RESTful Lookup — Test-Drive (2007 – 2026)

Query complete (8 ms elapsed)

{
  "NDC": [
    {
      "NDCCode": "69729-144-22",
      "PackageDescription": "12 TABLET in 1 PACKAGE (69729-144-22) ",
      "NDC11Code": "69729-0144-22",
      "ProductNDC": "69729-144",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Acetaminophen 500mg Caffeine 60mg Pyrilamine Maleate 15mg",
      "NonProprietaryName": "Acetaminophen 500mg Caffeine 60mg Pyrilamine Maleate 15mg",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200401",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part343",
      "LabelerName": "OPMX LLC",
      "SubstanceName": "CAFFEINE; PYRILAMINE MALEATE; ACETAMINOPHEN",
      "StrengthNumber": "60; 15; 500",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200401",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the temporary relief of these symptoms associated with menstrual periods. Cramps, bloating water-weight gain, headache, backache, muscle aches, fatigue."
    },
    {
      "NDCCode": "69729-145-22",
      "PackageDescription": "12 TABLET in 1 PACKAGE (69729-145-22) ",
      "NDC11Code": "69729-0145-22",
      "ProductNDC": "69729-145",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Acetaminophen 500mg Caffeine 60mg Pyrilamine Maleate 15mg",
      "NonProprietaryName": "Acetaminophen 500mg Caffeine 60mg Pyrilamine Maleate 15mg",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200401",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part343",
      "LabelerName": "OPMX LLC",
      "SubstanceName": "CAFFEINE; PYRILAMINE MALEATE; ACETAMINOPHEN",
      "StrengthNumber": "60; 15; 500",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200401",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the temporary relief of these symptoms associated with menstrual periods. Cramps, bloating water-weight gain, headache, backache, muscle aches, fatigue."
    },
    {
      "NDCCode": "69729-146-22",
      "PackageDescription": "12 TABLET in 1 PACKAGE (69729-146-22) ",
      "NDC11Code": "69729-0146-22",
      "ProductNDC": "69729-146",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Acetaminophen 500mg Caffeine 60mg Pyrilamine Maleate 15mg",
      "NonProprietaryName": "Acetaminophen 500mg Caffeine 60mg Pyrilamine Maleate 15mg",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200401",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part343",
      "LabelerName": "OPMX LLC",
      "SubstanceName": "CAFFEINE; PYRILAMINE MALEATE; ACETAMINOPHEN",
      "StrengthNumber": "60; 15; 500",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200401",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the temporary relief of these symptoms associated with menstrual periods. Cramps, bloating water-weight gain, headache, backache, muscle aches, fatigue."
    },
    {
      "NDCCode": "68345-820-22",
      "PackageDescription": "12 BOX in 1 CASE (68345-820-22)  > 144 POUCH in 1 BOX > .9 g in 1 POUCH",
      "NDC11Code": "68345-0820-22",
      "ProductNDC": "68345-820",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Repara Triple Antibiotic",
      "NonProprietaryName": "Bacitracin, Neomycin And Polymyxin B",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20071201",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part333B",
      "LabelerName": "PSS WORLD MEDICAL, INC.",
      "SubstanceName": "BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE",
      "StrengthNumber": "400; 3.5; 5000",
      "StrengthUnit": "[iU]/g; mg/g; [iU]/g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "First aid antibiotic to help prevent infection in: 1 minor cuts, 2 scrapes, 3 burns."
    },
    {
      "NDCCode": "82009-144-22",
      "PackageDescription": "2 KIT in 1 CARTON (82009-144-22)  / 1 KIT in 1 KIT *  1 SYRINGE in 1 TRAY (82009-145-11)  / .4 mL in 1 SYRINGE *  2 PACKET in 1 TRAY / 1 mL in 1 PACKET",
      "NDC11Code": "82009-0144-22",
      "ProductNDC": "82009-144",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Adalimumab-adbm",
      "NonProprietaryName": "Adalimumab-adbm",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20240430",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA761058",
      "LabelerName": "QUALLENT PHARMACEUTICALS HEALTH LLC",
      "Status": "Active",
      "LastUpdate": "2025-11-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240430",
      "SamplePackage": "N",
      "IndicationAndUsage": "Adalimumab-adbm is a tumor necrosis factor (TNF) blocker indicated for: 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. , 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. (1.8), 9  Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. (1.9).",
      "Description": "Adalimumab-adbm is a tumor necrosis factor blocker. Adalimumab-adbm is a recombinant human IgG1 monoclonal antibody produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. Adalimumab-adbm injection is supplied as a sterile, preservative-free solution of adalimumab-adbm for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (Adalimumab-adbm Pen) or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the pen is a single-dose, 1 mL prefilled glass syringe. The solution of Adalimumab-adbm is clear to slightly opalescent and colorless to slightly yellow, with a pH of about 5.5. Each 40 mg/0.4 mL prefilled syringe or prefilled pen delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of Adalimumab-adbm contains adalimumab-adbm (40 mg), glacial acetic acid (0.03 mg), polysorbate 80 (0.2 mg), sodium acetate trihydrate (0.47 mg), trehalose dihydrate (30.3 mg), and Water for Injection, USP. Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of Adalimumab-adbm contains adalimumab-adbm (40 mg), glacial acetic acid (0.13 mg), polysorbate 80 (0.8 mg), sodium acetate trihydrate (2.4 mg), trehalose dihydrate (65.0 mg), and Water for Injection, USP. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of Adalimumab-adbm contains adalimumab-adbm (20 mg), glacial acetic acid (0.06 mg), polysorbate 80 (0.4 mg), sodium acetate trihydrate (1.21 mg), trehalose dihydrate (32.5 mg), and Water for Injection, USP. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of Adalimumab-adbm contains adalimumab-adbm (10 mg), glacial acetic acid (0.03 mg), polysorbate 80 (0.2 mg), sodium acetate trihydrate (0.61 mg), trehalose dihydrate (16.3 mg), and Water for Injection, USP."
    },
    {
      "NDCCode": "69729-122-38",
      "PackageDescription": "144 TABLET in 1 POUCH (69729-122-38) ",
      "NDC11Code": "69729-0122-38",
      "ProductNDC": "69729-122",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl",
      "NonProprietaryName": "Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190826",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "OPMX LLC",
      "SubstanceName": "ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "500; 4; 10",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-12-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190826",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporarily relieves these symptoms of hay fever or other respiratory allergies: 1 headache, 2 nasal congestion, 3 sinus congestion & pressure, 4 runny nose and sneezing, 5 minor aches & pain."
    },
    {
      "NDCCode": "69729-222-38",
      "PackageDescription": "144 TABLET in 1 POUCH (69729-222-38) ",
      "NDC11Code": "69729-0222-38",
      "ProductNDC": "69729-222",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl",
      "NonProprietaryName": "Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190826",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "OPMX LLC",
      "SubstanceName": "ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "500; 4; 10",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20190826",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporarily relieves these symptoms of hay fever or other respiratory allergies: 1 Headache, 2 Nasal congestion, 3 Sinus congestion & pressure, 4 Runny nose and sneezing, 5 Minor aches & pain."
    },
    {
      "NDCCode": "69729-322-38",
      "PackageDescription": "144 TABLET in 1 POUCH (69729-322-38) ",
      "NDC11Code": "69729-0322-38",
      "ProductNDC": "69729-322",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl",
      "NonProprietaryName": "Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190826",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "OPMX LLC",
      "SubstanceName": "ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "500; 4; 10",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-03-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190826",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporarily relieves these symptoms of hay fever or other respiratory allergies: 1 Headache, 2 Nasal congestion, 3 Sinus congestion & pressure, 4 Runny nose and sneezing, 5 Minor aches & pain."
    },
    {
      "NDCCode": "69729-610-05",
      "PackageDescription": "1 TUBE in 1 BOX (69729-610-05)  / 14 g in 1 TUBE (69729-610-01) ",
      "NDC11Code": "69729-0610-05",
      "ProductNDC": "69729-610",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Canespies",
      "NonProprietaryName": "Tolnaftate",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20220726",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M005",
      "LabelerName": "OPMX LLC",
      "SubstanceName": "TOLNAFTATE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/100g",
      "Status": "Active",
      "LastUpdate": "2024-05-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220726",
      "SamplePackage": "N",
      "IndicationAndUsage": "PROVEN CLINICALLY EFFECTIVE IN THE TREATMENT OF ATHLETE'S FOOT (TINEA PEDIS), JOCK ITCH (TINEA CRURIS), RINGWORM (TINEA CORPORIS). PROVEN EFFECTIVE IN THE PREVENTION OF ATHLETE'S FOOT. EFFECTIVELY SOOTHES AND RELIEVES ITCHING ASSOCIATED WITH JOCK ITCH, SCALY SKIN BETWEEN THE TOES AND BURNING FEET."
    },
    {
      "NDCCode": "69729-615-05",
      "PackageDescription": "1 TUBE in 1 BOX (69729-615-05)  / 14 g in 1 TUBE (69729-615-01) ",
      "NDC11Code": "69729-0615-05",
      "ProductNDC": "69729-615",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Penimixcina",
      "NonProprietaryName": "Bacitracin, Neomycin Sulfate, Polymixin B Sulfate, Pramoxine Hydrochloride",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20180905",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M004",
      "LabelerName": "OPMX LLC",
      "SubstanceName": "BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE",
      "StrengthNumber": "500; 5; 5000; 10",
      "StrengthUnit": "[iU]/g; mg/g; [iU]/g; mg/g",
      "Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]",
      "Status": "Active",
      "LastUpdate": "2024-05-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180905",
      "SamplePackage": "N",
      "IndicationAndUsage": "FIRST AID TO HELP PREVENT INFECTION IN. MINOR CUTS. SCRAPES. BURNS."
    },
    {
      "NDCCode": "69729-782-10",
      "PackageDescription": "10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (69729-782-10) ",
      "NDC11Code": "69729-0782-10",
      "ProductNDC": "69729-782",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Acetaminophen, Guaifenesin, Dextromethorphan Hbr, Phenylephrine Hcl",
      "NonProprietaryName": "Acetaminophen, Guaifenesin, Dextromethorphan Hbr, Phenylephrine Hcl",
      "DosageFormName": "CAPSULE, LIQUID FILLED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190218",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "OPMX LLC",
      "SubstanceName": "ACETAMINOPHEN; GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "325; 200; 10; 5",
      "StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
      "Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-05-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190218",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporarily relieves common cold/flu symptoms: 1 Nasal congestion, 2 Sinus congestion & pressure, 3 Cough due to minor throat & bronchial irritation, 4 Minor aches & pain, 5 Headache, 6 Fever, 7 Sore throat, 8 Reduces swelling of nasal passages, 9 Temporarily restore freer breathing through the nose, 10 Promotes nasal and/or sinus drainage, 11 Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive."
    },
    {
      "NDCCode": "0006-5084-01",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0006-5084-01) ",
      "NDC11Code": "00006-5084-01",
      "ProductNDC": "0006-5084",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lipfendra",
      "NonProprietaryName": "Lipfendra",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260715",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA220848",
      "LabelerName": "Merck Sharp & Dohme LLC",
      "SubstanceName": "ENLICITIDE DECANOATE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Status": "Active",
      "LastUpdate": "2026-07-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260715",
      "SamplePackage": "N",
      "IndicationAndUsage": "LIPFENDRA® is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Cardiovascular outcomes trials have demonstrated that reducing LDL-C lowers the risk for major adverse cardiovascular events (MACE) in adults at increased risk when treated with statins or monoclonal antibody proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors as an add-on to statin therapy.",
      "Description": "LIPFENDRA (enlicitide) tablets for oral use contain enlicitide decanoate, a PCSK9 inhibitor. The chemical name of enlicitide decanoate is 6-({[(11S,17S,20S,23S,27S,39S,42S,63S,66R)-47-Fluoro-20-[(1R)-1-hydroxyethyl]-17-[(4-methoxyphenyl)methyl]-11,63-dimethyl-10,16,19,22,30,40,58,61,64,67,70-undecaoxo-28-oxa-1,9,15,18,21,24,31,41,51,62,65,68-dodecaazanonacyclo[37.18.11.23,6.124,42.133,37.144,51.011,15.023,27.045,50]triheptaconta-3,5,33(71),34,36,44(69),45,47,49,72-decaen-66-yl]methyl}amino)-N,N,N-trimethyl-6-oxohexan-1-aminium decanoate. Enlicitide decanoate is a white to off-white powder that is slightly soluble in water. The molecular formula is C92H129FN14O17 and the molecular weight is 1722.12 g/mol. The chemical structure of enlicitide decanoate is. LIPFENDRA is available as film-coated tablets for oral administration, each containing 20 mg of enlicitide (equivalent to 22.21 mg enlicitide decanoate) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium caprate. The film coating contains calcium carbonate, ethylene glycol and vinyl alcohol graft copolymer, glyceryl mono and dicaprylocaprate, polyvinyl alcohol, and talc. Carnauba wax is added as a polishing agent."
    },
    {
      "NDCCode": "0006-5084-59",
      "PackageDescription": "1 BOTTLE in 1 CARTON (0006-5084-59)  / 7 TABLET, FILM COATED in 1 BOTTLE (0006-5084-58) ",
      "NDC11Code": "00006-5084-59",
      "ProductNDC": "0006-5084",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lipfendra",
      "NonProprietaryName": "Lipfendra",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260715",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA220848",
      "LabelerName": "Merck Sharp & Dohme LLC",
      "SubstanceName": "ENLICITIDE DECANOATE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Status": "Active",
      "LastUpdate": "2026-07-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260715",
      "SamplePackage": "Y",
      "IndicationAndUsage": "LIPFENDRA® is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Cardiovascular outcomes trials have demonstrated that reducing LDL-C lowers the risk for major adverse cardiovascular events (MACE) in adults at increased risk when treated with statins or monoclonal antibody proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors as an add-on to statin therapy.",
      "Description": "LIPFENDRA (enlicitide) tablets for oral use contain enlicitide decanoate, a PCSK9 inhibitor. The chemical name of enlicitide decanoate is 6-({[(11S,17S,20S,23S,27S,39S,42S,63S,66R)-47-Fluoro-20-[(1R)-1-hydroxyethyl]-17-[(4-methoxyphenyl)methyl]-11,63-dimethyl-10,16,19,22,30,40,58,61,64,67,70-undecaoxo-28-oxa-1,9,15,18,21,24,31,41,51,62,65,68-dodecaazanonacyclo[37.18.11.23,6.124,42.133,37.144,51.011,15.023,27.045,50]triheptaconta-3,5,33(71),34,36,44(69),45,47,49,72-decaen-66-yl]methyl}amino)-N,N,N-trimethyl-6-oxohexan-1-aminium decanoate. Enlicitide decanoate is a white to off-white powder that is slightly soluble in water. The molecular formula is C92H129FN14O17 and the molecular weight is 1722.12 g/mol. The chemical structure of enlicitide decanoate is. LIPFENDRA is available as film-coated tablets for oral administration, each containing 20 mg of enlicitide (equivalent to 22.21 mg enlicitide decanoate) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium caprate. The film coating contains calcium carbonate, ethylene glycol and vinyl alcohol graft copolymer, glyceryl mono and dicaprylocaprate, polyvinyl alcohol, and talc. Carnauba wax is added as a polishing agent."
    },
    {
      "NDCCode": "0078-0331-84",
      "PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (0078-0331-84)  / 5 mL in 1 VIAL, SINGLE-USE",
      "NDC11Code": "00078-0331-84",
      "ProductNDC": "0078-0331",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Simulect",
      "NonProprietaryName": "Basiliximab",
      "DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19980512",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103764",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "BASILIXIMAB",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Interleukin 2 Receptor Antagonists [MoA], Interleukin 2 Receptor-directed Antibody Interactions [MoA], Interleukin-2 Receptor Blocking Antibody [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19980512",
      "SamplePackage": "N",
      "IndicationAndUsage": "Simulect® (basiliximab) is indicated for the prophylaxis of acute organ rejection in patients receiving renal transplantation when used as part of an immunosuppressive regimen that includes cyclosporine, USP (MODIFIED), and corticosteroids. The efficacy of Simulect for the prophylaxis of acute rejection in recipients of other solid organ allografts has not been demonstrated.",
      "Description": "Basiliximab is a chimeric (murine/human) monoclonal antibody (IgG1к), produced by recombinant DNA technology, that functions as an immunosuppressive agent, specifically binding to and blocking the interleukin-2 receptor α-chain (IL-2Rα, also known as CD25 antigen) on the surface of activated T-lymphocytes. Based on the amino acid sequence, the calculated molecular weight of the protein is 144 kilodaltons. It is a glycoprotein obtained from fermentation of an established mouse myeloma cell line genetically engineered to express plasmids containing the human heavy and light chain constant region genes and mouse heavy and light chain variable region genes encoding the RFT5 antibody that binds selectively to the IL-2Rα. Simulect® (basiliximab) for injection is a sterile, preservative-free lyophilisate, which is available in single-dose vials and is available in 10 mg and 20 mg strengths for intravenous administration after reconstitution. Each 10-mg vial contains 10 mg of basiliximab, and dibasic sodium phosphate (anhydrous) (0.50 mg), glycine (20.3 mg), mannitol (40.6 mg), monobasic potassium phosphate (3.66 mg), sodium chloride (0.82 mg), and sucrose (10.1 mg) to be reconstituted in 2.5 mL of Sterile Water for Injection, USP. Each 20-mg vial contains 20 mg of basiliximab, and dibasic sodium phosphate (anhydrous) (0.99 mg), glycine (40.1 mg), mannitol (80.1 mg), monobasic potassium phosphate (7.22 mg), sodium chloride (1.61 mg), and sucrose (20 mg) to be reconstituted in 5 mL of Sterile Water for Injection, USP."
    },
    {
      "NDCCode": "0078-0393-61",
      "PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (0078-0393-61)  / 2.5 mL in 1 VIAL, SINGLE-USE",
      "NDC11Code": "00078-0393-61",
      "ProductNDC": "0078-0393",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Simulect",
      "NonProprietaryName": "Basiliximab",
      "DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19980512",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103764",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "BASILIXIMAB",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/2.5mL",
      "Pharm_Classes": "Interleukin 2 Receptor Antagonists [MoA], Interleukin 2 Receptor-directed Antibody Interactions [MoA], Interleukin-2 Receptor Blocking Antibody [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19980512",
      "SamplePackage": "N",
      "IndicationAndUsage": "Simulect® (basiliximab) is indicated for the prophylaxis of acute organ rejection in patients receiving renal transplantation when used as part of an immunosuppressive regimen that includes cyclosporine, USP (MODIFIED), and corticosteroids. The efficacy of Simulect for the prophylaxis of acute rejection in recipients of other solid organ allografts has not been demonstrated.",
      "Description": "Basiliximab is a chimeric (murine/human) monoclonal antibody (IgG1к), produced by recombinant DNA technology, that functions as an immunosuppressive agent, specifically binding to and blocking the interleukin-2 receptor α-chain (IL-2Rα, also known as CD25 antigen) on the surface of activated T-lymphocytes. Based on the amino acid sequence, the calculated molecular weight of the protein is 144 kilodaltons. It is a glycoprotein obtained from fermentation of an established mouse myeloma cell line genetically engineered to express plasmids containing the human heavy and light chain constant region genes and mouse heavy and light chain variable region genes encoding the RFT5 antibody that binds selectively to the IL-2Rα. Simulect® (basiliximab) for injection is a sterile, preservative-free lyophilisate, which is available in single-dose vials and is available in 10 mg and 20 mg strengths for intravenous administration after reconstitution. Each 10-mg vial contains 10 mg of basiliximab, and dibasic sodium phosphate (anhydrous) (0.50 mg), glycine (20.3 mg), mannitol (40.6 mg), monobasic potassium phosphate (3.66 mg), sodium chloride (0.82 mg), and sucrose (10.1 mg) to be reconstituted in 2.5 mL of Sterile Water for Injection, USP. Each 20-mg vial contains 20 mg of basiliximab, and dibasic sodium phosphate (anhydrous) (0.99 mg), glycine (40.1 mg), mannitol (80.1 mg), monobasic potassium phosphate (7.22 mg), sodium chloride (1.61 mg), and sucrose (20 mg) to be reconstituted in 5 mL of Sterile Water for Injection, USP."
    },
    {
      "NDCCode": "10695-144-10",
      "PackageDescription": "1 kg in 1 CONTAINER (10695-144-10) ",
      "NDC11Code": "10695-0144-10",
      "ProductNDC": "10695-144",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Marbofloxacin",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20221116",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Willow Birch Pharma, LLC.",
      "SubstanceName": "MARBOFLOXACIN",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2026-02-06",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "16-NOV-22"
    },
    {
      "NDCCode": "12539-144-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE (12539-144-01) ",
      "NDC11Code": "12539-0144-01",
      "ProductNDC": "12539-144",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Uretron D/s",
      "NonProprietaryName": "Methenamine, Sodium Phosphate Monobasic, Phenyl Salicylate, Methylene Blue, And Hyoscyamine Sulfate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20221007",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals",
      "SubstanceName": "SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; PHENYL SALICYLATE; HYOSCYAMINE SULFATE; METHYLENE BLUE; METHENAMINE",
      "StrengthNumber": "40.8; 36.2; .12; 10.8; 81.6",
      "StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Oxidation-Reduction Activity [MoA], Oxidation-Reduction Agent [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-12-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20221007",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uretron D/Stablets are indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures.",
      "Description": "Uretron D/S tablets for oral administration. HYOSCYAMINE SULFATE. [620-61-1][3(S)-endo]-α-(Hydroxymethyl)-benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester sulfate(2:1)(salt); 1αH,5αH-tropan-3α-ol(-)-tropate(ester) sulfate(2:1)(salt);3α-tropanyl S-(-)-tropate; l-tropic acid ester with tropine; l-tropine tropate. C 34H 48N 2O 10S. Hyoscyamine Sulfate is an alkaloid of belladonna. Exists as a white crystalline powder. Its solutions are alkaline to litmus. Affected by light, it is slightly soluble in water; freely soluble in alcohol; sparingly soluble in ether. METHENAMINE. [100-97-0] 1,3,5,7-Tetraazatricyclo [3.3.1.-1 3,7] decane; hexamethylenetetramine; HMT; HMTA; hexamine; 1,3,5,7-tetraazaadamantane hexamethylenemine; Uritone; Urotropin. C 6H 12N 4; mol wt 140.19; C 51.40%, H 8.63%, N 39.96%. Methenamine (hexamethylenetetramine) exists as colorless, lustrous crystals or white crystalline powder. Its solutions are alkaline to litmus. Freely soluble in water, soluble in alcohol and in chloroform. METHYLENE BLUE. [61-73-4] 3,7-Bis(dimethylamino) phenothiazin-5-ium chloride; C.I. Basic Blue 9; methylthioninium chloride; tetramethylthionine chloride; 3,7-bis(dimethylamino) phenazathionium chloride. C 16H 18ClN 3S; mol wt 319.85, C 60.08%, H 5.67%, Cl 11.08%, N 13.14%, S 10.03%. Methylene Blue (Methylthionine chloride) exists as dark green crystals. It is soluble in water and in chloroform; sparingly soluble in alcohol. PHENYL SALICYLATE. [118-55-8] 2-Hydroxybenzoic acid phenyl ester; Salol. C 13H 10O 3; mol wt 214.22, C 72.89%, H 4.71%, O 22.41%. Made by the action of phosphorus oxy-chloride on a mixture of phenol and salicylic acid. Phenyl Salicylate exists as white crystals with a melting point of 41°-43° C. It is very slightly soluble in water and freely soluble in alcohol. SODIUM PHOSPHATE MONOBASIC. [7558-80-7] Phosphoric acid sodium salt (1:1); Sodium biphosphate; sodium dihydrogen phosphate; acid sodium phosphate; monosodium orthophosphate; primary sodium phosphate; H 2NaO 4P; mol wt 119.98, H 1.68%, Na 19.16%, O 53.34%, P 25.82%. Monohydrate, white, odorless slightly deliquesce crystals or granules. At 100° C loses all its water; when ignited it converts to metaphosphate. It is freely soluble in water and practically insoluble in alcohol. The aqueous solution is acid. pH of 0.1 molar aqueous solution at 25° C: 4.5. Uretron D/Stablets contain inactive ingredients: Crospovidone, Dicalcium Phosphate, FD&C Blue #1 Aluminum Lake, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Stearic Acid, Talc, and Titanium Dioxide."
    },
    {
      "NDCCode": "21130-863-09",
      "PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (21130-863-09)  / 144 SPRAY, METERED in 1 BOTTLE, SPRAY",
      "NDC11Code": "21130-0863-09",
      "ProductNDC": "21130-863",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Allergy Relief",
      "NonProprietaryName": "Fluticasone Propionate",
      "DosageFormName": "SPRAY, METERED",
      "RouteName": "NASAL",
      "StartMarketingDate": "20250106",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207957",
      "LabelerName": "Safeway",
      "SubstanceName": "FLUTICASONE PROPIONATE",
      "StrengthNumber": "50",
      "StrengthUnit": "ug/1",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-04-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250106",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: 1 nasal congestion, 2 itchy nose, 3 runny nose, 4 itchy, watery eyes, 5 sneezing."
    },
    {
      "NDCCode": "21130-863-10",
      "PackageDescription": "2 BOTTLE, SPRAY in 1 CARTON (21130-863-10)  / 144 SPRAY, METERED in 1 BOTTLE, SPRAY",
      "NDC11Code": "21130-0863-10",
      "ProductNDC": "21130-863",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Allergy Relief",
      "NonProprietaryName": "Fluticasone Propionate",
      "DosageFormName": "SPRAY, METERED",
      "RouteName": "NASAL",
      "StartMarketingDate": "20250106",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207957",
      "LabelerName": "Safeway",
      "SubstanceName": "FLUTICASONE PROPIONATE",
      "StrengthNumber": "50",
      "StrengthUnit": "ug/1",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-04-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250304",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: 1 nasal congestion, 2 itchy nose, 3 runny nose, 4 itchy, watery eyes, 5 sneezing."
    },
    {
      "NDCCode": "25021-144-99",
      "PackageDescription": "1 BOTTLE in 1 CARTON (25021-144-99)  / 100 mL in 1 BOTTLE",
      "NDC11Code": "25021-0144-99",
      "ProductNDC": "25021-144",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ampicillin And Sulbactam",
      "NonProprietaryName": "Ampicillin And Sulbactam",
      "DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20100812",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065403",
      "LabelerName": "Sagent Pharmaceuticals",
      "SubstanceName": "AMPICILLIN SODIUM; SULBACTAM SODIUM",
      "StrengthNumber": "100; 50",
      "StrengthUnit": "mg/mL; mg/mL",
      "Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-11-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20100812",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ampicillin and Sulbactam for Injection, USP is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli*, Klebsiella spp.* (including K. pneumoniae*), Proteus mirabilis*, Bacteroides fragilis*, Enterobacter spp.*, and Acinetobacter calcoaceticus*. NOTE: For information on use in pediatric patients see PRECAUTIONS-Pediatric Use and CLINICAL STUDIES sections. Intra-Abdominal Infections caused by beta-lactamase producing strains of Escherichia coli, Klebsiella spp. (including K. pneumoniae*), Bacteroides spp. (including B. fragilis), and Enterobacter spp.*. Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli*, and Bacteroides spp.* (including B. fragilis*). *Efficacy for this organism in this organ system was studied in fewer than 10 infections. While Ampicillin and Sulbactam for Injection, USP is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with Ampicillin and Sulbactam for Injection, USP due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to Ampicillin and Sulbactam for Injection, USP should not require the addition of another antibacterial. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to Ampicillin and Sulbactam for Injection, USP. Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above in the indicated organ systems. Once the results are known, therapy should be adjusted if appropriate. To reduce the development of drug-resistant bacteria and maintain effectiveness of Ampicillin and Sulbactam for Injection, USP and other antibacterial drugs, Ampicillin and Sulbactam for Injection, USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
      "Description": "Ampicillin and Sulbactam for Injection, USP is an injectable antibacterial combination consisting of the semisynthetic antibacterial ampicillin sodium and the beta-lactamase inhibitor sulbactam sodium for intravenous and intramuscular administration. Ampicillin sodium is derived from the penicillin nucleus, 6-aminopenicillanic acid. Chemically, it is monosodium (2S, 5R, 6R)-6-[(R)-2-amino-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate and has a molecular weight of 371.39. Its chemical formula is C16H18N3NaO4S. The structural formula is:. Sulbactam sodium is a derivative of the basic penicillin nucleus. Chemically, sulbactam sodium is sodium penicillinate sulfone; sodium (2S, 5R)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate 4,4-dioxide. Its chemical formula is C8H10NNaO5S with a molecular weight of 255.22. The structural formula is:. Ampicillin and Sulbactam for Injection, USP, ampicillin sodium/sulbactam sodium parenteral combination, is available as a white to off-white dry powder for reconstitution. Ampicillin and Sulbactam for Injection, USP dry powder is freely soluble in aqueous diluents to yield pale yellow to yellow solutions containing ampicillin sodium and sulbactam sodium equivalent to 250 mg ampicillin per mL and 125 mg sulbactam per mL. The pH of the solutions is between 8 and 10. Dilute solutions (up to 30 mg ampicillin and 15 mg sulbactam per mL) are essentially colorless to pale yellow. The pH of dilute solutions remains the same. Each sterile Pharmacy Bulk Package contains 15 grams Ampicillin and Sulbactam for Injection, USP (equivalent to 10 grams ampicillin as the sodium salt plus 5 grams sulbactam as the sodium salt). The sodium content is approximately 1150 mg (50 mEq) sodium. Ampicillin and Sulbactam for Injection, USP Pharmacy Bulk Package is a bottle containing a sterile preparation of ampicillin sodium and sulbactam sodium for parenteral use that contains many single doses. The Pharmacy Bulk Package is for use in a pharmacy admixture setting; it provides many single doses of Ampicillin and Sulbactam for Injection, USP for addition to suitable parenteral fluids in the preparation of admixtures for intravenous infusion. (See DIRECTIONS FOR USE - Directions for Proper Use of Pharmacy Bulk Package.) FURTHER DILUTION IS REQUIRED BEFORE USE."
    },
    {
      "NDCCode": "37000-871-51",
      "PackageDescription": "1 TUBE in 1 CARTON (37000-871-51)  > 144 g in 1 TUBE",
      "NDC11Code": "37000-0871-51",
      "ProductNDC": "37000-871",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Crest Pro-health",
      "ProprietaryNameSuffix": "Advanced",
      "NonProprietaryName": "Stannous Fluoride",
      "DosageFormName": "PASTE, DENTIFRICE",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20150201",
      "EndMarketingDate": "20190121",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part355",
      "LabelerName": "The Procter & Gamble Manufacturing Company",
      "SubstanceName": "STANNOUS FLUORIDE",
      "StrengthNumber": "1.6",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2019-01-22",
      "ProductNdcExcludeFlag": "N"
    },
    {
      "NDCCode": "37000-887-05",
      "PackageDescription": "1 TUBE in 1 CARTON (37000-887-05)  > 144 g in 1 TUBE",
      "NDC11Code": "37000-0887-05",
      "ProductNDC": "37000-887",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Crest Pro-health Advanced",
      "ProprietaryNameSuffix": "Extra Deep Clean",
      "NonProprietaryName": "Stannous Fluoride",
      "DosageFormName": "GEL, DENTIFRICE",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20160101",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part355",
      "LabelerName": "The Procter & Gamble Manufacturing Company",
      "SubstanceName": "STANNOUS FLUORIDE",
      "StrengthNumber": "1.6",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2019-06-22",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "37000-987-51",
      "PackageDescription": "1 TUBE in 1 CARTON (37000-987-51)  / 144 g in 1 TUBE",
      "NDC11Code": "37000-0987-51",
      "ProductNDC": "37000-987",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Crest Pro-health Advanced",
      "ProprietaryNameSuffix": "Enamel Restore",
      "NonProprietaryName": "Stannous Fluoride",
      "DosageFormName": "PASTE, DENTIFRICE",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20201231",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M021",
      "LabelerName": "The Procter & Gamble Manufacturing Company",
      "SubstanceName": "STANNOUS FLUORIDE",
      "StrengthNumber": "1.6",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2025-08-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201231",
      "SamplePackage": "N",
      "IndicationAndUsage": "aids in the prevention of cavities. helps prevent gingivitis. helps interfere with the harmful effects of plaque associated with gingivitis. helps control plaque bacteria that contribute to the development of gingivitis. builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact."
    },
    {
      "NDCCode": "37000-988-51",
      "PackageDescription": "1 TUBE in 1 CARTON (37000-988-51)  / 144 g in 1 TUBE",
      "NDC11Code": "37000-0988-51",
      "ProductNDC": "37000-988",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Crest Pro-health Advanced",
      "ProprietaryNameSuffix": "With A Touch Of Scope",
      "NonProprietaryName": "Stannous Fluoride",
      "DosageFormName": "PASTE, DENTIFRICE",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20201231",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M021",
      "LabelerName": "The Procter & Gamble Manufacturing Company",
      "SubstanceName": "STANNOUS FLUORIDE",
      "StrengthNumber": "1.6",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2025-08-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201231",
      "SamplePackage": "N",
      "IndicationAndUsage": "aids in the prevention of cavities. helps prevent gingivitis. helps interfere with the harmful effects of plaque associated with gingivitis. helps control plaque bacteria that contribute to the development of gingivitis. builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact."
    },
    {
      "NDCCode": "39892-0601-1",
      "PackageDescription": "5 BOX in 1 CASE (39892-0601-1)  > 144 TUBE in 1 BOX > 17 g in 1 TUBE",
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      "ProductTypeName": "HUMAN OTC DRUG",
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      "StartMarketingDate": "20100518",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part355",
      "LabelerName": "Owens and Minor",
      "SubstanceName": "SODIUM FLUORIDE",
      "StrengthNumber": "22",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Aids in the prevention of dental cavities."
    },
    {
      "NDCCode": "39892-0601-2",
      "PackageDescription": "5 BOX in 1 CASE (39892-0601-2)  > 144 TUBE in 1 BOX > 24 g in 1 TUBE",
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      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
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      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Aids in the prevention of dental cavities."
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    {
      "NDCCode": "45802-060-70",
      "PackageDescription": "144 PACKET in 1 CARTON (45802-060-70)  / .9 g in 1 PACKET",
      "NDC11Code": "45802-0060-70",
      "ProductNDC": "45802-060",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Bacitracin",
      "NonProprietaryName": "Bacitracin",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110620",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M004",
      "LabelerName": "Padagis Israel Pharmaceuticals Ltd",
      "SubstanceName": "BACITRACIN",
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      "StrengthUnit": "[USP'U]/g",
      "Pharm_Classes": "Decreased Cell Wall Synthesis & Repair [PE]",
      "Status": "Active",
      "LastUpdate": "2024-08-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20110620",
      "SamplePackage": "N",
      "IndicationAndUsage": "first aid to help prevent infection in: : 1 minor cuts , 2 scrapes , 3 burns."
    },
    {
      "NDCCode": "49348-144-46",
      "PackageDescription": "14 PATCH in 1 CARTON (49348-144-46)  > 24 h in 1 PATCH",
      "NDC11Code": "49348-0144-46",
      "ProductNDC": "49348-144",
      "ProductTypeName": "HUMAN OTC DRUG",
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      "ProprietaryNameSuffix": "Transdermal System Step 1",
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      "RouteName": "TRANSDERMAL",
      "StartMarketingDate": "20151102",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020076",
      "LabelerName": "Strategic Sourcing Services LLC",
      "SubstanceName": "NICOTINE",
      "StrengthNumber": "21",
      "StrengthUnit": "mg/24h",
      "Status": "Deprecated",
      "LastUpdate": "2021-12-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20151102",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "49527-059-01",
      "PackageDescription": "1 BOTTLE in 1 CARTON (49527-059-01)  > 144 mL in 1 BOTTLE",
      "NDC11Code": "49527-0059-01",
      "ProductNDC": "49527-059",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Clinique Broad Spectrum Spf 30 Sunscreen Body Mist",
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      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20170601",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "CLINIQUE LABORATORIES LLC",
      "SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE",
      "StrengthNumber": ".0261; .087; .0392",
      "StrengthUnit": "g/mL; g/mL; g/mL",
      "Status": "Deprecated",
      "LastUpdate": "2021-07-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20170601",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "51289-400-03",
      "PackageDescription": "144 TUBE in 1 BOX (51289-400-03)  > 43 g in 1 TUBE",
      "NDC11Code": "51289-0400-03",
      "ProductNDC": "51289-400",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Fluoride Gel",
      "NonProprietaryName": "Sodium Fluoride",
      "DosageFormName": "PASTE",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20150501",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part356",
      "LabelerName": "Yangzhou Hengyuan Daily Chemical Plastic Co.,Ltd",
      "SubstanceName": "SODIUM FLUORIDE",
      "StrengthNumber": ".22",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "helps protect against cavities."
    }
  ]
}
                    

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<NDCList>
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    <PackageDescription>12 TABLET in 1 PACKAGE (69729-144-22) </PackageDescription>
    <NDC11Code>69729-0144-22</NDC11Code>
    <ProductNDC>69729-144</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Acetaminophen 500mg Caffeine 60mg Pyrilamine Maleate 15mg</ProprietaryName>
    <NonProprietaryName>Acetaminophen 500mg Caffeine 60mg Pyrilamine Maleate 15mg</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200401</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part343</ApplicationNumber>
    <LabelerName>OPMX LLC</LabelerName>
    <SubstanceName>CAFFEINE; PYRILAMINE MALEATE; ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>60; 15; 500</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the temporary relief of these symptoms associated with menstrual periods. Cramps, bloating water-weight gain, headache, backache, muscle aches, fatigue.</IndicationAndUsage>
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  <NDC>
    <NDCCode>69729-145-22</NDCCode>
    <PackageDescription>12 TABLET in 1 PACKAGE (69729-145-22) </PackageDescription>
    <NDC11Code>69729-0145-22</NDC11Code>
    <ProductNDC>69729-145</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Acetaminophen 500mg Caffeine 60mg Pyrilamine Maleate 15mg</ProprietaryName>
    <NonProprietaryName>Acetaminophen 500mg Caffeine 60mg Pyrilamine Maleate 15mg</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200401</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part343</ApplicationNumber>
    <LabelerName>OPMX LLC</LabelerName>
    <SubstanceName>CAFFEINE; PYRILAMINE MALEATE; ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>60; 15; 500</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the temporary relief of these symptoms associated with menstrual periods. Cramps, bloating water-weight gain, headache, backache, muscle aches, fatigue.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>69729-146-22</NDCCode>
    <PackageDescription>12 TABLET in 1 PACKAGE (69729-146-22) </PackageDescription>
    <NDC11Code>69729-0146-22</NDC11Code>
    <ProductNDC>69729-146</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Acetaminophen 500mg Caffeine 60mg Pyrilamine Maleate 15mg</ProprietaryName>
    <NonProprietaryName>Acetaminophen 500mg Caffeine 60mg Pyrilamine Maleate 15mg</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200401</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part343</ApplicationNumber>
    <LabelerName>OPMX LLC</LabelerName>
    <SubstanceName>CAFFEINE; PYRILAMINE MALEATE; ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>60; 15; 500</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the temporary relief of these symptoms associated with menstrual periods. Cramps, bloating water-weight gain, headache, backache, muscle aches, fatigue.</IndicationAndUsage>
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  <NDC>
    <NDCCode>68345-820-22</NDCCode>
    <PackageDescription>12 BOX in 1 CASE (68345-820-22)  &gt; 144 POUCH in 1 BOX &gt; .9 g in 1 POUCH</PackageDescription>
    <NDC11Code>68345-0820-22</NDC11Code>
    <ProductNDC>68345-820</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Repara Triple Antibiotic</ProprietaryName>
    <NonProprietaryName>Bacitracin, Neomycin And Polymyxin B</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20071201</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part333B</ApplicationNumber>
    <LabelerName>PSS WORLD MEDICAL, INC.</LabelerName>
    <SubstanceName>BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE</SubstanceName>
    <StrengthNumber>400; 3.5; 5000</StrengthNumber>
    <StrengthUnit>[iU]/g; mg/g; [iU]/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>First aid antibiotic to help prevent infection in: 1 minor cuts, 2 scrapes, 3 burns.</IndicationAndUsage>
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    <NDCCode>82009-144-22</NDCCode>
    <PackageDescription>2 KIT in 1 CARTON (82009-144-22)  / 1 KIT in 1 KIT *  1 SYRINGE in 1 TRAY (82009-145-11)  / .4 mL in 1 SYRINGE *  2 PACKET in 1 TRAY / 1 mL in 1 PACKET</PackageDescription>
    <NDC11Code>82009-0144-22</NDC11Code>
    <ProductNDC>82009-144</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Adalimumab-adbm</ProprietaryName>
    <NonProprietaryName>Adalimumab-adbm</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20240430</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761058</ApplicationNumber>
    <LabelerName>QUALLENT PHARMACEUTICALS HEALTH LLC</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-11-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240430</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Adalimumab-adbm is a tumor necrosis factor (TNF) blocker indicated for: 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. , 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. (1.8), 9  Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. (1.9).</IndicationAndUsage>
    <Description>Adalimumab-adbm is a tumor necrosis factor blocker. Adalimumab-adbm is a recombinant human IgG1 monoclonal antibody produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. Adalimumab-adbm injection is supplied as a sterile, preservative-free solution of adalimumab-adbm for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (Adalimumab-adbm Pen) or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the pen is a single-dose, 1 mL prefilled glass syringe. The solution of Adalimumab-adbm is clear to slightly opalescent and colorless to slightly yellow, with a pH of about 5.5. Each 40 mg/0.4 mL prefilled syringe or prefilled pen delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of Adalimumab-adbm contains adalimumab-adbm (40 mg), glacial acetic acid (0.03 mg), polysorbate 80 (0.2 mg), sodium acetate trihydrate (0.47 mg), trehalose dihydrate (30.3 mg), and Water for Injection, USP. Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of Adalimumab-adbm contains adalimumab-adbm (40 mg), glacial acetic acid (0.13 mg), polysorbate 80 (0.8 mg), sodium acetate trihydrate (2.4 mg), trehalose dihydrate (65.0 mg), and Water for Injection, USP. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of Adalimumab-adbm contains adalimumab-adbm (20 mg), glacial acetic acid (0.06 mg), polysorbate 80 (0.4 mg), sodium acetate trihydrate (1.21 mg), trehalose dihydrate (32.5 mg), and Water for Injection, USP. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of Adalimumab-adbm contains adalimumab-adbm (10 mg), glacial acetic acid (0.03 mg), polysorbate 80 (0.2 mg), sodium acetate trihydrate (0.61 mg), trehalose dihydrate (16.3 mg), and Water for Injection, USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>69729-122-38</NDCCode>
    <PackageDescription>144 TABLET in 1 POUCH (69729-122-38) </PackageDescription>
    <NDC11Code>69729-0122-38</NDC11Code>
    <ProductNDC>69729-122</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl</ProprietaryName>
    <NonProprietaryName>Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190826</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>OPMX LLC</LabelerName>
    <SubstanceName>ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>500; 4; 10</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190826</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temporarily relieves these symptoms of hay fever or other respiratory allergies: 1 headache, 2 nasal congestion, 3 sinus congestion &amp; pressure, 4 runny nose and sneezing, 5 minor aches &amp; pain.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>69729-222-38</NDCCode>
    <PackageDescription>144 TABLET in 1 POUCH (69729-222-38) </PackageDescription>
    <NDC11Code>69729-0222-38</NDC11Code>
    <ProductNDC>69729-222</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl</ProprietaryName>
    <NonProprietaryName>Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190826</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>OPMX LLC</LabelerName>
    <SubstanceName>ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>500; 4; 10</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190826</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temporarily relieves these symptoms of hay fever or other respiratory allergies: 1 Headache, 2 Nasal congestion, 3 Sinus congestion &amp; pressure, 4 Runny nose and sneezing, 5 Minor aches &amp; pain.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>69729-322-38</NDCCode>
    <PackageDescription>144 TABLET in 1 POUCH (69729-322-38) </PackageDescription>
    <NDC11Code>69729-0322-38</NDC11Code>
    <ProductNDC>69729-322</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl</ProprietaryName>
    <NonProprietaryName>Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190826</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>OPMX LLC</LabelerName>
    <SubstanceName>ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>500; 4; 10</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190826</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temporarily relieves these symptoms of hay fever or other respiratory allergies: 1 Headache, 2 Nasal congestion, 3 Sinus congestion &amp; pressure, 4 Runny nose and sneezing, 5 Minor aches &amp; pain.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>69729-610-05</NDCCode>
    <PackageDescription>1 TUBE in 1 BOX (69729-610-05)  / 14 g in 1 TUBE (69729-610-01) </PackageDescription>
    <NDC11Code>69729-0610-05</NDC11Code>
    <ProductNDC>69729-610</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Canespies</ProprietaryName>
    <NonProprietaryName>Tolnaftate</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20220726</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M005</ApplicationNumber>
    <LabelerName>OPMX LLC</LabelerName>
    <SubstanceName>TOLNAFTATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-05-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220726</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>PROVEN CLINICALLY EFFECTIVE IN THE TREATMENT OF ATHLETE'S FOOT (TINEA PEDIS), JOCK ITCH (TINEA CRURIS), RINGWORM (TINEA CORPORIS). PROVEN EFFECTIVE IN THE PREVENTION OF ATHLETE'S FOOT. EFFECTIVELY SOOTHES AND RELIEVES ITCHING ASSOCIATED WITH JOCK ITCH, SCALY SKIN BETWEEN THE TOES AND BURNING FEET.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>69729-615-05</NDCCode>
    <PackageDescription>1 TUBE in 1 BOX (69729-615-05)  / 14 g in 1 TUBE (69729-615-01) </PackageDescription>
    <NDC11Code>69729-0615-05</NDC11Code>
    <ProductNDC>69729-615</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Penimixcina</ProprietaryName>
    <NonProprietaryName>Bacitracin, Neomycin Sulfate, Polymixin B Sulfate, Pramoxine Hydrochloride</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20180905</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M004</ApplicationNumber>
    <LabelerName>OPMX LLC</LabelerName>
    <SubstanceName>BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>500; 5; 5000; 10</StrengthNumber>
    <StrengthUnit>[iU]/g; mg/g; [iU]/g; mg/g</StrengthUnit>
    <Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis &amp; Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-05-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180905</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>FIRST AID TO HELP PREVENT INFECTION IN. MINOR CUTS. SCRAPES. BURNS.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>69729-782-10</NDCCode>
    <PackageDescription>10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (69729-782-10) </PackageDescription>
    <NDC11Code>69729-0782-10</NDC11Code>
    <ProductNDC>69729-782</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Acetaminophen, Guaifenesin, Dextromethorphan Hbr, Phenylephrine Hcl</ProprietaryName>
    <NonProprietaryName>Acetaminophen, Guaifenesin, Dextromethorphan Hbr, Phenylephrine Hcl</NonProprietaryName>
    <DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190218</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>OPMX LLC</LabelerName>
    <SubstanceName>ACETAMINOPHEN; GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>325; 200; 10; 5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-05-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190218</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temporarily relieves common cold/flu symptoms: 1 Nasal congestion, 2 Sinus congestion &amp; pressure, 3 Cough due to minor throat &amp; bronchial irritation, 4 Minor aches &amp; pain, 5 Headache, 6 Fever, 7 Sore throat, 8 Reduces swelling of nasal passages, 9 Temporarily restore freer breathing through the nose, 10 Promotes nasal and/or sinus drainage, 11 Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0006-5084-01</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0006-5084-01) </PackageDescription>
    <NDC11Code>00006-5084-01</NDC11Code>
    <ProductNDC>0006-5084</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lipfendra</ProprietaryName>
    <NonProprietaryName>Lipfendra</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260715</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA220848</ApplicationNumber>
    <LabelerName>Merck Sharp &amp; Dohme LLC</LabelerName>
    <SubstanceName>ENLICITIDE DECANOATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-07-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260715</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>LIPFENDRA® is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Cardiovascular outcomes trials have demonstrated that reducing LDL-C lowers the risk for major adverse cardiovascular events (MACE) in adults at increased risk when treated with statins or monoclonal antibody proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors as an add-on to statin therapy.</IndicationAndUsage>
    <Description>LIPFENDRA (enlicitide) tablets for oral use contain enlicitide decanoate, a PCSK9 inhibitor. The chemical name of enlicitide decanoate is 6-({[(11S,17S,20S,23S,27S,39S,42S,63S,66R)-47-Fluoro-20-[(1R)-1-hydroxyethyl]-17-[(4-methoxyphenyl)methyl]-11,63-dimethyl-10,16,19,22,30,40,58,61,64,67,70-undecaoxo-28-oxa-1,9,15,18,21,24,31,41,51,62,65,68-dodecaazanonacyclo[37.18.11.23,6.124,42.133,37.144,51.011,15.023,27.045,50]triheptaconta-3,5,33(71),34,36,44(69),45,47,49,72-decaen-66-yl]methyl}amino)-N,N,N-trimethyl-6-oxohexan-1-aminium decanoate. Enlicitide decanoate is a white to off-white powder that is slightly soluble in water. The molecular formula is C92H129FN14O17 and the molecular weight is 1722.12 g/mol. The chemical structure of enlicitide decanoate is. LIPFENDRA is available as film-coated tablets for oral administration, each containing 20 mg of enlicitide (equivalent to 22.21 mg enlicitide decanoate) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium caprate. The film coating contains calcium carbonate, ethylene glycol and vinyl alcohol graft copolymer, glyceryl mono and dicaprylocaprate, polyvinyl alcohol, and talc. Carnauba wax is added as a polishing agent.</Description>
  </NDC>
  <NDC>
    <NDCCode>0006-5084-59</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (0006-5084-59)  / 7 TABLET, FILM COATED in 1 BOTTLE (0006-5084-58) </PackageDescription>
    <NDC11Code>00006-5084-59</NDC11Code>
    <ProductNDC>0006-5084</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lipfendra</ProprietaryName>
    <NonProprietaryName>Lipfendra</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260715</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA220848</ApplicationNumber>
    <LabelerName>Merck Sharp &amp; Dohme LLC</LabelerName>
    <SubstanceName>ENLICITIDE DECANOATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-07-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260715</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>LIPFENDRA® is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Cardiovascular outcomes trials have demonstrated that reducing LDL-C lowers the risk for major adverse cardiovascular events (MACE) in adults at increased risk when treated with statins or monoclonal antibody proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors as an add-on to statin therapy.</IndicationAndUsage>
    <Description>LIPFENDRA (enlicitide) tablets for oral use contain enlicitide decanoate, a PCSK9 inhibitor. The chemical name of enlicitide decanoate is 6-({[(11S,17S,20S,23S,27S,39S,42S,63S,66R)-47-Fluoro-20-[(1R)-1-hydroxyethyl]-17-[(4-methoxyphenyl)methyl]-11,63-dimethyl-10,16,19,22,30,40,58,61,64,67,70-undecaoxo-28-oxa-1,9,15,18,21,24,31,41,51,62,65,68-dodecaazanonacyclo[37.18.11.23,6.124,42.133,37.144,51.011,15.023,27.045,50]triheptaconta-3,5,33(71),34,36,44(69),45,47,49,72-decaen-66-yl]methyl}amino)-N,N,N-trimethyl-6-oxohexan-1-aminium decanoate. Enlicitide decanoate is a white to off-white powder that is slightly soluble in water. The molecular formula is C92H129FN14O17 and the molecular weight is 1722.12 g/mol. The chemical structure of enlicitide decanoate is. LIPFENDRA is available as film-coated tablets for oral administration, each containing 20 mg of enlicitide (equivalent to 22.21 mg enlicitide decanoate) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium caprate. The film coating contains calcium carbonate, ethylene glycol and vinyl alcohol graft copolymer, glyceryl mono and dicaprylocaprate, polyvinyl alcohol, and talc. Carnauba wax is added as a polishing agent.</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-0331-84</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (0078-0331-84)  / 5 mL in 1 VIAL, SINGLE-USE</PackageDescription>
    <NDC11Code>00078-0331-84</NDC11Code>
    <ProductNDC>0078-0331</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Simulect</ProprietaryName>
    <NonProprietaryName>Basiliximab</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19980512</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103764</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>BASILIXIMAB</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Interleukin 2 Receptor Antagonists [MoA], Interleukin 2 Receptor-directed Antibody Interactions [MoA], Interleukin-2 Receptor Blocking Antibody [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19980512</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Simulect® (basiliximab) is indicated for the prophylaxis of acute organ rejection in patients receiving renal transplantation when used as part of an immunosuppressive regimen that includes cyclosporine, USP (MODIFIED), and corticosteroids. The efficacy of Simulect for the prophylaxis of acute rejection in recipients of other solid organ allografts has not been demonstrated.</IndicationAndUsage>
    <Description>Basiliximab is a chimeric (murine/human) monoclonal antibody (IgG1к), produced by recombinant DNA technology, that functions as an immunosuppressive agent, specifically binding to and blocking the interleukin-2 receptor α-chain (IL-2Rα, also known as CD25 antigen) on the surface of activated T-lymphocytes. Based on the amino acid sequence, the calculated molecular weight of the protein is 144 kilodaltons. It is a glycoprotein obtained from fermentation of an established mouse myeloma cell line genetically engineered to express plasmids containing the human heavy and light chain constant region genes and mouse heavy and light chain variable region genes encoding the RFT5 antibody that binds selectively to the IL-2Rα. Simulect® (basiliximab) for injection is a sterile, preservative-free lyophilisate, which is available in single-dose vials and is available in 10 mg and 20 mg strengths for intravenous administration after reconstitution. Each 10-mg vial contains 10 mg of basiliximab, and dibasic sodium phosphate (anhydrous) (0.50 mg), glycine (20.3 mg), mannitol (40.6 mg), monobasic potassium phosphate (3.66 mg), sodium chloride (0.82 mg), and sucrose (10.1 mg) to be reconstituted in 2.5 mL of Sterile Water for Injection, USP. Each 20-mg vial contains 20 mg of basiliximab, and dibasic sodium phosphate (anhydrous) (0.99 mg), glycine (40.1 mg), mannitol (80.1 mg), monobasic potassium phosphate (7.22 mg), sodium chloride (1.61 mg), and sucrose (20 mg) to be reconstituted in 5 mL of Sterile Water for Injection, USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-0393-61</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (0078-0393-61)  / 2.5 mL in 1 VIAL, SINGLE-USE</PackageDescription>
    <NDC11Code>00078-0393-61</NDC11Code>
    <ProductNDC>0078-0393</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Simulect</ProprietaryName>
    <NonProprietaryName>Basiliximab</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19980512</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103764</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>BASILIXIMAB</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/2.5mL</StrengthUnit>
    <Pharm_Classes>Interleukin 2 Receptor Antagonists [MoA], Interleukin 2 Receptor-directed Antibody Interactions [MoA], Interleukin-2 Receptor Blocking Antibody [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19980512</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Simulect® (basiliximab) is indicated for the prophylaxis of acute organ rejection in patients receiving renal transplantation when used as part of an immunosuppressive regimen that includes cyclosporine, USP (MODIFIED), and corticosteroids. The efficacy of Simulect for the prophylaxis of acute rejection in recipients of other solid organ allografts has not been demonstrated.</IndicationAndUsage>
    <Description>Basiliximab is a chimeric (murine/human) monoclonal antibody (IgG1к), produced by recombinant DNA technology, that functions as an immunosuppressive agent, specifically binding to and blocking the interleukin-2 receptor α-chain (IL-2Rα, also known as CD25 antigen) on the surface of activated T-lymphocytes. Based on the amino acid sequence, the calculated molecular weight of the protein is 144 kilodaltons. It is a glycoprotein obtained from fermentation of an established mouse myeloma cell line genetically engineered to express plasmids containing the human heavy and light chain constant region genes and mouse heavy and light chain variable region genes encoding the RFT5 antibody that binds selectively to the IL-2Rα. Simulect® (basiliximab) for injection is a sterile, preservative-free lyophilisate, which is available in single-dose vials and is available in 10 mg and 20 mg strengths for intravenous administration after reconstitution. Each 10-mg vial contains 10 mg of basiliximab, and dibasic sodium phosphate (anhydrous) (0.50 mg), glycine (20.3 mg), mannitol (40.6 mg), monobasic potassium phosphate (3.66 mg), sodium chloride (0.82 mg), and sucrose (10.1 mg) to be reconstituted in 2.5 mL of Sterile Water for Injection, USP. Each 20-mg vial contains 20 mg of basiliximab, and dibasic sodium phosphate (anhydrous) (0.99 mg), glycine (40.1 mg), mannitol (80.1 mg), monobasic potassium phosphate (7.22 mg), sodium chloride (1.61 mg), and sucrose (20 mg) to be reconstituted in 5 mL of Sterile Water for Injection, USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>10695-144-10</NDCCode>
    <PackageDescription>1 kg in 1 CONTAINER (10695-144-10) </PackageDescription>
    <NDC11Code>10695-0144-10</NDC11Code>
    <ProductNDC>10695-144</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Marbofloxacin</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20221116</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Willow Birch Pharma, LLC.</LabelerName>
    <SubstanceName>MARBOFLOXACIN</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-02-06</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>16-NOV-22</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>12539-144-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (12539-144-01) </PackageDescription>
    <NDC11Code>12539-0144-01</NDC11Code>
    <ProductNDC>12539-144</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Uretron D/s</ProprietaryName>
    <NonProprietaryName>Methenamine, Sodium Phosphate Monobasic, Phenyl Salicylate, Methylene Blue, And Hyoscyamine Sulfate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20221007</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals</LabelerName>
    <SubstanceName>SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; PHENYL SALICYLATE; HYOSCYAMINE SULFATE; METHYLENE BLUE; METHENAMINE</SubstanceName>
    <StrengthNumber>40.8; 36.2; .12; 10.8; 81.6</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Oxidation-Reduction Activity [MoA], Oxidation-Reduction Agent [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221007</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uretron D/Stablets are indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures.</IndicationAndUsage>
    <Description>Uretron D/S tablets for oral administration. HYOSCYAMINE SULFATE. [620-61-1][3(S)-endo]-α-(Hydroxymethyl)-benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester sulfate(2:1)(salt); 1αH,5αH-tropan-3α-ol(-)-tropate(ester) sulfate(2:1)(salt);3α-tropanyl S-(-)-tropate; l-tropic acid ester with tropine; l-tropine tropate. C 34H 48N 2O 10S. Hyoscyamine Sulfate is an alkaloid of belladonna. Exists as a white crystalline powder. Its solutions are alkaline to litmus. Affected by light, it is slightly soluble in water; freely soluble in alcohol; sparingly soluble in ether. METHENAMINE. [100-97-0] 1,3,5,7-Tetraazatricyclo [3.3.1.-1 3,7] decane; hexamethylenetetramine; HMT; HMTA; hexamine; 1,3,5,7-tetraazaadamantane hexamethylenemine; Uritone; Urotropin. C 6H 12N 4; mol wt 140.19; C 51.40%, H 8.63%, N 39.96%. Methenamine (hexamethylenetetramine) exists as colorless, lustrous crystals or white crystalline powder. Its solutions are alkaline to litmus. Freely soluble in water, soluble in alcohol and in chloroform. METHYLENE BLUE. [61-73-4] 3,7-Bis(dimethylamino) phenothiazin-5-ium chloride; C.I. Basic Blue 9; methylthioninium chloride; tetramethylthionine chloride; 3,7-bis(dimethylamino) phenazathionium chloride. C 16H 18ClN 3S; mol wt 319.85, C 60.08%, H 5.67%, Cl 11.08%, N 13.14%, S 10.03%. Methylene Blue (Methylthionine chloride) exists as dark green crystals. It is soluble in water and in chloroform; sparingly soluble in alcohol. PHENYL SALICYLATE. [118-55-8] 2-Hydroxybenzoic acid phenyl ester; Salol. C 13H 10O 3; mol wt 214.22, C 72.89%, H 4.71%, O 22.41%. Made by the action of phosphorus oxy-chloride on a mixture of phenol and salicylic acid. Phenyl Salicylate exists as white crystals with a melting point of 41°-43° C. It is very slightly soluble in water and freely soluble in alcohol. SODIUM PHOSPHATE MONOBASIC. [7558-80-7] Phosphoric acid sodium salt (1:1); Sodium biphosphate; sodium dihydrogen phosphate; acid sodium phosphate; monosodium orthophosphate; primary sodium phosphate; H 2NaO 4P; mol wt 119.98, H 1.68%, Na 19.16%, O 53.34%, P 25.82%. Monohydrate, white, odorless slightly deliquesce crystals or granules. At 100° C loses all its water; when ignited it converts to metaphosphate. It is freely soluble in water and practically insoluble in alcohol. The aqueous solution is acid. pH of 0.1 molar aqueous solution at 25° C: 4.5. Uretron D/Stablets contain inactive ingredients: Crospovidone, Dicalcium Phosphate, FD&amp;C Blue #1 Aluminum Lake, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Stearic Acid, Talc, and Titanium Dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>21130-863-09</NDCCode>
    <PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (21130-863-09)  / 144 SPRAY, METERED in 1 BOTTLE, SPRAY</PackageDescription>
    <NDC11Code>21130-0863-09</NDC11Code>
    <ProductNDC>21130-863</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Allergy Relief</ProprietaryName>
    <NonProprietaryName>Fluticasone Propionate</NonProprietaryName>
    <DosageFormName>SPRAY, METERED</DosageFormName>
    <RouteName>NASAL</RouteName>
    <StartMarketingDate>20250106</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207957</ApplicationNumber>
    <LabelerName>Safeway</LabelerName>
    <SubstanceName>FLUTICASONE PROPIONATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>ug/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250106</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: 1 nasal congestion, 2 itchy nose, 3 runny nose, 4 itchy, watery eyes, 5 sneezing.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>21130-863-10</NDCCode>
    <PackageDescription>2 BOTTLE, SPRAY in 1 CARTON (21130-863-10)  / 144 SPRAY, METERED in 1 BOTTLE, SPRAY</PackageDescription>
    <NDC11Code>21130-0863-10</NDC11Code>
    <ProductNDC>21130-863</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Allergy Relief</ProprietaryName>
    <NonProprietaryName>Fluticasone Propionate</NonProprietaryName>
    <DosageFormName>SPRAY, METERED</DosageFormName>
    <RouteName>NASAL</RouteName>
    <StartMarketingDate>20250106</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207957</ApplicationNumber>
    <LabelerName>Safeway</LabelerName>
    <SubstanceName>FLUTICASONE PROPIONATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>ug/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250304</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: 1 nasal congestion, 2 itchy nose, 3 runny nose, 4 itchy, watery eyes, 5 sneezing.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>25021-144-99</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (25021-144-99)  / 100 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>25021-0144-99</NDC11Code>
    <ProductNDC>25021-144</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ampicillin And Sulbactam</ProprietaryName>
    <NonProprietaryName>Ampicillin And Sulbactam</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20100812</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065403</ApplicationNumber>
    <LabelerName>Sagent Pharmaceuticals</LabelerName>
    <SubstanceName>AMPICILLIN SODIUM; SULBACTAM SODIUM</SubstanceName>
    <StrengthNumber>100; 50</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-11-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100812</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ampicillin and Sulbactam for Injection, USP is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli*, Klebsiella spp.* (including K. pneumoniae*), Proteus mirabilis*, Bacteroides fragilis*, Enterobacter spp.*, and Acinetobacter calcoaceticus*. NOTE: For information on use in pediatric patients see PRECAUTIONS-Pediatric Use and CLINICAL STUDIES sections. Intra-Abdominal Infections caused by beta-lactamase producing strains of Escherichia coli, Klebsiella spp. (including K. pneumoniae*), Bacteroides spp. (including B. fragilis), and Enterobacter spp.*. Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli*, and Bacteroides spp.* (including B. fragilis*). *Efficacy for this organism in this organ system was studied in fewer than 10 infections. While Ampicillin and Sulbactam for Injection, USP is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with Ampicillin and Sulbactam for Injection, USP due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to Ampicillin and Sulbactam for Injection, USP should not require the addition of another antibacterial. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to Ampicillin and Sulbactam for Injection, USP. Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above in the indicated organ systems. Once the results are known, therapy should be adjusted if appropriate. To reduce the development of drug-resistant bacteria and maintain effectiveness of Ampicillin and Sulbactam for Injection, USP and other antibacterial drugs, Ampicillin and Sulbactam for Injection, USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
    <Description>Ampicillin and Sulbactam for Injection, USP is an injectable antibacterial combination consisting of the semisynthetic antibacterial ampicillin sodium and the beta-lactamase inhibitor sulbactam sodium for intravenous and intramuscular administration. Ampicillin sodium is derived from the penicillin nucleus, 6-aminopenicillanic acid. Chemically, it is monosodium (2S, 5R, 6R)-6-[(R)-2-amino-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate and has a molecular weight of 371.39. Its chemical formula is C16H18N3NaO4S. The structural formula is:. Sulbactam sodium is a derivative of the basic penicillin nucleus. Chemically, sulbactam sodium is sodium penicillinate sulfone; sodium (2S, 5R)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate 4,4-dioxide. Its chemical formula is C8H10NNaO5S with a molecular weight of 255.22. The structural formula is:. Ampicillin and Sulbactam for Injection, USP, ampicillin sodium/sulbactam sodium parenteral combination, is available as a white to off-white dry powder for reconstitution. Ampicillin and Sulbactam for Injection, USP dry powder is freely soluble in aqueous diluents to yield pale yellow to yellow solutions containing ampicillin sodium and sulbactam sodium equivalent to 250 mg ampicillin per mL and 125 mg sulbactam per mL. The pH of the solutions is between 8 and 10. Dilute solutions (up to 30 mg ampicillin and 15 mg sulbactam per mL) are essentially colorless to pale yellow. The pH of dilute solutions remains the same. Each sterile Pharmacy Bulk Package contains 15 grams Ampicillin and Sulbactam for Injection, USP (equivalent to 10 grams ampicillin as the sodium salt plus 5 grams sulbactam as the sodium salt). The sodium content is approximately 1150 mg (50 mEq) sodium. Ampicillin and Sulbactam for Injection, USP Pharmacy Bulk Package is a bottle containing a sterile preparation of ampicillin sodium and sulbactam sodium for parenteral use that contains many single doses. The Pharmacy Bulk Package is for use in a pharmacy admixture setting; it provides many single doses of Ampicillin and Sulbactam for Injection, USP for addition to suitable parenteral fluids in the preparation of admixtures for intravenous infusion. (See DIRECTIONS FOR USE - Directions for Proper Use of Pharmacy Bulk Package.) FURTHER DILUTION IS REQUIRED BEFORE USE.</Description>
  </NDC>
  <NDC>
    <NDCCode>37000-871-51</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (37000-871-51)  &gt; 144 g in 1 TUBE</PackageDescription>
    <NDC11Code>37000-0871-51</NDC11Code>
    <ProductNDC>37000-871</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Crest Pro-health</ProprietaryName>
    <ProprietaryNameSuffix>Advanced</ProprietaryNameSuffix>
    <NonProprietaryName>Stannous Fluoride</NonProprietaryName>
    <DosageFormName>PASTE, DENTIFRICE</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20150201</StartMarketingDate>
    <EndMarketingDate>20190121</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part355</ApplicationNumber>
    <LabelerName>The Procter &amp; Gamble Manufacturing Company</LabelerName>
    <SubstanceName>STANNOUS FLUORIDE</SubstanceName>
    <StrengthNumber>1.6</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-01-22</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
  </NDC>
  <NDC>
    <NDCCode>37000-887-05</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (37000-887-05)  &gt; 144 g in 1 TUBE</PackageDescription>
    <NDC11Code>37000-0887-05</NDC11Code>
    <ProductNDC>37000-887</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Crest Pro-health Advanced</ProprietaryName>
    <ProprietaryNameSuffix>Extra Deep Clean</ProprietaryNameSuffix>
    <NonProprietaryName>Stannous Fluoride</NonProprietaryName>
    <DosageFormName>GEL, DENTIFRICE</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20160101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part355</ApplicationNumber>
    <LabelerName>The Procter &amp; Gamble Manufacturing Company</LabelerName>
    <SubstanceName>STANNOUS FLUORIDE</SubstanceName>
    <StrengthNumber>1.6</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-06-22</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>37000-987-51</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (37000-987-51)  / 144 g in 1 TUBE</PackageDescription>
    <NDC11Code>37000-0987-51</NDC11Code>
    <ProductNDC>37000-987</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Crest Pro-health Advanced</ProprietaryName>
    <ProprietaryNameSuffix>Enamel Restore</ProprietaryNameSuffix>
    <NonProprietaryName>Stannous Fluoride</NonProprietaryName>
    <DosageFormName>PASTE, DENTIFRICE</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20201231</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M021</ApplicationNumber>
    <LabelerName>The Procter &amp; Gamble Manufacturing Company</LabelerName>
    <SubstanceName>STANNOUS FLUORIDE</SubstanceName>
    <StrengthNumber>1.6</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-08-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201231</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>aids in the prevention of cavities. helps prevent gingivitis. helps interfere with the harmful effects of plaque associated with gingivitis. helps control plaque bacteria that contribute to the development of gingivitis. builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>37000-988-51</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (37000-988-51)  / 144 g in 1 TUBE</PackageDescription>
    <NDC11Code>37000-0988-51</NDC11Code>
    <ProductNDC>37000-988</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Crest Pro-health Advanced</ProprietaryName>
    <ProprietaryNameSuffix>With A Touch Of Scope</ProprietaryNameSuffix>
    <NonProprietaryName>Stannous Fluoride</NonProprietaryName>
    <DosageFormName>PASTE, DENTIFRICE</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20201231</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M021</ApplicationNumber>
    <LabelerName>The Procter &amp; Gamble Manufacturing Company</LabelerName>
    <SubstanceName>STANNOUS FLUORIDE</SubstanceName>
    <StrengthNumber>1.6</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-08-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201231</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>aids in the prevention of cavities. helps prevent gingivitis. helps interfere with the harmful effects of plaque associated with gingivitis. helps control plaque bacteria that contribute to the development of gingivitis. builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>39892-0601-1</NDCCode>
    <PackageDescription>5 BOX in 1 CASE (39892-0601-1)  &gt; 144 TUBE in 1 BOX &gt; 17 g in 1 TUBE</PackageDescription>
    <NDC11Code>39892-0601-01</NDC11Code>
    <ProductNDC>39892-0601</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Medichoice Anticavity Fluoride</ProprietaryName>
    <NonProprietaryName>Sodium Fluoride</NonProprietaryName>
    <DosageFormName>PASTE, DENTIFRICE</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20100518</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part355</ApplicationNumber>
    <LabelerName>Owens and Minor</LabelerName>
    <SubstanceName>SODIUM FLUORIDE</SubstanceName>
    <StrengthNumber>22</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Aids in the prevention of dental cavities.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>39892-0601-2</NDCCode>
    <PackageDescription>5 BOX in 1 CASE (39892-0601-2)  &gt; 144 TUBE in 1 BOX &gt; 24 g in 1 TUBE</PackageDescription>
    <NDC11Code>39892-0601-02</NDC11Code>
    <ProductNDC>39892-0601</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Medichoice Anticavity Fluoride</ProprietaryName>
    <NonProprietaryName>Sodium Fluoride</NonProprietaryName>
    <DosageFormName>PASTE, DENTIFRICE</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20100518</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part355</ApplicationNumber>
    <LabelerName>Owens and Minor</LabelerName>
    <SubstanceName>SODIUM FLUORIDE</SubstanceName>
    <StrengthNumber>22</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Aids in the prevention of dental cavities.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>45802-060-70</NDCCode>
    <PackageDescription>144 PACKET in 1 CARTON (45802-060-70)  / .9 g in 1 PACKET</PackageDescription>
    <NDC11Code>45802-0060-70</NDC11Code>
    <ProductNDC>45802-060</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Bacitracin</ProprietaryName>
    <NonProprietaryName>Bacitracin</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110620</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M004</ApplicationNumber>
    <LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
    <SubstanceName>BACITRACIN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>[USP'U]/g</StrengthUnit>
    <Pharm_Classes>Decreased Cell Wall Synthesis &amp; Repair [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-08-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110620</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>first aid to help prevent infection in: : 1 minor cuts , 2 scrapes , 3 burns.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>49348-144-46</NDCCode>
    <PackageDescription>14 PATCH in 1 CARTON (49348-144-46)  &gt; 24 h in 1 PATCH</PackageDescription>
    <NDC11Code>49348-0144-46</NDC11Code>
    <ProductNDC>49348-144</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Nicotine</ProprietaryName>
    <ProprietaryNameSuffix>Transdermal System Step 1</ProprietaryNameSuffix>
    <NonProprietaryName>Nicotine</NonProprietaryName>
    <DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
    <RouteName>TRANSDERMAL</RouteName>
    <StartMarketingDate>20151102</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020076</ApplicationNumber>
    <LabelerName>Strategic Sourcing Services LLC</LabelerName>
    <SubstanceName>NICOTINE</SubstanceName>
    <StrengthNumber>21</StrengthNumber>
    <StrengthUnit>mg/24h</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-12-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151102</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>49527-059-01</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (49527-059-01)  &gt; 144 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>49527-0059-01</NDC11Code>
    <ProductNDC>49527-059</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Clinique Broad Spectrum Spf 30 Sunscreen Body Mist</ProprietaryName>
    <NonProprietaryName>Avobenzone, Homosalate, And Octisalate</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20170601</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>CLINIQUE LABORATORIES LLC</LabelerName>
    <SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE</SubstanceName>
    <StrengthNumber>.0261; .087; .0392</StrengthNumber>
    <StrengthUnit>g/mL; g/mL; g/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-07-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>51289-400-03</NDCCode>
    <PackageDescription>144 TUBE in 1 BOX (51289-400-03)  &gt; 43 g in 1 TUBE</PackageDescription>
    <NDC11Code>51289-0400-03</NDC11Code>
    <ProductNDC>51289-400</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Fluoride Gel</ProprietaryName>
    <NonProprietaryName>Sodium Fluoride</NonProprietaryName>
    <DosageFormName>PASTE</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20150501</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part356</ApplicationNumber>
    <LabelerName>Yangzhou Hengyuan Daily Chemical Plastic Co.,Ltd</LabelerName>
    <SubstanceName>SODIUM FLUORIDE</SubstanceName>
    <StrengthNumber>.22</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>helps protect against cavities.</IndicationAndUsage>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>69729-144-22</NDCCode><ProprietaryName>Acetaminophen 500mg Caffeine 60mg Pyrilamine Maleate 15mg</ProprietaryName><NonProprietaryName>Acetaminophen 500mg Caffeine 60mg Pyrilamine Maleate 15mg</NonProprietaryName></NDC><NDC><NDCCode>69729-145-22</NDCCode><ProprietaryName>Acetaminophen 500mg Caffeine 60mg Pyrilamine Maleate 15mg</ProprietaryName><NonProprietaryName>Acetaminophen 500mg Caffeine 60mg Pyrilamine Maleate 15mg</NonProprietaryName></NDC><NDC><NDCCode>69729-146-22</NDCCode><ProprietaryName>Acetaminophen 500mg Caffeine 60mg Pyrilamine Maleate 15mg</ProprietaryName><NonProprietaryName>Acetaminophen 500mg Caffeine 60mg Pyrilamine Maleate 15mg</NonProprietaryName></NDC><NDC><NDCCode>68345-820-22</NDCCode><ProprietaryName>Repara Triple Antibiotic</ProprietaryName><NonProprietaryName>Bacitracin, Neomycin And Polymyxin 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Relief</ProprietaryName><NonProprietaryName>Fluticasone Propionate</NonProprietaryName></NDC><NDC><NDCCode>21130-863-10</NDCCode><ProprietaryName>Allergy Relief</ProprietaryName><NonProprietaryName>Fluticasone Propionate</NonProprietaryName></NDC><NDC><NDCCode>25021-144-99</NDCCode><ProprietaryName>Ampicillin And Sulbactam</ProprietaryName><NonProprietaryName>Ampicillin And Sulbactam</NonProprietaryName></NDC><NDC><NDCCode>37000-871-51</NDCCode><ProprietaryName>Crest Pro-health</ProprietaryName><NonProprietaryName>Stannous Fluoride</NonProprietaryName></NDC><NDC><NDCCode>37000-887-05</NDCCode><ProprietaryName>Crest Pro-health Advanced</ProprietaryName><NonProprietaryName>Stannous Fluoride</NonProprietaryName></NDC><NDC><NDCCode>37000-987-51</NDCCode><ProprietaryName>Crest Pro-health Advanced</ProprietaryName><NonProprietaryName>Stannous Fluoride</NonProprietaryName></NDC><NDC><NDCCode>37000-988-51</NDCCode><ProprietaryName>Crest Pro-health Advanced</ProprietaryName><NonProprietaryName>Stannous Fluoride</NonProprietaryName></NDC><NDC><NDCCode>39892-0601-1</NDCCode><ProprietaryName>Medichoice Anticavity Fluoride</ProprietaryName><NonProprietaryName>Sodium Fluoride</NonProprietaryName></NDC><NDC><NDCCode>39892-0601-2</NDCCode><ProprietaryName>Medichoice Anticavity Fluoride</ProprietaryName><NonProprietaryName>Sodium Fluoride</NonProprietaryName></NDC><NDC><NDCCode>45802-060-70</NDCCode><ProprietaryName>Bacitracin</ProprietaryName><NonProprietaryName>Bacitracin</NonProprietaryName></NDC><NDC><NDCCode>49348-144-46</NDCCode><ProprietaryName>Nicotine</ProprietaryName><NonProprietaryName>Nicotine</NonProprietaryName></NDC><NDC><NDCCode>49527-059-01</NDCCode><ProprietaryName>Clinique Broad Spectrum Spf 30 Sunscreen Body Mist</ProprietaryName><NonProprietaryName>Avobenzone, Homosalate, And Octisalate</NonProprietaryName></NDC><NDC><NDCCode>51289-400-03</NDCCode><ProprietaryName>Fluoride Gel</ProprietaryName><NonProprietaryName>Sodium Fluoride</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/04/2006",
      "LastUpdateDate": "12/11/2007",
      "AuthorizedOfficialLastName": "MONTECILLO",
      "AuthorizedOfficialFirstName": "RANIA",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-7363",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "801TX",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1346319878",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "REDMOND EYE CLINIC PLLC",
      "FirstLineMailingAddress": "16150 NE 85TH ST STE 206",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3543",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-3574",
      "MailingAddressFaxNumber": "425-881-0230",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "PracticeLocationAddressFaxNumber": "425-881-0230",
      "EnumerationDate": "11/07/2006",
      "LastUpdateDate": "07/08/2007",
      "AuthorizedOfficialLastName": "OTTEN",
      "AuthorizedOfficialFirstName": "LARRY",
      "AuthorizedOfficialMiddleName": "C",
      "AuthorizedOfficialTitle": "DR",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-3574",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "OD00001172",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
    },
    {
      "NPI": "1376755009",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "PERIMAN",
      "FirstName": "LAURA",
      "MiddleName": "MARIE",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "FirstLineMailingAddress": "623 W HIGHLAND DR",
      "MailingAddressCityName": "SEATTLE",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98119-3446",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "206-282-2716",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "SecondLinePracticeLocationAddress": "REDMOND EYE CLINIC",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "EnumerationDate": "05/04/2007",
      "LastUpdateDate": "07/08/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207W00000X",
      "Taxonomy1": "Ophthalmology",
      "LicenseNumber1": "MD00039796",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1659320539",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "MONTECILLO",
      "FirstName": "RANIA",
      "MiddleName": "B",
      "NamePrefix": "DR.",
      "Credential": "OD",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/09/2006",
      "LastUpdateDate": "12/19/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "3680",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1427560267",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ABOU SHADI",
      "FirstName": "RANIA",
      "NamePrefix": "MRS.",
      "Credential": "RPH",
      "FirstLineMailingAddress": "8862 161ST AVENUE NE",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-883-9532",
      "MailingAddressFaxNumber": "425-882-2743",
      "FirstLinePracticeLocationAddress": "8862 161ST AVENUE NE",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-883-9532",
      "PracticeLocationAddressFaxNumber": "425-882-2743",
      "EnumerationDate": "11/02/2017",
      "LastUpdateDate": "11/02/2017",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "3336C0003X",
      "Taxonomy1": "Community/Retail Pharmacy",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1528050523",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "DESCHUTES EYE CLINIC PC",
      "OtherOrgName": "THE EYE SURGERY INSTITUTE",
      "OtherOrgNameTypeCode": "3",
      "FirstLineMailingAddress": "813 SW HIGHLAND AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-3123",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-548-7170",
      "MailingAddressFaxNumber": "541-548-3842",
      "FirstLinePracticeLocationAddress": "813 SW HIGHLAND AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-3123",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-548-7170",
      "PracticeLocationAddressFaxNumber": "541-548-3842",
      "EnumerationDate": "08/17/2005",
      "LastUpdateDate": "12/01/2010",
      "AuthorizedOfficialLastName": "TRAUSTASON",
      "AuthorizedOfficialFirstName": "OLI",
      "AuthorizedOfficialMiddleName": "I",
      "AuthorizedOfficialTitle": "PRESIDENT",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "M.D.",
      "AuthorizedOfficialTelephoneNumber": "541-548-7170",
      "TaxonomyCode1": "207W00000X",
      "Taxonomy1": "Ophthalmology",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "053857000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierState1": "OR",
      "OtherIdentifierIssuer1": "REGENCE BCBS",
      "OtherIdentifier2": "CJ8770",
      "OtherIdentifierType2": "OTHER",
      "OtherIdentifierState2": "OR",
      "OtherIdentifierIssuer2": "RAILROAD MEDICARE",
      "OtherIdentifier3": "38080A",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierState3": "OR",
      "OtherIdentifierIssuer3": "CLEAR CHOICE",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1477596252",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "EYE CARE SPECIALISTS NORTHWEST PLLC",
      "OtherOrgName": "THE CHILDRENS EYE DOCTORS, THE FAMILY EYE DOCTORS, WOODLAWN OPTICAL",
      "OtherOrgNameTypeCode": "3",
      "FirstLineMailingAddress": "17130 AVONDALE WAY NE",
      "SecondLineMailingAddress": "SUITE 111",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-6600",
      "MailingAddressFaxNumber": "425-885-6580",
      "FirstLinePracticeLocationAddress": "17130 AVONDALE WAY NE",
      "SecondLinePracticeLocationAddress": "SUITE 111",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-6600",
      "PracticeLocationAddressFaxNumber": "425-885-6580",
      "EnumerationDate": "06/13/2006",
      "LastUpdateDate": "03/03/2008",
      "AuthorizedOfficialLastName": "LENART",
      "AuthorizedOfficialFirstName": "THOMAS",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "MD PHD",
      "AuthorizedOfficialTelephoneNumber": "425-885-6600",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "156FX1800X",
      "Taxonomy2": "Optician",
      "PrimaryTaxonomySwitch2": "N",
      "TaxonomyCode3": "207W00000X",
      "Taxonomy3": "Ophthalmology",
      "PrimaryTaxonomySwitch3": "Y",
      "OtherIdentifier1": "1568514032",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "NPI",
      "OtherIdentifier2": "1740297829",
      "OtherIdentifierType2": "OTHER",
      "OtherIdentifierIssuer2": "NPI",
      "OtherIdentifier3": "1205989522",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "NPI",
      "HealthcareProviderTaxonomyGroup1": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization.",
      "HealthcareProviderTaxonomyGroup2": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription2": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization.",
      "HealthcareProviderTaxonomyGroup3": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription3": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
    },
    {
      "NPI": "1215029343",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "EYE HEALTH PROFESSIONALS, P.C.",
      "FirstLineMailingAddress": "85 BARNES RD",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "WALLINGFORD",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06492-1832",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "203-284-9448",
      "MailingAddressFaxNumber": "203-269-1361",
      "FirstLinePracticeLocationAddress": "85 BARNES RD",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "WALLINGFORD",
      "PracticeLocationAddressStateName": "CT",
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      "MailingAddressFaxNumber": "419-843-9697",
      "FirstLinePracticeLocationAddress": "4411 N HOLLAND SYLVANIA RD",
      "SecondLinePracticeLocationAddress": "SUITE 201",
      "PracticeLocationAddressCityName": "TOLEDO",
      "PracticeLocationAddressStateName": "OH",
      "PracticeLocationAddressPostalCode": "43623-3525",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "419-843-3627",
      "PracticeLocationAddressFaxNumber": "419-843-9697",
      "EnumerationDate": "10/24/2005",
      "LastUpdateDate": "09/02/2011",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "35086663",
      "LicenseNumberStateCode1": "OH",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "2621621",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "OH",
      "OtherIdentifier2": "P00401238",
      "OtherIdentifierType2": "OTHER",
      "OtherIdentifierState2": "OH",
      "OtherIdentifierIssuer2": "RAILROAD MEDICARE"
    },
    {
      "NPI": "1033186986",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "NICOLA",
      "FirstName": "RANIA",
      "MiddleName": "SOLIMAN",
      "NamePrefix": "DR.",
      "Credential": "DDS",
      "FirstLineMailingAddress": "110 S WOODLAND ST",
      "MailingAddressCityName": "WINTER GARDEN",
      "MailingAddressStateName": "FL",
      "MailingAddressPostalCode": "34787-3546",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "407-905-8827",
      "MailingAddressFaxNumber": "407-645-4587",
      "FirstLinePracticeLocationAddress": "7900 FOREST CITY RD",
      "PracticeLocationAddressCityName": "ORLANDO",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "32810-3002",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "407-905-8827",
      "PracticeLocationAddressFaxNumber": "407-645-4587",
      "EnumerationDate": "02/28/2006",
      "LastUpdateDate": "07/28/2017",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1223G0001X",
      "Taxonomy1": "General Practice",
      "LicenseNumber1": "DN15582",
      "LicenseNumberStateCode1": "FL",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "122300000X",
      "Taxonomy2": "Dentist",
      "LicenseNumber2": "DN15582",
      "LicenseNumberStateCode2": "FL",
      "PrimaryTaxonomySwitch2": "Y",
      "OtherIdentifier1": "075156100",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "FL"
    },
    {
      "NPI": "1720032899",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ALBATAINEH",
      "FirstName": "RANIA",
      "MiddleName": "QASSIEM",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "11476 OKEECHOBEE BLVD",
      "MailingAddressCityName": "ROYAL PALM BEACH",
      "MailingAddressStateName": "FL",
      "MailingAddressPostalCode": "33411-8715",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "561-204-5111",
      "MailingAddressFaxNumber": "561-204-5150",
      "FirstLinePracticeLocationAddress": "11476 OKEECHOBEE BLVD",
      "PracticeLocationAddressCityName": "ROYAL PALM BEACH",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "33411-8715",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "561-204-5111",
      "PracticeLocationAddressFaxNumber": "561-204-5150",
      "EnumerationDate": "05/21/2006",
      "LastUpdateDate": "09/11/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "ME 79876",
      "LicenseNumberStateCode1": "FL",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1326095100",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ROSBOROUGH",
      "FirstName": "RANIA",
      "MiddleName": "BAJWA",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "3100 WYMAN PARK DR",
      "MailingAddressCityName": "BALTIMORE",
      "MailingAddressStateName": "MD",
      "MailingAddressPostalCode": "21211-2803",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "410-338-3500",
      "FirstLinePracticeLocationAddress": "3601 SW 160TH AVE",
      "SecondLinePracticeLocationAddress": "SUITE 250",
      "PracticeLocationAddressCityName": "MIRAMAR",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "33027-6308",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "877-866-7123",
      "EnumerationDate": "05/27/2006",
      "LastUpdateDate": "12/10/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "D0063732",
      "LicenseNumberStateCode1": "MD",
      "PrimaryTaxonomySwitch1": "Y",
      "TaxonomyCode2": "207Q00000X",
      "Taxonomy2": "Family Medicine",
      "LicenseNumber2": "0101257197",
      "LicenseNumberStateCode2": "VA",
      "PrimaryTaxonomySwitch2": "N"
    },
    {
      "NPI": "1528015310",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "HUSSEINI",
      "FirstName": "RANIA",
      "MiddleName": "I",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "111 CYPRESS ST",
      "MailingAddressCityName": "BROOKLINE",
      "MailingAddressStateName": "MA",
      "MailingAddressPostalCode": "02445-6002",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "508-718-4050",
      "FirstLinePracticeLocationAddress": "20 PATRIOT PL",
      "PracticeLocationAddressCityName": "FOXBORO",
      "PracticeLocationAddressStateName": "MA",
      "PracticeLocationAddressPostalCode": "02035-1375",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "508-718-4050",
      "EnumerationDate": "05/27/2006",
      "LastUpdateDate": "04/17/2012",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "209649",
      "LicenseNumberStateCode1": "MA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1760429591",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "RAYES-DANAN",
      "FirstName": "RANIA",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "OtherLastName": "RAYES",
      "OtherFirstName": "RANIA",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2500 METROHEALTH DR",
      "MailingAddressCityName": "CLEVELAND",
      "MailingAddressStateName": "OH",
      "MailingAddressPostalCode": "44109-1900",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "216-778-7800",
      "FirstLinePracticeLocationAddress": "2500 METROHEALTH DR",
      "PracticeLocationAddressCityName": "CLEVELAND",
      "PracticeLocationAddressStateName": "OH",
      "PracticeLocationAddressPostalCode": "44109-1900",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "216-778-7800",
      "EnumerationDate": "06/01/2006",
      "LastUpdateDate": "01/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207ZP0102X",
      "Taxonomy1": "Anatomic Pathology & Clinical Pathology",
      "LicenseNumber1": "35086346",
      "LicenseNumberStateCode1": "OH",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "2687703",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "OH"
    },
    {
      "NPI": "1699717660",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "AMPEY",
      "FirstName": "RANIA",
      "MiddleName": "L",
      "Credential": "LPC",
      "FirstLineMailingAddress": "5930 LOVERS LN",
      "SecondLineMailingAddress": "PREMIER NEUROPSYCHIATRY, PLC",
      "MailingAddressCityName": "PORTAGE",
      "MailingAddressStateName": "MI",
      "MailingAddressPostalCode": "49002-1673",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "269-873-1611",
      "FirstLinePracticeLocationAddress": "5930 LOVERS LN",
      "SecondLinePracticeLocationAddress": "PREMIER NEUROPSYCHIATRY, PLC",
      "PracticeLocationAddressCityName": "PORTAGE",
      "PracticeLocationAddressStateName": "MI",
      "PracticeLocationAddressPostalCode": "49002-1673",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "269-873-1611",
      "EnumerationDate": "06/12/2006",
      "LastUpdateDate": "12/30/2010",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional",
      "LicenseNumber1": "6401007658",
      "LicenseNumberStateCode1": "MI",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1801839667",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ABOUJAOUDE",
      "FirstName": "RANIA",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "PO BOX 1283",
      "MailingAddressCityName": "MEDFORD",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08055-6283",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "609-677-1046",
      "MailingAddressFaxNumber": "609-677-1306",
      "FirstLinePracticeLocationAddress": "200 TRENTON RD",
      "PracticeLocationAddressCityName": "BROWNS MILLS",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08015-1705",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "609-677-1046",
      "PracticeLocationAddressFaxNumber": "609-677-1306",
      "EnumerationDate": "06/13/2006",
      "LastUpdateDate": "09/15/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207RI0200X",
      "Taxonomy1": "Infectious Disease",
      "LicenseNumber1": "39215",
      "LicenseNumberStateCode1": "KY",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "207RI0200X",
      "Taxonomy2": "Infectious Disease",
      "LicenseNumber2": "25MA07672000",
      "LicenseNumberStateCode2": "NJ",
      "PrimaryTaxonomySwitch2": "Y"
    },
    {
      "NPI": "1184645301",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "BAIK",
      "FirstName": "RANIA",
      "Credential": "D.O.",
      "FirstLineMailingAddress": "602 ROUTE 169",
      "SecondLineMailingAddress": "PO BOX 865",
      "MailingAddressCityName": "WOODSTOCK",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06281-2225",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "860-821-3406",
      "MailingAddressFaxNumber": "860-821-3407",
      "FirstLinePracticeLocationAddress": "602 ROUTE 169",
      "PracticeLocationAddressCityName": "WOODSTOCK",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06281-2225",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "860-821-3406",
      "PracticeLocationAddressFaxNumber": "860-821-3407",
      "EnumerationDate": "07/22/2006",
      "LastUpdateDate": "01/14/2016",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "000260",
      "LicenseNumberStateCode1": "CT",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

                
{
  "NPI": [
    {
      "NPI": "1083349906",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "STAFFORD",
      "FirstName": "KADY",
      "NamePrefix": "MS.",
      "Credential": "LPC",
      "FirstLineMailingAddress": "13574 SW HIGHWAY 126",
      "MailingAddressCityName": "POWELL BUTTE",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97753-1541",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-480-6360",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
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}
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