{
"NDC": [
{
"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": "49230-188-51",
"PackageDescription": "2 BAG in 1 CARTON (49230-188-51) > 5000 mL in 1 BAG",
"NDC11Code": "49230-0188-51",
"ProductNDC": "49230-188",
"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": "19841130",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018883",
"LabelerName": "Fresenius Medical Care North America",
"SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
"StrengthNumber": "1.5; 567; 353; 25.7; 15.2",
"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": "2019-07-17",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "49230-191-51",
"PackageDescription": "2 BAG in 1 CARTON (49230-191-51) > 5000 mL in 1 BAG",
"NDC11Code": "49230-0191-51",
"ProductNDC": "49230-191",
"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": "19841130",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018883",
"LabelerName": "Fresenius Medical Care North America",
"SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
"StrengthNumber": "2.5; 567; 353; 25.7; 15.2",
"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": "2019-07-17",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "49230-194-51",
"PackageDescription": "2 BAG in 1 CARTON (49230-194-51) > 5000 mL in 1 BAG",
"NDC11Code": "49230-0194-51",
"ProductNDC": "49230-194",
"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": "19841130",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018883",
"LabelerName": "Fresenius Medical Care North America",
"SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
"StrengthNumber": "4.25; 567; 353; 25.7; 15.2",
"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": "2019-07-17",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "49230-197-51",
"PackageDescription": "2 BAG in 1 CARTON (49230-197-51) > 5000 mL in 1 BAG",
"NDC11Code": "49230-0197-51",
"ProductNDC": "49230-197",
"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": "19841130",
"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; 409; 25.7; 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": "2019-07-17",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "49230-200-51",
"PackageDescription": "2 BAG in 1 CARTON (49230-200-51) > 5000 mL in 1 BAG",
"NDC11Code": "49230-0200-51",
"ProductNDC": "49230-200",
"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": "19841130",
"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; 409; 25.7; 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": "2019-07-17",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "49230-203-51",
"PackageDescription": "2 BAG in 1 CARTON (49230-203-51) > 5000 mL in 1 BAG",
"NDC11Code": "49230-0203-51",
"ProductNDC": "49230-203",
"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": "19841130",
"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; 409; 25.7; 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": "2019-07-17",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "49230-206-51",
"PackageDescription": "2 BAG in 1 CARTON (49230-206-51) > 5000 mL in 1 BAG",
"NDC11Code": "49230-0206-51",
"ProductNDC": "49230-206",
"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": "1.5; 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": "49230-209-51",
"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": "49230-212-51",
"PackageDescription": "2 BAG in 1 CARTON (49230-212-51) > 5000 mL in 1 BAG",
"NDC11Code": "49230-0212-51",
"ProductNDC": "49230-212",
"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": "4.25; 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": "43598-645-18",
"PackageDescription": "180 TABLET, FILM COATED in 1 BOTTLE (43598-645-18) ",
"NDC11Code": "43598-0645-18",
"ProductNDC": "43598-645",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sacubitril And Valsartan",
"ProprietaryNameSuffix": "Sacubitril And Valsartan",
"NonProprietaryName": "Sacubitril And Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250716",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213627",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "SACUBITRIL; VALSARTAN",
"StrengthNumber": "97; 103",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250716",
"SamplePackage": "N",
"Description": "Sacubitril and valsartan tablets are a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contains a complex comprised of anionic forms of sacubitril and valsartan, sodium cations, and water molecules in the molar ratio of 1:1:3:2.5, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Octadecasodiumhexakis(4-{[(1S,3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4oxobutanoate)hexakis(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´-biphenyl]-4-yl]methyl}-L-valinate)—water (1/15). Its molecular formula (hemipentahydrate) is C48H55N6O8Na3 2.5 H2O. Its molecular mass is 957.99 g/mol and its schematic structural formula is. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are calcium carbonate, crospovidone, magnesium stearate, microcrystalline cellulose, polysorbate 80 and silicon dioxide. The film-coating material contains, diacetylated monoglycerides, hypromellose. Imprinting ink contains, ammonium hydroxide, ferrosoferric oxide, propylene glycol and shellac glaze."
},
{
"NDCCode": "43598-645-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (43598-645-60) ",
"NDC11Code": "43598-0645-60",
"ProductNDC": "43598-645",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sacubitril And Valsartan",
"ProprietaryNameSuffix": "Sacubitril And Valsartan",
"NonProprietaryName": "Sacubitril And Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250716",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213627",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "SACUBITRIL; VALSARTAN",
"StrengthNumber": "97; 103",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250716",
"SamplePackage": "N",
"Description": "Sacubitril and valsartan tablets are a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contains a complex comprised of anionic forms of sacubitril and valsartan, sodium cations, and water molecules in the molar ratio of 1:1:3:2.5, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Octadecasodiumhexakis(4-{[(1S,3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4oxobutanoate)hexakis(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´-biphenyl]-4-yl]methyl}-L-valinate)—water (1/15). Its molecular formula (hemipentahydrate) is C48H55N6O8Na3 2.5 H2O. Its molecular mass is 957.99 g/mol and its schematic structural formula is. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are calcium carbonate, crospovidone, magnesium stearate, microcrystalline cellulose, polysorbate 80 and silicon dioxide. The film-coating material contains, diacetylated monoglycerides, hypromellose. Imprinting ink contains, ammonium hydroxide, ferrosoferric oxide, propylene glycol and shellac glaze."
},
{
"NDCCode": "49230-188-10",
"PackageDescription": "12 BAG in 1 CARTON (49230-188-10) > 1000 mL in 1 BAG",
"NDC11Code": "49230-0188-10",
"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": "2015-08-21"
},
{
"NDCCode": "49230-188-15",
"PackageDescription": "6 BAG in 1 CARTON (49230-188-15) > 1500 mL in 1 BAG",
"NDC11Code": "49230-0188-15",
"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": "2015-08-21"
},
{
"NDCCode": "49230-188-20",
"PackageDescription": "6 BAG in 1 CARTON (49230-188-20) > 2000 mL in 1 BAG",
"NDC11Code": "49230-0188-20",
"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": "2015-08-21"
},
{
"NDCCode": "49230-188-23",
"PackageDescription": "6 BAG in 1 CARTON (49230-188-23) > 2000 mL in 1 BAG",
"NDC11Code": "49230-0188-23",
"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": "2015-08-21"
},
{
"NDCCode": "49230-188-25",
"PackageDescription": "4 BAG in 1 CARTON (49230-188-25) > 2500 mL in 1 BAG",
"NDC11Code": "49230-0188-25",
"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": "2015-08-21"
},
{
"NDCCode": "49230-188-30",
"PackageDescription": "4 BAG in 1 CARTON (49230-188-30) > 3000 mL in 1 BAG",
"NDC11Code": "49230-0188-30",
"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": "2015-08-21"
},
{
"NDCCode": "49230-188-50",
"PackageDescription": "2 BAG in 1 CARTON (49230-188-50) / 5000 mL in 1 BAG",
"NDC11Code": "49230-0188-50",
"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 Renal Therapies Group, LLC",
"SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
"StrengthNumber": "1.5; 567; 392; 25.7; 15.2",
"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": "19841130",
"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": "49230-188-52",
"PackageDescription": "2 BAG in 1 CARTON (49230-188-52) / 5000 mL in 1 BAG",
"NDC11Code": "49230-0188-52",
"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 Renal Therapies Group, LLC",
"SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
"StrengthNumber": "1.5; 567; 392; 25.7; 15.2",
"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": "19841130",
"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": "49230-188-60",
"PackageDescription": "2 BAG in 1 CARTON (49230-188-60) / 6000 mL in 1 BAG",
"NDC11Code": "49230-0188-60",
"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], 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": "19841130",
"EndMarketingDatePackage": "20230831",
"SamplePackage": "N"
},
{
"NDCCode": "49230-188-61",
"PackageDescription": "2 BAG in 1 CARTON (49230-188-61) > 6000 mL in 1 BAG",
"NDC11Code": "49230-0188-61",
"ProductNDC": "49230-188",
"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": "19841130",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018883",
"LabelerName": "Fresenius Medical Care North America",
"SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
"StrengthNumber": "1.5; 567; 353; 25.7; 15.2",
"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": "2019-07-17",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "49230-188-62",
"PackageDescription": "2 BAG in 1 CARTON (49230-188-62) / 6000 mL in 1 BAG",
"NDC11Code": "49230-0188-62",
"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 Renal Therapies Group, LLC",
"SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
"StrengthNumber": "1.5; 567; 392; 25.7; 15.2",
"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": "19841130",
"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": "49230-188-90",
"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": "49230-188-91",
"PackageDescription": "6 BAG in 1 CARTON (49230-188-91) > 1500 mL in 1 BAG",
"NDC11Code": "49230-0188-91",
"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": "49230-188-92",
"PackageDescription": "5 BAG in 1 CARTON (49230-188-92) > 2000 mL in 1 BAG",
"NDC11Code": "49230-0188-92",
"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": "49230-188-93",
"PackageDescription": "5 BAG in 1 CARTON (49230-188-93) > 2250 mL in 1 BAG",
"NDC11Code": "49230-0188-93",
"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": "49230-188-94",
"PackageDescription": "5 BAG in 1 CARTON (49230-188-94) > 2500 mL in 1 BAG",
"NDC11Code": "49230-0188-94",
"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": "49230-188-95",
"PackageDescription": "4 BAG in 1 CARTON (49230-188-95) > 3000 mL in 1 BAG",
"NDC11Code": "49230-0188-95",
"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": "49230-188-97",
"PackageDescription": "5 BAG in 1 CARTON (49230-188-97) > 2500 mL in 1 BAG",
"NDC11Code": "49230-0188-97",
"ProductNDC": "49230-188",
"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": "19841130",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018883",
"LabelerName": "Fresenius Medical Care North America",
"SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
"StrengthNumber": "1.5; 567; 353; 25.7; 15.2",
"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": "2019-07-17",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<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>49230-188-51</NDCCode>
<PackageDescription>2 BAG in 1 CARTON (49230-188-51) > 5000 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0188-51</NDC11Code>
<ProductNDC>49230-188</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>19841130</StartMarketingDate>
<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; 567; 353; 25.7; 15.2</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>2019-07-17</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>49230-191-51</NDCCode>
<PackageDescription>2 BAG in 1 CARTON (49230-191-51) > 5000 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0191-51</NDC11Code>
<ProductNDC>49230-191</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>19841130</StartMarketingDate>
<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; 567; 353; 25.7; 15.2</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>2019-07-17</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>49230-194-51</NDCCode>
<PackageDescription>2 BAG in 1 CARTON (49230-194-51) > 5000 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0194-51</NDC11Code>
<ProductNDC>49230-194</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>19841130</StartMarketingDate>
<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; 567; 353; 25.7; 15.2</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>2019-07-17</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>49230-197-51</NDCCode>
<PackageDescription>2 BAG in 1 CARTON (49230-197-51) > 5000 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0197-51</NDC11Code>
<ProductNDC>49230-197</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>19841130</StartMarketingDate>
<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; 409; 25.7; 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>2019-07-17</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>49230-200-51</NDCCode>
<PackageDescription>2 BAG in 1 CARTON (49230-200-51) > 5000 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0200-51</NDC11Code>
<ProductNDC>49230-200</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>19841130</StartMarketingDate>
<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; 409; 25.7; 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>2019-07-17</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>49230-203-51</NDCCode>
<PackageDescription>2 BAG in 1 CARTON (49230-203-51) > 5000 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0203-51</NDC11Code>
<ProductNDC>49230-203</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>19841130</StartMarketingDate>
<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; 409; 25.7; 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>2019-07-17</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>49230-206-51</NDCCode>
<PackageDescription>2 BAG in 1 CARTON (49230-206-51) > 5000 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0206-51</NDC11Code>
<ProductNDC>49230-206</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>1.5; 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>49230-209-51</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>49230-212-51</NDCCode>
<PackageDescription>2 BAG in 1 CARTON (49230-212-51) > 5000 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0212-51</NDC11Code>
<ProductNDC>49230-212</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>4.25; 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>43598-645-18</NDCCode>
<PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (43598-645-18) </PackageDescription>
<NDC11Code>43598-0645-18</NDC11Code>
<ProductNDC>43598-645</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sacubitril And Valsartan</ProprietaryName>
<ProprietaryNameSuffix>Sacubitril And Valsartan</ProprietaryNameSuffix>
<NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250716</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213627</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>SACUBITRIL; VALSARTAN</SubstanceName>
<StrengthNumber>97; 103</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250716</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Sacubitril and valsartan tablets are a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contains a complex comprised of anionic forms of sacubitril and valsartan, sodium cations, and water molecules in the molar ratio of 1:1:3:2.5, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Octadecasodiumhexakis(4-{[(1S,3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4oxobutanoate)hexakis(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´-biphenyl]-4-yl]methyl}-L-valinate)—water (1/15). Its molecular formula (hemipentahydrate) is C48H55N6O8Na3 2.5 H2O. Its molecular mass is 957.99 g/mol and its schematic structural formula is. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are calcium carbonate, crospovidone, magnesium stearate, microcrystalline cellulose, polysorbate 80 and silicon dioxide. The film-coating material contains, diacetylated monoglycerides, hypromellose. Imprinting ink contains, ammonium hydroxide, ferrosoferric oxide, propylene glycol and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>43598-645-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (43598-645-60) </PackageDescription>
<NDC11Code>43598-0645-60</NDC11Code>
<ProductNDC>43598-645</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sacubitril And Valsartan</ProprietaryName>
<ProprietaryNameSuffix>Sacubitril And Valsartan</ProprietaryNameSuffix>
<NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250716</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213627</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>SACUBITRIL; VALSARTAN</SubstanceName>
<StrengthNumber>97; 103</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250716</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Sacubitril and valsartan tablets are a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contains a complex comprised of anionic forms of sacubitril and valsartan, sodium cations, and water molecules in the molar ratio of 1:1:3:2.5, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Octadecasodiumhexakis(4-{[(1S,3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4oxobutanoate)hexakis(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´-biphenyl]-4-yl]methyl}-L-valinate)—water (1/15). Its molecular formula (hemipentahydrate) is C48H55N6O8Na3 2.5 H2O. Its molecular mass is 957.99 g/mol and its schematic structural formula is. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are calcium carbonate, crospovidone, magnesium stearate, microcrystalline cellulose, polysorbate 80 and silicon dioxide. The film-coating material contains, diacetylated monoglycerides, hypromellose. Imprinting ink contains, ammonium hydroxide, ferrosoferric oxide, propylene glycol and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>49230-188-10</NDCCode>
<PackageDescription>12 BAG in 1 CARTON (49230-188-10) > 1000 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0188-10</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>2015-08-21</LastUpdate>
</NDC>
<NDC>
<NDCCode>49230-188-15</NDCCode>
<PackageDescription>6 BAG in 1 CARTON (49230-188-15) > 1500 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0188-15</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>2015-08-21</LastUpdate>
</NDC>
<NDC>
<NDCCode>49230-188-20</NDCCode>
<PackageDescription>6 BAG in 1 CARTON (49230-188-20) > 2000 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0188-20</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>2015-08-21</LastUpdate>
</NDC>
<NDC>
<NDCCode>49230-188-23</NDCCode>
<PackageDescription>6 BAG in 1 CARTON (49230-188-23) > 2000 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0188-23</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>2015-08-21</LastUpdate>
</NDC>
<NDC>
<NDCCode>49230-188-25</NDCCode>
<PackageDescription>4 BAG in 1 CARTON (49230-188-25) > 2500 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0188-25</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>2015-08-21</LastUpdate>
</NDC>
<NDC>
<NDCCode>49230-188-30</NDCCode>
<PackageDescription>4 BAG in 1 CARTON (49230-188-30) > 3000 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0188-30</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>2015-08-21</LastUpdate>
</NDC>
<NDC>
<NDCCode>49230-188-50</NDCCode>
<PackageDescription>2 BAG in 1 CARTON (49230-188-50) / 5000 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0188-50</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 Renal Therapies Group, LLC</LabelerName>
<SubstanceName>DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.5; 567; 392; 25.7; 15.2</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>19841130</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>49230-188-52</NDCCode>
<PackageDescription>2 BAG in 1 CARTON (49230-188-52) / 5000 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0188-52</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 Renal Therapies Group, LLC</LabelerName>
<SubstanceName>DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.5; 567; 392; 25.7; 15.2</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>19841130</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>49230-188-60</NDCCode>
<PackageDescription>2 BAG in 1 CARTON (49230-188-60) / 6000 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0188-60</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], 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>19841130</StartMarketingDatePackage>
<EndMarketingDatePackage>20230831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49230-188-61</NDCCode>
<PackageDescription>2 BAG in 1 CARTON (49230-188-61) > 6000 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0188-61</NDC11Code>
<ProductNDC>49230-188</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>19841130</StartMarketingDate>
<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; 567; 353; 25.7; 15.2</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>2019-07-17</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>49230-188-62</NDCCode>
<PackageDescription>2 BAG in 1 CARTON (49230-188-62) / 6000 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0188-62</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 Renal Therapies Group, LLC</LabelerName>
<SubstanceName>DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.5; 567; 392; 25.7; 15.2</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>19841130</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>49230-188-90</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>49230-188-91</NDCCode>
<PackageDescription>6 BAG in 1 CARTON (49230-188-91) > 1500 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0188-91</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>49230-188-92</NDCCode>
<PackageDescription>5 BAG in 1 CARTON (49230-188-92) > 2000 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0188-92</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>49230-188-93</NDCCode>
<PackageDescription>5 BAG in 1 CARTON (49230-188-93) > 2250 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0188-93</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>49230-188-94</NDCCode>
<PackageDescription>5 BAG in 1 CARTON (49230-188-94) > 2500 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0188-94</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>49230-188-95</NDCCode>
<PackageDescription>4 BAG in 1 CARTON (49230-188-95) > 3000 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0188-95</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>49230-188-97</NDCCode>
<PackageDescription>5 BAG in 1 CARTON (49230-188-97) > 2500 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0188-97</NDC11Code>
<ProductNDC>49230-188</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>19841130</StartMarketingDate>
<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; 567; 353; 25.7; 15.2</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>2019-07-17</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
</NDCList>