{
"NDC": [
{
"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": "20271231",
"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": "63323-712-10",
"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": "20271231",
"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",
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"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": "20271231",
"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",
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"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": "20271231",
"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": "35356-712-15",
"PackageDescription": "15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (35356-712-15)",
"NDC11Code": "35356-0712-15",
"ProductNDC": "35356-712",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amitriptyline Hydrochloride",
"NonProprietaryName": "Amitriptyline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19970911",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040218",
"LabelerName": "Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC",
"SubstanceName": "AMITRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-03-30",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "43744-712-15",
"PackageDescription": "10 g in 1 DRUM (43744-712-15)",
"NDC11Code": "43744-0712-15",
"ProductNDC": "43744-712",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Penicillamine",
"DosageFormName": "POWDER",
"StartMarketingDate": "20130404",
"EndMarketingDate": "20130624",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "CBSCHEM LIMITED",
"SubstanceName": "PENICILLAMINE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20130624"
},
{
"NDCCode": "43744-712-20",
"PackageDescription": "15 g in 1 DRUM (43744-712-20)",
"NDC11Code": "43744-0712-20",
"ProductNDC": "43744-712",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Penicillamine",
"DosageFormName": "POWDER",
"StartMarketingDate": "20130404",
"EndMarketingDate": "20130624",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "CBSCHEM LIMITED",
"SubstanceName": "PENICILLAMINE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20130624"
},
{
"NDCCode": "50268-712-15",
"PackageDescription": "50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-712-15) > 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-712-11) ",
"NDC11Code": "50268-0712-15",
"ProductNDC": "50268-712",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20141202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077691",
"LabelerName": "AvPAK",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-11-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20141202",
"SamplePackage": "N"
},
{
"NDCCode": "59561-712-05",
"PackageDescription": "15 g in 1 PACKAGE (59561-712-05)",
"NDC11Code": "59561-0712-05",
"ProductNDC": "59561-712",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Quitacallos",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150505",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part358F",
"LabelerName": "Caribe Natural, Inc",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "17",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "QuitaCallos. Removedor de Callos. Corn & Callus Remover. Salicylic Acid 17%."
},
{
"NDCCode": "59651-712-14",
"PackageDescription": "1 TUBE in 1 CARTON (59651-712-14) / 15 g in 1 TUBE",
"NDC11Code": "59651-0712-14",
"ProductNDC": "59651-712",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tretinoin",
"NonProprietaryName": "Tretinoin",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250113",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218246",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "TRETINOIN",
"StrengthNumber": ".1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2025-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250113",
"SamplePackage": "N",
"IndicationAndUsage": "Tretinoin gel is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.",
"Description": "Tretinoin gel, USP, containing tretinoin USP, is used for the topical treatment of acne vulgaris. Tretinoin gel, USP contains tretinoin USP (retinoic acid, vitamin A acid) 0.1 mg (0.01%) by weight, in a gel vehicle of alcohol (90.5% w/w), butylated hydroxytoluene and hydroxypropyl cellulose. Chemically, tretinoin is all-trans-retinoic acid and has the following structure."
},
{
"NDCCode": "59779-712-01",
"PackageDescription": "1 BOTTLE in 1 BOX (59779-712-01) > 15 mL in 1 BOTTLE",
"NDC11Code": "59779-0712-01",
"ProductNDC": "59779-712",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cvshealth Antifungal",
"NonProprietaryName": "Clotrimazole",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151110",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333C",
"LabelerName": "CVS Pharmacy",
"SubstanceName": "CLOTRIMAZOLE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-10-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20170207",
"SamplePackage": "N"
},
{
"NDCCode": "62856-712-30",
"PackageDescription": "6 BLISTER PACK in 1 BOX, UNIT-DOSE (62856-712-30) / 15 CAPSULE in 1 BLISTER PACK (62856-712-05) ",
"NDC11Code": "62856-0712-30",
"ProductNDC": "62856-712",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lenvima",
"NonProprietaryName": "Lenvatinib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20180815",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206947",
"LabelerName": "Eisai Inc.",
"SubstanceName": "LENVATINIB",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Receptor Tyrosine Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180815",
"SamplePackage": "N",
"IndicationAndUsage": "LENVIMA is a kinase inhibitor that is indicated:. Differentiated Thyroid Cancer : 1 For the treatment of adult patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC). (1.1).",
"Description": "LENVIMA, a kinase inhibitor, is the mesylate salt of lenvatinib. Its chemical name is 4-[3-chloro-4-(N’-cyclopropylureido)phenoxy]-7-methoxyquinoline-6-carboxamide methanesulfonate. The molecular formula is C21H19ClN4O4 CH4O3S, and the molecular weight of the mesylate salt is 522.96. The chemical structure of lenvatinib mesylate is. Lenvatinib mesylate is a white to pale reddish yellow powder. It is slightly soluble in water and practically insoluble in ethanol (dehydrated). The dissociation constant (pKa value) of lenvatinib mesylate is 5.05 at 25°C. The partition coefficient (log P value) is 3.3. LENVIMA capsules for oral administration contain 4 mg or 10 mg of lenvatinib, equivalent to 4.90 mg or 12.25 mg of lenvatinib mesylate, respectively. The inactive ingredients are: calcium carbonate, hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose, mannitol, microcrystalline cellulose, and talc. In addition, the capsule shell contains ferric oxide red, ferric oxide yellow, hypromellose, and titanium dioxide. The printing ink contains black iron oxide, potassium hydroxide, propylene glycol, and shellac."
},
{
"NDCCode": "69784-712-15",
"PackageDescription": "30 CAPSULE, LIQUID FILLED in 1 BOTTLE (69784-712-15) ",
"NDC11Code": "69784-0712-15",
"ProductNDC": "69784-712",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Avodart",
"NonProprietaryName": "Dutasteride",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20221215",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021319",
"LabelerName": "Woodward Pharma Services LLC",
"SubstanceName": "DUTASTERIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20221215",
"SamplePackage": "N",
"IndicationAndUsage": "AVODART is a 5 alpha-reductase inhibitor indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: (1.1): 1 improve symptoms,, 2 reduce the risk of acute urinary retention, and, 3 reduce the risk of the need for BPH-related surgery.",
"Description": "AVODART is a synthetic 4-azasteroid compound that is a selective inhibitor of both the type 1 and type 2 isoforms of steroid 5 alpha-reductase, an intracellular enzyme that converts testosterone to DHT. Dutasteride is chemically designated as (5α,17β)-N-{2,5 bis(trifluoromethyl)phenyl}-3-oxo-4-azaandrost-1-ene-17-carboxamide. The empirical formula of dutasteride is C27H30F6N2O2, representing a molecular weight of 528.5 with the following structural formula. Dutasteride is a white to pale yellow powder with a melting point of 242° to 250°C. It is soluble in ethanol (44 mg/mL), methanol (64 mg/mL), and polyethylene glycol 400 (3 mg/mL), but it is insoluble in water. Each AVODART soft gelatin capsule, administered orally, contains 0.5 mg of dutasteride dissolved in a mixture of mono-di-glycerides of caprylic/capric acid and butylated hydroxytoluene. The inactive excipients in the capsule shell are ferric oxide (yellow), gelatin (from certified BSE-free bovine sources), glycerin, and titanium dioxide. The soft gelatin capsules are printed with edible red ink."
},
{
"NDCCode": "70166-712-10",
"PackageDescription": "10 BOTTLE in 1 CELLO PACK (70166-712-10) > 15 g in 1 BOTTLE",
"NDC11Code": "70166-0712-10",
"ProductNDC": "70166-712",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Polystyrene Sulfonate",
"NonProprietaryName": "Sodium Polystyrene Sulfonate",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL; RECTAL",
"StartMarketingDate": "20170207",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090313",
"LabelerName": "LOHXA",
"SubstanceName": "SODIUM POLYSTYRENE SULFONATE",
"StrengthNumber": "4.1",
"StrengthUnit": "meq/g",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20191022",
"SamplePackage": "N",
"IndicationAndUsage": "Sodium polystyrene sulfonate is indicated for the treatment of hyperkalemia.",
"Description": "Sodium polystyrene sulfonate is a benzene, diethenyl-polymer, with ethenylbenzene, sulfonated, sodium salt and has the following structural formula. The drug is a cream to light brown finely ground, powdered form of sodium polystyrene sulfonate, a cation-exchange resin prepared in the sodium phase with an in vitro exchange capacity of approximately 3.1 mEq ( in vivo approximately 1 mEq) of potassium per gram. The sodium content is approximately 100 mg (4.1 mEq) per gram of the drug. It can be administered orally or in an enema."
},
{
"NDCCode": "71919-712-07",
"PackageDescription": "15 mL in 1 VIAL, GLASS (71919-712-07) ",
"NDC11Code": "71919-0712-07",
"ProductNDC": "71919-712",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Viburnum Prunifolium",
"NonProprietaryName": "Viburnum Prunifolium",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110517",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "VIBURNUM PRUNIFOLIUM BARK",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20110517",
"SamplePackage": "N"
},
{
"NDCCode": "76041-712-15",
"PackageDescription": "1 BOTTLE in 1 CARTON (76041-712-15) > 150 mL in 1 BOTTLE",
"NDC11Code": "76041-0712-15",
"ProductNDC": "76041-712",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Moisturising Sunscreen",
"ProprietaryNameSuffix": "Spf 30",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110610",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Neals Yard (Natural Remedies) Limited",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "17.5",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2015-01-30"
},
{
"NDCCode": "80725-712-15",
"PackageDescription": "30 CAPSULE, LIQUID FILLED in 1 BOTTLE (80725-712-15) ",
"NDC11Code": "80725-0712-15",
"ProductNDC": "80725-712",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Avodart",
"NonProprietaryName": "Dutasteride",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20221215",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021319",
"LabelerName": "Waylis Therapeutics LLC",
"SubstanceName": "DUTASTERIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221215",
"SamplePackage": "N",
"IndicationAndUsage": "AVODART is a 5 alpha-reductase inhibitor indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: (1.1): 1 improve symptoms,, 2 reduce the risk of acute urinary retention, and, 3 reduce the risk of the need for BPH-related surgery.",
"Description": "AVODART is a synthetic 4-azasteroid compound that is a selective inhibitor of both the type 1 and type 2 isoforms of steroid 5 alpha-reductase, an intracellular enzyme that converts testosterone to DHT. Dutasteride is chemically designated as (5α,17β)-N-{2,5 bis(trifluoromethyl)phenyl}-3-oxo-4-azaandrost-1-ene-17-carboxamide. The empirical formula of dutasteride is C27H30F6N2O2, representing a molecular weight of 528.5 with the following structural formula. Dutasteride is a white to pale yellow powder with a melting point of 242° to 250°C. It is soluble in ethanol (44 mg/mL), methanol (64 mg/mL), and polyethylene glycol 400 (3 mg/mL), but it is insoluble in water. Each AVODART soft gelatin capsule, administered orally, contains 0.5 mg of dutasteride dissolved in a mixture of mono-di-glycerides of caprylic/capric acid and butylated hydroxytoluene. The inactive excipients in the capsule shell are ferric oxide (yellow), gelatin (from certified BSE-free bovine sources), glycerin, and titanium dioxide. The soft gelatin capsules are printed with edible red ink."
},
{
"NDCCode": "84515-712-01",
"PackageDescription": "15 g in 1 BOX (84515-712-01) ",
"NDC11Code": "84515-0712-01",
"ProductNDC": "84515-712",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dark Spot Corrector",
"NonProprietaryName": "Dark Spot Corrector",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241023",
"EndMarketingDate": "20311231",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Xinqian E Commerce Co Ltd",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20241023",
"EndMarketingDatePackage": "20311231",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "84682-712-01",
"PackageDescription": "15 g in 1 BOX (84682-712-01) ",
"NDC11Code": "84682-0712-01",
"ProductNDC": "84682-712",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Firming Cream",
"NonProprietaryName": "Firming Cream",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241025",
"EndMarketingDate": "20311031",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Yucheng E Commerce Co Ltd",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20241025",
"EndMarketingDatePackage": "20311031",
"SamplePackage": "N"
},
{
"NDCCode": "84756-712-02",
"PackageDescription": "15 g in 1 BOX (84756-712-02) ",
"NDC11Code": "84756-0712-02",
"ProductNDC": "84756-712",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Turmeric Booster Eye Cream",
"NonProprietaryName": "Turmeric Booster Eye Cream",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241212",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Ziqiu Import Export Co Ltd",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241212",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "63323-011-15",
"PackageDescription": "10 VIAL in 1 TRAY (63323-011-15) / 10 mL in 1 VIAL",
"NDC11Code": "63323-0011-15",
"ProductNDC": "63323-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chloramphenicol Sodium Succinate",
"NonProprietaryName": "Chloramphenicol Sodium Succinate",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20010112",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062365",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "CHLORAMPHENICOL SODIUM SUCCINATE",
"StrengthNumber": "1",
"StrengthUnit": "g/10mL",
"Pharm_Classes": "Amphenicol-class Antibacterial [EPC], Amphenicols [EXT]",
"Status": "Active",
"LastUpdate": "2024-10-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20010112",
"SamplePackage": "N",
"Description": "Chloramphenicol is an antibiotic that is clinically useful for, and should be reserved for, serious infections caused by organisms susceptible to its antimicrobial effects when less potentially hazardous therapeutic agents are ineffective or contraindicated. Sensitivity testing is essential to determine its indicated use, but may be performed concurrently with therapy initiated on clinical impression that one of the indicated conditions exists (see INDICATIONS AND USAGE section). When reconstituted as directed, each vial contains a sterile solution equivalent to 100 mg of chloramphenicol per mL (1 g/10 mL). Each gram (10 mL of a 10% solution) of chloramphenicol sodium succinate contains approximately 52 mg (2.25 mEq) of sodium. The chemical name for chloramphenicol sodium succinate is D-threo-(-)-2, 2-Dichloro-N-[β-hydroxy-α-(hydroxymethyl)-p-nitrophenethyl] acetamide α-(sodium succinate). The structural formula is."
},
{
"NDCCode": "63323-086-15",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (63323-086-15) > 15 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "63323-0086-15",
"ProductNDC": "63323-086",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Phosphates",
"NonProprietaryName": "Potassium Phosphate, Monobasic And Potassium Phosphate, Dibasic",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20000808",
"EndMarketingDate": "20221130",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC",
"StrengthNumber": "236; 224",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2022-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20000808",
"EndMarketingDatePackage": "20220531",
"SamplePackage": "N"
},
{
"NDCCode": "63323-106-15",
"PackageDescription": "24 BAG in 1 CASE (63323-106-15) / 500 mL in 1 BAG",
"NDC11Code": "63323-0106-15",
"ProductNDC": "63323-106",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Magnesium Sulfate",
"NonProprietaryName": "Magnesium Sulfate Heptahydrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20160315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206485",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "MAGNESIUM SULFATE HEPTAHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2024-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160315",
"SamplePackage": "N",
"IndicationAndUsage": "Magnesium sulfate in water for injection is indicated for the prevention and control of seizures in pre-eclampsia and eclampsia, respectively. When used judiciously it effectively prevents and controls the convulsions of eclampsia without producing deleterious depression of the central nervous system of the mother or infant. However, other effective drugs are available for this purpose.",
"Description": "Magnesium Sulfate in Water for Injection is a sterile, nonpyrogenic solution of magnesium sulfate heptahydrate in water for injection. May contain sulfuric acid and/or sodium hydroxide for pH adjustment. The pH is 4.5 (3.5 to 6.5). It is available in 4% and 8% concentrations. See HOW SUPPLIED section for the content and characteristics of available dosage forms and sizes. Magnesium sulfate, USP heptahydrate is chemically designated MgSO 4 7H 2O, colorless crystals or white powder freely soluble in water. 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. Exposure to temperatures above 25ºC/77ºF during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period."
},
{
"NDCCode": "63323-132-15",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 BOX (63323-132-15) / 15 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "63323-0132-15",
"ProductNDC": "63323-132",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mitoxantrone",
"NonProprietaryName": "Mitoxantrone Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20060411",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077496",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "MITOXANTRONE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-10-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060411",
"SamplePackage": "N",
"IndicationAndUsage": "Mitoxantrone Injection, USP is indicated for reducing neurologic disability and/or the frequency of clinical relapses in patients with secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis (i.e., patients whose neurologic status is significantly abnormal between relapses). Mitoxantrone Injection, USP is not indicated in the treatment of patients with primary progressive multiple sclerosis. The clinical patterns of multiple sclerosis in the studies were characterized as follows: secondary progressive and progressive relapsing disease were characterized by gradual increasing disability with or without superimposed clinical relapses, and worsening relapsing-remitting disease was characterized by clinical relapses resulting in a step-wise worsening of disability. Mitoxantrone Injection, USP in combination with corticosteroids is indicated as initial chemotherapy for the treatment of patients with pain related to advanced hormone-refractory prostate cancer. Mitoxantrone Injection, USP in combination with other approved drug(s) is indicated in the initial therapy of acute nonlymphocytic leukemia (ANLL) in adults. This category includes myelogenous, promyelocytic, monocytic, and erythroid acute leukemias.",
"Description": "Mitoxantrone Injection, USP (concentrate) is a synthetic antineoplastic anthracenedione for intravenous use. It is supplied as a concentrate that MUST BE DILUTED PRIOR TO INJECTION. The concentrate is a sterile, nonpyrogenic, dark blue aqueous solution containing mitoxantrone hydrochloride equivalent to 2 mg/mL mitoxantrone free base, with the following inactive ingredients: sodium chloride (0.800% w/v), sodium acetate (0.005% w/v), acetic acid (0.046% w/v), and water for injection. The solution has a pH of 3.0 to 4.5 and contains 0.14 mEq of sodium per mL. The product does not contain preservatives. The chemical name is 1,4-dihydroxy-5,8-bis[[2-[(2-hydroxyethyl) amino]ethyl]amino]-9,10- anthracenedione dihydrochloride and the structural formula is:."
},
{
"NDCCode": "63323-170-15",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (63323-170-15) > 15 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "63323-0170-15",
"ProductNDC": "63323-170",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Phosphates",
"NonProprietaryName": "Sodium Phosphate, Monobasic, Monohydrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20000906",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; SODIUM PHOSPHATE, DIBASIC, ANHYDROUS",
"StrengthNumber": "276; 142",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2021-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20000906",
"SamplePackage": "N",
"IndicationAndUsage": "Sodium Phosphates Injection, USP is indicated as a source of phosphate, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. The concomitant amount of sodium (4 mEq/mL) must be calculated into total electrolyte dose of such prepared solutions.",
"Description": "Sodium Phosphates Injection, USP, 3 mmol/mL (millimoles/mL), is a sterile, nonpyrogenic, concentrated solution containing a mixture of monobasic sodium phosphate and dibasic sodium phosphate in Water for Injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. Each mL contains: Monobasic sodium phosphate, monohydrate, 276 mg; dibasic sodium phosphate, anhydrous, 142 mg (equivalent to dibasic sodium phosphate, heptahydrate, 268 mg); Water for Injection q.s. In the 5 mL and 15 mL product, phosphoric acid and/or NaOH may have been added for pH adjustment. Each mL provides 3 mmol of phosphorus and 4 mEq sodium. It contains no bacteriostat, antimicrobial agent or added buffer. The pH is 5.7 (approx.). The osmolar concentration is 7 mOsmol/mL (calc.). The solution is intended as an alternative to potassium phosphate to provide phosphate ion (PO 43-) for addition to large volume infusion fluids for intravenous use. Sodium Phosphates, USP, monohydrate monobasic is chemically designated NaH 2PO 4 H 2O. Occurs as white, odorless crystals or granules freely soluble in water. Dibasic Sodium Phosphate, USP, anhydrous, is chemically designated Na 2HPO 4. Occurs as a colorless or white granular salt freely soluble in water."
},
{
"NDCCode": "63323-172-15",
"PackageDescription": "1 VIAL in 1 BOX (63323-172-15) > 15 mL in 1 VIAL",
"NDC11Code": "63323-0172-15",
"ProductNDC": "63323-172",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carboplatin",
"NonProprietaryName": "Carboplatin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20090915",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077432",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "CARBOPLATIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Platinum-containing Compounds [EXT],Platinum-based Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20090915",
"SamplePackage": "N"
},
{
"NDCCode": "63323-203-20",
"PackageDescription": "10 VIAL in 1 TRAY (63323-203-20) / 15 mL in 1 VIAL (63323-203-01) ",
"NDC11Code": "63323-0203-20",
"ProductNDC": "63323-203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20160817",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062663",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "750",
"StrengthUnit": "mg/15mL",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Active",
"LastUpdate": "2025-05-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160817",
"SamplePackage": "N",
"IndicationAndUsage": "Vancomycin Hydrochloride for Injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin Hydrochloride for Injection, USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin Hydrochloride for Injection, USP is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin Hydrochloride for Injection, USP has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin Hydrochloride for Injection, USP has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin Hydrochloride for Injection, USP has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection, USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.",
"Description": "Vancomycin Hydrochloride for Injection, USP, is an off-white to buff-colored lyophilized powder, for preparing intravenous (IV) infusions, in vials each containing the equivalent of 500 mg, 750 mg or 1 g vancomycin base. 500 mg of the base is equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection to a concentration of 50 mg/mL, the pH of the solution is between 2.5 and 4.5. This product is oxygen sensitive. Vancomycin Hydrochloride for Injection, USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION), AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE. Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopasis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is [3S-[3R*, 6S* (S*),7S*, 22S*, 23R*, 26R*, 36S*, 38aS*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[1,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]- benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. Vancomycin hydrochloride has the following structural formula:."
},
{
"NDCCode": "63323-203-26",
"PackageDescription": "10 VIAL in 1 TRAY (63323-203-26) / 15 mL in 1 VIAL (63323-203-41) ",
"NDC11Code": "63323-0203-26",
"ProductNDC": "63323-203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20160817",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062663",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "750",
"StrengthUnit": "mg/15mL",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Active",
"LastUpdate": "2025-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160817",
"SamplePackage": "N",
"IndicationAndUsage": "Vancomycin Hydrochloride for Injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin Hydrochloride for Injection, USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin Hydrochloride for Injection, USP is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin Hydrochloride for Injection, USP has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin Hydrochloride for Injection, USP has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin Hydrochloride for Injection, USP has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection, USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.",
"Description": "Vancomycin Hydrochloride for Injection, USP, is an off-white to buff-colored lyophilized powder, for preparing intravenous (IV) infusions, in vials containing the equivalent of 750 mg of the base is equivalent to 0.51 mmol. When reconstituted with Sterile Water for Injection to a concentration of 50 mg/mL, the pH of the solution is between 2.5 and 4.5. This product is oxygen sensitive. Vancomycin Hydrochloride for Injection, USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION), AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE. Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopasis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is [3S-[3R*, 6S* (S*),7S*, 22S*, 23R*, 26R*, 36S*,38aS*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[1,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]- benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. Vancomycin hydrochloride has the following structural formula:."
},
{
"NDCCode": "63323-229-15",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (63323-229-15) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-229-21) ",
"NDC11Code": "63323-0229-15",
"ProductNDC": "63323-229",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Protamine Sulfate",
"NonProprietaryName": "Protamine Sulfate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20001018",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089454",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "PROTAMINE SULFATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Heparin Binding Activity [MoA], Heparin Reversal Agent [EPC], Reversed Anticoagulation Activity [PE]",
"Status": "Active",
"LastUpdate": "2024-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20001018",
"SamplePackage": "N",
"IndicationAndUsage": "Protamine Sulfate Injection, USP is indicated in the treatment of heparin overdosage.",
"Description": "Protamines are simple proteins of low molecular weight that are rich in arginine and strongly basic. They occur in the sperm of salmon and certain other species of fish. Protamine sulfate occurs as fine white or off-white amorphous or crystalline powder. It is sparingly soluble in water. The pH is between 6.0 and 7.0. The cationic hydrogenated protamine at a pH of 6.8 to 7.1 reacts with anionic heparin at a pH of 5.0 to 7.5 to form an inactive complex. Protamine Sulfate Injection, USP is a sterile, isotonic solution of protamine sulfate. It acts as a heparin antagonist. It is also a weak anticoagulant. Each mL contains: Protamine sulfate 10 mg; sodium chloride 9 mg; Water for Injection q.s. Sulfuric acid and/or dibasic sodium phosphate (heptahydrate) may have been added for pH adjustment. The preparation is preservative free. Protamine sulfate is administered intravenously."
},
{
"NDCCode": "63323-300-30",
"PackageDescription": "10 VIAL in 1 BOX (63323-300-30) / 15 mL in 1 VIAL",
"NDC11Code": "63323-0300-30",
"ProductNDC": "63323-300",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Piperacillin And Tazobactam",
"NonProprietaryName": "Piperacillin Sodium,tazobactam Sodium",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20091013",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065523",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "PIPERACILLIN SODIUM; TAZOBACTAM SODIUM",
"StrengthNumber": "3; .375",
"StrengthUnit": "g/15mL; g/15mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20091013",
"SamplePackage": "N",
"IndicationAndUsage": "Piperacillin and tazobactam for injection is a combination product consisting of a penicillin-class antibacterial, piperacillin, and a β-lactamase inhibitor, tazobactam, indicated for the treatment of patients with moderate to severe infections caused by susceptible isolates of the designated bacteria in the conditions listed below.",
"Description": "Piperacillin and tazobactam for injection is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the β-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin. The chemical name of piperacillin sodium is sodium (2 S,5 R,6 R)-6-[( R)-2-(4-ethyl-2,3-dioxo-1-piperazinecarboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate. The chemical formula is C 23H 26N 5NaO 7S and the molecular weight is 539.5. The chemical structure of piperacillin sodium is:. Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2 S,3 S,5 R)-3-methyl-7-oxo-3-(1 H-1,2,3-triazol-1-ylmethyl)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide. The chemical formula is C 10H 11N 4NaO 5S and the molecular weight is 322.3. The chemical structure of tazobactam sodium is:. Piperacillin and tazobactam for injection, piperacillin/tazobactam parenteral combination, is a white to off-white sterile, cryodesiccated powder consisting of piperacillin and tazobactam as their sodium salts packaged in glass vials. The product does not contain excipients or preservatives. Each piperacillin and tazobactam for injection 2.25 g single dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 2 grams of piperacillin and tazobactam sodium equivalent to 0.25 g of tazobactam. Each vial contains 4.7 mEq (108 mg) of sodium. Each piperacillin and tazobactam for injection 3.375 g single dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 3 grams of piperacillin and tazobactam sodium equivalent to 0.375 g of tazobactam. Each vial contains 7.0 mEq (162 mg) of sodium. Each piperacillin and tazobactam for injection 4.5 g single dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 4 grams of piperacillin and tazobactam sodium equivalent to 0.5 g of tazobactam. Each vial contains 9.4 mEq (216 mg) of sodium. Piperacillin and tazobactam for injection is a monosodium salt of piperacillin and a monosodium salt of tazobactam containing a total of 2.35 mEq (54 mg) of sodium (Na +) per gram of piperacillin in the combination product."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>63323-712-15</NDCCode>
<PackageDescription>1540 mL in 1 BAG (63323-712-15) </PackageDescription>
<NDC11Code>63323-0712-15</NDC11Code>
<ProductNDC>63323-712</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<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>
<DosageFormName>INJECTION, EMULSION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20140825</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA200656</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<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</SubstanceName>
<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</StrengthNumber>
<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</StrengthUnit>
<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]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140825</StartMarketingDatePackage>
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<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)].</IndicationAndUsage>
<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.</Description>
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<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)].</IndicationAndUsage>
<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.</Description>
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<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.</Description>
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<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.</Description>
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<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59561-712-05</NDCCode>
<PackageDescription>15 g in 1 PACKAGE (59561-712-05)</PackageDescription>
<NDC11Code>59561-0712-05</NDC11Code>
<ProductNDC>59561-712</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Quitacallos</ProprietaryName>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150505</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part358F</ApplicationNumber>
<LabelerName>Caribe Natural, Inc</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>17</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>QuitaCallos. Removedor de Callos. Corn & Callus Remover. Salicylic Acid 17%.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59651-712-14</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (59651-712-14) / 15 g in 1 TUBE</PackageDescription>
<NDC11Code>59651-0712-14</NDC11Code>
<ProductNDC>59651-712</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tretinoin</ProprietaryName>
<NonProprietaryName>Tretinoin</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250113</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218246</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>TRETINOIN</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tretinoin gel is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.</IndicationAndUsage>
<Description>Tretinoin gel, USP, containing tretinoin USP, is used for the topical treatment of acne vulgaris. Tretinoin gel, USP contains tretinoin USP (retinoic acid, vitamin A acid) 0.1 mg (0.01%) by weight, in a gel vehicle of alcohol (90.5% w/w), butylated hydroxytoluene and hydroxypropyl cellulose. Chemically, tretinoin is all-trans-retinoic acid and has the following structure.</Description>
</NDC>
<NDC>
<NDCCode>59779-712-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (59779-712-01) > 15 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>59779-0712-01</NDC11Code>
<ProductNDC>59779-712</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cvshealth Antifungal</ProprietaryName>
<NonProprietaryName>Clotrimazole</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20151110</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333C</ApplicationNumber>
<LabelerName>CVS Pharmacy</LabelerName>
<SubstanceName>CLOTRIMAZOLE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-10-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170207</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62856-712-30</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 BOX, UNIT-DOSE (62856-712-30) / 15 CAPSULE in 1 BLISTER PACK (62856-712-05) </PackageDescription>
<NDC11Code>62856-0712-30</NDC11Code>
<ProductNDC>62856-712</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lenvima</ProprietaryName>
<NonProprietaryName>Lenvatinib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180815</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206947</ApplicationNumber>
<LabelerName>Eisai Inc.</LabelerName>
<SubstanceName>LENVATINIB</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC], Receptor Tyrosine Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LENVIMA is a kinase inhibitor that is indicated:. Differentiated Thyroid Cancer : 1 For the treatment of adult patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC). (1.1).</IndicationAndUsage>
<Description>LENVIMA, a kinase inhibitor, is the mesylate salt of lenvatinib. Its chemical name is 4-[3-chloro-4-(N’-cyclopropylureido)phenoxy]-7-methoxyquinoline-6-carboxamide methanesulfonate. The molecular formula is C21H19ClN4O4 CH4O3S, and the molecular weight of the mesylate salt is 522.96. The chemical structure of lenvatinib mesylate is. Lenvatinib mesylate is a white to pale reddish yellow powder. It is slightly soluble in water and practically insoluble in ethanol (dehydrated). The dissociation constant (pKa value) of lenvatinib mesylate is 5.05 at 25°C. The partition coefficient (log P value) is 3.3. LENVIMA capsules for oral administration contain 4 mg or 10 mg of lenvatinib, equivalent to 4.90 mg or 12.25 mg of lenvatinib mesylate, respectively. The inactive ingredients are: calcium carbonate, hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose, mannitol, microcrystalline cellulose, and talc. In addition, the capsule shell contains ferric oxide red, ferric oxide yellow, hypromellose, and titanium dioxide. The printing ink contains black iron oxide, potassium hydroxide, propylene glycol, and shellac.</Description>
</NDC>
<NDC>
<NDCCode>69784-712-15</NDCCode>
<PackageDescription>30 CAPSULE, LIQUID FILLED in 1 BOTTLE (69784-712-15) </PackageDescription>
<NDC11Code>69784-0712-15</NDC11Code>
<ProductNDC>69784-712</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Avodart</ProprietaryName>
<NonProprietaryName>Dutasteride</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221215</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021319</ApplicationNumber>
<LabelerName>Woodward Pharma Services LLC</LabelerName>
<SubstanceName>DUTASTERIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AVODART is a 5 alpha-reductase inhibitor indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: (1.1): 1 improve symptoms,, 2 reduce the risk of acute urinary retention, and, 3 reduce the risk of the need for BPH-related surgery.</IndicationAndUsage>
<Description>AVODART is a synthetic 4-azasteroid compound that is a selective inhibitor of both the type 1 and type 2 isoforms of steroid 5 alpha-reductase, an intracellular enzyme that converts testosterone to DHT. Dutasteride is chemically designated as (5α,17β)-N-{2,5 bis(trifluoromethyl)phenyl}-3-oxo-4-azaandrost-1-ene-17-carboxamide. The empirical formula of dutasteride is C27H30F6N2O2, representing a molecular weight of 528.5 with the following structural formula. Dutasteride is a white to pale yellow powder with a melting point of 242° to 250°C. It is soluble in ethanol (44 mg/mL), methanol (64 mg/mL), and polyethylene glycol 400 (3 mg/mL), but it is insoluble in water. Each AVODART soft gelatin capsule, administered orally, contains 0.5 mg of dutasteride dissolved in a mixture of mono-di-glycerides of caprylic/capric acid and butylated hydroxytoluene. The inactive excipients in the capsule shell are ferric oxide (yellow), gelatin (from certified BSE-free bovine sources), glycerin, and titanium dioxide. The soft gelatin capsules are printed with edible red ink.</Description>
</NDC>
<NDC>
<NDCCode>70166-712-10</NDCCode>
<PackageDescription>10 BOTTLE in 1 CELLO PACK (70166-712-10) > 15 g in 1 BOTTLE</PackageDescription>
<NDC11Code>70166-0712-10</NDC11Code>
<ProductNDC>70166-712</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Polystyrene Sulfonate</ProprietaryName>
<NonProprietaryName>Sodium Polystyrene Sulfonate</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL; RECTAL</RouteName>
<StartMarketingDate>20170207</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090313</ApplicationNumber>
<LabelerName>LOHXA</LabelerName>
<SubstanceName>SODIUM POLYSTYRENE SULFONATE</SubstanceName>
<StrengthNumber>4.1</StrengthNumber>
<StrengthUnit>meq/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191022</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sodium polystyrene sulfonate is indicated for the treatment of hyperkalemia.</IndicationAndUsage>
<Description>Sodium polystyrene sulfonate is a benzene, diethenyl-polymer, with ethenylbenzene, sulfonated, sodium salt and has the following structural formula. The drug is a cream to light brown finely ground, powdered form of sodium polystyrene sulfonate, a cation-exchange resin prepared in the sodium phase with an in vitro exchange capacity of approximately 3.1 mEq ( in vivo approximately 1 mEq) of potassium per gram. The sodium content is approximately 100 mg (4.1 mEq) per gram of the drug. It can be administered orally or in an enema.</Description>
</NDC>
<NDC>
<NDCCode>71919-712-07</NDCCode>
<PackageDescription>15 mL in 1 VIAL, GLASS (71919-712-07) </PackageDescription>
<NDC11Code>71919-0712-07</NDC11Code>
<ProductNDC>71919-712</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Viburnum Prunifolium</ProprietaryName>
<NonProprietaryName>Viburnum Prunifolium</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110517</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>VIBURNUM PRUNIFOLIUM BARK</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110517</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>76041-712-15</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (76041-712-15) > 150 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>76041-0712-15</NDC11Code>
<ProductNDC>76041-712</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Moisturising Sunscreen</ProprietaryName>
<ProprietaryNameSuffix>Spf 30</ProprietaryNameSuffix>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110610</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Neals Yard (Natural Remedies) Limited</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>17.5</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-01-30</LastUpdate>
</NDC>
<NDC>
<NDCCode>80725-712-15</NDCCode>
<PackageDescription>30 CAPSULE, LIQUID FILLED in 1 BOTTLE (80725-712-15) </PackageDescription>
<NDC11Code>80725-0712-15</NDC11Code>
<ProductNDC>80725-712</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Avodart</ProprietaryName>
<NonProprietaryName>Dutasteride</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221215</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021319</ApplicationNumber>
<LabelerName>Waylis Therapeutics LLC</LabelerName>
<SubstanceName>DUTASTERIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AVODART is a 5 alpha-reductase inhibitor indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: (1.1): 1 improve symptoms,, 2 reduce the risk of acute urinary retention, and, 3 reduce the risk of the need for BPH-related surgery.</IndicationAndUsage>
<Description>AVODART is a synthetic 4-azasteroid compound that is a selective inhibitor of both the type 1 and type 2 isoforms of steroid 5 alpha-reductase, an intracellular enzyme that converts testosterone to DHT. Dutasteride is chemically designated as (5α,17β)-N-{2,5 bis(trifluoromethyl)phenyl}-3-oxo-4-azaandrost-1-ene-17-carboxamide. The empirical formula of dutasteride is C27H30F6N2O2, representing a molecular weight of 528.5 with the following structural formula. Dutasteride is a white to pale yellow powder with a melting point of 242° to 250°C. It is soluble in ethanol (44 mg/mL), methanol (64 mg/mL), and polyethylene glycol 400 (3 mg/mL), but it is insoluble in water. Each AVODART soft gelatin capsule, administered orally, contains 0.5 mg of dutasteride dissolved in a mixture of mono-di-glycerides of caprylic/capric acid and butylated hydroxytoluene. The inactive excipients in the capsule shell are ferric oxide (yellow), gelatin (from certified BSE-free bovine sources), glycerin, and titanium dioxide. The soft gelatin capsules are printed with edible red ink.</Description>
</NDC>
<NDC>
<NDCCode>84515-712-01</NDCCode>
<PackageDescription>15 g in 1 BOX (84515-712-01) </PackageDescription>
<NDC11Code>84515-0712-01</NDC11Code>
<ProductNDC>84515-712</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dark Spot Corrector</ProprietaryName>
<NonProprietaryName>Dark Spot Corrector</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241023</StartMarketingDate>
<EndMarketingDate>20311231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Xinqian E Commerce Co Ltd</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20241023</StartMarketingDatePackage>
<EndMarketingDatePackage>20311231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84682-712-01</NDCCode>
<PackageDescription>15 g in 1 BOX (84682-712-01) </PackageDescription>
<NDC11Code>84682-0712-01</NDC11Code>
<ProductNDC>84682-712</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Firming Cream</ProprietaryName>
<NonProprietaryName>Firming Cream</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241025</StartMarketingDate>
<EndMarketingDate>20311031</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Yucheng E Commerce Co Ltd</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20241025</StartMarketingDatePackage>
<EndMarketingDatePackage>20311031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>84756-712-02</NDCCode>
<PackageDescription>15 g in 1 BOX (84756-712-02) </PackageDescription>
<NDC11Code>84756-0712-02</NDC11Code>
<ProductNDC>84756-712</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Turmeric Booster Eye Cream</ProprietaryName>
<NonProprietaryName>Turmeric Booster Eye Cream</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241212</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Ziqiu Import Export Co Ltd</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63323-011-15</NDCCode>
<PackageDescription>10 VIAL in 1 TRAY (63323-011-15) / 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>63323-0011-15</NDC11Code>
<ProductNDC>63323-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chloramphenicol Sodium Succinate</ProprietaryName>
<NonProprietaryName>Chloramphenicol Sodium Succinate</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20010112</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062365</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>CHLORAMPHENICOL SODIUM SUCCINATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/10mL</StrengthUnit>
<Pharm_Classes>Amphenicol-class Antibacterial [EPC], Amphenicols [EXT]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20010112</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Chloramphenicol is an antibiotic that is clinically useful for, and should be reserved for, serious infections caused by organisms susceptible to its antimicrobial effects when less potentially hazardous therapeutic agents are ineffective or contraindicated. Sensitivity testing is essential to determine its indicated use, but may be performed concurrently with therapy initiated on clinical impression that one of the indicated conditions exists (see INDICATIONS AND USAGE section). When reconstituted as directed, each vial contains a sterile solution equivalent to 100 mg of chloramphenicol per mL (1 g/10 mL). Each gram (10 mL of a 10% solution) of chloramphenicol sodium succinate contains approximately 52 mg (2.25 mEq) of sodium. The chemical name for chloramphenicol sodium succinate is D-threo-(-)-2, 2-Dichloro-N-[β-hydroxy-α-(hydroxymethyl)-p-nitrophenethyl] acetamide α-(sodium succinate). The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>63323-086-15</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (63323-086-15) > 15 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>63323-0086-15</NDC11Code>
<ProductNDC>63323-086</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Phosphates</ProprietaryName>
<NonProprietaryName>Potassium Phosphate, Monobasic And Potassium Phosphate, Dibasic</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20000808</StartMarketingDate>
<EndMarketingDate>20221130</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC</SubstanceName>
<StrengthNumber>236; 224</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20000808</StartMarketingDatePackage>
<EndMarketingDatePackage>20220531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63323-106-15</NDCCode>
<PackageDescription>24 BAG in 1 CASE (63323-106-15) / 500 mL in 1 BAG</PackageDescription>
<NDC11Code>63323-0106-15</NDC11Code>
<ProductNDC>63323-106</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Magnesium Sulfate</ProprietaryName>
<NonProprietaryName>Magnesium Sulfate Heptahydrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20160315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206485</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>MAGNESIUM SULFATE HEPTAHYDRATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Magnesium sulfate in water for injection is indicated for the prevention and control of seizures in pre-eclampsia and eclampsia, respectively. When used judiciously it effectively prevents and controls the convulsions of eclampsia without producing deleterious depression of the central nervous system of the mother or infant. However, other effective drugs are available for this purpose.</IndicationAndUsage>
<Description>Magnesium Sulfate in Water for Injection is a sterile, nonpyrogenic solution of magnesium sulfate heptahydrate in water for injection. May contain sulfuric acid and/or sodium hydroxide for pH adjustment. The pH is 4.5 (3.5 to 6.5). It is available in 4% and 8% concentrations. See HOW SUPPLIED section for the content and characteristics of available dosage forms and sizes. Magnesium sulfate, USP heptahydrate is chemically designated MgSO 4 7H 2O, colorless crystals or white powder freely soluble in water. 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. Exposure to temperatures above 25ºC/77ºF during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.</Description>
</NDC>
<NDC>
<NDCCode>63323-132-15</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 BOX (63323-132-15) / 15 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>63323-0132-15</NDC11Code>
<ProductNDC>63323-132</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mitoxantrone</ProprietaryName>
<NonProprietaryName>Mitoxantrone Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20060411</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077496</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>MITOXANTRONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060411</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mitoxantrone Injection, USP is indicated for reducing neurologic disability and/or the frequency of clinical relapses in patients with secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis (i.e., patients whose neurologic status is significantly abnormal between relapses). Mitoxantrone Injection, USP is not indicated in the treatment of patients with primary progressive multiple sclerosis. The clinical patterns of multiple sclerosis in the studies were characterized as follows: secondary progressive and progressive relapsing disease were characterized by gradual increasing disability with or without superimposed clinical relapses, and worsening relapsing-remitting disease was characterized by clinical relapses resulting in a step-wise worsening of disability. Mitoxantrone Injection, USP in combination with corticosteroids is indicated as initial chemotherapy for the treatment of patients with pain related to advanced hormone-refractory prostate cancer. Mitoxantrone Injection, USP in combination with other approved drug(s) is indicated in the initial therapy of acute nonlymphocytic leukemia (ANLL) in adults. This category includes myelogenous, promyelocytic, monocytic, and erythroid acute leukemias.</IndicationAndUsage>
<Description>Mitoxantrone Injection, USP (concentrate) is a synthetic antineoplastic anthracenedione for intravenous use. It is supplied as a concentrate that MUST BE DILUTED PRIOR TO INJECTION. The concentrate is a sterile, nonpyrogenic, dark blue aqueous solution containing mitoxantrone hydrochloride equivalent to 2 mg/mL mitoxantrone free base, with the following inactive ingredients: sodium chloride (0.800% w/v), sodium acetate (0.005% w/v), acetic acid (0.046% w/v), and water for injection. The solution has a pH of 3.0 to 4.5 and contains 0.14 mEq of sodium per mL. The product does not contain preservatives. The chemical name is 1,4-dihydroxy-5,8-bis[[2-[(2-hydroxyethyl) amino]ethyl]amino]-9,10- anthracenedione dihydrochloride and the structural formula is:.</Description>
</NDC>
<NDC>
<NDCCode>63323-170-15</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (63323-170-15) > 15 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>63323-0170-15</NDC11Code>
<ProductNDC>63323-170</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Phosphates</ProprietaryName>
<NonProprietaryName>Sodium Phosphate, Monobasic, Monohydrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20000906</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; SODIUM PHOSPHATE, DIBASIC, ANHYDROUS</SubstanceName>
<StrengthNumber>276; 142</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20000906</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sodium Phosphates Injection, USP is indicated as a source of phosphate, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. The concomitant amount of sodium (4 mEq/mL) must be calculated into total electrolyte dose of such prepared solutions.</IndicationAndUsage>
<Description>Sodium Phosphates Injection, USP, 3 mmol/mL (millimoles/mL), is a sterile, nonpyrogenic, concentrated solution containing a mixture of monobasic sodium phosphate and dibasic sodium phosphate in Water for Injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. Each mL contains: Monobasic sodium phosphate, monohydrate, 276 mg; dibasic sodium phosphate, anhydrous, 142 mg (equivalent to dibasic sodium phosphate, heptahydrate, 268 mg); Water for Injection q.s. In the 5 mL and 15 mL product, phosphoric acid and/or NaOH may have been added for pH adjustment. Each mL provides 3 mmol of phosphorus and 4 mEq sodium. It contains no bacteriostat, antimicrobial agent or added buffer. The pH is 5.7 (approx.). The osmolar concentration is 7 mOsmol/mL (calc.). The solution is intended as an alternative to potassium phosphate to provide phosphate ion (PO 43-) for addition to large volume infusion fluids for intravenous use. Sodium Phosphates, USP, monohydrate monobasic is chemically designated NaH 2PO 4 H 2O. Occurs as white, odorless crystals or granules freely soluble in water. Dibasic Sodium Phosphate, USP, anhydrous, is chemically designated Na 2HPO 4. Occurs as a colorless or white granular salt freely soluble in water.</Description>
</NDC>
<NDC>
<NDCCode>63323-172-15</NDCCode>
<PackageDescription>1 VIAL in 1 BOX (63323-172-15) > 15 mL in 1 VIAL</PackageDescription>
<NDC11Code>63323-0172-15</NDC11Code>
<ProductNDC>63323-172</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carboplatin</ProprietaryName>
<NonProprietaryName>Carboplatin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20090915</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077432</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>CARBOPLATIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Platinum-containing Compounds [EXT],Platinum-based Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-11-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63323-203-20</NDCCode>
<PackageDescription>10 VIAL in 1 TRAY (63323-203-20) / 15 mL in 1 VIAL (63323-203-01) </PackageDescription>
<NDC11Code>63323-0203-20</NDC11Code>
<ProductNDC>63323-203</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20160817</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062663</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/15mL</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160817</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vancomycin Hydrochloride for Injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin Hydrochloride for Injection, USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin Hydrochloride for Injection, USP is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin Hydrochloride for Injection, USP has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin Hydrochloride for Injection, USP has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin Hydrochloride for Injection, USP has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection, USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.</IndicationAndUsage>
<Description>Vancomycin Hydrochloride for Injection, USP, is an off-white to buff-colored lyophilized powder, for preparing intravenous (IV) infusions, in vials each containing the equivalent of 500 mg, 750 mg or 1 g vancomycin base. 500 mg of the base is equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection to a concentration of 50 mg/mL, the pH of the solution is between 2.5 and 4.5. This product is oxygen sensitive. Vancomycin Hydrochloride for Injection, USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION), AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE. Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopasis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is [3S-[3R*, 6S* (S*),7S*, 22S*, 23R*, 26R*, 36S*, 38aS*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[1,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]- benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. Vancomycin hydrochloride has the following structural formula:.</Description>
</NDC>
<NDC>
<NDCCode>63323-203-26</NDCCode>
<PackageDescription>10 VIAL in 1 TRAY (63323-203-26) / 15 mL in 1 VIAL (63323-203-41) </PackageDescription>
<NDC11Code>63323-0203-26</NDC11Code>
<ProductNDC>63323-203</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20160817</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062663</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/15mL</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160817</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vancomycin Hydrochloride for Injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin Hydrochloride for Injection, USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin Hydrochloride for Injection, USP is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin Hydrochloride for Injection, USP has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin Hydrochloride for Injection, USP has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin Hydrochloride for Injection, USP has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection, USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.</IndicationAndUsage>
<Description>Vancomycin Hydrochloride for Injection, USP, is an off-white to buff-colored lyophilized powder, for preparing intravenous (IV) infusions, in vials containing the equivalent of 750 mg of the base is equivalent to 0.51 mmol. When reconstituted with Sterile Water for Injection to a concentration of 50 mg/mL, the pH of the solution is between 2.5 and 4.5. This product is oxygen sensitive. Vancomycin Hydrochloride for Injection, USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION), AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE. Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopasis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is [3S-[3R*, 6S* (S*),7S*, 22S*, 23R*, 26R*, 36S*,38aS*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[1,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]- benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. Vancomycin hydrochloride has the following structural formula:.</Description>
</NDC>
<NDC>
<NDCCode>63323-229-15</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (63323-229-15) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-229-21) </PackageDescription>
<NDC11Code>63323-0229-15</NDC11Code>
<ProductNDC>63323-229</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Protamine Sulfate</ProprietaryName>
<NonProprietaryName>Protamine Sulfate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20001018</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089454</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>PROTAMINE SULFATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Heparin Binding Activity [MoA], Heparin Reversal Agent [EPC], Reversed Anticoagulation Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20001018</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Protamine Sulfate Injection, USP is indicated in the treatment of heparin overdosage.</IndicationAndUsage>
<Description>Protamines are simple proteins of low molecular weight that are rich in arginine and strongly basic. They occur in the sperm of salmon and certain other species of fish. Protamine sulfate occurs as fine white or off-white amorphous or crystalline powder. It is sparingly soluble in water. The pH is between 6.0 and 7.0. The cationic hydrogenated protamine at a pH of 6.8 to 7.1 reacts with anionic heparin at a pH of 5.0 to 7.5 to form an inactive complex. Protamine Sulfate Injection, USP is a sterile, isotonic solution of protamine sulfate. It acts as a heparin antagonist. It is also a weak anticoagulant. Each mL contains: Protamine sulfate 10 mg; sodium chloride 9 mg; Water for Injection q.s. Sulfuric acid and/or dibasic sodium phosphate (heptahydrate) may have been added for pH adjustment. The preparation is preservative free. Protamine sulfate is administered intravenously.</Description>
</NDC>
<NDC>
<NDCCode>63323-300-30</NDCCode>
<PackageDescription>10 VIAL in 1 BOX (63323-300-30) / 15 mL in 1 VIAL</PackageDescription>
<NDC11Code>63323-0300-30</NDC11Code>
<ProductNDC>63323-300</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Piperacillin And Tazobactam</ProprietaryName>
<NonProprietaryName>Piperacillin Sodium,tazobactam Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20091013</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065523</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>PIPERACILLIN SODIUM; TAZOBACTAM SODIUM</SubstanceName>
<StrengthNumber>3; .375</StrengthNumber>
<StrengthUnit>g/15mL; g/15mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091013</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Piperacillin and tazobactam for injection is a combination product consisting of a penicillin-class antibacterial, piperacillin, and a β-lactamase inhibitor, tazobactam, indicated for the treatment of patients with moderate to severe infections caused by susceptible isolates of the designated bacteria in the conditions listed below.</IndicationAndUsage>
<Description>Piperacillin and tazobactam for injection is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the β-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin. The chemical name of piperacillin sodium is sodium (2 S,5 R,6 R)-6-[( R)-2-(4-ethyl-2,3-dioxo-1-piperazinecarboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate. The chemical formula is C 23H 26N 5NaO 7S and the molecular weight is 539.5. The chemical structure of piperacillin sodium is:. Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2 S,3 S,5 R)-3-methyl-7-oxo-3-(1 H-1,2,3-triazol-1-ylmethyl)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide. The chemical formula is C 10H 11N 4NaO 5S and the molecular weight is 322.3. The chemical structure of tazobactam sodium is:. Piperacillin and tazobactam for injection, piperacillin/tazobactam parenteral combination, is a white to off-white sterile, cryodesiccated powder consisting of piperacillin and tazobactam as their sodium salts packaged in glass vials. The product does not contain excipients or preservatives. Each piperacillin and tazobactam for injection 2.25 g single dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 2 grams of piperacillin and tazobactam sodium equivalent to 0.25 g of tazobactam. Each vial contains 4.7 mEq (108 mg) of sodium. Each piperacillin and tazobactam for injection 3.375 g single dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 3 grams of piperacillin and tazobactam sodium equivalent to 0.375 g of tazobactam. Each vial contains 7.0 mEq (162 mg) of sodium. Each piperacillin and tazobactam for injection 4.5 g single dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 4 grams of piperacillin and tazobactam sodium equivalent to 0.5 g of tazobactam. Each vial contains 9.4 mEq (216 mg) of sodium. Piperacillin and tazobactam for injection is a monosodium salt of piperacillin and a monosodium salt of tazobactam containing a total of 2.35 mEq (54 mg) of sodium (Na +) per gram of piperacillin in the combination product.</Description>
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