RESTful Lookup — Test-Drive (2007 – 2026)

<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>63323-824-75</NDCCode>
    <PackageDescription>20 BAG in 1 CASE (63323-824-75)  / 500 mL in 1 BAG (63323-824-25) </PackageDescription>
    <NDC11Code>63323-0824-75</NDC11Code>
    <ProductNDC>63323-824</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dextrose</ProprietaryName>
    <NonProprietaryName>Dextrose Monohydrate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20190329</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209448</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>DEXTROSE MONOHYDRATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-03-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190329</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dextrose Injection is indicated as source of water and calories.</IndicationAndUsage>
    <Description>10% Dextrose Injection, USP is a sterile, non-pyrogenic solution for fluid replenishment and caloric supply in single dose containers for intravenous administration. The solution contains no bacteriostatic, antimicrobial agent or added buffer and is intended only for use as a single-dose injection. The pH range is 4.0 (3.2 to 6.5). Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6  H2O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula:. Water for Injection, USP is chemically designated H2O. Dextrose is derived from corn. The flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers (freeflex® bag). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers. The flexible container is a closed system, and air is prefilled in the container to facilitate drainage. The container does not require entry of external air during administration. The container has two ports: one is the administration outlet port for attachment of an intravenous administration set and the other port has a medication site for addition of supplemental medication ([see Instructions for Use (2.3)]). The primary function of the overwrap is to protect the container from the physical environment.</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-824-74</NDCCode>
    <PackageDescription>30 BAG in 1 CASE (63323-824-74)  / 250 mL in 1 BAG (63323-824-24) </PackageDescription>
    <NDC11Code>63323-0824-74</NDC11Code>
    <ProductNDC>63323-824</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dextrose</ProprietaryName>
    <NonProprietaryName>Dextrose Monohydrate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20190329</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209448</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>DEXTROSE MONOHYDRATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-03-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190329</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dextrose Injection is indicated as source of water and calories.</IndicationAndUsage>
    <Description>10% Dextrose Injection, USP is a sterile, non-pyrogenic solution for fluid replenishment and caloric supply in single dose containers for intravenous administration. The solution contains no bacteriostatic, antimicrobial agent or added buffer and is intended only for use as a single-dose injection. The pH range is 4.0 (3.2 to 6.5). Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6  H2O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula:. Water for Injection, USP is chemically designated H2O. Dextrose is derived from corn. The flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers (freeflex® bag). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers. The flexible container is a closed system, and air is prefilled in the container to facilitate drainage. The container does not require entry of external air during administration. The container has two ports: one is the administration outlet port for attachment of an intravenous administration set and the other port has a medication site for addition of supplemental medication ([see Instructions for Use (2.3)]). The primary function of the overwrap is to protect the container from the physical environment.</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-824-76</NDCCode>
    <PackageDescription>10 BAG in 1 CASE (63323-824-76)  / 1000 mL in 1 BAG (63323-824-26) </PackageDescription>
    <NDC11Code>63323-0824-76</NDC11Code>
    <ProductNDC>63323-824</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dextrose</ProprietaryName>
    <NonProprietaryName>Dextrose Monohydrate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20190329</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209448</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>DEXTROSE MONOHYDRATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-03-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190329</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dextrose Injection is indicated as source of water and calories.</IndicationAndUsage>
    <Description>10% Dextrose Injection, USP is a sterile, non-pyrogenic solution for fluid replenishment and caloric supply in single dose containers for intravenous administration. The solution contains no bacteriostatic, antimicrobial agent or added buffer and is intended only for use as a single-dose injection. The pH range is 4.0 (3.2 to 6.5). Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6  H2O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula:. Water for Injection, USP is chemically designated H2O. Dextrose is derived from corn. The flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers (freeflex® bag). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers. The flexible container is a closed system, and air is prefilled in the container to facilitate drainage. The container does not require entry of external air during administration. The container has two ports: one is the administration outlet port for attachment of an intravenous administration set and the other port has a medication site for addition of supplemental medication ([see Instructions for Use (2.3)]). The primary function of the overwrap is to protect the container from the physical environment.</Description>
  </NDC>
  <NDC>
    <NDCCode>41250-824-75</NDCCode>
    <PackageDescription>1 JAR in 1 CARTON (41250-824-75)  / 100 g in 1 JAR</PackageDescription>
    <NDC11Code>41250-0824-75</NDC11Code>
    <ProductNDC>41250-824</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Chest Rub</ProprietaryName>
    <NonProprietaryName>Camphor, Eucalyptus Oil, Menthol</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20100112</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>Meijer, Inc.</LabelerName>
    <SubstanceName>CAMPHOR (NATURAL); EUCALYPTUS OIL; MENTHOL</SubstanceName>
    <StrengthNumber>48; 12; 26</StrengthNumber>
    <StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-07-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100112</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>on chest and throat, temporarily relieves cough due to common cold. on muscles and joints, temporarily relieves minor aches and pains.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>43744-824-33</NDCCode>
    <PackageDescription>75 g in 1 DRUM (43744-824-33)</PackageDescription>
    <NDC11Code>43744-0824-33</NDC11Code>
    <ProductNDC>43744-824</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Rifampin</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20111010</StartMarketingDate>
    <EndMarketingDate>20130630</EndMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>CBSCHEM LIMITED</LabelerName>
    <SubstanceName>RIFAMPIN</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20130630</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>43744-824-75</NDCCode>
    <PackageDescription>15000 g in 1 DRUM (43744-824-75)</PackageDescription>
    <NDC11Code>43744-0824-75</NDC11Code>
    <ProductNDC>43744-824</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Rifampin</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20111010</StartMarketingDate>
    <EndMarketingDate>20130630</EndMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>CBSCHEM LIMITED</LabelerName>
    <SubstanceName>RIFAMPIN</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20130630</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>63323-164-75</NDCCode>
    <PackageDescription>20 BAG in 1 CASE (63323-164-75)  / 500 mL in 1 BAG (63323-164-25) </PackageDescription>
    <NDC11Code>63323-0164-75</NDC11Code>
    <ProductNDC>63323-164</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lactated Ringers</ProprietaryName>
    <NonProprietaryName>Sodium Chloride, Sodium Lactate, Potassium Chloride, Calcium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20190128</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209338</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE</SubstanceName>
    <StrengthNumber>600; 310; 30; 20</StrengthNumber>
    <StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
    <Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-04-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190128</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lactated Ringer's Injection is indicated as a source of water and electrolytes or as an alkalinizing agent.</IndicationAndUsage>
    <Description>Lactated Ringer's Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1. The flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers ( freeflex® bag). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers.</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-269-77</NDCCode>
    <PackageDescription>20 VIAL in 1 BOX (63323-269-77)  / 50 mL in 1 VIAL (63323-269-75) </PackageDescription>
    <NDC11Code>63323-0269-77</NDC11Code>
    <ProductNDC>63323-269</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diprivan</ProprietaryName>
    <NonProprietaryName>Propofol</NonProprietaryName>
    <DosageFormName>INJECTION, EMULSION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20091113</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019627</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>PROPOFOL</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>General Anesthesia [PE], General Anesthetic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20091113</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>DIPRIVAN is an intravenous general anesthetic and sedation drug indicated for: : 1 Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age , 2 Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age , 3 Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients , 4 Sedation for Adult Patients in Combination with Regional Anesthesia , 5 Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients .</IndicationAndUsage>
    <Description>DIPRIVAN® (propofol) injectable emulsion, USP is an anesthetic available as a sterile, nonpyrogenic white or almost white homogeneous emulsion for intravenous administration. The structural formula is:. Chemical name: 2,6 diisopropylphenol. Molecular formula: C12H18O. Molecular weight: 178.27. Propofol is slightly soluble in water. The pKa is 11. The octanol/water partition coefficient for propofol is 6761:1 at a pH of 6 to 8.5. Each mL of DIPRIVAN® (Propofol) injectable emulsion, USP contains 10 mg of propofol, 100 mg of soybean oil (100 mg/mL), 22.5 mg of glycerol (22.5 mg/mL), 12 mg of purified egg phospholipids (12 mg/mL), 0.055 mg of disodium edetate anhydrous (equivalent to 0.055 mg of disodium edetate) (0.05 mg/mL) as microbial inhibitor, and sodium hydroxide to adjust pH, in water for injection. DIPRIVAN is isotonic and has a pH of 7 to 8.5.</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-530-75</NDCCode>
    <PackageDescription>20 BAG in 1 CASE (63323-530-75)  &gt; 500 mL in 1 BAG (63323-530-21) </PackageDescription>
    <NDC11Code>63323-0530-75</NDC11Code>
    <ProductNDC>63323-530</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Chloride</ProprietaryName>
    <NonProprietaryName>Sodium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20200320</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209476</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>SODIUM CHLORIDE</SubstanceName>
    <StrengthNumber>3</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-10-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200320</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>3% Sodium Chloride Injection is indicated as a source of water and electrolytes.</IndicationAndUsage>
    <Description>3% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, hypertonic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. The pH may have been adjusted with hydrochloric acid. It contains no antimicrobial agents. Composition, ionic concentration, osmolarity, and pH are shown in Table 1. The flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers (freeflex® bag). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers.</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-623-75</NDCCode>
    <PackageDescription>500 mL in 1 BAG (63323-623-75) </PackageDescription>
    <NDC11Code>63323-0623-75</NDC11Code>
    <ProductNDC>63323-623</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Chloride</ProprietaryName>
    <NonProprietaryName>Sodium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20170919</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207310</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>SODIUM CHLORIDE</SubstanceName>
    <StrengthNumber>9</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-04-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170919</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Intravenous solutions containing sodium chloride are indicated for parenteral replenishment of fluid and sodium chloride as required by the clinical condition of the patient.</IndicationAndUsage>
    <Description>0.9% Sodium Chloride Injection, USP solution is sterile and nonpyrogenic. It is a parenteral solution containing sodium chloride in water for injection intended for intravenous administration. For 0.9% Sodium Chloride Injection, USP, each 100 mL contains 900 mg sodium chloride in water for injection. Electrolytes per 1,000 mL: sodium 154 mEq; chloride 154 mEq. The osmolarity is 308 mOsmol/L (calc.). The pH in the 100 mL and smaller containers is 6.0; for the 250 mL and larger containers, the pH is 5.6. The pH range is 4.5 to 7.0 for all containers. The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded. The solution is a parenteral fluid and electrolyte replenisher. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for injection, USP is chemically designated H2O. The flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers (freeflex® bag). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers.</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-624-75</NDCCode>
    <PackageDescription>20 BAG in 1 CASE (63323-624-75)  / 500 mL in 1 BAG (63323-624-07) </PackageDescription>
    <NDC11Code>63323-0624-75</NDC11Code>
    <ProductNDC>63323-624</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dextrose</ProprietaryName>
    <NonProprietaryName>Dextrose Monohydrate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20161021</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207449</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>DEXTROSE MONOHYDRATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-04-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161021</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Intravenous solutions containing dextrose are indicated for parenteral replenishment of fluid and minimal carbohydrate calories as required by the clinical condition of the patient.</IndicationAndUsage>
    <Description>5% Dextrose Injection, USP solution is sterile and nonpyrogenic.  It is a parenteral solution containing dextrose in water for injection intended for intravenous administration. Each 100 mL of 5% Dextrose Injection, USP, contains dextrose monohydrate, 5 g in water for injection.  The caloric value is 170 kcal/L.  The osmolarity is 252 mOsmol/L (calc.), which is slightly hypotonic. The solution pH is 4.3 (3.2 to 6.5). This solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only as a single-dose injection.  When smaller doses are required the unused portion should be discarded. 5% Dextrose Injection, USP is a parenteral fluid and nutrient replenisher. Dextrose, USP is chemically designated D-glucose monohydrate (C 6H 12O 6  H 2O), a hexose sugar freely soluble in water.  It has the following structural formula:. Water for Injection, USP is chemically designated H 2O. The flexible container is fabricated from a specially formulated non-plasticized film containing polypropylene and thermoplastic elastomers ( freeflex® bag).  The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly.  Solutions in contact with the flexible container can leach out certain of the container’s chemical components in very small amounts within the expiration period.  The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers.</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-632-75</NDCCode>
    <PackageDescription>20 BAG in 1 CASE (63323-632-75)  &gt; 500 mL in 1 BAG (63323-632-20) </PackageDescription>
    <NDC11Code>63323-0632-75</NDC11Code>
    <ProductNDC>63323-632</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Chloride</ProprietaryName>
    <NonProprietaryName>Sodium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20170919</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207310</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>SODIUM CHLORIDE</SubstanceName>
    <StrengthNumber>9</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-02-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170919</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Intravenous solutions containing sodium chloride are indicated for parenteral replenishment of fluid and sodium chloride as required by the clinical condition of the patient.</IndicationAndUsage>
    <Description>0.9% Sodium Chloride Injection, USP solution is sterile and nonpyrogenic. It is a parenteral solution containing sodium chloride in water for injection intended for intravenous administration. For 0.9% Sodium Chloride Injection, USP, each 100 mL contains 900 mg sodium chloride in water for injection. Electrolytes per 1,000 mL: sodium 154 mEq; chloride 154 mEq. The osmolarity is 308 mOsmol/L (calc.). The pH in the 100 mL and smaller containers is 6.0; for the 250 mL and larger containers, the pH is 5.6. The pH range is 4.5 to 7.0 for all containers. The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded. The solution is a parenteral fluid and electrolyte replenisher. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for injection, USP is chemically designated H2O. The flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers (freeflex® bag). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers.</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-867-75</NDCCode>
    <PackageDescription>30 BAG in 1 CASE (63323-867-75)  / 250 mL in 1 BAG</PackageDescription>
    <NDC11Code>63323-0867-75</NDC11Code>
    <ProductNDC>63323-867</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dextrose And Sodium Chloride</ProprietaryName>
    <NonProprietaryName>Dextrose Monohydrate And Sodium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20201026</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211194</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>DEXTROSE MONOHYDRATE; SODIUM CHLORIDE</SubstanceName>
    <StrengthNumber>5; .3</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201026</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Intravenous solutions containing dextrose and sodium chloride are indicated for parenteral replenishment of fluid, minimal carbohydrate calories, and sodium chloride as required by the clinical condition of the patient.</IndicationAndUsage>
    <Description>Dextrose and Sodium Chloride Injection, USP solutions are sterile and nonpyrogenic. They are large volume parenteral solutions containing 5 grams per 100 mL of Dextrose and 0.3 grams per 100 mL of Sodium Chloride in water for injection intended for intravenous administration. See Table for summary of content and characteristics of these solutions. The solutions contain no bacteriostat, antimicrobial agent or added buffer and each is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded. The solutions are parenteral fluid, nutrient and electrolyte replenishers. Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6  H2O), a hexose sugar freely soluble in water. It has the following structural formula:. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H2O. The flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers (freeflex® bag). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers.</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-869-75</NDCCode>
    <PackageDescription>30 BAG in 1 CASE (63323-869-75)  / 250 mL in 1 BAG (63323-869-05) </PackageDescription>
    <NDC11Code>63323-0869-75</NDC11Code>
    <ProductNDC>63323-869</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dextrose And Sodium Chloride</ProprietaryName>
    <NonProprietaryName>Dextrose Monohydrate And Sodium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20201026</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211276</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>DEXTROSE MONOHYDRATE; SODIUM CHLORIDE</SubstanceName>
    <StrengthNumber>5; .45</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-10-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201026</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Intravenous solutions containing dextrose and sodium chloride are indicated for parenteral replenishment of fluid, minimal carbohydrate calories, and sodium chloride as required by the clinical condition of the patient.</IndicationAndUsage>
    <Description>5% Dextrose and 0.45% Sodium Chloride Injection, USP solutions are sterile and nonpyrogenic. They are large volume parenteral solutions containing 5 grams per 100 mL of Dextrose monohydrate and 0.45 grams per 100 mL of Sodium Chloride in water for injection intended for intravenous administration. Each 100 mL of 5% Dextrose and 0.45% Sodium Chloride Injection, USP contains dextrose, hydrous 5 g and sodium chloride 0.45 g in water for injection. Electrolytes per 1000 mL: sodium (Na+), 77 mEq; chloride (Cl-) 77 mEq. The osmolarity is 406 mOsmol/L (calc.), which is hypertonic. The caloric value is 170 kcal/L. The pH is 4.3 (3.5 to 6.5). 5% Dextrose and 0.45% Sodium Chloride Injection, USP contains no bacteriostat, antimicrobial agent or added buffer and is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded. 5% Dextrose and 0.45% Sodium Chloride Injection, USP is a parenteral fluid, nutrient and electrolyte replenisher. Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6  H2O), a hexose sugar freely soluble in water. It has the following structural formula:. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H2O. The flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers (freeflex® bag). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers.</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-873-75</NDCCode>
    <PackageDescription>30 BAG in 1 CASE (63323-873-75)  / 250 mL in 1 BAG (63323-873-15) </PackageDescription>
    <NDC11Code>63323-0873-75</NDC11Code>
    <ProductNDC>63323-873</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dextrose And Sodium Chloride</ProprietaryName>
    <NonProprietaryName>Dextrose Monohydrate And Sodium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20201026</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211221</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>DEXTROSE MONOHYDRATE; SODIUM CHLORIDE</SubstanceName>
    <StrengthNumber>5; .225</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201026</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Intravenous solutions containing dextrose and sodium chloride are indicated for parenteral replenishment of fluid, minimal carbohydrate calories, and sodium chloride as required by the clinical condition of the patient.</IndicationAndUsage>
    <Description>Dextrose and Sodium Chloride Injection, USP solutions are sterile and nonpyrogenic. They are large volume parenteral solutions containing 5 grams per 100 mL of Dextrose monohydrate and 0.225 grams per 100 mL of Sodium Chloride in water for injection intended for intravenous administration. Each 100 mL of 5% Dextrose and 0.225% Sodium Chloride Injection, USP contains dextrose, hydrous 5g and sodium chloride 0.225g in water for injection. Electrolytes per 1000 mL: sodium (Na+), 38.5 mEq; chloride (Cl-) 38.5 mEq. The osmolarity is 329 mOsmol/L (calc.), which is hypertonic. The caloric value is 170 kcal/L. The pH is 4.3 (3.5 to 6.5). 5% Dextrose and 0.225% Sodium Chloride Injection, USP contains no bacteriostat, antimicrobial agent or added buffer and each is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded. 5% Dextrose and 0.225% Sodium Chloride Injection, USP are parenteral fluid, nutrient and electrolyte replenishers. Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6  H2O), a hexose sugar freely soluble in water. It has the following structural formula:. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H2O. The flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers (freeflex® bag). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers.</Description>
  </NDC>
  <NDC>
    <NDCCode>24236-824-23</NDCCode>
    <PackageDescription>180 TABLET, FILM COATED in 1 CANISTER (24236-824-23)</PackageDescription>
    <NDC11Code>24236-0824-23</NDC11Code>
    <ProductNDC>24236-824</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Plavix</ProprietaryName>
    <NonProprietaryName>Clopidogrel Bisulfate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130319</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020839</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</LabelerName>
    <SubstanceName>CLOPIDOGREL BISULFATE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2016-03-11</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>67457-824-99</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (67457-824-99)  / 30 mL in 1 VIAL, SINGLE-DOSE (67457-824-15) </PackageDescription>
    <NDC11Code>67457-0824-99</NDC11Code>
    <ProductNDC>67457-824</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20181206</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA209481</ApplicationNumber>
    <LabelerName>Mylan Institutional LLC</LabelerName>
    <SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1.5</StrengthNumber>
    <StrengthUnit>g/30mL</StrengthUnit>
    <Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181206</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Vancomycin Hydrochloride for Injection is a glycopeptide antibacterial indicated in adult and pediatric patients (neonates and older) for the treatment of: : 1 Septicemia (1.1), 2 Infective Endocarditis (1.2), 3 Skin and Skin Structure Infections (1.3) , 4 Bone Infections (1.4), 5 Lower Respiratory Tract Infections (1.5).</IndicationAndUsage>
    <Description>Vancomycin Hydrochloride for Injection, USP, contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibacterial derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride, USP is (Sa)-(3S,6R,7R,22R,23S,26S,36R,38aR)-44-[[2-O-(3-Amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino)valeramido]-2, 5, 24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[l, 6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24  HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride, USP has the following structural formula:. Vancomycin Hydrochloride for Injection, USP is a sterile off-white to light tan colored lyophilized plug or powder for injection. Vancomycin Hydrochloride for Injection, USP is supplied in single-dose vials, containing 256 mg, 769 mg, 1.28 g, 1.54 g, 1.79 g or 2.05 g of vancomycin hydrochloride, USP equivalent to 250 mg, 750 mg, 1.25 g, 1.5 g, 1.75 g or 2 g of vancomycin base. The lyophilized powder is reconstituted with Sterile Water for Injection, USP which forms a clear, colorless or light to dark tan solution and subsequently diluted prior to intravenous administration [see Dosage and Administration (2.5)].</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-205-00</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (63323-205-00)  / 100 mL in 1 VIAL, SINGLE-DOSE (63323-205-31) </PackageDescription>
    <NDC11Code>63323-0205-00</NDC11Code>
    <ProductNDC>63323-205</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Omegaven</ProprietaryName>
    <NonProprietaryName>Fish Oil</NonProprietaryName>
    <DosageFormName>INJECTION, EMULSION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20180727</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA210589</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>FISH OIL</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-09-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180727</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Omegaven is indicated as a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis (PNAC). Limitations of Use: 1 Omegaven is not indicated for the prevention of PNAC. It has not been demonstrated that Omegaven prevents PNAC in parenteral nutrition (PN)-dependent patients [see Clinical Studies (14)]., 2 It has not been demonstrated that the clinical outcomes observed in patients treated with Omegaven are a result of the omega-6: omega-3 fatty acid ratio of the product [see Clinical Studies (14)].</IndicationAndUsage>
    <Description>Omegaven (fish oil triglycerides) is a sterile, nonpyrogenic, white, homogenous emulsion for intravenous infusion as a supply of calories in patients with PNAC. Each mL of Omegaven contains 0.1 g of fish oil, 0.012 g egg phospholipids, 0.025 g glycerin, 0.15 to 0.3 mg dl-alpha-tocopherol, 0.3 mg sodium oleate, water for injection, and sodium hydroxide for pH adjustment (pH 6 to 9). The phosphate content is 0.015 mmol/mL. The fish oil included in Omegaven is a triglyceride mixture consisting of esters of long-chain saturated fatty acids and unsaturated fatty acids with the following structure:. where , , and are long chain acyl groups. Because triglycerides often contain different long chain fatty acids at each position, possible structures can have molecular weights ranging from 700 to 1000 g/mol. The main fatty acid components of the fish oil in Omegaven are EPA (13% to 26%) and DHA (14% to 27%). The fish oil also contains palmitic acid (4% to 12%), oleic acid (4% to 11%), palmitoleic acid (4% to 10%), myristic acid (2% to 7%), and arachidonic acid (0.2% to 2.0%). Additionally, the mean contents of linoleic acid and alpha-linolenic acid are 1.5% and 1.1%, respectively. The fish oil component has a total omega-3 fatty acid content of 40% to 54%. The empirical formula, molecular weight, and chemical structure of the main fatty acid components are:. Omegaven 5 g/50 mL contains 5 grams of fish oil and 0.6 g egg phospholipids, 1.25 g glycerin, 7.5 to 15 mg dl-alpha-tocopherol, 0.015 g sodium oleate, water for injection, and sodium hydroxide for pH adjustment (pH 6 to 9) packaged in a single-dose 50-mL glass bottle enclosed with a rubber stopper. The phosphate content of the drug product is 0.75 mmol. The mean content of the two major fatty acid components in 50 mL are 1.0 g EPA (range: 0.6 to 1.5 g) and 0.96 g DHA (range: 0.7 to 1.7 g). Additionally, the mean content of linoleic acid, alphalinolenic acid, and arachidonic acid per 50 mL are 0.16 g, 0.07 g, and 0.13 g, respectively. Omegaven 10 g/100 mL contains 10 grams of fish oil and 1.2 g egg phospholipids, 2.5 g glycerin, 15 to 30 mg dl-alpha-tocopherol, 0.03 g sodium oleate, water for injection, and sodium hydroxide for pH adjustment (pH 6 to 9) packaged in a single-dose 100-mL glass bottle enclosed with rubber stopper. The phosphate content of the drug product is 1.5 mmol. The mean content of the two major fatty acid components in 100 mL are 2.0 g EPA (range: 1.2 to 3.0 g) and 1.9 g DHA (range: 1.3 to 3.3 g). Additionally, the mean content of linoleic acid, alpha-linolenic acid, and arachidonic acid per 100 mL are 0.31g, 0.13 g, and 0.25 g; respectively. The total energy content of Omegaven is 112 kcal/100 mL (1.12 kcal/mL), including lipids, phospholipids, and glycerol. Omegaven has an osmolality of approximately 342 mOsm/kg water (which represents an osmolarity of 273 mOsm/L). Omegaven contains no more than 25 mcg/L of aluminum.</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-205-50</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (63323-205-50)  / 50 mL in 1 VIAL, SINGLE-DOSE (63323-205-21) </PackageDescription>
    <NDC11Code>63323-0205-50</NDC11Code>
    <ProductNDC>63323-205</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Omegaven</ProprietaryName>
    <NonProprietaryName>Fish Oil</NonProprietaryName>
    <DosageFormName>INJECTION, EMULSION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20180727</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA210589</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>FISH OIL</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-09-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180727</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Omegaven is indicated as a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis (PNAC). Limitations of Use: 1 Omegaven is not indicated for the prevention of PNAC. It has not been demonstrated that Omegaven prevents PNAC in parenteral nutrition (PN)-dependent patients [see Clinical Studies (14)]., 2 It has not been demonstrated that the clinical outcomes observed in patients treated with Omegaven are a result of the omega-6: omega-3 fatty acid ratio of the product [see Clinical Studies (14)].</IndicationAndUsage>
    <Description>Omegaven (fish oil triglycerides) is a sterile, nonpyrogenic, white, homogenous emulsion for intravenous infusion as a supply of calories in patients with PNAC. Each mL of Omegaven contains 0.1 g of fish oil, 0.012 g egg phospholipids, 0.025 g glycerin, 0.15 to 0.3 mg dl-alpha-tocopherol, 0.3 mg sodium oleate, water for injection, and sodium hydroxide for pH adjustment (pH 6 to 9). The phosphate content is 0.015 mmol/mL. The fish oil included in Omegaven is a triglyceride mixture consisting of esters of long-chain saturated fatty acids and unsaturated fatty acids with the following structure:. where , , and are long chain acyl groups. Because triglycerides often contain different long chain fatty acids at each position, possible structures can have molecular weights ranging from 700 to 1000 g/mol. The main fatty acid components of the fish oil in Omegaven are EPA (13% to 26%) and DHA (14% to 27%). The fish oil also contains palmitic acid (4% to 12%), oleic acid (4% to 11%), palmitoleic acid (4% to 10%), myristic acid (2% to 7%), and arachidonic acid (0.2% to 2.0%). Additionally, the mean contents of linoleic acid and alpha-linolenic acid are 1.5% and 1.1%, respectively. The fish oil component has a total omega-3 fatty acid content of 40% to 54%. The empirical formula, molecular weight, and chemical structure of the main fatty acid components are:. Omegaven 5 g/50 mL contains 5 grams of fish oil and 0.6 g egg phospholipids, 1.25 g glycerin, 7.5 to 15 mg dl-alpha-tocopherol, 0.015 g sodium oleate, water for injection, and sodium hydroxide for pH adjustment (pH 6 to 9) packaged in a single-dose 50-mL glass bottle enclosed with a rubber stopper. The phosphate content of the drug product is 0.75 mmol. The mean content of the two major fatty acid components in 50 mL are 1.0 g EPA (range: 0.6 to 1.5 g) and 0.96 g DHA (range: 0.7 to 1.7 g). Additionally, the mean content of linoleic acid, alphalinolenic acid, and arachidonic acid per 50 mL are 0.16 g, 0.07 g, and 0.13 g, respectively. Omegaven 10 g/100 mL contains 10 grams of fish oil and 1.2 g egg phospholipids, 2.5 g glycerin, 15 to 30 mg dl-alpha-tocopherol, 0.03 g sodium oleate, water for injection, and sodium hydroxide for pH adjustment (pH 6 to 9) packaged in a single-dose 100-mL glass bottle enclosed with rubber stopper. The phosphate content of the drug product is 1.5 mmol. The mean content of the two major fatty acid components in 100 mL are 2.0 g EPA (range: 1.2 to 3.0 g) and 1.9 g DHA (range: 1.3 to 3.3 g). Additionally, the mean content of linoleic acid, alpha-linolenic acid, and arachidonic acid per 100 mL are 0.31g, 0.13 g, and 0.25 g; respectively. The total energy content of Omegaven is 112 kcal/100 mL (1.12 kcal/mL), including lipids, phospholipids, and glycerol. Omegaven has an osmolality of approximately 342 mOsm/kg water (which represents an osmolarity of 273 mOsm/L). Omegaven contains no more than 25 mcg/L of aluminum.</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-451-01</NDCCode>
    <PackageDescription>25 VIAL, SINGLE-DOSE in 1 BOX (63323-451-01)  / 1 mL in 1 VIAL, SINGLE-DOSE (63323-451-00) </PackageDescription>
    <NDC11Code>63323-0451-01</NDC11Code>
    <ProductNDC>63323-451</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Morphine Sulfate</ProprietaryName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20180410</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA204223</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>MORPHINE SULFATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-09-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180410</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Morphine Sulfate Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration [see Warnings and Precautions (5.1)], and persist over the course of therapy, reserve opioid analgesics, including Morphine Sulfate injection, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
    <Description>Morphine sulfate is an opioid agonist. Morphine Sulfate Injection, USP is available as a sterile, nonpyrogenic solution of morphine sulfate, free of antioxidants and preservatives in single-dose vials for intravenous and intramuscular administration. The chemical name for Morphine sulfate is 7,8-Didehydro-4,5-epoxy-17-methyl-(5α,6α)-morphinan-3,6 α-diol sulfate (2: 1) (salt), pentahydrate. The molecular weight is 758.83. Its molecular formula is (C17H19NO3)2  H2SO4  5H2O and it has the following chemical structure. Morphine sulfate is a fine white powder. When exposed to air it gradually loses water of hydration, and darkens on prolonged exposure to light. It is soluble in water and ethanol at room temperature. Each milliliter of sterile solution contains 2 mg (equivalent to 1.75 mg Morphine), 4 mg (equivalent to 3.50 mg Morphine), or 10 mg (equivalent to 8.73 mg Morphine) of Morphine Sulfate, USP in 1 mL total volume of water for injection solution with inactive ingredients. The inactive ingredients in Morphine Sulfate Injection, USP include. Edetate disodium 0.2 mg; citric acid 0.4 mg; sodium chloride to adjust isotonicity and water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH.</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-452-01</NDCCode>
    <PackageDescription>25 VIAL, SINGLE-DOSE in 1 BOX (63323-452-01)  / 1 mL in 1 VIAL, SINGLE-DOSE (63323-452-00) </PackageDescription>
    <NDC11Code>63323-0452-01</NDC11Code>
    <ProductNDC>63323-452</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Morphine Sulfate</ProprietaryName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20180410</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA204223</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>MORPHINE SULFATE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-09-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180410</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Morphine Sulfate Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration [see Warnings and Precautions (5.1)], and persist over the course of therapy, reserve opioid analgesics, including Morphine Sulfate injection, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
    <Description>Morphine sulfate is an opioid agonist. Morphine Sulfate Injection, USP is available as a sterile, nonpyrogenic solution of morphine sulfate, free of antioxidants and preservatives in single-dose vials for intravenous and intramuscular administration. The chemical name for Morphine sulfate is 7,8-Didehydro-4,5-epoxy-17-methyl-(5α,6α)-morphinan-3,6 α-diol sulfate (2: 1) (salt), pentahydrate. The molecular weight is 758.83. Its molecular formula is (C17H19NO3)2  H2SO4  5H2O and it has the following chemical structure. Morphine sulfate is a fine white powder. When exposed to air it gradually loses water of hydration, and darkens on prolonged exposure to light. It is soluble in water and ethanol at room temperature. Each milliliter of sterile solution contains 2 mg (equivalent to 1.75 mg Morphine), 4 mg (equivalent to 3.50 mg Morphine), or 10 mg (equivalent to 8.73 mg Morphine) of Morphine Sulfate, USP in 1 mL total volume of water for injection solution with inactive ingredients. The inactive ingredients in Morphine Sulfate Injection, USP include. Edetate disodium 0.2 mg; citric acid 0.4 mg; sodium chloride to adjust isotonicity and water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH.</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-454-01</NDCCode>
    <PackageDescription>25 VIAL, SINGLE-DOSE in 1 BOX (63323-454-01)  / 1 mL in 1 VIAL, SINGLE-DOSE (63323-454-00) </PackageDescription>
    <NDC11Code>63323-0454-01</NDC11Code>
    <ProductNDC>63323-454</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Morphine Sulfate</ProprietaryName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20180410</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA204223</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>MORPHINE SULFATE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-09-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180410</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Morphine Sulfate Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration [see Warnings and Precautions (5.1)], and persist over the course of therapy, reserve opioid analgesics, including Morphine Sulfate injection, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
    <Description>Morphine sulfate is an opioid agonist. Morphine Sulfate Injection, USP is available as a sterile, nonpyrogenic solution of morphine sulfate, free of antioxidants and preservatives in single-dose vials for intravenous and intramuscular administration. The chemical name for Morphine sulfate is 7,8-Didehydro-4,5-epoxy-17-methyl-(5α,6α)-morphinan-3,6 α-diol sulfate (2: 1) (salt), pentahydrate. The molecular weight is 758.83. Its molecular formula is (C17H19NO3)2  H2SO4  5H2O and it has the following chemical structure. Morphine sulfate is a fine white powder. When exposed to air it gradually loses water of hydration, and darkens on prolonged exposure to light. It is soluble in water and ethanol at room temperature. Each milliliter of sterile solution contains 2 mg (equivalent to 1.75 mg Morphine), 4 mg (equivalent to 3.50 mg Morphine), or 10 mg (equivalent to 8.73 mg Morphine) of Morphine Sulfate, USP in 1 mL total volume of water for injection solution with inactive ingredients. The inactive ingredients in Morphine Sulfate Injection, USP include. Edetate disodium 0.2 mg; citric acid 0.4 mg; sodium chloride to adjust isotonicity and water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH.</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-455-01</NDCCode>
    <PackageDescription>25 VIAL, SINGLE-DOSE in 1 BOX (63323-455-01)  / 1 mL in 1 VIAL, SINGLE-DOSE (63323-455-00) </PackageDescription>
    <NDC11Code>63323-0455-01</NDC11Code>
    <ProductNDC>63323-455</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Morphine Sulfate</ProprietaryName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20180410</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA204223</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>MORPHINE SULFATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2025-03-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180410</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Morphine Sulfate Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve Morphine Sulfate Injection for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: : 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
    <Description>Morphine sulfate is an opioid agonist.  Morphine Sulfate Injection, USP is available as a sterile, nonpyrogenic solution of morphine sulfate, free of antioxidants and preservatives in single-dose vials for intravenous and intramuscular administration. The chemical name for Morphine sulfate is 7,8-Didehydro-4,5-epoxy-17-methyl-(5α,6α)-morphinan-3,6 α-diol sulfate (2: 1) (salt), pentahydrate.  The molecular weight is 758.83.  Its molecular formula is (C 17H 19NO 3) 2  H 2SO 4  5H 2O and it has the following chemical structure:. Morphine sulfate is a fine white powder.  When exposed to air it gradually loses water of hydration, and darkens on prolonged exposure to light.  It is soluble in water and ethanol at room temperature. Each milliliter of sterile solution contains 2 mg (equivalent to 1.75 mg Morphine), 4 mg (equivalent to 3.50 mg Morphine), 5 mg (equivalent to 4.37 mg Morphine), 8 mg (equivalent to 6.99 mg Morphine) or 10 mg (equivalent to 8.73 mg Morphine) of Morphine Sulfate USP in 1 mL total volume of water for injection solution with inactive ingredients. The inactive ingredients in Morphine Sulfate Injection, USP include:. Edetate disodium 0.2 mg; citric acid 0.4 mg; sodium chloride to adjust isotonicity and water for injection.  Hydrochloric acid and/or sodium hydroxide may be added to adjust pH.</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-458-01</NDCCode>
    <PackageDescription>25 VIAL, SINGLE-DOSE in 1 BOX (63323-458-01)  / 1 mL in 1 VIAL, SINGLE-DOSE (63323-458-00) </PackageDescription>
    <NDC11Code>63323-0458-01</NDC11Code>
    <ProductNDC>63323-458</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Morphine Sulfate</ProprietaryName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20180410</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA204223</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>MORPHINE SULFATE</SubstanceName>
    <StrengthNumber>8</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2025-03-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180410</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Morphine Sulfate Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve Morphine Sulfate Injection for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: : 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
    <Description>Morphine sulfate is an opioid agonist.  Morphine Sulfate Injection, USP is available as a sterile, nonpyrogenic solution of morphine sulfate, free of antioxidants and preservatives in single-dose vials for intravenous and intramuscular administration. The chemical name for Morphine sulfate is 7,8-Didehydro-4,5-epoxy-17-methyl-(5α,6α)-morphinan-3,6 α-diol sulfate (2: 1) (salt), pentahydrate.  The molecular weight is 758.83.  Its molecular formula is (C 17H 19NO 3) 2  H 2SO 4  5H 2O and it has the following chemical structure:. Morphine sulfate is a fine white powder.  When exposed to air it gradually loses water of hydration, and darkens on prolonged exposure to light.  It is soluble in water and ethanol at room temperature. Each milliliter of sterile solution contains 2 mg (equivalent to 1.75 mg Morphine), 4 mg (equivalent to 3.50 mg Morphine), 5 mg (equivalent to 4.37 mg Morphine), 8 mg (equivalent to 6.99 mg Morphine) or 10 mg (equivalent to 8.73 mg Morphine) of Morphine Sulfate USP in 1 mL total volume of water for injection solution with inactive ingredients. The inactive ingredients in Morphine Sulfate Injection, USP include:. Edetate disodium 0.2 mg; citric acid 0.4 mg; sodium chloride to adjust isotonicity and water for injection.  Hydrochloric acid and/or sodium hydroxide may be added to adjust pH.</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-506-01</NDCCode>
    <PackageDescription>25 VIAL in 1 TRAY (63323-506-01)  / 1 mL in 1 VIAL (63323-506-00) </PackageDescription>
    <NDC11Code>63323-0506-01</NDC11Code>
    <ProductNDC>63323-506</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dexamethasone Sodium Phosphate</ProprietaryName>
    <NonProprietaryName>Dexamethasone Sodium Phosphate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20030529</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040491</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>DEXAMETHASONE SODIUM PHOSPHATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20030529</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Dexamethasone Sodium Phosphate Injection, USP, is a water-soluble inorganic ester of dexamethasone which produces a rapid response even when injected intramuscularly. Dexamethasone Sodium Phosphate, USP chemically is Pregna-1,4-diene-3,20-dione, 9-fluoro-11,17- dihydroxy-16-methyl-21-(phosphonooxy)-, disodium salt, (11ß, 16α). It occurs as a white to creamy white powder, is exceedingly hygroscopic, is soluble in water and its solutions have a pH between 7.0 and 8.5. It has the following structural formula. Each mL of Dexamethasone Sodium Phosphate Injection, USP (Preservative Free) contains Dexamethasone Sodium Phosphate, USP equivalent to 10 mg dexamethasone phosphate; 24.75 mg sodium citrate, dihydrate; and Water for Injection, q.s. pH adjusted with citric acid or sodium hydroxide, if necessary. pH: 7.0 to 8.5. Each mL Dexamethasone Sodium Phosphate Injection, USP (Preserved) contains dexamethasone sodium phosphate, USP equivalent to 10 mg dexamethasone phosphate; 13.5 mg sodium citrate, dihydrate; 10 mg benzyl alcohol; and Water for Injection, q.s. pH adjusted with citric acid or sodium hydroxide, if necessary. pH: 7.0 to 8.5.</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-506-13</NDCCode>
    <PackageDescription>25 VIAL in 1 TRAY (63323-506-13)  / 1 mL in 1 VIAL (63323-506-03) </PackageDescription>
    <NDC11Code>63323-0506-13</NDC11Code>
    <ProductNDC>63323-506</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dexamethasone Sodium Phosphate</ProprietaryName>
    <NonProprietaryName>Dexamethasone Sodium Phosphate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20030529</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040491</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>DEXAMETHASONE SODIUM PHOSPHATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250106</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Dexamethasone Sodium Phosphate Injection, USP, is a water-soluble inorganic ester of dexamethasone which produces a rapid response even when injected intramuscularly. Dexamethasone Sodium Phosphate, USP chemically is Pregna-1,4-diene-3,20-dione, 9-fluoro-11,17- dihydroxy-16-methyl-21-(phosphonooxy)-, disodium salt, (11ß, 16α). It occurs as a white to creamy white powder, is exceedingly hygroscopic, is soluble in water and its solutions have a pH between 7.0 and 8.5. It has the following structural formula. Each mL of Dexamethasone Sodium Phosphate Injection, USP (Preservative Free) contains Dexamethasone Sodium Phosphate, USP equivalent to 10 mg dexamethasone phosphate; 24.75 mg sodium citrate, dihydrate; and Water for Injection, q.s. pH adjusted with citric acid or sodium hydroxide, if necessary. pH: 7.0 to 8.5. Each mL Dexamethasone Sodium Phosphate Injection, USP (Preserved) contains dexamethasone sodium phosphate, USP equivalent to 10 mg dexamethasone phosphate; 13.5 mg sodium citrate, dihydrate; 10 mg benzyl alcohol; and Water for Injection, q.s. pH adjusted with citric acid or sodium hydroxide, if necessary. pH: 7.0 to 8.5.</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-506-16</NDCCode>
    <PackageDescription>25 VIAL in 1 TRAY (63323-506-16)  / 1 mL in 1 VIAL (63323-506-41) </PackageDescription>
    <NDC11Code>63323-0506-16</NDC11Code>
    <ProductNDC>63323-506</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dexamethasone Sodium Phosphate</ProprietaryName>
    <NonProprietaryName>Dexamethasone Sodium Phosphate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20030529</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040491</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>DEXAMETHASONE SODIUM PHOSPHATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20030529</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Dexamethasone Sodium Phosphate Injection, USP, is a water-soluble inorganic ester of dexamethasone which produces a rapid response even when injected intramuscularly. Dexamethasone Sodium Phosphate, USP chemically is Pregna-1,4-diene-3,20-dione, 9-fluoro-11,17- dihydroxy-16-methyl-21-(phosphonooxy)-, disodium salt, (11ß, 16α). It occurs as a white to creamy white powder, is exceedingly hygroscopic, is soluble in water and its solutions have a pH between 7.0 and 8.5. It has the following structural formula. Each mL of Dexamethasone Sodium Phosphate Injection, USP (Preservative Free) contains Dexamethasone Sodium Phosphate, USP equivalent to 10 mg dexamethasone phosphate; 24.75 mg sodium citrate, dihydrate; and Water for Injection, q.s. pH adjusted with citric acid or sodium hydroxide, if necessary. pH: 7.0 to 8.5. Each mL Dexamethasone Sodium Phosphate Injection, USP (Preserved) contains dexamethasone sodium phosphate, USP equivalent to 10 mg dexamethasone phosphate; 13.5 mg sodium citrate, dihydrate; 10 mg benzyl alcohol; and Water for Injection, q.s. pH adjusted with citric acid or sodium hydroxide, if necessary. pH: 7.0 to 8.5.</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-516-10</NDCCode>
    <PackageDescription>10 VIAL in 1 TRAY (63323-516-10)  / 10 mL in 1 VIAL (63323-516-01) </PackageDescription>
    <NDC11Code>63323-0516-10</NDC11Code>
    <ProductNDC>63323-516</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dexamethasone Sodium Phosphate</ProprietaryName>
    <NonProprietaryName>Dexamethasone Sodium Phosphate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20050405</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040572</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>DEXAMETHASONE SODIUM PHOSPHATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20050405</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Dexamethasone Sodium Phosphate Injection, USP, is a water-soluble inorganic ester of dexamethasone which produces a rapid response even when injected intramuscularly. Dexamethasone Sodium Phosphate, USP chemically is Pregna-1,4-diene-3,20-dione, 9-fluoro-11,17- dihydroxy-16-methyl-21-(phosphonooxy)-, disodium salt, (11ß, 16α). It occurs as a white to creamy white powder, is exceedingly hygroscopic, is soluble in water and its solutions have a pH between 7.0 and 8.5. It has the following structural formula. Each mL of Dexamethasone Sodium Phosphate Injection, USP (Preservative Free) contains Dexamethasone Sodium Phosphate, USP equivalent to 10 mg dexamethasone phosphate; 24.75 mg sodium citrate, dihydrate; and Water for Injection, q.s. pH adjusted with citric acid or sodium hydroxide, if necessary. pH: 7.0 to 8.5. Each mL Dexamethasone Sodium Phosphate Injection, USP (Preserved) contains dexamethasone sodium phosphate, USP equivalent to 10 mg dexamethasone phosphate; 13.5 mg sodium citrate, dihydrate; 10 mg benzyl alcohol; and Water for Injection, q.s. pH adjusted with citric acid or sodium hydroxide, if necessary. pH: 7.0 to 8.5.</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-667-10</NDCCode>
    <PackageDescription>10 BAG in 1 CASE (63323-667-10)  / 1000 mL in 1 BAG (63323-667-01) </PackageDescription>
    <NDC11Code>63323-0667-10</NDC11Code>
    <ProductNDC>63323-667</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Potassium Chloride</ProprietaryName>
    <NonProprietaryName>Potassium Chloride, Dextrose Monohydrate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20210423</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212346</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>POTASSIUM CHLORIDE; DEXTROSE MONOHYDRATE</SubstanceName>
    <StrengthNumber>75; 5</StrengthNumber>
    <StrengthUnit>mg/100mL; g/100mL</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-05-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210423</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Potassium Chloride in 5% Dextrose Injection is indicated as a source of water, electrolytes and calories.</IndicationAndUsage>
    <Description>Potassium Chloride in 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in a single-dose container for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1. D-Glucose monohydrate. Dextrose is derived from corn. The flexible plastic container is fabricated from a specially formulated nonplasticized, film containing polypropylene and thermoplastic elastomers (freeflex® bag). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers.</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-781-10</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (63323-781-10)  &gt; 10 mL in 1 VIAL (63323-781-21) </PackageDescription>
    <NDC11Code>63323-0781-10</NDC11Code>
    <ProductNDC>63323-781</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Vecuronium Bromide</ProprietaryName>
    <NonProprietaryName>Vecuronium Bromide</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20160630</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205390</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>VECURONIUM BROMIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-06-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160630</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Vecuronium bromide is indicated as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.</IndicationAndUsage>
    <Description>Vecuronium Bromide for Injection is a nondepolarizing neuromuscular blocking agent of intermediate duration, chemically designated as 1-(3a, 17b-Dihydroxy-2b-piperidino-5a-androstan-16b, 5a-yl)-1-methylpiperidinium bromide, diacetate. The structural formula is. Its chemical formula is C34H57BrN2O4 with molecular weight 637.75. Vecuronium Bromide for Injection is supplied as a sterile nonpyrogenic freeze-dried buffered cake of very fine microscopic crystalline particles for intravenous injection only. Each vial contains 10 mg or 20 mg of vecuronium bromide, USP. In addition, each 10 mg vial contains 20.75 mg citric acid anhydrous, 16.25 mg dibasic sodium phosphate anhydrous, 97 mg mannitol (to adjust tonicity), sodium hydroxide and/or phosphoric acid to buffer and adjust to a pH range of 3.5 to 4.5. Each 20 mg vial contains 41.5 mg citric acid anhydrous, 32.5 mg dibasic sodium phosphate anhydrous, 194 mg mannitol (to adjust tonicity), sodium hydroxide and/or phosphoric acid to buffer and adjust to a pH range of 3.5 to 4.5.</Description>
  </NDC>
</NDCList>