RESTful Lookup — Test-Drive (2007 – 2026)

Query complete (31 ms elapsed)

{
  "NDC": [
    {
      "NDCCode": "17856-1303-2",
      "PackageDescription": "120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1303-2)  / .3 mL in 1 SYRINGE",
      "NDC11Code": "17856-1303-02",
      "ProductNDC": "17856-1303",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Infants",
      "NonProprietaryName": "Simethicone",
      "DosageFormName": "SUSPENSION/ DROPS",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200901",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M002",
      "LabelerName": "ATLANTIC BIOLOGICALS CORP.",
      "SubstanceName": "DIMETHICONE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/.3mL",
      "Pharm_Classes": "Skin Barrier Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2025-04-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210630",
      "SamplePackage": "N",
      "IndicationAndUsage": "relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods."
    },
    {
      "NDCCode": "17856-1303-5",
      "PackageDescription": "60 SYRINGE in 1 BOX, UNIT-DOSE (17856-1303-5)  / 1.2 mL in 1 SYRINGE",
      "NDC11Code": "17856-1303-05",
      "ProductNDC": "17856-1303",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Infants",
      "NonProprietaryName": "Simethicone",
      "DosageFormName": "SUSPENSION/ DROPS",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200901",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M002",
      "LabelerName": "ATLANTIC BIOLOGICALS CORP.",
      "SubstanceName": "DIMETHICONE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/.3mL",
      "Pharm_Classes": "Skin Barrier Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2025-04-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210630",
      "SamplePackage": "N",
      "IndicationAndUsage": "relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods."
    },
    {
      "NDCCode": "17856-1303-1",
      "PackageDescription": "120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1303-1)  / .3 mL in 1 SYRINGE",
      "NDC11Code": "17856-1303-01",
      "ProductNDC": "17856-1303",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Infants",
      "NonProprietaryName": "Simethicone",
      "DosageFormName": "SUSPENSION/ DROPS",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200901",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M002",
      "LabelerName": "ATLANTIC BIOLOGICALS CORP.",
      "SubstanceName": "DIMETHICONE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/.3mL",
      "Pharm_Classes": "Skin Barrier Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2025-04-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210630",
      "SamplePackage": "N",
      "IndicationAndUsage": "relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods."
    },
    {
      "NDCCode": "17856-1303-3",
      "PackageDescription": "120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1303-3)  / .6 mL in 1 SYRINGE",
      "NDC11Code": "17856-1303-03",
      "ProductNDC": "17856-1303",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Infants",
      "NonProprietaryName": "Simethicone",
      "DosageFormName": "SUSPENSION/ DROPS",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200901",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M002",
      "LabelerName": "ATLANTIC BIOLOGICALS CORP.",
      "SubstanceName": "DIMETHICONE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/.3mL",
      "Pharm_Classes": "Skin Barrier Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2025-04-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210630",
      "SamplePackage": "N",
      "IndicationAndUsage": "relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods."
    },
    {
      "NDCCode": "17856-1303-4",
      "PackageDescription": "120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1303-4)  / .6 mL in 1 SYRINGE",
      "NDC11Code": "17856-1303-04",
      "ProductNDC": "17856-1303",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Infants",
      "NonProprietaryName": "Simethicone",
      "DosageFormName": "SUSPENSION/ DROPS",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200901",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M002",
      "LabelerName": "ATLANTIC BIOLOGICALS CORP.",
      "SubstanceName": "DIMETHICONE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/.3mL",
      "Pharm_Classes": "Skin Barrier Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2025-04-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210630",
      "SamplePackage": "N",
      "IndicationAndUsage": "relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods."
    },
    {
      "NDCCode": "36987-1303-2",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (36987-1303-2)",
      "NDC11Code": "36987-1303-02",
      "ProductNDC": "36987-1303",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Blueberry",
      "NonProprietaryName": "Blueberry",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19720829",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102192",
      "LabelerName": "Nelco Laboratories, Inc.",
      "SubstanceName": "BLUEBERRY",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
      "Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
    },
    {
      "NDCCode": "37662-1303-2",
      "PackageDescription": "200 PELLET in 1 VIAL, GLASS (37662-1303-2) ",
      "NDC11Code": "37662-1303-02",
      "ProductNDC": "37662-1303",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Veratrum Album",
      "NonProprietaryName": "Veratrum Album",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220811",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Hahnemann Laboratories, INC.",
      "SubstanceName": "VERATRUM ALBUM ROOT",
      "StrengthNumber": "30",
      "StrengthUnit": "[hp_C]/1",
      "Status": "Active",
      "LastUpdate": "2022-08-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220811",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "48951-1303-2",
      "PackageDescription": "1350 PELLET in 1 BOTTLE, GLASS (48951-1303-2) ",
      "NDC11Code": "48951-1303-02",
      "ProductNDC": "48951-1303",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Agaricus Conchae Special Order",
      "NonProprietaryName": "Agaricus Conchae Special Order",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090901",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Uriel Pharmacy Inc.",
      "SubstanceName": "DRYOPTERIS FILIX-MAS ROOT; SILVER; OSTREA EDULIS SHELL; AMANITA MUSCARIA FRUITING BODY",
      "StrengthNumber": "3; 6; 7; 8",
      "StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
      "Status": "Deprecated",
      "LastUpdate": "2020-11-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20090901",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "51672-1303-2",
      "PackageDescription": "1 TUBE in 1 CARTON (51672-1303-2)  / 30 g in 1 TUBE",
      "NDC11Code": "51672-1303-02",
      "ProductNDC": "51672-1303",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Econazole Nitrate",
      "NonProprietaryName": "Econazole Nitrate",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20021126",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076005",
      "LabelerName": "Sun Pharmaceutical Industries, Inc.",
      "SubstanceName": "ECONAZOLE NITRATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
      "Status": "Active",
      "LastUpdate": "2025-08-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20021126",
      "SamplePackage": "N",
      "IndicationAndUsage": "Econazole nitrate cream is indicated for topical application in the treatment of tinea pedis, tinea cruris, and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Microsporum canis, Microsporum audouini, Microsporum gypseum,and Epidermophyton floccosum,in the treatment of cutaneous candidiasis, and in the treatment of tinea versicolor.",
      "Description": "Econazole nitrate cream contains the antifungal agent, econazole nitrate USP 1%, in a water-miscible base consisting of benzoic acid, butylated hydroxytoluene, mineral oil, oleoyl polyoxylglycerides PEG-6-32 stearate/glycol stearate and purified water. The white to off-white soft cream is for topical use only. Chemically, econazole nitrate is 1-[2-{(4-chloro-phenyl) methoxy}-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole mononitrate. Its structure is as follows."
    },
    {
      "NDCCode": "54565-1303-2",
      "PackageDescription": "354 mL in 1 BOTTLE, PLASTIC (54565-1303-2) ",
      "NDC11Code": "54565-1303-02",
      "ProductNDC": "54565-1303",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Aveeno Baby Daily Moisture",
      "NonProprietaryName": "Dimethicone",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20101201",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part347",
      "LabelerName": "KDC/ONE Development Corporation, Inc",
      "SubstanceName": "DIMETHICONE",
      "StrengthNumber": "12",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2021-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20171107",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "60681-1303-2",
      "PackageDescription": "50 VIAL, GLASS in 1 CARTON (60681-1303-2)  > 1 mL in 1 VIAL, GLASS",
      "NDC11Code": "60681-1303-02",
      "ProductNDC": "60681-1303",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Pleo Lari",
      "NonProprietaryName": "Laricifomes Officinalis Fruiting Body",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "19980119",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Sanum Kehlbeck GmbH & Co. KG",
      "SubstanceName": "LARICIFOMES OFFICINALIS FRUITING BODY",
      "StrengthNumber": "5",
      "StrengthUnit": "[hp_X]/mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "For temporary relief of pain associated with arthritis."
    },
    {
      "NDCCode": "64942-1303-2",
      "PackageDescription": "1 CONTAINER in 1 CARTON (64942-1303-2)  / 48 g in 1 CONTAINER (64942-1303-1) ",
      "NDC11Code": "64942-1303-02",
      "ProductNDC": "64942-1303",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Degree",
      "ProprietaryNameSuffix": "Clinical Sheer Powder Antiperspirant And Deodorant",
      "NonProprietaryName": "Aluminum Zirconium Tetrachlorohydrex Gly",
      "DosageFormName": "STICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20201030",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M019",
      "LabelerName": "Conopco Inc. d/b/a Unilever",
      "SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
      "StrengthNumber": "20",
      "StrengthUnit": "g/100g",
      "Status": "Active",
      "LastUpdate": "2024-10-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201030",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses▪  reduces underarm wetness ▪  extra effective."
    },
    {
      "NDCCode": "65044-1303-2",
      "PackageDescription": "10 mL in 1 VIAL (65044-1303-2) ",
      "NDC11Code": "65044-1303-02",
      "ProductNDC": "65044-1303",
      "ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Pollens - Weeds, Careless/pigweed Mix",
      "NonProprietaryName": "Careless/pigweed Mix",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19410419",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103888",
      "LabelerName": "Jubilant HollisterStier LLC",
      "SubstanceName": "AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN",
      "StrengthNumber": ".1; .1",
      "StrengthUnit": "g/mL; g/mL",
      "Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]",
      "Status": "Active",
      "LastUpdate": "2026-06-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19410419",
      "SamplePackage": "N",
      "IndicationAndUsage": "NON-STANDARDIZED ALLERGENIC EXTRACTS are indicated for: 1 Skin test diagnosis of individuals with a clinical history of allergy to the specific corresponding allergens.",
      "Description": "Non-standardized allergenic extracts are labeled “No U.S.  Standard of Potency”. Non-standardized allergenic extracts are supplied in a Glycero Cocas extraction solution, which consists of 0.5% sodium chloride for isotonicity, 0.275% sodium bicarbonate as a buffer, and 50% glycerin (volume/volume) as preservative. Non-standardized allergenic extracts are supplied as a weight to volume (w/v) solution of allergen in extraction solution.  Product concentrations vary based on the source.  Refer to the vial label for the product concentration. Source material mold mycelia and Candida albicans cells are cultivated on liquid medium which may contain one or more of the following constituents:  casein hydrolysate; malt extract; yeast extract; maltose; dextrose; ammonium nitrate, calcium carbonate, calcium chloride, ammonium citrate, potassium phosphate, sodium citrate, citric acid; magnesium sulfate; or trace elements.  Acetone and ether may be used as drying and de-fatting agents.  Candida albicans cells are treated with phenol, which is removed by dialysis. Dog Hair and Dander extracts are manufactured in 3 product forms: 1 Dog Hair and Dander (Regular Process) is derived from extraction of the source material without additional processing, and is prepared at 1:10 w/v in Glycero-Cocas., 2 Acetone Precipitated (AP) Dog Hair and Dander is derived from the acetone precipitated aqueous extract and is prepared at 1:100 w/v in Glycero-Cocas., 3 Ultrafiltered (UF) Dog Hair and Dander is derived from the UF aqueous extract and is prepared at 1:650 w/v in Glycero‑Cocas."
    },
    {
      "NDCCode": "67296-1303-2",
      "PackageDescription": "20 TABLET in 1 BOTTLE (67296-1303-2) ",
      "NDC11Code": "67296-1303-02",
      "ProductNDC": "67296-1303",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Alprazolam",
      "NonProprietaryName": "Alprazolam",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120723",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074215",
      "LabelerName": "RedPharm Drug, Inc.",
      "SubstanceName": "ALPRAZOLAM",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [CS]",
      "DEASchedule": "CIV",
      "Status": "Deprecated",
      "LastUpdate": "2021-08-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20120723",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "69238-1303-2",
      "PackageDescription": "2 BLISTER PACK in 1 CARTON (69238-1303-2)  / 14 TABLET, FILM COATED in 1 BLISTER PACK",
      "NDC11Code": "69238-1303-02",
      "ProductNDC": "69238-1303",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Teriflunomide",
      "NonProprietaryName": "Teriflunomide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20181001",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209613",
      "LabelerName": "Amneal Pharmaceuticals NY LLC",
      "SubstanceName": "TERIFLUNOMIDE",
      "StrengthNumber": "7",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20181001",
      "SamplePackage": "N",
      "IndicationAndUsage": "Teriflunomide tablets are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.",
      "Description": "Teriflunomide is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-Cyano-3-hydroxy-but-2-enoic acid-(4-trifluoromethylphenyl)-amide. Its molecular weight is 270.21 g/mol, and the empirical formula is C12H9F3N2O2 with the following chemical structure. Teriflunomide is a white to off-white solid that is sparingly soluble in acetone, slightly soluble in ethanol and practically insoluble in water. Teriflunomide is formulated as film-coated tablets for oral administration. Teriflunomide tablets contain 7 mg or 14 mg of teriflunomide and the following inactive ingredients: corn starch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. The film coating for the 7 mg and 14 mg tablet is made of colloidal anhydrous silica, FD & C Blue # 2/indigo carmine aluminum lake, hypromellose, polyethylene glycol, titanium dioxide and in addition to these, the 7 mg tablet film coating includes iron oxide yellow."
    },
    {
      "NDCCode": "71335-1303-2",
      "PackageDescription": "60 TABLET, COATED in 1 BOTTLE (71335-1303-2) ",
      "NDC11Code": "71335-1303-02",
      "ProductNDC": "71335-1303",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metformin Hydrochloride",
      "NonProprietaryName": "Metformin Hydrochloride",
      "DosageFormName": "TABLET, COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190501",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA205096",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2026-04-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190821",
      "SamplePackage": "N",
      "IndicationAndUsage": "Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.",
      "Description": "Metformin hydrochloride tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5 ∙ HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets, USP contain 500 mg, 850 mg or 1,000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients povidone and magnesium stearate. In addition, the coating for the 500 mg, 850 mg and 1,000 mg tablets contains hypromellose and polyethylene glycol."
    },
    {
      "NDCCode": "0363-1303-10",
      "PackageDescription": "296 mL in 1 BOTTLE, GLASS (0363-1303-10)",
      "NDC11Code": "00363-1303-10",
      "ProductNDC": "0363-1303",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Magnesium Citrate",
      "NonProprietaryName": "Magnesium Citrate",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090402",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part334",
      "LabelerName": "Walgreens",
      "SubstanceName": "MAGNESIUM CITRATE",
      "StrengthNumber": "2.65",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2017-11-29"
    },
    {
      "NDCCode": "51672-1303-1",
      "PackageDescription": "1 TUBE in 1 CARTON (51672-1303-1)  / 15 g in 1 TUBE",
      "NDC11Code": "51672-1303-01",
      "ProductNDC": "51672-1303",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Econazole Nitrate",
      "NonProprietaryName": "Econazole Nitrate",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20021126",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076005",
      "LabelerName": "Sun Pharmaceutical Industries, Inc.",
      "SubstanceName": "ECONAZOLE NITRATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
      "Status": "Active",
      "LastUpdate": "2025-08-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20021126",
      "SamplePackage": "N",
      "IndicationAndUsage": "Econazole nitrate cream is indicated for topical application in the treatment of tinea pedis, tinea cruris, and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Microsporum canis, Microsporum audouini, Microsporum gypseum,and Epidermophyton floccosum,in the treatment of cutaneous candidiasis, and in the treatment of tinea versicolor.",
      "Description": "Econazole nitrate cream contains the antifungal agent, econazole nitrate USP 1%, in a water-miscible base consisting of benzoic acid, butylated hydroxytoluene, mineral oil, oleoyl polyoxylglycerides PEG-6-32 stearate/glycol stearate and purified water. The white to off-white soft cream is for topical use only. Chemically, econazole nitrate is 1-[2-{(4-chloro-phenyl) methoxy}-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole mononitrate. Its structure is as follows."
    },
    {
      "NDCCode": "51672-1303-8",
      "PackageDescription": "1 TUBE in 1 CARTON (51672-1303-8)  / 85 g in 1 TUBE",
      "NDC11Code": "51672-1303-08",
      "ProductNDC": "51672-1303",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Econazole Nitrate",
      "NonProprietaryName": "Econazole Nitrate",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20021126",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076005",
      "LabelerName": "Sun Pharmaceutical Industries, Inc.",
      "SubstanceName": "ECONAZOLE NITRATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
      "Status": "Active",
      "LastUpdate": "2025-08-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20021126",
      "SamplePackage": "N",
      "IndicationAndUsage": "Econazole nitrate cream is indicated for topical application in the treatment of tinea pedis, tinea cruris, and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Microsporum canis, Microsporum audouini, Microsporum gypseum,and Epidermophyton floccosum,in the treatment of cutaneous candidiasis, and in the treatment of tinea versicolor.",
      "Description": "Econazole nitrate cream contains the antifungal agent, econazole nitrate USP 1%, in a water-miscible base consisting of benzoic acid, butylated hydroxytoluene, mineral oil, oleoyl polyoxylglycerides PEG-6-32 stearate/glycol stearate and purified water. The white to off-white soft cream is for topical use only. Chemically, econazole nitrate is 1-[2-{(4-chloro-phenyl) methoxy}-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole mononitrate. Its structure is as follows."
    },
    {
      "NDCCode": "17856-0007-2",
      "PackageDescription": "20 mL in 1 CUP (17856-0007-2)",
      "NDC11Code": "17856-0007-02",
      "ProductNDC": "17856-0007",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sulfatrim",
      "NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
      "DosageFormName": "SUSPENSION",
      "RouteName": "ORAL",
      "StartMarketingDate": "19830701",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018615",
      "LabelerName": "Atlantic Biologicals Corps",
      "SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
      "StrengthNumber": "200; 40",
      "StrengthUnit": "mg/5mL; mg/5mL",
      "Pharm_Classes": "Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim oral suspension and other antibacterial drugs, sulfamethoxazole and trimethoprim oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy.",
      "Description": "Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product containing 200 mg sulfamethoxazole and 40 mg trimethoprim per 5 mL for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl)sulfanilamide; the molecular formula is C10H11N3O3S. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula is. Trimethoprim is 2,4-diamino-5-(3,4,5- trimethoxybenzyl) pyrimidine; the molecular formula is C14H18N4O3. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3 and. It has the following structural formula is. INACTIVE INGREDIENTS: alcohol (less than 0.5%), carboxymethylcellulose sodium, citric acid, FD&C Red #40, FD&C Yellow #6, cherry flavor, methylparaben, microcrystalline cellulose and carboxymethylcellulose sodium, polysorbate 80, propylene glycol, propylparaben, purified water, saccharin sodium, simethicone emulsion, sucrose."
    },
    {
      "NDCCode": "17856-0008-2",
      "PackageDescription": "1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (17856-0008-2) ",
      "NDC11Code": "17856-0008-02",
      "ProductNDC": "17856-0008",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Mucinex",
      "NonProprietaryName": "Guaifenesin",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120703",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021282",
      "LabelerName": "ATLANTIC BIOLOGICAS CORP.",
      "SubstanceName": "GUAIFENESIN",
      "StrengthNumber": "600",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]",
      "Status": "Active",
      "LastUpdate": "2025-12-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240605",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive."
    },
    {
      "NDCCode": "17856-0016-2",
      "PackageDescription": "5 mL in 1 SYRINGE (17856-0016-2) ",
      "NDC11Code": "17856-0016-02",
      "ProductNDC": "17856-0016",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Phenobarbital",
      "NonProprietaryName": "Phenobarbital",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180303",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "ATLANTIC BIOLOGICALS CORP",
      "SubstanceName": "PHENOBARBITAL",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/5mL",
      "DEASchedule": "CIV",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20180316",
      "SamplePackage": "N",
      "IndicationAndUsage": "A. Sedative. B. Anticonvulsant- For the treatment of generalized and partial seizures.",
      "Description": "The barbiturates are nonselective central nervous system (CNS) depressants that are primarily used as sedative-hypnotics. In subhypnotic doses, they are also used as anticonvulsants. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act. Phenobarbital is a barbituric acid derivative and occurs as white, odorless, small crystals or crystalline powder that is very slightly soluble in water; soluble in alcohol, in either, and in solutions of fixed alkali hydroxides and carbonates; sparingly soluble in chloroform. Phenobarbital is 5-ethyl-5-phenylbarbituric acid and has the empirical formula C12H12N2O3. Its molecular weight is 232.24. It has the following structural formula. Phenobarbital is a substituted pyrimidine derivative in which the basic structure is barbituric acid, a substance that has no CNS activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring. Each 5 mL (teaspoon) contains 20 mg Phenobarbital and Alcohol 15%. The oral solution also contains FD&C Red #40, orange flavor, glycerin, sucrose, and water."
    },
    {
      "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": "17856-0023-2",
      "PackageDescription": "60 SYRINGE in 1 BOX, UNIT-DOSE (17856-0023-2)  / .125 mL in 1 SYRINGE",
      "NDC11Code": "17856-0023-02",
      "ProductNDC": "17856-0023",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxycodone Hydrochloride",
      "NonProprietaryName": "Oxycodone Hydrochloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180601",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209897",
      "LabelerName": "ALTANTIC BIOLOGICALS CORP",
      "SubstanceName": "OXYCODONE HYDROCHLORIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20230309",
      "SamplePackage": "N",
      "IndicationAndUsage": "Oxycodone Hydrochloride Oral Solution is an opioid agonist indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. (1). Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/mL) is indicated for the relief of pain in opioid-tolerant adults. Limitations of Use (1) Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Oxycodone Hydrochloride Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: : 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
      "Description": "Oxycodone Hydrochloride Oral Solution is an agonist, available as a yellow solution 100 mg/5 mL (20 mg/mL) for oral administration. The chemical name is (5R,9R,13S,14S)-4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 351.82. Its molecular formula is C18H21NO4.HCl, and it has the following chemical structure. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine.It is soluble in water and slightly soluble in alcohol. The inactive ingredients in Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/ mL): include: citric acid anhydrous, D&C Yellow #10, mixed berry flavor, purified water, sodium citrate dihydrate, sodium benzoate, saccharin sodium, sorbitol."
    },
    {
      "NDCCode": "17856-0024-2",
      "PackageDescription": "50 CUP in 1 BOX, UNIT-DOSE (17856-0024-2)  / 30 g in 1 CUP",
      "NDC11Code": "17856-0024-02",
      "ProductNDC": "17856-0024",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Polystyrene Sulfonate",
      "NonProprietaryName": "Sodium Polystyrene Sulfonate",
      "DosageFormName": "POWDER, FOR SUSPENSION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140414",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202333",
      "LabelerName": "ATLANTIC BIOLOGICALS CORP.",
      "SubstanceName": "SODIUM POLYSTYRENE SULFONATE",
      "StrengthNumber": "4.1",
      "StrengthUnit": "meq/g",
      "Status": "Active",
      "LastUpdate": "2025-05-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230411",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sodium Polystyrene Sulfonate Powder, for Suspension is indicated for the treatment of hyperkalemia. Limitation of Use. Sodium Polystyrene Sulfonate Powder, for Suspension should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action [see Clinical Pharmacology (12.2)].",
      "Description": "Sodium Polystyrene Sulfonate Powder, for Suspension is a benzene, diethenyl-polymer, with ethenylbenzene, sulfonated, sodium salt and has the following structural formula. The drug is a cream to light brown finely ground, powdered form of sodium polystyrene sulfonate, a cation-exchange resin prepared in the sodium phase with an in vitro exchange capacity of approximately 3.1 mEq (. in vivo. approximately 1 mEq) of potassium per gram. The sodium content is approximately 100 mg (4.1 mEq) per gram of the drug. It can be administered orally or rectally as an enema. One gram of Sodium Polystyrene Sulfonate Powder, for Suspension contains 4.1 mEq of sodium."
    },
    {
      "NDCCode": "17856-0025-2",
      "PackageDescription": "72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0025-2)  / 5 mL in 1 CUP, UNIT-DOSE (17856-0025-6) ",
      "NDC11Code": "17856-0025-02",
      "ProductNDC": "17856-0025",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Max Relief Junior",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230514",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M",
      "LabelerName": "ATLANTIC BIOLOGICALS CORP.",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "160",
      "StrengthUnit": "mg/5mL",
      "Status": "Active",
      "LastUpdate": "2024-03-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240228",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses: 1 temporarily , 2 reduces fever, 3 relieves minor aches and pains due to:, 4 the common cold, 5 flu, 6 headache, 7 sore throat, 8 toothache."
    },
    {
      "NDCCode": "17856-0029-1",
      "PackageDescription": "72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0029-1)  > 10 mL in 1 CUP, UNIT-DOSE (17856-0029-2) ",
      "NDC11Code": "17856-0029-01",
      "ProductNDC": "17856-0029",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Carbamazepine",
      "NonProprietaryName": "Carbamazepine",
      "DosageFormName": "SUSPENSION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20020605",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075714",
      "LabelerName": "ATLANTIC BIOLOGICALS CORP.",
      "SubstanceName": "CARBAMAZEPINE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20220926",
      "SamplePackage": "N",
      "IndicationAndUsage": "Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: 1 Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types., 2 Generalized tonic-clonic seizures (grand mal)., 3 Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see PRECAUTIONS, General).",
      "Description": "Carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as a suspension of 100 mg/5 mL (teaspoon). Its chemical name is 5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula is. Inactive Ingredients: alcohol free lemon lime flavor, citric acid anhydrous, FD&C Yellow No. 6, hypromellose, orange flavor, potassium sorbate, propylene glycol, purified water, sorbitol solution, sucrose, vanillin, and xanthan gum. It may contain 10% citric acid solution or 10% sodium citrate solution to adjust pH between 3.0 and 5.0."
    },
    {
      "NDCCode": "17856-0034-2",
      "PackageDescription": "50 CAPSULE, LIQUID FILLED in 1 POUCH (17856-0034-2)",
      "NDC11Code": "17856-0034-02",
      "ProductNDC": "17856-0034",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Omega-3-acid Ethyl Esters",
      "NonProprietaryName": "Omega-3-acid Ethyl Esters",
      "DosageFormName": "CAPSULE, LIQUID FILLED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20151130",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204940",
      "LabelerName": "Atlantic Biologicals Corps",
      "SubstanceName": "OMEGA-3-ACID ETHYL ESTERS",
      "StrengthNumber": "1",
      "StrengthUnit": "g/1",
      "Pharm_Classes": "Fatty Acids, Omega-3 [CS],Omega-3 Fatty Acid [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Omega-3-acid ethyl esters capsules, USP are indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia (HTG). Patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters capsules, USP and should continue this diet during treatment with omega-3-acid ethyl esters capsules, USP. Usage Considerations. Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with omega-3-acid ethyl esters capsules, USP. Every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (such as beta blockers, thiazides, estrogens) should be discontinued or changed if possible prior to consideration of triglyceride-lowering drug therapy. Limitations of Use. The effect of omega-3-acid ethyl esters capsules, USP on the risk for pancreatitis has not been determined. The effect of omega-3-acid ethyl esters capsules, USP on cardiovascular mortality and morbidity has not been determined.",
      "Description": "Omega-3-acid ethyl esters, USP, a lipid-regulating agent, are supplied as a liquid-filled gel capsule for oral administration. Each 1 gram capsule of omega-3-acid ethyl esters, USP contains at least 900 mg of the ethyl esters of omega-3 fatty acids sourced from fish oils. These are predominantly a combination of ethyl esters of eicosapentaenoic acid (EPA - approximately 465 mg) and docosahexaenoic acid (DHA - approximately 375 mg). The empirical formula of EPA ethyl ester is C H O , and the molecular weight of EPA ethyl ester is 330.51. The structural formula of EPA ethyl ester is: 22342. The empirical formula of DHA ethyl ester is C H O , and the molecular weight of DHA ethyl ester is 356.55. The structural formula of DHA ethyl ester is: 24362. Omega-3-acid ethyl esters capsules, USP also contain the following inactive ingredients: alpha-tocopherol, gelatin, glycerin and purified water (components of the capsule shell)."
    },
    {
      "NDCCode": "17856-0045-2",
      "PackageDescription": "120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0045-2)  / 1.25 mL in 1 SYRINGE (17856-0045-6) ",
      "NDC11Code": "17856-0045-02",
      "ProductNDC": "17856-0045",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Max Relief Junior",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230514",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M",
      "LabelerName": "ATLANTIC BIOLOGICALS CORP.",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "160",
      "StrengthUnit": "mg/5mL",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240228",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses: 1 temporarily , 2 reduces fever, 3 relieves minor aches and pains due to:, 4 the common cold, 5 flu, 6 headache, 7 sore throat, 8 toothache."
    },
    {
      "NDCCode": "17856-0045-3",
      "PackageDescription": "120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0045-3)  / 2.5 mL in 1 SYRINGE (17856-0045-7) ",
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      "ProductNDC": "17856-0045",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Max Relief Junior",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230514",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M",
      "LabelerName": "ATLANTIC BIOLOGICALS CORP.",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "160",
      "StrengthUnit": "mg/5mL",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240228",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses: 1 temporarily , 2 reduces fever, 3 relieves minor aches and pains due to:, 4 the common cold, 5 flu, 6 headache, 7 sore throat, 8 toothache."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"17856-1303-2","ProprietaryName":"Infants","NonProprietaryName":"Simethicone"},{"NDCCode":"17856-1303-5","ProprietaryName":"Infants","NonProprietaryName":"Simethicone"},{"NDCCode":"17856-1303-1","ProprietaryName":"Infants","NonProprietaryName":"Simethicone"},{"NDCCode":"17856-1303-3","ProprietaryName":"Infants","NonProprietaryName":"Simethicone"},{"NDCCode":"17856-1303-4","ProprietaryName":"Infants","NonProprietaryName":"Simethicone"},{"NDCCode":"36987-1303-2","ProprietaryName":"Blueberry","NonProprietaryName":"Blueberry"},{"NDCCode":"37662-1303-2","ProprietaryName":"Veratrum Album","NonProprietaryName":"Veratrum Album"},{"NDCCode":"48951-1303-2","ProprietaryName":"Agaricus Conchae Special Order","NonProprietaryName":"Agaricus Conchae Special Order"},{"NDCCode":"51672-1303-2","ProprietaryName":"Econazole Nitrate","NonProprietaryName":"Econazole Nitrate"},{"NDCCode":"54565-1303-2","ProprietaryName":"Aveeno Baby Daily Moisture","NonProprietaryName":"Dimethicone"},{"NDCCode":"60681-1303-2","ProprietaryName":"Pleo Lari","NonProprietaryName":"Laricifomes Officinalis Fruiting Body"},{"NDCCode":"64942-1303-2","ProprietaryName":"Degree","NonProprietaryName":"Aluminum Zirconium Tetrachlorohydrex Gly"},{"NDCCode":"65044-1303-2","ProprietaryName":"Pollens - Weeds, Careless/pigweed Mix","NonProprietaryName":"Careless/pigweed Mix"},{"NDCCode":"67296-1303-2","ProprietaryName":"Alprazolam","NonProprietaryName":"Alprazolam"},{"NDCCode":"69238-1303-2","ProprietaryName":"Teriflunomide","NonProprietaryName":"Teriflunomide"},{"NDCCode":"71335-1303-2","ProprietaryName":"Metformin Hydrochloride","NonProprietaryName":"Metformin Hydrochloride"},{"NDCCode":"0363-1303-10","ProprietaryName":"Magnesium Citrate","NonProprietaryName":"Magnesium Citrate"},{"NDCCode":"51672-1303-1","ProprietaryName":"Econazole Nitrate","NonProprietaryName":"Econazole Nitrate"},{"NDCCode":"51672-1303-8","ProprietaryName":"Econazole Nitrate","NonProprietaryName":"Econazole Nitrate"},{"NDCCode":"17856-0007-2","ProprietaryName":"Sulfatrim","NonProprietaryName":"Sulfamethoxazole And Trimethoprim"},{"NDCCode":"17856-0008-2","ProprietaryName":"Mucinex","NonProprietaryName":"Guaifenesin"},{"NDCCode":"17856-0016-2","ProprietaryName":"Phenobarbital","NonProprietaryName":"Phenobarbital"},{"NDCCode":"17856-0021-2","ProprietaryName":"Renagel","NonProprietaryName":"Renagel"},{"NDCCode":"17856-0023-2","ProprietaryName":"Oxycodone Hydrochloride","NonProprietaryName":"Oxycodone Hydrochloride"},{"NDCCode":"17856-0024-2","ProprietaryName":"Sodium Polystyrene Sulfonate","NonProprietaryName":"Sodium Polystyrene Sulfonate"},{"NDCCode":"17856-0025-2","ProprietaryName":"Max Relief Junior","NonProprietaryName":"Acetaminophen"},{"NDCCode":"17856-0029-1","ProprietaryName":"Carbamazepine","NonProprietaryName":"Carbamazepine"},{"NDCCode":"17856-0034-2","ProprietaryName":"Omega-3-acid Ethyl Esters","NonProprietaryName":"Omega-3-acid Ethyl Esters"},{"NDCCode":"17856-0045-2","ProprietaryName":"Max Relief Junior","NonProprietaryName":"Acetaminophen"},{"NDCCode":"17856-0045-3","ProprietaryName":"Max Relief Junior","NonProprietaryName":"Acetaminophen"}]}
                    

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<NDCList>
  <NDC>
    <NDCCode>17856-1303-2</NDCCode>
    <PackageDescription>120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1303-2)  / .3 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>17856-1303-02</NDC11Code>
    <ProductNDC>17856-1303</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Infants</ProprietaryName>
    <NonProprietaryName>Simethicone</NonProprietaryName>
    <DosageFormName>SUSPENSION/ DROPS</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200901</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M002</ApplicationNumber>
    <LabelerName>ATLANTIC BIOLOGICALS CORP.</LabelerName>
    <SubstanceName>DIMETHICONE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/.3mL</StrengthUnit>
    <Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210630</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>17856-1303-5</NDCCode>
    <PackageDescription>60 SYRINGE in 1 BOX, UNIT-DOSE (17856-1303-5)  / 1.2 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>17856-1303-05</NDC11Code>
    <ProductNDC>17856-1303</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Infants</ProprietaryName>
    <NonProprietaryName>Simethicone</NonProprietaryName>
    <DosageFormName>SUSPENSION/ DROPS</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200901</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M002</ApplicationNumber>
    <LabelerName>ATLANTIC BIOLOGICALS CORP.</LabelerName>
    <SubstanceName>DIMETHICONE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/.3mL</StrengthUnit>
    <Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210630</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>17856-1303-1</NDCCode>
    <PackageDescription>120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1303-1)  / .3 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>17856-1303-01</NDC11Code>
    <ProductNDC>17856-1303</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Infants</ProprietaryName>
    <NonProprietaryName>Simethicone</NonProprietaryName>
    <DosageFormName>SUSPENSION/ DROPS</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200901</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M002</ApplicationNumber>
    <LabelerName>ATLANTIC BIOLOGICALS CORP.</LabelerName>
    <SubstanceName>DIMETHICONE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/.3mL</StrengthUnit>
    <Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210630</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
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  </NDC>
  <NDC>
    <NDCCode>17856-1303-3</NDCCode>
    <PackageDescription>120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1303-3)  / .6 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>17856-1303-03</NDC11Code>
    <ProductNDC>17856-1303</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Infants</ProprietaryName>
    <NonProprietaryName>Simethicone</NonProprietaryName>
    <DosageFormName>SUSPENSION/ DROPS</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200901</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M002</ApplicationNumber>
    <LabelerName>ATLANTIC BIOLOGICALS CORP.</LabelerName>
    <SubstanceName>DIMETHICONE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/.3mL</StrengthUnit>
    <Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210630</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>17856-1303-4</NDCCode>
    <PackageDescription>120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1303-4)  / .6 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>17856-1303-04</NDC11Code>
    <ProductNDC>17856-1303</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Infants</ProprietaryName>
    <NonProprietaryName>Simethicone</NonProprietaryName>
    <DosageFormName>SUSPENSION/ DROPS</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200901</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M002</ApplicationNumber>
    <LabelerName>ATLANTIC BIOLOGICALS CORP.</LabelerName>
    <SubstanceName>DIMETHICONE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/.3mL</StrengthUnit>
    <Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210630</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods.</IndicationAndUsage>
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  <NDC>
    <NDCCode>36987-1303-2</NDCCode>
    <PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (36987-1303-2)</PackageDescription>
    <NDC11Code>36987-1303-02</NDC11Code>
    <ProductNDC>36987-1303</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Blueberry</ProprietaryName>
    <NonProprietaryName>Blueberry</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19720829</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102192</ApplicationNumber>
    <LabelerName>Nelco Laboratories, Inc.</LabelerName>
    <SubstanceName>BLUEBERRY</SubstanceName>
    <StrengthNumber>.05</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
    <Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
  </NDC>
  <NDC>
    <NDCCode>37662-1303-2</NDCCode>
    <PackageDescription>200 PELLET in 1 VIAL, GLASS (37662-1303-2) </PackageDescription>
    <NDC11Code>37662-1303-02</NDC11Code>
    <ProductNDC>37662-1303</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Veratrum Album</ProprietaryName>
    <NonProprietaryName>Veratrum Album</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220811</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Hahnemann Laboratories, INC.</LabelerName>
    <SubstanceName>VERATRUM ALBUM ROOT</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>[hp_C]/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2022-08-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220811</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>48951-1303-2</NDCCode>
    <PackageDescription>1350 PELLET in 1 BOTTLE, GLASS (48951-1303-2) </PackageDescription>
    <NDC11Code>48951-1303-02</NDC11Code>
    <ProductNDC>48951-1303</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Agaricus Conchae Special Order</ProprietaryName>
    <NonProprietaryName>Agaricus Conchae Special Order</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090901</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Uriel Pharmacy Inc.</LabelerName>
    <SubstanceName>DRYOPTERIS FILIX-MAS ROOT; SILVER; OSTREA EDULIS SHELL; AMANITA MUSCARIA FRUITING BODY</SubstanceName>
    <StrengthNumber>3; 6; 7; 8</StrengthNumber>
    <StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-11-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>51672-1303-2</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (51672-1303-2)  / 30 g in 1 TUBE</PackageDescription>
    <NDC11Code>51672-1303-02</NDC11Code>
    <ProductNDC>51672-1303</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Econazole Nitrate</ProprietaryName>
    <NonProprietaryName>Econazole Nitrate</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20021126</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076005</ApplicationNumber>
    <LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
    <SubstanceName>ECONAZOLE NITRATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20021126</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Econazole nitrate cream is indicated for topical application in the treatment of tinea pedis, tinea cruris, and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Microsporum canis, Microsporum audouini, Microsporum gypseum,and Epidermophyton floccosum,in the treatment of cutaneous candidiasis, and in the treatment of tinea versicolor.</IndicationAndUsage>
    <Description>Econazole nitrate cream contains the antifungal agent, econazole nitrate USP 1%, in a water-miscible base consisting of benzoic acid, butylated hydroxytoluene, mineral oil, oleoyl polyoxylglycerides PEG-6-32 stearate/glycol stearate and purified water. The white to off-white soft cream is for topical use only. Chemically, econazole nitrate is 1-[2-{(4-chloro-phenyl) methoxy}-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole mononitrate. Its structure is as follows.</Description>
  </NDC>
  <NDC>
    <NDCCode>54565-1303-2</NDCCode>
    <PackageDescription>354 mL in 1 BOTTLE, PLASTIC (54565-1303-2) </PackageDescription>
    <NDC11Code>54565-1303-02</NDC11Code>
    <ProductNDC>54565-1303</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Aveeno Baby Daily Moisture</ProprietaryName>
    <NonProprietaryName>Dimethicone</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20101201</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part347</ApplicationNumber>
    <LabelerName>KDC/ONE Development Corporation, Inc</LabelerName>
    <SubstanceName>DIMETHICONE</SubstanceName>
    <StrengthNumber>12</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171107</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>60681-1303-2</NDCCode>
    <PackageDescription>50 VIAL, GLASS in 1 CARTON (60681-1303-2)  &gt; 1 mL in 1 VIAL, GLASS</PackageDescription>
    <NDC11Code>60681-1303-02</NDC11Code>
    <ProductNDC>60681-1303</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Pleo Lari</ProprietaryName>
    <NonProprietaryName>Laricifomes Officinalis Fruiting Body</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19980119</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Sanum Kehlbeck GmbH &amp; Co. KG</LabelerName>
    <SubstanceName>LARICIFOMES OFFICINALIS FRUITING BODY</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>[hp_X]/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>For temporary relief of pain associated with arthritis.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>64942-1303-2</NDCCode>
    <PackageDescription>1 CONTAINER in 1 CARTON (64942-1303-2)  / 48 g in 1 CONTAINER (64942-1303-1) </PackageDescription>
    <NDC11Code>64942-1303-02</NDC11Code>
    <ProductNDC>64942-1303</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Degree</ProprietaryName>
    <ProprietaryNameSuffix>Clinical Sheer Powder Antiperspirant And Deodorant</ProprietaryNameSuffix>
    <NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly</NonProprietaryName>
    <DosageFormName>STICK</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20201030</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M019</ApplicationNumber>
    <LabelerName>Conopco Inc. d/b/a Unilever</LabelerName>
    <SubstanceName>ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-10-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201030</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses▪  reduces underarm wetness ▪  extra effective.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>65044-1303-2</NDCCode>
    <PackageDescription>10 mL in 1 VIAL (65044-1303-2) </PackageDescription>
    <NDC11Code>65044-1303-02</NDC11Code>
    <ProductNDC>65044-1303</ProductNDC>
    <ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
    <ProprietaryName>Pollens - Weeds, Careless/pigweed Mix</ProprietaryName>
    <NonProprietaryName>Careless/pigweed Mix</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19410419</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103888</ApplicationNumber>
    <LabelerName>Jubilant HollisterStier LLC</LabelerName>
    <SubstanceName>AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN</SubstanceName>
    <StrengthNumber>.1; .1</StrengthNumber>
    <StrengthUnit>g/mL; g/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19410419</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>NON-STANDARDIZED ALLERGENIC EXTRACTS are indicated for: 1 Skin test diagnosis of individuals with a clinical history of allergy to the specific corresponding allergens.</IndicationAndUsage>
    <Description>Non-standardized allergenic extracts are labeled “No U.S.  Standard of Potency”. Non-standardized allergenic extracts are supplied in a Glycero Cocas extraction solution, which consists of 0.5% sodium chloride for isotonicity, 0.275% sodium bicarbonate as a buffer, and 50% glycerin (volume/volume) as preservative. Non-standardized allergenic extracts are supplied as a weight to volume (w/v) solution of allergen in extraction solution.  Product concentrations vary based on the source.  Refer to the vial label for the product concentration. Source material mold mycelia and Candida albicans cells are cultivated on liquid medium which may contain one or more of the following constituents:  casein hydrolysate; malt extract; yeast extract; maltose; dextrose; ammonium nitrate, calcium carbonate, calcium chloride, ammonium citrate, potassium phosphate, sodium citrate, citric acid; magnesium sulfate; or trace elements.  Acetone and ether may be used as drying and de-fatting agents.  Candida albicans cells are treated with phenol, which is removed by dialysis. Dog Hair and Dander extracts are manufactured in 3 product forms: 1 Dog Hair and Dander (Regular Process) is derived from extraction of the source material without additional processing, and is prepared at 1:10 w/v in Glycero-Cocas., 2 Acetone Precipitated (AP) Dog Hair and Dander is derived from the acetone precipitated aqueous extract and is prepared at 1:100 w/v in Glycero-Cocas., 3 Ultrafiltered (UF) Dog Hair and Dander is derived from the UF aqueous extract and is prepared at 1:650 w/v in Glycero‑Cocas.</Description>
  </NDC>
  <NDC>
    <NDCCode>67296-1303-2</NDCCode>
    <PackageDescription>20 TABLET in 1 BOTTLE (67296-1303-2) </PackageDescription>
    <NDC11Code>67296-1303-02</NDC11Code>
    <ProductNDC>67296-1303</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Alprazolam</ProprietaryName>
    <NonProprietaryName>Alprazolam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120723</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074215</ApplicationNumber>
    <LabelerName>RedPharm Drug, Inc.</LabelerName>
    <SubstanceName>ALPRAZOLAM</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2021-08-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120723</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>69238-1303-2</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 CARTON (69238-1303-2)  / 14 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>69238-1303-02</NDC11Code>
    <ProductNDC>69238-1303</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Teriflunomide</ProprietaryName>
    <NonProprietaryName>Teriflunomide</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20181001</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209613</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>TERIFLUNOMIDE</SubstanceName>
    <StrengthNumber>7</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Teriflunomide tablets are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
    <Description>Teriflunomide is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-Cyano-3-hydroxy-but-2-enoic acid-(4-trifluoromethylphenyl)-amide. Its molecular weight is 270.21 g/mol, and the empirical formula is C12H9F3N2O2 with the following chemical structure. Teriflunomide is a white to off-white solid that is sparingly soluble in acetone, slightly soluble in ethanol and practically insoluble in water. Teriflunomide is formulated as film-coated tablets for oral administration. Teriflunomide tablets contain 7 mg or 14 mg of teriflunomide and the following inactive ingredients: corn starch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. The film coating for the 7 mg and 14 mg tablet is made of colloidal anhydrous silica, FD &amp; C Blue # 2/indigo carmine aluminum lake, hypromellose, polyethylene glycol, titanium dioxide and in addition to these, the 7 mg tablet film coating includes iron oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>71335-1303-2</NDCCode>
    <PackageDescription>60 TABLET, COATED in 1 BOTTLE (71335-1303-2) </PackageDescription>
    <NDC11Code>71335-1303-02</NDC11Code>
    <ProductNDC>71335-1303</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metformin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190501</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205096</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-04-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190821</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>Metformin hydrochloride tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5 ∙ HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets, USP contain 500 mg, 850 mg or 1,000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients povidone and magnesium stearate. In addition, the coating for the 500 mg, 850 mg and 1,000 mg tablets contains hypromellose and polyethylene glycol.</Description>
  </NDC>
  <NDC>
    <NDCCode>0363-1303-10</NDCCode>
    <PackageDescription>296 mL in 1 BOTTLE, GLASS (0363-1303-10)</PackageDescription>
    <NDC11Code>00363-1303-10</NDC11Code>
    <ProductNDC>0363-1303</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Magnesium Citrate</ProprietaryName>
    <NonProprietaryName>Magnesium Citrate</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090402</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part334</ApplicationNumber>
    <LabelerName>Walgreens</LabelerName>
    <SubstanceName>MAGNESIUM CITRATE</SubstanceName>
    <StrengthNumber>2.65</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-11-29</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>51672-1303-1</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (51672-1303-1)  / 15 g in 1 TUBE</PackageDescription>
    <NDC11Code>51672-1303-01</NDC11Code>
    <ProductNDC>51672-1303</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Econazole Nitrate</ProprietaryName>
    <NonProprietaryName>Econazole Nitrate</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20021126</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076005</ApplicationNumber>
    <LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
    <SubstanceName>ECONAZOLE NITRATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20021126</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Econazole nitrate cream is indicated for topical application in the treatment of tinea pedis, tinea cruris, and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Microsporum canis, Microsporum audouini, Microsporum gypseum,and Epidermophyton floccosum,in the treatment of cutaneous candidiasis, and in the treatment of tinea versicolor.</IndicationAndUsage>
    <Description>Econazole nitrate cream contains the antifungal agent, econazole nitrate USP 1%, in a water-miscible base consisting of benzoic acid, butylated hydroxytoluene, mineral oil, oleoyl polyoxylglycerides PEG-6-32 stearate/glycol stearate and purified water. The white to off-white soft cream is for topical use only. Chemically, econazole nitrate is 1-[2-{(4-chloro-phenyl) methoxy}-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole mononitrate. Its structure is as follows.</Description>
  </NDC>
  <NDC>
    <NDCCode>51672-1303-8</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (51672-1303-8)  / 85 g in 1 TUBE</PackageDescription>
    <NDC11Code>51672-1303-08</NDC11Code>
    <ProductNDC>51672-1303</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Econazole Nitrate</ProprietaryName>
    <NonProprietaryName>Econazole Nitrate</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20021126</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076005</ApplicationNumber>
    <LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
    <SubstanceName>ECONAZOLE NITRATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20021126</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Econazole nitrate cream is indicated for topical application in the treatment of tinea pedis, tinea cruris, and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Microsporum canis, Microsporum audouini, Microsporum gypseum,and Epidermophyton floccosum,in the treatment of cutaneous candidiasis, and in the treatment of tinea versicolor.</IndicationAndUsage>
    <Description>Econazole nitrate cream contains the antifungal agent, econazole nitrate USP 1%, in a water-miscible base consisting of benzoic acid, butylated hydroxytoluene, mineral oil, oleoyl polyoxylglycerides PEG-6-32 stearate/glycol stearate and purified water. The white to off-white soft cream is for topical use only. Chemically, econazole nitrate is 1-[2-{(4-chloro-phenyl) methoxy}-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole mononitrate. Its structure is as follows.</Description>
  </NDC>
  <NDC>
    <NDCCode>17856-0007-2</NDCCode>
    <PackageDescription>20 mL in 1 CUP (17856-0007-2)</PackageDescription>
    <NDC11Code>17856-0007-02</NDC11Code>
    <ProductNDC>17856-0007</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sulfatrim</ProprietaryName>
    <NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19830701</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA018615</ApplicationNumber>
    <LabelerName>Atlantic Biologicals Corps</LabelerName>
    <SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
    <StrengthNumber>200; 40</StrengthNumber>
    <StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
    <Pharm_Classes>Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim oral suspension and other antibacterial drugs, sulfamethoxazole and trimethoprim oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy.</IndicationAndUsage>
    <Description>Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product containing 200 mg sulfamethoxazole and 40 mg trimethoprim per 5 mL for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl)sulfanilamide; the molecular formula is C10H11N3O3S. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula is. Trimethoprim is 2,4-diamino-5-(3,4,5- trimethoxybenzyl) pyrimidine; the molecular formula is C14H18N4O3. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3 and. It has the following structural formula is. INACTIVE INGREDIENTS: alcohol (less than 0.5%), carboxymethylcellulose sodium, citric acid, FD&amp;C Red #40, FD&amp;C Yellow #6, cherry flavor, methylparaben, microcrystalline cellulose and carboxymethylcellulose sodium, polysorbate 80, propylene glycol, propylparaben, purified water, saccharin sodium, simethicone emulsion, sucrose.</Description>
  </NDC>
  <NDC>
    <NDCCode>17856-0008-2</NDCCode>
    <PackageDescription>1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (17856-0008-2) </PackageDescription>
    <NDC11Code>17856-0008-02</NDC11Code>
    <ProductNDC>17856-0008</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Mucinex</ProprietaryName>
    <NonProprietaryName>Guaifenesin</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120703</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021282</ApplicationNumber>
    <LabelerName>ATLANTIC BIOLOGICAS CORP.</LabelerName>
    <SubstanceName>GUAIFENESIN</SubstanceName>
    <StrengthNumber>600</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240605</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>17856-0016-2</NDCCode>
    <PackageDescription>5 mL in 1 SYRINGE (17856-0016-2) </PackageDescription>
    <NDC11Code>17856-0016-02</NDC11Code>
    <ProductNDC>17856-0016</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phenobarbital</ProprietaryName>
    <NonProprietaryName>Phenobarbital</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180303</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>ATLANTIC BIOLOGICALS CORP</LabelerName>
    <SubstanceName>PHENOBARBITAL</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180316</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>A. Sedative. B. Anticonvulsant- For the treatment of generalized and partial seizures.</IndicationAndUsage>
    <Description>The barbiturates are nonselective central nervous system (CNS) depressants that are primarily used as sedative-hypnotics. In subhypnotic doses, they are also used as anticonvulsants. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act. Phenobarbital is a barbituric acid derivative and occurs as white, odorless, small crystals or crystalline powder that is very slightly soluble in water; soluble in alcohol, in either, and in solutions of fixed alkali hydroxides and carbonates; sparingly soluble in chloroform. Phenobarbital is 5-ethyl-5-phenylbarbituric acid and has the empirical formula C12H12N2O3. Its molecular weight is 232.24. It has the following structural formula. Phenobarbital is a substituted pyrimidine derivative in which the basic structure is barbituric acid, a substance that has no CNS activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring. Each 5 mL (teaspoon) contains 20 mg Phenobarbital and Alcohol 15%. The oral solution also contains FD&amp;C Red #40, orange flavor, glycerin, sucrose, and water.</Description>
  </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>17856-0023-2</NDCCode>
    <PackageDescription>60 SYRINGE in 1 BOX, UNIT-DOSE (17856-0023-2)  / .125 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>17856-0023-02</NDC11Code>
    <ProductNDC>17856-0023</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180601</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209897</ApplicationNumber>
    <LabelerName>ALTANTIC BIOLOGICALS CORP</LabelerName>
    <SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230309</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Oxycodone Hydrochloride Oral Solution is an opioid agonist indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. (1). Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/mL) is indicated for the relief of pain in opioid-tolerant adults. Limitations of Use (1) Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Oxycodone Hydrochloride Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: : 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
    <Description>Oxycodone Hydrochloride Oral Solution is an agonist, available as a yellow solution 100 mg/5 mL (20 mg/mL) for oral administration. The chemical name is (5R,9R,13S,14S)-4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 351.82. Its molecular formula is C18H21NO4.HCl, and it has the following chemical structure. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine.It is soluble in water and slightly soluble in alcohol. The inactive ingredients in Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/ mL): include: citric acid anhydrous, D&amp;C Yellow #10, mixed berry flavor, purified water, sodium citrate dihydrate, sodium benzoate, saccharin sodium, sorbitol.</Description>
  </NDC>
  <NDC>
    <NDCCode>17856-0024-2</NDCCode>
    <PackageDescription>50 CUP in 1 BOX, UNIT-DOSE (17856-0024-2)  / 30 g in 1 CUP</PackageDescription>
    <NDC11Code>17856-0024-02</NDC11Code>
    <ProductNDC>17856-0024</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Polystyrene Sulfonate</ProprietaryName>
    <NonProprietaryName>Sodium Polystyrene Sulfonate</NonProprietaryName>
    <DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140414</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202333</ApplicationNumber>
    <LabelerName>ATLANTIC BIOLOGICALS CORP.</LabelerName>
    <SubstanceName>SODIUM POLYSTYRENE SULFONATE</SubstanceName>
    <StrengthNumber>4.1</StrengthNumber>
    <StrengthUnit>meq/g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-05-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230411</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sodium Polystyrene Sulfonate Powder, for Suspension is indicated for the treatment of hyperkalemia. Limitation of Use. Sodium Polystyrene Sulfonate Powder, for Suspension should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action [see Clinical Pharmacology (12.2)].</IndicationAndUsage>
    <Description>Sodium Polystyrene Sulfonate Powder, for Suspension is a benzene, diethenyl-polymer, with ethenylbenzene, sulfonated, sodium salt and has the following structural formula. The drug is a cream to light brown finely ground, powdered form of sodium polystyrene sulfonate, a cation-exchange resin prepared in the sodium phase with an in vitro exchange capacity of approximately 3.1 mEq (. in vivo. approximately 1 mEq) of potassium per gram. The sodium content is approximately 100 mg (4.1 mEq) per gram of the drug. It can be administered orally or rectally as an enema. One gram of Sodium Polystyrene Sulfonate Powder, for Suspension contains 4.1 mEq of sodium.</Description>
  </NDC>
  <NDC>
    <NDCCode>17856-0025-2</NDCCode>
    <PackageDescription>72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0025-2)  / 5 mL in 1 CUP, UNIT-DOSE (17856-0025-6) </PackageDescription>
    <NDC11Code>17856-0025-02</NDC11Code>
    <ProductNDC>17856-0025</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Max Relief Junior</ProprietaryName>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230514</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M</ApplicationNumber>
    <LabelerName>ATLANTIC BIOLOGICALS CORP.</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>160</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-03-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240228</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses: 1 temporarily , 2 reduces fever, 3 relieves minor aches and pains due to:, 4 the common cold, 5 flu, 6 headache, 7 sore throat, 8 toothache.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>17856-0029-1</NDCCode>
    <PackageDescription>72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0029-1)  &gt; 10 mL in 1 CUP, UNIT-DOSE (17856-0029-2) </PackageDescription>
    <NDC11Code>17856-0029-01</NDC11Code>
    <ProductNDC>17856-0029</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carbamazepine</ProprietaryName>
    <NonProprietaryName>Carbamazepine</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20020605</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075714</ApplicationNumber>
    <LabelerName>ATLANTIC BIOLOGICALS CORP.</LabelerName>
    <SubstanceName>CARBAMAZEPINE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220926</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: 1 Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types., 2 Generalized tonic-clonic seizures (grand mal)., 3 Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see PRECAUTIONS, General).</IndicationAndUsage>
    <Description>Carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as a suspension of 100 mg/5 mL (teaspoon). Its chemical name is 5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula is. Inactive Ingredients: alcohol free lemon lime flavor, citric acid anhydrous, FD&amp;C Yellow No. 6, hypromellose, orange flavor, potassium sorbate, propylene glycol, purified water, sorbitol solution, sucrose, vanillin, and xanthan gum. It may contain 10% citric acid solution or 10% sodium citrate solution to adjust pH between 3.0 and 5.0.</Description>
  </NDC>
  <NDC>
    <NDCCode>17856-0034-2</NDCCode>
    <PackageDescription>50 CAPSULE, LIQUID FILLED in 1 POUCH (17856-0034-2)</PackageDescription>
    <NDC11Code>17856-0034-02</NDC11Code>
    <ProductNDC>17856-0034</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Omega-3-acid Ethyl Esters</ProprietaryName>
    <NonProprietaryName>Omega-3-acid Ethyl Esters</NonProprietaryName>
    <DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20151130</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204940</ApplicationNumber>
    <LabelerName>Atlantic Biologicals Corps</LabelerName>
    <SubstanceName>OMEGA-3-ACID ETHYL ESTERS</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/1</StrengthUnit>
    <Pharm_Classes>Fatty Acids, Omega-3 [CS],Omega-3 Fatty Acid [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Omega-3-acid ethyl esters capsules, USP are indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia (HTG). Patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters capsules, USP and should continue this diet during treatment with omega-3-acid ethyl esters capsules, USP. Usage Considerations. Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with omega-3-acid ethyl esters capsules, USP. Every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (such as beta blockers, thiazides, estrogens) should be discontinued or changed if possible prior to consideration of triglyceride-lowering drug therapy. Limitations of Use. The effect of omega-3-acid ethyl esters capsules, USP on the risk for pancreatitis has not been determined. The effect of omega-3-acid ethyl esters capsules, USP on cardiovascular mortality and morbidity has not been determined.</IndicationAndUsage>
    <Description>Omega-3-acid ethyl esters, USP, a lipid-regulating agent, are supplied as a liquid-filled gel capsule for oral administration. Each 1 gram capsule of omega-3-acid ethyl esters, USP contains at least 900 mg of the ethyl esters of omega-3 fatty acids sourced from fish oils. These are predominantly a combination of ethyl esters of eicosapentaenoic acid (EPA - approximately 465 mg) and docosahexaenoic acid (DHA - approximately 375 mg). The empirical formula of EPA ethyl ester is C H O , and the molecular weight of EPA ethyl ester is 330.51. The structural formula of EPA ethyl ester is: 22342. The empirical formula of DHA ethyl ester is C H O , and the molecular weight of DHA ethyl ester is 356.55. The structural formula of DHA ethyl ester is: 24362. Omega-3-acid ethyl esters capsules, USP also contain the following inactive ingredients: alpha-tocopherol, gelatin, glycerin and purified water (components of the capsule shell).</Description>
  </NDC>
  <NDC>
    <NDCCode>17856-0045-2</NDCCode>
    <PackageDescription>120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0045-2)  / 1.25 mL in 1 SYRINGE (17856-0045-6) </PackageDescription>
    <NDC11Code>17856-0045-02</NDC11Code>
    <ProductNDC>17856-0045</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Max Relief Junior</ProprietaryName>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230514</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M</ApplicationNumber>
    <LabelerName>ATLANTIC BIOLOGICALS CORP.</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>160</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240228</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses: 1 temporarily , 2 reduces fever, 3 relieves minor aches and pains due to:, 4 the common cold, 5 flu, 6 headache, 7 sore throat, 8 toothache.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>17856-0045-3</NDCCode>
    <PackageDescription>120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0045-3)  / 2.5 mL in 1 SYRINGE (17856-0045-7) </PackageDescription>
    <NDC11Code>17856-0045-03</NDC11Code>
    <ProductNDC>17856-0045</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Max Relief Junior</ProprietaryName>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230514</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M</ApplicationNumber>
    <LabelerName>ATLANTIC BIOLOGICALS CORP.</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>160</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240228</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses: 1 temporarily , 2 reduces fever, 3 relieves minor aches and pains due to:, 4 the common cold, 5 flu, 6 headache, 7 sore throat, 8 toothache.</IndicationAndUsage>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>17856-1303-2</NDCCode><ProprietaryName>Infants</ProprietaryName><NonProprietaryName>Simethicone</NonProprietaryName></NDC><NDC><NDCCode>17856-1303-5</NDCCode><ProprietaryName>Infants</ProprietaryName><NonProprietaryName>Simethicone</NonProprietaryName></NDC><NDC><NDCCode>17856-1303-1</NDCCode><ProprietaryName>Infants</ProprietaryName><NonProprietaryName>Simethicone</NonProprietaryName></NDC><NDC><NDCCode>17856-1303-3</NDCCode><ProprietaryName>Infants</ProprietaryName><NonProprietaryName>Simethicone</NonProprietaryName></NDC><NDC><NDCCode>17856-1303-4</NDCCode><ProprietaryName>Infants</ProprietaryName><NonProprietaryName>Simethicone</NonProprietaryName></NDC><NDC><NDCCode>36987-1303-2</NDCCode><ProprietaryName>Blueberry</ProprietaryName><NonProprietaryName>Blueberry</NonProprietaryName></NDC><NDC><NDCCode>37662-1303-2</NDCCode><ProprietaryName>Veratrum Album</ProprietaryName><NonProprietaryName>Veratrum Album</NonProprietaryName></NDC><NDC><NDCCode>48951-1303-2</NDCCode><ProprietaryName>Agaricus Conchae Special Order</ProprietaryName><NonProprietaryName>Agaricus Conchae Special Order</NonProprietaryName></NDC><NDC><NDCCode>51672-1303-2</NDCCode><ProprietaryName>Econazole Nitrate</ProprietaryName><NonProprietaryName>Econazole Nitrate</NonProprietaryName></NDC><NDC><NDCCode>54565-1303-2</NDCCode><ProprietaryName>Aveeno Baby Daily Moisture</ProprietaryName><NonProprietaryName>Dimethicone</NonProprietaryName></NDC><NDC><NDCCode>60681-1303-2</NDCCode><ProprietaryName>Pleo Lari</ProprietaryName><NonProprietaryName>Laricifomes Officinalis Fruiting Body</NonProprietaryName></NDC><NDC><NDCCode>64942-1303-2</NDCCode><ProprietaryName>Degree</ProprietaryName><NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly</NonProprietaryName></NDC><NDC><NDCCode>65044-1303-2</NDCCode><ProprietaryName>Pollens - Weeds, Careless/pigweed Mix</ProprietaryName><NonProprietaryName>Careless/pigweed Mix</NonProprietaryName></NDC><NDC><NDCCode>67296-1303-2</NDCCode><ProprietaryName>Alprazolam</ProprietaryName><NonProprietaryName>Alprazolam</NonProprietaryName></NDC><NDC><NDCCode>69238-1303-2</NDCCode><ProprietaryName>Teriflunomide</ProprietaryName><NonProprietaryName>Teriflunomide</NonProprietaryName></NDC><NDC><NDCCode>71335-1303-2</NDCCode><ProprietaryName>Metformin Hydrochloride</ProprietaryName><NonProprietaryName>Metformin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0363-1303-10</NDCCode><ProprietaryName>Magnesium Citrate</ProprietaryName><NonProprietaryName>Magnesium Citrate</NonProprietaryName></NDC><NDC><NDCCode>51672-1303-1</NDCCode><ProprietaryName>Econazole Nitrate</ProprietaryName><NonProprietaryName>Econazole Nitrate</NonProprietaryName></NDC><NDC><NDCCode>51672-1303-8</NDCCode><ProprietaryName>Econazole Nitrate</ProprietaryName><NonProprietaryName>Econazole Nitrate</NonProprietaryName></NDC><NDC><NDCCode>17856-0007-2</NDCCode><ProprietaryName>Sulfatrim</ProprietaryName><NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName></NDC><NDC><NDCCode>17856-0008-2</NDCCode><ProprietaryName>Mucinex</ProprietaryName><NonProprietaryName>Guaifenesin</NonProprietaryName></NDC><NDC><NDCCode>17856-0016-2</NDCCode><ProprietaryName>Phenobarbital</ProprietaryName><NonProprietaryName>Phenobarbital</NonProprietaryName></NDC><NDC><NDCCode>17856-0021-2</NDCCode><ProprietaryName>Renagel</ProprietaryName><NonProprietaryName>Renagel</NonProprietaryName></NDC><NDC><NDCCode>17856-0023-2</NDCCode><ProprietaryName>Oxycodone Hydrochloride</ProprietaryName><NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>17856-0024-2</NDCCode><ProprietaryName>Sodium Polystyrene Sulfonate</ProprietaryName><NonProprietaryName>Sodium Polystyrene Sulfonate</NonProprietaryName></NDC><NDC><NDCCode>17856-0025-2</NDCCode><ProprietaryName>Max Relief Junior</ProprietaryName><NonProprietaryName>Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>17856-0029-1</NDCCode><ProprietaryName>Carbamazepine</ProprietaryName><NonProprietaryName>Carbamazepine</NonProprietaryName></NDC><NDC><NDCCode>17856-0034-2</NDCCode><ProprietaryName>Omega-3-acid Ethyl Esters</ProprietaryName><NonProprietaryName>Omega-3-acid Ethyl Esters</NonProprietaryName></NDC><NDC><NDCCode>17856-0045-2</NDCCode><ProprietaryName>Max Relief Junior</ProprietaryName><NonProprietaryName>Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>17856-0045-3</NDCCode><ProprietaryName>Max Relief Junior</ProprietaryName><NonProprietaryName>Acetaminophen</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
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      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "860-821-3406",
      "MailingAddressFaxNumber": "860-821-3407",
      "FirstLinePracticeLocationAddress": "602 ROUTE 169",
      "PracticeLocationAddressCityName": "WOODSTOCK",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06281-2225",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "860-821-3406",
      "PracticeLocationAddressFaxNumber": "860-821-3407",
      "EnumerationDate": "07/22/2006",
      "LastUpdateDate": "01/14/2016",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "000260",
      "LicenseNumberStateCode1": "CT",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

                
{
  "NPI": [
    {
      "NPI": "1083349906",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "STAFFORD",
      "FirstName": "KADY",
      "NamePrefix": "MS.",
      "Credential": "LPC",
      "FirstLineMailingAddress": "13574 SW HIGHWAY 126",
      "MailingAddressCityName": "POWELL BUTTE",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97753-1541",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-480-6360",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-203-0307",
      "EnumerationDate": "07/24/2022",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional Counselor",
      "LicenseNumber1": "LPC6225",
      "LicenseNumberStateCode1": "ID",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C9084",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1215724679",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "SCHAY",
      "FirstName": "ANGELICA",
      "MiddleName": "NICOLE",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1841",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1841",
      "EnumerationDate": "04/21/2025",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101Y00000X",
      "Taxonomy1": "Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101Y00000X",
      "PrimaryTaxonomy": "Counselor"
    },
    {
      "NPI": "1013556505",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "IVENS",
      "FirstName": "KRYSTA",
      "FirstLineMailingAddress": "743 NW QUINCE AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-1250",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "360-526-1448",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "971-217-6150",
      "EnumerationDate": "12/31/2019",
      "LastUpdateDate": "02/15/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C7963",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "02/15/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1497336275",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ARANT",
      "FirstName": "ERIN",
      "MiddleName": "HENNESSEY",
      "FirstLineMailingAddress": "4639 SW 37TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-6776",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "04/14/2021",
      "LastUpdateDate": "04/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "225X00000X",
      "Taxonomy1": "Occupational Therapist",
      "LicenseNumber1": "390047",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/14/2021",
      "PrimaryTaxonomyCode": "225X00000X",
      "PrimaryTaxonomy": "Occupational Therapist"
    },
    {
      "NPI": "1174191407",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "GRIMALT",
      "FirstName": "EUGENIA",
      "MiddleName": "N",
      "Credential": "PT",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "06/14/2021",
      "LastUpdateDate": "06/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "2251P0200X",
      "Taxonomy1": "Pediatric Physical Therapist",
      "LicenseNumber1": "63979",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization.",
      "CertificationDate": "06/14/2021",
      "PrimaryTaxonomyCode": "2251P0200X",
      "PrimaryTaxonomy": "Pediatric Physical Therapist"
    },
    {
      "NPI": "1912604117",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "PAINTER",
      "FirstName": "JENNIFER",
      "FirstLineMailingAddress": "20080 DOANNA WAY UNIT 3",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-2931",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "209-743-9813",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/08/2023",
      "LastUpdateDate": "02/08/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/08/2023",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1396434700",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "GROVE",
      "FirstName": "JENNIFER",
      "MiddleName": "RHEA",
      "FirstLineMailingAddress": "303 NW BROADWAY ST",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97703-2658",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "801-573-6047",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "801-573-6047",
      "EnumerationDate": "05/02/2023",
      "LastUpdateDate": "05/02/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1041C0700X",
      "Taxonomy1": "Clinical Social Worker",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "05/02/2023",
      "PrimaryTaxonomyCode": "1041C0700X",
      "PrimaryTaxonomy": "Clinical Social Worker"
    },
    {
      "NPI": "1407698970",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "REDDEN",
      "FirstName": "SHANNON",
      "Credential": "CHW",
      "OtherLastName": "MCDOUGALL",
      "OtherFirstName": "SHANNON",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2312 NE 5TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8488",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-460-2192",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "PracticeLocationAddressFaxNumber": "541-550-7956",
      "EnumerationDate": "06/06/2024",
      "LastUpdateDate": "06/06/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "172V00000X",
      "Taxonomy1": "Community Health Worker",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "06/06/2024",
      "PrimaryTaxonomyCode": "172V00000X",
      "PrimaryTaxonomy": "Community Health Worker"
    },
    {
      "NPI": "1942022256",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "JACQUOT",
      "FirstName": "SHAYLA",
      "FirstLineMailingAddress": "PO BOX 1397",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97709-1397",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "10/28/2024",
      "LastUpdateDate": "10/28/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "10/26/2024",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
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}
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