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How to Find 10237-831-14 NDC Data Using DataLabs API

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{
  "NDC": [
    {
      "NDCCode": "10237-831-14",
      "PackageDescription": "40 g in 1 CANISTER (10237-831-14)",
      "NDC11Code": "10237-0831-14",
      "ProductNDC": "10237-831",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ladys Choice Invisible Solid",
      "ProprietaryNameSuffix": "Antiperspirant Deodorant Powder Fresh",
      "NonProprietaryName": "Aluminum Chlorohydrate",
      "DosageFormName": "STICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20020601",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part350",
      "LabelerName": "Church & Dwight Co., Inc.",
      "SubstanceName": "ALUMINUM CHLOROHYDRATE",
      "StrengthNumber": "20",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "reduces underarm perspiration."
    },
    {
      "NDCCode": "46122-831-45",
      "PackageDescription": "14 PATCH in 1 CARTON (46122-831-45)  / 24 h in 1 PATCH",
      "NDC11Code": "46122-0831-45",
      "ProductNDC": "46122-831",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Nicotine Transdermal System",
      "ProprietaryNameSuffix": "Step 3",
      "NonProprietaryName": "Nicotine",
      "DosageFormName": "PATCH, EXTENDED RELEASE",
      "RouteName": "TRANSDERMAL",
      "StartMarketingDate": "20260701",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020076",
      "LabelerName": "AmerisourceBergen Drug Corporation",
      "SubstanceName": "NICOTINE",
      "StrengthNumber": "7",
      "StrengthUnit": "mg/24h",
      "Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
      "Status": "Active",
      "LastUpdate": "2026-07-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260701",
      "SamplePackage": "N",
      "IndicationAndUsage": "reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
    },
    {
      "NDCCode": "51009-831-14",
      "PackageDescription": "13.5 g in 1 CANISTER (51009-831-14) ",
      "NDC11Code": "51009-0831-14",
      "ProductNDC": "51009-831",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Naturally Dry",
      "ProprietaryNameSuffix": "Natural",
      "NonProprietaryName": "Aluminum Chlorohydrate",
      "DosageFormName": "STICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20120102",
      "EndMarketingDate": "20220501",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part350",
      "LabelerName": "Tom's of Maine, Inc.",
      "SubstanceName": "ALUMINUM CHLOROHYDRATE",
      "StrengthNumber": ".22",
      "StrengthUnit": "g/g",
      "Status": "Deprecated",
      "LastUpdate": "2022-05-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20120102",
      "EndMarketingDatePackage": "20220501",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "59779-831-29",
      "PackageDescription": "1 BOTTLE, WITH APPLICATOR in 1 CARTON (59779-831-29)  > 14.17 g in 1 BOTTLE, WITH APPLICATOR (59779-831-21)",
      "NDC11Code": "59779-0831-29",
      "ProductNDC": "59779-831",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Instant Toothache Pain Relief",
      "NonProprietaryName": "Benzocaine",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20091001",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part333B",
      "LabelerName": "CVS Pharmacy",
      "SubstanceName": "BENZOCAINE",
      "StrengthNumber": "20",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2019-02-16",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "10237-591-14",
      "PackageDescription": "6804 g in 1 BAG (10237-591-14) ",
      "NDC11Code": "10237-0591-14",
      "ProductNDC": "10237-591",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Arm And Hammer Baking Soda",
      "NonProprietaryName": "Sodium Bicarbonate",
      "DosageFormName": "POWDER, FOR SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20000101",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "Church & Dwight Co., Inc.",
      "SubstanceName": "SODIUM BICARBONATE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-03-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20000101",
      "EndMarketingDatePackage": "20260325",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "10237-832-14",
      "PackageDescription": "40 g in 1 CANISTER (10237-832-14)",
      "NDC11Code": "10237-0832-14",
      "ProductNDC": "10237-832",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ladys Choice Invisible Solid",
      "ProprietaryNameSuffix": "Antiperspirant Deodorant Shower Fresh",
      "NonProprietaryName": "Aluminum Chlorohydrate",
      "DosageFormName": "STICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20020601",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part350",
      "LabelerName": "Church & Dwight Co., Inc.",
      "SubstanceName": "ALUMINUM CHLOROHYDRATE",
      "StrengthNumber": "20",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "reduces underarm perspiration."
    },
    {
      "NDCCode": "10237-833-14",
      "PackageDescription": "40 g in 1 CANISTER (10237-833-14)",
      "NDC11Code": "10237-0833-14",
      "ProductNDC": "10237-833",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ladys Choice Invisible Solid",
      "ProprietaryNameSuffix": "Antiperspirant Deodorant Cucumber Melon",
      "NonProprietaryName": "Aluminum Chlorohydrate",
      "DosageFormName": "STICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20030601",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part350",
      "LabelerName": "Church & Dwight Co., Inc.",
      "SubstanceName": "ALUMINUM CHLOROHYDRATE",
      "StrengthNumber": "20",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "reduces underarm perspiration."
    },
    {
      "NDCCode": "10237-834-14",
      "PackageDescription": "40 g in 1 CANISTER (10237-834-14)",
      "NDC11Code": "10237-0834-14",
      "ProductNDC": "10237-834",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ladys Choice Invisible Solid",
      "ProprietaryNameSuffix": "Antiperspirant Deodorant Coconut Lime",
      "NonProprietaryName": "Aluminum Chlorohydrate",
      "DosageFormName": "STICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20040201",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part350",
      "LabelerName": "Church & Dwight Co., Inc.",
      "SubstanceName": "ALUMINUM CHLOROHYDRATE",
      "StrengthNumber": "20",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "reduces underarm perspiration."
    },
    {
      "NDCCode": "16729-259-38",
      "PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (16729-259-38)  > 100 mL in 1 VIAL, SINGLE-USE",
      "NDC11Code": "16729-0259-38",
      "ProductNDC": "16729-259",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Eptifibatide",
      "NonProprietaryName": "Eptifibatide",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20180405",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA205557",
      "LabelerName": "Accord Healthcare Inc.",
      "SubstanceName": "EPTIFIBATIDE",
      "StrengthNumber": ".75",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-05-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20180405",
      "SamplePackage": "N",
      "IndicationAndUsage": "Eptifibatide Injection is a platelet aggregation inhibitor indicated for: 1 Treatment of acute coronary syndrome (ACS) managed medically or with percutaneous coronary intervention (PCI) ( 1.1) , 2 Treatment of patients undergoing PCI (including intracoronary stenting) (  1.2)  .",
      "Description": "Eptifibatide is a cyclic heptapeptide containing 6 amino acids and 1 mercaptopropionyl (des-amino cysteinyl) residue. An interchain disulfide bridge is formed between the cysteine amide and the mercaptopropionyl moieties. Chemically it is N 6-(aminoiminomethyl)-N 2-(3-mercapto-1-oxopropyl)-L-lysylglycyl-L-α-aspartyl-L-tryptophyl-L-prolyl-L-cysteinamide, cyclic (1→6)-disulfide. Eptifibatide binds to the platelet receptor glycoprotein (GP) IIb/IIIa of human platelets and inhibits platelet aggregation. The eptifibatide peptide is produced by solution-phase peptide synthesis, and is purified by preparative reverse-phase liquid chromatography and lyophilized. The structural formula is. Eptifibatide Injection is a clear, colorless, sterile, non-pyrogenic solution for intravenous (IV) use with an empirical formula of C 35H 49N 11O 9S 2 and a molecular weight of 831.96. Each 10-mL vial contains 2 mg/mL of Eptifibatide and each 100-mL vial contains either 0.75 mg/mL of Eptifibatide or 2 mg/mL of Eptifibatide. Each vial of either size also contains 5.25 mg/mL citric acid and sodium hydroxide to adjust the pH to 5.35."
    },
    {
      "NDCCode": "16729-260-03",
      "PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (16729-260-03)  > 10 mL in 1 VIAL, SINGLE-USE",
      "NDC11Code": "16729-0260-03",
      "ProductNDC": "16729-260",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Eptifibatide",
      "NonProprietaryName": "Eptifibatide",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20180409",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA205557",
      "LabelerName": "Accord Healthcare Inc.",
      "SubstanceName": "EPTIFIBATIDE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-05-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20180409",
      "SamplePackage": "N",
      "IndicationAndUsage": "Eptifibatide Injection is a platelet aggregation inhibitor indicated for: 1 Treatment of acute coronary syndrome (ACS) managed medically or with percutaneous coronary intervention (PCI) ( 1.1) , 2 Treatment of patients undergoing PCI (including intracoronary stenting) (  1.2)  .",
      "Description": "Eptifibatide is a cyclic heptapeptide containing 6 amino acids and 1 mercaptopropionyl (des-amino cysteinyl) residue. An interchain disulfide bridge is formed between the cysteine amide and the mercaptopropionyl moieties. Chemically it is N 6-(aminoiminomethyl)-N 2-(3-mercapto-1-oxopropyl)-L-lysylglycyl-L-α-aspartyl-L-tryptophyl-L-prolyl-L-cysteinamide, cyclic (1→6)-disulfide. Eptifibatide binds to the platelet receptor glycoprotein (GP) IIb/IIIa of human platelets and inhibits platelet aggregation. The eptifibatide peptide is produced by solution-phase peptide synthesis, and is purified by preparative reverse-phase liquid chromatography and lyophilized. The structural formula is. Eptifibatide Injection is a clear, colorless, sterile, non-pyrogenic solution for intravenous (IV) use with an empirical formula of C 35H 49N 11O 9S 2 and a molecular weight of 831.96. Each 10-mL vial contains 2 mg/mL of Eptifibatide and each 100-mL vial contains either 0.75 mg/mL of Eptifibatide or 2 mg/mL of Eptifibatide. Each vial of either size also contains 5.25 mg/mL citric acid and sodium hydroxide to adjust the pH to 5.35."
    },
    {
      "NDCCode": "16729-260-38",
      "PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (16729-260-38)  > 100 mL in 1 VIAL, SINGLE-USE",
      "NDC11Code": "16729-0260-38",
      "ProductNDC": "16729-260",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Eptifibatide",
      "NonProprietaryName": "Eptifibatide",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20180409",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA205557",
      "LabelerName": "Accord Healthcare Inc.",
      "SubstanceName": "EPTIFIBATIDE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-05-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20180412",
      "SamplePackage": "N",
      "IndicationAndUsage": "Eptifibatide Injection is a platelet aggregation inhibitor indicated for: 1 Treatment of acute coronary syndrome (ACS) managed medically or with percutaneous coronary intervention (PCI) ( 1.1) , 2 Treatment of patients undergoing PCI (including intracoronary stenting) (  1.2)  .",
      "Description": "Eptifibatide is a cyclic heptapeptide containing 6 amino acids and 1 mercaptopropionyl (des-amino cysteinyl) residue. An interchain disulfide bridge is formed between the cysteine amide and the mercaptopropionyl moieties. Chemically it is N 6-(aminoiminomethyl)-N 2-(3-mercapto-1-oxopropyl)-L-lysylglycyl-L-α-aspartyl-L-tryptophyl-L-prolyl-L-cysteinamide, cyclic (1→6)-disulfide. Eptifibatide binds to the platelet receptor glycoprotein (GP) IIb/IIIa of human platelets and inhibits platelet aggregation. The eptifibatide peptide is produced by solution-phase peptide synthesis, and is purified by preparative reverse-phase liquid chromatography and lyophilized. The structural formula is. Eptifibatide Injection is a clear, colorless, sterile, non-pyrogenic solution for intravenous (IV) use with an empirical formula of C 35H 49N 11O 9S 2 and a molecular weight of 831.96. Each 10-mL vial contains 2 mg/mL of Eptifibatide and each 100-mL vial contains either 0.75 mg/mL of Eptifibatide or 2 mg/mL of Eptifibatide. Each vial of either size also contains 5.25 mg/mL citric acid and sodium hydroxide to adjust the pH to 5.35."
    },
    {
      "NDCCode": "23155-831-31",
      "PackageDescription": "1 VIAL, GLASS in 1 CARTON (23155-831-31)  / 5 mL in 1 VIAL, GLASS",
      "NDC11Code": "23155-0831-31",
      "ProductNDC": "23155-831",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Acetazolamide",
      "NonProprietaryName": "Acetazolamide",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20221115",
      "EndMarketingDate": "20270930",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202693",
      "LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
      "SubstanceName": "ACETAZOLAMIDE SODIUM",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], Sulfonamides [CS]",
      "Status": "Active",
      "LastUpdate": "2026-04-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20221115",
      "EndMarketingDatePackage": "20270930",
      "SamplePackage": "N",
      "IndicationAndUsage": "For adjunctive treatment of: edema due to congestive heart failure; drug-induced edema; centrencephalic epilepsies (petit mal, unlocalized seizures); chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where delay of surgery is desired in order to lower intraocular pressure. Acetazolamide is also indicated for the prevention or amelioration of symptoms associated with acute mountain sickness in climbers attempting rapid ascent and in those who are very susceptible to acute mountain sickness despite gradual ascent.",
      "Description": "Acetazolamide, an inhibitor of the enzyme carbonic anhydrase is a white to faintly yellowish white crystalline, odorless powder, weakly acidic, very slightly soluble in water and slightly soluble in alcohol. The chemical name for acetazolamide is N-(5-Sulfamoyl-1, 3, 4-thiadiazol-2-yl) acetamide and has the following chemical structure. MW 222.25                                  C4H6N4O3S2. Acetazolamide is available for intravenous use, and is supplied as a sterile powder requiring reconstitution. Each vial contains an amount of acetazolamide sodium equivalent to 500 mg of acetazolamide. The bulk solution is adjusted to pH 9.6 using sodium hydroxide NF and, if necessary, hydrochloric acid NF prior to lyophilization."
    },
    {
      "NDCCode": "33261-831-99",
      "PackageDescription": "180 TABLET in 1 BOTTLE, PLASTIC (33261-831-99)",
      "NDC11Code": "33261-0831-99",
      "ProductNDC": "33261-831",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Glimepiride",
      "NonProprietaryName": "Glimepiride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130613",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091220",
      "LabelerName": "Aidarex Pharmaceuticals LLC",
      "SubstanceName": "GLIMEPIRIDE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Sulfonylurea [EPC],Sulfonylurea Compounds [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "Glimepiride tablets USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14.1)].",
      "Description": "Glimepiride is an oral sulfonylurea that contains the active ingredient glimepiride. Chemically, glimepiride is identified as 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido) ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea (C24H34N4O5S) with a molecular weight of 490.62. Glimepiride USP is a white to almost white, crystalline, odorless to practically odorless powder and is practically insoluble in water.The structural formula is.  Glimepiride Tablets contain the active ingredient glimepiride and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate and sodium starch glycolate. In addition, Glimepiride 1 mg tablets contain Ferric Oxide Red, Glimepiride 2 mg tablets contain FD&C Blue #2 Indigo carmine Lake and Ferric Oxide Yellow, Glimepiride 3 mg tablets contain Ferric Oxide Yellow, Glimepiride 4 mg tablets contain FD&C Blue #2 Indigo carmine Lake and Glimepiride 6 mg tablets contain Ferric Oxide Red."
    },
    {
      "NDCCode": "42291-831-30",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (42291-831-30) ",
      "NDC11Code": "42291-0831-30",
      "ProductNDC": "42291-831",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Teriflunomide",
      "NonProprietaryName": "Teriflunomide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230420",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209700",
      "LabelerName": "AvKARE",
      "SubstanceName": "TERIFLUNOMIDE",
      "StrengthNumber": "14",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-01-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230420",
      "SamplePackage": "N",
      "IndicationAndUsage": "Teriflunomide tablets are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.",
      "Description": "Teriflunomide is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-cyano-3-hydroxy-N-(4-(trifluoromethyl)phenyl)but-2-enamide. Its molecular weight is 270.21, and the molecular formula is C 12H 9F 3N 2O 2 with the following chemical structure:. Teriflunomide is a white crystalline powder that is sparingly soluble in acetone and ethyl acetate, slightly soluble in polyethylene glycol and ethanol, very slightly soluble in isopropanol and methanol and practically insoluble in water. Teriflunomide is formulated as film-coated tablets for oral administration. Teriflunomide tablets contain 7 mg or 14 mg of teriflunomide and the following inactive ingredients: colloidal silicon dioxide, FD&C Blue #2/Indigo Carmine Aluminum Lake, hydroxypropyl cellulose, hypromellose 2910, lactose monohydrate, maize starch, microcrystalline cellulose, polyethylene glycol 8000, sodium starch glycolate, sodium stearyl fumarate, talc, and titanium dioxide. In addition, the 7 mg tablet contains FD&C Blue #1/Brilliant Blue FCF Aluminum Lake and iron oxide yellow."
    },
    {
      "NDCCode": "61919-831-30",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (61919-831-30)",
      "NDC11Code": "61919-0831-30",
      "ProductNDC": "61919-831",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fenofibrate",
      "NonProprietaryName": "Fenofibrate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076635",
      "LabelerName": "DirectRX",
      "SubstanceName": "FENOFIBRATE",
      "StrengthNumber": "160",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Treatment of HypercholesterolemiaFenofibrate tablets, USP are indicated as adjunctive therapy to diet to reduce elevated LDL-C, Total-C, Triglycerides and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (See National Cholesterol Education Program [NCEP] Treatment Guidelines, below).Treatment of HypertriglyceridemiaFenofibrate tablets, USP are also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (Fredrickson Types IV and V hyperlipidemia). Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention.Markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate tablet, USP therapy on reducing this risk has not been adequately studied.Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV and V hyperlipoproteinemia2.The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, thiazide diuretics and beta-blockers, are sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia.The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with non-drug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet. (See WARNINGS and PRECAUTIONS).Fredrickson Classification of HyperlipoproteinemiasC = cholesterolTG = triglyceridesLDL = low density lipoproteinVLDL = very low density lipoproteinIDL = intermediate density lipoproteinLipid Elevation TypeLipoprotein ElevatedMajorMinorI (rare)chylomicronsTG↑↔CIIaLDLC-IIbLDL, VLDLCTGIII (rare)IDLC, TG-IVVLDLTG↑↔CV (rare)chylomicrons, VLDLTG↑↔NCEP Treatment Guidelines: LDL-C Goals and Cutpoints for Therapeutic Lifestyle Changes and Drug Therapy in Different Risk Categories†CHD = coronary heart disease††Some authorities recommend use of LDL-lowering drugs in this category if an LDL-C level of < 100 mg/dL cannot be achieved by therapeutic lifestyle changes. Others prefer use of drugs that primarily modify triglycerides and HDL-C, e.g., nicotinic acid or fibrate. Clinical judgment also may call for deferring drug therapy in this subcategory.†††Almost all people with 0 to 1 risk factor have 10-year risk < 10%; thus, 10-year risk assessment in people with 0 to 1 risk factor is not necessary.Risk CategoryLDL Goal (mg/dL)LDL Level at Which to Initiate Therapeutic Lifestyle Changes (mg/dL)LDL Level at Which to Consider Drug Therapy (mg/dL)CHD† or CHD risk equivalents (10-years risk > 20%)< 100≥ 100≥ 130 (100 to 129: drug optional)††2+ Risk Factors (10-year risk ≤ 20%)< 130≥ 13010-year risk 10% to 20%: ≥ 130 10-year risk < 10%: ≥ 1600 to 1 Risk Factor†††< 160≥ 160≥ 190 (160 to 189: LDL- lowering drug optional)After the LDL-C goal has been achieved, if the TG is still ≥ 200 mg/dL, non HDL-C (total-C minus HDL-C) becomes a secondary target of therapy. Non-HDL-C goals are set 30 mg/dL higher than LDL-C goals for each risk category.",
      "Description": "Fenofibrate tablets, USP is a lipid regulating agent available as tablets for oral administration. Each tablet contains 54 mg or 160 mg of fenofibrate, USP. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following molecular structure. structure. The molecular formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate, USP is very soluble in methylene chloride, slightly soluble in alcohal and prectically insoluble in water. The melting point is 79 - 82° C. Fenofibrate, USP is a white or almost white crystalline powder. Inactive Ingredients: Each tablet contains colloidal silicon dioxide, crospovidone, lecithin (soya), microcrystalline cellulose, polyvinyl alcohol, povidone, pregelatinized starch, sodium lauryl sulfate, sodium stearyl fumarate, talc, titanium dioxide and xanthan gum. Meets USP Dissolution Test 2."
    },
    {
      "NDCCode": "69269-831-01",
      "PackageDescription": "57 g in 1 BOTTLE (69269-831-01)",
      "NDC11Code": "69269-0831-01",
      "ProductNDC": "69269-831",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Obagi Nu-derm Clear Fx",
      "NonProprietaryName": "Arbutin",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20141001",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "YS PLUS CORPORATION",
      "SubstanceName": "ARBUTIN",
      "StrengthNumber": "4.02",
      "StrengthUnit": "mg/57g",
      "Status": "Deprecated",
      "LastUpdate": "2017-06-14"
    },
    {
      "NDCCode": "70954-831-10",
      "PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (70954-831-10)  / 15 mL in 1 BOTTLE, GLASS",
      "NDC11Code": "70954-0831-10",
      "ProductNDC": "70954-831",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Calcitriol",
      "NonProprietaryName": "Calcitriol",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260513",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021068",
      "LabelerName": "ANI Pharmaceuticals, Inc.",
      "SubstanceName": "CALCITRIOL",
      "StrengthNumber": "1",
      "StrengthUnit": "ug/mL",
      "Pharm_Classes": "Cholecalciferol [CS], Vitamin D3 Analog [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-07-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260513",
      "SamplePackage": "N",
      "IndicationAndUsage": "Predialysis Patients. Calcitriol is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. A serum iPTH level of ≥ 100 pg/mL is strongly suggestive of secondary hyperparathyroidism. Dialysis Patients. Calcitriol is indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. In these patients, calcitriol administration enhances calcium absorption, reduces serum alkaline phosphatase levels, and may reduce elevated parathyroid hormone levels and the histological manifestations of osteitis fibrosa cystica and defective mineralization. Hypoparathyroidism Patients. Calcitriol is also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypoparathyroidism.",
      "Description": "Calcitriol oral solution is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the body. Calcitriol is available as an oral solution, for oral administration, containing 1 mcg/mL of calcitriol, USP. Calcitriol oral solution contains butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT) as antioxidants and medium chain triglycerides. Calcitriol is a white, crystalline compound which occurs naturally in humans. It has a calculated molecular weight of 416.65 and is soluble in organic solvents but relatively insoluble in water. Chemically, calcitriol is 9,10-seco(5Z,7E)-5,7,10(19)-cholestatriene-1α, 3β, 25-triol and has the following structural formula. The other names frequently used for calcitriol are 1α,25-dihydroxycholecalciferol, 1,25-dihydroxyvitamin D3, 1,25-DHCC, 1,25(OH)2D3 and 1,25-diOHC."
    },
    {
      "NDCCode": "72288-831-43",
      "PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (72288-831-43) ",
      "NDC11Code": "72288-0831-43",
      "ProductNDC": "72288-831",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Mineral Oil",
      "NonProprietaryName": "Mineral Oil",
      "DosageFormName": "OIL",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180501",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part334",
      "LabelerName": "Amazon.Com Services LLC",
      "SubstanceName": "MINERAL OIL",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-09-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20180501",
      "SamplePackage": "N",
      "IndicationAndUsage": "for relief of occasional constipation (irregularity).  Generally productes bowel movement in 6 to 8 hours."
    },
    {
      "NDCCode": "81284-831-05",
      "PackageDescription": "5 AMPULE in 1 CARTON (81284-831-05)  / 5 mL in 1 AMPULE",
      "NDC11Code": "81284-0831-05",
      "ProductNDC": "81284-831",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Anticholium",
      "NonProprietaryName": "Physostigmine Salicylate",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20231005",
      "MarketingCategoryName": "UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE",
      "LabelerName": "Provepharm Inc.",
      "SubstanceName": "PHYSOSTIGMINE SALICYLATE",
      "StrengthNumber": ".4",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2025-11-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20231005",
      "SamplePackage": "N",
      "IndicationAndUsage": "ANTICHOLIUM® is indicated for: 1. the use as an antidote and/or antagonist in case of intoxication with and/or overdose of: 1 alcohol, 2 tropane alkaloids (hyoscyamine, atropine, scopolamine, as e.g. in brugmansia, datura, atropa belladonna), 3 amanita pantherina and amanita muscaria, 4 tricyclic antidepressants (amitriptyline, imipramine, trimipramine, clomipramine, doxepine), 5 antiemetics/antihistamines (phenothiazine, thioridazine, chlorpromazine, promethazine, diphenhydramine, dimenhydrinate), 6 neuroleptic drugs (especially butyrophenones), 7 benzodiazepines, 8 tolterodine, oxybutynine, 9 amantadine, diphenhydramine, 10 baclofen, 11 4-hydroxybutyric acid (GHB), 12 inhalation anesthetics, 13 ketamine, 14 3-quinuclidinyl benzilate."
    },
    {
      "NDCCode": "10237-590-10",
      "PackageDescription": "1020.58 kg in 1 SUPERSACK (10237-590-10) ",
      "NDC11Code": "10237-0590-10",
      "ProductNDC": "10237-590",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Sodium Bicarbonate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "19770130",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Church & Dwight Co., Inc.",
      "SubstanceName": "SODIUM BICARBONATE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2024-03-14",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "30-JAN-77"
    },
    {
      "NDCCode": "10237-590-25",
      "PackageDescription": "22.68 kg in 1 BAG (10237-590-25) ",
      "NDC11Code": "10237-0590-25",
      "ProductNDC": "10237-590",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Sodium Bicarbonate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "19770130",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Church & Dwight Co., Inc.",
      "SubstanceName": "SODIUM BICARBONATE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2024-03-14",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "30-JAN-77"
    },
    {
      "NDCCode": "10237-590-90",
      "PackageDescription": "90718.47 kg in 1 PACKAGE (10237-590-90) ",
      "NDC11Code": "10237-0590-90",
      "ProductNDC": "10237-590",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Sodium Bicarbonate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "19770130",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Church & Dwight Co., Inc.",
      "SubstanceName": "SODIUM BICARBONATE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2024-03-14",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "30-JAN-77"
    },
    {
      "NDCCode": "10237-591-35",
      "PackageDescription": "1588 g in 1 CARTON (10237-591-35) ",
      "NDC11Code": "10237-0591-35",
      "ProductNDC": "10237-591",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Arm And Hammer Baking Soda",
      "NonProprietaryName": "Sodium Bicarbonate",
      "DosageFormName": "POWDER, FOR SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20000101",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "Church & Dwight Co., Inc.",
      "SubstanceName": "SODIUM BICARBONATE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-07-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20000101",
      "EndMarketingDatePackage": "20260713",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "10237-592-10",
      "PackageDescription": "22.68 kg in 1 BAG (10237-592-10) ",
      "NDC11Code": "10237-0592-10",
      "ProductNDC": "10237-592",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Sodium Bicarbonate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "19770130",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Church & Dwight Co., Inc.",
      "SubstanceName": "SODIUM BICARBONATE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2024-03-14",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "30-JAN-77"
    },
    {
      "NDCCode": "10237-592-22",
      "PackageDescription": "997.903 kg in 1 SUPERSACK (10237-592-22) ",
      "NDC11Code": "10237-0592-22",
      "ProductNDC": "10237-592",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Sodium Bicarbonate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "19770130",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Church & Dwight Co., Inc.",
      "SubstanceName": "SODIUM BICARBONATE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2024-03-14",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "30-JAN-77"
    },
    {
      "NDCCode": "10237-592-25",
      "PackageDescription": "1133 kg in 1 SUPERSACK (10237-592-25) ",
      "NDC11Code": "10237-0592-25",
      "ProductNDC": "10237-592",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Sodium Bicarbonate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "19770130",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Church & Dwight Co., Inc.",
      "SubstanceName": "SODIUM BICARBONATE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2024-03-14",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "30-JAN-77"
    },
    {
      "NDCCode": "10237-738-19",
      "PackageDescription": "1 CARTON in 1 CARTON (10237-738-19)  > 1 TUBE in 1 CARTON (10237-738-18)  > 5.1 g in 1 TUBE",
      "NDC11Code": "10237-0738-19",
      "ProductNDC": "10237-738",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Orajel Nighttime Instant Relief For Teething Pain",
      "ProprietaryNameSuffix": "Longer Lasting Extra Strength",
      "NonProprietaryName": "Benzocaine",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20100618",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part356",
      "LabelerName": "Church & Dwight Co., Inc.",
      "SubstanceName": "BENZOCAINE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2018-09-14",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "10237-775-42",
      "PackageDescription": "119 g in 1 TUBE (10237-775-42) ",
      "NDC11Code": "10237-0775-42",
      "ProductNDC": "10237-775",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Orajel",
      "NonProprietaryName": "Sodium Fluoride",
      "DosageFormName": "GEL, DENTIFRICE",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20180720",
      "EndMarketingDate": "20251114",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M021",
      "LabelerName": "Church & Dwight Co., Inc.",
      "SubstanceName": "SODIUM FLUORIDE",
      "StrengthNumber": "1.5",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2025-11-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20180720",
      "EndMarketingDatePackage": "20251114",
      "SamplePackage": "N",
      "IndicationAndUsage": "Aids in the prevention of dental decay."
    },
    {
      "NDCCode": "0338-9558-10",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0338-9558-10)  / 100 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "00338-9558-10",
      "ProductNDC": "0338-9558",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Eptifibatide",
      "NonProprietaryName": "Eptifibatide",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20190201",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208554",
      "LabelerName": "Baxter Healthcare Company",
      "SubstanceName": "EPTIFIBATIDE",
      "StrengthNumber": "75",
      "StrengthUnit": "mg/100mL",
      "Pharm_Classes": "Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-05-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190201",
      "SamplePackage": "N",
      "IndicationAndUsage": "Eptifibatide injection is a platelet aggregation inhibitor indicated for: : 1 Treatment of acute coronary syndrome (ACS) managed medically or with percutaneous coronary intervention (PCI) (1.1), 2 Treatment of patients undergoing PCI (including intracoronary stenting) (1.2).",
      "Description": "Eptifibatide is a cyclic heptapeptide containing 6 amino acids and 1 mercaptopropionyl (des-amino cysteinyl) residue. An interchain disulfide bridge is formed between the cysteine amide and the mercaptopropionyl moieties. Chemically it is N6-(aminoiminomethyl)-N2-(3-mercapto-1-oxopropyl)-L-lysylglycyl-L-α-aspartyl-L-tryptophyl-L-prolyl-L-cysteinamide, cyclic (1→6)-disulfide. Eptifibatide binds to the platelet receptor glycoprotein (GP) IIb/IIIa of human platelets and inhibits platelet aggregation. The eptifibatide peptide is produced by solution-phase peptide synthesis, and is purified by preparative reverse-phase liquid chromatography and lyophilized. The structural formula is. Eptifibatide Injection is a clear, colorless, sterile, non-pyrogenic solution for intravenous (IV) use with an empirical formula of C35H49N11O9S2 and a molecular weight of 831.96. Eptifibatide injection is a refrigerated, premixed, sterile, non-pyrogenic single-dose solution packaged in the Galaxy container. The 100 mL container consists of 0.75 mg/mL of eptifibatide. The container also contains 5.25 mg/mL citric acid and sodium hydroxide to adjust the pH to 5.35. The Galaxy container is fabricated from a specially designed multilayered plastic. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period. The suitability of the plastic has been confirmed in tests in animals according to the USP biological tests for plastic containers, as well as by tissue culture toxicity studies."
    },
    {
      "NDCCode": "0409-4178-03",
      "PackageDescription": "12 BAG in 1 CASE (0409-4178-03)  > 500 mL in 1 BAG",
      "NDC11Code": "00409-4178-03",
      "ProductNDC": "0409-4178",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Aminosyn-pf",
      "NonProprietaryName": "Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Glycine, Histidine, Proline, Serine, Taurine, And Tyrosine",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19850906",
      "EndMarketingDate": "20231201",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019398",
      "LabelerName": "Hospira, Inc.",
      "SubstanceName": "ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; TAURINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE",
      "StrengthNumber": "490; 861; 370; 576; 270; 220; 534; 831; 475; 125; 300; 570; 347; 50; 360; 125; 44; 452",
      "StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
      "Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2023-12-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "19850906",
      "EndMarketingDatePackage": "20231201",
      "SamplePackage": "N"
    }
  ]
}
                    
{"NDC":[{"NDCCode":"10237-831-14","ProprietaryName":"Ladys Choice Invisible Solid","NonProprietaryName":"Aluminum Chlorohydrate"},{"NDCCode":"46122-831-45","ProprietaryName":"Nicotine Transdermal System","NonProprietaryName":"Nicotine"},{"NDCCode":"51009-831-14","ProprietaryName":"Naturally Dry","NonProprietaryName":"Aluminum Chlorohydrate"},{"NDCCode":"59779-831-29","ProprietaryName":"Instant Toothache Pain Relief","NonProprietaryName":"Benzocaine"},{"NDCCode":"10237-591-14","ProprietaryName":"Arm And Hammer Baking Soda","NonProprietaryName":"Sodium Bicarbonate"},{"NDCCode":"10237-832-14","ProprietaryName":"Ladys Choice Invisible Solid","NonProprietaryName":"Aluminum Chlorohydrate"},{"NDCCode":"10237-833-14","ProprietaryName":"Ladys Choice Invisible Solid","NonProprietaryName":"Aluminum Chlorohydrate"},{"NDCCode":"10237-834-14","ProprietaryName":"Ladys Choice Invisible Solid","NonProprietaryName":"Aluminum Chlorohydrate"},{"NDCCode":"16729-259-38","ProprietaryName":"Eptifibatide","NonProprietaryName":"Eptifibatide"},{"NDCCode":"16729-260-03","ProprietaryName":"Eptifibatide","NonProprietaryName":"Eptifibatide"},{"NDCCode":"16729-260-38","ProprietaryName":"Eptifibatide","NonProprietaryName":"Eptifibatide"},{"NDCCode":"23155-831-31","ProprietaryName":"Acetazolamide","NonProprietaryName":"Acetazolamide"},{"NDCCode":"33261-831-99","ProprietaryName":"Glimepiride","NonProprietaryName":"Glimepiride"},{"NDCCode":"42291-831-30","ProprietaryName":"Teriflunomide","NonProprietaryName":"Teriflunomide"},{"NDCCode":"61919-831-30","ProprietaryName":"Fenofibrate","NonProprietaryName":"Fenofibrate"},{"NDCCode":"69269-831-01","ProprietaryName":"Obagi Nu-derm Clear Fx","NonProprietaryName":"Arbutin"},{"NDCCode":"70954-831-10","ProprietaryName":"Calcitriol","NonProprietaryName":"Calcitriol"},{"NDCCode":"72288-831-43","ProprietaryName":"Mineral Oil","NonProprietaryName":"Mineral Oil"},{"NDCCode":"81284-831-05","ProprietaryName":"Anticholium","NonProprietaryName":"Physostigmine Salicylate"},{"NDCCode":"10237-590-10","NonProprietaryName":"Sodium Bicarbonate"},{"NDCCode":"10237-590-25","NonProprietaryName":"Sodium Bicarbonate"},{"NDCCode":"10237-590-90","NonProprietaryName":"Sodium Bicarbonate"},{"NDCCode":"10237-591-35","ProprietaryName":"Arm And Hammer Baking Soda","NonProprietaryName":"Sodium Bicarbonate"},{"NDCCode":"10237-592-10","NonProprietaryName":"Sodium Bicarbonate"},{"NDCCode":"10237-592-22","NonProprietaryName":"Sodium Bicarbonate"},{"NDCCode":"10237-592-25","NonProprietaryName":"Sodium Bicarbonate"},{"NDCCode":"10237-738-19","ProprietaryName":"Orajel Nighttime Instant Relief For Teething Pain","NonProprietaryName":"Benzocaine"},{"NDCCode":"10237-775-42","ProprietaryName":"Orajel","NonProprietaryName":"Sodium Fluoride"},{"NDCCode":"0338-9558-10","ProprietaryName":"Eptifibatide","NonProprietaryName":"Eptifibatide"},{"NDCCode":"0409-4178-03","ProprietaryName":"Aminosyn-pf","NonProprietaryName":"Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Glycine, Histidine, Proline, Serine, Taurine, And Tyrosine"}]}
                    
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>10237-831-14</NDCCode>
    <PackageDescription>40 g in 1 CANISTER (10237-831-14)</PackageDescription>
    <NDC11Code>10237-0831-14</NDC11Code>
    <ProductNDC>10237-831</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ladys Choice Invisible Solid</ProprietaryName>
    <ProprietaryNameSuffix>Antiperspirant Deodorant Powder Fresh</ProprietaryNameSuffix>
    <NonProprietaryName>Aluminum Chlorohydrate</NonProprietaryName>
    <DosageFormName>STICK</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20020601</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part350</ApplicationNumber>
    <LabelerName>Church &amp; Dwight Co., Inc.</LabelerName>
    <SubstanceName>ALUMINUM CHLOROHYDRATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>reduces underarm perspiration.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>46122-831-45</NDCCode>
    <PackageDescription>14 PATCH in 1 CARTON (46122-831-45)  / 24 h in 1 PATCH</PackageDescription>
    <NDC11Code>46122-0831-45</NDC11Code>
    <ProductNDC>46122-831</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Nicotine Transdermal System</ProprietaryName>
    <ProprietaryNameSuffix>Step 3</ProprietaryNameSuffix>
    <NonProprietaryName>Nicotine</NonProprietaryName>
    <DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
    <RouteName>TRANSDERMAL</RouteName>
    <StartMarketingDate>20260701</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020076</ApplicationNumber>
    <LabelerName>AmerisourceBergen Drug Corporation</LabelerName>
    <SubstanceName>NICOTINE</SubstanceName>
    <StrengthNumber>7</StrengthNumber>
    <StrengthUnit>mg/24h</StrengthUnit>
    <Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260701</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>51009-831-14</NDCCode>
    <PackageDescription>13.5 g in 1 CANISTER (51009-831-14) </PackageDescription>
    <NDC11Code>51009-0831-14</NDC11Code>
    <ProductNDC>51009-831</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Naturally Dry</ProprietaryName>
    <ProprietaryNameSuffix>Natural</ProprietaryNameSuffix>
    <NonProprietaryName>Aluminum Chlorohydrate</NonProprietaryName>
    <DosageFormName>STICK</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20120102</StartMarketingDate>
    <EndMarketingDate>20220501</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part350</ApplicationNumber>
    <LabelerName>Tom's of Maine, Inc.</LabelerName>
    <SubstanceName>ALUMINUM CHLOROHYDRATE</SubstanceName>
    <StrengthNumber>.22</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-05-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20120102</StartMarketingDatePackage>
    <EndMarketingDatePackage>20220501</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>59779-831-29</NDCCode>
    <PackageDescription>1 BOTTLE, WITH APPLICATOR in 1 CARTON (59779-831-29)  &gt; 14.17 g in 1 BOTTLE, WITH APPLICATOR (59779-831-21)</PackageDescription>
    <NDC11Code>59779-0831-29</NDC11Code>
    <ProductNDC>59779-831</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Instant Toothache Pain Relief</ProprietaryName>
    <NonProprietaryName>Benzocaine</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20091001</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part333B</ApplicationNumber>
    <LabelerName>CVS Pharmacy</LabelerName>
    <SubstanceName>BENZOCAINE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-02-16</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>10237-591-14</NDCCode>
    <PackageDescription>6804 g in 1 BAG (10237-591-14) </PackageDescription>
    <NDC11Code>10237-0591-14</NDC11Code>
    <ProductNDC>10237-591</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Arm And Hammer Baking Soda</ProprietaryName>
    <NonProprietaryName>Sodium Bicarbonate</NonProprietaryName>
    <DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20000101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>Church &amp; Dwight Co., Inc.</LabelerName>
    <SubstanceName>SODIUM BICARBONATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-03-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20000101</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260325</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>10237-832-14</NDCCode>
    <PackageDescription>40 g in 1 CANISTER (10237-832-14)</PackageDescription>
    <NDC11Code>10237-0832-14</NDC11Code>
    <ProductNDC>10237-832</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ladys Choice Invisible Solid</ProprietaryName>
    <ProprietaryNameSuffix>Antiperspirant Deodorant Shower Fresh</ProprietaryNameSuffix>
    <NonProprietaryName>Aluminum Chlorohydrate</NonProprietaryName>
    <DosageFormName>STICK</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20020601</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part350</ApplicationNumber>
    <LabelerName>Church &amp; Dwight Co., Inc.</LabelerName>
    <SubstanceName>ALUMINUM CHLOROHYDRATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>reduces underarm perspiration.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10237-833-14</NDCCode>
    <PackageDescription>40 g in 1 CANISTER (10237-833-14)</PackageDescription>
    <NDC11Code>10237-0833-14</NDC11Code>
    <ProductNDC>10237-833</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ladys Choice Invisible Solid</ProprietaryName>
    <ProprietaryNameSuffix>Antiperspirant Deodorant Cucumber Melon</ProprietaryNameSuffix>
    <NonProprietaryName>Aluminum Chlorohydrate</NonProprietaryName>
    <DosageFormName>STICK</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20030601</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part350</ApplicationNumber>
    <LabelerName>Church &amp; Dwight Co., Inc.</LabelerName>
    <SubstanceName>ALUMINUM CHLOROHYDRATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>reduces underarm perspiration.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10237-834-14</NDCCode>
    <PackageDescription>40 g in 1 CANISTER (10237-834-14)</PackageDescription>
    <NDC11Code>10237-0834-14</NDC11Code>
    <ProductNDC>10237-834</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ladys Choice Invisible Solid</ProprietaryName>
    <ProprietaryNameSuffix>Antiperspirant Deodorant Coconut Lime</ProprietaryNameSuffix>
    <NonProprietaryName>Aluminum Chlorohydrate</NonProprietaryName>
    <DosageFormName>STICK</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20040201</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part350</ApplicationNumber>
    <LabelerName>Church &amp; Dwight Co., Inc.</LabelerName>
    <SubstanceName>ALUMINUM CHLOROHYDRATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>reduces underarm perspiration.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>16729-259-38</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (16729-259-38)  &gt; 100 mL in 1 VIAL, SINGLE-USE</PackageDescription>
    <NDC11Code>16729-0259-38</NDC11Code>
    <ProductNDC>16729-259</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Eptifibatide</ProprietaryName>
    <NonProprietaryName>Eptifibatide</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20180405</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205557</ApplicationNumber>
    <LabelerName>Accord Healthcare Inc.</LabelerName>
    <SubstanceName>EPTIFIBATIDE</SubstanceName>
    <StrengthNumber>.75</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-05-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180405</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Eptifibatide Injection is a platelet aggregation inhibitor indicated for: 1 Treatment of acute coronary syndrome (ACS) managed medically or with percutaneous coronary intervention (PCI) ( 1.1) , 2 Treatment of patients undergoing PCI (including intracoronary stenting) (  1.2)  .</IndicationAndUsage>
    <Description>Eptifibatide is a cyclic heptapeptide containing 6 amino acids and 1 mercaptopropionyl (des-amino cysteinyl) residue. An interchain disulfide bridge is formed between the cysteine amide and the mercaptopropionyl moieties. Chemically it is N 6-(aminoiminomethyl)-N 2-(3-mercapto-1-oxopropyl)-L-lysylglycyl-L-α-aspartyl-L-tryptophyl-L-prolyl-L-cysteinamide, cyclic (1→6)-disulfide. Eptifibatide binds to the platelet receptor glycoprotein (GP) IIb/IIIa of human platelets and inhibits platelet aggregation. The eptifibatide peptide is produced by solution-phase peptide synthesis, and is purified by preparative reverse-phase liquid chromatography and lyophilized. The structural formula is. Eptifibatide Injection is a clear, colorless, sterile, non-pyrogenic solution for intravenous (IV) use with an empirical formula of C 35H 49N 11O 9S 2 and a molecular weight of 831.96. Each 10-mL vial contains 2 mg/mL of Eptifibatide and each 100-mL vial contains either 0.75 mg/mL of Eptifibatide or 2 mg/mL of Eptifibatide. Each vial of either size also contains 5.25 mg/mL citric acid and sodium hydroxide to adjust the pH to 5.35.</Description>
  </NDC>
  <NDC>
    <NDCCode>16729-260-03</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (16729-260-03)  &gt; 10 mL in 1 VIAL, SINGLE-USE</PackageDescription>
    <NDC11Code>16729-0260-03</NDC11Code>
    <ProductNDC>16729-260</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Eptifibatide</ProprietaryName>
    <NonProprietaryName>Eptifibatide</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20180409</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205557</ApplicationNumber>
    <LabelerName>Accord Healthcare Inc.</LabelerName>
    <SubstanceName>EPTIFIBATIDE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-05-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180409</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Eptifibatide Injection is a platelet aggregation inhibitor indicated for: 1 Treatment of acute coronary syndrome (ACS) managed medically or with percutaneous coronary intervention (PCI) ( 1.1) , 2 Treatment of patients undergoing PCI (including intracoronary stenting) (  1.2)  .</IndicationAndUsage>
    <Description>Eptifibatide is a cyclic heptapeptide containing 6 amino acids and 1 mercaptopropionyl (des-amino cysteinyl) residue. An interchain disulfide bridge is formed between the cysteine amide and the mercaptopropionyl moieties. Chemically it is N 6-(aminoiminomethyl)-N 2-(3-mercapto-1-oxopropyl)-L-lysylglycyl-L-α-aspartyl-L-tryptophyl-L-prolyl-L-cysteinamide, cyclic (1→6)-disulfide. Eptifibatide binds to the platelet receptor glycoprotein (GP) IIb/IIIa of human platelets and inhibits platelet aggregation. The eptifibatide peptide is produced by solution-phase peptide synthesis, and is purified by preparative reverse-phase liquid chromatography and lyophilized. The structural formula is. Eptifibatide Injection is a clear, colorless, sterile, non-pyrogenic solution for intravenous (IV) use with an empirical formula of C 35H 49N 11O 9S 2 and a molecular weight of 831.96. Each 10-mL vial contains 2 mg/mL of Eptifibatide and each 100-mL vial contains either 0.75 mg/mL of Eptifibatide or 2 mg/mL of Eptifibatide. Each vial of either size also contains 5.25 mg/mL citric acid and sodium hydroxide to adjust the pH to 5.35.</Description>
  </NDC>
  <NDC>
    <NDCCode>16729-260-38</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (16729-260-38)  &gt; 100 mL in 1 VIAL, SINGLE-USE</PackageDescription>
    <NDC11Code>16729-0260-38</NDC11Code>
    <ProductNDC>16729-260</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Eptifibatide</ProprietaryName>
    <NonProprietaryName>Eptifibatide</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20180409</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205557</ApplicationNumber>
    <LabelerName>Accord Healthcare Inc.</LabelerName>
    <SubstanceName>EPTIFIBATIDE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-05-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180412</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Eptifibatide Injection is a platelet aggregation inhibitor indicated for: 1 Treatment of acute coronary syndrome (ACS) managed medically or with percutaneous coronary intervention (PCI) ( 1.1) , 2 Treatment of patients undergoing PCI (including intracoronary stenting) (  1.2)  .</IndicationAndUsage>
    <Description>Eptifibatide is a cyclic heptapeptide containing 6 amino acids and 1 mercaptopropionyl (des-amino cysteinyl) residue. An interchain disulfide bridge is formed between the cysteine amide and the mercaptopropionyl moieties. Chemically it is N 6-(aminoiminomethyl)-N 2-(3-mercapto-1-oxopropyl)-L-lysylglycyl-L-α-aspartyl-L-tryptophyl-L-prolyl-L-cysteinamide, cyclic (1→6)-disulfide. Eptifibatide binds to the platelet receptor glycoprotein (GP) IIb/IIIa of human platelets and inhibits platelet aggregation. The eptifibatide peptide is produced by solution-phase peptide synthesis, and is purified by preparative reverse-phase liquid chromatography and lyophilized. The structural formula is. Eptifibatide Injection is a clear, colorless, sterile, non-pyrogenic solution for intravenous (IV) use with an empirical formula of C 35H 49N 11O 9S 2 and a molecular weight of 831.96. Each 10-mL vial contains 2 mg/mL of Eptifibatide and each 100-mL vial contains either 0.75 mg/mL of Eptifibatide or 2 mg/mL of Eptifibatide. Each vial of either size also contains 5.25 mg/mL citric acid and sodium hydroxide to adjust the pH to 5.35.</Description>
  </NDC>
  <NDC>
    <NDCCode>23155-831-31</NDCCode>
    <PackageDescription>1 VIAL, GLASS in 1 CARTON (23155-831-31)  / 5 mL in 1 VIAL, GLASS</PackageDescription>
    <NDC11Code>23155-0831-31</NDC11Code>
    <ProductNDC>23155-831</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Acetazolamide</ProprietaryName>
    <NonProprietaryName>Acetazolamide</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20221115</StartMarketingDate>
    <EndMarketingDate>20270930</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202693</ApplicationNumber>
    <LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>ACETAZOLAMIDE SODIUM</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], Sulfonamides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20221115</StartMarketingDatePackage>
    <EndMarketingDatePackage>20270930</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For adjunctive treatment of: edema due to congestive heart failure; drug-induced edema; centrencephalic epilepsies (petit mal, unlocalized seizures); chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where delay of surgery is desired in order to lower intraocular pressure. Acetazolamide is also indicated for the prevention or amelioration of symptoms associated with acute mountain sickness in climbers attempting rapid ascent and in those who are very susceptible to acute mountain sickness despite gradual ascent.</IndicationAndUsage>
    <Description>Acetazolamide, an inhibitor of the enzyme carbonic anhydrase is a white to faintly yellowish white crystalline, odorless powder, weakly acidic, very slightly soluble in water and slightly soluble in alcohol. The chemical name for acetazolamide is N-(5-Sulfamoyl-1, 3, 4-thiadiazol-2-yl) acetamide and has the following chemical structure. MW 222.25                                  C4H6N4O3S2. Acetazolamide is available for intravenous use, and is supplied as a sterile powder requiring reconstitution. Each vial contains an amount of acetazolamide sodium equivalent to 500 mg of acetazolamide. The bulk solution is adjusted to pH 9.6 using sodium hydroxide NF and, if necessary, hydrochloric acid NF prior to lyophilization.</Description>
  </NDC>
  <NDC>
    <NDCCode>33261-831-99</NDCCode>
    <PackageDescription>180 TABLET in 1 BOTTLE, PLASTIC (33261-831-99)</PackageDescription>
    <NDC11Code>33261-0831-99</NDC11Code>
    <ProductNDC>33261-831</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Glimepiride</ProprietaryName>
    <NonProprietaryName>Glimepiride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130613</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091220</ApplicationNumber>
    <LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
    <SubstanceName>GLIMEPIRIDE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Sulfonylurea [EPC],Sulfonylurea Compounds [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Glimepiride tablets USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14.1)].</IndicationAndUsage>
    <Description>Glimepiride is an oral sulfonylurea that contains the active ingredient glimepiride. Chemically, glimepiride is identified as 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido) ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea (C24H34N4O5S) with a molecular weight of 490.62. Glimepiride USP is a white to almost white, crystalline, odorless to practically odorless powder and is practically insoluble in water.The structural formula is.  Glimepiride Tablets contain the active ingredient glimepiride and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate and sodium starch glycolate. In addition, Glimepiride 1 mg tablets contain Ferric Oxide Red, Glimepiride 2 mg tablets contain FD&amp;C Blue #2 Indigo carmine Lake and Ferric Oxide Yellow, Glimepiride 3 mg tablets contain Ferric Oxide Yellow, Glimepiride 4 mg tablets contain FD&amp;C Blue #2 Indigo carmine Lake and Glimepiride 6 mg tablets contain Ferric Oxide Red.</Description>
  </NDC>
  <NDC>
    <NDCCode>42291-831-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (42291-831-30) </PackageDescription>
    <NDC11Code>42291-0831-30</NDC11Code>
    <ProductNDC>42291-831</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Teriflunomide</ProprietaryName>
    <NonProprietaryName>Teriflunomide</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230420</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209700</ApplicationNumber>
    <LabelerName>AvKARE</LabelerName>
    <SubstanceName>TERIFLUNOMIDE</SubstanceName>
    <StrengthNumber>14</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230420</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Teriflunomide tablets are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
    <Description>Teriflunomide is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-cyano-3-hydroxy-N-(4-(trifluoromethyl)phenyl)but-2-enamide. Its molecular weight is 270.21, and the molecular formula is C 12H 9F 3N 2O 2 with the following chemical structure:. Teriflunomide is a white crystalline powder that is sparingly soluble in acetone and ethyl acetate, slightly soluble in polyethylene glycol and ethanol, very slightly soluble in isopropanol and methanol and practically insoluble in water. Teriflunomide is formulated as film-coated tablets for oral administration. Teriflunomide tablets contain 7 mg or 14 mg of teriflunomide and the following inactive ingredients: colloidal silicon dioxide, FD&amp;C Blue #2/Indigo Carmine Aluminum Lake, hydroxypropyl cellulose, hypromellose 2910, lactose monohydrate, maize starch, microcrystalline cellulose, polyethylene glycol 8000, sodium starch glycolate, sodium stearyl fumarate, talc, and titanium dioxide. In addition, the 7 mg tablet contains FD&amp;C Blue #1/Brilliant Blue FCF Aluminum Lake and iron oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>61919-831-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (61919-831-30)</PackageDescription>
    <NDC11Code>61919-0831-30</NDC11Code>
    <ProductNDC>61919-831</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fenofibrate</ProprietaryName>
    <NonProprietaryName>Fenofibrate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076635</ApplicationNumber>
    <LabelerName>DirectRX</LabelerName>
    <SubstanceName>FENOFIBRATE</SubstanceName>
    <StrengthNumber>160</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Treatment of HypercholesterolemiaFenofibrate tablets, USP are indicated as adjunctive therapy to diet to reduce elevated LDL-C, Total-C, Triglycerides and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (See National Cholesterol Education Program [NCEP] Treatment Guidelines, below).Treatment of HypertriglyceridemiaFenofibrate tablets, USP are also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (Fredrickson Types IV and V hyperlipidemia). Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention.Markedly elevated levels of serum triglycerides (e.g. &gt; 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate tablet, USP therapy on reducing this risk has not been adequately studied.Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV and V hyperlipoproteinemia2.The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, thiazide diuretics and beta-blockers, are sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia.The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with non-drug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet. (See WARNINGS and PRECAUTIONS).Fredrickson Classification of HyperlipoproteinemiasC = cholesterolTG = triglyceridesLDL = low density lipoproteinVLDL = very low density lipoproteinIDL = intermediate density lipoproteinLipid Elevation TypeLipoprotein ElevatedMajorMinorI (rare)chylomicronsTG↑↔CIIaLDLC-IIbLDL, VLDLCTGIII (rare)IDLC, TG-IVVLDLTG↑↔CV (rare)chylomicrons, VLDLTG↑↔NCEP Treatment Guidelines: LDL-C Goals and Cutpoints for Therapeutic Lifestyle Changes and Drug Therapy in Different Risk Categories†CHD = coronary heart disease††Some authorities recommend use of LDL-lowering drugs in this category if an LDL-C level of &lt; 100 mg/dL cannot be achieved by therapeutic lifestyle changes. Others prefer use of drugs that primarily modify triglycerides and HDL-C, e.g., nicotinic acid or fibrate. Clinical judgment also may call for deferring drug therapy in this subcategory.†††Almost all people with 0 to 1 risk factor have 10-year risk &lt; 10%; thus, 10-year risk assessment in people with 0 to 1 risk factor is not necessary.Risk CategoryLDL Goal (mg/dL)LDL Level at Which to Initiate Therapeutic Lifestyle Changes (mg/dL)LDL Level at Which to Consider Drug Therapy (mg/dL)CHD† or CHD risk equivalents (10-years risk &gt; 20%)&lt; 100≥ 100≥ 130 (100 to 129: drug optional)††2+ Risk Factors (10-year risk ≤ 20%)&lt; 130≥ 13010-year risk 10% to 20%: ≥ 130 10-year risk &lt; 10%: ≥ 1600 to 1 Risk Factor†††&lt; 160≥ 160≥ 190 (160 to 189: LDL- lowering drug optional)After the LDL-C goal has been achieved, if the TG is still ≥ 200 mg/dL, non HDL-C (total-C minus HDL-C) becomes a secondary target of therapy. Non-HDL-C goals are set 30 mg/dL higher than LDL-C goals for each risk category.</IndicationAndUsage>
    <Description>Fenofibrate tablets, USP is a lipid regulating agent available as tablets for oral administration. Each tablet contains 54 mg or 160 mg of fenofibrate, USP. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following molecular structure. structure. The molecular formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate, USP is very soluble in methylene chloride, slightly soluble in alcohal and prectically insoluble in water. The melting point is 79 - 82° C. Fenofibrate, USP is a white or almost white crystalline powder. Inactive Ingredients: Each tablet contains colloidal silicon dioxide, crospovidone, lecithin (soya), microcrystalline cellulose, polyvinyl alcohol, povidone, pregelatinized starch, sodium lauryl sulfate, sodium stearyl fumarate, talc, titanium dioxide and xanthan gum. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>69269-831-01</NDCCode>
    <PackageDescription>57 g in 1 BOTTLE (69269-831-01)</PackageDescription>
    <NDC11Code>69269-0831-01</NDC11Code>
    <ProductNDC>69269-831</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Obagi Nu-derm Clear Fx</ProprietaryName>
    <NonProprietaryName>Arbutin</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20141001</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>YS PLUS CORPORATION</LabelerName>
    <SubstanceName>ARBUTIN</SubstanceName>
    <StrengthNumber>4.02</StrengthNumber>
    <StrengthUnit>mg/57g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-06-14</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>70954-831-10</NDCCode>
    <PackageDescription>1 BOTTLE, GLASS in 1 CARTON (70954-831-10)  / 15 mL in 1 BOTTLE, GLASS</PackageDescription>
    <NDC11Code>70954-0831-10</NDC11Code>
    <ProductNDC>70954-831</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Calcitriol</ProprietaryName>
    <NonProprietaryName>Calcitriol</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260513</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021068</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>CALCITRIOL</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Cholecalciferol [CS], Vitamin D3 Analog [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260513</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Predialysis Patients. Calcitriol is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. A serum iPTH level of ≥ 100 pg/mL is strongly suggestive of secondary hyperparathyroidism. Dialysis Patients. Calcitriol is indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. In these patients, calcitriol administration enhances calcium absorption, reduces serum alkaline phosphatase levels, and may reduce elevated parathyroid hormone levels and the histological manifestations of osteitis fibrosa cystica and defective mineralization. Hypoparathyroidism Patients. Calcitriol is also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypoparathyroidism.</IndicationAndUsage>
    <Description>Calcitriol oral solution is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the body. Calcitriol is available as an oral solution, for oral administration, containing 1 mcg/mL of calcitriol, USP. Calcitriol oral solution contains butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT) as antioxidants and medium chain triglycerides. Calcitriol is a white, crystalline compound which occurs naturally in humans. It has a calculated molecular weight of 416.65 and is soluble in organic solvents but relatively insoluble in water. Chemically, calcitriol is 9,10-seco(5Z,7E)-5,7,10(19)-cholestatriene-1α, 3β, 25-triol and has the following structural formula. The other names frequently used for calcitriol are 1α,25-dihydroxycholecalciferol, 1,25-dihydroxyvitamin D3, 1,25-DHCC, 1,25(OH)2D3 and 1,25-diOHC.</Description>
  </NDC>
  <NDC>
    <NDCCode>72288-831-43</NDCCode>
    <PackageDescription>473 mL in 1 BOTTLE, PLASTIC (72288-831-43) </PackageDescription>
    <NDC11Code>72288-0831-43</NDC11Code>
    <ProductNDC>72288-831</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Mineral Oil</ProprietaryName>
    <NonProprietaryName>Mineral Oil</NonProprietaryName>
    <DosageFormName>OIL</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180501</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part334</ApplicationNumber>
    <LabelerName>Amazon.Com Services LLC</LabelerName>
    <SubstanceName>MINERAL OIL</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-09-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for relief of occasional constipation (irregularity).  Generally productes bowel movement in 6 to 8 hours.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>81284-831-05</NDCCode>
    <PackageDescription>5 AMPULE in 1 CARTON (81284-831-05)  / 5 mL in 1 AMPULE</PackageDescription>
    <NDC11Code>81284-0831-05</NDC11Code>
    <ProductNDC>81284-831</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Anticholium</ProprietaryName>
    <NonProprietaryName>Physostigmine Salicylate</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20231005</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE</MarketingCategoryName>
    <LabelerName>Provepharm Inc.</LabelerName>
    <SubstanceName>PHYSOSTIGMINE SALICYLATE</SubstanceName>
    <StrengthNumber>.4</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-11-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231005</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ANTICHOLIUM® is indicated for: 1. the use as an antidote and/or antagonist in case of intoxication with and/or overdose of: 1 alcohol, 2 tropane alkaloids (hyoscyamine, atropine, scopolamine, as e.g. in brugmansia, datura, atropa belladonna), 3 amanita pantherina and amanita muscaria, 4 tricyclic antidepressants (amitriptyline, imipramine, trimipramine, clomipramine, doxepine), 5 antiemetics/antihistamines (phenothiazine, thioridazine, chlorpromazine, promethazine, diphenhydramine, dimenhydrinate), 6 neuroleptic drugs (especially butyrophenones), 7 benzodiazepines, 8 tolterodine, oxybutynine, 9 amantadine, diphenhydramine, 10 baclofen, 11 4-hydroxybutyric acid (GHB), 12 inhalation anesthetics, 13 ketamine, 14 3-quinuclidinyl benzilate.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10237-590-10</NDCCode>
    <PackageDescription>1020.58 kg in 1 SUPERSACK (10237-590-10) </PackageDescription>
    <NDC11Code>10237-0590-10</NDC11Code>
    <ProductNDC>10237-590</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Sodium Bicarbonate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>19770130</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Church &amp; Dwight Co., Inc.</LabelerName>
    <SubstanceName>SODIUM BICARBONATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2024-03-14</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>30-JAN-77</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>10237-590-25</NDCCode>
    <PackageDescription>22.68 kg in 1 BAG (10237-590-25) </PackageDescription>
    <NDC11Code>10237-0590-25</NDC11Code>
    <ProductNDC>10237-590</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Sodium Bicarbonate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>19770130</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Church &amp; Dwight Co., Inc.</LabelerName>
    <SubstanceName>SODIUM BICARBONATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2024-03-14</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>30-JAN-77</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>10237-590-90</NDCCode>
    <PackageDescription>90718.47 kg in 1 PACKAGE (10237-590-90) </PackageDescription>
    <NDC11Code>10237-0590-90</NDC11Code>
    <ProductNDC>10237-590</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Sodium Bicarbonate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>19770130</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Church &amp; Dwight Co., Inc.</LabelerName>
    <SubstanceName>SODIUM BICARBONATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2024-03-14</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>30-JAN-77</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>10237-591-35</NDCCode>
    <PackageDescription>1588 g in 1 CARTON (10237-591-35) </PackageDescription>
    <NDC11Code>10237-0591-35</NDC11Code>
    <ProductNDC>10237-591</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Arm And Hammer Baking Soda</ProprietaryName>
    <NonProprietaryName>Sodium Bicarbonate</NonProprietaryName>
    <DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20000101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>Church &amp; Dwight Co., Inc.</LabelerName>
    <SubstanceName>SODIUM BICARBONATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-07-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20000101</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260713</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>10237-592-10</NDCCode>
    <PackageDescription>22.68 kg in 1 BAG (10237-592-10) </PackageDescription>
    <NDC11Code>10237-0592-10</NDC11Code>
    <ProductNDC>10237-592</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Sodium Bicarbonate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>19770130</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Church &amp; Dwight Co., Inc.</LabelerName>
    <SubstanceName>SODIUM BICARBONATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2024-03-14</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>30-JAN-77</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>10237-592-22</NDCCode>
    <PackageDescription>997.903 kg in 1 SUPERSACK (10237-592-22) </PackageDescription>
    <NDC11Code>10237-0592-22</NDC11Code>
    <ProductNDC>10237-592</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Sodium Bicarbonate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>19770130</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Church &amp; Dwight Co., Inc.</LabelerName>
    <SubstanceName>SODIUM BICARBONATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2024-03-14</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>30-JAN-77</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>10237-592-25</NDCCode>
    <PackageDescription>1133 kg in 1 SUPERSACK (10237-592-25) </PackageDescription>
    <NDC11Code>10237-0592-25</NDC11Code>
    <ProductNDC>10237-592</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Sodium Bicarbonate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>19770130</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Church &amp; Dwight Co., Inc.</LabelerName>
    <SubstanceName>SODIUM BICARBONATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2024-03-14</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>30-JAN-77</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>10237-738-19</NDCCode>
    <PackageDescription>1 CARTON in 1 CARTON (10237-738-19)  &gt; 1 TUBE in 1 CARTON (10237-738-18)  &gt; 5.1 g in 1 TUBE</PackageDescription>
    <NDC11Code>10237-0738-19</NDC11Code>
    <ProductNDC>10237-738</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Orajel Nighttime Instant Relief For Teething Pain</ProprietaryName>
    <ProprietaryNameSuffix>Longer Lasting Extra Strength</ProprietaryNameSuffix>
    <NonProprietaryName>Benzocaine</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20100618</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part356</ApplicationNumber>
    <LabelerName>Church &amp; Dwight Co., Inc.</LabelerName>
    <SubstanceName>BENZOCAINE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-09-14</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>10237-775-42</NDCCode>
    <PackageDescription>119 g in 1 TUBE (10237-775-42) </PackageDescription>
    <NDC11Code>10237-0775-42</NDC11Code>
    <ProductNDC>10237-775</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Orajel</ProprietaryName>
    <NonProprietaryName>Sodium Fluoride</NonProprietaryName>
    <DosageFormName>GEL, DENTIFRICE</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20180720</StartMarketingDate>
    <EndMarketingDate>20251114</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M021</ApplicationNumber>
    <LabelerName>Church &amp; Dwight Co., Inc.</LabelerName>
    <SubstanceName>SODIUM FLUORIDE</SubstanceName>
    <StrengthNumber>1.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20180720</StartMarketingDatePackage>
    <EndMarketingDatePackage>20251114</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Aids in the prevention of dental decay.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0338-9558-10</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0338-9558-10)  / 100 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>00338-9558-10</NDC11Code>
    <ProductNDC>0338-9558</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Eptifibatide</ProprietaryName>
    <NonProprietaryName>Eptifibatide</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20190201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208554</ApplicationNumber>
    <LabelerName>Baxter Healthcare Company</LabelerName>
    <SubstanceName>EPTIFIBATIDE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/100mL</StrengthUnit>
    <Pharm_Classes>Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Eptifibatide injection is a platelet aggregation inhibitor indicated for: : 1 Treatment of acute coronary syndrome (ACS) managed medically or with percutaneous coronary intervention (PCI) (1.1), 2 Treatment of patients undergoing PCI (including intracoronary stenting) (1.2).</IndicationAndUsage>
    <Description>Eptifibatide is a cyclic heptapeptide containing 6 amino acids and 1 mercaptopropionyl (des-amino cysteinyl) residue. An interchain disulfide bridge is formed between the cysteine amide and the mercaptopropionyl moieties. Chemically it is N6-(aminoiminomethyl)-N2-(3-mercapto-1-oxopropyl)-L-lysylglycyl-L-α-aspartyl-L-tryptophyl-L-prolyl-L-cysteinamide, cyclic (1→6)-disulfide. Eptifibatide binds to the platelet receptor glycoprotein (GP) IIb/IIIa of human platelets and inhibits platelet aggregation. The eptifibatide peptide is produced by solution-phase peptide synthesis, and is purified by preparative reverse-phase liquid chromatography and lyophilized. The structural formula is. Eptifibatide Injection is a clear, colorless, sterile, non-pyrogenic solution for intravenous (IV) use with an empirical formula of C35H49N11O9S2 and a molecular weight of 831.96. Eptifibatide injection is a refrigerated, premixed, sterile, non-pyrogenic single-dose solution packaged in the Galaxy container. The 100 mL container consists of 0.75 mg/mL of eptifibatide. The container also contains 5.25 mg/mL citric acid and sodium hydroxide to adjust the pH to 5.35. The Galaxy container is fabricated from a specially designed multilayered plastic. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period. The suitability of the plastic has been confirmed in tests in animals according to the USP biological tests for plastic containers, as well as by tissue culture toxicity studies.</Description>
  </NDC>
  <NDC>
    <NDCCode>0409-4178-03</NDCCode>
    <PackageDescription>12 BAG in 1 CASE (0409-4178-03)  &gt; 500 mL in 1 BAG</PackageDescription>
    <NDC11Code>00409-4178-03</NDC11Code>
    <ProductNDC>0409-4178</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Aminosyn-pf</ProprietaryName>
    <NonProprietaryName>Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Glycine, Histidine, Proline, Serine, Taurine, And Tyrosine</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19850906</StartMarketingDate>
    <EndMarketingDate>20231201</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019398</ApplicationNumber>
    <LabelerName>Hospira, Inc.</LabelerName>
    <SubstanceName>ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; TAURINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE</SubstanceName>
    <StrengthNumber>490; 861; 370; 576; 270; 220; 534; 831; 475; 125; 300; 570; 347; 50; 360; 125; 44; 452</StrengthNumber>
    <StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
    <Pharm_Classes>Amino Acid [EPC], Amino Acids [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-12-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>19850906</StartMarketingDatePackage>
    <EndMarketingDatePackage>20231201</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
</NDCList>
                    
<NDCList><NDC><NDCCode>10237-831-14</NDCCode><ProprietaryName>Ladys Choice Invisible Solid</ProprietaryName><NonProprietaryName>Aluminum Chlorohydrate</NonProprietaryName></NDC><NDC><NDCCode>46122-831-45</NDCCode><ProprietaryName>Nicotine Transdermal System</ProprietaryName><NonProprietaryName>Nicotine</NonProprietaryName></NDC><NDC><NDCCode>51009-831-14</NDCCode><ProprietaryName>Naturally Dry</ProprietaryName><NonProprietaryName>Aluminum Chlorohydrate</NonProprietaryName></NDC><NDC><NDCCode>59779-831-29</NDCCode><ProprietaryName>Instant Toothache Pain Relief</ProprietaryName><NonProprietaryName>Benzocaine</NonProprietaryName></NDC><NDC><NDCCode>10237-591-14</NDCCode><ProprietaryName>Arm And Hammer Baking Soda</ProprietaryName><NonProprietaryName>Sodium Bicarbonate</NonProprietaryName></NDC><NDC><NDCCode>10237-832-14</NDCCode><ProprietaryName>Ladys Choice Invisible Solid</ProprietaryName><NonProprietaryName>Aluminum Chlorohydrate</NonProprietaryName></NDC><NDC><NDCCode>10237-833-14</NDCCode><ProprietaryName>Ladys Choice Invisible Solid</ProprietaryName><NonProprietaryName>Aluminum Chlorohydrate</NonProprietaryName></NDC><NDC><NDCCode>10237-834-14</NDCCode><ProprietaryName>Ladys Choice Invisible Solid</ProprietaryName><NonProprietaryName>Aluminum Chlorohydrate</NonProprietaryName></NDC><NDC><NDCCode>16729-259-38</NDCCode><ProprietaryName>Eptifibatide</ProprietaryName><NonProprietaryName>Eptifibatide</NonProprietaryName></NDC><NDC><NDCCode>16729-260-03</NDCCode><ProprietaryName>Eptifibatide</ProprietaryName><NonProprietaryName>Eptifibatide</NonProprietaryName></NDC><NDC><NDCCode>16729-260-38</NDCCode><ProprietaryName>Eptifibatide</ProprietaryName><NonProprietaryName>Eptifibatide</NonProprietaryName></NDC><NDC><NDCCode>23155-831-31</NDCCode><ProprietaryName>Acetazolamide</ProprietaryName><NonProprietaryName>Acetazolamide</NonProprietaryName></NDC><NDC><NDCCode>33261-831-99</NDCCode><ProprietaryName>Glimepiride</ProprietaryName><NonProprietaryName>Glimepiride</NonProprietaryName></NDC><NDC><NDCCode>42291-831-30</NDCCode><ProprietaryName>Teriflunomide</ProprietaryName><NonProprietaryName>Teriflunomide</NonProprietaryName></NDC><NDC><NDCCode>61919-831-30</NDCCode><ProprietaryName>Fenofibrate</ProprietaryName><NonProprietaryName>Fenofibrate</NonProprietaryName></NDC><NDC><NDCCode>69269-831-01</NDCCode><ProprietaryName>Obagi Nu-derm Clear Fx</ProprietaryName><NonProprietaryName>Arbutin</NonProprietaryName></NDC><NDC><NDCCode>70954-831-10</NDCCode><ProprietaryName>Calcitriol</ProprietaryName><NonProprietaryName>Calcitriol</NonProprietaryName></NDC><NDC><NDCCode>72288-831-43</NDCCode><ProprietaryName>Mineral Oil</ProprietaryName><NonProprietaryName>Mineral Oil</NonProprietaryName></NDC><NDC><NDCCode>81284-831-05</NDCCode><ProprietaryName>Anticholium</ProprietaryName><NonProprietaryName>Physostigmine Salicylate</NonProprietaryName></NDC><NDC><NDCCode>10237-590-10</NDCCode><NonProprietaryName>Sodium Bicarbonate</NonProprietaryName></NDC><NDC><NDCCode>10237-590-25</NDCCode><NonProprietaryName>Sodium Bicarbonate</NonProprietaryName></NDC><NDC><NDCCode>10237-590-90</NDCCode><NonProprietaryName>Sodium Bicarbonate</NonProprietaryName></NDC><NDC><NDCCode>10237-591-35</NDCCode><ProprietaryName>Arm And Hammer Baking Soda</ProprietaryName><NonProprietaryName>Sodium Bicarbonate</NonProprietaryName></NDC><NDC><NDCCode>10237-592-10</NDCCode><NonProprietaryName>Sodium Bicarbonate</NonProprietaryName></NDC><NDC><NDCCode>10237-592-22</NDCCode><NonProprietaryName>Sodium Bicarbonate</NonProprietaryName></NDC><NDC><NDCCode>10237-592-25</NDCCode><NonProprietaryName>Sodium Bicarbonate</NonProprietaryName></NDC><NDC><NDCCode>10237-738-19</NDCCode><ProprietaryName>Orajel Nighttime Instant Relief For Teething Pain</ProprietaryName><NonProprietaryName>Benzocaine</NonProprietaryName></NDC><NDC><NDCCode>10237-775-42</NDCCode><ProprietaryName>Orajel</ProprietaryName><NonProprietaryName>Sodium Fluoride</NonProprietaryName></NDC><NDC><NDCCode>0338-9558-10</NDCCode><ProprietaryName>Eptifibatide</ProprietaryName><NonProprietaryName>Eptifibatide</NonProprietaryName></NDC><NDC><NDCCode>0409-4178-03</NDCCode><ProprietaryName>Aminosyn-pf</ProprietaryName><NonProprietaryName>Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Glycine, Histidine, Proline, Serine, Taurine, And Tyrosine</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

DataLabs Coding Library - Quering NPI Registry - REST API Examples

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

Output

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

Done. Press any key to exit ...
            
        

Full Text Search Fundamentals

Facts

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

How does it work

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

Full Text Search & DataLabs REST API

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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