked skin. helps protect from the drying effects of wind and cold weather.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>21130-619-11</NDCCode>
    <PackageDescription>325 mL in 1 BOTTLE, PLASTIC (21130-619-11)</PackageDescription>
    <NDC11Code>21130-0619-11</NDC11Code>
    <ProductNDC>21130-619</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Safeway Care</ProprietaryName>
    <ProprietaryNameSuffix>Medicated Dandruff</ProprietaryNameSuffix>
    <NonProprietaryName>Selenium Sulfide</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20140225</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part358H</ApplicationNumber>
    <LabelerName>SAFEWAY INC</LabelerName>
    <SubstanceName>SELENIUM SULFIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>FOR RELIEF OF FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF AND SEBORRHEIC DERMATITIS AND TO HELP PREVENT THE CHANCE OF RECURRENCE.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>21695-619-40</NDCCode>
    <PackageDescription>40 TABLET in 1 BOTTLE (21695-619-40)</PackageDescription>
    <NDC11Code>21695-0619-40</NDC11Code>
    <ProductNDC>21695-619</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
    <NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20071127</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040778</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp</LabelerName>
    <SubstanceName>OXYCODONE; ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>10; 325</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Oxycodone and Acetaminophen Tablets, USP are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
    <Description>Each tablet for oral administration contains. Oxycodone Hydrochloride, USP……………. 10 mg*. Acetaminophen, USP………………………325 mg. *10 mg oxycodone HCl is equivalent to 8.9637 mg of oxycodone. Oxycodone and Acetaminophen Tablets, USP also contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch and stearic acid. Oxycodone, 14-hydroxydihydrocodeinone, is a semisynthetic opioid analgesic which occurs as a white, odorless, crystalline powder having a saline, bitter taste. The molecular formula for oxycodone hydrochloride is C18H21NO4HCl and the molecular weight 351.82. It is derived from the opium alkaloid thebaine, and may be represented by the following structural formula. Acetaminophen, 4’-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.16. It may be represented by the following structural formula.</Description>
  </NDC>
  <NDC>
    <NDCCode>21695-619-60</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE (21695-619-60)</PackageDescription>
    <NDC11Code>21695-0619-60</NDC11Code>
    <ProductNDC>21695-619</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
    <NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20071127</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040778</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp</LabelerName>
    <SubstanceName>OXYCODONE; ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>10; 325</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Oxycodone and Acetaminophen Tablets, USP are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
    <Description>Each tablet for oral administration contains. Oxycodone Hydrochloride, USP……………. 10 mg*. Acetaminophen, USP………………………325 mg. *10 mg oxycodone HCl is equivalent to 8.9637 mg of oxycodone. Oxycodone and Acetaminophen Tablets, USP also contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch and stearic acid. Oxycodone, 14-hydroxydihydrocodeinone, is a semisynthetic opioid analgesic which occurs as a white, odorless, crystalline powder having a saline, bitter taste. The molecular formula for oxycodone hydrochloride is C18H21NO4HCl and the molecular weight 351.82. It is derived from the opium alkaloid thebaine, and may be represented by the following structural formula. Acetaminophen, 4’-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.16. It may be represented by the following structural formula.</Description>
  </NDC>
  <NDC>
    <NDCCode>25021-619-02</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (25021-619-02)  / 2 mL in 1 VIAL</PackageDescription>
    <NDC11Code>25021-0619-02</NDC11Code>
    <ProductNDC>25021-619</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sugammadex</ProprietaryName>
    <NonProprietaryName>Sugammadex Sodium</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20260701</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215575</ApplicationNumber>
    <LabelerName>Sagent Pharmaceuticals</LabelerName>
    <SubstanceName>SUGAMMADEX SODIUM</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>gamma-Cyclodextrins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260701</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sugammadex injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients aged 2 years and older undergoing surgery. Additional pediatric use information is approved for Merck Sharp &amp; Dohme LLC's BRIDION® (sugammadex) injection. However, due to Merck Sharp &amp; Dohme LLC's marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
    <Description>Sugammadex injection, for intravenous use, contains sugammadex sodium, a modified gamma cyclodextrin chemically designated as 6A,6B,6C,6D,6E,6F,6G,6H-Octakis-S-(2-carboxyethyl)-6A,6B,6C,6D,6E,6F,6G,6H-octathio-γ-cyclodextrin sodium salt (1:8) with a molecular weight of 2178.01. The structural formula is:. Sugammadex injection is supplied as a sterile, non-pyrogenic aqueous solution that is clear, colorless to slightly yellow-brown for intravenous injection only. Each mL contains 100 mg sugammadex, which is equivalent to 108.8 mg sugammadex sodium. The aqueous solution is adjusted to a pH of between 7 and 8 with hydrochloric acid and/or sodium hydroxide. The osmolality of the product is between 300 and 500 mOsmol/kg. Sugammadex injection may contain up to 7 mg per mL of the mono OH-derivative of sugammadex [see Clinical Pharmacology (12.2)]. This derivative is chemically designated as 6A,6B,6C,6D,6E,6F,6G-Heptakis-S-(2-carboxyethyl)-6A,6B,6C,6D,6E,6F,6G-heptathio-γ-cyclodextrin sodium salt (1:7) with a molecular weight of 2067.90. The structural formula is:.</Description>
  </NDC>
  <NDC>
    <NDCCode>25021-619-05</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (25021-619-05)  / 5 mL in 1 VIAL</PackageDescription>
    <NDC11Code>25021-0619-05</NDC11Code>
    <ProductNDC>25021-619</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sugammadex</ProprietaryName>
    <NonProprietaryName>Sugammadex Sodium</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20260701</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215575</ApplicationNumber>
    <LabelerName>Sagent Pharmaceuticals</LabelerName>
    <SubstanceName>SUGAMMADEX SODIUM</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>gamma-Cyclodextrins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260701</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sugammadex injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients aged 2 years and older undergoing surgery. Additional pediatric use information is approved for Merck Sharp &amp; Dohme LLC's BRIDION® (sugammadex) injection. However, due to Merck Sharp &amp; Dohme LLC's marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
    <Description>Sugammadex injection, for intravenous use, contains sugammadex sodium, a modified gamma cyclodextrin chemically designated as 6A,6B,6C,6D,6E,6F,6G,6H-Octakis-S-(2-carboxyethyl)-6A,6B,6C,6D,6E,6F,6G,6H-octathio-γ-cyclodextrin sodium salt (1:8) with a molecular weight of 2178.01. The structural formula is:. Sugammadex injection is supplied as a sterile, non-pyrogenic aqueous solution that is clear, colorless to slightly yellow-brown for intravenous injection only. Each mL contains 100 mg sugammadex, which is equivalent to 108.8 mg sugammadex sodium. The aqueous solution is adjusted to a pH of between 7 and 8 with hydrochloric acid and/or sodium hydroxide. The osmolality of the product is between 300 and 500 mOsmol/kg. Sugammadex injection may contain up to 7 mg per mL of the mono OH-derivative of sugammadex [see Clinical Pharmacology (12.2)]. This derivative is chemically designated as 6A,6B,6C,6D,6E,6F,6G-Heptakis-S-(2-carboxyethyl)-6A,6B,6C,6D,6E,6F,6G-heptathio-γ-cyclodextrin sodium salt (1:7) with a molecular weight of 2067.90. The structural formula is:.</Description>
  </NDC>
  <NDC>
    <NDCCode>33992-0619-8</NDCCode>
    <PackageDescription>8 BLISTER PACK in 1 CARTON (33992-0619-8)  &gt; 1 CAPSULE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>33992-0619-08</NDC11Code>
    <ProductNDC>33992-0619</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Mucus Relief Cold, Flu, Sore Throat</ProprietaryName>
    <ProprietaryNameSuffix>Maximum Strength</ProprietaryNameSuffix>
    <NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180630</StartMarketingDate>
    <EndMarketingDate>20231231</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>ASSURED / DOLLAR TREE (Greenbrier International, Inc.)</LabelerName>
    <SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>325; 10; 200; 5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20180630</StartMarketingDatePackage>
    <EndMarketingDatePackage>20231231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>35356-619-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (35356-619-30) </PackageDescription>
    <NDC11Code>35356-0619-30</NDC11Code>
    <ProductNDC>35356-619</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lamotrigine</ProprietaryName>
    <NonProprietaryName>Lamotrigine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120309</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078525</ApplicationNumber>
    <LabelerName>Lake Erie Medical &amp; Surgical Supply DBA Quality Care Products LLC</LabelerName>
    <SubstanceName>LAMOTRIGINE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-10-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120309</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>35356-619-60</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE (35356-619-60) </PackageDescription>
    <NDC11Code>35356-0619-60</NDC11Code>
    <ProductNDC>35356-619</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lamotrigine</ProprietaryName>
    <NonProprietaryName>Lamotrigine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120309</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078525</ApplicationNumber>
    <LabelerName>Lake Erie Medical &amp; Surgical Supply DBA Quality Care Products LLC</LabelerName>
    <SubstanceName>LAMOTRIGINE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-10-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180713</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>37808-619-91</NDCCode>
    <PackageDescription>6 POWDER, FOR SOLUTION in 1 CARTON (37808-619-91) </PackageDescription>
    <NDC11Code>37808-0619-91</NDC11Code>
    <ProductNDC>37808-619</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Severe Cold And Flu</ProprietaryName>
    <NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl</NonProprietaryName>
    <DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180530</StartMarketingDate>
    <EndMarketingDate>20250101</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>H E B</LabelerName>
    <SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>500; 20; 10</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20180530</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250101</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves these symptoms due to a cold:. minor aches and pains. minor sore throat pain. headache. nasal and sinus congestion. cough due to minor throat and bronchial irritation. temporarily reduces fever.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>41163-619-01</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (41163-619-01)  &gt; 10 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>41163-0619-01</NDC11Code>
    <ProductNDC>41163-619</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Heartburn Relief</ProprietaryName>
    <NonProprietaryName>Ranitidine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130615</StartMarketingDate>
    <EndMarketingDate>20180715</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA200536</ApplicationNumber>
    <LabelerName>SUPERVALU INC.</LabelerName>
    <SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-07-16</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
  </NDC>
  <NDC>
    <NDCCode>41190-619-40</NDCCode>
    <PackageDescription>354 mL in 1 BOTTLE, PUMP (41190-619-40) </PackageDescription>
    <NDC11Code>41190-0619-40</NDC11Code>
    <ProductNDC>41190-619</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Daily Moisturizing</ProprietaryName>
    <NonProprietaryName>Dimethicone</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20100614</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>Wakefern Food Corp</LabelerName>
    <SubstanceName>DIMETHICONE</SubstanceName>
    <StrengthNumber>1.3</StrengthNumber>
    <StrengthUnit>kg/100mL</StrengthUnit>
    <Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-10-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100614</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps prevent and temporarily protects chafed, chapped, cracked skin. helps protect from the drying effects of wind and cold weather.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>42291-619-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (42291-619-01) </PackageDescription>
    <NDC11Code>42291-0619-01</NDC11Code>
    <ProductNDC>42291-619</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Minoxidil</ProprietaryName>
    <NonProprietaryName>Minoxidil</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130801</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA072709</ApplicationNumber>
    <LabelerName>AvKARE</LabelerName>
    <SubstanceName>MINOXIDIL</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130801</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Because of the potential for serious adverse effects, minoxidil tablets are indicated only in the treatment of hypertension that is symptomatic or associated with target organ damage and is not manageable with maximum therapeutic doses of a diuretic plus two other antihypertensive drugs. At the present time use in milder degrees of hypertension is not recommended because the benefit-risk relationship in such patients has not been defined. Minoxidil reduced supine diastolic blood pressure by 20 mm Hg or to 90 mm Hg or less in approximately 75% of patients, most of who had hypertension that could not be controlled by other drugs.</IndicationAndUsage>
    <Description>Minoxidil tablets contain minoxidil, an antihypertensive peripheral vasodilator. Minoxidil occurs as a white to off-white, crystalline powder, soluble in alcohol and propylene glycol; sparingly soluble in methanol; slightly soluble in water; practically insoluble in chloroform, acetone and ethyl acetate. The chemical name for minoxidil is 2,4-Pyrimidinediamine, 6-(1-piperidinyl)-, 3-oxide. The structural formula is represented below. Minoxidil tablets for oral administration contain either 2.5 mg or 10 mg of minoxidil. Inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>42291-619-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (42291-619-90) </PackageDescription>
    <NDC11Code>42291-0619-90</NDC11Code>
    <ProductNDC>42291-619</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Minoxidil</ProprietaryName>
    <NonProprietaryName>Minoxidil</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130801</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA072709</ApplicationNumber>
    <LabelerName>AvKARE, Inc.</LabelerName>
    <SubstanceName>MINOXIDIL</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-04-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130801</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>42549-619-12</NDCCode>
    <PackageDescription>120 TABLET, FILM COATED in 1 BOTTLE (42549-619-12)</PackageDescription>
    <NDC11Code>42549-0619-12</NDC11Code>
    <ProductNDC>42549-619</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Topiramate</ProprietaryName>
    <NonProprietaryName>Topiramate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090327</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090278</ApplicationNumber>
    <LabelerName>STAT Rx USA LLC</LabelerName>
    <SubstanceName>TOPIRAMATE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-07</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Topiramate tablets are indicated as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures. Effectiveness was demonstrated in a controlled trial in patients with epilepsy who had no more than 2 seizures in the 3 months prior to enrollment. Safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials.</IndicationAndUsage>
    <Description>Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg circular tablets for oral administration. Topiramate is a white crystalline powder with a bitter taste. Topiramate USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.37. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets contain the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, magnesium stearate, purified water, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, individual tablets contain. 50 mg tablets: iron oxide yellow100 mg tablets: iron oxide yellow, and D&amp;C Yellow # 10 Aluminum Lake200 mg tablets: iron oxide red, lecithin (soya), and iron oxide black.</Description>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>0268-0619-10</NDCCode><ProprietaryName>Canis Lupus Familiaris Skin</ProprietaryName><NonProprietaryName>Dog Epithelia</NonProprietaryName></NDC><NDC><NDCCode>0268-0619-50</NDCCode><ProprietaryName>Canis Lupus Familiaris Skin</ProprietaryName><NonProprietaryName>Dog Epithelia</NonProprietaryName></NDC><NDC><NDCCode>13811-619-10</NDCCode><ProprietaryName>Timolol Maleate</ProprietaryName><NonProprietaryName>Timolol Maleate</NonProprietaryName></NDC><NDC><NDCCode>36998-0619-0</NDCCode><NonProprietaryName>Meclizine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>42291-619-10</NDCCode><ProprietaryName>Minoxidil</ProprietaryName><NonProprietaryName>Minoxidil</NonProprietaryName></NDC><NDC><NDCCode>47335-619-10</NDCCode><ProprietaryName>Drizalma Sprinkle</ProprietaryName><NonProprietaryName>Duloxetine</NonProprietaryName></NDC><NDC><NDCCode>49288-0619-3</NDCCode><ProprietaryName>Absidia Ramosa</ProprietaryName><NonProprietaryName>Absidia Ramosa</NonProprietaryName></NDC><NDC><NDCCode>60429-619-10</NDCCode><ProprietaryName>Antipyrine And Benzocaine</ProprietaryName><NonProprietaryName>Antipyrine And Benzocaine</NonProprietaryName></NDC><NDC><NDCCode>63187-619-10</NDCCode><ProprietaryName>Sildenafil</ProprietaryName><NonProprietaryName>Sildenafil</NonProprietaryName></NDC><NDC><NDCCode>67296-0619-1</NDCCode><ProprietaryName>Zolpidem Tartrate</ProprietaryName><NonProprietaryName>Zolpidem Tartrate</NonProprietaryName></NDC><NDC><NDCCode>67457-619-10</NDCCode><ProprietaryName>Zoledronic Acid</ProprietaryName><NonProprietaryName>Zoledronic Acid</NonProprietaryName></NDC><NDC><NDCCode>68083-619-10</NDCCode><ProprietaryName>Midazolam In Sodium Chloride</ProprietaryName><NonProprietaryName>Midazolam In Sodium Chloride</NonProprietaryName></NDC><NDC><NDCCode>68382-619-10</NDCCode><ProprietaryName>Colesevelam</ProprietaryName><NonProprietaryName>Colesevelam</NonProprietaryName></NDC><NDC><NDCCode>70756-619-10</NDCCode><ProprietaryName>Furosemide</ProprietaryName><NonProprietaryName>Furosemide</NonProprietaryName></NDC><NDC><NDCCode>71919-619-10</NDCCode><ProprietaryName>Sedum Acre</ProprietaryName><NonProprietaryName>Sedum Acre</NonProprietaryName></NDC><NDC><NDCCode>0363-0619-44</NDCCode><ProprietaryName>Daily Moisturizing</ProprietaryName><NonProprietaryName>Daily Moistruizing</NonProprietaryName></NDC><NDC><NDCCode>21130-619-11</NDCCode><ProprietaryName>Safeway Care</ProprietaryName><NonProprietaryName>Selenium Sulfide</NonProprietaryName></NDC><NDC><NDCCode>21695-619-40</NDCCode><ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName><NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>21695-619-60</NDCCode><ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName><NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>25021-619-02</NDCCode><ProprietaryName>Sugammadex</ProprietaryName><NonProprietaryName>Sugammadex Sodium</NonProprietaryName></NDC><NDC><NDCCode>25021-619-05</NDCCode><ProprietaryName>Sugammadex</ProprietaryName><NonProprietaryName>Sugammadex Sodium</NonProprietaryName></NDC><NDC><NDCCode>33992-0619-8</NDCCode><ProprietaryName>Mucus Relief Cold, Flu, Sore Throat</ProprietaryName><NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl</NonProprietaryName></NDC><NDC><NDCCode>35356-619-30</NDCCode><ProprietaryName>Lamotrigine</ProprietaryName><NonProprietaryName>Lamotrigine</NonProprietaryName></NDC><NDC><NDCCode>35356-619-60</NDCCode><ProprietaryName>Lamotrigine</ProprietaryName><NonProprietaryName>Lamotrigine</NonProprietaryName></NDC><NDC><NDCCode>37808-619-91</NDCCode><ProprietaryName>Severe Cold And Flu</ProprietaryName><NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl</NonProprietaryName></NDC><NDC><NDCCode>41163-619-01</NDCCode><ProprietaryName>Heartburn Relief</ProprietaryName><NonProprietaryName>Ranitidine</NonProprietaryName></NDC><NDC><NDCCode>41190-619-40</NDCCode><ProprietaryName>Daily Moisturizing</ProprietaryName><NonProprietaryName>Dimethicone</NonProprietaryName></NDC><NDC><NDCCode>42291-619-01</NDCCode><ProprietaryName>Minoxidil</ProprietaryName><NonProprietaryName>Minoxidil</NonProprietaryName></NDC><NDC><NDCCode>42291-619-90</NDCCode><ProprietaryName>Minoxidil</ProprietaryName><NonProprietaryName>Minoxidil</NonProprietaryName></NDC><NDC><NDCCode>42549-619-12</NDCCode><ProprietaryName>Topiramate</ProprietaryName><NonProprietaryName>Topiramate</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",
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      "NPI": "1225534910",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "MAZHAR",
      "FirstName": "SAHAR",
      "MiddleName": "RANIA",
      "FirstLineMailingAddress": "1108 ROSS CLARK CIR",
      "MailingAddressCityName": "DOTHAN",
      "MailingAddressStateName": "AL",
      "MailingAddressPostalCode": "36301-3022",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "334-712-3329",
      "FirstLinePracticeLocationAddress": "1108 ROSS CLARK CIR",
      "PracticeLocationAddressCityName": "DOTHAN",
      "PracticeLocationAddressStateName": "AL",
      "PracticeLocationAddressPostalCode": "36301-3022",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "334-712-3329",
      "EnumerationDate": "04/02/2018",
      "LastUpdateDate": "04/02/2018",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "390200000X",
      "Taxonomy1": "Student in an Organized Health Care Education/Training Program",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1922502889",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "FADLALLA",
      "FirstName": "RANIA",
      "MiddleName": "ABDALLA DAW ELBEIT",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 BAY AVE",
      "MailingAddressCityName": "MONTCLAIR",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "07042-4837",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "973-429-6196",
      "FirstLinePracticeLocationAddress": "1 BAY AVE",
      "PracticeLocationAddressCityName": "MONTCLAIR",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "07042-4837",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "973-429-6196",
      "EnumerationDate": "03/23/2018",
      "LastUpdateDate": "03/23/2018",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "390200000X",
      "Taxonomy1": "Student in an Organized Health Care Education/Training Program",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1629068499",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "FAHOURY",
      "FirstName": "RANIA",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "FirstLineMailingAddress": "4411 N HOLLAND SYLVANIA RD",
      "SecondLineMailingAddress": "SUITE 201",
      "MailingAddressCityName": "TOLEDO",
      "MailingAddressStateName": "OH",
      "MailingAddressPostalCode": "43623-3525",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "419-843-3627",
      "MailingAddressFaxNumber": "419-843-9697",
      "FirstLinePracticeLocationAddress": "4411 N HOLLAND SYLVANIA RD",
      "SecondLinePracticeLocationAddress": "SUITE 201",
      "PracticeLocationAddressCityName": "TOLEDO",
      "PracticeLocationAddressStateName": "OH",
      "PracticeLocationAddressPostalCode": "43623-3525",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "419-843-3627",
      "PracticeLocationAddressFaxNumber": "419-843-9697",
      "EnumerationDate": "10/24/2005",
      "LastUpdateDate": "09/02/2011",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "35086663",
      "LicenseNumberStateCode1": "OH",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "2621621",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "OH",
      "OtherIdentifier2": "P00401238",
      "OtherIdentifierType2": "OTHER",
      "OtherIdentifierState2": "OH",
      "OtherIdentifierIssuer2": "RAILROAD MEDICARE"
    },
    {
      "NPI": "1033186986",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "NICOLA",
      "FirstName": "RANIA",
      "MiddleName": "SOLIMAN",
      "NamePrefix": "DR.",
      "Credential": "DDS",
      "FirstLineMailingAddress": "110 S WOODLAND ST",
      "MailingAddressCityName": "WINTER GARDEN",
      "MailingAddressStateName": "FL",
      "MailingAddressPostalCode": "34787-3546",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "407-905-8827",
      "MailingAddressFaxNumber": "407-645-4587",
      "FirstLinePracticeLocationAddress": "7900 FOREST CITY RD",
      "PracticeLocationAddressCityName": "ORLANDO",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "32810-3002",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "407-905-8827",
      "PracticeLocationAddressFaxNumber": "407-645-4587",
      "EnumerationDate": "02/28/2006",
      "LastUpdateDate": "07/28/2017",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1223G0001X",
      "Taxonomy1": "General Practice",
      "LicenseNumber1": "DN15582",
      "LicenseNumberStateCode1": "FL",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "122300000X",
      "Taxonomy2": "Dentist",
      "LicenseNumber2": "DN15582",
      "LicenseNumberStateCode2": "FL",
      "PrimaryTaxonomySwitch2": "Y",
      "OtherIdentifier1": "075156100",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "FL"
    },
    {
      "NPI": "1720032899",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ALBATAINEH",
      "FirstName": "RANIA",
      "MiddleName": "QASSIEM",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "11476 OKEECHOBEE BLVD",
      "MailingAddressCityName": "ROYAL PALM BEACH",
      "MailingAddressStateName": "FL",
      "MailingAddressPostalCode": "33411-8715",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "561-204-5111",
      "MailingAddressFaxNumber": "561-204-5150",
      "FirstLinePracticeLocationAddress": "11476 OKEECHOBEE BLVD",
      "PracticeLocationAddressCityName": "ROYAL PALM BEACH",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "33411-8715",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "561-204-5111",
      "PracticeLocationAddressFaxNumber": "561-204-5150",
      "EnumerationDate": "05/21/2006",
      "LastUpdateDate": "09/11/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "ME 79876",
      "LicenseNumberStateCode1": "FL",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1326095100",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ROSBOROUGH",
      "FirstName": "RANIA",
      "MiddleName": "BAJWA",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "3100 WYMAN PARK DR",
      "MailingAddressCityName": "BALTIMORE",
      "MailingAddressStateName": "MD",
      "MailingAddressPostalCode": "21211-2803",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "410-338-3500",
      "FirstLinePracticeLocationAddress": "3601 SW 160TH AVE",
      "SecondLinePracticeLocationAddress": "SUITE 250",
      "PracticeLocationAddressCityName": "MIRAMAR",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "33027-6308",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "877-866-7123",
      "EnumerationDate": "05/27/2006",
      "LastUpdateDate": "12/10/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "D0063732",
      "LicenseNumberStateCode1": "MD",
      "PrimaryTaxonomySwitch1": "Y",
      "TaxonomyCode2": "207Q00000X",
      "Taxonomy2": "Family Medicine",
      "LicenseNumber2": "0101257197",
      "LicenseNumberStateCode2": "VA",
      "PrimaryTaxonomySwitch2": "N"
    },
    {
      "NPI": "1528015310",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "HUSSEINI",
      "FirstName": "RANIA",
      "MiddleName": "I",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "111 CYPRESS ST",
      "MailingAddressCityName": "BROOKLINE",
      "MailingAddressStateName": "MA",
      "MailingAddressPostalCode": "02445-6002",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "508-718-4050",
      "FirstLinePracticeLocationAddress": "20 PATRIOT PL",
      "PracticeLocationAddressCityName": "FOXBORO",
      "PracticeLocationAddressStateName": "MA",
      "PracticeLocationAddressPostalCode": "02035-1375",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "508-718-4050",
      "EnumerationDate": "05/27/2006",
      "LastUpdateDate": "04/17/2012",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "209649",
      "LicenseNumberStateCode1": "MA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1760429591",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "RAYES-DANAN",
      "FirstName": "RANIA",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "OtherLastName": "RAYES",
      "OtherFirstName": "RANIA",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2500 METROHEALTH DR",
      "MailingAddressCityName": "CLEVELAND",
      "MailingAddressStateName": "OH",
      "MailingAddressPostalCode": "44109-1900",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "216-778-7800",
      "FirstLinePracticeLocationAddress": "2500 METROHEALTH DR",
      "PracticeLocationAddressCityName": "CLEVELAND",
      "PracticeLocationAddressStateName": "OH",
      "PracticeLocationAddressPostalCode": "44109-1900",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "216-778-7800",
      "EnumerationDate": "06/01/2006",
      "LastUpdateDate": "01/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207ZP0102X",
      "Taxonomy1": "Anatomic Pathology & Clinical Pathology",
      "LicenseNumber1": "35086346",
      "LicenseNumberStateCode1": "OH",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "2687703",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "OH"
    },
    {
      "NPI": "1699717660",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "AMPEY",
      "FirstName": "RANIA",
      "MiddleName": "L",
      "Credential": "LPC",
      "FirstLineMailingAddress": "5930 LOVERS LN",
      "SecondLineMailingAddress": "PREMIER NEUROPSYCHIATRY, PLC",
      "MailingAddressCityName": "PORTAGE",
      "MailingAddressStateName": "MI",
      "MailingAddressPostalCode": "49002-1673",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "269-873-1611",
      "FirstLinePracticeLocationAddress": "5930 LOVERS LN",
      "SecondLinePracticeLocationAddress": "PREMIER NEUROPSYCHIATRY, PLC",
      "PracticeLocationAddressCityName": "PORTAGE",
      "PracticeLocationAddressStateName": "MI",
      "PracticeLocationAddressPostalCode": "49002-1673",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "269-873-1611",
      "EnumerationDate": "06/12/2006",
      "LastUpdateDate": "12/30/2010",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional",
      "LicenseNumber1": "6401007658",
      "LicenseNumberStateCode1": "MI",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1801839667",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ABOUJAOUDE",
      "FirstName": "RANIA",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "PO BOX 1283",
      "MailingAddressCityName": "MEDFORD",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08055-6283",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "609-677-1046",
      "MailingAddressFaxNumber": "609-677-1306",
      "FirstLinePracticeLocationAddress": "200 TRENTON RD",
      "PracticeLocationAddressCityName": "BROWNS MILLS",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08015-1705",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "609-677-1046",
      "PracticeLocationAddressFaxNumber": "609-677-1306",
      "EnumerationDate": "06/13/2006",
      "LastUpdateDate": "09/15/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207RI0200X",
      "Taxonomy1": "Infectious Disease",
      "LicenseNumber1": "39215",
      "LicenseNumberStateCode1": "KY",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "207RI0200X",
      "Taxonomy2": "Infectious Disease",
      "LicenseNumber2": "25MA07672000",
      "LicenseNumberStateCode2": "NJ",
      "PrimaryTaxonomySwitch2": "Y"
    },
    {
      "NPI": "1184645301",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "BAIK",
      "FirstName": "RANIA",
      "Credential": "D.O.",
      "FirstLineMailingAddress": "602 ROUTE 169",
      "SecondLineMailingAddress": "PO BOX 865",
      "MailingAddressCityName": "WOODSTOCK",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06281-2225",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "860-821-3406",
      "MailingAddressFaxNumber": "860-821-3407",
      "FirstLinePracticeLocationAddress": "602 ROUTE 169",
      "PracticeLocationAddressCityName": "WOODSTOCK",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06281-2225",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "860-821-3406",
      "PracticeLocationAddressFaxNumber": "860-821-3407",
      "EnumerationDate": "07/22/2006",
      "LastUpdateDate": "01/14/2016",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "000260",
      "LicenseNumberStateCode1": "CT",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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