{
"NDC": [
{
"NDCCode": "49230-209-90",
"PackageDescription": "12 BAG in 1 CARTON (49230-209-90) > 1000 mL in 1 BAG",
"NDC11Code": "49230-0209-90",
"ProductNDC": "49230-209",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Delflex",
"NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "19920819",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020171",
"LabelerName": "Fresenius Medical Care North America",
"SubstanceName": "CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE",
"StrengthNumber": "18.4; 2.5; 5.08; 538; 448",
"StrengthUnit": "mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL",
"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]",
"Status": "Deprecated",
"LastUpdate": "2015-08-21"
},
{
"NDCCode": "49230-188-90",
"PackageDescription": "12 BAG in 1 CARTON (49230-188-90) > 1000 mL in 1 BAG",
"NDC11Code": "49230-0188-90",
"ProductNDC": "49230-188",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Delflex",
"NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "19841130",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018883",
"LabelerName": "Fresenius Medical Care North America",
"SubstanceName": "CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE",
"StrengthNumber": "25.7; 1.5; 15.2; 567; 392",
"StrengthUnit": "mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL",
"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]",
"Status": "Deprecated",
"LastUpdate": "2015-04-03"
},
{
"NDCCode": "49230-191-90",
"PackageDescription": "12 BAG in 1 CARTON (49230-191-90) > 1000 mL in 1 BAG",
"NDC11Code": "49230-0191-90",
"ProductNDC": "49230-191",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Delflex",
"NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "19841130",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018883",
"LabelerName": "Fresenius Medical Care North America",
"SubstanceName": "CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE",
"StrengthNumber": "25.7; 2.5; 15.2; 567; 392",
"StrengthUnit": "mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL",
"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]",
"Status": "Deprecated",
"LastUpdate": "2015-04-03"
},
{
"NDCCode": "49230-194-90",
"PackageDescription": "12 BAG in 1 CARTON (49230-194-90) > 1000 mL in 1 BAG",
"NDC11Code": "49230-0194-90",
"ProductNDC": "49230-194",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Delflex",
"NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "19841130",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018883",
"LabelerName": "Fresenius Medical Care North America",
"SubstanceName": "CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE",
"StrengthNumber": "25.7; 4.25; 15.2; 567; 392",
"StrengthUnit": "mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL",
"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]",
"Status": "Deprecated",
"LastUpdate": "2015-04-03"
},
{
"NDCCode": "49230-197-90",
"PackageDescription": "12 BAG in 1 CARTON (49230-197-90) > 1000 mL in 1 BAG",
"NDC11Code": "49230-0197-90",
"ProductNDC": "49230-197",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Delflex",
"NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "19841130",
"EndMarketingDate": "20160630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018883",
"LabelerName": "Fresenius Medical Care North America",
"SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
"StrengthNumber": "1.5; 538; 448; 25.7; 5.08",
"StrengthUnit": "g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"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]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "49230-200-90",
"PackageDescription": "12 BAG in 1 CARTON (49230-200-90) > 1000 mL in 1 BAG",
"NDC11Code": "49230-0200-90",
"ProductNDC": "49230-200",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Delflex",
"NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "19841130",
"EndMarketingDate": "20160630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018883",
"LabelerName": "Fresenius Medical Care North America",
"SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
"StrengthNumber": "2.5; 538; 448; 25.7; 5.08",
"StrengthUnit": "g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"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]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "49230-203-90",
"PackageDescription": "12 BAG in 1 CARTON (49230-203-90) > 1000 mL in 1 BAG",
"NDC11Code": "49230-0203-90",
"ProductNDC": "49230-203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Delflex",
"NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "19841130",
"EndMarketingDate": "20160630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018883",
"LabelerName": "Fresenius Medical Care North America",
"SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
"StrengthNumber": "4.25; 538; 448; 25.7; 5.08",
"StrengthUnit": "g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "49230-206-90",
"PackageDescription": "12 BAG in 1 CARTON (49230-206-90) > 1000 mL in 1 BAG",
"NDC11Code": "49230-0206-90",
"ProductNDC": "49230-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Delflex",
"NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "19920819",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020171",
"LabelerName": "Fresenius Medical Care North America",
"SubstanceName": "CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE",
"StrengthNumber": "18.4; 1.5; 5.08; 538; 448",
"StrengthUnit": "mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL",
"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]",
"Status": "Deprecated",
"LastUpdate": "2015-08-21"
},
{
"NDCCode": "49230-212-90",
"PackageDescription": "12 BAG in 1 CARTON (49230-212-90) > 1000 mL in 1 BAG",
"NDC11Code": "49230-0212-90",
"ProductNDC": "49230-212",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Delflex",
"NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "19920819",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020171",
"LabelerName": "Fresenius Medical Care North America",
"SubstanceName": "CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE",
"StrengthNumber": "18.4; 4.25; 5.08; 538; 448",
"StrengthUnit": "mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL",
"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]",
"Status": "Deprecated",
"LastUpdate": "2015-08-21"
},
{
"NDCCode": "49230-645-51",
"PackageDescription": "1 BOTTLE in 1 CARTON (49230-645-51) / 90 TABLET, CHEWABLE in 1 BOTTLE",
"NDC11Code": "49230-0645-51",
"ProductNDC": "49230-645",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Velphoro",
"NonProprietaryName": "Sucroferric Oxyhydroxide",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20131127",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205109",
"LabelerName": "Fresenius Medical Care Renal Therapies Group, LLC",
"SubstanceName": "FERRIC OXYHYDROXIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20131127",
"SamplePackage": "N",
"IndicationAndUsage": "Velphoro is indicated for the control of serum phosphorus levels in adults and pediatric patients 9 years of age and older with chronic kidney disease (CKD) on dialysis.",
"Description": "The Velphoro drug substance is a mixture of polynuclear iron(III)-oxyhydroxide, sucrose, and starches. The active moiety of Velphoro, polynuclear iron(III)-oxyhydroxide, is practically insoluble and cannot be absorbed. Velphoro chewable tablets for oral use are brown, circular, bi-planar, and are embossed with \"PA 500\" on 1 side. Each tablet of Velphoro contains 500 mg iron (in 2,500 mg sucroferric oxyhydroxide). One tablet is equivalent to approximately 1.4 g of carbohydrates (750 mg sucrose and 700 mg starches as potato starch and pregelatinized maize starch). The inactive ingredients are berry flavor, neohesperidin dihydrochalcone, magnesium stearate, and silica (colloidal, anhydrous)."
},
{
"NDCCode": "49230-209-15",
"PackageDescription": "6 BAG in 1 CARTON (49230-209-15) > 1500 mL in 1 BAG",
"NDC11Code": "49230-0209-15",
"ProductNDC": "49230-209",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Delflex",
"NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "19920819",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020171",
"LabelerName": "Fresenius Medical Care North America",
"SubstanceName": "CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE",
"StrengthNumber": "18.4; 2.5; 5.08; 538; 448",
"StrengthUnit": "mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL",
"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]",
"Status": "Deprecated",
"LastUpdate": "2015-08-21"
},
{
"NDCCode": "49230-209-23",
"PackageDescription": "6 BAG in 1 CARTON (49230-209-23) / 2000 mL in 1 BAG",
"NDC11Code": "49230-0209-23",
"ProductNDC": "49230-209",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Delflex",
"NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "19920819",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020171",
"LabelerName": "Fresenius Medical Care Renal Therapies Group, LLC",
"SubstanceName": "SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; DEXTROSE MONOHYDRATE",
"StrengthNumber": "18.4; 2.5; 5.08; 538; 448",
"StrengthUnit": "mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL",
"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], 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": "Deprecated",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19920819",
"SamplePackage": "N",
"IndicationAndUsage": "DELFLEX® is indicated in the treatment of chronic kidney failure in patients being maintained on peritoneal dialysis.",
"Description": "The DELFLEX® peritoneal dialysis solutions (standard and low magnesium/low calcium) are sterile, non-pyrogenic formulations of dextrose and electrolytes in water for injection, USP, for use in peritoneal dialysis. These solutions do not contain antimicrobial agents or additional buffers. Composition, calculated osmolarity, pH, and ionic concentrations are shown in Table 2. Dextrose, USP, is chemically designated D-glucose monohydrate (C 6H 12O 6H 2O) a hexose sugar freely soluble in water. The structural formula is shown here:. Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl 22H 2O) white fragments or granules freely soluble in water. Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl 2 6H 2O) colorless flakes or crystals very soluble in water. Sodium lactate solution, USP, is chemically designated (CH 3CH(OH)COONa), a 60% aqueous solution miscible in water. Sodium chloride, USP, is chemically designated (NaCl), a white, crystalline compound freely soluble in water. Water for injection, USP, is chemically designated (H 2O). Hydrochloric Acid or Sodium Hydroxide may be added for pH adjustment. pH is 5.5 ± 0.5. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. Since the inner bag is compounded from flexible plastic, water may permeate from the inner bag into the overwrap in quantities insufficient to affect the solution significantly. Solutions in contact with the plastic inner bag can cause certain chemical components of the bag to leach out in very small amounts; however, the safety of the plastic formulation is supported by biological tests for plastic containers."
},
{
"NDCCode": "49230-209-25",
"PackageDescription": "4 BAG in 1 CARTON (49230-209-25) > 2500 mL in 1 BAG",
"NDC11Code": "49230-0209-25",
"ProductNDC": "49230-209",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Delflex",
"NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "19920819",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020171",
"LabelerName": "Fresenius Medical Care North America",
"SubstanceName": "CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE",
"StrengthNumber": "18.4; 2.5; 5.08; 538; 448",
"StrengthUnit": "mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL",
"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]",
"Status": "Deprecated",
"LastUpdate": "2015-08-21"
},
{
"NDCCode": "49230-209-30",
"PackageDescription": "4 BAG in 1 CARTON (49230-209-30) / 3000 mL in 1 BAG",
"NDC11Code": "49230-0209-30",
"ProductNDC": "49230-209",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Delflex",
"NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "19920819",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020171",
"LabelerName": "Fresenius Medical Care Renal Therapies Group, LLC",
"SubstanceName": "SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; DEXTROSE MONOHYDRATE",
"StrengthNumber": "538; 448; 18.4; 5.08; 2.5",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL",
"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], 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": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19920819",
"SamplePackage": "N",
"IndicationAndUsage": "DELFLEX® is indicated in the treatment of chronic kidney failure in patients being maintained on peritoneal dialysis.",
"Description": "The DELFLEX® peritoneal dialysis solutions (standard and low magnesium/low calcium) are sterile, non-pyrogenic formulations of dextrose and electrolytes in water for injection, USP, for use in peritoneal dialysis. These solutions do not contain antimicrobial agents or additional buffers. Composition, calculated osmolarity, pH, and ionic concentrations are shown in Table 2. Dextrose, USP, is chemically designated D-glucose monohydrate (C 6H 12O 6H 2O) a hexose sugar freely soluble in water. The structural formula is shown here:. Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl 22H 2O) white fragments or granules freely soluble in water. Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl 26H 2O) colorless flakes or crystals very soluble in water. Sodium lactate solution, USP, is chemically designated (CH 3CH(OH)COONa), a 60% aqueous solution miscible in water. Sodium chloride, USP, is chemically designated (NaCl), a white, crystalline compound freely soluble in water. Water for injection, USP, is chemically designated (H 2O). Hydrochloric Acid or Sodium Hydroxide may be added for pH adjustment. pH is 5.5 ± 0.5. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. Since the inner bag is compounded from flexible plastic, water may permeate from the inner bag into the overwrap in quantities insufficient to affect the solution significantly. Solutions in contact with the plastic inner bag can cause certain chemical components of the bag to leach out in very small amounts; however, the safety of the plastic formulation is supported by biological tests for plastic containers."
},
{
"NDCCode": "49230-209-32",
"PackageDescription": "4 BAG in 1 CARTON (49230-209-32) / 3000 mL in 1 BAG",
"NDC11Code": "49230-0209-32",
"ProductNDC": "49230-209",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Delflex",
"NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "19920819",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020171",
"LabelerName": "Fresenius Medical Care Renal Therapies Group, LLC",
"SubstanceName": "SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; DEXTROSE MONOHYDRATE",
"StrengthNumber": "538; 448; 18.4; 5.08; 2.5",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL",
"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], 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": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19920819",
"SamplePackage": "N",
"IndicationAndUsage": "DELFLEX® is indicated in the treatment of chronic kidney failure in patients being maintained on peritoneal dialysis.",
"Description": "The DELFLEX® peritoneal dialysis solutions (standard and low magnesium/low calcium) are sterile, non-pyrogenic formulations of dextrose and electrolytes in water for injection, USP, for use in peritoneal dialysis. These solutions do not contain antimicrobial agents or additional buffers. Composition, calculated osmolarity, pH, and ionic concentrations are shown in Table 2. Dextrose, USP, is chemically designated D-glucose monohydrate (C 6H 12O 6H 2O) a hexose sugar freely soluble in water. The structural formula is shown here:. Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl 22H 2O) white fragments or granules freely soluble in water. Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl 26H 2O) colorless flakes or crystals very soluble in water. Sodium lactate solution, USP, is chemically designated (CH 3CH(OH)COONa), a 60% aqueous solution miscible in water. Sodium chloride, USP, is chemically designated (NaCl), a white, crystalline compound freely soluble in water. Water for injection, USP, is chemically designated (H 2O). Hydrochloric Acid or Sodium Hydroxide may be added for pH adjustment. pH is 5.5 ± 0.5. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. Since the inner bag is compounded from flexible plastic, water may permeate from the inner bag into the overwrap in quantities insufficient to affect the solution significantly. Solutions in contact with the plastic inner bag can cause certain chemical components of the bag to leach out in very small amounts; however, the safety of the plastic formulation is supported by biological tests for plastic containers."
},
{
"NDCCode": "49230-209-50",
"PackageDescription": "2 BAG in 1 CARTON (49230-209-50) / 5000 mL in 1 BAG",
"NDC11Code": "49230-0209-50",
"ProductNDC": "49230-209",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Delflex",
"NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "19920819",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020171",
"LabelerName": "Fresenius Medical Care Renal Therapies Group, LLC",
"SubstanceName": "SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; DEXTROSE MONOHYDRATE",
"StrengthNumber": "538; 448; 18.4; 5.08; 2.5",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL",
"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], 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": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19920819",
"SamplePackage": "N",
"IndicationAndUsage": "DELFLEX® is indicated in the treatment of chronic kidney failure in patients being maintained on peritoneal dialysis.",
"Description": "The DELFLEX® peritoneal dialysis solutions (standard and low magnesium/low calcium) are sterile, non-pyrogenic formulations of dextrose and electrolytes in water for injection, USP, for use in peritoneal dialysis. These solutions do not contain antimicrobial agents or additional buffers. Composition, calculated osmolarity, pH, and ionic concentrations are shown in Table 2. Dextrose, USP, is chemically designated D-glucose monohydrate (C 6H 12O 6H 2O) a hexose sugar freely soluble in water. The structural formula is shown here:. Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl 22H 2O) white fragments or granules freely soluble in water. Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl 26H 2O) colorless flakes or crystals very soluble in water. Sodium lactate solution, USP, is chemically designated (CH 3CH(OH)COONa), a 60% aqueous solution miscible in water. Sodium chloride, USP, is chemically designated (NaCl), a white, crystalline compound freely soluble in water. Water for injection, USP, is chemically designated (H 2O). Hydrochloric Acid or Sodium Hydroxide may be added for pH adjustment. pH is 5.5 ± 0.5. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. Since the inner bag is compounded from flexible plastic, water may permeate from the inner bag into the overwrap in quantities insufficient to affect the solution significantly. Solutions in contact with the plastic inner bag can cause certain chemical components of the bag to leach out in very small amounts; however, the safety of the plastic formulation is supported by biological tests for plastic containers."
},
{
"NDCCode": "49230-209-51",
"PackageDescription": "2 BAG in 1 CARTON (49230-209-51) > 5000 mL in 1 BAG",
"NDC11Code": "49230-0209-51",
"ProductNDC": "49230-209",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Delflex",
"ProprietaryNameSuffix": "Neutral Ph",
"NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "19920819",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020171",
"LabelerName": "Fresenius Medical Care North America",
"SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
"StrengthNumber": "2.5; 538; 409; 18.4; 5.08",
"StrengthUnit": "g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "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],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS],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]",
"Status": "Deprecated",
"LastUpdate": "2019-06-18",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "49230-209-52",
"PackageDescription": "2 BAG in 1 CARTON (49230-209-52) / 5000 mL in 1 BAG",
"NDC11Code": "49230-0209-52",
"ProductNDC": "49230-209",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Delflex",
"NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "19920819",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020171",
"LabelerName": "Fresenius Medical Care Renal Therapies Group, LLC",
"SubstanceName": "SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; DEXTROSE MONOHYDRATE",
"StrengthNumber": "538; 448; 18.4; 5.08; 2.5",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL",
"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], 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": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19920819",
"SamplePackage": "N",
"IndicationAndUsage": "DELFLEX® is indicated in the treatment of chronic kidney failure in patients being maintained on peritoneal dialysis.",
"Description": "The DELFLEX® peritoneal dialysis solutions (standard and low magnesium/low calcium) are sterile, non-pyrogenic formulations of dextrose and electrolytes in water for injection, USP, for use in peritoneal dialysis. These solutions do not contain antimicrobial agents or additional buffers. Composition, calculated osmolarity, pH, and ionic concentrations are shown in Table 2. Dextrose, USP, is chemically designated D-glucose monohydrate (C 6H 12O 6H 2O) a hexose sugar freely soluble in water. The structural formula is shown here:. Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl 22H 2O) white fragments or granules freely soluble in water. Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl 26H 2O) colorless flakes or crystals very soluble in water. Sodium lactate solution, USP, is chemically designated (CH 3CH(OH)COONa), a 60% aqueous solution miscible in water. Sodium chloride, USP, is chemically designated (NaCl), a white, crystalline compound freely soluble in water. Water for injection, USP, is chemically designated (H 2O). Hydrochloric Acid or Sodium Hydroxide may be added for pH adjustment. pH is 5.5 ± 0.5. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. Since the inner bag is compounded from flexible plastic, water may permeate from the inner bag into the overwrap in quantities insufficient to affect the solution significantly. Solutions in contact with the plastic inner bag can cause certain chemical components of the bag to leach out in very small amounts; however, the safety of the plastic formulation is supported by biological tests for plastic containers."
},
{
"NDCCode": "49230-209-60",
"PackageDescription": "2 BAG in 1 CARTON (49230-209-60) / 6000 mL in 1 BAG",
"NDC11Code": "49230-0209-60",
"ProductNDC": "49230-209",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Delflex",
"NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "19920819",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020171",
"LabelerName": "Fresenius Medical Care North America",
"SubstanceName": "CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE",
"StrengthNumber": "18.4; 2.5; 5.08; 538; 448",
"StrengthUnit": "mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL",
"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], 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": "Deprecated",
"LastUpdate": "2023-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19920819",
"EndMarketingDatePackage": "20230831",
"SamplePackage": "N"
},
{
"NDCCode": "49230-209-61",
"PackageDescription": "2 BAG in 1 CARTON (49230-209-61) > 6000 mL in 1 BAG",
"NDC11Code": "49230-0209-61",
"ProductNDC": "49230-209",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Delflex",
"ProprietaryNameSuffix": "Neutral Ph",
"NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "19920819",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020171",
"LabelerName": "Fresenius Medical Care North America",
"SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
"StrengthNumber": "2.5; 538; 409; 18.4; 5.08",
"StrengthUnit": "g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "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],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS],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]",
"Status": "Deprecated",
"LastUpdate": "2019-06-18",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "49230-209-62",
"PackageDescription": "2 BAG in 1 CARTON (49230-209-62) / 6000 mL in 1 BAG",
"NDC11Code": "49230-0209-62",
"ProductNDC": "49230-209",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Delflex",
"NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "19920819",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020171",
"LabelerName": "Fresenius Medical Care Renal Therapies Group, LLC",
"SubstanceName": "SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; DEXTROSE MONOHYDRATE",
"StrengthNumber": "538; 448; 18.4; 5.08; 2.5",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL",
"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], 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": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19920819",
"SamplePackage": "N",
"IndicationAndUsage": "DELFLEX® is indicated in the treatment of chronic kidney failure in patients being maintained on peritoneal dialysis.",
"Description": "The DELFLEX® peritoneal dialysis solutions (standard and low magnesium/low calcium) are sterile, non-pyrogenic formulations of dextrose and electrolytes in water for injection, USP, for use in peritoneal dialysis. These solutions do not contain antimicrobial agents or additional buffers. Composition, calculated osmolarity, pH, and ionic concentrations are shown in Table 2. Dextrose, USP, is chemically designated D-glucose monohydrate (C 6H 12O 6H 2O) a hexose sugar freely soluble in water. The structural formula is shown here:. Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl 22H 2O) white fragments or granules freely soluble in water. Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl 26H 2O) colorless flakes or crystals very soluble in water. Sodium lactate solution, USP, is chemically designated (CH 3CH(OH)COONa), a 60% aqueous solution miscible in water. Sodium chloride, USP, is chemically designated (NaCl), a white, crystalline compound freely soluble in water. Water for injection, USP, is chemically designated (H 2O). Hydrochloric Acid or Sodium Hydroxide may be added for pH adjustment. pH is 5.5 ± 0.5. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. Since the inner bag is compounded from flexible plastic, water may permeate from the inner bag into the overwrap in quantities insufficient to affect the solution significantly. Solutions in contact with the plastic inner bag can cause certain chemical components of the bag to leach out in very small amounts; however, the safety of the plastic formulation is supported by biological tests for plastic containers."
},
{
"NDCCode": "49230-209-91",
"PackageDescription": "6 BAG in 1 CARTON (49230-209-91) > 1500 mL in 1 BAG",
"NDC11Code": "49230-0209-91",
"ProductNDC": "49230-209",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Delflex",
"NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "19920819",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020171",
"LabelerName": "Fresenius Medical Care North America",
"SubstanceName": "CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE",
"StrengthNumber": "18.4; 2.5; 5.08; 538; 448",
"StrengthUnit": "mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL",
"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]",
"Status": "Deprecated",
"LastUpdate": "2015-08-21"
},
{
"NDCCode": "49230-209-92",
"PackageDescription": "5 BAG in 1 CARTON (49230-209-92) / 2000 mL in 1 BAG",
"NDC11Code": "49230-0209-92",
"ProductNDC": "49230-209",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Delflex",
"NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "19920819",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020171",
"LabelerName": "Fresenius Medical Care Renal Therapies Group, LLC",
"SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
"StrengthNumber": "2.5; 538; 448; 18.4; 5.08",
"StrengthUnit": "g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"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], 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": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19920819",
"SamplePackage": "N",
"IndicationAndUsage": "DELFLEX® is indicated in the treatment of chronic kidney failure in patients being maintained on peritoneal dialysis.",
"Description": "The DELFLEX® peritoneal dialysis solutions (low magnesium/low calcium) are sterile, non-pyrogenic formulations of dextrose and electrolytes in water for injection, USP, for use in peritoneal dialysis. These solutions do not contain antimicrobial agents or additional buffers. The staysafe exchange set utilizes an easy to use dial designed to eliminate the use of clamps and to prevent touch contamination of internal connection components. Composition, calculated osmolarity, pH, and ionic concentrations are shown in Table 2. Dextrose, USP, is chemically designated D-glucose monohydrate (C6H12O6H2O) a hexose sugar freely soluble in water. The structural formula is shown here. Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl 22H 2O) white fragments or granules freely soluble in water. Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl 26H 2O) colorless flakes or crystals very soluble in water. Sodium lactate solution, USP, is chemically designated (CH 3CH(OH) COONa), a 60% aqueous solution miscible in water. Sodium chloride, USP, is chemically designated (NaCI), a white, crystalline compound freely soluble in water. Water for injection, USP, is chemically designated (H 2O). Hydrochloric Acid or Sodium Hydroxide may be added for pH adjustment. pH is 5.5 ± 0.5. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. Since the inner bag is compounded from a specific polyvinyl chloride, water may permeate from the inner bag into the overwrap in quantities insufficient to affect the solution significantly. Solutions in contact with the plastic inner bag can cause certain chemical components of the bag to leach out in very small amounts; however, the safety of the plastic formulation is supported by biological tests for plastic containers."
},
{
"NDCCode": "49230-209-93",
"PackageDescription": "5 BAG in 1 CARTON (49230-209-93) > 2250 mL in 1 BAG",
"NDC11Code": "49230-0209-93",
"ProductNDC": "49230-209",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Delflex",
"NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "19920819",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020171",
"LabelerName": "Fresenius Medical Care North America",
"SubstanceName": "CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE",
"StrengthNumber": "18.4; 2.5; 5.08; 538; 448",
"StrengthUnit": "mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL",
"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]",
"Status": "Deprecated",
"LastUpdate": "2015-08-21"
},
{
"NDCCode": "49230-209-94",
"PackageDescription": "5 BAG in 1 CARTON (49230-209-94) / 2500 mL in 1 BAG",
"NDC11Code": "49230-0209-94",
"ProductNDC": "49230-209",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Delflex",
"NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "19920819",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020171",
"LabelerName": "Fresenius Medical Care Renal Therapies Group, LLC",
"SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
"StrengthNumber": "2.5; 538; 448; 18.4; 5.08",
"StrengthUnit": "g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"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], 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": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19920819",
"SamplePackage": "N",
"IndicationAndUsage": "DELFLEX® is indicated in the treatment of chronic kidney failure in patients being maintained on peritoneal dialysis.",
"Description": "The DELFLEX® peritoneal dialysis solutions (low magnesium/low calcium) are sterile, non-pyrogenic formulations of dextrose and electrolytes in water for injection, USP, for use in peritoneal dialysis. These solutions do not contain antimicrobial agents or additional buffers. The staysafe exchange set utilizes an easy to use dial designed to eliminate the use of clamps and to prevent touch contamination of internal connection components. Composition, calculated osmolarity, pH, and ionic concentrations are shown in Table 2. Dextrose, USP, is chemically designated D-glucose monohydrate (C6H12O6H2O) a hexose sugar freely soluble in water. The structural formula is shown here. Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl 22H 2O) white fragments or granules freely soluble in water. Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl 26H 2O) colorless flakes or crystals very soluble in water. Sodium lactate solution, USP, is chemically designated (CH 3CH(OH) COONa), a 60% aqueous solution miscible in water. Sodium chloride, USP, is chemically designated (NaCI), a white, crystalline compound freely soluble in water. Water for injection, USP, is chemically designated (H 2O). Hydrochloric Acid or Sodium Hydroxide may be added for pH adjustment. pH is 5.5 ± 0.5. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. Since the inner bag is compounded from a specific polyvinyl chloride, water may permeate from the inner bag into the overwrap in quantities insufficient to affect the solution significantly. Solutions in contact with the plastic inner bag can cause certain chemical components of the bag to leach out in very small amounts; however, the safety of the plastic formulation is supported by biological tests for plastic containers."
},
{
"NDCCode": "49230-209-95",
"PackageDescription": "4 BAG in 1 CARTON (49230-209-95) / 3000 mL in 1 BAG",
"NDC11Code": "49230-0209-95",
"ProductNDC": "49230-209",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Delflex",
"NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "19920819",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020171",
"LabelerName": "Fresenius Medical Care Renal Therapies Group, LLC",
"SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
"StrengthNumber": "2.5; 538; 448; 18.4; 5.08",
"StrengthUnit": "g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"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], 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": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19920819",
"SamplePackage": "N",
"IndicationAndUsage": "DELFLEX® is indicated in the treatment of chronic kidney failure in patients being maintained on peritoneal dialysis.",
"Description": "The DELFLEX® peritoneal dialysis solutions (low magnesium/low calcium) are sterile, non-pyrogenic formulations of dextrose and electrolytes in water for injection, USP, for use in peritoneal dialysis. These solutions do not contain antimicrobial agents or additional buffers. The staysafe exchange set utilizes an easy to use dial designed to eliminate the use of clamps and to prevent touch contamination of internal connection components. Composition, calculated osmolarity, pH, and ionic concentrations are shown in Table 2. Dextrose, USP, is chemically designated D-glucose monohydrate (C6H12O6H2O) a hexose sugar freely soluble in water. The structural formula is shown here. Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl 22H 2O) white fragments or granules freely soluble in water. Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl 26H 2O) colorless flakes or crystals very soluble in water. Sodium lactate solution, USP, is chemically designated (CH 3CH(OH) COONa), a 60% aqueous solution miscible in water. Sodium chloride, USP, is chemically designated (NaCI), a white, crystalline compound freely soluble in water. Water for injection, USP, is chemically designated (H 2O). Hydrochloric Acid or Sodium Hydroxide may be added for pH adjustment. pH is 5.5 ± 0.5. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. Since the inner bag is compounded from a specific polyvinyl chloride, water may permeate from the inner bag into the overwrap in quantities insufficient to affect the solution significantly. Solutions in contact with the plastic inner bag can cause certain chemical components of the bag to leach out in very small amounts; however, the safety of the plastic formulation is supported by biological tests for plastic containers."
},
{
"NDCCode": "49230-209-97",
"PackageDescription": "5 BAG in 1 CARTON (49230-209-97) > 2500 mL in 1 BAG",
"NDC11Code": "49230-0209-97",
"ProductNDC": "49230-209",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Delflex",
"ProprietaryNameSuffix": "Neutral Ph",
"NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "19920819",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020171",
"LabelerName": "Fresenius Medical Care North America",
"SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
"StrengthNumber": "2.5; 538; 409; 18.4; 5.08",
"StrengthUnit": "g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "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],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS],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]",
"Status": "Deprecated",
"LastUpdate": "2019-06-18",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "10370-209-09",
"PackageDescription": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (10370-209-09) ",
"NDC11Code": "10370-0209-09",
"ProductNDC": "10370-209",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibric Acid",
"ProprietaryNameSuffix": "Delayed-release",
"NonProprietaryName": "Fenofibric Acid",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130718",
"EndMarketingDate": "20210228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201573",
"LabelerName": "Par Pharmaceutical, Inc.",
"SubstanceName": "CHOLINE FENOFIBRATE",
"StrengthNumber": "45",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-03-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130718",
"EndMarketingDatePackage": "20210228",
"SamplePackage": "N"
},
{
"NDCCode": "29300-209-19",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (29300-209-19) ",
"NDC11Code": "29300-0209-19",
"ProductNDC": "29300-209",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pramipexole Dihydrochloride",
"NonProprietaryName": "Pramipexole Dihydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207011",
"LabelerName": "Unichem Pharmaceuticals (USA), Inc.",
"SubstanceName": "PRAMIPEXOLE DIHYDROCHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190301",
"SamplePackage": "N",
"IndicationAndUsage": "Pramipexole dihydrochloride is a non-ergot dopamine agonist indicated for the treatment of: 1 Parkinson's disease (PD) (1.1), 2 Moderate-to-severe primary Restless Legs Syndrome (RLS) (1.2).",
"Description": "Pramipexole dihydrochloride tablets contain pramipexole dihydrochloride. Pramipexole is a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride monohydrate is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C10H17N3S·2HCl·H2O, and its molecular weight is 302.26. The structural formula is:. Pramipexole dihydrochloride USP is a white or almost white, crystalline powder. Melting occurs above 280°C, with decomposition. Pramipexole dihydrochloride is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane. Pramipexole dihydrochloride tablets 0.125 mg: Each tablet contains 0.125 mg pramipexole dihydrochloride USP. Pramipexole dihydrochloride tablets 0.25 mg: Each tablet contains 0.25 mg pramipexole dihydrochloride USP. Pramipexole dihydrochloride tablets 0.5 mg: Each tablet contains 0.5 mg pramipexole dihydrochloride USP. Pramipexole dihydrochloride tablets 0.75 mg: Each tablet contains 0.75 mg pramipexole dihydrochloride USP. Pramipexole dihydrochloride tablets 1 mg: Each tablet contains 1 mg pramipexole dihydrochloride USP. Pramipexole dihydrochloride tablets 1.5 mg: Each tablet contains 1.5 mg pramipexole dihydrochloride USP. Inactive ingredients for all strengths of Pramipexole dihydrochloride tablets consist of silicified microcrystalline cellulose, croscarmellose sodium and magnesium stearate."
},
{
"NDCCode": "43353-209-60",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (43353-209-60)",
"NDC11Code": "43353-0209-60",
"ProductNDC": "43353-209",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nifedipine",
"NonProprietaryName": "Nifedipine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20001204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075269",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "NIFEDIPINE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Nifedipine extended-release tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Nifedipine extended-release tablets are an extended-release tablet dosage form of the calcium channel blocker nifedipine. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-, dimethyl ester. The molecular formula is C17H18N2O6 and has the structural formula. Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3. Nifedipine extended-release tablets contain 60 mg of nifedipine for once-a-day oral administration. In addition, each tablet contains the following inactive ingredients: ethylcellulose, ferric oxide yellow, hydroxyethyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyacrylic dispersion (copolymer of ethyl acrylate and methyl methacrylate), polyethylene glycol, silicon dioxide, sodium lauryl sulfate, talc, and titanium dioxide. Nifedipine extended-release tablets meet USP Dissolution Test 4."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>49230-209-90</NDCCode>
<PackageDescription>12 BAG in 1 CARTON (49230-209-90) > 1000 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0209-90</NDC11Code>
<ProductNDC>49230-209</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Delflex</ProprietaryName>
<NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAPERITONEAL</RouteName>
<StartMarketingDate>19920819</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020171</ApplicationNumber>
<LabelerName>Fresenius Medical Care North America</LabelerName>
<SubstanceName>CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE</SubstanceName>
<StrengthNumber>18.4; 2.5; 5.08; 538; 448</StrengthNumber>
<StrengthUnit>mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL</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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-08-21</LastUpdate>
</NDC>
<NDC>
<NDCCode>49230-188-90</NDCCode>
<PackageDescription>12 BAG in 1 CARTON (49230-188-90) > 1000 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0188-90</NDC11Code>
<ProductNDC>49230-188</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Delflex</ProprietaryName>
<NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAPERITONEAL</RouteName>
<StartMarketingDate>19841130</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018883</ApplicationNumber>
<LabelerName>Fresenius Medical Care North America</LabelerName>
<SubstanceName>CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE</SubstanceName>
<StrengthNumber>25.7; 1.5; 15.2; 567; 392</StrengthNumber>
<StrengthUnit>mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL</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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-04-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>49230-191-90</NDCCode>
<PackageDescription>12 BAG in 1 CARTON (49230-191-90) > 1000 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0191-90</NDC11Code>
<ProductNDC>49230-191</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Delflex</ProprietaryName>
<NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAPERITONEAL</RouteName>
<StartMarketingDate>19841130</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018883</ApplicationNumber>
<LabelerName>Fresenius Medical Care North America</LabelerName>
<SubstanceName>CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE</SubstanceName>
<StrengthNumber>25.7; 2.5; 15.2; 567; 392</StrengthNumber>
<StrengthUnit>mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL</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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-04-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>49230-194-90</NDCCode>
<PackageDescription>12 BAG in 1 CARTON (49230-194-90) > 1000 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0194-90</NDC11Code>
<ProductNDC>49230-194</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Delflex</ProprietaryName>
<NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAPERITONEAL</RouteName>
<StartMarketingDate>19841130</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018883</ApplicationNumber>
<LabelerName>Fresenius Medical Care North America</LabelerName>
<SubstanceName>CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE</SubstanceName>
<StrengthNumber>25.7; 4.25; 15.2; 567; 392</StrengthNumber>
<StrengthUnit>mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL</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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-04-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>49230-197-90</NDCCode>
<PackageDescription>12 BAG in 1 CARTON (49230-197-90) > 1000 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0197-90</NDC11Code>
<ProductNDC>49230-197</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Delflex</ProprietaryName>
<NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAPERITONEAL</RouteName>
<StartMarketingDate>19841130</StartMarketingDate>
<EndMarketingDate>20160630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018883</ApplicationNumber>
<LabelerName>Fresenius Medical Care North America</LabelerName>
<SubstanceName>DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.5; 538; 448; 25.7; 5.08</StrengthNumber>
<StrengthUnit>g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>49230-200-90</NDCCode>
<PackageDescription>12 BAG in 1 CARTON (49230-200-90) > 1000 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0200-90</NDC11Code>
<ProductNDC>49230-200</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Delflex</ProprietaryName>
<NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAPERITONEAL</RouteName>
<StartMarketingDate>19841130</StartMarketingDate>
<EndMarketingDate>20160630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018883</ApplicationNumber>
<LabelerName>Fresenius Medical Care North America</LabelerName>
<SubstanceName>DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE</SubstanceName>
<StrengthNumber>2.5; 538; 448; 25.7; 5.08</StrengthNumber>
<StrengthUnit>g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>49230-203-90</NDCCode>
<PackageDescription>12 BAG in 1 CARTON (49230-203-90) > 1000 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0203-90</NDC11Code>
<ProductNDC>49230-203</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Delflex</ProprietaryName>
<NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAPERITONEAL</RouteName>
<StartMarketingDate>19841130</StartMarketingDate>
<EndMarketingDate>20160630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018883</ApplicationNumber>
<LabelerName>Fresenius Medical Care North America</LabelerName>
<SubstanceName>DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE</SubstanceName>
<StrengthNumber>4.25; 538; 448; 25.7; 5.08</StrengthNumber>
<StrengthUnit>g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>49230-206-90</NDCCode>
<PackageDescription>12 BAG in 1 CARTON (49230-206-90) > 1000 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0206-90</NDC11Code>
<ProductNDC>49230-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Delflex</ProprietaryName>
<NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAPERITONEAL</RouteName>
<StartMarketingDate>19920819</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020171</ApplicationNumber>
<LabelerName>Fresenius Medical Care North America</LabelerName>
<SubstanceName>CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE</SubstanceName>
<StrengthNumber>18.4; 1.5; 5.08; 538; 448</StrengthNumber>
<StrengthUnit>mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL</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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-08-21</LastUpdate>
</NDC>
<NDC>
<NDCCode>49230-212-90</NDCCode>
<PackageDescription>12 BAG in 1 CARTON (49230-212-90) > 1000 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0212-90</NDC11Code>
<ProductNDC>49230-212</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Delflex</ProprietaryName>
<NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAPERITONEAL</RouteName>
<StartMarketingDate>19920819</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020171</ApplicationNumber>
<LabelerName>Fresenius Medical Care North America</LabelerName>
<SubstanceName>CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE</SubstanceName>
<StrengthNumber>18.4; 4.25; 5.08; 538; 448</StrengthNumber>
<StrengthUnit>mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL</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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-08-21</LastUpdate>
</NDC>
<NDC>
<NDCCode>49230-645-51</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (49230-645-51) / 90 TABLET, CHEWABLE in 1 BOTTLE</PackageDescription>
<NDC11Code>49230-0645-51</NDC11Code>
<ProductNDC>49230-645</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Velphoro</ProprietaryName>
<NonProprietaryName>Sucroferric Oxyhydroxide</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131127</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205109</ApplicationNumber>
<LabelerName>Fresenius Medical Care Renal Therapies Group, LLC</LabelerName>
<SubstanceName>FERRIC OXYHYDROXIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Velphoro is indicated for the control of serum phosphorus levels in adults and pediatric patients 9 years of age and older with chronic kidney disease (CKD) on dialysis.</IndicationAndUsage>
<Description>The Velphoro drug substance is a mixture of polynuclear iron(III)-oxyhydroxide, sucrose, and starches. The active moiety of Velphoro, polynuclear iron(III)-oxyhydroxide, is practically insoluble and cannot be absorbed. Velphoro chewable tablets for oral use are brown, circular, bi-planar, and are embossed with "PA 500" on 1 side. Each tablet of Velphoro contains 500 mg iron (in 2,500 mg sucroferric oxyhydroxide). One tablet is equivalent to approximately 1.4 g of carbohydrates (750 mg sucrose and 700 mg starches as potato starch and pregelatinized maize starch). The inactive ingredients are berry flavor, neohesperidin dihydrochalcone, magnesium stearate, and silica (colloidal, anhydrous).</Description>
</NDC>
<NDC>
<NDCCode>49230-209-15</NDCCode>
<PackageDescription>6 BAG in 1 CARTON (49230-209-15) > 1500 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0209-15</NDC11Code>
<ProductNDC>49230-209</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Delflex</ProprietaryName>
<NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAPERITONEAL</RouteName>
<StartMarketingDate>19920819</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020171</ApplicationNumber>
<LabelerName>Fresenius Medical Care North America</LabelerName>
<SubstanceName>CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE</SubstanceName>
<StrengthNumber>18.4; 2.5; 5.08; 538; 448</StrengthNumber>
<StrengthUnit>mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL</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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-08-21</LastUpdate>
</NDC>
<NDC>
<NDCCode>49230-209-23</NDCCode>
<PackageDescription>6 BAG in 1 CARTON (49230-209-23) / 2000 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0209-23</NDC11Code>
<ProductNDC>49230-209</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Delflex</ProprietaryName>
<NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAPERITONEAL</RouteName>
<StartMarketingDate>19920819</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020171</ApplicationNumber>
<LabelerName>Fresenius Medical Care Renal Therapies Group, LLC</LabelerName>
<SubstanceName>SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; DEXTROSE MONOHYDRATE</SubstanceName>
<StrengthNumber>18.4; 2.5; 5.08; 538; 448</StrengthNumber>
<StrengthUnit>mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL</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], 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>Deprecated</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19920819</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DELFLEX® is indicated in the treatment of chronic kidney failure in patients being maintained on peritoneal dialysis.</IndicationAndUsage>
<Description>The DELFLEX® peritoneal dialysis solutions (standard and low magnesium/low calcium) are sterile, non-pyrogenic formulations of dextrose and electrolytes in water for injection, USP, for use in peritoneal dialysis. These solutions do not contain antimicrobial agents or additional buffers. Composition, calculated osmolarity, pH, and ionic concentrations are shown in Table 2. Dextrose, USP, is chemically designated D-glucose monohydrate (C 6H 12O 6H 2O) a hexose sugar freely soluble in water. The structural formula is shown here:. Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl 22H 2O) white fragments or granules freely soluble in water. Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl 2 6H 2O) colorless flakes or crystals very soluble in water. Sodium lactate solution, USP, is chemically designated (CH 3CH(OH)COONa), a 60% aqueous solution miscible in water. Sodium chloride, USP, is chemically designated (NaCl), a white, crystalline compound freely soluble in water. Water for injection, USP, is chemically designated (H 2O). Hydrochloric Acid or Sodium Hydroxide may be added for pH adjustment. pH is 5.5 ± 0.5. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. Since the inner bag is compounded from flexible plastic, water may permeate from the inner bag into the overwrap in quantities insufficient to affect the solution significantly. Solutions in contact with the plastic inner bag can cause certain chemical components of the bag to leach out in very small amounts; however, the safety of the plastic formulation is supported by biological tests for plastic containers.</Description>
</NDC>
<NDC>
<NDCCode>49230-209-25</NDCCode>
<PackageDescription>4 BAG in 1 CARTON (49230-209-25) > 2500 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0209-25</NDC11Code>
<ProductNDC>49230-209</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Delflex</ProprietaryName>
<NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAPERITONEAL</RouteName>
<StartMarketingDate>19920819</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020171</ApplicationNumber>
<LabelerName>Fresenius Medical Care North America</LabelerName>
<SubstanceName>CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE</SubstanceName>
<StrengthNumber>18.4; 2.5; 5.08; 538; 448</StrengthNumber>
<StrengthUnit>mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL</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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-08-21</LastUpdate>
</NDC>
<NDC>
<NDCCode>49230-209-30</NDCCode>
<PackageDescription>4 BAG in 1 CARTON (49230-209-30) / 3000 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0209-30</NDC11Code>
<ProductNDC>49230-209</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Delflex</ProprietaryName>
<NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAPERITONEAL</RouteName>
<StartMarketingDate>19920819</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020171</ApplicationNumber>
<LabelerName>Fresenius Medical Care Renal Therapies Group, LLC</LabelerName>
<SubstanceName>SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; DEXTROSE MONOHYDRATE</SubstanceName>
<StrengthNumber>538; 448; 18.4; 5.08; 2.5</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL</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], 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>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19920819</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DELFLEX® is indicated in the treatment of chronic kidney failure in patients being maintained on peritoneal dialysis.</IndicationAndUsage>
<Description>The DELFLEX® peritoneal dialysis solutions (standard and low magnesium/low calcium) are sterile, non-pyrogenic formulations of dextrose and electrolytes in water for injection, USP, for use in peritoneal dialysis. These solutions do not contain antimicrobial agents or additional buffers. Composition, calculated osmolarity, pH, and ionic concentrations are shown in Table 2. Dextrose, USP, is chemically designated D-glucose monohydrate (C 6H 12O 6H 2O) a hexose sugar freely soluble in water. The structural formula is shown here:. Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl 22H 2O) white fragments or granules freely soluble in water. Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl 26H 2O) colorless flakes or crystals very soluble in water. Sodium lactate solution, USP, is chemically designated (CH 3CH(OH)COONa), a 60% aqueous solution miscible in water. Sodium chloride, USP, is chemically designated (NaCl), a white, crystalline compound freely soluble in water. Water for injection, USP, is chemically designated (H 2O). Hydrochloric Acid or Sodium Hydroxide may be added for pH adjustment. pH is 5.5 ± 0.5. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. Since the inner bag is compounded from flexible plastic, water may permeate from the inner bag into the overwrap in quantities insufficient to affect the solution significantly. Solutions in contact with the plastic inner bag can cause certain chemical components of the bag to leach out in very small amounts; however, the safety of the plastic formulation is supported by biological tests for plastic containers.</Description>
</NDC>
<NDC>
<NDCCode>49230-209-32</NDCCode>
<PackageDescription>4 BAG in 1 CARTON (49230-209-32) / 3000 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0209-32</NDC11Code>
<ProductNDC>49230-209</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Delflex</ProprietaryName>
<NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAPERITONEAL</RouteName>
<StartMarketingDate>19920819</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020171</ApplicationNumber>
<LabelerName>Fresenius Medical Care Renal Therapies Group, LLC</LabelerName>
<SubstanceName>SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; DEXTROSE MONOHYDRATE</SubstanceName>
<StrengthNumber>538; 448; 18.4; 5.08; 2.5</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL</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], 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>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19920819</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DELFLEX® is indicated in the treatment of chronic kidney failure in patients being maintained on peritoneal dialysis.</IndicationAndUsage>
<Description>The DELFLEX® peritoneal dialysis solutions (standard and low magnesium/low calcium) are sterile, non-pyrogenic formulations of dextrose and electrolytes in water for injection, USP, for use in peritoneal dialysis. These solutions do not contain antimicrobial agents or additional buffers. Composition, calculated osmolarity, pH, and ionic concentrations are shown in Table 2. Dextrose, USP, is chemically designated D-glucose monohydrate (C 6H 12O 6H 2O) a hexose sugar freely soluble in water. The structural formula is shown here:. Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl 22H 2O) white fragments or granules freely soluble in water. Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl 26H 2O) colorless flakes or crystals very soluble in water. Sodium lactate solution, USP, is chemically designated (CH 3CH(OH)COONa), a 60% aqueous solution miscible in water. Sodium chloride, USP, is chemically designated (NaCl), a white, crystalline compound freely soluble in water. Water for injection, USP, is chemically designated (H 2O). Hydrochloric Acid or Sodium Hydroxide may be added for pH adjustment. pH is 5.5 ± 0.5. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. Since the inner bag is compounded from flexible plastic, water may permeate from the inner bag into the overwrap in quantities insufficient to affect the solution significantly. Solutions in contact with the plastic inner bag can cause certain chemical components of the bag to leach out in very small amounts; however, the safety of the plastic formulation is supported by biological tests for plastic containers.</Description>
</NDC>
<NDC>
<NDCCode>49230-209-50</NDCCode>
<PackageDescription>2 BAG in 1 CARTON (49230-209-50) / 5000 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0209-50</NDC11Code>
<ProductNDC>49230-209</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Delflex</ProprietaryName>
<NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAPERITONEAL</RouteName>
<StartMarketingDate>19920819</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020171</ApplicationNumber>
<LabelerName>Fresenius Medical Care Renal Therapies Group, LLC</LabelerName>
<SubstanceName>SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; DEXTROSE MONOHYDRATE</SubstanceName>
<StrengthNumber>538; 448; 18.4; 5.08; 2.5</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL</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], 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>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19920819</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DELFLEX® is indicated in the treatment of chronic kidney failure in patients being maintained on peritoneal dialysis.</IndicationAndUsage>
<Description>The DELFLEX® peritoneal dialysis solutions (standard and low magnesium/low calcium) are sterile, non-pyrogenic formulations of dextrose and electrolytes in water for injection, USP, for use in peritoneal dialysis. These solutions do not contain antimicrobial agents or additional buffers. Composition, calculated osmolarity, pH, and ionic concentrations are shown in Table 2. Dextrose, USP, is chemically designated D-glucose monohydrate (C 6H 12O 6H 2O) a hexose sugar freely soluble in water. The structural formula is shown here:. Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl 22H 2O) white fragments or granules freely soluble in water. Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl 26H 2O) colorless flakes or crystals very soluble in water. Sodium lactate solution, USP, is chemically designated (CH 3CH(OH)COONa), a 60% aqueous solution miscible in water. Sodium chloride, USP, is chemically designated (NaCl), a white, crystalline compound freely soluble in water. Water for injection, USP, is chemically designated (H 2O). Hydrochloric Acid or Sodium Hydroxide may be added for pH adjustment. pH is 5.5 ± 0.5. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. Since the inner bag is compounded from flexible plastic, water may permeate from the inner bag into the overwrap in quantities insufficient to affect the solution significantly. Solutions in contact with the plastic inner bag can cause certain chemical components of the bag to leach out in very small amounts; however, the safety of the plastic formulation is supported by biological tests for plastic containers.</Description>
</NDC>
<NDC>
<NDCCode>49230-209-51</NDCCode>
<PackageDescription>2 BAG in 1 CARTON (49230-209-51) > 5000 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0209-51</NDC11Code>
<ProductNDC>49230-209</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Delflex</ProprietaryName>
<ProprietaryNameSuffix>Neutral Ph</ProprietaryNameSuffix>
<NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAPERITONEAL</RouteName>
<StartMarketingDate>19920819</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020171</ApplicationNumber>
<LabelerName>Fresenius Medical Care North America</LabelerName>
<SubstanceName>DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE</SubstanceName>
<StrengthNumber>2.5; 538; 409; 18.4; 5.08</StrengthNumber>
<StrengthUnit>g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>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],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS],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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-06-18</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>49230-209-52</NDCCode>
<PackageDescription>2 BAG in 1 CARTON (49230-209-52) / 5000 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0209-52</NDC11Code>
<ProductNDC>49230-209</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Delflex</ProprietaryName>
<NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAPERITONEAL</RouteName>
<StartMarketingDate>19920819</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020171</ApplicationNumber>
<LabelerName>Fresenius Medical Care Renal Therapies Group, LLC</LabelerName>
<SubstanceName>SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; DEXTROSE MONOHYDRATE</SubstanceName>
<StrengthNumber>538; 448; 18.4; 5.08; 2.5</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL</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], 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>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19920819</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DELFLEX® is indicated in the treatment of chronic kidney failure in patients being maintained on peritoneal dialysis.</IndicationAndUsage>
<Description>The DELFLEX® peritoneal dialysis solutions (standard and low magnesium/low calcium) are sterile, non-pyrogenic formulations of dextrose and electrolytes in water for injection, USP, for use in peritoneal dialysis. These solutions do not contain antimicrobial agents or additional buffers. Composition, calculated osmolarity, pH, and ionic concentrations are shown in Table 2. Dextrose, USP, is chemically designated D-glucose monohydrate (C 6H 12O 6H 2O) a hexose sugar freely soluble in water. The structural formula is shown here:. Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl 22H 2O) white fragments or granules freely soluble in water. Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl 26H 2O) colorless flakes or crystals very soluble in water. Sodium lactate solution, USP, is chemically designated (CH 3CH(OH)COONa), a 60% aqueous solution miscible in water. Sodium chloride, USP, is chemically designated (NaCl), a white, crystalline compound freely soluble in water. Water for injection, USP, is chemically designated (H 2O). Hydrochloric Acid or Sodium Hydroxide may be added for pH adjustment. pH is 5.5 ± 0.5. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. Since the inner bag is compounded from flexible plastic, water may permeate from the inner bag into the overwrap in quantities insufficient to affect the solution significantly. Solutions in contact with the plastic inner bag can cause certain chemical components of the bag to leach out in very small amounts; however, the safety of the plastic formulation is supported by biological tests for plastic containers.</Description>
</NDC>
<NDC>
<NDCCode>49230-209-60</NDCCode>
<PackageDescription>2 BAG in 1 CARTON (49230-209-60) / 6000 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0209-60</NDC11Code>
<ProductNDC>49230-209</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Delflex</ProprietaryName>
<NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAPERITONEAL</RouteName>
<StartMarketingDate>19920819</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020171</ApplicationNumber>
<LabelerName>Fresenius Medical Care North America</LabelerName>
<SubstanceName>CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE</SubstanceName>
<StrengthNumber>18.4; 2.5; 5.08; 538; 448</StrengthNumber>
<StrengthUnit>mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL</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], 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>Deprecated</Status>
<LastUpdate>2023-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19920819</StartMarketingDatePackage>
<EndMarketingDatePackage>20230831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49230-209-61</NDCCode>
<PackageDescription>2 BAG in 1 CARTON (49230-209-61) > 6000 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0209-61</NDC11Code>
<ProductNDC>49230-209</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Delflex</ProprietaryName>
<ProprietaryNameSuffix>Neutral Ph</ProprietaryNameSuffix>
<NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAPERITONEAL</RouteName>
<StartMarketingDate>19920819</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020171</ApplicationNumber>
<LabelerName>Fresenius Medical Care North America</LabelerName>
<SubstanceName>DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE</SubstanceName>
<StrengthNumber>2.5; 538; 409; 18.4; 5.08</StrengthNumber>
<StrengthUnit>g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>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],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS],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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-06-18</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>49230-209-62</NDCCode>
<PackageDescription>2 BAG in 1 CARTON (49230-209-62) / 6000 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0209-62</NDC11Code>
<ProductNDC>49230-209</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Delflex</ProprietaryName>
<NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAPERITONEAL</RouteName>
<StartMarketingDate>19920819</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020171</ApplicationNumber>
<LabelerName>Fresenius Medical Care Renal Therapies Group, LLC</LabelerName>
<SubstanceName>SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; DEXTROSE MONOHYDRATE</SubstanceName>
<StrengthNumber>538; 448; 18.4; 5.08; 2.5</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL</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], 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>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19920819</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DELFLEX® is indicated in the treatment of chronic kidney failure in patients being maintained on peritoneal dialysis.</IndicationAndUsage>
<Description>The DELFLEX® peritoneal dialysis solutions (standard and low magnesium/low calcium) are sterile, non-pyrogenic formulations of dextrose and electrolytes in water for injection, USP, for use in peritoneal dialysis. These solutions do not contain antimicrobial agents or additional buffers. Composition, calculated osmolarity, pH, and ionic concentrations are shown in Table 2. Dextrose, USP, is chemically designated D-glucose monohydrate (C 6H 12O 6H 2O) a hexose sugar freely soluble in water. The structural formula is shown here:. Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl 22H 2O) white fragments or granules freely soluble in water. Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl 26H 2O) colorless flakes or crystals very soluble in water. Sodium lactate solution, USP, is chemically designated (CH 3CH(OH)COONa), a 60% aqueous solution miscible in water. Sodium chloride, USP, is chemically designated (NaCl), a white, crystalline compound freely soluble in water. Water for injection, USP, is chemically designated (H 2O). Hydrochloric Acid or Sodium Hydroxide may be added for pH adjustment. pH is 5.5 ± 0.5. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. Since the inner bag is compounded from flexible plastic, water may permeate from the inner bag into the overwrap in quantities insufficient to affect the solution significantly. Solutions in contact with the plastic inner bag can cause certain chemical components of the bag to leach out in very small amounts; however, the safety of the plastic formulation is supported by biological tests for plastic containers.</Description>
</NDC>
<NDC>
<NDCCode>49230-209-91</NDCCode>
<PackageDescription>6 BAG in 1 CARTON (49230-209-91) > 1500 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0209-91</NDC11Code>
<ProductNDC>49230-209</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Delflex</ProprietaryName>
<NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAPERITONEAL</RouteName>
<StartMarketingDate>19920819</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020171</ApplicationNumber>
<LabelerName>Fresenius Medical Care North America</LabelerName>
<SubstanceName>CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE</SubstanceName>
<StrengthNumber>18.4; 2.5; 5.08; 538; 448</StrengthNumber>
<StrengthUnit>mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL</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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-08-21</LastUpdate>
</NDC>
<NDC>
<NDCCode>49230-209-92</NDCCode>
<PackageDescription>5 BAG in 1 CARTON (49230-209-92) / 2000 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0209-92</NDC11Code>
<ProductNDC>49230-209</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Delflex</ProprietaryName>
<NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAPERITONEAL</RouteName>
<StartMarketingDate>19920819</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020171</ApplicationNumber>
<LabelerName>Fresenius Medical Care Renal Therapies Group, LLC</LabelerName>
<SubstanceName>DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE</SubstanceName>
<StrengthNumber>2.5; 538; 448; 18.4; 5.08</StrengthNumber>
<StrengthUnit>g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</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], 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>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19920819</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DELFLEX® is indicated in the treatment of chronic kidney failure in patients being maintained on peritoneal dialysis.</IndicationAndUsage>
<Description>The DELFLEX® peritoneal dialysis solutions (low magnesium/low calcium) are sterile, non-pyrogenic formulations of dextrose and electrolytes in water for injection, USP, for use in peritoneal dialysis. These solutions do not contain antimicrobial agents or additional buffers. The staysafe exchange set utilizes an easy to use dial designed to eliminate the use of clamps and to prevent touch contamination of internal connection components. Composition, calculated osmolarity, pH, and ionic concentrations are shown in Table 2. Dextrose, USP, is chemically designated D-glucose monohydrate (C6H12O6H2O) a hexose sugar freely soluble in water. The structural formula is shown here. Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl 22H 2O) white fragments or granules freely soluble in water. Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl 26H 2O) colorless flakes or crystals very soluble in water. Sodium lactate solution, USP, is chemically designated (CH 3CH(OH) COONa), a 60% aqueous solution miscible in water. Sodium chloride, USP, is chemically designated (NaCI), a white, crystalline compound freely soluble in water. Water for injection, USP, is chemically designated (H 2O). Hydrochloric Acid or Sodium Hydroxide may be added for pH adjustment. pH is 5.5 ± 0.5. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. Since the inner bag is compounded from a specific polyvinyl chloride, water may permeate from the inner bag into the overwrap in quantities insufficient to affect the solution significantly. Solutions in contact with the plastic inner bag can cause certain chemical components of the bag to leach out in very small amounts; however, the safety of the plastic formulation is supported by biological tests for plastic containers.</Description>
</NDC>
<NDC>
<NDCCode>49230-209-93</NDCCode>
<PackageDescription>5 BAG in 1 CARTON (49230-209-93) > 2250 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0209-93</NDC11Code>
<ProductNDC>49230-209</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Delflex</ProprietaryName>
<NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAPERITONEAL</RouteName>
<StartMarketingDate>19920819</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020171</ApplicationNumber>
<LabelerName>Fresenius Medical Care North America</LabelerName>
<SubstanceName>CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE</SubstanceName>
<StrengthNumber>18.4; 2.5; 5.08; 538; 448</StrengthNumber>
<StrengthUnit>mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL</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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-08-21</LastUpdate>
</NDC>
<NDC>
<NDCCode>49230-209-94</NDCCode>
<PackageDescription>5 BAG in 1 CARTON (49230-209-94) / 2500 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0209-94</NDC11Code>
<ProductNDC>49230-209</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Delflex</ProprietaryName>
<NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAPERITONEAL</RouteName>
<StartMarketingDate>19920819</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020171</ApplicationNumber>
<LabelerName>Fresenius Medical Care Renal Therapies Group, LLC</LabelerName>
<SubstanceName>DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE</SubstanceName>
<StrengthNumber>2.5; 538; 448; 18.4; 5.08</StrengthNumber>
<StrengthUnit>g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</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], 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>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19920819</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DELFLEX® is indicated in the treatment of chronic kidney failure in patients being maintained on peritoneal dialysis.</IndicationAndUsage>
<Description>The DELFLEX® peritoneal dialysis solutions (low magnesium/low calcium) are sterile, non-pyrogenic formulations of dextrose and electrolytes in water for injection, USP, for use in peritoneal dialysis. These solutions do not contain antimicrobial agents or additional buffers. The staysafe exchange set utilizes an easy to use dial designed to eliminate the use of clamps and to prevent touch contamination of internal connection components. Composition, calculated osmolarity, pH, and ionic concentrations are shown in Table 2. Dextrose, USP, is chemically designated D-glucose monohydrate (C6H12O6H2O) a hexose sugar freely soluble in water. The structural formula is shown here. Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl 22H 2O) white fragments or granules freely soluble in water. Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl 26H 2O) colorless flakes or crystals very soluble in water. Sodium lactate solution, USP, is chemically designated (CH 3CH(OH) COONa), a 60% aqueous solution miscible in water. Sodium chloride, USP, is chemically designated (NaCI), a white, crystalline compound freely soluble in water. Water for injection, USP, is chemically designated (H 2O). Hydrochloric Acid or Sodium Hydroxide may be added for pH adjustment. pH is 5.5 ± 0.5. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. Since the inner bag is compounded from a specific polyvinyl chloride, water may permeate from the inner bag into the overwrap in quantities insufficient to affect the solution significantly. Solutions in contact with the plastic inner bag can cause certain chemical components of the bag to leach out in very small amounts; however, the safety of the plastic formulation is supported by biological tests for plastic containers.</Description>
</NDC>
<NDC>
<NDCCode>49230-209-95</NDCCode>
<PackageDescription>4 BAG in 1 CARTON (49230-209-95) / 3000 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0209-95</NDC11Code>
<ProductNDC>49230-209</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Delflex</ProprietaryName>
<NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAPERITONEAL</RouteName>
<StartMarketingDate>19920819</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020171</ApplicationNumber>
<LabelerName>Fresenius Medical Care Renal Therapies Group, LLC</LabelerName>
<SubstanceName>DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE</SubstanceName>
<StrengthNumber>2.5; 538; 448; 18.4; 5.08</StrengthNumber>
<StrengthUnit>g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</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], 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>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19920819</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DELFLEX® is indicated in the treatment of chronic kidney failure in patients being maintained on peritoneal dialysis.</IndicationAndUsage>
<Description>The DELFLEX® peritoneal dialysis solutions (low magnesium/low calcium) are sterile, non-pyrogenic formulations of dextrose and electrolytes in water for injection, USP, for use in peritoneal dialysis. These solutions do not contain antimicrobial agents or additional buffers. The staysafe exchange set utilizes an easy to use dial designed to eliminate the use of clamps and to prevent touch contamination of internal connection components. Composition, calculated osmolarity, pH, and ionic concentrations are shown in Table 2. Dextrose, USP, is chemically designated D-glucose monohydrate (C6H12O6H2O) a hexose sugar freely soluble in water. The structural formula is shown here. Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl 22H 2O) white fragments or granules freely soluble in water. Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl 26H 2O) colorless flakes or crystals very soluble in water. Sodium lactate solution, USP, is chemically designated (CH 3CH(OH) COONa), a 60% aqueous solution miscible in water. Sodium chloride, USP, is chemically designated (NaCI), a white, crystalline compound freely soluble in water. Water for injection, USP, is chemically designated (H 2O). Hydrochloric Acid or Sodium Hydroxide may be added for pH adjustment. pH is 5.5 ± 0.5. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. Since the inner bag is compounded from a specific polyvinyl chloride, water may permeate from the inner bag into the overwrap in quantities insufficient to affect the solution significantly. Solutions in contact with the plastic inner bag can cause certain chemical components of the bag to leach out in very small amounts; however, the safety of the plastic formulation is supported by biological tests for plastic containers.</Description>
</NDC>
<NDC>
<NDCCode>49230-209-97</NDCCode>
<PackageDescription>5 BAG in 1 CARTON (49230-209-97) > 2500 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0209-97</NDC11Code>
<ProductNDC>49230-209</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Delflex</ProprietaryName>
<ProprietaryNameSuffix>Neutral Ph</ProprietaryNameSuffix>
<NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAPERITONEAL</RouteName>
<StartMarketingDate>19920819</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020171</ApplicationNumber>
<LabelerName>Fresenius Medical Care North America</LabelerName>
<SubstanceName>DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE</SubstanceName>
<StrengthNumber>2.5; 538; 409; 18.4; 5.08</StrengthNumber>
<StrengthUnit>g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>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],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS],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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-06-18</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>10370-209-09</NDCCode>
<PackageDescription>90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (10370-209-09) </PackageDescription>
<NDC11Code>10370-0209-09</NDC11Code>
<ProductNDC>10370-209</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibric Acid</ProprietaryName>
<ProprietaryNameSuffix>Delayed-release</ProprietaryNameSuffix>
<NonProprietaryName>Fenofibric Acid</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130718</StartMarketingDate>
<EndMarketingDate>20210228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201573</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<SubstanceName>CHOLINE FENOFIBRATE</SubstanceName>
<StrengthNumber>45</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-03-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130718</StartMarketingDatePackage>
<EndMarketingDatePackage>20210228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>29300-209-19</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (29300-209-19) </PackageDescription>
<NDC11Code>29300-0209-19</NDC11Code>
<ProductNDC>29300-209</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pramipexole Dihydrochloride</ProprietaryName>
<NonProprietaryName>Pramipexole Dihydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207011</ApplicationNumber>
<LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
<SubstanceName>PRAMIPEXOLE DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pramipexole dihydrochloride is a non-ergot dopamine agonist indicated for the treatment of: 1 Parkinson's disease (PD) (1.1), 2 Moderate-to-severe primary Restless Legs Syndrome (RLS) (1.2).</IndicationAndUsage>
<Description>Pramipexole dihydrochloride tablets contain pramipexole dihydrochloride. Pramipexole is a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride monohydrate is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C10H17N3S·2HCl·H2O, and its molecular weight is 302.26. The structural formula is:. Pramipexole dihydrochloride USP is a white or almost white, crystalline powder. Melting occurs above 280°C, with decomposition. Pramipexole dihydrochloride is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane. Pramipexole dihydrochloride tablets 0.125 mg: Each tablet contains 0.125 mg pramipexole dihydrochloride USP. Pramipexole dihydrochloride tablets 0.25 mg: Each tablet contains 0.25 mg pramipexole dihydrochloride USP. Pramipexole dihydrochloride tablets 0.5 mg: Each tablet contains 0.5 mg pramipexole dihydrochloride USP. Pramipexole dihydrochloride tablets 0.75 mg: Each tablet contains 0.75 mg pramipexole dihydrochloride USP. Pramipexole dihydrochloride tablets 1 mg: Each tablet contains 1 mg pramipexole dihydrochloride USP. Pramipexole dihydrochloride tablets 1.5 mg: Each tablet contains 1.5 mg pramipexole dihydrochloride USP. Inactive ingredients for all strengths of Pramipexole dihydrochloride tablets consist of silicified microcrystalline cellulose, croscarmellose sodium and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>43353-209-60</NDCCode>
<PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE (43353-209-60)</PackageDescription>
<NDC11Code>43353-0209-60</NDC11Code>
<ProductNDC>43353-209</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nifedipine</ProprietaryName>
<NonProprietaryName>Nifedipine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20001204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075269</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>NIFEDIPINE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Nifedipine extended-release tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Nifedipine extended-release tablets are an extended-release tablet dosage form of the calcium channel blocker nifedipine. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-, dimethyl ester. The molecular formula is C17H18N2O6 and has the structural formula. Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3. Nifedipine extended-release tablets contain 60 mg of nifedipine for once-a-day oral administration. In addition, each tablet contains the following inactive ingredients: ethylcellulose, ferric oxide yellow, hydroxyethyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyacrylic dispersion (copolymer of ethyl acrylate and methyl methacrylate), polyethylene glycol, silicon dioxide, sodium lauryl sulfate, talc, and titanium dioxide. Nifedipine extended-release tablets meet USP Dissolution Test 4.</Description>
</NDC>
</NDCList>