RESTful Lookup — Test-Drive (2007 – 2026)

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{
  "NDC": [
    {
      "NDCCode": "54257-270-05",
      "PackageDescription": "500 TABLET in 1 BOTTLE (54257-270-05) ",
      "NDC11Code": "54257-0270-05",
      "ProductNDC": "54257-270",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Allergy Relief",
      "NonProprietaryName": "Cetirizine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200124",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209274",
      "LabelerName": "Magno-Humphries, Inc.",
      "SubstanceName": "CETIRIZINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2021-11-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200124",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose , 2 sneezing , 3 itchy, watery eyes, 4 itching of the nose or throat."
    },
    {
      "NDCCode": "54257-270-02",
      "PackageDescription": "100 TABLET in 1 BOTTLE (54257-270-02) ",
      "NDC11Code": "54257-0270-02",
      "ProductNDC": "54257-270",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Allergy Relief",
      "NonProprietaryName": "Cetirizine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200124",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209274",
      "LabelerName": "Magno-Humphries, Inc.",
      "SubstanceName": "CETIRIZINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2021-11-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200124",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose , 2 sneezing , 3 itchy, watery eyes, 4 itching of the nose or throat."
    },
    {
      "NDCCode": "42291-270-05",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (42291-270-05)  > 5 mL in 1 BOTTLE, PLASTIC",
      "NDC11Code": "42291-0270-05",
      "ProductNDC": "42291-270",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Epinastine Hcl",
      "NonProprietaryName": "Epinastine Hydrochloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20111115",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090870",
      "LabelerName": "AvKARE, Inc.",
      "SubstanceName": "EPINASTINE HYDROCHLORIDE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Adrenergic Agonists [MoA],Adrenergic Receptor Agonist [EPC],Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2015-02-27"
    },
    {
      "NDCCode": "42543-270-05",
      "PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 CONTAINER (42543-270-05) ",
      "NDC11Code": "42543-0270-05",
      "ProductNDC": "42543-270",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Potassium Chloride",
      "NonProprietaryName": "Potassium Chloride",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190701",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210097",
      "LabelerName": "Vensun Pharmaceuticals, Inc.",
      "SubstanceName": "POTASSIUM CHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "meq/1",
      "Pharm_Classes": "Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2020-07-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20190701",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "55111-270-05",
      "PackageDescription": "500 TABLET in 1 BOTTLE (55111-270-05)",
      "NDC11Code": "55111-0270-05",
      "ProductNDC": "55111-270",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amlodipine Besylate",
      "NonProprietaryName": "Amlodipine Besylate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20070723",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076692",
      "LabelerName": "Dr Reddy's Laboratories",
      "SubstanceName": "AMLODIPINE BESYLATE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Amlodipine besylate tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.",
      "Description": "Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S, and its structural formula is. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets are formulated as white tablets equivalent to 2.5, 5 and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose and sodium starch glycolate."
    },
    {
      "NDCCode": "59137-282-05",
      "PackageDescription": "1 KIT in 1 CARTON (59137-282-05)  *  5 mL in 1 VIAL (59137-270-01)  *  5 mL in 1 SYRINGE (59137-280-01) ",
      "NDC11Code": "59137-0282-05",
      "ProductNDC": "59137-282",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ixinity",
      "NonProprietaryName": "Coagulation Factor Ix (recombinant)",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20170512",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125426",
      "LabelerName": "Medexus Pharma, Inc.",
      "Status": "Active",
      "LastUpdate": "2024-04-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210701",
      "SamplePackage": "N",
      "IndicationAndUsage": "IXINITY, Coagulation Factor IX (Recombinant), is a human blood coagulation factor indicated in adults and children with hemophilia B for: 1 On-demand treatment and control of bleeding episodes , 2 Perioperative management , 3 Routine prophylaxis to reduce the frequency of bleeding episodes .",
      "Description": "IXINITY [coagulation factor IX (recombinant)] is a purified protein that has 415 amino acids. It has an amino acid sequence that is comparable to the Thr148 allelic form of plasma-derived factor IX. Coagulation factor IX (recombinant) is a single-chain glycoprotein with a molecular mass of about 55,000 Dalton that is secreted by a genetically engineered mammalian cell line derived from Chinese hamster ovary (CHO) cells. No human or animal proteins are added during any stage of manufacturing or formulation of IXINITY. The CHO cell line secretes recombinant factor IX into a defined cell culture medium that does not contain hormones. The recombinant factor IX is purified by a chromatography purification process. The process includes three validated steps for virus inactivation and removal, namely, solvent/detergent treatment, a chromatographic step, and nanofiltration. The process also includes a validated step to reduce the presence of CHO proteins in the final drug product. IXINITY is formulated as a sterile, nonpyrogenic lyophilized powder to be reconstituted with Sterile Water for Injection for intravenous administration. It does not contain any preservatives and is available in single-dose vials containing the labeled amount of factor IX activity, expressed in international units (IU). Each vial contains nominally 250, 500, 1000, 1500, 2000, or 3000 IU of recombinant coagulation factor IX. After reconstitution of the lyophilized powder, all dosage strengths yield a clear, colorless solution. The concentrations of excipients are."
    },
    {
      "NDCCode": "59651-270-05",
      "PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-270-05) ",
      "NDC11Code": "59651-0270-05",
      "ProductNDC": "59651-270",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Glipizide",
      "NonProprietaryName": "Glipizide",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170512",
      "EndMarketingDate": "20251130",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206928",
      "LabelerName": "Aurobindo Pharma Limited",
      "SubstanceName": "GLIPIZIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-12-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20170512",
      "EndMarketingDatePackage": "20251130",
      "SamplePackage": "N",
      "IndicationAndUsage": "Glipizide extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
      "Description": "Glipizide extended-release tablets (glipizide) is an oral sulfonylurea. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazinecarboxamido)ethyl] phenyl]sulfonyl]urea. The molecular formula is C21 H27 N5 O4 S; the molecular weight is 445.55; the structural formula is shown below. Glipizide is a white or almost white crystalline odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide.Inert ingredients in the 2.5 mg, 5 mg and 10 mg formulations are: acetyltributyl citrate, ammonium hydroxide, hydroxyethyl cellulose, hydroxypropyl cellulose, iron oxide black, lactose monohydrate, magnesium stearate, methacrylic acid and methyl methacrylate copolymer (1:1), polyethylene glycol, propylene glycol and shellac glaze in ethanol. System Components and Performance. Glipizide extended-release tablets are formulated as a polymer matrix based once-a-day controlled release tablet for oral use and is designed to deliver 2.5 mg, 5 mg or 10 mg of glipizide."
    },
    {
      "NDCCode": "65628-272-03",
      "PackageDescription": "1 KIT in 1 CARTON (65628-272-03)  *  150 mL in 1 BOTTLE (65628-270-05)  *  300 mL in 1 BOTTLE (65628-270-10)  *  150 mL in 1 BOTTLE (65628-271-05)  *  300 mL in 1 BOTTLE (65628-271-10)  *  90 mL in 1 BOTTLE (65628-271-03)  *  90 mL in 1 BOTTLE (65628-270-03) ",
      "NDC11Code": "65628-0272-03",
      "ProductNDC": "65628-272",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Konvomep",
      "NonProprietaryName": "Omeprazole And Sodium Bicarbonate",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20230215",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA213593",
      "LabelerName": "Azurity Pharmaceuticals, Inc.",
      "Status": "Active",
      "LastUpdate": "2025-12-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230215",
      "SamplePackage": "N",
      "IndicationAndUsage": "KONVOMEP is indicated in adults for: 1 short-term treatment (4 to 8 weeks) of active benign gastric ulcer., 2 reduction of risk of upper gastrointestinal (GI) bleeding in critically ill adult patients.",
      "Description": "KONVOMEP (omeprazole and sodium bicarbonate for oral suspension) is a combination of omeprazole, a PPI, and sodium bicarbonate, an antacid. Omeprazole is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole, a racemic mixture of two enantiomers that inhibits gastric acid secretion. Its empirical formula is C 17H 19N 3O 3S, with a molecular weight of 345.42. The structural formula is:. Omeprazole is a white to off-white crystalline powder which melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media but has acceptable stability under alkaline conditions. Sodium bicarbonate raises the gastric pH and protects the omeprazole from acid degradation. Sodium bicarbonate is a white crystalline powder. It is soluble in water and insoluble in alcohol. One gram of sodium bicarbonate dissolves in 12 mL of water at 25ºC. The pH of a freshly prepared 0.1 molar aqueous solution is 8.3 at 25ºC. Aqueous solutions slowly convert to sodium carbonate through loss of carbon dioxide. The molecular formula is NaHCO 3and the molecular weight is 84.01. The structural formula is:. KONVOMEP is supplied as a kit. Each kit is comprised of 1 bottle of pre‑weighed omeprazole powder and 1 bottle of pre‑measured strawberry‑flavored diluent to be reconstituted for oral administration. The strawberry‑flavored diluent contains sodium bicarbonate and the following inactive ingredients: benzyl alcohol, carboxymethylcellulose sodium, FD&C Red No. 40, poloxamer 188, purified water, simethicone emulsion, sodium citrate (dihydrate), sorbitol solution, strawberry flavor (natural and artificial flavors, propylene glycol, and glycerin), and sucralose. After reconstitution each mL contains 2 mg omeprazole and 84 mg sodium bicarbonate."
    },
    {
      "NDCCode": "65628-272-05",
      "PackageDescription": "1 KIT in 1 CARTON (65628-272-05)  *  150 mL in 1 BOTTLE (65628-270-05)  *  300 mL in 1 BOTTLE (65628-270-10)  *  150 mL in 1 BOTTLE (65628-271-05)  *  300 mL in 1 BOTTLE (65628-271-10)  *  90 mL in 1 BOTTLE (65628-271-03)  *  90 mL in 1 BOTTLE (65628-270-03) ",
      "NDC11Code": "65628-0272-05",
      "ProductNDC": "65628-272",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Konvomep",
      "NonProprietaryName": "Omeprazole And Sodium Bicarbonate",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20230215",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA213593",
      "LabelerName": "Azurity Pharmaceuticals, Inc.",
      "Status": "Active",
      "LastUpdate": "2025-12-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230215",
      "SamplePackage": "N",
      "IndicationAndUsage": "KONVOMEP is indicated in adults for: 1 short-term treatment (4 to 8 weeks) of active benign gastric ulcer., 2 reduction of risk of upper gastrointestinal (GI) bleeding in critically ill adult patients.",
      "Description": "KONVOMEP (omeprazole and sodium bicarbonate for oral suspension) is a combination of omeprazole, a PPI, and sodium bicarbonate, an antacid. Omeprazole is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole, a racemic mixture of two enantiomers that inhibits gastric acid secretion. Its empirical formula is C 17H 19N 3O 3S, with a molecular weight of 345.42. The structural formula is:. Omeprazole is a white to off-white crystalline powder which melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media but has acceptable stability under alkaline conditions. Sodium bicarbonate raises the gastric pH and protects the omeprazole from acid degradation. Sodium bicarbonate is a white crystalline powder. It is soluble in water and insoluble in alcohol. One gram of sodium bicarbonate dissolves in 12 mL of water at 25ºC. The pH of a freshly prepared 0.1 molar aqueous solution is 8.3 at 25ºC. Aqueous solutions slowly convert to sodium carbonate through loss of carbon dioxide. The molecular formula is NaHCO 3and the molecular weight is 84.01. The structural formula is:. KONVOMEP is supplied as a kit. Each kit is comprised of 1 bottle of pre‑weighed omeprazole powder and 1 bottle of pre‑measured strawberry‑flavored diluent to be reconstituted for oral administration. The strawberry‑flavored diluent contains sodium bicarbonate and the following inactive ingredients: benzyl alcohol, carboxymethylcellulose sodium, FD&C Red No. 40, poloxamer 188, purified water, simethicone emulsion, sodium citrate (dihydrate), sorbitol solution, strawberry flavor (natural and artificial flavors, propylene glycol, and glycerin), and sucralose. After reconstitution each mL contains 2 mg omeprazole and 84 mg sodium bicarbonate."
    },
    {
      "NDCCode": "65628-272-10",
      "PackageDescription": "1 KIT in 1 CARTON (65628-272-10)  *  150 mL in 1 BOTTLE (65628-270-05)  *  300 mL in 1 BOTTLE (65628-270-10)  *  150 mL in 1 BOTTLE (65628-271-05)  *  300 mL in 1 BOTTLE (65628-271-10)  *  90 mL in 1 BOTTLE (65628-271-03)  *  90 mL in 1 BOTTLE (65628-270-03) ",
      "NDC11Code": "65628-0272-10",
      "ProductNDC": "65628-272",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Konvomep",
      "NonProprietaryName": "Omeprazole And Sodium Bicarbonate",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20230215",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA213593",
      "LabelerName": "Azurity Pharmaceuticals, Inc.",
      "Status": "Active",
      "LastUpdate": "2025-12-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230215",
      "SamplePackage": "N",
      "IndicationAndUsage": "KONVOMEP is indicated in adults for: 1 short-term treatment (4 to 8 weeks) of active benign gastric ulcer., 2 reduction of risk of upper gastrointestinal (GI) bleeding in critically ill adult patients.",
      "Description": "KONVOMEP (omeprazole and sodium bicarbonate for oral suspension) is a combination of omeprazole, a PPI, and sodium bicarbonate, an antacid. Omeprazole is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole, a racemic mixture of two enantiomers that inhibits gastric acid secretion. Its empirical formula is C 17H 19N 3O 3S, with a molecular weight of 345.42. The structural formula is:. Omeprazole is a white to off-white crystalline powder which melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media but has acceptable stability under alkaline conditions. Sodium bicarbonate raises the gastric pH and protects the omeprazole from acid degradation. Sodium bicarbonate is a white crystalline powder. It is soluble in water and insoluble in alcohol. One gram of sodium bicarbonate dissolves in 12 mL of water at 25ºC. The pH of a freshly prepared 0.1 molar aqueous solution is 8.3 at 25ºC. Aqueous solutions slowly convert to sodium carbonate through loss of carbon dioxide. The molecular formula is NaHCO 3and the molecular weight is 84.01. The structural formula is:. KONVOMEP is supplied as a kit. Each kit is comprised of 1 bottle of pre‑weighed omeprazole powder and 1 bottle of pre‑measured strawberry‑flavored diluent to be reconstituted for oral administration. The strawberry‑flavored diluent contains sodium bicarbonate and the following inactive ingredients: benzyl alcohol, carboxymethylcellulose sodium, FD&C Red No. 40, poloxamer 188, purified water, simethicone emulsion, sodium citrate (dihydrate), sorbitol solution, strawberry flavor (natural and artificial flavors, propylene glycol, and glycerin), and sucralose. After reconstitution each mL contains 2 mg omeprazole and 84 mg sodium bicarbonate."
    },
    {
      "NDCCode": "66902-450-06",
      "PackageDescription": "1 KIT in 1 CARTON (66902-450-06)  *  1 PATCH in 1 POUCH (66902-270-05)  / 11 g in 1 PATCH *  1 PATCH in 1 POUCH (66902-270-06)  / 23 g in 1 PATCH *  1 PATCH in 1 POUCH (66902-270-04)  / 7 g in 1 PATCH",
      "NDC11Code": "66902-0450-06",
      "ProductNDC": "66902-450",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cvs Health Lidocaine Pain-relieving",
      "NonProprietaryName": "Lidocaine",
      "DosageFormName": "KIT",
      "RouteName": "TRANSDERMAL",
      "StartMarketingDate": "20200602",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "NATURAL ESSENTIALS, INC.",
      "Status": "Active",
      "LastUpdate": "2024-10-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200602",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the temporary relief of pain."
    },
    {
      "NDCCode": "68428-270-05",
      "PackageDescription": "150 PELLET in 1 VIAL, GLASS (68428-270-05) ",
      "NDC11Code": "68428-0270-05",
      "ProductNDC": "68428-270",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cadmium Sulphuricum",
      "NonProprietaryName": "Cadmium Sulfate",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20101028",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Washington Homeopathic Products",
      "SubstanceName": "CADMIUM SULFATE",
      "StrengthNumber": "30",
      "StrengthUnit": "[hp_C]/1",
      "Status": "Deprecated",
      "LastUpdate": "2022-04-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20101028",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "71052-270-05",
      "PackageDescription": "25 g in 1 BOTTLE (71052-270-05) ",
      "NDC11Code": "71052-0270-05",
      "ProductNDC": "71052-270",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Budesonide",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20191031",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Darmerica, LLC",
      "SubstanceName": "BUDESONIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Unfinished",
      "LastUpdate": "2026-05-15",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "31-OCT-19"
    },
    {
      "NDCCode": "77110-270-05",
      "PackageDescription": "59 mL in 1 BOTTLE (77110-270-05) ",
      "NDC11Code": "77110-0270-05",
      "ProductNDC": "77110-270",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hand Sanitizer",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200615",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "Biominerales Pharma, LLC",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200615",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when water and soap are not available."
    },
    {
      "NDCCode": "78952-270-05",
      "PackageDescription": "1 L in 1 BOTTLE (78952-270-05) ",
      "NDC11Code": "78952-0270-05",
      "ProductNDC": "78952-270",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Stay Well Advanced Hand Sanitizer",
      "NonProprietaryName": "Ethyl Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200706",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "BluSky Partners LLC",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "L/100L",
      "Status": "Deprecated",
      "LastUpdate": "2020-09-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200706",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "84756-270-05",
      "PackageDescription": "100 mL in 1 BOTTLE (84756-270-05) ",
      "NDC11Code": "84756-0270-05",
      "ProductNDC": "84756-270",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Rosemary Essential Oil",
      "NonProprietaryName": "Rosemary Essential Oil",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20241104",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M032",
      "LabelerName": "Yiwu Luoxin E� Commerce Co Ltd",
      "SubstanceName": "MINOXIDIL",
      "StrengthNumber": "5",
      "StrengthUnit": "g/100mL",
      "Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20241104",
      "SamplePackage": "N",
      "IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
    },
    {
      "NDCCode": "54257-180-07",
      "PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (54257-180-07) ",
      "NDC11Code": "54257-0180-07",
      "ProductNDC": "54257-180",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Famotidine",
      "NonProprietaryName": "Famotidine",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160426",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206531",
      "LabelerName": "Magno-Humphries, Inc.",
      "SubstanceName": "FAMOTIDINE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-05-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20160426",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "54257-802-02",
      "PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (54257-802-02) ",
      "NDC11Code": "54257-0802-02",
      "ProductNDC": "54257-802",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Famotidine",
      "NonProprietaryName": "Famotidine",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160426",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206531",
      "LabelerName": "Magno-Humphries, Inc.",
      "SubstanceName": "FAMOTIDINE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-05-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20160426",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0023-8842-05",
      "PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (0023-8842-05)  / 5 mL in 1 BOTTLE, DROPPER",
      "NDC11Code": "00023-8842-05",
      "ProductNDC": "0023-8842",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Alocril",
      "NonProprietaryName": "Nedocromil Sodium",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20000203",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021009",
      "LabelerName": "Allergan, Inc.",
      "SubstanceName": "NEDOCROMIL SODIUM",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Decreased Histamine Release [PE], Mast Cell Stabilizer [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-05-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20000203",
      "SamplePackage": "N",
      "IndicationAndUsage": "ALOCRIL® ophthalmic solution is indicated for the treatment of itching associated with allergic conjunctivitis.",
      "Description": "ALOCRIL® (nedocromil sodium ophthalmic solution) 2% is a clear, yellow, sterile solution for topical ophthalmic use. Nedocromil sodium is represented by the following structural formula. Chemical Name: 4H-Pyrano[3,2-g]quinoline-2,8-dicarboxylic acid, 9-ethyl-6,9-dihydro-4,6-dioxo-10-propyl-, disodium salt. Each mL contains: Active: Nedocromil sodium 20 mg/mL (2%); Preservative: Benzalkonium chloride 0.01%; Inactives: Edetate disodium 0.05%, purified water, and sodium chloride 0.5%. It has a pH range of 4.0 to 5.5 and an osmolality range of 270 to 330 mOsm/kg."
    },
    {
      "NDCCode": "0264-7055-10",
      "PackageDescription": "10 AMPULE in 1 CARTON (0264-7055-10)  > 5 mL in 1 AMPULE (0264-7055-05) ",
      "NDC11Code": "00264-7055-10",
      "ProductNDC": "0264-7055",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clorotekal",
      "NonProprietaryName": "Chloroprocaine Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRATHECAL",
      "StartMarketingDate": "20180501",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA208791",
      "LabelerName": "B. Braun Medical Inc.",
      "SubstanceName": "CHLOROPROCAINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2025-11-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20180501",
      "SamplePackage": "N",
      "IndicationAndUsage": "CLOROTEKAL® (chloroprocaine hydrochloride) is indicated for intrathecal injection for the production of subarachnoid block (spinal anesthesia) in adults undergoing surgical procedures. Indicated procedures include those suitable for CLOROTEKAL®'s short duration of action.",
      "Description": "CLOROTEKAL® is a sterile non pyrogenic local anesthetic. The active ingredient in CLOROTEKAL® is chloroprocaine hydrochloride (benzoic acid, 4-amino-2-chloro-2-(diethylamino) ethyl ester, monohydrochloride), an ester local anesthetic, which is represented by the following structural formula. 1 mL of solution for injection contains 10 mg of chloroprocaine hydrochloride, equivalent to 44.05 mg/5 mL (8.81 mg/mL) chloroprocaine. It also contains the following inactive ingredients: hydrochloric acid 1N (for pH adjustment), sodium chloride, water for injection. The pH of the solution is between 3.0 and 4.0. The osmolality of the solution is 270 – 300 mOsm/kg."
    },
    {
      "NDCCode": "0404-9897-05",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 BAG (0404-9897-05)  / 5 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "00404-9897-05",
      "ProductNDC": "0404-9897",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lidocaine Hydrochloride",
      "NonProprietaryName": "Lidocaine Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL",
      "StartMarketingDate": "20220112",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203082",
      "LabelerName": "Henry Schein, Inc.",
      "SubstanceName": "LIDOCAINE HYDROCHLORIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2026-09-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20220112",
      "SamplePackage": "N",
      "IndicationAndUsage": "Lidocaine hydrochloride injection is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.",
      "Description": "Lidocaine hydrochloride injection, USP is sterile, nonpyrogenic, aqueous solution that contains a local anesthetic agent and is administered parenterally by injection. See INDICATIONS AND USAGE section for specific uses. Lidocaine hydrochloride injection, USP contains lidocaine hydrochloride, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the molecular weight 270.8. Lidocaine hydrochloride (C14H22N2O  HCl) has the following structural formula. Lidocaine hydrochloride injection, USP is a sterile, nonpyrogenic, isotonic solution containing sodium chloride. The pH of the solution is adjusted to approximately 6.5 (5.0 to 7.0) with sodium hydroxide and/or hydrochloric acid."
    },
    {
      "NDCCode": "0409-4164-05",
      "PackageDescription": "6 POUCH in 1 CASE (0409-4164-05)  > 1 BAG in 1 POUCH > 1000 mL in 1 BAG",
      "NDC11Code": "00409-4164-05",
      "ProductNDC": "0409-4164",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Aminosyn Ii",
      "NonProprietaryName": "Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Histidine, Proline, Serine, N-acetyl-tyrosine, And Glycine",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20050901",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019438",
      "LabelerName": "Hospira, Inc.",
      "SubstanceName": "ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; HISTIDINE; PROLINE; SERINE; N-ACETYLTYROSINE; GLYCINE",
      "StrengthNumber": "660; 1000; 1050; 172; 298; 400; 200; 500; 993; 1018; 700; 738; 300; 722; 530; 270; 500",
      "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",
      "Pharm_Classes": "Amino Acid [EPC],Amino Acids [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-04-18",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "0597-0197-05",
      "PackageDescription": "2 VIAL, SINGLE-DOSE in 1 CARTON (0597-0197-05)  / 50 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "00597-0197-05",
      "ProductNDC": "0597-0197",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Praxbind",
      "NonProprietaryName": "Idarucizumab",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20151021",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA761025",
      "LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
      "SubstanceName": "IDARUCIZUMAB",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Antibodies, Monoclonal, Humanized [CS], Humanized Monoclonal Antibody Fragment [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-02-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20151021",
      "SamplePackage": "N",
      "IndicationAndUsage": "PRAXBIND is indicated in patients treated with Pradaxa when reversal of the anticoagulant effects of dabigatran is needed: 1 For emergency surgery/urgent procedures, 2 In life-threatening or uncontrolled bleeding.",
      "Description": "Idarucizumab is a humanized monoclonal antibody fragment (Fab) derived from an IgG1 isotype molecule, whose target is the direct thrombin inhibitor dabigatran. Using recombinant expression technology, idarucizumab is produced in a well characterized recombinant (mammalian) CHO cell line and is purified using standard technology. Idarucizumab is composed of a light chain of 219 amino acids and a heavy chain fragment of 225 amino acids, covalently linked together by one disulfide bond between cysteine 225 of the heavy chain fragment and cysteine 219 of the light chain, and has an estimated molecular mass of approximately 47,766 Daltons. PRAXBIND (idarucizumab) is a sterile, preservative-free, colorless to slightly yellow, clear to slightly opalescent solution for intravenous administration. PRAXBIND (idarucizumab) is supplied in 2 single-dose vials, each containing 2.5 g of idarucizumab in 50 mL formulated as a buffered, isotonic, solution containing acetic acid glacial (10.05 mg), polysorbate 20 (10 mg), sodium acetate (88.82 mg), sorbitol (2004.20 mg), and water for injection with an osmolality of 270-330 mOsm/kg and a pH of 5.3-5.7."
    },
    {
      "NDCCode": "0781-8085-32",
      "PackageDescription": "270 TABLET, FILM COATED in 1 CARTON (0781-8085-32) ",
      "NDC11Code": "00781-8085-32",
      "ProductNDC": "0781-8085",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pirfenidone",
      "NonProprietaryName": "Pirfenidone",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220502",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212560",
      "LabelerName": "Sandoz Inc",
      "SubstanceName": "PIRFENIDONE",
      "StrengthNumber": "267",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Pyridone [EPC], Pyridones [CS]",
      "Status": "Active",
      "LastUpdate": "2023-05-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220502",
      "SamplePackage": "N",
      "IndicationAndUsage": "Pirfenidone tablets are indicated for the treatment of idiopathic pulmonary fibrosis (IPF).",
      "Description": "Pirfenidone belongs to the chemical class of pyridone. Pirfenidone tablets are available as film-coated tablets containing 267 mg (yellow) and 801 mg (dark pink) pirfenidone for oral administration. Pirfenidone has a molecular formula of C12H11NO and a molecular weight of 185.23. Pirfenidone has the following structural formula, which has been referred to as 5-methyl-1-phenyl-2-1(H)-pyridone or 5-methyl-1-phenyl-2-(1H)-pyridone. Pirfenidone is a white to pale yellow crystalline, non-hygroscopic powder. It is more soluble in methanol, ethyl alcohol, acetone and chloroform than in water and 1.0 N HCl. The melting point is approximately 108°C. Pirfenidone tablet contains pirfenidone and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, pregelatinized starch, and silicon dioxide. 267 mg tablets contains opadry II yellow which consist of: iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. 801 mg tablets contains opadry II pink which consist of: iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide."
    },
    {
      "NDCCode": "0904-5632-53",
      "PackageDescription": "270 CAPSULE in 1 BOTTLE (0904-5632-53)",
      "NDC11Code": "00904-5632-53",
      "ProductNDC": "0904-5632",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Gabapentin",
      "NonProprietaryName": "Gabapentin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20050406",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075360",
      "LabelerName": "Major Pharmaceuticals",
      "SubstanceName": "GABAPENTIN",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2017-05-31"
    },
    {
      "NDCCode": "11673-270-24",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (11673-270-24)  / 24 TABLET in 1 BLISTER PACK",
      "NDC11Code": "11673-0270-24",
      "ProductNDC": "11673-270",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Maximum Strength Urinary Pain Relief",
      "NonProprietaryName": "Phenazopyridine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230125",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "TARGET CORPORATION",
      "SubstanceName": "PHENAZOPYRIDINE HYDROCHLORIDE",
      "StrengthNumber": "99.5",
      "StrengthUnit": "mg/1",
      "Status": "Active",
      "LastUpdate": "2026-01-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230125",
      "SamplePackage": "N",
      "IndicationAndUsage": "Relief from urinary pain, burning, urgency and frequency associated with urinary tract infections. Treatment should not exceed 2 days; see Directions."
    },
    {
      "NDCCode": "11822-6040-7",
      "PackageDescription": "270 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (11822-6040-7) ",
      "NDC11Code": "11822-6040-07",
      "ProductNDC": "11822-6040",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Naproxen Sodium",
      "NonProprietaryName": "Naproxen Sodium",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220718",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204872",
      "LabelerName": "Rite Aid Corporation",
      "SubstanceName": "NAPROXEN SODIUM",
      "StrengthNumber": "220",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-05-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20220718",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves minor aches and pains due to:headachemuscular achesthe common coldtoothachebackachemenstrual crampsminor pain of arthritis. temporarily reduces fever."
    },
    {
      "NDCCode": "16571-739-27",
      "PackageDescription": "270 TABLET, FILM COATED in 1 BOTTLE (16571-739-27) ",
      "NDC11Code": "16571-0739-27",
      "ProductNDC": "16571-739",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sevelamer Carbonate",
      "NonProprietaryName": "Sevelamer Carbonate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20201216",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204451",
      "LabelerName": "Rising Pharmaceuticals, Inc.",
      "SubstanceName": "SEVELAMER CARBONATE",
      "StrengthNumber": "800",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2024-12-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20201216",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sevelamer carbonate tablets are indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis.",
      "Description": "The active ingredient in sevelamer carbonate tablets is sevelamer carbonate, a polymeric amine that binds phosphate and is meant for oral administration. It was developed as a pharmaceutical alternative to sevelamer hydrochloride. Sevelamer carbonate is an anion exchange resin, with the same polymeric structure as sevelamer hydrochloride, in which carbonate replaces chloride as the counterion. While the counterions differ for the two salts, the polymer itself, the active moiety involved in phosphate-binding, is the same. Sevelamer carbonate is known chemically as poly(allylamine-co-N,N'-diallyl-1,3-diamino-2-hydroxypropane) carbonate salt. Sevelamer carbonate is hygroscopic, but insoluble in water. The structure is represented in Figure 1.Figure 1: Chemical Structure of Sevelamer Carbonate a, b = number of primary amine groups             a + b = 9 c = number of cross-linking groups                     c = 1 m = large number to indicate extended polymer network."
    },
    {
      "NDCCode": "16714-270-01",
      "PackageDescription": "1 TUBE in 1 CARTON (16714-270-01)  / 20 g in 1 TUBE",
      "NDC11Code": "16714-0270-01",
      "ProductNDC": "16714-270",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tretinoin",
      "NonProprietaryName": "Tretinoin",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20230105",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215713",
      "LabelerName": "NORTHSTAR RX LLC",
      "SubstanceName": "TRETINOIN",
      "StrengthNumber": ".25",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
      "Status": "Active",
      "LastUpdate": "2025-05-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230105",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tretinoin cream is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.",
      "Description": "Tretinoin Cream USP, 0.025% is used for the topical treatment of acne vulgaris. Tretinoin cream contains tretinoin in 0.025% by weight, in a hydrophilic cream vehicle of butylated hydroxytoluene, isopropyl myristate, polyoxyl stearate type II, purified water, sorbic acid, stearic acid, stearyl alcohol and xanthan gum. Chemically, tretinoin is all-trans-retinoic acid and has the following structure:."
    },
    {
      "NDCCode": "16714-270-02",
      "PackageDescription": "1 TUBE in 1 CARTON (16714-270-02)  / 45 g in 1 TUBE",
      "NDC11Code": "16714-0270-02",
      "ProductNDC": "16714-270",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tretinoin",
      "NonProprietaryName": "Tretinoin",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20230105",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215713",
      "LabelerName": "NORTHSTAR RX LLC",
      "SubstanceName": "TRETINOIN",
      "StrengthNumber": ".25",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
      "Status": "Active",
      "LastUpdate": "2025-05-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230105",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tretinoin cream is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.",
      "Description": "Tretinoin Cream USP, 0.025% is used for the topical treatment of acne vulgaris. Tretinoin cream contains tretinoin in 0.025% by weight, in a hydrophilic cream vehicle of butylated hydroxytoluene, isopropyl myristate, polyoxyl stearate type II, purified water, sorbic acid, stearic acid, stearyl alcohol and xanthan gum. Chemically, tretinoin is all-trans-retinoic acid and has the following structure:."
    }
  ]
}
                    

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    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
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    <ProprietaryName>Epinastine Hcl</ProprietaryName>
    <NonProprietaryName>Epinastine Hydrochloride</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20111115</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090870</ApplicationNumber>
    <LabelerName>AvKARE, Inc.</LabelerName>
    <SubstanceName>EPINASTINE HYDROCHLORIDE</SubstanceName>
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    <NDCCode>42543-270-05</NDCCode>
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    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Potassium Chloride</ProprietaryName>
    <NonProprietaryName>Potassium Chloride</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
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    <StartMarketingDate>20190701</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210097</ApplicationNumber>
    <LabelerName>Vensun Pharmaceuticals, Inc.</LabelerName>
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    <StrengthUnit>meq/1</StrengthUnit>
    <Pharm_Classes>Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]</Pharm_Classes>
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  <NDC>
    <NDCCode>55111-270-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (55111-270-05)</PackageDescription>
    <NDC11Code>55111-0270-05</NDC11Code>
    <ProductNDC>55111-270</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amlodipine Besylate</ProprietaryName>
    <NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070723</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076692</ApplicationNumber>
    <LabelerName>Dr Reddy's Laboratories</LabelerName>
    <SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
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    <NDCCode>59137-282-05</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (59137-282-05)  *  5 mL in 1 VIAL (59137-270-01)  *  5 mL in 1 SYRINGE (59137-280-01) </PackageDescription>
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    <ProductNDC>59137-282</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ixinity</ProprietaryName>
    <NonProprietaryName>Coagulation Factor Ix (recombinant)</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20170512</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125426</ApplicationNumber>
    <LabelerName>Medexus Pharma, Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2024-04-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210701</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>IXINITY, Coagulation Factor IX (Recombinant), is a human blood coagulation factor indicated in adults and children with hemophilia B for: 1 On-demand treatment and control of bleeding episodes , 2 Perioperative management , 3 Routine prophylaxis to reduce the frequency of bleeding episodes .</IndicationAndUsage>
    <Description>IXINITY [coagulation factor IX (recombinant)] is a purified protein that has 415 amino acids. It has an amino acid sequence that is comparable to the Thr148 allelic form of plasma-derived factor IX. Coagulation factor IX (recombinant) is a single-chain glycoprotein with a molecular mass of about 55,000 Dalton that is secreted by a genetically engineered mammalian cell line derived from Chinese hamster ovary (CHO) cells. No human or animal proteins are added during any stage of manufacturing or formulation of IXINITY. The CHO cell line secretes recombinant factor IX into a defined cell culture medium that does not contain hormones. The recombinant factor IX is purified by a chromatography purification process. The process includes three validated steps for virus inactivation and removal, namely, solvent/detergent treatment, a chromatographic step, and nanofiltration. The process also includes a validated step to reduce the presence of CHO proteins in the final drug product. IXINITY is formulated as a sterile, nonpyrogenic lyophilized powder to be reconstituted with Sterile Water for Injection for intravenous administration. It does not contain any preservatives and is available in single-dose vials containing the labeled amount of factor IX activity, expressed in international units (IU). Each vial contains nominally 250, 500, 1000, 1500, 2000, or 3000 IU of recombinant coagulation factor IX. After reconstitution of the lyophilized powder, all dosage strengths yield a clear, colorless solution. The concentrations of excipients are.</Description>
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  <NDC>
    <NDCCode>59651-270-05</NDCCode>
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    <NDC11Code>59651-0270-05</NDC11Code>
    <ProductNDC>59651-270</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Glipizide</ProprietaryName>
    <NonProprietaryName>Glipizide</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170512</StartMarketingDate>
    <EndMarketingDate>20251130</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206928</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>GLIPIZIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Sulfonylurea Compounds [CS], Sulfonylurea [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-12-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20170512</StartMarketingDatePackage>
    <EndMarketingDatePackage>20251130</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Glipizide extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>Glipizide extended-release tablets (glipizide) is an oral sulfonylurea. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazinecarboxamido)ethyl] phenyl]sulfonyl]urea. The molecular formula is C21 H27 N5 O4 S; the molecular weight is 445.55; the structural formula is shown below. Glipizide is a white or almost white crystalline odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide.Inert ingredients in the 2.5 mg, 5 mg and 10 mg formulations are: acetyltributyl citrate, ammonium hydroxide, hydroxyethyl cellulose, hydroxypropyl cellulose, iron oxide black, lactose monohydrate, magnesium stearate, methacrylic acid and methyl methacrylate copolymer (1:1), polyethylene glycol, propylene glycol and shellac glaze in ethanol. System Components and Performance. Glipizide extended-release tablets are formulated as a polymer matrix based once-a-day controlled release tablet for oral use and is designed to deliver 2.5 mg, 5 mg or 10 mg of glipizide.</Description>
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  <NDC>
    <NDCCode>65628-272-03</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (65628-272-03)  *  150 mL in 1 BOTTLE (65628-270-05)  *  300 mL in 1 BOTTLE (65628-270-10)  *  150 mL in 1 BOTTLE (65628-271-05)  *  300 mL in 1 BOTTLE (65628-271-10)  *  90 mL in 1 BOTTLE (65628-271-03)  *  90 mL in 1 BOTTLE (65628-270-03) </PackageDescription>
    <NDC11Code>65628-0272-03</NDC11Code>
    <ProductNDC>65628-272</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Konvomep</ProprietaryName>
    <NonProprietaryName>Omeprazole And Sodium Bicarbonate</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20230215</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA213593</ApplicationNumber>
    <LabelerName>Azurity Pharmaceuticals, Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-12-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230215</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>KONVOMEP is indicated in adults for: 1 short-term treatment (4 to 8 weeks) of active benign gastric ulcer., 2 reduction of risk of upper gastrointestinal (GI) bleeding in critically ill adult patients.</IndicationAndUsage>
    <Description>KONVOMEP (omeprazole and sodium bicarbonate for oral suspension) is a combination of omeprazole, a PPI, and sodium bicarbonate, an antacid. Omeprazole is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole, a racemic mixture of two enantiomers that inhibits gastric acid secretion. Its empirical formula is C 17H 19N 3O 3S, with a molecular weight of 345.42. The structural formula is:. Omeprazole is a white to off-white crystalline powder which melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media but has acceptable stability under alkaline conditions. Sodium bicarbonate raises the gastric pH and protects the omeprazole from acid degradation. Sodium bicarbonate is a white crystalline powder. It is soluble in water and insoluble in alcohol. One gram of sodium bicarbonate dissolves in 12 mL of water at 25ºC. The pH of a freshly prepared 0.1 molar aqueous solution is 8.3 at 25ºC. Aqueous solutions slowly convert to sodium carbonate through loss of carbon dioxide. The molecular formula is NaHCO 3and the molecular weight is 84.01. The structural formula is:. KONVOMEP is supplied as a kit. Each kit is comprised of 1 bottle of pre‑weighed omeprazole powder and 1 bottle of pre‑measured strawberry‑flavored diluent to be reconstituted for oral administration. The strawberry‑flavored diluent contains sodium bicarbonate and the following inactive ingredients: benzyl alcohol, carboxymethylcellulose sodium, FD&amp;C Red No. 40, poloxamer 188, purified water, simethicone emulsion, sodium citrate (dihydrate), sorbitol solution, strawberry flavor (natural and artificial flavors, propylene glycol, and glycerin), and sucralose. After reconstitution each mL contains 2 mg omeprazole and 84 mg sodium bicarbonate.</Description>
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    <NDCCode>65628-272-05</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (65628-272-05)  *  150 mL in 1 BOTTLE (65628-270-05)  *  300 mL in 1 BOTTLE (65628-270-10)  *  150 mL in 1 BOTTLE (65628-271-05)  *  300 mL in 1 BOTTLE (65628-271-10)  *  90 mL in 1 BOTTLE (65628-271-03)  *  90 mL in 1 BOTTLE (65628-270-03) </PackageDescription>
    <NDC11Code>65628-0272-05</NDC11Code>
    <ProductNDC>65628-272</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Konvomep</ProprietaryName>
    <NonProprietaryName>Omeprazole And Sodium Bicarbonate</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20230215</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA213593</ApplicationNumber>
    <LabelerName>Azurity Pharmaceuticals, Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-12-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230215</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>KONVOMEP is indicated in adults for: 1 short-term treatment (4 to 8 weeks) of active benign gastric ulcer., 2 reduction of risk of upper gastrointestinal (GI) bleeding in critically ill adult patients.</IndicationAndUsage>
    <Description>KONVOMEP (omeprazole and sodium bicarbonate for oral suspension) is a combination of omeprazole, a PPI, and sodium bicarbonate, an antacid. Omeprazole is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole, a racemic mixture of two enantiomers that inhibits gastric acid secretion. Its empirical formula is C 17H 19N 3O 3S, with a molecular weight of 345.42. The structural formula is:. Omeprazole is a white to off-white crystalline powder which melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media but has acceptable stability under alkaline conditions. Sodium bicarbonate raises the gastric pH and protects the omeprazole from acid degradation. Sodium bicarbonate is a white crystalline powder. It is soluble in water and insoluble in alcohol. One gram of sodium bicarbonate dissolves in 12 mL of water at 25ºC. The pH of a freshly prepared 0.1 molar aqueous solution is 8.3 at 25ºC. Aqueous solutions slowly convert to sodium carbonate through loss of carbon dioxide. The molecular formula is NaHCO 3and the molecular weight is 84.01. The structural formula is:. KONVOMEP is supplied as a kit. Each kit is comprised of 1 bottle of pre‑weighed omeprazole powder and 1 bottle of pre‑measured strawberry‑flavored diluent to be reconstituted for oral administration. The strawberry‑flavored diluent contains sodium bicarbonate and the following inactive ingredients: benzyl alcohol, carboxymethylcellulose sodium, FD&amp;C Red No. 40, poloxamer 188, purified water, simethicone emulsion, sodium citrate (dihydrate), sorbitol solution, strawberry flavor (natural and artificial flavors, propylene glycol, and glycerin), and sucralose. After reconstitution each mL contains 2 mg omeprazole and 84 mg sodium bicarbonate.</Description>
  </NDC>
  <NDC>
    <NDCCode>65628-272-10</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (65628-272-10)  *  150 mL in 1 BOTTLE (65628-270-05)  *  300 mL in 1 BOTTLE (65628-270-10)  *  150 mL in 1 BOTTLE (65628-271-05)  *  300 mL in 1 BOTTLE (65628-271-10)  *  90 mL in 1 BOTTLE (65628-271-03)  *  90 mL in 1 BOTTLE (65628-270-03) </PackageDescription>
    <NDC11Code>65628-0272-10</NDC11Code>
    <ProductNDC>65628-272</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Konvomep</ProprietaryName>
    <NonProprietaryName>Omeprazole And Sodium Bicarbonate</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20230215</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA213593</ApplicationNumber>
    <LabelerName>Azurity Pharmaceuticals, Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-12-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230215</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>KONVOMEP is indicated in adults for: 1 short-term treatment (4 to 8 weeks) of active benign gastric ulcer., 2 reduction of risk of upper gastrointestinal (GI) bleeding in critically ill adult patients.</IndicationAndUsage>
    <Description>KONVOMEP (omeprazole and sodium bicarbonate for oral suspension) is a combination of omeprazole, a PPI, and sodium bicarbonate, an antacid. Omeprazole is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole, a racemic mixture of two enantiomers that inhibits gastric acid secretion. Its empirical formula is C 17H 19N 3O 3S, with a molecular weight of 345.42. The structural formula is:. Omeprazole is a white to off-white crystalline powder which melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media but has acceptable stability under alkaline conditions. Sodium bicarbonate raises the gastric pH and protects the omeprazole from acid degradation. Sodium bicarbonate is a white crystalline powder. It is soluble in water and insoluble in alcohol. One gram of sodium bicarbonate dissolves in 12 mL of water at 25ºC. The pH of a freshly prepared 0.1 molar aqueous solution is 8.3 at 25ºC. Aqueous solutions slowly convert to sodium carbonate through loss of carbon dioxide. The molecular formula is NaHCO 3and the molecular weight is 84.01. The structural formula is:. KONVOMEP is supplied as a kit. Each kit is comprised of 1 bottle of pre‑weighed omeprazole powder and 1 bottle of pre‑measured strawberry‑flavored diluent to be reconstituted for oral administration. The strawberry‑flavored diluent contains sodium bicarbonate and the following inactive ingredients: benzyl alcohol, carboxymethylcellulose sodium, FD&amp;C Red No. 40, poloxamer 188, purified water, simethicone emulsion, sodium citrate (dihydrate), sorbitol solution, strawberry flavor (natural and artificial flavors, propylene glycol, and glycerin), and sucralose. After reconstitution each mL contains 2 mg omeprazole and 84 mg sodium bicarbonate.</Description>
  </NDC>
  <NDC>
    <NDCCode>66902-450-06</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (66902-450-06)  *  1 PATCH in 1 POUCH (66902-270-05)  / 11 g in 1 PATCH *  1 PATCH in 1 POUCH (66902-270-06)  / 23 g in 1 PATCH *  1 PATCH in 1 POUCH (66902-270-04)  / 7 g in 1 PATCH</PackageDescription>
    <NDC11Code>66902-0450-06</NDC11Code>
    <ProductNDC>66902-450</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cvs Health Lidocaine Pain-relieving</ProprietaryName>
    <NonProprietaryName>Lidocaine</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <RouteName>TRANSDERMAL</RouteName>
    <StartMarketingDate>20200602</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>NATURAL ESSENTIALS, INC.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2024-10-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200602</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the temporary relief of pain.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>68428-270-05</NDCCode>
    <PackageDescription>150 PELLET in 1 VIAL, GLASS (68428-270-05) </PackageDescription>
    <NDC11Code>68428-0270-05</NDC11Code>
    <ProductNDC>68428-270</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cadmium Sulphuricum</ProprietaryName>
    <NonProprietaryName>Cadmium Sulfate</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20101028</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Washington Homeopathic Products</LabelerName>
    <SubstanceName>CADMIUM SULFATE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>[hp_C]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-04-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20101028</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>71052-270-05</NDCCode>
    <PackageDescription>25 g in 1 BOTTLE (71052-270-05) </PackageDescription>
    <NDC11Code>71052-0270-05</NDC11Code>
    <ProductNDC>71052-270</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Budesonide</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20191031</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Darmerica, LLC</LabelerName>
    <SubstanceName>BUDESONIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-05-15</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>31-OCT-19</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>77110-270-05</NDCCode>
    <PackageDescription>59 mL in 1 BOTTLE (77110-270-05) </PackageDescription>
    <NDC11Code>77110-0270-05</NDC11Code>
    <ProductNDC>77110-270</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200615</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>Biominerales Pharma, LLC</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200615</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when water and soap are not available.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>78952-270-05</NDCCode>
    <PackageDescription>1 L in 1 BOTTLE (78952-270-05) </PackageDescription>
    <NDC11Code>78952-0270-05</NDC11Code>
    <ProductNDC>78952-270</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Stay Well Advanced Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200706</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>BluSky Partners LLC</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>L/100L</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-09-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200706</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>84756-270-05</NDCCode>
    <PackageDescription>100 mL in 1 BOTTLE (84756-270-05) </PackageDescription>
    <NDC11Code>84756-0270-05</NDC11Code>
    <ProductNDC>84756-270</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Rosemary Essential Oil</ProprietaryName>
    <NonProprietaryName>Rosemary Essential Oil</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20241104</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M032</ApplicationNumber>
    <LabelerName>Yiwu Luoxin E� Commerce Co Ltd</LabelerName>
    <SubstanceName>MINOXIDIL</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241104</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>54257-180-07</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (54257-180-07) </PackageDescription>
    <NDC11Code>54257-0180-07</NDC11Code>
    <ProductNDC>54257-180</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Famotidine</ProprietaryName>
    <NonProprietaryName>Famotidine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160426</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206531</ApplicationNumber>
    <LabelerName>Magno-Humphries, Inc.</LabelerName>
    <SubstanceName>FAMOTIDINE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-05-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160426</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>54257-802-02</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (54257-802-02) </PackageDescription>
    <NDC11Code>54257-0802-02</NDC11Code>
    <ProductNDC>54257-802</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Famotidine</ProprietaryName>
    <NonProprietaryName>Famotidine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160426</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206531</ApplicationNumber>
    <LabelerName>Magno-Humphries, Inc.</LabelerName>
    <SubstanceName>FAMOTIDINE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-05-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160426</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0023-8842-05</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (0023-8842-05)  / 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>00023-8842-05</NDC11Code>
    <ProductNDC>0023-8842</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Alocril</ProprietaryName>
    <NonProprietaryName>Nedocromil Sodium</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20000203</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021009</ApplicationNumber>
    <LabelerName>Allergan, Inc.</LabelerName>
    <SubstanceName>NEDOCROMIL SODIUM</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Decreased Histamine Release [PE], Mast Cell Stabilizer [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-05-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20000203</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ALOCRIL® ophthalmic solution is indicated for the treatment of itching associated with allergic conjunctivitis.</IndicationAndUsage>
    <Description>ALOCRIL® (nedocromil sodium ophthalmic solution) 2% is a clear, yellow, sterile solution for topical ophthalmic use. Nedocromil sodium is represented by the following structural formula. Chemical Name: 4H-Pyrano[3,2-g]quinoline-2,8-dicarboxylic acid, 9-ethyl-6,9-dihydro-4,6-dioxo-10-propyl-, disodium salt. Each mL contains: Active: Nedocromil sodium 20 mg/mL (2%); Preservative: Benzalkonium chloride 0.01%; Inactives: Edetate disodium 0.05%, purified water, and sodium chloride 0.5%. It has a pH range of 4.0 to 5.5 and an osmolality range of 270 to 330 mOsm/kg.</Description>
  </NDC>
  <NDC>
    <NDCCode>0264-7055-10</NDCCode>
    <PackageDescription>10 AMPULE in 1 CARTON (0264-7055-10)  &gt; 5 mL in 1 AMPULE (0264-7055-05) </PackageDescription>
    <NDC11Code>00264-7055-10</NDC11Code>
    <ProductNDC>0264-7055</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clorotekal</ProprietaryName>
    <NonProprietaryName>Chloroprocaine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRATHECAL</RouteName>
    <StartMarketingDate>20180501</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA208791</ApplicationNumber>
    <LabelerName>B. Braun Medical Inc.</LabelerName>
    <SubstanceName>CHLOROPROCAINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>CLOROTEKAL® (chloroprocaine hydrochloride) is indicated for intrathecal injection for the production of subarachnoid block (spinal anesthesia) in adults undergoing surgical procedures. Indicated procedures include those suitable for CLOROTEKAL®'s short duration of action.</IndicationAndUsage>
    <Description>CLOROTEKAL® is a sterile non pyrogenic local anesthetic. The active ingredient in CLOROTEKAL® is chloroprocaine hydrochloride (benzoic acid, 4-amino-2-chloro-2-(diethylamino) ethyl ester, monohydrochloride), an ester local anesthetic, which is represented by the following structural formula. 1 mL of solution for injection contains 10 mg of chloroprocaine hydrochloride, equivalent to 44.05 mg/5 mL (8.81 mg/mL) chloroprocaine. It also contains the following inactive ingredients: hydrochloric acid 1N (for pH adjustment), sodium chloride, water for injection. The pH of the solution is between 3.0 and 4.0. The osmolality of the solution is 270 – 300 mOsm/kg.</Description>
  </NDC>
  <NDC>
    <NDCCode>0404-9897-05</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 BAG (0404-9897-05)  / 5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>00404-9897-05</NDC11Code>
    <ProductNDC>0404-9897</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lidocaine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL</RouteName>
    <StartMarketingDate>20220112</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203082</ApplicationNumber>
    <LabelerName>Henry Schein, Inc.</LabelerName>
    <SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220112</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lidocaine hydrochloride injection is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.</IndicationAndUsage>
    <Description>Lidocaine hydrochloride injection, USP is sterile, nonpyrogenic, aqueous solution that contains a local anesthetic agent and is administered parenterally by injection. See INDICATIONS AND USAGE section for specific uses. Lidocaine hydrochloride injection, USP contains lidocaine hydrochloride, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the molecular weight 270.8. Lidocaine hydrochloride (C14H22N2O  HCl) has the following structural formula. Lidocaine hydrochloride injection, USP is a sterile, nonpyrogenic, isotonic solution containing sodium chloride. The pH of the solution is adjusted to approximately 6.5 (5.0 to 7.0) with sodium hydroxide and/or hydrochloric acid.</Description>
  </NDC>
  <NDC>
    <NDCCode>0409-4164-05</NDCCode>
    <PackageDescription>6 POUCH in 1 CASE (0409-4164-05)  &gt; 1 BAG in 1 POUCH &gt; 1000 mL in 1 BAG</PackageDescription>
    <NDC11Code>00409-4164-05</NDC11Code>
    <ProductNDC>0409-4164</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Aminosyn Ii</ProprietaryName>
    <NonProprietaryName>Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Histidine, Proline, Serine, N-acetyl-tyrosine, And Glycine</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20050901</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019438</ApplicationNumber>
    <LabelerName>Hospira, Inc.</LabelerName>
    <SubstanceName>ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; HISTIDINE; PROLINE; SERINE; N-ACETYLTYROSINE; GLYCINE</SubstanceName>
    <StrengthNumber>660; 1000; 1050; 172; 298; 400; 200; 500; 993; 1018; 700; 738; 300; 722; 530; 270; 500</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</StrengthUnit>
    <Pharm_Classes>Amino Acid [EPC],Amino Acids [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-04-18</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>0597-0197-05</NDCCode>
    <PackageDescription>2 VIAL, SINGLE-DOSE in 1 CARTON (0597-0197-05)  / 50 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>00597-0197-05</NDC11Code>
    <ProductNDC>0597-0197</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Praxbind</ProprietaryName>
    <NonProprietaryName>Idarucizumab</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20151021</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761025</ApplicationNumber>
    <LabelerName>Boehringer Ingelheim Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>IDARUCIZUMAB</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Antibodies, Monoclonal, Humanized [CS], Humanized Monoclonal Antibody Fragment [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-02-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151021</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>PRAXBIND is indicated in patients treated with Pradaxa when reversal of the anticoagulant effects of dabigatran is needed: 1 For emergency surgery/urgent procedures, 2 In life-threatening or uncontrolled bleeding.</IndicationAndUsage>
    <Description>Idarucizumab is a humanized monoclonal antibody fragment (Fab) derived from an IgG1 isotype molecule, whose target is the direct thrombin inhibitor dabigatran. Using recombinant expression technology, idarucizumab is produced in a well characterized recombinant (mammalian) CHO cell line and is purified using standard technology. Idarucizumab is composed of a light chain of 219 amino acids and a heavy chain fragment of 225 amino acids, covalently linked together by one disulfide bond between cysteine 225 of the heavy chain fragment and cysteine 219 of the light chain, and has an estimated molecular mass of approximately 47,766 Daltons. PRAXBIND (idarucizumab) is a sterile, preservative-free, colorless to slightly yellow, clear to slightly opalescent solution for intravenous administration. PRAXBIND (idarucizumab) is supplied in 2 single-dose vials, each containing 2.5 g of idarucizumab in 50 mL formulated as a buffered, isotonic, solution containing acetic acid glacial (10.05 mg), polysorbate 20 (10 mg), sodium acetate (88.82 mg), sorbitol (2004.20 mg), and water for injection with an osmolality of 270-330 mOsm/kg and a pH of 5.3-5.7.</Description>
  </NDC>
  <NDC>
    <NDCCode>0781-8085-32</NDCCode>
    <PackageDescription>270 TABLET, FILM COATED in 1 CARTON (0781-8085-32) </PackageDescription>
    <NDC11Code>00781-8085-32</NDC11Code>
    <ProductNDC>0781-8085</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pirfenidone</ProprietaryName>
    <NonProprietaryName>Pirfenidone</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220502</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212560</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>PIRFENIDONE</SubstanceName>
    <StrengthNumber>267</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Pyridone [EPC], Pyridones [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-05-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220502</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pirfenidone tablets are indicated for the treatment of idiopathic pulmonary fibrosis (IPF).</IndicationAndUsage>
    <Description>Pirfenidone belongs to the chemical class of pyridone. Pirfenidone tablets are available as film-coated tablets containing 267 mg (yellow) and 801 mg (dark pink) pirfenidone for oral administration. Pirfenidone has a molecular formula of C12H11NO and a molecular weight of 185.23. Pirfenidone has the following structural formula, which has been referred to as 5-methyl-1-phenyl-2-1(H)-pyridone or 5-methyl-1-phenyl-2-(1H)-pyridone. Pirfenidone is a white to pale yellow crystalline, non-hygroscopic powder. It is more soluble in methanol, ethyl alcohol, acetone and chloroform than in water and 1.0 N HCl. The melting point is approximately 108°C. Pirfenidone tablet contains pirfenidone and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, pregelatinized starch, and silicon dioxide. 267 mg tablets contains opadry II yellow which consist of: iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. 801 mg tablets contains opadry II pink which consist of: iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0904-5632-53</NDCCode>
    <PackageDescription>270 CAPSULE in 1 BOTTLE (0904-5632-53)</PackageDescription>
    <NDC11Code>00904-5632-53</NDC11Code>
    <ProductNDC>0904-5632</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Gabapentin</ProprietaryName>
    <NonProprietaryName>Gabapentin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20050406</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075360</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <SubstanceName>GABAPENTIN</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-05-31</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>11673-270-24</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (11673-270-24)  / 24 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>11673-0270-24</NDC11Code>
    <ProductNDC>11673-270</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Maximum Strength Urinary Pain Relief</ProprietaryName>
    <NonProprietaryName>Phenazopyridine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230125</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>TARGET CORPORATION</LabelerName>
    <SubstanceName>PHENAZOPYRIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>99.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-01-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230125</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Relief from urinary pain, burning, urgency and frequency associated with urinary tract infections. Treatment should not exceed 2 days; see Directions.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>11822-6040-7</NDCCode>
    <PackageDescription>270 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (11822-6040-7) </PackageDescription>
    <NDC11Code>11822-6040-07</NDC11Code>
    <ProductNDC>11822-6040</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Naproxen Sodium</ProprietaryName>
    <NonProprietaryName>Naproxen Sodium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220718</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204872</ApplicationNumber>
    <LabelerName>Rite Aid Corporation</LabelerName>
    <SubstanceName>NAPROXEN SODIUM</SubstanceName>
    <StrengthNumber>220</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220718</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves minor aches and pains due to:headachemuscular achesthe common coldtoothachebackachemenstrual crampsminor pain of arthritis. temporarily reduces fever.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>16571-739-27</NDCCode>
    <PackageDescription>270 TABLET, FILM COATED in 1 BOTTLE (16571-739-27) </PackageDescription>
    <NDC11Code>16571-0739-27</NDC11Code>
    <ProductNDC>16571-739</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sevelamer Carbonate</ProprietaryName>
    <NonProprietaryName>Sevelamer Carbonate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201216</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204451</ApplicationNumber>
    <LabelerName>Rising Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>SEVELAMER CARBONATE</SubstanceName>
    <StrengthNumber>800</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201216</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sevelamer carbonate tablets are indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis.</IndicationAndUsage>
    <Description>The active ingredient in sevelamer carbonate tablets is sevelamer carbonate, a polymeric amine that binds phosphate and is meant for oral administration. It was developed as a pharmaceutical alternative to sevelamer hydrochloride. Sevelamer carbonate is an anion exchange resin, with the same polymeric structure as sevelamer hydrochloride, in which carbonate replaces chloride as the counterion. While the counterions differ for the two salts, the polymer itself, the active moiety involved in phosphate-binding, is the same. Sevelamer carbonate is known chemically as poly(allylamine-co-N,N'-diallyl-1,3-diamino-2-hydroxypropane) carbonate salt. Sevelamer carbonate is hygroscopic, but insoluble in water. The structure is represented in Figure 1.Figure 1: Chemical Structure of Sevelamer Carbonate a, b = number of primary amine groups             a + b = 9 c = number of cross-linking groups                     c = 1 m = large number to indicate extended polymer network.</Description>
  </NDC>
  <NDC>
    <NDCCode>16714-270-01</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (16714-270-01)  / 20 g in 1 TUBE</PackageDescription>
    <NDC11Code>16714-0270-01</NDC11Code>
    <ProductNDC>16714-270</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tretinoin</ProprietaryName>
    <NonProprietaryName>Tretinoin</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20230105</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215713</ApplicationNumber>
    <LabelerName>NORTHSTAR RX LLC</LabelerName>
    <SubstanceName>TRETINOIN</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-05-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230105</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tretinoin cream is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.</IndicationAndUsage>
    <Description>Tretinoin Cream USP, 0.025% is used for the topical treatment of acne vulgaris. Tretinoin cream contains tretinoin in 0.025% by weight, in a hydrophilic cream vehicle of butylated hydroxytoluene, isopropyl myristate, polyoxyl stearate type II, purified water, sorbic acid, stearic acid, stearyl alcohol and xanthan gum. Chemically, tretinoin is all-trans-retinoic acid and has the following structure:.</Description>
  </NDC>
  <NDC>
    <NDCCode>16714-270-02</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (16714-270-02)  / 45 g in 1 TUBE</PackageDescription>
    <NDC11Code>16714-0270-02</NDC11Code>
    <ProductNDC>16714-270</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tretinoin</ProprietaryName>
    <NonProprietaryName>Tretinoin</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20230105</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215713</ApplicationNumber>
    <LabelerName>NORTHSTAR RX LLC</LabelerName>
    <SubstanceName>TRETINOIN</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-05-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230105</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tretinoin cream is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.</IndicationAndUsage>
    <Description>Tretinoin Cream USP, 0.025% is used for the topical treatment of acne vulgaris. Tretinoin cream contains tretinoin in 0.025% by weight, in a hydrophilic cream vehicle of butylated hydroxytoluene, isopropyl myristate, polyoxyl stearate type II, purified water, sorbic acid, stearic acid, stearyl alcohol and xanthan gum. Chemically, tretinoin is all-trans-retinoic acid and has the following structure:.</Description>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>54257-270-05</NDCCode><ProprietaryName>Allergy Relief</ProprietaryName><NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>54257-270-02</NDCCode><ProprietaryName>Allergy Relief</ProprietaryName><NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>42291-270-05</NDCCode><ProprietaryName>Epinastine Hcl</ProprietaryName><NonProprietaryName>Epinastine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>42543-270-05</NDCCode><ProprietaryName>Potassium Chloride</ProprietaryName><NonProprietaryName>Potassium Chloride</NonProprietaryName></NDC><NDC><NDCCode>55111-270-05</NDCCode><ProprietaryName>Amlodipine Besylate</ProprietaryName><NonProprietaryName>Amlodipine Besylate</NonProprietaryName></NDC><NDC><NDCCode>59137-282-05</NDCCode><ProprietaryName>Ixinity</ProprietaryName><NonProprietaryName>Coagulation Factor Ix (recombinant)</NonProprietaryName></NDC><NDC><NDCCode>59651-270-05</NDCCode><ProprietaryName>Glipizide</ProprietaryName><NonProprietaryName>Glipizide</NonProprietaryName></NDC><NDC><NDCCode>65628-272-03</NDCCode><ProprietaryName>Konvomep</ProprietaryName><NonProprietaryName>Omeprazole And Sodium Bicarbonate</NonProprietaryName></NDC><NDC><NDCCode>65628-272-05</NDCCode><ProprietaryName>Konvomep</ProprietaryName><NonProprietaryName>Omeprazole And Sodium Bicarbonate</NonProprietaryName></NDC><NDC><NDCCode>65628-272-10</NDCCode><ProprietaryName>Konvomep</ProprietaryName><NonProprietaryName>Omeprazole And Sodium Bicarbonate</NonProprietaryName></NDC><NDC><NDCCode>66902-450-06</NDCCode><ProprietaryName>Cvs Health Lidocaine Pain-relieving</ProprietaryName><NonProprietaryName>Lidocaine</NonProprietaryName></NDC><NDC><NDCCode>68428-270-05</NDCCode><ProprietaryName>Cadmium Sulphuricum</ProprietaryName><NonProprietaryName>Cadmium Sulfate</NonProprietaryName></NDC><NDC><NDCCode>71052-270-05</NDCCode><NonProprietaryName>Budesonide</NonProprietaryName></NDC><NDC><NDCCode>77110-270-05</NDCCode><ProprietaryName>Hand Sanitizer</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>78952-270-05</NDCCode><ProprietaryName>Stay Well Advanced Hand Sanitizer</ProprietaryName><NonProprietaryName>Ethyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>84756-270-05</NDCCode><ProprietaryName>Rosemary Essential Oil</ProprietaryName><NonProprietaryName>Rosemary Essential Oil</NonProprietaryName></NDC><NDC><NDCCode>54257-180-07</NDCCode><ProprietaryName>Famotidine</ProprietaryName><NonProprietaryName>Famotidine</NonProprietaryName></NDC><NDC><NDCCode>54257-802-02</NDCCode><ProprietaryName>Famotidine</ProprietaryName><NonProprietaryName>Famotidine</NonProprietaryName></NDC><NDC><NDCCode>0023-8842-05</NDCCode><ProprietaryName>Alocril</ProprietaryName><NonProprietaryName>Nedocromil Sodium</NonProprietaryName></NDC><NDC><NDCCode>0264-7055-10</NDCCode><ProprietaryName>Clorotekal</ProprietaryName><NonProprietaryName>Chloroprocaine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0404-9897-05</NDCCode><ProprietaryName>Lidocaine Hydrochloride</ProprietaryName><NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0409-4164-05</NDCCode><ProprietaryName>Aminosyn Ii</ProprietaryName><NonProprietaryName>Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Histidine, Proline, Serine, N-acetyl-tyrosine, And Glycine</NonProprietaryName></NDC><NDC><NDCCode>0597-0197-05</NDCCode><ProprietaryName>Praxbind</ProprietaryName><NonProprietaryName>Idarucizumab</NonProprietaryName></NDC><NDC><NDCCode>0781-8085-32</NDCCode><ProprietaryName>Pirfenidone</ProprietaryName><NonProprietaryName>Pirfenidone</NonProprietaryName></NDC><NDC><NDCCode>0904-5632-53</NDCCode><ProprietaryName>Gabapentin</ProprietaryName><NonProprietaryName>Gabapentin</NonProprietaryName></NDC><NDC><NDCCode>11673-270-24</NDCCode><ProprietaryName>Maximum Strength Urinary Pain Relief</ProprietaryName><NonProprietaryName>Phenazopyridine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>11822-6040-7</NDCCode><ProprietaryName>Naproxen Sodium</ProprietaryName><NonProprietaryName>Naproxen Sodium</NonProprietaryName></NDC><NDC><NDCCode>16571-739-27</NDCCode><ProprietaryName>Sevelamer Carbonate</ProprietaryName><NonProprietaryName>Sevelamer Carbonate</NonProprietaryName></NDC><NDC><NDCCode>16714-270-01</NDCCode><ProprietaryName>Tretinoin</ProprietaryName><NonProprietaryName>Tretinoin</NonProprietaryName></NDC><NDC><NDCCode>16714-270-02</NDCCode><ProprietaryName>Tretinoin</ProprietaryName><NonProprietaryName>Tretinoin</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/04/2006",
      "LastUpdateDate": "12/11/2007",
      "AuthorizedOfficialLastName": "MONTECILLO",
      "AuthorizedOfficialFirstName": "RANIA",
      "AuthorizedOfficialTitle": "OWNER",
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      "PracticeLocationAddressFaxNumber": "860-821-3407",
      "EnumerationDate": "07/22/2006",
      "LastUpdateDate": "01/14/2016",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "000260",
      "LicenseNumberStateCode1": "CT",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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