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How to Find 72197-040-06 NDC Data Using DataLabs API

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{
  "NDC": [
    {
      "NDCCode": "72197-040-06",
      "PackageDescription": "170 g in 1 JAR (72197-040-06) ",
      "NDC11Code": "72197-0040-06",
      "ProductNDC": "72197-040",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Pharmacys Prescription Petroleum Jelly",
      "NonProprietaryName": "Petrolatum",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210122",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part347",
      "LabelerName": "American Consumer Products Corp",
      "SubstanceName": "PETROLATUM",
      "StrengthNumber": "99.9",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20210122",
      "SamplePackage": "N",
      "IndicationAndUsage": "USES: Temporarily protects minor: cuts, scrapes, burns  Temporarily protects and helps relieve chapped or cracked skin and lips  Helps protect from the drying effects of wind and cold weather."
    },
    {
      "NDCCode": "72197-041-06",
      "PackageDescription": "170 g in 1 JAR (72197-041-06) ",
      "NDC11Code": "72197-0041-06",
      "ProductNDC": "72197-041",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Pharmacys Prescription Petroleum Jelly",
      "NonProprietaryName": "Petrolatum",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210122",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part347",
      "LabelerName": "American Consumer Products Corp",
      "SubstanceName": "PETROLATUM",
      "StrengthNumber": "99.9",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20210122",
      "SamplePackage": "N",
      "IndicationAndUsage": "USE: Helps treat and prevent diaper rash and seal out wetness."
    },
    {
      "NDCCode": "72197-044-06",
      "PackageDescription": "170 g in 1 JAR (72197-044-06) ",
      "NDC11Code": "72197-0044-06",
      "ProductNDC": "72197-044",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Pharmacys Prescription Petroleum Jelly",
      "NonProprietaryName": "Petrolatum",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210615",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "American Consumer Products Corp",
      "SubstanceName": "PETROLATUM",
      "StrengthNumber": "99.9",
      "StrengthUnit": "g/100g",
      "Status": "Active",
      "LastUpdate": "2025-01-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210615",
      "SamplePackage": "N",
      "IndicationAndUsage": "USE: Helps treat and prevent diaper rash and seal out wetness."
    },
    {
      "NDCCode": "72197-045-06",
      "PackageDescription": "170 g in 1 JAR (72197-045-06) ",
      "NDC11Code": "72197-0045-06",
      "ProductNDC": "72197-045",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Pharmacys Prescription Petroleum Jelly",
      "NonProprietaryName": "Petrolatum",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210616",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "American Consumer Products Corp",
      "SubstanceName": "PETROLATUM",
      "StrengthNumber": "99.9",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2026-08-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210616",
      "SamplePackage": "N",
      "IndicationAndUsage": "USES: Temporarily protects minor: cuts, scrapes, burns  Temporarily protects and helps relieve chapped or cracked skin and lips  Helps protect from the drying effects of wind and cold weather."
    },
    {
      "NDCCode": "33358-040-06",
      "PackageDescription": "6 TABLET, FILM COATED in 1 BOTTLE (33358-040-06)",
      "NDC11Code": "33358-0040-06",
      "ProductNDC": "33358-040",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Azithromycin",
      "NonProprietaryName": "Azithromycin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20141113",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065404",
      "LabelerName": "RxChange Co.",
      "SubstanceName": "AZITHROMYCIN ANHYDROUS",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Macrolide Antimicrobial [EPC],Macrolides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "Description": "Azithromycin tablets contain the active ingredient azithromycin, an azalide, a subclass of macrolide antibiotics, for oral administration. Azithromycin has the chemical name (2R, 3S, 4R, 5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-ß-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one.Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12 , and its molecular weight is 749. Azithromycin has the following structural formula. Anhydrous azithromycin is a white amorphous powder with a molecular formula of C38H72N2O12 and a molecular weight of 749.Azithromycin tablet is supplied for oral administration as white, film-coated, oval shaped biconvex tablets containing anhydrous azithromycin 250 mg or 500 mg and the following inactive ingredients: microcrystalline cellulose, corn starch, croscarmellose sodium, magnesium trisilicate, magnesium stearate, colloidal silicon dioxide, hydroxypropyl cellulose, sodium lauryl sulfate, hypromellose, titanium dioxide and polyethylene glycol."
    },
    {
      "NDCCode": "34666-040-06",
      "PackageDescription": "60 TABLET in 1 BLISTER PACK (34666-040-06) ",
      "NDC11Code": "34666-0040-06",
      "ProductNDC": "34666-040",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "K-loss",
      "NonProprietaryName": "Fucus Vesiculosus, Graphites, Phytolacca Decandra",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110725",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "NARTEX LABORATORIOS HOMEOPATICOS SA DE CV",
      "SubstanceName": "FUCUS VESICULOSUS; GRAPHITE; PHYTOLACCA AMERICANA ROOT",
      "StrengthNumber": "4; 4; 4",
      "StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1",
      "Status": "Deprecated",
      "LastUpdate": "2019-12-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20110725",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "50066-040-06",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (50066-040-06)  / 177 mL in 1 BOTTLE, PLASTIC",
      "NDC11Code": "50066-0040-06",
      "ProductNDC": "50066-040",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Medicasp Anti-dandruff",
      "NonProprietaryName": "Coal Tar",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20251125",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M032",
      "LabelerName": "Genomma Lab USA",
      "SubstanceName": "COAL TAR",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2025-12-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20251125",
      "SamplePackage": "N",
      "IndicationAndUsage": "controls the symptoms of: 1 dandruff, 2 seborrheic dermatitis, 3 psoriasis."
    },
    {
      "NDCCode": "52244-040-06",
      "PackageDescription": "6 BLISTER PACK in 1 CARTON (52244-040-06)  / 1 CARTRIDGE in 1 BLISTER PACK / 1 mL in 1 CARTRIDGE",
      "NDC11Code": "52244-0040-06",
      "ProductNDC": "52244-040",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Edex",
      "NonProprietaryName": "Alprostadil",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRACAVERNOUS",
      "StartMarketingDate": "20120315",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020649",
      "LabelerName": "Endo USA, Inc.",
      "SubstanceName": "ALPROSTADIL",
      "StrengthNumber": "40",
      "StrengthUnit": "ug/mL",
      "Pharm_Classes": "Genitourinary Arterial Vasodilation [PE], Prostaglandin Analog [EPC], Prostaglandin E1 Agonist [EPC], Prostaglandin Receptor Agonists [MoA], Prostaglandins [CS], Venous Vasodilation [PE]",
      "Status": "Active",
      "LastUpdate": "2026-07-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20120315",
      "SamplePackage": "N",
      "IndicationAndUsage": "edex® is indicated for the treatment of erectile dysfunction due to neurogenic, vasculogenic, psychogenic, or mixed etiology.",
      "Description": "edex® (alprostadil for injection) is a sterile, pyrogen-free powder containing alprostadil in an alfadex (α-cyclodextrin) inclusion complex. Alprostadil is an endogenous substance known as prostaglandin E1 (PGE1). edex® is supplied in single-dose, dual-chamber cartridges. edex® is lyophilized in single-dose, dual-chamber cartridges intended for use with the reusable edex® injection device. One chamber of the cartridge contains alprostadil, alfadex and lactose as a sterile, pyrogen-free powder. The other chamber contains 1.075 mL of sterile 0.9% sodium chloride. The edex® cartridges are supplied in three strengths: 10-mcg cartridge (10.75 mcg alprostadil, 347.55 mcg α-cyclodextrin, 51.06 mg lactose); 20-mcg cartridge (21.5 mcg alprostadil, 695.2 mcg α-cyclodextrin, 51.06 mg lactose); 40-mcg cartridge (43 mcg alprostadil, 1,390.3 mcg α-cyclodextrin, 51.06 mg lactose). The edex® injection device is used to reconstitute the sterile powder in one chamber with the sterile 0.9% sodium chloride in the other chamber. After reconstitution, the edex® injection device is used to administer the intracavernous injection of alprostadil. The chemical name for alprostadil is (1R,2R,3R)-3-Hydroxy-2-[(E)-(3S)-3-hydroxy-1-octenyl]-5-oxocyclopentane heptanoic acid. The empirical formula is C20H34O5 and the molecular weight is 354.49. The chemical structure is:. The α-cyclodextrin inclusion complex improves the water solubility of alprostadil. The empirical formula of α-cyclodextrin is C36H60O30 and the molecular weight is 972.85. The chemical structure is. Alprostadil alfadex is a white, odorless, hygroscopic powder. It is freely soluble in water and practically insoluble in ethanol, ethyl acetate and ether. After reconstitution, the active ingredient, alprostadil, immediately dissociates from the α-cyclodextrin inclusion complex. The reconstituted solution is clear and colorless and has a pH between 4.0 and 8.0. When the single-dose, dual-chamber cartridge containing either 10.75, 21.5, or 43 mcg of alprostadil is placed into the edex® injection device and reconstituted, the deliverable amount of alprostadil in each milliliter is 10, 20 or 40 mcg, respectively."
    },
    {
      "NDCCode": "52376-040-06",
      "PackageDescription": ".6 mL in 1 BOTTLE (52376-040-06)",
      "NDC11Code": "52376-0040-06",
      "ProductNDC": "52376-040",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Equitance Sunscreen Broad Spectrum Spf 36",
      "NonProprietaryName": "Octinoxate Zinc Oxide",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160412",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Sunstar Americas, Inc",
      "SubstanceName": "OCTINOXATE; ZINC OXIDE",
      "StrengthNumber": "6.5; 16.88",
      "StrengthUnit": "g/100mL; g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "61734-040-06",
      "PackageDescription": "10 g in 1 TUBE (61734-040-06)",
      "NDC11Code": "61734-0040-06",
      "ProductNDC": "61734-040",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Petroleum",
      "NonProprietaryName": "Petrolatum",
      "DosageFormName": "JELLY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20100507",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part347",
      "LabelerName": "Delon Laboratories (1990) Ltd",
      "SubstanceName": "PETROLATUM",
      "StrengthNumber": "100",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "68225-040-06",
      "PackageDescription": "660 VIAL in 1 CONTAINER (68225-040-06)  / 5 mL in 1 VIAL",
      "NDC11Code": "68225-0040-06",
      "ProductNDC": "68225-040",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Thrombin, Topical (recombinant)",
      "DosageFormName": "POWDER, FOR SOLUTION",
      "StartMarketingDate": "20080609",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Patheon Italia S.p.A",
      "SubstanceName": "THROMBIN ALFA",
      "StrengthNumber": "1000",
      "StrengthUnit": "[iU]/mL",
      "Status": "Unfinished",
      "LastUpdate": "2025-08-23",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "23-JUL-25"
    },
    {
      "NDCCode": "71027-040-06",
      "PackageDescription": "1 BOTTLE in 1 CARTON (71027-040-06)  > 177 mL in 1 BOTTLE",
      "NDC11Code": "71027-0040-06",
      "ProductNDC": "71027-040",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Daytime Cough",
      "NonProprietaryName": "Daytime Cough",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170301",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "KINGSTON PHARMA LLC",
      "SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "325; 10; 5",
      "StrengthUnit": "mg/15mL; mg/15mL; mg/15mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-08-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20170301",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses: 1 Temporarily relieves these common cold/flu symptoms Minor aches and painsHeadacheSore throatNasal congestionFeverCough due to minor throat and bronchial irritation."
    },
    {
      "NDCCode": "71884-040-06",
      "PackageDescription": "18927 mL in 1 PAIL (71884-040-06) ",
      "NDC11Code": "71884-0040-06",
      "ProductNDC": "71884-040",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "My-shield Sanitizing",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "SOAP",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20180501",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "Enviro Specialty Chemicals Inc",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2026-07-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20180501",
      "SamplePackage": "N",
      "IndicationAndUsage": " Hand wash to help reduce bacteria that potentially can cause disease Helps to prevent cross-contamination by hand contact Helps to prevent drying of skin  Recommended for repeat use."
    },
    {
      "NDCCode": "72606-040-06",
      "PackageDescription": "3 KIT in 1 CARTON (72606-040-06)  / 1 KIT in 1 KIT *  1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE *  1 mL in 1 PACKET",
      "NDC11Code": "72606-0040-06",
      "ProductNDC": "72606-040",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Adalimumab",
      "NonProprietaryName": "Adalimumab-aaty",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20231130",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA761219",
      "LabelerName": "CELLTRION USA, Inc.",
      "Status": "Active",
      "LastUpdate": "2026-07-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20231130",
      "SamplePackage": "N",
      "IndicationAndUsage": "Adalimumab-aaty is a tumor necrosis factor (TNF) blocker indicated for: 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. (1.9).",
      "Description": "Adalimumab-aaty is a tumor necrosis factor blocker. Adalimumab-aaty is a recombinant human IgG1 monoclonal antibody created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-aaty is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. Adalimumab-aaty injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, auto-injector (Adalimumab-aaty AI), as a single-dose, 1 mL prefilled syringe with safety guard, or a single-dose, 1 mL prefilled syringe. Enclosed within the auto-injector is a single-dose, 1 mL prefilled syringe. The solution of Adalimumab-aaty is clear to opalescent, and colorless to pale brown, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled syringe with safety guard or auto-injector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of Adalimumab-aaty contains adalimumab-aaty (80 mg), acetic acid (0.13 mg), glycine (15.02 mg), polysorbate 80 (0.8 mg), sodium acetate (0.48 mg) and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or prefilled syringe with safety guard or auto-injector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of Adalimumab-aaty contains adalimumab-aaty (40 mg), acetic acid (0.06 mg), glycine (7.51 mg), polysorbate 80 (0.4 mg), sodium acetate (0.24 mg) and Water for Injection, USP. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of Adalimumab-aaty contains adalimumab-aaty (20 mg), acetic acid (0.03 mg), glycine (3.75 mg), polysorbate 80 (0.2 mg), sodium acetate (0.12 mg) and Water for Injection, USP."
    },
    {
      "NDCCode": "72761-040-06",
      "PackageDescription": "50 kg in 1 DRUM (72761-040-06) ",
      "NDC11Code": "72761-0040-06",
      "ProductNDC": "72761-040",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Indomethacin",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20251201",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Aurore Pharmaceuticals Private Limited",
      "SubstanceName": "INDOMETHACIN",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2025-12-25",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "01-DEC-25"
    },
    {
      "NDCCode": "77231-040-06",
      "PackageDescription": "190 mL in 1 BOTTLE (77231-040-06) ",
      "NDC11Code": "77231-0040-06",
      "ProductNDC": "77231-040",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hand Sanitizer",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200521",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "GIA EVOLUTION SA DE CV",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "72",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2021-07-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200521",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
    },
    {
      "NDCCode": "78174-040-06",
      "PackageDescription": ".118294 L in 1 BOTTLE (78174-040-06) ",
      "NDC11Code": "78174-0040-06",
      "ProductNDC": "78174-040",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Klean Genix Hand Sanitizer Fluid",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210109",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Custom Chemical Services, LLC",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "70.0984",
      "StrengthUnit": "L/100L",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20210109",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses Hand sanitizer to help reduce bacteria on the skin. Recommended for repeated use."
    },
    {
      "NDCCode": "83511-040-06",
      "PackageDescription": "5 kg in 1 DRUM (83511-040-06) ",
      "NDC11Code": "83511-0040-06",
      "ProductNDC": "83511-040",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Benzgalantamine Gluconate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20260522",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "STHREE CHEMICALS PRIVATE LIMITED",
      "SubstanceName": "GALANTAMINE",
      "StrengthNumber": "35",
      "StrengthUnit": "kg/35kg",
      "Status": "Unfinished",
      "LastUpdate": "2026-06-02",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "22-MAY-26"
    },
    {
      "NDCCode": "85207-040-06",
      "PackageDescription": "20000 g in 1 BAG (85207-040-06) ",
      "NDC11Code": "85207-0040-06",
      "ProductNDC": "85207-040",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Hydroxy Progesterone Caproate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20260227",
      "MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
      "LabelerName": "SCH Global Services Private Limited",
      "SubstanceName": "HYDROXYPROGESTERONE CAPROATE",
      "StrengthNumber": "100",
      "StrengthUnit": "g/100g",
      "Status": "Unfinished",
      "LastUpdate": "2026-03-07",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "27-FEB-26"
    },
    {
      "NDCCode": "15478-040-01",
      "PackageDescription": "4.25 g in 1 PACKAGE (15478-040-01) ",
      "NDC11Code": "15478-0040-01",
      "ProductNDC": "15478-040",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Fixmyskin Healing Balm Vanilla Flavor",
      "NonProprietaryName": "Hydrocortisone",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20111117",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part348",
      "LabelerName": "Topical Pharmaceuticals Inc.",
      "SubstanceName": "HYDROCORTISONE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2021-05-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20111117",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "42291-040-90",
      "PackageDescription": "90 CAPSULE in 1 BOTTLE (42291-040-90) ",
      "NDC11Code": "42291-0040-90",
      "ProductNDC": "42291-040",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lisdexamfetamine Dimesylate",
      "NonProprietaryName": "Lisdexamfetamine",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250604",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202830",
      "LabelerName": "AvKARE",
      "SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
      "StrengthNumber": "60",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2025-06-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250604",
      "SamplePackage": "N",
      "IndicationAndUsage": "Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)] . .",
      "Description": "Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: crospovidone, isopropyl alcohol, lactose monohydrate, microcrystalline cellulose and sodium stearyl fumarate. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and one or more of the following: D&C Yellow #10, FD&C Blue #1, FD&C Red #40 and iron oxide yellow. The imprint on the capsule shells contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution."
    },
    {
      "NDCCode": "43116-040-01",
      "PackageDescription": "1 U in 1 POUCH (43116-040-01) ",
      "NDC11Code": "43116-0040-01",
      "ProductNDC": "43116-040",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Eyelid Wipes",
      "NonProprietaryName": "Eyelid Wipes",
      "DosageFormName": "CLOTH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250606",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M005",
      "LabelerName": "Shenzhen Shierjie Biological Engineering Co., LTD",
      "SubstanceName": "4-TERPINEOL; MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL",
      "StrengthNumber": ".003; .04",
      "StrengthUnit": "U/100U; U/100U",
      "Status": "Active",
      "LastUpdate": "2025-06-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250606",
      "SamplePackage": "N",
      "IndicationAndUsage": "Eyelid Wipes for Dry Eyes and Blepharitis Relief, Stay Hygienic."
    },
    {
      "NDCCode": "43116-040-02",
      "PackageDescription": "30 U in 1 BOX (43116-040-02) ",
      "NDC11Code": "43116-0040-02",
      "ProductNDC": "43116-040",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Eyelid Wipes",
      "NonProprietaryName": "Eyelid Wipes",
      "DosageFormName": "CLOTH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250606",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M005",
      "LabelerName": "Shenzhen Shierjie Biological Engineering Co., LTD",
      "SubstanceName": "4-TERPINEOL; MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL",
      "StrengthNumber": ".003; .04",
      "StrengthUnit": "U/100U; U/100U",
      "Status": "Active",
      "LastUpdate": "2025-06-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250606",
      "SamplePackage": "N",
      "IndicationAndUsage": "Eyelid Wipes for Dry Eyes and Blepharitis Relief, Stay Hygienic."
    },
    {
      "NDCCode": "43116-040-03",
      "PackageDescription": "60 U in 1 BOX (43116-040-03) ",
      "NDC11Code": "43116-0040-03",
      "ProductNDC": "43116-040",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Eyelid Wipes",
      "NonProprietaryName": "Eyelid Wipes",
      "DosageFormName": "CLOTH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250606",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M005",
      "LabelerName": "Shenzhen Shierjie Biological Engineering Co., LTD",
      "SubstanceName": "4-TERPINEOL; MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL",
      "StrengthNumber": ".003; .04",
      "StrengthUnit": "U/100U; U/100U",
      "Status": "Active",
      "LastUpdate": "2025-06-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250606",
      "SamplePackage": "N",
      "IndicationAndUsage": "Eyelid Wipes for Dry Eyes and Blepharitis Relief, Stay Hygienic."
    },
    {
      "NDCCode": "43473-040-01",
      "PackageDescription": ".9 g in 1 PACKET (43473-040-01) ",
      "NDC11Code": "43473-0040-01",
      "ProductNDC": "43473-040",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Firstar Burn",
      "NonProprietaryName": "Lidocaine Hydrochloride",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240702",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "Nantong Health & Beyond Hygienic Products Inc.",
      "SubstanceName": "LIDOCAINE HYDROCHLORIDE; BENZALKONIUM CHLORIDE",
      "StrengthNumber": ".5; .13",
      "StrengthUnit": "g/100g; g/100g",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2026-05-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240702",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses. Temporary relief of pain associated with minor cuts, scrapes, and burns. Helps protect against harmful bacteria."
    },
    {
      "NDCCode": "50555-040-02",
      "PackageDescription": "1 TUBE in 1 CARTON (50555-040-02)  > 90 g in 1 TUBE (50555-040-01)",
      "NDC11Code": "50555-0040-02",
      "ProductNDC": "50555-040",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Pororo Toothpas Te Mixed Fruits",
      "NonProprietaryName": "Sodium Monofluorophosphate",
      "DosageFormName": "PASTE, DENTIFRICE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160801",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part355",
      "LabelerName": "KMPHARMACEUTICAL CO.,LTD",
      "SubstanceName": "SODIUM MONOFLUOROPHOSPHATE",
      "StrengthNumber": ".31",
      "StrengthUnit": "g/90g",
      "Status": "Deprecated",
      "LastUpdate": "2021-06-03",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231"
    },
    {
      "NDCCode": "51285-040-01",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (51285-040-01) ",
      "NDC11Code": "51285-0040-01",
      "ProductNDC": "51285-040",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ziac",
      "NonProprietaryName": "Bisoprolol Fumarate And Hydrochlorothiazide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "19931026",
      "EndMarketingDate": "20250630",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020186",
      "LabelerName": "Teva Women's Health LLC",
      "SubstanceName": "BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "10; 6.25",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-06-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "19931026",
      "EndMarketingDatePackage": "20250630",
      "SamplePackage": "N",
      "IndicationAndUsage": "ZIAC (bisoprolol fumarate and hydrochlorothiazide) is indicated in the management of hypertension.",
      "Description": "ZIAC® (bisoprolol fumarate and hydrochlorothiazide) is indicated for the treatment of hypertension. It combines two antihypertensive agents in a once-daily dosage: a synthetic beta1-selective (cardioselective) adrenoceptor blocking agent (bisoprolol fumarate) and a benzothiadiazine diuretic (hydrochlorothiazide). Bisoprolol fumarate is chemically described as (±)-1-[4-[[2-(1-methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol(E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is (C18H31NO4)2C4H4O4 and it has a molecular weight of 766.97. Its structural formula is. Bisoprolol fumarate is a white crystalline powder, approximately equally hydrophilic and lipophilic, and readily soluble in water, methanol, ethanol, and chloroform. Hydrochlorothiazide (HCTZ) is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. It is a white, or practically white, practically odorless crystalline powder. It is slightly soluble in water, sparingly soluble in dilute sodium hydroxide solution, freely soluble in n-butylamine and dimethylformamide, sparingly soluble in methanol, and insoluble in ether, chloroform, and dilute mineral acids. Its empirical formula is C7H8ClN3O4S2 and it has a molecular weight of 297.73. Its structural formula is. Each ZIAC®-2.5 mg/6.25 mg tablet for oral administration contains. Bisoprolol fumarate…………………………………………..2.5 mg. Hydrochlorothiazide………………………………………..6.25 mg. Each ZIAC®-5 mg/6.25 mg tablet for oral administration contains. Bisoprolol fumarate……………………………………………5 mg. Hydrochlorothiazide………………………………………..6.25 mg. Each ZIAC®-10 mg/6.25 mg tablet for oral administration contains. Bisoprolol fumarate…………………………………………...10 mg. Hydrochlorothiazide………………………………………..6.25 mg. Inactive ingredients include Corn Starch, Dibasic Calcium Phosphate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, and Titanium Dioxide. The 10 mg/6.25mg tablet also contains Colloidal Silicon Dioxide. The 5 mg/6.25 mg tablet also contains Colloidal Silicon Dioxide, and Red and Yellow Iron Oxide. The 2.5 mg/6.25 mg tablet also contains Crospovidone, Pregelatinized Starch, and Yellow Iron Oxide."
    },
    {
      "NDCCode": "51862-510-06",
      "PackageDescription": "6 BLISTER PACK in 1 CARTON (51862-510-06)  > 1 KIT in 1 BLISTER PACK (51862-510-01) ",
      "NDC11Code": "51862-0510-06",
      "ProductNDC": "51862-510",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Trivora",
      "NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20160803",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074538",
      "LabelerName": "Mayne Pharma Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2025-07-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20160803",
      "SamplePackage": "N",
      "IndicationAndUsage": "Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and the IUD, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.",
      "Description": "Each Trivora cycle of 28 tablets consists of three different drug phases as follows: Phase 1 comprised of 6 blue tablets, each containing 0.050 mg of levonorgestrel (d(-)13 beta-ethyl-17-alpha-ethinyl-17- beta-hydroxygon-4-en-3-one), a totally synthetic progestogen, and 0.030 mg of ethinyl estradiol (19- nor-17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol); phase 2 comprised of 5 white tablets, each containing 0.075 mg levonorgestrel and 0.040 mg ethinyl estradiol; and phase 3 comprised of 10 pink tablets, each containing 0.125 mg levonorgestrel and 0.030 mg ethinyl estradiol; then followed by 7 peach inert tablets. The inactive ingredients present in the blue, white and pink tablets are lactose monohydrate, magnesium stearate, povidone and starch (corn). Each blue tablet also contains FD&C Blue #1. Each pink tablet also contains FD&C Red #40. Each inactive peach tablet contains the following inactive ingredients: anhydrous lactose, FD&C Yellow #6, lactose monohydrate, magnesium stearate and microcrystalline cellulose."
    },
    {
      "NDCCode": "52244-040-02",
      "PackageDescription": "2 BLISTER PACK in 1 CARTON (52244-040-02)  / 1 CARTRIDGE in 1 BLISTER PACK / 1 mL in 1 CARTRIDGE",
      "NDC11Code": "52244-0040-02",
      "ProductNDC": "52244-040",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Edex",
      "NonProprietaryName": "Alprostadil",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRACAVERNOUS",
      "StartMarketingDate": "20120315",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020649",
      "LabelerName": "Endo USA, Inc.",
      "SubstanceName": "ALPROSTADIL",
      "StrengthNumber": "40",
      "StrengthUnit": "ug/mL",
      "Pharm_Classes": "Genitourinary Arterial Vasodilation [PE], Prostaglandin Analog [EPC], Prostaglandin E1 Agonist [EPC], Prostaglandin Receptor Agonists [MoA], Prostaglandins [CS], Venous Vasodilation [PE]",
      "Status": "Active",
      "LastUpdate": "2026-07-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20120315",
      "SamplePackage": "N",
      "IndicationAndUsage": "edex® is indicated for the treatment of erectile dysfunction due to neurogenic, vasculogenic, psychogenic, or mixed etiology.",
      "Description": "edex® (alprostadil for injection) is a sterile, pyrogen-free powder containing alprostadil in an alfadex (α-cyclodextrin) inclusion complex. Alprostadil is an endogenous substance known as prostaglandin E1 (PGE1). edex® is supplied in single-dose, dual-chamber cartridges. edex® is lyophilized in single-dose, dual-chamber cartridges intended for use with the reusable edex® injection device. One chamber of the cartridge contains alprostadil, alfadex and lactose as a sterile, pyrogen-free powder. The other chamber contains 1.075 mL of sterile 0.9% sodium chloride. The edex® cartridges are supplied in three strengths: 10-mcg cartridge (10.75 mcg alprostadil, 347.55 mcg α-cyclodextrin, 51.06 mg lactose); 20-mcg cartridge (21.5 mcg alprostadil, 695.2 mcg α-cyclodextrin, 51.06 mg lactose); 40-mcg cartridge (43 mcg alprostadil, 1,390.3 mcg α-cyclodextrin, 51.06 mg lactose). The edex® injection device is used to reconstitute the sterile powder in one chamber with the sterile 0.9% sodium chloride in the other chamber. After reconstitution, the edex® injection device is used to administer the intracavernous injection of alprostadil. The chemical name for alprostadil is (1R,2R,3R)-3-Hydroxy-2-[(E)-(3S)-3-hydroxy-1-octenyl]-5-oxocyclopentane heptanoic acid. The empirical formula is C20H34O5 and the molecular weight is 354.49. The chemical structure is:. The α-cyclodextrin inclusion complex improves the water solubility of alprostadil. The empirical formula of α-cyclodextrin is C36H60O30 and the molecular weight is 972.85. The chemical structure is. Alprostadil alfadex is a white, odorless, hygroscopic powder. It is freely soluble in water and practically insoluble in ethanol, ethyl acetate and ether. After reconstitution, the active ingredient, alprostadil, immediately dissociates from the α-cyclodextrin inclusion complex. The reconstituted solution is clear and colorless and has a pH between 4.0 and 8.0. When the single-dose, dual-chamber cartridge containing either 10.75, 21.5, or 43 mcg of alprostadil is placed into the edex® injection device and reconstituted, the deliverable amount of alprostadil in each milliliter is 10, 20 or 40 mcg, respectively."
    },
    {
      "NDCCode": "53002-1566-6",
      "PackageDescription": "6 BLISTER PACK in 1 PACKAGE (53002-1566-6)  / 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "53002-1566-06",
      "ProductNDC": "53002-1566",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Trivora",
      "NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20160803",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074538",
      "LabelerName": "RPK Pharmaceuticals, Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20170901",
      "SamplePackage": "N",
      "IndicationAndUsage": "Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and the IUD, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.",
      "Description": "Each Trivora cycle of 28 tablets consists of three different drug phases as follows: Phase 1 comprised of 6 blue tablets, each containing 0.050 mg of levonorgestrel (d(-)13 beta-ethyl-17-alpha-ethinyl-17- beta-hydroxygon-4-en-3-one), a totally synthetic progestogen, and 0.030 mg of ethinyl estradiol (19- nor-17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol); phase 2 comprised of 5 white tablets, each containing 0.075 mg levonorgestrel and 0.040 mg ethinyl estradiol; and phase 3 comprised of 10 pink tablets, each containing 0.125 mg levonorgestrel and 0.030 mg ethinyl estradiol; then followed by 7 peach inert tablets. The inactive ingredients present in the blue, white and pink tablets are lactose monohydrate, magnesium stearate, povidone and starch (corn). Each blue tablet also contains FD&C Blue #1. Each pink tablet also contains FD&C Red #40. Each inactive peach tablet contains the following inactive ingredients: anhydrous lactose, FD&C Yellow #6, lactose monohydrate, magnesium stearate and microcrystalline cellulose."
    }
  ]
}
                    
{"NDC":[{"NDCCode":"72197-040-06","ProprietaryName":"Pharmacys Prescription Petroleum Jelly","NonProprietaryName":"Petrolatum"},{"NDCCode":"72197-041-06","ProprietaryName":"Pharmacys Prescription Petroleum Jelly","NonProprietaryName":"Petrolatum"},{"NDCCode":"72197-044-06","ProprietaryName":"Pharmacys Prescription Petroleum Jelly","NonProprietaryName":"Petrolatum"},{"NDCCode":"72197-045-06","ProprietaryName":"Pharmacys Prescription Petroleum Jelly","NonProprietaryName":"Petrolatum"},{"NDCCode":"33358-040-06","ProprietaryName":"Azithromycin","NonProprietaryName":"Azithromycin"},{"NDCCode":"34666-040-06","ProprietaryName":"K-loss","NonProprietaryName":"Fucus Vesiculosus, Graphites, Phytolacca Decandra"},{"NDCCode":"50066-040-06","ProprietaryName":"Medicasp Anti-dandruff","NonProprietaryName":"Coal Tar"},{"NDCCode":"52244-040-06","ProprietaryName":"Edex","NonProprietaryName":"Alprostadil"},{"NDCCode":"52376-040-06","ProprietaryName":"Equitance Sunscreen Broad Spectrum Spf 36","NonProprietaryName":"Octinoxate Zinc Oxide"},{"NDCCode":"61734-040-06","ProprietaryName":"Petroleum","NonProprietaryName":"Petrolatum"},{"NDCCode":"68225-040-06","NonProprietaryName":"Thrombin, Topical (recombinant)"},{"NDCCode":"71027-040-06","ProprietaryName":"Daytime Cough","NonProprietaryName":"Daytime Cough"},{"NDCCode":"71884-040-06","ProprietaryName":"My-shield Sanitizing","NonProprietaryName":"Benzalkonium Chloride"},{"NDCCode":"72606-040-06","ProprietaryName":"Adalimumab","NonProprietaryName":"Adalimumab-aaty"},{"NDCCode":"72761-040-06","NonProprietaryName":"Indomethacin"},{"NDCCode":"77231-040-06","ProprietaryName":"Hand Sanitizer","NonProprietaryName":"Alcohol"},{"NDCCode":"78174-040-06","ProprietaryName":"Klean Genix Hand Sanitizer Fluid","NonProprietaryName":"Alcohol"},{"NDCCode":"83511-040-06","NonProprietaryName":"Benzgalantamine Gluconate"},{"NDCCode":"85207-040-06","NonProprietaryName":"Hydroxy Progesterone Caproate"},{"NDCCode":"15478-040-01","ProprietaryName":"Fixmyskin Healing Balm Vanilla Flavor","NonProprietaryName":"Hydrocortisone"},{"NDCCode":"42291-040-90","ProprietaryName":"Lisdexamfetamine Dimesylate","NonProprietaryName":"Lisdexamfetamine"},{"NDCCode":"43116-040-01","ProprietaryName":"Eyelid Wipes","NonProprietaryName":"Eyelid Wipes"},{"NDCCode":"43116-040-02","ProprietaryName":"Eyelid Wipes","NonProprietaryName":"Eyelid Wipes"},{"NDCCode":"43116-040-03","ProprietaryName":"Eyelid Wipes","NonProprietaryName":"Eyelid Wipes"},{"NDCCode":"43473-040-01","ProprietaryName":"Firstar Burn","NonProprietaryName":"Lidocaine Hydrochloride"},{"NDCCode":"50555-040-02","ProprietaryName":"Pororo Toothpas Te Mixed Fruits","NonProprietaryName":"Sodium Monofluorophosphate"},{"NDCCode":"51285-040-01","ProprietaryName":"Ziac","NonProprietaryName":"Bisoprolol Fumarate And Hydrochlorothiazide"},{"NDCCode":"51862-510-06","ProprietaryName":"Trivora","NonProprietaryName":"Levonorgestrel And Ethinyl Estradiol"},{"NDCCode":"52244-040-02","ProprietaryName":"Edex","NonProprietaryName":"Alprostadil"},{"NDCCode":"53002-1566-6","ProprietaryName":"Trivora","NonProprietaryName":"Levonorgestrel And Ethinyl Estradiol"}]}
                    
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>72197-040-06</NDCCode>
    <PackageDescription>170 g in 1 JAR (72197-040-06) </PackageDescription>
    <NDC11Code>72197-0040-06</NDC11Code>
    <ProductNDC>72197-040</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Pharmacys Prescription Petroleum Jelly</ProprietaryName>
    <NonProprietaryName>Petrolatum</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210122</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part347</ApplicationNumber>
    <LabelerName>American Consumer Products Corp</LabelerName>
    <SubstanceName>PETROLATUM</SubstanceName>
    <StrengthNumber>99.9</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210122</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>USES: Temporarily protects minor: cuts, scrapes, burns  Temporarily protects and helps relieve chapped or cracked skin and lips  Helps protect from the drying effects of wind and cold weather.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>72197-041-06</NDCCode>
    <PackageDescription>170 g in 1 JAR (72197-041-06) </PackageDescription>
    <NDC11Code>72197-0041-06</NDC11Code>
    <ProductNDC>72197-041</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Pharmacys Prescription Petroleum Jelly</ProprietaryName>
    <NonProprietaryName>Petrolatum</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210122</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part347</ApplicationNumber>
    <LabelerName>American Consumer Products Corp</LabelerName>
    <SubstanceName>PETROLATUM</SubstanceName>
    <StrengthNumber>99.9</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210122</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>USE: Helps treat and prevent diaper rash and seal out wetness.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>72197-044-06</NDCCode>
    <PackageDescription>170 g in 1 JAR (72197-044-06) </PackageDescription>
    <NDC11Code>72197-0044-06</NDC11Code>
    <ProductNDC>72197-044</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Pharmacys Prescription Petroleum Jelly</ProprietaryName>
    <NonProprietaryName>Petrolatum</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210615</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>American Consumer Products Corp</LabelerName>
    <SubstanceName>PETROLATUM</SubstanceName>
    <StrengthNumber>99.9</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-01-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210615</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>USE: Helps treat and prevent diaper rash and seal out wetness.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>72197-045-06</NDCCode>
    <PackageDescription>170 g in 1 JAR (72197-045-06) </PackageDescription>
    <NDC11Code>72197-0045-06</NDC11Code>
    <ProductNDC>72197-045</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Pharmacys Prescription Petroleum Jelly</ProprietaryName>
    <NonProprietaryName>Petrolatum</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210616</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>American Consumer Products Corp</LabelerName>
    <SubstanceName>PETROLATUM</SubstanceName>
    <StrengthNumber>99.9</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-08-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210616</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>USES: Temporarily protects minor: cuts, scrapes, burns  Temporarily protects and helps relieve chapped or cracked skin and lips  Helps protect from the drying effects of wind and cold weather.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>33358-040-06</NDCCode>
    <PackageDescription>6 TABLET, FILM COATED in 1 BOTTLE (33358-040-06)</PackageDescription>
    <NDC11Code>33358-0040-06</NDC11Code>
    <ProductNDC>33358-040</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Azithromycin</ProprietaryName>
    <NonProprietaryName>Azithromycin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20141113</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065404</ApplicationNumber>
    <LabelerName>RxChange Co.</LabelerName>
    <SubstanceName>AZITHROMYCIN ANHYDROUS</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Macrolide Antimicrobial [EPC],Macrolides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <Description>Azithromycin tablets contain the active ingredient azithromycin, an azalide, a subclass of macrolide antibiotics, for oral administration. Azithromycin has the chemical name (2R, 3S, 4R, 5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-ß-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one.Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12 , and its molecular weight is 749. Azithromycin has the following structural formula. Anhydrous azithromycin is a white amorphous powder with a molecular formula of C38H72N2O12 and a molecular weight of 749.Azithromycin tablet is supplied for oral administration as white, film-coated, oval shaped biconvex tablets containing anhydrous azithromycin 250 mg or 500 mg and the following inactive ingredients: microcrystalline cellulose, corn starch, croscarmellose sodium, magnesium trisilicate, magnesium stearate, colloidal silicon dioxide, hydroxypropyl cellulose, sodium lauryl sulfate, hypromellose, titanium dioxide and polyethylene glycol.</Description>
  </NDC>
  <NDC>
    <NDCCode>34666-040-06</NDCCode>
    <PackageDescription>60 TABLET in 1 BLISTER PACK (34666-040-06) </PackageDescription>
    <NDC11Code>34666-0040-06</NDC11Code>
    <ProductNDC>34666-040</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>K-loss</ProprietaryName>
    <NonProprietaryName>Fucus Vesiculosus, Graphites, Phytolacca Decandra</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110725</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>NARTEX LABORATORIOS HOMEOPATICOS SA DE CV</LabelerName>
    <SubstanceName>FUCUS VESICULOSUS; GRAPHITE; PHYTOLACCA AMERICANA ROOT</SubstanceName>
    <StrengthNumber>4; 4; 4</StrengthNumber>
    <StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-12-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110725</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>50066-040-06</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (50066-040-06)  / 177 mL in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>50066-0040-06</NDC11Code>
    <ProductNDC>50066-040</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Medicasp Anti-dandruff</ProprietaryName>
    <NonProprietaryName>Coal Tar</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20251125</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M032</ApplicationNumber>
    <LabelerName>Genomma Lab USA</LabelerName>
    <SubstanceName>COAL TAR</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-12-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251125</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>controls the symptoms of: 1 dandruff, 2 seborrheic dermatitis, 3 psoriasis.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>52244-040-06</NDCCode>
    <PackageDescription>6 BLISTER PACK in 1 CARTON (52244-040-06)  / 1 CARTRIDGE in 1 BLISTER PACK / 1 mL in 1 CARTRIDGE</PackageDescription>
    <NDC11Code>52244-0040-06</NDC11Code>
    <ProductNDC>52244-040</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Edex</ProprietaryName>
    <NonProprietaryName>Alprostadil</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRACAVERNOUS</RouteName>
    <StartMarketingDate>20120315</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020649</ApplicationNumber>
    <LabelerName>Endo USA, Inc.</LabelerName>
    <SubstanceName>ALPROSTADIL</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Genitourinary Arterial Vasodilation [PE], Prostaglandin Analog [EPC], Prostaglandin E1 Agonist [EPC], Prostaglandin Receptor Agonists [MoA], Prostaglandins [CS], Venous Vasodilation [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120315</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>edex® is indicated for the treatment of erectile dysfunction due to neurogenic, vasculogenic, psychogenic, or mixed etiology.</IndicationAndUsage>
    <Description>edex® (alprostadil for injection) is a sterile, pyrogen-free powder containing alprostadil in an alfadex (α-cyclodextrin) inclusion complex. Alprostadil is an endogenous substance known as prostaglandin E1 (PGE1). edex® is supplied in single-dose, dual-chamber cartridges. edex® is lyophilized in single-dose, dual-chamber cartridges intended for use with the reusable edex® injection device. One chamber of the cartridge contains alprostadil, alfadex and lactose as a sterile, pyrogen-free powder. The other chamber contains 1.075 mL of sterile 0.9% sodium chloride. The edex® cartridges are supplied in three strengths: 10-mcg cartridge (10.75 mcg alprostadil, 347.55 mcg α-cyclodextrin, 51.06 mg lactose); 20-mcg cartridge (21.5 mcg alprostadil, 695.2 mcg α-cyclodextrin, 51.06 mg lactose); 40-mcg cartridge (43 mcg alprostadil, 1,390.3 mcg α-cyclodextrin, 51.06 mg lactose). The edex® injection device is used to reconstitute the sterile powder in one chamber with the sterile 0.9% sodium chloride in the other chamber. After reconstitution, the edex® injection device is used to administer the intracavernous injection of alprostadil. The chemical name for alprostadil is (1R,2R,3R)-3-Hydroxy-2-[(E)-(3S)-3-hydroxy-1-octenyl]-5-oxocyclopentane heptanoic acid. The empirical formula is C20H34O5 and the molecular weight is 354.49. The chemical structure is:. The α-cyclodextrin inclusion complex improves the water solubility of alprostadil. The empirical formula of α-cyclodextrin is C36H60O30 and the molecular weight is 972.85. The chemical structure is. Alprostadil alfadex is a white, odorless, hygroscopic powder. It is freely soluble in water and practically insoluble in ethanol, ethyl acetate and ether. After reconstitution, the active ingredient, alprostadil, immediately dissociates from the α-cyclodextrin inclusion complex. The reconstituted solution is clear and colorless and has a pH between 4.0 and 8.0. When the single-dose, dual-chamber cartridge containing either 10.75, 21.5, or 43 mcg of alprostadil is placed into the edex® injection device and reconstituted, the deliverable amount of alprostadil in each milliliter is 10, 20 or 40 mcg, respectively.</Description>
  </NDC>
  <NDC>
    <NDCCode>52376-040-06</NDCCode>
    <PackageDescription>.6 mL in 1 BOTTLE (52376-040-06)</PackageDescription>
    <NDC11Code>52376-0040-06</NDC11Code>
    <ProductNDC>52376-040</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Equitance Sunscreen Broad Spectrum Spf 36</ProprietaryName>
    <NonProprietaryName>Octinoxate Zinc Oxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20160412</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Sunstar Americas, Inc</LabelerName>
    <SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>6.5; 16.88</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>61734-040-06</NDCCode>
    <PackageDescription>10 g in 1 TUBE (61734-040-06)</PackageDescription>
    <NDC11Code>61734-0040-06</NDC11Code>
    <ProductNDC>61734-040</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Petroleum</ProprietaryName>
    <NonProprietaryName>Petrolatum</NonProprietaryName>
    <DosageFormName>JELLY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20100507</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part347</ApplicationNumber>
    <LabelerName>Delon Laboratories (1990) Ltd</LabelerName>
    <SubstanceName>PETROLATUM</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>68225-040-06</NDCCode>
    <PackageDescription>660 VIAL in 1 CONTAINER (68225-040-06)  / 5 mL in 1 VIAL</PackageDescription>
    <NDC11Code>68225-0040-06</NDC11Code>
    <ProductNDC>68225-040</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Thrombin, Topical (recombinant)</NonProprietaryName>
    <DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
    <StartMarketingDate>20080609</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Patheon Italia S.p.A</LabelerName>
    <SubstanceName>THROMBIN ALFA</SubstanceName>
    <StrengthNumber>1000</StrengthNumber>
    <StrengthUnit>[iU]/mL</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-08-23</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>23-JUL-25</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>71027-040-06</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (71027-040-06)  &gt; 177 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>71027-0040-06</NDC11Code>
    <ProductNDC>71027-040</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Daytime Cough</ProprietaryName>
    <NonProprietaryName>Daytime Cough</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170301</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>KINGSTON PHARMA LLC</LabelerName>
    <SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>325; 10; 5</StrengthNumber>
    <StrengthUnit>mg/15mL; mg/15mL; mg/15mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-08-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170301</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses: 1 Temporarily relieves these common cold/flu symptoms Minor aches and painsHeadacheSore throatNasal congestionFeverCough due to minor throat and bronchial irritation.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>71884-040-06</NDCCode>
    <PackageDescription>18927 mL in 1 PAIL (71884-040-06) </PackageDescription>
    <NDC11Code>71884-0040-06</NDC11Code>
    <ProductNDC>71884-040</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>My-shield Sanitizing</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>SOAP</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20180501</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>505G(a)(3)</ApplicationNumber>
    <LabelerName>Enviro Specialty Chemicals Inc</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-07-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage> Hand wash to help reduce bacteria that potentially can cause disease Helps to prevent cross-contamination by hand contact Helps to prevent drying of skin  Recommended for repeat use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>72606-040-06</NDCCode>
    <PackageDescription>3 KIT in 1 CARTON (72606-040-06)  / 1 KIT in 1 KIT *  1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE *  1 mL in 1 PACKET</PackageDescription>
    <NDC11Code>72606-0040-06</NDC11Code>
    <ProductNDC>72606-040</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Adalimumab</ProprietaryName>
    <NonProprietaryName>Adalimumab-aaty</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20231130</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761219</ApplicationNumber>
    <LabelerName>CELLTRION USA, Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-07-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231130</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Adalimumab-aaty is a tumor necrosis factor (TNF) blocker indicated for: 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. (1.9).</IndicationAndUsage>
    <Description>Adalimumab-aaty is a tumor necrosis factor blocker. Adalimumab-aaty is a recombinant human IgG1 monoclonal antibody created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-aaty is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. Adalimumab-aaty injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, auto-injector (Adalimumab-aaty AI), as a single-dose, 1 mL prefilled syringe with safety guard, or a single-dose, 1 mL prefilled syringe. Enclosed within the auto-injector is a single-dose, 1 mL prefilled syringe. The solution of Adalimumab-aaty is clear to opalescent, and colorless to pale brown, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled syringe with safety guard or auto-injector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of Adalimumab-aaty contains adalimumab-aaty (80 mg), acetic acid (0.13 mg), glycine (15.02 mg), polysorbate 80 (0.8 mg), sodium acetate (0.48 mg) and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or prefilled syringe with safety guard or auto-injector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of Adalimumab-aaty contains adalimumab-aaty (40 mg), acetic acid (0.06 mg), glycine (7.51 mg), polysorbate 80 (0.4 mg), sodium acetate (0.24 mg) and Water for Injection, USP. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of Adalimumab-aaty contains adalimumab-aaty (20 mg), acetic acid (0.03 mg), glycine (3.75 mg), polysorbate 80 (0.2 mg), sodium acetate (0.12 mg) and Water for Injection, USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>72761-040-06</NDCCode>
    <PackageDescription>50 kg in 1 DRUM (72761-040-06) </PackageDescription>
    <NDC11Code>72761-0040-06</NDC11Code>
    <ProductNDC>72761-040</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Indomethacin</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20251201</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Aurore Pharmaceuticals Private Limited</LabelerName>
    <SubstanceName>INDOMETHACIN</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-12-25</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>01-DEC-25</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>77231-040-06</NDCCode>
    <PackageDescription>190 mL in 1 BOTTLE (77231-040-06) </PackageDescription>
    <NDC11Code>77231-0040-06</NDC11Code>
    <ProductNDC>77231-040</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200521</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>GIA EVOLUTION SA DE CV</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>72</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-07-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200521</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>78174-040-06</NDCCode>
    <PackageDescription>.118294 L in 1 BOTTLE (78174-040-06) </PackageDescription>
    <NDC11Code>78174-0040-06</NDC11Code>
    <ProductNDC>78174-040</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Klean Genix Hand Sanitizer Fluid</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210109</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Custom Chemical Services, LLC</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>70.0984</StrengthNumber>
    <StrengthUnit>L/100L</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210109</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses Hand sanitizer to help reduce bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>83511-040-06</NDCCode>
    <PackageDescription>5 kg in 1 DRUM (83511-040-06) </PackageDescription>
    <NDC11Code>83511-0040-06</NDC11Code>
    <ProductNDC>83511-040</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Benzgalantamine Gluconate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20260522</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>STHREE CHEMICALS PRIVATE LIMITED</LabelerName>
    <SubstanceName>GALANTAMINE</SubstanceName>
    <StrengthNumber>35</StrengthNumber>
    <StrengthUnit>kg/35kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-06-02</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>22-MAY-26</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>85207-040-06</NDCCode>
    <PackageDescription>20000 g in 1 BAG (85207-040-06) </PackageDescription>
    <NDC11Code>85207-0040-06</NDC11Code>
    <ProductNDC>85207-040</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Hydroxy Progesterone Caproate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20260227</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>SCH Global Services Private Limited</LabelerName>
    <SubstanceName>HYDROXYPROGESTERONE CAPROATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-03-07</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>27-FEB-26</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>15478-040-01</NDCCode>
    <PackageDescription>4.25 g in 1 PACKAGE (15478-040-01) </PackageDescription>
    <NDC11Code>15478-0040-01</NDC11Code>
    <ProductNDC>15478-040</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Fixmyskin Healing Balm Vanilla Flavor</ProprietaryName>
    <NonProprietaryName>Hydrocortisone</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20111117</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part348</ApplicationNumber>
    <LabelerName>Topical Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>HYDROCORTISONE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-05-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20111117</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>42291-040-90</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (42291-040-90) </PackageDescription>
    <NDC11Code>42291-0040-90</NDC11Code>
    <ProductNDC>42291-040</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
    <NonProprietaryName>Lisdexamfetamine</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250604</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202830</ApplicationNumber>
    <LabelerName>AvKARE</LabelerName>
    <SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-06-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250604</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)] . .</IndicationAndUsage>
    <Description>Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: crospovidone, isopropyl alcohol, lactose monohydrate, microcrystalline cellulose and sodium stearyl fumarate. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and one or more of the following: D&amp;C Yellow #10, FD&amp;C Blue #1, FD&amp;C Red #40 and iron oxide yellow. The imprint on the capsule shells contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>43116-040-01</NDCCode>
    <PackageDescription>1 U in 1 POUCH (43116-040-01) </PackageDescription>
    <NDC11Code>43116-0040-01</NDC11Code>
    <ProductNDC>43116-040</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Eyelid Wipes</ProprietaryName>
    <NonProprietaryName>Eyelid Wipes</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20250606</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M005</ApplicationNumber>
    <LabelerName>Shenzhen Shierjie Biological Engineering Co., LTD</LabelerName>
    <SubstanceName>4-TERPINEOL; MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL</SubstanceName>
    <StrengthNumber>.003; .04</StrengthNumber>
    <StrengthUnit>U/100U; U/100U</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-06-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250606</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Eyelid Wipes for Dry Eyes and Blepharitis Relief, Stay Hygienic.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>43116-040-02</NDCCode>
    <PackageDescription>30 U in 1 BOX (43116-040-02) </PackageDescription>
    <NDC11Code>43116-0040-02</NDC11Code>
    <ProductNDC>43116-040</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Eyelid Wipes</ProprietaryName>
    <NonProprietaryName>Eyelid Wipes</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20250606</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M005</ApplicationNumber>
    <LabelerName>Shenzhen Shierjie Biological Engineering Co., LTD</LabelerName>
    <SubstanceName>4-TERPINEOL; MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL</SubstanceName>
    <StrengthNumber>.003; .04</StrengthNumber>
    <StrengthUnit>U/100U; U/100U</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-06-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250606</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Eyelid Wipes for Dry Eyes and Blepharitis Relief, Stay Hygienic.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>43116-040-03</NDCCode>
    <PackageDescription>60 U in 1 BOX (43116-040-03) </PackageDescription>
    <NDC11Code>43116-0040-03</NDC11Code>
    <ProductNDC>43116-040</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Eyelid Wipes</ProprietaryName>
    <NonProprietaryName>Eyelid Wipes</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20250606</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M005</ApplicationNumber>
    <LabelerName>Shenzhen Shierjie Biological Engineering Co., LTD</LabelerName>
    <SubstanceName>4-TERPINEOL; MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL</SubstanceName>
    <StrengthNumber>.003; .04</StrengthNumber>
    <StrengthUnit>U/100U; U/100U</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-06-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250606</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Eyelid Wipes for Dry Eyes and Blepharitis Relief, Stay Hygienic.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>43473-040-01</NDCCode>
    <PackageDescription>.9 g in 1 PACKET (43473-040-01) </PackageDescription>
    <NDC11Code>43473-0040-01</NDC11Code>
    <ProductNDC>43473-040</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Firstar Burn</ProprietaryName>
    <NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240702</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>Nantong Health &amp; Beyond Hygienic Products Inc.</LabelerName>
    <SubstanceName>LIDOCAINE HYDROCHLORIDE; BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>.5; .13</StrengthNumber>
    <StrengthUnit>g/100g; g/100g</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240702</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses. Temporary relief of pain associated with minor cuts, scrapes, and burns. Helps protect against harmful bacteria.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>50555-040-02</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (50555-040-02)  &gt; 90 g in 1 TUBE (50555-040-01)</PackageDescription>
    <NDC11Code>50555-0040-02</NDC11Code>
    <ProductNDC>50555-040</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Pororo Toothpas Te Mixed Fruits</ProprietaryName>
    <NonProprietaryName>Sodium Monofluorophosphate</NonProprietaryName>
    <DosageFormName>PASTE, DENTIFRICE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160801</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part355</ApplicationNumber>
    <LabelerName>KMPHARMACEUTICAL CO.,LTD</LabelerName>
    <SubstanceName>SODIUM MONOFLUOROPHOSPHATE</SubstanceName>
    <StrengthNumber>.31</StrengthNumber>
    <StrengthUnit>g/90g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-06-03</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>51285-040-01</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (51285-040-01) </PackageDescription>
    <NDC11Code>51285-0040-01</NDC11Code>
    <ProductNDC>51285-040</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ziac</ProprietaryName>
    <NonProprietaryName>Bisoprolol Fumarate And Hydrochlorothiazide</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19931026</StartMarketingDate>
    <EndMarketingDate>20250630</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020186</ApplicationNumber>
    <LabelerName>Teva Women's Health LLC</LabelerName>
    <SubstanceName>BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE</SubstanceName>
    <StrengthNumber>10; 6.25</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-06-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>19931026</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250630</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ZIAC (bisoprolol fumarate and hydrochlorothiazide) is indicated in the management of hypertension.</IndicationAndUsage>
    <Description>ZIAC® (bisoprolol fumarate and hydrochlorothiazide) is indicated for the treatment of hypertension. It combines two antihypertensive agents in a once-daily dosage: a synthetic beta1-selective (cardioselective) adrenoceptor blocking agent (bisoprolol fumarate) and a benzothiadiazine diuretic (hydrochlorothiazide). Bisoprolol fumarate is chemically described as (±)-1-[4-[[2-(1-methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol(E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is (C18H31NO4)2C4H4O4 and it has a molecular weight of 766.97. Its structural formula is. Bisoprolol fumarate is a white crystalline powder, approximately equally hydrophilic and lipophilic, and readily soluble in water, methanol, ethanol, and chloroform. Hydrochlorothiazide (HCTZ) is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. It is a white, or practically white, practically odorless crystalline powder. It is slightly soluble in water, sparingly soluble in dilute sodium hydroxide solution, freely soluble in n-butylamine and dimethylformamide, sparingly soluble in methanol, and insoluble in ether, chloroform, and dilute mineral acids. Its empirical formula is C7H8ClN3O4S2 and it has a molecular weight of 297.73. Its structural formula is. Each ZIAC®-2.5 mg/6.25 mg tablet for oral administration contains. Bisoprolol fumarate…………………………………………..2.5 mg. Hydrochlorothiazide………………………………………..6.25 mg. Each ZIAC®-5 mg/6.25 mg tablet for oral administration contains. Bisoprolol fumarate……………………………………………5 mg. Hydrochlorothiazide………………………………………..6.25 mg. Each ZIAC®-10 mg/6.25 mg tablet for oral administration contains. Bisoprolol fumarate…………………………………………...10 mg. Hydrochlorothiazide………………………………………..6.25 mg. Inactive ingredients include Corn Starch, Dibasic Calcium Phosphate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, and Titanium Dioxide. The 10 mg/6.25mg tablet also contains Colloidal Silicon Dioxide. The 5 mg/6.25 mg tablet also contains Colloidal Silicon Dioxide, and Red and Yellow Iron Oxide. The 2.5 mg/6.25 mg tablet also contains Crospovidone, Pregelatinized Starch, and Yellow Iron Oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>51862-510-06</NDCCode>
    <PackageDescription>6 BLISTER PACK in 1 CARTON (51862-510-06)  &gt; 1 KIT in 1 BLISTER PACK (51862-510-01) </PackageDescription>
    <NDC11Code>51862-0510-06</NDC11Code>
    <ProductNDC>51862-510</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Trivora</ProprietaryName>
    <NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20160803</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074538</ApplicationNumber>
    <LabelerName>Mayne Pharma Inc.</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2025-07-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160803</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and the IUD, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.</IndicationAndUsage>
    <Description>Each Trivora cycle of 28 tablets consists of three different drug phases as follows: Phase 1 comprised of 6 blue tablets, each containing 0.050 mg of levonorgestrel (d(-)13 beta-ethyl-17-alpha-ethinyl-17- beta-hydroxygon-4-en-3-one), a totally synthetic progestogen, and 0.030 mg of ethinyl estradiol (19- nor-17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol); phase 2 comprised of 5 white tablets, each containing 0.075 mg levonorgestrel and 0.040 mg ethinyl estradiol; and phase 3 comprised of 10 pink tablets, each containing 0.125 mg levonorgestrel and 0.030 mg ethinyl estradiol; then followed by 7 peach inert tablets. The inactive ingredients present in the blue, white and pink tablets are lactose monohydrate, magnesium stearate, povidone and starch (corn). Each blue tablet also contains FD&amp;C Blue #1. Each pink tablet also contains FD&amp;C Red #40. Each inactive peach tablet contains the following inactive ingredients: anhydrous lactose, FD&amp;C Yellow #6, lactose monohydrate, magnesium stearate and microcrystalline cellulose.</Description>
  </NDC>
  <NDC>
    <NDCCode>52244-040-02</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 CARTON (52244-040-02)  / 1 CARTRIDGE in 1 BLISTER PACK / 1 mL in 1 CARTRIDGE</PackageDescription>
    <NDC11Code>52244-0040-02</NDC11Code>
    <ProductNDC>52244-040</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Edex</ProprietaryName>
    <NonProprietaryName>Alprostadil</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRACAVERNOUS</RouteName>
    <StartMarketingDate>20120315</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020649</ApplicationNumber>
    <LabelerName>Endo USA, Inc.</LabelerName>
    <SubstanceName>ALPROSTADIL</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Genitourinary Arterial Vasodilation [PE], Prostaglandin Analog [EPC], Prostaglandin E1 Agonist [EPC], Prostaglandin Receptor Agonists [MoA], Prostaglandins [CS], Venous Vasodilation [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120315</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>edex® is indicated for the treatment of erectile dysfunction due to neurogenic, vasculogenic, psychogenic, or mixed etiology.</IndicationAndUsage>
    <Description>edex® (alprostadil for injection) is a sterile, pyrogen-free powder containing alprostadil in an alfadex (α-cyclodextrin) inclusion complex. Alprostadil is an endogenous substance known as prostaglandin E1 (PGE1). edex® is supplied in single-dose, dual-chamber cartridges. edex® is lyophilized in single-dose, dual-chamber cartridges intended for use with the reusable edex® injection device. One chamber of the cartridge contains alprostadil, alfadex and lactose as a sterile, pyrogen-free powder. The other chamber contains 1.075 mL of sterile 0.9% sodium chloride. The edex® cartridges are supplied in three strengths: 10-mcg cartridge (10.75 mcg alprostadil, 347.55 mcg α-cyclodextrin, 51.06 mg lactose); 20-mcg cartridge (21.5 mcg alprostadil, 695.2 mcg α-cyclodextrin, 51.06 mg lactose); 40-mcg cartridge (43 mcg alprostadil, 1,390.3 mcg α-cyclodextrin, 51.06 mg lactose). The edex® injection device is used to reconstitute the sterile powder in one chamber with the sterile 0.9% sodium chloride in the other chamber. After reconstitution, the edex® injection device is used to administer the intracavernous injection of alprostadil. The chemical name for alprostadil is (1R,2R,3R)-3-Hydroxy-2-[(E)-(3S)-3-hydroxy-1-octenyl]-5-oxocyclopentane heptanoic acid. The empirical formula is C20H34O5 and the molecular weight is 354.49. The chemical structure is:. The α-cyclodextrin inclusion complex improves the water solubility of alprostadil. The empirical formula of α-cyclodextrin is C36H60O30 and the molecular weight is 972.85. The chemical structure is. Alprostadil alfadex is a white, odorless, hygroscopic powder. It is freely soluble in water and practically insoluble in ethanol, ethyl acetate and ether. After reconstitution, the active ingredient, alprostadil, immediately dissociates from the α-cyclodextrin inclusion complex. The reconstituted solution is clear and colorless and has a pH between 4.0 and 8.0. When the single-dose, dual-chamber cartridge containing either 10.75, 21.5, or 43 mcg of alprostadil is placed into the edex® injection device and reconstituted, the deliverable amount of alprostadil in each milliliter is 10, 20 or 40 mcg, respectively.</Description>
  </NDC>
  <NDC>
    <NDCCode>53002-1566-6</NDCCode>
    <PackageDescription>6 BLISTER PACK in 1 PACKAGE (53002-1566-6)  / 1 KIT in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>53002-1566-06</NDC11Code>
    <ProductNDC>53002-1566</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Trivora</ProprietaryName>
    <NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20160803</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074538</ApplicationNumber>
    <LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and the IUD, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.</IndicationAndUsage>
    <Description>Each Trivora cycle of 28 tablets consists of three different drug phases as follows: Phase 1 comprised of 6 blue tablets, each containing 0.050 mg of levonorgestrel (d(-)13 beta-ethyl-17-alpha-ethinyl-17- beta-hydroxygon-4-en-3-one), a totally synthetic progestogen, and 0.030 mg of ethinyl estradiol (19- nor-17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol); phase 2 comprised of 5 white tablets, each containing 0.075 mg levonorgestrel and 0.040 mg ethinyl estradiol; and phase 3 comprised of 10 pink tablets, each containing 0.125 mg levonorgestrel and 0.030 mg ethinyl estradiol; then followed by 7 peach inert tablets. The inactive ingredients present in the blue, white and pink tablets are lactose monohydrate, magnesium stearate, povidone and starch (corn). Each blue tablet also contains FD&amp;C Blue #1. Each pink tablet also contains FD&amp;C Red #40. Each inactive peach tablet contains the following inactive ingredients: anhydrous lactose, FD&amp;C Yellow #6, lactose monohydrate, magnesium stearate and microcrystalline cellulose.</Description>
  </NDC>
</NDCList>
                    
<NDCList><NDC><NDCCode>72197-040-06</NDCCode><ProprietaryName>Pharmacys Prescription Petroleum Jelly</ProprietaryName><NonProprietaryName>Petrolatum</NonProprietaryName></NDC><NDC><NDCCode>72197-041-06</NDCCode><ProprietaryName>Pharmacys Prescription Petroleum Jelly</ProprietaryName><NonProprietaryName>Petrolatum</NonProprietaryName></NDC><NDC><NDCCode>72197-044-06</NDCCode><ProprietaryName>Pharmacys Prescription Petroleum Jelly</ProprietaryName><NonProprietaryName>Petrolatum</NonProprietaryName></NDC><NDC><NDCCode>72197-045-06</NDCCode><ProprietaryName>Pharmacys Prescription Petroleum Jelly</ProprietaryName><NonProprietaryName>Petrolatum</NonProprietaryName></NDC><NDC><NDCCode>33358-040-06</NDCCode><ProprietaryName>Azithromycin</ProprietaryName><NonProprietaryName>Azithromycin</NonProprietaryName></NDC><NDC><NDCCode>34666-040-06</NDCCode><ProprietaryName>K-loss</ProprietaryName><NonProprietaryName>Fucus Vesiculosus, Graphites, Phytolacca Decandra</NonProprietaryName></NDC><NDC><NDCCode>50066-040-06</NDCCode><ProprietaryName>Medicasp Anti-dandruff</ProprietaryName><NonProprietaryName>Coal Tar</NonProprietaryName></NDC><NDC><NDCCode>52244-040-06</NDCCode><ProprietaryName>Edex</ProprietaryName><NonProprietaryName>Alprostadil</NonProprietaryName></NDC><NDC><NDCCode>52376-040-06</NDCCode><ProprietaryName>Equitance Sunscreen Broad Spectrum Spf 36</ProprietaryName><NonProprietaryName>Octinoxate Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>61734-040-06</NDCCode><ProprietaryName>Petroleum</ProprietaryName><NonProprietaryName>Petrolatum</NonProprietaryName></NDC><NDC><NDCCode>68225-040-06</NDCCode><NonProprietaryName>Thrombin, Topical (recombinant)</NonProprietaryName></NDC><NDC><NDCCode>71027-040-06</NDCCode><ProprietaryName>Daytime Cough</ProprietaryName><NonProprietaryName>Daytime Cough</NonProprietaryName></NDC><NDC><NDCCode>71884-040-06</NDCCode><ProprietaryName>My-shield Sanitizing</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>72606-040-06</NDCCode><ProprietaryName>Adalimumab</ProprietaryName><NonProprietaryName>Adalimumab-aaty</NonProprietaryName></NDC><NDC><NDCCode>72761-040-06</NDCCode><NonProprietaryName>Indomethacin</NonProprietaryName></NDC><NDC><NDCCode>77231-040-06</NDCCode><ProprietaryName>Hand Sanitizer</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>78174-040-06</NDCCode><ProprietaryName>Klean Genix Hand Sanitizer Fluid</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>83511-040-06</NDCCode><NonProprietaryName>Benzgalantamine Gluconate</NonProprietaryName></NDC><NDC><NDCCode>85207-040-06</NDCCode><NonProprietaryName>Hydroxy Progesterone Caproate</NonProprietaryName></NDC><NDC><NDCCode>15478-040-01</NDCCode><ProprietaryName>Fixmyskin Healing Balm Vanilla Flavor</ProprietaryName><NonProprietaryName>Hydrocortisone</NonProprietaryName></NDC><NDC><NDCCode>42291-040-90</NDCCode><ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName><NonProprietaryName>Lisdexamfetamine</NonProprietaryName></NDC><NDC><NDCCode>43116-040-01</NDCCode><ProprietaryName>Eyelid Wipes</ProprietaryName><NonProprietaryName>Eyelid Wipes</NonProprietaryName></NDC><NDC><NDCCode>43116-040-02</NDCCode><ProprietaryName>Eyelid Wipes</ProprietaryName><NonProprietaryName>Eyelid Wipes</NonProprietaryName></NDC><NDC><NDCCode>43116-040-03</NDCCode><ProprietaryName>Eyelid Wipes</ProprietaryName><NonProprietaryName>Eyelid Wipes</NonProprietaryName></NDC><NDC><NDCCode>43473-040-01</NDCCode><ProprietaryName>Firstar Burn</ProprietaryName><NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>50555-040-02</NDCCode><ProprietaryName>Pororo Toothpas Te Mixed Fruits</ProprietaryName><NonProprietaryName>Sodium Monofluorophosphate</NonProprietaryName></NDC><NDC><NDCCode>51285-040-01</NDCCode><ProprietaryName>Ziac</ProprietaryName><NonProprietaryName>Bisoprolol Fumarate And Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>51862-510-06</NDCCode><ProprietaryName>Trivora</ProprietaryName><NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>52244-040-02</NDCCode><ProprietaryName>Edex</ProprietaryName><NonProprietaryName>Alprostadil</NonProprietaryName></NDC><NDC><NDCCode>53002-1566-6</NDCCode><ProprietaryName>Trivora</ProprietaryName><NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

DataLabs Coding Library - Quering NPI Registry - REST API Examples

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

Output

            
{
  "NPI": [
    {
      "NPI": "1295783033",
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      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "207RI0200X",
      "Taxonomy2": "Infectious Disease",
      "LicenseNumber2": "25MA07672000",
      "LicenseNumberStateCode2": "NJ",
      "PrimaryTaxonomySwitch2": "Y"
    },
    {
      "NPI": "1184645301",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "BAIK",
      "FirstName": "RANIA",
      "Credential": "D.O.",
      "FirstLineMailingAddress": "602 ROUTE 169",
      "SecondLineMailingAddress": "PO BOX 865",
      "MailingAddressCityName": "WOODSTOCK",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06281-2225",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "860-821-3406",
      "MailingAddressFaxNumber": "860-821-3407",
      "FirstLinePracticeLocationAddress": "602 ROUTE 169",
      "PracticeLocationAddressCityName": "WOODSTOCK",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06281-2225",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "860-821-3406",
      "PracticeLocationAddressFaxNumber": "860-821-3407",
      "EnumerationDate": "07/22/2006",
      "LastUpdateDate": "01/14/2016",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "000260",
      "LicenseNumberStateCode1": "CT",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

Full Text Search Fundamentals

Facts

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

How does it work

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

Full Text Search & DataLabs REST API

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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