RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "54868-0990-0",
      "PackageDescription": "10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (54868-0990-0)",
      "NDC11Code": "54868-0990-00",
      "ProductNDC": "54868-0990",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cipro",
      "NonProprietaryName": "Ciprofloxacin Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "19950207",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019537",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2014-05-12"
    },
    {
      "NDCCode": "10117-0990-0",
      "PackageDescription": "50 kg in 1 DRUM (10117-0990-0) ",
      "NDC11Code": "10117-0990-00",
      "ProductNDC": "10117-0990",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Sodium Ibuprofen Dihydrate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20050401",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "BASF Corporation",
      "SubstanceName": "IBUPROFEN SODIUM",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2025-11-07",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "01-APR-05"
    },
    {
      "NDCCode": "70518-0990-0",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (70518-0990-0) ",
      "NDC11Code": "70518-0990-00",
      "ProductNDC": "70518-0990",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clopidogrel Bisulfate",
      "NonProprietaryName": "Clopidogrel Bisulfate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180125",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090494",
      "LabelerName": "REMEDYREPACK INC.",
      "SubstanceName": "CLOPIDOGREL BISULFATE",
      "StrengthNumber": "75",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2020-05-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20180125",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "54868-0990-1",
      "PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (54868-0990-1)",
      "NDC11Code": "54868-0990-01",
      "ProductNDC": "54868-0990",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cipro",
      "NonProprietaryName": "Ciprofloxacin Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "19950207",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019537",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2014-05-12"
    },
    {
      "NDCCode": "54868-0990-2",
      "PackageDescription": "14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (54868-0990-2)",
      "NDC11Code": "54868-0990-02",
      "ProductNDC": "54868-0990",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cipro",
      "NonProprietaryName": "Ciprofloxacin Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "19950207",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019537",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2014-05-12"
    },
    {
      "NDCCode": "54868-0990-4",
      "PackageDescription": "15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (54868-0990-4)",
      "NDC11Code": "54868-0990-04",
      "ProductNDC": "54868-0990",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cipro",
      "NonProprietaryName": "Ciprofloxacin Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "19950207",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019537",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2014-05-12"
    },
    {
      "NDCCode": "54868-0990-5",
      "PackageDescription": "6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (54868-0990-5)",
      "NDC11Code": "54868-0990-05",
      "ProductNDC": "54868-0990",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cipro",
      "NonProprietaryName": "Ciprofloxacin Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "19950207",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019537",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2014-05-12"
    },
    {
      "NDCCode": "0990-6138-03",
      "PackageDescription": "24 BOTTLE, PLASTIC in 1 CASE (0990-6138-03)  / 500 mL in 1 BOTTLE, PLASTIC",
      "NDC11Code": "00990-6138-03",
      "ProductNDC": "0990-6138",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Chloride",
      "NonProprietaryName": "Sodium Chloride",
      "DosageFormName": "IRRIGANT",
      "RouteName": "IRRIGATION",
      "StartMarketingDate": "20190801",
      "EndMarketingDate": "20260501",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA017514",
      "LabelerName": "ICU Medical Inc.",
      "SubstanceName": "SODIUM CHLORIDE",
      "StrengthNumber": "900",
      "StrengthUnit": "mg/100mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-05-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20191001",
      "EndMarketingDatePackage": "20260501",
      "SamplePackage": "N",
      "IndicationAndUsage": "Each of these solutions is indicated for all general irrigation, washing, rinsing and dilution purposes which permit use of a sterile, nonpyrogenic electrolyte solution.",
      "Description": "These products are sterile, nonpyrogenic solutions of electrolytes in water for injection intended only for sterile irrigation, washing, rinsing and dilution purposes. Each 100 mL of 0.9% Sodium Chloride Irrigation, USP contains: Sodium chloride 900 mg; pH 5.6 (4.5 to 7.0). May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. The solution is isotonic (308 mOsmol/liter, CALC.) and has the following electrolyte content (mEq/liter): Na+ 154; Cl− 154. These irrigations contain no bacteriostat, antimicrobial agent or added buffer and are intended only for use as single-dose or short procedure irrigation. When smaller volumes are required the unused portion should be discarded. Each of these irrigations may be classified as a sterile irrigant, wash, rinse, diluent and pharmaceutical vehicle. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. The semi-rigid container is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The container requires no vapor barrier to maintain the proper drug concentration. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period."
    },
    {
      "NDCCode": "0990-6139-03",
      "PackageDescription": "24 BOTTLE, PLASTIC in 1 CASE (0990-6139-03)  / 500 mL in 1 BOTTLE, PLASTIC",
      "NDC11Code": "00990-6139-03",
      "ProductNDC": "0990-6139",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sterile Water",
      "NonProprietaryName": "Water",
      "DosageFormName": "IRRIGANT",
      "RouteName": "IRRIGATION",
      "StartMarketingDate": "20190801",
      "EndMarketingDate": "20260501",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA017513",
      "LabelerName": "ICU Medical Inc.",
      "SubstanceName": "WATER",
      "StrengthNumber": "1",
      "StrengthUnit": "mL/mL",
      "Status": "Deprecated",
      "LastUpdate": "2026-05-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20190901",
      "EndMarketingDatePackage": "20260501",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sterile Water for Irrigation, USP is indicated for all general irrigation, washing, rinsing and dilution purposes which permit use of sterile, nonpyrogenic, solute-free water.",
      "Description": "Sterile Water for Irrigation, USP is a sterile, distilled, nonpyrogenic water for injection intended only for sterile irrigation, washing, rinsing and dilution purposes. pH 5.5 (5.0 to 7.0). Sterile Water for Irrigation, USP contains no bacteriostat, antimicrobial agent or added buffer and is intended for use only as a single-dose or short procedure irrigation. When smaller volumes are required the unused portion should be discarded. Sterile Water for Irrigation, USP may be classified as a sterile irrigant, wash, rinse, diluent and pharmaceutical vehicle. Water for Irrigation, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. The semi-rigid container is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The container requires no vapor barrier to maintain the proper drug concentration. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period."
    },
    {
      "NDCCode": "0990-7118-07",
      "PackageDescription": "6 BAG in 1 CASE (0990-7118-07)  / 2000 mL in 1 BAG",
      "NDC11Code": "00990-7118-07",
      "ProductNDC": "0990-7118",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sterile Water",
      "NonProprietaryName": "Water",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20190601",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019869",
      "LabelerName": "ICU Medical Inc.",
      "SubstanceName": "WATER",
      "StrengthNumber": "1",
      "StrengthUnit": "mL/mL",
      "Status": "Active",
      "LastUpdate": "2026-06-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190601",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sterile Water for Injection, USP in the Pharmacy Bulk Package is indicated for use with automated compounding devices for preparing intravenous admixtures in the pharmacy.",
      "Description": "Sterile Water for Injection, USP is a sterile, nonpyrogenic water for injection intended only for dilution purposes. The pH is 5.4 (5.0 to 7.0). The Pharmacy Bulk Package is a sterile dosage form which contains multiple single doses for use only in a pharmacy bulk admixture program. Sterile Water for Injection, USP contains no bacteriostat, antimicrobial agent or added buffer. Sterile Water for Injection, USP may be classified as a sterile diluent and pharmaceutical vehicle. Sterile Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions inside the plastic container also can leach out certain of its chemical components in very small amounts before the expiration period is attained. However, the safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers."
    },
    {
      "NDCCode": "0990-7138-09",
      "PackageDescription": "12 BOTTLE, PLASTIC in 1 CASE (0990-7138-09)  / 1000 mL in 1 BOTTLE, PLASTIC",
      "NDC11Code": "00990-7138-09",
      "ProductNDC": "0990-7138",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Chloride",
      "NonProprietaryName": "Sodium Chloride",
      "DosageFormName": "IRRIGANT",
      "RouteName": "IRRIGATION",
      "StartMarketingDate": "20190801",
      "EndMarketingDate": "20260401",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA017514",
      "LabelerName": "ICU Medical Inc.",
      "SubstanceName": "SODIUM CHLORIDE",
      "StrengthNumber": "900",
      "StrengthUnit": "mg/100mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-04-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20190901",
      "EndMarketingDatePackage": "20260401",
      "SamplePackage": "N",
      "IndicationAndUsage": "Each of these solutions is indicated for all general irrigation, washing, rinsing and dilution purposes which permit use of a sterile, nonpyrogenic electrolyte solution.",
      "Description": "These products are sterile, nonpyrogenic solutions of electrolytes in water for injection intended only for sterile irrigation, washing, rinsing and dilution purposes. Each 100 mL of 0.9% Sodium Chloride Irrigation, USP contains: Sodium chloride 900 mg; pH 5.6 (4.5 to 7.0). May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. The solution is isotonic (308 mOsmol/liter, CALC.) and has the following electrolyte content (mEq/liter): Na+ 154; Cl− 154. These irrigations contain no bacteriostat, antimicrobial agent or added buffer and are intended only for use as single-dose or short procedure irrigation. When smaller volumes are required the unused portion should be discarded. Each of these irrigations may be classified as a sterile irrigant, wash, rinse, diluent and pharmaceutical vehicle. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. The semi-rigid container is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The container requires no vapor barrier to maintain the proper drug concentration. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period."
    },
    {
      "NDCCode": "0990-7139-09",
      "PackageDescription": "12 BOTTLE, PLASTIC in 1 CASE (0990-7139-09)  / 1000 mL in 1 BOTTLE, PLASTIC",
      "NDC11Code": "00990-7139-09",
      "ProductNDC": "0990-7139",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sterile Water",
      "NonProprietaryName": "Water",
      "DosageFormName": "IRRIGANT",
      "RouteName": "IRRIGATION",
      "StartMarketingDate": "20190801",
      "EndMarketingDate": "20260601",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA017513",
      "LabelerName": "ICU Medical Inc.",
      "SubstanceName": "WATER",
      "StrengthNumber": "1",
      "StrengthUnit": "mL/mL",
      "Status": "Deprecated",
      "LastUpdate": "2026-04-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20191201",
      "EndMarketingDatePackage": "20260401",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sterile Water for Irrigation, USP is indicated for all general irrigation, washing, rinsing and dilution purposes which permit use of sterile, nonpyrogenic, solute-free water.",
      "Description": "Sterile Water for Irrigation, USP is a sterile, distilled, nonpyrogenic water for injection intended only for sterile irrigation, washing, rinsing and dilution purposes. pH 5.5 (5.0 to 7.0). Sterile Water for Irrigation, USP contains no bacteriostat, antimicrobial agent or added buffer and is intended for use only as a single-dose or short procedure irrigation. When smaller volumes are required the unused portion should be discarded. Sterile Water for Irrigation, USP may be classified as a sterile irrigant, wash, rinse, diluent and pharmaceutical vehicle. Water for Irrigation, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. The semi-rigid container is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The container requires no vapor barrier to maintain the proper drug concentration. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period."
    },
    {
      "NDCCode": "0990-7139-36",
      "PackageDescription": "9 BOTTLE, PLASTIC in 1 CASE (0990-7139-36)  / 1500 mL in 1 BOTTLE, PLASTIC",
      "NDC11Code": "00990-7139-36",
      "ProductNDC": "0990-7139",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sterile Water",
      "NonProprietaryName": "Water",
      "DosageFormName": "IRRIGANT",
      "RouteName": "IRRIGATION",
      "StartMarketingDate": "20190801",
      "EndMarketingDate": "20260601",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA017513",
      "LabelerName": "ICU Medical Inc.",
      "SubstanceName": "WATER",
      "StrengthNumber": "1",
      "StrengthUnit": "mL/mL",
      "Status": "Deprecated",
      "LastUpdate": "2026-06-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20191001",
      "EndMarketingDatePackage": "20260601",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sterile Water for Irrigation, USP is indicated for all general irrigation, washing, rinsing and dilution purposes which permit use of sterile, nonpyrogenic, solute-free water.",
      "Description": "Sterile Water for Irrigation, USP is a sterile, distilled, nonpyrogenic water for injection intended only for sterile irrigation, washing, rinsing and dilution purposes. pH 5.5 (5.0 to 7.0). Sterile Water for Irrigation, USP contains no bacteriostat, antimicrobial agent or added buffer and is intended for use only as a single-dose or short procedure irrigation. When smaller volumes are required the unused portion should be discarded. Sterile Water for Irrigation, USP may be classified as a sterile irrigant, wash, rinse, diluent and pharmaceutical vehicle. Water for Irrigation, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. The semi-rigid container is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The container requires no vapor barrier to maintain the proper drug concentration. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period."
    },
    {
      "NDCCode": "0990-7372-03",
      "PackageDescription": "24 POUCH in 1 CASE (0990-7372-03)  / 1 BAG in 1 POUCH / 500 mL in 1 BAG",
      "NDC11Code": "00990-7372-03",
      "ProductNDC": "0990-7372",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ionosol Mb And Dextrose",
      "NonProprietaryName": "Dextrose Monohydrate, Sodium Lactate, Potassium Chloride, Magnesium Chloride, Potassium Phosphate, Monobasic, And Sodium Phosphate, Monobasic, Monohydrate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20190701",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019513",
      "LabelerName": "ICU Medical Inc.",
      "SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM LACTATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE; MONOBASIC POTASSIUM PHOSPHATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE",
      "StrengthNumber": "5; 260; 141; 30; 15; 25",
      "StrengthUnit": "g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
      "Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2026-06-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20200101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ionosol MB and 5% Dextrose Injection is indicated for intravenous administration to infants for treatment of dehydration, acidosis, diarrhea, and burns, but only after administration of an initial priming solution: 15 mL of 5% dextrose and 0.45% Sodium Chloride Injection/kg of body weight. In adults, Ionosol MB and 5% Dextrose Injection is indicated postoperatively for intravenous fluid and electrolyte maintenance therapy, with a small amount of carbohydrate calories for reducing catabolism of endogenous protein reserves.",
      "Description": "Ionosol MB and 5% Dextrose Injection (Multiple Electrolytes and 5% Dextrose Injection Type 1, USP) is a sterile, nonpyrogenic solution designed for intravenous administration. The solution is formulated to provide fluid and electrolytes for treatment of dehydration and acidosis. Each 100 mL contains dextrose, hydrous 5 g; sodium lactate, anhydrous 260 mg; potassium chloride 141 mg; magnesium chloride, hexahydrate 30 mg; monobasic potassium phosphate, anhydrous 15 mg; and monobasic sodium phosphate, monohydrate 25 mg. Each liter contains 25 mEq sodium (Na+); 20 mEq potassium (K+); 3 mEq magnesium (Mg++); 22 mEq chloride (Cl¯); 3 mM of phosphate (PO4≡); and 23 mEq lactate (CH3CH(OH)COO¯). The electrolyte content is hypotonic (100 mOsmol/L) in relation to the extracellular fluid (1pprox.. 280 mOsmol/L). The osmolarity for the total solution is 352 mOsmol/L (calc.). May contain hydrochloric acid for pH adjustment. pH is 5.0 (4.0 to 6.5). Dextrose, USP, hydrous is chemically designated C6H12O6  H2O (D-glucose, monohydrate), a hexose sugar freely soluble in water. Dextrose, hydrous has the following structural formula:. Magnesium Chloride, USP, hexahydrate is chemically designated MgCl2  6H2O, colorless flakes or crystals very soluble in water. Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Monobasic Potassium Phosphate, NF, anhydrous is chemically designated KH2PO4, colorless crystals or white granular powder freely soluble in water. Sodium Lactate, USP is chemically designated CH3CH(OH)COONa, a 60% aqueous solution miscible in water. Monobasic Sodium Phosphate, USP, monohydrate is chemically designated NaH2PO4 H2O, white crystals or granules freely soluble in water. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions inside the plastic container also can leach out certain of their chemical components in very small amounts before the expiration period is attained. However, the safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers."
    },
    {
      "NDCCode": "0990-7372-62",
      "PackageDescription": "24 POUCH in 1 CASE (0990-7372-62)  / 1 BAG in 1 POUCH / 250 mL in 1 BAG",
      "NDC11Code": "00990-7372-62",
      "ProductNDC": "0990-7372",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ionosol Mb And Dextrose",
      "NonProprietaryName": "Dextrose Monohydrate, Sodium Lactate, Potassium Chloride, Magnesium Chloride, Potassium Phosphate, Monobasic, And Sodium Phosphate, Monobasic, Monohydrate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20190701",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019513",
      "LabelerName": "ICU Medical Inc.",
      "SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM LACTATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE; MONOBASIC POTASSIUM PHOSPHATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE",
      "StrengthNumber": "5; 260; 141; 30; 15; 25",
      "StrengthUnit": "g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
      "Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2026-06-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190701",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ionosol MB and 5% Dextrose Injection is indicated for intravenous administration to infants for treatment of dehydration, acidosis, diarrhea, and burns, but only after administration of an initial priming solution: 15 mL of 5% dextrose and 0.45% Sodium Chloride Injection/kg of body weight. In adults, Ionosol MB and 5% Dextrose Injection is indicated postoperatively for intravenous fluid and electrolyte maintenance therapy, with a small amount of carbohydrate calories for reducing catabolism of endogenous protein reserves.",
      "Description": "Ionosol MB and 5% Dextrose Injection (Multiple Electrolytes and 5% Dextrose Injection Type 1, USP) is a sterile, nonpyrogenic solution designed for intravenous administration. The solution is formulated to provide fluid and electrolytes for treatment of dehydration and acidosis. Each 100 mL contains dextrose, hydrous 5 g; sodium lactate, anhydrous 260 mg; potassium chloride 141 mg; magnesium chloride, hexahydrate 30 mg; monobasic potassium phosphate, anhydrous 15 mg; and monobasic sodium phosphate, monohydrate 25 mg. Each liter contains 25 mEq sodium (Na+); 20 mEq potassium (K+); 3 mEq magnesium (Mg++); 22 mEq chloride (Cl¯); 3 mM of phosphate (PO4≡); and 23 mEq lactate (CH3CH(OH)COO¯). The electrolyte content is hypotonic (100 mOsmol/L) in relation to the extracellular fluid (1pprox.. 280 mOsmol/L). The osmolarity for the total solution is 352 mOsmol/L (calc.). May contain hydrochloric acid for pH adjustment. pH is 5.0 (4.0 to 6.5). Dextrose, USP, hydrous is chemically designated C6H12O6  H2O (D-glucose, monohydrate), a hexose sugar freely soluble in water. Dextrose, hydrous has the following structural formula:. Magnesium Chloride, USP, hexahydrate is chemically designated MgCl2  6H2O, colorless flakes or crystals very soluble in water. Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Monobasic Potassium Phosphate, NF, anhydrous is chemically designated KH2PO4, colorless crystals or white granular powder freely soluble in water. Sodium Lactate, USP is chemically designated CH3CH(OH)COONa, a 60% aqueous solution miscible in water. Monobasic Sodium Phosphate, USP, monohydrate is chemically designated NaH2PO4 H2O, white crystals or granules freely soluble in water. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions inside the plastic container also can leach out certain of their chemical components in very small amounts before the expiration period is attained. However, the safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers."
    },
    {
      "NDCCode": "0990-7670-03",
      "PackageDescription": "24 BAG in 1 CASE (0990-7670-03)  / 500 mL in 1 BAG",
      "NDC11Code": "00990-7670-03",
      "ProductNDC": "0990-7670",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Normosol-r",
      "NonProprietaryName": "Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, And Magnesium Chloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20190901",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA017586",
      "LabelerName": "ICU Medical Inc.",
      "SubstanceName": "SODIUM CHLORIDE; SODIUM ACETATE ANHYDROUS; SODIUM GLUCONATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE",
      "StrengthNumber": "526; 222; 502; 37; 30",
      "StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
      "Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2026-06-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20191231",
      "SamplePackage": "N",
      "IndicationAndUsage": "Normosol-R pH 7.4 is indicated for replacement of acute extracellular fluid volume losses in surgery, trauma, burns or shock. Normosol-R pH 7.4 also can be used as an adjunct to restore a decrease in circulatory volume in patients with moderate blood loss. Normosol-R pH 7.4 is not intended to supplant transfusion of whole blood or packed red cells in the presence of uncontrolled hemorrhage or severe reductions of red cell volume. Normosol-R pH 7.4 is particularly valuable as a solution for use in starting blood, i.e., as a priming solution for the infusion set. No hemolysis of blood is seen at the interface or with mixed solution and blood. It may also be used as a diluent to aid in the transfusion of packed red blood cells (PRBC). Normosol-R pH 7.4 and physiologic saline solution (0.9% Sodium Chloride Injection, USP) are compatible with both young and old PRBC.",
      "Description": "Normosol®-R pH 7.4 is a sterile, nonpyrogenic, isotonic solution of balanced electrolytes in water for injection. The solution is administered by intravenous infusion for parenteral replacement of acute losses of extracellular fluid. Each 100 mL of Normosol-R pH 7.4 contains sodium chloride, 526 mg; sodium acetate, 222 mg; sodium gluconate, 502 mg; potassium chloride, 37 mg; magnesium chloride, hexahydrate 30 mg. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. pH range 6.5 to 7.6; 295 mOsmol/liter (calc.). Electrolytes per 1000 mL (not including pH adjustment): Sodium 140 mEq; potassium 5 mEq; magnesium 3 mEq; chloride 98 mEq; acetate 27 mEq; gluconate 23 mEq. The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded. Normosol-R pH 7.4 is a parenteral fluid and electrolyte replenisher. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Magnesium Chloride, USP is chemically designated magnesium chloride, hexahydrate (MgCl2  6H2O) deliquescent crystals very soluble in water. Sodium Acetate, USP is chemically designated sodium acetate, anhydrous (C2H3NaO2), a hygroscopic powder soluble in water. It has the following structural formula. Sodium gluconate is chemically designated C6H11NaO7, the normal sodium salt of gluconic acid soluble in water. It has the following structural formula. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated polyvinyl chloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period."
    },
    {
      "NDCCode": "0990-7670-09",
      "PackageDescription": "12 BAG in 1 CASE (0990-7670-09)  / 1000 mL in 1 BAG",
      "NDC11Code": "00990-7670-09",
      "ProductNDC": "0990-7670",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Normosol-r",
      "NonProprietaryName": "Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, And Magnesium Chloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20190901",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA017586",
      "LabelerName": "ICU Medical Inc.",
      "SubstanceName": "SODIUM CHLORIDE; SODIUM ACETATE ANHYDROUS; SODIUM GLUCONATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE",
      "StrengthNumber": "526; 222; 502; 37; 30",
      "StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
      "Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2026-06-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190901",
      "SamplePackage": "N",
      "IndicationAndUsage": "Normosol-R pH 7.4 is indicated for replacement of acute extracellular fluid volume losses in surgery, trauma, burns or shock. Normosol-R pH 7.4 also can be used as an adjunct to restore a decrease in circulatory volume in patients with moderate blood loss. Normosol-R pH 7.4 is not intended to supplant transfusion of whole blood or packed red cells in the presence of uncontrolled hemorrhage or severe reductions of red cell volume. Normosol-R pH 7.4 is particularly valuable as a solution for use in starting blood, i.e., as a priming solution for the infusion set. No hemolysis of blood is seen at the interface or with mixed solution and blood. It may also be used as a diluent to aid in the transfusion of packed red blood cells (PRBC). Normosol-R pH 7.4 and physiologic saline solution (0.9% Sodium Chloride Injection, USP) are compatible with both young and old PRBC.",
      "Description": "Normosol®-R pH 7.4 is a sterile, nonpyrogenic, isotonic solution of balanced electrolytes in water for injection. The solution is administered by intravenous infusion for parenteral replacement of acute losses of extracellular fluid. Each 100 mL of Normosol-R pH 7.4 contains sodium chloride, 526 mg; sodium acetate, 222 mg; sodium gluconate, 502 mg; potassium chloride, 37 mg; magnesium chloride, hexahydrate 30 mg. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. pH range 6.5 to 7.6; 295 mOsmol/liter (calc.). Electrolytes per 1000 mL (not including pH adjustment): Sodium 140 mEq; potassium 5 mEq; magnesium 3 mEq; chloride 98 mEq; acetate 27 mEq; gluconate 23 mEq. The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded. Normosol-R pH 7.4 is a parenteral fluid and electrolyte replenisher. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Magnesium Chloride, USP is chemically designated magnesium chloride, hexahydrate (MgCl2  6H2O) deliquescent crystals very soluble in water. Sodium Acetate, USP is chemically designated sodium acetate, anhydrous (C2H3NaO2), a hygroscopic powder soluble in water. It has the following structural formula. Sodium gluconate is chemically designated C6H11NaO7, the normal sodium salt of gluconic acid soluble in water. It has the following structural formula. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated polyvinyl chloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period."
    },
    {
      "NDCCode": "0990-7730-36",
      "PackageDescription": "20 POUCH in 1 CASE (0990-7730-36)  / 4 BAG in 1 POUCH / 50 mL in 1 BAG",
      "NDC11Code": "00990-7730-36",
      "ProductNDC": "0990-7730",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Chloride",
      "NonProprietaryName": "Sodium Chloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20190401",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018090",
      "LabelerName": "ICU Medical Inc.",
      "SubstanceName": "SODIUM CHLORIDE",
      "StrengthNumber": "450",
      "StrengthUnit": "mg/100mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-11-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20191231",
      "SamplePackage": "N",
      "IndicationAndUsage": "Intravenous solutions containing sodium chloride are indicated for parenteral replenishment of fluid and sodium chloride as required by the clinical condition of the patient.",
      "Description": "Sodium Chloride Injection, USP solutions are sterile and nonpyrogenic. They are parenteral solutions containing various concentrations of sodium chloride in water for injection intended for intravenous administration. For 0.45% Sodium Chloride Injection, USP, each 100 mL contains 450 mg sodium chloride in water for injection. Electrolytes per 1000 mL: sodium 77 mEq; chloride 77 mEq. The osmolarity is 154 mOsmol/L (calc.). For 0.9% Sodium Chloride Injection, USP, each 100 mL contains 900 mg sodium chloride in water for injection. Electrolytes per 1000 mL: sodium 154 mEq; chloride 154 mEq. The osmolarity is 308 mOsmol/L (calc.). The pH for both concentrations in the 100 mL and smaller containers is 6.0; for the 250 mL and larger containers, the pH is 5.6. The pH range is 4.5 to 7.0 for all containers. The solutions contain no bacteriostat, antimicrobial agent or added buffer and each is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded. The solutions are parenteral fluid and electrolyte replenishers. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period."
    },
    {
      "NDCCode": "0990-7730-37",
      "PackageDescription": "20 POUCH in 1 CASE (0990-7730-37)  / 4 BAG in 1 POUCH / 100 mL in 1 BAG",
      "NDC11Code": "00990-7730-37",
      "ProductNDC": "0990-7730",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Chloride",
      "NonProprietaryName": "Sodium Chloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20190401",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018090",
      "LabelerName": "ICU Medical Inc.",
      "SubstanceName": "SODIUM CHLORIDE",
      "StrengthNumber": "450",
      "StrengthUnit": "mg/100mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-11-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20191231",
      "SamplePackage": "N",
      "IndicationAndUsage": "Intravenous solutions containing sodium chloride are indicated for parenteral replenishment of fluid and sodium chloride as required by the clinical condition of the patient.",
      "Description": "Sodium Chloride Injection, USP solutions are sterile and nonpyrogenic. They are parenteral solutions containing various concentrations of sodium chloride in water for injection intended for intravenous administration. For 0.45% Sodium Chloride Injection, USP, each 100 mL contains 450 mg sodium chloride in water for injection. Electrolytes per 1000 mL: sodium 77 mEq; chloride 77 mEq. The osmolarity is 154 mOsmol/L (calc.). For 0.9% Sodium Chloride Injection, USP, each 100 mL contains 900 mg sodium chloride in water for injection. Electrolytes per 1000 mL: sodium 154 mEq; chloride 154 mEq. The osmolarity is 308 mOsmol/L (calc.). The pH for both concentrations in the 100 mL and smaller containers is 6.0; for the 250 mL and larger containers, the pH is 5.6. The pH range is 4.5 to 7.0 for all containers. The solutions contain no bacteriostat, antimicrobial agent or added buffer and each is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded. The solutions are parenteral fluid and electrolyte replenishers. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period."
    },
    {
      "NDCCode": "0990-7828-08",
      "PackageDescription": "4 POUCH in 1 CASE (0990-7828-08)  / 1 BAG in 1 POUCH / 3000 mL in 1 BAG",
      "NDC11Code": "00990-7828-08",
      "ProductNDC": "0990-7828",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lactated Ringers",
      "NonProprietaryName": "Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride",
      "DosageFormName": "IRRIGANT",
      "RouteName": "IRRIGATION",
      "StartMarketingDate": "20190701",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019416",
      "LabelerName": "ICU Medical Inc.",
      "SubstanceName": "SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE",
      "StrengthNumber": "600; 310; 30; 20",
      "StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL",
      "Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-06-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190701",
      "SamplePackage": "N",
      "IndicationAndUsage": "Lactated Ringer’s Irrigation is indicated for all  general irrigation, washing and rinsing purposes which permit use of a  sterile, nonpyrogenic electrolyte solution.",
      "Description": "Lactated Ringer’s Irrigation is a sterile, nonpyrogenic solution of electrolytes in water for injection intended only for sterile irrigation, washing and rinsing purposes. The composition is based on a modification of the injectable formula originally known as Hartmann’s Solution. Each 100 mL of Lactated Ringer’s Irrigation contains: Sodium chloride 600 mg; sodium lactate, anhydrous 310 mg; potassium chloride 30 mg; calcium chloride, dihydrate 20 mg. The pH is 6.6 (6.0 — 7.5). The solution is isotonic (274 mOsmol/liter, calc.) and has the following electrolyte content (mEq/liter): Sodium (Na+) 130; potassium (K+) 4; calcium (Ca++) 3; chloride (Cl−) 109 and lactate (CH3CH(OH)COO−) 28. Contains sodium hydroxide and may contain hydrochloric acid for pH adjustment. The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose or short procedure irrigation. When smaller volumes are required, the unused portion should be discarded. Lactated Ringer’s Irrigation may be classified as a sterile irrigant, wash, rinse and pharmaceutical vehicle. Calcium Chloride, USP is chemically designated calcium chloride, dihydrate (CaCl2  2H2O), white fragments or granules freely soluble in water. Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Sodium Lactate, USP is chemically designated C3H5NaO3, a 60% aqueous solution miscible in water. It has the following structural formula. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions inside the plastic container also can leach out certain of its chemical components in very small amounts before the expiration period is attained. However, the safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers."
    },
    {
      "NDCCode": "0990-7929-03",
      "PackageDescription": "24 POUCH in 1 CASE (0990-7929-03)  / 1 BAG in 1 POUCH / 500 mL in 1 BAG",
      "NDC11Code": "00990-7929-03",
      "ProductNDC": "0990-7929",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lactated Ringers And Dextrose",
      "NonProprietaryName": "Sodium Chloride, Sodium Lactate, Potassium Chloride, Calcium Chloride, And Dextrose Monohydrate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20190624",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA017608",
      "LabelerName": "ICU Medical Inc.",
      "SubstanceName": "SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE",
      "StrengthNumber": "600; 310; 30; 20; 5",
      "StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL",
      "Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-06-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190801",
      "SamplePackage": "N",
      "IndicationAndUsage": "These solutions are indicated for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories, as required by the clinical condition of the patient.",
      "Description": "These products are sterile, nonpyrogenic solutions each containing isotonic concentrations of electrolytes (with or without dextrose) in water for injection. The solutions containing dextrose and electrolytes are hypertonic; those containing only electrolytes are isotonic. They are administered by intravenous infusion for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories. Each 100 mL of Lactated Ringer's Injection, USP contains sodium chloride 600 mg, sodium lactate, anhydrous 310 mg, potassium chloride 30 mg and calcium chloride, dihydrate 20 mg. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. A liter provides 9 calories (from lactate), sodium (Na+), 130 mEq, potassium (K+) 4 mEq, calcium (Ca++) 3 mEq, chloride (Cl−) 109 mEq and lactate [CH3CH(OH) COO−] 28 mEq. The electrolyte content is isotonic (273 mOsmol/liter, calc.) in relation to the extracellular fluid (approx. 280 mOsmol/liter). The pH of the solution is 6.6 (6.0 − 7.5).    Each 100 mL of Lactated Ringer's and 5% Dextrose Injection, USP contains dextrose, hydrous 5 g plus the same ingredients and mEq values as Lactated Ringer's Injection, USP (contains only hydrochloric acid for pH adjustment). A liter provides 179 calories (from dextrose and lactate) and has a hypertonic osmolar concentration of 525 mOsmol (calc.). The pH is 4.9 (4.0 − 6.5).    The solutions contain no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and each is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded.    The solutions are parenteral fluid, nutrient and/or electrolyte replenishers.    Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6  H2O), a hexose sugar freely soluble in water. It has the following structural formula.   Calcium Chloride, USP is chemically designated calcium chloride, dihydrate (CaCl2  2 H2O), white fragments or granules freely soluble in water.    Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water.   Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water.     Sodium Lactate, USP is chemically designated monosodium lactate [CH3CH(OH)COONa], a 60% aqueous solution miscible in water. It has the following structural formula.     Water for Injection, USP is chemically designated H2O.   The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions inside the plastic container also can leach out certain of their chemical components in very small amounts before the expiration period is attained. However, the safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers."
    },
    {
      "NDCCode": "0990-7929-09",
      "PackageDescription": "12 POUCH in 1 CASE (0990-7929-09)  / 1 BAG in 1 POUCH / 1000 mL in 1 BAG",
      "NDC11Code": "00990-7929-09",
      "ProductNDC": "0990-7929",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lactated Ringers And Dextrose",
      "NonProprietaryName": "Sodium Chloride, Sodium Lactate, Potassium Chloride, Calcium Chloride, And Dextrose Monohydrate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20190624",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA017608",
      "LabelerName": "ICU Medical Inc.",
      "SubstanceName": "SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE",
      "StrengthNumber": "600; 310; 30; 20; 5",
      "StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL",
      "Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-06-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190801",
      "SamplePackage": "N",
      "IndicationAndUsage": "These solutions are indicated for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories, as required by the clinical condition of the patient.",
      "Description": "These products are sterile, nonpyrogenic solutions each containing isotonic concentrations of electrolytes (with or without dextrose) in water for injection. The solutions containing dextrose and electrolytes are hypertonic; those containing only electrolytes are isotonic. They are administered by intravenous infusion for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories. Each 100 mL of Lactated Ringer's Injection, USP contains sodium chloride 600 mg, sodium lactate, anhydrous 310 mg, potassium chloride 30 mg and calcium chloride, dihydrate 20 mg. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. A liter provides 9 calories (from lactate), sodium (Na+), 130 mEq, potassium (K+) 4 mEq, calcium (Ca++) 3 mEq, chloride (Cl−) 109 mEq and lactate [CH3CH(OH) COO−] 28 mEq. The electrolyte content is isotonic (273 mOsmol/liter, calc.) in relation to the extracellular fluid (approx. 280 mOsmol/liter). The pH of the solution is 6.6 (6.0 − 7.5).    Each 100 mL of Lactated Ringer's and 5% Dextrose Injection, USP contains dextrose, hydrous 5 g plus the same ingredients and mEq values as Lactated Ringer's Injection, USP (contains only hydrochloric acid for pH adjustment). A liter provides 179 calories (from dextrose and lactate) and has a hypertonic osmolar concentration of 525 mOsmol (calc.). The pH is 4.9 (4.0 − 6.5).    The solutions contain no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and each is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded.    The solutions are parenteral fluid, nutrient and/or electrolyte replenishers.    Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6  H2O), a hexose sugar freely soluble in water. It has the following structural formula.   Calcium Chloride, USP is chemically designated calcium chloride, dihydrate (CaCl2  2 H2O), white fragments or granules freely soluble in water.    Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water.   Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water.     Sodium Lactate, USP is chemically designated monosodium lactate [CH3CH(OH)COONa], a 60% aqueous solution miscible in water. It has the following structural formula.     Water for Injection, USP is chemically designated H2O.   The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions inside the plastic container also can leach out certain of their chemical components in very small amounts before the expiration period is attained. However, the safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers."
    },
    {
      "NDCCode": "0990-7953-02",
      "PackageDescription": "24 POUCH in 1 CASE (0990-7953-02)  / 1 BAG in 1 POUCH / 250 mL in 1 BAG",
      "NDC11Code": "00990-7953-02",
      "ProductNDC": "0990-7953",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lactated Ringers",
      "NonProprietaryName": "Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20190624",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA017641",
      "LabelerName": "ICU Medical Inc.",
      "SubstanceName": "SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE",
      "StrengthNumber": "600; 310; 30; 20",
      "StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL",
      "Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-06-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190624",
      "SamplePackage": "N",
      "IndicationAndUsage": "These solutions are indicated for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories, as required by the clinical condition of the patient.",
      "Description": "These products are sterile, nonpyrogenic solutions each containing isotonic concentrations of electrolytes (with or without dextrose) in water for injection. The solutions containing dextrose and electrolytes are hypertonic; those containing only electrolytes are isotonic. They are administered by intravenous infusion for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories. Each 100 mL of Lactated Ringer's Injection, USP contains sodium chloride 600 mg, sodium lactate, anhydrous 310 mg, potassium chloride 30 mg and calcium chloride, dihydrate 20 mg. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. A liter provides 9 calories (from lactate), sodium (Na+), 130 mEq, potassium (K+) 4 mEq, calcium (Ca++) 3 mEq, chloride (Cl−) 109 mEq and lactate [CH3CH(OH) COO−] 28 mEq. The electrolyte content is isotonic (273 mOsmol/liter, calc.) in relation to the extracellular fluid (approx. 280 mOsmol/liter). The pH of the solution is 6.6 (6.0 − 7.5).    Each 100 mL of Lactated Ringer's and 5% Dextrose Injection, USP contains dextrose, hydrous 5 g plus the same ingredients and mEq values as Lactated Ringer's Injection, USP (contains only hydrochloric acid for pH adjustment). A liter provides 179 calories (from dextrose and lactate) and has a hypertonic osmolar concentration of 525 mOsmol (calc.). The pH is 4.9 (4.0 − 6.5).    The solutions contain no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and each is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded.    The solutions are parenteral fluid, nutrient and/or electrolyte replenishers.    Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6  H2O), a hexose sugar freely soluble in water. It has the following structural formula.   Calcium Chloride, USP is chemically designated calcium chloride, dihydrate (CaCl2  2 H2O), white fragments or granules freely soluble in water.    Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water.   Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water.     Sodium Lactate, USP is chemically designated monosodium lactate [CH3CH(OH)COONa], a 60% aqueous solution miscible in water. It has the following structural formula.     Water for Injection, USP is chemically designated H2O.   The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions inside the plastic container also can leach out certain of their chemical components in very small amounts before the expiration period is attained. However, the safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers."
    },
    {
      "NDCCode": "0990-7953-03",
      "PackageDescription": "24 POUCH in 1 CASE (0990-7953-03)  / 1 BAG in 1 POUCH / 500 mL in 1 BAG",
      "NDC11Code": "00990-7953-03",
      "ProductNDC": "0990-7953",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lactated Ringers",
      "NonProprietaryName": "Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20190624",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA017641",
      "LabelerName": "ICU Medical Inc.",
      "SubstanceName": "SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE",
      "StrengthNumber": "600; 310; 30; 20",
      "StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL",
      "Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-06-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190801",
      "SamplePackage": "N",
      "IndicationAndUsage": "These solutions are indicated for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories, as required by the clinical condition of the patient.",
      "Description": "These products are sterile, nonpyrogenic solutions each containing isotonic concentrations of electrolytes (with or without dextrose) in water for injection. The solutions containing dextrose and electrolytes are hypertonic; those containing only electrolytes are isotonic. They are administered by intravenous infusion for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories. Each 100 mL of Lactated Ringer's Injection, USP contains sodium chloride 600 mg, sodium lactate, anhydrous 310 mg, potassium chloride 30 mg and calcium chloride, dihydrate 20 mg. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. A liter provides 9 calories (from lactate), sodium (Na+), 130 mEq, potassium (K+) 4 mEq, calcium (Ca++) 3 mEq, chloride (Cl−) 109 mEq and lactate [CH3CH(OH) COO−] 28 mEq. The electrolyte content is isotonic (273 mOsmol/liter, calc.) in relation to the extracellular fluid (approx. 280 mOsmol/liter). The pH of the solution is 6.6 (6.0 − 7.5).    Each 100 mL of Lactated Ringer's and 5% Dextrose Injection, USP contains dextrose, hydrous 5 g plus the same ingredients and mEq values as Lactated Ringer's Injection, USP (contains only hydrochloric acid for pH adjustment). A liter provides 179 calories (from dextrose and lactate) and has a hypertonic osmolar concentration of 525 mOsmol (calc.). The pH is 4.9 (4.0 − 6.5).    The solutions contain no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and each is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded.    The solutions are parenteral fluid, nutrient and/or electrolyte replenishers.    Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6  H2O), a hexose sugar freely soluble in water. It has the following structural formula.   Calcium Chloride, USP is chemically designated calcium chloride, dihydrate (CaCl2  2 H2O), white fragments or granules freely soluble in water.    Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water.   Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water.     Sodium Lactate, USP is chemically designated monosodium lactate [CH3CH(OH)COONa], a 60% aqueous solution miscible in water. It has the following structural formula.     Water for Injection, USP is chemically designated H2O.   The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions inside the plastic container also can leach out certain of their chemical components in very small amounts before the expiration period is attained. However, the safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers."
    },
    {
      "NDCCode": "0990-7953-09",
      "PackageDescription": "12 POUCH in 1 CASE (0990-7953-09)  / 1 BAG in 1 POUCH / 1000 mL in 1 BAG",
      "NDC11Code": "00990-7953-09",
      "ProductNDC": "0990-7953",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lactated Ringers",
      "NonProprietaryName": "Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20190624",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA017641",
      "LabelerName": "ICU Medical Inc.",
      "SubstanceName": "SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE",
      "StrengthNumber": "600; 310; 30; 20",
      "StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL",
      "Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-06-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190801",
      "SamplePackage": "N",
      "IndicationAndUsage": "These solutions are indicated for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories, as required by the clinical condition of the patient.",
      "Description": "These products are sterile, nonpyrogenic solutions each containing isotonic concentrations of electrolytes (with or without dextrose) in water for injection. The solutions containing dextrose and electrolytes are hypertonic; those containing only electrolytes are isotonic. They are administered by intravenous infusion for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories. Each 100 mL of Lactated Ringer's Injection, USP contains sodium chloride 600 mg, sodium lactate, anhydrous 310 mg, potassium chloride 30 mg and calcium chloride, dihydrate 20 mg. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. A liter provides 9 calories (from lactate), sodium (Na+), 130 mEq, potassium (K+) 4 mEq, calcium (Ca++) 3 mEq, chloride (Cl−) 109 mEq and lactate [CH3CH(OH) COO−] 28 mEq. The electrolyte content is isotonic (273 mOsmol/liter, calc.) in relation to the extracellular fluid (approx. 280 mOsmol/liter). The pH of the solution is 6.6 (6.0 − 7.5).    Each 100 mL of Lactated Ringer's and 5% Dextrose Injection, USP contains dextrose, hydrous 5 g plus the same ingredients and mEq values as Lactated Ringer's Injection, USP (contains only hydrochloric acid for pH adjustment). A liter provides 179 calories (from dextrose and lactate) and has a hypertonic osmolar concentration of 525 mOsmol (calc.). The pH is 4.9 (4.0 − 6.5).    The solutions contain no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and each is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded.    The solutions are parenteral fluid, nutrient and/or electrolyte replenishers.    Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6  H2O), a hexose sugar freely soluble in water. It has the following structural formula.   Calcium Chloride, USP is chemically designated calcium chloride, dihydrate (CaCl2  2 H2O), white fragments or granules freely soluble in water.    Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water.   Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water.     Sodium Lactate, USP is chemically designated monosodium lactate [CH3CH(OH)COONa], a 60% aqueous solution miscible in water. It has the following structural formula.     Water for Injection, USP is chemically designated H2O.   The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions inside the plastic container also can leach out certain of their chemical components in very small amounts before the expiration period is attained. However, the safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers."
    },
    {
      "NDCCode": "0990-7967-09",
      "PackageDescription": "12 POUCH in 1 CASE (0990-7967-09)  / 1 BAG in 1 POUCH / 1000 mL in 1 BAG",
      "NDC11Code": "00990-7967-09",
      "ProductNDC": "0990-7967",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Normosol-r",
      "NonProprietaryName": "Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, And Magnesium Chloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20190918",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA017586",
      "LabelerName": "ICU Medical Inc.",
      "SubstanceName": "SODIUM CHLORIDE; SODIUM ACETATE ANHYDROUS; SODIUM GLUCONATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE",
      "StrengthNumber": "526; 222; 502; 37; 30",
      "StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
      "Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2026-06-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190918",
      "SamplePackage": "N",
      "IndicationAndUsage": "Normosol-R is indicated for replacement of acute extracellular fluid volume losses in  surgery, trauma, burns or shock. Normosol-R also can be used as an  adjunct to restore a decrease in circulatory volume in patients with  moderate blood loss. Normosol-R is not intended to supplant transfusion  of whole blood or packed red cells in the presence of uncontrolled  hemorrhage or severe reductions of red cell volume.",
      "Description": "Normosol-R is a sterile, nonpyrogenic isotonic solution of balanced electrolytes in water for injection. The solution is administered by intravenous infusion for parenteral replacement of acute losses of extracellular fluid. Each 100 mL of Normosol-R contains sodium chloride, 526 mg; sodium acetate, 222 mg; sodium gluconate, 502 mg; potassium chloride, 37 mg; magnesium chloride hexahydrate, 30 mg. May contain HCl and/or NaOH for pH adjustment. pH 6.6 (4.0 to 8.0); 294 mOsmol/liter (calc.). Electrolytes per 1000 mL (not including pH adjustment): Sodium 140 mEq; potassium 5 mEq; magnesium 3 mEq; chloride 98 mEq; acetate 27 mEq; gluconate 23 mEq. The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded. Normosol-R is a parenteral fluid and electrolyte replenisher. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Magnesium Chloride, USP is chemically designated magnesium chloride hexahydrate (MgCl2  6H2O) deliquescent crystals very soluble in water. Sodium Acetate, USP, is chemically designated sodium acetate anhydrous (C2H3NaO2), a hygroscopic powder soluble in water. It has the following structural formula. Sodium gluconate is chemically designated C6H11NaO7, the normal sodium salt of gluconic acid soluble in water. It has the following structural formula. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated polyvinyl chloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period."
    },
    {
      "NDCCode": "0990-7972-05",
      "PackageDescription": "12 BAG in 1 CASE (0990-7972-05)  / 1000 mL in 1 BAG",
      "NDC11Code": "00990-7972-05",
      "ProductNDC": "0990-7972",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Chloride",
      "NonProprietaryName": "Sodium Chloride",
      "DosageFormName": "IRRIGANT",
      "RouteName": "IRRIGATION",
      "StartMarketingDate": "20190801",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018314",
      "LabelerName": "ICU Medical Inc.",
      "SubstanceName": "SODIUM CHLORIDE",
      "StrengthNumber": "900",
      "StrengthUnit": "mg/100mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-06-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20200101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Each of these solutions is indicated for all general irrigation, washing, rinsing and dilution purposes which permit use of a sterile, nonpyrogenic electrolyte solution.",
      "Description": "These products are sterile, nonpyrogenic solutions of electrolytes in water for injection intended only for sterile irrigation, washing, rinsing and dilution purposes. Each 100 mL of 0.9% Sodium Chloride Irrigation, USP contains: Sodium chloride 900 mg; pH 5.6 (4.5 to 7.0). May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. The solution is isotonic (308 mOsmol/liter, CALC.) and has the following electrolyte content (mEq/liter): Na+ 154; Cl− 154. These irrigations contain no bacteriostat, antimicrobial agent or added buffer and are intended only for use as single-dose or short procedure irrigation. When smaller volumes are required the unused portion should be discarded. Each of these irrigations may be classified as a sterile irrigant, wash, rinse, diluent and pharmaceutical vehicle. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. The semi-rigid container is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The container requires no vapor barrier to maintain the proper drug concentration. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period."
    },
    {
      "NDCCode": "0990-7972-07",
      "PackageDescription": "6 BAG in 1 CASE (0990-7972-07)  / 2000 mL in 1 BAG",
      "NDC11Code": "00990-7972-07",
      "ProductNDC": "0990-7972",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Chloride",
      "NonProprietaryName": "Sodium Chloride",
      "DosageFormName": "IRRIGANT",
      "RouteName": "IRRIGATION",
      "StartMarketingDate": "20190801",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018314",
      "LabelerName": "ICU Medical Inc.",
      "SubstanceName": "SODIUM CHLORIDE",
      "StrengthNumber": "900",
      "StrengthUnit": "mg/100mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-06-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190801",
      "SamplePackage": "N",
      "IndicationAndUsage": "Each of these solutions is indicated for all general irrigation, washing, rinsing and dilution purposes which permit use of a sterile, nonpyrogenic electrolyte solution.",
      "Description": "These products are sterile, nonpyrogenic solutions of electrolytes in water for injection intended only for sterile irrigation, washing, rinsing and dilution purposes. Each 100 mL of 0.9% Sodium Chloride Irrigation, USP contains: Sodium chloride 900 mg; pH 5.6 (4.5 to 7.0). May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. The solution is isotonic (308 mOsmol/liter, CALC.) and has the following electrolyte content (mEq/liter): Na+ 154; Cl− 154. These irrigations contain no bacteriostat, antimicrobial agent or added buffer and are intended only for use as single-dose or short procedure irrigation. When smaller volumes are required the unused portion should be discarded. Each of these irrigations may be classified as a sterile irrigant, wash, rinse, diluent and pharmaceutical vehicle. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. The semi-rigid container is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The container requires no vapor barrier to maintain the proper drug concentration. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period."
    },
    {
      "NDCCode": "0990-7972-08",
      "PackageDescription": "4 POUCH in 1 CASE (0990-7972-08)  / 1 BAG in 1 POUCH / 3000 mL in 1 BAG",
      "NDC11Code": "00990-7972-08",
      "ProductNDC": "0990-7972",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Chloride",
      "NonProprietaryName": "Sodium Chloride",
      "DosageFormName": "IRRIGANT",
      "RouteName": "IRRIGATION",
      "StartMarketingDate": "20190701",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018314",
      "LabelerName": "ICU Medical Inc.",
      "SubstanceName": "SODIUM CHLORIDE",
      "StrengthNumber": "900",
      "StrengthUnit": "mg/100mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-06-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190701",
      "SamplePackage": "N",
      "IndicationAndUsage": "This sterile, nonpyrogenic electrolyte solution is indicated for all general irrigation, washing, rinsing and dilution purposes including blood cell washing (when used in conjunction with automated intraoperative blood salvaging equipment).",
      "Description": "This product is a sterile, nonpyrogenic solution of electrolytes in water for injection intended only for sterile irrigation, rinsing, dilution and cell washing purposes. Each 100 mL of 0.9% Sodium Chloride Irrigation, USP contains: Sodium chloride 900 mg. pH 5.6 (4.5 — 7.0). The solution is isotonic (308 mOsmol/liter, calc.) and has the following electrolyte content (mEq/liter): Na+ 154; Cl¯ 154. This irrigation solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose, short procedure irrigation, or cell washing fluid. When smaller volumes are required the unused portion should be discarded. It may be classified as a sterile irrigant, rinse, diluent, cell wash and pharmaceutical vehicle. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period."
    },
    {
      "NDCCode": "0990-7973-05",
      "PackageDescription": "12 POUCH in 1 CASE (0990-7973-05)  / 1 BAG in 1 POUCH / 1000 mL in 1 BAG",
      "NDC11Code": "00990-7973-05",
      "ProductNDC": "0990-7973",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sterile Water",
      "NonProprietaryName": "Water",
      "DosageFormName": "IRRIGANT",
      "RouteName": "IRRIGATION",
      "StartMarketingDate": "20190801",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018313",
      "LabelerName": "ICU Medical Inc.",
      "SubstanceName": "WATER",
      "StrengthNumber": "1",
      "StrengthUnit": "mL/mL",
      "Status": "Active",
      "LastUpdate": "2026-03-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190901",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sterile Water for Irrigation, USP is indicated for all general irrigation, washing, rinsing and dilution purposes which permit use of sterile, nonpyrogenic, solute-free water.",
      "Description": "Sterile Water for Irrigation, USP is a sterile, distilled, nonpyrogenic water for injection intended only for sterile irrigation, washing, rinsing and dilution purposes. pH 5.5 (5.0 to 7.0). Sterile Water for Irrigation, USP contains no bacteriostat, antimicrobial agent or added buffer and is intended for use only as a single-dose or short procedure irrigation. When smaller volumes are required the unused portion should be discarded. Sterile Water for Irrigation, USP may be classified as a sterile irrigant, wash, rinse, diluent and pharmaceutical vehicle. Water for Irrigation, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. The semi-rigid container is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The container requires no vapor barrier to maintain the proper drug concentration. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"54868-0990-0","ProprietaryName":"Cipro","NonProprietaryName":"Ciprofloxacin Hydrochloride"},{"NDCCode":"10117-0990-0","NonProprietaryName":"Sodium Ibuprofen Dihydrate"},{"NDCCode":"70518-0990-0","ProprietaryName":"Clopidogrel Bisulfate","NonProprietaryName":"Clopidogrel Bisulfate"},{"NDCCode":"54868-0990-1","ProprietaryName":"Cipro","NonProprietaryName":"Ciprofloxacin Hydrochloride"},{"NDCCode":"54868-0990-2","ProprietaryName":"Cipro","NonProprietaryName":"Ciprofloxacin Hydrochloride"},{"NDCCode":"54868-0990-4","ProprietaryName":"Cipro","NonProprietaryName":"Ciprofloxacin Hydrochloride"},{"NDCCode":"54868-0990-5","ProprietaryName":"Cipro","NonProprietaryName":"Ciprofloxacin Hydrochloride"},{"NDCCode":"0990-6138-03","ProprietaryName":"Sodium Chloride","NonProprietaryName":"Sodium Chloride"},{"NDCCode":"0990-6139-03","ProprietaryName":"Sterile Water","NonProprietaryName":"Water"},{"NDCCode":"0990-7118-07","ProprietaryName":"Sterile Water","NonProprietaryName":"Water"},{"NDCCode":"0990-7138-09","ProprietaryName":"Sodium Chloride","NonProprietaryName":"Sodium Chloride"},{"NDCCode":"0990-7139-09","ProprietaryName":"Sterile Water","NonProprietaryName":"Water"},{"NDCCode":"0990-7139-36","ProprietaryName":"Sterile Water","NonProprietaryName":"Water"},{"NDCCode":"0990-7372-03","ProprietaryName":"Ionosol Mb And Dextrose","NonProprietaryName":"Dextrose Monohydrate, Sodium Lactate, Potassium Chloride, Magnesium Chloride, Potassium Phosphate, Monobasic, And Sodium Phosphate, Monobasic, Monohydrate"},{"NDCCode":"0990-7372-62","ProprietaryName":"Ionosol Mb And Dextrose","NonProprietaryName":"Dextrose Monohydrate, Sodium Lactate, Potassium Chloride, Magnesium Chloride, Potassium Phosphate, Monobasic, And Sodium Phosphate, Monobasic, Monohydrate"},{"NDCCode":"0990-7670-03","ProprietaryName":"Normosol-r","NonProprietaryName":"Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, And Magnesium Chloride"},{"NDCCode":"0990-7670-09","ProprietaryName":"Normosol-r","NonProprietaryName":"Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, And Magnesium Chloride"},{"NDCCode":"0990-7730-36","ProprietaryName":"Sodium Chloride","NonProprietaryName":"Sodium Chloride"},{"NDCCode":"0990-7730-37","ProprietaryName":"Sodium Chloride","NonProprietaryName":"Sodium Chloride"},{"NDCCode":"0990-7828-08","ProprietaryName":"Lactated Ringers","NonProprietaryName":"Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride"},{"NDCCode":"0990-7929-03","ProprietaryName":"Lactated Ringers And Dextrose","NonProprietaryName":"Sodium Chloride, Sodium Lactate, Potassium Chloride, Calcium Chloride, And Dextrose Monohydrate"},{"NDCCode":"0990-7929-09","ProprietaryName":"Lactated Ringers And Dextrose","NonProprietaryName":"Sodium Chloride, Sodium Lactate, Potassium Chloride, Calcium Chloride, And Dextrose Monohydrate"},{"NDCCode":"0990-7953-02","ProprietaryName":"Lactated Ringers","NonProprietaryName":"Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride"},{"NDCCode":"0990-7953-03","ProprietaryName":"Lactated Ringers","NonProprietaryName":"Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride"},{"NDCCode":"0990-7953-09","ProprietaryName":"Lactated Ringers","NonProprietaryName":"Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride"},{"NDCCode":"0990-7967-09","ProprietaryName":"Normosol-r","NonProprietaryName":"Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, And Magnesium Chloride"},{"NDCCode":"0990-7972-05","ProprietaryName":"Sodium Chloride","NonProprietaryName":"Sodium Chloride"},{"NDCCode":"0990-7972-07","ProprietaryName":"Sodium Chloride","NonProprietaryName":"Sodium Chloride"},{"NDCCode":"0990-7972-08","ProprietaryName":"Sodium Chloride","NonProprietaryName":"Sodium Chloride"},{"NDCCode":"0990-7973-05","ProprietaryName":"Sterile Water","NonProprietaryName":"Water"}]}
                    

<NDCList><NDC><NDCCode>54868-0990-0</NDCCode><ProprietaryName>Cipro</ProprietaryName><NonProprietaryName>Ciprofloxacin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>10117-0990-0</NDCCode><NonProprietaryName>Sodium Ibuprofen Dihydrate</NonProprietaryName></NDC><NDC><NDCCode>70518-0990-0</NDCCode><ProprietaryName>Clopidogrel Bisulfate</ProprietaryName><NonProprietaryName>Clopidogrel Bisulfate</NonProprietaryName></NDC><NDC><NDCCode>54868-0990-1</NDCCode><ProprietaryName>Cipro</ProprietaryName><NonProprietaryName>Ciprofloxacin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>54868-0990-2</NDCCode><ProprietaryName>Cipro</ProprietaryName><NonProprietaryName>Ciprofloxacin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>54868-0990-4</NDCCode><ProprietaryName>Cipro</ProprietaryName><NonProprietaryName>Ciprofloxacin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>54868-0990-5</NDCCode><ProprietaryName>Cipro</ProprietaryName><NonProprietaryName>Ciprofloxacin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0990-6138-03</NDCCode><ProprietaryName>Sodium Chloride</ProprietaryName><NonProprietaryName>Sodium Chloride</NonProprietaryName></NDC><NDC><NDCCode>0990-6139-03</NDCCode><ProprietaryName>Sterile Water</ProprietaryName><NonProprietaryName>Water</NonProprietaryName></NDC><NDC><NDCCode>0990-7118-07</NDCCode><ProprietaryName>Sterile Water</ProprietaryName><NonProprietaryName>Water</NonProprietaryName></NDC><NDC><NDCCode>0990-7138-09</NDCCode><ProprietaryName>Sodium Chloride</ProprietaryName><NonProprietaryName>Sodium Chloride</NonProprietaryName></NDC><NDC><NDCCode>0990-7139-09</NDCCode><ProprietaryName>Sterile Water</ProprietaryName><NonProprietaryName>Water</NonProprietaryName></NDC><NDC><NDCCode>0990-7139-36</NDCCode><ProprietaryName>Sterile Water</ProprietaryName><NonProprietaryName>Water</NonProprietaryName></NDC><NDC><NDCCode>0990-7372-03</NDCCode><ProprietaryName>Ionosol Mb And Dextrose</ProprietaryName><NonProprietaryName>Dextrose Monohydrate, Sodium Lactate, Potassium Chloride, Magnesium Chloride, Potassium Phosphate, Monobasic, And Sodium Phosphate, Monobasic, Monohydrate</NonProprietaryName></NDC><NDC><NDCCode>0990-7372-62</NDCCode><ProprietaryName>Ionosol Mb And Dextrose</ProprietaryName><NonProprietaryName>Dextrose Monohydrate, Sodium Lactate, Potassium Chloride, Magnesium Chloride, Potassium Phosphate, Monobasic, And Sodium Phosphate, Monobasic, Monohydrate</NonProprietaryName></NDC><NDC><NDCCode>0990-7670-03</NDCCode><ProprietaryName>Normosol-r</ProprietaryName><NonProprietaryName>Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, And Magnesium Chloride</NonProprietaryName></NDC><NDC><NDCCode>0990-7670-09</NDCCode><ProprietaryName>Normosol-r</ProprietaryName><NonProprietaryName>Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, And Magnesium Chloride</NonProprietaryName></NDC><NDC><NDCCode>0990-7730-36</NDCCode><ProprietaryName>Sodium Chloride</ProprietaryName><NonProprietaryName>Sodium Chloride</NonProprietaryName></NDC><NDC><NDCCode>0990-7730-37</NDCCode><ProprietaryName>Sodium Chloride</ProprietaryName><NonProprietaryName>Sodium Chloride</NonProprietaryName></NDC><NDC><NDCCode>0990-7828-08</NDCCode><ProprietaryName>Lactated Ringers</ProprietaryName><NonProprietaryName>Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride</NonProprietaryName></NDC><NDC><NDCCode>0990-7929-03</NDCCode><ProprietaryName>Lactated Ringers And Dextrose</ProprietaryName><NonProprietaryName>Sodium Chloride, Sodium Lactate, Potassium Chloride, Calcium Chloride, And Dextrose Monohydrate</NonProprietaryName></NDC><NDC><NDCCode>0990-7929-09</NDCCode><ProprietaryName>Lactated Ringers And Dextrose</ProprietaryName><NonProprietaryName>Sodium Chloride, Sodium Lactate, Potassium Chloride, Calcium Chloride, And Dextrose Monohydrate</NonProprietaryName></NDC><NDC><NDCCode>0990-7953-02</NDCCode><ProprietaryName>Lactated Ringers</ProprietaryName><NonProprietaryName>Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride</NonProprietaryName></NDC><NDC><NDCCode>0990-7953-03</NDCCode><ProprietaryName>Lactated Ringers</ProprietaryName><NonProprietaryName>Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride</NonProprietaryName></NDC><NDC><NDCCode>0990-7953-09</NDCCode><ProprietaryName>Lactated Ringers</ProprietaryName><NonProprietaryName>Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride</NonProprietaryName></NDC><NDC><NDCCode>0990-7967-09</NDCCode><ProprietaryName>Normosol-r</ProprietaryName><NonProprietaryName>Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, And Magnesium Chloride</NonProprietaryName></NDC><NDC><NDCCode>0990-7972-05</NDCCode><ProprietaryName>Sodium Chloride</ProprietaryName><NonProprietaryName>Sodium Chloride</NonProprietaryName></NDC><NDC><NDCCode>0990-7972-07</NDCCode><ProprietaryName>Sodium Chloride</ProprietaryName><NonProprietaryName>Sodium Chloride</NonProprietaryName></NDC><NDC><NDCCode>0990-7972-08</NDCCode><ProprietaryName>Sodium Chloride</ProprietaryName><NonProprietaryName>Sodium Chloride</NonProprietaryName></NDC><NDC><NDCCode>0990-7973-05</NDCCode><ProprietaryName>Sterile Water</ProprietaryName><NonProprietaryName>Water</NonProprietaryName></NDC></NDCList>