{
"NDC": [
{
"NDCCode": "24571-117-05",
"PackageDescription": "2 BAG in 1 CASE (24571-117-05) > 5 L in 1 BAG",
"NDC11Code": "24571-0117-05",
"ProductNDC": "24571-117",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phoxillum",
"ProprietaryNameSuffix": "B22k4/0",
"NonProprietaryName": "Magnesium Chloride, Sodium Chloride, Sodium Bicarbonate, Potassium Chloride And Sodium Phosphate Dibasic Dihydrate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20150113",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207026",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE; SODIUM PHOSPHATE DIBASIC DIHYDRATE",
"StrengthNumber": "3.05; 6.95; 2.21; .314; .187",
"StrengthUnit": "g/L; g/L; g/L; g/L; g/L",
"Pharm_Classes": "Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-11-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20150113",
"SamplePackage": "N"
},
{
"NDCCode": "24571-117-06",
"PackageDescription": "2 BAG in 1 CASE (24571-117-06) / 5 L in 1 BAG",
"NDC11Code": "24571-0117-06",
"ProductNDC": "24571-117",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phoxillum",
"ProprietaryNameSuffix": "B22k4/0",
"NonProprietaryName": "Magnesium Chloride, Sodium Chloride, Sodium Bicarbonate, Potassium Chloride, And Sodium Phosphate Dibasic Dihydrate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20150113",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207026",
"LabelerName": "Vantive US Healthcare LLC",
"SubstanceName": "MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC",
"StrengthNumber": "3.05; 6.95; 2.21; .314; .187",
"StrengthUnit": "g/L; g/L; g/L; g/L; g/L",
"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], 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 Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150113",
"SamplePackage": "N",
"IndicationAndUsage": "PRISMASOL and PHOXILLUM solutions are indicated in pediatric and adult patients for use as a replacement solution in Continuous Renal Replacement Therapy (CRRT) to replace plasma volume removed by ultrafiltration and to correct electrolyte and acid-base imbalances. They may also be used in case of drug poisoning when CRRT is used to remove dialyzable substances.",
"Description": "PRISMASOL and PHOXILLUM solutions are clear, sterile, free of bacterial endotoxins and contain no bacteriostatic or antimicrobial agents. These solutions are used in Continuous Renal Replacement Therapies (CRRT) as a replacement solution in hemofiltration and hemodiafiltration. Depending on the product (see Table 2), the two compartments contain. Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl2 2H2O). Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl2 6H2O). Sodium chloride, USP, is chemically designated NaCl. Potassium chloride, USP, is chemically designated KCl. Sodium bicarbonate, USP, is chemically designated NaHCO3. Dextrose, USP, is chemically designated D-Glucose anhydrous (C6H12O6) or D-Glucose monohydrate (C6H12O6 H2O). Lactic acid, USP, is chemically designated CH3CH(OH)COOH. Dibasic sodium phosphate, USP, is chemically designated as disodium hydrogen phosphate, dihydrate (Na2HPO4 2H2O). The pH of the final solution is in the range of 7.0 to 8.5."
},
{
"NDCCode": "24571-102-05",
"PackageDescription": "2 BAG in 1 CASE (24571-102-05) > 5 L in 1 BAG",
"NDC11Code": "24571-0102-05",
"ProductNDC": "24571-102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prismasol",
"ProprietaryNameSuffix": "Bgk2/0",
"NonProprietaryName": "Magnesium Chloride, Dextrose Monohydrate, Lactic Acid, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20061025",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021703",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "MAGNESIUM CHLORIDE; DEXTROSE MONOHYDRATE; LACTIC ACID, UNSPECIFIED FORM; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE",
"StrengthNumber": "2.03; 22; 5.4; 6.46; 3.09; .157",
"StrengthUnit": "g/L; g/L; g/L; g/L; g/L; g/L",
"Pharm_Classes": "Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-11-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20061025",
"SamplePackage": "N"
},
{
"NDCCode": "24571-103-05",
"PackageDescription": "2 BAG in 1 CASE (24571-103-05) > 5 L in 1 BAG",
"NDC11Code": "24571-0103-05",
"ProductNDC": "24571-103",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prismasol",
"ProprietaryNameSuffix": "Bgk2/3.5",
"NonProprietaryName": "Calcium Chloride, Magnesium Chloride, Dextrose Monohydrate, Lactic Acid, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20061025",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021703",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; DEXTROSE MONOHYDRATE; LACTIC ACID, UNSPECIFIED FORM; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE",
"StrengthNumber": "5.15; 2.03; 22; 5.4; 6.46; 3.09; .157",
"StrengthUnit": "g/L; g/L; g/L; g/L; g/L; g/L; g/L",
"Pharm_Classes": "Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-11-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20061025",
"SamplePackage": "N"
},
{
"NDCCode": "24571-104-05",
"PackageDescription": "2 BAG in 1 CASE (24571-104-05) > 5 L in 1 BAG",
"NDC11Code": "24571-0104-05",
"ProductNDC": "24571-104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prismasol",
"ProprietaryNameSuffix": "Bgk4/3.5",
"NonProprietaryName": "Calcium Chloride, Magnesium Chloride, Dextrose Monohydrate, Lactic Acid, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20061025",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021703",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; DEXTROSE MONOHYDRATE; LACTIC ACID, UNSPECIFIED FORM; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE",
"StrengthNumber": "5.15; 2.03; 22; 5.4; 6.46; 3.09; .314",
"StrengthUnit": "g/L; g/L; g/L; g/L; g/L; g/L; g/L",
"Pharm_Classes": "Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-11-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20061025",
"SamplePackage": "N"
},
{
"NDCCode": "24571-105-05",
"PackageDescription": "2 BAG in 1 CASE (24571-105-05) > 5 L in 1 BAG",
"NDC11Code": "24571-0105-05",
"ProductNDC": "24571-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prismasol",
"ProprietaryNameSuffix": "Bgk4/2.5",
"NonProprietaryName": "Calcium Chloride, Magnesium Chloride, Dextrose Monohydrate, Lactic Acid, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20061025",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021703",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; DEXTROSE MONOHYDRATE; LACTIC ACID, UNSPECIFIED FORM; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE",
"StrengthNumber": "3.68; 3.05; 22; 5.4; 6.46; 3.09; .314",
"StrengthUnit": "g/L; g/L; g/L; g/L; g/L; g/L; g/L",
"Pharm_Classes": "Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-11-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20061025",
"SamplePackage": "N"
},
{
"NDCCode": "24571-108-05",
"PackageDescription": "2 BAG in 1 CASE (24571-108-05) > 5 L in 1 BAG",
"NDC11Code": "24571-0108-05",
"ProductNDC": "24571-108",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prismasol",
"ProprietaryNameSuffix": "Bgk0/2.5",
"NonProprietaryName": "Calcium Chloride, Magnesium Chloride, Dextrose Monohydrate, Lactic Acid, Sodium Chloride And Sodium Bicarbonate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20061025",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021703",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; DEXTROSE MONOHYDRATE; LACTIC ACID, UNSPECIFIED FORM; SODIUM CHLORIDE; SODIUM BICARBONATE",
"StrengthNumber": "3.68; 3.05; 22; 5.4; 6.46; 3.09",
"StrengthUnit": "g/L; g/L; g/L; g/L; g/L; g/L",
"Pharm_Classes": "Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-11-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20061025",
"SamplePackage": "N"
},
{
"NDCCode": "24571-111-05",
"PackageDescription": "2 BAG in 1 CASE (24571-111-05) > 5 L in 1 BAG",
"NDC11Code": "24571-0111-05",
"ProductNDC": "24571-111",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prismasol",
"ProprietaryNameSuffix": "B22gk4/0",
"NonProprietaryName": "Magnesium Chloride, Dextrose Monohydrate, Lactic Acid, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20061025",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021703",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "MAGNESIUM CHLORIDE; DEXTROSE MONOHYDRATE; LACTIC ACID, UNSPECIFIED FORM; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE",
"StrengthNumber": "3.05; 22; 5.4; 7.07; 2.21; .314",
"StrengthUnit": "g/L; g/L; g/L; g/L; g/L; g/L",
"Pharm_Classes": "Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-11-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20081010",
"SamplePackage": "N"
},
{
"NDCCode": "24571-113-05",
"PackageDescription": "2 BAG in 1 CASE (24571-113-05) > 5 L in 1 BAG",
"NDC11Code": "24571-0113-05",
"ProductNDC": "24571-113",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prismasol",
"ProprietaryNameSuffix": "Bk0/0/1.2",
"NonProprietaryName": "Magnesium Chloride, Lactic Acid, Sodium Chloride And Sodium Bicarbonate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20061025",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021703",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "MAGNESIUM CHLORIDE; LACTIC ACID, UNSPECIFIED FORM; SODIUM CHLORIDE; SODIUM BICARBONATE",
"StrengthNumber": "2.44; 5.4; 6.46; 3.09",
"StrengthUnit": "g/L; g/L; g/L; g/L",
"Pharm_Classes": "Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-11-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20081010",
"SamplePackage": "N"
},
{
"NDCCode": "24571-114-05",
"PackageDescription": "2 BAG in 1 CASE (24571-114-05) > 5 L in 1 BAG",
"NDC11Code": "24571-0114-05",
"ProductNDC": "24571-114",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prismasol",
"ProprietaryNameSuffix": "Bgk4/0/1.2",
"NonProprietaryName": "Magnesium Chloride, Dextrose Monohydrate, Lactic Acid, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20061025",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021703",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "MAGNESIUM CHLORIDE; DEXTROSE MONOHYDRATE; LACTIC ACID, UNSPECIFIED FORM; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE",
"StrengthNumber": "2.44; 22; 5.4; 6.46; 3.09; .314",
"StrengthUnit": "g/L; g/L; g/L; g/L; g/L; g/L",
"Pharm_Classes": "Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-11-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20081010",
"SamplePackage": "N"
},
{
"NDCCode": "24571-116-05",
"PackageDescription": "2 BAG in 1 CASE (24571-116-05) > 5 L in 1 BAG",
"NDC11Code": "24571-0116-05",
"ProductNDC": "24571-116",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phoxillum",
"ProprietaryNameSuffix": "Bk4/2.5",
"NonProprietaryName": "Calcium Chloride, Magnesium Chloride, Sodium Chloride, Sodium Bicarbonate, Potassium Chloride And Sodium Phosphate Dibasic Dihydrate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20150113",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207026",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE; SODIUM PHOSPHATE DIBASIC DIHYDRATE",
"StrengthNumber": "3.68; 3.05; 6.34; 3.09; .314; .187",
"StrengthUnit": "g/L; g/L; g/L; g/L; g/L; g/L",
"Pharm_Classes": "Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-11-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20150113",
"SamplePackage": "N"
},
{
"NDCCode": "24571-105-06",
"PackageDescription": "2 BAG in 1 CASE (24571-105-06) / 5 L in 1 BAG",
"NDC11Code": "24571-0105-06",
"ProductNDC": "24571-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prismasol",
"ProprietaryNameSuffix": "Bgk4/2.5",
"NonProprietaryName": "Calcium Chloride, Magnesium Chloride, Dextrose Anhydrous, Lactic Acid, Sodium Chloride, Sodium Bicarbonate, And Potassium Chloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20061025",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021703",
"LabelerName": "Vantive US Healthcare LLC",
"SubstanceName": "CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; ANHYDROUS DEXTROSE; LACTIC ACID; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE",
"StrengthNumber": "3.68; 3.05; 20; 5.4; 6.46; 3.09; .314",
"StrengthUnit": "g/L; g/L; g/L; g/L; g/L; g/L; g/L",
"Pharm_Classes": "Acidifying Activity [MoA], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [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 Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange 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], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20061025",
"SamplePackage": "N",
"IndicationAndUsage": "PRISMASOL and PHOXILLUM solutions are indicated in pediatric and adult patients for use as a replacement solution in Continuous Renal Replacement Therapy (CRRT) to replace plasma volume removed by ultrafiltration and to correct electrolyte and acid-base imbalances. They may also be used in case of drug poisoning when CRRT is used to remove dialyzable substances.",
"Description": "PRISMASOL and PHOXILLUM solutions are clear, sterile, free of bacterial endotoxins and contain no bacteriostatic or antimicrobial agents. These solutions are used in Continuous Renal Replacement Therapies (CRRT) as a replacement solution in hemofiltration and hemodiafiltration. Depending on the product (see Table 2), the two compartments contain. Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl2 2H2O). Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl2 6H2O). Sodium chloride, USP, is chemically designated NaCl. Potassium chloride, USP, is chemically designated KCl. Sodium bicarbonate, USP, is chemically designated NaHCO3. Dextrose, USP, is chemically designated D-Glucose anhydrous (C6H12O6) or D-Glucose monohydrate (C6H12O6 H2O). Lactic acid, USP, is chemically designated CH3CH(OH)COOH. Dibasic sodium phosphate, USP, is chemically designated as disodium hydrogen phosphate, dihydrate (Na2HPO4 2H2O). The pH of the final solution is in the range of 7.0 to 8.5."
},
{
"NDCCode": "24571-108-06",
"PackageDescription": "2 BAG in 1 CASE (24571-108-06) / 5 L in 1 BAG",
"NDC11Code": "24571-0108-06",
"ProductNDC": "24571-108",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prismasol",
"ProprietaryNameSuffix": "Bgk0/2.5",
"NonProprietaryName": "Calcium Chloride, Magnesium Chloride, Dextrose Anhydrous, Lactic Acid, Sodium Chloride, And Sodium Bicarbonate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20061025",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021703",
"LabelerName": "Vantive US Healthcare LLC",
"SubstanceName": "CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; ANHYDROUS DEXTROSE; LACTIC ACID; SODIUM CHLORIDE; SODIUM BICARBONATE",
"StrengthNumber": "3.68; 3.05; 20; 5.4; 6.46; 3.09",
"StrengthUnit": "g/L; g/L; g/L; g/L; g/L; g/L",
"Pharm_Classes": "Acidifying Activity [MoA], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20061025",
"SamplePackage": "N",
"IndicationAndUsage": "PRISMASOL and PHOXILLUM solutions are indicated in pediatric and adult patients for use as a replacement solution in Continuous Renal Replacement Therapy (CRRT) to replace plasma volume removed by ultrafiltration and to correct electrolyte and acid-base imbalances. They may also be used in case of drug poisoning when CRRT is used to remove dialyzable substances.",
"Description": "PRISMASOL and PHOXILLUM solutions are clear, sterile, free of bacterial endotoxins and contain no bacteriostatic or antimicrobial agents. These solutions are used in Continuous Renal Replacement Therapies (CRRT) as a replacement solution in hemofiltration and hemodiafiltration. Depending on the product (see Table 2), the two compartments contain. Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl2 2H2O). Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl2 6H2O). Sodium chloride, USP, is chemically designated NaCl. Potassium chloride, USP, is chemically designated KCl. Sodium bicarbonate, USP, is chemically designated NaHCO3. Dextrose, USP, is chemically designated D-Glucose anhydrous (C6H12O6) or D-Glucose monohydrate (C6H12O6 H2O). Lactic acid, USP, is chemically designated CH3CH(OH)COOH. Dibasic sodium phosphate, USP, is chemically designated as disodium hydrogen phosphate, dihydrate (Na2HPO4 2H2O). The pH of the final solution is in the range of 7.0 to 8.5."
},
{
"NDCCode": "24571-111-06",
"PackageDescription": "2 BAG in 1 CASE (24571-111-06) / 5 L in 1 BAG",
"NDC11Code": "24571-0111-06",
"ProductNDC": "24571-111",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prismasol",
"ProprietaryNameSuffix": "B22gk4/0",
"NonProprietaryName": "Magnesium Chloride, Dextrose Anhydrous, Lactic Acid, Sodium Chloride, Sodium Bicarbonate, And Potassium Chloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20061025",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021703",
"LabelerName": "Vantive US Healthcare LLC",
"SubstanceName": "MAGNESIUM CHLORIDE; ANHYDROUS DEXTROSE; LACTIC ACID; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE",
"StrengthNumber": "3.05; 20; 5.4; 7.07; 2.21; .314",
"StrengthUnit": "g/L; g/L; g/L; g/L; g/L; g/L",
"Pharm_Classes": "Acidifying Activity [MoA], Calculi Dissolution Agent [EPC], 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 Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange 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], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20081010",
"SamplePackage": "N",
"IndicationAndUsage": "PRISMASOL and PHOXILLUM solutions are indicated in pediatric and adult patients for use as a replacement solution in Continuous Renal Replacement Therapy (CRRT) to replace plasma volume removed by ultrafiltration and to correct electrolyte and acid-base imbalances. They may also be used in case of drug poisoning when CRRT is used to remove dialyzable substances.",
"Description": "PRISMASOL and PHOXILLUM solutions are clear, sterile, free of bacterial endotoxins and contain no bacteriostatic or antimicrobial agents. These solutions are used in Continuous Renal Replacement Therapies (CRRT) as a replacement solution in hemofiltration and hemodiafiltration. Depending on the product (see Table 2), the two compartments contain. Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl2 2H2O). Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl2 6H2O). Sodium chloride, USP, is chemically designated NaCl. Potassium chloride, USP, is chemically designated KCl. Sodium bicarbonate, USP, is chemically designated NaHCO3. Dextrose, USP, is chemically designated D-Glucose anhydrous (C6H12O6) or D-Glucose monohydrate (C6H12O6 H2O). Lactic acid, USP, is chemically designated CH3CH(OH)COOH. Dibasic sodium phosphate, USP, is chemically designated as disodium hydrogen phosphate, dihydrate (Na2HPO4 2H2O). The pH of the final solution is in the range of 7.0 to 8.5."
},
{
"NDCCode": "24571-116-06",
"PackageDescription": "2 BAG in 1 CASE (24571-116-06) / 5 L in 1 BAG",
"NDC11Code": "24571-0116-06",
"ProductNDC": "24571-116",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phoxillum",
"ProprietaryNameSuffix": "Bk4/2.5",
"NonProprietaryName": "Calcium Chloride, Magnesium Chloride, Sodium Chloride, Sodium Bicarbonate, Potassium Chloride, And Sodium Phosphate Dibasic Dihydrate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20150113",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207026",
"LabelerName": "Vantive US Healthcare LLC",
"SubstanceName": "CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC",
"StrengthNumber": "3.68; 3.05; 6.34; 3.09; .314; .187",
"StrengthUnit": "g/L; g/L; g/L; g/L; g/L; g/L",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [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 Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange 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], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150113",
"SamplePackage": "N",
"IndicationAndUsage": "PRISMASOL and PHOXILLUM solutions are indicated in pediatric and adult patients for use as a replacement solution in Continuous Renal Replacement Therapy (CRRT) to replace plasma volume removed by ultrafiltration and to correct electrolyte and acid-base imbalances. They may also be used in case of drug poisoning when CRRT is used to remove dialyzable substances.",
"Description": "PRISMASOL and PHOXILLUM solutions are clear, sterile, free of bacterial endotoxins and contain no bacteriostatic or antimicrobial agents. These solutions are used in Continuous Renal Replacement Therapies (CRRT) as a replacement solution in hemofiltration and hemodiafiltration. Depending on the product (see Table 2), the two compartments contain. Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl2 2H2O). Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl2 6H2O). Sodium chloride, USP, is chemically designated NaCl. Potassium chloride, USP, is chemically designated KCl. Sodium bicarbonate, USP, is chemically designated NaHCO3. Dextrose, USP, is chemically designated D-Glucose anhydrous (C6H12O6) or D-Glucose monohydrate (C6H12O6 H2O). Lactic acid, USP, is chemically designated CH3CH(OH)COOH. Dibasic sodium phosphate, USP, is chemically designated as disodium hydrogen phosphate, dihydrate (Na2HPO4 2H2O). The pH of the final solution is in the range of 7.0 to 8.5."
},
{
"NDCCode": "27241-117-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (27241-117-05) ",
"NDC11Code": "27241-0117-05",
"ProductNDC": "27241-117",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180720",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210138",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "160",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180720",
"SamplePackage": "N"
},
{
"NDCCode": "29300-117-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-117-05) ",
"NDC11Code": "29300-0117-05",
"ProductNDC": "29300-117",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090162",
"LabelerName": "Unichem Pharmaceuticals (USA), Inc.",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130701",
"SamplePackage": "N",
"IndicationAndUsage": "Topiramate tablets are indicated for: : 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).",
"Description": "Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round shaped tablets for oral administration. Topiramate, USP is a white crystalline powder with a bitter taste. Topiramate, USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate, USP has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate, USP is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets, USP contain the following inactive ingredients: lactose monohydrate, pregelatinized corn starch, microcrystalline cellulose, sodium starch glycolate Type A (Potato), magnesium stearate, hypromellose, polysorbate 80, polyethylene glycol, and titanium dioxide. In addition the 25 mg, 100 mg and 200 mg tablets also contain yellow iron oxide; the 25 mg and 100 mg tablets also contain red iron oxide."
},
{
"NDCCode": "31722-117-32",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (31722-117-32) / 5 mL in 1 VIAL, SINGLE-DOSE (31722-117-05) ",
"NDC11Code": "31722-0117-32",
"ProductNDC": "31722-117",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hydrochloride",
"NonProprietaryName": "Lidocaine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL",
"StartMarketingDate": "20211108",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214339",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE ANHYDROUS",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211108",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocaine hydrochloride injection is indicated in adult and pediatric patients for the production of local or regional anesthesia or analgesia for surgery, dental, and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of lidocaine hydrochloride injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration ( 2.2)].",
"Description": "Lidocaine hydrochloride injection, USP contains lidocaine hydrochloride, USP, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for lidocaine hydrochloride is by injection, for infiltration, nerve block, epidural and caudal use. Lidocaine hydrochloride, USP is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the molecular weight of 270.8. g/mol. Lidocaine hydrochloride molecular formula is C 14H 22N 2O.HCl, and has the following structural formula:. Lidocaine hydrochloride injection, USP is a sterile, nonpyrogenic, isotonic solution containing sodium chloride and preservative-free solution. The pH of these solutions is adjusted to approximately 6.5 (5.0 to 7.0) with sodium hydroxide and hydrochloric acid. £ Quantity is equivalent to 7 mg/mL lidocaine hydrochloride, USP (monohydrate). μ Quantity is equivalent to 21.4 mg/mL lidocaine hydrochloride, USP (monohydrate)."
},
{
"NDCCode": "31722-117-35",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (31722-117-35) / 5 mL in 1 VIAL, SINGLE-DOSE (31722-117-05) ",
"NDC11Code": "31722-0117-35",
"ProductNDC": "31722-117",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hydrochloride",
"NonProprietaryName": "Lidocaine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL",
"StartMarketingDate": "20211108",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214339",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE ANHYDROUS",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240409",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocaine hydrochloride injection is indicated in adult and pediatric patients for the production of local or regional anesthesia or analgesia for surgery, dental, and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of lidocaine hydrochloride injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration ( 2.2)].",
"Description": "Lidocaine hydrochloride injection, USP contains lidocaine hydrochloride, USP, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for lidocaine hydrochloride is by injection, for infiltration, nerve block, epidural and caudal use. Lidocaine hydrochloride, USP is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the molecular weight of 270.8. g/mol. Lidocaine hydrochloride molecular formula is C 14H 22N 2O.HCl, and has the following structural formula:. Lidocaine hydrochloride injection, USP is a sterile, nonpyrogenic, isotonic solution containing sodium chloride and preservative-free solution. The pH of these solutions is adjusted to approximately 6.5 (5.0 to 7.0) with sodium hydroxide and hydrochloric acid. £ Quantity is equivalent to 7 mg/mL lidocaine hydrochloride, USP (monohydrate). μ Quantity is equivalent to 21.4 mg/mL lidocaine hydrochloride, USP (monohydrate)."
},
{
"NDCCode": "43066-117-05",
"PackageDescription": "5 CARTON in 1 CARTON (43066-117-05) / 1 SYRINGE, PLASTIC in 1 CARTON (43066-117-01) / 10 mL in 1 SYRINGE, PLASTIC",
"NDC11Code": "43066-0117-05",
"ProductNDC": "43066-117",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketamine Hydrochloride",
"NonProprietaryName": "Ketamine Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20250917",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219684",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "KETAMINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "General Anesthesia [PE], General Anesthetic [EPC]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250917",
"SamplePackage": "N",
"IndicationAndUsage": "Ketamine hydrochloride injection is indicated: 1 as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation., 2 for the induction of anesthesia prior to the administration of other general anesthetic agents., 3 as a supplement to other anesthetic agents.",
"Description": "Ketamine Hydrochloride Injection, USP, for intravenous or intramuscular use, contains ketamine, a nonbarbiturate general anesthetic. Ketamine hydrochloride, USP is a white crystalline powder and has a molecular formula of C13H16ClNOHCl and a molecular weight of 274.19 g/mol. The chemical name for ketamine hydrochloride is (±)-2-(o-Chlorophenyl)-2-(methylamino)cyclohexanone hydrochloride. The chemical structure of ketamine hydrochloride is. It is formulated as a slightly acidic (pH 3.5-5.5) sterile solution for intravenous or intramuscular injection. Each milliliter (mL) of the single-dose pre-filled syringe contain 10 mg ketamine base (equivalent to 11.53 mg ketamine hydrochloride) in water for injection. The 10 mg/mL solution has been made isotonic with 6.60 mg sodium chloride."
},
{
"NDCCode": "47124-445-05",
"PackageDescription": "117 mL in 1 BOTTLE (47124-445-05) ",
"NDC11Code": "47124-0445-05",
"ProductNDC": "47124-445",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sport Sunscreen Spf 30",
"ProprietaryNameSuffix": "Wegmans",
"NonProprietaryName": "Avobenzone - 3.0% Homosalate - 15.0% Octisalate - 5.0% Octocrylene - 7.0%",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130103",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Wegman",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "3; 15; 5; 7",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20130103",
"SamplePackage": "N",
"IndicationAndUsage": "Uses helps prevent sunburn."
},
{
"NDCCode": "47124-450-05",
"PackageDescription": "117 mL in 1 BOTTLE (47124-450-05) ",
"NDC11Code": "47124-0450-05",
"ProductNDC": "47124-450",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sunscreen Spf 30",
"ProprietaryNameSuffix": "Wegmans",
"NonProprietaryName": "Avobenzone - 3.0% Homosalate - 10.0% Octisalate - 5.0% Octocrylene - 10.0%",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130103",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Wegman",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "3; 10; 5; 10",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20130103",
"SamplePackage": "N",
"IndicationAndUsage": "Uses helps prevent sunburn."
},
{
"NDCCode": "49643-117-05",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49643-117-05) ",
"NDC11Code": "49643-0117-05",
"ProductNDC": "49643-117",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Pullularia",
"NonProprietaryName": "Pullularia Pullulans",
"DosageFormName": "INJECTION",
"RouteName": "CUTANEOUS; INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740312",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102211",
"LabelerName": "Allermed Laboratories, Inc.",
"SubstanceName": "AUREOBASIDIUM PULLULANS VAR. PULLUTANS",
"StrengthNumber": ".01",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19740312",
"SamplePackage": "N",
"IndicationAndUsage": "Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.",
"Description": "Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength."
},
{
"NDCCode": "49884-117-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (49884-117-05)",
"NDC11Code": "49884-0117-05",
"ProductNDC": "49884-117",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amiloride Hydrochloride",
"NonProprietaryName": "Amiloride Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19860122",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070346",
"LabelerName": "Par Pharmaceutical Inc.",
"SubstanceName": "AMILORIDE HYDROCHLORIDE ANHYDROUS",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "50228-117-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (50228-117-05) ",
"NDC11Code": "50228-0117-05",
"ProductNDC": "50228-117",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rosuvastatin",
"NonProprietaryName": "Rosuvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190424",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206381",
"LabelerName": "ScieGen Pharmaceuticals, Inc.",
"SubstanceName": "ROSUVASTATIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230907",
"SamplePackage": "N",
"IndicationAndUsage": "Rosuvastatin tablets are indicated: 1 To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults at increased risk for CV events., 2 As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C):in adults with hypercholesterolemia.and slow the progression of atherosclerosis in adults.in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH).",
"Description": "Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium, USP is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2 [methyl(methylsulfonyl)amino]pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The empirical formula for rosuvastatin calcium is (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1001.14. Rosuvastatin calcium, USP is a white to almost white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 1.4 at pH of 7.0. Rosuvastatin tablets, USP for oral use contain rosuvastatin 5 mg, 10 mg, 20 mg, or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium, USP) and the following inactive ingredients: Each tablet contains: crospovidone, dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, red ferric oxide, triacetin and titanium dioxide."
},
{
"NDCCode": "50742-117-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (50742-117-05) ",
"NDC11Code": "50742-0117-05",
"ProductNDC": "50742-117",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desipramine Hydrochloride",
"NonProprietaryName": "Desipramine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180106",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204963",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "DESIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-12-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180106",
"SamplePackage": "N"
},
{
"NDCCode": "54348-117-05",
"PackageDescription": "1 BOTTLE in 1 BOX (54348-117-05) > 5 TABLET in 1 BOTTLE",
"NDC11Code": "54348-0117-05",
"ProductNDC": "54348-117",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine",
"NonProprietaryName": "Promethazine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190711",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040712",
"LabelerName": "PharmPak, Inc.",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Active",
"LastUpdate": "2022-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190711",
"SamplePackage": "N",
"IndicationAndUsage": "Promethazine hydrochloride tablets, USP are useful for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of. anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.",
"Description": "Each 12.5 mg promethazine hydrochloride tablet for oral administration contains 12.5 mg promethazine hydrochloride. Each 25 mg promethazine hydrochloride tablet for oral administration contains 25 mg promethazine hydrochloride. Each 50 mg promethazine hydrochloride tablet for oral administration contains 50 mg promethazine hydrochloride. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, and methylcellulose. In addition, 50 mg tablet contains FD&C Red #40 and 12.5 mg tablet contains FD&C Yellow #6. Promethazine hydrochloride is a racemic compound; the empirical formula is C 17H 20N 2SHCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula:. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol."
},
{
"NDCCode": "58159-117-05",
"PackageDescription": "5 kg in 1 DRUM (58159-117-05) ",
"NDC11Code": "58159-0117-05",
"ProductNDC": "58159-117",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Choline Chloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20241204",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "NURAY CHEMICALS PRIVATE LIMITED",
"SubstanceName": "CHOLINE CHLORIDE",
"StrengthNumber": "35",
"StrengthUnit": "kg/35kg",
"Status": "Unfinished",
"LastUpdate": "2024-12-13",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "04-DEC-24"
},
{
"NDCCode": "59900-117-05",
"PackageDescription": "1000 mL in 1 BOTTLE, PLASTIC (59900-117-05) ",
"NDC11Code": "59900-0117-05",
"ProductNDC": "59900-117",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Smart San Hand Sanitizer",
"NonProprietaryName": "Ethanol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20081201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Best Sanitizers, Inc",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "620",
"StrengthUnit": "mL/1000mL",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20081201",
"SamplePackage": "N",
"IndicationAndUsage": "Sanitize hands to help reduce bacteria that potentially can cause disease. Helps to prevent cross contamination. Helps to prevent drying of the skin. Recommended for repeated use ."
},
{
"NDCCode": "61442-117-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (61442-117-05) ",
"NDC11Code": "61442-0117-05",
"ProductNDC": "61442-117",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glimepiride",
"NonProprietaryName": "Glimepiride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077911",
"LabelerName": "Carlsbad Technology, Inc.",
"SubstanceName": "GLIMEPIRIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120101",
"SamplePackage": "N",
"IndicationAndUsage": "Glimepiride Tablet are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies ( 14.1) ]. Limitations of Use. Glimepiride should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.",
"Description": "Glimepiride Tablets are an oral sulfonylurea that contains the active ingredient glimepiride. Chemically, glimepiride is identified as 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido) ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea (C 24H 34N 4O 5S) with a molecular weight of 490.62. Glimepiride is a white to yellowish-white, crystalline, odorless to practically odorless powder and is practically insoluble in water. The structural formula is:. Glimepiride Tablets contain the active ingredient glimepiride and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer, povidone, and sodium starch glycolate."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>24571-117-05</NDCCode>
<PackageDescription>2 BAG in 1 CASE (24571-117-05) > 5 L in 1 BAG</PackageDescription>
<NDC11Code>24571-0117-05</NDC11Code>
<ProductNDC>24571-117</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phoxillum</ProprietaryName>
<ProprietaryNameSuffix>B22k4/0</ProprietaryNameSuffix>
<NonProprietaryName>Magnesium Chloride, Sodium Chloride, Sodium Bicarbonate, Potassium Chloride And Sodium Phosphate Dibasic Dihydrate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20150113</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207026</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE; SODIUM PHOSPHATE DIBASIC DIHYDRATE</SubstanceName>
<StrengthNumber>3.05; 6.95; 2.21; .314; .187</StrengthNumber>
<StrengthUnit>g/L; g/L; g/L; g/L; g/L</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>24571-117-06</NDCCode>
<PackageDescription>2 BAG in 1 CASE (24571-117-06) / 5 L in 1 BAG</PackageDescription>
<NDC11Code>24571-0117-06</NDC11Code>
<ProductNDC>24571-117</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phoxillum</ProprietaryName>
<ProprietaryNameSuffix>B22k4/0</ProprietaryNameSuffix>
<NonProprietaryName>Magnesium Chloride, Sodium Chloride, Sodium Bicarbonate, Potassium Chloride, And Sodium Phosphate Dibasic Dihydrate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20150113</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207026</ApplicationNumber>
<LabelerName>Vantive US Healthcare LLC</LabelerName>
<SubstanceName>MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC</SubstanceName>
<StrengthNumber>3.05; 6.95; 2.21; .314; .187</StrengthNumber>
<StrengthUnit>g/L; g/L; g/L; g/L; g/L</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], 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 Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PRISMASOL and PHOXILLUM solutions are indicated in pediatric and adult patients for use as a replacement solution in Continuous Renal Replacement Therapy (CRRT) to replace plasma volume removed by ultrafiltration and to correct electrolyte and acid-base imbalances. They may also be used in case of drug poisoning when CRRT is used to remove dialyzable substances.</IndicationAndUsage>
<Description>PRISMASOL and PHOXILLUM solutions are clear, sterile, free of bacterial endotoxins and contain no bacteriostatic or antimicrobial agents. These solutions are used in Continuous Renal Replacement Therapies (CRRT) as a replacement solution in hemofiltration and hemodiafiltration. Depending on the product (see Table 2), the two compartments contain. Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl2 2H2O). Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl2 6H2O). Sodium chloride, USP, is chemically designated NaCl. Potassium chloride, USP, is chemically designated KCl. Sodium bicarbonate, USP, is chemically designated NaHCO3. Dextrose, USP, is chemically designated D-Glucose anhydrous (C6H12O6) or D-Glucose monohydrate (C6H12O6 H2O). Lactic acid, USP, is chemically designated CH3CH(OH)COOH. Dibasic sodium phosphate, USP, is chemically designated as disodium hydrogen phosphate, dihydrate (Na2HPO4 2H2O). The pH of the final solution is in the range of 7.0 to 8.5.</Description>
</NDC>
<NDC>
<NDCCode>24571-102-05</NDCCode>
<PackageDescription>2 BAG in 1 CASE (24571-102-05) > 5 L in 1 BAG</PackageDescription>
<NDC11Code>24571-0102-05</NDC11Code>
<ProductNDC>24571-102</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prismasol</ProprietaryName>
<ProprietaryNameSuffix>Bgk2/0</ProprietaryNameSuffix>
<NonProprietaryName>Magnesium Chloride, Dextrose Monohydrate, Lactic Acid, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20061025</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021703</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>MAGNESIUM CHLORIDE; DEXTROSE MONOHYDRATE; LACTIC ACID, UNSPECIFIED FORM; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>2.03; 22; 5.4; 6.46; 3.09; .157</StrengthNumber>
<StrengthUnit>g/L; g/L; g/L; g/L; g/L; g/L</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20061025</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>24571-103-05</NDCCode>
<PackageDescription>2 BAG in 1 CASE (24571-103-05) > 5 L in 1 BAG</PackageDescription>
<NDC11Code>24571-0103-05</NDC11Code>
<ProductNDC>24571-103</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prismasol</ProprietaryName>
<ProprietaryNameSuffix>Bgk2/3.5</ProprietaryNameSuffix>
<NonProprietaryName>Calcium Chloride, Magnesium Chloride, Dextrose Monohydrate, Lactic Acid, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20061025</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021703</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; DEXTROSE MONOHYDRATE; LACTIC ACID, UNSPECIFIED FORM; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>5.15; 2.03; 22; 5.4; 6.46; 3.09; .157</StrengthNumber>
<StrengthUnit>g/L; g/L; g/L; g/L; g/L; g/L; g/L</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20061025</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>24571-104-05</NDCCode>
<PackageDescription>2 BAG in 1 CASE (24571-104-05) > 5 L in 1 BAG</PackageDescription>
<NDC11Code>24571-0104-05</NDC11Code>
<ProductNDC>24571-104</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prismasol</ProprietaryName>
<ProprietaryNameSuffix>Bgk4/3.5</ProprietaryNameSuffix>
<NonProprietaryName>Calcium Chloride, Magnesium Chloride, Dextrose Monohydrate, Lactic Acid, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20061025</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021703</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; DEXTROSE MONOHYDRATE; LACTIC ACID, UNSPECIFIED FORM; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>5.15; 2.03; 22; 5.4; 6.46; 3.09; .314</StrengthNumber>
<StrengthUnit>g/L; g/L; g/L; g/L; g/L; g/L; g/L</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20061025</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>24571-105-05</NDCCode>
<PackageDescription>2 BAG in 1 CASE (24571-105-05) > 5 L in 1 BAG</PackageDescription>
<NDC11Code>24571-0105-05</NDC11Code>
<ProductNDC>24571-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prismasol</ProprietaryName>
<ProprietaryNameSuffix>Bgk4/2.5</ProprietaryNameSuffix>
<NonProprietaryName>Calcium Chloride, Magnesium Chloride, Dextrose Monohydrate, Lactic Acid, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20061025</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021703</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; DEXTROSE MONOHYDRATE; LACTIC ACID, UNSPECIFIED FORM; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>3.68; 3.05; 22; 5.4; 6.46; 3.09; .314</StrengthNumber>
<StrengthUnit>g/L; g/L; g/L; g/L; g/L; g/L; g/L</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20061025</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>24571-108-05</NDCCode>
<PackageDescription>2 BAG in 1 CASE (24571-108-05) > 5 L in 1 BAG</PackageDescription>
<NDC11Code>24571-0108-05</NDC11Code>
<ProductNDC>24571-108</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prismasol</ProprietaryName>
<ProprietaryNameSuffix>Bgk0/2.5</ProprietaryNameSuffix>
<NonProprietaryName>Calcium Chloride, Magnesium Chloride, Dextrose Monohydrate, Lactic Acid, Sodium Chloride And Sodium Bicarbonate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20061025</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021703</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; DEXTROSE MONOHYDRATE; LACTIC ACID, UNSPECIFIED FORM; SODIUM CHLORIDE; SODIUM BICARBONATE</SubstanceName>
<StrengthNumber>3.68; 3.05; 22; 5.4; 6.46; 3.09</StrengthNumber>
<StrengthUnit>g/L; g/L; g/L; g/L; g/L; g/L</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20061025</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>24571-111-05</NDCCode>
<PackageDescription>2 BAG in 1 CASE (24571-111-05) > 5 L in 1 BAG</PackageDescription>
<NDC11Code>24571-0111-05</NDC11Code>
<ProductNDC>24571-111</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prismasol</ProprietaryName>
<ProprietaryNameSuffix>B22gk4/0</ProprietaryNameSuffix>
<NonProprietaryName>Magnesium Chloride, Dextrose Monohydrate, Lactic Acid, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20061025</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021703</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>MAGNESIUM CHLORIDE; DEXTROSE MONOHYDRATE; LACTIC ACID, UNSPECIFIED FORM; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>3.05; 22; 5.4; 7.07; 2.21; .314</StrengthNumber>
<StrengthUnit>g/L; g/L; g/L; g/L; g/L; g/L</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20081010</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>24571-113-05</NDCCode>
<PackageDescription>2 BAG in 1 CASE (24571-113-05) > 5 L in 1 BAG</PackageDescription>
<NDC11Code>24571-0113-05</NDC11Code>
<ProductNDC>24571-113</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prismasol</ProprietaryName>
<ProprietaryNameSuffix>Bk0/0/1.2</ProprietaryNameSuffix>
<NonProprietaryName>Magnesium Chloride, Lactic Acid, Sodium Chloride And Sodium Bicarbonate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20061025</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021703</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>MAGNESIUM CHLORIDE; LACTIC ACID, UNSPECIFIED FORM; SODIUM CHLORIDE; SODIUM BICARBONATE</SubstanceName>
<StrengthNumber>2.44; 5.4; 6.46; 3.09</StrengthNumber>
<StrengthUnit>g/L; g/L; g/L; g/L</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20081010</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>24571-114-05</NDCCode>
<PackageDescription>2 BAG in 1 CASE (24571-114-05) > 5 L in 1 BAG</PackageDescription>
<NDC11Code>24571-0114-05</NDC11Code>
<ProductNDC>24571-114</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prismasol</ProprietaryName>
<ProprietaryNameSuffix>Bgk4/0/1.2</ProprietaryNameSuffix>
<NonProprietaryName>Magnesium Chloride, Dextrose Monohydrate, Lactic Acid, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20061025</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021703</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>MAGNESIUM CHLORIDE; DEXTROSE MONOHYDRATE; LACTIC ACID, UNSPECIFIED FORM; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>2.44; 22; 5.4; 6.46; 3.09; .314</StrengthNumber>
<StrengthUnit>g/L; g/L; g/L; g/L; g/L; g/L</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20081010</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>24571-116-05</NDCCode>
<PackageDescription>2 BAG in 1 CASE (24571-116-05) > 5 L in 1 BAG</PackageDescription>
<NDC11Code>24571-0116-05</NDC11Code>
<ProductNDC>24571-116</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phoxillum</ProprietaryName>
<ProprietaryNameSuffix>Bk4/2.5</ProprietaryNameSuffix>
<NonProprietaryName>Calcium Chloride, Magnesium Chloride, Sodium Chloride, Sodium Bicarbonate, Potassium Chloride And Sodium Phosphate Dibasic Dihydrate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20150113</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207026</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE; SODIUM PHOSPHATE DIBASIC DIHYDRATE</SubstanceName>
<StrengthNumber>3.68; 3.05; 6.34; 3.09; .314; .187</StrengthNumber>
<StrengthUnit>g/L; g/L; g/L; g/L; g/L; g/L</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>24571-105-06</NDCCode>
<PackageDescription>2 BAG in 1 CASE (24571-105-06) / 5 L in 1 BAG</PackageDescription>
<NDC11Code>24571-0105-06</NDC11Code>
<ProductNDC>24571-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prismasol</ProprietaryName>
<ProprietaryNameSuffix>Bgk4/2.5</ProprietaryNameSuffix>
<NonProprietaryName>Calcium Chloride, Magnesium Chloride, Dextrose Anhydrous, Lactic Acid, Sodium Chloride, Sodium Bicarbonate, And Potassium Chloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20061025</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021703</ApplicationNumber>
<LabelerName>Vantive US Healthcare LLC</LabelerName>
<SubstanceName>CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; ANHYDROUS DEXTROSE; LACTIC ACID; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>3.68; 3.05; 20; 5.4; 6.46; 3.09; .314</StrengthNumber>
<StrengthUnit>g/L; g/L; g/L; g/L; g/L; g/L; g/L</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [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 Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange 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], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20061025</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PRISMASOL and PHOXILLUM solutions are indicated in pediatric and adult patients for use as a replacement solution in Continuous Renal Replacement Therapy (CRRT) to replace plasma volume removed by ultrafiltration and to correct electrolyte and acid-base imbalances. They may also be used in case of drug poisoning when CRRT is used to remove dialyzable substances.</IndicationAndUsage>
<Description>PRISMASOL and PHOXILLUM solutions are clear, sterile, free of bacterial endotoxins and contain no bacteriostatic or antimicrobial agents. These solutions are used in Continuous Renal Replacement Therapies (CRRT) as a replacement solution in hemofiltration and hemodiafiltration. Depending on the product (see Table 2), the two compartments contain. Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl2 2H2O). Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl2 6H2O). Sodium chloride, USP, is chemically designated NaCl. Potassium chloride, USP, is chemically designated KCl. Sodium bicarbonate, USP, is chemically designated NaHCO3. Dextrose, USP, is chemically designated D-Glucose anhydrous (C6H12O6) or D-Glucose monohydrate (C6H12O6 H2O). Lactic acid, USP, is chemically designated CH3CH(OH)COOH. Dibasic sodium phosphate, USP, is chemically designated as disodium hydrogen phosphate, dihydrate (Na2HPO4 2H2O). The pH of the final solution is in the range of 7.0 to 8.5.</Description>
</NDC>
<NDC>
<NDCCode>24571-108-06</NDCCode>
<PackageDescription>2 BAG in 1 CASE (24571-108-06) / 5 L in 1 BAG</PackageDescription>
<NDC11Code>24571-0108-06</NDC11Code>
<ProductNDC>24571-108</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prismasol</ProprietaryName>
<ProprietaryNameSuffix>Bgk0/2.5</ProprietaryNameSuffix>
<NonProprietaryName>Calcium Chloride, Magnesium Chloride, Dextrose Anhydrous, Lactic Acid, Sodium Chloride, And Sodium Bicarbonate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20061025</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021703</ApplicationNumber>
<LabelerName>Vantive US Healthcare LLC</LabelerName>
<SubstanceName>CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; ANHYDROUS DEXTROSE; LACTIC ACID; SODIUM CHLORIDE; SODIUM BICARBONATE</SubstanceName>
<StrengthNumber>3.68; 3.05; 20; 5.4; 6.46; 3.09</StrengthNumber>
<StrengthUnit>g/L; g/L; g/L; g/L; g/L; g/L</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20061025</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PRISMASOL and PHOXILLUM solutions are indicated in pediatric and adult patients for use as a replacement solution in Continuous Renal Replacement Therapy (CRRT) to replace plasma volume removed by ultrafiltration and to correct electrolyte and acid-base imbalances. They may also be used in case of drug poisoning when CRRT is used to remove dialyzable substances.</IndicationAndUsage>
<Description>PRISMASOL and PHOXILLUM solutions are clear, sterile, free of bacterial endotoxins and contain no bacteriostatic or antimicrobial agents. These solutions are used in Continuous Renal Replacement Therapies (CRRT) as a replacement solution in hemofiltration and hemodiafiltration. Depending on the product (see Table 2), the two compartments contain. Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl2 2H2O). Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl2 6H2O). Sodium chloride, USP, is chemically designated NaCl. Potassium chloride, USP, is chemically designated KCl. Sodium bicarbonate, USP, is chemically designated NaHCO3. Dextrose, USP, is chemically designated D-Glucose anhydrous (C6H12O6) or D-Glucose monohydrate (C6H12O6 H2O). Lactic acid, USP, is chemically designated CH3CH(OH)COOH. Dibasic sodium phosphate, USP, is chemically designated as disodium hydrogen phosphate, dihydrate (Na2HPO4 2H2O). The pH of the final solution is in the range of 7.0 to 8.5.</Description>
</NDC>
<NDC>
<NDCCode>24571-111-06</NDCCode>
<PackageDescription>2 BAG in 1 CASE (24571-111-06) / 5 L in 1 BAG</PackageDescription>
<NDC11Code>24571-0111-06</NDC11Code>
<ProductNDC>24571-111</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prismasol</ProprietaryName>
<ProprietaryNameSuffix>B22gk4/0</ProprietaryNameSuffix>
<NonProprietaryName>Magnesium Chloride, Dextrose Anhydrous, Lactic Acid, Sodium Chloride, Sodium Bicarbonate, And Potassium Chloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20061025</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021703</ApplicationNumber>
<LabelerName>Vantive US Healthcare LLC</LabelerName>
<SubstanceName>MAGNESIUM CHLORIDE; ANHYDROUS DEXTROSE; LACTIC ACID; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>3.05; 20; 5.4; 7.07; 2.21; .314</StrengthNumber>
<StrengthUnit>g/L; g/L; g/L; g/L; g/L; g/L</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Calculi Dissolution Agent [EPC], 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 Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange 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], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20081010</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PRISMASOL and PHOXILLUM solutions are indicated in pediatric and adult patients for use as a replacement solution in Continuous Renal Replacement Therapy (CRRT) to replace plasma volume removed by ultrafiltration and to correct electrolyte and acid-base imbalances. They may also be used in case of drug poisoning when CRRT is used to remove dialyzable substances.</IndicationAndUsage>
<Description>PRISMASOL and PHOXILLUM solutions are clear, sterile, free of bacterial endotoxins and contain no bacteriostatic or antimicrobial agents. These solutions are used in Continuous Renal Replacement Therapies (CRRT) as a replacement solution in hemofiltration and hemodiafiltration. Depending on the product (see Table 2), the two compartments contain. Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl2 2H2O). Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl2 6H2O). Sodium chloride, USP, is chemically designated NaCl. Potassium chloride, USP, is chemically designated KCl. Sodium bicarbonate, USP, is chemically designated NaHCO3. Dextrose, USP, is chemically designated D-Glucose anhydrous (C6H12O6) or D-Glucose monohydrate (C6H12O6 H2O). Lactic acid, USP, is chemically designated CH3CH(OH)COOH. Dibasic sodium phosphate, USP, is chemically designated as disodium hydrogen phosphate, dihydrate (Na2HPO4 2H2O). The pH of the final solution is in the range of 7.0 to 8.5.</Description>
</NDC>
<NDC>
<NDCCode>24571-116-06</NDCCode>
<PackageDescription>2 BAG in 1 CASE (24571-116-06) / 5 L in 1 BAG</PackageDescription>
<NDC11Code>24571-0116-06</NDC11Code>
<ProductNDC>24571-116</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phoxillum</ProprietaryName>
<ProprietaryNameSuffix>Bk4/2.5</ProprietaryNameSuffix>
<NonProprietaryName>Calcium Chloride, Magnesium Chloride, Sodium Chloride, Sodium Bicarbonate, Potassium Chloride, And Sodium Phosphate Dibasic Dihydrate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20150113</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207026</ApplicationNumber>
<LabelerName>Vantive US Healthcare LLC</LabelerName>
<SubstanceName>CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC</SubstanceName>
<StrengthNumber>3.68; 3.05; 6.34; 3.09; .314; .187</StrengthNumber>
<StrengthUnit>g/L; g/L; g/L; g/L; g/L; g/L</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [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 Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange 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], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PRISMASOL and PHOXILLUM solutions are indicated in pediatric and adult patients for use as a replacement solution in Continuous Renal Replacement Therapy (CRRT) to replace plasma volume removed by ultrafiltration and to correct electrolyte and acid-base imbalances. They may also be used in case of drug poisoning when CRRT is used to remove dialyzable substances.</IndicationAndUsage>
<Description>PRISMASOL and PHOXILLUM solutions are clear, sterile, free of bacterial endotoxins and contain no bacteriostatic or antimicrobial agents. These solutions are used in Continuous Renal Replacement Therapies (CRRT) as a replacement solution in hemofiltration and hemodiafiltration. Depending on the product (see Table 2), the two compartments contain. Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl2 2H2O). Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl2 6H2O). Sodium chloride, USP, is chemically designated NaCl. Potassium chloride, USP, is chemically designated KCl. Sodium bicarbonate, USP, is chemically designated NaHCO3. Dextrose, USP, is chemically designated D-Glucose anhydrous (C6H12O6) or D-Glucose monohydrate (C6H12O6 H2O). Lactic acid, USP, is chemically designated CH3CH(OH)COOH. Dibasic sodium phosphate, USP, is chemically designated as disodium hydrogen phosphate, dihydrate (Na2HPO4 2H2O). The pH of the final solution is in the range of 7.0 to 8.5.</Description>
</NDC>
<NDC>
<NDCCode>27241-117-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (27241-117-05) </PackageDescription>
<NDC11Code>27241-0117-05</NDC11Code>
<ProductNDC>27241-117</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibrate</ProprietaryName>
<NonProprietaryName>Fenofibrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180720</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210138</ApplicationNumber>
<LabelerName>Ajanta Pharma USA Inc.</LabelerName>
<SubstanceName>FENOFIBRATE</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180720</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>29300-117-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-117-05) </PackageDescription>
<NDC11Code>29300-0117-05</NDC11Code>
<ProductNDC>29300-117</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090162</ApplicationNumber>
<LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topiramate tablets are indicated for: : 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).</IndicationAndUsage>
<Description>Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round shaped tablets for oral administration. Topiramate, USP is a white crystalline powder with a bitter taste. Topiramate, USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate, USP has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate, USP is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets, USP contain the following inactive ingredients: lactose monohydrate, pregelatinized corn starch, microcrystalline cellulose, sodium starch glycolate Type A (Potato), magnesium stearate, hypromellose, polysorbate 80, polyethylene glycol, and titanium dioxide. In addition the 25 mg, 100 mg and 200 mg tablets also contain yellow iron oxide; the 25 mg and 100 mg tablets also contain red iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>31722-117-32</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (31722-117-32) / 5 mL in 1 VIAL, SINGLE-DOSE (31722-117-05) </PackageDescription>
<NDC11Code>31722-0117-32</NDC11Code>
<ProductNDC>31722-117</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL</RouteName>
<StartMarketingDate>20211108</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214339</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE ANHYDROUS</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211108</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocaine hydrochloride injection is indicated in adult and pediatric patients for the production of local or regional anesthesia or analgesia for surgery, dental, and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of lidocaine hydrochloride injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration ( 2.2)].</IndicationAndUsage>
<Description>Lidocaine hydrochloride injection, USP contains lidocaine hydrochloride, USP, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for lidocaine hydrochloride is by injection, for infiltration, nerve block, epidural and caudal use. Lidocaine hydrochloride, USP is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the molecular weight of 270.8. g/mol. Lidocaine hydrochloride molecular formula is C 14H 22N 2O.HCl, and has the following structural formula:. Lidocaine hydrochloride injection, USP is a sterile, nonpyrogenic, isotonic solution containing sodium chloride and preservative-free solution. The pH of these solutions is adjusted to approximately 6.5 (5.0 to 7.0) with sodium hydroxide and hydrochloric acid. £ Quantity is equivalent to 7 mg/mL lidocaine hydrochloride, USP (monohydrate). μ Quantity is equivalent to 21.4 mg/mL lidocaine hydrochloride, USP (monohydrate).</Description>
</NDC>
<NDC>
<NDCCode>31722-117-35</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (31722-117-35) / 5 mL in 1 VIAL, SINGLE-DOSE (31722-117-05) </PackageDescription>
<NDC11Code>31722-0117-35</NDC11Code>
<ProductNDC>31722-117</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL</RouteName>
<StartMarketingDate>20211108</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214339</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE ANHYDROUS</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240409</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocaine hydrochloride injection is indicated in adult and pediatric patients for the production of local or regional anesthesia or analgesia for surgery, dental, and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of lidocaine hydrochloride injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration ( 2.2)].</IndicationAndUsage>
<Description>Lidocaine hydrochloride injection, USP contains lidocaine hydrochloride, USP, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for lidocaine hydrochloride is by injection, for infiltration, nerve block, epidural and caudal use. Lidocaine hydrochloride, USP is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the molecular weight of 270.8. g/mol. Lidocaine hydrochloride molecular formula is C 14H 22N 2O.HCl, and has the following structural formula:. Lidocaine hydrochloride injection, USP is a sterile, nonpyrogenic, isotonic solution containing sodium chloride and preservative-free solution. The pH of these solutions is adjusted to approximately 6.5 (5.0 to 7.0) with sodium hydroxide and hydrochloric acid. £ Quantity is equivalent to 7 mg/mL lidocaine hydrochloride, USP (monohydrate). μ Quantity is equivalent to 21.4 mg/mL lidocaine hydrochloride, USP (monohydrate).</Description>
</NDC>
<NDC>
<NDCCode>43066-117-05</NDCCode>
<PackageDescription>5 CARTON in 1 CARTON (43066-117-05) / 1 SYRINGE, PLASTIC in 1 CARTON (43066-117-01) / 10 mL in 1 SYRINGE, PLASTIC</PackageDescription>
<NDC11Code>43066-0117-05</NDC11Code>
<ProductNDC>43066-117</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketamine Hydrochloride</ProprietaryName>
<NonProprietaryName>Ketamine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20250917</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219684</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>KETAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>General Anesthesia [PE], General Anesthetic [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250917</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ketamine hydrochloride injection is indicated: 1 as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation., 2 for the induction of anesthesia prior to the administration of other general anesthetic agents., 3 as a supplement to other anesthetic agents.</IndicationAndUsage>
<Description>Ketamine Hydrochloride Injection, USP, for intravenous or intramuscular use, contains ketamine, a nonbarbiturate general anesthetic. Ketamine hydrochloride, USP is a white crystalline powder and has a molecular formula of C13H16ClNOHCl and a molecular weight of 274.19 g/mol. The chemical name for ketamine hydrochloride is (±)-2-(o-Chlorophenyl)-2-(methylamino)cyclohexanone hydrochloride. The chemical structure of ketamine hydrochloride is. It is formulated as a slightly acidic (pH 3.5-5.5) sterile solution for intravenous or intramuscular injection. Each milliliter (mL) of the single-dose pre-filled syringe contain 10 mg ketamine base (equivalent to 11.53 mg ketamine hydrochloride) in water for injection. The 10 mg/mL solution has been made isotonic with 6.60 mg sodium chloride.</Description>
</NDC>
<NDC>
<NDCCode>47124-445-05</NDCCode>
<PackageDescription>117 mL in 1 BOTTLE (47124-445-05) </PackageDescription>
<NDC11Code>47124-0445-05</NDC11Code>
<ProductNDC>47124-445</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sport Sunscreen Spf 30</ProprietaryName>
<ProprietaryNameSuffix>Wegmans</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone - 3.0% Homosalate - 15.0% Octisalate - 5.0% Octocrylene - 7.0%</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130103</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Wegman</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>3; 15; 5; 7</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130103</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>47124-450-05</NDCCode>
<PackageDescription>117 mL in 1 BOTTLE (47124-450-05) </PackageDescription>
<NDC11Code>47124-0450-05</NDC11Code>
<ProductNDC>47124-450</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sunscreen Spf 30</ProprietaryName>
<ProprietaryNameSuffix>Wegmans</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone - 3.0% Homosalate - 10.0% Octisalate - 5.0% Octocrylene - 10.0%</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130103</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Wegman</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>3; 10; 5; 10</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130103</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49643-117-05</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (49643-117-05) </PackageDescription>
<NDC11Code>49643-0117-05</NDC11Code>
<ProductNDC>49643-117</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Pullularia</ProprietaryName>
<NonProprietaryName>Pullularia Pullulans</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>CUTANEOUS; INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740312</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102211</ApplicationNumber>
<LabelerName>Allermed Laboratories, Inc.</LabelerName>
<SubstanceName>AUREOBASIDIUM PULLULANS VAR. PULLUTANS</SubstanceName>
<StrengthNumber>.01</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19740312</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.</IndicationAndUsage>
<Description>Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength.</Description>
</NDC>
<NDC>
<NDCCode>49884-117-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (49884-117-05)</PackageDescription>
<NDC11Code>49884-0117-05</NDC11Code>
<ProductNDC>49884-117</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amiloride Hydrochloride</ProprietaryName>
<NonProprietaryName>Amiloride Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19860122</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070346</ApplicationNumber>
<LabelerName>Par Pharmaceutical Inc.</LabelerName>
<SubstanceName>AMILORIDE HYDROCHLORIDE ANHYDROUS</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>50228-117-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (50228-117-05) </PackageDescription>
<NDC11Code>50228-0117-05</NDC11Code>
<ProductNDC>50228-117</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rosuvastatin</ProprietaryName>
<NonProprietaryName>Rosuvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190424</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206381</ApplicationNumber>
<LabelerName>ScieGen Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ROSUVASTATIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230907</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rosuvastatin tablets are indicated: 1 To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults at increased risk for CV events., 2 As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C):in adults with hypercholesterolemia.and slow the progression of atherosclerosis in adults.in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH).</IndicationAndUsage>
<Description>Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium, USP is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2 [methyl(methylsulfonyl)amino]pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The empirical formula for rosuvastatin calcium is (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1001.14. Rosuvastatin calcium, USP is a white to almost white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 1.4 at pH of 7.0. Rosuvastatin tablets, USP for oral use contain rosuvastatin 5 mg, 10 mg, 20 mg, or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium, USP) and the following inactive ingredients: Each tablet contains: crospovidone, dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, red ferric oxide, triacetin and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>50742-117-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (50742-117-05) </PackageDescription>
<NDC11Code>50742-0117-05</NDC11Code>
<ProductNDC>50742-117</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desipramine Hydrochloride</ProprietaryName>
<NonProprietaryName>Desipramine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180106</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204963</ApplicationNumber>
<LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>DESIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-12-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>54348-117-05</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (54348-117-05) > 5 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>54348-0117-05</NDC11Code>
<ProductNDC>54348-117</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine</ProprietaryName>
<NonProprietaryName>Promethazine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190711</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040712</ApplicationNumber>
<LabelerName>PharmPak, Inc.</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190711</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Promethazine hydrochloride tablets, USP are useful for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of. anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.</IndicationAndUsage>
<Description>Each 12.5 mg promethazine hydrochloride tablet for oral administration contains 12.5 mg promethazine hydrochloride. Each 25 mg promethazine hydrochloride tablet for oral administration contains 25 mg promethazine hydrochloride. Each 50 mg promethazine hydrochloride tablet for oral administration contains 50 mg promethazine hydrochloride. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, and methylcellulose. In addition, 50 mg tablet contains FD&C Red #40 and 12.5 mg tablet contains FD&C Yellow #6. Promethazine hydrochloride is a racemic compound; the empirical formula is C 17H 20N 2SHCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula:. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol.</Description>
</NDC>
<NDC>
<NDCCode>58159-117-05</NDCCode>
<PackageDescription>5 kg in 1 DRUM (58159-117-05) </PackageDescription>
<NDC11Code>58159-0117-05</NDC11Code>
<ProductNDC>58159-117</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Choline Chloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20241204</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>NURAY CHEMICALS PRIVATE LIMITED</LabelerName>
<SubstanceName>CHOLINE CHLORIDE</SubstanceName>
<StrengthNumber>35</StrengthNumber>
<StrengthUnit>kg/35kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-12-13</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>04-DEC-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>59900-117-05</NDCCode>
<PackageDescription>1000 mL in 1 BOTTLE, PLASTIC (59900-117-05) </PackageDescription>
<NDC11Code>59900-0117-05</NDC11Code>
<ProductNDC>59900-117</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Smart San Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethanol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20081201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Best Sanitizers, Inc</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>620</StrengthNumber>
<StrengthUnit>mL/1000mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20081201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sanitize hands to help reduce bacteria that potentially can cause disease. Helps to prevent cross contamination. Helps to prevent drying of the skin. Recommended for repeated use .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61442-117-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (61442-117-05) </PackageDescription>
<NDC11Code>61442-0117-05</NDC11Code>
<ProductNDC>61442-117</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glimepiride</ProprietaryName>
<NonProprietaryName>Glimepiride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077911</ApplicationNumber>
<LabelerName>Carlsbad Technology, Inc.</LabelerName>
<SubstanceName>GLIMEPIRIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfonylurea Compounds [CS], Sulfonylurea [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glimepiride Tablet are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies ( 14.1) ]. Limitations of Use. Glimepiride should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.</IndicationAndUsage>
<Description>Glimepiride Tablets are an oral sulfonylurea that contains the active ingredient glimepiride. Chemically, glimepiride is identified as 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido) ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea (C 24H 34N 4O 5S) with a molecular weight of 490.62. Glimepiride is a white to yellowish-white, crystalline, odorless to practically odorless powder and is practically insoluble in water. The structural formula is:. Glimepiride Tablets contain the active ingredient glimepiride and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer, povidone, and sodium starch glycolate.</Description>
</NDC>
</NDCList>