{
"NDC": [
{
"NDCCode": "0990-7922-25",
"PackageDescription": "24 BAG in 1 CASE (0990-7922-25) > 250 mL in 1 BAG",
"NDC11Code": "00990-7922-25",
"ProductNDC": "0990-7922",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextrose",
"NonProprietaryName": "Dextrose Monohydrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20191001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016367",
"LabelerName": "ICU Medical Inc.",
"SubstanceName": "DEXTROSE MONOHYDRATE",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20191001",
"SamplePackage": "N"
},
{
"NDCCode": "0409-7922-25",
"PackageDescription": "24 BAG in 1 CASE (0409-7922-25) > 250 mL in 1 BAG",
"NDC11Code": "00409-7922-25",
"ProductNDC": "0409-7922",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextrose",
"NonProprietaryName": "Dextrose Monohydrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20050909",
"EndMarketingDate": "20210201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016367",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "DEXTROSE MONOHYDRATE",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20090416",
"EndMarketingDatePackage": "20210201",
"SamplePackage": "N"
},
{
"NDCCode": "0990-7922-02",
"PackageDescription": "24 POUCH in 1 CASE (0990-7922-02) / 1 BAG in 1 POUCH / 250 mL in 1 BAG",
"NDC11Code": "00990-7922-02",
"ProductNDC": "0990-7922",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextrose",
"NonProprietaryName": "Dextrose Monohydrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20190715",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016367",
"LabelerName": "ICU Medical, Inc.",
"SubstanceName": "DEXTROSE MONOHYDRATE",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190801",
"SamplePackage": "N",
"IndicationAndUsage": "Dextrose Injection (5% and 10%) is indicated as a source of water and calories in adult and pediatric patients, and may also be used as a diluent for reconstitution of a powder or liquid drug product.",
"Description": "Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6 ∙ H2O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula. Water for Injection, USP is chemically designated H2O. Dextrose Injection, USP (5% and 10%) solutions are sterile and nonpyrogenic. They are parenteral solutions containing various concentrations of dextrose in water for injection intended for intravenous administration. Each 100 mL of 5% Dextrose Injection, USP, contains dextrose, hydrous 5 g in water for injection. The caloric value is 170 kcal/L. The osmolarity is 252 mOsmol/L (calc.), which is slightly hypotonic. Each 100 mL of 10% Dextrose Injection, USP, contains dextrose, hydrous 10 g in water for injection. The caloric value is 340 kcal/L. The osmolarity is 505 mOsmol/L (calc.), which is hypertonic. The pH for both concentrations is 4.3 (range is 3.2 to 6.5). The solutions contain no bacteriostatic, antimicrobial agent or added buffer and each is supplied as single-dose containers. Dextrose is derived from corn. 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": "0990-7922-03",
"PackageDescription": "24 POUCH in 1 CASE (0990-7922-03) / 1 BAG in 1 POUCH / 500 mL in 1 BAG",
"NDC11Code": "00990-7922-03",
"ProductNDC": "0990-7922",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextrose",
"NonProprietaryName": "Dextrose Monohydrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20190715",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016367",
"LabelerName": "ICU Medical, Inc.",
"SubstanceName": "DEXTROSE MONOHYDRATE",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190801",
"SamplePackage": "N",
"IndicationAndUsage": "Dextrose Injection (5% and 10%) is indicated as a source of water and calories in adult and pediatric patients, and may also be used as a diluent for reconstitution of a powder or liquid drug product.",
"Description": "Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6 ∙ H2O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula. Water for Injection, USP is chemically designated H2O. Dextrose Injection, USP (5% and 10%) solutions are sterile and nonpyrogenic. They are parenteral solutions containing various concentrations of dextrose in water for injection intended for intravenous administration. Each 100 mL of 5% Dextrose Injection, USP, contains dextrose, hydrous 5 g in water for injection. The caloric value is 170 kcal/L. The osmolarity is 252 mOsmol/L (calc.), which is slightly hypotonic. Each 100 mL of 10% Dextrose Injection, USP, contains dextrose, hydrous 10 g in water for injection. The caloric value is 340 kcal/L. The osmolarity is 505 mOsmol/L (calc.), which is hypertonic. The pH for both concentrations is 4.3 (range is 3.2 to 6.5). The solutions contain no bacteriostatic, antimicrobial agent or added buffer and each is supplied as single-dose containers. Dextrose is derived from corn. 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": "0990-7922-09",
"PackageDescription": "12 POUCH in 1 CASE (0990-7922-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG",
"NDC11Code": "00990-7922-09",
"ProductNDC": "0990-7922",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextrose",
"NonProprietaryName": "Dextrose Monohydrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20190715",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016367",
"LabelerName": "ICU Medical, Inc.",
"SubstanceName": "DEXTROSE MONOHYDRATE",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190901",
"SamplePackage": "N",
"IndicationAndUsage": "Dextrose Injection (5% and 10%) is indicated as a source of water and calories in adult and pediatric patients, and may also be used as a diluent for reconstitution of a powder or liquid drug product.",
"Description": "Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6 ∙ H2O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula. Water for Injection, USP is chemically designated H2O. Dextrose Injection, USP (5% and 10%) solutions are sterile and nonpyrogenic. They are parenteral solutions containing various concentrations of dextrose in water for injection intended for intravenous administration. Each 100 mL of 5% Dextrose Injection, USP, contains dextrose, hydrous 5 g in water for injection. The caloric value is 170 kcal/L. The osmolarity is 252 mOsmol/L (calc.), which is slightly hypotonic. Each 100 mL of 10% Dextrose Injection, USP, contains dextrose, hydrous 10 g in water for injection. The caloric value is 340 kcal/L. The osmolarity is 505 mOsmol/L (calc.), which is hypertonic. The pH for both concentrations is 4.3 (range is 3.2 to 6.5). The solutions contain no bacteriostatic, antimicrobial agent or added buffer and each is supplied as single-dose containers. Dextrose is derived from corn. 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": "0990-7922-53",
"PackageDescription": "24 POUCH in 1 CASE (0990-7922-53) / 1 BAG in 1 POUCH / 250 mL in 1 BAG",
"NDC11Code": "00990-7922-53",
"ProductNDC": "0990-7922",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextrose",
"NonProprietaryName": "Dextrose Monohydrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20190715",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016367",
"LabelerName": "ICU Medical, Inc.",
"SubstanceName": "DEXTROSE MONOHYDRATE",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191001",
"SamplePackage": "N",
"IndicationAndUsage": "Dextrose Injection (5% and 10%) is indicated as a source of water and calories in adult and pediatric patients, and may also be used as a diluent for reconstitution of a powder or liquid drug product.",
"Description": "Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6 ∙ H2O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula. Water for Injection, USP is chemically designated H2O. Dextrose Injection, USP (5% and 10%) solutions are sterile and nonpyrogenic. They are parenteral solutions containing various concentrations of dextrose in water for injection intended for intravenous administration. Each 100 mL of 5% Dextrose Injection, USP, contains dextrose, hydrous 5 g in water for injection. The caloric value is 170 kcal/L. The osmolarity is 252 mOsmol/L (calc.), which is slightly hypotonic. Each 100 mL of 10% Dextrose Injection, USP, contains dextrose, hydrous 10 g in water for injection. The caloric value is 340 kcal/L. The osmolarity is 505 mOsmol/L (calc.), which is hypertonic. The pH for both concentrations is 4.3 (range is 3.2 to 6.5). The solutions contain no bacteriostatic, antimicrobial agent or added buffer and each is supplied as single-dose containers. Dextrose is derived from corn. 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": "0990-7922-55",
"PackageDescription": "18 POUCH in 1 CASE (0990-7922-55) / 1 BAG in 1 POUCH / 500 mL in 1 BAG",
"NDC11Code": "00990-7922-55",
"ProductNDC": "0990-7922",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextrose",
"NonProprietaryName": "Dextrose Monohydrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20190715",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016367",
"LabelerName": "ICU Medical, Inc.",
"SubstanceName": "DEXTROSE MONOHYDRATE",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190801",
"SamplePackage": "N",
"IndicationAndUsage": "Dextrose Injection (5% and 10%) is indicated as a source of water and calories in adult and pediatric patients, and may also be used as a diluent for reconstitution of a powder or liquid drug product.",
"Description": "Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6 ∙ H2O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula. Water for Injection, USP is chemically designated H2O. Dextrose Injection, USP (5% and 10%) solutions are sterile and nonpyrogenic. They are parenteral solutions containing various concentrations of dextrose in water for injection intended for intravenous administration. Each 100 mL of 5% Dextrose Injection, USP, contains dextrose, hydrous 5 g in water for injection. The caloric value is 170 kcal/L. The osmolarity is 252 mOsmol/L (calc.), which is slightly hypotonic. Each 100 mL of 10% Dextrose Injection, USP, contains dextrose, hydrous 10 g in water for injection. The caloric value is 340 kcal/L. The osmolarity is 505 mOsmol/L (calc.), which is hypertonic. The pH for both concentrations is 4.3 (range is 3.2 to 6.5). The solutions contain no bacteriostatic, antimicrobial agent or added buffer and each is supplied as single-dose containers. Dextrose is derived from corn. 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": "0990-7922-61",
"PackageDescription": "32 POUCH in 1 CASE (0990-7922-61) / 1 BAG in 1 POUCH / 150 mL in 1 BAG",
"NDC11Code": "00990-7922-61",
"ProductNDC": "0990-7922",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextrose",
"NonProprietaryName": "Dextrose Monohydrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20190715",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016367",
"LabelerName": "ICU Medical, Inc.",
"SubstanceName": "DEXTROSE MONOHYDRATE",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190801",
"SamplePackage": "N",
"IndicationAndUsage": "Dextrose Injection (5% and 10%) is indicated as a source of water and calories in adult and pediatric patients, and may also be used as a diluent for reconstitution of a powder or liquid drug product.",
"Description": "Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6 ∙ H2O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula. Water for Injection, USP is chemically designated H2O. Dextrose Injection, USP (5% and 10%) solutions are sterile and nonpyrogenic. They are parenteral solutions containing various concentrations of dextrose in water for injection intended for intravenous administration. Each 100 mL of 5% Dextrose Injection, USP, contains dextrose, hydrous 5 g in water for injection. The caloric value is 170 kcal/L. The osmolarity is 252 mOsmol/L (calc.), which is slightly hypotonic. Each 100 mL of 10% Dextrose Injection, USP, contains dextrose, hydrous 10 g in water for injection. The caloric value is 340 kcal/L. The osmolarity is 505 mOsmol/L (calc.), which is hypertonic. The pH for both concentrations is 4.3 (range is 3.2 to 6.5). The solutions contain no bacteriostatic, antimicrobial agent or added buffer and each is supplied as single-dose containers. Dextrose is derived from corn. 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": "0990-5138-25",
"PackageDescription": "24 BOTTLE, PLASTIC in 1 CASE (0990-5138-25) / 250 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "00990-5138-25",
"ProductNDC": "0990-5138",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Chloride",
"NonProprietaryName": "Sodium Chloride",
"DosageFormName": "IRRIGANT",
"RouteName": "IRRIGATION",
"StartMarketingDate": "20240801",
"EndMarketingDate": "20260501",
"MarketingCategoryName": "UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE",
"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": "20240801",
"EndMarketingDatePackage": "20260501",
"SamplePackage": "N"
},
{
"NDCCode": "0990-7923-20",
"PackageDescription": "12 POUCH in 1 CASE (0990-7923-20) / 4 BAG in 1 POUCH / 25 mL in 1 BAG",
"NDC11Code": "00990-7923-20",
"ProductNDC": "0990-7923",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextrose",
"NonProprietaryName": "Dextrose Monohydrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20190715",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016367",
"LabelerName": "ICU Medical, Inc.",
"SubstanceName": "DEXTROSE MONOHYDRATE",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190801",
"SamplePackage": "N",
"IndicationAndUsage": "Dextrose Injection (5% and 10%) is indicated as a source of water and calories in adult and pediatric patients, and may also be used as a diluent for reconstitution of a powder or liquid drug product.",
"Description": "Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6 ∙ H2O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula. Water for Injection, USP is chemically designated H2O. Dextrose Injection, USP (5% and 10%) solutions are sterile and nonpyrogenic. They are parenteral solutions containing various concentrations of dextrose in water for injection intended for intravenous administration. Each 100 mL of 5% Dextrose Injection, USP, contains dextrose, hydrous 5 g in water for injection. The caloric value is 170 kcal/L. The osmolarity is 252 mOsmol/L (calc.), which is slightly hypotonic. Each 100 mL of 10% Dextrose Injection, USP, contains dextrose, hydrous 10 g in water for injection. The caloric value is 340 kcal/L. The osmolarity is 505 mOsmol/L (calc.), which is hypertonic. The pH for both concentrations is 4.3 (range is 3.2 to 6.5). The solutions contain no bacteriostatic, antimicrobial agent or added buffer and each is supplied as single-dose containers. Dextrose is derived from corn. 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": "0990-7983-25",
"PackageDescription": "24 BAG in 1 CASE (0990-7983-25) > 250 mL in 1 BAG",
"NDC11Code": "00990-7983-25",
"ProductNDC": "0990-7983",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Chloride",
"NonProprietaryName": "Sodium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20190815",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016366",
"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": "2022-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190815",
"SamplePackage": "N"
},
{
"NDCCode": "0990-7984-20",
"PackageDescription": "12 POUCH in 1 CASE (0990-7984-20) / 4 BAG in 1 POUCH / 25 mL in 1 BAG",
"NDC11Code": "00990-7984-20",
"ProductNDC": "0990-7984",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Chloride",
"NonProprietaryName": "Sodium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20190401",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016366",
"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": "2025-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191101",
"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": "0990-7985-25",
"PackageDescription": "24 BAG in 1 CASE (0990-7985-25) > 250 mL in 1 BAG",
"NDC11Code": "00990-7985-25",
"ProductNDC": "0990-7985",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Chloride",
"NonProprietaryName": "Sodium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200125",
"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": "Deprecated",
"LastUpdate": "2022-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200125",
"SamplePackage": "N"
},
{
"NDCCode": "59779-990-25",
"PackageDescription": "25 BLISTER PACK in 1 CARTON (59779-990-25) > 1 TABLET, COATED in 1 BLISTER PACK",
"NDC11Code": "59779-0990-25",
"ProductNDC": "59779-990",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bisacody",
"ProprietaryNameSuffix": "Enteric Coated",
"NonProprietaryName": "Bisacodyl",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130110",
"EndMarketingDate": "20201231",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "CVS Pharmacy",
"SubstanceName": "BISACODYL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130110",
"EndMarketingDatePackage": "20201231",
"SamplePackage": "N"
},
{
"NDCCode": "65862-990-25",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 CARTON (65862-990-25) > 1 mL in 1 VIAL, MULTI-DOSE (65862-990-01) ",
"NDC11Code": "65862-0990-25",
"ProductNDC": "65862-990",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Heparin Sodium",
"NonProprietaryName": "Heparin Sodium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20140612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202957",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "HEPARIN SODIUM",
"StrengthNumber": "1000",
"StrengthUnit": "[USP'U]/mL",
"Pharm_Classes": "Anti-coagulant [EPC],Heparin [CS],Unfractionated Heparin [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-03-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20140612",
"SamplePackage": "N"
},
{
"NDCCode": "0169-7902-01",
"PackageDescription": "1 KIT in 1 KIT (0169-7902-01) * 4 mL in 1 VIAL, GLASS (0169-7922-90) * 4 mL in 1 SYRINGE, GLASS (0169-7009-98) * 4 mL in 1 VIAL, GLASS (0169-7922-11) ",
"NDC11Code": "00169-7902-01",
"ProductNDC": "0169-7902",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rebinyn",
"NonProprietaryName": "Coagulation Factor Ix Recombinant, Glycopegylated",
"DosageFormName": "KIT",
"StartMarketingDate": "20171201",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125611",
"LabelerName": "Novo Nordisk",
"Status": "Active",
"LastUpdate": "2024-08-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171201",
"SamplePackage": "N",
"IndicationAndUsage": "REBINYN, Coagulation Factor IX (Recombinant), GlycoPEGylated, is a recombinant DNA-derived coagulation Factor IX concentrate indicated for use in adults and children with hemophilia B (congenital Factor IX deficiency) for: 1 On-demand treatment and control of bleeding episodes, 2 Perioperative management of bleeding, 3 Routine prophylaxis to reduce the frequency of bleeding episodes.",
"Description": "REBINYN is a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution with the provided histidine diluent for intravenous infusion. After reconstitution, the solution appears as a clear and colorless to slightly yellow liquid, free from visible particles and contains the following excipients per mL: sodium chloride, 2.34 mg; histidine, 3.10 mg; sucrose, 10 mg; mannitol, 25 mg; polysorbate 80, 0.05 mg. REBINYN is available in single-dose vials containing the labeled amount of Factor IX activity, expressed in IU. Each vial contains nominally 500 IU, 1000 IU, 2000, or 3000 IU. REBINYN potency is assigned using an in vitro, activated partial thromboplastin time (aPTT)-based, one-stage clotting assay calibrated against the World Health Organization (WHO) international standard for Factor IX concentrates. REBINYN contains no preservatives. REBINYN is a purified recombinant human Factor IX (rFIX) with a 40 kilodalton (kDa) polyethylene-glycol (PEG) conjugated to the protein. The 40 kDa PEG group is selectively attached to specific -N-linked glycans in the rFIX activation peptide, with mono-PEGylated rFIX as the predominant form of REBINYN. The rFIX protein in REBINYN consists of a gamma-carboxylated (Gla) domain, two EGF-like (epidermal growth factor) domains, an activation peptide (which is cleaved off upon activation), and a protease domain. Once activated, the resulting rFIX has structural and functional properties similar to those of endogenous activated Factor IX. The primary amino acid sequence in REBINYN is identical to the Thr148 allelic form of human plasma-derived Factor IX and consists of 415 amino acids. The average molecular weight of REBINYN is approximately 98 kDa and the molecular weight of the protein moiety alone is 56 kDa. The nominal specific activity of REBINYN is 144 IU/mg protein. REBINYN is produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells. No additives of human or animal origin are used in the cell culture, purification, conjugation, or formulation of REBINYN. The rFIX protein is purified by a series of chromatographic steps, including an affinity chromatography step using a monoclonal antibody (produced in CHO cells), to selectively isolate rFIX from the cell culture medium. The production process includes two dedicated viral clearance steps, namely a detergent treatment step for inactivation and a 20 nm filtration step for removal of viruses. The conjugation of the PEG-group is done by an enzymatic reaction during the purification process, followed by final purification of REBINYN."
},
{
"NDCCode": "0169-7902-97",
"PackageDescription": "1 KIT in 1 KIT (0169-7902-97) * 4 mL in 1 VIAL, GLASS (0169-7922-90) * 4 mL in 1 SYRINGE, GLASS (0169-7009-98) * 4 mL in 1 VIAL, GLASS (0169-7922-11) ",
"NDC11Code": "00169-7902-97",
"ProductNDC": "0169-7902",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rebinyn",
"NonProprietaryName": "Coagulation Factor Ix Recombinant, Glycopegylated",
"DosageFormName": "KIT",
"StartMarketingDate": "20171201",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125611",
"LabelerName": "Novo Nordisk",
"Status": "Active",
"LastUpdate": "2024-08-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220505",
"SamplePackage": "Y",
"IndicationAndUsage": "REBINYN, Coagulation Factor IX (Recombinant), GlycoPEGylated, is a recombinant DNA-derived coagulation Factor IX concentrate indicated for use in adults and children with hemophilia B (congenital Factor IX deficiency) for: 1 On-demand treatment and control of bleeding episodes, 2 Perioperative management of bleeding, 3 Routine prophylaxis to reduce the frequency of bleeding episodes.",
"Description": "REBINYN is a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution with the provided histidine diluent for intravenous infusion. After reconstitution, the solution appears as a clear and colorless to slightly yellow liquid, free from visible particles and contains the following excipients per mL: sodium chloride, 2.34 mg; histidine, 3.10 mg; sucrose, 10 mg; mannitol, 25 mg; polysorbate 80, 0.05 mg. REBINYN is available in single-dose vials containing the labeled amount of Factor IX activity, expressed in IU. Each vial contains nominally 500 IU, 1000 IU, 2000, or 3000 IU. REBINYN potency is assigned using an in vitro, activated partial thromboplastin time (aPTT)-based, one-stage clotting assay calibrated against the World Health Organization (WHO) international standard for Factor IX concentrates. REBINYN contains no preservatives. REBINYN is a purified recombinant human Factor IX (rFIX) with a 40 kilodalton (kDa) polyethylene-glycol (PEG) conjugated to the protein. The 40 kDa PEG group is selectively attached to specific -N-linked glycans in the rFIX activation peptide, with mono-PEGylated rFIX as the predominant form of REBINYN. The rFIX protein in REBINYN consists of a gamma-carboxylated (Gla) domain, two EGF-like (epidermal growth factor) domains, an activation peptide (which is cleaved off upon activation), and a protease domain. Once activated, the resulting rFIX has structural and functional properties similar to those of endogenous activated Factor IX. The primary amino acid sequence in REBINYN is identical to the Thr148 allelic form of human plasma-derived Factor IX and consists of 415 amino acids. The average molecular weight of REBINYN is approximately 98 kDa and the molecular weight of the protein moiety alone is 56 kDa. The nominal specific activity of REBINYN is 144 IU/mg protein. REBINYN is produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells. No additives of human or animal origin are used in the cell culture, purification, conjugation, or formulation of REBINYN. The rFIX protein is purified by a series of chromatographic steps, including an affinity chromatography step using a monoclonal antibody (produced in CHO cells), to selectively isolate rFIX from the cell culture medium. The production process includes two dedicated viral clearance steps, namely a detergent treatment step for inactivation and a 20 nm filtration step for removal of viruses. The conjugation of the PEG-group is done by an enzymatic reaction during the purification process, followed by final purification of REBINYN."
},
{
"NDCCode": "0113-0990-38",
"PackageDescription": "296 mL in 1 BOTTLE (0113-0990-38)",
"NDC11Code": "00113-0990-38",
"ProductNDC": "0113-0990",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Good Sense Night Time",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20101014",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "L Perrigo Company",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
"StrengthNumber": "500; 15; 6.25",
"StrengthUnit": "mg/15mL; mg/15mL; mg/15mL",
"Status": "Deprecated",
"LastUpdate": "2017-11-10"
},
{
"NDCCode": "0363-0990-38",
"PackageDescription": "296 mL in 1 BOTTLE (0363-0990-38)",
"NDC11Code": "00363-0990-38",
"ProductNDC": "0363-0990",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nighttime Cold And Flu Relief",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide And Doxylamine Succinate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20080730",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Walgreen Company",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
"StrengthNumber": "500; 15; 6.25",
"StrengthUnit": "mg/15mL; mg/15mL; mg/15mL",
"Status": "Deprecated",
"LastUpdate": "2017-11-22"
},
{
"NDCCode": "0363-0990-40",
"PackageDescription": "355 mL in 1 BOTTLE (0363-0990-40)",
"NDC11Code": "00363-0990-40",
"ProductNDC": "0363-0990",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nighttime Cold And Flu Relief",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide And Doxylamine Succinate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20080730",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Walgreen Company",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
"StrengthNumber": "500; 15; 6.25",
"StrengthUnit": "mg/15mL; mg/15mL; mg/15mL",
"Status": "Deprecated",
"LastUpdate": "2017-11-22"
},
{
"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": "0990-7901-09",
"PackageDescription": "12 POUCH in 1 CASE (0990-7901-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG",
"NDC11Code": "00990-7901-09",
"ProductNDC": "0990-7901",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride In Dextrose And Sodium Chloride",
"NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, And Potassium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018365",
"LabelerName": "ICU Medical Inc.",
"SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE",
"StrengthNumber": "50; 2.25; 1.49",
"StrengthUnit": "g/1000mL; g/1000mL; g/1000mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200201",
"SamplePackage": "N",
"IndicationAndUsage": "These solutions are indicated in patients requiring parenteral administration of potassium chloride with minimal carbohydrate calories and sodium chloride.",
"Description": "Intravenous solutions with potassium chloride (I.V. solutions with KCl) are sterile and nonpyrogenic solutions in water for injection. They are for administration by intravenous infusion only. See Tables for summary of content and characteristics of these solutions. The solutions contain no bacteriostat, antimicrobial agent or added buffer and each is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded. These 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. 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. 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 the 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": "0990-7918-19",
"PackageDescription": "12 POUCH in 1 CASE (0990-7918-19) / 1 BAG in 1 POUCH / 500 mL in 1 BAG",
"NDC11Code": "00990-7918-19",
"ProductNDC": "0990-7918",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextrose",
"NonProprietaryName": "Dextrose",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20191001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018561",
"LabelerName": "ICU Medical Inc.",
"SubstanceName": "DEXTROSE MONOHYDRATE",
"StrengthNumber": "70",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191001",
"SamplePackage": "N",
"IndicationAndUsage": "Dextrose Injection 20%, 30%, 40%, 50% and 70%, mixed with amino acids or other compatible intravenous fluids, is indicated as a source of calories for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.",
"Description": "Dextrose Injection, USP 20%, 30%, 40%, 50% and 70% are sterile, nonpyrogenic, hypertonic solutions of Dextrose, USP in Water for Injection in a polyvinylchloride flexible plastic container for intravenous administration after appropriate admixture or dilution [see Dosage and Administration (2.1)]. Partial-fill containers, designed to facilitate admixture or dilution to provide dextrose in various concentrations, are available in various sizes. See Table 1 for the content and characteristics of these concentrated solutions. The solutions contain no bacteriostatic, antimicrobial agent or added buffer and are intended only for use as a single-dose injection following admixture or dilution. The pH is 4.3 (range is 3.2 to 6.5). Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6 H2O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula. Dextrose may be derived from corn. Water for Injection, USP is chemically designated H2O. Dextrose Injection contains no more than 25 mcg/L of aluminum."
},
{
"NDCCode": "0990-7935-19",
"PackageDescription": "12 POUCH in 1 CASE (0990-7935-19) / 1 BAG in 1 POUCH / 500 mL in 1 BAG",
"NDC11Code": "00990-7935-19",
"ProductNDC": "0990-7935",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextrose",
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"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20191001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018564",
"LabelerName": "ICU Medical Inc.",
"SubstanceName": "DEXTROSE MONOHYDRATE",
"StrengthNumber": "20",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191001",
"SamplePackage": "N",
"IndicationAndUsage": "Dextrose Injection 20%, 30%, 40%, 50% and 70%, mixed with amino acids or other compatible intravenous fluids, is indicated as a source of calories for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.",
"Description": "Dextrose Injection, USP 20%, 30%, 40%, 50% and 70% are sterile, nonpyrogenic, hypertonic solutions of Dextrose, USP in Water for Injection in a polyvinylchloride flexible plastic container for intravenous administration after appropriate admixture or dilution [see Dosage and Administration (2.1)]. Partial-fill containers, designed to facilitate admixture or dilution to provide dextrose in various concentrations, are available in various sizes. See Table 1 for the content and characteristics of these concentrated solutions. The solutions contain no bacteriostatic, antimicrobial agent or added buffer and are intended only for use as a single-dose injection following admixture or dilution. The pH is 4.3 (range is 3.2 to 6.5). Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6 H2O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula. Dextrose may be derived from corn. Water for Injection, USP is chemically designated H2O. Dextrose Injection contains no more than 25 mcg/L of aluminum."
},
{
"NDCCode": "0990-7936-19",
"PackageDescription": "12 POUCH in 1 CASE (0990-7936-19) / 1 BAG in 1 POUCH / 500 mL in 1 BAG",
"NDC11Code": "00990-7936-19",
"ProductNDC": "0990-7936",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20191001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018563",
"LabelerName": "ICU Medical Inc.",
"SubstanceName": "DEXTROSE MONOHYDRATE",
"StrengthNumber": "50",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191001",
"SamplePackage": "N",
"IndicationAndUsage": "Dextrose Injection 20%, 30%, 40%, 50% and 70%, mixed with amino acids or other compatible intravenous fluids, is indicated as a source of calories for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.",
"Description": "Dextrose Injection, USP 20%, 30%, 40%, 50% and 70% are sterile, nonpyrogenic, hypertonic solutions of Dextrose, USP in Water for Injection in a polyvinylchloride flexible plastic container for intravenous administration after appropriate admixture or dilution [see Dosage and Administration (2.1)]. Partial-fill containers, designed to facilitate admixture or dilution to provide dextrose in various concentrations, are available in various sizes. See Table 1 for the content and characteristics of these concentrated solutions. The solutions contain no bacteriostatic, antimicrobial agent or added buffer and are intended only for use as a single-dose injection following admixture or dilution. The pH is 4.3 (range is 3.2 to 6.5). Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6 H2O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula. Dextrose may be derived from corn. Water for Injection, USP is chemically designated H2O. Dextrose Injection contains no more than 25 mcg/L of aluminum."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextrose",
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"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20191001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018562",
"LabelerName": "ICU Medical Inc.",
"SubstanceName": "DEXTROSE MONOHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191001",
"SamplePackage": "N",
"IndicationAndUsage": "Dextrose Injection 20%, 30%, 40%, 50% and 70%, mixed with amino acids or other compatible intravenous fluids, is indicated as a source of calories for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.",
"Description": "Dextrose Injection, USP 20%, 30%, 40%, 50% and 70% are sterile, nonpyrogenic, hypertonic solutions of Dextrose, USP in Water for Injection in a polyvinylchloride flexible plastic container for intravenous administration after appropriate admixture or dilution [see Dosage and Administration (2.1)]. Partial-fill containers, designed to facilitate admixture or dilution to provide dextrose in various concentrations, are available in various sizes. See Table 1 for the content and characteristics of these concentrated solutions. The solutions contain no bacteriostatic, antimicrobial agent or added buffer and are intended only for use as a single-dose injection following admixture or dilution. The pH is 4.3 (range is 3.2 to 6.5). Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6 H2O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula. Dextrose may be derived from corn. Water for Injection, USP is chemically designated H2O. Dextrose Injection contains no more than 25 mcg/L of aluminum."
},
{
"NDCCode": "0990-8004-15",
"PackageDescription": "12 POUCH in 1 CASE (0990-8004-15) / 1 BAG in 1 POUCH / 500 mL in 1 BAG",
"NDC11Code": "00990-8004-15",
"ProductNDC": "0990-8004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextrose",
"NonProprietaryName": "Dextrose",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20191001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019345",
"LabelerName": "ICU Medical Inc.",
"SubstanceName": "DEXTROSE MONOHYDRATE",
"StrengthNumber": "30",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191001",
"SamplePackage": "N",
"IndicationAndUsage": "Dextrose Injection 20%, 30%, 40%, 50% and 70%, mixed with amino acids or other compatible intravenous fluids, is indicated as a source of calories for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.",
"Description": "Dextrose Injection, USP 20%, 30%, 40%, 50% and 70% are sterile, nonpyrogenic, hypertonic solutions of Dextrose, USP in Water for Injection in a polyvinylchloride flexible plastic container for intravenous administration after appropriate admixture or dilution [see Dosage and Administration (2.1)]. Partial-fill containers, designed to facilitate admixture or dilution to provide dextrose in various concentrations, are available in various sizes. See Table 1 for the content and characteristics of these concentrated solutions. The solutions contain no bacteriostatic, antimicrobial agent or added buffer and are intended only for use as a single-dose injection following admixture or dilution. The pH is 4.3 (range is 3.2 to 6.5). Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6 H2O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula. Dextrose may be derived from corn. Water for Injection, USP is chemically designated H2O. Dextrose Injection contains no more than 25 mcg/L of aluminum."
},
{
"NDCCode": "10056-990-38",
"PackageDescription": "296 mL in 1 BOTTLE (10056-990-38)",
"NDC11Code": "10056-0990-38",
"ProductNDC": "10056-990",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fulton Street Market Cold And Flu",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20100715",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Access Business Group LLC",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
"StrengthNumber": "500; 15; 6.25",
"StrengthUnit": "mg/15mL; mg/15mL; mg/15mL",
"Status": "Deprecated",
"LastUpdate": "2017-11-22"
},
{
"NDCCode": "30142-990-38",
"PackageDescription": "295 mL in 1 BOTTLE (30142-990-38)",
"NDC11Code": "30142-0990-38",
"ProductNDC": "30142-990",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nite Time",
"ProprietaryNameSuffix": "Multi Symptom Cold Flu Relief",
"NonProprietaryName": "- Acetaminophen, Dextromethorphan Hydrobromide And Doxylamine Succinate Liquid",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20090805",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Kroger Company",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
"StrengthNumber": "500; 15; 6.25",
"StrengthUnit": "mg/15mL; mg/15mL; mg/15mL",
"Status": "Deprecated",
"LastUpdate": "2017-12-07"
}
]
}
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<NDCList>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
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<LabelerName>Hospira, Inc.</LabelerName>
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<Status>Deprecated</Status>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20090416</StartMarketingDatePackage>
<EndMarketingDatePackage>20210201</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
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<LabelerName>ICU Medical, Inc.</LabelerName>
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<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dextrose Injection (5% and 10%) is indicated as a source of water and calories in adult and pediatric patients, and may also be used as a diluent for reconstitution of a powder or liquid drug product.</IndicationAndUsage>
<Description>Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6 ∙ H2O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula. Water for Injection, USP is chemically designated H2O. Dextrose Injection, USP (5% and 10%) solutions are sterile and nonpyrogenic. They are parenteral solutions containing various concentrations of dextrose in water for injection intended for intravenous administration. Each 100 mL of 5% Dextrose Injection, USP, contains dextrose, hydrous 5 g in water for injection. The caloric value is 170 kcal/L. The osmolarity is 252 mOsmol/L (calc.), which is slightly hypotonic. Each 100 mL of 10% Dextrose Injection, USP, contains dextrose, hydrous 10 g in water for injection. The caloric value is 340 kcal/L. The osmolarity is 505 mOsmol/L (calc.), which is hypertonic. The pH for both concentrations is 4.3 (range is 3.2 to 6.5). The solutions contain no bacteriostatic, antimicrobial agent or added buffer and each is supplied as single-dose containers. Dextrose is derived from corn. 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.</Description>
</NDC>
<NDC>
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<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dextrose Injection (5% and 10%) is indicated as a source of water and calories in adult and pediatric patients, and may also be used as a diluent for reconstitution of a powder or liquid drug product.</IndicationAndUsage>
<Description>Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6 ∙ H2O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula. Water for Injection, USP is chemically designated H2O. Dextrose Injection, USP (5% and 10%) solutions are sterile and nonpyrogenic. They are parenteral solutions containing various concentrations of dextrose in water for injection intended for intravenous administration. Each 100 mL of 5% Dextrose Injection, USP, contains dextrose, hydrous 5 g in water for injection. The caloric value is 170 kcal/L. The osmolarity is 252 mOsmol/L (calc.), which is slightly hypotonic. Each 100 mL of 10% Dextrose Injection, USP, contains dextrose, hydrous 10 g in water for injection. The caloric value is 340 kcal/L. The osmolarity is 505 mOsmol/L (calc.), which is hypertonic. The pH for both concentrations is 4.3 (range is 3.2 to 6.5). The solutions contain no bacteriostatic, antimicrobial agent or added buffer and each is supplied as single-dose containers. Dextrose is derived from corn. 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.</Description>
</NDC>
<NDC>
<NDCCode>0990-7922-09</NDCCode>
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<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dextrose Injection (5% and 10%) is indicated as a source of water and calories in adult and pediatric patients, and may also be used as a diluent for reconstitution of a powder or liquid drug product.</IndicationAndUsage>
<Description>Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6 ∙ H2O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula. Water for Injection, USP is chemically designated H2O. Dextrose Injection, USP (5% and 10%) solutions are sterile and nonpyrogenic. They are parenteral solutions containing various concentrations of dextrose in water for injection intended for intravenous administration. Each 100 mL of 5% Dextrose Injection, USP, contains dextrose, hydrous 5 g in water for injection. The caloric value is 170 kcal/L. The osmolarity is 252 mOsmol/L (calc.), which is slightly hypotonic. Each 100 mL of 10% Dextrose Injection, USP, contains dextrose, hydrous 10 g in water for injection. The caloric value is 340 kcal/L. The osmolarity is 505 mOsmol/L (calc.), which is hypertonic. The pH for both concentrations is 4.3 (range is 3.2 to 6.5). The solutions contain no bacteriostatic, antimicrobial agent or added buffer and each is supplied as single-dose containers. Dextrose is derived from corn. 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.</Description>
</NDC>
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<LabelerName>ICU Medical, Inc.</LabelerName>
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<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dextrose Injection (5% and 10%) is indicated as a source of water and calories in adult and pediatric patients, and may also be used as a diluent for reconstitution of a powder or liquid drug product.</IndicationAndUsage>
<Description>Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6 ∙ H2O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula. Water for Injection, USP is chemically designated H2O. Dextrose Injection, USP (5% and 10%) solutions are sterile and nonpyrogenic. They are parenteral solutions containing various concentrations of dextrose in water for injection intended for intravenous administration. Each 100 mL of 5% Dextrose Injection, USP, contains dextrose, hydrous 5 g in water for injection. The caloric value is 170 kcal/L. The osmolarity is 252 mOsmol/L (calc.), which is slightly hypotonic. Each 100 mL of 10% Dextrose Injection, USP, contains dextrose, hydrous 10 g in water for injection. The caloric value is 340 kcal/L. The osmolarity is 505 mOsmol/L (calc.), which is hypertonic. The pH for both concentrations is 4.3 (range is 3.2 to 6.5). The solutions contain no bacteriostatic, antimicrobial agent or added buffer and each is supplied as single-dose containers. Dextrose is derived from corn. 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.</Description>
</NDC>
<NDC>
<NDCCode>0990-7922-55</NDCCode>
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<NDC11Code>00990-7922-55</NDC11Code>
<ProductNDC>0990-7922</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextrose</ProprietaryName>
<NonProprietaryName>Dextrose Monohydrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
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<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016367</ApplicationNumber>
<LabelerName>ICU Medical, Inc.</LabelerName>
<SubstanceName>DEXTROSE MONOHYDRATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dextrose Injection (5% and 10%) is indicated as a source of water and calories in adult and pediatric patients, and may also be used as a diluent for reconstitution of a powder or liquid drug product.</IndicationAndUsage>
<Description>Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6 ∙ H2O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula. Water for Injection, USP is chemically designated H2O. Dextrose Injection, USP (5% and 10%) solutions are sterile and nonpyrogenic. They are parenteral solutions containing various concentrations of dextrose in water for injection intended for intravenous administration. Each 100 mL of 5% Dextrose Injection, USP, contains dextrose, hydrous 5 g in water for injection. The caloric value is 170 kcal/L. The osmolarity is 252 mOsmol/L (calc.), which is slightly hypotonic. Each 100 mL of 10% Dextrose Injection, USP, contains dextrose, hydrous 10 g in water for injection. The caloric value is 340 kcal/L. The osmolarity is 505 mOsmol/L (calc.), which is hypertonic. The pH for both concentrations is 4.3 (range is 3.2 to 6.5). The solutions contain no bacteriostatic, antimicrobial agent or added buffer and each is supplied as single-dose containers. Dextrose is derived from corn. 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.</Description>
</NDC>
<NDC>
<NDCCode>0990-7922-61</NDCCode>
<PackageDescription>32 POUCH in 1 CASE (0990-7922-61) / 1 BAG in 1 POUCH / 150 mL in 1 BAG</PackageDescription>
<NDC11Code>00990-7922-61</NDC11Code>
<ProductNDC>0990-7922</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextrose</ProprietaryName>
<NonProprietaryName>Dextrose Monohydrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20190715</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016367</ApplicationNumber>
<LabelerName>ICU Medical, Inc.</LabelerName>
<SubstanceName>DEXTROSE MONOHYDRATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dextrose Injection (5% and 10%) is indicated as a source of water and calories in adult and pediatric patients, and may also be used as a diluent for reconstitution of a powder or liquid drug product.</IndicationAndUsage>
<Description>Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6 ∙ H2O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula. Water for Injection, USP is chemically designated H2O. Dextrose Injection, USP (5% and 10%) solutions are sterile and nonpyrogenic. They are parenteral solutions containing various concentrations of dextrose in water for injection intended for intravenous administration. Each 100 mL of 5% Dextrose Injection, USP, contains dextrose, hydrous 5 g in water for injection. The caloric value is 170 kcal/L. The osmolarity is 252 mOsmol/L (calc.), which is slightly hypotonic. Each 100 mL of 10% Dextrose Injection, USP, contains dextrose, hydrous 10 g in water for injection. The caloric value is 340 kcal/L. The osmolarity is 505 mOsmol/L (calc.), which is hypertonic. The pH for both concentrations is 4.3 (range is 3.2 to 6.5). The solutions contain no bacteriostatic, antimicrobial agent or added buffer and each is supplied as single-dose containers. Dextrose is derived from corn. 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.</Description>
</NDC>
<NDC>
<NDCCode>0990-5138-25</NDCCode>
<PackageDescription>24 BOTTLE, PLASTIC in 1 CASE (0990-5138-25) / 250 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00990-5138-25</NDC11Code>
<ProductNDC>0990-5138</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Chloride</ProprietaryName>
<NonProprietaryName>Sodium Chloride</NonProprietaryName>
<DosageFormName>IRRIGANT</DosageFormName>
<RouteName>IRRIGATION</RouteName>
<StartMarketingDate>20240801</StartMarketingDate>
<EndMarketingDate>20260501</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE</MarketingCategoryName>
<LabelerName>ICU Medical, Inc.</LabelerName>
<SubstanceName>SODIUM CHLORIDE</SubstanceName>
<StrengthNumber>900</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20240801</StartMarketingDatePackage>
<EndMarketingDatePackage>20260501</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0990-7923-20</NDCCode>
<PackageDescription>12 POUCH in 1 CASE (0990-7923-20) / 4 BAG in 1 POUCH / 25 mL in 1 BAG</PackageDescription>
<NDC11Code>00990-7923-20</NDC11Code>
<ProductNDC>0990-7923</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextrose</ProprietaryName>
<NonProprietaryName>Dextrose Monohydrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20190715</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016367</ApplicationNumber>
<LabelerName>ICU Medical, Inc.</LabelerName>
<SubstanceName>DEXTROSE MONOHYDRATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dextrose Injection (5% and 10%) is indicated as a source of water and calories in adult and pediatric patients, and may also be used as a diluent for reconstitution of a powder or liquid drug product.</IndicationAndUsage>
<Description>Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6 ∙ H2O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula. Water for Injection, USP is chemically designated H2O. Dextrose Injection, USP (5% and 10%) solutions are sterile and nonpyrogenic. They are parenteral solutions containing various concentrations of dextrose in water for injection intended for intravenous administration. Each 100 mL of 5% Dextrose Injection, USP, contains dextrose, hydrous 5 g in water for injection. The caloric value is 170 kcal/L. The osmolarity is 252 mOsmol/L (calc.), which is slightly hypotonic. Each 100 mL of 10% Dextrose Injection, USP, contains dextrose, hydrous 10 g in water for injection. The caloric value is 340 kcal/L. The osmolarity is 505 mOsmol/L (calc.), which is hypertonic. The pH for both concentrations is 4.3 (range is 3.2 to 6.5). The solutions contain no bacteriostatic, antimicrobial agent or added buffer and each is supplied as single-dose containers. Dextrose is derived from corn. 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.</Description>
</NDC>
<NDC>
<NDCCode>0990-7983-25</NDCCode>
<PackageDescription>24 BAG in 1 CASE (0990-7983-25) > 250 mL in 1 BAG</PackageDescription>
<NDC11Code>00990-7983-25</NDC11Code>
<ProductNDC>0990-7983</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Chloride</ProprietaryName>
<NonProprietaryName>Sodium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20190815</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016366</ApplicationNumber>
<LabelerName>ICU Medical Inc.</LabelerName>
<SubstanceName>SODIUM CHLORIDE</SubstanceName>
<StrengthNumber>900</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0990-7984-20</NDCCode>
<PackageDescription>12 POUCH in 1 CASE (0990-7984-20) / 4 BAG in 1 POUCH / 25 mL in 1 BAG</PackageDescription>
<NDC11Code>00990-7984-20</NDC11Code>
<ProductNDC>0990-7984</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Chloride</ProprietaryName>
<NonProprietaryName>Sodium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20190401</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016366</ApplicationNumber>
<LabelerName>ICU Medical Inc.</LabelerName>
<SubstanceName>SODIUM CHLORIDE</SubstanceName>
<StrengthNumber>900</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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.</IndicationAndUsage>
<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.</Description>
</NDC>
<NDC>
<NDCCode>0990-7985-25</NDCCode>
<PackageDescription>24 BAG in 1 CASE (0990-7985-25) > 250 mL in 1 BAG</PackageDescription>
<NDC11Code>00990-7985-25</NDC11Code>
<ProductNDC>0990-7985</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Chloride</ProprietaryName>
<NonProprietaryName>Sodium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200125</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018090</ApplicationNumber>
<LabelerName>ICU Medical Inc.</LabelerName>
<SubstanceName>SODIUM CHLORIDE</SubstanceName>
<StrengthNumber>450</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59779-990-25</NDCCode>
<PackageDescription>25 BLISTER PACK in 1 CARTON (59779-990-25) > 1 TABLET, COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>59779-0990-25</NDC11Code>
<ProductNDC>59779-990</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bisacody</ProprietaryName>
<ProprietaryNameSuffix>Enteric Coated</ProprietaryNameSuffix>
<NonProprietaryName>Bisacodyl</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130110</StartMarketingDate>
<EndMarketingDate>20201231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>CVS Pharmacy</LabelerName>
<SubstanceName>BISACODYL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130110</StartMarketingDatePackage>
<EndMarketingDatePackage>20201231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>65862-990-25</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 CARTON (65862-990-25) > 1 mL in 1 VIAL, MULTI-DOSE (65862-990-01) </PackageDescription>
<NDC11Code>65862-0990-25</NDC11Code>
<ProductNDC>65862-990</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Heparin Sodium</ProprietaryName>
<NonProprietaryName>Heparin Sodium</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20140612</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202957</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>HEPARIN SODIUM</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>[USP'U]/mL</StrengthUnit>
<Pharm_Classes>Anti-coagulant [EPC],Heparin [CS],Unfractionated Heparin [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-03-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0169-7902-01</NDCCode>
<PackageDescription>1 KIT in 1 KIT (0169-7902-01) * 4 mL in 1 VIAL, GLASS (0169-7922-90) * 4 mL in 1 SYRINGE, GLASS (0169-7009-98) * 4 mL in 1 VIAL, GLASS (0169-7922-11) </PackageDescription>
<NDC11Code>00169-7902-01</NDC11Code>
<ProductNDC>0169-7902</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rebinyn</ProprietaryName>
<NonProprietaryName>Coagulation Factor Ix Recombinant, Glycopegylated</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20171201</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125611</ApplicationNumber>
<LabelerName>Novo Nordisk</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-08-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>REBINYN, Coagulation Factor IX (Recombinant), GlycoPEGylated, is a recombinant DNA-derived coagulation Factor IX concentrate indicated for use in adults and children with hemophilia B (congenital Factor IX deficiency) for: 1 On-demand treatment and control of bleeding episodes, 2 Perioperative management of bleeding, 3 Routine prophylaxis to reduce the frequency of bleeding episodes.</IndicationAndUsage>
<Description>REBINYN is a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution with the provided histidine diluent for intravenous infusion. After reconstitution, the solution appears as a clear and colorless to slightly yellow liquid, free from visible particles and contains the following excipients per mL: sodium chloride, 2.34 mg; histidine, 3.10 mg; sucrose, 10 mg; mannitol, 25 mg; polysorbate 80, 0.05 mg. REBINYN is available in single-dose vials containing the labeled amount of Factor IX activity, expressed in IU. Each vial contains nominally 500 IU, 1000 IU, 2000, or 3000 IU. REBINYN potency is assigned using an in vitro, activated partial thromboplastin time (aPTT)-based, one-stage clotting assay calibrated against the World Health Organization (WHO) international standard for Factor IX concentrates. REBINYN contains no preservatives. REBINYN is a purified recombinant human Factor IX (rFIX) with a 40 kilodalton (kDa) polyethylene-glycol (PEG) conjugated to the protein. The 40 kDa PEG group is selectively attached to specific -N-linked glycans in the rFIX activation peptide, with mono-PEGylated rFIX as the predominant form of REBINYN. The rFIX protein in REBINYN consists of a gamma-carboxylated (Gla) domain, two EGF-like (epidermal growth factor) domains, an activation peptide (which is cleaved off upon activation), and a protease domain. Once activated, the resulting rFIX has structural and functional properties similar to those of endogenous activated Factor IX. The primary amino acid sequence in REBINYN is identical to the Thr148 allelic form of human plasma-derived Factor IX and consists of 415 amino acids. The average molecular weight of REBINYN is approximately 98 kDa and the molecular weight of the protein moiety alone is 56 kDa. The nominal specific activity of REBINYN is 144 IU/mg protein. REBINYN is produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells. No additives of human or animal origin are used in the cell culture, purification, conjugation, or formulation of REBINYN. The rFIX protein is purified by a series of chromatographic steps, including an affinity chromatography step using a monoclonal antibody (produced in CHO cells), to selectively isolate rFIX from the cell culture medium. The production process includes two dedicated viral clearance steps, namely a detergent treatment step for inactivation and a 20 nm filtration step for removal of viruses. The conjugation of the PEG-group is done by an enzymatic reaction during the purification process, followed by final purification of REBINYN.</Description>
</NDC>
<NDC>
<NDCCode>0169-7902-97</NDCCode>
<PackageDescription>1 KIT in 1 KIT (0169-7902-97) * 4 mL in 1 VIAL, GLASS (0169-7922-90) * 4 mL in 1 SYRINGE, GLASS (0169-7009-98) * 4 mL in 1 VIAL, GLASS (0169-7922-11) </PackageDescription>
<NDC11Code>00169-7902-97</NDC11Code>
<ProductNDC>0169-7902</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rebinyn</ProprietaryName>
<NonProprietaryName>Coagulation Factor Ix Recombinant, Glycopegylated</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20171201</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125611</ApplicationNumber>
<LabelerName>Novo Nordisk</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-08-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220505</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>REBINYN, Coagulation Factor IX (Recombinant), GlycoPEGylated, is a recombinant DNA-derived coagulation Factor IX concentrate indicated for use in adults and children with hemophilia B (congenital Factor IX deficiency) for: 1 On-demand treatment and control of bleeding episodes, 2 Perioperative management of bleeding, 3 Routine prophylaxis to reduce the frequency of bleeding episodes.</IndicationAndUsage>
<Description>REBINYN is a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution with the provided histidine diluent for intravenous infusion. After reconstitution, the solution appears as a clear and colorless to slightly yellow liquid, free from visible particles and contains the following excipients per mL: sodium chloride, 2.34 mg; histidine, 3.10 mg; sucrose, 10 mg; mannitol, 25 mg; polysorbate 80, 0.05 mg. REBINYN is available in single-dose vials containing the labeled amount of Factor IX activity, expressed in IU. Each vial contains nominally 500 IU, 1000 IU, 2000, or 3000 IU. REBINYN potency is assigned using an in vitro, activated partial thromboplastin time (aPTT)-based, one-stage clotting assay calibrated against the World Health Organization (WHO) international standard for Factor IX concentrates. REBINYN contains no preservatives. REBINYN is a purified recombinant human Factor IX (rFIX) with a 40 kilodalton (kDa) polyethylene-glycol (PEG) conjugated to the protein. The 40 kDa PEG group is selectively attached to specific -N-linked glycans in the rFIX activation peptide, with mono-PEGylated rFIX as the predominant form of REBINYN. The rFIX protein in REBINYN consists of a gamma-carboxylated (Gla) domain, two EGF-like (epidermal growth factor) domains, an activation peptide (which is cleaved off upon activation), and a protease domain. Once activated, the resulting rFIX has structural and functional properties similar to those of endogenous activated Factor IX. The primary amino acid sequence in REBINYN is identical to the Thr148 allelic form of human plasma-derived Factor IX and consists of 415 amino acids. The average molecular weight of REBINYN is approximately 98 kDa and the molecular weight of the protein moiety alone is 56 kDa. The nominal specific activity of REBINYN is 144 IU/mg protein. REBINYN is produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells. No additives of human or animal origin are used in the cell culture, purification, conjugation, or formulation of REBINYN. The rFIX protein is purified by a series of chromatographic steps, including an affinity chromatography step using a monoclonal antibody (produced in CHO cells), to selectively isolate rFIX from the cell culture medium. The production process includes two dedicated viral clearance steps, namely a detergent treatment step for inactivation and a 20 nm filtration step for removal of viruses. The conjugation of the PEG-group is done by an enzymatic reaction during the purification process, followed by final purification of REBINYN.</Description>
</NDC>
<NDC>
<NDCCode>0113-0990-38</NDCCode>
<PackageDescription>296 mL in 1 BOTTLE (0113-0990-38)</PackageDescription>
<NDC11Code>00113-0990-38</NDC11Code>
<ProductNDC>0113-0990</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Good Sense Night Time</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101014</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>L Perrigo Company</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE</SubstanceName>
<StrengthNumber>500; 15; 6.25</StrengthNumber>
<StrengthUnit>mg/15mL; mg/15mL; mg/15mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-11-10</LastUpdate>
</NDC>
<NDC>
<NDCCode>0363-0990-38</NDCCode>
<PackageDescription>296 mL in 1 BOTTLE (0363-0990-38)</PackageDescription>
<NDC11Code>00363-0990-38</NDC11Code>
<ProductNDC>0363-0990</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nighttime Cold And Flu Relief</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide And Doxylamine Succinate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080730</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Walgreen Company</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE</SubstanceName>
<StrengthNumber>500; 15; 6.25</StrengthNumber>
<StrengthUnit>mg/15mL; mg/15mL; mg/15mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-11-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>0363-0990-40</NDCCode>
<PackageDescription>355 mL in 1 BOTTLE (0363-0990-40)</PackageDescription>
<NDC11Code>00363-0990-40</NDC11Code>
<ProductNDC>0363-0990</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nighttime Cold And Flu Relief</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide And Doxylamine Succinate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080730</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Walgreen Company</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE</SubstanceName>
<StrengthNumber>500; 15; 6.25</StrengthNumber>
<StrengthUnit>mg/15mL; mg/15mL; mg/15mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-11-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>0990-7372-03</NDCCode>
<PackageDescription>24 POUCH in 1 CASE (0990-7372-03) / 1 BAG in 1 POUCH / 500 mL in 1 BAG</PackageDescription>
<NDC11Code>00990-7372-03</NDC11Code>
<ProductNDC>0990-7372</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ionosol Mb And Dextrose</ProprietaryName>
<NonProprietaryName>Dextrose Monohydrate, Sodium Lactate, Potassium Chloride, Magnesium Chloride, Potassium Phosphate, Monobasic, And Sodium Phosphate, Monobasic, Monohydrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20190701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019513</ApplicationNumber>
<LabelerName>ICU Medical Inc.</LabelerName>
<SubstanceName>DEXTROSE MONOHYDRATE; SODIUM LACTATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE; MONOBASIC POTASSIUM PHOSPHATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE</SubstanceName>
<StrengthNumber>5; 260; 141; 30; 15; 25</StrengthNumber>
<StrengthUnit>g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<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]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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.</IndicationAndUsage>
<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.</Description>
</NDC>
<NDC>
<NDCCode>0990-7372-62</NDCCode>
<PackageDescription>24 POUCH in 1 CASE (0990-7372-62) / 1 BAG in 1 POUCH / 250 mL in 1 BAG</PackageDescription>
<NDC11Code>00990-7372-62</NDC11Code>
<ProductNDC>0990-7372</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ionosol Mb And Dextrose</ProprietaryName>
<NonProprietaryName>Dextrose Monohydrate, Sodium Lactate, Potassium Chloride, Magnesium Chloride, Potassium Phosphate, Monobasic, And Sodium Phosphate, Monobasic, Monohydrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20190701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019513</ApplicationNumber>
<LabelerName>ICU Medical Inc.</LabelerName>
<SubstanceName>DEXTROSE MONOHYDRATE; SODIUM LACTATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE; MONOBASIC POTASSIUM PHOSPHATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE</SubstanceName>
<StrengthNumber>5; 260; 141; 30; 15; 25</StrengthNumber>
<StrengthUnit>g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<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]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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.</IndicationAndUsage>
<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.</Description>
</NDC>
<NDC>
<NDCCode>0990-7901-09</NDCCode>
<PackageDescription>12 POUCH in 1 CASE (0990-7901-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG</PackageDescription>
<NDC11Code>00990-7901-09</NDC11Code>
<ProductNDC>0990-7901</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride In Dextrose And Sodium Chloride</ProprietaryName>
<NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, And Potassium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018365</ApplicationNumber>
<LabelerName>ICU Medical Inc.</LabelerName>
<SubstanceName>DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>50; 2.25; 1.49</StrengthNumber>
<StrengthUnit>g/1000mL; g/1000mL; g/1000mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>These solutions are indicated in patients requiring parenteral administration of potassium chloride with minimal carbohydrate calories and sodium chloride.</IndicationAndUsage>
<Description>Intravenous solutions with potassium chloride (I.V. solutions with KCl) are sterile and nonpyrogenic solutions in water for injection. They are for administration by intravenous infusion only. See Tables for summary of content and characteristics of these solutions. The solutions contain no bacteriostat, antimicrobial agent or added buffer and each is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded. These 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. 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. 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 the 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.</Description>
</NDC>
<NDC>
<NDCCode>0990-7918-19</NDCCode>
<PackageDescription>12 POUCH in 1 CASE (0990-7918-19) / 1 BAG in 1 POUCH / 500 mL in 1 BAG</PackageDescription>
<NDC11Code>00990-7918-19</NDC11Code>
<ProductNDC>0990-7918</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextrose</ProprietaryName>
<NonProprietaryName>Dextrose</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20191001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018561</ApplicationNumber>
<LabelerName>ICU Medical Inc.</LabelerName>
<SubstanceName>DEXTROSE MONOHYDRATE</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dextrose Injection 20%, 30%, 40%, 50% and 70%, mixed with amino acids or other compatible intravenous fluids, is indicated as a source of calories for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.</IndicationAndUsage>
<Description>Dextrose Injection, USP 20%, 30%, 40%, 50% and 70% are sterile, nonpyrogenic, hypertonic solutions of Dextrose, USP in Water for Injection in a polyvinylchloride flexible plastic container for intravenous administration after appropriate admixture or dilution [see Dosage and Administration (2.1)]. Partial-fill containers, designed to facilitate admixture or dilution to provide dextrose in various concentrations, are available in various sizes. See Table 1 for the content and characteristics of these concentrated solutions. The solutions contain no bacteriostatic, antimicrobial agent or added buffer and are intended only for use as a single-dose injection following admixture or dilution. The pH is 4.3 (range is 3.2 to 6.5). Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6 H2O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula. Dextrose may be derived from corn. Water for Injection, USP is chemically designated H2O. Dextrose Injection contains no more than 25 mcg/L of aluminum.</Description>
</NDC>
<NDC>
<NDCCode>0990-7935-19</NDCCode>
<PackageDescription>12 POUCH in 1 CASE (0990-7935-19) / 1 BAG in 1 POUCH / 500 mL in 1 BAG</PackageDescription>
<NDC11Code>00990-7935-19</NDC11Code>
<ProductNDC>0990-7935</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextrose</ProprietaryName>
<NonProprietaryName>Dextrose</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20191001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018564</ApplicationNumber>
<LabelerName>ICU Medical Inc.</LabelerName>
<SubstanceName>DEXTROSE MONOHYDRATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dextrose Injection 20%, 30%, 40%, 50% and 70%, mixed with amino acids or other compatible intravenous fluids, is indicated as a source of calories for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.</IndicationAndUsage>
<Description>Dextrose Injection, USP 20%, 30%, 40%, 50% and 70% are sterile, nonpyrogenic, hypertonic solutions of Dextrose, USP in Water for Injection in a polyvinylchloride flexible plastic container for intravenous administration after appropriate admixture or dilution [see Dosage and Administration (2.1)]. Partial-fill containers, designed to facilitate admixture or dilution to provide dextrose in various concentrations, are available in various sizes. See Table 1 for the content and characteristics of these concentrated solutions. The solutions contain no bacteriostatic, antimicrobial agent or added buffer and are intended only for use as a single-dose injection following admixture or dilution. The pH is 4.3 (range is 3.2 to 6.5). Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6 H2O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula. Dextrose may be derived from corn. Water for Injection, USP is chemically designated H2O. Dextrose Injection contains no more than 25 mcg/L of aluminum.</Description>
</NDC>
<NDC>
<NDCCode>0990-7936-19</NDCCode>
<PackageDescription>12 POUCH in 1 CASE (0990-7936-19) / 1 BAG in 1 POUCH / 500 mL in 1 BAG</PackageDescription>
<NDC11Code>00990-7936-19</NDC11Code>
<ProductNDC>0990-7936</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextrose</ProprietaryName>
<NonProprietaryName>Dextrose</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20191001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018563</ApplicationNumber>
<LabelerName>ICU Medical Inc.</LabelerName>
<SubstanceName>DEXTROSE MONOHYDRATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dextrose Injection 20%, 30%, 40%, 50% and 70%, mixed with amino acids or other compatible intravenous fluids, is indicated as a source of calories for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.</IndicationAndUsage>
<Description>Dextrose Injection, USP 20%, 30%, 40%, 50% and 70% are sterile, nonpyrogenic, hypertonic solutions of Dextrose, USP in Water for Injection in a polyvinylchloride flexible plastic container for intravenous administration after appropriate admixture or dilution [see Dosage and Administration (2.1)]. Partial-fill containers, designed to facilitate admixture or dilution to provide dextrose in various concentrations, are available in various sizes. See Table 1 for the content and characteristics of these concentrated solutions. The solutions contain no bacteriostatic, antimicrobial agent or added buffer and are intended only for use as a single-dose injection following admixture or dilution. The pH is 4.3 (range is 3.2 to 6.5). Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6 H2O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula. Dextrose may be derived from corn. Water for Injection, USP is chemically designated H2O. Dextrose Injection contains no more than 25 mcg/L of aluminum.</Description>
</NDC>
<NDC>
<NDCCode>0990-7937-19</NDCCode>
<PackageDescription>12 POUCH in 1 CASE (0990-7937-19) / 1 BAG in 1 POUCH / 500 mL in 1 BAG</PackageDescription>
<NDC11Code>00990-7937-19</NDC11Code>
<ProductNDC>0990-7937</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextrose</ProprietaryName>
<NonProprietaryName>Dextrose</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20191001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018562</ApplicationNumber>
<LabelerName>ICU Medical Inc.</LabelerName>
<SubstanceName>DEXTROSE MONOHYDRATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dextrose Injection 20%, 30%, 40%, 50% and 70%, mixed with amino acids or other compatible intravenous fluids, is indicated as a source of calories for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.</IndicationAndUsage>
<Description>Dextrose Injection, USP 20%, 30%, 40%, 50% and 70% are sterile, nonpyrogenic, hypertonic solutions of Dextrose, USP in Water for Injection in a polyvinylchloride flexible plastic container for intravenous administration after appropriate admixture or dilution [see Dosage and Administration (2.1)]. Partial-fill containers, designed to facilitate admixture or dilution to provide dextrose in various concentrations, are available in various sizes. See Table 1 for the content and characteristics of these concentrated solutions. The solutions contain no bacteriostatic, antimicrobial agent or added buffer and are intended only for use as a single-dose injection following admixture or dilution. The pH is 4.3 (range is 3.2 to 6.5). Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6 H2O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula. Dextrose may be derived from corn. Water for Injection, USP is chemically designated H2O. Dextrose Injection contains no more than 25 mcg/L of aluminum.</Description>
</NDC>
<NDC>
<NDCCode>0990-8004-15</NDCCode>
<PackageDescription>12 POUCH in 1 CASE (0990-8004-15) / 1 BAG in 1 POUCH / 500 mL in 1 BAG</PackageDescription>
<NDC11Code>00990-8004-15</NDC11Code>
<ProductNDC>0990-8004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextrose</ProprietaryName>
<NonProprietaryName>Dextrose</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20191001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019345</ApplicationNumber>
<LabelerName>ICU Medical Inc.</LabelerName>
<SubstanceName>DEXTROSE MONOHYDRATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dextrose Injection 20%, 30%, 40%, 50% and 70%, mixed with amino acids or other compatible intravenous fluids, is indicated as a source of calories for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.</IndicationAndUsage>
<Description>Dextrose Injection, USP 20%, 30%, 40%, 50% and 70% are sterile, nonpyrogenic, hypertonic solutions of Dextrose, USP in Water for Injection in a polyvinylchloride flexible plastic container for intravenous administration after appropriate admixture or dilution [see Dosage and Administration (2.1)]. Partial-fill containers, designed to facilitate admixture or dilution to provide dextrose in various concentrations, are available in various sizes. See Table 1 for the content and characteristics of these concentrated solutions. The solutions contain no bacteriostatic, antimicrobial agent or added buffer and are intended only for use as a single-dose injection following admixture or dilution. The pH is 4.3 (range is 3.2 to 6.5). Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6 H2O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula. Dextrose may be derived from corn. Water for Injection, USP is chemically designated H2O. Dextrose Injection contains no more than 25 mcg/L of aluminum.</Description>
</NDC>
<NDC>
<NDCCode>10056-990-38</NDCCode>
<PackageDescription>296 mL in 1 BOTTLE (10056-990-38)</PackageDescription>
<NDC11Code>10056-0990-38</NDC11Code>
<ProductNDC>10056-990</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fulton Street Market Cold And Flu</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100715</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Access Business Group LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE</SubstanceName>
<StrengthNumber>500; 15; 6.25</StrengthNumber>
<StrengthUnit>mg/15mL; mg/15mL; mg/15mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-11-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>30142-990-38</NDCCode>
<PackageDescription>295 mL in 1 BOTTLE (30142-990-38)</PackageDescription>
<NDC11Code>30142-0990-38</NDC11Code>
<ProductNDC>30142-990</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nite Time</ProprietaryName>
<ProprietaryNameSuffix>Multi Symptom Cold Flu Relief</ProprietaryNameSuffix>
<NonProprietaryName>- Acetaminophen, Dextromethorphan Hydrobromide And Doxylamine Succinate Liquid</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090805</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Kroger Company</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE</SubstanceName>
<StrengthNumber>500; 15; 6.25</StrengthNumber>
<StrengthUnit>mg/15mL; mg/15mL; mg/15mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-07</LastUpdate>
</NDC>
</NDCList>