RESTful Lookup — Test-Drive (2007 – 2026)

<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>76045-004-11</NDCCode>
    <PackageDescription>10 SYRINGE, GLASS in 1 CARTON (76045-004-11)  / 1 mL in 1 SYRINGE, GLASS (76045-004-01) </PackageDescription>
    <NDC11Code>76045-0004-11</NDC11Code>
    <ProductNDC>76045-004</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Morphine Sulfate</ProprietaryName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20131030</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>2026-09-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191125</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Morphine Sulfate Injection is an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. (1). Limitations of Use: : 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration 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. (1, 5.1).</IndicationAndUsage>
    <Description>Morphine Sulfate Injection, USP, contains morphine, an opioid agonist, in the form of sulfate salt which is isolated as morphine sulfate pentahydrate. The chemical name for Morphine sulfate pentahydrate is 7,8-Didehydro-4,5-epoxy-17-methyl-(5α,6α)-morphinan-3,6 α-diol sulfate (2: 1) (salt) pentahydrate. The molecular formula is (C17H19NO3)2  H2SO4  5H2O and the molecular weight is 758.83. The chemical structure of Morphine sulfate pentahydrate is:. Morphine sulfate pentahydrate 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. Morphine Sulfate Injection, USP, for intravenous and intramuscular administration, is a sterile, nonpyrogenic solution of Morphine Sulfate, free of antioxidants and preservatives. It is available in single-dose prefilled syringes, in the following strengths: : 1 For the 1 mg/0.5 mL product: Each single-dose prefilled syringe contains 1 mg Morphine Sulfate pentahydrate (equivalent to 0.75 mg Morphine), 0.03 mg of calcium chloride, 0.06 mg of edetate sodium, sodium chloride to adjust tonicity, citric acid and sodium citrate as buffering agents in 0.5 mL water for injection., 2 For the 2 mg/mL and 4 mg/mL products: Each single-dose prefilled syringe contains 2 mg (equivalent to 1.50 mg Morphine) or 4 mg (equivalent to 3.01 mg of Morphine) of Morphine Sulfate pentahydrate, 0.053 mg of calcium chloride, 0.111 mg of edetate disodium, sodium chloride to adjust tonicity, citric acid and sodium citrate as buffering agents, in 1 mL water for injection. .</Description>
  </NDC>
  <NDC>
    <NDCCode>76045-004-10</NDCCode>
    <PackageDescription>24 BLISTER PACK in 1 CARTON (76045-004-10)  &gt; 1 SYRINGE, GLASS in 1 BLISTER PACK &gt; 1 mL in 1 SYRINGE, GLASS</PackageDescription>
    <NDC11Code>76045-0004-10</NDC11Code>
    <ProductNDC>76045-004</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Morphine Sulfate</ProprietaryName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20131030</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>Deprecated</Status>
    <LastUpdate>2021-03-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20131030</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>76045-004-12</NDCCode>
    <PackageDescription>24 BLISTER PACK in 1 CARTON (76045-004-12)  &gt; 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-004-02)  &gt; 1 mL in 1 SYRINGE, GLASS</PackageDescription>
    <NDC11Code>76045-0004-12</NDC11Code>
    <ProductNDC>76045-004</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Morphine Sulfate</ProprietaryName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20131030</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>Deprecated</Status>
    <LastUpdate>2025-09-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200911</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.</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 prefilled syringes 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 1 mL single-dose pre-filled syringe 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: : 1 For the 2 mg/mL and 4 mg/mL products: 8.4 mg sodium chloride, 2.3 mg of sodium citrate, 0.74 mg of citric acid, 0.111 mg of edetate disodium, 0.053 mg of calcium chloride and water for injection. , 2 For the 5 mg/mL, 8 mg/mL and 10 mg/mL products: 7.5 mg sodium chloride, 3.45 mg of sodium citrate, 1.11 mg of citric acid, 0.111 mg of edetate disodium, 0.053 mg of calcium chloride and water for injection. .</Description>
  </NDC>
  <NDC>
    <NDCCode>76045-005-11</NDCCode>
    <PackageDescription>10 SYRINGE, GLASS in 1 CARTON (76045-005-11)  / 1 mL in 1 SYRINGE, GLASS (76045-005-01) </PackageDescription>
    <NDC11Code>76045-0005-11</NDC11Code>
    <ProductNDC>76045-005</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Morphine Sulfate</ProprietaryName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20131030</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>2026-09-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191125</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Morphine Sulfate Injection is an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. (1). Limitations of Use: : 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration 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. (1, 5.1).</IndicationAndUsage>
    <Description>Morphine Sulfate Injection, USP, contains morphine, an opioid agonist, in the form of sulfate salt which is isolated as morphine sulfate pentahydrate. The chemical name for Morphine sulfate pentahydrate is 7,8-Didehydro-4,5-epoxy-17-methyl-(5α,6α)-morphinan-3,6 α-diol sulfate (2: 1) (salt) pentahydrate. The molecular formula is (C17H19NO3)2  H2SO4  5H2O and the molecular weight is 758.83. The chemical structure of Morphine sulfate pentahydrate is:. Morphine sulfate pentahydrate 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. Morphine Sulfate Injection, USP, for intravenous and intramuscular administration, is a sterile, nonpyrogenic solution of Morphine Sulfate, free of antioxidants and preservatives. It is available in single-dose prefilled syringes, in the following strengths: : 1 For the 1 mg/0.5 mL product: Each single-dose prefilled syringe contains 1 mg Morphine Sulfate pentahydrate (equivalent to 0.75 mg Morphine), 0.03 mg of calcium chloride, 0.06 mg of edetate sodium, sodium chloride to adjust tonicity, citric acid and sodium citrate as buffering agents in 0.5 mL water for injection., 2 For the 2 mg/mL and 4 mg/mL products: Each single-dose prefilled syringe contains 2 mg (equivalent to 1.50 mg Morphine) or 4 mg (equivalent to 3.01 mg of Morphine) of Morphine Sulfate pentahydrate, 0.053 mg of calcium chloride, 0.111 mg of edetate disodium, sodium chloride to adjust tonicity, citric acid and sodium citrate as buffering agents, in 1 mL water for injection. .</Description>
  </NDC>
  <NDC>
    <NDCCode>76045-006-11</NDCCode>
    <PackageDescription>10 SYRINGE, GLASS in 1 CARTON (76045-006-11)  / 1 mL in 1 SYRINGE, GLASS (76045-006-01) </PackageDescription>
    <NDC11Code>76045-0006-11</NDC11Code>
    <ProductNDC>76045-006</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Morphine Sulfate</ProprietaryName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20131030</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>2025-04-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191125</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.</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 prefilled syringes 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 1 mL single-dose pre-filled syringe 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: : 1 For the 2 mg/mL and 4 mg/mL products: 8.4 mg sodium chloride, 2.3 mg of sodium citrate, 0.74 mg of citric acid, 0.111 mg of edetate disodium, 0.053 mg of calcium chloride and water for injection. , 2 For the 5 mg/mL, 8 mg/mL and 10 mg/mL products: 7.5 mg sodium chloride, 3.45 mg of sodium citrate, 1.11 mg of citric acid, 0.111 mg of edetate disodium, 0.053 mg of calcium chloride and water for injection. .</Description>
  </NDC>
  <NDC>
    <NDCCode>76045-007-11</NDCCode>
    <PackageDescription>10 SYRINGE, GLASS in 1 CARTON (76045-007-11)  / 1 mL in 1 SYRINGE, GLASS (76045-007-01) </PackageDescription>
    <NDC11Code>76045-0007-11</NDC11Code>
    <ProductNDC>76045-007</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Morphine Sulfate</ProprietaryName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20131030</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>2025-04-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191125</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.</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 prefilled syringes 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 1 mL single-dose pre-filled syringe 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: : 1 For the 2 mg/mL and 4 mg/mL products: 8.4 mg sodium chloride, 2.3 mg of sodium citrate, 0.74 mg of citric acid, 0.111 mg of edetate disodium, 0.053 mg of calcium chloride and water for injection. , 2 For the 5 mg/mL, 8 mg/mL and 10 mg/mL products: 7.5 mg sodium chloride, 3.45 mg of sodium citrate, 1.11 mg of citric acid, 0.111 mg of edetate disodium, 0.053 mg of calcium chloride and water for injection. .</Description>
  </NDC>
  <NDC>
    <NDCCode>76045-008-11</NDCCode>
    <PackageDescription>10 SYRINGE, GLASS in 1 CARTON (76045-008-11)  / 1 mL in 1 SYRINGE, GLASS (76045-008-01) </PackageDescription>
    <NDC11Code>76045-0008-11</NDC11Code>
    <ProductNDC>76045-008</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Morphine Sulfate</ProprietaryName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20131030</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>Deprecated</Status>
    <LastUpdate>2025-04-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191125</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.</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 prefilled syringes 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 1 mL single-dose pre-filled syringe 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: : 1 For the 2 mg/mL and 4 mg/mL products: 8.4 mg sodium chloride, 2.3 mg of sodium citrate, 0.74 mg of citric acid, 0.111 mg of edetate disodium, 0.053 mg of calcium chloride and water for injection. , 2 For the 5 mg/mL, 8 mg/mL and 10 mg/mL products: 7.5 mg sodium chloride, 3.45 mg of sodium citrate, 1.11 mg of citric acid, 0.111 mg of edetate disodium, 0.053 mg of calcium chloride and water for injection. .</Description>
  </NDC>
  <NDC>
    <NDCCode>76045-009-11</NDCCode>
    <PackageDescription>10 SYRINGE in 1 CARTON (76045-009-11)  / 1 mL in 1 SYRINGE (76045-009-01) </PackageDescription>
    <NDC11Code>76045-0009-11</NDC11Code>
    <ProductNDC>76045-009</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dilaudid</ProprietaryName>
    <NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20181204</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019034</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>HYDROMORPHONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-08-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181204</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>DILAUDID INJECTION is indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy [see Warnings and Precautions (5.2)], reserve opioid analgesics, including DILAUDID 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>DILAUDID (hydromorphone hydrochloride), a hydrogenated ketone of morphine, is an opioid agonist. DILAUDID INJECTION is available as a sterile, aqueous solution in clear and colorless single-dose prefilled syringes for slow intravenous, subcutaneous, or intramuscular administration. Each 1 mL of solution contains 0.2 mg, 1 mg or 2 mg of hydromorphone hydrochloride. The chemical name of DILAUDID is 4,5α-epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 321.80. Its molecular formula is C17H19NO3·HCl, and it has the following chemical structure. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. The inactive ingredients in DILAUDID (hydromorphone hydrochloride) include: 0.2% sodium citrate and 0.2% citric acid added as a buffer to maintain a pH between 3.5 and 5.5.</Description>
  </NDC>
  <NDC>
    <NDCCode>76045-010-11</NDCCode>
    <PackageDescription>10 SYRINGE in 1 CARTON (76045-010-11)  / 1 mL in 1 SYRINGE (76045-010-01) </PackageDescription>
    <NDC11Code>76045-0010-11</NDC11Code>
    <ProductNDC>76045-010</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dilaudid</ProprietaryName>
    <NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20161216</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019034</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>HYDROMORPHONE HYDROCHLORIDE</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>2026-08-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161216</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>DILAUDID INJECTION is indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy [see Warnings and Precautions (5.2)], reserve opioid analgesics, including DILAUDID 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>DILAUDID (hydromorphone hydrochloride), a hydrogenated ketone of morphine, is an opioid agonist. DILAUDID INJECTION is available as a sterile, aqueous solution in clear and colorless single-dose prefilled syringes for slow intravenous, subcutaneous, or intramuscular administration. Each 1 mL of solution contains 0.2 mg, 1 mg or 2 mg of hydromorphone hydrochloride. The chemical name of DILAUDID is 4,5α-epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 321.80. Its molecular formula is C17H19NO3·HCl, and it has the following chemical structure. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. The inactive ingredients in DILAUDID (hydromorphone hydrochloride) include: 0.2% sodium citrate and 0.2% citric acid added as a buffer to maintain a pH between 3.5 and 5.5.</Description>
  </NDC>
  <NDC>
    <NDCCode>76045-121-11</NDCCode>
    <PackageDescription>10 SYRINGE in 1 CARTON (76045-121-11)  / 1 mL in 1 SYRINGE (76045-121-01) </PackageDescription>
    <NDC11Code>76045-0121-11</NDC11Code>
    <ProductNDC>76045-121</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dilaudid</ProprietaryName>
    <NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20161216</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019034</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>HYDROMORPHONE HYDROCHLORIDE</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>2026-08-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200116</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>DILAUDID INJECTION is indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy [see Warnings and Precautions (5.2)], reserve opioid analgesics, including DILAUDID 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>DILAUDID (hydromorphone hydrochloride), a hydrogenated ketone of morphine, is an opioid agonist. DILAUDID INJECTION is available as a sterile, aqueous solution in clear and colorless single-dose prefilled syringes for slow intravenous, subcutaneous, or intramuscular administration. Each 1 mL of solution contains 0.2 mg, 1 mg or 2 mg of hydromorphone hydrochloride. The chemical name of DILAUDID is 4,5α-epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 321.80. Its molecular formula is C17H19NO3·HCl, and it has the following chemical structure. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. The inactive ingredients in DILAUDID (hydromorphone hydrochloride) include: 0.2% sodium citrate and 0.2% citric acid added as a buffer to maintain a pH between 3.5 and 5.5.</Description>
  </NDC>
  <NDC>
    <NDCCode>76045-005-12</NDCCode>
    <PackageDescription>24 BLISTER PACK in 1 CARTON (76045-005-12)  &gt; 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-005-02)  &gt; 1 mL in 1 SYRINGE, GLASS</PackageDescription>
    <NDC11Code>76045-0005-12</NDC11Code>
    <ProductNDC>76045-005</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Morphine Sulfate</ProprietaryName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20131030</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>Deprecated</Status>
    <LastUpdate>2025-09-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200911</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.</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 prefilled syringes 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 1 mL single-dose pre-filled syringe 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: : 1 For the 2 mg/mL and 4 mg/mL products: 8.4 mg sodium chloride, 2.3 mg of sodium citrate, 0.74 mg of citric acid, 0.111 mg of edetate disodium, 0.053 mg of calcium chloride and water for injection. , 2 For the 5 mg/mL, 8 mg/mL and 10 mg/mL products: 7.5 mg sodium chloride, 3.45 mg of sodium citrate, 1.11 mg of citric acid, 0.111 mg of edetate disodium, 0.053 mg of calcium chloride and water for injection. .</Description>
  </NDC>
  <NDC>
    <NDCCode>76045-006-12</NDCCode>
    <PackageDescription>24 BLISTER PACK in 1 CARTON (76045-006-12)  &gt; 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-006-02)  &gt; 1 mL in 1 SYRINGE, GLASS</PackageDescription>
    <NDC11Code>76045-0006-12</NDC11Code>
    <ProductNDC>76045-006</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Morphine Sulfate</ProprietaryName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20131030</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>2025-09-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200911</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.</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 prefilled syringes 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 1 mL single-dose pre-filled syringe 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: : 1 For the 2 mg/mL and 4 mg/mL products: 8.4 mg sodium chloride, 2.3 mg of sodium citrate, 0.74 mg of citric acid, 0.111 mg of edetate disodium, 0.053 mg of calcium chloride and water for injection. , 2 For the 5 mg/mL, 8 mg/mL and 10 mg/mL products: 7.5 mg sodium chloride, 3.45 mg of sodium citrate, 1.11 mg of citric acid, 0.111 mg of edetate disodium, 0.053 mg of calcium chloride and water for injection. .</Description>
  </NDC>
  <NDC>
    <NDCCode>76045-007-10</NDCCode>
    <PackageDescription>24 BLISTER PACK in 1 CARTON (76045-007-10)  &gt; 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-007-00)  &gt; 1 mL in 1 SYRINGE, GLASS</PackageDescription>
    <NDC11Code>76045-0007-10</NDC11Code>
    <ProductNDC>76045-007</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Morphine Sulfate</ProprietaryName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20131030</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>2025-09-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20131030</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.</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 prefilled syringes 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 1 mL single-dose pre-filled syringe 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: : 1 For the 2 mg/mL and 4 mg/mL products: 8.4 mg sodium chloride, 2.3 mg of sodium citrate, 0.74 mg of citric acid, 0.111 mg of edetate disodium, 0.053 mg of calcium chloride and water for injection. , 2 For the 5 mg/mL, 8 mg/mL and 10 mg/mL products: 7.5 mg sodium chloride, 3.45 mg of sodium citrate, 1.11 mg of citric acid, 0.111 mg of edetate disodium, 0.053 mg of calcium chloride and water for injection. .</Description>
  </NDC>
  <NDC>
    <NDCCode>76045-008-10</NDCCode>
    <PackageDescription>24 BLISTER PACK in 1 CARTON (76045-008-10)  &gt; 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-008-00)  &gt; 1 mL in 1 SYRINGE, GLASS</PackageDescription>
    <NDC11Code>76045-0008-10</NDC11Code>
    <ProductNDC>76045-008</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Morphine Sulfate</ProprietaryName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20131030</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>Deprecated</Status>
    <LastUpdate>2025-09-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20131030</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.</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 prefilled syringes 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 1 mL single-dose pre-filled syringe 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: : 1 For the 2 mg/mL and 4 mg/mL products: 8.4 mg sodium chloride, 2.3 mg of sodium citrate, 0.74 mg of citric acid, 0.111 mg of edetate disodium, 0.053 mg of calcium chloride and water for injection. , 2 For the 5 mg/mL, 8 mg/mL and 10 mg/mL products: 7.5 mg sodium chloride, 3.45 mg of sodium citrate, 1.11 mg of citric acid, 0.111 mg of edetate disodium, 0.053 mg of calcium chloride and water for injection. .</Description>
  </NDC>
  <NDC>
    <NDCCode>76045-106-10</NDCCode>
    <PackageDescription>24 BLISTER PACK in 1 CARTON (76045-106-10)  &gt; 1 SYRINGE, GLASS in 1 BLISTER PACK &gt; 1 mL in 1 SYRINGE, GLASS</PackageDescription>
    <NDC11Code>76045-0106-10</NDC11Code>
    <ProductNDC>76045-106</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dexamethasone Sodium Phosphate</ProprietaryName>
    <NonProprietaryName>Dexamethasone Sodium Phosphate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE</RouteName>
    <StartMarketingDate>20151030</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203129</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>DEXAMETHASONE SODIUM PHOSPHATE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-02-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151030</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Intravenous or intramuscular administration. When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, those products labeled for intravenous or intramuscular use are indicated as follows: Endocrine disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance).Acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs are used).Preoperatively, and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful.Shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected.Congenital adrenal hyperplasia.Nonsuppurative thyroiditis.Hypercalcemia associated with cancer. Rheumatic disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Post-traumatic osteoarthritis.Synovitis of osteoarthritis.Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy).Acute and subacute bursitis.Epicondylitis.Acute nonspecific tenosynovitis.Acute gouty arthritis.Psoriatic arthritis.Ankylosing spondylitis. Collagen diseases.During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus. Acute rheumatic carditis. Dermatologic diseases. Pemphigus. Severe erythema multiforme (Stevens-Johnson Syndrome). Exfoliative dermatitis. Bullous dermatitis herpetiformis. Severe seborrheic dermatitis. Severe psoriasis. Mycosis fungoides. Allergic states. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in:Bronchial asthma.Contact dermatitis.Atopic dermatitis.Serum sickness.Seasonal or perennial allergic rhinitis.Drug hypersensitivity reactions.Urticarial transfusion reactions.Acute noninfectious laryngeal edema (epinephrine is the drug of first choice). Ophthalmic diseases.Severe acute and chronic allergic and inflammatory processes involving the eye, such as:Herpes zoster ophthalmicus.Iritis, iridocyclitis.Chorioretinitis.Diffuse posterior uveitis and choroiditis.Optic neuritis.Sympathetic ophthalmia.Anterior segment inflammation.Allergic conjunctivitis.Allergic corneal marginal ulcers.Keratitis. Gastrointestinal diseases. To tide the patient over a critical period of the disease in: Ulcerative colitis (systemic therapy). Regional enteritis (systemic therapy). Respiratory diseases. Symptomatic Sarcoidosis. Berylliosis.Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate anti-tuberculosis chemotherapy.Loeffler's syndrome not manageable by other means.Aspiration pneumonitis. Hematologic disorders. Acquired (autoimmune) hemolytic anemia.Idiopathic thrombocytopenic purpura in adults (I.V. only; I.M. administration is contraindicated).Secondary thrombocytopenia in adults.Erythroblastopenia (RBC anemia).Congenital (erythroid) hypoplastic anemia. Neoplastic diseases. For palliative management of: Leukemias and lymphomas in adults. Acute leukemia of childhood. Edematous states. To induce diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.Nervous system.Acute exacerbations of multiple sclerosis. Miscellaneous.Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate anti-tuberculosis chemotherapy.Trichinosis with neurologic or myocardial involvement.Diagnostic testing of adrenocortical hyperfunction.Cerebral edema of diverse etiologies in conjunction with adequate neurological evaluation and management. Intra-articular or soft tissue administration. When the strength and dosage form of the drug lend the preparation to the treatment of the condition, those products labeled for intra-articular or soft tissue administration are indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Synovitis osteoarthritis.Rheumatoid arthritis.Acute and subacute bursitis.Acute gouty arthritis.Epicondylitis.Acute nonspecific tenosynovitis.Post-traumatic osteoarthritis. Intralesional administration. When the strength and dosage form of the drug lend the preparation to the treatment of the condition, those products labeled for intralesional administration are indicated for: Keloids.Localized hypertrophic, infiltrated, inflammatory lesions of: lichen planus, psoriatic plaques, granuloma annulare, and lichen simplex chronicus (neurodermatitis).Discoid lupus erythematosus.Necrobiosis lipoidica diabeticorum.Alopecia areata.They also may be useful in cystic tumors of an aponeurosis tendon (ganglia).</IndicationAndUsage>
    <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, C22H28FNa2O8P, has a molecular weight of 516.41 and chemically is Pregn-4-ene-3, 20-dione, 9-fluoro-11, 17-dihydroxy-16-methyl-21 (phosphonooxy)-, disodium salt, (11β, 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:. Dexamethasone Sodium Phosphate Injection, USP is available in 4 mg/mL. Each mL of Dexamethasone Sodium Phosphate injection contains Dexamethasone Sodium Phosphate, USP equivalent to 4 mg of Dexamethasone Phosphate. Made isotonic with sodium citrate. pH adjusted with citric acid or sodium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>76045-109-10</NDCCode>
    <PackageDescription>24 BLISTER PACK in 1 CARTON (76045-109-10)  / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS (76045-109-01) </PackageDescription>
    <NDC11Code>76045-0109-10</NDC11Code>
    <ProductNDC>76045-109</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dexamethasone Sodium Phosphate</ProprietaryName>
    <NonProprietaryName>Dexamethasone Sodium Phosphate</NonProprietaryName>
    <DosageFormName>INJECTION, EMULSION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20180706</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209192</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>2026-01-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180706</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 has a molecular weight of 516.41 and 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; 25.80 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.</Description>
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  <NDC>
    <NDCCode>76045-210-10</NDCCode>
    <PackageDescription>24 BLISTER PACK in 1 CARTON (76045-210-10)  / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-210-00)  / 1 mL in 1 SYRINGE, GLASS</PackageDescription>
    <NDC11Code>76045-0210-10</NDC11Code>
    <ProductNDC>76045-210</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dexamethasone Sodium Phosphate</ProprietaryName>
    <NonProprietaryName>Dexamethasone Sodium Phosphate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE</RouteName>
    <StartMarketingDate>20201130</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203129</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>DEXAMETHASONE SODIUM PHOSPHATE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-28</LastUpdate>
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    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>A. Intravenous or intramuscular administration. When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, those products labeled for intravenous or intramuscular use are indicated as follows:1. Endocrine disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance). Acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs are used).  Preoperatively, and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful. Shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected. Congenital adrenal hyperplasia.  Nonsuppurative thyroiditis. Hypercalcemia associated with cancer. 2. Rheumatic disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Post-traumatic osteoarthritis. Synovitis of osteoarthritis.  Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Acute and subacute bursitis.  Epicondylitis.  Acute nonspecific tenosynovitis.  Acute gouty arthritis.  Psoriatic arthritis.  Ankylosing spondylitis. 3. Collagen diseases. During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus. Acute rheumatic carditis. 4. Dermatologic diseases. Pemphigus.  Severe erythema multiforme (Stevens-Johnson Syndrome).  Exfoliative dermatitis.  Bullous dermatitis herpetiformis.  Severe seborrheic dermatitis.  Severe psoriasis.  Mycosis fungoides. 5. Allergic states. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in: Bronchial asthma.  Contact dermatitis.  Atopic dermatitis.  Serum sickness.  Seasonal or perennial allergic rhinitis.  Drug hypersensitivity reactions.  Urticarial transfusion reactions. Acute noninfectious laryngeal edema (epinephrine is the drug of first choice). 6. Ophthalmic diseases. Severe acute and chronic allergic and inflammatory processes involving the eye, such as:  Herpes zoster ophthalmicus.  Iritis, iridocyclitis.  Chorioretinitis.  Diffuse posterior uveitis and choroiditis.  Optic neuritis.  Sympathetic ophthalmia.  Anterior segment inflammation.  Allergic conjunctivitis.  Allergic corneal marginal ulcers.  Keratitis. 7. Gastrointestinal diseases. To tide the patient over a critical period of the disease in: Ulcerative colitis (systemic therapy). Regional enteritis (systemic therapy). 8. Respiratory diseases. Symptomatic Sarcoidosis.  Berylliosis.  Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate anti-tuberculosis chemotherapy. Loeffler's syndrome not manageable by other means.  Aspiration pneumonitis. 9. Hematologic disorders. Acquired (autoimmune) hemolytic anemia.  Idiopathic thrombocytopenic purpura in adults (I.V. only; I.M. administration is contraindicated).  Secondary thrombocytopenia in adults.  Erythroblastopenia (RBC anemia).  Congenital (erythroid) hypoplastic anemia. 10. Neoplastic diseases. For palliative management of: Leukemias and lymphomas in adults.  Acute leukemia of childhood.11. Edematous states. To induce diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 12.Nervous system. Acute exacerbations of multiple sclerosis. 13. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate anti-tuberculosis chemotherapy. Trichinosis with neurologic or myocardial involvement.  Diagnostic testing of adrenocortical hyperfunction.  Cerebral edema of diverse etiologies in conjunction with adequate neurological evaluation and management. . B. Intra-articular or soft tissue administration. When the strength and dosage form of the drug lend the preparation to the treatment of the condition, those products labeled for intra-articular or soft tissue administration are indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:.  Synovitis osteoarthritis. .  Rheumatoid arthritis. .  Acute and subacute bursitis. .  Acute gouty arthritis. .  Epicondylitis. .  Acute nonspecific tenosynovitis. .  Post-traumatic osteoarthritis. C. Intralesional administration. When the strength and dosage form of the drug lend the preparation to the treatment of the condition, those products labeled for intralesional administration are indicated for:.  Keloids. .  Localized hypertrophic, infiltrated, inflammatory lesions of: lichen planus, psoriatic plaques, granuloma annulare, and lichen simplex chronicus (neurodermatitis). .  Discoid lupus erythematosus. .  Necrobiosis lipoidica diabeticorum. .  Alopecia areata. .  They also may be useful in cystic tumors of an aponeurosis tendon (ganglia). .</IndicationAndUsage>
    <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, C22H28FNa2O8P, has a molecular weight of 516.41 and chemically is Pregn-4-ene-3, 20-dione, 9-fluoro-11, 17-dihydroxy-16-methyl-21 (phosphonooxy)-, disodium salt, (11β, 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:. Dexamethasone Sodium Phosphate Injection, USP is available in 4 mg/mL. Each mL of Dexamethasone Sodium Phosphate injection contains Dexamethasone Sodium Phosphate, USP equivalent to 4 mg of Dexamethasone Phosphate. Made isotonic with sodium citrate. pH adjusted with citric acid or sodium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>76045-212-10</NDCCode>
    <PackageDescription>24 BLISTER PACK in 1 CARTON (76045-212-10)  / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS (76045-212-00) </PackageDescription>
    <NDC11Code>76045-0212-10</NDC11Code>
    <ProductNDC>76045-212</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dexamethasone Sodium Phosphate</ProprietaryName>
    <NonProprietaryName>Dexamethasone Sodium Phosphate</NonProprietaryName>
    <DosageFormName>INJECTION, EMULSION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20240221</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209192</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>2026-01-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240221</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 has a molecular weight of 516.41 and 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; 25.80 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.</Description>
  </NDC>
  <NDC>
    <NDCCode>76045-238-10</NDCCode>
    <PackageDescription>10 SYRINGE, GLASS in 1 CARTON (76045-238-10)  / .5 mL in 1 SYRINGE, GLASS (76045-238-01) </PackageDescription>
    <NDC11Code>76045-0238-10</NDC11Code>
    <ProductNDC>76045-238</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Morphine Sulfate</ProprietaryName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20131030</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA204223</ApplicationNumber>
    <LabelerName>Fresenius Kabi, USA LLC</LabelerName>
    <SubstanceName>MORPHINE SULFATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/.5mL</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-09-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260529</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Morphine Sulfate Injection is an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. (1). Limitations of Use: : 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration 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. (1, 5.1).</IndicationAndUsage>
    <Description>Morphine Sulfate Injection, USP, contains morphine, an opioid agonist, in the form of sulfate salt which is isolated as morphine sulfate pentahydrate. The chemical name for Morphine sulfate pentahydrate is 7,8-Didehydro-4,5-epoxy-17-methyl-(5α,6α)-morphinan-3,6 α-diol sulfate (2: 1) (salt) pentahydrate. The molecular formula is (C17H19NO3)2  H2SO4  5H2O and the molecular weight is 758.83. The chemical structure of Morphine sulfate pentahydrate is:. Morphine sulfate pentahydrate 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. Morphine Sulfate Injection, USP, for intravenous and intramuscular administration, is a sterile, nonpyrogenic solution of Morphine Sulfate, free of antioxidants and preservatives. It is available in single-dose prefilled syringes, in the following strengths: : 1 For the 1 mg/0.5 mL product: Each single-dose prefilled syringe contains 1 mg Morphine Sulfate pentahydrate (equivalent to 0.75 mg Morphine), 0.03 mg of calcium chloride, 0.06 mg of edetate sodium, sodium chloride to adjust tonicity, citric acid and sodium citrate as buffering agents in 0.5 mL water for injection., 2 For the 2 mg/mL and 4 mg/mL products: Each single-dose prefilled syringe contains 2 mg (equivalent to 1.50 mg Morphine) or 4 mg (equivalent to 3.01 mg of Morphine) of Morphine Sulfate pentahydrate, 0.053 mg of calcium chloride, 0.111 mg of edetate disodium, sodium chloride to adjust tonicity, citric acid and sodium citrate as buffering agents, in 1 mL water for injection. .</Description>
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    <NDCCode>10014-004-11</NDCCode>
    <PackageDescription>3115 L in 1 CYLINDER (10014-004-11) </PackageDescription>
    <NDC11Code>10014-0004-11</NDC11Code>
    <ProductNDC>10014-004</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Helium</ProprietaryName>
    <NonProprietaryName>Helium</NonProprietaryName>
    <DosageFormName>GAS</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>19721006</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA206826</ApplicationNumber>
    <LabelerName>Aero All Gas Company</LabelerName>
    <SubstanceName>HELIUM</SubstanceName>
    <StrengthNumber>990</StrengthNumber>
    <StrengthUnit>mL/L</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-10-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19721006</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>11054-004-11</NDCCode>
    <PackageDescription>3022 L in 1 CYLINDER (11054-004-11) </PackageDescription>
    <NDC11Code>11054-0004-11</NDC11Code>
    <ProductNDC>11054-004</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Helium</ProprietaryName>
    <NonProprietaryName>Helium</NonProprietaryName>
    <DosageFormName>GAS</DosageFormName>
    <RouteName>INTRACORONARY; RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>19971106</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA205843</ApplicationNumber>
    <LabelerName>AIRGAS USA, LLC</LabelerName>
    <SubstanceName>HELIUM</SubstanceName>
    <StrengthNumber>992</StrengthNumber>
    <StrengthUnit>mL/L</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-09-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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    <SamplePackage>N</SamplePackage>
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    <NDCCode>11390-004-11</NDCCode>
    <PackageDescription>174.336 L in 1 CYLINDER (11390-004-11)</PackageDescription>
    <NDC11Code>11390-0004-11</NDC11Code>
    <ProductNDC>11390-004</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carbon Dioxide</ProprietaryName>
    <NonProprietaryName>Carbon Dioxide</NonProprietaryName>
    <DosageFormName>GAS</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20000720</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
    <LabelerName>Airgas Southwest, Inc.</LabelerName>
    <SubstanceName>CARBON DIOXIDE</SubstanceName>
    <StrengthNumber>990</StrengthNumber>
    <StrengthUnit>mL/L</StrengthUnit>
    <Pharm_Classes>Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>13107-004-11</NDCCode>
    <PackageDescription>10 TABLET, FILM COATED in 1 BOTTLE (13107-004-11) </PackageDescription>
    <NDC11Code>13107-0004-11</NDC11Code>
    <ProductNDC>13107-004</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydrocodone Bitartrate And Ibuprofen</ProprietaryName>
    <NonProprietaryName>Hydrocodone Bitartrate And Ibuprofen</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160602</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204575</ApplicationNumber>
    <LabelerName>Aurolife Pharma, LLC</LabelerName>
    <SubstanceName>HYDROCODONE BITARTRATE; IBUPROFEN</SubstanceName>
    <StrengthNumber>7.5; 200</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-12-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hydrocodone Bitartrate and Ibuprofen Tablets are indicated for the short-term management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of UseCarefully consider the potential benefits and risks of Hydrocodone Bitartrate and Ibuprofen Tablets and other treatment options before deciding to use Hydrocodone Bitartrate and Ibuprofen Tablets Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Cardiovascular Thrombotic Events, Gastrointestinal Bleeding, Ulceration, and Perforation). Do not use Hydrocodone Bitartrate and Ibuprofen Tablets for the treatment of conditions such as osteoarthritis or rheumatoid arthritis.Because of the risks of addiction, abuse, misuse, overdose and death, which can occur at any dosage or duration and persist over the course of therapy (seeWARNINGS), reserve opioid analgesics, including Hydrocodone Bitartrate and Ibuprofen Tablets 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>Each hydrocodone bitartrate and ibuprofen tablet contains: Hydrocodone Bitartrate, USP  7.5 mg Ibuprofen, USP    200 mgHydrocodone Bitartrate and Ibuprofen Tablets are supplied in a fixed combination tablet form for oral administration. Hydrocodone Bitartrate and Ibuprofen Tablets combines the opioid agonist agent, hydrocodone bitartrate, with the nonsteroidal anti-inflammatory (NSAID) agent, ibuprofen.Hydrocodone bitartrate is a semisynthetic opioid agonist. Its chemical name is: 4,5 α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). Its chemical formula is: C18H21NO3C4H6O62½H2O, and the molecular weight is 494.50. Its structural formula is. Ibuprofen is a non-steroidal anti-inflammatory agent [non-selective COX inhibitor] with analgesic and antipyretic properties. Its chemical name is: (±)-2-(p-isobutylphenyl) propionic acid. Its chemical formula is: C13H18O2, and the molecular weight is: 206.29. Its structural formula is. Inactive ingredients in Hydrocodone Bitartrate and Ibuprofen tablets include: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, sodium starch glycolate, sodium lauryl sulfate, polysorbate 80, hypromellose, titanium dioxide and polyethylene glycol.</Description>
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    <NDCCode>14445-004-11</NDCCode>
    <PackageDescription>21 kg in 1 DRUM (14445-004-11) </PackageDescription>
    <NDC11Code>14445-0004-11</NDC11Code>
    <ProductNDC>14445-004</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Dicycloamine Hydrochloride</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20131218</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Indoco Remedies Limited</LabelerName>
    <SubstanceName>DICYCLOMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2024-11-27</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>18-DEC-13</StartMarketingDatePackage>
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    <NDCCode>28107-004-11</NDCCode>
    <PackageDescription>.946 kg in 1 BOTTLE (28107-004-11) </PackageDescription>
    <NDC11Code>28107-0004-11</NDC11Code>
    <ProductNDC>28107-004</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cleanwell Natural Antibacterial Foaming Orange Vanilla</ProprietaryName>
    <NonProprietaryName>Cleanwell Natural Antibacterial Foaming Orange Vanilla</NonProprietaryName>
    <DosageFormName>SOAP</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20071101</StartMarketingDate>
    <EndMarketingDate>20190529</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part356</ApplicationNumber>
    <LabelerName>CleanWell, LLC</LabelerName>
    <SubstanceName>THYMOL</SubstanceName>
    <StrengthNumber>.0004</StrengthNumber>
    <StrengthUnit>1/kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-05-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20071101</StartMarketingDatePackage>
    <EndMarketingDatePackage>20190529</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
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    <PackageDescription>80 CLOTH in 1 DRUM (43116-004-11) </PackageDescription>
    <NDC11Code>43116-0004-11</NDC11Code>
    <ProductNDC>43116-004</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Shierjie Disinfecting Soft Wipes Antibacterial</ProprietaryName>
    <NonProprietaryName>Shierjie Disinfecting Soft Wipes Antibacterial</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200331</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Shenzhen Shierjie Biotech Co .,LTD</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE; PHENOXYETHANOL; CHLORHEXIDINE ACETATE</SubstanceName>
    <StrengthNumber>.1; .02; .1</StrengthNumber>
    <StrengthUnit>g/1001; g/1001; g/1001</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-10-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200331</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
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    <PackageDescription>2 BLISTER PACK in 1 CARTON (43674-004-02)  / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK / .11 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>43674-0004-02</NDC11Code>
    <ProductNDC>43674-004</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rezenopy</ProprietaryName>
    <NonProprietaryName>Naloxone Hydrochloride</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>NASAL</RouteName>
    <StartMarketingDate>20250210</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA215487</ApplicationNumber>
    <LabelerName>Summit Biosciences Inc</LabelerName>
    <SubstanceName>NALOXONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/.11mL</StrengthUnit>
    <Pharm_Classes>Opioid Antagonist [EPC], Opioid Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250210</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>REZENOPY nasal spray is indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression in adult and pediatric patients. REZENOPY nasal spray is intended for immediate administration as emergency therapy in settings where opioids may be present. REZENOPY nasal spray is not a substitute for emergency medical care.</IndicationAndUsage>
    <Description>REZENOPY (naloxone hydrochloride) nasal spray is a pre-filled, single dose intranasal spray. Chemically, naloxone hydrochloride is the hydrochloride salt of 17-Allyl-4,5α-epoxy- 3,14-dihydroxymorphinan-6-one hydrochloride with the following structure. Molecular Formula: C19H21N04HCl2H20Relative Molecular Mass: 399.87. Naloxone hydrochloride, an opioid antagonist, occurs as a white, to slightly off-white powder or almost white crystalline powder and contains two molecules of water of hydration. It is freely soluble in water, in dilute acids, and in strong alkali; slightly soluble in ethanol. pKa values (proton on Nitrogen) are respectively 7.94 at 20°C and 7.82 at 37°C. Each REZENOPY nasal spray delivers 10 mg naloxone hydrochloride (equivalent to 9 mg of naloxone) in a 0.11 mL aqueous solution. Inactive ingredients include glycerin, trisodium citrate dihydrate, hydrochloric acid and sodium hydroxide to adjust pH, and purified water. The pH range is 3.9 to 4.5.</Description>
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    <NDCCode>48883-004-11</NDCCode>
    <PackageDescription>13810 L in 1 DEWAR (48883-004-11)</PackageDescription>
    <NDC11Code>48883-0004-11</NDC11Code>
    <ProductNDC>48883-004</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nitrous Oxide</ProprietaryName>
    <NonProprietaryName>Nitrous Oxide</NonProprietaryName>
    <DosageFormName>GAS</DosageFormName>
    <RouteName>RECTAL</RouteName>
    <StartMarketingDate>20080102</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
    <LabelerName>Encompass Medical &amp; Specialty Gases, Ltd.</LabelerName>
    <SubstanceName>NITROUS OXIDE</SubstanceName>
    <StrengthNumber>990</StrengthNumber>
    <StrengthUnit>mL/L</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>49204-004-11</NDCCode>
    <PackageDescription>9340 L in 1 CYLINDER (49204-004-11) </PackageDescription>
    <NDC11Code>49204-0004-11</NDC11Code>
    <ProductNDC>49204-004</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Air</ProprietaryName>
    <NonProprietaryName>Air</NonProprietaryName>
    <DosageFormName>GAS</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>19770701</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA205712</ApplicationNumber>
    <LabelerName>HARTMAN BROTHERS, INC.</LabelerName>
    <SubstanceName>OXYGEN</SubstanceName>
    <StrengthNumber>210</StrengthNumber>
    <StrengthUnit>mL/L</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-10-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19770701</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>49972-004-11</NDCCode>
    <PackageDescription>493 L in 1 CYLINDER (49972-004-11)</PackageDescription>
    <NDC11Code>49972-0004-11</NDC11Code>
    <ProductNDC>49972-004</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nitrous Oxide</ProprietaryName>
    <NonProprietaryName>Nitrous Oxide</NonProprietaryName>
    <DosageFormName>GAS</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20071001</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
    <LabelerName>Praxair Distribution Southeast LLC</LabelerName>
    <SubstanceName>NITROUS OXIDE</SubstanceName>
    <StrengthNumber>990</StrengthNumber>
    <StrengthUnit>mL/L</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
</NDCList>