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How to Find 69729-145-22 NDC Data Using DataLabs API

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{
  "NDC": [
    {
      "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": "69729-144-22",
      "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": "69729-146-22",
      "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": "16364-145-22",
      "PackageDescription": "5000 TABLET, FILM COATED in 1 CONTAINER (16364-145-22) ",
      "NDC11Code": "16364-0145-22",
      "ProductNDC": "16364-145",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Quetiapine Fumarate",
      "DosageFormName": "TABLET, FILM COATED",
      "StartMarketingDate": "20151216",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Intas Pharmaceuticals Limited",
      "SubstanceName": "QUETIAPINE FUMARATE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Status": "Unfinished",
      "LastUpdate": "2022-10-15",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "16-DEC-15"
    },
    {
      "NDCCode": "16729-145-22",
      "PackageDescription": "5000 TABLET, FILM COATED in 1 CONTAINER (16729-145-22) ",
      "NDC11Code": "16729-0145-22",
      "ProductNDC": "16729-145",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Quetiapine",
      "DosageFormName": "TABLET, FILM COATED",
      "StartMarketingDate": "20151216",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Accord Healthcare Inc.",
      "SubstanceName": "QUETIAPINE FUMARATE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Status": "Unfinished",
      "LastUpdate": "2022-11-08",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "16-DEC-15"
    },
    {
      "NDCCode": "44224-0118-1",
      "PackageDescription": "1 KIT in 1 KIT (44224-0118-1)  *  .8 mL in 1 PACKAGE (52124-0001-1)  *  .5 g in 1 TUBE (52124-0003-1)  *  2 TABLET, FILM COATED in 1 PACKET (47682-116-99)  *  1 CAPSULE in 1 PACKET (47682-182-46)  *  2 TABLET, FILM COATED in 1 PACKET (47682-808-99)  *  2 TABLET, FILM COATED in 1 PACKET (47682-145-99)  *  22 g in 1 PACKET (52380-0001-3)",
      "NDC11Code": "44224-0118-01",
      "ProductNDC": "44224-0118",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Mountain Series Weekender Medical",
      "NonProprietaryName": "Benzalkonium Chloride, Povidone-iodine, Acetaminophen, Aspirin, Diphenhydramine Hydrochloride, Ibuprofen, Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20110801",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Tender Corporation dba Adventure Medical Kits",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "59765-145-22",
      "PackageDescription": "5000 TABLET, FILM COATED in 1 CONTAINER (59765-145-22) ",
      "NDC11Code": "59765-0145-22",
      "ProductNDC": "59765-145",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Quetiapine Fumarate",
      "DosageFormName": "TABLET, FILM COATED",
      "StartMarketingDate": "20151216",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Intas Pharmaceuticals Limited",
      "SubstanceName": "QUETIAPINE FUMARATE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Status": "Unfinished",
      "LastUpdate": "2022-10-15",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "16-DEC-15"
    },
    {
      "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": "69729-610-05",
      "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": "10096-2175-1",
      "PackageDescription": "75 mL in 1 CANISTER (10096-2175-1) ",
      "NDC11Code": "10096-2175-01",
      "ProductNDC": "10096-2175",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Avon Wild Country",
      "ProprietaryNameSuffix": "Roll-on Anti-perspirant Deodorant",
      "NonProprietaryName": "Aluminum Chlorohydrate",
      "DosageFormName": "STICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240320",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M019",
      "LabelerName": "The Avon Company",
      "SubstanceName": "ALUMINUM CHLOROHYDRATE",
      "StrengthNumber": "145",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2024-03-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240320",
      "SamplePackage": "N",
      "IndicationAndUsage": "reduces underarm perspiration."
    },
    {
      "NDCCode": "11673-145-01",
      "PackageDescription": "2 BLISTER PACK in 1 CARTON (11673-145-01)  > 10 TABLET, COATED in 1 BLISTER PACK",
      "NDC11Code": "11673-0145-01",
      "ProductNDC": "11673-145",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Up And Up Mucus Relief Cold And Sinus",
      "NonProprietaryName": "Acetaminophen, Guaifenesin, Phenylephrine Hcl",
      "DosageFormName": "TABLET, COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130924",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "Target Corporation",
      "SubstanceName": "ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "325; 200; 5",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2017-11-22"
    },
    {
      "NDCCode": "11673-145-39",
      "PackageDescription": "3 BLISTER PACK in 1 CARTON (11673-145-39)  > 10 TABLET, COATED in 1 BLISTER PACK",
      "NDC11Code": "11673-0145-39",
      "ProductNDC": "11673-145",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Up And Up Mucus Relief Cold And Sinus",
      "NonProprietaryName": "Acetaminophen, Guaifenesin, Phenylephrine Hcl",
      "DosageFormName": "TABLET, COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130924",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "Target Corporation",
      "SubstanceName": "ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "325; 200; 5",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2017-11-22"
    },
    {
      "NDCCode": "43353-272-30",
      "PackageDescription": "30 TABLET in 1 BOTTLE (43353-272-30)",
      "NDC11Code": "43353-0272-30",
      "ProductNDC": "43353-272",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tricor",
      "NonProprietaryName": "Fenofibrate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160205",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021656",
      "LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
      "SubstanceName": "FENOFIBRATE",
      "StrengthNumber": "145",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-07-22",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "IndicationAndUsage": "TRICOR is a peroxisome proliferator receptor alpha (PPARα) activator indicated as an adjunct to diet: 1 To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.1)., 2 For treatment of adult patients with severe hypertriglyceridemia (1.2).",
      "Description": "TRICOR (fenofibrate tablets), is a lipid regulating agent available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79-82°C. Fenofibrate is a white solid which is stable under ordinary conditions. Inactive Ingredients. Each tablet contains hypromellose 2910 (3 cps), docusate sodium, sucrose, sodium lauryl sulfate, lactose monohydrate, silicified microcrystalline cellulose, crospovidone, and magnesium stearate. In addition, individual tablets contain. 48 mg tablets. polyvinyl alcohol, titanium dioxide, talc, soybean lecithin, xanthan gum, D&C Yellow #10 aluminum lake, FD&C Yellow #6 /sunset yellow FCF aluminum lake, FD&C Blue #2 /indigo carmine aluminum lake. 145 mg tablets. polyvinyl alcohol, titanium dioxide, talc, soybean lecithin, xanthan gum."
    },
    {
      "NDCCode": "43353-272-83",
      "PackageDescription": "3600 TABLET in 1 BOTTLE (43353-272-83)",
      "NDC11Code": "43353-0272-83",
      "ProductNDC": "43353-272",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tricor",
      "NonProprietaryName": "Fenofibrate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160205",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021656",
      "LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
      "SubstanceName": "FENOFIBRATE",
      "StrengthNumber": "145",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-07-22",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "IndicationAndUsage": "TRICOR is a peroxisome proliferator receptor alpha (PPARα) activator indicated as an adjunct to diet: 1 To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.1)., 2 For treatment of adult patients with severe hypertriglyceridemia (1.2).",
      "Description": "TRICOR (fenofibrate tablets), is a lipid regulating agent available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79-82°C. Fenofibrate is a white solid which is stable under ordinary conditions. Inactive Ingredients. Each tablet contains hypromellose 2910 (3 cps), docusate sodium, sucrose, sodium lauryl sulfate, lactose monohydrate, silicified microcrystalline cellulose, crospovidone, and magnesium stearate. In addition, individual tablets contain. 48 mg tablets. polyvinyl alcohol, titanium dioxide, talc, soybean lecithin, xanthan gum, D&C Yellow #10 aluminum lake, FD&C Yellow #6 /sunset yellow FCF aluminum lake, FD&C Blue #2 /indigo carmine aluminum lake. 145 mg tablets. polyvinyl alcohol, titanium dioxide, talc, soybean lecithin, xanthan gum."
    },
    {
      "NDCCode": "49348-145-46",
      "PackageDescription": "14 PATCH in 1 CARTON (49348-145-46)  > 24 h in 1 PATCH",
      "NDC11Code": "49348-0145-46",
      "ProductNDC": "49348-145",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Nicotine",
      "ProprietaryNameSuffix": "Transdermal System Step 2",
      "NonProprietaryName": "Nicotine",
      "DosageFormName": "PATCH, EXTENDED RELEASE",
      "RouteName": "TRANSDERMAL",
      "StartMarketingDate": "20151102",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020076",
      "LabelerName": "Strategic Sourcing Services LLC",
      "SubstanceName": "NICOTINE",
      "StrengthNumber": "14",
      "StrengthUnit": "mg/24h",
      "Status": "Deprecated",
      "LastUpdate": "2021-12-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20151102",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "51407-741-12",
      "PackageDescription": "120 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (51407-741-12) ",
      "NDC11Code": "51407-0741-12",
      "ProductNDC": "51407-741",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Zileuton",
      "NonProprietaryName": "Zileuton",
      "DosageFormName": "TABLET, MULTILAYER, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20191216",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212670",
      "LabelerName": "Golden State Medical Supply, Inc.",
      "SubstanceName": "ZILEUTON",
      "StrengthNumber": "600",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "5-Lipoxygenase Inhibitor [EPC], 5-Lipoxygenase Inhibitors [MoA], Decreased Leukotriene Production [PE]",
      "Status": "Active",
      "LastUpdate": "2023-03-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230119",
      "SamplePackage": "N",
      "IndicationAndUsage": "Zileuton extended-release tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older. Zileuton extended-release tablets are not indicated for use in the reversal of bronchospasm in acute asthma attacks.  Therapy with zileuton extended-release tablets can be continued during acute exacerbations of asthma.",
      "Description": "Zileuton is an orally active inhibitor of 5-lipoxygenase, the enzyme that catalyzes the formation of leukotrienes from arachidonic acid. Zileuton has the chemical name (±)-1-(1-Benzo[b]thien-2-ylethyl)-1-hydroxyurea and the following chemical structure. Zileuton has the molecular formula C 11H 12N 2O 2S and a molecular weight of 236.29. It is a racemic mixture (50:50) of R(+) and S(-) enantiomers. Zileuton is a practically odorless, white to off-white powder that is soluble in methanol and ethanol, slightly soluble in acetonitrile, and practically insoluble in water and hexane. The melting point ranges from 144.2° to 145.2°C. Zileuton extended-release tablets for oral administration are triple-layer tablets comprised of an immediate-release layer, a middle (barrier) layer, and an extended-release layer. Zileuton extended-release tablets are oblong, film-coated tablets with one red layer between two white layers, debossed on one side with \"P723\" and plain on other side. Each tablet contains 600 mg of zileuton and the following inactive ingredients: colloidal silicon dioxide, glyceryl behenate, hydroxypropyl cellulose, hydroxypropyl methylcellulose, hypromellose, iron oxide red, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, pregelatinized starch and sodium starch glycolate."
    },
    {
      "NDCCode": "57627-145-02",
      "PackageDescription": "1 CONTAINER in 1 CARTON (57627-145-02)  > 13 g in 1 CONTAINER (57627-145-01)",
      "NDC11Code": "57627-0145-02",
      "ProductNDC": "57627-145",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sandy Beige Smart Finish Makeup Spf 18",
      "ProprietaryNameSuffix": "Merle Norman",
      "NonProprietaryName": "Titanium Dioxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110503",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Merle Norman",
      "SubstanceName": "TITANIUM DIOXIDE",
      "StrengthNumber": "13",
      "StrengthUnit": "g/13g",
      "Status": "Deprecated",
      "LastUpdate": "2014-04-22"
    },
    {
      "NDCCode": "61715-145-20",
      "PackageDescription": "10 BLISTER PACK in 1 CARTON (61715-145-20)  > 2 TABLET, COATED in 1 BLISTER PACK",
      "NDC11Code": "61715-0145-20",
      "ProductNDC": "61715-145",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Preferred Plus Mucus Relief Cold And Sinus",
      "NonProprietaryName": "Acetaminophen, Guaifenesin, Phenylephrine Hcl",
      "DosageFormName": "TABLET, COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20141204",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "Kinray",
      "SubstanceName": "ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "325; 200; 5",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2017-11-22"
    },
    {
      "NDCCode": "69452-145-13",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (69452-145-13) ",
      "NDC11Code": "69452-0145-13",
      "ProductNDC": "69452-145",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Paricalcitol",
      "NonProprietaryName": "Paricalcitol",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160816",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202539",
      "LabelerName": "Bionpharma Inc.",
      "SubstanceName": "PARICALCITOL",
      "StrengthNumber": "1",
      "StrengthUnit": "ug/1",
      "Pharm_Classes": "Ergocalciferols [CS], Vitamin D Analog [EPC], Vitamin D2 Analog [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-12-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160816",
      "SamplePackage": "N",
      "IndicationAndUsage": "Paricalcitol is a vitamin D analog indicated in adults for the prevention and treatment of secondary hyperparathyroidism associated with: 1 Chronic kidney disease (CKD) Stages 3 and 4 ( 1.1). , 2 CKD Stage 5 in patients on hemodialysis or peritoneal dialysis ( 1.2). .",
      "Description": "Paricalcitol, USP, the active ingredient in paricalcitol capsules, is a synthetically manufactured, metabolically active vitamin D analog of calcitriol with modifications to the side chain (D 2) and the A (19-nor) ring. Paricalcitol is available as soft gelatin capsules for oral administration containing 1 microgram, 2 micrograms or 4 micrograms of paricalcitol. Each capsule also contains medium chain triglycerides, alcohol, and butylated hydroxytoluene. The medium chain triglycerides are fractionated from coconut oil or palm kernel oil. The capsule shell is composed of gelatin, glycerin, titanium dioxide, iron oxide red (2 microgram capsules only), iron oxide yellow (2 microgram and 4 microgram capsules), iron oxide black (1 microgram capsules only), and water. The capsules are printed with black ink composed of purified water, black iron oxide, isopropyl alcohol, propylene glycol and hypromellose. Paricalcitol is a white, crystalline powder with the empirical formula of C 27H 44O 3, which corresponds to a molecular weight of 416.64. Paricalcitol is chemically designated as 19-nor-1α,3β,25-trihydroxy-9,10-secoergosta-5(Z),7(E),22(E)-triene and has the following structural formula:."
    },
    {
      "NDCCode": "69842-138-22",
      "PackageDescription": "177 mL in 1 BOTTLE (69842-138-22) ",
      "NDC11Code": "69842-0138-22",
      "ProductNDC": "69842-138",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cvs Health",
      "ProprietaryNameSuffix": "Baby Spf 50 Sun",
      "NonProprietaryName": "Octinoxate, Octisalate, Zinc Oxide",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160309",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "CVS Pharmacy",
      "SubstanceName": "OCTINOXATE; OCTISALATE; ZINC OXIDE",
      "StrengthNumber": "75; 50; 145",
      "StrengthUnit": "mg/mL; mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-10-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20160309",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see  ​Directions​), decreases the risk of skin cancer and early skin aging caused by the sun ."
    },
    {
      "NDCCode": "69842-178-22",
      "PackageDescription": "177 mL in 1 BOTTLE (69842-178-22) ",
      "NDC11Code": "69842-0178-22",
      "ProductNDC": "69842-178",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cvs Health",
      "ProprietaryNameSuffix": "Baby Spf 50 Mineral-based Sun",
      "NonProprietaryName": "Octinoxate, Octisalate, Zinc Oxide",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20180309",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "CVS Pharmacy",
      "SubstanceName": "OCTINOXATE; OCTISALATE; ZINC OXIDE",
      "StrengthNumber": "75; 50; 145",
      "StrengthUnit": "mg/mL; mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-10-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20180309",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see  ​Directions​), decreases the risk of skin cancer and early skin aging caused by the sun ."
    },
    {
      "NDCCode": "70934-145-30",
      "PackageDescription": "30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70934-145-30) ",
      "NDC11Code": "70934-0145-30",
      "ProductNDC": "70934-145",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pantoprazole Sodium",
      "NonProprietaryName": "Pantoprazole Sodium",
      "DosageFormName": "TABLET, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180725",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090074",
      "LabelerName": "Denton Pharma, Inc. DBA Northwind Pharmaceuticals",
      "SubstanceName": "PANTOPRAZOLE SODIUM",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20180725",
      "SamplePackage": "N",
      "IndicationAndUsage": "Pantoprazole is a proton pump inhibitor indicated (PPI) for the following: : 1   Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) ( 1.1) , 2   Maintenance of Healing of Erosive Esophagitis ( 1.2) , 3   Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE)  Syndrome (  1.3)  .",
      "Description": "The active ingredient in pantoprazole sodium delayed-release tablets USP a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl] -1 H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C 16H 14F 2N 3NaO 4S x 1.5 H 2O, with a molecular weight of 432.4. The structural formula is:. Pantoprazole sodium (sesquihydrate), USP is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium (sesquihydrate), USP is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium is supplied as a delayed-release tablet, available in two strengths 20 mg pantoprazole (equivalent to 22.56 mg of pantoprazole sodium) and 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium). Pantoprazole sodium delayed-release tablet, USP contains the following inactive ingredients: calcium stearate, crospovidone, hydroxypropyl cellulose, hypromellose, mannitol, methacrylic acid copolymer dispersion, propylene glycol, sodium carbonate, talc, titanium dioxide, and triethyl citrate. Pantoprazole sodium delayed-release tablets, USP ( 40 mg and 20 mg) complies with USP dissolution test 2."
    },
    {
      "NDCCode": "71141-947-71",
      "PackageDescription": "177 mL in 1 BOTTLE (71141-947-71) ",
      "NDC11Code": "71141-0947-71",
      "ProductNDC": "71141-947",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cien Sun By Lidl Kids Sunscreen Spf 50 Plus",
      "NonProprietaryName": "Octisalate, Zinc Oxide",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210430",
      "EndMarketingDate": "20250419",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "LIDL US LLC",
      "SubstanceName": "OCTISALATE; ZINC OXIDE",
      "StrengthNumber": "50; 145",
      "StrengthUnit": "mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-04-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20210430",
      "EndMarketingDatePackage": "20250419",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging casued by the sun ."
    },
    {
      "NDCCode": "69729-003-10",
      "PackageDescription": "10 BLISTER PACK in 1 CARTON (69729-003-10)  / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
      "NDC11Code": "69729-0003-10",
      "ProductNDC": "69729-003",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ampigrin Ultra Forte Night",
      "NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate",
      "DosageFormName": "CAPSULE, LIQUID FILLED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220610",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "OPMX LLC",
      "SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; ACETAMINOPHEN",
      "StrengthNumber": "15; 6.25; 325",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-07-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220610",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporarily relieves common cold/flu symptoms: 1 Cough due to minor throat & bronchial irritation, 2 Sore throat, 3 Headache, 4 Minor aches & pains, 5 Fever, 6 Runny nose & sneezing."
    },
    {
      "NDCCode": "69729-006-02",
      "PackageDescription": "1 BOTTLE in 1 CARTON (69729-006-02)  / 60 mL in 1 BOTTLE",
      "NDC11Code": "69729-0006-02",
      "ProductNDC": "69729-006",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Temperal-ito",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "SUSPENSION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230602",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M013",
      "LabelerName": "OPMX Chula Vista",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "160",
      "StrengthUnit": "mg/5mL",
      "Status": "Active",
      "LastUpdate": "2024-11-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230602",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "69729-006-04",
      "PackageDescription": "1 BOTTLE in 1 CARTON (69729-006-04)  / 118 mL in 1 BOTTLE",
      "NDC11Code": "69729-0006-04",
      "ProductNDC": "69729-006",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Temperal-ito",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "SUSPENSION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230602",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M013",
      "LabelerName": "OPMX Chula Vista",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "160",
      "StrengthUnit": "mg/5mL",
      "Status": "Active",
      "LastUpdate": "2024-11-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230602",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "69729-008-10",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (69729-008-10)  / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
      "NDC11Code": "69729-0008-10",
      "ProductNDC": "69729-008",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Activcin",
      "NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride",
      "DosageFormName": "CAPSULE, LIQUID FILLED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220523",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "OPMX LLC.",
      "SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "10; 325; 5",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-04-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220523",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporarily relieves common cold/flu symptoms: 1 Nasal congestion, 2 Cough due to minor throat & bronchial irritation, 3 Sore throat, 4 Headache, 5 Minor aches & pains, 6 Fever."
    },
    {
      "NDCCode": "69729-018-18",
      "PackageDescription": "18 LOZENGE in 1 BLISTER PACK (69729-018-18) ",
      "NDC11Code": "69729-0018-18",
      "ProductNDC": "69729-018",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cherry Sore Throat Lozenges",
      "NonProprietaryName": "Benzocaine",
      "DosageFormName": "LOZENGE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180327",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part356",
      "LabelerName": "OPMX LLC",
      "SubstanceName": "BENZOCAINE; MENTHOL",
      "StrengthNumber": "15; 3.6",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-10-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20180327",
      "SamplePackage": "N"
    }
  ]
}
                    
{"NDC":[{"NDCCode":"69729-145-22","ProprietaryName":"Acetaminophen 500mg Caffeine 60mg Pyrilamine Maleate 15mg","NonProprietaryName":"Acetaminophen 500mg Caffeine 60mg Pyrilamine Maleate 15mg"},{"NDCCode":"69729-144-22","ProprietaryName":"Acetaminophen 500mg Caffeine 60mg Pyrilamine Maleate 15mg","NonProprietaryName":"Acetaminophen 500mg Caffeine 60mg Pyrilamine Maleate 15mg"},{"NDCCode":"69729-146-22","ProprietaryName":"Acetaminophen 500mg Caffeine 60mg Pyrilamine Maleate 15mg","NonProprietaryName":"Acetaminophen 500mg Caffeine 60mg Pyrilamine Maleate 15mg"},{"NDCCode":"16364-145-22","NonProprietaryName":"Quetiapine Fumarate"},{"NDCCode":"16729-145-22","NonProprietaryName":"Quetiapine"},{"NDCCode":"44224-0118-1","ProprietaryName":"Mountain Series Weekender Medical","NonProprietaryName":"Benzalkonium Chloride, Povidone-iodine, Acetaminophen, Aspirin, Diphenhydramine Hydrochloride, Ibuprofen, Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate"},{"NDCCode":"59765-145-22","NonProprietaryName":"Quetiapine Fumarate"},{"NDCCode":"82009-144-22","ProprietaryName":"Adalimumab-adbm","NonProprietaryName":"Adalimumab-adbm"},{"NDCCode":"69729-610-05","ProprietaryName":"Canespies","NonProprietaryName":"Tolnaftate"},{"NDCCode":"69729-615-05","ProprietaryName":"Penimixcina","NonProprietaryName":"Bacitracin, Neomycin Sulfate, Polymixin B Sulfate, Pramoxine Hydrochloride"},{"NDCCode":"69729-782-10","ProprietaryName":"Acetaminophen, Guaifenesin, Dextromethorphan Hbr, Phenylephrine Hcl","NonProprietaryName":"Acetaminophen, Guaifenesin, Dextromethorphan Hbr, Phenylephrine Hcl"},{"NDCCode":"10096-2175-1","ProprietaryName":"Avon Wild Country","NonProprietaryName":"Aluminum Chlorohydrate"},{"NDCCode":"11673-145-01","ProprietaryName":"Up And Up Mucus Relief Cold And Sinus","NonProprietaryName":"Acetaminophen, Guaifenesin, Phenylephrine Hcl"},{"NDCCode":"11673-145-39","ProprietaryName":"Up And Up Mucus Relief Cold And Sinus","NonProprietaryName":"Acetaminophen, Guaifenesin, Phenylephrine Hcl"},{"NDCCode":"43353-272-30","ProprietaryName":"Tricor","NonProprietaryName":"Fenofibrate"},{"NDCCode":"43353-272-83","ProprietaryName":"Tricor","NonProprietaryName":"Fenofibrate"},{"NDCCode":"49348-145-46","ProprietaryName":"Nicotine","NonProprietaryName":"Nicotine"},{"NDCCode":"51407-741-12","ProprietaryName":"Zileuton","NonProprietaryName":"Zileuton"},{"NDCCode":"57627-145-02","ProprietaryName":"Sandy Beige Smart Finish Makeup Spf 18","NonProprietaryName":"Titanium Dioxide"},{"NDCCode":"61715-145-20","ProprietaryName":"Preferred Plus Mucus Relief Cold And Sinus","NonProprietaryName":"Acetaminophen, Guaifenesin, Phenylephrine Hcl"},{"NDCCode":"69452-145-13","ProprietaryName":"Paricalcitol","NonProprietaryName":"Paricalcitol"},{"NDCCode":"69842-138-22","ProprietaryName":"Cvs Health","NonProprietaryName":"Octinoxate, Octisalate, Zinc Oxide"},{"NDCCode":"69842-178-22","ProprietaryName":"Cvs Health","NonProprietaryName":"Octinoxate, Octisalate, Zinc Oxide"},{"NDCCode":"70934-145-30","ProprietaryName":"Pantoprazole Sodium","NonProprietaryName":"Pantoprazole Sodium"},{"NDCCode":"71141-947-71","ProprietaryName":"Cien Sun By Lidl Kids Sunscreen Spf 50 Plus","NonProprietaryName":"Octisalate, Zinc Oxide"},{"NDCCode":"69729-003-10","ProprietaryName":"Ampigrin Ultra Forte Night","NonProprietaryName":"Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate"},{"NDCCode":"69729-006-02","ProprietaryName":"Temperal-ito","NonProprietaryName":"Acetaminophen"},{"NDCCode":"69729-006-04","ProprietaryName":"Temperal-ito","NonProprietaryName":"Acetaminophen"},{"NDCCode":"69729-008-10","ProprietaryName":"Activcin","NonProprietaryName":"Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride"},{"NDCCode":"69729-018-18","ProprietaryName":"Cherry Sore Throat Lozenges","NonProprietaryName":"Benzocaine"}]}
                    
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<NDCList>
  <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>
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    <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>69729-144-22</NDCCode>
    <PackageDescription>12 TABLET in 1 PACKAGE (69729-144-22) </PackageDescription>
    <NDC11Code>69729-0144-22</NDC11Code>
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    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Acetaminophen 500mg Caffeine 60mg Pyrilamine Maleate 15mg</ProprietaryName>
    <NonProprietaryName>Acetaminophen 500mg Caffeine 60mg Pyrilamine Maleate 15mg</NonProprietaryName>
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    <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>69729-146-22</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>
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    <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>16364-145-22</NDCCode>
    <PackageDescription>5000 TABLET, FILM COATED in 1 CONTAINER (16364-145-22) </PackageDescription>
    <NDC11Code>16364-0145-22</NDC11Code>
    <ProductNDC>16364-145</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <StartMarketingDate>20151216</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Intas Pharmaceuticals Limited</LabelerName>
    <SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2022-10-15</LastUpdate>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>16-DEC-15</StartMarketingDatePackage>
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  <NDC>
    <NDCCode>16729-145-22</NDCCode>
    <PackageDescription>5000 TABLET, FILM COATED in 1 CONTAINER (16729-145-22) </PackageDescription>
    <NDC11Code>16729-0145-22</NDC11Code>
    <ProductNDC>16729-145</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Quetiapine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <StartMarketingDate>20151216</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Accord Healthcare Inc.</LabelerName>
    <SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2022-11-08</LastUpdate>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>16-DEC-15</StartMarketingDatePackage>
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  <NDC>
    <NDCCode>44224-0118-1</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (44224-0118-1)  *  .8 mL in 1 PACKAGE (52124-0001-1)  *  .5 g in 1 TUBE (52124-0003-1)  *  2 TABLET, FILM COATED in 1 PACKET (47682-116-99)  *  1 CAPSULE in 1 PACKET (47682-182-46)  *  2 TABLET, FILM COATED in 1 PACKET (47682-808-99)  *  2 TABLET, FILM COATED in 1 PACKET (47682-145-99)  *  22 g in 1 PACKET (52380-0001-3)</PackageDescription>
    <NDC11Code>44224-0118-01</NDC11Code>
    <ProductNDC>44224-0118</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Mountain Series Weekender Medical</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride, Povidone-iodine, Acetaminophen, Aspirin, Diphenhydramine Hydrochloride, Ibuprofen, Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20110801</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Tender Corporation dba Adventure Medical Kits</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
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  <NDC>
    <NDCCode>59765-145-22</NDCCode>
    <PackageDescription>5000 TABLET, FILM COATED in 1 CONTAINER (59765-145-22) </PackageDescription>
    <NDC11Code>59765-0145-22</NDC11Code>
    <ProductNDC>59765-145</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <StartMarketingDate>20151216</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Intas Pharmaceuticals Limited</LabelerName>
    <SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2022-10-15</LastUpdate>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>16-DEC-15</StartMarketingDatePackage>
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  <NDC>
    <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>69729-610-05</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>10096-2175-1</NDCCode>
    <PackageDescription>75 mL in 1 CANISTER (10096-2175-1) </PackageDescription>
    <NDC11Code>10096-2175-01</NDC11Code>
    <ProductNDC>10096-2175</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Avon Wild Country</ProprietaryName>
    <ProprietaryNameSuffix>Roll-on Anti-perspirant Deodorant</ProprietaryNameSuffix>
    <NonProprietaryName>Aluminum Chlorohydrate</NonProprietaryName>
    <DosageFormName>STICK</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240320</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M019</ApplicationNumber>
    <LabelerName>The Avon Company</LabelerName>
    <SubstanceName>ALUMINUM CHLOROHYDRATE</SubstanceName>
    <StrengthNumber>145</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-03-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240320</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>reduces underarm perspiration.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>11673-145-01</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 CARTON (11673-145-01)  &gt; 10 TABLET, COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>11673-0145-01</NDC11Code>
    <ProductNDC>11673-145</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Up And Up Mucus Relief Cold And Sinus</ProprietaryName>
    <NonProprietaryName>Acetaminophen, Guaifenesin, Phenylephrine Hcl</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130924</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>Target Corporation</LabelerName>
    <SubstanceName>ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>325; 200; 5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-11-22</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>11673-145-39</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (11673-145-39)  &gt; 10 TABLET, COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>11673-0145-39</NDC11Code>
    <ProductNDC>11673-145</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Up And Up Mucus Relief Cold And Sinus</ProprietaryName>
    <NonProprietaryName>Acetaminophen, Guaifenesin, Phenylephrine Hcl</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130924</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>Target Corporation</LabelerName>
    <SubstanceName>ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>325; 200; 5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-11-22</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>43353-272-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (43353-272-30)</PackageDescription>
    <NDC11Code>43353-0272-30</NDC11Code>
    <ProductNDC>43353-272</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tricor</ProprietaryName>
    <NonProprietaryName>Fenofibrate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160205</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021656</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>FENOFIBRATE</SubstanceName>
    <StrengthNumber>145</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-07-22</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>TRICOR is a peroxisome proliferator receptor alpha (PPARα) activator indicated as an adjunct to diet: 1 To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.1)., 2 For treatment of adult patients with severe hypertriglyceridemia (1.2).</IndicationAndUsage>
    <Description>TRICOR (fenofibrate tablets), is a lipid regulating agent available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79-82°C. Fenofibrate is a white solid which is stable under ordinary conditions. Inactive Ingredients. Each tablet contains hypromellose 2910 (3 cps), docusate sodium, sucrose, sodium lauryl sulfate, lactose monohydrate, silicified microcrystalline cellulose, crospovidone, and magnesium stearate. In addition, individual tablets contain. 48 mg tablets. polyvinyl alcohol, titanium dioxide, talc, soybean lecithin, xanthan gum, D&amp;C Yellow #10 aluminum lake, FD&amp;C Yellow #6 /sunset yellow FCF aluminum lake, FD&amp;C Blue #2 /indigo carmine aluminum lake. 145 mg tablets. polyvinyl alcohol, titanium dioxide, talc, soybean lecithin, xanthan gum.</Description>
  </NDC>
  <NDC>
    <NDCCode>43353-272-83</NDCCode>
    <PackageDescription>3600 TABLET in 1 BOTTLE (43353-272-83)</PackageDescription>
    <NDC11Code>43353-0272-83</NDC11Code>
    <ProductNDC>43353-272</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tricor</ProprietaryName>
    <NonProprietaryName>Fenofibrate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160205</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021656</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>FENOFIBRATE</SubstanceName>
    <StrengthNumber>145</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-07-22</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>TRICOR is a peroxisome proliferator receptor alpha (PPARα) activator indicated as an adjunct to diet: 1 To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.1)., 2 For treatment of adult patients with severe hypertriglyceridemia (1.2).</IndicationAndUsage>
    <Description>TRICOR (fenofibrate tablets), is a lipid regulating agent available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79-82°C. Fenofibrate is a white solid which is stable under ordinary conditions. Inactive Ingredients. Each tablet contains hypromellose 2910 (3 cps), docusate sodium, sucrose, sodium lauryl sulfate, lactose monohydrate, silicified microcrystalline cellulose, crospovidone, and magnesium stearate. In addition, individual tablets contain. 48 mg tablets. polyvinyl alcohol, titanium dioxide, talc, soybean lecithin, xanthan gum, D&amp;C Yellow #10 aluminum lake, FD&amp;C Yellow #6 /sunset yellow FCF aluminum lake, FD&amp;C Blue #2 /indigo carmine aluminum lake. 145 mg tablets. polyvinyl alcohol, titanium dioxide, talc, soybean lecithin, xanthan gum.</Description>
  </NDC>
  <NDC>
    <NDCCode>49348-145-46</NDCCode>
    <PackageDescription>14 PATCH in 1 CARTON (49348-145-46)  &gt; 24 h in 1 PATCH</PackageDescription>
    <NDC11Code>49348-0145-46</NDC11Code>
    <ProductNDC>49348-145</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Nicotine</ProprietaryName>
    <ProprietaryNameSuffix>Transdermal System Step 2</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>14</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>51407-741-12</NDCCode>
    <PackageDescription>120 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (51407-741-12) </PackageDescription>
    <NDC11Code>51407-0741-12</NDC11Code>
    <ProductNDC>51407-741</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zileuton</ProprietaryName>
    <NonProprietaryName>Zileuton</NonProprietaryName>
    <DosageFormName>TABLET, MULTILAYER, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20191216</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212670</ApplicationNumber>
    <LabelerName>Golden State Medical Supply, Inc.</LabelerName>
    <SubstanceName>ZILEUTON</SubstanceName>
    <StrengthNumber>600</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>5-Lipoxygenase Inhibitor [EPC], 5-Lipoxygenase Inhibitors [MoA], Decreased Leukotriene Production [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-03-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230119</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Zileuton extended-release tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older. Zileuton extended-release tablets are not indicated for use in the reversal of bronchospasm in acute asthma attacks.  Therapy with zileuton extended-release tablets can be continued during acute exacerbations of asthma.</IndicationAndUsage>
    <Description>Zileuton is an orally active inhibitor of 5-lipoxygenase, the enzyme that catalyzes the formation of leukotrienes from arachidonic acid. Zileuton has the chemical name (±)-1-(1-Benzo[b]thien-2-ylethyl)-1-hydroxyurea and the following chemical structure. Zileuton has the molecular formula C 11H 12N 2O 2S and a molecular weight of 236.29. It is a racemic mixture (50:50) of R(+) and S(-) enantiomers. Zileuton is a practically odorless, white to off-white powder that is soluble in methanol and ethanol, slightly soluble in acetonitrile, and practically insoluble in water and hexane. The melting point ranges from 144.2° to 145.2°C. Zileuton extended-release tablets for oral administration are triple-layer tablets comprised of an immediate-release layer, a middle (barrier) layer, and an extended-release layer. Zileuton extended-release tablets are oblong, film-coated tablets with one red layer between two white layers, debossed on one side with "P723" and plain on other side. Each tablet contains 600 mg of zileuton and the following inactive ingredients: colloidal silicon dioxide, glyceryl behenate, hydroxypropyl cellulose, hydroxypropyl methylcellulose, hypromellose, iron oxide red, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, pregelatinized starch and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>57627-145-02</NDCCode>
    <PackageDescription>1 CONTAINER in 1 CARTON (57627-145-02)  &gt; 13 g in 1 CONTAINER (57627-145-01)</PackageDescription>
    <NDC11Code>57627-0145-02</NDC11Code>
    <ProductNDC>57627-145</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sandy Beige Smart Finish Makeup Spf 18</ProprietaryName>
    <ProprietaryNameSuffix>Merle Norman</ProprietaryNameSuffix>
    <NonProprietaryName>Titanium Dioxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110503</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Merle Norman</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>13</StrengthNumber>
    <StrengthUnit>g/13g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-04-22</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>61715-145-20</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (61715-145-20)  &gt; 2 TABLET, COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>61715-0145-20</NDC11Code>
    <ProductNDC>61715-145</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Preferred Plus Mucus Relief Cold And Sinus</ProprietaryName>
    <NonProprietaryName>Acetaminophen, Guaifenesin, Phenylephrine Hcl</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20141204</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>Kinray</LabelerName>
    <SubstanceName>ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>325; 200; 5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-11-22</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>69452-145-13</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE, PLASTIC (69452-145-13) </PackageDescription>
    <NDC11Code>69452-0145-13</NDC11Code>
    <ProductNDC>69452-145</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Paricalcitol</ProprietaryName>
    <NonProprietaryName>Paricalcitol</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160816</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202539</ApplicationNumber>
    <LabelerName>Bionpharma Inc.</LabelerName>
    <SubstanceName>PARICALCITOL</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>ug/1</StrengthUnit>
    <Pharm_Classes>Ergocalciferols [CS], Vitamin D Analog [EPC], Vitamin D2 Analog [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-12-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160816</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Paricalcitol is a vitamin D analog indicated in adults for the prevention and treatment of secondary hyperparathyroidism associated with: 1 Chronic kidney disease (CKD) Stages 3 and 4 ( 1.1). , 2 CKD Stage 5 in patients on hemodialysis or peritoneal dialysis ( 1.2). .</IndicationAndUsage>
    <Description>Paricalcitol, USP, the active ingredient in paricalcitol capsules, is a synthetically manufactured, metabolically active vitamin D analog of calcitriol with modifications to the side chain (D 2) and the A (19-nor) ring. Paricalcitol is available as soft gelatin capsules for oral administration containing 1 microgram, 2 micrograms or 4 micrograms of paricalcitol. Each capsule also contains medium chain triglycerides, alcohol, and butylated hydroxytoluene. The medium chain triglycerides are fractionated from coconut oil or palm kernel oil. The capsule shell is composed of gelatin, glycerin, titanium dioxide, iron oxide red (2 microgram capsules only), iron oxide yellow (2 microgram and 4 microgram capsules), iron oxide black (1 microgram capsules only), and water. The capsules are printed with black ink composed of purified water, black iron oxide, isopropyl alcohol, propylene glycol and hypromellose. Paricalcitol is a white, crystalline powder with the empirical formula of C 27H 44O 3, which corresponds to a molecular weight of 416.64. Paricalcitol is chemically designated as 19-nor-1α,3β,25-trihydroxy-9,10-secoergosta-5(Z),7(E),22(E)-triene and has the following structural formula:.</Description>
  </NDC>
  <NDC>
    <NDCCode>69842-138-22</NDCCode>
    <PackageDescription>177 mL in 1 BOTTLE (69842-138-22) </PackageDescription>
    <NDC11Code>69842-0138-22</NDC11Code>
    <ProductNDC>69842-138</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cvs Health</ProprietaryName>
    <ProprietaryNameSuffix>Baby Spf 50 Sun</ProprietaryNameSuffix>
    <NonProprietaryName>Octinoxate, Octisalate, Zinc Oxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20160309</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>CVS Pharmacy</LabelerName>
    <SubstanceName>OCTINOXATE; OCTISALATE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>75; 50; 145</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-10-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160309</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see  ​Directions​), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>69842-178-22</NDCCode>
    <PackageDescription>177 mL in 1 BOTTLE (69842-178-22) </PackageDescription>
    <NDC11Code>69842-0178-22</NDC11Code>
    <ProductNDC>69842-178</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cvs Health</ProprietaryName>
    <ProprietaryNameSuffix>Baby Spf 50 Mineral-based Sun</ProprietaryNameSuffix>
    <NonProprietaryName>Octinoxate, Octisalate, Zinc Oxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20180309</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>CVS Pharmacy</LabelerName>
    <SubstanceName>OCTINOXATE; OCTISALATE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>75; 50; 145</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-10-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180309</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see  ​Directions​), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>70934-145-30</NDCCode>
    <PackageDescription>30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70934-145-30) </PackageDescription>
    <NDC11Code>70934-0145-30</NDC11Code>
    <ProductNDC>70934-145</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pantoprazole Sodium</ProprietaryName>
    <NonProprietaryName>Pantoprazole Sodium</NonProprietaryName>
    <DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180725</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090074</ApplicationNumber>
    <LabelerName>Denton Pharma, Inc. DBA Northwind Pharmaceuticals</LabelerName>
    <SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180725</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pantoprazole is a proton pump inhibitor indicated (PPI) for the following: : 1   Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) ( 1.1) , 2   Maintenance of Healing of Erosive Esophagitis ( 1.2) , 3   Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE)  Syndrome (  1.3)  .</IndicationAndUsage>
    <Description>The active ingredient in pantoprazole sodium delayed-release tablets USP a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl] -1 H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C 16H 14F 2N 3NaO 4S x 1.5 H 2O, with a molecular weight of 432.4. The structural formula is:. Pantoprazole sodium (sesquihydrate), USP is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium (sesquihydrate), USP is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium is supplied as a delayed-release tablet, available in two strengths 20 mg pantoprazole (equivalent to 22.56 mg of pantoprazole sodium) and 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium). Pantoprazole sodium delayed-release tablet, USP contains the following inactive ingredients: calcium stearate, crospovidone, hydroxypropyl cellulose, hypromellose, mannitol, methacrylic acid copolymer dispersion, propylene glycol, sodium carbonate, talc, titanium dioxide, and triethyl citrate. Pantoprazole sodium delayed-release tablets, USP ( 40 mg and 20 mg) complies with USP dissolution test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>71141-947-71</NDCCode>
    <PackageDescription>177 mL in 1 BOTTLE (71141-947-71) </PackageDescription>
    <NDC11Code>71141-0947-71</NDC11Code>
    <ProductNDC>71141-947</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cien Sun By Lidl Kids Sunscreen Spf 50 Plus</ProprietaryName>
    <NonProprietaryName>Octisalate, Zinc Oxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210430</StartMarketingDate>
    <EndMarketingDate>20250419</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>LIDL US LLC</LabelerName>
    <SubstanceName>OCTISALATE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>50; 145</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-04-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20210430</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250419</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging casued by the sun .</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>69729-003-10</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (69729-003-10)  / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>69729-0003-10</NDC11Code>
    <ProductNDC>69729-003</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ampigrin Ultra Forte Night</ProprietaryName>
    <NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate</NonProprietaryName>
    <DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220610</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>OPMX LLC</LabelerName>
    <SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>15; 6.25; 325</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220610</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temporarily relieves common cold/flu symptoms: 1 Cough due to minor throat &amp; bronchial irritation, 2 Sore throat, 3 Headache, 4 Minor aches &amp; pains, 5 Fever, 6 Runny nose &amp; sneezing.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>69729-006-02</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (69729-006-02)  / 60 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>69729-0006-02</NDC11Code>
    <ProductNDC>69729-006</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Temperal-ito</ProprietaryName>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230602</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M013</ApplicationNumber>
    <LabelerName>OPMX Chula Vista</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>160</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-11-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230602</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>69729-006-04</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (69729-006-04)  / 118 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>69729-0006-04</NDC11Code>
    <ProductNDC>69729-006</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Temperal-ito</ProprietaryName>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230602</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M013</ApplicationNumber>
    <LabelerName>OPMX Chula Vista</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>160</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-11-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230602</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>69729-008-10</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (69729-008-10)  / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>69729-0008-10</NDC11Code>
    <ProductNDC>69729-008</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Activcin</ProprietaryName>
    <NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220523</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>OPMX LLC.</LabelerName>
    <SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10; 325; 5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-04-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220523</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temporarily relieves common cold/flu symptoms: 1 Nasal congestion, 2 Cough due to minor throat &amp; bronchial irritation, 3 Sore throat, 4 Headache, 5 Minor aches &amp; pains, 6 Fever.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>69729-018-18</NDCCode>
    <PackageDescription>18 LOZENGE in 1 BLISTER PACK (69729-018-18) </PackageDescription>
    <NDC11Code>69729-0018-18</NDC11Code>
    <ProductNDC>69729-018</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cherry Sore Throat Lozenges</ProprietaryName>
    <NonProprietaryName>Benzocaine</NonProprietaryName>
    <DosageFormName>LOZENGE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180327</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part356</ApplicationNumber>
    <LabelerName>OPMX LLC</LabelerName>
    <SubstanceName>BENZOCAINE; MENTHOL</SubstanceName>
    <StrengthNumber>15; 3.6</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-10-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180327</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
</NDCList>
                    
<NDCList><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>69729-144-22</NDCCode><ProprietaryName>Acetaminophen 500mg Caffeine 60mg Pyrilamine Maleate 15mg</ProprietaryName><NonProprietaryName>Acetaminophen 500mg Caffeine 60mg Pyrilamine Maleate 15mg</NonProprietaryName></NDC><NDC><NDCCode>69729-146-22</NDCCode><ProprietaryName>Acetaminophen 500mg Caffeine 60mg Pyrilamine Maleate 15mg</ProprietaryName><NonProprietaryName>Acetaminophen 500mg Caffeine 60mg Pyrilamine Maleate 15mg</NonProprietaryName></NDC><NDC><NDCCode>16364-145-22</NDCCode><NonProprietaryName>Quetiapine Fumarate</NonProprietaryName></NDC><NDC><NDCCode>16729-145-22</NDCCode><NonProprietaryName>Quetiapine</NonProprietaryName></NDC><NDC><NDCCode>44224-0118-1</NDCCode><ProprietaryName>Mountain Series Weekender Medical</ProprietaryName><NonProprietaryName>Benzalkonium Chloride, Povidone-iodine, Acetaminophen, Aspirin, Diphenhydramine Hydrochloride, Ibuprofen, Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate</NonProprietaryName></NDC><NDC><NDCCode>59765-145-22</NDCCode><NonProprietaryName>Quetiapine Fumarate</NonProprietaryName></NDC><NDC><NDCCode>82009-144-22</NDCCode><ProprietaryName>Adalimumab-adbm</ProprietaryName><NonProprietaryName>Adalimumab-adbm</NonProprietaryName></NDC><NDC><NDCCode>69729-610-05</NDCCode><ProprietaryName>Canespies</ProprietaryName><NonProprietaryName>Tolnaftate</NonProprietaryName></NDC><NDC><NDCCode>69729-615-05</NDCCode><ProprietaryName>Penimixcina</ProprietaryName><NonProprietaryName>Bacitracin, Neomycin Sulfate, Polymixin B Sulfate, Pramoxine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>69729-782-10</NDCCode><ProprietaryName>Acetaminophen, Guaifenesin, Dextromethorphan Hbr, Phenylephrine Hcl</ProprietaryName><NonProprietaryName>Acetaminophen, Guaifenesin, Dextromethorphan Hbr, Phenylephrine Hcl</NonProprietaryName></NDC><NDC><NDCCode>10096-2175-1</NDCCode><ProprietaryName>Avon Wild Country</ProprietaryName><NonProprietaryName>Aluminum Chlorohydrate</NonProprietaryName></NDC><NDC><NDCCode>11673-145-01</NDCCode><ProprietaryName>Up And Up Mucus Relief Cold And Sinus</ProprietaryName><NonProprietaryName>Acetaminophen, Guaifenesin, Phenylephrine Hcl</NonProprietaryName></NDC><NDC><NDCCode>11673-145-39</NDCCode><ProprietaryName>Up And Up Mucus Relief Cold And Sinus</ProprietaryName><NonProprietaryName>Acetaminophen, Guaifenesin, Phenylephrine Hcl</NonProprietaryName></NDC><NDC><NDCCode>43353-272-30</NDCCode><ProprietaryName>Tricor</ProprietaryName><NonProprietaryName>Fenofibrate</NonProprietaryName></NDC><NDC><NDCCode>43353-272-83</NDCCode><ProprietaryName>Tricor</ProprietaryName><NonProprietaryName>Fenofibrate</NonProprietaryName></NDC><NDC><NDCCode>49348-145-46</NDCCode><ProprietaryName>Nicotine</ProprietaryName><NonProprietaryName>Nicotine</NonProprietaryName></NDC><NDC><NDCCode>51407-741-12</NDCCode><ProprietaryName>Zileuton</ProprietaryName><NonProprietaryName>Zileuton</NonProprietaryName></NDC><NDC><NDCCode>57627-145-02</NDCCode><ProprietaryName>Sandy Beige Smart Finish Makeup Spf 18</ProprietaryName><NonProprietaryName>Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>61715-145-20</NDCCode><ProprietaryName>Preferred Plus Mucus Relief Cold And Sinus</ProprietaryName><NonProprietaryName>Acetaminophen, Guaifenesin, Phenylephrine Hcl</NonProprietaryName></NDC><NDC><NDCCode>69452-145-13</NDCCode><ProprietaryName>Paricalcitol</ProprietaryName><NonProprietaryName>Paricalcitol</NonProprietaryName></NDC><NDC><NDCCode>69842-138-22</NDCCode><ProprietaryName>Cvs Health</ProprietaryName><NonProprietaryName>Octinoxate, Octisalate, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>69842-178-22</NDCCode><ProprietaryName>Cvs Health</ProprietaryName><NonProprietaryName>Octinoxate, Octisalate, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>70934-145-30</NDCCode><ProprietaryName>Pantoprazole Sodium</ProprietaryName><NonProprietaryName>Pantoprazole Sodium</NonProprietaryName></NDC><NDC><NDCCode>71141-947-71</NDCCode><ProprietaryName>Cien Sun By Lidl Kids Sunscreen Spf 50 Plus</ProprietaryName><NonProprietaryName>Octisalate, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>69729-003-10</NDCCode><ProprietaryName>Ampigrin Ultra Forte Night</ProprietaryName><NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate</NonProprietaryName></NDC><NDC><NDCCode>69729-006-02</NDCCode><ProprietaryName>Temperal-ito</ProprietaryName><NonProprietaryName>Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>69729-006-04</NDCCode><ProprietaryName>Temperal-ito</ProprietaryName><NonProprietaryName>Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>69729-008-10</NDCCode><ProprietaryName>Activcin</ProprietaryName><NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>69729-018-18</NDCCode><ProprietaryName>Cherry Sore Throat Lozenges</ProprietaryName><NonProprietaryName>Benzocaine</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

DataLabs Coding Library - Quering NPI Registry - REST API Examples

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

Output

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
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      "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 ...
            
        

Full Text Search Fundamentals

Facts

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

How does it work

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

Full Text Search & DataLabs REST API

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

                
{
  "NPI": [
    {
      "NPI": "1083349906",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "STAFFORD",
      "FirstName": "KADY",
      "NamePrefix": "MS.",
      "Credential": "LPC",
      "FirstLineMailingAddress": "13574 SW HIGHWAY 126",
      "MailingAddressCityName": "POWELL BUTTE",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97753-1541",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-480-6360",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-203-0307",
      "EnumerationDate": "07/24/2022",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional Counselor",
      "LicenseNumber1": "LPC6225",
      "LicenseNumberStateCode1": "ID",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C9084",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1215724679",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "SCHAY",
      "FirstName": "ANGELICA",
      "MiddleName": "NICOLE",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1841",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1841",
      "EnumerationDate": "04/21/2025",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101Y00000X",
      "Taxonomy1": "Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101Y00000X",
      "PrimaryTaxonomy": "Counselor"
    },
    {
      "NPI": "1013556505",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "IVENS",
      "FirstName": "KRYSTA",
      "FirstLineMailingAddress": "743 NW QUINCE AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-1250",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "360-526-1448",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "971-217-6150",
      "EnumerationDate": "12/31/2019",
      "LastUpdateDate": "02/15/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C7963",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "02/15/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1497336275",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ARANT",
      "FirstName": "ERIN",
      "MiddleName": "HENNESSEY",
      "FirstLineMailingAddress": "4639 SW 37TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-6776",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "04/14/2021",
      "LastUpdateDate": "04/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "225X00000X",
      "Taxonomy1": "Occupational Therapist",
      "LicenseNumber1": "390047",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/14/2021",
      "PrimaryTaxonomyCode": "225X00000X",
      "PrimaryTaxonomy": "Occupational Therapist"
    },
    {
      "NPI": "1174191407",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "GRIMALT",
      "FirstName": "EUGENIA",
      "MiddleName": "N",
      "Credential": "PT",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "06/14/2021",
      "LastUpdateDate": "06/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "2251P0200X",
      "Taxonomy1": "Pediatric Physical Therapist",
      "LicenseNumber1": "63979",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization.",
      "CertificationDate": "06/14/2021",
      "PrimaryTaxonomyCode": "2251P0200X",
      "PrimaryTaxonomy": "Pediatric Physical Therapist"
    },
    {
      "NPI": "1912604117",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "PAINTER",
      "FirstName": "JENNIFER",
      "FirstLineMailingAddress": "20080 DOANNA WAY UNIT 3",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-2931",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "209-743-9813",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/08/2023",
      "LastUpdateDate": "02/08/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/08/2023",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1396434700",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "GROVE",
      "FirstName": "JENNIFER",
      "MiddleName": "RHEA",
      "FirstLineMailingAddress": "303 NW BROADWAY ST",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97703-2658",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "801-573-6047",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "801-573-6047",
      "EnumerationDate": "05/02/2023",
      "LastUpdateDate": "05/02/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1041C0700X",
      "Taxonomy1": "Clinical Social Worker",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "05/02/2023",
      "PrimaryTaxonomyCode": "1041C0700X",
      "PrimaryTaxonomy": "Clinical Social Worker"
    },
    {
      "NPI": "1407698970",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "REDDEN",
      "FirstName": "SHANNON",
      "Credential": "CHW",
      "OtherLastName": "MCDOUGALL",
      "OtherFirstName": "SHANNON",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2312 NE 5TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8488",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-460-2192",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "PracticeLocationAddressFaxNumber": "541-550-7956",
      "EnumerationDate": "06/06/2024",
      "LastUpdateDate": "06/06/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "172V00000X",
      "Taxonomy1": "Community Health Worker",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "06/06/2024",
      "PrimaryTaxonomyCode": "172V00000X",
      "PrimaryTaxonomy": "Community Health Worker"
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}
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