RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "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": "73069-164-76",
      "PackageDescription": "12 VIAL, MULTI-DOSE in 1 BOX (73069-164-76)  > 50 mL in 1 VIAL, MULTI-DOSE",
      "NDC11Code": "73069-0164-76",
      "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": "63323-164-74",
      "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": "63323-178-76",
      "PackageDescription": "10 BAG in 1 CASE (63323-178-76)  > 1000 mL in 1 BAG",
      "NDC11Code": "63323-0178-76",
      "ProductNDC": "63323-178",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sterile Water",
      "NonProprietaryName": "Water",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20171124",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209689",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "WATER",
      "StrengthNumber": "1000",
      "StrengthUnit": "mL/1000mL",
      "Status": "Active",
      "LastUpdate": "2022-11-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20171124",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sterile Water for Injection is indicated for use only as a solvent or diluent vehicle for parenterally administered drugs or solutions and as a source of water for parenteral fluid replenishment after suitable additives are introduced. For intravenous administration, an osmolar concentration not less than two-fifths (0.4) of the normal osmolarity of the extracellular fluid (280 mOsmol/liter) is essential to avoid intravascular hemolysis.",
      "Description": "Sterile Water for Injection, USP is a sterile, nonpyrogenic, solute-free preparation of distilled water for injection.  It is for use only as a sterile solvent or diluent vehicle for drugs or solutions suitable for parenteral administration.  The pH is 5.5 (5.0 to 7.0). Sterile Water for Injection contains no bacteriostat, antimicrobial agent or added buffer and is intended only for single dose injection after admixture with an appropriate solute or solution.  When smaller amounts are required, the unused portion should be discarded. Sterile Water for Injection is a pharmaceutic aid (vehicle) and parenteral fluid replenisher after addition of an appropriate solute. 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": "63323-623-76",
      "PackageDescription": "1000 mL in 1 BAG (63323-623-76) ",
      "NDC11Code": "63323-0623-76",
      "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": "63323-824-76",
      "PackageDescription": "10 BAG in 1 CASE (63323-824-76)  / 1000 mL in 1 BAG (63323-824-26) ",
      "NDC11Code": "63323-0824-76",
      "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": "63323-712-10",
      "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": "31645-164-02",
      "PackageDescription": "1 TUBE in 1 BOX (31645-164-02)  > 35 g in 1 TUBE (31645-164-01)",
      "NDC11Code": "31645-0164-02",
      "ProductNDC": "31645-164",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Super Bb 10-in-1 Beauty Balm Cream",
      "ProprietaryNameSuffix": "Spf 30",
      "NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130105",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "PHYSICIANS FORMULA INC",
      "SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": "5.76; 2.94",
      "StrengthUnit": "g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "69315-164-01",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (69315-164-01) ",
      "NDC11Code": "69315-0164-01",
      "ProductNDC": "69315-164",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydroxyurea",
      "NonProprietaryName": "Hydroxyurea",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200709",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA213438",
      "LabelerName": "Leading Pharma, LLC",
      "SubstanceName": "HYDROXYUREA",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antimetabolite [EPC], Urea [CS]",
      "Status": "Active",
      "LastUpdate": "2024-10-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200709",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hydroxyurea capsules, USP is indicated for the treatment of: 1 Resistant chronic myeloid leukemia., 2 Locally advanced squamous cell carcinomas of the head and neck (excluding the lip) in combination with chemoradiation.",
      "Description": "Hydroxyurea Capsules USP is an antimetabolite available for oral use as capsules containing 500 mg hydroxyurea, USP. Inactive ingredients include Colorants (D&C Yellow No. 10, FD&C Red No.3, FD&C Blue No.1), gelatin, lactose anhydrous, magnesium stearate and silicon dioxide and titanium dioxide. Hydroxyurea is a White or almost white, crystalline powder. It is hygroscopic and soluble in water, but practically insoluble in alcohol. The empirical formula is CH4N2O2 and it has a molecular weight of 76.05. Its structural formula is."
    },
    {
      "NDCCode": "69680-164-30",
      "PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69680-164-30) ",
      "NDC11Code": "69680-0164-30",
      "ProductNDC": "69680-164",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Memantine Hydrochloride",
      "NonProprietaryName": "Memantine Hydrochloride",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20231215",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA213985",
      "LabelerName": "Vitruvias Therapeutics, Inc.",
      "SubstanceName": "MEMANTINE HYDROCHLORIDE",
      "StrengthNumber": "28",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-02-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20231215",
      "SamplePackage": "N",
      "IndicationAndUsage": "Memantine hydrochloride extended-release capsules is indicated for the treatment of moderate to severe dementia of the Alzheimer's type.",
      "Description": "Memantine hydrochloride extended-release capsules is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder and is soluble in water. Memantine hydrochloride extended-release capsules are supplied for oral administration as 7 mg, 14 mg, 21 mg and 28 mg capsules. Among them, 7 mg strength is supplied in opaque light green cap and opaque white body capsule, with \"LPM\" black imprint on the cap and \"7 mg\" black imprint on the body, 14 mg strength is supplied in opaque blue cap and opaque white body capsule, with \"LPM\" black imprint on the cap and \"14 mg\" black imprint on the body, 21 mg strength is supplied in opaque white cap and opaque white body capsule, with \"LPM\" black imprint on the cap and \"21 mg\" black imprint on the body, 28 mg strength is supplied in the opaque rich yellow cap and opaque white body capsule, with \"LPM\" black imprint on the cap and \"28 mg\" black imprint on the body. Each capsule contains extended-release white to off-white beads with the labeled amount of memantine hydrochloride and the following inactive ingredients: sugar spheres (sucrose, maize starch, and dextrin), polyvinylpyrrolidone, hypromellose, talc, polyethylene glycol, triethyl citrate, ethylcellulose, ammonium hydroxide, oleic acid, and medium chain triglycerides in hard gelatin capsules. In addition, the capsule shells contain gelatin and titanium dioxide and are imprinted with black ink. Colorants in capsule shells are brilliant blue (7 mg, 14 mg), erythrosine (14 mg only) and ferric oxide yellow (7 mg, 28 mg). The black ink mainly contains shellac, black iron oxide, dehydrated alcohol, purified water and propylene glycol, with trace amount of isopropyl alcohol, butyl alcohol, strong ammonia solution and potassium hydroxide."
    },
    {
      "NDCCode": "63323-398-12",
      "PackageDescription": "10 VIAL in 1 TRAY (63323-398-12)  / 5 mL in 1 VIAL",
      "NDC11Code": "63323-0398-12",
      "ProductNDC": "63323-398",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Azithromycin",
      "NonProprietaryName": "Azithromycin Monohydrate",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20060320",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065179",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "AZITHROMYCIN MONOHYDRATE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2026-05-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20060320",
      "SamplePackage": "N",
      "IndicationAndUsage": "Azithromycin for Injection, USP is indicated for the treatment of patients with infections caused by susceptible strains of the designated microorganisms in the conditions listed below.   As recommended dosages, durations of therapy, and applicable patient populations vary among these infections, please see DOSAGE AND ADMINISTRATION for dosing recommendations. Community-acquired pneumonia due to Chlamydia pneumoniae, Haemophilus influenzae, Legionella pneumophila, Moraxella catarrhalis, Mycoplasma pneumoniae, Staphylococcus aureus, or Streptococcus pneumoniae in patients who require initial intravenous therapy. Pelvic inflammatory disease due to Chlamydia trachomatis, Neisseria gonorrhoeae, or Mycoplasma hominis in patients who require initial intravenous therapy.  If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with Azithromycin for Injection, USP. Azithromycin for Injection, USP should be followed by azithromycin by the oral route as required (see DOSAGE AND ADMINISTRATION). Appropriate culture and susceptibility tests should be performed before treatment to determine the causative microorganism and its susceptibility to azithromycin.  Therapy with azithromycin may be initiated before results of these tests are known; once the results become available, antimicrobial therapy should be adjusted accordingly. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Azithromycin for Injection, USP and other antibacterial drugs, Azithromycin 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.",
      "Description": "Azithromycin for Injection, USP contains the active ingredient azithromycin, an azalide, a subclass of macrolide antibiotics, for intravenous injection.  Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3- C-methyl-3- O-methyl-α- L- ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β- D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one.  Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring.  Azithromycin has the following structural formula:. Azithromycin, as the monohydrate, is a white crystalline powder with a molecular formula of C 38H 72N 2O 12H 2O and a molecular weight of 767.00. Azithromycin for Injection, USP consists of azithromycin monohydrate and the following inactive ingredients: citric acid and sodium hydroxide.  Azithromycin for Injection, USP is supplied in lyophilized form in a 10 mL vial equivalent to 500 mg of azithromycin for intravenous administration.  Reconstitution, according to label directions, results in approximately 5 mL of azithromycin for intravenous injection with each mL containing azithromycin monohydrate equivalent to 100 mg of azithromycin.  After reconstitution each mL contains: azithromycin monohydrate equivalent to 100 mg of azithromycin, 76.9 mg of citric acid, and sodium hydroxide for pH adjustment."
    },
    {
      "NDCCode": "63323-815-02",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (63323-815-02)  / 2 mL in 1 VIAL, SINGLE-DOSE (63323-815-21) ",
      "NDC11Code": "63323-0815-02",
      "ProductNDC": "63323-815",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amikacin Sulfate",
      "NonProprietaryName": "Amikacin Sulfate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20151209",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA205604",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "AMIKACIN SULFATE",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]",
      "Status": "Active",
      "LastUpdate": "2023-07-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20151209",
      "SamplePackage": "N",
      "IndicationAndUsage": "Amikacin sulfate injection, USP is indicated in the short-term treatment of serious infections due to susceptible strains of Gram-negative bacteria, including Pseudomonas species, Escherichia coli, species of indole-positive and indole-negative Proteus, Providencia species, Klebsiella species, Enterobacter species, Serratia species, and Acinetobacter species. To reduce the development of drug-resistant bacteria and maintain the effectiveness of amikacin and other antibacterial drugs, amikacin 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.",
      "Description": "Amikacin sulfate injection, USP is a semi-synthetic aminoglycoside antibiotic derived from kanamycin. It is O-3-amino-3-deoxy-α-D-glucopyranosyl-(1→4)-O-[6-amino-6-deoxy-α-D-glucopyranosyl-(1→6)]- N3-(4-amino-L-2-hydroxybutyryl)-2-deoxy-L-streptamine sulfate (1:2). C22H43N5O13  2H2SO4             M.W. 781.76. The dosage form is supplied as a sterile, colorless to light straw colored solution for IM or IV use. The 500 mg per 2 mL vial and 1 gram per 4 mL vial contains per each mL: 250 mg amikacin (as the sulfate), 0.66% sodium metabisulfite, 2.5% sodium citrate dihydrate, water for injection qs, with pH adjusted to 4.5 with sulfuric acid."
    },
    {
      "NDCCode": "63323-815-04",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (63323-815-04)  / 4 mL in 1 VIAL, SINGLE-DOSE (63323-815-22) ",
      "NDC11Code": "63323-0815-04",
      "ProductNDC": "63323-815",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amikacin Sulfate",
      "NonProprietaryName": "Amikacin Sulfate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20151209",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA205604",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "AMIKACIN SULFATE",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]",
      "Status": "Active",
      "LastUpdate": "2023-07-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20151209",
      "SamplePackage": "N",
      "IndicationAndUsage": "Amikacin sulfate injection, USP is indicated in the short-term treatment of serious infections due to susceptible strains of Gram-negative bacteria, including Pseudomonas species, Escherichia coli, species of indole-positive and indole-negative Proteus, Providencia species, Klebsiella species, Enterobacter species, Serratia species, and Acinetobacter species. To reduce the development of drug-resistant bacteria and maintain the effectiveness of amikacin and other antibacterial drugs, amikacin 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.",
      "Description": "Amikacin sulfate injection, USP is a semi-synthetic aminoglycoside antibiotic derived from kanamycin. It is O-3-amino-3-deoxy-α-D-glucopyranosyl-(1→4)-O-[6-amino-6-deoxy-α-D-glucopyranosyl-(1→6)]- N3-(4-amino-L-2-hydroxybutyryl)-2-deoxy-L-streptamine sulfate (1:2). C22H43N5O13  2H2SO4             M.W. 781.76. The dosage form is supplied as a sterile, colorless to light straw colored solution for IM or IV use. The 500 mg per 2 mL vial and 1 gram per 4 mL vial contains per each mL: 250 mg amikacin (as the sulfate), 0.66% sodium metabisulfite, 2.5% sodium citrate dihydrate, water for injection qs, with pH adjusted to 4.5 with sulfuric acid."
    },
    {
      "NDCCode": "0143-9260-01",
      "PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (0143-9260-01)  / 10 mL in 1 VIAL, MULTI-DOSE",
      "NDC11Code": "00143-9260-01",
      "ProductNDC": "0143-9260",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Mesna",
      "NonProprietaryName": "Mesna",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20040223",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075739",
      "LabelerName": "Hikma Pharmaceuticals USA Inc.",
      "SubstanceName": "MESNA",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Cytoprotective Agent [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-05-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20040223",
      "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 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 7.3."
    },
    {
      "NDCCode": "0143-9281-10",
      "PackageDescription": "10 BAG in 1 BOX (0143-9281-10)  / 100 mL in 1 BAG (0143-9281-01) ",
      "NDC11Code": "00143-9281-10",
      "ProductNDC": "0143-9281",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levetiracetam In Sodium Chloride",
      "NonProprietaryName": "Levetiracetam In Sodium Chloride",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20250208",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211356",
      "LabelerName": "Hikma Pharmaceuticals USA Inc.",
      "SubstanceName": "LEVETIRACETAM",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2025-03-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250208",
      "SamplePackage": "N",
      "Description": "Levetiracetam in Sodium Chloride Injection is an antiepileptic drug available as a clear, colorless, sterile solution for intravenous administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam in Sodium Chloride Injection is a clear, colorless, sterile solution that is available in a single-dose dual port bag with an aluminum over wrap. The container closure is not made with natural rubber latex. 500 mg/100 mL: One 100 mL bag contains 500 mg of levetiracetam (5 mg/mL), water for injection, 820 mg sodium chloride, 5.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,000 mg/100 mL: One 100 mL bag contains 1,000 mg of levetiracetam (10 mg/mL), water for injection, 750 mg sodium chloride, 6.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,500 mg/100 mL: One 100 mL bag contains 1,500 mg of levetiracetam (15 mg/mL), water for injection, 540 mg sodium chloride, 7.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate."
    },
    {
      "NDCCode": "0143-9282-10",
      "PackageDescription": "10 BAG in 1 BOX (0143-9282-10)  / 100 mL in 1 BAG (0143-9282-01) ",
      "NDC11Code": "00143-9282-10",
      "ProductNDC": "0143-9282",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levetiracetam In Sodium Chloride",
      "NonProprietaryName": "Levetiracetam In Sodium Chloride",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20250208",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211356",
      "LabelerName": "Hikma Pharmaceuticals USA Inc.",
      "SubstanceName": "LEVETIRACETAM",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2025-03-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250208",
      "SamplePackage": "N",
      "Description": "Levetiracetam in Sodium Chloride Injection is an antiepileptic drug available as a clear, colorless, sterile solution for intravenous administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam in Sodium Chloride Injection is a clear, colorless, sterile solution that is available in a single-dose dual port bag with an aluminum over wrap. The container closure is not made with natural rubber latex. 500 mg/100 mL: One 100 mL bag contains 500 mg of levetiracetam (5 mg/mL), water for injection, 820 mg sodium chloride, 5.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,000 mg/100 mL: One 100 mL bag contains 1,000 mg of levetiracetam (10 mg/mL), water for injection, 750 mg sodium chloride, 6.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,500 mg/100 mL: One 100 mL bag contains 1,500 mg of levetiracetam (15 mg/mL), water for injection, 540 mg sodium chloride, 7.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate."
    },
    {
      "NDCCode": "0143-9283-10",
      "PackageDescription": "10 BAG in 1 BOX (0143-9283-10)  / 100 mL in 1 BAG (0143-9283-01) ",
      "NDC11Code": "00143-9283-10",
      "ProductNDC": "0143-9283",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levetiracetam In Sodium Chloride",
      "NonProprietaryName": "Levetiracetam In Sodium Chloride",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20250208",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211356",
      "LabelerName": "Hikma Pharmaceuticals USA Inc.",
      "SubstanceName": "LEVETIRACETAM",
      "StrengthNumber": "15",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2025-03-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250208",
      "SamplePackage": "N",
      "Description": "Levetiracetam in Sodium Chloride Injection is an antiepileptic drug available as a clear, colorless, sterile solution for intravenous administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam in Sodium Chloride Injection is a clear, colorless, sterile solution that is available in a single-dose dual port bag with an aluminum over wrap. The container closure is not made with natural rubber latex. 500 mg/100 mL: One 100 mL bag contains 500 mg of levetiracetam (5 mg/mL), water for injection, 820 mg sodium chloride, 5.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,000 mg/100 mL: One 100 mL bag contains 1,000 mg of levetiracetam (10 mg/mL), water for injection, 750 mg sodium chloride, 6.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,500 mg/100 mL: One 100 mL bag contains 1,500 mg of levetiracetam (15 mg/mL), water for injection, 540 mg sodium chloride, 7.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate."
    },
    {
      "NDCCode": "0264-1009-90",
      "PackageDescription": "24 CONTAINER in 1 CASE (0264-1009-90)  / 100 mL in 1 CONTAINER",
      "NDC11Code": "00264-1009-90",
      "ProductNDC": "0264-1009",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levetiracetam",
      "NonProprietaryName": "Levetiracetam",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20240513",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209705",
      "LabelerName": "B. Braun Medical Inc.",
      "SubstanceName": "LEVETIRACETAM",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2025-04-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240513",
      "SamplePackage": "N",
      "IndicationAndUsage": "Levetiracetam in Sodium Chloride Injection is indicated for adjunct therapy in adults (greater than or equal to 16 years of age) with the following seizure types when oral administration is temporarily not feasible: 1 Partial-onset seizures (1.1) , 2 Myoclonic seizures in patients with juvenile myoclonic epilepsy (1.2), 3 Primary generalized tonic-clonic seizures (1.3).",
      "Description": "Levetiracetam in Sodium Chloride Injection is an antiepileptic drug available as a clear, colorless, sterile solution for intravenous administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam in Sodium Chloride Injection is a clear, colorless, sterile solution that is available in a single-dose dual port container. This container closure is not made with natural rubber latex, PVC or DEHP. 500 mg/100 mL: One 100 mL fill container contains 500 mg of levetiracetam (5 mg/mL), water for injection, 820 mg sodium chloride, 5.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,000 mg/100 mL: One 100 mL fill container contains 1,000 mg of levetiracetam (10 mg/mL), water for injection, 750 mg sodium chloride, 6.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,500 mg/100 mL: One 100 mL fill container contains 1,500 mg of levetiracetam (15 mg/mL), water for injection, 540 mg sodium chloride, 7.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. The container/solution unit is a closed system and is not dependent upon entry of external air during administration. The container has two ports, one is for the intravenous administration set and the other is a medication addition. Each is covered by a tamperproof barrier. Refer to the DIRECTIONS FOR USE of the container to properly identify the ports. No vapor barrier is necessary."
    },
    {
      "NDCCode": "0264-1509-90",
      "PackageDescription": "24 CONTAINER in 1 CASE (0264-1509-90)  / 100 mL in 1 CONTAINER",
      "NDC11Code": "00264-1509-90",
      "ProductNDC": "0264-1509",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levetiracetam",
      "NonProprietaryName": "Levetiracetam",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20240513",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209705",
      "LabelerName": "B. Braun Medical Inc.",
      "SubstanceName": "LEVETIRACETAM",
      "StrengthNumber": "15",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2025-04-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240513",
      "SamplePackage": "N",
      "IndicationAndUsage": "Levetiracetam in Sodium Chloride Injection is indicated for adjunct therapy in adults (greater than or equal to 16 years of age) with the following seizure types when oral administration is temporarily not feasible: 1 Partial-onset seizures (1.1) , 2 Myoclonic seizures in patients with juvenile myoclonic epilepsy (1.2), 3 Primary generalized tonic-clonic seizures (1.3).",
      "Description": "Levetiracetam in Sodium Chloride Injection is an antiepileptic drug available as a clear, colorless, sterile solution for intravenous administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam in Sodium Chloride Injection is a clear, colorless, sterile solution that is available in a single-dose dual port container. This container closure is not made with natural rubber latex, PVC or DEHP. 500 mg/100 mL: One 100 mL fill container contains 500 mg of levetiracetam (5 mg/mL), water for injection, 820 mg sodium chloride, 5.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,000 mg/100 mL: One 100 mL fill container contains 1,000 mg of levetiracetam (10 mg/mL), water for injection, 750 mg sodium chloride, 6.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,500 mg/100 mL: One 100 mL fill container contains 1,500 mg of levetiracetam (15 mg/mL), water for injection, 540 mg sodium chloride, 7.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. The container/solution unit is a closed system and is not dependent upon entry of external air during administration. The container has two ports, one is for the intravenous administration set and the other is a medication addition. Each is covered by a tamperproof barrier. Refer to the DIRECTIONS FOR USE of the container to properly identify the ports. No vapor barrier is necessary."
    },
    {
      "NDCCode": "0264-5009-90",
      "PackageDescription": "24 CONTAINER in 1 CASE (0264-5009-90)  / 100 mL in 1 CONTAINER",
      "NDC11Code": "00264-5009-90",
      "ProductNDC": "0264-5009",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levetiracetam",
      "NonProprietaryName": "Levetiracetam",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20240513",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209705",
      "LabelerName": "B. Braun Medical Inc.",
      "SubstanceName": "LEVETIRACETAM",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2025-04-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240513",
      "SamplePackage": "N",
      "IndicationAndUsage": "Levetiracetam in Sodium Chloride Injection is indicated for adjunct therapy in adults (greater than or equal to 16 years of age) with the following seizure types when oral administration is temporarily not feasible: 1 Partial-onset seizures (1.1) , 2 Myoclonic seizures in patients with juvenile myoclonic epilepsy (1.2), 3 Primary generalized tonic-clonic seizures (1.3).",
      "Description": "Levetiracetam in Sodium Chloride Injection is an antiepileptic drug available as a clear, colorless, sterile solution for intravenous administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam in Sodium Chloride Injection is a clear, colorless, sterile solution that is available in a single-dose dual port container. This container closure is not made with natural rubber latex, PVC or DEHP. 500 mg/100 mL: One 100 mL fill container contains 500 mg of levetiracetam (5 mg/mL), water for injection, 820 mg sodium chloride, 5.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,000 mg/100 mL: One 100 mL fill container contains 1,000 mg of levetiracetam (10 mg/mL), water for injection, 750 mg sodium chloride, 6.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,500 mg/100 mL: One 100 mL fill container contains 1,500 mg of levetiracetam (15 mg/mL), water for injection, 540 mg sodium chloride, 7.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. The container/solution unit is a closed system and is not dependent upon entry of external air during administration. The container has two ports, one is for the intravenous administration set and the other is a medication addition. Each is covered by a tamperproof barrier. Refer to the DIRECTIONS FOR USE of the container to properly identify the ports. No vapor barrier is necessary."
    },
    {
      "NDCCode": "0338-1305-01",
      "PackageDescription": "1 VIAL, MULTI-DOSE in 1 BOX (0338-1305-01)  / 10 mL in 1 VIAL, MULTI-DOSE",
      "NDC11Code": "00338-1305-01",
      "ProductNDC": "0338-1305",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Mesnex",
      "NonProprietaryName": "Mesna",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19881230",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019884",
      "LabelerName": "Baxter Healthcare Company",
      "SubstanceName": "MESNA",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Cytoprotective Agent [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-05-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19881230",
      "SamplePackage": "N",
      "IndicationAndUsage": "MESNEX is indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis. Limitation of Use: MESNEX is not indicated to reduce the risk of hematuria due to other pathological conditions such as thrombocytopenia.",
      "Description": "MESNEX (mesna) 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+. MESNEX injection is a sterile, nonpyrogenic, aqueous solution of clear and colorless appearance in clear glass multidose vials for intravenous administration. MESNEX injection contains 100 mg/mL mesna, 0.25 mg/mL edetate disodium and sodium hydroxide for pH adjustment. MESNEX injection multidose vials also contain 10.4 mg/mL of benzyl alcohol as a preservative. The solution has a pH range of 7.5-8.5. MESNEX tablets are white, oblong, scored biconvex film-coated tablets with the imprint M4. They contain 400 mg mesna. The excipients are calcium phosphate, cornstarch, hydroxypropylmethylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, simethicone, and titanium dioxide."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"63323-164-76","ProprietaryName":"Lactated Ringers","NonProprietaryName":"Sodium Chloride, Sodium Lactate, Potassium Chloride, Calcium Chloride"},{"NDCCode":"73069-164-76","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"},{"NDCCode":"63323-164-74","ProprietaryName":"Lactated Ringers","NonProprietaryName":"Sodium Chloride, Sodium Lactate, Potassium Chloride, Calcium Chloride"},{"NDCCode":"63323-164-75","ProprietaryName":"Lactated Ringers","NonProprietaryName":"Sodium Chloride, Sodium Lactate, Potassium Chloride, Calcium Chloride"},{"NDCCode":"63323-178-76","ProprietaryName":"Sterile Water","NonProprietaryName":"Water"},{"NDCCode":"63323-623-76","ProprietaryName":"Sodium Chloride","NonProprietaryName":"Sodium Chloride"},{"NDCCode":"63323-824-76","ProprietaryName":"Dextrose","NonProprietaryName":"Dextrose Monohydrate"},{"NDCCode":"63323-712-10","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"},{"NDCCode":"63323-712-15","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"},{"NDCCode":"63323-712-20","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"},{"NDCCode":"63323-712-25","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"},{"NDCCode":"63323-714-14","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"},{"NDCCode":"63323-714-19","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"},{"NDCCode":"63323-714-24","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"},{"NDCCode":"63323-733-10","ProprietaryName":"Mesna","NonProprietaryName":"Mesna"},{"NDCCode":"63323-733-11","ProprietaryName":"Mesna","NonProprietaryName":"Mesna"},{"NDCCode":"31645-164-02","ProprietaryName":"Super Bb 10-in-1 Beauty Balm Cream","NonProprietaryName":"Titanium Dioxide, Zinc Oxide"},{"NDCCode":"69315-164-01","ProprietaryName":"Hydroxyurea","NonProprietaryName":"Hydroxyurea"},{"NDCCode":"69680-164-30","ProprietaryName":"Memantine Hydrochloride","NonProprietaryName":"Memantine Hydrochloride"},{"NDCCode":"63323-398-12","ProprietaryName":"Azithromycin","NonProprietaryName":"Azithromycin Monohydrate"},{"NDCCode":"63323-815-02","ProprietaryName":"Amikacin Sulfate","NonProprietaryName":"Amikacin Sulfate"},{"NDCCode":"63323-815-04","ProprietaryName":"Amikacin Sulfate","NonProprietaryName":"Amikacin Sulfate"},{"NDCCode":"0143-9260-01","ProprietaryName":"Mesna","NonProprietaryName":"Mesna"},{"NDCCode":"0143-9281-10","ProprietaryName":"Levetiracetam In Sodium Chloride","NonProprietaryName":"Levetiracetam In Sodium Chloride"},{"NDCCode":"0143-9282-10","ProprietaryName":"Levetiracetam In Sodium Chloride","NonProprietaryName":"Levetiracetam In Sodium Chloride"},{"NDCCode":"0143-9283-10","ProprietaryName":"Levetiracetam In Sodium Chloride","NonProprietaryName":"Levetiracetam In Sodium Chloride"},{"NDCCode":"0264-1009-90","ProprietaryName":"Levetiracetam","NonProprietaryName":"Levetiracetam"},{"NDCCode":"0264-1509-90","ProprietaryName":"Levetiracetam","NonProprietaryName":"Levetiracetam"},{"NDCCode":"0264-5009-90","ProprietaryName":"Levetiracetam","NonProprietaryName":"Levetiracetam"},{"NDCCode":"0338-1305-01","ProprietaryName":"Mesnex","NonProprietaryName":"Mesna"}]}
                    

<NDCList><NDC><NDCCode>63323-164-76</NDCCode><ProprietaryName>Lactated Ringers</ProprietaryName><NonProprietaryName>Sodium Chloride, Sodium Lactate, Potassium Chloride, Calcium Chloride</NonProprietaryName></NDC><NDC><NDCCode>73069-164-76</NDCCode><ProprietaryName>Viatrexx-facial</ProprietaryName><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</NonProprietaryName></NDC><NDC><NDCCode>63323-164-74</NDCCode><ProprietaryName>Lactated Ringers</ProprietaryName><NonProprietaryName>Sodium Chloride, Sodium Lactate, Potassium Chloride, Calcium Chloride</NonProprietaryName></NDC><NDC><NDCCode>63323-164-75</NDCCode><ProprietaryName>Lactated Ringers</ProprietaryName><NonProprietaryName>Sodium Chloride, Sodium Lactate, Potassium Chloride, Calcium Chloride</NonProprietaryName></NDC><NDC><NDCCode>63323-178-76</NDCCode><ProprietaryName>Sterile Water</ProprietaryName><NonProprietaryName>Water</NonProprietaryName></NDC><NDC><NDCCode>63323-623-76</NDCCode><ProprietaryName>Sodium Chloride</ProprietaryName><NonProprietaryName>Sodium Chloride</NonProprietaryName></NDC><NDC><NDCCode>63323-824-76</NDCCode><ProprietaryName>Dextrose</ProprietaryName><NonProprietaryName>Dextrose Monohydrate</NonProprietaryName></NDC><NDC><NDCCode>63323-712-10</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>63323-712-15</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, Glutamic Acid, Serine, Aspartic Acid And Tyrosine</NonProprietaryName></NDC><NDC><NDCCode>63323-714-14</NDCCode><ProprietaryName>Perikabiven</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>63323-714-19</NDCCode><ProprietaryName>Perikabiven</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>63323-714-24</NDCCode><ProprietaryName>Perikabiven</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>63323-733-10</NDCCode><ProprietaryName>Mesna</ProprietaryName><NonProprietaryName>Mesna</NonProprietaryName></NDC><NDC><NDCCode>63323-733-11</NDCCode><ProprietaryName>Mesna</ProprietaryName><NonProprietaryName>Mesna</NonProprietaryName></NDC><NDC><NDCCode>31645-164-02</NDCCode><ProprietaryName>Super Bb 10-in-1 Beauty Balm Cream</ProprietaryName><NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>69315-164-01</NDCCode><ProprietaryName>Hydroxyurea</ProprietaryName><NonProprietaryName>Hydroxyurea</NonProprietaryName></NDC><NDC><NDCCode>69680-164-30</NDCCode><ProprietaryName>Memantine Hydrochloride</ProprietaryName><NonProprietaryName>Memantine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>63323-398-12</NDCCode><ProprietaryName>Azithromycin</ProprietaryName><NonProprietaryName>Azithromycin Monohydrate</NonProprietaryName></NDC><NDC><NDCCode>63323-815-02</NDCCode><ProprietaryName>Amikacin Sulfate</ProprietaryName><NonProprietaryName>Amikacin Sulfate</NonProprietaryName></NDC><NDC><NDCCode>63323-815-04</NDCCode><ProprietaryName>Amikacin Sulfate</ProprietaryName><NonProprietaryName>Amikacin Sulfate</NonProprietaryName></NDC><NDC><NDCCode>0143-9260-01</NDCCode><ProprietaryName>Mesna</ProprietaryName><NonProprietaryName>Mesna</NonProprietaryName></NDC><NDC><NDCCode>0143-9281-10</NDCCode><ProprietaryName>Levetiracetam In Sodium Chloride</ProprietaryName><NonProprietaryName>Levetiracetam In Sodium Chloride</NonProprietaryName></NDC><NDC><NDCCode>0143-9282-10</NDCCode><ProprietaryName>Levetiracetam In Sodium Chloride</ProprietaryName><NonProprietaryName>Levetiracetam In Sodium Chloride</NonProprietaryName></NDC><NDC><NDCCode>0143-9283-10</NDCCode><ProprietaryName>Levetiracetam In Sodium Chloride</ProprietaryName><NonProprietaryName>Levetiracetam In Sodium Chloride</NonProprietaryName></NDC><NDC><NDCCode>0264-1009-90</NDCCode><ProprietaryName>Levetiracetam</ProprietaryName><NonProprietaryName>Levetiracetam</NonProprietaryName></NDC><NDC><NDCCode>0264-1509-90</NDCCode><ProprietaryName>Levetiracetam</ProprietaryName><NonProprietaryName>Levetiracetam</NonProprietaryName></NDC><NDC><NDCCode>0264-5009-90</NDCCode><ProprietaryName>Levetiracetam</ProprietaryName><NonProprietaryName>Levetiracetam</NonProprietaryName></NDC><NDC><NDCCode>0338-1305-01</NDCCode><ProprietaryName>Mesnex</ProprietaryName><NonProprietaryName>Mesna</NonProprietaryName></NDC></NDCList>