RESTful Lookup — Test-Drive (2007 – 2026)

Query complete (29 ms elapsed)

{
  "NDC": [
    {
      "NDCCode": "54414-028-05",
      "PackageDescription": "141 g in 1 CAN (54414-028-05) ",
      "NDC11Code": "54414-0028-05",
      "ProductNDC": "54414-028",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dermatone Spf50 Sunscreen",
      "NonProprietaryName": "Avabenzone 3% Homosalate 10% Octisalate 5%",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250806",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Dermatone Labs LLC",
      "SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE",
      "StrengthNumber": "3; 10; 5",
      "StrengthUnit": "g/100g; g/100g; g/100g",
      "Status": "Active",
      "LastUpdate": "2026-05-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250806",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps prevent sunburn."
    },
    {
      "NDCCode": "10019-028-05",
      "PackageDescription": "10 VIAL, MULTI-DOSE in 1 PACKAGE (10019-028-05)  > 5 mL in 1 VIAL, MULTI-DOSE (10019-028-37)",
      "NDC11Code": "10019-0028-05",
      "ProductNDC": "10019-028",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Midazolam Hydrochloride",
      "NonProprietaryName": "Midazolam Hydrochloride",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20100304",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075243",
      "LabelerName": "Baxter Healthcare Corporation",
      "SubstanceName": "MIDAZOLAM HYDROCHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]",
      "DEASchedule": "CIV",
      "Status": "Deprecated",
      "LastUpdate": "2015-11-18"
    },
    {
      "NDCCode": "11410-028-05",
      "PackageDescription": "1 JAR in 1 BOX (11410-028-05)  > 4 g in 1 JAR",
      "NDC11Code": "11410-0028-05",
      "ProductNDC": "11410-028",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Proactiv Cover And Heal Duo Concealer Light And Medium",
      "NonProprietaryName": "Salicylic Acid",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20171025",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part333D",
      "LabelerName": "The Proactiv Company, LLC",
      "SubstanceName": "SALICYLIC ACID",
      "StrengthNumber": "1.5",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "11788-028-05",
      "PackageDescription": "500 CAPSULE in 1 BOTTLE (11788-028-05) ",
      "NDC11Code": "11788-0028-05",
      "ProductNDC": "11788-028",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Benzonatate",
      "NonProprietaryName": "Benzonatate",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190314",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210562",
      "LabelerName": "AiPing Pharmaceutical, Inc.",
      "SubstanceName": "BENZONATATE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20190314",
      "SamplePackage": "N",
      "IndicationAndUsage": "Benzonatate USP is indicated for the symptomatic relief of cough.",
      "Description": "Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p-(butylamino) benzoate; with a molecular weight of 603.7. C 30H 53NO 11. Each soft gelatin capsule, for oral administration, contains 100 mg, 150 mg or 200 mg of benzonatate USP. Benzonatate Capsules, USP also contain the following inactive ingredients: D&C Yellow #10, gelatin, glycerin, purified water, methylparaben and propylparaben. Imprinting ink is composed of isopropyl alcohol, n-butyl alcohol, propylene glycol, shellac, and titanium dioxide."
    },
    {
      "NDCCode": "42385-028-05",
      "PackageDescription": "500 g in 1 BOTTLE, GLASS (42385-028-05)",
      "NDC11Code": "42385-0028-05",
      "ProductNDC": "42385-028",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Latanoprost",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20090601",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Aptuit Laurus Private Limited",
      "SubstanceName": "LATANOPROST",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "52343-028-05",
      "PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (52343-028-05) ",
      "NDC11Code": "52343-0028-05",
      "ProductNDC": "52343-028",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Carvedilol",
      "NonProprietaryName": "Carvedilol",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20070905",
      "EndMarketingDate": "20201201",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078332",
      "LabelerName": "ACETRIS HEALTH, LLC",
      "SubstanceName": "CARVEDILOL",
      "StrengthNumber": "12.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2020-12-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20070905",
      "EndMarketingDatePackage": "20201201",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "55681-028-14",
      "PackageDescription": "144 PACKET in 1 CARTON (55681-028-14)  / 5 g in 1 PACKET (55681-028-05) ",
      "NDC11Code": "55681-0028-14",
      "ProductNDC": "55681-028",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Procure Lanacare",
      "NonProprietaryName": "Lanolin 30%",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250915",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "Twin Med LLC",
      "SubstanceName": "LANOLIN",
      "StrengthNumber": "30",
      "StrengthUnit": "g/100g",
      "Status": "Active",
      "LastUpdate": "2025-09-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250915",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses: 1 Temporarily protects minor cuts, scrapes, and burns, 2 Temporarily protects and helps relieve chafed, chapped or cracked skin, 3 Helps protect from the drying effects of wind and cold weather."
    },
    {
      "NDCCode": "57344-028-05",
      "PackageDescription": "72 TABLET in 1 BOTTLE, PLASTIC (57344-028-05) ",
      "NDC11Code": "57344-0028-05",
      "ProductNDC": "57344-028",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Diphenhydramine Hydrochloride",
      "NonProprietaryName": "Diphenhydramine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20121215",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part338",
      "LabelerName": "AAA Pharmaceutical, Inc.",
      "SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2019-10-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20121215",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "60429-028-05",
      "PackageDescription": "500 CAPSULE in 1 BOTTLE (60429-028-05)",
      "NDC11Code": "60429-0028-05",
      "ProductNDC": "60429-028",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Benzonatate",
      "NonProprietaryName": "Benzonatate",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20070725",
      "EndMarketingDate": "20180228",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040749",
      "LabelerName": "Golden State Medical Supply, Inc.",
      "SubstanceName": "BENZONATATE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-03-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "63148-028-05",
      "PackageDescription": "532 mL in 1 BOTTLE, PLASTIC (63148-028-05) ",
      "NDC11Code": "63148-0028-05",
      "ProductNDC": "63148-028",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Life Is Healed",
      "ProprietaryNameSuffix": "Daily Moisturizing",
      "NonProprietaryName": "Dimethicone",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210720",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "Apollo Health and Beauty Care",
      "SubstanceName": "DIMETHICONE",
      "StrengthNumber": "12",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Skin Barrier Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2026-05-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20210720",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps prevent and temporarily protects chafed, chapped or cracked skin."
    },
    {
      "NDCCode": "64406-028-01",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (64406-028-01)  / .05 mL in 1 VIAL, SINGLE-DOSE (64406-028-02) ",
      "NDC11Code": "64406-0028-01",
      "ProductNDC": "64406-028",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Opuviz",
      "NonProprietaryName": "Aflibercept-yszy",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVITREAL",
      "StartMarketingDate": "20250531",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA761350",
      "LabelerName": "Biogen Inc.",
      "SubstanceName": "AFLIBERCEPT",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2025-09-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20250531",
      "SamplePackage": "N",
      "IndicationAndUsage": "OPUVIZ is indicated for the treatment of.",
      "Description": "Aflibercept-yszy is a recombinant fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 formulated as an iso-osmotic solution for intravitreal administration. Aflibercept-yszy is a dimeric glycoprotein with a protein molecular weight of 97 kilodaltons (kDa) and contains glycosylation, constituting an additional 15% of the total molecular mass, resulting in a total molecular weight of 115 kDa. Aflibercept-yszy is produced in recombinant Chinese hamster ovary (CHO) cells. OPUVIZ (aflibercept-yszy) injection is a sterile, clear, and colorless to pale yellow solution. OPUVIZ does not contain anti-microbial preservative and is supplied as a sterile, aqueous solution for intravitreal injection in a single-dose glass vial designed to deliver 0.05 mL (50 microliters) of solution containing 2 mg of aflibercept-yszy in dibasic sodium phosphate (0.008 mg), monobasic sodium phosphate (0.040 mg), polysorbate 20 (0.015 mg), sucrose (4 mg) and water for injection, with a pH of 6.2."
    },
    {
      "NDCCode": "64406-028-03",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (64406-028-03)  / .05 mL in 1 VIAL, SINGLE-DOSE (64406-028-02) ",
      "NDC11Code": "64406-0028-03",
      "ProductNDC": "64406-028",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Opuviz",
      "NonProprietaryName": "Aflibercept-yszy",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVITREAL",
      "StartMarketingDate": "20250531",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA761350",
      "LabelerName": "Biogen Inc.",
      "SubstanceName": "AFLIBERCEPT",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2025-09-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20250531",
      "SamplePackage": "N",
      "IndicationAndUsage": "OPUVIZ is indicated for the treatment of.",
      "Description": "Aflibercept-yszy is a recombinant fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 formulated as an iso-osmotic solution for intravitreal administration. Aflibercept-yszy is a dimeric glycoprotein with a protein molecular weight of 97 kilodaltons (kDa) and contains glycosylation, constituting an additional 15% of the total molecular mass, resulting in a total molecular weight of 115 kDa. Aflibercept-yszy is produced in recombinant Chinese hamster ovary (CHO) cells. OPUVIZ (aflibercept-yszy) injection is a sterile, clear, and colorless to pale yellow solution. OPUVIZ does not contain anti-microbial preservative and is supplied as a sterile, aqueous solution for intravitreal injection in a single-dose glass vial designed to deliver 0.05 mL (50 microliters) of solution containing 2 mg of aflibercept-yszy in dibasic sodium phosphate (0.008 mg), monobasic sodium phosphate (0.040 mg), polysorbate 20 (0.015 mg), sucrose (4 mg) and water for injection, with a pH of 6.2."
    },
    {
      "NDCCode": "64406-028-04",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (64406-028-04)  / .05 mL in 1 VIAL, SINGLE-DOSE (64406-028-05) ",
      "NDC11Code": "64406-0028-04",
      "ProductNDC": "64406-028",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Opuviz",
      "NonProprietaryName": "Aflibercept-yszy",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVITREAL",
      "StartMarketingDate": "20250531",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA761350",
      "LabelerName": "Biogen Inc.",
      "SubstanceName": "AFLIBERCEPT",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2025-09-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20250531",
      "SamplePackage": "Y",
      "IndicationAndUsage": "OPUVIZ is indicated for the treatment of.",
      "Description": "Aflibercept-yszy is a recombinant fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 formulated as an iso-osmotic solution for intravitreal administration. Aflibercept-yszy is a dimeric glycoprotein with a protein molecular weight of 97 kilodaltons (kDa) and contains glycosylation, constituting an additional 15% of the total molecular mass, resulting in a total molecular weight of 115 kDa. Aflibercept-yszy is produced in recombinant Chinese hamster ovary (CHO) cells. OPUVIZ (aflibercept-yszy) injection is a sterile, clear, and colorless to pale yellow solution. OPUVIZ does not contain anti-microbial preservative and is supplied as a sterile, aqueous solution for intravitreal injection in a single-dose glass vial designed to deliver 0.05 mL (50 microliters) of solution containing 2 mg of aflibercept-yszy in dibasic sodium phosphate (0.008 mg), monobasic sodium phosphate (0.040 mg), polysorbate 20 (0.015 mg), sucrose (4 mg) and water for injection, with a pH of 6.2."
    },
    {
      "NDCCode": "64406-028-06",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (64406-028-06)  / .05 mL in 1 VIAL, SINGLE-DOSE (64406-028-05) ",
      "NDC11Code": "64406-0028-06",
      "ProductNDC": "64406-028",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Opuviz",
      "NonProprietaryName": "Aflibercept-yszy",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVITREAL",
      "StartMarketingDate": "20250531",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA761350",
      "LabelerName": "Biogen Inc.",
      "SubstanceName": "AFLIBERCEPT",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2025-09-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20250531",
      "SamplePackage": "Y",
      "IndicationAndUsage": "OPUVIZ is indicated for the treatment of.",
      "Description": "Aflibercept-yszy is a recombinant fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 formulated as an iso-osmotic solution for intravitreal administration. Aflibercept-yszy is a dimeric glycoprotein with a protein molecular weight of 97 kilodaltons (kDa) and contains glycosylation, constituting an additional 15% of the total molecular mass, resulting in a total molecular weight of 115 kDa. Aflibercept-yszy is produced in recombinant Chinese hamster ovary (CHO) cells. OPUVIZ (aflibercept-yszy) injection is a sterile, clear, and colorless to pale yellow solution. OPUVIZ does not contain anti-microbial preservative and is supplied as a sterile, aqueous solution for intravitreal injection in a single-dose glass vial designed to deliver 0.05 mL (50 microliters) of solution containing 2 mg of aflibercept-yszy in dibasic sodium phosphate (0.008 mg), monobasic sodium phosphate (0.040 mg), polysorbate 20 (0.015 mg), sucrose (4 mg) and water for injection, with a pH of 6.2."
    },
    {
      "NDCCode": "65219-028-05",
      "PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (65219-028-05)  / 1 mL in 1 SYRINGE, GLASS",
      "NDC11Code": "65219-0028-05",
      "ProductNDC": "65219-028",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ganirelix Acetate",
      "NonProprietaryName": "Ganirelix Acetate",
      "DosageFormName": "INJECTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20230324",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215658",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "GANIRELIX ACETATE",
      "StrengthNumber": "250",
      "StrengthUnit": "ug/.5mL",
      "Pharm_Classes": "Decreased GnRH Secretion [PE], Gonadotropin Releasing Hormone Receptor Antagonist [EPC], Gonadotropin Releasing Hormone Receptor Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-05-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230324",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ganirelix Acetate Injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation.",
      "Description": "Ganirelix Acetate Injection is a synthetic decapeptide with high antagonistic activity against naturally occurring gonadotropin-releasing hormone (GnRH). Ganirelix Acetate is derived from native GnRH with substitutions of amino acids at positions 1, 2, 3, 6, 8, and 10 to form the following molecular formula of the peptide: N-acetyl-3-(2-naphthyl)-D-alanyl-4-chloro-D-phenylalanyl-3-(3-pyridyl)-D-alanyl-L-seryl-L-tyrosyl-N9,N10-diethyl-D-homoarginyl-L-leucyl-N9,N10-diethyl-L-homoarginyl-L-prolyl-D-alanylamide acetate. The molecular weight for Ganirelix Acetate is 1570.4 as an anhydrous free base. The structural formula is as follows:. Ganirelix Acetate. Ganirelix Acetate Injection is supplied as a colorless, sterile, ready-to-use, aqueous solution intended for SUBCUTANEOUS administration only. Each single dose, sterile, prefilled syringe contains 250 mcg/0.5 mL of Ganirelix Acetate, 0.1 mg glacial acetic acid, 23.5 mg mannitol, and water for injection adjusted to pH 5.0 with acetic acid, NF and/or sodium hydroxide, NF."
    },
    {
      "NDCCode": "65841-028-05",
      "PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (65841-028-05) ",
      "NDC11Code": "65841-0028-05",
      "ProductNDC": "65841-028",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metformin Hydrochloride",
      "NonProprietaryName": "Metformin Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20050928",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077064",
      "LabelerName": "Zydus Lifesciences Limited",
      "SubstanceName": "METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2024-07-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20050928",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "68382-028-05",
      "PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (68382-028-05) ",
      "NDC11Code": "68382-0028-05",
      "ProductNDC": "68382-028",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metformin Hydrochloride",
      "NonProprietaryName": "Metformin Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20050928",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077064",
      "LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
      "SubstanceName": "METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Biguanide [EPC],Biguanides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-12-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20050928",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "69539-028-05",
      "PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (69539-028-05) ",
      "NDC11Code": "69539-0028-05",
      "ProductNDC": "69539-028",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lacosamide",
      "NonProprietaryName": "Lacosamide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220319",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204921",
      "LabelerName": "MSN LABORATORIES PRIVATE LIMITED",
      "SubstanceName": "LACOSAMIDE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "DEASchedule": "CV",
      "Status": "Active",
      "LastUpdate": "2022-04-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220319",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "70010-028-05",
      "PackageDescription": "500 TABLET in 1 BOTTLE (70010-028-05) ",
      "NDC11Code": "70010-0028-05",
      "ProductNDC": "70010-028",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ramelteon",
      "NonProprietaryName": "Ramelteon",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20201001",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA213186",
      "LabelerName": "Granules Pharmaceuticals Inc.",
      "SubstanceName": "RAMELTEON",
      "StrengthNumber": "8",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Melatonin Receptor Agonist [EPC], Melatonin Receptor Agonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2023-08-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201001",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. The clinical trials performed in support of efficacy were up to six months in duration. The final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six week studies (adults and elderly), and at the end of the six month study (adults and elderly) [see Clinical Studies (14)].",
      "Description": "Ramelteon is an orally active hypnotic chemically designated as ( S)- N-[2-(1,6,7,8-tetrahydro-2 H-indeno-[5,4- b]furan-8-yl)ethyl]propionamide and containing one chiral center. The compound is produced as the ( S)-enantiomer, with an empirical formula of C 16 H 21 NO 2, molecular weight of 259.34, and the following chemical structure:. Ramelteon is freely soluble in organic solvents, such as methanol, ethanol, and dimethyl sulfoxide; soluble in 1-octanol and acetonitrile; and very slightly soluble in water and in aqueous buffers from pH 3 to pH 11. Each Ramelteon tablet includes the following inactive ingredients: copovidone, corn starch, hydroxypropyl cellulose, iron oxide yellow, lactose monohydrate, magnesium stearate, polyethylene glycol, and titanium dioxide."
    },
    {
      "NDCCode": "71209-028-05",
      "PackageDescription": "100 TABLET in 1 BOTTLE (71209-028-05) ",
      "NDC11Code": "71209-0028-05",
      "ProductNDC": "71209-028",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Venlafaxine",
      "NonProprietaryName": "Venlafaxine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20181203",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206250",
      "LabelerName": "Cadila Pharmaceuticals Limited",
      "SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
      "StrengthNumber": "75",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20181203",
      "SamplePackage": "N",
      "IndicationAndUsage": "Venlafaxine tablets are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine tablets in the treatment of major depressive disorder was established in 6 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4 week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (seeCLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.",
      "Description": "Venlafaxine hydrochloride, USP is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethylamino)methyl]-p- methoxybenzyl]cyclohexanol hydrochloride. The structural formula is shown below. C17H27NO2 HCl                                                              M.W. 313.87 Venlafaxine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol: water (0.2 M sodium chloride) partition coefficient is 0.43. Compressed tablets contain venlafaxine hydrochloride, USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg venlafaxine. Inactive ingredients consist of colloidal silicon dioxide, ferric oxide yellow, ferric oxide red, lactose monohydrate, magnesium stearate, and sodium starch glycolate."
    },
    {
      "NDCCode": "71261-028-05",
      "PackageDescription": "1 POUCH in 1 CARTON (71261-028-05)  / 14 g in 1 POUCH (71261-028-04) ",
      "NDC11Code": "71261-0028-05",
      "ProductNDC": "71261-028",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Jungsaemmool Essential Skin Nuder Cushion Fair Light",
      "NonProprietaryName": "Titanium Dioxide, Octinoxate, Octisalate",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240729",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Jungsaemmool Beauty Co., Ltd.",
      "SubstanceName": "TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE",
      "StrengthNumber": "65.1; 67; 40",
      "StrengthUnit": "mg/g; mg/g; mg/g",
      "Status": "Active",
      "LastUpdate": "2026-04-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260417",
      "SamplePackage": "N",
      "IndicationAndUsage": "Helps prevent sunburn If used as directed with other sun protection measures (see Directions) decrease the risk of skin cancer and early skin aging caused by the sun."
    },
    {
      "NDCCode": "72197-028-05",
      "PackageDescription": "147 mL in 1 BOTTLE (72197-028-05) ",
      "NDC11Code": "72197-0028-05",
      "ProductNDC": "72197-028",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Pharmacys Prescription Hand Sanitizer",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200505",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "American Consumer Products Corp",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "65",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200505",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses - Helps reduce bacteria on the skin that could cause disease. Recommended for repeated use."
    },
    {
      "NDCCode": "72205-028-05",
      "PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (72205-028-05) ",
      "NDC11Code": "72205-0028-05",
      "ProductNDC": "72205-028",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Febuxostat",
      "NonProprietaryName": "Febuxostat",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20191230",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210461",
      "LabelerName": "Novadoz Pharmaceuticals LLC",
      "SubstanceName": "FEBUXOSTAT",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-02-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20191230",
      "SamplePackage": "N",
      "IndicationAndUsage": "Febuxostat tablets are xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable.Limitations of Use: Febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia.",
      "Description": "Febuxostat is a xanthine oxidase inhibitor. The active ingredient in febuxostat is 2-[3-cyano-4-(2-methylpropoxy) phenyl]-4-methylthiazole-5-carboxylic acid hemihydrate, with a molecular weight of 325.39. The molecular formula is C16H16N2O3S 1/2 H2O. The chemical structure is. Febuxostat is a non-hygroscopic, white to yellowish crystalline powder that is soluble in dimethyl formamide, slightly soluble in methanol and insoluble in water. The melting range is 207oC to 210°C. Febuxostat tablets for oral use contain the active ingredient, febuxostat, and are available in two dosage strengths, 40 mg and 80 mg. Inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, microcrystalline cellulose and magnesium stearate. Febuxostat tablets are coated with polyvinyl alcohol, macrogol, titanium dioxide, talc, D&C yellow #10 aluminum lake, FD&C blue #1/brilliant blue FCF aluminum lake, FD&C blue #2/indigo carmine AL 3%-5% (40 mg), additionally iron oxide yellow (80 mg)."
    },
    {
      "NDCCode": "72241-028-05",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE (72241-028-05) ",
      "NDC11Code": "72241-0028-05",
      "ProductNDC": "72241-028",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Acyclovir",
      "NonProprietaryName": "Acyclovir",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210818",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA201445",
      "LabelerName": "Modavar Pharmaceuticals LLC",
      "SubstanceName": "ACYCLOVIR",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
      "Status": "Active",
      "LastUpdate": "2026-04-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20210818",
      "SamplePackage": "N",
      "IndicationAndUsage": "Herpes Zoster Infections:Acyclovir capsules is indicated for the acute treatment of herpes zoster (shingles).Genital Herpes:Acyclovir capsules is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes.Chickenpox:Acyclovir capsules is indicated for the treatment of chickenpox (varicella).",
      "Description": "Acyclovir, a synthetic nucleoside analogue active against herpesviruses. Acyclovir Capsules, is a formulation for oral administration. Each Acyclovir Capsule contains 200 mg of acyclovir and the inactive ingredients corn starch, lactose monohydrate, magnesium stearate, and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C Blue No. 2, and titanium dioxide. Printed with edible black ink. Acyclovir is a white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir are 2.27 and 9.25.The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula. VIROLOGYMechanism of Antiviral Action:Acyclovir is a synthetic purine nucleoside analogue with in vitro and in vivo inhibitory activity against herpes simplex virus types 1 (HSV-1), 2 (HSV-2), and varicella-zoster virus (VZV). The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV and VZV. This viral enzyme converts acyclovir into acyclovir monophosphate, a nucleotide analogue. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. In vitro, acyclovir triphosphate stops replication of herpes viral DNA. This is accomplished in 3 ways: 1) competitive inhibition of viral DNA polymerase, 2) incorporation into and termination of the growing viral DNA chain, and 3) inactivation of the viral DNA polymerase. The greater antiviral activity of acyclovir against HSV compared with VZV is due to its more efficient phosphorylation by the viral TK. Antiviral Activities: The quantitative relationship between the in vitro susceptibility of herpes viruses to antivirals and the clinical response to therapy has not been established in humans, and virus sensitivity testing has not been standardized. Sensitivity testing results, expressed as the concentration of drug required to inhibit by 50% the growth of virus in cell culture (IC50), vary greatly depending upon a number of factors. Using plaque-reduction assays, the IC50 against herpes simplex virus isolates ranges from 0.02 to 13.5 mcg/mL for HSV-1 and from 0.01 to 9.9 mcg/mL for HSV-2. The IC50 for acyclovir against most laboratory strains and clinical isolates of VZV ranges from 0.12 to 10.8 mcg/mL. Acyclovir also demonstrates activity against the Oka vaccine strain of VZV with a mean IC50 of 1.35 mcg/mL.Drug Resistance: Resistance of HSV and VZV to acyclovir can result from qualitative and quantitative changes in the viral TK and/or DNA polymerase. Clinical isolates of HSV and VZV with reduced susceptibility to acyclovir have been recovered from immunocompromised patients, especially with advanced HIV infection. While most of the acyclovir-resistant mutants isolated thus far from immunocompromised patients have been found to be TK-deficient mutants, other mutants involving the viral TK gene (TK partial and TK altered) and DNA polymerase have been isolated. TK-negative mutants may cause severe disease in infants and immunocompromised adults. The possibility of viral resistance to acyclovir should be considered in patients who show poor clinical response during therapy."
    },
    {
      "NDCCode": "72643-028-05",
      "PackageDescription": "50 kg in 1 DRUM (72643-028-05) ",
      "NDC11Code": "72643-0028-05",
      "ProductNDC": "72643-028",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Disulfiram",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20220307",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Solara Active Pharma Sciences Limited",
      "SubstanceName": "DISULFIRAM",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "07-MAR-22"
    },
    {
      "NDCCode": "72888-028-05",
      "PackageDescription": "500 TABLET in 1 BOTTLE (72888-028-05) ",
      "NDC11Code": "72888-0028-05",
      "ProductNDC": "72888-028",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lamotrigine",
      "NonProprietaryName": "Lamotrigine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20211029",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078625",
      "LabelerName": "Advagen Pharma Limited",
      "SubstanceName": "LAMOTRIGINE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-11-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20211029",
      "SamplePackage": "N",
      "Description": "Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs Lamotrigine’s. Its chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)- as-triazine, its molecular formula is C 9H 7N 5Cl 2, and its molecular weight is 256.09. Lamotrigine is a white to pale cream-colored powder and has a pK aof 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is:. Lamotrigine tablets, USP are supplied for oral administration as 25 mg, 100 mg, 150 mg and 200 mg tablets. Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. Meets USP Dissolution Test 2."
    },
    {
      "NDCCode": "73126-028-05",
      "PackageDescription": "355 mL in 1 BOTTLE (73126-028-05) ",
      "NDC11Code": "73126-0028-05",
      "ProductNDC": "73126-028",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Shock Doctor Hand Sanitizer- Eucalyptus",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200901",
      "EndMarketingDate": "20240420",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "LAB-CLEAN, INC",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-04-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20200901",
      "EndMarketingDatePackage": "20240420",
      "SamplePackage": "N",
      "IndicationAndUsage": "For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use."
    },
    {
      "NDCCode": "73212-028-05",
      "PackageDescription": "5 g in 1 BOTTLE (73212-028-05) ",
      "NDC11Code": "73212-0028-05",
      "ProductNDC": "73212-028",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Phentolamine Mesylate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20230102",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Qingdao Biopeptek Co., Ltd.",
      "SubstanceName": "PHENTOLAMINE MESYLATE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Unfinished",
      "LastUpdate": "2026-01-12",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "02-JAN-23"
    },
    {
      "NDCCode": "73905-028-05",
      "PackageDescription": "980 mL in 1 BOTTLE (73905-028-05) ",
      "NDC11Code": "73905-0028-05",
      "ProductNDC": "73905-028",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hand Sanitizer",
      "NonProprietaryName": "Ethyl Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200320",
      "EndMarketingDate": "20240423",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-04-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20200320",
      "EndMarketingDatePackage": "20240423",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "75448-028-05",
      "PackageDescription": "320 mL in 1 BAG (75448-028-05) ",
      "NDC11Code": "75448-0028-05",
      "ProductNDC": "75448-028",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Egolan Hand Sanitizer",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20201013",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Sanrace Biotechnology Co., Ltd.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "75",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20201013",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hand sanitizer to help reduce bacteria on the skin."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"54414-028-05","ProprietaryName":"Dermatone Spf50 Sunscreen","NonProprietaryName":"Avabenzone 3% Homosalate 10% Octisalate 5%"},{"NDCCode":"10019-028-05","ProprietaryName":"Midazolam Hydrochloride","NonProprietaryName":"Midazolam Hydrochloride"},{"NDCCode":"11410-028-05","ProprietaryName":"Proactiv Cover And Heal Duo Concealer Light And Medium","NonProprietaryName":"Salicylic Acid"},{"NDCCode":"11788-028-05","ProprietaryName":"Benzonatate","NonProprietaryName":"Benzonatate"},{"NDCCode":"42385-028-05","NonProprietaryName":"Latanoprost"},{"NDCCode":"52343-028-05","ProprietaryName":"Carvedilol","NonProprietaryName":"Carvedilol"},{"NDCCode":"55681-028-14","ProprietaryName":"Procure Lanacare","NonProprietaryName":"Lanolin 30%"},{"NDCCode":"57344-028-05","ProprietaryName":"Diphenhydramine Hydrochloride","NonProprietaryName":"Diphenhydramine Hydrochloride"},{"NDCCode":"60429-028-05","ProprietaryName":"Benzonatate","NonProprietaryName":"Benzonatate"},{"NDCCode":"63148-028-05","ProprietaryName":"Life Is Healed","NonProprietaryName":"Dimethicone"},{"NDCCode":"64406-028-01","ProprietaryName":"Opuviz","NonProprietaryName":"Aflibercept-yszy"},{"NDCCode":"64406-028-03","ProprietaryName":"Opuviz","NonProprietaryName":"Aflibercept-yszy"},{"NDCCode":"64406-028-04","ProprietaryName":"Opuviz","NonProprietaryName":"Aflibercept-yszy"},{"NDCCode":"64406-028-06","ProprietaryName":"Opuviz","NonProprietaryName":"Aflibercept-yszy"},{"NDCCode":"65219-028-05","ProprietaryName":"Ganirelix Acetate","NonProprietaryName":"Ganirelix Acetate"},{"NDCCode":"65841-028-05","ProprietaryName":"Metformin Hydrochloride","NonProprietaryName":"Metformin Hydrochloride"},{"NDCCode":"68382-028-05","ProprietaryName":"Metformin Hydrochloride","NonProprietaryName":"Metformin Hydrochloride"},{"NDCCode":"69539-028-05","ProprietaryName":"Lacosamide","NonProprietaryName":"Lacosamide"},{"NDCCode":"70010-028-05","ProprietaryName":"Ramelteon","NonProprietaryName":"Ramelteon"},{"NDCCode":"71209-028-05","ProprietaryName":"Venlafaxine","NonProprietaryName":"Venlafaxine"},{"NDCCode":"71261-028-05","ProprietaryName":"Jungsaemmool Essential Skin Nuder Cushion Fair Light","NonProprietaryName":"Titanium Dioxide, Octinoxate, Octisalate"},{"NDCCode":"72197-028-05","ProprietaryName":"Pharmacys Prescription Hand Sanitizer","NonProprietaryName":"Alcohol"},{"NDCCode":"72205-028-05","ProprietaryName":"Febuxostat","NonProprietaryName":"Febuxostat"},{"NDCCode":"72241-028-05","ProprietaryName":"Acyclovir","NonProprietaryName":"Acyclovir"},{"NDCCode":"72643-028-05","NonProprietaryName":"Disulfiram"},{"NDCCode":"72888-028-05","ProprietaryName":"Lamotrigine","NonProprietaryName":"Lamotrigine"},{"NDCCode":"73126-028-05","ProprietaryName":"Shock Doctor Hand Sanitizer- Eucalyptus","NonProprietaryName":"Benzalkonium Chloride"},{"NDCCode":"73212-028-05","NonProprietaryName":"Phentolamine Mesylate"},{"NDCCode":"73905-028-05","ProprietaryName":"Hand Sanitizer","NonProprietaryName":"Ethyl Alcohol"},{"NDCCode":"75448-028-05","ProprietaryName":"Egolan Hand Sanitizer","NonProprietaryName":"Alcohol"}]}
                    

<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>54414-028-05</NDCCode>
    <PackageDescription>141 g in 1 CAN (54414-028-05) </PackageDescription>
    <NDC11Code>54414-0028-05</NDC11Code>
    <ProductNDC>54414-028</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dermatone Spf50 Sunscreen</ProprietaryName>
    <NonProprietaryName>Avabenzone 3% Homosalate 10% Octisalate 5%</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20250806</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Dermatone Labs LLC</LabelerName>
    <SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE</SubstanceName>
    <StrengthNumber>3; 10; 5</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-05-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250806</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps prevent sunburn.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10019-028-05</NDCCode>
    <PackageDescription>10 VIAL, MULTI-DOSE in 1 PACKAGE (10019-028-05)  &gt; 5 mL in 1 VIAL, MULTI-DOSE (10019-028-37)</PackageDescription>
    <NDC11Code>10019-0028-05</NDC11Code>
    <ProductNDC>10019-028</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Midazolam Hydrochloride</ProprietaryName>
    <NonProprietaryName>Midazolam Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20100304</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075243</ApplicationNumber>
    <LabelerName>Baxter Healthcare Corporation</LabelerName>
    <SubstanceName>MIDAZOLAM HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2015-11-18</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>11410-028-05</NDCCode>
    <PackageDescription>1 JAR in 1 BOX (11410-028-05)  &gt; 4 g in 1 JAR</PackageDescription>
    <NDC11Code>11410-0028-05</NDC11Code>
    <ProductNDC>11410-028</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Proactiv Cover And Heal Duo Concealer Light And Medium</ProprietaryName>
    <NonProprietaryName>Salicylic Acid</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20171025</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part333D</ApplicationNumber>
    <LabelerName>The Proactiv Company, LLC</LabelerName>
    <SubstanceName>SALICYLIC ACID</SubstanceName>
    <StrengthNumber>1.5</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>11788-028-05</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (11788-028-05) </PackageDescription>
    <NDC11Code>11788-0028-05</NDC11Code>
    <ProductNDC>11788-028</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Benzonatate</ProprietaryName>
    <NonProprietaryName>Benzonatate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190314</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210562</ApplicationNumber>
    <LabelerName>AiPing Pharmaceutical, Inc.</LabelerName>
    <SubstanceName>BENZONATATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190314</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Benzonatate USP is indicated for the symptomatic relief of cough.</IndicationAndUsage>
    <Description>Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p-(butylamino) benzoate; with a molecular weight of 603.7. C 30H 53NO 11. Each soft gelatin capsule, for oral administration, contains 100 mg, 150 mg or 200 mg of benzonatate USP. Benzonatate Capsules, USP also contain the following inactive ingredients: D&amp;C Yellow #10, gelatin, glycerin, purified water, methylparaben and propylparaben. Imprinting ink is composed of isopropyl alcohol, n-butyl alcohol, propylene glycol, shellac, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>42385-028-05</NDCCode>
    <PackageDescription>500 g in 1 BOTTLE, GLASS (42385-028-05)</PackageDescription>
    <NDC11Code>42385-0028-05</NDC11Code>
    <ProductNDC>42385-028</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Latanoprost</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20090601</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Aptuit Laurus Private Limited</LabelerName>
    <SubstanceName>LATANOPROST</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>52343-028-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (52343-028-05) </PackageDescription>
    <NDC11Code>52343-0028-05</NDC11Code>
    <ProductNDC>52343-028</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carvedilol</ProprietaryName>
    <NonProprietaryName>Carvedilol</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070905</StartMarketingDate>
    <EndMarketingDate>20201201</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078332</ApplicationNumber>
    <LabelerName>ACETRIS HEALTH, LLC</LabelerName>
    <SubstanceName>CARVEDILOL</SubstanceName>
    <StrengthNumber>12.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-12-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20070905</StartMarketingDatePackage>
    <EndMarketingDatePackage>20201201</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>55681-028-14</NDCCode>
    <PackageDescription>144 PACKET in 1 CARTON (55681-028-14)  / 5 g in 1 PACKET (55681-028-05) </PackageDescription>
    <NDC11Code>55681-0028-14</NDC11Code>
    <ProductNDC>55681-028</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Procure Lanacare</ProprietaryName>
    <NonProprietaryName>Lanolin 30%</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20250915</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>Twin Med LLC</LabelerName>
    <SubstanceName>LANOLIN</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-09-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses: 1 Temporarily protects minor cuts, scrapes, and burns, 2 Temporarily protects and helps relieve chafed, chapped or cracked skin, 3 Helps protect from the drying effects of wind and cold weather.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>57344-028-05</NDCCode>
    <PackageDescription>72 TABLET in 1 BOTTLE, PLASTIC (57344-028-05) </PackageDescription>
    <NDC11Code>57344-0028-05</NDC11Code>
    <ProductNDC>57344-028</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Diphenhydramine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Diphenhydramine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20121215</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part338</ApplicationNumber>
    <LabelerName>AAA Pharmaceutical, Inc.</LabelerName>
    <SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-10-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20121215</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>60429-028-05</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (60429-028-05)</PackageDescription>
    <NDC11Code>60429-0028-05</NDC11Code>
    <ProductNDC>60429-028</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Benzonatate</ProprietaryName>
    <NonProprietaryName>Benzonatate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070725</StartMarketingDate>
    <EndMarketingDate>20180228</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040749</ApplicationNumber>
    <LabelerName>Golden State Medical Supply, Inc.</LabelerName>
    <SubstanceName>BENZONATATE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-03-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>63148-028-05</NDCCode>
    <PackageDescription>532 mL in 1 BOTTLE, PLASTIC (63148-028-05) </PackageDescription>
    <NDC11Code>63148-0028-05</NDC11Code>
    <ProductNDC>63148-028</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Life Is Healed</ProprietaryName>
    <ProprietaryNameSuffix>Daily Moisturizing</ProprietaryNameSuffix>
    <NonProprietaryName>Dimethicone</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210720</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>505G(a)(3)</ApplicationNumber>
    <LabelerName>Apollo Health and Beauty Care</LabelerName>
    <SubstanceName>DIMETHICONE</SubstanceName>
    <StrengthNumber>12</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210720</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps prevent and temporarily protects chafed, chapped or cracked skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>64406-028-01</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (64406-028-01)  / .05 mL in 1 VIAL, SINGLE-DOSE (64406-028-02) </PackageDescription>
    <NDC11Code>64406-0028-01</NDC11Code>
    <ProductNDC>64406-028</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Opuviz</ProprietaryName>
    <NonProprietaryName>Aflibercept-yszy</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVITREAL</RouteName>
    <StartMarketingDate>20250531</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761350</ApplicationNumber>
    <LabelerName>Biogen Inc.</LabelerName>
    <SubstanceName>AFLIBERCEPT</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-09-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250531</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>OPUVIZ is indicated for the treatment of.</IndicationAndUsage>
    <Description>Aflibercept-yszy is a recombinant fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 formulated as an iso-osmotic solution for intravitreal administration. Aflibercept-yszy is a dimeric glycoprotein with a protein molecular weight of 97 kilodaltons (kDa) and contains glycosylation, constituting an additional 15% of the total molecular mass, resulting in a total molecular weight of 115 kDa. Aflibercept-yszy is produced in recombinant Chinese hamster ovary (CHO) cells. OPUVIZ (aflibercept-yszy) injection is a sterile, clear, and colorless to pale yellow solution. OPUVIZ does not contain anti-microbial preservative and is supplied as a sterile, aqueous solution for intravitreal injection in a single-dose glass vial designed to deliver 0.05 mL (50 microliters) of solution containing 2 mg of aflibercept-yszy in dibasic sodium phosphate (0.008 mg), monobasic sodium phosphate (0.040 mg), polysorbate 20 (0.015 mg), sucrose (4 mg) and water for injection, with a pH of 6.2.</Description>
  </NDC>
  <NDC>
    <NDCCode>64406-028-03</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (64406-028-03)  / .05 mL in 1 VIAL, SINGLE-DOSE (64406-028-02) </PackageDescription>
    <NDC11Code>64406-0028-03</NDC11Code>
    <ProductNDC>64406-028</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Opuviz</ProprietaryName>
    <NonProprietaryName>Aflibercept-yszy</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVITREAL</RouteName>
    <StartMarketingDate>20250531</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761350</ApplicationNumber>
    <LabelerName>Biogen Inc.</LabelerName>
    <SubstanceName>AFLIBERCEPT</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-09-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250531</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>OPUVIZ is indicated for the treatment of.</IndicationAndUsage>
    <Description>Aflibercept-yszy is a recombinant fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 formulated as an iso-osmotic solution for intravitreal administration. Aflibercept-yszy is a dimeric glycoprotein with a protein molecular weight of 97 kilodaltons (kDa) and contains glycosylation, constituting an additional 15% of the total molecular mass, resulting in a total molecular weight of 115 kDa. Aflibercept-yszy is produced in recombinant Chinese hamster ovary (CHO) cells. OPUVIZ (aflibercept-yszy) injection is a sterile, clear, and colorless to pale yellow solution. OPUVIZ does not contain anti-microbial preservative and is supplied as a sterile, aqueous solution for intravitreal injection in a single-dose glass vial designed to deliver 0.05 mL (50 microliters) of solution containing 2 mg of aflibercept-yszy in dibasic sodium phosphate (0.008 mg), monobasic sodium phosphate (0.040 mg), polysorbate 20 (0.015 mg), sucrose (4 mg) and water for injection, with a pH of 6.2.</Description>
  </NDC>
  <NDC>
    <NDCCode>64406-028-04</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (64406-028-04)  / .05 mL in 1 VIAL, SINGLE-DOSE (64406-028-05) </PackageDescription>
    <NDC11Code>64406-0028-04</NDC11Code>
    <ProductNDC>64406-028</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Opuviz</ProprietaryName>
    <NonProprietaryName>Aflibercept-yszy</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVITREAL</RouteName>
    <StartMarketingDate>20250531</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761350</ApplicationNumber>
    <LabelerName>Biogen Inc.</LabelerName>
    <SubstanceName>AFLIBERCEPT</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-09-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250531</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>OPUVIZ is indicated for the treatment of.</IndicationAndUsage>
    <Description>Aflibercept-yszy is a recombinant fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 formulated as an iso-osmotic solution for intravitreal administration. Aflibercept-yszy is a dimeric glycoprotein with a protein molecular weight of 97 kilodaltons (kDa) and contains glycosylation, constituting an additional 15% of the total molecular mass, resulting in a total molecular weight of 115 kDa. Aflibercept-yszy is produced in recombinant Chinese hamster ovary (CHO) cells. OPUVIZ (aflibercept-yszy) injection is a sterile, clear, and colorless to pale yellow solution. OPUVIZ does not contain anti-microbial preservative and is supplied as a sterile, aqueous solution for intravitreal injection in a single-dose glass vial designed to deliver 0.05 mL (50 microliters) of solution containing 2 mg of aflibercept-yszy in dibasic sodium phosphate (0.008 mg), monobasic sodium phosphate (0.040 mg), polysorbate 20 (0.015 mg), sucrose (4 mg) and water for injection, with a pH of 6.2.</Description>
  </NDC>
  <NDC>
    <NDCCode>64406-028-06</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (64406-028-06)  / .05 mL in 1 VIAL, SINGLE-DOSE (64406-028-05) </PackageDescription>
    <NDC11Code>64406-0028-06</NDC11Code>
    <ProductNDC>64406-028</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Opuviz</ProprietaryName>
    <NonProprietaryName>Aflibercept-yszy</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVITREAL</RouteName>
    <StartMarketingDate>20250531</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761350</ApplicationNumber>
    <LabelerName>Biogen Inc.</LabelerName>
    <SubstanceName>AFLIBERCEPT</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-09-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250531</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>OPUVIZ is indicated for the treatment of.</IndicationAndUsage>
    <Description>Aflibercept-yszy is a recombinant fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 formulated as an iso-osmotic solution for intravitreal administration. Aflibercept-yszy is a dimeric glycoprotein with a protein molecular weight of 97 kilodaltons (kDa) and contains glycosylation, constituting an additional 15% of the total molecular mass, resulting in a total molecular weight of 115 kDa. Aflibercept-yszy is produced in recombinant Chinese hamster ovary (CHO) cells. OPUVIZ (aflibercept-yszy) injection is a sterile, clear, and colorless to pale yellow solution. OPUVIZ does not contain anti-microbial preservative and is supplied as a sterile, aqueous solution for intravitreal injection in a single-dose glass vial designed to deliver 0.05 mL (50 microliters) of solution containing 2 mg of aflibercept-yszy in dibasic sodium phosphate (0.008 mg), monobasic sodium phosphate (0.040 mg), polysorbate 20 (0.015 mg), sucrose (4 mg) and water for injection, with a pH of 6.2.</Description>
  </NDC>
  <NDC>
    <NDCCode>65219-028-05</NDCCode>
    <PackageDescription>1 SYRINGE, GLASS in 1 CARTON (65219-028-05)  / 1 mL in 1 SYRINGE, GLASS</PackageDescription>
    <NDC11Code>65219-0028-05</NDC11Code>
    <ProductNDC>65219-028</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ganirelix Acetate</ProprietaryName>
    <NonProprietaryName>Ganirelix Acetate</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20230324</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215658</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>GANIRELIX ACETATE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>ug/.5mL</StrengthUnit>
    <Pharm_Classes>Decreased GnRH Secretion [PE], Gonadotropin Releasing Hormone Receptor Antagonist [EPC], Gonadotropin Releasing Hormone Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-05-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230324</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ganirelix Acetate Injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation.</IndicationAndUsage>
    <Description>Ganirelix Acetate Injection is a synthetic decapeptide with high antagonistic activity against naturally occurring gonadotropin-releasing hormone (GnRH). Ganirelix Acetate is derived from native GnRH with substitutions of amino acids at positions 1, 2, 3, 6, 8, and 10 to form the following molecular formula of the peptide: N-acetyl-3-(2-naphthyl)-D-alanyl-4-chloro-D-phenylalanyl-3-(3-pyridyl)-D-alanyl-L-seryl-L-tyrosyl-N9,N10-diethyl-D-homoarginyl-L-leucyl-N9,N10-diethyl-L-homoarginyl-L-prolyl-D-alanylamide acetate. The molecular weight for Ganirelix Acetate is 1570.4 as an anhydrous free base. The structural formula is as follows:. Ganirelix Acetate. Ganirelix Acetate Injection is supplied as a colorless, sterile, ready-to-use, aqueous solution intended for SUBCUTANEOUS administration only. Each single dose, sterile, prefilled syringe contains 250 mcg/0.5 mL of Ganirelix Acetate, 0.1 mg glacial acetic acid, 23.5 mg mannitol, and water for injection adjusted to pH 5.0 with acetic acid, NF and/or sodium hydroxide, NF.</Description>
  </NDC>
  <NDC>
    <NDCCode>65841-028-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (65841-028-05) </PackageDescription>
    <NDC11Code>65841-0028-05</NDC11Code>
    <ProductNDC>65841-028</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metformin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20050928</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077064</ApplicationNumber>
    <LabelerName>Zydus Lifesciences Limited</LabelerName>
    <SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20050928</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>68382-028-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (68382-028-05) </PackageDescription>
    <NDC11Code>68382-0028-05</NDC11Code>
    <ProductNDC>68382-028</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metformin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20050928</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077064</ApplicationNumber>
    <LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
    <SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Biguanide [EPC],Biguanides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-12-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20050928</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>69539-028-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (69539-028-05) </PackageDescription>
    <NDC11Code>69539-0028-05</NDC11Code>
    <ProductNDC>69539-028</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lacosamide</ProprietaryName>
    <NonProprietaryName>Lacosamide</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220319</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204921</ApplicationNumber>
    <LabelerName>MSN LABORATORIES PRIVATE LIMITED</LabelerName>
    <SubstanceName>LACOSAMIDE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2022-04-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220319</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>70010-028-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (70010-028-05) </PackageDescription>
    <NDC11Code>70010-0028-05</NDC11Code>
    <ProductNDC>70010-028</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ramelteon</ProprietaryName>
    <NonProprietaryName>Ramelteon</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201001</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213186</ApplicationNumber>
    <LabelerName>Granules Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>RAMELTEON</SubstanceName>
    <StrengthNumber>8</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Melatonin Receptor Agonist [EPC], Melatonin Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-08-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. The clinical trials performed in support of efficacy were up to six months in duration. The final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six week studies (adults and elderly), and at the end of the six month study (adults and elderly) [see Clinical Studies (14)].</IndicationAndUsage>
    <Description>Ramelteon is an orally active hypnotic chemically designated as ( S)- N-[2-(1,6,7,8-tetrahydro-2 H-indeno-[5,4- b]furan-8-yl)ethyl]propionamide and containing one chiral center. The compound is produced as the ( S)-enantiomer, with an empirical formula of C 16 H 21 NO 2, molecular weight of 259.34, and the following chemical structure:. Ramelteon is freely soluble in organic solvents, such as methanol, ethanol, and dimethyl sulfoxide; soluble in 1-octanol and acetonitrile; and very slightly soluble in water and in aqueous buffers from pH 3 to pH 11. Each Ramelteon tablet includes the following inactive ingredients: copovidone, corn starch, hydroxypropyl cellulose, iron oxide yellow, lactose monohydrate, magnesium stearate, polyethylene glycol, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>71209-028-05</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (71209-028-05) </PackageDescription>
    <NDC11Code>71209-0028-05</NDC11Code>
    <ProductNDC>71209-028</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Venlafaxine</ProprietaryName>
    <NonProprietaryName>Venlafaxine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20181203</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206250</ApplicationNumber>
    <LabelerName>Cadila Pharmaceuticals Limited</LabelerName>
    <SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181203</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Venlafaxine tablets are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine tablets in the treatment of major depressive disorder was established in 6 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4 week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (seeCLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Venlafaxine hydrochloride, USP is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethylamino)methyl]-p- methoxybenzyl]cyclohexanol hydrochloride. The structural formula is shown below. C17H27NO2 HCl                                                              M.W. 313.87 Venlafaxine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol: water (0.2 M sodium chloride) partition coefficient is 0.43. Compressed tablets contain venlafaxine hydrochloride, USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg venlafaxine. Inactive ingredients consist of colloidal silicon dioxide, ferric oxide yellow, ferric oxide red, lactose monohydrate, magnesium stearate, and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>71261-028-05</NDCCode>
    <PackageDescription>1 POUCH in 1 CARTON (71261-028-05)  / 14 g in 1 POUCH (71261-028-04) </PackageDescription>
    <NDC11Code>71261-0028-05</NDC11Code>
    <ProductNDC>71261-028</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Jungsaemmool Essential Skin Nuder Cushion Fair Light</ProprietaryName>
    <NonProprietaryName>Titanium Dioxide, Octinoxate, Octisalate</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240729</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Jungsaemmool Beauty Co., Ltd.</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE</SubstanceName>
    <StrengthNumber>65.1; 67; 40</StrengthNumber>
    <StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-04-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260417</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Helps prevent sunburn If used as directed with other sun protection measures (see Directions) decrease the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>72197-028-05</NDCCode>
    <PackageDescription>147 mL in 1 BOTTLE (72197-028-05) </PackageDescription>
    <NDC11Code>72197-0028-05</NDC11Code>
    <ProductNDC>72197-028</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Pharmacys Prescription Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200505</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>American Consumer Products Corp</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>65</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200505</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses - Helps reduce bacteria on the skin that could cause disease. Recommended for repeated use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>72205-028-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (72205-028-05) </PackageDescription>
    <NDC11Code>72205-0028-05</NDC11Code>
    <ProductNDC>72205-028</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Febuxostat</ProprietaryName>
    <NonProprietaryName>Febuxostat</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20191230</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210461</ApplicationNumber>
    <LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
    <SubstanceName>FEBUXOSTAT</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191230</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Febuxostat tablets are xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable.Limitations of Use: Febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia.</IndicationAndUsage>
    <Description>Febuxostat is a xanthine oxidase inhibitor. The active ingredient in febuxostat is 2-[3-cyano-4-(2-methylpropoxy) phenyl]-4-methylthiazole-5-carboxylic acid hemihydrate, with a molecular weight of 325.39. The molecular formula is C16H16N2O3S 1/2 H2O. The chemical structure is. Febuxostat is a non-hygroscopic, white to yellowish crystalline powder that is soluble in dimethyl formamide, slightly soluble in methanol and insoluble in water. The melting range is 207oC to 210°C. Febuxostat tablets for oral use contain the active ingredient, febuxostat, and are available in two dosage strengths, 40 mg and 80 mg. Inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, microcrystalline cellulose and magnesium stearate. Febuxostat tablets are coated with polyvinyl alcohol, macrogol, titanium dioxide, talc, D&amp;C yellow #10 aluminum lake, FD&amp;C blue #1/brilliant blue FCF aluminum lake, FD&amp;C blue #2/indigo carmine AL 3%-5% (40 mg), additionally iron oxide yellow (80 mg).</Description>
  </NDC>
  <NDC>
    <NDCCode>72241-028-05</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (72241-028-05) </PackageDescription>
    <NDC11Code>72241-0028-05</NDC11Code>
    <ProductNDC>72241-028</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Acyclovir</ProprietaryName>
    <NonProprietaryName>Acyclovir</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210818</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA201445</ApplicationNumber>
    <LabelerName>Modavar Pharmaceuticals LLC</LabelerName>
    <SubstanceName>ACYCLOVIR</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210818</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Herpes Zoster Infections:Acyclovir capsules is indicated for the acute treatment of herpes zoster (shingles).Genital Herpes:Acyclovir capsules is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes.Chickenpox:Acyclovir capsules is indicated for the treatment of chickenpox (varicella).</IndicationAndUsage>
    <Description>Acyclovir, a synthetic nucleoside analogue active against herpesviruses. Acyclovir Capsules, is a formulation for oral administration. Each Acyclovir Capsule contains 200 mg of acyclovir and the inactive ingredients corn starch, lactose monohydrate, magnesium stearate, and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&amp;C Blue No. 2, and titanium dioxide. Printed with edible black ink. Acyclovir is a white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir are 2.27 and 9.25.The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula. VIROLOGYMechanism of Antiviral Action:Acyclovir is a synthetic purine nucleoside analogue with in vitro and in vivo inhibitory activity against herpes simplex virus types 1 (HSV-1), 2 (HSV-2), and varicella-zoster virus (VZV). The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV and VZV. This viral enzyme converts acyclovir into acyclovir monophosphate, a nucleotide analogue. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. In vitro, acyclovir triphosphate stops replication of herpes viral DNA. This is accomplished in 3 ways: 1) competitive inhibition of viral DNA polymerase, 2) incorporation into and termination of the growing viral DNA chain, and 3) inactivation of the viral DNA polymerase. The greater antiviral activity of acyclovir against HSV compared with VZV is due to its more efficient phosphorylation by the viral TK. Antiviral Activities: The quantitative relationship between the in vitro susceptibility of herpes viruses to antivirals and the clinical response to therapy has not been established in humans, and virus sensitivity testing has not been standardized. Sensitivity testing results, expressed as the concentration of drug required to inhibit by 50% the growth of virus in cell culture (IC50), vary greatly depending upon a number of factors. Using plaque-reduction assays, the IC50 against herpes simplex virus isolates ranges from 0.02 to 13.5 mcg/mL for HSV-1 and from 0.01 to 9.9 mcg/mL for HSV-2. The IC50 for acyclovir against most laboratory strains and clinical isolates of VZV ranges from 0.12 to 10.8 mcg/mL. Acyclovir also demonstrates activity against the Oka vaccine strain of VZV with a mean IC50 of 1.35 mcg/mL.Drug Resistance: Resistance of HSV and VZV to acyclovir can result from qualitative and quantitative changes in the viral TK and/or DNA polymerase. Clinical isolates of HSV and VZV with reduced susceptibility to acyclovir have been recovered from immunocompromised patients, especially with advanced HIV infection. While most of the acyclovir-resistant mutants isolated thus far from immunocompromised patients have been found to be TK-deficient mutants, other mutants involving the viral TK gene (TK partial and TK altered) and DNA polymerase have been isolated. TK-negative mutants may cause severe disease in infants and immunocompromised adults. The possibility of viral resistance to acyclovir should be considered in patients who show poor clinical response during therapy.</Description>
  </NDC>
  <NDC>
    <NDCCode>72643-028-05</NDCCode>
    <PackageDescription>50 kg in 1 DRUM (72643-028-05) </PackageDescription>
    <NDC11Code>72643-0028-05</NDC11Code>
    <ProductNDC>72643-028</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Disulfiram</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20220307</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Solara Active Pharma Sciences Limited</LabelerName>
    <SubstanceName>DISULFIRAM</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>07-MAR-22</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>72888-028-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (72888-028-05) </PackageDescription>
    <NDC11Code>72888-0028-05</NDC11Code>
    <ProductNDC>72888-028</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lamotrigine</ProprietaryName>
    <NonProprietaryName>Lamotrigine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20211029</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078625</ApplicationNumber>
    <LabelerName>Advagen Pharma Limited</LabelerName>
    <SubstanceName>LAMOTRIGINE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211029</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs Lamotrigine’s. Its chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)- as-triazine, its molecular formula is C 9H 7N 5Cl 2, and its molecular weight is 256.09. Lamotrigine is a white to pale cream-colored powder and has a pK aof 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is:. Lamotrigine tablets, USP are supplied for oral administration as 25 mg, 100 mg, 150 mg and 200 mg tablets. Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>73126-028-05</NDCCode>
    <PackageDescription>355 mL in 1 BOTTLE (73126-028-05) </PackageDescription>
    <NDC11Code>73126-0028-05</NDC11Code>
    <ProductNDC>73126-028</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Shock Doctor Hand Sanitizer- Eucalyptus</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200901</StartMarketingDate>
    <EndMarketingDate>20240420</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>LAB-CLEAN, INC</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-04-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20200901</StartMarketingDatePackage>
    <EndMarketingDatePackage>20240420</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>73212-028-05</NDCCode>
    <PackageDescription>5 g in 1 BOTTLE (73212-028-05) </PackageDescription>
    <NDC11Code>73212-0028-05</NDC11Code>
    <ProductNDC>73212-028</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Phentolamine Mesylate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20230102</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Qingdao Biopeptek Co., Ltd.</LabelerName>
    <SubstanceName>PHENTOLAMINE MESYLATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-01-12</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>02-JAN-23</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>73905-028-05</NDCCode>
    <PackageDescription>980 mL in 1 BOTTLE (73905-028-05) </PackageDescription>
    <NDC11Code>73905-0028-05</NDC11Code>
    <ProductNDC>73905-028</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200320</StartMarketingDate>
    <EndMarketingDate>20240423</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>505G(a)(3)</ApplicationNumber>
    <LabelerName>ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-04-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20200320</StartMarketingDatePackage>
    <EndMarketingDatePackage>20240423</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>75448-028-05</NDCCode>
    <PackageDescription>320 mL in 1 BAG (75448-028-05) </PackageDescription>
    <NDC11Code>75448-0028-05</NDC11Code>
    <ProductNDC>75448-028</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Egolan Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20201013</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Sanrace Biotechnology Co., Ltd.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201013</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hand sanitizer to help reduce bacteria on the skin.</IndicationAndUsage>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>54414-028-05</NDCCode><ProprietaryName>Dermatone Spf50 Sunscreen</ProprietaryName><NonProprietaryName>Avabenzone 3% Homosalate 10% Octisalate 5%</NonProprietaryName></NDC><NDC><NDCCode>10019-028-05</NDCCode><ProprietaryName>Midazolam Hydrochloride</ProprietaryName><NonProprietaryName>Midazolam Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>11410-028-05</NDCCode><ProprietaryName>Proactiv Cover And Heal Duo Concealer Light And Medium</ProprietaryName><NonProprietaryName>Salicylic Acid</NonProprietaryName></NDC><NDC><NDCCode>11788-028-05</NDCCode><ProprietaryName>Benzonatate</ProprietaryName><NonProprietaryName>Benzonatate</NonProprietaryName></NDC><NDC><NDCCode>42385-028-05</NDCCode><NonProprietaryName>Latanoprost</NonProprietaryName></NDC><NDC><NDCCode>52343-028-05</NDCCode><ProprietaryName>Carvedilol</ProprietaryName><NonProprietaryName>Carvedilol</NonProprietaryName></NDC><NDC><NDCCode>55681-028-14</NDCCode><ProprietaryName>Procure Lanacare</ProprietaryName><NonProprietaryName>Lanolin 30%</NonProprietaryName></NDC><NDC><NDCCode>57344-028-05</NDCCode><ProprietaryName>Diphenhydramine Hydrochloride</ProprietaryName><NonProprietaryName>Diphenhydramine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>60429-028-05</NDCCode><ProprietaryName>Benzonatate</ProprietaryName><NonProprietaryName>Benzonatate</NonProprietaryName></NDC><NDC><NDCCode>63148-028-05</NDCCode><ProprietaryName>Life Is Healed</ProprietaryName><NonProprietaryName>Dimethicone</NonProprietaryName></NDC><NDC><NDCCode>64406-028-01</NDCCode><ProprietaryName>Opuviz</ProprietaryName><NonProprietaryName>Aflibercept-yszy</NonProprietaryName></NDC><NDC><NDCCode>64406-028-03</NDCCode><ProprietaryName>Opuviz</ProprietaryName><NonProprietaryName>Aflibercept-yszy</NonProprietaryName></NDC><NDC><NDCCode>64406-028-04</NDCCode><ProprietaryName>Opuviz</ProprietaryName><NonProprietaryName>Aflibercept-yszy</NonProprietaryName></NDC><NDC><NDCCode>64406-028-06</NDCCode><ProprietaryName>Opuviz</ProprietaryName><NonProprietaryName>Aflibercept-yszy</NonProprietaryName></NDC><NDC><NDCCode>65219-028-05</NDCCode><ProprietaryName>Ganirelix Acetate</ProprietaryName><NonProprietaryName>Ganirelix Acetate</NonProprietaryName></NDC><NDC><NDCCode>65841-028-05</NDCCode><ProprietaryName>Metformin Hydrochloride</ProprietaryName><NonProprietaryName>Metformin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>68382-028-05</NDCCode><ProprietaryName>Metformin Hydrochloride</ProprietaryName><NonProprietaryName>Metformin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>69539-028-05</NDCCode><ProprietaryName>Lacosamide</ProprietaryName><NonProprietaryName>Lacosamide</NonProprietaryName></NDC><NDC><NDCCode>70010-028-05</NDCCode><ProprietaryName>Ramelteon</ProprietaryName><NonProprietaryName>Ramelteon</NonProprietaryName></NDC><NDC><NDCCode>71209-028-05</NDCCode><ProprietaryName>Venlafaxine</ProprietaryName><NonProprietaryName>Venlafaxine</NonProprietaryName></NDC><NDC><NDCCode>71261-028-05</NDCCode><ProprietaryName>Jungsaemmool Essential Skin Nuder Cushion Fair Light</ProprietaryName><NonProprietaryName>Titanium Dioxide, Octinoxate, Octisalate</NonProprietaryName></NDC><NDC><NDCCode>72197-028-05</NDCCode><ProprietaryName>Pharmacys Prescription Hand Sanitizer</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>72205-028-05</NDCCode><ProprietaryName>Febuxostat</ProprietaryName><NonProprietaryName>Febuxostat</NonProprietaryName></NDC><NDC><NDCCode>72241-028-05</NDCCode><ProprietaryName>Acyclovir</ProprietaryName><NonProprietaryName>Acyclovir</NonProprietaryName></NDC><NDC><NDCCode>72643-028-05</NDCCode><NonProprietaryName>Disulfiram</NonProprietaryName></NDC><NDC><NDCCode>72888-028-05</NDCCode><ProprietaryName>Lamotrigine</ProprietaryName><NonProprietaryName>Lamotrigine</NonProprietaryName></NDC><NDC><NDCCode>73126-028-05</NDCCode><ProprietaryName>Shock Doctor Hand Sanitizer- Eucalyptus</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>73212-028-05</NDCCode><NonProprietaryName>Phentolamine Mesylate</NonProprietaryName></NDC><NDC><NDCCode>73905-028-05</NDCCode><ProprietaryName>Hand Sanitizer</ProprietaryName><NonProprietaryName>Ethyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>75448-028-05</NDCCode><ProprietaryName>Egolan Hand Sanitizer</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/04/2006",
      "LastUpdateDate": "12/11/2007",
      "AuthorizedOfficialLastName": "MONTECILLO",
      "AuthorizedOfficialFirstName": "RANIA",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-7363",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "801TX",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1346319878",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "REDMOND EYE CLINIC PLLC",
      "FirstLineMailingAddress": "16150 NE 85TH ST STE 206",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3543",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-3574",
      "MailingAddressFaxNumber": "425-881-0230",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "PracticeLocationAddressFaxNumber": "425-881-0230",
      "EnumerationDate": "11/07/2006",
      "LastUpdateDate": "07/08/2007",
      "AuthorizedOfficialLastName": "OTTEN",
      "AuthorizedOfficialFirstName": "LARRY",
      "AuthorizedOfficialMiddleName": "C",
      "AuthorizedOfficialTitle": "DR",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-3574",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "OD00001172",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
    },
    {
      "NPI": "1376755009",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "PERIMAN",
      "FirstName": "LAURA",
      "MiddleName": "MARIE",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "FirstLineMailingAddress": "623 W HIGHLAND DR",
      "MailingAddressCityName": "SEATTLE",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98119-3446",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "206-282-2716",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "SecondLinePracticeLocationAddress": "REDMOND EYE CLINIC",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
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  ]
}

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

                
{
  "NPI": [
    {
      "NPI": "1083349906",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "STAFFORD",
      "FirstName": "KADY",
      "NamePrefix": "MS.",
      "Credential": "LPC",
      "FirstLineMailingAddress": "13574 SW HIGHWAY 126",
      "MailingAddressCityName": "POWELL BUTTE",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97753-1541",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-480-6360",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-203-0307",
      "EnumerationDate": "07/24/2022",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional Counselor",
      "LicenseNumber1": "LPC6225",
      "LicenseNumberStateCode1": "ID",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C9084",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1215724679",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "SCHAY",
      "FirstName": "ANGELICA",
      "MiddleName": "NICOLE",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1841",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1841",
      "EnumerationDate": "04/21/2025",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101Y00000X",
      "Taxonomy1": "Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101Y00000X",
      "PrimaryTaxonomy": "Counselor"
    },
    {
      "NPI": "1013556505",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "IVENS",
      "FirstName": "KRYSTA",
      "FirstLineMailingAddress": "743 NW QUINCE AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-1250",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "360-526-1448",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "971-217-6150",
      "EnumerationDate": "12/31/2019",
      "LastUpdateDate": "02/15/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C7963",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "02/15/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1497336275",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ARANT",
      "FirstName": "ERIN",
      "MiddleName": "HENNESSEY",
      "FirstLineMailingAddress": "4639 SW 37TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-6776",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "04/14/2021",
      "LastUpdateDate": "04/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "225X00000X",
      "Taxonomy1": "Occupational Therapist",
      "LicenseNumber1": "390047",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/14/2021",
      "PrimaryTaxonomyCode": "225X00000X",
      "PrimaryTaxonomy": "Occupational Therapist"
    },
    {
      "NPI": "1174191407",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "GRIMALT",
      "FirstName": "EUGENIA",
      "MiddleName": "N",
      "Credential": "PT",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "06/14/2021",
      "LastUpdateDate": "06/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "2251P0200X",
      "Taxonomy1": "Pediatric Physical Therapist",
      "LicenseNumber1": "63979",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization.",
      "CertificationDate": "06/14/2021",
      "PrimaryTaxonomyCode": "2251P0200X",
      "PrimaryTaxonomy": "Pediatric Physical Therapist"
    },
    {
      "NPI": "1912604117",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "PAINTER",
      "FirstName": "JENNIFER",
      "FirstLineMailingAddress": "20080 DOANNA WAY UNIT 3",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-2931",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "209-743-9813",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/08/2023",
      "LastUpdateDate": "02/08/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/08/2023",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1396434700",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "GROVE",
      "FirstName": "JENNIFER",
      "MiddleName": "RHEA",
      "FirstLineMailingAddress": "303 NW BROADWAY ST",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97703-2658",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "801-573-6047",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "801-573-6047",
      "EnumerationDate": "05/02/2023",
      "LastUpdateDate": "05/02/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1041C0700X",
      "Taxonomy1": "Clinical Social Worker",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "05/02/2023",
      "PrimaryTaxonomyCode": "1041C0700X",
      "PrimaryTaxonomy": "Clinical Social Worker"
    },
    {
      "NPI": "1407698970",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "REDDEN",
      "FirstName": "SHANNON",
      "Credential": "CHW",
      "OtherLastName": "MCDOUGALL",
      "OtherFirstName": "SHANNON",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2312 NE 5TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8488",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-460-2192",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "PracticeLocationAddressFaxNumber": "541-550-7956",
      "EnumerationDate": "06/06/2024",
      "LastUpdateDate": "06/06/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "172V00000X",
      "Taxonomy1": "Community Health Worker",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "06/06/2024",
      "PrimaryTaxonomyCode": "172V00000X",
      "PrimaryTaxonomy": "Community Health Worker"
    },
    {
      "NPI": "1942022256",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "JACQUOT",
      "FirstName": "SHAYLA",
      "FirstLineMailingAddress": "PO BOX 1397",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97709-1397",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "10/28/2024",
      "LastUpdateDate": "10/28/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "10/26/2024",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1912723131",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "WEIMER",
      "FirstName": "ALAYNA",
      "FirstLineMailingAddress": "2748 NW 19TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-7766",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-499-8292",
      "EnumerationDate": "12/03/2024",
      "LastUpdateDate": "12/03/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "171M00000X",
      "Taxonomy1": "Case Manager/Care Coordinator",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/03/2024",
      "PrimaryTaxonomyCode": "171M00000X",
      "PrimaryTaxonomy": "Case Manager/Care Coordinator"
    },
    {
      "NPI": "1790594125",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "WIDDER",
      "FirstName": "JENNIFER",
      "MiddleName": "LYNN",
      "FirstLineMailingAddress": "22350 CALGARY DR",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-9216",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-749-8895",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1858",
      "EnumerationDate": "12/31/2024",
      "LastUpdateDate": "12/31/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "175T00000X",
      "Taxonomy1": "Peer Specialist",
      "LicenseNumber1": "112910",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/31/2024",
      "PrimaryTaxonomyCode": "175T00000X",
      "PrimaryTaxonomy": "Peer Specialist"
    },
    {
      "NPI": "1538965306",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "PARSONS",
      "FirstName": "JEANINE",
      "MiddleName": "JEWELL",
      "FirstLineMailingAddress": "2821 SW 28TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8681",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "760-927-4761",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/21/2025",
      "LastUpdateDate": "02/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "175T00000X",
      "Taxonomy1": "Peer Specialist",
      "LicenseNumber1": "113398",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/21/2025",
      "PrimaryTaxonomyCode": "175T00000X",
      "PrimaryTaxonomy": "Peer Specialist"
    }
  ]
}
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