RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "63323-164-74",
      "PackageDescription": "30 BAG in 1 CASE (63323-164-74)  / 250 mL in 1 BAG (63323-164-24) ",
      "NDC11Code": "63323-0164-74",
      "ProductNDC": "63323-164",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lactated Ringers",
      "NonProprietaryName": "Sodium Chloride, Sodium Lactate, Potassium Chloride, Calcium Chloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20190128",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209338",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE",
      "StrengthNumber": "600; 310; 30; 20",
      "StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL",
      "Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-04-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190128",
      "SamplePackage": "N",
      "IndicationAndUsage": "Lactated Ringer's Injection is indicated as a source of water and electrolytes or as an alkalinizing agent.",
      "Description": "Lactated Ringer's Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1. The flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers ( freeflex® bag). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers."
    },
    {
      "NDCCode": "63323-164-75",
      "PackageDescription": "20 BAG in 1 CASE (63323-164-75)  / 500 mL in 1 BAG (63323-164-25) ",
      "NDC11Code": "63323-0164-75",
      "ProductNDC": "63323-164",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lactated Ringers",
      "NonProprietaryName": "Sodium Chloride, Sodium Lactate, Potassium Chloride, Calcium Chloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20190128",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209338",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE",
      "StrengthNumber": "600; 310; 30; 20",
      "StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL",
      "Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-04-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190128",
      "SamplePackage": "N",
      "IndicationAndUsage": "Lactated Ringer's Injection is indicated as a source of water and electrolytes or as an alkalinizing agent.",
      "Description": "Lactated Ringer's Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1. The flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers ( freeflex® bag). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers."
    },
    {
      "NDCCode": "63323-164-76",
      "PackageDescription": "10 BAG in 1 CASE (63323-164-76)  / 1000 mL in 1 BAG (63323-164-26) ",
      "NDC11Code": "63323-0164-76",
      "ProductNDC": "63323-164",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lactated Ringers",
      "NonProprietaryName": "Sodium Chloride, Sodium Lactate, Potassium Chloride, Calcium Chloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20190128",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209338",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE",
      "StrengthNumber": "600; 310; 30; 20",
      "StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL",
      "Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-04-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190128",
      "SamplePackage": "N",
      "IndicationAndUsage": "Lactated Ringer's Injection is indicated as a source of water and electrolytes or as an alkalinizing agent.",
      "Description": "Lactated Ringer's Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1. The flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers ( freeflex® bag). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers."
    },
    {
      "NDCCode": "63739-164-34",
      "PackageDescription": "5 TRAY in 1 CASE (63739-164-34)  / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (63739-164-74) ",
      "NDC11Code": "63739-0164-34",
      "ProductNDC": "63739-164",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Potassium Chloride",
      "NonProprietaryName": "Potassium Chloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220701",
      "EndMarketingDate": "20260731",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210766",
      "LabelerName": "McKesson Corporation dba SKY Packaging",
      "SubstanceName": "POTASSIUM CHLORIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "meq/15mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-07-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20220701",
      "EndMarketingDatePackage": "20260731",
      "SamplePackage": "N",
      "IndicationAndUsage": "Potassium Chloride is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient.",
      "Description": "Potassium Chloride is a white crystalline or colorless solid. It is soluble in water and slightly soluble in alcohol. Chemically, Potassium Chloride is K-Cl with a molecular mass of 74.55. Oral Solution 10%: Each 15 mL of solution contains 1.5 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow No. 6, glycerin, orange flavor, purified water, sodium benzoate, sodium citrate dihydrate, and sucralose."
    },
    {
      "NDCCode": "73069-164-74",
      "PackageDescription": "6 VIAL, MULTI-DOSE in 1 BOX (73069-164-74)  > 50 mL in 1 VIAL, MULTI-DOSE",
      "NDC11Code": "73069-0164-74",
      "ProductNDC": "73069-164",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Viatrexx-facial",
      "NonProprietaryName": "Adrenal, Collagen, Cutis, Diosorea, Epithelial Growth Factor, Erythrocytes, Fumaric Acid, Funiculus, Gingko, Hyaluronidase, Il 1 - Beta, Kalum Aspariticum, Multi B Vitamin Complex (b 1,2,3,5,6,9,12), Muscle, Natrum Oxalaceticum, Natrum Pyruvicum, Placenta, Quinhydrone, Succinic Acid, Silicea And Trifolium",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
      "StartMarketingDate": "20190329",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "VIATREXX BIO INCORPORATED",
      "SubstanceName": "SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; PORK COLLAGEN; CUMINALDEHYDE; DIOSCOREA VILLOSA TUBER; SUS SCROFA RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; FUMARIC ACID; SUS SCROFA UMBILICAL CORD; BOS TAURUS UMBILICAL CORD; GINKGO; HYALURONIDASE; POTASSIUM ASPARTATE; THIAMINE; RIBOFLAVIN; PANTOTHENIC ACID; PYRIDOXINE; CYANOCOBALAMIN; FOLIC ACID; PORK; BEEF; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUS SCROFA PLACENTA; BOS TAURUS PLACENTA; QUINHYDRONE; SUCCINIC ACID; SILICON DIOXIDE; RED CLOVER; INTERLEUKIN-1 .BETA. HUMAN; BOS TAURUS SKIN; SUS SCROFA SKIN; NIACIN",
      "StrengthNumber": "31; 31; 201; 31; 31; 201; 201; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 31; 201; 201; 201; 31",
      "StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
      "Pharm_Classes": "Endoglycosidase [EPC],Glycoside Hydrolases [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Non-Standardized Animal Skin Allergenic Extract [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2021-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20190506",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "63323-304-74",
      "PackageDescription": "1 BOTTLE in 1 CARTON (63323-304-74)  / 180 mL in 1 BOTTLE",
      "NDC11Code": "63323-0304-74",
      "ProductNDC": "63323-304",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Piperacillin And Tazobactam",
      "NonProprietaryName": "Piperacillin Sodium And Tazobactam Sodium",
      "DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20110531",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090498",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "PIPERACILLIN SODIUM; TAZOBACTAM SODIUM",
      "StrengthNumber": "36; 4.5",
      "StrengthUnit": "g/180mL; g/180mL",
      "Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-10-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20110531",
      "SamplePackage": "N",
      "IndicationAndUsage": "Piperacillin and tazobactam for injection is a combination product consisting of a penicillin-class antibacterial, piperacillin, and a β-lactamase inhibitor, tazobactam, indicated for the treatment of patients with moderate to severe infections caused by susceptible isolates of the designated bacteria in the conditions listed below.",
      "Description": "Piperacillin and tazobactam for injection is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the β-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin.  The chemical name of piperacillin sodium is sodium (2 S,5 R,6 R)-6-[( R)-2-(4-ethyl-2,3-dioxo-1-piperazinecarboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate.  The chemical formula is C 23H 26N 5NaO 7S and the molecular weight is 539.5.  The chemical structure of piperacillin sodium is:. Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone.  Its chemical name is sodium (2 S,3 S,5 R)-3-methyl-7-oxo-3-(1 H-1,2,3-triazol-1-ylmethyl)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide.  The chemical formula is C 10H 11N 4NaO 5S and the molecular weight is 322.3.  The chemical structure of tazobactam sodium is:. Piperacillin and tazobactam for injection, piperacillin/tazobactam parenteral combination, is a white to off-white sterile, cryodesiccated powder consisting of piperacillin and tazobactam as their sodium salts packaged in glass bottles.  The product does not contain excipients or preservatives. The pharmacy bulk package bottle is a container of sterile preparation which contains many single doses for parenteral use.  The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion. Each piperacillin and tazobactam for injection 40.5 g pharmacy bulk package bottle contains piperacillin sodium equivalent to 36 grams of piperacillin and tazobactam sodium equivalent to 4.5 g of tazobactam sufficient for delivery of multiple doses. Piperacillin and tazobactam for injection is a monosodium salt of piperacillin and a monosodium salt of tazobactam containing a total of 2.35 mEq (54 mg) of sodium (Na +) per gram of piperacillin in the combination product."
    },
    {
      "NDCCode": "63323-505-74",
      "PackageDescription": "250 mL in 1 BAG (63323-505-74) ",
      "NDC11Code": "63323-0505-74",
      "ProductNDC": "63323-505",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Citrate Blood",
      "ProprietaryNameSuffix": "Pack Units, (pl 146 Plastic)",
      "NonProprietaryName": "Anticoagulant Sodium Citrate Solution",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20140929",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "BN770923",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "TRISODIUM CITRATE DIHYDRATE",
      "StrengthNumber": "4",
      "StrengthUnit": "g/100mL",
      "Pharm_Classes": "Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2023-04-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20140929",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "63323-517-74",
      "PackageDescription": "24 BAG in 1 CASE (63323-517-74)  / 250 mL in 1 BAG (63323-517-01) ",
      "NDC11Code": "63323-0517-74",
      "ProductNDC": "63323-517",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Heparin Sodium",
      "NonProprietaryName": "Heparin Sodium",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20170824",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA017029",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "HEPARIN SODIUM",
      "StrengthNumber": "10000",
      "StrengthUnit": "[USP'U]/100mL",
      "Pharm_Classes": "Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-05-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20170824",
      "SamplePackage": "N",
      "IndicationAndUsage": "Heparin sodium is indicated for: 1 Prophylaxis and treatment of venous thromboembolism and pulmonary embolism;, 2 Atrial fibrillation with embolization; , 3 Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation); , 4 Prevention of clotting in arterial and cardiac surgery; , 5 Prophylaxis and treatment of peripheral arterial embolism; , 6 Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures. .",
      "Description": "Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans, possessing anticoagulant properties.  It is composed of polymers of alternating derivations of α-D-glucosamido (N-sulfated O-sulfated O-sulfated or N-acetylated) and O-sulfated uronic acid (α-L-iduronic acid or β-D-glucoronic acid). Structure of Heparin Sodium (representative subunits). Heparin Sodium in 0.45% Sodium Chloride Injection and Heparin Sodium in 5% Dextrose Injection are sterile, nonpyrogenic solutions prepared from heparin sodium (derived from porcine intestinal mucosa) for intravenous administration.  The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. Heparin Sodium in 0.45% Sodium Chloride Injection, is available as follows. Each 100 mL contains heparin sodium 5,000 or 10,000 USP Units; sodium chloride, 0.45 g; edetate disodium, dihydrate, 0.0111 g added as a stabilizer and water for injection, q.s.  Each liter contains the following electrolytes: Sodium 77 mEq and chloride 77 mEq; pH 5.0 to 7.5.  The solution may contain sodium hydroxide and/or hydrochloric acid for pH adjustment. Heparin Sodium in 5% Dextrose Injection, is available as follows. Each 100 mL contains heparin sodium 5,000 or 10,000 USP Units; dextrose hydrous, 5 g; citric acid anhydrous, 51 mg and sodium citrate dihydrate, 334 mg added as buffers; and sodium metabisulfite, 20 mg added as an antioxidant.  Each liter contains the following electrolytes: Sodium 39 mEq and citrate 42 mEq; pH 5.0 to 7.5."
    },
    {
      "NDCCode": "63323-523-74",
      "PackageDescription": "24 BAG in 1 CASE (63323-523-74)  / 250 mL in 1 BAG (63323-523-01) ",
      "NDC11Code": "63323-0523-74",
      "ProductNDC": "63323-523",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Heparin Sodium",
      "NonProprietaryName": "Heparin Sodium",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20170824",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA017029",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "HEPARIN SODIUM",
      "StrengthNumber": "10000",
      "StrengthUnit": "[USP'U]/100mL",
      "Pharm_Classes": "Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-05-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20170824",
      "SamplePackage": "N",
      "IndicationAndUsage": "Heparin sodium is indicated for: 1 Prophylaxis and treatment of venous thromboembolism and pulmonary embolism;, 2 Atrial fibrillation with embolization; , 3 Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation); , 4 Prevention of clotting in arterial and cardiac surgery; , 5 Prophylaxis and treatment of peripheral arterial embolism; , 6 Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures. .",
      "Description": "Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans, possessing anticoagulant properties.  It is composed of polymers of alternating derivations of α-D-glucosamido (N-sulfated O-sulfated O-sulfated or N-acetylated) and O-sulfated uronic acid (α-L-iduronic acid or β-D-glucoronic acid). Structure of Heparin Sodium (representative subunits). Heparin Sodium in 0.45% Sodium Chloride Injection and Heparin Sodium in 5% Dextrose Injection are sterile, nonpyrogenic solutions prepared from heparin sodium (derived from porcine intestinal mucosa) for intravenous administration.  The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. Heparin Sodium in 0.45% Sodium Chloride Injection, is available as follows. Each 100 mL contains heparin sodium 5,000 or 10,000 USP Units; sodium chloride, 0.45 g; edetate disodium, dihydrate, 0.0111 g added as a stabilizer and water for injection, q.s.  Each liter contains the following electrolytes: Sodium 77 mEq and chloride 77 mEq; pH 5.0 to 7.5.  The solution may contain sodium hydroxide and/or hydrochloric acid for pH adjustment. Heparin Sodium in 5% Dextrose Injection, is available as follows. Each 100 mL contains heparin sodium 5,000 or 10,000 USP Units; dextrose hydrous, 5 g; citric acid anhydrous, 51 mg and sodium citrate dihydrate, 334 mg added as buffers; and sodium metabisulfite, 20 mg added as an antioxidant.  Each liter contains the following electrolytes: Sodium 39 mEq and citrate 42 mEq; pH 5.0 to 7.5."
    },
    {
      "NDCCode": "63323-623-74",
      "PackageDescription": "250 mL in 1 BAG (63323-623-74) ",
      "NDC11Code": "63323-0623-74",
      "ProductNDC": "63323-623",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Chloride",
      "NonProprietaryName": "Sodium Chloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20170919",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207310",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "SODIUM CHLORIDE",
      "StrengthNumber": "9",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-04-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20170919",
      "SamplePackage": "N",
      "IndicationAndUsage": "Intravenous solutions containing sodium chloride are indicated for parenteral replenishment of fluid and sodium chloride as required by the clinical condition of the patient.",
      "Description": "0.9% Sodium Chloride Injection, USP solution is sterile and nonpyrogenic. It is a parenteral solution containing sodium chloride in water for injection intended for intravenous administration. For 0.9% Sodium Chloride Injection, USP, each 100 mL contains 900 mg sodium chloride in water for injection. Electrolytes per 1,000 mL: sodium 154 mEq; chloride 154 mEq. The osmolarity is 308 mOsmol/L (calc.). The pH in the 100 mL and smaller containers is 6.0; for the 250 mL and larger containers, the pH is 5.6. The pH range is 4.5 to 7.0 for all containers. The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded. The solution is a parenteral fluid and electrolyte replenisher. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for injection, USP is chemically designated H2O. The flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers (freeflex® bag). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers."
    },
    {
      "NDCCode": "63323-624-74",
      "PackageDescription": "30 BAG in 1 CASE (63323-624-74)  / 250 mL in 1 BAG (63323-624-04) ",
      "NDC11Code": "63323-0624-74",
      "ProductNDC": "63323-624",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dextrose",
      "NonProprietaryName": "Dextrose Monohydrate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20161021",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207449",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "DEXTROSE MONOHYDRATE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2024-04-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20161021",
      "SamplePackage": "N",
      "IndicationAndUsage": "Intravenous solutions containing dextrose are indicated for parenteral replenishment of fluid and minimal carbohydrate calories as required by the clinical condition of the patient.",
      "Description": "5% Dextrose Injection, USP solution is sterile and nonpyrogenic.  It is a parenteral solution containing dextrose in water for injection intended for intravenous administration. Each 100 mL of 5% Dextrose Injection, USP, contains dextrose monohydrate, 5 g in water for injection.  The caloric value is 170 kcal/L.  The osmolarity is 252 mOsmol/L (calc.), which is slightly hypotonic. The solution pH is 4.3 (3.2 to 6.5). This solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only as a single-dose injection.  When smaller doses are required the unused portion should be discarded. 5% Dextrose Injection, USP is a parenteral fluid and nutrient replenisher. Dextrose, USP is chemically designated D-glucose monohydrate (C 6H 12O 6  H 2O), a hexose sugar freely soluble in water.  It has the following structural formula:. Water for Injection, USP is chemically designated H 2O. The flexible container is fabricated from a specially formulated non-plasticized film containing polypropylene and thermoplastic elastomers ( freeflex® bag).  The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly.  Solutions in contact with the flexible container can leach out certain of the container’s chemical components in very small amounts within the expiration period.  The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers."
    },
    {
      "NDCCode": "63323-820-74",
      "PackageDescription": "10 BAG in 1 CASE (63323-820-74)  / 250 mL in 1 BAG (63323-820-04) ",
      "NDC11Code": "63323-0820-74",
      "ProductNDC": "63323-820",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Smoflipid",
      "NonProprietaryName": "Smoflipid",
      "DosageFormName": "INJECTION, EMULSION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20160713",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA207648",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "SOYBEAN OIL; MEDIUM-CHAIN TRIGLYCERIDES; OLIVE OIL; FISH OIL",
      "StrengthNumber": "6; 6; 5; 3",
      "StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL",
      "Pharm_Classes": "Lipid Emulsion [EPC], Lipid Emulsion [EPC], Lipids [CS], Lipids [CS]",
      "Status": "Active",
      "LastUpdate": "2025-09-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160713",
      "SamplePackage": "N",
      "IndicationAndUsage": "SMOFlipid is indicated in adult and pediatric patients, including term and preterm neonates, as a source of calories and essential fatty acids for parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated.",
      "Description": "SMOFlipid is a sterile, nonpyrogenic, white, homogenous lipid emulsion for intravenous infusion. The lipid content of SMOFlipid is 0.2 g/mL, and comprises a mixture of soybean oil, MCTs, olive oil, and fish oil. The mean concentration of linoleic acid (an omega-6 essential fatty acid) is 35 mg/mL (range of 28 to 50 mg/mL), and alpha-linolenic acid (an omega-3 essential fatty acid) is 4.5 mg/mL (range of 3 to 7 mg/mL). The phosphate content is 15 mmol/L. The total energy content, including fat, phospholipids, and glycerol is 2,000 kcal/L. Each 100 mL of SMOFlipid contains approximately 6 g soybean oil, 6 g MCT, 5 g olive oil, 3 g fish oil, 1.2 g egg phospholipids, 2.5 g glycerin, 16.3 to 22.5 mg all-rac-alpha-tocopherol, 0.03 g sodium oleate, water for injection, and sodium hydroxide for pH adjustment (pH 6 to 9). SMOFlipid has an osmolality of approximately 380 mOsm/kg water (which represents an osmolarity of 270 mOsm/L). The oils included in SMOFlipid consist of a mixture of triglycerides of predominantly unsaturated fatty acids with the following structure:. where , , and are saturated and unsaturated fatty acid residues. The major components of the fatty acids in SMOFlipid are oleic acid (23% to 35%), linoleic acid (14% to 25%), caprylic acid (13% to 24%), palmitic acid (7% to 12%), capric acid (5% to 15%), stearic acid (1.5% to 4%), alpha-linolenic acid (1.5% to 3.5%), eicosapentaenoic acid (EPA; 1% to 3.5%), and docosahexaenoic acid (DHA; 1% to 3.5%). SMOFlipid contains no more than 25 mcg/L of aluminum. The container is not made with natural rubber latex, PVC, or DEHP."
    },
    {
      "NDCCode": "63323-824-74",
      "PackageDescription": "30 BAG in 1 CASE (63323-824-74)  / 250 mL in 1 BAG (63323-824-24) ",
      "NDC11Code": "63323-0824-74",
      "ProductNDC": "63323-824",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dextrose",
      "NonProprietaryName": "Dextrose Monohydrate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20190329",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209448",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "DEXTROSE MONOHYDRATE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2026-03-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190329",
      "SamplePackage": "N",
      "IndicationAndUsage": "Dextrose Injection is indicated as source of water and calories.",
      "Description": "10% Dextrose Injection, USP is a sterile, non-pyrogenic solution for fluid replenishment and caloric supply in single dose containers for intravenous administration. The solution contains no bacteriostatic, antimicrobial agent or added buffer and is intended only for use as a single-dose injection. The pH range is 4.0 (3.2 to 6.5). Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6  H2O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula:. Water for Injection, USP is chemically designated H2O. Dextrose is derived from corn. The flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers (freeflex® bag). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers. The flexible container is a closed system, and air is prefilled in the container to facilitate drainage. The container does not require entry of external air during administration. The container has two ports: one is the administration outlet port for attachment of an intravenous administration set and the other port has a medication site for addition of supplemental medication ([see Instructions for Use (2.3)]). The primary function of the overwrap is to protect the container from the physical environment."
    },
    {
      "NDCCode": "63323-850-04",
      "PackageDescription": "12 BAG in 1 CASE (63323-850-04)  / 250 mL in 1 BAG (63323-850-74) ",
      "NDC11Code": "63323-0850-04",
      "ProductNDC": "63323-850",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Moxifloxacin",
      "NonProprietaryName": "Moxifloxacin Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20150318",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA205572",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "MOXIFLOXACIN HYDROCHLORIDE",
      "StrengthNumber": "400",
      "StrengthUnit": "mg/250mL",
      "Pharm_Classes": "Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]",
      "Status": "Active",
      "LastUpdate": "2024-05-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20150318",
      "SamplePackage": "N",
      "IndicationAndUsage": "Moxifloxacin Injection is a fluoroquinolone antibacterial drug indicated for treating infections in adults ≥ 18 years of age caused by designated, susceptible bacteria. (1, 12.4) : 1 Community Acquired Pneumonia (1.1) , 2 Skin and Skin Structure Infections: Uncomplicated (1.2) and Complicated (1.3) , 3 Complicated Intra-Abdominal Infections (1.4) , 4 Acute Bacterial Sinusitis (1.5) , 5 Acute Bacterial Exacerbation of Chronic Bronchitis (1.6) .",
      "Description": "Moxifloxacin is a synthetic broad spectrum antibacterial agent for intravenous administration. Moxifloxacin, a fluoroquinolone, is available as a buffered monohydrochloride salt of 1-cyclopropyl-7-[(S,S)-2,8-diazabicyclo[4.3.0]non-8-yl]-6- fluoro-8-methoxy-1,4-dihydro-4-oxo-3 quinoline carboxylic acid. It is a slightly yellow to yellow crystalline substance. Its chemical structure is as follows:. Moxifloxacin Injection is sterile solution for infusion in a ready-to-use, single-dose flexible bag."
    },
    {
      "NDCCode": "63323-850-74",
      "PackageDescription": "250 mL in 1 BAG (63323-850-74) ",
      "NDC11Code": "63323-0850-74",
      "ProductNDC": "63323-850",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Moxifloxacin",
      "NonProprietaryName": "Moxifloxacin Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20150318",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA205572",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "MOXIFLOXACIN HYDROCHLORIDE",
      "StrengthNumber": "400",
      "StrengthUnit": "mg/250mL",
      "Pharm_Classes": "Quinolone Antimicrobial [EPC], Quinolones [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2023-04-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20150318",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "63323-867-74",
      "PackageDescription": "20 BAG in 1 CASE (63323-867-74)  / 500 mL in 1 BAG",
      "NDC11Code": "63323-0867-74",
      "ProductNDC": "63323-867",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dextrose And Sodium Chloride",
      "NonProprietaryName": "Dextrose Monohydrate And Sodium Chloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20201026",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211194",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE",
      "StrengthNumber": "5; .3",
      "StrengthUnit": "g/100mL; g/100mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-05-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20201026",
      "SamplePackage": "N",
      "IndicationAndUsage": "Intravenous solutions containing dextrose and sodium chloride are indicated for parenteral replenishment of fluid, minimal carbohydrate calories, and sodium chloride as required by the clinical condition of the patient.",
      "Description": "Dextrose and Sodium Chloride Injection, USP solutions are sterile and nonpyrogenic. They are large volume parenteral solutions containing 5 grams per 100 mL of Dextrose and 0.3 grams per 100 mL of Sodium Chloride in water for injection intended for intravenous administration. See Table for summary of content and characteristics of these solutions. The solutions contain no bacteriostat, antimicrobial agent or added buffer and each is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded. The solutions are parenteral fluid, nutrient and electrolyte replenishers. Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6  H2O), a hexose sugar freely soluble in water. It has the following structural formula:. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H2O. The flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers (freeflex® bag). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers."
    },
    {
      "NDCCode": "63323-869-74",
      "PackageDescription": "20 BAG in 1 CASE (63323-869-74)  / 500 mL in 1 BAG (63323-869-04) ",
      "NDC11Code": "63323-0869-74",
      "ProductNDC": "63323-869",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dextrose And Sodium Chloride",
      "NonProprietaryName": "Dextrose Monohydrate And Sodium Chloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20201026",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211276",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE",
      "StrengthNumber": "5; .45",
      "StrengthUnit": "g/100mL; g/100mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-10-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201026",
      "SamplePackage": "N",
      "IndicationAndUsage": "Intravenous solutions containing dextrose and sodium chloride are indicated for parenteral replenishment of fluid, minimal carbohydrate calories, and sodium chloride as required by the clinical condition of the patient.",
      "Description": "5% Dextrose and 0.45% Sodium Chloride Injection, USP solutions are sterile and nonpyrogenic. They are large volume parenteral solutions containing 5 grams per 100 mL of Dextrose monohydrate and 0.45 grams per 100 mL of Sodium Chloride in water for injection intended for intravenous administration. Each 100 mL of 5% Dextrose and 0.45% Sodium Chloride Injection, USP contains dextrose, hydrous 5 g and sodium chloride 0.45 g in water for injection. Electrolytes per 1000 mL: sodium (Na+), 77 mEq; chloride (Cl-) 77 mEq. The osmolarity is 406 mOsmol/L (calc.), which is hypertonic. The caloric value is 170 kcal/L. The pH is 4.3 (3.5 to 6.5). 5% Dextrose and 0.45% Sodium Chloride Injection, USP contains no bacteriostat, antimicrobial agent or added buffer and is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded. 5% Dextrose and 0.45% Sodium Chloride Injection, USP is a parenteral fluid, nutrient and electrolyte replenisher. Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6  H2O), a hexose sugar freely soluble in water. It has the following structural formula:. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H2O. The flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers (freeflex® bag). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers."
    },
    {
      "NDCCode": "63323-870-74",
      "PackageDescription": "10 BAG in 1 CASE (63323-870-74)  / 1000 mL in 1 BAG (63323-870-04) ",
      "NDC11Code": "63323-0870-74",
      "ProductNDC": "63323-870",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dextrose And Sodium Chloride",
      "NonProprietaryName": "Dextrose Monohydrate And Sodium Chloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20201026",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211211",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE",
      "StrengthNumber": "5; .9",
      "StrengthUnit": "g/100mL; g/100mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-11-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201026",
      "SamplePackage": "N",
      "IndicationAndUsage": "Intravenous solutions containing dextrose and sodium chloride are indicated for parenteral replenishment of fluid, minimal carbohydrate calories, and sodium chloride as required by the clinical condition of the patient.",
      "Description": "Dextrose and Sodium Chloride Injection, USP solutions are sterile and nonpyrogenic. They are large volume parenteral solutions containing 5 grams per 100 mL of Dextrose monohydrate and 0.9 grams per 100 mL of Sodium Chloride in water for injection intended for intravenous administration. Electrolytes per 1000 mL: sodium (Na+), 154 mEq; chloride (Cl-) 154 mEq. The osmolarity is 560 mOsmol/L (calc.), which is hypertonic. The caloric value is 170 kcal/L. The pH is 4.3 (3.5 to 6.5). The solutions contain no bacteriostat, antimicrobial agent or added buffer and each is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded. The solutions are parenteral fluid, nutrient and electrolyte replenishers. Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6  H2O), a hexose sugar freely soluble in water. It has the following structural formula:. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H2O. The flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers (freeflex® bag). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers."
    },
    {
      "NDCCode": "63323-873-74",
      "PackageDescription": "20 BAG in 1 CASE (63323-873-74)  > 500 mL in 1 BAG",
      "NDC11Code": "63323-0873-74",
      "ProductNDC": "63323-873",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dextrose And Sodium Chloride",
      "NonProprietaryName": "Dextrose Monohydrate And Sodium Chloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20201026",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211221",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE",
      "StrengthNumber": "5; .225",
      "StrengthUnit": "g/100mL; g/100mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
      "Status": "Active",
      "LastUpdate": "2021-01-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201026",
      "SamplePackage": "N",
      "IndicationAndUsage": "Intravenous solutions containing dextrose and sodium chloride are indicated for parenteral replenishment of fluid, minimal carbohydrate calories, and sodium chloride as required by the clinical condition of the patient.",
      "Description": "Dextrose and Sodium Chloride Injection, USP solutions are sterile and nonpyrogenic. They are large volume parenteral solutions containing 5 grams per 100 mL of Dextrose monohydrate and 0.225 grams per 100 mL of Sodium Chloride in water for injection intended for intravenous administration. Each 100 mL of 5% Dextrose and 0.225% Sodium Chloride Injection, USP contains dextrose, hydrous 5g and sodium chloride 0.225g in water for injection. Electrolytes per 1000 mL: sodium (Na+), 38.5 mEq; chloride (Cl-) 38.5 mEq. The osmolarity is 329 mOsmol/L (calc.), which is hypertonic. The caloric value is 170 kcal/L. The pH is 4.3 (3.5 to 6.5). 5% Dextrose and 0.225% Sodium Chloride Injection, USP contains no bacteriostat, antimicrobial agent or added buffer and each is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded. 5% Dextrose and 0.225% Sodium Chloride Injection, USP are parenteral fluid, nutrient and electrolyte replenishers. Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6  H2O), a hexose sugar freely soluble in water. It has the following structural formula:. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H2O. The flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers (freeflex® bag). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers."
    },
    {
      "NDCCode": "63323-712-10",
      "PackageDescription": "1026 mL in 1 BAG (63323-712-10) ",
      "NDC11Code": "63323-0712-10",
      "ProductNDC": "63323-712",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Kabiven",
      "NonProprietaryName": "Dextrose, Soybean Oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid And Tyrosine",
      "DosageFormName": "INJECTION, EMULSION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20140825",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA200656",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "DEXTROSE MONOHYDRATE; SOYBEAN OIL; SODIUM ACETATE; POTASSIUM CHLORIDE; SODIUM GLYCEROPHOSPHATE ANHYDROUS; MAGNESIUM SULFATE HEPTAHYDRATE; CALCIUM CHLORIDE; LYSINE HYDROCHLORIDE; PHENYLALANINE; LEUCINE; VALINE; HISTIDINE; THREONINE; METHIONINE; ISOLEUCINE; TRYPTOPHAN; ALANINE; ARGININE; GLYCINE; PROLINE; GLUTAMIC ACID; SERINE; ASPARTIC ACID; TYROSINE",
      "StrengthNumber": "10.8; 3.9; 239; 174; 147; 96; 29; 263; 231; 231; 213; 199; 164; 164; 164; 55; 467; 330; 231; 199; 164; 131; 99; 6.7",
      "StrengthUnit": "g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
      "Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Lipid Emulsion [EPC], Lipids [CS], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2025-10-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20140825",
      "SamplePackage": "N",
      "IndicationAndUsage": "KABIVEN is indicated as a source of calories, protein, electrolytes and essential fatty acids for adult patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. KABIVEN may be used to prevent essential fatty acid deficiency or treat negative nitrogen balance in adult patients. Limitations of Use. KABIVEN is not recommended for use in pediatric patients under the age of 2 years, including preterm infants because the fixed content of the formulation does not meet the nutritional requirements of this age group [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)].",
      "Description": "KABIVEN is a sterile, hypertonic emulsion, for central venous administration, in a Three Chamber Bag. The product contains no added sulfites. Chamber 1 contains Dextrose monohydrate solution for fluid replenishment and caloric supply. Chamber 2 contains the Amino Acid solution with Electrolytes, which comprises essential and nonessential amino acids provided with electrolytes. Chamber 3 contains Intralipid® 20% (a 20% Lipid Injectable Emulsion), prepared for intravenous administration as a source of calories and essential fatty acids. See below for formulations of each chamber and Table 2 for strength, pH, osmolarity, ionic concentration and caloric content of KABIVEN when all the chambers are mixed together. Chamber 1: Contains sterile, hypertonic solution of Dextrose, USP in water for injection with a pH range of 3.5 to 5.5. Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6  H2O) and has the following structure:. Dextrose is derived from corn. Chamber 2: Contains a sterile, solution of amino acids and electrolytes in water for injection. In addition, glacial acetic acid has been added to adjust the pH so that the final solution pH is 5.4 to 5.8. The formulas for the individual electrolytes and amino acids are as follows:. Chamber 3: Contains a 20% Lipid Injectable Emulsion (Intralipid® 20%) which is made up of 20% Soybean Oil, 1.2% Egg Yolk Phospholipids, 2.25% Glycerin, and water for injection. In addition, sodium hydroxide has been added to adjust the pH. The final product pH range is 6 to 9. The soybean oil is a refined natural product consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure:. where are saturated and unsaturated fatty acid residues. The major component fatty acids are linoleic (48 to 58 %), oleic (17 to 30%), palmitic (9 to 13%), linolenic (5 to 11%) and stearic acid (2.5 to 5%). These fatty acids have the following chemical and structural formulas:. Purified egg phosphatides are a mixture of naturally occurring phospholipids which are isolated from the egg yolk. These phospholipids have the following general structure:. contain saturated and unsaturated fatty acids that abound in neutral fats. R3 is primarily either the choline or ethanolamine ester of phosphoric acid. Glycerin is chemically designated C3H8O3 and is a clear colorless, hygroscopic syrupy liquid. It has the following structural formula:. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional oxygen and moisture barrier when necessary. An oxygen absorber is placed between the inner bag and the overpouch. The container is not made with natural rubber latex or polyvinyl chloride (PVC). KABIVEN contains no more than 25 mcg/L of aluminum."
    },
    {
      "NDCCode": "63323-712-15",
      "PackageDescription": "1540 mL in 1 BAG (63323-712-15) ",
      "NDC11Code": "63323-0712-15",
      "ProductNDC": "63323-712",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Kabiven",
      "NonProprietaryName": "Dextrose, Soybean Oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid And Tyrosine",
      "DosageFormName": "INJECTION, EMULSION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20140825",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA200656",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "DEXTROSE MONOHYDRATE; SOYBEAN OIL; SODIUM ACETATE; POTASSIUM CHLORIDE; SODIUM GLYCEROPHOSPHATE ANHYDROUS; MAGNESIUM SULFATE HEPTAHYDRATE; CALCIUM CHLORIDE; LYSINE HYDROCHLORIDE; PHENYLALANINE; LEUCINE; VALINE; HISTIDINE; THREONINE; METHIONINE; ISOLEUCINE; TRYPTOPHAN; ALANINE; ARGININE; GLYCINE; PROLINE; GLUTAMIC ACID; SERINE; ASPARTIC ACID; TYROSINE",
      "StrengthNumber": "10.8; 3.9; 239; 174; 147; 96; 29; 263; 231; 231; 213; 199; 164; 164; 164; 55; 467; 330; 231; 199; 164; 131; 99; 6.7",
      "StrengthUnit": "g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
      "Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Lipid Emulsion [EPC], Lipids [CS], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2025-10-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20140825",
      "SamplePackage": "N",
      "IndicationAndUsage": "KABIVEN is indicated as a source of calories, protein, electrolytes and essential fatty acids for adult patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. KABIVEN may be used to prevent essential fatty acid deficiency or treat negative nitrogen balance in adult patients. Limitations of Use. KABIVEN is not recommended for use in pediatric patients under the age of 2 years, including preterm infants because the fixed content of the formulation does not meet the nutritional requirements of this age group [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)].",
      "Description": "KABIVEN is a sterile, hypertonic emulsion, for central venous administration, in a Three Chamber Bag. The product contains no added sulfites. Chamber 1 contains Dextrose monohydrate solution for fluid replenishment and caloric supply. Chamber 2 contains the Amino Acid solution with Electrolytes, which comprises essential and nonessential amino acids provided with electrolytes. Chamber 3 contains Intralipid® 20% (a 20% Lipid Injectable Emulsion), prepared for intravenous administration as a source of calories and essential fatty acids. See below for formulations of each chamber and Table 2 for strength, pH, osmolarity, ionic concentration and caloric content of KABIVEN when all the chambers are mixed together. Chamber 1: Contains sterile, hypertonic solution of Dextrose, USP in water for injection with a pH range of 3.5 to 5.5. Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6  H2O) and has the following structure:. Dextrose is derived from corn. Chamber 2: Contains a sterile, solution of amino acids and electrolytes in water for injection. In addition, glacial acetic acid has been added to adjust the pH so that the final solution pH is 5.4 to 5.8. The formulas for the individual electrolytes and amino acids are as follows:. Chamber 3: Contains a 20% Lipid Injectable Emulsion (Intralipid® 20%) which is made up of 20% Soybean Oil, 1.2% Egg Yolk Phospholipids, 2.25% Glycerin, and water for injection. In addition, sodium hydroxide has been added to adjust the pH. The final product pH range is 6 to 9. The soybean oil is a refined natural product consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure:. where are saturated and unsaturated fatty acid residues. The major component fatty acids are linoleic (48 to 58 %), oleic (17 to 30%), palmitic (9 to 13%), linolenic (5 to 11%) and stearic acid (2.5 to 5%). These fatty acids have the following chemical and structural formulas:. Purified egg phosphatides are a mixture of naturally occurring phospholipids which are isolated from the egg yolk. These phospholipids have the following general structure:. contain saturated and unsaturated fatty acids that abound in neutral fats. R3 is primarily either the choline or ethanolamine ester of phosphoric acid. Glycerin is chemically designated C3H8O3 and is a clear colorless, hygroscopic syrupy liquid. It has the following structural formula:. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional oxygen and moisture barrier when necessary. An oxygen absorber is placed between the inner bag and the overpouch. The container is not made with natural rubber latex or polyvinyl chloride (PVC). KABIVEN contains no more than 25 mcg/L of aluminum."
    },
    {
      "NDCCode": "63323-712-20",
      "PackageDescription": "2053 mL in 1 BAG (63323-712-20) ",
      "NDC11Code": "63323-0712-20",
      "ProductNDC": "63323-712",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Kabiven",
      "NonProprietaryName": "Dextrose, Soybean Oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid And Tyrosine",
      "DosageFormName": "INJECTION, EMULSION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20140825",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA200656",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "DEXTROSE MONOHYDRATE; SOYBEAN OIL; SODIUM ACETATE; POTASSIUM CHLORIDE; SODIUM GLYCEROPHOSPHATE ANHYDROUS; MAGNESIUM SULFATE HEPTAHYDRATE; CALCIUM CHLORIDE; LYSINE HYDROCHLORIDE; PHENYLALANINE; LEUCINE; VALINE; HISTIDINE; THREONINE; METHIONINE; ISOLEUCINE; TRYPTOPHAN; ALANINE; ARGININE; GLYCINE; PROLINE; GLUTAMIC ACID; SERINE; ASPARTIC ACID; TYROSINE",
      "StrengthNumber": "10.8; 3.9; 239; 174; 147; 96; 29; 263; 231; 231; 213; 199; 164; 164; 164; 55; 467; 330; 231; 199; 164; 131; 99; 6.7",
      "StrengthUnit": "g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
      "Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Lipid Emulsion [EPC], Lipids [CS], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2025-10-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20140825",
      "SamplePackage": "N",
      "IndicationAndUsage": "KABIVEN is indicated as a source of calories, protein, electrolytes and essential fatty acids for adult patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. KABIVEN may be used to prevent essential fatty acid deficiency or treat negative nitrogen balance in adult patients. Limitations of Use. KABIVEN is not recommended for use in pediatric patients under the age of 2 years, including preterm infants because the fixed content of the formulation does not meet the nutritional requirements of this age group [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)].",
      "Description": "KABIVEN is a sterile, hypertonic emulsion, for central venous administration, in a Three Chamber Bag. The product contains no added sulfites. Chamber 1 contains Dextrose monohydrate solution for fluid replenishment and caloric supply. Chamber 2 contains the Amino Acid solution with Electrolytes, which comprises essential and nonessential amino acids provided with electrolytes. Chamber 3 contains Intralipid® 20% (a 20% Lipid Injectable Emulsion), prepared for intravenous administration as a source of calories and essential fatty acids. See below for formulations of each chamber and Table 2 for strength, pH, osmolarity, ionic concentration and caloric content of KABIVEN when all the chambers are mixed together. Chamber 1: Contains sterile, hypertonic solution of Dextrose, USP in water for injection with a pH range of 3.5 to 5.5. Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6  H2O) and has the following structure:. Dextrose is derived from corn. Chamber 2: Contains a sterile, solution of amino acids and electrolytes in water for injection. In addition, glacial acetic acid has been added to adjust the pH so that the final solution pH is 5.4 to 5.8. The formulas for the individual electrolytes and amino acids are as follows:. Chamber 3: Contains a 20% Lipid Injectable Emulsion (Intralipid® 20%) which is made up of 20% Soybean Oil, 1.2% Egg Yolk Phospholipids, 2.25% Glycerin, and water for injection. In addition, sodium hydroxide has been added to adjust the pH. The final product pH range is 6 to 9. The soybean oil is a refined natural product consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure:. where are saturated and unsaturated fatty acid residues. The major component fatty acids are linoleic (48 to 58 %), oleic (17 to 30%), palmitic (9 to 13%), linolenic (5 to 11%) and stearic acid (2.5 to 5%). These fatty acids have the following chemical and structural formulas:. Purified egg phosphatides are a mixture of naturally occurring phospholipids which are isolated from the egg yolk. These phospholipids have the following general structure:. contain saturated and unsaturated fatty acids that abound in neutral fats. R3 is primarily either the choline or ethanolamine ester of phosphoric acid. Glycerin is chemically designated C3H8O3 and is a clear colorless, hygroscopic syrupy liquid. It has the following structural formula:. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional oxygen and moisture barrier when necessary. An oxygen absorber is placed between the inner bag and the overpouch. The container is not made with natural rubber latex or polyvinyl chloride (PVC). KABIVEN contains no more than 25 mcg/L of aluminum."
    },
    {
      "NDCCode": "63323-712-25",
      "PackageDescription": "2566 mL in 1 BAG (63323-712-25) ",
      "NDC11Code": "63323-0712-25",
      "ProductNDC": "63323-712",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Kabiven",
      "NonProprietaryName": "Dextrose, Soybean Oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid And Tyrosine",
      "DosageFormName": "INJECTION, EMULSION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20140825",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA200656",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "DEXTROSE MONOHYDRATE; SOYBEAN OIL; SODIUM ACETATE; POTASSIUM CHLORIDE; SODIUM GLYCEROPHOSPHATE ANHYDROUS; MAGNESIUM SULFATE HEPTAHYDRATE; CALCIUM CHLORIDE; LYSINE HYDROCHLORIDE; PHENYLALANINE; LEUCINE; VALINE; HISTIDINE; THREONINE; METHIONINE; ISOLEUCINE; TRYPTOPHAN; ALANINE; ARGININE; GLYCINE; PROLINE; GLUTAMIC ACID; SERINE; ASPARTIC ACID; TYROSINE",
      "StrengthNumber": "10.8; 3.9; 239; 174; 147; 96; 29; 263; 231; 231; 213; 199; 164; 164; 164; 55; 467; 330; 231; 199; 164; 131; 99; 6.7",
      "StrengthUnit": "g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
      "Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Lipid Emulsion [EPC], Lipids [CS], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2025-10-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20140825",
      "SamplePackage": "N",
      "IndicationAndUsage": "KABIVEN is indicated as a source of calories, protein, electrolytes and essential fatty acids for adult patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. KABIVEN may be used to prevent essential fatty acid deficiency or treat negative nitrogen balance in adult patients. Limitations of Use. KABIVEN is not recommended for use in pediatric patients under the age of 2 years, including preterm infants because the fixed content of the formulation does not meet the nutritional requirements of this age group [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)].",
      "Description": "KABIVEN is a sterile, hypertonic emulsion, for central venous administration, in a Three Chamber Bag. The product contains no added sulfites. Chamber 1 contains Dextrose monohydrate solution for fluid replenishment and caloric supply. Chamber 2 contains the Amino Acid solution with Electrolytes, which comprises essential and nonessential amino acids provided with electrolytes. Chamber 3 contains Intralipid® 20% (a 20% Lipid Injectable Emulsion), prepared for intravenous administration as a source of calories and essential fatty acids. See below for formulations of each chamber and Table 2 for strength, pH, osmolarity, ionic concentration and caloric content of KABIVEN when all the chambers are mixed together. Chamber 1: Contains sterile, hypertonic solution of Dextrose, USP in water for injection with a pH range of 3.5 to 5.5. Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6  H2O) and has the following structure:. Dextrose is derived from corn. Chamber 2: Contains a sterile, solution of amino acids and electrolytes in water for injection. In addition, glacial acetic acid has been added to adjust the pH so that the final solution pH is 5.4 to 5.8. The formulas for the individual electrolytes and amino acids are as follows:. Chamber 3: Contains a 20% Lipid Injectable Emulsion (Intralipid® 20%) which is made up of 20% Soybean Oil, 1.2% Egg Yolk Phospholipids, 2.25% Glycerin, and water for injection. In addition, sodium hydroxide has been added to adjust the pH. The final product pH range is 6 to 9. The soybean oil is a refined natural product consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure:. where are saturated and unsaturated fatty acid residues. The major component fatty acids are linoleic (48 to 58 %), oleic (17 to 30%), palmitic (9 to 13%), linolenic (5 to 11%) and stearic acid (2.5 to 5%). These fatty acids have the following chemical and structural formulas:. Purified egg phosphatides are a mixture of naturally occurring phospholipids which are isolated from the egg yolk. These phospholipids have the following general structure:. contain saturated and unsaturated fatty acids that abound in neutral fats. R3 is primarily either the choline or ethanolamine ester of phosphoric acid. Glycerin is chemically designated C3H8O3 and is a clear colorless, hygroscopic syrupy liquid. It has the following structural formula:. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional oxygen and moisture barrier when necessary. An oxygen absorber is placed between the inner bag and the overpouch. The container is not made with natural rubber latex or polyvinyl chloride (PVC). KABIVEN contains no more than 25 mcg/L of aluminum."
    },
    {
      "NDCCode": "63323-714-14",
      "PackageDescription": "1440 mL in 1 BAG (63323-714-14) ",
      "NDC11Code": "63323-0714-14",
      "ProductNDC": "63323-714",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Perikabiven",
      "NonProprietaryName": "Dextrose, Soybean Oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid And Tyrosine",
      "DosageFormName": "INJECTION, EMULSION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20140825",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA200656",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "DEXTROSE MONOHYDRATE; SOYBEAN OIL; SODIUM ACETATE; POTASSIUM CHLORIDE; SODIUM GLYCEROPHOSPHATE ANHYDROUS; MAGNESIUM SULFATE HEPTAHYDRATE; CALCIUM CHLORIDE; LYSINE HYDROCHLORIDE; PHENYLALANINE; LEUCINE; VALINE; HISTIDINE; THREONINE; METHIONINE; ISOLEUCINE; TRYPTOPHAN; ALANINE; ARGININE; GLYCINE; PROLINE; GLUTAMIC ACID; SERINE; ASPARTIC ACID; TYROSINE",
      "StrengthNumber": "7.5; 3.5; 170; 124; 105; 68; 20; 187; 164; 164; 152; 141; 116; 116; 116; 40; 333; 235; 164; 141; 116; 94; 71; 4.8",
      "StrengthUnit": "g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
      "Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Lipid Emulsion [EPC], Lipids [CS], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2025-10-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20140825",
      "SamplePackage": "N",
      "IndicationAndUsage": "PERIKABIVEN is indicated as a source of calories, protein, electrolytes and essential fatty acids for adult patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. PERIKABIVEN may be used to prevent essential fatty acid deficiency or treat negative nitrogen balance in adult patients.",
      "Description": "PERIKABIVEN is a sterile, hypertonic emulsion, for peripheral or central venous administration, in a Three Chamber Bag. The product contains no added sulfites. Chamber 1 contains Dextrose monohydrate solution for fluid replenishment and caloric supply. Chamber 2 contains the Amino Acid solution with Electrolytes, which comprises essential and nonessential amino acids provided with electrolytes. Chamber 3 contains Intralipid® 20% (a 20% Lipid Injectable Emulsion), prepared for intravenous administration as a source of calories and essential fatty acids. See below for formulations of each chamber and Table 2 for strength, pH, osmolarity, ionic concentration and caloric content of PERIKABIVEN when all the chambers are mixed together. Chamber 1: Contains sterile, hypertonic solution of Dextrose, USP in water for injection with a pH range of 3.5 to 5.5. Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6  H2O) and has the following structure:. Dextrose is derived from corn. Chamber 2: Contains a sterile solution of amino acids and electrolytes in water for injection. In addition, glacial acetic acid has been added to adjust the pH so that the final solution pH is 5.4 to 5.8. The formulas for the individual electrolytes and amino acids are as follows:. Chamber 3: Contains a 20% Lipid Injectable Emulsion (Intralipid® 20%) which is made up of 20% Soybean Oil, 1.2% Egg Yolk Phospholipids, 2.25% Glycerin, and water for injection. In addition, sodium hydroxide has been added to adjust the pH. The final product pH range is 6 to 9. The soybean oil is a refined natural product consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure:. where are saturated and unsaturated fatty acid residues. The major component fatty acids are linoleic (48 to 58 %), oleic (17 to 30%), palmitic (9 to 13%), linolenic (5 to 11%) and stearic acid (2.5 to 5%). These fatty acids have the following chemical and structural formulas:. Purified egg phosphatides are a mixture of naturally occurring phospholipids which are isolated from the egg yolk. These phospholipids have the following general structure:. contain saturated and unsaturated fatty acids that abound in neutral fats. R3 is primarily either the choline or ethanolamine ester of phosphoric acid. Glycerin is chemically designated C3H8O3 and is a clear colorless, hygroscopic syrupy liquid. It has the following structural formula:. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional oxygen and moisture barrier when necessary. An oxygen absorber is placed between the inner bag and the overpouch. The container is not made with natural rubber latex or polyvinyl chloride (PVC). PERIKABIVEN contains no more than 25 mcg/L of aluminum."
    },
    {
      "NDCCode": "63323-714-19",
      "PackageDescription": "1920 mL in 1 BAG (63323-714-19) ",
      "NDC11Code": "63323-0714-19",
      "ProductNDC": "63323-714",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Perikabiven",
      "NonProprietaryName": "Dextrose, Soybean Oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid And Tyrosine",
      "DosageFormName": "INJECTION, EMULSION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20140825",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA200656",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "DEXTROSE MONOHYDRATE; SOYBEAN OIL; SODIUM ACETATE; POTASSIUM CHLORIDE; SODIUM GLYCEROPHOSPHATE ANHYDROUS; MAGNESIUM SULFATE HEPTAHYDRATE; CALCIUM CHLORIDE; LYSINE HYDROCHLORIDE; PHENYLALANINE; LEUCINE; VALINE; HISTIDINE; THREONINE; METHIONINE; ISOLEUCINE; TRYPTOPHAN; ALANINE; ARGININE; GLYCINE; PROLINE; GLUTAMIC ACID; SERINE; ASPARTIC ACID; TYROSINE",
      "StrengthNumber": "7.5; 3.5; 170; 124; 105; 68; 20; 187; 164; 164; 152; 141; 116; 116; 116; 40; 333; 235; 164; 141; 116; 94; 71; 4.8",
      "StrengthUnit": "g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
      "Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Lipid Emulsion [EPC], Lipids [CS], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2025-10-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20140825",
      "SamplePackage": "N",
      "IndicationAndUsage": "PERIKABIVEN is indicated as a source of calories, protein, electrolytes and essential fatty acids for adult patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. PERIKABIVEN may be used to prevent essential fatty acid deficiency or treat negative nitrogen balance in adult patients.",
      "Description": "PERIKABIVEN is a sterile, hypertonic emulsion, for peripheral or central venous administration, in a Three Chamber Bag. The product contains no added sulfites. Chamber 1 contains Dextrose monohydrate solution for fluid replenishment and caloric supply. Chamber 2 contains the Amino Acid solution with Electrolytes, which comprises essential and nonessential amino acids provided with electrolytes. Chamber 3 contains Intralipid® 20% (a 20% Lipid Injectable Emulsion), prepared for intravenous administration as a source of calories and essential fatty acids. See below for formulations of each chamber and Table 2 for strength, pH, osmolarity, ionic concentration and caloric content of PERIKABIVEN when all the chambers are mixed together. Chamber 1: Contains sterile, hypertonic solution of Dextrose, USP in water for injection with a pH range of 3.5 to 5.5. Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6  H2O) and has the following structure:. Dextrose is derived from corn. Chamber 2: Contains a sterile solution of amino acids and electrolytes in water for injection. In addition, glacial acetic acid has been added to adjust the pH so that the final solution pH is 5.4 to 5.8. The formulas for the individual electrolytes and amino acids are as follows:. Chamber 3: Contains a 20% Lipid Injectable Emulsion (Intralipid® 20%) which is made up of 20% Soybean Oil, 1.2% Egg Yolk Phospholipids, 2.25% Glycerin, and water for injection. In addition, sodium hydroxide has been added to adjust the pH. The final product pH range is 6 to 9. The soybean oil is a refined natural product consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure:. where are saturated and unsaturated fatty acid residues. The major component fatty acids are linoleic (48 to 58 %), oleic (17 to 30%), palmitic (9 to 13%), linolenic (5 to 11%) and stearic acid (2.5 to 5%). These fatty acids have the following chemical and structural formulas:. Purified egg phosphatides are a mixture of naturally occurring phospholipids which are isolated from the egg yolk. These phospholipids have the following general structure:. contain saturated and unsaturated fatty acids that abound in neutral fats. R3 is primarily either the choline or ethanolamine ester of phosphoric acid. Glycerin is chemically designated C3H8O3 and is a clear colorless, hygroscopic syrupy liquid. It has the following structural formula:. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional oxygen and moisture barrier when necessary. An oxygen absorber is placed between the inner bag and the overpouch. The container is not made with natural rubber latex or polyvinyl chloride (PVC). PERIKABIVEN contains no more than 25 mcg/L of aluminum."
    },
    {
      "NDCCode": "63323-714-24",
      "PackageDescription": "2400 mL in 1 BAG (63323-714-24) ",
      "NDC11Code": "63323-0714-24",
      "ProductNDC": "63323-714",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Perikabiven",
      "NonProprietaryName": "Dextrose, Soybean Oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid And Tyrosine",
      "DosageFormName": "INJECTION, EMULSION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20140825",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA200656",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "ALANINE; ARGININE; ASPARTIC ACID; CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE HYDROCHLORIDE; MAGNESIUM SULFATE HEPTAHYDRATE; METHIONINE; PHENYLALANINE; POTASSIUM CHLORIDE; PROLINE; SERINE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE ANHYDROUS; SOYBEAN OIL; THREONINE; TRYPTOPHAN; TYROSINE; VALINE",
      "StrengthNumber": "333; 235; 71; 20; 6.8; 116; 164; 141; 116; 164; 187; 68; 116; 164; 174; 141; 94; 170; 105; 3.5; 116; 40; 4.8; 152",
      "StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
      "Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Lipid Emulsion [EPC], Lipids [CS], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2023-02-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20140825",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "63323-733-10",
      "PackageDescription": "10 VIAL, MULTI-DOSE in 1 TRAY (63323-733-10)  / 10 mL in 1 VIAL, MULTI-DOSE (63323-733-01) ",
      "NDC11Code": "63323-0733-10",
      "ProductNDC": "63323-733",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Mesna",
      "NonProprietaryName": "Mesna",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20010905",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075811",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "MESNA",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Cytoprotective Agent [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-10-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20010905",
      "SamplePackage": "N",
      "IndicationAndUsage": "Mesna Injection is indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis. Limitation of Use:Mesna Injection is not indicated to reduce the risk of hematuria due to other pathological conditions such as thrombocytopenia.",
      "Description": "Mesna Injection is a detoxifying agent to inhibit the hemorrhagic cystitis induced by ifosfamide.  The active ingredient, mesna, is a synthetic sulfhydryl compound designated as sodium-2-mercaptoethane sulfonate with a molecular formula of C2H5NaO3S2 and a molecular weight of 164.18.  Its structural formula is as follows:HS–CH2–CH2SO3–Na+ Mesna Injection is a sterile, nonpyrogenic, aqueous solution of clear and colorless appearance in clear glass multiple dose vials for intravenous administration.  Mesna Injection contains 100 mg/mL mesna, 0.25 mg/mL edetate disodium and sodium hydroxide for pH adjustment.  Mesna Injection multiple dose vials also contain 10.4 mg/mL of benzyl alcohol as a preservative.  The solution has a pH range of 6.5 to 8.5."
    },
    {
      "NDCCode": "63323-733-11",
      "PackageDescription": "1 VIAL, MULTI-DOSE in 1 BOX (63323-733-11)  / 10 mL in 1 VIAL, MULTI-DOSE",
      "NDC11Code": "63323-0733-11",
      "ProductNDC": "63323-733",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Mesna",
      "NonProprietaryName": "Mesna",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20010905",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075811",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "MESNA",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Cytoprotective Agent [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-10-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20010905",
      "SamplePackage": "N",
      "IndicationAndUsage": "Mesna Injection is indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis. Limitation of Use:Mesna Injection is not indicated to reduce the risk of hematuria due to other pathological conditions such as thrombocytopenia.",
      "Description": "Mesna Injection is a detoxifying agent to inhibit the hemorrhagic cystitis induced by ifosfamide.  The active ingredient, mesna, is a synthetic sulfhydryl compound designated as sodium-2-mercaptoethane sulfonate with a molecular formula of C2H5NaO3S2 and a molecular weight of 164.18.  Its structural formula is as follows:HS–CH2–CH2SO3–Na+ Mesna Injection is a sterile, nonpyrogenic, aqueous solution of clear and colorless appearance in clear glass multiple dose vials for intravenous administration.  Mesna Injection contains 100 mg/mL mesna, 0.25 mg/mL edetate disodium and sodium hydroxide for pH adjustment.  Mesna Injection multiple dose vials also contain 10.4 mg/mL of benzyl alcohol as a preservative.  The solution has a pH range of 6.5 to 8.5."
    },
    {
      "NDCCode": "42708-164-30",
      "PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (42708-164-30) ",
      "NDC11Code": "42708-0164-30",
      "ProductNDC": "42708-164",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydrochlorothiazide",
      "NonProprietaryName": "Hydrochlorothiazide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150115",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA085182",
      "LabelerName": "QPharma Inc",
      "SubstanceName": "HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Active",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230324",
      "SamplePackage": "Y",
      "IndicationAndUsage": "Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated  with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension. Use in Pregnancy. Routine use of diuretics during normal pregnancy is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of toxemia. Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy (see PRECAUTIONS, Pregnancy). Dependent edema in pregnancy, resulting from restriction of venous return by the gravid uterus, is properly treated through elevation of the lower extremities and use of support stockings. Use of diuretics to lower intravascular volume in this instance is illogical and unnecessary. During normal pregnancy there is hypervolemia  which is not harmful to the fetus or the mother in the absence of cardiovascular disease. However, it may be associated with edema, rarely generalized edema. If such edema causes discomfort, increased recumbency will often provide relief. Rarely this edema may cause extreme discomfort which is not relieved by rest. In these instances, a short course of diuretic therapy may provide relief and be appropriate.",
      "Description": "Hydrochlorothiazide is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. Its chemical name is 6-chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its molecular formula is C 7H 8CIN 3O 4S 2and its structural formula is:. It is a white, or practically white, crystalline powder with a molecular weight of 297.74 which is slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform and in dilute mineral acids. Each tablet for oral administration contains 12.5 mg, 25 mg or 50 mg of hydrochlorothiazide respectively. In addition, each tablet contains following inactive ingredients: anhydrous lactose, D&C Yellow No.10 aluminum lake, FD&C Red No. 40 aluminum lake, magnesium stearate, pregelatinized starch and sodium starch glycolate."
    },
    {
      "NDCCode": "63323-221-38",
      "PackageDescription": "25 VIAL in 1 TRAY (63323-221-38)  > 10 mL in 1 VIAL (63323-221-33) ",
      "NDC11Code": "63323-0221-38",
      "ProductNDC": "63323-221",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Vancomycin Hydrochloride",
      "NonProprietaryName": "Vancomycin Hydrochloride",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20171101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204107",
      "LabelerName": "Fresenius Kabi, LLC",
      "SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/10mL",
      "Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
      "Status": "Active",
      "LastUpdate": "2022-12-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20171101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Vancomycin Hydrochloride for Injection USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (ß-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin Hydrochloride for Injection USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin Hydrochloride for Injection USP is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections,  skin and skin-structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin Hydrochloride for Injection USP has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g.,  E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin Hydrochloride for Injection USP has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by   C. difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.",
      "Description": "Vancomycin Hydrochloride for Injection USP is a lyophilized powder for preparing intravenous (IV) infusions, in vials containing the equivalent of 500 mg vancomycin base. 500 mg of the base are equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection to a concentration of 50 mg/mL pH of the solution is between 2.5 and 4.5. This product is oxygen sensitive. Vancomycin Hydrochloride for Injection USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION). AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE. Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is 3S- [3 R*,6 S*( S*),7 S*,22 S*,23 R*,26 R*,36 S*,38a S*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-amino- 2,3,6-trideoxy-3-C-methyl-a-L-lyxo-hexopyranosyl)-ß-D-glucopyranosyl]oxy]-10,19-dichloro- 2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[[4-methyl- 2-(methylamino)-1-oxopentyl]amino]-2,5,24,38,39-pentaoxo-22 H-8,11:18,21-dietheno-23,36- (iminomethano)-13,16:31,35-dimetheno-1 H,16 H-[1,6,9]oxadiazacyclohexadecino[4,5- m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C 66H 75Cl 2N 9O 24 HCl and the molecular weight is 1,485.74. Vancomycin hydrochloride has the following structural formula:."
    }
  ]
}
                    

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Tyrosine</NonProprietaryName></NDC><NDC><NDCCode>63323-712-15</NDCCode><ProprietaryName>Kabiven</ProprietaryName><NonProprietaryName>Dextrose, Soybean Oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid And Tyrosine</NonProprietaryName></NDC><NDC><NDCCode>63323-712-20</NDCCode><ProprietaryName>Kabiven</ProprietaryName><NonProprietaryName>Dextrose, Soybean Oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid And Tyrosine</NonProprietaryName></NDC><NDC><NDCCode>63323-712-25</NDCCode><ProprietaryName>Kabiven</ProprietaryName><NonProprietaryName>Dextrose, Soybean Oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, 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Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid And Tyrosine</NonProprietaryName></NDC><NDC><NDCCode>63323-733-10</NDCCode><ProprietaryName>Mesna</ProprietaryName><NonProprietaryName>Mesna</NonProprietaryName></NDC><NDC><NDCCode>63323-733-11</NDCCode><ProprietaryName>Mesna</ProprietaryName><NonProprietaryName>Mesna</NonProprietaryName></NDC><NDC><NDCCode>42708-164-30</NDCCode><ProprietaryName>Hydrochlorothiazide</ProprietaryName><NonProprietaryName>Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>63323-221-38</NDCCode><ProprietaryName>Vancomycin Hydrochloride</ProprietaryName><NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName></NDC></NDCList>