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How to Find 63672-0021-9 NDC Data Using DataLabs API

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{
  "NDC": [
    {
      "NDCCode": "63672-0021-9",
      "PackageDescription": "20000 CAPSULE in 1 DRUM (63672-0021-9) ",
      "NDC11Code": "63672-0021-09",
      "ProductNDC": "63672-0021",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tamsulosin Hydrochloride",
      "NonProprietaryName": "Tamsulosin Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100427",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078801",
      "LabelerName": "Synthon Pharmaceuticals, Inc.",
      "SubstanceName": "TAMSULOSIN HYDROCHLORIDE",
      "StrengthNumber": ".4",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-12-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240115",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tamsulosin hydrochloride capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)] . Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension.",
      "Description": "Tamsulosin hydrochloride is an antagonist of alpha 1Aadrenoceptors in the prostate. Tamsulosin hydrochloride is (-)-( R)-5-[2-[[2-( o-Ethoxyphenoxy)ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride. Tamsulosin hydrochloride is a white crystalline powder that melts with decomposition at approximately 230°C. It is sparingly soluble in water and methanol, slightly soluble in glacial acetic acid and ethanol, and practically insoluble in ether. The empirical formula of tamsulosin hydrochloride is C 20H 28N 2O 5S ∙ HCl. The molecular weight of tamsulosin hydrochloride is 444.98. Its structural formula is:. Each tamsulosin hydrochloride capsule for oral administration contains tamsulosin hydrochloride, USP 0.4 mg, and the following inactive ingredients: methacrylic acid copolymer, microcrystalline cellulose, purified water, talc, triethyl citrate, black iron oxide, FD&C Blue No. 2, gelatin, red iron oxide, titanium dioxide, yellow iron oxide and trace amounts of antifoam DC 1510, industrial methylated spirit, lecithin, n-butyl alcohol, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, ammonium, potassium hydroxide and shellac. Complies with USP Dissolution Test 4."
    },
    {
      "NDCCode": "63672-0021-0",
      "PackageDescription": "20200 CAPSULE in 1 DRUM (63672-0021-0)",
      "NDC11Code": "63672-0021-00",
      "ProductNDC": "63672-0021",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tamsulosin Hydrochloride",
      "NonProprietaryName": "Tamsulosin Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100427",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078801",
      "LabelerName": "Synthon Pharmaceuticals, Inc.",
      "SubstanceName": "TAMSULOSIN HYDROCHLORIDE",
      "StrengthNumber": ".4",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "0168-0021-09",
      "PackageDescription": "1 PACKET in 1 CARTON (0168-0021-09)  > .9 g in 1 PACKET",
      "NDC11Code": "00168-0021-09",
      "ProductNDC": "0168-0021",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Double Antibiotic",
      "NonProprietaryName": "Bacitracin Zinc And Polymyxin B Sulfate",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20100106",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part333B",
      "LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.",
      "SubstanceName": "BACITRACIN ZINC; POLYMYXIN B SULFATE",
      "StrengthNumber": "500; 10000",
      "StrengthUnit": "[USP'U]/g; [USP'U]/g",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "0498-4221-01",
      "PackageDescription": "1 KIT in 1 KIT (0498-4221-01)  *  85 g in 1 CAN (0498-0031-40)  *  .9 g in 1 PACKET (0498-0750-35)  *  85 g in 1 CAN (0498-0021-40)  *  .4 mL in 1 POUCH (0498-0143-04)  *  .3 mL in 1 AMPULE (0498-3334-00)  *  2 TABLET in 1 PACKET (0498-0114-01)  *  118 mL in 1 BOTTLE (0498-0100-02) ",
      "NDC11Code": "00498-4221-01",
      "ProductNDC": "0498-4221",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "4221 First Aid Kit",
      "NonProprietaryName": "4221 First Aid Kit",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20181018",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Honeywell Safety Products USA, INC",
      "Status": "Deprecated",
      "LastUpdate": "2022-12-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20181018",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0498-4248-01",
      "PackageDescription": "1 KIT in 1 KIT (0498-4248-01)  *  2 TABLET in 1 PACKET *  .9 g in 1 PACKET (0498-0800-35)  *  2 TABLET in 1 PACKET *  1.4 mL in 1 PACKET (0498-0501-00)  *  .4 mL in 1 POUCH (0498-0143-04)  *  .5 g in 1 PACKET (0498-0750-36)  *  85 g in 1 CAN (0498-0021-40)  *  85 g in 1 CAN (0498-0031-40)  *  .3 mL in 1 AMPULE (0498-3334-00)  *  118 mL in 1 BOTTLE (0498-0100-02)  *  2 TABLET in 1 PACKET *  .9 g in 1 PACKET (0498-0801-35)  *  15 mL in 1 BOTTLE, DROPPER *  .4 mL in 1 POUCH (0498-0733-00)  *  2 TABLET in 1 PACKET (0498-2422-01) ",
      "NDC11Code": "00498-4248-01",
      "ProductNDC": "0498-4248",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "4248 First Aid Kit",
      "NonProprietaryName": "4248 First Aid Kit",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20181018",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Honeywell Safety Products USA, INC",
      "Status": "Deprecated",
      "LastUpdate": "2022-12-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20181018",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0498-4329-01",
      "PackageDescription": "1 KIT in 1 KIT (0498-4329-01)  *  30 mL in 1 BOTTLE (0498-0100-01)  *  1.4 mL in 1 PACKET (0498-0501-00)  *  .9 g in 1 PACKET *  2 TABLET in 1 PACKET *  .4 mL in 1 POUCH (0498-0143-04)  *  2 TABLET in 1 PACKET (0498-2110-01)  *  85 g in 1 CAN (0498-0021-40)  *  85 g in 1 CAN (0498-0031-40)  *  .3 mL in 1 AMPULE (0498-3334-00)  *  .5 g in 1 PACKET (0498-0750-36)  *  118 mL in 1 BOTTLE (0498-0100-02) ",
      "NDC11Code": "00498-4329-01",
      "ProductNDC": "0498-4329",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "4329 First Aid Kit",
      "NonProprietaryName": "4329 First Aid Kit",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20181018",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Honeywell Safety Products USA, INC",
      "Status": "Deprecated",
      "LastUpdate": "2022-12-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20181018",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0498-4338-01",
      "PackageDescription": "1 KIT in 1 KIT (0498-4338-01)  *  30 mL in 1 BOTTLE (0498-0100-01)  *  118 mL in 1 BOTTLE (0498-0100-02)  *  2 TABLET in 1 PACKET *  .9 g in 1 PACKET *  2 TABLET in 1 PACKET (0498-2110-01)  *  1.4 mL in 1 PACKET (0498-0501-00)  *  2 TABLET in 1 PACKET *  .4 mL in 1 POUCH (0498-0143-04)  *  .5 g in 1 PACKET (0498-0750-36)  *  85 g in 1 CAN (0498-0021-40)  *  85 g in 1 CAN (0498-0031-40)  *  .3 mL in 1 AMPULE (0498-3334-00) ",
      "NDC11Code": "00498-4338-01",
      "ProductNDC": "0498-4338",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "4338 First Aid Kit",
      "NonProprietaryName": "4338 First Aid Kit",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20181018",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Honeywell Safety Products USA, INC",
      "Status": "Deprecated",
      "LastUpdate": "2022-12-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20181018",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0498-4357-01",
      "PackageDescription": "1 KIT in 1 KIT (0498-4357-01)  *  14 g in 1 TUBE *  118 mL in 1 BOTTLE (0498-0100-02)  *  .9 g in 1 PACKET (0498-0801-35)  *  3.5 g in 1 PACKET (0498-0203-00)  *  85 g in 1 CAN (0498-0021-40)  *  .9 g in 1 PACKET (0498-0800-35)  *  .4 mL in 1 POUCH (0498-0143-04)  *  .5 g in 1 PACKET (0498-0750-36) ",
      "NDC11Code": "00498-4357-01",
      "ProductNDC": "0498-4357",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "4357 First Aid Kit",
      "NonProprietaryName": "4357 First Aid Kit",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20181018",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Honeywell Safety Products USA, INC",
      "Status": "Deprecated",
      "LastUpdate": "2024-06-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20181018",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "34645-0021-1",
      "PackageDescription": "1 PACKET in 1 POUCH (34645-0021-1)  / 2.9 mL in 1 PACKET",
      "NDC11Code": "34645-0021-01",
      "ProductNDC": "34645-0021",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Alcohol Swabsticks 1s Sterile",
      "NonProprietaryName": "Isopropyl Alcohol",
      "DosageFormName": "SWAB",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20220101",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "Jianerkang Medical Co., Ltd",
      "SubstanceName": "ISOPROPYL ALCOHOL",
      "StrengthNumber": ".7",
      "StrengthUnit": "mL/mL",
      "Status": "Active",
      "LastUpdate": "2023-10-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220101",
      "SamplePackage": "N",
      "IndicationAndUsage": "For skin cleansing prior to injection."
    },
    {
      "NDCCode": "38217-0021-1",
      "PackageDescription": "2 BAG in 1 CARTON (38217-0021-1)  / 5.9 kg in 1 BAG",
      "NDC11Code": "38217-0021-01",
      "ProductNDC": "38217-0021",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Meropenem",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "19960923",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Sumitomo Pharma Co., Ltd.",
      "SubstanceName": "MEROPENEM",
      "StrengthNumber": "5",
      "StrengthUnit": "kg/5.9kg",
      "Status": "Unfinished",
      "LastUpdate": "2023-12-12",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "27-MAR-06"
    },
    {
      "NDCCode": "49687-0021-0",
      "PackageDescription": "1 KIT in 1 KIT (49687-0021-0)  *  20 POUCH in 1 KIT (49687-0012-0)  / .9 g in 1 POUCH *  10 POUCH in 1 KIT (49687-0014-0)  / .9 g in 1 POUCH *  10 PACKAGE in 1 KIT (49687-0013-0)  / .9 g in 1 PACKAGE *  6 PACKAGE in 1 BOX (49687-0015-1)  / .9 g in 1 PACKAGE *  2 BOX in 1 BOX / 10 PATCH in 1 BOX (49687-0011-1)  / .9 g in 1 PATCH *  1 TUBE in 1 BOX (49687-0010-1)  / 30 mL in 1 TUBE",
      "NDC11Code": "49687-0021-00",
      "ProductNDC": "49687-0021",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Large Ansi First Aid Kit",
      "NonProprietaryName": "Water, Benzalkonium Chloride, Isopropyl Alcohol, Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, Lidocaine Hydrochloride",
      "DosageFormName": "KIT",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20160809",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M003",
      "LabelerName": "CMC Group, Inc.",
      "Status": "Active",
      "LastUpdate": "2025-04-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160809",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "50090-0021-9",
      "PackageDescription": "100 TABLET, COATED in 1 BOTTLE (50090-0021-9)",
      "NDC11Code": "50090-0021-09",
      "ProductNDC": "50090-0021",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Doxycycline",
      "NonProprietaryName": "Doxycycline Hyclate",
      "DosageFormName": "TABLET, COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20030702",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065095",
      "LabelerName": "A-S Medication Solutions LLC",
      "SubstanceName": "DOXYCYCLINE HYCLATE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2018-01-10",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "67835-0021-9",
      "PackageDescription": "1 BAG in 1 DRUM (67835-0021-9)  > .05 kg in 1 BAG",
      "NDC11Code": "67835-0021-09",
      "ProductNDC": "67835-0021",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Famotidine",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20200601",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "SMS Pharmaceuticals Limited",
      "SubstanceName": "FAMOTIDINE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2020-06-02",
      "ListingRecordCertifiedThrough": "20211231"
    },
    {
      "NDCCode": "71335-0021-9",
      "PackageDescription": "14 TABLET in 1 BOTTLE (71335-0021-9) ",
      "NDC11Code": "71335-0021-09",
      "ProductNDC": "71335-0021",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Valacyclovir Hydrochloride",
      "NonProprietaryName": "Valacyclovir Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100524",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077135",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "VALACYCLOVIR HYDROCHLORIDE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
      "Status": "Deprecated",
      "LastUpdate": "2023-03-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20200521",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "17856-0021-2",
      "PackageDescription": "1 TABLET in 1 POUCH (17856-0021-2)",
      "NDC11Code": "17856-0021-02",
      "ProductNDC": "17856-0021",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Renagel",
      "NonProprietaryName": "Renagel",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20080606",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021179",
      "LabelerName": "Atlantic Biologicals Corps",
      "SubstanceName": "SEVELAMER HYDROCHLORIDE",
      "StrengthNumber": "800",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Phosphate Binder [EPC],Phosphate Chelating Activity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "RENAGEL  (sevelamer hydrochloride) is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. The safety and efficacy of Renagel in CKD patients who are not on dialysis have not been studied.  ®  Renagel is a  Registered Trademark of Genzyme Corporation.",
      "Description": "The active ingredient in Renagel Tablets is sevelamer hydrochloride, a polymeric amine that binds phosphate and is meant for oral administration. Sevelamer hydrochloride is poly(allylamine hydrochloride) crosslinked with epichlorohydrin in which forty percent of the amines are protonated. It is known chemically as poly(allylamine- -N,N’-diallyl-1,3-diamino-2-hydroxypropane) hydrochloride. Sevelamer hydrochloride is hydrophilic, but insoluble in water. The structure is represented in . coFigure 1. Figure 1. Chemical Structure of Sevelamer Hydrochloride.       a, b = number of primary amine groups                 a + b = 9.       c = number of crosslinking groups                         c = 1.       n = fraction of protonated amines                          n = 0.4.       m = large number to indicate extended polymer network. The primary amine groups shown in the structure are derived directly from poly(allylamine hydrochloride). The crosslinking groups consist of two secondary amine groups derived from poly(allylamine hydrochloride) and one molecule of epichlorohydrin. Each film-coated tablet of Renagel contains either 800 mg or 400 mg of sevelamer hydrochloride on an anhydrous basis. The inactive ingredients are hypromellose, diacetylated monoglyceride, colloidal silicon dioxide, and stearic acid. The tablet imprint contains iron oxide black ink.  Renagel Tablets:   ®."
    },
    {
      "NDCCode": "32228-021-01",
      "PackageDescription": "4 BOTTLE in 1 BOX (32228-021-01)  / .9 kg in 1 BOTTLE",
      "NDC11Code": "32228-0021-01",
      "ProductNDC": "32228-021",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Adalimumab-aaty",
      "DosageFormName": "LIQUID",
      "StartMarketingDate": "20230523",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "CELLTRION, Inc.",
      "SubstanceName": "ADALIMUMAB-AATY",
      "StrengthNumber": ".9",
      "StrengthUnit": "kg/.9kg",
      "Status": "Unfinished",
      "LastUpdate": "2026-06-17",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "23-MAY-23"
    },
    {
      "NDCCode": "32228-021-02",
      "PackageDescription": "4 BOTTLE in 1 BOX (32228-021-02)  / 1.8 kg in 1 BOTTLE",
      "NDC11Code": "32228-0021-02",
      "ProductNDC": "32228-021",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Adalimumab-aaty",
      "DosageFormName": "LIQUID",
      "StartMarketingDate": "20230523",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "CELLTRION, Inc.",
      "SubstanceName": "ADALIMUMAB-AATY",
      "StrengthNumber": ".9",
      "StrengthUnit": "kg/.9kg",
      "Status": "Unfinished",
      "LastUpdate": "2026-06-17",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "23-MAY-23"
    },
    {
      "NDCCode": "32228-021-03",
      "PackageDescription": "1 BOTTLE in 1 BOX (32228-021-03)  / 9 kg in 1 BOTTLE",
      "NDC11Code": "32228-0021-03",
      "ProductNDC": "32228-021",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Adalimumab-aaty",
      "DosageFormName": "LIQUID",
      "StartMarketingDate": "20230523",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "CELLTRION, Inc.",
      "SubstanceName": "ADALIMUMAB-AATY",
      "StrengthNumber": ".9",
      "StrengthUnit": "kg/.9kg",
      "Status": "Unfinished",
      "LastUpdate": "2026-06-17",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "23-MAY-23"
    },
    {
      "NDCCode": "33342-021-08",
      "PackageDescription": "50 TABLET, FILM COATED in 1 BOTTLE (33342-021-08) ",
      "NDC11Code": "33342-0021-08",
      "ProductNDC": "33342-021",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levofloxacin",
      "NonProprietaryName": "Levofloxacin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120322",
      "EndMarketingDate": "20250731",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA200839",
      "LabelerName": "Macleods Pharmaceuticals Limited",
      "SubstanceName": "LEVOFLOXACIN",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2025-08-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20120322",
      "EndMarketingDatePackage": "20250731",
      "SamplePackage": "N",
      "IndicationAndUsage": "Levofloxacin tablets are fluoroquinolone antibacterial indicated in adults (18 years of age and older) with infections caused by designated, susceptible bacteria and in pediatric patients where indicated (1, 12.4).  Pneumonia: Nosocomial (1.1) and Community Acquired (1.2, 1.3)  Skin and Skin Structure Infections (SSSI): Complicated (1.4) and Uncomplicated (1.5)  Chronic bacterial prostatitis (1.6)  Inhalational Anthrax, Post-Exposure in adult and pediatric patients (1.7)  Plague in adult and pediatric patients (1.8)  Urinary Tract Infections (UTI): Complicated (1.9, 1.10) and Uncomplicated (1.12)  Acute Pyelonephritis (1.11)  Acute Bacterial Exacerbation of Chronic Bronchitis (1.13)  Acute Bacterial Sinusitis (1.14). Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tablets and other antibacterial drugs, levofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria (1.15).",
      "Description": "Levofloxacin USP are synthetic antibacterial agents for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (--(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate.Figure 1: The Chemical Structure of Levofloxacin.   The empirical formula is C18H20FN3O4 ½ H2O and the molecular weight is 370.38. Levofloxacin USP is a light yellowish-white to yellow-white crystal or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin, USP is essentially constant (approximately 100 mg/mL). Levofloxacin USP is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin USP has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al +3 >Cu +2 >Zn +2 >Mg +2 >Ca +2 . Levofloxacin USP is available as film-coated tablets and contain the following inactive ingredients: 1 250 mg (as expressed in the anhydrous form): hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80 and synthetic red iron oxide., 2 500 mg (as expressed in the anhydrous form): hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80 and synthetic red and yellow iron oxides., 3 750 mg (as expressed in the anhydrous form): hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80."
    },
    {
      "NDCCode": "36800-021-09",
      "PackageDescription": "9 PATCH in 1 PACKAGE (36800-021-09) ",
      "NDC11Code": "36800-0021-09",
      "ProductNDC": "36800-021",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Salicylic Acid",
      "NonProprietaryName": "Medicated Corn Removers",
      "DosageFormName": "PATCH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20120103",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M030",
      "LabelerName": "Topco Associates LLC",
      "SubstanceName": "SALICYLIC ACID",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/91",
      "Status": "Active",
      "LastUpdate": "2026-01-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20120103",
      "SamplePackage": "N",
      "IndicationAndUsage": "for the removal of corns. relieves pain by removing corns."
    },
    {
      "NDCCode": "42406-021-00",
      "PackageDescription": "1 BOX in 1 CARTON (42406-021-00)  > 4.3 g in 1 BOX",
      "NDC11Code": "42406-0021-00",
      "ProductNDC": "42406-021",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sugar Poppy Lip Treatment Sunscreen Spf 15",
      "NonProprietaryName": "Avobenzone, Octinoxate",
      "DosageFormName": "PASTE",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20161027",
      "EndMarketingDate": "20220107",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Fresh Inc.",
      "SubstanceName": "AVOBENZONE; OCTINOXATE",
      "StrengthNumber": "20; 74.9",
      "StrengthUnit": "mg/g; mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20161027",
      "EndMarketingDatePackage": "20220107",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "42658-021-01",
      "PackageDescription": "1 VIAL in 1 BOX (42658-021-01)  / 4 mL in 1 VIAL",
      "NDC11Code": "42658-0021-01",
      "ProductNDC": "42658-021",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Daunorubicin Hydrochloride",
      "NonProprietaryName": "Daunorubicin Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20200120",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208759",
      "LabelerName": "Hisun Pharmaceuticals USA, Inc.",
      "SubstanceName": "DAUNORUBICIN HYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Topoisomerase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-01-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20200120",
      "SamplePackage": "N",
      "IndicationAndUsage": "Daunorubicin hydrochloride injection in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for remission induction in acute lymphocytic leukemia of children and adults.",
      "Description": "Daunorubicin hydrochloride is the hydrochloride salt of an anthracycline cytotoxic antibiotic produced by a strain of Streptomyces coeruleorubidus. It is provided as a deep red sterile liquid in vials for intravenous administration only. Each mL contains 5 mg daunorubicin (equivalent to 5.34 mg of daunorubicin hydrochloride), 9 mg sodium chloride; sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection, q.s. It has the following structural formula which may be described with the chemical name of (1S,3S)-3-Acetyl-1,2,3,4,6,11-hexahydro-3,5,12-trihydroxy-10-methoxy-6,11-dioxo-1-naphthacenyl 3-amino-2,3,6-trideoxy-α-L- lyxo-hexopyranoside hydrochloride. Its molecular formula is C 27H 29NO 10HCl with a molecular weight of 563.99. It is a hygroscopic crystalline powder. The pH of a 5 mg/mL aqueous solution is 3 to 4."
    },
    {
      "NDCCode": "42658-021-02",
      "PackageDescription": "10 VIAL in 1 CARTON (42658-021-02)  / 4 mL in 1 VIAL",
      "NDC11Code": "42658-0021-02",
      "ProductNDC": "42658-021",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Daunorubicin Hydrochloride",
      "NonProprietaryName": "Daunorubicin Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20200120",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208759",
      "LabelerName": "Hisun Pharmaceuticals USA, Inc.",
      "SubstanceName": "DAUNORUBICIN HYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Topoisomerase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-01-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20210127",
      "SamplePackage": "N",
      "IndicationAndUsage": "Daunorubicin hydrochloride injection in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for remission induction in acute lymphocytic leukemia of children and adults.",
      "Description": "Daunorubicin hydrochloride is the hydrochloride salt of an anthracycline cytotoxic antibiotic produced by a strain of Streptomyces coeruleorubidus. It is provided as a deep red sterile liquid in vials for intravenous administration only. Each mL contains 5 mg daunorubicin (equivalent to 5.34 mg of daunorubicin hydrochloride), 9 mg sodium chloride; sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection, q.s. It has the following structural formula which may be described with the chemical name of (1S,3S)-3-Acetyl-1,2,3,4,6,11-hexahydro-3,5,12-trihydroxy-10-methoxy-6,11-dioxo-1-naphthacenyl 3-amino-2,3,6-trideoxy-α-L- lyxo-hexopyranoside hydrochloride. Its molecular formula is C 27H 29NO 10HCl with a molecular weight of 563.99. It is a hygroscopic crystalline powder. The pH of a 5 mg/mL aqueous solution is 3 to 4."
    },
    {
      "NDCCode": "42658-021-91",
      "PackageDescription": "1 VIAL in 1 BOX (42658-021-91)  / 4 mL in 1 VIAL",
      "NDC11Code": "42658-0021-91",
      "ProductNDC": "42658-021",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Daunorubicin Hydrochloride",
      "NonProprietaryName": "Daunorubicin Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20200120",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208759",
      "LabelerName": "Hisun Pharmaceuticals USA, Inc.",
      "SubstanceName": "DAUNORUBICIN HYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Topoisomerase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2023-02-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230115",
      "SamplePackage": "N",
      "IndicationAndUsage": "Daunorubicin hydrochloride injection in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for remission induction in acute lymphocytic leukemia of children and adults.",
      "Description": "Daunorubicin hydrochloride is the hydrochloride salt of an anthracycline cytotoxic antibiotic produced by a strain of Streptomyces coeruleorubidus. It is provided as a deep red sterile liquid in vials for intravenous administration only. Each mL contains 5 mg daunorubicin (equivalent to 5.34 mg of daunorubicin hydrochloride), 9 mg sodium chloride; sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection, q.s. It has the following structural formula which may be described with the chemical name of (1S,3S)-3-Acetyl-1,2,3,4,6,11-hexahydro-3,5,12-trihydroxy-10-methoxy-6,11-dioxo-1-naphthacenyl 3-amino-2,3,6-trideoxy-α-L- lyxo-hexopyranoside hydrochloride. Its molecular formula is C 27H 29NO 10HCl with a molecular weight of 563.99. It is a hygroscopic crystalline powder. The pH of a 5 mg/mL aqueous solution is 3 to 4."
    },
    {
      "NDCCode": "42658-021-92",
      "PackageDescription": "10 VIAL in 1 CARTON (42658-021-92)  / 4 mL in 1 VIAL",
      "NDC11Code": "42658-0021-92",
      "ProductNDC": "42658-021",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Daunorubicin Hydrochloride",
      "NonProprietaryName": "Daunorubicin Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20200120",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208759",
      "LabelerName": "Hisun Pharmaceuticals USA, Inc.",
      "SubstanceName": "DAUNORUBICIN HYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Topoisomerase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2023-02-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20221219",
      "SamplePackage": "N",
      "IndicationAndUsage": "Daunorubicin hydrochloride injection in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for remission induction in acute lymphocytic leukemia of children and adults.",
      "Description": "Daunorubicin hydrochloride is the hydrochloride salt of an anthracycline cytotoxic antibiotic produced by a strain of Streptomyces coeruleorubidus. It is provided as a deep red sterile liquid in vials for intravenous administration only. Each mL contains 5 mg daunorubicin (equivalent to 5.34 mg of daunorubicin hydrochloride), 9 mg sodium chloride; sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection, q.s. It has the following structural formula which may be described with the chemical name of (1S,3S)-3-Acetyl-1,2,3,4,6,11-hexahydro-3,5,12-trihydroxy-10-methoxy-6,11-dioxo-1-naphthacenyl 3-amino-2,3,6-trideoxy-α-L- lyxo-hexopyranoside hydrochloride. Its molecular formula is C 27H 29NO 10HCl with a molecular weight of 563.99. It is a hygroscopic crystalline powder. The pH of a 5 mg/mL aqueous solution is 3 to 4."
    },
    {
      "NDCCode": "43419-021-04",
      "PackageDescription": "30 mL in 1 JAR (43419-021-04)",
      "NDC11Code": "43419-0021-04",
      "ProductNDC": "43419-021",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sulwhasoo Lumitouch Foundation",
      "ProprietaryNameSuffix": "No.21 Natural Beige",
      "NonProprietaryName": "Octinoxate, Titanium Dioxide, And Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110103",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "AMOREPACIFIC",
      "SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": ".9; .498; .588",
      "StrengthUnit": "mL/30mL; mL/30mL; mL/30mL",
      "Status": "Deprecated",
      "LastUpdate": "2018-09-15",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "44237-021-16",
      "PackageDescription": "2 BLISTER PACK in 1 CARTON (44237-021-16)  > 9 LOZENGE in 1 BLISTER PACK",
      "NDC11Code": "44237-0021-16",
      "ProductNDC": "44237-021",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Herbion Naturals Mint Cough Drops",
      "NonProprietaryName": "Menthol",
      "DosageFormName": "LOZENGE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150101",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "Herbion Pakistan (Pvt) Ltd",
      "SubstanceName": "MENTHOL",
      "StrengthNumber": "5.5",
      "StrengthUnit": "mg/2.51",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": ". Uses: 1 temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold, 2 for temporary relief of occasional minor irritation, pain, sore mouth and sore throat."
    },
    {
      "NDCCode": "45802-021-46",
      "PackageDescription": "56.2 g in 1 BOTTLE, PLASTIC (45802-021-46) ",
      "NDC11Code": "45802-0021-46",
      "ProductNDC": "45802-021",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Betamethasone Dipropionate",
      "NonProprietaryName": "Betamethasone Dipropionate",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20060630",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA072538",
      "LabelerName": "Padagis Israel Pharmaceuticals Ltd",
      "SubstanceName": "BETAMETHASONE DIPROPIONATE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-10-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20060630",
      "SamplePackage": "N",
      "IndicationAndUsage": "Betamethasone Dipropionate Lotion USP, 0.05% is a medium-potency corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years and older.",
      "Description": "Betamethasone Dipropionate Lotion USP, 0.05% contains betamethasone dipropionate, USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has high corticosteroid activity and slight mineralocorticoid activity. Betamethasone dipropionate is the 17, 21-dipropionate ester of betamethasone. Chemically, betamethasone dipropionate is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C28H37FO7, a molecular weight of 504.6, and the following structural formula. Betamethasone dipropionate is a white to creamy white, odorless crystalline powder, insoluble in water. Each gram of Betamethasone Dipropionate Lotion USP, 0.05% contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in a lotion base of carbomer homopolymer type B, isopropyl alcohol, and purified water. Sodium hydroxide is used to adjust pH."
    },
    {
      "NDCCode": "49288-0021-1",
      "PackageDescription": "2 mL in 1 VIAL, MULTI-DOSE (49288-0021-1)",
      "NDC11Code": "49288-0021-01",
      "ProductNDC": "49288-0021",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "White Ash",
      "NonProprietaryName": "White Ash",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19920413",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "FRAXINUS AMERICANA POLLEN",
      "StrengthNumber": ".1",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
    },
    {
      "NDCCode": "49288-0021-2",
      "PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49288-0021-2)",
      "NDC11Code": "49288-0021-02",
      "ProductNDC": "49288-0021",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "White Ash",
      "NonProprietaryName": "White Ash",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19920413",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "FRAXINUS AMERICANA POLLEN",
      "StrengthNumber": ".1",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
    }
  ]
}
                    
{"NDC":[{"NDCCode":"63672-0021-9","ProprietaryName":"Tamsulosin Hydrochloride","NonProprietaryName":"Tamsulosin Hydrochloride"},{"NDCCode":"63672-0021-0","ProprietaryName":"Tamsulosin Hydrochloride","NonProprietaryName":"Tamsulosin Hydrochloride"},{"NDCCode":"0168-0021-09","ProprietaryName":"Double Antibiotic","NonProprietaryName":"Bacitracin Zinc And Polymyxin B Sulfate"},{"NDCCode":"0498-4221-01","ProprietaryName":"4221 First Aid Kit","NonProprietaryName":"4221 First Aid Kit"},{"NDCCode":"0498-4248-01","ProprietaryName":"4248 First Aid Kit","NonProprietaryName":"4248 First Aid Kit"},{"NDCCode":"0498-4329-01","ProprietaryName":"4329 First Aid Kit","NonProprietaryName":"4329 First Aid Kit"},{"NDCCode":"0498-4338-01","ProprietaryName":"4338 First Aid Kit","NonProprietaryName":"4338 First Aid Kit"},{"NDCCode":"0498-4357-01","ProprietaryName":"4357 First Aid Kit","NonProprietaryName":"4357 First Aid Kit"},{"NDCCode":"34645-0021-1","ProprietaryName":"Alcohol Swabsticks 1s Sterile","NonProprietaryName":"Isopropyl Alcohol"},{"NDCCode":"38217-0021-1","NonProprietaryName":"Meropenem"},{"NDCCode":"49687-0021-0","ProprietaryName":"Large Ansi First Aid Kit","NonProprietaryName":"Water, Benzalkonium Chloride, Isopropyl Alcohol, Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, Lidocaine Hydrochloride"},{"NDCCode":"50090-0021-9","ProprietaryName":"Doxycycline","NonProprietaryName":"Doxycycline Hyclate"},{"NDCCode":"67835-0021-9","NonProprietaryName":"Famotidine"},{"NDCCode":"71335-0021-9","ProprietaryName":"Valacyclovir Hydrochloride","NonProprietaryName":"Valacyclovir Hydrochloride"},{"NDCCode":"17856-0021-2","ProprietaryName":"Renagel","NonProprietaryName":"Renagel"},{"NDCCode":"32228-021-01","NonProprietaryName":"Adalimumab-aaty"},{"NDCCode":"32228-021-02","NonProprietaryName":"Adalimumab-aaty"},{"NDCCode":"32228-021-03","NonProprietaryName":"Adalimumab-aaty"},{"NDCCode":"33342-021-08","ProprietaryName":"Levofloxacin","NonProprietaryName":"Levofloxacin"},{"NDCCode":"36800-021-09","ProprietaryName":"Salicylic Acid","NonProprietaryName":"Medicated Corn Removers"},{"NDCCode":"42406-021-00","ProprietaryName":"Sugar Poppy Lip Treatment Sunscreen Spf 15","NonProprietaryName":"Avobenzone, Octinoxate"},{"NDCCode":"42658-021-01","ProprietaryName":"Daunorubicin Hydrochloride","NonProprietaryName":"Daunorubicin Hydrochloride"},{"NDCCode":"42658-021-02","ProprietaryName":"Daunorubicin Hydrochloride","NonProprietaryName":"Daunorubicin Hydrochloride"},{"NDCCode":"42658-021-91","ProprietaryName":"Daunorubicin Hydrochloride","NonProprietaryName":"Daunorubicin Hydrochloride"},{"NDCCode":"42658-021-92","ProprietaryName":"Daunorubicin Hydrochloride","NonProprietaryName":"Daunorubicin Hydrochloride"},{"NDCCode":"43419-021-04","ProprietaryName":"Sulwhasoo Lumitouch Foundation","NonProprietaryName":"Octinoxate, Titanium Dioxide, And Zinc Oxide"},{"NDCCode":"44237-021-16","ProprietaryName":"Herbion Naturals Mint Cough Drops","NonProprietaryName":"Menthol"},{"NDCCode":"45802-021-46","ProprietaryName":"Betamethasone Dipropionate","NonProprietaryName":"Betamethasone Dipropionate"},{"NDCCode":"49288-0021-1","ProprietaryName":"White Ash","NonProprietaryName":"White Ash"},{"NDCCode":"49288-0021-2","ProprietaryName":"White Ash","NonProprietaryName":"White Ash"}]}
                    
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>63672-0021-9</NDCCode>
    <PackageDescription>20000 CAPSULE in 1 DRUM (63672-0021-9) </PackageDescription>
    <NDC11Code>63672-0021-09</NDC11Code>
    <ProductNDC>63672-0021</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tamsulosin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Tamsulosin Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100427</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078801</ApplicationNumber>
    <LabelerName>Synthon Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>TAMSULOSIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>.4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tamsulosin hydrochloride capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)] . Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension.</IndicationAndUsage>
    <Description>Tamsulosin hydrochloride is an antagonist of alpha 1Aadrenoceptors in the prostate. Tamsulosin hydrochloride is (-)-( R)-5-[2-[[2-( o-Ethoxyphenoxy)ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride. Tamsulosin hydrochloride is a white crystalline powder that melts with decomposition at approximately 230°C. It is sparingly soluble in water and methanol, slightly soluble in glacial acetic acid and ethanol, and practically insoluble in ether. The empirical formula of tamsulosin hydrochloride is C 20H 28N 2O 5S ∙ HCl. The molecular weight of tamsulosin hydrochloride is 444.98. Its structural formula is:. Each tamsulosin hydrochloride capsule for oral administration contains tamsulosin hydrochloride, USP 0.4 mg, and the following inactive ingredients: methacrylic acid copolymer, microcrystalline cellulose, purified water, talc, triethyl citrate, black iron oxide, FD&amp;C Blue No. 2, gelatin, red iron oxide, titanium dioxide, yellow iron oxide and trace amounts of antifoam DC 1510, industrial methylated spirit, lecithin, n-butyl alcohol, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, ammonium, potassium hydroxide and shellac. Complies with USP Dissolution Test 4.</Description>
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  <NDC>
    <NDCCode>63672-0021-0</NDCCode>
    <PackageDescription>20200 CAPSULE in 1 DRUM (63672-0021-0)</PackageDescription>
    <NDC11Code>63672-0021-00</NDC11Code>
    <ProductNDC>63672-0021</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tamsulosin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Tamsulosin Hydrochloride</NonProprietaryName>
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    <StartMarketingDate>20100427</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078801</ApplicationNumber>
    <LabelerName>Synthon Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>TAMSULOSIN HYDROCHLORIDE</SubstanceName>
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    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
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    <NDCCode>0168-0021-09</NDCCode>
    <PackageDescription>1 PACKET in 1 CARTON (0168-0021-09)  &gt; .9 g in 1 PACKET</PackageDescription>
    <NDC11Code>00168-0021-09</NDC11Code>
    <ProductNDC>0168-0021</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Double Antibiotic</ProprietaryName>
    <NonProprietaryName>Bacitracin Zinc And Polymyxin B Sulfate</NonProprietaryName>
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    <StartMarketingDate>20100106</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part333B</ApplicationNumber>
    <LabelerName>E. Fougera &amp; Co. a division of Fougera Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>BACITRACIN ZINC; POLYMYXIN B SULFATE</SubstanceName>
    <StrengthNumber>500; 10000</StrengthNumber>
    <StrengthUnit>[USP'U]/g; [USP'U]/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
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    <PackageDescription>1 KIT in 1 KIT (0498-4221-01)  *  85 g in 1 CAN (0498-0031-40)  *  .9 g in 1 PACKET (0498-0750-35)  *  85 g in 1 CAN (0498-0021-40)  *  .4 mL in 1 POUCH (0498-0143-04)  *  .3 mL in 1 AMPULE (0498-3334-00)  *  2 TABLET in 1 PACKET (0498-0114-01)  *  118 mL in 1 BOTTLE (0498-0100-02) </PackageDescription>
    <NDC11Code>00498-4221-01</NDC11Code>
    <ProductNDC>0498-4221</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>4221 First Aid Kit</ProprietaryName>
    <NonProprietaryName>4221 First Aid Kit</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20181018</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Honeywell Safety Products USA, INC</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2022-12-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181018</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
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    <NDCCode>0498-4248-01</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (0498-4248-01)  *  2 TABLET in 1 PACKET *  .9 g in 1 PACKET (0498-0800-35)  *  2 TABLET in 1 PACKET *  1.4 mL in 1 PACKET (0498-0501-00)  *  .4 mL in 1 POUCH (0498-0143-04)  *  .5 g in 1 PACKET (0498-0750-36)  *  85 g in 1 CAN (0498-0021-40)  *  85 g in 1 CAN (0498-0031-40)  *  .3 mL in 1 AMPULE (0498-3334-00)  *  118 mL in 1 BOTTLE (0498-0100-02)  *  2 TABLET in 1 PACKET *  .9 g in 1 PACKET (0498-0801-35)  *  15 mL in 1 BOTTLE, DROPPER *  .4 mL in 1 POUCH (0498-0733-00)  *  2 TABLET in 1 PACKET (0498-2422-01) </PackageDescription>
    <NDC11Code>00498-4248-01</NDC11Code>
    <ProductNDC>0498-4248</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>4248 First Aid Kit</ProprietaryName>
    <NonProprietaryName>4248 First Aid Kit</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20181018</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Honeywell Safety Products USA, INC</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2022-12-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181018</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
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    <PackageDescription>1 KIT in 1 KIT (0498-4329-01)  *  30 mL in 1 BOTTLE (0498-0100-01)  *  1.4 mL in 1 PACKET (0498-0501-00)  *  .9 g in 1 PACKET *  2 TABLET in 1 PACKET *  .4 mL in 1 POUCH (0498-0143-04)  *  2 TABLET in 1 PACKET (0498-2110-01)  *  85 g in 1 CAN (0498-0021-40)  *  85 g in 1 CAN (0498-0031-40)  *  .3 mL in 1 AMPULE (0498-3334-00)  *  .5 g in 1 PACKET (0498-0750-36)  *  118 mL in 1 BOTTLE (0498-0100-02) </PackageDescription>
    <NDC11Code>00498-4329-01</NDC11Code>
    <ProductNDC>0498-4329</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>4329 First Aid Kit</ProprietaryName>
    <NonProprietaryName>4329 First Aid Kit</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20181018</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Honeywell Safety Products USA, INC</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2022-12-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181018</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
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    <NDCCode>0498-4338-01</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (0498-4338-01)  *  30 mL in 1 BOTTLE (0498-0100-01)  *  118 mL in 1 BOTTLE (0498-0100-02)  *  2 TABLET in 1 PACKET *  .9 g in 1 PACKET *  2 TABLET in 1 PACKET (0498-2110-01)  *  1.4 mL in 1 PACKET (0498-0501-00)  *  2 TABLET in 1 PACKET *  .4 mL in 1 POUCH (0498-0143-04)  *  .5 g in 1 PACKET (0498-0750-36)  *  85 g in 1 CAN (0498-0021-40)  *  85 g in 1 CAN (0498-0031-40)  *  .3 mL in 1 AMPULE (0498-3334-00) </PackageDescription>
    <NDC11Code>00498-4338-01</NDC11Code>
    <ProductNDC>0498-4338</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>4338 First Aid Kit</ProprietaryName>
    <NonProprietaryName>4338 First Aid Kit</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20181018</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Honeywell Safety Products USA, INC</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2022-12-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181018</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
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    <PackageDescription>1 KIT in 1 KIT (0498-4357-01)  *  14 g in 1 TUBE *  118 mL in 1 BOTTLE (0498-0100-02)  *  .9 g in 1 PACKET (0498-0801-35)  *  3.5 g in 1 PACKET (0498-0203-00)  *  85 g in 1 CAN (0498-0021-40)  *  .9 g in 1 PACKET (0498-0800-35)  *  .4 mL in 1 POUCH (0498-0143-04)  *  .5 g in 1 PACKET (0498-0750-36) </PackageDescription>
    <NDC11Code>00498-4357-01</NDC11Code>
    <ProductNDC>0498-4357</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>4357 First Aid Kit</ProprietaryName>
    <NonProprietaryName>4357 First Aid Kit</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20181018</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Honeywell Safety Products USA, INC</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2024-06-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181018</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
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    <NDCCode>34645-0021-1</NDCCode>
    <PackageDescription>1 PACKET in 1 POUCH (34645-0021-1)  / 2.9 mL in 1 PACKET</PackageDescription>
    <NDC11Code>34645-0021-01</NDC11Code>
    <ProductNDC>34645-0021</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Alcohol Swabsticks 1s Sterile</ProprietaryName>
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    <DosageFormName>SWAB</DosageFormName>
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    <StartMarketingDate>20220101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>505G(a)(3)</ApplicationNumber>
    <LabelerName>Jianerkang Medical Co., Ltd</LabelerName>
    <SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
    <StrengthNumber>.7</StrengthNumber>
    <StrengthUnit>mL/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2023-10-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
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    <NDCCode>38217-0021-1</NDCCode>
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    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Sumitomo Pharma Co., Ltd.</LabelerName>
    <SubstanceName>MEROPENEM</SubstanceName>
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    <Status>Unfinished</Status>
    <LastUpdate>2023-12-12</LastUpdate>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>27-MAR-06</StartMarketingDatePackage>
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    <NDCCode>49687-0021-0</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (49687-0021-0)  *  20 POUCH in 1 KIT (49687-0012-0)  / .9 g in 1 POUCH *  10 POUCH in 1 KIT (49687-0014-0)  / .9 g in 1 POUCH *  10 PACKAGE in 1 KIT (49687-0013-0)  / .9 g in 1 PACKAGE *  6 PACKAGE in 1 BOX (49687-0015-1)  / .9 g in 1 PACKAGE *  2 BOX in 1 BOX / 10 PATCH in 1 BOX (49687-0011-1)  / .9 g in 1 PATCH *  1 TUBE in 1 BOX (49687-0010-1)  / 30 mL in 1 TUBE</PackageDescription>
    <NDC11Code>49687-0021-00</NDC11Code>
    <ProductNDC>49687-0021</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Large Ansi First Aid Kit</ProprietaryName>
    <NonProprietaryName>Water, Benzalkonium Chloride, Isopropyl Alcohol, Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, Lidocaine Hydrochloride</NonProprietaryName>
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    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20160809</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M003</ApplicationNumber>
    <LabelerName>CMC Group, Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-04-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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    <NDC11Code>50090-0021-09</NDC11Code>
    <ProductNDC>50090-0021</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline</ProprietaryName>
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    <StartMarketingDate>20030702</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065095</ApplicationNumber>
    <LabelerName>A-S Medication Solutions LLC</LabelerName>
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    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-01-10</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
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    <NDCCode>67835-0021-9</NDCCode>
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    <NDC11Code>67835-0021-09</NDC11Code>
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    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>SMS Pharmaceuticals Limited</LabelerName>
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    <StrengthUnit>kg/kg</StrengthUnit>
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    <LastUpdate>2020-06-02</LastUpdate>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>71335-0021-9</NDCCode>
    <PackageDescription>14 TABLET in 1 BOTTLE (71335-0021-9) </PackageDescription>
    <NDC11Code>71335-0021-09</NDC11Code>
    <ProductNDC>71335-0021</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Valacyclovir Hydrochloride</ProprietaryName>
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    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100524</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077135</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>VALACYCLOVIR HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-03-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200521</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>17856-0021-2</NDCCode>
    <PackageDescription>1 TABLET in 1 POUCH (17856-0021-2)</PackageDescription>
    <NDC11Code>17856-0021-02</NDC11Code>
    <ProductNDC>17856-0021</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Renagel</ProprietaryName>
    <NonProprietaryName>Renagel</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080606</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021179</ApplicationNumber>
    <LabelerName>Atlantic Biologicals Corps</LabelerName>
    <SubstanceName>SEVELAMER HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>800</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Phosphate Binder [EPC],Phosphate Chelating Activity [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>RENAGEL  (sevelamer hydrochloride) is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. The safety and efficacy of Renagel in CKD patients who are not on dialysis have not been studied.  ®  Renagel is a  Registered Trademark of Genzyme Corporation.</IndicationAndUsage>
    <Description>The active ingredient in Renagel Tablets is sevelamer hydrochloride, a polymeric amine that binds phosphate and is meant for oral administration. Sevelamer hydrochloride is poly(allylamine hydrochloride) crosslinked with epichlorohydrin in which forty percent of the amines are protonated. It is known chemically as poly(allylamine- -N,N’-diallyl-1,3-diamino-2-hydroxypropane) hydrochloride. Sevelamer hydrochloride is hydrophilic, but insoluble in water. The structure is represented in . coFigure 1. Figure 1. Chemical Structure of Sevelamer Hydrochloride.       a, b = number of primary amine groups                 a + b = 9.       c = number of crosslinking groups                         c = 1.       n = fraction of protonated amines                          n = 0.4.       m = large number to indicate extended polymer network. The primary amine groups shown in the structure are derived directly from poly(allylamine hydrochloride). The crosslinking groups consist of two secondary amine groups derived from poly(allylamine hydrochloride) and one molecule of epichlorohydrin. Each film-coated tablet of Renagel contains either 800 mg or 400 mg of sevelamer hydrochloride on an anhydrous basis. The inactive ingredients are hypromellose, diacetylated monoglyceride, colloidal silicon dioxide, and stearic acid. The tablet imprint contains iron oxide black ink.  Renagel Tablets:   ®.</Description>
  </NDC>
  <NDC>
    <NDCCode>32228-021-01</NDCCode>
    <PackageDescription>4 BOTTLE in 1 BOX (32228-021-01)  / .9 kg in 1 BOTTLE</PackageDescription>
    <NDC11Code>32228-0021-01</NDC11Code>
    <ProductNDC>32228-021</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Adalimumab-aaty</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <StartMarketingDate>20230523</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>CELLTRION, Inc.</LabelerName>
    <SubstanceName>ADALIMUMAB-AATY</SubstanceName>
    <StrengthNumber>.9</StrengthNumber>
    <StrengthUnit>kg/.9kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-06-17</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>23-MAY-23</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>32228-021-02</NDCCode>
    <PackageDescription>4 BOTTLE in 1 BOX (32228-021-02)  / 1.8 kg in 1 BOTTLE</PackageDescription>
    <NDC11Code>32228-0021-02</NDC11Code>
    <ProductNDC>32228-021</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Adalimumab-aaty</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <StartMarketingDate>20230523</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>CELLTRION, Inc.</LabelerName>
    <SubstanceName>ADALIMUMAB-AATY</SubstanceName>
    <StrengthNumber>.9</StrengthNumber>
    <StrengthUnit>kg/.9kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-06-17</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>23-MAY-23</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>32228-021-03</NDCCode>
    <PackageDescription>1 BOTTLE in 1 BOX (32228-021-03)  / 9 kg in 1 BOTTLE</PackageDescription>
    <NDC11Code>32228-0021-03</NDC11Code>
    <ProductNDC>32228-021</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Adalimumab-aaty</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <StartMarketingDate>20230523</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>CELLTRION, Inc.</LabelerName>
    <SubstanceName>ADALIMUMAB-AATY</SubstanceName>
    <StrengthNumber>.9</StrengthNumber>
    <StrengthUnit>kg/.9kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-06-17</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>23-MAY-23</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>33342-021-08</NDCCode>
    <PackageDescription>50 TABLET, FILM COATED in 1 BOTTLE (33342-021-08) </PackageDescription>
    <NDC11Code>33342-0021-08</NDC11Code>
    <ProductNDC>33342-021</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levofloxacin</ProprietaryName>
    <NonProprietaryName>Levofloxacin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120322</StartMarketingDate>
    <EndMarketingDate>20250731</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA200839</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>LEVOFLOXACIN</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-08-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20120322</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250731</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Levofloxacin tablets are fluoroquinolone antibacterial indicated in adults (18 years of age and older) with infections caused by designated, susceptible bacteria and in pediatric patients where indicated (1, 12.4).  Pneumonia: Nosocomial (1.1) and Community Acquired (1.2, 1.3)  Skin and Skin Structure Infections (SSSI): Complicated (1.4) and Uncomplicated (1.5)  Chronic bacterial prostatitis (1.6)  Inhalational Anthrax, Post-Exposure in adult and pediatric patients (1.7)  Plague in adult and pediatric patients (1.8)  Urinary Tract Infections (UTI): Complicated (1.9, 1.10) and Uncomplicated (1.12)  Acute Pyelonephritis (1.11)  Acute Bacterial Exacerbation of Chronic Bronchitis (1.13)  Acute Bacterial Sinusitis (1.14). Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tablets and other antibacterial drugs, levofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria (1.15).</IndicationAndUsage>
    <Description>Levofloxacin USP are synthetic antibacterial agents for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (--(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate.Figure 1: The Chemical Structure of Levofloxacin.   The empirical formula is C18H20FN3O4 ½ H2O and the molecular weight is 370.38. Levofloxacin USP is a light yellowish-white to yellow-white crystal or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin, USP is essentially constant (approximately 100 mg/mL). Levofloxacin USP is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin USP has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al +3 &gt;Cu +2 &gt;Zn +2 &gt;Mg +2 &gt;Ca +2 . Levofloxacin USP is available as film-coated tablets and contain the following inactive ingredients: 1 250 mg (as expressed in the anhydrous form): hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80 and synthetic red iron oxide., 2 500 mg (as expressed in the anhydrous form): hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80 and synthetic red and yellow iron oxides., 3 750 mg (as expressed in the anhydrous form): hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80.</Description>
  </NDC>
  <NDC>
    <NDCCode>36800-021-09</NDCCode>
    <PackageDescription>9 PATCH in 1 PACKAGE (36800-021-09) </PackageDescription>
    <NDC11Code>36800-0021-09</NDC11Code>
    <ProductNDC>36800-021</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Salicylic Acid</ProprietaryName>
    <NonProprietaryName>Medicated Corn Removers</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20120103</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M030</ApplicationNumber>
    <LabelerName>Topco Associates LLC</LabelerName>
    <SubstanceName>SALICYLIC ACID</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/91</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-01-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120103</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for the removal of corns. relieves pain by removing corns.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>42406-021-00</NDCCode>
    <PackageDescription>1 BOX in 1 CARTON (42406-021-00)  &gt; 4.3 g in 1 BOX</PackageDescription>
    <NDC11Code>42406-0021-00</NDC11Code>
    <ProductNDC>42406-021</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sugar Poppy Lip Treatment Sunscreen Spf 15</ProprietaryName>
    <NonProprietaryName>Avobenzone, Octinoxate</NonProprietaryName>
    <DosageFormName>PASTE</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20161027</StartMarketingDate>
    <EndMarketingDate>20220107</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Fresh Inc.</LabelerName>
    <SubstanceName>AVOBENZONE; OCTINOXATE</SubstanceName>
    <StrengthNumber>20; 74.9</StrengthNumber>
    <StrengthUnit>mg/g; mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20161027</StartMarketingDatePackage>
    <EndMarketingDatePackage>20220107</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>42658-021-01</NDCCode>
    <PackageDescription>1 VIAL in 1 BOX (42658-021-01)  / 4 mL in 1 VIAL</PackageDescription>
    <NDC11Code>42658-0021-01</NDC11Code>
    <ProductNDC>42658-021</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Daunorubicin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Daunorubicin Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20200120</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208759</ApplicationNumber>
    <LabelerName>Hisun Pharmaceuticals USA, Inc.</LabelerName>
    <SubstanceName>DAUNORUBICIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Topoisomerase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200120</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Daunorubicin hydrochloride injection in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for remission induction in acute lymphocytic leukemia of children and adults.</IndicationAndUsage>
    <Description>Daunorubicin hydrochloride is the hydrochloride salt of an anthracycline cytotoxic antibiotic produced by a strain of Streptomyces coeruleorubidus. It is provided as a deep red sterile liquid in vials for intravenous administration only. Each mL contains 5 mg daunorubicin (equivalent to 5.34 mg of daunorubicin hydrochloride), 9 mg sodium chloride; sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection, q.s. It has the following structural formula which may be described with the chemical name of (1S,3S)-3-Acetyl-1,2,3,4,6,11-hexahydro-3,5,12-trihydroxy-10-methoxy-6,11-dioxo-1-naphthacenyl 3-amino-2,3,6-trideoxy-α-L- lyxo-hexopyranoside hydrochloride. Its molecular formula is C 27H 29NO 10HCl with a molecular weight of 563.99. It is a hygroscopic crystalline powder. The pH of a 5 mg/mL aqueous solution is 3 to 4.</Description>
  </NDC>
  <NDC>
    <NDCCode>42658-021-02</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (42658-021-02)  / 4 mL in 1 VIAL</PackageDescription>
    <NDC11Code>42658-0021-02</NDC11Code>
    <ProductNDC>42658-021</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Daunorubicin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Daunorubicin Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20200120</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208759</ApplicationNumber>
    <LabelerName>Hisun Pharmaceuticals USA, Inc.</LabelerName>
    <SubstanceName>DAUNORUBICIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Topoisomerase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210127</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Daunorubicin hydrochloride injection in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for remission induction in acute lymphocytic leukemia of children and adults.</IndicationAndUsage>
    <Description>Daunorubicin hydrochloride is the hydrochloride salt of an anthracycline cytotoxic antibiotic produced by a strain of Streptomyces coeruleorubidus. It is provided as a deep red sterile liquid in vials for intravenous administration only. Each mL contains 5 mg daunorubicin (equivalent to 5.34 mg of daunorubicin hydrochloride), 9 mg sodium chloride; sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection, q.s. It has the following structural formula which may be described with the chemical name of (1S,3S)-3-Acetyl-1,2,3,4,6,11-hexahydro-3,5,12-trihydroxy-10-methoxy-6,11-dioxo-1-naphthacenyl 3-amino-2,3,6-trideoxy-α-L- lyxo-hexopyranoside hydrochloride. Its molecular formula is C 27H 29NO 10HCl with a molecular weight of 563.99. It is a hygroscopic crystalline powder. The pH of a 5 mg/mL aqueous solution is 3 to 4.</Description>
  </NDC>
  <NDC>
    <NDCCode>42658-021-91</NDCCode>
    <PackageDescription>1 VIAL in 1 BOX (42658-021-91)  / 4 mL in 1 VIAL</PackageDescription>
    <NDC11Code>42658-0021-91</NDC11Code>
    <ProductNDC>42658-021</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Daunorubicin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Daunorubicin Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20200120</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208759</ApplicationNumber>
    <LabelerName>Hisun Pharmaceuticals USA, Inc.</LabelerName>
    <SubstanceName>DAUNORUBICIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Topoisomerase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-02-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Daunorubicin hydrochloride injection in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for remission induction in acute lymphocytic leukemia of children and adults.</IndicationAndUsage>
    <Description>Daunorubicin hydrochloride is the hydrochloride salt of an anthracycline cytotoxic antibiotic produced by a strain of Streptomyces coeruleorubidus. It is provided as a deep red sterile liquid in vials for intravenous administration only. Each mL contains 5 mg daunorubicin (equivalent to 5.34 mg of daunorubicin hydrochloride), 9 mg sodium chloride; sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection, q.s. It has the following structural formula which may be described with the chemical name of (1S,3S)-3-Acetyl-1,2,3,4,6,11-hexahydro-3,5,12-trihydroxy-10-methoxy-6,11-dioxo-1-naphthacenyl 3-amino-2,3,6-trideoxy-α-L- lyxo-hexopyranoside hydrochloride. Its molecular formula is C 27H 29NO 10HCl with a molecular weight of 563.99. It is a hygroscopic crystalline powder. The pH of a 5 mg/mL aqueous solution is 3 to 4.</Description>
  </NDC>
  <NDC>
    <NDCCode>42658-021-92</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (42658-021-92)  / 4 mL in 1 VIAL</PackageDescription>
    <NDC11Code>42658-0021-92</NDC11Code>
    <ProductNDC>42658-021</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Daunorubicin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Daunorubicin Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20200120</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208759</ApplicationNumber>
    <LabelerName>Hisun Pharmaceuticals USA, Inc.</LabelerName>
    <SubstanceName>DAUNORUBICIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Topoisomerase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-02-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221219</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Daunorubicin hydrochloride injection in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for remission induction in acute lymphocytic leukemia of children and adults.</IndicationAndUsage>
    <Description>Daunorubicin hydrochloride is the hydrochloride salt of an anthracycline cytotoxic antibiotic produced by a strain of Streptomyces coeruleorubidus. It is provided as a deep red sterile liquid in vials for intravenous administration only. Each mL contains 5 mg daunorubicin (equivalent to 5.34 mg of daunorubicin hydrochloride), 9 mg sodium chloride; sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection, q.s. It has the following structural formula which may be described with the chemical name of (1S,3S)-3-Acetyl-1,2,3,4,6,11-hexahydro-3,5,12-trihydroxy-10-methoxy-6,11-dioxo-1-naphthacenyl 3-amino-2,3,6-trideoxy-α-L- lyxo-hexopyranoside hydrochloride. Its molecular formula is C 27H 29NO 10HCl with a molecular weight of 563.99. It is a hygroscopic crystalline powder. The pH of a 5 mg/mL aqueous solution is 3 to 4.</Description>
  </NDC>
  <NDC>
    <NDCCode>43419-021-04</NDCCode>
    <PackageDescription>30 mL in 1 JAR (43419-021-04)</PackageDescription>
    <NDC11Code>43419-0021-04</NDC11Code>
    <ProductNDC>43419-021</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sulwhasoo Lumitouch Foundation</ProprietaryName>
    <ProprietaryNameSuffix>No.21 Natural Beige</ProprietaryNameSuffix>
    <NonProprietaryName>Octinoxate, Titanium Dioxide, And Zinc Oxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110103</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>AMOREPACIFIC</LabelerName>
    <SubstanceName>OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>.9; .498; .588</StrengthNumber>
    <StrengthUnit>mL/30mL; mL/30mL; mL/30mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-09-15</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>44237-021-16</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 CARTON (44237-021-16)  &gt; 9 LOZENGE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>44237-0021-16</NDC11Code>
    <ProductNDC>44237-021</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Herbion Naturals Mint Cough Drops</ProprietaryName>
    <NonProprietaryName>Menthol</NonProprietaryName>
    <DosageFormName>LOZENGE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>Herbion Pakistan (Pvt) Ltd</LabelerName>
    <SubstanceName>MENTHOL</SubstanceName>
    <StrengthNumber>5.5</StrengthNumber>
    <StrengthUnit>mg/2.51</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>. Uses: 1 temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold, 2 for temporary relief of occasional minor irritation, pain, sore mouth and sore throat.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>45802-021-46</NDCCode>
    <PackageDescription>56.2 g in 1 BOTTLE, PLASTIC (45802-021-46) </PackageDescription>
    <NDC11Code>45802-0021-46</NDC11Code>
    <ProductNDC>45802-021</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Betamethasone Dipropionate</ProprietaryName>
    <NonProprietaryName>Betamethasone Dipropionate</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20060630</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA072538</ApplicationNumber>
    <LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
    <SubstanceName>BETAMETHASONE DIPROPIONATE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20060630</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Betamethasone Dipropionate Lotion USP, 0.05% is a medium-potency corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years and older.</IndicationAndUsage>
    <Description>Betamethasone Dipropionate Lotion USP, 0.05% contains betamethasone dipropionate, USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has high corticosteroid activity and slight mineralocorticoid activity. Betamethasone dipropionate is the 17, 21-dipropionate ester of betamethasone. Chemically, betamethasone dipropionate is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C28H37FO7, a molecular weight of 504.6, and the following structural formula. Betamethasone dipropionate is a white to creamy white, odorless crystalline powder, insoluble in water. Each gram of Betamethasone Dipropionate Lotion USP, 0.05% contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in a lotion base of carbomer homopolymer type B, isopropyl alcohol, and purified water. Sodium hydroxide is used to adjust pH.</Description>
  </NDC>
  <NDC>
    <NDCCode>49288-0021-1</NDCCode>
    <PackageDescription>2 mL in 1 VIAL, MULTI-DOSE (49288-0021-1)</PackageDescription>
    <NDC11Code>49288-0021-01</NDC11Code>
    <ProductNDC>49288-0021</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>White Ash</ProprietaryName>
    <NonProprietaryName>White Ash</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19920413</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102223</ApplicationNumber>
    <LabelerName>Antigen Laboratories, Inc.</LabelerName>
    <SubstanceName>FRAXINUS AMERICANA POLLEN</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
    <Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
  </NDC>
  <NDC>
    <NDCCode>49288-0021-2</NDCCode>
    <PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (49288-0021-2)</PackageDescription>
    <NDC11Code>49288-0021-02</NDC11Code>
    <ProductNDC>49288-0021</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>White Ash</ProprietaryName>
    <NonProprietaryName>White Ash</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19920413</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102223</ApplicationNumber>
    <LabelerName>Antigen Laboratories, Inc.</LabelerName>
    <SubstanceName>FRAXINUS AMERICANA POLLEN</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
    <Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
  </NDC>
</NDCList>
                    
<NDCList><NDC><NDCCode>63672-0021-9</NDCCode><ProprietaryName>Tamsulosin Hydrochloride</ProprietaryName><NonProprietaryName>Tamsulosin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>63672-0021-0</NDCCode><ProprietaryName>Tamsulosin Hydrochloride</ProprietaryName><NonProprietaryName>Tamsulosin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0168-0021-09</NDCCode><ProprietaryName>Double Antibiotic</ProprietaryName><NonProprietaryName>Bacitracin Zinc And Polymyxin B Sulfate</NonProprietaryName></NDC><NDC><NDCCode>0498-4221-01</NDCCode><ProprietaryName>4221 First Aid Kit</ProprietaryName><NonProprietaryName>4221 First Aid Kit</NonProprietaryName></NDC><NDC><NDCCode>0498-4248-01</NDCCode><ProprietaryName>4248 First Aid Kit</ProprietaryName><NonProprietaryName>4248 First Aid Kit</NonProprietaryName></NDC><NDC><NDCCode>0498-4329-01</NDCCode><ProprietaryName>4329 First Aid Kit</ProprietaryName><NonProprietaryName>4329 First Aid Kit</NonProprietaryName></NDC><NDC><NDCCode>0498-4338-01</NDCCode><ProprietaryName>4338 First Aid Kit</ProprietaryName><NonProprietaryName>4338 First Aid Kit</NonProprietaryName></NDC><NDC><NDCCode>0498-4357-01</NDCCode><ProprietaryName>4357 First Aid Kit</ProprietaryName><NonProprietaryName>4357 First Aid Kit</NonProprietaryName></NDC><NDC><NDCCode>34645-0021-1</NDCCode><ProprietaryName>Alcohol Swabsticks 1s Sterile</ProprietaryName><NonProprietaryName>Isopropyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>38217-0021-1</NDCCode><NonProprietaryName>Meropenem</NonProprietaryName></NDC><NDC><NDCCode>49687-0021-0</NDCCode><ProprietaryName>Large Ansi First Aid Kit</ProprietaryName><NonProprietaryName>Water, Benzalkonium Chloride, Isopropyl Alcohol, Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, Lidocaine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>50090-0021-9</NDCCode><ProprietaryName>Doxycycline</ProprietaryName><NonProprietaryName>Doxycycline Hyclate</NonProprietaryName></NDC><NDC><NDCCode>67835-0021-9</NDCCode><NonProprietaryName>Famotidine</NonProprietaryName></NDC><NDC><NDCCode>71335-0021-9</NDCCode><ProprietaryName>Valacyclovir Hydrochloride</ProprietaryName><NonProprietaryName>Valacyclovir Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>17856-0021-2</NDCCode><ProprietaryName>Renagel</ProprietaryName><NonProprietaryName>Renagel</NonProprietaryName></NDC><NDC><NDCCode>32228-021-01</NDCCode><NonProprietaryName>Adalimumab-aaty</NonProprietaryName></NDC><NDC><NDCCode>32228-021-02</NDCCode><NonProprietaryName>Adalimumab-aaty</NonProprietaryName></NDC><NDC><NDCCode>32228-021-03</NDCCode><NonProprietaryName>Adalimumab-aaty</NonProprietaryName></NDC><NDC><NDCCode>33342-021-08</NDCCode><ProprietaryName>Levofloxacin</ProprietaryName><NonProprietaryName>Levofloxacin</NonProprietaryName></NDC><NDC><NDCCode>36800-021-09</NDCCode><ProprietaryName>Salicylic Acid</ProprietaryName><NonProprietaryName>Medicated Corn Removers</NonProprietaryName></NDC><NDC><NDCCode>42406-021-00</NDCCode><ProprietaryName>Sugar Poppy Lip Treatment Sunscreen Spf 15</ProprietaryName><NonProprietaryName>Avobenzone, Octinoxate</NonProprietaryName></NDC><NDC><NDCCode>42658-021-01</NDCCode><ProprietaryName>Daunorubicin Hydrochloride</ProprietaryName><NonProprietaryName>Daunorubicin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>42658-021-02</NDCCode><ProprietaryName>Daunorubicin Hydrochloride</ProprietaryName><NonProprietaryName>Daunorubicin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>42658-021-91</NDCCode><ProprietaryName>Daunorubicin Hydrochloride</ProprietaryName><NonProprietaryName>Daunorubicin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>42658-021-92</NDCCode><ProprietaryName>Daunorubicin Hydrochloride</ProprietaryName><NonProprietaryName>Daunorubicin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>43419-021-04</NDCCode><ProprietaryName>Sulwhasoo Lumitouch Foundation</ProprietaryName><NonProprietaryName>Octinoxate, Titanium Dioxide, And Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>44237-021-16</NDCCode><ProprietaryName>Herbion Naturals Mint Cough Drops</ProprietaryName><NonProprietaryName>Menthol</NonProprietaryName></NDC><NDC><NDCCode>45802-021-46</NDCCode><ProprietaryName>Betamethasone Dipropionate</ProprietaryName><NonProprietaryName>Betamethasone Dipropionate</NonProprietaryName></NDC><NDC><NDCCode>49288-0021-1</NDCCode><ProprietaryName>White Ash</ProprietaryName><NonProprietaryName>White Ash</NonProprietaryName></NDC><NDC><NDCCode>49288-0021-2</NDCCode><ProprietaryName>White Ash</ProprietaryName><NonProprietaryName>White Ash</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

DataLabs Coding Library - Quering NPI Registry - REST API Examples

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

Output

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
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      "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"
    },
    {
      "NPI": "1942022256",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "JACQUOT",
      "FirstName": "SHAYLA",
      "FirstLineMailingAddress": "PO BOX 1397",
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}
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