{
"NDC": [
{
"NDCCode": "70063-500-12",
"PackageDescription": "28 SUPPOSITORY in 1 BOX (70063-500-12) ",
"NDC11Code": "70063-0500-12",
"ProductNDC": "70063-500",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocortisone Acetate",
"NonProprietaryName": "Hydrocortisone Acetate",
"DosageFormName": "SUPPOSITORY",
"RouteName": "RECTAL",
"StartMarketingDate": "20180309",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "SI Pharmaceuticals, LLC",
"SubstanceName": "HYDROCORTISONE ACETATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-03-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180309",
"SamplePackage": "N"
},
{
"NDCCode": "70063-500-28",
"PackageDescription": "28 SUPPOSITORY in 1 BOX (70063-500-28) ",
"NDC11Code": "70063-0500-28",
"ProductNDC": "70063-500",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocortisone Acetate",
"NonProprietaryName": "Hydrocortisone Acetate",
"DosageFormName": "SUPPOSITORY",
"RouteName": "RECTAL",
"StartMarketingDate": "20180309",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "SI Pharmaceuticals, LLC",
"SubstanceName": "HYDROCORTISONE ACETATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-05-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180309",
"SamplePackage": "N"
},
{
"NDCCode": "0264-1101-55",
"PackageDescription": "12 CONTAINER in 1 CASE (0264-1101-55) > 500 mL in 1 CONTAINER",
"NDC11Code": "00264-1101-55",
"ProductNDC": "0264-1101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextrose",
"NonProprietaryName": "Dextrose",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20110727",
"EndMarketingDate": "20150101",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "DEXTROSE",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2015-01-09"
},
{
"NDCCode": "0264-1933-10",
"PackageDescription": "12 CONTAINER in 1 CASE (0264-1933-10) / 500 mL in 1 CONTAINER",
"NDC11Code": "00264-1933-10",
"ProductNDC": "0264-1933",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trophamine",
"NonProprietaryName": "Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Cysteine Hydrochloride, Histidine, Tyrosine, N-acetyl-tyrosine, Alanine, Arginine, Proline, Serine, Glycine, Aspartic Acid, Glutamic Acid, And Taurine",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20201027",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019018",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; CYSTEINE HYDROCHLORIDE; HISTIDINE; TYROSINE; ACETYL L-TYROSINE; ALANINE; ARGININE; PROLINE; SERINE; GLYCINE; ASPARTIC ACID; GLUTAMIC ACID; TAURINE",
"StrengthNumber": ".82; 1.4; 1.2; .34; .48; .42; .2; .78; .024; .48; .044; .24; .54; 1.2; .68; .38; .36; .32; .5; .025",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL",
"Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201027",
"SamplePackage": "N",
"IndicationAndUsage": "TrophAmine® is indicated for the nutritional support of infants (including those of low birth weight) and young pediatric patients requiring TPN via either central or peripheral infusion routes. Parenteral nutrition with TrophAmine® is indicated to prevent nitrogen and weight loss or treat negative nitrogen balance in infants and young pediatric patients where (1) the alimentary tract, by the oral, gastrostomy, or jejunostomy route, cannot or should not be used, or adequate protein intake is not feasible by these routes; (2) gastrointestinal absorption of protein is impaired; or (3) protein requirements are substantially increased as with extensive burns. Dosage, route of administration, and concomitant infusion of non-protein calories are dependent on various factors, such as nutritional and metabolic status of the patient, anticipated duration of parenteral nutritional support, and vein tolerance. See WARNINGS, PRECAUTIONS, Pediatric Use, AND DOSAGE AND ADMINISTRATION.",
"Description": "TrophAmine® (10% Amino Acid Injection) is a sterile, nonpyrogenic, hypertonic solution containing crystalline amino acids. All amino acids designated USP are the “L”-isomer with the exception of Glycine USP, which does not have an isomer. Each 100 mL contains."
},
{
"NDCCode": "0264-1940-10",
"PackageDescription": "12 CONTAINER in 1 CASE (0264-1940-10) > 500 mL in 1 CONTAINER",
"NDC11Code": "00264-1940-10",
"ProductNDC": "0264-1940",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "PARENTERAL",
"StartMarketingDate": "19780321",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085870",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "14.9",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC]",
"Status": "Deprecated",
"LastUpdate": "2014-04-22"
},
{
"NDCCode": "0264-1965-10",
"PackageDescription": "12 CONTAINER in 1 CASE (0264-1965-10) > 500 mL in 1 CONTAINER",
"NDC11Code": "00264-1965-10",
"ProductNDC": "0264-1965",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hespan",
"NonProprietaryName": "Hetastarch In Sodium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19910404",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "BN890105",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "HETASTARCH; SODIUM CHLORIDE",
"StrengthNumber": "6; .9",
"StrengthUnit": "g/100mL; g/100mL",
"Pharm_Classes": "Increased Intravascular Volume [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plasma Volume Expander [EPC], Starch [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19910404",
"SamplePackage": "N",
"IndicationAndUsage": "HESPAN® is indicated in the treatment of hypovolemia when plasma volume expansion is desired in settings where adequate alternative treatment is unavailable. It is not a substitute for blood or plasma. The adjunctive use of HESPAN® in leukapheresis has also been shown to be safe and efficacious in improving the harvesting and increasing the yield of granulocytes by centrifugal means.",
"Description": "HESPAN® (6% hetastarch in 0.9% sodium chloride injection) is a sterile, nonpyrogenic solution for intravenous administration. Each 100 mL contains. Hetastarch.................................................. 6 g. Sodium Chloride, USP............................... 0.9 g. Water for Injection, USP............................. qs. pH adjusted with Sodium Hydroxide, NF if necessary. Concentration of Electrolytes (mEq/L): Sodium 154, Chloride 154. pH: approximately 5.9 with negligible buffering capacity. Calc. Osmolarity: approximately 309 mOsM. Hetastarch is a synthetic colloid derived from a waxy starch composed almost entirely of amylopectin. Hydroxyethyl ether groups are introduced into the glucose units of the starch, and the resultant material is hydrolyzed to yield a product with a molecular weight suitable for use as a plasma volume expander and erythrocyte sedimenting agent. The molar substitution is approximately 0.75 which means hetastarch has an average of approximately 75 hydroxyethyl groups for every 100 glucose units. The weight average molecular weight is approximately 600,000 with a range of 450,000 to 800,000 and with at least 80% of the polymers falling within the range of 20,000 to 2,600,000. Hydroxyethyl groups are attached by ether linkage primarily at C-2 of the glucose unit and to a lesser extent at C-3 and C-6. The polymer resembles glycogen, and the polymerized D-glucose units are joined primarily by α-1,4 linkages with occasional α-1,6 branching linkages. The chemical name for hetastarch is hydroxyethyl starch. The structural formula is as follows. Amylopectin derivative in which R2 and R3 are H or CH2CH2OH and R6 is H, CH2CH2OH, or a branching point in the starch polymer connected through an α-1,6 link to additional D-glucopyranosyl units. HESPAN® is a clear, pale yellow to amber solution. Exposure to prolonged adverse storage conditions may result in a change to a turbid deep brown or the formation of a crystalline precipitate. Do not use the solution if these conditions are evident. Not made with natural rubber latex, PVC or DEHP. The plastic container is made from a multi-layered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. 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 moisture barrier when necessary. The closure system has two ports; the one for the administration set has a tamper evident plastic protector."
},
{
"NDCCode": "0264-1968-10",
"PackageDescription": "12 CONTAINER in 1 CASE (0264-1968-10) > 500 mL in 1 CONTAINER",
"NDC11Code": "00264-1968-10",
"ProductNDC": "0264-1968",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxyethyl Starch In Sodium Chloride",
"NonProprietaryName": "Hydroxyethyl Starch In Sodium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20150109",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "BA110013",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "HYDROXYETHYL STARCH 130/0.4; SODIUM CHLORIDE",
"StrengthNumber": "6; 900",
"StrengthUnit": "g/100mL; mg/100mL",
"Pharm_Classes": "Plasma Volume Expander [EPC],Increased Intravascular Volume [PE],Osmotic Activity [MoA],Starch [CS],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20150109",
"SamplePackage": "N"
},
{
"NDCCode": "0264-4001-55",
"PackageDescription": "12 CONTAINER in 1 CASE (0264-4001-55) > 500 mL in 1 CONTAINER",
"NDC11Code": "00264-4001-55",
"ProductNDC": "0264-4001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Chloride",
"NonProprietaryName": "Sodium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20110908",
"EndMarketingDate": "20151001",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "SODIUM CHLORIDE",
"StrengthNumber": ".9",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2015-11-18"
},
{
"NDCCode": "0264-4021-55",
"PackageDescription": "12 CONTAINER in 1 CASE (0264-4021-55) > 500 mL in 1 CONTAINER",
"NDC11Code": "00264-4021-55",
"ProductNDC": "0264-4021",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Chloride",
"NonProprietaryName": "Sodium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20110908",
"EndMarketingDate": "20151001",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "SODIUM CHLORIDE",
"StrengthNumber": ".45",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2015-11-18"
},
{
"NDCCode": "0264-4460-10",
"PackageDescription": "12 CARTON in 1 CASE (0264-4460-10) / 1 CONTAINER in 1 CARTON / 500 mL in 1 CONTAINER",
"NDC11Code": "00264-4460-10",
"ProductNDC": "0264-4460",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nutrilipid I.v. Fat Emulsion",
"NonProprietaryName": "Soybean Oil",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20140630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019531",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "SOYBEAN OIL",
"StrengthNumber": "20",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Lipid Emulsion [EPC], Lipids [CS]",
"Status": "Active",
"LastUpdate": "2026-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140630",
"SamplePackage": "N",
"IndicationAndUsage": "Nutrilipid® 20% is indicated as a source of calories and essential fatty acids for parenteral nutrition and as a source of essential fatty acids when a deficiency occurs when oral or enteral nutrition is not possible, insufficient, or contraindicated.",
"Description": "Nutrilipid 20% is a homogenous white and milky sterile, nonpyrogenic lipid emulsion for intravenous administration. Each 100 mL of Nutrilipid 20% contains: Soybean Oil 20 g; Egg Yolk Phospholipid 1.2 g; Glycerin USP (glycerol) 2.5 g; Sodium Oleate 0.03 g; Water for Injection USP qs. pH adjusted with Sodium Hydroxide NF. pH: 6.8 (6.0-8.9); Osmolality: 390 mOsmol/kg (actual). Contains emulsified fat particles averaging approximately 0.26 micron in diameter, similar to naturally occurring chylomicrons. The total caloric value, including fat, phospholipid, and glycerol is 2.0 Kcal per mL. Soybean oil is a refined natural product consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure. are saturated and unsaturated fatty acid residues. The major component fatty acids are linoleic (48% - 58%), oleic (17% - 30%), palmitic (9% -13%), linolenic (4% - 11%), and stearic (2.5% - 5.0%). These fatty acids have the folIowing chemical and structural formulas. Egg yolk phospholipids are a mixture of naturally occurring phospholipids isolated from egg yolk. Glycerol is chemically designated C3H8O3 and is a clear colorless, hygroscopic syrupy liquid. It is added to adjust tonicity. Not made with natural rubber latex, PVC or DEHP. Drug product contains no more than 25 mcg/L of aluminum."
},
{
"NDCCode": "0264-4460-20",
"PackageDescription": "12 CARTON in 1 CASE (0264-4460-20) > 1 CONTAINER in 1 CARTON > 500 mL in 1 CONTAINER",
"NDC11Code": "00264-4460-20",
"ProductNDC": "0264-4460",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nutrilipid I.v. Fat Emulsion",
"NonProprietaryName": "Soybean Oil",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20140630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019531",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "SOYBEAN OIL",
"StrengthNumber": "20",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Lipid Emulsion [EPC],Lipids [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20140630",
"SamplePackage": "N"
},
{
"NDCCode": "0264-9361-55",
"PackageDescription": "12 CARTON in 1 CASE (0264-9361-55) > 1 CONTAINER in 1 CARTON > 500 mL in 1 CONTAINER",
"NDC11Code": "00264-9361-55",
"ProductNDC": "0264-9361",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trophamine",
"NonProprietaryName": "Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Cysteine Hydrochloride, Histidine, Tyrosine, N-acetyl-tyrosine, Alanine, Arginine, Proline, Serine, Glycine, Aspartic Acid, Glutamic Acid, And Taurine",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19840720",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019018",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "ACETYL L-TYROSINE; ALANINE; ARGININE; ASPARTIC ACID; CYSTEINE HYDROCHLORIDE; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; TAURINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE",
"StrengthNumber": ".12; .32; .73; .19; .02; .3; .22; .29; .49; .84; .69; .2; .29; .41; .23; .015; .25; .12; .044; .47",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL",
"Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "19840720",
"SamplePackage": "N"
},
{
"NDCCode": "0338-0519-12",
"PackageDescription": "500 mL in 1 BAG (0338-0519-12)",
"NDC11Code": "00338-0519-12",
"ProductNDC": "0338-0519",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Intralipid",
"NonProprietaryName": "Soybean Oil",
"DosageFormName": "EMULSION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20130530",
"MarketingCategoryName": "UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "SOYBEAN OIL",
"StrengthNumber": "20",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Lipid Emulsion [EPC],Lipids [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2015-05-29"
},
{
"NDCCode": "0338-1005-03",
"PackageDescription": "12 BAG in 1 CARTON (0338-1005-03) / 500 mL in 1 BAG",
"NDC11Code": "00338-1005-03",
"ProductNDC": "0338-1005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dopamine Hydrochloride And Dextrose",
"NonProprietaryName": "Dopamine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19870327",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019615",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "DOPAMINE HYDROCHLORIDE",
"StrengthNumber": "80",
"StrengthUnit": "mg/100mL",
"Pharm_Classes": "Catecholamine [EPC], Catecholamines [CS]",
"Status": "Active",
"LastUpdate": "2026-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19870327",
"SamplePackage": "N",
"IndicationAndUsage": "Dopamine hydrochloride is indicated for the correction of hemodynamic imbalances present in the shock syndrome due to myocardial infarctions, trauma, endotoxic septicemia, open heart surgery, renal failure and chronic cardiac decompensation as in congestive failure. Where appropriate, restoration of blood volume with a suitable plasma expander or whole blood should be instituted or completed prior to administration of dopamine hydrochloride. Patients most likely to respond adequately to dopamine hydrochloride are those in whom physiological parameters, such as urine flow, myocardial function and blood pressure have not undergone profound deterioration. Reports indicate that the shorter the time interval between onset of signs and symptoms and initiation of therapy with volume correction and dopamine hydrochloride, the better the prognosis.",
"Description": "Dopamine Hydrochloride and 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution of Dopamine Hydrochloride, USP and Dextrose, USP in Water for Injection. Structural formulas are shown below. Dopamine Hydrochloride and 5% Dextrose Injection, USP is intended for intravenous use only. It contains no antimicrobial agents. The pH is adjusted with hydrochloric acid and is 3.5 (2.5 to 4.5). Approximately 5 mEq/L sodium bisulfite is added as a stabilizer. The solution provides a caloric content of 170 kcal/L. The solution is intended for single use only. When smaller doses are required, the unused portion should be discarded. Composition and osmolarity are given below. 800 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 800 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 261 mOsmol/L (calc). 1600 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 1600 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 269 mOsmol/L (calc). 3200 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 3200 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 286 mOsmol/L (calc). Dopamine administered intravenously is a myocardial inotropic agent which also may increase mesenteric and renal blood flow plus urinary output. Dopamine hydrochloride is designated chemically as 3,4-dihydroxyphenethylamine hydrochloride, a white crystalline powder freely soluble in water. Dopamine (also referred to as 3-hydroxytyramine) is a naturally occurring biochemical catecholamine precursor of norepinephrine. This VIAFLEX Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 2207 Plastic). VIAFLEX containers, including VIAFLEX Plus containers, are made of flexible plastic and are for parenteral use. VIAFLEX Plus on the container indicates the presence of a drug additive in a drug vehicle. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies."
},
{
"NDCCode": "0338-1007-03",
"PackageDescription": "12 BAG in 1 CARTON (0338-1007-03) / 500 mL in 1 BAG",
"NDC11Code": "00338-1007-03",
"ProductNDC": "0338-1007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dopamine Hydrochloride And Dextrose",
"NonProprietaryName": "Dopamine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19870327",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019615",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "DOPAMINE HYDROCHLORIDE",
"StrengthNumber": "160",
"StrengthUnit": "mg/100mL",
"Pharm_Classes": "Catecholamine [EPC], Catecholamines [CS]",
"Status": "Active",
"LastUpdate": "2026-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19870327",
"SamplePackage": "N",
"IndicationAndUsage": "Dopamine hydrochloride is indicated for the correction of hemodynamic imbalances present in the shock syndrome due to myocardial infarctions, trauma, endotoxic septicemia, open heart surgery, renal failure and chronic cardiac decompensation as in congestive failure. Where appropriate, restoration of blood volume with a suitable plasma expander or whole blood should be instituted or completed prior to administration of dopamine hydrochloride. Patients most likely to respond adequately to dopamine hydrochloride are those in whom physiological parameters, such as urine flow, myocardial function and blood pressure have not undergone profound deterioration. Reports indicate that the shorter the time interval between onset of signs and symptoms and initiation of therapy with volume correction and dopamine hydrochloride, the better the prognosis.",
"Description": "Dopamine Hydrochloride and 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution of Dopamine Hydrochloride, USP and Dextrose, USP in Water for Injection. Structural formulas are shown below. Dopamine Hydrochloride and 5% Dextrose Injection, USP is intended for intravenous use only. It contains no antimicrobial agents. The pH is adjusted with hydrochloric acid and is 3.5 (2.5 to 4.5). Approximately 5 mEq/L sodium bisulfite is added as a stabilizer. The solution provides a caloric content of 170 kcal/L. The solution is intended for single use only. When smaller doses are required, the unused portion should be discarded. Composition and osmolarity are given below. 800 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 800 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 261 mOsmol/L (calc). 1600 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 1600 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 269 mOsmol/L (calc). 3200 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 3200 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 286 mOsmol/L (calc). Dopamine administered intravenously is a myocardial inotropic agent which also may increase mesenteric and renal blood flow plus urinary output. Dopamine hydrochloride is designated chemically as 3,4-dihydroxyphenethylamine hydrochloride, a white crystalline powder freely soluble in water. Dopamine (also referred to as 3-hydroxytyramine) is a naturally occurring biochemical catecholamine precursor of norepinephrine. This VIAFLEX Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 2207 Plastic). VIAFLEX containers, including VIAFLEX Plus containers, are made of flexible plastic and are for parenteral use. VIAFLEX Plus on the container indicates the presence of a drug additive in a drug vehicle. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies."
},
{
"NDCCode": "0338-9540-07",
"PackageDescription": "12 BAG in 1 CARTON (0338-9540-07) / 500 mL in 1 BAG (0338-9540-03) ",
"NDC11Code": "00338-9540-07",
"ProductNDC": "0338-9540",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clinolipid",
"NonProprietaryName": "Olive Oil And Soybean Oil",
"DosageFormName": "INJECTION, EMULSION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20160101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204508",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "OLIVE OIL; SOYBEAN OIL",
"StrengthNumber": "16; 4",
"StrengthUnit": "g/100mL; g/100mL",
"Pharm_Classes": "Lipid Emulsion [EPC], Lipid Emulsion [EPC], Lipids [CS], Lipids [CS]",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160101",
"SamplePackage": "N",
"IndicationAndUsage": "CLINOLIPID is indicated in adults and pediatric patients, including term and preterm neonates, as a source of calories and essential fatty acids for parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated.",
"Description": "CLINOLIPID lipid injectable emulsion, USP is a sterile, non-pyrogenic, homogenous, white, milky lipid emulsion for intravenous infusion. The lipid content of CLINOLIPID is 0.2 g/mL and comprises a mixture of refined olive oil and refined soybean oil in an approximate ratio of 4:1 (olive:soy). The mean concentration of linoleic acid (an omega-6 essential fatty acid) is 35.8 mg/mL (range 27.6 to 44.0 mg/mL) and α-linolenic acid (an omega-3 essential fatty acid) is 4.7 mg/mL (range 1.0 to 8.4 mg/mL). The phospholipids provide 470 milligrams or 15 mmol of phosphorus per liter. The total energy content, including fat, phospholipids and glycerin is 2000 kcal/L. Each 100 mL of CLINOLIPID 20% contains approximately 16 g of Olive Oil NF and 4 g of Soybean Oil USP, 1.2 g Egg Phospholipids NF, 2.25 g Glycerin USP, 0.03 g Sodium Oleate, and Water for Injection USP. Sodium Hydroxide NF for pH adjustment, pH: 6.0 to 9.0. The olive and soybean oils are refined natural products consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure. The major component fatty acids are linoleic (13.8 to 22.0%), oleic (44.3 to 79.5%), palmitic (7.6 to 19.3%), linolenic (0.5 to 4.2%), palmitoleic (0.0 to 3.2%) and stearic (0.7 to 5.0%). These fatty acids have the following chemical and structural formulas. CLINOLIPID has an osmolality of approximately 340 mOsmol/kg water (which represents an osmolarity of 260 mOsmol/liter of emulsion). CLINOLIPID contains no more than 25 mcg/L of aluminum."
},
{
"NDCCode": "0407-1416-12",
"PackageDescription": "10 BOTTLE, PLASTIC in 1 BOX (0407-1416-12) / 500 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "00407-1416-12",
"ProductNDC": "0407-1416",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omnipaque",
"NonProprietaryName": "Iohexol",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20180427",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018956",
"LabelerName": "GE Healthcare Inc.",
"SubstanceName": "IOHEXOL",
"StrengthNumber": "12",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180427",
"SamplePackage": "N",
"IndicationAndUsage": "OMNIPAQUE is a radiographic contrast agent indicated for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular, and body cavity imaging procedures in adults and pediatric patients. (1).",
"Description": "Iohexol is a nonionic radiographic contrast agent available as: 1 OMNIPAQUE (iohexol) injection for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular, and body cavity use, 2 OMNIPAQUE (iohexol) oral solution for oral use."
},
{
"NDCCode": "0409-1555-54",
"PackageDescription": "12 BAG in 1 CASE (0409-1555-54) / 500 mL in 1 BAG (0409-1555-64) ",
"NDC11Code": "00409-1555-54",
"ProductNDC": "0409-1555",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hextend",
"NonProprietaryName": "Hetastarch",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20050202",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "BN200952",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "HETASTARCH",
"StrengthNumber": "6",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Increased Intravascular Volume [PE], Osmotic Activity [MoA], Plasma Volume Expander [EPC], Starch [CS]",
"Status": "Active",
"LastUpdate": "2026-05-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20050202",
"SamplePackage": "N",
"IndicationAndUsage": "HEXTEND (6% Hetastarch in Lactated Electrolyte Injection) is indicated in the treatment of hypovolemia when plasma volume expansion is desired in settings where adequate alternative treatment is unavailable. It is not a substitute for blood or plasma.",
"Description": "HEXTEND® (6% Hetastarch in Lactated Electrolyte Injection) is a sterile, nonpyrogenic solution for intravenous administration. The composition, pH, and osmolarity are given in Table 1 and the electrolyte composition in Table 2. HEXTEND (6% Hetastarch in Lactated Electrolyte Injection) is an artificial colloidal solution, pharmacologically classified as a plasma volume expander, and is intended to support oncotic pressure as well as provide electrolytes. HEXTEND contains high molecular weight hetastarch at a concentration of 6% as an oncotic agent to permit retention of intravascular fluid until the hetastarch is replaced by blood proteins. Hetastarch is an artificial colloid derived from a waxy starch composed almost entirely of amylopectin. Hydroxyethyl ether groups are introduced into the glucose units of the starch, and the resultant material is hydrolyzed to yield a product with a molecular weight suitable for use as a plasma volume expander. Hetastarch is characterized by its molar substitution and also by its molecular weight. The molar substitution is approximately 0.75 which means hetastarch has an average of approximately 75 hydroxyethyl groups for every 100 glucose units. The weight average molecular weight is approximately 670,000 with a range of 450,000 to 800,000 and with at least 80% of the polymer units falling within the range of 20,000 to 2,500,000. Hydroxyethyl groups are attached by ether linkage primarily at C-2 of the glucose unit and to a lesser extent at C-3 and C-6. The polymer resembles glycogen, and the polymerized D-glucose units are joined primarily by α-1,4 linkages with occasional α-1,6 branching linkages. The degree of branching is approximately 1:20 which means that there is an average of approximately one α-1,6 branch for every 20 glucose monomer units. The chemical name for hetastarch is hydroxyethyl starch. The structural formula is as follows. Amylopectin derivative in which R2 and R3 are H or CH2CH2OH and R6 is H, CH2CH2OH, or a branching point in the starch polymer connected through an α-1,6 link to additional D-glucopyranosyl units. HEXTEND is a clear, pale yellow to amber solution. Exposure to prolonged adverse storage conditions may result in a change to a turbid deep brown or the formation of a crystalline precipitate. Do not use the solution if these conditions are evident. HEXTEND is formulated with normal physiological levels of calcium. Calcium chloride in water dissociates to provide calcium (Ca++) and chloride (Cl-) ions. These are the normal constituents of the body fluids and are dependent on various physiologic mechanisms for maintenance of balance between intake and output. Approximately 80% of body calcium is excreted in the feces as insoluble salts; urinary excretion accounts for the remaining 20%. HEXTEND also contains normal physiological levels of sodium. Additionally, chloride is present at levels closer to those normally found in blood than in plasma expanders in 0.9% Sodium Chloride Injection. Sodium chloride in water dissociates to provide sodium (Na+) and chloride (Cl-) ions. Sodium (Na+) is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. Chloride (Cl-) has an integral role in buffering action when oxygen and carbon dioxide exchange occurs in the red blood cells. The distribution and excretion of sodium (Na+) and chloride (Cl-) are largely under the control of the kidneys, which maintain a balance between intake and output. HEXTEND also contains slightly lower than normal physiological levels of potassium and magnesium. Potassium chloride in water dissociates to provide potassium (K+) and chloride (Cl-) ions. Potassium is found in low concentrations in plasma and extracellular fluids (3.5 to 5.0 mEq/L in a healthy adult). It is the most abundant cation within the body's cells (160 mEq/L of intracellular water). Potassium plays an important role in electrolyte balance. Normally about 80 to 90% of the potassium intake is excreted in the urine with the remainder in the stools and, to a small extent, in the perspiration. The kidney does not conserve potassium well so that during fasting or in patients on a potassium-free diet, potassium loss from the body continues thereby resulting in potassium depletion. Magnesium chloride in water dissociates to provide magnesium (Mg++) and chloride (Cl-). Magnesium is largely an intracellular ion with low concentrations (1.5 to 2.5 mEq/L) found in plasma. Dextrose is included in the formulation. Solutions containing carbohydrate in the form of dextrose yield blood glucose, provide calories, and may also aid in minimizing liver glycogen depletion thereby exerting a protein sparing effect. Dextrose injected parenterally undergoes oxidation to carbon dioxide and water. Lactate is provided at 28 mEq/L. Sodium lactate in water dissociates to provide sodium (Na+) and lactate (C3H5O3-) ions. The lactate anion provides an alkaline effect resulting from simultaneous removal of lactate and hydrogen ions by the liver. In the liver, the lactate is metabolized to glycogen, which is ultimately converted to carbon dioxide and water by oxidative metabolism. The lactate anion acts as a source (alternate) of bicarbonate when normal production and utilization of lactic acid is not impaired as a result of disordered lactate metabolism. Since metabolic conversion is dependent on the integrity of cellular oxidative processes, lactate may be inadequate or ineffective as a source of bicarbonate in patients suffering from acidosis associated with shock or other disorders involving reduced perfusion of body tissues. When oxidative activity is intact, one to two hours is required for metabolism of lactate. Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. The average normal adult daily requirement ranges from 2 to 3 L (1.0 to 1.5 L each for insensible water loss by perspiration and urine production). Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments, and sodium (Na+) plays a major role in maintaining physiological equilibrium. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. 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 moisture barrier when necessary. The closure system has two ports; the one for the administration set has a tamper evident plastic protector."
},
{
"NDCCode": "0409-3863-05",
"PackageDescription": "12 BOTTLE, GLASS in 1 CASE (0409-3863-05) > 500 mL in 1 BOTTLE, GLASS",
"NDC11Code": "00409-3863-05",
"ProductNDC": "0409-3863",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Foscarnet Sodium",
"NonProprietaryName": "Foscarnet Sodium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20100707",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077174",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "FOSCARNET SODIUM",
"StrengthNumber": "24",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA],Pyrophosphate Analog [Chemical/Ingredient],Pyrophosphate Analog DNA Polymerase Inhibitor [EPC],Chelating Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-05-02"
},
{
"NDCCode": "0409-4160-03",
"PackageDescription": "12 POUCH in 1 CASE (0409-4160-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG",
"NDC11Code": "00409-4160-03",
"ProductNDC": "0409-4160",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aminosyn Ii",
"NonProprietaryName": "Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Histidine, Proline, Serine, N-acetyl-tyrosine, And Glycine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19860403",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019438",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; HISTIDINE; PROLINE; SERINE; N-ACETYL-TYROSINE; GLYCINE",
"StrengthNumber": "462; 700; 735; 120; 209; 280; 140; 350; 695; 713; 490; 517; 210; 505; 371; 189; 350",
"StrengthUnit": "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 [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-05-23"
},
{
"NDCCode": "0409-4162-03",
"PackageDescription": "12 POUCH in 1 CASE (0409-4162-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG",
"NDC11Code": "00409-4162-03",
"ProductNDC": "0409-4162",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aminosyn Ii",
"NonProprietaryName": "Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Histidine, Proline, Serine, N-acetyl-tyrosine, And Glycine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20050729",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019438",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; HISTIDINE; PROLINE; SERINE; N-ACETYLTYROSINE; GLYCINE",
"StrengthNumber": "561; 850; 893; 146; 253; 340; 170; 425; 844; 865; 595; 627; 255; 614; 450; 230; 425",
"StrengthUnit": "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]",
"Status": "Deprecated",
"LastUpdate": "2019-04-18",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0409-4164-03",
"PackageDescription": "12 POUCH in 1 CASE (0409-4164-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG",
"NDC11Code": "00409-4164-03",
"ProductNDC": "0409-4164",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aminosyn Ii",
"NonProprietaryName": "Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Histidine, Proline, Serine, N-acetyl-tyrosine, And Glycine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20050901",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019438",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; HISTIDINE; PROLINE; SERINE; N-ACETYLTYROSINE; GLYCINE",
"StrengthNumber": "660; 1000; 1050; 172; 298; 400; 200; 500; 993; 1018; 700; 738; 300; 722; 530; 270; 500",
"StrengthUnit": "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]",
"Status": "Deprecated",
"LastUpdate": "2019-04-18",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0409-4166-03",
"PackageDescription": "12 POUCH in 1 CASE (0409-4166-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG",
"NDC11Code": "00409-4166-03",
"ProductNDC": "0409-4166",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aminosyn Rf",
"NonProprietaryName": "Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Arginine, And Histidine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20110218",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018429",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ARGININE; HISTIDINE",
"StrengthNumber": "462; 726; 535; 726; 726; 330; 165; 528; 600; 429",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-04-18",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0409-4168-03",
"PackageDescription": "12 POUCH in 1 CASE (0409-4168-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG",
"NDC11Code": "00409-4168-03",
"ProductNDC": "0409-4168",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aminosyn",
"NonProprietaryName": "Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Histidine, Proline, Serine, Tyrosine, And Glycine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20100819",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019374",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; HISTIDINE; PROLINE; SERINE; TYROSINE; GLYCINE",
"StrengthNumber": "789; 1576; 265; 206; 228; 272; 88; 789; 660; 507; 154; 448; 221; 33; 660",
"StrengthUnit": "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]",
"Status": "Deprecated",
"LastUpdate": "2019-04-18",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0409-4171-03",
"PackageDescription": "12 BAG in 1 CASE (0409-4171-03) > 500 mL in 1 BAG",
"NDC11Code": "00409-4171-03",
"ProductNDC": "0409-4171",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aminosyn Ii With Electrolytes",
"NonProprietaryName": "Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Alanine, Arginine, Histidine, Proline, Serine, Glycine, Valine, Aspartic Acid, N-acetyl-tyrosine, Glutamic Acid, Magnesium Chloride, Sodium Phosphate, Dibasic, Sodium Chloride, And Potassium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19860403",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019437",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; ALANINE; ARGININE; HISTIDINE; PROLINE; SERINE; GLYCINE; VALINE; ASPARTIC ACID; N-ACETYLTYROSINE; GLUTAMIC ACID; MAGNESIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM; SODIUM CHLORIDE; POTASSIUM CHLORIDE",
"StrengthNumber": "561; 850; 893; 146; 253; 340; 170; 844; 865; 255; 614; 450; 425; 425; 595; 230; 627; 102; 425; 60; 492",
"StrengthUnit": "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],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-04-18",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0409-4178-03",
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"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019398",
"LabelerName": "Hospira, Inc.",
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"LastUpdate": "2023-12-02",
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"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19850906",
"EndMarketingDatePackage": "20231201",
"SamplePackage": "N"
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"Status": "Deprecated",
"LastUpdate": "2019-04-20",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
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<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>DEXTROSE</SubstanceName>
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<PackageDescription>12 CONTAINER in 1 CASE (0264-1933-10) / 500 mL in 1 CONTAINER</PackageDescription>
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<StartMarketingDate>20201027</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
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<LabelerName>B. Braun Medical Inc.</LabelerName>
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<StrengthNumber>.82; 1.4; 1.2; .34; .48; .42; .2; .78; .024; .48; .044; .24; .54; 1.2; .68; .38; .36; .32; .5; .025</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
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<LastUpdate>2026-08-25</LastUpdate>
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<IndicationAndUsage>TrophAmine® is indicated for the nutritional support of infants (including those of low birth weight) and young pediatric patients requiring TPN via either central or peripheral infusion routes. Parenteral nutrition with TrophAmine® is indicated to prevent nitrogen and weight loss or treat negative nitrogen balance in infants and young pediatric patients where (1) the alimentary tract, by the oral, gastrostomy, or jejunostomy route, cannot or should not be used, or adequate protein intake is not feasible by these routes; (2) gastrointestinal absorption of protein is impaired; or (3) protein requirements are substantially increased as with extensive burns. Dosage, route of administration, and concomitant infusion of non-protein calories are dependent on various factors, such as nutritional and metabolic status of the patient, anticipated duration of parenteral nutritional support, and vein tolerance. See WARNINGS, PRECAUTIONS, Pediatric Use, AND DOSAGE AND ADMINISTRATION.</IndicationAndUsage>
<Description>TrophAmine® (10% Amino Acid Injection) is a sterile, nonpyrogenic, hypertonic solution containing crystalline amino acids. All amino acids designated USP are the “L”-isomer with the exception of Glycine USP, which does not have an isomer. Each 100 mL contains.</Description>
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<NDCCode>0264-1940-10</NDCCode>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>PARENTERAL</RouteName>
<StartMarketingDate>19780321</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085870</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
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<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-04-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>0264-1965-10</NDCCode>
<PackageDescription>12 CONTAINER in 1 CASE (0264-1965-10) > 500 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00264-1965-10</NDC11Code>
<ProductNDC>0264-1965</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hespan</ProprietaryName>
<NonProprietaryName>Hetastarch In Sodium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19910404</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>BN890105</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>HETASTARCH; SODIUM CHLORIDE</SubstanceName>
<StrengthNumber>6; .9</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Increased Intravascular Volume [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plasma Volume Expander [EPC], Starch [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19910404</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HESPAN® is indicated in the treatment of hypovolemia when plasma volume expansion is desired in settings where adequate alternative treatment is unavailable. It is not a substitute for blood or plasma. The adjunctive use of HESPAN® in leukapheresis has also been shown to be safe and efficacious in improving the harvesting and increasing the yield of granulocytes by centrifugal means.</IndicationAndUsage>
<Description>HESPAN® (6% hetastarch in 0.9% sodium chloride injection) is a sterile, nonpyrogenic solution for intravenous administration. Each 100 mL contains. Hetastarch.................................................. 6 g. Sodium Chloride, USP............................... 0.9 g. Water for Injection, USP............................. qs. pH adjusted with Sodium Hydroxide, NF if necessary. Concentration of Electrolytes (mEq/L): Sodium 154, Chloride 154. pH: approximately 5.9 with negligible buffering capacity. Calc. Osmolarity: approximately 309 mOsM. Hetastarch is a synthetic colloid derived from a waxy starch composed almost entirely of amylopectin. Hydroxyethyl ether groups are introduced into the glucose units of the starch, and the resultant material is hydrolyzed to yield a product with a molecular weight suitable for use as a plasma volume expander and erythrocyte sedimenting agent. The molar substitution is approximately 0.75 which means hetastarch has an average of approximately 75 hydroxyethyl groups for every 100 glucose units. The weight average molecular weight is approximately 600,000 with a range of 450,000 to 800,000 and with at least 80% of the polymers falling within the range of 20,000 to 2,600,000. Hydroxyethyl groups are attached by ether linkage primarily at C-2 of the glucose unit and to a lesser extent at C-3 and C-6. The polymer resembles glycogen, and the polymerized D-glucose units are joined primarily by α-1,4 linkages with occasional α-1,6 branching linkages. The chemical name for hetastarch is hydroxyethyl starch. The structural formula is as follows. Amylopectin derivative in which R2 and R3 are H or CH2CH2OH and R6 is H, CH2CH2OH, or a branching point in the starch polymer connected through an α-1,6 link to additional D-glucopyranosyl units. HESPAN® is a clear, pale yellow to amber solution. Exposure to prolonged adverse storage conditions may result in a change to a turbid deep brown or the formation of a crystalline precipitate. Do not use the solution if these conditions are evident. Not made with natural rubber latex, PVC or DEHP. The plastic container is made from a multi-layered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. 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 moisture barrier when necessary. The closure system has two ports; the one for the administration set has a tamper evident plastic protector.</Description>
</NDC>
<NDC>
<NDCCode>0264-1968-10</NDCCode>
<PackageDescription>12 CONTAINER in 1 CASE (0264-1968-10) > 500 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00264-1968-10</NDC11Code>
<ProductNDC>0264-1968</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxyethyl Starch In Sodium Chloride</ProprietaryName>
<NonProprietaryName>Hydroxyethyl Starch In Sodium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20150109</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>BA110013</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>HYDROXYETHYL STARCH 130/0.4; SODIUM CHLORIDE</SubstanceName>
<StrengthNumber>6; 900</StrengthNumber>
<StrengthUnit>g/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Plasma Volume Expander [EPC],Increased Intravascular Volume [PE],Osmotic Activity [MoA],Starch [CS],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150109</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0264-4001-55</NDCCode>
<PackageDescription>12 CONTAINER in 1 CASE (0264-4001-55) > 500 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00264-4001-55</NDC11Code>
<ProductNDC>0264-4001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Chloride</ProprietaryName>
<NonProprietaryName>Sodium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20110908</StartMarketingDate>
<EndMarketingDate>20151001</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>SODIUM CHLORIDE</SubstanceName>
<StrengthNumber>.9</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-11-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>0264-4021-55</NDCCode>
<PackageDescription>12 CONTAINER in 1 CASE (0264-4021-55) > 500 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00264-4021-55</NDC11Code>
<ProductNDC>0264-4021</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Chloride</ProprietaryName>
<NonProprietaryName>Sodium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20110908</StartMarketingDate>
<EndMarketingDate>20151001</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>SODIUM CHLORIDE</SubstanceName>
<StrengthNumber>.45</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-11-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>0264-4460-10</NDCCode>
<PackageDescription>12 CARTON in 1 CASE (0264-4460-10) / 1 CONTAINER in 1 CARTON / 500 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00264-4460-10</NDC11Code>
<ProductNDC>0264-4460</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nutrilipid I.v. Fat Emulsion</ProprietaryName>
<NonProprietaryName>Soybean Oil</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20140630</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019531</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>SOYBEAN OIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Lipid Emulsion [EPC], Lipids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nutrilipid® 20% is indicated as a source of calories and essential fatty acids for parenteral nutrition and as a source of essential fatty acids when a deficiency occurs when oral or enteral nutrition is not possible, insufficient, or contraindicated.</IndicationAndUsage>
<Description>Nutrilipid 20% is a homogenous white and milky sterile, nonpyrogenic lipid emulsion for intravenous administration. Each 100 mL of Nutrilipid 20% contains: Soybean Oil 20 g; Egg Yolk Phospholipid 1.2 g; Glycerin USP (glycerol) 2.5 g; Sodium Oleate 0.03 g; Water for Injection USP qs. pH adjusted with Sodium Hydroxide NF. pH: 6.8 (6.0-8.9); Osmolality: 390 mOsmol/kg (actual). Contains emulsified fat particles averaging approximately 0.26 micron in diameter, similar to naturally occurring chylomicrons. The total caloric value, including fat, phospholipid, and glycerol is 2.0 Kcal per mL. Soybean oil is a refined natural product consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure. are saturated and unsaturated fatty acid residues. The major component fatty acids are linoleic (48% - 58%), oleic (17% - 30%), palmitic (9% -13%), linolenic (4% - 11%), and stearic (2.5% - 5.0%). These fatty acids have the folIowing chemical and structural formulas. Egg yolk phospholipids are a mixture of naturally occurring phospholipids isolated from egg yolk. Glycerol is chemically designated C3H8O3 and is a clear colorless, hygroscopic syrupy liquid. It is added to adjust tonicity. Not made with natural rubber latex, PVC or DEHP. Drug product contains no more than 25 mcg/L of aluminum.</Description>
</NDC>
<NDC>
<NDCCode>0264-4460-20</NDCCode>
<PackageDescription>12 CARTON in 1 CASE (0264-4460-20) > 1 CONTAINER in 1 CARTON > 500 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00264-4460-20</NDC11Code>
<ProductNDC>0264-4460</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nutrilipid I.v. Fat Emulsion</ProprietaryName>
<NonProprietaryName>Soybean Oil</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20140630</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019531</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>SOYBEAN OIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Lipid Emulsion [EPC],Lipids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0264-9361-55</NDCCode>
<PackageDescription>12 CARTON in 1 CASE (0264-9361-55) > 1 CONTAINER in 1 CARTON > 500 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00264-9361-55</NDC11Code>
<ProductNDC>0264-9361</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trophamine</ProprietaryName>
<NonProprietaryName>Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Cysteine Hydrochloride, Histidine, Tyrosine, N-acetyl-tyrosine, Alanine, Arginine, Proline, Serine, Glycine, Aspartic Acid, Glutamic Acid, And Taurine</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19840720</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019018</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>ACETYL L-TYROSINE; ALANINE; ARGININE; ASPARTIC ACID; CYSTEINE HYDROCHLORIDE; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; TAURINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE</SubstanceName>
<StrengthNumber>.12; .32; .73; .19; .02; .3; .22; .29; .49; .84; .69; .2; .29; .41; .23; .015; .25; .12; .044; .47</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19840720</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0338-0519-12</NDCCode>
<PackageDescription>500 mL in 1 BAG (0338-0519-12)</PackageDescription>
<NDC11Code>00338-0519-12</NDC11Code>
<ProductNDC>0338-0519</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Intralipid</ProprietaryName>
<NonProprietaryName>Soybean Oil</NonProprietaryName>
<DosageFormName>EMULSION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20130530</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE</MarketingCategoryName>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>SOYBEAN OIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Lipid Emulsion [EPC],Lipids [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-05-29</LastUpdate>
</NDC>
<NDC>
<NDCCode>0338-1005-03</NDCCode>
<PackageDescription>12 BAG in 1 CARTON (0338-1005-03) / 500 mL in 1 BAG</PackageDescription>
<NDC11Code>00338-1005-03</NDC11Code>
<ProductNDC>0338-1005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dopamine Hydrochloride And Dextrose</ProprietaryName>
<NonProprietaryName>Dopamine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19870327</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019615</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>DOPAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Pharm_Classes>Catecholamine [EPC], Catecholamines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19870327</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dopamine hydrochloride is indicated for the correction of hemodynamic imbalances present in the shock syndrome due to myocardial infarctions, trauma, endotoxic septicemia, open heart surgery, renal failure and chronic cardiac decompensation as in congestive failure. Where appropriate, restoration of blood volume with a suitable plasma expander or whole blood should be instituted or completed prior to administration of dopamine hydrochloride. Patients most likely to respond adequately to dopamine hydrochloride are those in whom physiological parameters, such as urine flow, myocardial function and blood pressure have not undergone profound deterioration. Reports indicate that the shorter the time interval between onset of signs and symptoms and initiation of therapy with volume correction and dopamine hydrochloride, the better the prognosis.</IndicationAndUsage>
<Description>Dopamine Hydrochloride and 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution of Dopamine Hydrochloride, USP and Dextrose, USP in Water for Injection. Structural formulas are shown below. Dopamine Hydrochloride and 5% Dextrose Injection, USP is intended for intravenous use only. It contains no antimicrobial agents. The pH is adjusted with hydrochloric acid and is 3.5 (2.5 to 4.5). Approximately 5 mEq/L sodium bisulfite is added as a stabilizer. The solution provides a caloric content of 170 kcal/L. The solution is intended for single use only. When smaller doses are required, the unused portion should be discarded. Composition and osmolarity are given below. 800 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 800 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 261 mOsmol/L (calc). 1600 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 1600 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 269 mOsmol/L (calc). 3200 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 3200 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 286 mOsmol/L (calc). Dopamine administered intravenously is a myocardial inotropic agent which also may increase mesenteric and renal blood flow plus urinary output. Dopamine hydrochloride is designated chemically as 3,4-dihydroxyphenethylamine hydrochloride, a white crystalline powder freely soluble in water. Dopamine (also referred to as 3-hydroxytyramine) is a naturally occurring biochemical catecholamine precursor of norepinephrine. This VIAFLEX Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 2207 Plastic). VIAFLEX containers, including VIAFLEX Plus containers, are made of flexible plastic and are for parenteral use. VIAFLEX Plus on the container indicates the presence of a drug additive in a drug vehicle. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.</Description>
</NDC>
<NDC>
<NDCCode>0338-1007-03</NDCCode>
<PackageDescription>12 BAG in 1 CARTON (0338-1007-03) / 500 mL in 1 BAG</PackageDescription>
<NDC11Code>00338-1007-03</NDC11Code>
<ProductNDC>0338-1007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dopamine Hydrochloride And Dextrose</ProprietaryName>
<NonProprietaryName>Dopamine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19870327</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019615</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>DOPAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Pharm_Classes>Catecholamine [EPC], Catecholamines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19870327</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dopamine hydrochloride is indicated for the correction of hemodynamic imbalances present in the shock syndrome due to myocardial infarctions, trauma, endotoxic septicemia, open heart surgery, renal failure and chronic cardiac decompensation as in congestive failure. Where appropriate, restoration of blood volume with a suitable plasma expander or whole blood should be instituted or completed prior to administration of dopamine hydrochloride. Patients most likely to respond adequately to dopamine hydrochloride are those in whom physiological parameters, such as urine flow, myocardial function and blood pressure have not undergone profound deterioration. Reports indicate that the shorter the time interval between onset of signs and symptoms and initiation of therapy with volume correction and dopamine hydrochloride, the better the prognosis.</IndicationAndUsage>
<Description>Dopamine Hydrochloride and 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution of Dopamine Hydrochloride, USP and Dextrose, USP in Water for Injection. Structural formulas are shown below. Dopamine Hydrochloride and 5% Dextrose Injection, USP is intended for intravenous use only. It contains no antimicrobial agents. The pH is adjusted with hydrochloric acid and is 3.5 (2.5 to 4.5). Approximately 5 mEq/L sodium bisulfite is added as a stabilizer. The solution provides a caloric content of 170 kcal/L. The solution is intended for single use only. When smaller doses are required, the unused portion should be discarded. Composition and osmolarity are given below. 800 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 800 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 261 mOsmol/L (calc). 1600 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 1600 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 269 mOsmol/L (calc). 3200 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 3200 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 286 mOsmol/L (calc). Dopamine administered intravenously is a myocardial inotropic agent which also may increase mesenteric and renal blood flow plus urinary output. Dopamine hydrochloride is designated chemically as 3,4-dihydroxyphenethylamine hydrochloride, a white crystalline powder freely soluble in water. Dopamine (also referred to as 3-hydroxytyramine) is a naturally occurring biochemical catecholamine precursor of norepinephrine. This VIAFLEX Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 2207 Plastic). VIAFLEX containers, including VIAFLEX Plus containers, are made of flexible plastic and are for parenteral use. VIAFLEX Plus on the container indicates the presence of a drug additive in a drug vehicle. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.</Description>
</NDC>
<NDC>
<NDCCode>0338-9540-07</NDCCode>
<PackageDescription>12 BAG in 1 CARTON (0338-9540-07) / 500 mL in 1 BAG (0338-9540-03) </PackageDescription>
<NDC11Code>00338-9540-07</NDC11Code>
<ProductNDC>0338-9540</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clinolipid</ProprietaryName>
<NonProprietaryName>Olive Oil And Soybean Oil</NonProprietaryName>
<DosageFormName>INJECTION, EMULSION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20160101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204508</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>OLIVE OIL; SOYBEAN OIL</SubstanceName>
<StrengthNumber>16; 4</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Lipid Emulsion [EPC], Lipid Emulsion [EPC], Lipids [CS], Lipids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CLINOLIPID is indicated in adults and pediatric patients, including term and preterm neonates, as a source of calories and essential fatty acids for parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated.</IndicationAndUsage>
<Description>CLINOLIPID lipid injectable emulsion, USP is a sterile, non-pyrogenic, homogenous, white, milky lipid emulsion for intravenous infusion. The lipid content of CLINOLIPID is 0.2 g/mL and comprises a mixture of refined olive oil and refined soybean oil in an approximate ratio of 4:1 (olive:soy). The mean concentration of linoleic acid (an omega-6 essential fatty acid) is 35.8 mg/mL (range 27.6 to 44.0 mg/mL) and α-linolenic acid (an omega-3 essential fatty acid) is 4.7 mg/mL (range 1.0 to 8.4 mg/mL). The phospholipids provide 470 milligrams or 15 mmol of phosphorus per liter. The total energy content, including fat, phospholipids and glycerin is 2000 kcal/L. Each 100 mL of CLINOLIPID 20% contains approximately 16 g of Olive Oil NF and 4 g of Soybean Oil USP, 1.2 g Egg Phospholipids NF, 2.25 g Glycerin USP, 0.03 g Sodium Oleate, and Water for Injection USP. Sodium Hydroxide NF for pH adjustment, pH: 6.0 to 9.0. The olive and soybean oils are refined natural products consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure. The major component fatty acids are linoleic (13.8 to 22.0%), oleic (44.3 to 79.5%), palmitic (7.6 to 19.3%), linolenic (0.5 to 4.2%), palmitoleic (0.0 to 3.2%) and stearic (0.7 to 5.0%). These fatty acids have the following chemical and structural formulas. CLINOLIPID has an osmolality of approximately 340 mOsmol/kg water (which represents an osmolarity of 260 mOsmol/liter of emulsion). CLINOLIPID contains no more than 25 mcg/L of aluminum.</Description>
</NDC>
<NDC>
<NDCCode>0407-1416-12</NDCCode>
<PackageDescription>10 BOTTLE, PLASTIC in 1 BOX (0407-1416-12) / 500 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00407-1416-12</NDC11Code>
<ProductNDC>0407-1416</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omnipaque</ProprietaryName>
<NonProprietaryName>Iohexol</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180427</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018956</ApplicationNumber>
<LabelerName>GE Healthcare Inc.</LabelerName>
<SubstanceName>IOHEXOL</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180427</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>OMNIPAQUE is a radiographic contrast agent indicated for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular, and body cavity imaging procedures in adults and pediatric patients. (1).</IndicationAndUsage>
<Description>Iohexol is a nonionic radiographic contrast agent available as: 1 OMNIPAQUE (iohexol) injection for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular, and body cavity use, 2 OMNIPAQUE (iohexol) oral solution for oral use.</Description>
</NDC>
<NDC>
<NDCCode>0409-1555-54</NDCCode>
<PackageDescription>12 BAG in 1 CASE (0409-1555-54) / 500 mL in 1 BAG (0409-1555-64) </PackageDescription>
<NDC11Code>00409-1555-54</NDC11Code>
<ProductNDC>0409-1555</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hextend</ProprietaryName>
<NonProprietaryName>Hetastarch</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20050202</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>BN200952</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>HETASTARCH</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Increased Intravascular Volume [PE], Osmotic Activity [MoA], Plasma Volume Expander [EPC], Starch [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HEXTEND (6% Hetastarch in Lactated Electrolyte Injection) is indicated in the treatment of hypovolemia when plasma volume expansion is desired in settings where adequate alternative treatment is unavailable. It is not a substitute for blood or plasma.</IndicationAndUsage>
<Description>HEXTEND® (6% Hetastarch in Lactated Electrolyte Injection) is a sterile, nonpyrogenic solution for intravenous administration. The composition, pH, and osmolarity are given in Table 1 and the electrolyte composition in Table 2. HEXTEND (6% Hetastarch in Lactated Electrolyte Injection) is an artificial colloidal solution, pharmacologically classified as a plasma volume expander, and is intended to support oncotic pressure as well as provide electrolytes. HEXTEND contains high molecular weight hetastarch at a concentration of 6% as an oncotic agent to permit retention of intravascular fluid until the hetastarch is replaced by blood proteins. Hetastarch is an artificial colloid derived from a waxy starch composed almost entirely of amylopectin. Hydroxyethyl ether groups are introduced into the glucose units of the starch, and the resultant material is hydrolyzed to yield a product with a molecular weight suitable for use as a plasma volume expander. Hetastarch is characterized by its molar substitution and also by its molecular weight. The molar substitution is approximately 0.75 which means hetastarch has an average of approximately 75 hydroxyethyl groups for every 100 glucose units. The weight average molecular weight is approximately 670,000 with a range of 450,000 to 800,000 and with at least 80% of the polymer units falling within the range of 20,000 to 2,500,000. Hydroxyethyl groups are attached by ether linkage primarily at C-2 of the glucose unit and to a lesser extent at C-3 and C-6. The polymer resembles glycogen, and the polymerized D-glucose units are joined primarily by α-1,4 linkages with occasional α-1,6 branching linkages. The degree of branching is approximately 1:20 which means that there is an average of approximately one α-1,6 branch for every 20 glucose monomer units. The chemical name for hetastarch is hydroxyethyl starch. The structural formula is as follows. Amylopectin derivative in which R2 and R3 are H or CH2CH2OH and R6 is H, CH2CH2OH, or a branching point in the starch polymer connected through an α-1,6 link to additional D-glucopyranosyl units. HEXTEND is a clear, pale yellow to amber solution. Exposure to prolonged adverse storage conditions may result in a change to a turbid deep brown or the formation of a crystalline precipitate. Do not use the solution if these conditions are evident. HEXTEND is formulated with normal physiological levels of calcium. Calcium chloride in water dissociates to provide calcium (Ca++) and chloride (Cl-) ions. These are the normal constituents of the body fluids and are dependent on various physiologic mechanisms for maintenance of balance between intake and output. Approximately 80% of body calcium is excreted in the feces as insoluble salts; urinary excretion accounts for the remaining 20%. HEXTEND also contains normal physiological levels of sodium. Additionally, chloride is present at levels closer to those normally found in blood than in plasma expanders in 0.9% Sodium Chloride Injection. Sodium chloride in water dissociates to provide sodium (Na+) and chloride (Cl-) ions. Sodium (Na+) is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. Chloride (Cl-) has an integral role in buffering action when oxygen and carbon dioxide exchange occurs in the red blood cells. The distribution and excretion of sodium (Na+) and chloride (Cl-) are largely under the control of the kidneys, which maintain a balance between intake and output. HEXTEND also contains slightly lower than normal physiological levels of potassium and magnesium. Potassium chloride in water dissociates to provide potassium (K+) and chloride (Cl-) ions. Potassium is found in low concentrations in plasma and extracellular fluids (3.5 to 5.0 mEq/L in a healthy adult). It is the most abundant cation within the body's cells (160 mEq/L of intracellular water). Potassium plays an important role in electrolyte balance. Normally about 80 to 90% of the potassium intake is excreted in the urine with the remainder in the stools and, to a small extent, in the perspiration. The kidney does not conserve potassium well so that during fasting or in patients on a potassium-free diet, potassium loss from the body continues thereby resulting in potassium depletion. Magnesium chloride in water dissociates to provide magnesium (Mg++) and chloride (Cl-). Magnesium is largely an intracellular ion with low concentrations (1.5 to 2.5 mEq/L) found in plasma. Dextrose is included in the formulation. Solutions containing carbohydrate in the form of dextrose yield blood glucose, provide calories, and may also aid in minimizing liver glycogen depletion thereby exerting a protein sparing effect. Dextrose injected parenterally undergoes oxidation to carbon dioxide and water. Lactate is provided at 28 mEq/L. Sodium lactate in water dissociates to provide sodium (Na+) and lactate (C3H5O3-) ions. The lactate anion provides an alkaline effect resulting from simultaneous removal of lactate and hydrogen ions by the liver. In the liver, the lactate is metabolized to glycogen, which is ultimately converted to carbon dioxide and water by oxidative metabolism. The lactate anion acts as a source (alternate) of bicarbonate when normal production and utilization of lactic acid is not impaired as a result of disordered lactate metabolism. Since metabolic conversion is dependent on the integrity of cellular oxidative processes, lactate may be inadequate or ineffective as a source of bicarbonate in patients suffering from acidosis associated with shock or other disorders involving reduced perfusion of body tissues. When oxidative activity is intact, one to two hours is required for metabolism of lactate. Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. The average normal adult daily requirement ranges from 2 to 3 L (1.0 to 1.5 L each for insensible water loss by perspiration and urine production). Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments, and sodium (Na+) plays a major role in maintaining physiological equilibrium. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. 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 moisture barrier when necessary. The closure system has two ports; the one for the administration set has a tamper evident plastic protector.</Description>
</NDC>
<NDC>
<NDCCode>0409-3863-05</NDCCode>
<PackageDescription>12 BOTTLE, GLASS in 1 CASE (0409-3863-05) > 500 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>00409-3863-05</NDC11Code>
<ProductNDC>0409-3863</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Foscarnet Sodium</ProprietaryName>
<NonProprietaryName>Foscarnet Sodium</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20100707</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077174</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>FOSCARNET SODIUM</SubstanceName>
<StrengthNumber>24</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA],Pyrophosphate Analog [Chemical/Ingredient],Pyrophosphate Analog DNA Polymerase Inhibitor [EPC],Chelating Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-05-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>0409-4160-03</NDCCode>
<PackageDescription>12 POUCH in 1 CASE (0409-4160-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG</PackageDescription>
<NDC11Code>00409-4160-03</NDC11Code>
<ProductNDC>0409-4160</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aminosyn Ii</ProprietaryName>
<NonProprietaryName>Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Histidine, Proline, Serine, N-acetyl-tyrosine, And Glycine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19860403</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019438</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; HISTIDINE; PROLINE; SERINE; N-ACETYL-TYROSINE; GLYCINE</SubstanceName>
<StrengthNumber>462; 700; 735; 120; 209; 280; 140; 350; 695; 713; 490; 517; 210; 505; 371; 189; 350</StrengthNumber>
<StrengthUnit>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 [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-05-23</LastUpdate>
</NDC>
<NDC>
<NDCCode>0409-4162-03</NDCCode>
<PackageDescription>12 POUCH in 1 CASE (0409-4162-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG</PackageDescription>
<NDC11Code>00409-4162-03</NDC11Code>
<ProductNDC>0409-4162</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aminosyn Ii</ProprietaryName>
<NonProprietaryName>Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Histidine, Proline, Serine, N-acetyl-tyrosine, And Glycine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20050729</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019438</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; HISTIDINE; PROLINE; SERINE; N-ACETYLTYROSINE; GLYCINE</SubstanceName>
<StrengthNumber>561; 850; 893; 146; 253; 340; 170; 425; 844; 865; 595; 627; 255; 614; 450; 230; 425</StrengthNumber>
<StrengthUnit>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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-04-18</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0409-4164-03</NDCCode>
<PackageDescription>12 POUCH in 1 CASE (0409-4164-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG</PackageDescription>
<NDC11Code>00409-4164-03</NDC11Code>
<ProductNDC>0409-4164</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aminosyn Ii</ProprietaryName>
<NonProprietaryName>Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Histidine, Proline, Serine, N-acetyl-tyrosine, And Glycine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20050901</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019438</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; HISTIDINE; PROLINE; SERINE; N-ACETYLTYROSINE; GLYCINE</SubstanceName>
<StrengthNumber>660; 1000; 1050; 172; 298; 400; 200; 500; 993; 1018; 700; 738; 300; 722; 530; 270; 500</StrengthNumber>
<StrengthUnit>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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-04-18</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0409-4166-03</NDCCode>
<PackageDescription>12 POUCH in 1 CASE (0409-4166-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG</PackageDescription>
<NDC11Code>00409-4166-03</NDC11Code>
<ProductNDC>0409-4166</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aminosyn Rf</ProprietaryName>
<NonProprietaryName>Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Arginine, And Histidine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20110218</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018429</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ARGININE; HISTIDINE</SubstanceName>
<StrengthNumber>462; 726; 535; 726; 726; 330; 165; 528; 600; 429</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-04-18</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0409-4168-03</NDCCode>
<PackageDescription>12 POUCH in 1 CASE (0409-4168-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG</PackageDescription>
<NDC11Code>00409-4168-03</NDC11Code>
<ProductNDC>0409-4168</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aminosyn</ProprietaryName>
<NonProprietaryName>Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Histidine, Proline, Serine, Tyrosine, And Glycine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20100819</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019374</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; HISTIDINE; PROLINE; SERINE; TYROSINE; GLYCINE</SubstanceName>
<StrengthNumber>789; 1576; 265; 206; 228; 272; 88; 789; 660; 507; 154; 448; 221; 33; 660</StrengthNumber>
<StrengthUnit>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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-04-18</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0409-4171-03</NDCCode>
<PackageDescription>12 BAG in 1 CASE (0409-4171-03) > 500 mL in 1 BAG</PackageDescription>
<NDC11Code>00409-4171-03</NDC11Code>
<ProductNDC>0409-4171</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aminosyn Ii With Electrolytes</ProprietaryName>
<NonProprietaryName>Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Alanine, Arginine, Histidine, Proline, Serine, Glycine, Valine, Aspartic Acid, N-acetyl-tyrosine, Glutamic Acid, Magnesium Chloride, Sodium Phosphate, Dibasic, Sodium Chloride, And Potassium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19860403</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019437</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; ALANINE; ARGININE; HISTIDINE; PROLINE; SERINE; GLYCINE; VALINE; ASPARTIC ACID; N-ACETYLTYROSINE; GLUTAMIC ACID; MAGNESIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM; SODIUM CHLORIDE; POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>561; 850; 893; 146; 253; 340; 170; 844; 865; 255; 614; 450; 425; 425; 595; 230; 627; 102; 425; 60; 492</StrengthNumber>
<StrengthUnit>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],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-04-18</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0409-4178-03</NDCCode>
<PackageDescription>12 BAG in 1 CASE (0409-4178-03) > 500 mL in 1 BAG</PackageDescription>
<NDC11Code>00409-4178-03</NDC11Code>
<ProductNDC>0409-4178</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aminosyn-pf</ProprietaryName>
<NonProprietaryName>Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Glycine, Histidine, Proline, Serine, Taurine, And Tyrosine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19850906</StartMarketingDate>
<EndMarketingDate>20231201</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019398</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; TAURINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE</SubstanceName>
<StrengthNumber>490; 861; 370; 576; 270; 220; 534; 831; 475; 125; 300; 570; 347; 50; 360; 125; 44; 452</StrengthNumber>
<StrengthUnit>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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-12-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19850906</StartMarketingDatePackage>
<EndMarketingDatePackage>20231201</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0409-4187-03</NDCCode>
<PackageDescription>12 POUCH in 1 CASE (0409-4187-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG</PackageDescription>
<NDC11Code>00409-4187-03</NDC11Code>
<ProductNDC>0409-4187</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aminosyn</ProprietaryName>
<NonProprietaryName>Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Histidine, Proline, Serine, Tyrosine, And Glycine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20120306</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017673</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; HISTIDINE; PROLINE; SERINE; TYROSINE; GLYCINE</SubstanceName>
<StrengthNumber>620; 810; 624; 340; 380; 460; 150; 680; 1100; 850; 260; 750; 370; 44; 1100</StrengthNumber>
<StrengthUnit>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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-04-18</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0409-4191-03</NDCCode>
<PackageDescription>12 POUCH in 1 CASE (0409-4191-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG</PackageDescription>
<NDC11Code>00409-4191-03</NDC11Code>
<ProductNDC>0409-4191</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aminosyn</ProprietaryName>
<NonProprietaryName>Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Histidine, Proline, Serine, Tyrosine, And Glycine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20120306</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017673</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; HISTIDINE; PROLINE; SERINE; TYROSINE; GLYCINE</SubstanceName>
<StrengthNumber>720; 940; 720; 400; 440; 520; 160; 800; 1280; 980; 300; 860; 420; 44; 1280</StrengthNumber>
<StrengthUnit>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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-04-18</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0409-4200-03</NDCCode>
<PackageDescription>12 POUCH in 1 CASE (0409-4200-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG</PackageDescription>
<NDC11Code>00409-4200-03</NDC11Code>
<ProductNDC>0409-4200</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aminosyn</ProprietaryName>
<NonProprietaryName>Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Histidine, Proline, Serine, Tyrosine, Glycine, Sodium Chloride, Magnesium Chloride, Sodium Phosphate, Dibasic, And Potassium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20110323</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017789</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; HISTIDINE; PROLINE; SERINE; TYROSINE; GLYCINE; SODIUM CHLORIDE; MAGNESIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC; POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>510; 660; 510; 280; 310; 370; 120; 560; 900; 690; 210; 610; 300; 44; 900; 28; 102; 425; 487</StrengthNumber>
<StrengthUnit>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],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-04-20</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0409-4203-03</NDCCode>
<PackageDescription>12 POUCH in 1 CASE (0409-4203-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG</PackageDescription>
<NDC11Code>00409-4203-03</NDC11Code>
<ProductNDC>0409-4203</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aminosyn</ProprietaryName>
<NonProprietaryName>Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Histidine, Proline, Serine, Tyrosine, Glycine, Sodium Chloride, Magnesium Chloride, Sodium Phosphate, Dibasic, And Potassium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20110323</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017673</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; HISTIDINE; PROLINE; SERINE; TYROSINE; GLYCINE; SODIUM CHLORIDE; MAGNESIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC; POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>620; 810; 624; 340; 380; 460; 150; 680; 1100; 850; 260; 750; 370; 44; 1100; 28; 102; 425; 487</StrengthNumber>
<StrengthUnit>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>Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Amino Acid [EPC],Amino Acids [CS],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-04-20</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
</NDCList>