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How to Find 49281-326-50 NDC Data Using DataLabs API

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{
  "NDC": [
    {
      "NDCCode": "49281-326-50",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-326-50)  / .5 mL in 1 SYRINGE, GLASS (49281-326-88) ",
      "NDC11Code": "49281-0326-50",
      "ProductNDC": "49281-326",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone Qiv Sh 2025",
      "NonProprietaryName": "Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/croatia/10136rv/2023 X-425a (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20250306",
      "EndMarketingDate": "20251231",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "15; 15; 15; 15",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20250306",
      "EndMarketingDatePackage": "20251231",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fluzone® Quadrivalent Southern Hemisphere is a vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. Fluzone Quadrivalent Southern Hemisphere is approved for use in persons 6 months of age and older.",
      "Description": "Fluzone Quadrivalent Southern Hemisphere (Influenza Vaccine) for intramuscular use is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a \"split virus\". The split virus containing hemagglutinin (HA) antigen is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The Fluzone Quadrivalent process uses an additional concentration factor after the ultrafiltration step to obtain a higher HA antigen concentration. The purified split virus from the four strains included in the vaccine are produced separately and then combined to make the quadrivalent formulation. Fluzone Quadrivalent Southern Hemisphere is an injectable suspension and is clear and slightly opalescent in color. Antibiotics are not used in the manufacture of Fluzone Quadrivalent Southern Hemisphere. No presentation of Fluzone Quadrivalent Southern Hemisphere is made with natural rubber latex. Fluzone Quadrivalent Southern Hemisphere is standardized according to United States Public Health Service requirements and is formulated to contain HA of each of the following four influenza strains recommended for the 2025 Southern Hemisphere influenza season: A/Victoria/4897/2022 IVR-238 (H1N1), A/Croatia/10136RV/2023 X-425A (H3N2), B/Phuket/3073/2013 (B Yamagata lineage), and B/Michigan/01/2021 (a B/Austria/1359417/2021-like virus, B Victoria lineage). The amounts of HA and other ingredients per dose of vaccine are listed in Table 7. The 0.5 mL single-dose, pre-filled syringe presentation is manufactured and formulated without thimerosal or any other preservative. The 5 mL multi-dose vial presentation contains thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose from the multi-dose vial contains 25 mcg mercury. Each 0.25 mL dose from the multi-dose vial contains 12.5 mcg mercury."
    },
    {
      "NDCCode": "13733-326-01",
      "PackageDescription": "50 g in 1 TUBE (13733-326-01)",
      "NDC11Code": "13733-0326-01",
      "ProductNDC": "13733-326",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "All Around Safe Block Aqua Sun Gel",
      "NonProprietaryName": "Octinoxate, Octocrylene, Octisalate, Avobenzone",
      "DosageFormName": "GEL",
      "RouteName": "CUTANEOUS",
      "StartMarketingDate": "20170701",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Able C&C Co., Ltd.",
      "SubstanceName": "OCTOCRYLENE; OCTINOXATE; OCTISALATE; AVOBENZONE",
      "StrengthNumber": "5; 7; 4.5; 3",
      "StrengthUnit": "mg/g; mg/g; mg/g; mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2018-12-28",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "42973-326-00",
      "PackageDescription": "50 kg in 1 CONTAINER (42973-326-00) ",
      "NDC11Code": "42973-0326-00",
      "ProductNDC": "42973-326",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Cetrorelix Acetate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20210526",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Apicore Pharmaceuticals Private Limited",
      "SubstanceName": "CETRORELIX ACETATE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2025-12-23",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "26-MAY-21"
    },
    {
      "NDCCode": "46144-326-50",
      "PackageDescription": "500 g in 1 BOTTLE, PLASTIC (46144-326-50)",
      "NDC11Code": "46144-0326-50",
      "ProductNDC": "46144-326",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Polidocanol",
      "DosageFormName": "PASTE",
      "StartMarketingDate": "20171001",
      "MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
      "LabelerName": "API Solutions, Inc.",
      "SubstanceName": "POLIDOCANOL",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20211231"
    },
    {
      "NDCCode": "49643-326-50",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (49643-326-50) ",
      "NDC11Code": "49643-0326-50",
      "ProductNDC": "49643-326",
      "ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Grama Grass Pollen",
      "NonProprietaryName": "Bouteloua Spp.",
      "DosageFormName": "INJECTION",
      "RouteName": "CUTANEOUS; INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740312",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102211",
      "LabelerName": "Allermed Laboratories, Inc.",
      "SubstanceName": "BOUTELOUA GRACILIS POLLEN",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]",
      "Status": "Active",
      "LastUpdate": "2025-06-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19740312",
      "SamplePackage": "N",
      "IndicationAndUsage": "Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.",
      "Description": "Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength."
    },
    {
      "NDCCode": "49716-326-50",
      "PackageDescription": "50 kg in 1 DRUM (49716-326-50) ",
      "NDC11Code": "49716-0326-50",
      "ProductNDC": "49716-326",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Gabapentin",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20231011",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "IOL Chemicals and Pharmaceuticals Ltd.",
      "SubstanceName": "GABAPENTIN",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2023-10-12",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "11-OCT-23"
    },
    {
      "NDCCode": "49967-326-01",
      "PackageDescription": "1 JAR in 1 CARTON (49967-326-01)  / 50 g in 1 JAR",
      "NDC11Code": "49967-0326-01",
      "ProductNDC": "49967-326",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lancome Paris Renergie Lift Multi Action Broad Spectrum Spf 15 Sunscreen Lifting And Firming For Dry Skin",
      "NonProprietaryName": "Avobenzone, Octisalate And Octocrylene",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130201",
      "EndMarketingDate": "20231020",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "L'Oreal USA Products Inc",
      "SubstanceName": "AVOBENZONE; OCTISALATE; OCTOCRYLENE",
      "StrengthNumber": "30; 50; 70",
      "StrengthUnit": "mg/g; mg/g; mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2023-10-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20130201",
      "EndMarketingDatePackage": "20231020",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "54575-326-50",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (54575-326-50)",
      "NDC11Code": "54575-0326-50",
      "ProductNDC": "54575-326",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Mite D Pteronyssinus",
      "NonProprietaryName": "Dermatophagoides Pteronyssinus",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19911211",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101378",
      "LabelerName": "Allergy Laboratories, Inc.",
      "SubstanceName": "DERMATOPHAGOIDES PTERONYSSINUS",
      "StrengthNumber": "10000",
      "StrengthUnit": "[AU]/mL",
      "Pharm_Classes": "Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [CS],Insect Proteins [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Standardized mite extract is used for the diagnosis and treatment of allergic disease to mite. Diagnosis of allergic disease to mite is made through a combined medical history sufficiently complete to identify allergic symptoms to mite and identification of mite allergy by diagnostic skin testing. Hyposensitization therapy to mite is treatment for patients exhibiting allergic reactions to mite. Immunotherapy is intended for patients whose symptoms cannot be satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. (5).",
      "Description": "The standardized mite extract contains the extractables of Dermatophagoides farinae or Dermatophagoides pteronyssinus. The standardized (Allergy Unit) extract in these vials is designed primarily for the physician equipped to prepare dilutions and mixtures as required. The extract is sterile and contains 50% (v/v) glycerine as a preservative. It is intended for subcutaneous injection. Source material for the mite extract is the whole bodies of the mite. The mites are grown on a medium containing yeast and pork and are processed in a manner to remove at least 99% of the growth medium. The medium contains no material of human origin. Several manufacturers submitted intradermal skin test data on an extract of mite medium from one supplier using patients who were puncture test reactive (∑ E ≥40mm) to mite extracts. By intradermal testing there was one reaction (∑ E ≥20mm) in 44 individuals at an estimated 1% level of medium content of mites, and 4 reactions in 40 individuals at an estimated 10% content. Two of the individuals who were skin test reactive to the mite extract and who were also skin test reactive to the mite medium extract were also skin tested by puncture method with an extract of yeast (Saccharomyces sp.) and were reactive. The mite extract is standardized by assay using ELISA Competition (1) against a reference extract distributed by the Center for Biologics Evaluation and Research, U.S. Food and Drug Administration. Potency based on Allergy Units (AU/ml) is printed on the label. The F.D.A. reference extract has been assigned 10,000 AU/ml based on quantitative skin testing (2). The mite extract is labeled 10,000 AU/ml because it is statistically equivalent in potency to the reference extract."
    },
    {
      "NDCCode": "55513-326-01",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (55513-326-01)  / 50 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "55513-0326-01",
      "ProductNDC": "55513-326",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Riabni",
      "NonProprietaryName": "Rituximab-arrx",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20210106",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA761140",
      "LabelerName": "Amgen, Inc",
      "SubstanceName": "RITUXIMAB",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/50mL",
      "Pharm_Classes": "CD20-directed Antibody Interactions [MoA], CD20-directed Cytolytic Antibody [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-07-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20210106",
      "SamplePackage": "N",
      "IndicationAndUsage": "RIABNI is a CD20-directed cytolytic antibody indicated for the treatment of: 1 Adult patients with Non-Hodgkin's Lymphoma (NHL) (1.1).Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent.Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy.Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or other anthracycline-based chemotherapy regimens., 2 Adult patients with Chronic Lymphocytic Leukemia (CLL) (1.2).Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC)., 3 Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately- to-severely- active RA who have inadequate response to one or more TNF antagonist therapies (1.3)., 4 Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids (1.4)., 5 Moderate to severe Pemphigus Vulgaris (PV) in adult patients (1.5).",
      "Description": "Rituximab-arrx is a genetically engineered chimeric murine/human monoclonal IgG1 kappa antibody directed against the CD20 antigen. Rituximab-arrx has an approximate molecular weight of 145 kD. Rituximab-arrx is produced in a mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium. RIABNI (rituximab-arrx) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for intravenous infusion. RIABNI is supplied at a concentration of 10 mg/mL in either 100 mg/10 mL or 500 mg/50 mL single-dose vials. Each mL of solution contains 10 mg rituximab-arrx, polysorbate 80 (0.7 mg), sodium chloride (9 mg), sodium citrate dihydrate (7.35 mg), and Water for Injection, USP. Hydrochloric acid is used to adjust the buffer solution pH. The pH is 6.5."
    },
    {
      "NDCCode": "55513-326-21",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (55513-326-21)  / 50 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "55513-0326-21",
      "ProductNDC": "55513-326",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Riabni",
      "NonProprietaryName": "Rituximab-arrx",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20210106",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA761140",
      "LabelerName": "Amgen, Inc",
      "SubstanceName": "RITUXIMAB",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/50mL",
      "Pharm_Classes": "CD20-directed Antibody Interactions [MoA], CD20-directed Cytolytic Antibody [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-07-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250721",
      "SamplePackage": "N",
      "IndicationAndUsage": "RIABNI is a CD20-directed cytolytic antibody indicated for the treatment of: 1 Adult patients with Non-Hodgkin's Lymphoma (NHL) (1.1).Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent.Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy.Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or other anthracycline-based chemotherapy regimens., 2 Adult patients with Chronic Lymphocytic Leukemia (CLL) (1.2).Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC)., 3 Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately- to-severely- active RA who have inadequate response to one or more TNF antagonist therapies (1.3)., 4 Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids (1.4)., 5 Moderate to severe Pemphigus Vulgaris (PV) in adult patients (1.5).",
      "Description": "Rituximab-arrx is a genetically engineered chimeric murine/human monoclonal IgG1 kappa antibody directed against the CD20 antigen. Rituximab-arrx has an approximate molecular weight of 145 kD. Rituximab-arrx is produced in a mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium. RIABNI (rituximab-arrx) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for intravenous infusion. RIABNI is supplied at a concentration of 10 mg/mL in either 100 mg/10 mL or 500 mg/50 mL single-dose vials. Each mL of solution contains 10 mg rituximab-arrx, polysorbate 80 (0.7 mg), sodium chloride (9 mg), sodium citrate dihydrate (7.35 mg), and Water for Injection, USP. Hydrochloric acid is used to adjust the buffer solution pH. The pH is 6.5."
    },
    {
      "NDCCode": "55758-326-50",
      "PackageDescription": "25 PACKET in 1 BOX (55758-326-50)  / 2 TABLET, COATED in 1 PACKET (55758-326-02) ",
      "NDC11Code": "55758-0326-50",
      "ProductNDC": "55758-326",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dolex Fem",
      "NonProprietaryName": "Acetaminophen, Caffeine, Pyrilamine Maleate",
      "DosageFormName": "TABLET, COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20201001",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M013",
      "LabelerName": "Pharmadel LLC",
      "SubstanceName": "ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE",
      "StrengthNumber": "500; 60; 15",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20230407",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the temporary relief of these symptoms associated with menstrual periods: 1 cramps, 2 bloating, 3 water- weight gain, 4 headache, 5 backache, 6 Muscle aches, 7 fatigue."
    },
    {
      "NDCCode": "58411-326-50",
      "PackageDescription": "1 JAR in 1 CARTON (58411-326-50)  / 27 mL in 1 JAR",
      "NDC11Code": "58411-0326-50",
      "ProductNDC": "58411-326",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cle De Peau Beaute The Foundation",
      "ProprietaryNameSuffix": "Wb20",
      "NonProprietaryName": "Octinoxate And Titanium Dioxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20170801",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "SHISEIDO AMERICAS CORPORATION",
      "SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
      "StrengthNumber": "1228; 1039",
      "StrengthUnit": "mg/27mL; mg/27mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20170801",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
    },
    {
      "NDCCode": "58657-326-50",
      "PackageDescription": "1 BOTTLE, DROPPER in 1 BOX (58657-326-50)  / 50 mL in 1 BOTTLE, DROPPER",
      "NDC11Code": "58657-0326-50",
      "ProductNDC": "58657-326",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Multi-vitamin With Fluoride",
      "NonProprietaryName": "Vitamin A, Ascorbic Acid, Cholecalciferol, Alpha-tocopherol Acetate, Thiamine Hydrochloride, Riboflavin 5-phosphate Sodium, Cyanocobalamin, Niacinamide, Pyridoxine Hydrochloride And Sodium Fluoride",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170224",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Method Pharmaceuticals, LLC",
      "SubstanceName": "RIBOFLAVIN 5'-PHOSPHATE SODIUM; VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL SUCCINATE, D-; THIAMINE HYDROCHLORIDE; CYANOCOBALAMIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; SODIUM FLUORIDE",
      "StrengthNumber": ".6; 1500; 35; 400; 5; .5; 2; 8; .4; .5",
      "StrengthUnit": "mg/mL; [iU]/mL; mg/mL; [iU]/mL; [iU]/mL; mg/mL; ug/mL; mg/mL; mg/mL; mg/mL",
      "Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Photoabsorption [MoA], Photoenhancer [EPC], Photosensitizing Activity [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-10-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20170224",
      "SamplePackage": "N",
      "IndicationAndUsage": "Supplementation of the diet with vitamins A, C and D. Multi-Vitamin Drops with Fluoride 0.5 mg also provides fluoride for caries prophylaxis. The American Academy of Pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation. The American Academy of Pediatrics recommend that infants and young children 6 months to 3 years of age, in areas where the drinking water contains less than 0.3 ppm of fluoride, and children 3-6 years of age, in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride, receive 0.5 mg of supplemental fluoride daily which is provided in a dose of 1 mL of Multi-Vitamin Drops with Fluoride 0.5 mg (See Dosage and Administration). Multi-Vitamin Drops with Fluoride 0.5 mg supply significant amounts of vitamins A, C and D to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop. Thus, in a single easy-to-use preparation, children obtain essential vitamins and fluoride."
    },
    {
      "NDCCode": "58892-326-50",
      "PackageDescription": "1 TUBE in 1 CARTON (58892-326-50)  / 44.4 mL in 1 TUBE",
      "NDC11Code": "58892-0326-50",
      "ProductNDC": "58892-326",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Tizo3",
      "NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20070521",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Fallien Cosmeceuticals, LTD",
      "SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": "85.4; 40.7",
      "StrengthUnit": "mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20150325",
      "SamplePackage": "N",
      "IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
    },
    {
      "NDCCode": "59469-326-10",
      "PackageDescription": "1 BOTTLE, GLASS in 1 BOX (59469-326-10)  > 50 mL in 1 BOTTLE, GLASS",
      "NDC11Code": "59469-0326-10",
      "ProductNDC": "59469-326",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cangust",
      "NonProprietaryName": "Horse Chestnut, Arnica Montana Root, Gold Trichloride, Activated Charcoal, Lachesis Muta Venom, Prunus Laurocerasus Leaf, Strophanthus Gratus Seed, And Tobacco Leaf",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190108",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "PEKANA Naturheilmittel GmbH",
      "SubstanceName": "HORSE CHESTNUT; ARNICA MONTANA ROOT; GOLD TRICHLORIDE; ACTIVATED CHARCOAL; LACHESIS MUTA VENOM; PRUNUS LAUROCERASUS LEAF; STROPHANTHUS GRATUS SEED; TOBACCO LEAF",
      "StrengthNumber": "2; 4; 6; 8; 8; 3; 4; 6",
      "StrengthUnit": "[hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]",
      "Status": "Active",
      "LastUpdate": "2022-12-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190108",
      "SamplePackage": "N",
      "IndicationAndUsage": "For relief of minor upper body stiffness and pain. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated."
    },
    {
      "NDCCode": "59886-326-77",
      "PackageDescription": "1 TUBE in 1 BOX (59886-326-77)  > 50 g in 1 TUBE",
      "NDC11Code": "59886-0326-77",
      "ProductNDC": "59886-326",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ultrasolsunscreen",
      "ProprietaryNameSuffix": "Sunscreen Face Cream Spf 34",
      "NonProprietaryName": "Avobenzone, Octinoxate, Octisalate, Oxybenzone",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20100301",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Fischer Pharmaceuticals Ltd",
      "SubstanceName": "AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE",
      "StrengthNumber": "2; 7.5; 3; 3",
      "StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "68462-326-50",
      "PackageDescription": "50 TABLET, FILM COATED in 1 BOTTLE (68462-326-50) ",
      "NDC11Code": "68462-0326-50",
      "ProductNDC": "68462-326",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levofloxacin",
      "NonProprietaryName": "Levofloxacin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190618",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA200250",
      "LabelerName": "GLENMARK PHARMACEUTICALS INC., USA",
      "SubstanceName": "LEVOFLOXACIN",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2019-10-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20190618",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "69230-326-50",
      "PackageDescription": "1 BOTTLE in 1 CARTON (69230-326-50)  > 50 TABLET, FILM COATED in 1 BOTTLE",
      "NDC11Code": "69230-0326-50",
      "ProductNDC": "69230-326",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Famotidine",
      "NonProprietaryName": "Famotidine",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20211108",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215766",
      "LabelerName": "Camber Consumer Care Inc",
      "SubstanceName": "FAMOTIDINE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2022-10-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20211108",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "70700-326-50",
      "PackageDescription": "50 TABLET in 1 BOTTLE (70700-326-50) ",
      "NDC11Code": "70700-0326-50",
      "ProductNDC": "70700-326",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Gallifrey",
      "NonProprietaryName": "Norethindrone Acetate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240906",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA205278",
      "LabelerName": "Xiromed LLC",
      "SubstanceName": "NORETHINDRONE ACETATE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Progesterone Congeners [CS], Progestin [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-07-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240906",
      "SamplePackage": "N",
      "IndicationAndUsage": "Gallifrey (Norethindrone Acetate Tablets, USP), 5 mg. Gallifrey is indicated for the treatment of secondary amenorrhea, endometriosis, and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer. Gallifrey is not intended, recommended or approved to be used with concomitant estrogen therapy in postmenopausal women for endometrial protection.",
      "Description": "Gallifrey (Norethindrone acetate tablets, USP), 5 mg oral tablets. Gallifrey, (17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one acetate), a synthetic, orally active progestin, is the acetic acid ester of norethindrone. It is a white, or creamy white, crystalline powder. Gallifrey tablets contain the following inactive ingredients: lactose anhydrous, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The USP Dissolution Test is pending."
    },
    {
      "NDCCode": "71919-326-09",
      "PackageDescription": "50 mL in 1 BOTTLE, GLASS (71919-326-09) ",
      "NDC11Code": "71919-0326-09",
      "ProductNDC": "71919-326",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Grindelia",
      "NonProprietaryName": "Grindelia Squarrosa Flowering Top",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100623",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Washington Homeopathic Products",
      "SubstanceName": "GRINDELIA SQUARROSA FLOWERING TOP",
      "StrengthNumber": "30",
      "StrengthUnit": "[hp_C]/mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20100623",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "72603-326-01",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (72603-326-01)  / 50 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "72603-0326-01",
      "ProductNDC": "72603-326",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cyclophosphamide",
      "NonProprietaryName": "Cyclophosphamide",
      "DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
      "RouteName": "INTRAVENOUS; ORAL",
      "StartMarketingDate": "20190510",
      "EndMarketingDate": "20260531",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210046",
      "LabelerName": "NorthStar RxLLC",
      "SubstanceName": "CYCLOPHOSPHAMIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/50mL",
      "Status": "Deprecated",
      "LastUpdate": "2026-06-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20190510",
      "EndMarketingDatePackage": "20260531",
      "SamplePackage": "N",
      "IndicationAndUsage": "Cyclophosphamide for injection is an alkylating drug indicated for treatment of: 1 Malignant Diseases: malignant lymphomas: Hodgkin's disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt's lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma. (1.1).",
      "Description": "Cyclophosphamide is a synthetic antineoplastic drug chemically related to the nitrogen mustards. The chemical name for cyclophosphamide is 2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate, and has the following structural formula. Cyclophosphamide, USP is a white crystalline powder with the molecular formula C7H15Cl2N2O2PH2O and a molecular weight of 279.1. Cyclophosphamide is soluble in water, saline, or ethanol. Cyclophosphamide for Injection, USP is a sterile white powder available as 500 mg, 1 g, and 2 g strength vials. : 1 500 mg vial contains 534.5 mg cyclophosphamide monohydrate equivalent to 500 mg cyclophosphamide, USP., 2 1 g vial contains 1069 mg cyclophosphamide monohydrate equivalent to 1 g cyclophosphamide, USP, 3 2 g vial contains 2138 mg cyclophosphamide monohydrate equivalent to 2 g cyclophosphamide, USP."
    },
    {
      "NDCCode": "84756-326-04",
      "PackageDescription": "50 mL in 1 BOTTLE (84756-326-04) ",
      "NDC11Code": "84756-0326-04",
      "ProductNDC": "84756-326",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hair Strengthening Oil",
      "NonProprietaryName": "Hair Strengthening Oil",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20241113",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M032",
      "LabelerName": "Yiwu Luoxin E �Commerce Co Ltd",
      "SubstanceName": "MINOXIDIL",
      "StrengthNumber": "5",
      "StrengthUnit": "g/100mL",
      "Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20241113",
      "SamplePackage": "N",
      "IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
    },
    {
      "NDCCode": "49281-013-50",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-013-50)  > .5 mL in 1 SYRINGE, GLASS (49281-013-88)",
      "NDC11Code": "49281-0013-50",
      "ProductNDC": "49281-013",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone",
      "NonProprietaryName": "Influenza A Virus A/california/7/2009 X-179a (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/texas/50/2012 X-223a (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/massachusetts/2/2012 Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20130628",
      "EndMarketingDate": "20140630",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "15; 15; 15",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2014-07-07"
    },
    {
      "NDCCode": "49281-014-50",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-014-50)  > .5 mL in 1 SYRINGE, GLASS (49281-014-88)",
      "NDC11Code": "49281-0014-50",
      "ProductNDC": "49281-014",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone",
      "NonProprietaryName": "Influenza A Virus A/california/7/2009 X-179a (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/texas/50/2012 X-223a (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/massachusetts/2/2012 Bx-51b Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20140627",
      "EndMarketingDate": "20150630",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "15; 15; 15",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2015-07-03"
    },
    {
      "NDCCode": "49281-016-50",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-016-50)  / .5 mL in 1 SYRINGE, GLASS (49281-016-88) ",
      "NDC11Code": "49281-0016-50",
      "ProductNDC": "49281-016",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone Hd Tiv Sh 2026",
      "NonProprietaryName": "Influenza A Virus A/switzerland/6849/2025 Ivr-278 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/singapore/gp20238/2024 Ivr-277 (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20260220",
      "EndMarketingDate": "20261231",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Vaccines US Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/SWITZERLAND/6849/2025 IVR-278 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/SINGAPORE/GP20238/2024 IVR-277 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "60; 60; 60",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Active",
      "LastUpdate": "2026-05-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20260220",
      "EndMarketingDatePackage": "20261231",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fluzone® High-Dose Southern Hemisphere is a vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine. Fluzone High-Dose Southern Hemisphere is approved for use in persons 65 years of age and older.",
      "Description": "Fluzone High-Dose Southern Hemisphere (Influenza Vaccine) for intramuscular use is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a \"split virus\". The split virus containing hemagglutinin (HA) antigen is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The Fluzone High-Dose Southern Hemisphere process uses an additional concentration factor after the ultrafiltration step to obtain a higher HA antigen concentration. The purified split virus from the three strains included in the vaccine are produced separately and then combined to make the trivalent formulation. Fluzone High-Dose Southern Hemisphere is an injectable suspension and is a colorless opalescent liquid. Neither antibiotics nor preservative are used in the manufacture of Fluzone High-Dose Southern Hemisphere. The Fluzone High-Dose Southern Hemisphere prefilled syringe presentation is not made with natural rubber latex. Fluzone High-Dose Southern Hemisphere is standardized according to United States Public Health Service requirements and is formulated to contain HA of each of the following three influenza strains recommended for the 2026 influenza season: A/Switzerland/6849/2025 IVR-278 (A/Missouri/11/2025 pdm09-like virus) (H1N1), A/Singapore/GP20238/2024 IVR-277 (H3N2), and B/Michigan/01/2021 (a B/Austria/1359417/2021-like virus, B Victoria lineage). The amounts of HA and other ingredients per dose of vaccine are listed in Table 2."
    },
    {
      "NDCCode": "49281-026-50",
      "PackageDescription": "10 SYRINGE in 1 CARTON (49281-026-50)  / .5 mL in 1 SYRINGE (49281-026-88) ",
      "NDC11Code": "49281-0026-50",
      "ProductNDC": "49281-026",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Nuvaxovid 2026-27",
      "NonProprietaryName": "Nvx-cov2928",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20260827",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125817",
      "LabelerName": "Sanofi Vaccines US Inc.",
      "SubstanceName": "NVX-COV2928",
      "StrengthNumber": "5",
      "StrengthUnit": "ug/.5mL",
      "Status": "Active",
      "LastUpdate": "2026-09-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260827",
      "SamplePackage": "N",
      "IndicationAndUsage": "NUVAXOVID is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). NUVAXOVID is approved for use in individuals who are: 1 65 years of age and older, or, 2 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.",
      "Description": "NUVAXOVID (COVID-19 Vaccine, Adjuvanted) is a colorless to slightly yellow, clear to mildly opalescent sterile suspension for intramuscular use that is free from visible particles. Each 0.5 mL dose of NUVAXOVID (2026-2027 Formula) contains 5 mcg of recombinant spike glycoprotein (rS) of the SARS-CoV-2 JN.1-descendent variant XFG and 50 mcg Matrix-M adjuvant. The Matrix-M adjuvant is composed of Fraction-A (42.5 mcg) and Fraction-C (7.5 mcg) of saponin extracts from the soapbark tree, Quillaja saponaria Molina. The rS protein is produced by recombinant DNA technology using a baculovirus expression system in the Sf9 insect cell line that is derived from the Spodoptera frugiperda species. Each 0.5 mL dose of NUVAXOVID also contains the following ingredients: cholesterol (30.5 mcg), phosphatidylcholine (23 mcg), potassium dihydrogen phosphate (3.85 mcg), potassium chloride (2.25 mcg), disodium hydrogen phosphate dihydrate (14.7 mcg), disodium hydrogen phosphate heptahydrate (2.465 mg), sodium dihydrogen phosphate monohydrate (0.445 mg), sodium chloride (8.766 mg), polysorbate 80 (0.050 mg), and Water for Injection. The pH is adjusted with sodium hydroxide or hydrochloric acid. Each 0.5 mL dose of NUVAXOVID may also contain residual amounts of baculovirus and Sf9 cell proteins (≤ 0.96 mcg), baculovirus and cellular DNA (≤ 0.00016 mcg), lentil lectin (< 0.025 mcg), methyl-α-D-mannopyranoside (2 mcg), simethicone (< 0.92 mcg), pluronic F-68 (< 2.19 mcg), Triton X-100 (< 0.025 mcg), Tergitol (NP9) (< 0.05 mcg), and DL-α-tocopherol (≤ 0.05 mcg). NUVAXOVID does not contain a preservative. The syringe tip cap and plunger stopper are not made with natural rubber latex."
    },
    {
      "NDCCode": "49281-312-50",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-312-50)  / .5 mL in 1 SYRINGE, GLASS (49281-312-88) ",
      "NDC11Code": "49281-0312-50",
      "ProductNDC": "49281-312",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone Northern Hemisphere",
      "NonProprietaryName": "Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)",
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      "MarketingCategoryName": "BLA",
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  </NDC>
  <NDC>
    <NDCCode>49716-326-50</NDCCode>
    <PackageDescription>50 kg in 1 DRUM (49716-326-50) </PackageDescription>
    <NDC11Code>49716-0326-50</NDC11Code>
    <ProductNDC>49716-326</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Gabapentin</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20231011</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>IOL Chemicals and Pharmaceuticals Ltd.</LabelerName>
    <SubstanceName>GABAPENTIN</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2023-10-12</LastUpdate>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>11-OCT-23</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>49967-326-01</NDCCode>
    <PackageDescription>1 JAR in 1 CARTON (49967-326-01)  / 50 g in 1 JAR</PackageDescription>
    <NDC11Code>49967-0326-01</NDC11Code>
    <ProductNDC>49967-326</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lancome Paris Renergie Lift Multi Action Broad Spectrum Spf 15 Sunscreen Lifting And Firming For Dry Skin</ProprietaryName>
    <NonProprietaryName>Avobenzone, Octisalate And Octocrylene</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130201</StartMarketingDate>
    <EndMarketingDate>20231020</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>L'Oreal USA Products Inc</LabelerName>
    <SubstanceName>AVOBENZONE; OCTISALATE; OCTOCRYLENE</SubstanceName>
    <StrengthNumber>30; 50; 70</StrengthNumber>
    <StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-10-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20130201</StartMarketingDatePackage>
    <EndMarketingDatePackage>20231020</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>54575-326-50</NDCCode>
    <PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (54575-326-50)</PackageDescription>
    <NDC11Code>54575-0326-50</NDC11Code>
    <ProductNDC>54575-326</ProductNDC>
    <ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
    <ProprietaryName>Standardized Mite D Pteronyssinus</ProprietaryName>
    <NonProprietaryName>Dermatophagoides Pteronyssinus</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19911211</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101378</ApplicationNumber>
    <LabelerName>Allergy Laboratories, Inc.</LabelerName>
    <SubstanceName>DERMATOPHAGOIDES PTERONYSSINUS</SubstanceName>
    <StrengthNumber>10000</StrengthNumber>
    <StrengthUnit>[AU]/mL</StrengthUnit>
    <Pharm_Classes>Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [CS],Insect Proteins [CS],Allergens [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Standardized mite extract is used for the diagnosis and treatment of allergic disease to mite. Diagnosis of allergic disease to mite is made through a combined medical history sufficiently complete to identify allergic symptoms to mite and identification of mite allergy by diagnostic skin testing. Hyposensitization therapy to mite is treatment for patients exhibiting allergic reactions to mite. Immunotherapy is intended for patients whose symptoms cannot be satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. (5).</IndicationAndUsage>
    <Description>The standardized mite extract contains the extractables of Dermatophagoides farinae or Dermatophagoides pteronyssinus. The standardized (Allergy Unit) extract in these vials is designed primarily for the physician equipped to prepare dilutions and mixtures as required. The extract is sterile and contains 50% (v/v) glycerine as a preservative. It is intended for subcutaneous injection. Source material for the mite extract is the whole bodies of the mite. The mites are grown on a medium containing yeast and pork and are processed in a manner to remove at least 99% of the growth medium. The medium contains no material of human origin. Several manufacturers submitted intradermal skin test data on an extract of mite medium from one supplier using patients who were puncture test reactive (∑ E ≥40mm) to mite extracts. By intradermal testing there was one reaction (∑ E ≥20mm) in 44 individuals at an estimated 1% level of medium content of mites, and 4 reactions in 40 individuals at an estimated 10% content. Two of the individuals who were skin test reactive to the mite extract and who were also skin test reactive to the mite medium extract were also skin tested by puncture method with an extract of yeast (Saccharomyces sp.) and were reactive. The mite extract is standardized by assay using ELISA Competition (1) against a reference extract distributed by the Center for Biologics Evaluation and Research, U.S. Food and Drug Administration. Potency based on Allergy Units (AU/ml) is printed on the label. The F.D.A. reference extract has been assigned 10,000 AU/ml based on quantitative skin testing (2). The mite extract is labeled 10,000 AU/ml because it is statistically equivalent in potency to the reference extract.</Description>
  </NDC>
  <NDC>
    <NDCCode>55513-326-01</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (55513-326-01)  / 50 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>55513-0326-01</NDC11Code>
    <ProductNDC>55513-326</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Riabni</ProprietaryName>
    <NonProprietaryName>Rituximab-arrx</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20210106</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761140</ApplicationNumber>
    <LabelerName>Amgen, Inc</LabelerName>
    <SubstanceName>RITUXIMAB</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/50mL</StrengthUnit>
    <Pharm_Classes>CD20-directed Antibody Interactions [MoA], CD20-directed Cytolytic Antibody [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210106</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>RIABNI is a CD20-directed cytolytic antibody indicated for the treatment of: 1 Adult patients with Non-Hodgkin's Lymphoma (NHL) (1.1).Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent.Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy.Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or other anthracycline-based chemotherapy regimens., 2 Adult patients with Chronic Lymphocytic Leukemia (CLL) (1.2).Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC)., 3 Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately- to-severely- active RA who have inadequate response to one or more TNF antagonist therapies (1.3)., 4 Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids (1.4)., 5 Moderate to severe Pemphigus Vulgaris (PV) in adult patients (1.5).</IndicationAndUsage>
    <Description>Rituximab-arrx is a genetically engineered chimeric murine/human monoclonal IgG1 kappa antibody directed against the CD20 antigen. Rituximab-arrx has an approximate molecular weight of 145 kD. Rituximab-arrx is produced in a mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium. RIABNI (rituximab-arrx) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for intravenous infusion. RIABNI is supplied at a concentration of 10 mg/mL in either 100 mg/10 mL or 500 mg/50 mL single-dose vials. Each mL of solution contains 10 mg rituximab-arrx, polysorbate 80 (0.7 mg), sodium chloride (9 mg), sodium citrate dihydrate (7.35 mg), and Water for Injection, USP. Hydrochloric acid is used to adjust the buffer solution pH. The pH is 6.5.</Description>
  </NDC>
  <NDC>
    <NDCCode>55513-326-21</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (55513-326-21)  / 50 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>55513-0326-21</NDC11Code>
    <ProductNDC>55513-326</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Riabni</ProprietaryName>
    <NonProprietaryName>Rituximab-arrx</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20210106</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761140</ApplicationNumber>
    <LabelerName>Amgen, Inc</LabelerName>
    <SubstanceName>RITUXIMAB</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/50mL</StrengthUnit>
    <Pharm_Classes>CD20-directed Antibody Interactions [MoA], CD20-directed Cytolytic Antibody [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250721</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>RIABNI is a CD20-directed cytolytic antibody indicated for the treatment of: 1 Adult patients with Non-Hodgkin's Lymphoma (NHL) (1.1).Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent.Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy.Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or other anthracycline-based chemotherapy regimens., 2 Adult patients with Chronic Lymphocytic Leukemia (CLL) (1.2).Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC)., 3 Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately- to-severely- active RA who have inadequate response to one or more TNF antagonist therapies (1.3)., 4 Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids (1.4)., 5 Moderate to severe Pemphigus Vulgaris (PV) in adult patients (1.5).</IndicationAndUsage>
    <Description>Rituximab-arrx is a genetically engineered chimeric murine/human monoclonal IgG1 kappa antibody directed against the CD20 antigen. Rituximab-arrx has an approximate molecular weight of 145 kD. Rituximab-arrx is produced in a mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium. RIABNI (rituximab-arrx) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for intravenous infusion. RIABNI is supplied at a concentration of 10 mg/mL in either 100 mg/10 mL or 500 mg/50 mL single-dose vials. Each mL of solution contains 10 mg rituximab-arrx, polysorbate 80 (0.7 mg), sodium chloride (9 mg), sodium citrate dihydrate (7.35 mg), and Water for Injection, USP. Hydrochloric acid is used to adjust the buffer solution pH. The pH is 6.5.</Description>
  </NDC>
  <NDC>
    <NDCCode>55758-326-50</NDCCode>
    <PackageDescription>25 PACKET in 1 BOX (55758-326-50)  / 2 TABLET, COATED in 1 PACKET (55758-326-02) </PackageDescription>
    <NDC11Code>55758-0326-50</NDC11Code>
    <ProductNDC>55758-326</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dolex Fem</ProprietaryName>
    <NonProprietaryName>Acetaminophen, Caffeine, Pyrilamine Maleate</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201001</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M013</ApplicationNumber>
    <LabelerName>Pharmadel LLC</LabelerName>
    <SubstanceName>ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE</SubstanceName>
    <StrengthNumber>500; 60; 15</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230407</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the temporary relief of these symptoms associated with menstrual periods: 1 cramps, 2 bloating, 3 water- weight gain, 4 headache, 5 backache, 6 Muscle aches, 7 fatigue.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>58411-326-50</NDCCode>
    <PackageDescription>1 JAR in 1 CARTON (58411-326-50)  / 27 mL in 1 JAR</PackageDescription>
    <NDC11Code>58411-0326-50</NDC11Code>
    <ProductNDC>58411-326</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cle De Peau Beaute The Foundation</ProprietaryName>
    <ProprietaryNameSuffix>Wb20</ProprietaryNameSuffix>
    <NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20170801</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>SHISEIDO AMERICAS CORPORATION</LabelerName>
    <SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>1228; 1039</StrengthNumber>
    <StrengthUnit>mg/27mL; mg/27mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170801</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>58657-326-50</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 BOX (58657-326-50)  / 50 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>58657-0326-50</NDC11Code>
    <ProductNDC>58657-326</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Multi-vitamin With Fluoride</ProprietaryName>
    <NonProprietaryName>Vitamin A, Ascorbic Acid, Cholecalciferol, Alpha-tocopherol Acetate, Thiamine Hydrochloride, Riboflavin 5-phosphate Sodium, Cyanocobalamin, Niacinamide, Pyridoxine Hydrochloride And Sodium Fluoride</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170224</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Method Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>RIBOFLAVIN 5'-PHOSPHATE SODIUM; VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL SUCCINATE, D-; THIAMINE HYDROCHLORIDE; CYANOCOBALAMIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; SODIUM FLUORIDE</SubstanceName>
    <StrengthNumber>.6; 1500; 35; 400; 5; .5; 2; 8; .4; .5</StrengthNumber>
    <StrengthUnit>mg/mL; [iU]/mL; mg/mL; [iU]/mL; [iU]/mL; mg/mL; ug/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Photoabsorption [MoA], Photoenhancer [EPC], Photosensitizing Activity [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170224</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Supplementation of the diet with vitamins A, C and D. Multi-Vitamin Drops with Fluoride 0.5 mg also provides fluoride for caries prophylaxis. The American Academy of Pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation. The American Academy of Pediatrics recommend that infants and young children 6 months to 3 years of age, in areas where the drinking water contains less than 0.3 ppm of fluoride, and children 3-6 years of age, in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride, receive 0.5 mg of supplemental fluoride daily which is provided in a dose of 1 mL of Multi-Vitamin Drops with Fluoride 0.5 mg (See Dosage and Administration). Multi-Vitamin Drops with Fluoride 0.5 mg supply significant amounts of vitamins A, C and D to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop. Thus, in a single easy-to-use preparation, children obtain essential vitamins and fluoride.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>58892-326-50</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (58892-326-50)  / 44.4 mL in 1 TUBE</PackageDescription>
    <NDC11Code>58892-0326-50</NDC11Code>
    <ProductNDC>58892-326</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Tizo3</ProprietaryName>
    <NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20070521</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Fallien Cosmeceuticals, LTD</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>85.4; 40.7</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150325</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>59469-326-10</NDCCode>
    <PackageDescription>1 BOTTLE, GLASS in 1 BOX (59469-326-10)  &gt; 50 mL in 1 BOTTLE, GLASS</PackageDescription>
    <NDC11Code>59469-0326-10</NDC11Code>
    <ProductNDC>59469-326</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cangust</ProprietaryName>
    <NonProprietaryName>Horse Chestnut, Arnica Montana Root, Gold Trichloride, Activated Charcoal, Lachesis Muta Venom, Prunus Laurocerasus Leaf, Strophanthus Gratus Seed, And Tobacco Leaf</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190108</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>PEKANA Naturheilmittel GmbH</LabelerName>
    <SubstanceName>HORSE CHESTNUT; ARNICA MONTANA ROOT; GOLD TRICHLORIDE; ACTIVATED CHARCOAL; LACHESIS MUTA VENOM; PRUNUS LAUROCERASUS LEAF; STROPHANTHUS GRATUS SEED; TOBACCO LEAF</SubstanceName>
    <StrengthNumber>2; 4; 6; 8; 8; 3; 4; 6</StrengthNumber>
    <StrengthUnit>[hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-12-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190108</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For relief of minor upper body stiffness and pain. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>59886-326-77</NDCCode>
    <PackageDescription>1 TUBE in 1 BOX (59886-326-77)  &gt; 50 g in 1 TUBE</PackageDescription>
    <NDC11Code>59886-0326-77</NDC11Code>
    <ProductNDC>59886-326</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ultrasolsunscreen</ProprietaryName>
    <ProprietaryNameSuffix>Sunscreen Face Cream Spf 34</ProprietaryNameSuffix>
    <NonProprietaryName>Avobenzone, Octinoxate, Octisalate, Oxybenzone</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20100301</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Fischer Pharmaceuticals Ltd</LabelerName>
    <SubstanceName>AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE</SubstanceName>
    <StrengthNumber>2; 7.5; 3; 3</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>68462-326-50</NDCCode>
    <PackageDescription>50 TABLET, FILM COATED in 1 BOTTLE (68462-326-50) </PackageDescription>
    <NDC11Code>68462-0326-50</NDC11Code>
    <ProductNDC>68462-326</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levofloxacin</ProprietaryName>
    <NonProprietaryName>Levofloxacin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190618</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA200250</ApplicationNumber>
    <LabelerName>GLENMARK PHARMACEUTICALS INC., USA</LabelerName>
    <SubstanceName>LEVOFLOXACIN</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-10-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190618</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>69230-326-50</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (69230-326-50)  &gt; 50 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
    <NDC11Code>69230-0326-50</NDC11Code>
    <ProductNDC>69230-326</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Famotidine</ProprietaryName>
    <NonProprietaryName>Famotidine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20211108</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215766</ApplicationNumber>
    <LabelerName>Camber Consumer Care Inc</LabelerName>
    <SubstanceName>FAMOTIDINE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-10-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211108</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>70700-326-50</NDCCode>
    <PackageDescription>50 TABLET in 1 BOTTLE (70700-326-50) </PackageDescription>
    <NDC11Code>70700-0326-50</NDC11Code>
    <ProductNDC>70700-326</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Gallifrey</ProprietaryName>
    <NonProprietaryName>Norethindrone Acetate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240906</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205278</ApplicationNumber>
    <LabelerName>Xiromed LLC</LabelerName>
    <SubstanceName>NORETHINDRONE ACETATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240906</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Gallifrey (Norethindrone Acetate Tablets, USP), 5 mg. Gallifrey is indicated for the treatment of secondary amenorrhea, endometriosis, and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer. Gallifrey is not intended, recommended or approved to be used with concomitant estrogen therapy in postmenopausal women for endometrial protection.</IndicationAndUsage>
    <Description>Gallifrey (Norethindrone acetate tablets, USP), 5 mg oral tablets. Gallifrey, (17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one acetate), a synthetic, orally active progestin, is the acetic acid ester of norethindrone. It is a white, or creamy white, crystalline powder. Gallifrey tablets contain the following inactive ingredients: lactose anhydrous, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The USP Dissolution Test is pending.</Description>
  </NDC>
  <NDC>
    <NDCCode>71919-326-09</NDCCode>
    <PackageDescription>50 mL in 1 BOTTLE, GLASS (71919-326-09) </PackageDescription>
    <NDC11Code>71919-0326-09</NDC11Code>
    <ProductNDC>71919-326</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Grindelia</ProprietaryName>
    <NonProprietaryName>Grindelia Squarrosa Flowering Top</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100623</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Washington Homeopathic Products</LabelerName>
    <SubstanceName>GRINDELIA SQUARROSA FLOWERING TOP</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>[hp_C]/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100623</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>72603-326-01</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (72603-326-01)  / 50 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>72603-0326-01</NDC11Code>
    <ProductNDC>72603-326</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cyclophosphamide</ProprietaryName>
    <NonProprietaryName>Cyclophosphamide</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS; ORAL</RouteName>
    <StartMarketingDate>20190510</StartMarketingDate>
    <EndMarketingDate>20260531</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210046</ApplicationNumber>
    <LabelerName>NorthStar RxLLC</LabelerName>
    <SubstanceName>CYCLOPHOSPHAMIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/50mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20190510</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260531</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cyclophosphamide for injection is an alkylating drug indicated for treatment of: 1 Malignant Diseases: malignant lymphomas: Hodgkin's disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt's lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma. (1.1).</IndicationAndUsage>
    <Description>Cyclophosphamide is a synthetic antineoplastic drug chemically related to the nitrogen mustards. The chemical name for cyclophosphamide is 2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate, and has the following structural formula. Cyclophosphamide, USP is a white crystalline powder with the molecular formula C7H15Cl2N2O2PH2O and a molecular weight of 279.1. Cyclophosphamide is soluble in water, saline, or ethanol. Cyclophosphamide for Injection, USP is a sterile white powder available as 500 mg, 1 g, and 2 g strength vials. : 1 500 mg vial contains 534.5 mg cyclophosphamide monohydrate equivalent to 500 mg cyclophosphamide, USP., 2 1 g vial contains 1069 mg cyclophosphamide monohydrate equivalent to 1 g cyclophosphamide, USP, 3 2 g vial contains 2138 mg cyclophosphamide monohydrate equivalent to 2 g cyclophosphamide, USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>84756-326-04</NDCCode>
    <PackageDescription>50 mL in 1 BOTTLE (84756-326-04) </PackageDescription>
    <NDC11Code>84756-0326-04</NDC11Code>
    <ProductNDC>84756-326</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hair Strengthening Oil</ProprietaryName>
    <NonProprietaryName>Hair Strengthening Oil</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20241113</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M032</ApplicationNumber>
    <LabelerName>Yiwu Luoxin E �Commerce Co Ltd</LabelerName>
    <SubstanceName>MINOXIDIL</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241113</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>49281-013-50</NDCCode>
    <PackageDescription>10 SYRINGE, GLASS in 1 PACKAGE (49281-013-50)  &gt; .5 mL in 1 SYRINGE, GLASS (49281-013-88)</PackageDescription>
    <NDC11Code>49281-0013-50</NDC11Code>
    <ProductNDC>49281-013</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Fluzone</ProprietaryName>
    <NonProprietaryName>Influenza A Virus A/california/7/2009 X-179a (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/texas/50/2012 X-223a (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/massachusetts/2/2012 Antigen (formaldehyde Inactivated)</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20130628</StartMarketingDate>
    <EndMarketingDate>20140630</EndMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103914</ApplicationNumber>
    <LabelerName>Sanofi Pasteur Inc.</LabelerName>
    <SubstanceName>INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
    <StrengthNumber>15; 15; 15</StrengthNumber>
    <StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-07-07</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>49281-014-50</NDCCode>
    <PackageDescription>10 SYRINGE, GLASS in 1 PACKAGE (49281-014-50)  &gt; .5 mL in 1 SYRINGE, GLASS (49281-014-88)</PackageDescription>
    <NDC11Code>49281-0014-50</NDC11Code>
    <ProductNDC>49281-014</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Fluzone</ProprietaryName>
    <NonProprietaryName>Influenza A Virus A/california/7/2009 X-179a (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/texas/50/2012 X-223a (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/massachusetts/2/2012 Bx-51b Antigen (formaldehyde Inactivated)</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20140627</StartMarketingDate>
    <EndMarketingDate>20150630</EndMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103914</ApplicationNumber>
    <LabelerName>Sanofi Pasteur Inc.</LabelerName>
    <SubstanceName>INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
    <StrengthNumber>15; 15; 15</StrengthNumber>
    <StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2015-07-03</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>49281-016-50</NDCCode>
    <PackageDescription>10 SYRINGE, GLASS in 1 PACKAGE (49281-016-50)  / .5 mL in 1 SYRINGE, GLASS (49281-016-88) </PackageDescription>
    <NDC11Code>49281-0016-50</NDC11Code>
    <ProductNDC>49281-016</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Fluzone Hd Tiv Sh 2026</ProprietaryName>
    <NonProprietaryName>Influenza A Virus A/switzerland/6849/2025 Ivr-278 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/singapore/gp20238/2024 Ivr-277 (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20260220</StartMarketingDate>
    <EndMarketingDate>20261231</EndMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103914</ApplicationNumber>
    <LabelerName>Sanofi Vaccines US Inc.</LabelerName>
    <SubstanceName>INFLUENZA A VIRUS A/SWITZERLAND/6849/2025 IVR-278 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/SINGAPORE/GP20238/2024 IVR-277 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
    <StrengthNumber>60; 60; 60</StrengthNumber>
    <StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-05-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20260220</StartMarketingDatePackage>
    <EndMarketingDatePackage>20261231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluzone® High-Dose Southern Hemisphere is a vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine. Fluzone High-Dose Southern Hemisphere is approved for use in persons 65 years of age and older.</IndicationAndUsage>
    <Description>Fluzone High-Dose Southern Hemisphere (Influenza Vaccine) for intramuscular use is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a "split virus". The split virus containing hemagglutinin (HA) antigen is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The Fluzone High-Dose Southern Hemisphere process uses an additional concentration factor after the ultrafiltration step to obtain a higher HA antigen concentration. The purified split virus from the three strains included in the vaccine are produced separately and then combined to make the trivalent formulation. Fluzone High-Dose Southern Hemisphere is an injectable suspension and is a colorless opalescent liquid. Neither antibiotics nor preservative are used in the manufacture of Fluzone High-Dose Southern Hemisphere. The Fluzone High-Dose Southern Hemisphere prefilled syringe presentation is not made with natural rubber latex. Fluzone High-Dose Southern Hemisphere is standardized according to United States Public Health Service requirements and is formulated to contain HA of each of the following three influenza strains recommended for the 2026 influenza season: A/Switzerland/6849/2025 IVR-278 (A/Missouri/11/2025 pdm09-like virus) (H1N1), A/Singapore/GP20238/2024 IVR-277 (H3N2), and B/Michigan/01/2021 (a B/Austria/1359417/2021-like virus, B Victoria lineage). The amounts of HA and other ingredients per dose of vaccine are listed in Table 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>49281-026-50</NDCCode>
    <PackageDescription>10 SYRINGE in 1 CARTON (49281-026-50)  / .5 mL in 1 SYRINGE (49281-026-88) </PackageDescription>
    <NDC11Code>49281-0026-50</NDC11Code>
    <ProductNDC>49281-026</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Nuvaxovid 2026-27</ProprietaryName>
    <NonProprietaryName>Nvx-cov2928</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20260827</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125817</ApplicationNumber>
    <LabelerName>Sanofi Vaccines US Inc.</LabelerName>
    <SubstanceName>NVX-COV2928</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>ug/.5mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-09-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260827</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>NUVAXOVID is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). NUVAXOVID is approved for use in individuals who are: 1 65 years of age and older, or, 2 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.</IndicationAndUsage>
    <Description>NUVAXOVID (COVID-19 Vaccine, Adjuvanted) is a colorless to slightly yellow, clear to mildly opalescent sterile suspension for intramuscular use that is free from visible particles. Each 0.5 mL dose of NUVAXOVID (2026-2027 Formula) contains 5 mcg of recombinant spike glycoprotein (rS) of the SARS-CoV-2 JN.1-descendent variant XFG and 50 mcg Matrix-M adjuvant. The Matrix-M adjuvant is composed of Fraction-A (42.5 mcg) and Fraction-C (7.5 mcg) of saponin extracts from the soapbark tree, Quillaja saponaria Molina. The rS protein is produced by recombinant DNA technology using a baculovirus expression system in the Sf9 insect cell line that is derived from the Spodoptera frugiperda species. Each 0.5 mL dose of NUVAXOVID also contains the following ingredients: cholesterol (30.5 mcg), phosphatidylcholine (23 mcg), potassium dihydrogen phosphate (3.85 mcg), potassium chloride (2.25 mcg), disodium hydrogen phosphate dihydrate (14.7 mcg), disodium hydrogen phosphate heptahydrate (2.465 mg), sodium dihydrogen phosphate monohydrate (0.445 mg), sodium chloride (8.766 mg), polysorbate 80 (0.050 mg), and Water for Injection. The pH is adjusted with sodium hydroxide or hydrochloric acid. Each 0.5 mL dose of NUVAXOVID may also contain residual amounts of baculovirus and Sf9 cell proteins (≤ 0.96 mcg), baculovirus and cellular DNA (≤ 0.00016 mcg), lentil lectin (&lt; 0.025 mcg), methyl-α-D-mannopyranoside (2 mcg), simethicone (&lt; 0.92 mcg), pluronic F-68 (&lt; 2.19 mcg), Triton X-100 (&lt; 0.025 mcg), Tergitol (NP9) (&lt; 0.05 mcg), and DL-α-tocopherol (≤ 0.05 mcg). NUVAXOVID does not contain a preservative. The syringe tip cap and plunger stopper are not made with natural rubber latex.</Description>
  </NDC>
  <NDC>
    <NDCCode>49281-312-50</NDCCode>
    <PackageDescription>10 SYRINGE, GLASS in 1 PACKAGE (49281-312-50)  / .5 mL in 1 SYRINGE, GLASS (49281-312-88) </PackageDescription>
    <NDC11Code>49281-0312-50</NDC11Code>
    <ProductNDC>49281-312</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Fluzone Northern Hemisphere</ProprietaryName>
    <NonProprietaryName>Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20240304</StartMarketingDate>
    <EndMarketingDate>20240630</EndMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103914</ApplicationNumber>
    <LabelerName>Sanofi Pasteur Inc.</LabelerName>
    <SubstanceName>INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
    <StrengthNumber>15; 15; 15</StrengthNumber>
    <StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-07-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20240304</StartMarketingDatePackage>
    <EndMarketingDatePackage>20240630</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluzone® is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B virus contained in the vaccine. Fluzone is approved for use in persons 6 months of age and older.</IndicationAndUsage>
    <Description>Fluzone (Influenza Vaccine) for intramuscular use is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a "split virus". The split virus containing hemagglutinin (HA) antigen is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The purified split virus from the three strains included in the vaccine are produced separately and then combined to make the trivalent formulation. Fluzone is an injectable suspension and is clear and slightly opalescent in color. Antibiotics are not used in the manufacture of Fluzone. No presentation of Fluzone is made with natural rubber latex. Fluzone is standardized according to United States Public Health Service requirements and is formulated to contain HA of each of the following three influenza strains recommended for the 2023–2024 influenza season: A/Victoria/4897/2022 IVR-238 (H1N1), A/Darwin/9/2021 SAN-010 (H3N2) and B/Michigan/01/2021 (a B/Austria/1359417/2021-like virus, B Victoria lineage). The amounts of HA and other ingredients per dose of vaccine are listed in Table 9. The 0.5 mL single-dose, pre-filled syringe presentation is manufactured and formulated without thimerosal or any other preservative. The 5 mL multi-dose vial presentation contains thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose from the multi-dose vial contains 25 mcg mercury. Each 0.25 mL dose from the multi-dose vial contains 12.5 mcg mercury.</Description>
  </NDC>
  <NDC>
    <NDCCode>49281-316-50</NDCCode>
    <PackageDescription>10 SYRINGE, GLASS in 1 PACKAGE (49281-316-50)  &gt; .5 mL in 1 SYRINGE, GLASS (49281-316-88)</PackageDescription>
    <NDC11Code>49281-0316-50</NDC11Code>
    <ProductNDC>49281-316</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Fluzone Quadrivalent Southern Hemisphere</ProprietaryName>
    <NonProprietaryName>Influenza A Virus A/california/7/2009 X-179a (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/hong Kong/4801/2014 X-263b (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/brisbane/60/2008 Antigen (formaldehyde Inactivated)</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20160324</StartMarketingDate>
    <EndMarketingDate>20161231</EndMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103914</ApplicationNumber>
    <LabelerName>Sanofi Pasteur Inc.</LabelerName>
    <SubstanceName>INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
    <StrengthNumber>15; 15; 15; 15</StrengthNumber>
    <StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-01-05</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>49281-320-50</NDCCode>
    <PackageDescription>10 SYRINGE, GLASS in 1 PACKAGE (49281-320-50)  &gt; .5 mL in 1 SYRINGE, GLASS (49281-320-88) </PackageDescription>
    <NDC11Code>49281-0320-50</NDC11Code>
    <ProductNDC>49281-320</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Fluzone Quadrivalent Southern Hemisphere</ProprietaryName>
    <NonProprietaryName>Influenza A Virus A/brisbane/02/2018 Ivr-190 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/south Australia/34/2019 Ivr-197 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/washington/02/2019 Antigen (formaldehyde Inactivated)</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20190930</StartMarketingDate>
    <EndMarketingDate>20201231</EndMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103914</ApplicationNumber>
    <LabelerName>Sanofi Pasteur Inc.</LabelerName>
    <SubstanceName>INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/SOUTH AUSTRALIA/34/2019 IVR-197 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
    <StrengthNumber>15; 15; 15; 15</StrengthNumber>
    <StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20190930</StartMarketingDatePackage>
    <EndMarketingDatePackage>20201231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>49281-321-50</NDCCode>
    <PackageDescription>10 SYRINGE, GLASS in 1 PACKAGE (49281-321-50)  &gt; .5 mL in 1 SYRINGE, GLASS (49281-321-88) </PackageDescription>
    <NDC11Code>49281-0321-50</NDC11Code>
    <ProductNDC>49281-321</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Fluzone Quadrivalent Southern Hemisphere</ProprietaryName>
    <NonProprietaryName>Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/hong Kong/2671/2019 Ivr-208 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/washington/02/2019 Antigen (formaldehyde Inactivated)</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20210204</StartMarketingDate>
    <EndMarketingDate>20211231</EndMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103914</ApplicationNumber>
    <LabelerName>Sanofi Pasteur Inc.</LabelerName>
    <SubstanceName>INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/2671/2019 IVR-208 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
    <StrengthNumber>15; 15; 15; 15</StrengthNumber>
    <StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20210204</StartMarketingDatePackage>
    <EndMarketingDatePackage>20211231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
</NDCList>
                    
<NDCList><NDC><NDCCode>49281-326-50</NDCCode><ProprietaryName>Fluzone Qiv Sh 2025</ProprietaryName><NonProprietaryName>Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/croatia/10136rv/2023 X-425a (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>13733-326-01</NDCCode><ProprietaryName>All Around Safe Block Aqua Sun Gel</ProprietaryName><NonProprietaryName>Octinoxate, Octocrylene, Octisalate, Avobenzone</NonProprietaryName></NDC><NDC><NDCCode>42973-326-00</NDCCode><NonProprietaryName>Cetrorelix Acetate</NonProprietaryName></NDC><NDC><NDCCode>46144-326-50</NDCCode><NonProprietaryName>Polidocanol</NonProprietaryName></NDC><NDC><NDCCode>49643-326-50</NDCCode><ProprietaryName>Grama Grass Pollen</ProprietaryName><NonProprietaryName>Bouteloua Spp.</NonProprietaryName></NDC><NDC><NDCCode>49716-326-50</NDCCode><NonProprietaryName>Gabapentin</NonProprietaryName></NDC><NDC><NDCCode>49967-326-01</NDCCode><ProprietaryName>Lancome Paris Renergie Lift Multi Action Broad Spectrum Spf 15 Sunscreen Lifting And Firming For Dry Skin</ProprietaryName><NonProprietaryName>Avobenzone, Octisalate And Octocrylene</NonProprietaryName></NDC><NDC><NDCCode>54575-326-50</NDCCode><ProprietaryName>Standardized Mite D Pteronyssinus</ProprietaryName><NonProprietaryName>Dermatophagoides Pteronyssinus</NonProprietaryName></NDC><NDC><NDCCode>55513-326-01</NDCCode><ProprietaryName>Riabni</ProprietaryName><NonProprietaryName>Rituximab-arrx</NonProprietaryName></NDC><NDC><NDCCode>55513-326-21</NDCCode><ProprietaryName>Riabni</ProprietaryName><NonProprietaryName>Rituximab-arrx</NonProprietaryName></NDC><NDC><NDCCode>55758-326-50</NDCCode><ProprietaryName>Dolex Fem</ProprietaryName><NonProprietaryName>Acetaminophen, Caffeine, Pyrilamine Maleate</NonProprietaryName></NDC><NDC><NDCCode>58411-326-50</NDCCode><ProprietaryName>Cle De Peau Beaute The Foundation</ProprietaryName><NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>58657-326-50</NDCCode><ProprietaryName>Multi-vitamin With Fluoride</ProprietaryName><NonProprietaryName>Vitamin A, Ascorbic Acid, Cholecalciferol, Alpha-tocopherol Acetate, Thiamine Hydrochloride, Riboflavin 5-phosphate Sodium, Cyanocobalamin, Niacinamide, Pyridoxine Hydrochloride And Sodium Fluoride</NonProprietaryName></NDC><NDC><NDCCode>58892-326-50</NDCCode><ProprietaryName>Tizo3</ProprietaryName><NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>59469-326-10</NDCCode><ProprietaryName>Cangust</ProprietaryName><NonProprietaryName>Horse Chestnut, Arnica Montana Root, Gold Trichloride, Activated Charcoal, Lachesis Muta Venom, Prunus Laurocerasus Leaf, Strophanthus Gratus Seed, And Tobacco Leaf</NonProprietaryName></NDC><NDC><NDCCode>59886-326-77</NDCCode><ProprietaryName>Ultrasolsunscreen</ProprietaryName><NonProprietaryName>Avobenzone, Octinoxate, Octisalate, Oxybenzone</NonProprietaryName></NDC><NDC><NDCCode>68462-326-50</NDCCode><ProprietaryName>Levofloxacin</ProprietaryName><NonProprietaryName>Levofloxacin</NonProprietaryName></NDC><NDC><NDCCode>69230-326-50</NDCCode><ProprietaryName>Famotidine</ProprietaryName><NonProprietaryName>Famotidine</NonProprietaryName></NDC><NDC><NDCCode>70700-326-50</NDCCode><ProprietaryName>Gallifrey</ProprietaryName><NonProprietaryName>Norethindrone Acetate</NonProprietaryName></NDC><NDC><NDCCode>71919-326-09</NDCCode><ProprietaryName>Grindelia</ProprietaryName><NonProprietaryName>Grindelia Squarrosa Flowering Top</NonProprietaryName></NDC><NDC><NDCCode>72603-326-01</NDCCode><ProprietaryName>Cyclophosphamide</ProprietaryName><NonProprietaryName>Cyclophosphamide</NonProprietaryName></NDC><NDC><NDCCode>84756-326-04</NDCCode><ProprietaryName>Hair Strengthening Oil</ProprietaryName><NonProprietaryName>Hair Strengthening Oil</NonProprietaryName></NDC><NDC><NDCCode>49281-013-50</NDCCode><ProprietaryName>Fluzone</ProprietaryName><NonProprietaryName>Influenza A Virus A/california/7/2009 X-179a (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/texas/50/2012 X-223a (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/massachusetts/2/2012 Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-014-50</NDCCode><ProprietaryName>Fluzone</ProprietaryName><NonProprietaryName>Influenza A Virus A/california/7/2009 X-179a (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/texas/50/2012 X-223a (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/massachusetts/2/2012 Bx-51b Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-016-50</NDCCode><ProprietaryName>Fluzone Hd Tiv Sh 2026</ProprietaryName><NonProprietaryName>Influenza A Virus A/switzerland/6849/2025 Ivr-278 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/singapore/gp20238/2024 Ivr-277 (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-026-50</NDCCode><ProprietaryName>Nuvaxovid 2026-27</ProprietaryName><NonProprietaryName>Nvx-cov2928</NonProprietaryName></NDC><NDC><NDCCode>49281-312-50</NDCCode><ProprietaryName>Fluzone Northern Hemisphere</ProprietaryName><NonProprietaryName>Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-316-50</NDCCode><ProprietaryName>Fluzone Quadrivalent Southern Hemisphere</ProprietaryName><NonProprietaryName>Influenza A Virus A/california/7/2009 X-179a (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/hong Kong/4801/2014 X-263b (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/brisbane/60/2008 Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-320-50</NDCCode><ProprietaryName>Fluzone Quadrivalent Southern Hemisphere</ProprietaryName><NonProprietaryName>Influenza A Virus A/brisbane/02/2018 Ivr-190 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/south Australia/34/2019 Ivr-197 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/washington/02/2019 Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-321-50</NDCCode><ProprietaryName>Fluzone Quadrivalent Southern Hemisphere</ProprietaryName><NonProprietaryName>Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/hong Kong/2671/2019 Ivr-208 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/washington/02/2019 Antigen (formaldehyde Inactivated)</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.

Parameter Meaning Notes
domain Domain
  • Currently following data domains are supported:
    • NPI - NPI Number Lookup
    • HCPCS - Healthcare Provider Procedure Coding System Lookup
    • NDC - National Drug Code Lookup
    • NDCA - Animal Drug Product Listing Directory Lookup
    • CLIA - Clinical Laboratory Improvement Amendments
    • HPTC - Healthcare Provider Taxonomy Code Lookup
    • NAICS - North American Industry Classification System Lookup
    • LOINC - Logical Observation Identifiers Names and Codes (LOINC®) Lookup
    • DRG - Diagnosis-Related Group Lookup
    • ICD9 - Ninth Revision of the International Classification of Diseases Lookup
    • ICD10 - Tenth Revision of the International Classification of Diseases Lookup
    • ICD10DRUGS - ICD-10-CM Table Of Drugs And Chemicals Lookup
    • ZIP - Postal Codes used by the United States Postal Service
operation Operation
  • Generic operations:
    • check_status - this method allows to get current code status.
    • search - allows retrieval of set of items (up to 30) 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.
    • 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.
  • 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.
q Query
  • The search expression. May vary depending on the operation.
    • Free form text like: “q=blood glucose monitor” (search operation)
    • Exact code value : “q=1285636522” (getcode operation)
    • List of codes : “q=1285636522,1730198755,1427145176,1487730636” (getcodes operation)
zipcode Query for NPI by Zip code/radius Lookup
  • The search expression for zip code.
    • Exact code value : “zipcode=98052” (search operation)
radius Query for NPI by Zip code/radius Lookup
  • The search expression for radius.
    • Exact code value : “radius=20” (search operation)
fromdate Query for Deactivated NPI
  • The search expression for fromdate.
    • Exact code value : “fromdate=05/01/2023” (search operation - format MM/DD/YYYY)
todate Query for Deactivated NPI
  • The search expression for tomdate.
    • Exact code value : “todate=05/31/2023” (search operation - format MM/DD/YYYY)
tin Query for IRS Lookup
  • The search expression for tin number.
    • Exact code value : “tin=942404110” (search operation)
tinname Query for IRS Lookup
  • The search expression for tin name.
    • Free form text like: “tinname=apple inc.” (search operation)
rt Data format
  • If you don't specify an rt parameter, the API returns data in the JSON format. This is equivalent to rt=json.
  • Accepted values are:
    • json
    • minjson (minified json)
    • xml
    • minxml (minified xml)
token Your API key
num Number of search results to return
  • You can specify the how many results to return for the current search.
  • Valid values are integers between 1 and 100, inclusive.
  • If num is not used, a value of 30 is assumed.
friendlyprint Returns a response with indentations and line breaks
  • If friendlyprint is not used, a “true” value is assumed. This is equivalent to friendlyprint=true.
  • Accepted values are:
    • true - the results returned by the server will be more “human readable”.
    • false - the results returned by the server will not have indentations and line breaks.
ICD9/ICD10 Parameters
codeType Specifies whether ICD code is "dx"(Diagnosis) or "pcs"(Procedure).
  • Required for ICD only.
  • If you don't specify an codeType parameter this is equivalent to codeType=dx.
  • Accepted values are:
    • dx (diagnosis)
    • pcs (procedure)
qf Specifies predicate in form of tuple "qf=City:true:Phoenix".
  • Expected to be one or many "qf" parameters in request.
  • Required for following operations:
    • validate
    • paginate_with_predicates
    • search_with_predicates
  • Tuple values are (order based):
    • NPI Field Name
      • NPI
      • Phone
      • Fax
      • FirstName
      • LastName
      • OrganizationName
      • OtherOrganizationName
      • Address1
      • Address2
      • Zip
      • City
      • State
      • IndividualOrganizationCode
    • Exact Match
      • true
      • false
    • Expected Field Value
orderField Sort order field name
  • Expected to be one "orderField" parameter in request.
  • Required for following operations:
    • paginate_with_predicates
  • Values are:
    • NPI
    • Phone
    • Fax
    • FirstName
    • LastName
    • OrganizationName
    • OtherOrganizationName
    • Address1
    • Address2
    • Zip
    • City
    • State
    • IndividualOrganizationCode
pageNo Page Number
  • Ordinal page number.
  • Required for following operations:
    • paginate_with_predicates
    • zipradius
    • npideactivated
pageSize Page Size
  • Expected page size.
  • Required for following operations:
    • paginate_with_predicates

DataLabs Coding Library - Quering NPI Registry - REST API Examples

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();
    }
}
            
        

Output

            
{
  "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",
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      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

Full Text Search Fundamentals

Facts

Everybody uses full text search. Full-text search is the most common technique used in search engines. The amount of information has just become too much to access it using navigation and categories alone. Full-text search reduces the hassle of searching for a keyword in huge amounts of metadata, such as the World Wide Web and commercial-scale databases. Full-text search became popular in late 1990s, when the Internet and Big Data began to became a part of everyday life.

How does it work

Users only provide keywords and expect the search engine to provide good results. Relevancy of documents is expected to be good and users want the results they are looking to be present in the top ten. How relevant a document is search engine decides based on scientifically proven algorithms. Besides getting the best results the user wants to be supported during the search process. Features like suggestions and highlighting on the result excerpt can help with this.

Full Text Search & DataLabs REST API

DataLabs REST API allows you to search the full text of healthcare providers database (NPI Registry). To find the information you need and make your search easy, please use our REST API for automation, or visit our NPI Lookup page for manual search ( NPI Number Lookup). We are still improving and enhancing Full Text NPI Search based on users feedbacks. Please email your comments and suggestions for improvement using our feedback page.

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();
        }
    }
                
            

Output

                
    {
      "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();
        }
    }
                
            

Output

                
    {
      "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();
        }
    }
                
            

Output

                
    {
      "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();
        }
    }
                
            

Output

                
{
  "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",
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}
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