RESTful Lookup — Test-Drive (2007 – 2026)

Query complete (35 ms elapsed)

{
  "NDC": [
    {
      "NDCCode": "30142-088-10",
      "PackageDescription": "30 mL in 1 BOTTLE, PLASTIC (30142-088-10) ",
      "NDC11Code": "30142-0088-10",
      "ProductNDC": "30142-088",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Iodine Tincture",
      "NonProprietaryName": "Iodine Tincture",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20010621",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M003",
      "LabelerName": "The Kroger Co.",
      "SubstanceName": "IODINE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2026-03-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20010621",
      "SamplePackage": "N",
      "IndicationAndUsage": "First aid to help prevent skin infection in: 1 minor cuts, 2 scrapes, 3 burns."
    },
    {
      "NDCCode": "11344-088-10",
      "PackageDescription": "30 mL in 1 BOTTLE, PLASTIC (11344-088-10) ",
      "NDC11Code": "11344-0088-10",
      "ProductNDC": "11344-088",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Iodine",
      "NonProprietaryName": "Iodine",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20081108",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Vi-Jon, LLC",
      "SubstanceName": "ALCOHOL; IODINE; SODIUM IODIDE",
      "StrengthNumber": "470; 20; 20.4",
      "StrengthUnit": "mg/mL; mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-11-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20081108",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "33261-088-10",
      "PackageDescription": "10 TABLET, EXTENDED RELEASE in 1 BOTTLE (33261-088-10)",
      "NDC11Code": "33261-0088-10",
      "ProductNDC": "33261-088",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Orphenadrine Citrate",
      "NonProprietaryName": "Orphenadrine Citrate",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19980619",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040284",
      "LabelerName": "Aidarex Pharmaceuticals LLC",
      "SubstanceName": "ORPHENADRINE CITRATE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "Orphenadrine citrate extended-release tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions.",
      "Description": "Orphenadrine citrate is the citrate salt of orphenadrine. It occurs as a white, crystalline powder having a bitter taste. It is practically odorless; sparingly soluble in water, slightly soluble in alcohol. The chemical name of orphenadrine citrate is (±)-N,N-Dimethyl-2-[(o-methyl-α-phenylbenzyl)oxy]ethylamine citrate (1:1) having molecular formula C18H23NOC6H8O7 and molecular weight of 461.51. It has the following structural formula. Each tablet for oral administration contains 100 mg orphenadrine citrate. Each Orphenadrine citrate extended-release tablet contains the following inactive ingredients: hydroxypropyl methylcellulose, lactose monohydrate and magnesium stearate."
    },
    {
      "NDCCode": "33342-088-12",
      "PackageDescription": "10 BLISTER PACK in 1 CARTON (33342-088-12)  > 10 TABLET, FILM COATED in 1 BLISTER PACK",
      "NDC11Code": "33342-0088-12",
      "ProductNDC": "33342-088",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Rizatriptan",
      "NonProprietaryName": "Rizatriptan",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140311",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203147",
      "LabelerName": "Macleods Pharmaceuticals Limited",
      "SubstanceName": "RIZATRIPTAN BENZOATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2022-07-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20140311",
      "SamplePackage": "N",
      "IndicationAndUsage": "Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use  Rizatriptan benzoate tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks.  Rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)].  Rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks.  Safety and effectiveness of rizatriptan benzoate tablets have not been established for cluster headache.",
      "Description": "Rizatriptan benzoate tablets, USP contain rizatriptan benzoate, USP a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate, USP is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is. Its molecular formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate, USP is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. Rizatriptan benzoate tablets, USP are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients:. lactose monohydrate, microcrystalline cellulose, pregelatinized maize starch, ferric oxide (red), and magnesium stearate."
    },
    {
      "NDCCode": "40032-088-31",
      "PackageDescription": "3 BLISTER PACK in 1 CARTON (40032-088-31)  > 10 TABLET, FILM COATED in 1 BLISTER PACK (40032-088-30) ",
      "NDC11Code": "40032-0088-31",
      "ProductNDC": "40032-088",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Voriconazole",
      "NonProprietaryName": "Voriconazole",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160524",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207371",
      "LabelerName": "Novel Laboratories, Inc.",
      "SubstanceName": "VORICONAZOLE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20160524",
      "SamplePackage": "N",
      "IndicationAndUsage": "Voriconazole is an azole antifungal drug indicated for use in the treatment of: : 1 Invasive aspergillosis (1.1), 2 Candidemia (non-neutropenics) and disseminated candidiasis in skin, abdomen, kidney, bladder wall and wounds (1.2), 3 Esophageal candidiasis (1.3), 4 Serious infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani , in patients intolerant of, or refractory to, other therapy (1.4).",
      "Description": "Voriconazole, an azole antifungal agent, is available as film-coated tablets for oral administration. The structural formula is. Voriconazole is designated chemically as (αR, βS)-α-(2,4-Difluorophenyl)-5-fluoro-β-methyl-α-(1H-1,2,4-triazol-1-ylmethyl)-4-pyrimidineethanol with a molecular formula of C16H14F3N5O and a molecular weight of 349.3. Voriconazole, USP drug substance is a white to off-white crystalline powder. Voriconazole Tablets contain 50 mg or 200 mg of voriconazole. The inactive ingredients include lactose monohydrate, pregelatinized starch (maize starch), croscarmellose sodium, povidone, magnesium stearate and a coating containing hypromellose (HPMC 2910), titanium dioxide, lactose monohydrate and triacetin."
    },
    {
      "NDCCode": "41163-088-10",
      "PackageDescription": "30 mL in 1 BOTTLE, PLASTIC (41163-088-10) ",
      "NDC11Code": "41163-0088-10",
      "ProductNDC": "41163-088",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Iodine",
      "NonProprietaryName": "Iodine",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20050204",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M003",
      "LabelerName": "United Natural Foods, Inc. dba UNFI",
      "SubstanceName": "IODINE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2026-02-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20050204",
      "SamplePackage": "N",
      "IndicationAndUsage": "First aid to help prevent skin infection in: 1 minor cuts, 2 scrapes, 3 burns."
    },
    {
      "NDCCode": "43386-088-31",
      "PackageDescription": "3 BLISTER PACK in 1 CARTON (43386-088-31)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (43386-088-30) ",
      "NDC11Code": "43386-0088-31",
      "ProductNDC": "43386-088",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Voriconazole",
      "NonProprietaryName": "Voriconazole",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160524",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207371",
      "LabelerName": "Lupin Pharmaceuticals,Inc.",
      "SubstanceName": "VORICONAZOLE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2024-02-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20160524",
      "SamplePackage": "N",
      "IndicationAndUsage": "Voriconazole is an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with: 1 Invasive aspergillosis (1.1), 2 Candidemia in non-neutropenics and other deep tissue Candida infections (1.2), 3 Esophageal candidiasis (1.3), 4 Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani, in patients intolerant of, or refractory to, other therapy (1.4).",
      "Description": "Voriconazole, an azole antifungal agent is available as film-coated tablets for oral administration. The structural formula is. Voriconazole is designated chemically as (2R,3S)-2-(2, 4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4 triazol-1-yl)-2-butanol with an empirical formula of C16H14F3N5O and a molecular weight of 349.3. Voriconazole drug substance is a white to almost white powder. Voriconazole Tablets contain 50 mg or 200 mg of voriconazole. The inactive ingredients include lactose monohydrate, pregelatinized starch (maize starch), croscarmellose sodium, povidone, magnesium stearate and a coating containing hypromellose (HPMC 2910), titanium dioxide, lactose monohydrate and triacetin."
    },
    {
      "NDCCode": "43744-088-10",
      "PackageDescription": "1 g in 1 DRUM (43744-088-10)",
      "NDC11Code": "43744-0088-10",
      "ProductNDC": "43744-088",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Betahistine Hydrochloride",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20120323",
      "EndMarketingDate": "20130624",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "CBSCHEM LIMITED",
      "SubstanceName": "BETAHISTINE HYDROCHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20130624"
    },
    {
      "NDCCode": "43744-088-15",
      "PackageDescription": "10 g in 1 DRUM (43744-088-15)",
      "NDC11Code": "43744-0088-15",
      "ProductNDC": "43744-088",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Betahistine Hydrochloride",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20120323",
      "EndMarketingDate": "20130624",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "CBSCHEM LIMITED",
      "SubstanceName": "BETAHISTINE HYDROCHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20130624"
    },
    {
      "NDCCode": "46708-088-10",
      "PackageDescription": "100 TABLET in 1 CARTON (46708-088-10)",
      "NDC11Code": "46708-0088-10",
      "ProductNDC": "46708-088",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Telmisartan",
      "NonProprietaryName": "Telmisartan",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130306",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202130",
      "LabelerName": "Alembic Pharmaceuticals Limited",
      "SubstanceName": "TELMISARTAN",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2015-05-15"
    },
    {
      "NDCCode": "50804-088-10",
      "PackageDescription": "30 mL in 1 BOTTLE, PLASTIC (50804-088-10) ",
      "NDC11Code": "50804-0088-10",
      "ProductNDC": "50804-088",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Iodine",
      "NonProprietaryName": "Iodine",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20081108",
      "EndMarketingDate": "20260501",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M003",
      "LabelerName": "Perrigo Direct, Inc",
      "SubstanceName": "ALCOHOL; IODINE; SODIUM IODIDE",
      "StrengthNumber": "470; 20; 20.4",
      "StrengthUnit": "mg/mL; mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2026-05-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20081108",
      "EndMarketingDatePackage": "20260501",
      "SamplePackage": "N",
      "IndicationAndUsage": "First aid to help prevent skin infection in: 1 minor cuts, 2 scrapes, 3 burns."
    },
    {
      "NDCCode": "51079-088-56",
      "PackageDescription": "10 DOSE PACK in 1 CARTON (51079-088-56)  > 30 BLISTER PACK in 1 DOSE PACK (51079-088-30)  > 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-088-01)",
      "NDC11Code": "51079-0088-56",
      "ProductNDC": "51079-088",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Mirtazapine",
      "NonProprietaryName": "Mirtazapine",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20030801",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076122",
      "LabelerName": "Mylan Institutional Inc.",
      "SubstanceName": "MIRTAZAPINE",
      "StrengthNumber": "45",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2018-12-02",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "52536-108-10",
      "PackageDescription": "1 KIT in 1 CARTON (52536-108-10)  *  15 g in 1 BOTTLE (52536-098-10)  *  289 mL in 1 BOTTLE (52536-088-10) ",
      "NDC11Code": "52536-0108-10",
      "ProductNDC": "52536-108",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Vancomycin Hydrochloride For Oral Solution",
      "NonProprietaryName": "Vancomycin Hydrochloride",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20230331",
      "MarketingCategoryName": "NDA AUTHORIZED GENERIC",
      "ApplicationNumber": "NDA208910",
      "LabelerName": "Wilshire Pharmaceuticals, Inc.",
      "Status": "Active",
      "LastUpdate": "2026-07-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230331",
      "SamplePackage": "N",
      "IndicationAndUsage": "Vancomycin hydrochloride is indicated for the treatment of Clostridium difficile‑associated diarrhea in adults and pediatric patients less than 18 years of age. Vancomycin hydrochloride is also indicated for the treatment of enterocolitis caused by Staphylococcus aureus(including methicillin‑resistant strains) in adults and pediatric patients less than 18 years of age. Important Limitations of Use: 1 Parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin must be given orally for these infections., 2 Orally administered vancomycin hydrochloride is not effective for treatment of other types of infections.",
      "Description": "Vancomycin hydrochloride for oral administration contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis(formerly Nocardia orientalis), which has the chemical formula C 66H 75Cl 2N 9O 24HCl. The molecular weight of vancomycin hydrochloride is 1485.71 g/mol. Vancomycin hydrochloride has the structural formula. Each vancomycin hydrochloride for oral solution kit contains a bottle of vancomycin hydrochloride USP, as white to almost white or tan to brown powder for oral solution, and a bottle of pre‑measured Grape‑Flavored Diluent, in the strengths and volumes listed in Table 3. The Grape‑Flavored Diluent used to reconstitute the oral solution contains: artificial grape flavor, citric acid (anhydrous), D&C Yellow No. 10, FD&C Red No. 40, purified water, sodium benzoate and sucralose."
    },
    {
      "NDCCode": "54575-088-10",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (54575-088-10)",
      "NDC11Code": "54575-0088-10",
      "ProductNDC": "54575-088",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hungarian Smooth Brome Pollen",
      "NonProprietaryName": "Bromus Inermis Pollen",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19671207",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101376",
      "LabelerName": "Allergy Laboratories, Inc.",
      "SubstanceName": "BROMUS INERMIS POLLEN",
      "StrengthNumber": "1",
      "StrengthUnit": "g/20mL",
      "Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established:             Coffee             Cottonseed       Flaxseed             Housefly             Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens."
    },
    {
      "NDCCode": "55513-160-01",
      "PackageDescription": "1 KIT in 1 PACKAGE (55513-160-01)  *  3.088 mL in 1 VIAL (55513-150-01)  *  10.6 mL in 1 VIAL (55513-155-01) ",
      "NDC11Code": "55513-0160-01",
      "ProductNDC": "55513-160",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Blincyto",
      "NonProprietaryName": "Blinatumomab",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20141218",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125557",
      "LabelerName": "Amgen, Inc",
      "Status": "Active",
      "LastUpdate": "2026-04-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20141218",
      "SamplePackage": "N",
      "IndicationAndUsage": "BLINCYTO is a bispecific CD19-directed CD3 T-cell engager indicated for the treatment of adult and pediatric patients one month and older with: 1 CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. (1.1), 2 Relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL). (1.2), 3 CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (ALL) in the consolidation phase of multiphase chemotherapy. (1.3).",
      "Description": "Blinatumomab is a bispecific CD19-directed CD3 T-cell engager. Blinatumomab is produced in Chinese hamster ovary cells. It consists of 504 amino acids and has a molecular weight of approximately 54 kilodaltons. Each BLINCYTO package contains one vial BLINCYTO and one vial IV Solution Stabilizer. BLINCYTO (blinatumomab) for injection is supplied in a single-dose vial as a sterile, preservative-free, white to off-white lyophilized powder for intravenous use. Each single-dose vial of BLINCYTO contains 35 mcg blinatumomab, citric acid monohydrate (3.35 mg), lysine hydrochloride (23.23 mg), polysorbate 80 (0.64 mg), trehalose dihydrate (95.5 mg), and sodium hydroxide to adjust pH to 7.0. After reconstitution with 3 mL of preservative-free Sterile Water for Injection, USP, the resulting concentration is 12.5 mcg/mL blinatumomab. IV Solution Stabilizer is supplied in a single-dose vial as a sterile, preservative-free, colorless to slightly yellow, clear solution. Each single-dose vial of IV Solution Stabilizer contains citric acid monohydrate (52.5 mg), lysine hydrochloride (2283.8 mg), polysorbate 80 (10 mg), sodium hydroxide to adjust pH to 7.0, and water for injection."
    },
    {
      "NDCCode": "55513-160-21",
      "PackageDescription": "1 KIT in 1 PACKAGE (55513-160-21)  *  3.088 mL in 1 VIAL (55513-150-01)  *  10.6 mL in 1 VIAL (55513-155-01) ",
      "NDC11Code": "55513-0160-21",
      "ProductNDC": "55513-160",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Blincyto",
      "NonProprietaryName": "Blinatumomab",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20141218",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125557",
      "LabelerName": "Amgen, Inc",
      "Status": "Active",
      "LastUpdate": "2026-04-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260430",
      "SamplePackage": "N",
      "IndicationAndUsage": "BLINCYTO is a bispecific CD19-directed CD3 T-cell engager indicated for the treatment of adult and pediatric patients one month and older with: 1 CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. (1.1), 2 Relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL). (1.2), 3 CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (ALL) in the consolidation phase of multiphase chemotherapy. (1.3).",
      "Description": "Blinatumomab is a bispecific CD19-directed CD3 T-cell engager. Blinatumomab is produced in Chinese hamster ovary cells. It consists of 504 amino acids and has a molecular weight of approximately 54 kilodaltons. Each BLINCYTO package contains one vial BLINCYTO and one vial IV Solution Stabilizer. BLINCYTO (blinatumomab) for injection is supplied in a single-dose vial as a sterile, preservative-free, white to off-white lyophilized powder for intravenous use. Each single-dose vial of BLINCYTO contains 35 mcg blinatumomab, citric acid monohydrate (3.35 mg), lysine hydrochloride (23.23 mg), polysorbate 80 (0.64 mg), trehalose dihydrate (95.5 mg), and sodium hydroxide to adjust pH to 7.0. After reconstitution with 3 mL of preservative-free Sterile Water for Injection, USP, the resulting concentration is 12.5 mcg/mL blinatumomab. IV Solution Stabilizer is supplied in a single-dose vial as a sterile, preservative-free, colorless to slightly yellow, clear solution. Each single-dose vial of IV Solution Stabilizer contains citric acid monohydrate (52.5 mg), lysine hydrochloride (2283.8 mg), polysorbate 80 (10 mg), sodium hydroxide to adjust pH to 7.0, and water for injection."
    },
    {
      "NDCCode": "58159-088-04",
      "PackageDescription": "10 kg in 1 DRUM (58159-088-04) ",
      "NDC11Code": "58159-0088-04",
      "ProductNDC": "58159-088",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Oxcarbazepine",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20211019",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "NURAY CHEMICALS PRIVATE LIMITED",
      "SubstanceName": "OXCARBAZEPINE",
      "StrengthNumber": "35",
      "StrengthUnit": "kg/35kg",
      "Status": "Unfinished",
      "LastUpdate": "2021-10-28",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "19-OCT-21"
    },
    {
      "NDCCode": "61715-088-11",
      "PackageDescription": "11 BLISTER PACK in 1 CARTON (61715-088-11)  > 10 GUM, CHEWING in 1 BLISTER PACK",
      "NDC11Code": "61715-0088-11",
      "ProductNDC": "61715-088",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Preferred Plus Nicotine Polacrilex Gum, Original Flavor",
      "NonProprietaryName": "Nicotine Polacrilex",
      "DosageFormName": "GUM, CHEWING",
      "RouteName": "BUCCAL",
      "StartMarketingDate": "19990315",
      "EndMarketingDate": "20180131",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074507",
      "LabelerName": "Preferred Plus (Kinray)",
      "SubstanceName": "NICOTINE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231",
      "StartMarketingDatePackage": "19990315",
      "EndMarketingDatePackage": "20180131",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "62332-088-10",
      "PackageDescription": "100 TABLET in 1 CARTON (62332-088-10) ",
      "NDC11Code": "62332-0088-10",
      "ProductNDC": "62332-088",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Telmisartan",
      "NonProprietaryName": "Telmisartan",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160625",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202130",
      "LabelerName": "Alembic Pharmaceuticals Inc.",
      "SubstanceName": "TELMISARTAN",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-06-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160625",
      "SamplePackage": "N",
      "IndicationAndUsage": "Telmisartanis an angiotensin II receptor blocker (ARB) indicated for.  Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1)  Cardiovascular (CV) risk reduction in patients unable to take ACE inhibitors (1.2).",
      "Description": "Telmisartanis a non-peptide angiotensin II receptor (type AT1) antagonist. Telmisartan is chemically described as 4’-[(1,4’-dimethyl-2’-propyl [2,6’-bi-1H-benzimidazol]-1’-yl)methyl]-[1,1’-biphenyl]-2-carboxylic acid. Its empirical formula is C33H30N4O2, its molecular weight is 514.63, and its structural formula is:.   Telmisartan is a white to slightly yellowish solid. It is practically insoluble in water and in the pH range of 3 to 9, sparingly soluble in strong acid (except insoluble in hydrochloric acid), and soluble in strong base.Telmisartan tablets, USP  are available as tablets for oral administration, containing 20 mg, 40 mg or 80 mg of telmisartan. The tablets contain the following inactive ingredients: mannitol, sodium hydroxide, meglumine, povidone, sodium stearyl fumarate and magnesium stearate. Telmisartan tablets are hygroscopic and require protection from moisture. The USP Dissolution Test is pending."
    },
    {
      "NDCCode": "62750-088-10",
      "PackageDescription": "25 BAR, CHEWABLE in 1 BOTTLE (62750-088-10) ",
      "NDC11Code": "62750-0088-10",
      "ProductNDC": "62750-088",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Zicam Cold Remedy Medicated Fruit Drops",
      "NonProprietaryName": "Zinc Acetate Anhydrous And Zinc Gluconate",
      "DosageFormName": "BAR, CHEWABLE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200710",
      "EndMarketingDate": "20220831",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Matrixx Initiatives, Inc.",
      "SubstanceName": "ZINC ACETATE ANHYDROUS; ZINC GLUCONATE",
      "StrengthNumber": "2; 2",
      "StrengthUnit": "[hp_X]/1; [hp_X]/1",
      "Pharm_Classes": "Copper Absorption Inhibitor [EPC], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Decreased Copper Ion Absorption [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2022-09-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20200710",
      "EndMarketingDatePackage": "20220831",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "63323-088-61",
      "PackageDescription": "10 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (63323-088-61)  / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE",
      "NDC11Code": "63323-0088-61",
      "ProductNDC": "63323-088",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Chloride",
      "NonProprietaryName": "Sodium Chloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20010112",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "SODIUM CHLORIDE",
      "StrengthNumber": "234",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-10-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20010112",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sodium Chloride Injection, USP is indicated for parenteral restoration of sodium ion in patients with restricted oral intake.  Sodium replacement is specifically indicated in patients with hyponatremia or low salt syndrome.  Sodium chloride injection may also be added to compatible carbohydrate solutions such as dextrose in water to provide electrolytes.",
      "Description": "Sodium Chloride Injection, USP is a sterile, nonpyrogenic, concentrated solution for intravenous administration ONLY AFTER DILUTION to replenish electrolytes.  The preparation contains 4 mEq/mL (23.4%) sodium chloride, in Water for Injection.  The solution contains no bacteriostat, antimicrobial agent or added buffer; pH of the solution ranges from 4.5 to 7.0.  Each mL contains: Sodium chloride 234 mg; Water for Injection q.s. pH may have been adjusted with hydrochloric acid.  The osmolar concentration of the 4 mEq/mL solution is 8 mOsmol/mL (calculated).  Sodium chloride is chemically designated NaCI, a white crystalline compound freely soluble in water. A pharmacy bulk package is a sterile dosage form containing many single doses.  The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for IV infusion."
    },
    {
      "NDCCode": "63323-088-63",
      "PackageDescription": "10 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (63323-088-63)  / 200 mL in 1 VIAL, PHARMACY BULK PACKAGE",
      "NDC11Code": "63323-0088-63",
      "ProductNDC": "63323-088",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Chloride",
      "NonProprietaryName": "Sodium Chloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20010112",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "SODIUM CHLORIDE",
      "StrengthNumber": "234",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-10-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20010112",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sodium Chloride Injection, USP is indicated for parenteral restoration of sodium ion in patients with restricted oral intake.  Sodium replacement is specifically indicated in patients with hyponatremia or low salt syndrome.  Sodium chloride injection may also be added to compatible carbohydrate solutions such as dextrose in water to provide electrolytes.",
      "Description": "Sodium Chloride Injection, USP is a sterile, nonpyrogenic, concentrated solution for intravenous administration ONLY AFTER DILUTION to replenish electrolytes.  The preparation contains 4 mEq/mL (23.4%) sodium chloride, in Water for Injection.  The solution contains no bacteriostat, antimicrobial agent or added buffer; pH of the solution ranges from 4.5 to 7.0.  Each mL contains: Sodium chloride 234 mg; Water for Injection q.s. pH may have been adjusted with hydrochloric acid.  The osmolar concentration of the 4 mEq/mL solution is 8 mOsmol/mL (calculated).  Sodium chloride is chemically designated NaCI, a white crystalline compound freely soluble in water. A pharmacy bulk package is a sterile dosage form containing many single doses.  The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for IV infusion."
    },
    {
      "NDCCode": "63402-088-10",
      "PackageDescription": "1 KIT in 1 CARTON (63402-088-10)  *  2 POUCH in 1 CARTON (63402-020-02)  / 1 FILM, SOLUBLE in 1 POUCH (63402-020-01)  *  2 POUCH in 1 CARTON (63402-025-02)  / 1 FILM, SOLUBLE in 1 POUCH (63402-025-01)  *  2 POUCH in 1 CARTON (63402-030-02)  / 1 FILM, SOLUBLE in 1 POUCH (63402-030-01)  *  2 POUCH in 1 CARTON (63402-015-02)  / 1 FILM, SOLUBLE in 1 POUCH (63402-015-01)  *  2 POUCH in 1 CARTON (63402-010-02)  / 1 FILM, SOLUBLE in 1 POUCH (63402-010-01) ",
      "NDC11Code": "63402-0088-10",
      "ProductNDC": "63402-088",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Kynmobi",
      "NonProprietaryName": "Apomorphine Hydrochloride",
      "DosageFormName": "KIT",
      "RouteName": "SUBLINGUAL",
      "StartMarketingDate": "20200521",
      "EndMarketingDate": "20230630",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA210875",
      "LabelerName": "Sunovion Pharmaceuticals Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2023-07-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20200521",
      "EndMarketingDatePackage": "20230630",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "68016-088-10",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (68016-088-10)  > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
      "NDC11Code": "68016-0088-10",
      "ProductNDC": "68016-088",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Loratadine Odt",
      "NonProprietaryName": "Loratadine",
      "DosageFormName": "TABLET, ORALLY DISINTEGRATING",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180411",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208477",
      "LabelerName": "Chain Drug Consortium, LLC",
      "SubstanceName": "LORATADINE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Status": "Active",
      "LastUpdate": "2022-11-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180411",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing , 3 itchy, watery eyes , 4 itching of the nose or throat."
    },
    {
      "NDCCode": "68025-088-10",
      "PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-088-10) ",
      "NDC11Code": "68025-0088-10",
      "ProductNDC": "68025-088",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Relexxii",
      "NonProprietaryName": "Methylphenidate Hydrochloride",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220623",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA216117",
      "LabelerName": "Vertical Pharmaceuticals, LLC",
      "SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
      "StrengthNumber": "45",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20220623",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "69804-088-10",
      "PackageDescription": "28500 mg in 1 JAR (69804-088-10) ",
      "NDC11Code": "69804-0088-10",
      "ProductNDC": "69804-088",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Numbify Sanitize",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200429",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part348",
      "LabelerName": "Ridge Properties",
      "SubstanceName": "LIDOCAINE HYDROCHLORIDE; BENZALKONIUM CHLORIDE",
      "StrengthNumber": "400; 13",
      "StrengthUnit": "mg/10000mg; mg/10000mg",
      "Status": "Deprecated",
      "LastUpdate": "2021-07-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200429",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "70655-088-10",
      "PackageDescription": "10 BAG in 1 CARTON (70655-088-10)  > 200 mL in 1 BAG",
      "NDC11Code": "70655-0088-10",
      "ProductNDC": "70655-088",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fluconazole In Sodium Chloride",
      "NonProprietaryName": "Fluconazole, Sodium Chloride",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20180912",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076766",
      "LabelerName": "Renaissance SSA, LLC",
      "SubstanceName": "FLUCONAZOLE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20180912",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fluconazole in Sodium Chloride Injection, USP is indicated for the treatment of: 1 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia., 2 Cryptococcal meningitis. Before prescribing Fluconazole in Sodium Chloride Injection, USP for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted.",
      "Description": "Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as a sterile solution for intravenous use in INTRAVIA plastic container. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight 306.3. The structural formula is. Fluconazole is a white crystalline solid which is slightly soluble in water and saline. Fluconazole in Sodium Chloride Injection, USP is an iso-osmotic, sterile, nonpyrogenic solution of fluconazole in a sodium chloride diluent. Each mL contains 2 mg of fluconazole and 9 mg of sodium chloride. The pH ranges from 4.0 to 6.5. Injection volumes of 100 mL and 200 mL are packaged in INTRAVIA plastic containers. The flexible container is manufactured from a specially designed multilayer plastic (PL 2408). Solutions in contact with the plastic container leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. The flexible container has a foil overwrap. Water can permeate the plastic into the overwrap, but the amount is insufficient to significantly affect the premixed solution. Fluconazole in Sodium Chloride Injection, USP meets USP Organic Impurities Procedure 3."
    },
    {
      "NDCCode": "71052-088-10",
      "PackageDescription": "1000 g in 1 CONTAINER (71052-088-10) ",
      "NDC11Code": "71052-0088-10",
      "ProductNDC": "71052-088",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Trimeprazine Tartrate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20210219",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "DARMERICA, LLC",
      "SubstanceName": "TRIMEPRAZINE TARTRATE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Unfinished",
      "LastUpdate": "2026-03-07",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19-FEB-21"
    },
    {
      "NDCCode": "71205-088-10",
      "PackageDescription": "10 TABLET, FILM COATED in 1 BOTTLE (71205-088-10) ",
      "NDC11Code": "71205-0088-10",
      "ProductNDC": "71205-088",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sildenafil",
      "NonProprietaryName": "Sildenafil",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20171211",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077342",
      "LabelerName": "Proficient Rx LP",
      "SubstanceName": "SILDENAFIL CITRATE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2021-05-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180801",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sildenafil tablets are indicated for the treatment of erectile dysfunction.",
      "Description": "Sildenafil tablets USP, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). 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. C22H30N6O4SC6H8O7 M.W. 666.7. Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water. Sildenafil citrate, USP is formulated as white to off-white, film-coated, modified oval-shaped, convex tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, USP, each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol – part. hydrolyzed, talc, and titanium dioxide."
    },
    {
      "NDCCode": "71919-088-10",
      "PackageDescription": "100 mL in 1 BOTTLE, GLASS (71919-088-10) ",
      "NDC11Code": "71919-0088-10",
      "ProductNDC": "71919-088",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Artemisia Vulgaris",
      "NonProprietaryName": "Artemisia Vulgaris Root",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110406",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Washington Homeopathic Products",
      "SubstanceName": "ARTEMISIA VULGARIS ROOT",
      "StrengthNumber": "30",
      "StrengthUnit": "[hp_C]/mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-03-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20110406",
      "SamplePackage": "N"
    }
  ]
}
                    

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<NDCList>
  <NDC>
    <NDCCode>30142-088-10</NDCCode>
    <PackageDescription>30 mL in 1 BOTTLE, PLASTIC (30142-088-10) </PackageDescription>
    <NDC11Code>30142-0088-10</NDC11Code>
    <ProductNDC>30142-088</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Iodine Tincture</ProprietaryName>
    <NonProprietaryName>Iodine Tincture</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20010621</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M003</ApplicationNumber>
    <LabelerName>The Kroger Co.</LabelerName>
    <SubstanceName>IODINE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-03-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20010621</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>First aid to help prevent skin infection in: 1 minor cuts, 2 scrapes, 3 burns.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>11344-088-10</NDCCode>
    <PackageDescription>30 mL in 1 BOTTLE, PLASTIC (11344-088-10) </PackageDescription>
    <NDC11Code>11344-0088-10</NDC11Code>
    <ProductNDC>11344-088</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Iodine</ProprietaryName>
    <NonProprietaryName>Iodine</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20081108</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Vi-Jon, LLC</LabelerName>
    <SubstanceName>ALCOHOL; IODINE; SODIUM IODIDE</SubstanceName>
    <StrengthNumber>470; 20; 20.4</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-11-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20081108</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
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  <NDC>
    <NDCCode>33261-088-10</NDCCode>
    <PackageDescription>10 TABLET, EXTENDED RELEASE in 1 BOTTLE (33261-088-10)</PackageDescription>
    <NDC11Code>33261-0088-10</NDC11Code>
    <ProductNDC>33261-088</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Orphenadrine Citrate</ProprietaryName>
    <NonProprietaryName>Orphenadrine Citrate</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19980619</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040284</ApplicationNumber>
    <LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
    <SubstanceName>ORPHENADRINE CITRATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Orphenadrine citrate extended-release tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions.</IndicationAndUsage>
    <Description>Orphenadrine citrate is the citrate salt of orphenadrine. It occurs as a white, crystalline powder having a bitter taste. It is practically odorless; sparingly soluble in water, slightly soluble in alcohol. The chemical name of orphenadrine citrate is (±)-N,N-Dimethyl-2-[(o-methyl-α-phenylbenzyl)oxy]ethylamine citrate (1:1) having molecular formula C18H23NOC6H8O7 and molecular weight of 461.51. It has the following structural formula. Each tablet for oral administration contains 100 mg orphenadrine citrate. Each Orphenadrine citrate extended-release tablet contains the following inactive ingredients: hydroxypropyl methylcellulose, lactose monohydrate and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>33342-088-12</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (33342-088-12)  &gt; 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>33342-0088-12</NDC11Code>
    <ProductNDC>33342-088</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rizatriptan</ProprietaryName>
    <NonProprietaryName>Rizatriptan</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140311</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203147</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>RIZATRIPTAN BENZOATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-07-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140311</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use  Rizatriptan benzoate tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks.  Rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)].  Rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks.  Safety and effectiveness of rizatriptan benzoate tablets have not been established for cluster headache.</IndicationAndUsage>
    <Description>Rizatriptan benzoate tablets, USP contain rizatriptan benzoate, USP a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate, USP is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is. Its molecular formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate, USP is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. Rizatriptan benzoate tablets, USP are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients:. lactose monohydrate, microcrystalline cellulose, pregelatinized maize starch, ferric oxide (red), and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>40032-088-31</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (40032-088-31)  &gt; 10 TABLET, FILM COATED in 1 BLISTER PACK (40032-088-30) </PackageDescription>
    <NDC11Code>40032-0088-31</NDC11Code>
    <ProductNDC>40032-088</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Voriconazole</ProprietaryName>
    <NonProprietaryName>Voriconazole</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160524</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207371</ApplicationNumber>
    <LabelerName>Novel Laboratories, Inc.</LabelerName>
    <SubstanceName>VORICONAZOLE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160524</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Voriconazole is an azole antifungal drug indicated for use in the treatment of: : 1 Invasive aspergillosis (1.1), 2 Candidemia (non-neutropenics) and disseminated candidiasis in skin, abdomen, kidney, bladder wall and wounds (1.2), 3 Esophageal candidiasis (1.3), 4 Serious infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani , in patients intolerant of, or refractory to, other therapy (1.4).</IndicationAndUsage>
    <Description>Voriconazole, an azole antifungal agent, is available as film-coated tablets for oral administration. The structural formula is. Voriconazole is designated chemically as (αR, βS)-α-(2,4-Difluorophenyl)-5-fluoro-β-methyl-α-(1H-1,2,4-triazol-1-ylmethyl)-4-pyrimidineethanol with a molecular formula of C16H14F3N5O and a molecular weight of 349.3. Voriconazole, USP drug substance is a white to off-white crystalline powder. Voriconazole Tablets contain 50 mg or 200 mg of voriconazole. The inactive ingredients include lactose monohydrate, pregelatinized starch (maize starch), croscarmellose sodium, povidone, magnesium stearate and a coating containing hypromellose (HPMC 2910), titanium dioxide, lactose monohydrate and triacetin.</Description>
  </NDC>
  <NDC>
    <NDCCode>41163-088-10</NDCCode>
    <PackageDescription>30 mL in 1 BOTTLE, PLASTIC (41163-088-10) </PackageDescription>
    <NDC11Code>41163-0088-10</NDC11Code>
    <ProductNDC>41163-088</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Iodine</ProprietaryName>
    <NonProprietaryName>Iodine</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20050204</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M003</ApplicationNumber>
    <LabelerName>United Natural Foods, Inc. dba UNFI</LabelerName>
    <SubstanceName>IODINE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-02-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20050204</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>First aid to help prevent skin infection in: 1 minor cuts, 2 scrapes, 3 burns.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>43386-088-31</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (43386-088-31)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (43386-088-30) </PackageDescription>
    <NDC11Code>43386-0088-31</NDC11Code>
    <ProductNDC>43386-088</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Voriconazole</ProprietaryName>
    <NonProprietaryName>Voriconazole</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160524</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207371</ApplicationNumber>
    <LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
    <SubstanceName>VORICONAZOLE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-02-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160524</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Voriconazole is an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with: 1 Invasive aspergillosis (1.1), 2 Candidemia in non-neutropenics and other deep tissue Candida infections (1.2), 3 Esophageal candidiasis (1.3), 4 Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani, in patients intolerant of, or refractory to, other therapy (1.4).</IndicationAndUsage>
    <Description>Voriconazole, an azole antifungal agent is available as film-coated tablets for oral administration. The structural formula is. Voriconazole is designated chemically as (2R,3S)-2-(2, 4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4 triazol-1-yl)-2-butanol with an empirical formula of C16H14F3N5O and a molecular weight of 349.3. Voriconazole drug substance is a white to almost white powder. Voriconazole Tablets contain 50 mg or 200 mg of voriconazole. The inactive ingredients include lactose monohydrate, pregelatinized starch (maize starch), croscarmellose sodium, povidone, magnesium stearate and a coating containing hypromellose (HPMC 2910), titanium dioxide, lactose monohydrate and triacetin.</Description>
  </NDC>
  <NDC>
    <NDCCode>43744-088-10</NDCCode>
    <PackageDescription>1 g in 1 DRUM (43744-088-10)</PackageDescription>
    <NDC11Code>43744-0088-10</NDC11Code>
    <ProductNDC>43744-088</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Betahistine Hydrochloride</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20120323</StartMarketingDate>
    <EndMarketingDate>20130624</EndMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>CBSCHEM LIMITED</LabelerName>
    <SubstanceName>BETAHISTINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20130624</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>43744-088-15</NDCCode>
    <PackageDescription>10 g in 1 DRUM (43744-088-15)</PackageDescription>
    <NDC11Code>43744-0088-15</NDC11Code>
    <ProductNDC>43744-088</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Betahistine Hydrochloride</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20120323</StartMarketingDate>
    <EndMarketingDate>20130624</EndMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>CBSCHEM LIMITED</LabelerName>
    <SubstanceName>BETAHISTINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20130624</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>46708-088-10</NDCCode>
    <PackageDescription>100 TABLET in 1 CARTON (46708-088-10)</PackageDescription>
    <NDC11Code>46708-0088-10</NDC11Code>
    <ProductNDC>46708-088</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Telmisartan</ProprietaryName>
    <NonProprietaryName>Telmisartan</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130306</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202130</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
    <SubstanceName>TELMISARTAN</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2015-05-15</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>50804-088-10</NDCCode>
    <PackageDescription>30 mL in 1 BOTTLE, PLASTIC (50804-088-10) </PackageDescription>
    <NDC11Code>50804-0088-10</NDC11Code>
    <ProductNDC>50804-088</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Iodine</ProprietaryName>
    <NonProprietaryName>Iodine</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20081108</StartMarketingDate>
    <EndMarketingDate>20260501</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M003</ApplicationNumber>
    <LabelerName>Perrigo Direct, Inc</LabelerName>
    <SubstanceName>ALCOHOL; IODINE; SODIUM IODIDE</SubstanceName>
    <StrengthNumber>470; 20; 20.4</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-05-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20081108</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260501</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>First aid to help prevent skin infection in: 1 minor cuts, 2 scrapes, 3 burns.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>51079-088-56</NDCCode>
    <PackageDescription>10 DOSE PACK in 1 CARTON (51079-088-56)  &gt; 30 BLISTER PACK in 1 DOSE PACK (51079-088-30)  &gt; 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-088-01)</PackageDescription>
    <NDC11Code>51079-0088-56</NDC11Code>
    <ProductNDC>51079-088</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Mirtazapine</ProprietaryName>
    <NonProprietaryName>Mirtazapine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20030801</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076122</ApplicationNumber>
    <LabelerName>Mylan Institutional Inc.</LabelerName>
    <SubstanceName>MIRTAZAPINE</SubstanceName>
    <StrengthNumber>45</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-12-02</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>52536-108-10</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (52536-108-10)  *  15 g in 1 BOTTLE (52536-098-10)  *  289 mL in 1 BOTTLE (52536-088-10) </PackageDescription>
    <NDC11Code>52536-0108-10</NDC11Code>
    <ProductNDC>52536-108</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Vancomycin Hydrochloride For Oral Solution</ProprietaryName>
    <NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20230331</StartMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA208910</ApplicationNumber>
    <LabelerName>Wilshire Pharmaceuticals, Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-07-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230331</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Vancomycin hydrochloride is indicated for the treatment of Clostridium difficile‑associated diarrhea in adults and pediatric patients less than 18 years of age. Vancomycin hydrochloride is also indicated for the treatment of enterocolitis caused by Staphylococcus aureus(including methicillin‑resistant strains) in adults and pediatric patients less than 18 years of age. Important Limitations of Use: 1 Parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin must be given orally for these infections., 2 Orally administered vancomycin hydrochloride is not effective for treatment of other types of infections.</IndicationAndUsage>
    <Description>Vancomycin hydrochloride for oral administration contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis(formerly Nocardia orientalis), which has the chemical formula C 66H 75Cl 2N 9O 24HCl. The molecular weight of vancomycin hydrochloride is 1485.71 g/mol. Vancomycin hydrochloride has the structural formula. Each vancomycin hydrochloride for oral solution kit contains a bottle of vancomycin hydrochloride USP, as white to almost white or tan to brown powder for oral solution, and a bottle of pre‑measured Grape‑Flavored Diluent, in the strengths and volumes listed in Table 3. The Grape‑Flavored Diluent used to reconstitute the oral solution contains: artificial grape flavor, citric acid (anhydrous), D&amp;C Yellow No. 10, FD&amp;C Red No. 40, purified water, sodium benzoate and sucralose.</Description>
  </NDC>
  <NDC>
    <NDCCode>54575-088-10</NDCCode>
    <PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (54575-088-10)</PackageDescription>
    <NDC11Code>54575-0088-10</NDC11Code>
    <ProductNDC>54575-088</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hungarian Smooth Brome Pollen</ProprietaryName>
    <NonProprietaryName>Bromus Inermis Pollen</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19671207</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101376</ApplicationNumber>
    <LabelerName>Allergy Laboratories, Inc.</LabelerName>
    <SubstanceName>BROMUS INERMIS POLLEN</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/20mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
    <Description>Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established:             Coffee             Cottonseed       Flaxseed             Housefly             Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens.</Description>
  </NDC>
  <NDC>
    <NDCCode>55513-160-01</NDCCode>
    <PackageDescription>1 KIT in 1 PACKAGE (55513-160-01)  *  3.088 mL in 1 VIAL (55513-150-01)  *  10.6 mL in 1 VIAL (55513-155-01) </PackageDescription>
    <NDC11Code>55513-0160-01</NDC11Code>
    <ProductNDC>55513-160</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Blincyto</ProprietaryName>
    <NonProprietaryName>Blinatumomab</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20141218</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125557</ApplicationNumber>
    <LabelerName>Amgen, Inc</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-04-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20141218</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>BLINCYTO is a bispecific CD19-directed CD3 T-cell engager indicated for the treatment of adult and pediatric patients one month and older with: 1 CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. (1.1), 2 Relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL). (1.2), 3 CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (ALL) in the consolidation phase of multiphase chemotherapy. (1.3).</IndicationAndUsage>
    <Description>Blinatumomab is a bispecific CD19-directed CD3 T-cell engager. Blinatumomab is produced in Chinese hamster ovary cells. It consists of 504 amino acids and has a molecular weight of approximately 54 kilodaltons. Each BLINCYTO package contains one vial BLINCYTO and one vial IV Solution Stabilizer. BLINCYTO (blinatumomab) for injection is supplied in a single-dose vial as a sterile, preservative-free, white to off-white lyophilized powder for intravenous use. Each single-dose vial of BLINCYTO contains 35 mcg blinatumomab, citric acid monohydrate (3.35 mg), lysine hydrochloride (23.23 mg), polysorbate 80 (0.64 mg), trehalose dihydrate (95.5 mg), and sodium hydroxide to adjust pH to 7.0. After reconstitution with 3 mL of preservative-free Sterile Water for Injection, USP, the resulting concentration is 12.5 mcg/mL blinatumomab. IV Solution Stabilizer is supplied in a single-dose vial as a sterile, preservative-free, colorless to slightly yellow, clear solution. Each single-dose vial of IV Solution Stabilizer contains citric acid monohydrate (52.5 mg), lysine hydrochloride (2283.8 mg), polysorbate 80 (10 mg), sodium hydroxide to adjust pH to 7.0, and water for injection.</Description>
  </NDC>
  <NDC>
    <NDCCode>55513-160-21</NDCCode>
    <PackageDescription>1 KIT in 1 PACKAGE (55513-160-21)  *  3.088 mL in 1 VIAL (55513-150-01)  *  10.6 mL in 1 VIAL (55513-155-01) </PackageDescription>
    <NDC11Code>55513-0160-21</NDC11Code>
    <ProductNDC>55513-160</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Blincyto</ProprietaryName>
    <NonProprietaryName>Blinatumomab</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20141218</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125557</ApplicationNumber>
    <LabelerName>Amgen, Inc</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-04-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260430</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>BLINCYTO is a bispecific CD19-directed CD3 T-cell engager indicated for the treatment of adult and pediatric patients one month and older with: 1 CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. (1.1), 2 Relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL). (1.2), 3 CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (ALL) in the consolidation phase of multiphase chemotherapy. (1.3).</IndicationAndUsage>
    <Description>Blinatumomab is a bispecific CD19-directed CD3 T-cell engager. Blinatumomab is produced in Chinese hamster ovary cells. It consists of 504 amino acids and has a molecular weight of approximately 54 kilodaltons. Each BLINCYTO package contains one vial BLINCYTO and one vial IV Solution Stabilizer. BLINCYTO (blinatumomab) for injection is supplied in a single-dose vial as a sterile, preservative-free, white to off-white lyophilized powder for intravenous use. Each single-dose vial of BLINCYTO contains 35 mcg blinatumomab, citric acid monohydrate (3.35 mg), lysine hydrochloride (23.23 mg), polysorbate 80 (0.64 mg), trehalose dihydrate (95.5 mg), and sodium hydroxide to adjust pH to 7.0. After reconstitution with 3 mL of preservative-free Sterile Water for Injection, USP, the resulting concentration is 12.5 mcg/mL blinatumomab. IV Solution Stabilizer is supplied in a single-dose vial as a sterile, preservative-free, colorless to slightly yellow, clear solution. Each single-dose vial of IV Solution Stabilizer contains citric acid monohydrate (52.5 mg), lysine hydrochloride (2283.8 mg), polysorbate 80 (10 mg), sodium hydroxide to adjust pH to 7.0, and water for injection.</Description>
  </NDC>
  <NDC>
    <NDCCode>58159-088-04</NDCCode>
    <PackageDescription>10 kg in 1 DRUM (58159-088-04) </PackageDescription>
    <NDC11Code>58159-0088-04</NDC11Code>
    <ProductNDC>58159-088</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Oxcarbazepine</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20211019</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>NURAY CHEMICALS PRIVATE LIMITED</LabelerName>
    <SubstanceName>OXCARBAZEPINE</SubstanceName>
    <StrengthNumber>35</StrengthNumber>
    <StrengthUnit>kg/35kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2021-10-28</LastUpdate>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19-OCT-21</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>61715-088-11</NDCCode>
    <PackageDescription>11 BLISTER PACK in 1 CARTON (61715-088-11)  &gt; 10 GUM, CHEWING in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>61715-0088-11</NDC11Code>
    <ProductNDC>61715-088</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Preferred Plus Nicotine Polacrilex Gum, Original Flavor</ProprietaryName>
    <NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
    <DosageFormName>GUM, CHEWING</DosageFormName>
    <RouteName>BUCCAL</RouteName>
    <StartMarketingDate>19990315</StartMarketingDate>
    <EndMarketingDate>20180131</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074507</ApplicationNumber>
    <LabelerName>Preferred Plus (Kinray)</LabelerName>
    <SubstanceName>NICOTINE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19990315</StartMarketingDatePackage>
    <EndMarketingDatePackage>20180131</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>62332-088-10</NDCCode>
    <PackageDescription>100 TABLET in 1 CARTON (62332-088-10) </PackageDescription>
    <NDC11Code>62332-0088-10</NDC11Code>
    <ProductNDC>62332-088</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Telmisartan</ProprietaryName>
    <NonProprietaryName>Telmisartan</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160625</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202130</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>TELMISARTAN</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-06-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160625</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Telmisartanis an angiotensin II receptor blocker (ARB) indicated for.  Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1)  Cardiovascular (CV) risk reduction in patients unable to take ACE inhibitors (1.2).</IndicationAndUsage>
    <Description>Telmisartanis a non-peptide angiotensin II receptor (type AT1) antagonist. Telmisartan is chemically described as 4’-[(1,4’-dimethyl-2’-propyl [2,6’-bi-1H-benzimidazol]-1’-yl)methyl]-[1,1’-biphenyl]-2-carboxylic acid. Its empirical formula is C33H30N4O2, its molecular weight is 514.63, and its structural formula is:.   Telmisartan is a white to slightly yellowish solid. It is practically insoluble in water and in the pH range of 3 to 9, sparingly soluble in strong acid (except insoluble in hydrochloric acid), and soluble in strong base.Telmisartan tablets, USP  are available as tablets for oral administration, containing 20 mg, 40 mg or 80 mg of telmisartan. The tablets contain the following inactive ingredients: mannitol, sodium hydroxide, meglumine, povidone, sodium stearyl fumarate and magnesium stearate. Telmisartan tablets are hygroscopic and require protection from moisture. The USP Dissolution Test is pending.</Description>
  </NDC>
  <NDC>
    <NDCCode>62750-088-10</NDCCode>
    <PackageDescription>25 BAR, CHEWABLE in 1 BOTTLE (62750-088-10) </PackageDescription>
    <NDC11Code>62750-0088-10</NDC11Code>
    <ProductNDC>62750-088</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Zicam Cold Remedy Medicated Fruit Drops</ProprietaryName>
    <NonProprietaryName>Zinc Acetate Anhydrous And Zinc Gluconate</NonProprietaryName>
    <DosageFormName>BAR, CHEWABLE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200710</StartMarketingDate>
    <EndMarketingDate>20220831</EndMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Matrixx Initiatives, Inc.</LabelerName>
    <SubstanceName>ZINC ACETATE ANHYDROUS; ZINC GLUCONATE</SubstanceName>
    <StrengthNumber>2; 2</StrengthNumber>
    <StrengthUnit>[hp_X]/1; [hp_X]/1</StrengthUnit>
    <Pharm_Classes>Copper Absorption Inhibitor [EPC], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-09-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20200710</StartMarketingDatePackage>
    <EndMarketingDatePackage>20220831</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>63323-088-61</NDCCode>
    <PackageDescription>10 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (63323-088-61)  / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE</PackageDescription>
    <NDC11Code>63323-0088-61</NDC11Code>
    <ProductNDC>63323-088</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Chloride</ProprietaryName>
    <NonProprietaryName>Sodium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20010112</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>SODIUM CHLORIDE</SubstanceName>
    <StrengthNumber>234</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-10-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20010112</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sodium Chloride Injection, USP is indicated for parenteral restoration of sodium ion in patients with restricted oral intake.  Sodium replacement is specifically indicated in patients with hyponatremia or low salt syndrome.  Sodium chloride injection may also be added to compatible carbohydrate solutions such as dextrose in water to provide electrolytes.</IndicationAndUsage>
    <Description>Sodium Chloride Injection, USP is a sterile, nonpyrogenic, concentrated solution for intravenous administration ONLY AFTER DILUTION to replenish electrolytes.  The preparation contains 4 mEq/mL (23.4%) sodium chloride, in Water for Injection.  The solution contains no bacteriostat, antimicrobial agent or added buffer; pH of the solution ranges from 4.5 to 7.0.  Each mL contains: Sodium chloride 234 mg; Water for Injection q.s. pH may have been adjusted with hydrochloric acid.  The osmolar concentration of the 4 mEq/mL solution is 8 mOsmol/mL (calculated).  Sodium chloride is chemically designated NaCI, a white crystalline compound freely soluble in water. A pharmacy bulk package is a sterile dosage form containing many single doses.  The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for IV infusion.</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-088-63</NDCCode>
    <PackageDescription>10 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (63323-088-63)  / 200 mL in 1 VIAL, PHARMACY BULK PACKAGE</PackageDescription>
    <NDC11Code>63323-0088-63</NDC11Code>
    <ProductNDC>63323-088</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Chloride</ProprietaryName>
    <NonProprietaryName>Sodium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20010112</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>SODIUM CHLORIDE</SubstanceName>
    <StrengthNumber>234</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-10-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20010112</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sodium Chloride Injection, USP is indicated for parenteral restoration of sodium ion in patients with restricted oral intake.  Sodium replacement is specifically indicated in patients with hyponatremia or low salt syndrome.  Sodium chloride injection may also be added to compatible carbohydrate solutions such as dextrose in water to provide electrolytes.</IndicationAndUsage>
    <Description>Sodium Chloride Injection, USP is a sterile, nonpyrogenic, concentrated solution for intravenous administration ONLY AFTER DILUTION to replenish electrolytes.  The preparation contains 4 mEq/mL (23.4%) sodium chloride, in Water for Injection.  The solution contains no bacteriostat, antimicrobial agent or added buffer; pH of the solution ranges from 4.5 to 7.0.  Each mL contains: Sodium chloride 234 mg; Water for Injection q.s. pH may have been adjusted with hydrochloric acid.  The osmolar concentration of the 4 mEq/mL solution is 8 mOsmol/mL (calculated).  Sodium chloride is chemically designated NaCI, a white crystalline compound freely soluble in water. A pharmacy bulk package is a sterile dosage form containing many single doses.  The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for IV infusion.</Description>
  </NDC>
  <NDC>
    <NDCCode>63402-088-10</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (63402-088-10)  *  2 POUCH in 1 CARTON (63402-020-02)  / 1 FILM, SOLUBLE in 1 POUCH (63402-020-01)  *  2 POUCH in 1 CARTON (63402-025-02)  / 1 FILM, SOLUBLE in 1 POUCH (63402-025-01)  *  2 POUCH in 1 CARTON (63402-030-02)  / 1 FILM, SOLUBLE in 1 POUCH (63402-030-01)  *  2 POUCH in 1 CARTON (63402-015-02)  / 1 FILM, SOLUBLE in 1 POUCH (63402-015-01)  *  2 POUCH in 1 CARTON (63402-010-02)  / 1 FILM, SOLUBLE in 1 POUCH (63402-010-01) </PackageDescription>
    <NDC11Code>63402-0088-10</NDC11Code>
    <ProductNDC>63402-088</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Kynmobi</ProprietaryName>
    <NonProprietaryName>Apomorphine Hydrochloride</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <RouteName>SUBLINGUAL</RouteName>
    <StartMarketingDate>20200521</StartMarketingDate>
    <EndMarketingDate>20230630</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA210875</ApplicationNumber>
    <LabelerName>Sunovion Pharmaceuticals Inc.</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2023-07-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20200521</StartMarketingDatePackage>
    <EndMarketingDatePackage>20230630</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>68016-088-10</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (68016-088-10)  &gt; 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>68016-0088-10</NDC11Code>
    <ProductNDC>68016-088</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Loratadine Odt</ProprietaryName>
    <NonProprietaryName>Loratadine</NonProprietaryName>
    <DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180411</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208477</ApplicationNumber>
    <LabelerName>Chain Drug Consortium, LLC</LabelerName>
    <SubstanceName>LORATADINE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2022-11-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180411</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing , 3 itchy, watery eyes , 4 itching of the nose or throat.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>68025-088-10</NDCCode>
    <PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-088-10) </PackageDescription>
    <NDC11Code>68025-0088-10</NDC11Code>
    <ProductNDC>68025-088</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Relexxii</ProprietaryName>
    <NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220623</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA216117</ApplicationNumber>
    <LabelerName>Vertical Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>45</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220623</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>69804-088-10</NDCCode>
    <PackageDescription>28500 mg in 1 JAR (69804-088-10) </PackageDescription>
    <NDC11Code>69804-0088-10</NDC11Code>
    <ProductNDC>69804-088</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Numbify Sanitize</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200429</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part348</ApplicationNumber>
    <LabelerName>Ridge Properties</LabelerName>
    <SubstanceName>LIDOCAINE HYDROCHLORIDE; BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>400; 13</StrengthNumber>
    <StrengthUnit>mg/10000mg; mg/10000mg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-07-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200429</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>70655-088-10</NDCCode>
    <PackageDescription>10 BAG in 1 CARTON (70655-088-10)  &gt; 200 mL in 1 BAG</PackageDescription>
    <NDC11Code>70655-0088-10</NDC11Code>
    <ProductNDC>70655-088</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluconazole In Sodium Chloride</ProprietaryName>
    <NonProprietaryName>Fluconazole, Sodium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20180912</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076766</ApplicationNumber>
    <LabelerName>Renaissance SSA, LLC</LabelerName>
    <SubstanceName>FLUCONAZOLE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180912</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluconazole in Sodium Chloride Injection, USP is indicated for the treatment of: 1 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia., 2 Cryptococcal meningitis. Before prescribing Fluconazole in Sodium Chloride Injection, USP for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted.</IndicationAndUsage>
    <Description>Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as a sterile solution for intravenous use in INTRAVIA plastic container. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight 306.3. The structural formula is. Fluconazole is a white crystalline solid which is slightly soluble in water and saline. Fluconazole in Sodium Chloride Injection, USP is an iso-osmotic, sterile, nonpyrogenic solution of fluconazole in a sodium chloride diluent. Each mL contains 2 mg of fluconazole and 9 mg of sodium chloride. The pH ranges from 4.0 to 6.5. Injection volumes of 100 mL and 200 mL are packaged in INTRAVIA plastic containers. The flexible container is manufactured from a specially designed multilayer plastic (PL 2408). Solutions in contact with the plastic container leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. The flexible container has a foil overwrap. Water can permeate the plastic into the overwrap, but the amount is insufficient to significantly affect the premixed solution. Fluconazole in Sodium Chloride Injection, USP meets USP Organic Impurities Procedure 3.</Description>
  </NDC>
  <NDC>
    <NDCCode>71052-088-10</NDCCode>
    <PackageDescription>1000 g in 1 CONTAINER (71052-088-10) </PackageDescription>
    <NDC11Code>71052-0088-10</NDC11Code>
    <ProductNDC>71052-088</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Trimeprazine Tartrate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20210219</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>DARMERICA, LLC</LabelerName>
    <SubstanceName>TRIMEPRAZINE TARTRATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-03-07</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19-FEB-21</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>71205-088-10</NDCCode>
    <PackageDescription>10 TABLET, FILM COATED in 1 BOTTLE (71205-088-10) </PackageDescription>
    <NDC11Code>71205-0088-10</NDC11Code>
    <ProductNDC>71205-088</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sildenafil</ProprietaryName>
    <NonProprietaryName>Sildenafil</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171211</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077342</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>SILDENAFIL CITRATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2021-05-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180801</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sildenafil tablets are indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
    <Description>Sildenafil tablets USP, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). 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. C22H30N6O4SC6H8O7 M.W. 666.7. Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water. Sildenafil citrate, USP is formulated as white to off-white, film-coated, modified oval-shaped, convex tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, USP, each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol – part. hydrolyzed, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>71919-088-10</NDCCode>
    <PackageDescription>100 mL in 1 BOTTLE, GLASS (71919-088-10) </PackageDescription>
    <NDC11Code>71919-0088-10</NDC11Code>
    <ProductNDC>71919-088</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Artemisia Vulgaris</ProprietaryName>
    <NonProprietaryName>Artemisia Vulgaris Root</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110406</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Washington Homeopathic Products</LabelerName>
    <SubstanceName>ARTEMISIA VULGARIS ROOT</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>[hp_C]/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-03-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110406</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>30142-088-10</NDCCode><ProprietaryName>Iodine Tincture</ProprietaryName><NonProprietaryName>Iodine Tincture</NonProprietaryName></NDC><NDC><NDCCode>11344-088-10</NDCCode><ProprietaryName>Iodine</ProprietaryName><NonProprietaryName>Iodine</NonProprietaryName></NDC><NDC><NDCCode>33261-088-10</NDCCode><ProprietaryName>Orphenadrine Citrate</ProprietaryName><NonProprietaryName>Orphenadrine Citrate</NonProprietaryName></NDC><NDC><NDCCode>33342-088-12</NDCCode><ProprietaryName>Rizatriptan</ProprietaryName><NonProprietaryName>Rizatriptan</NonProprietaryName></NDC><NDC><NDCCode>40032-088-31</NDCCode><ProprietaryName>Voriconazole</ProprietaryName><NonProprietaryName>Voriconazole</NonProprietaryName></NDC><NDC><NDCCode>41163-088-10</NDCCode><ProprietaryName>Iodine</ProprietaryName><NonProprietaryName>Iodine</NonProprietaryName></NDC><NDC><NDCCode>43386-088-31</NDCCode><ProprietaryName>Voriconazole</ProprietaryName><NonProprietaryName>Voriconazole</NonProprietaryName></NDC><NDC><NDCCode>43744-088-10</NDCCode><NonProprietaryName>Betahistine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>43744-088-15</NDCCode><NonProprietaryName>Betahistine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>46708-088-10</NDCCode><ProprietaryName>Telmisartan</ProprietaryName><NonProprietaryName>Telmisartan</NonProprietaryName></NDC><NDC><NDCCode>50804-088-10</NDCCode><ProprietaryName>Iodine</ProprietaryName><NonProprietaryName>Iodine</NonProprietaryName></NDC><NDC><NDCCode>51079-088-56</NDCCode><ProprietaryName>Mirtazapine</ProprietaryName><NonProprietaryName>Mirtazapine</NonProprietaryName></NDC><NDC><NDCCode>52536-108-10</NDCCode><ProprietaryName>Vancomycin Hydrochloride For Oral Solution</ProprietaryName><NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>54575-088-10</NDCCode><ProprietaryName>Hungarian Smooth Brome Pollen</ProprietaryName><NonProprietaryName>Bromus Inermis Pollen</NonProprietaryName></NDC><NDC><NDCCode>55513-160-01</NDCCode><ProprietaryName>Blincyto</ProprietaryName><NonProprietaryName>Blinatumomab</NonProprietaryName></NDC><NDC><NDCCode>55513-160-21</NDCCode><ProprietaryName>Blincyto</ProprietaryName><NonProprietaryName>Blinatumomab</NonProprietaryName></NDC><NDC><NDCCode>58159-088-04</NDCCode><NonProprietaryName>Oxcarbazepine</NonProprietaryName></NDC><NDC><NDCCode>61715-088-11</NDCCode><ProprietaryName>Preferred Plus Nicotine Polacrilex Gum, Original Flavor</ProprietaryName><NonProprietaryName>Nicotine Polacrilex</NonProprietaryName></NDC><NDC><NDCCode>62332-088-10</NDCCode><ProprietaryName>Telmisartan</ProprietaryName><NonProprietaryName>Telmisartan</NonProprietaryName></NDC><NDC><NDCCode>62750-088-10</NDCCode><ProprietaryName>Zicam Cold Remedy Medicated Fruit Drops</ProprietaryName><NonProprietaryName>Zinc Acetate Anhydrous And Zinc Gluconate</NonProprietaryName></NDC><NDC><NDCCode>63323-088-61</NDCCode><ProprietaryName>Sodium Chloride</ProprietaryName><NonProprietaryName>Sodium Chloride</NonProprietaryName></NDC><NDC><NDCCode>63323-088-63</NDCCode><ProprietaryName>Sodium Chloride</ProprietaryName><NonProprietaryName>Sodium Chloride</NonProprietaryName></NDC><NDC><NDCCode>63402-088-10</NDCCode><ProprietaryName>Kynmobi</ProprietaryName><NonProprietaryName>Apomorphine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>68016-088-10</NDCCode><ProprietaryName>Loratadine Odt</ProprietaryName><NonProprietaryName>Loratadine</NonProprietaryName></NDC><NDC><NDCCode>68025-088-10</NDCCode><ProprietaryName>Relexxii</ProprietaryName><NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>69804-088-10</NDCCode><ProprietaryName>Numbify Sanitize</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>70655-088-10</NDCCode><ProprietaryName>Fluconazole In Sodium Chloride</ProprietaryName><NonProprietaryName>Fluconazole, Sodium Chloride</NonProprietaryName></NDC><NDC><NDCCode>71052-088-10</NDCCode><NonProprietaryName>Trimeprazine Tartrate</NonProprietaryName></NDC><NDC><NDCCode>71205-088-10</NDCCode><ProprietaryName>Sildenafil</ProprietaryName><NonProprietaryName>Sildenafil</NonProprietaryName></NDC><NDC><NDCCode>71919-088-10</NDCCode><ProprietaryName>Artemisia Vulgaris</ProprietaryName><NonProprietaryName>Artemisia Vulgaris Root</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",
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      "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",
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      "Gender": "Female",
      "TaxonomyCode1": "175T00000X",
      "Taxonomy1": "Peer Specialist",
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      "PrimaryTaxonomy": "Peer Specialist"
    },
    {
      "NPI": "1538965306",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
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      "MiddleName": "JEWELL",
      "FirstLineMailingAddress": "2821 SW 28TH ST",
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      "MailingAddressStateName": "OR",
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      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "760-927-4761",
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      "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",
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      "CertificationDate": "02/21/2025",
      "PrimaryTaxonomyCode": "175T00000X",
      "PrimaryTaxonomy": "Peer Specialist"
    }
  ]
}
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