RESTful Lookup — Test-Drive (2007 – 2026)

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    <NDCCode>0264-4050-90</NDCCode>
    <PackageDescription>24 CONTAINER in 1 CASE (0264-4050-90)  / 50 mL in 1 CONTAINER</PackageDescription>
    <NDC11Code>00264-4050-90</NDC11Code>
    <ProductNDC>0264-4050</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Acetaminophen</ProprietaryName>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20231010</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA204957</ApplicationNumber>
    <LabelerName>B. Braun Medical Inc.</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-03-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231010</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Acetaminophen Injection is indicated for: 1 the management of mild to moderate pain in adult and pediatric patients 2 years and older, 2 the management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older, 3 the reduction of fever in adult and pediatric patients.</IndicationAndUsage>
    <Description>Acetaminophen is a non-salicylate antipyretic and non-opioid analgesic agent. Its chemical name is N-acetyl-p-aminophenol. Acetaminophen has a molecular weight of 151.16. Its structural formula is. Acetaminophen Injection is a sterile, clear, colorless, non pyrogenic, isotonic formulation of acetaminophen intended for intravenous infusion. It has a pH of approximately 5.0 and an osmolality of approximately 290 mOsm/kg. Each 50 mL contains 500 mg Acetaminophen, USP, 1,900 mg Mannitol, USP, 15 mg Sodium Citrate Dihydrate USP, and Water for Injection, USP qs. pH is adjusted with glacial acetic acid. Not made with natural rubber latex, PVC or DEHP.</Description>
  </NDC>
  <NDC>
    <NDCCode>0264-4050-80</NDCCode>
    <PackageDescription>24 CONTAINER in 1 CASE (0264-4050-80)  / 50 mL in 1 CONTAINER</PackageDescription>
    <NDC11Code>00264-4050-80</NDC11Code>
    <ProductNDC>0264-4050</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Acetaminophen</ProprietaryName>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20210218</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA204957</ApplicationNumber>
    <LabelerName>B. Braun Medical Inc.</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2023-06-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210218</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Acetaminophen Injection is indicated for: 1 the management of mild to moderate pain in adult and pediatric patients 2 years and older, 2 the management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older, 3 the reduction of fever in adult and pediatric patients.</IndicationAndUsage>
    <Description>Acetaminophen is a non-salicylate antipyretic and non-opioid analgesic agent. Its chemical name is N-acetyl-p-aminophenol. Acetaminophen has a molecular weight of 151.16. Its structural formula is:. Acetaminophen Injection is a sterile, clear, colorless, non pyrogenic, isotonic formulation of acetaminophen intended for intravenous infusion. It has a pH of approximately 5.0 and an osmolality of approximately 290 mOsm/kg. Each 100 mL contains 1,000 mg Acetaminophen, USP, 3,800 mg Mannitol, USP, 30 mg Sodium Citrate Dihydrate USP, and Water for Injection, USP qs. Each 50 mL contains 500 mg Acetaminophen, USP, 1,900 mg Mannitol, USP, 15 mg Sodium Citrate Dihydrate USP, and Water for Injection, USP qs. pH is adjusted with glacial acetic acid. Not made with natural rubber latex, PVC or DEHP.</Description>
  </NDC>
  <NDC>
    <NDCCode>0264-4050-85</NDCCode>
    <PackageDescription>6 CARTON in 1 CASE (0264-4050-85)  &gt; 4 CONTAINER in 1 CARTON (0264-4050-80)  &gt; 50 mL in 1 CONTAINER</PackageDescription>
    <NDC11Code>00264-4050-85</NDC11Code>
    <ProductNDC>0264-4050</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Acetaminophen</ProprietaryName>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20210218</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA204957</ApplicationNumber>
    <LabelerName>B. Braun Medical Inc.</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-06-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210218</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0264-1009-90</NDCCode>
    <PackageDescription>24 CONTAINER in 1 CASE (0264-1009-90)  / 100 mL in 1 CONTAINER</PackageDescription>
    <NDC11Code>00264-1009-90</NDC11Code>
    <ProductNDC>0264-1009</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levetiracetam</ProprietaryName>
    <NonProprietaryName>Levetiracetam</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20240513</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209705</ApplicationNumber>
    <LabelerName>B. Braun Medical Inc.</LabelerName>
    <SubstanceName>LEVETIRACETAM</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240513</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Levetiracetam in Sodium Chloride Injection is indicated for adjunct therapy in adults (greater than or equal to 16 years of age) with the following seizure types when oral administration is temporarily not feasible: 1 Partial-onset seizures (1.1) , 2 Myoclonic seizures in patients with juvenile myoclonic epilepsy (1.2), 3 Primary generalized tonic-clonic seizures (1.3).</IndicationAndUsage>
    <Description>Levetiracetam in Sodium Chloride Injection is an antiepileptic drug available as a clear, colorless, sterile solution for intravenous administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam in Sodium Chloride Injection is a clear, colorless, sterile solution that is available in a single-dose dual port container. This container closure is not made with natural rubber latex, PVC or DEHP. 500 mg/100 mL: One 100 mL fill container contains 500 mg of levetiracetam (5 mg/mL), water for injection, 820 mg sodium chloride, 5.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,000 mg/100 mL: One 100 mL fill container contains 1,000 mg of levetiracetam (10 mg/mL), water for injection, 750 mg sodium chloride, 6.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,500 mg/100 mL: One 100 mL fill container contains 1,500 mg of levetiracetam (15 mg/mL), water for injection, 540 mg sodium chloride, 7.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. The container/solution unit is a closed system and is not dependent upon entry of external air during administration. The container has two ports, one is for the intravenous administration set and the other is a medication addition. Each is covered by a tamperproof barrier. Refer to the DIRECTIONS FOR USE of the container to properly identify the ports. No vapor barrier is necessary.</Description>
  </NDC>
  <NDC>
    <NDCCode>0264-1509-90</NDCCode>
    <PackageDescription>24 CONTAINER in 1 CASE (0264-1509-90)  / 100 mL in 1 CONTAINER</PackageDescription>
    <NDC11Code>00264-1509-90</NDC11Code>
    <ProductNDC>0264-1509</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levetiracetam</ProprietaryName>
    <NonProprietaryName>Levetiracetam</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20240513</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209705</ApplicationNumber>
    <LabelerName>B. Braun Medical Inc.</LabelerName>
    <SubstanceName>LEVETIRACETAM</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240513</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Levetiracetam in Sodium Chloride Injection is indicated for adjunct therapy in adults (greater than or equal to 16 years of age) with the following seizure types when oral administration is temporarily not feasible: 1 Partial-onset seizures (1.1) , 2 Myoclonic seizures in patients with juvenile myoclonic epilepsy (1.2), 3 Primary generalized tonic-clonic seizures (1.3).</IndicationAndUsage>
    <Description>Levetiracetam in Sodium Chloride Injection is an antiepileptic drug available as a clear, colorless, sterile solution for intravenous administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam in Sodium Chloride Injection is a clear, colorless, sterile solution that is available in a single-dose dual port container. This container closure is not made with natural rubber latex, PVC or DEHP. 500 mg/100 mL: One 100 mL fill container contains 500 mg of levetiracetam (5 mg/mL), water for injection, 820 mg sodium chloride, 5.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,000 mg/100 mL: One 100 mL fill container contains 1,000 mg of levetiracetam (10 mg/mL), water for injection, 750 mg sodium chloride, 6.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,500 mg/100 mL: One 100 mL fill container contains 1,500 mg of levetiracetam (15 mg/mL), water for injection, 540 mg sodium chloride, 7.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. The container/solution unit is a closed system and is not dependent upon entry of external air during administration. The container has two ports, one is for the intravenous administration set and the other is a medication addition. Each is covered by a tamperproof barrier. Refer to the DIRECTIONS FOR USE of the container to properly identify the ports. No vapor barrier is necessary.</Description>
  </NDC>
  <NDC>
    <NDCCode>0264-4100-90</NDCCode>
    <PackageDescription>24 CONTAINER in 1 CASE (0264-4100-90)  / 100 mL in 1 CONTAINER</PackageDescription>
    <NDC11Code>00264-4100-90</NDC11Code>
    <ProductNDC>0264-4100</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Acetaminophen</ProprietaryName>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20210218</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA204957</ApplicationNumber>
    <LabelerName>B. Braun Medical Inc.</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2023-06-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210218</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Acetaminophen Injection is indicated for: 1 the management of mild to moderate pain in adult and pediatric patients 2 years and older, 2 the management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older, 3 the reduction of fever in adult and pediatric patients.</IndicationAndUsage>
    <Description>Acetaminophen is a non-salicylate antipyretic and non-opioid analgesic agent. Its chemical name is N-acetyl-p-aminophenol. Acetaminophen has a molecular weight of 151.16. Its structural formula is:. Acetaminophen Injection is a sterile, clear, colorless, non pyrogenic, isotonic formulation of acetaminophen intended for intravenous infusion. It has a pH of approximately 5.0 and an osmolality of approximately 290 mOsm/kg. Each 100 mL contains 1,000 mg Acetaminophen, USP, 3,800 mg Mannitol, USP, 30 mg Sodium Citrate Dihydrate USP, and Water for Injection, USP qs. Each 50 mL contains 500 mg Acetaminophen, USP, 1,900 mg Mannitol, USP, 15 mg Sodium Citrate Dihydrate USP, and Water for Injection, USP qs. pH is adjusted with glacial acetic acid. Not made with natural rubber latex, PVC or DEHP.</Description>
  </NDC>
  <NDC>
    <NDCCode>0264-4100-95</NDCCode>
    <PackageDescription>6 CARTON in 1 CASE (0264-4100-95)  &gt; 4 CONTAINER in 1 CARTON (0264-4100-90)  &gt; 100 mL in 1 CONTAINER</PackageDescription>
    <NDC11Code>00264-4100-95</NDC11Code>
    <ProductNDC>0264-4100</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Acetaminophen</ProprietaryName>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20210218</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA204957</ApplicationNumber>
    <LabelerName>B. Braun Medical Inc.</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-06-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210218</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0264-5009-90</NDCCode>
    <PackageDescription>24 CONTAINER in 1 CASE (0264-5009-90)  / 100 mL in 1 CONTAINER</PackageDescription>
    <NDC11Code>00264-5009-90</NDC11Code>
    <ProductNDC>0264-5009</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levetiracetam</ProprietaryName>
    <NonProprietaryName>Levetiracetam</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20240513</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209705</ApplicationNumber>
    <LabelerName>B. Braun Medical Inc.</LabelerName>
    <SubstanceName>LEVETIRACETAM</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240513</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Levetiracetam in Sodium Chloride Injection is indicated for adjunct therapy in adults (greater than or equal to 16 years of age) with the following seizure types when oral administration is temporarily not feasible: 1 Partial-onset seizures (1.1) , 2 Myoclonic seizures in patients with juvenile myoclonic epilepsy (1.2), 3 Primary generalized tonic-clonic seizures (1.3).</IndicationAndUsage>
    <Description>Levetiracetam in Sodium Chloride Injection is an antiepileptic drug available as a clear, colorless, sterile solution for intravenous administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam in Sodium Chloride Injection is a clear, colorless, sterile solution that is available in a single-dose dual port container. This container closure is not made with natural rubber latex, PVC or DEHP. 500 mg/100 mL: One 100 mL fill container contains 500 mg of levetiracetam (5 mg/mL), water for injection, 820 mg sodium chloride, 5.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,000 mg/100 mL: One 100 mL fill container contains 1,000 mg of levetiracetam (10 mg/mL), water for injection, 750 mg sodium chloride, 6.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,500 mg/100 mL: One 100 mL fill container contains 1,500 mg of levetiracetam (15 mg/mL), water for injection, 540 mg sodium chloride, 7.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. The container/solution unit is a closed system and is not dependent upon entry of external air during administration. The container has two ports, one is for the intravenous administration set and the other is a medication addition. Each is covered by a tamperproof barrier. Refer to the DIRECTIONS FOR USE of the container to properly identify the ports. No vapor barrier is necessary.</Description>
  </NDC>
  <NDC>
    <NDCCode>0264-7800-90</NDCCode>
    <PackageDescription>10 CONTAINER in 1 CARTON (0264-7800-90)  &gt; 1000 mL in 1 CONTAINER</PackageDescription>
    <NDC11Code>00264-7800-90</NDC11Code>
    <ProductNDC>0264-7800</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Chloride</ProprietaryName>
    <NonProprietaryName>Sodium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19880309</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019635</ApplicationNumber>
    <LabelerName>B. Braun Medical Inc.</LabelerName>
    <SubstanceName>SODIUM CHLORIDE</SubstanceName>
    <StrengthNumber>.9</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>Deprecated</Status>
    <LastUpdate>2023-02-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180709</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>21695-264-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (21695-264-90)</PackageDescription>
    <NDC11Code>21695-0264-90</NDC11Code>
    <ProductNDC>21695-264</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diazepam</ProprietaryName>
    <NonProprietaryName>Diazepam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20091109</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA071321</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp.</LabelerName>
    <SubstanceName>DIAZEPAM</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <Description>Diazepam is a benzodiazepine derivative. Chemically, diazepam is 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. It is a colorless to light yellow crystalline compound, and is insoluble in water. Its structural formula is. C16H13ClN2O M.W. 284.75. Diazepam is available as 2 mg, 5 mg, and 10 mg tablets for oral administration and contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide; colorants: 5 mg only (D&amp;C Yellow No. 10 and FD&amp;C Yellow No. 6); 10 mg only (FD&amp;C Blue No. 1); magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>24658-264-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (24658-264-90) </PackageDescription>
    <NDC11Code>24658-0264-90</NDC11Code>
    <ProductNDC>24658-264</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rosuvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Rosuvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230823</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207752</ApplicationNumber>
    <LabelerName>PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS</LabelerName>
    <SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-01-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230823</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Rosuvastatin tablets are an HMG Co-A reductase inhibitor indicated for: 1 adult patients with primary hyperlipidemia and mixed dyslipidemia as an adjunct to diet to reduce elevated total-C, LDL-C, ApoB, nonHDL-C, and TG levels and to increase HDLC (1.1), 2 pediatric patients 8 to 17 years of age with heterozygous familial hypercholesterotemia (HeFH] to reduce elevated total-C, LDL-C and ApoB after failing an adequate trial of diet therapy (1.2), 3 adult patients with hypertriglyceridemia as an adjunct to diet (1.3), 4 adult patients with primary dysbetalipoproteinemia [Type III hyperlipoproteinemia) as an adjunct to diet (1.4), 5 adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LOL-G, total-G, and ApoB (1.5), 6 slowing the progression of atherosclerosis as part of a treatment strategy lo lower total-C and LDL-C as an adjunct to diet (1.6), 7 risk reduction of MI, stroke, and arterial revascularization procedures in patients without clinically evident CHD, but with multiple risk factors (1.7).</IndicationAndUsage>
    <Description>Rosuvastatin calcium USP is a synthetic lipid-lowering agent for oral administration. The chemical name for rosuvastatin calcium USP is bis[(E)-7-[4(4-fluorophenyl)-6-isopropyl-2[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The empirical formula for rosuvastatin calcium USP is (C22H27FN3O6S)2 Ca and the molecular weight is 1001.14. Rosuvastatin calcium USP is a white to off-white powder that is soluble in dimethyl formamide, dimethyl sulphoxide, acetonitrile and acetone, slightly soluble in water and methanol. Rosuvastatin calcium USP is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin tablets USP for oral administration contain 5, 10, 20, or 40 mg of rosuvastatin and the following inactive ingredients: Each tablet contains: crospovidone, dibasic calcium phosphate dihydrate, iron oxide yellow, iron oxide red, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin.</Description>
  </NDC>
  <NDC>
    <NDCCode>43063-264-90</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE, PLASTIC (43063-264-90) </PackageDescription>
    <NDC11Code>43063-0264-90</NDC11Code>
    <ProductNDC>43063-264</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tamsulosin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Tamsulosin Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100427</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078801</ApplicationNumber>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>TAMSULOSIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>.4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-10-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100428</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tamsulosin hydrochloride capsules USP are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies ( 14)]. Tamsulosin hydrochloride capsules USP are not indicated for the treatment of hypertension.</IndicationAndUsage>
    <Description>Tamsulosin hydrochloride is an antagonist of alpha 1A adrenoceptors in the prostate. Tamsulosin hydrochloride is (-)-( R)-5-[2-[[2-( o-Ethoxyphenoxy) ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride. Tamsulosin hydrochloride is a white crystalline powder that melts with decomposition at approximately 230°C. It is sparingly soluble in water and methanol, slightly soluble in glacial acetic acid and ethanol, and practically insoluble in ether. The empirical formula of tamsulosin hydrochloride is C 20H 28N 2O 5S  HCl. The molecular weight of tamsulosin hydrochloride is 444.98. Its structural formula is:. Each tamsulosin hydrochloride capsule USP for oral administration contains tamsulosin hydrochloride 0.4 mg, and the following inactive ingredients: methacrylic acid copolymer, microcrystalline cellulose, purified water, talc, triethyl citrate, black iron oxide, FD&amp;C Blue No. 2, gelatin, red iron oxide, titanium dioxide, yellow iron oxide and trace amounts of antifoam DC 1510, industrial methylated spirit, lecithin, n-butyl alcohol, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, ammonium, potassium hydroxide and shellac. Complies with USP Dissolution Test 4.</Description>
  </NDC>
  <NDC>
    <NDCCode>46708-264-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-264-90) </PackageDescription>
    <NDC11Code>46708-0264-90</NDC11Code>
    <ProductNDC>46708-264</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ropinirole</ProprietaryName>
    <NonProprietaryName>Ropinirole</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130314</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202786</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
    <SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>6</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-01-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130314</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ropinirole extended-release tablets are non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease (1.1).</IndicationAndUsage>
    <Description>Ropinirole extended-release tablets contains ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to yellow solid with a melting range of 243° to 250°C and a solubility of 133 mg/mL in water. Each capsule shaped, film coated tablet contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg ropinirole hydrochloride equivalent to ropinirole 2 mg, 4 mg, 6 mg, 8 mg, or 12 mg, respectively. Inactive ingredients consist of carboxymethylcellulose sodium, colloidal silicon dioxide, hydrogenated castor oil, hypromellose, magnesium stearate, povidone, pregelatinized starch, ethylcellulose and one or more of the following: FD&amp;C Blue No. 2 aluminum lake, ferric oxides (black, red, yellow), polyethylene glycol 6000, polyethylene glycol 8000, titanium dioxide, talc.</Description>
  </NDC>
  <NDC>
    <NDCCode>50090-0264-5</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-0264-5) </PackageDescription>
    <NDC11Code>50090-0264-05</NDC11Code>
    <ProductNDC>50090-0264</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amitriptyline Hydrochloride</ProprietaryName>
    <NonProprietaryName>Amitriptyline Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19970911</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040218</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>AMITRIPTYLINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-02-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20141128</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>67877-264-90</NDCCode>
    <PackageDescription>90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-264-90) </PackageDescription>
    <NDC11Code>67877-0264-90</NDC11Code>
    <ProductNDC>67877-264</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Duloxetine</ProprietaryName>
    <NonProprietaryName>Duloxetine</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120501</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203197</ApplicationNumber>
    <LabelerName>Ascend Laboratories, LLC</LabelerName>
    <SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Duloxetine is indicated for the treatment of: 1 Major depressive disorder in adults , 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults and pediatric patients 13 years of age and older, 5 Chronic musculoskeletal pain in adults.</IndicationAndUsage>
    <Description>Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration.Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride is a white to off-white crystalline powder, which is slightly soluble in water.Each capsule contains enteric-coated pellets of 20, 30, or 60 mg of duloxetine (equivalent to 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include FD&amp;C Blue No. 2, gelatin, hypromellose, hydroxypropyl cellulose, sodium lauryl sulfate, crosspovidone, sugar spheres, hypromellose phthalates, talc, titanium dioxide, and triethyl citrate. The 20 and 60 mg capsules also contain iron oxide yellow. The printing ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide, black iron oxide (for 20 mg and 30 mg strengths), titanium dioxide and purified water.</Description>
  </NDC>
  <NDC>
    <NDCCode>68462-264-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (68462-264-90) </PackageDescription>
    <NDC11Code>68462-0264-90</NDC11Code>
    <ProductNDC>68462-264</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rosuvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Rosuvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160719</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA079172</ApplicationNumber>
    <LabelerName>Glenmark Pharmaceutials Inc., USA</LabelerName>
    <SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160719</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Rosuvastatin tablets are indicated: : 1 To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults at increased risk for CV events. , 2 As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C): , 3 in adults with hypercholesterolemia., 4 and slow the progression of atherosclerosis in adults. , 5 in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). , 6 in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH)., 7 As an adjunct to diet for the treatment of adults with: , 8 Primary dysbetalipoproteinemia. , 9 Hypertriglyceridemia. .</IndicationAndUsage>
    <Description>Rosuvastatin calcium, USP is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium, USP is bis[(E)-7[4-(4-fluorophenyl)-6-isopropyl-2-(methyl(methylsulfonyl) amino] pyrimidin-5-yl]-(3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula:. The empirical formula for rosuvastatin calcium, USP is (C22H27FN3O6S)2Ca and the molecular weight is 1,001.14. Rosuvastatin calcium, USP is a white to off-white powder that is very slightly soluble in water, insoluble in methanol and ethanol. Rosuvastatin calcium, USP is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin Tablets, USP for oral use contain 5 mg, 10 mg, 20 mg, or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium) and the following inactive ingredients: crospovidone, ferric oxide red, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate, titanium dioxide and triacetin.</Description>
  </NDC>
  <NDC>
    <NDCCode>71205-264-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (71205-264-90) </PackageDescription>
    <NDC11Code>71205-0264-90</NDC11Code>
    <ProductNDC>71205-264</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atorvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20111201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076477</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2020-01-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.</IndicationAndUsage>
    <Description>Atorvastatin calcium is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. Atorvastatin calcium is [R-(R*,R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The molecular formula of atorvastatin calcium is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.41. Its structural formula is. Atorvastatin calcium tablets for oral administration contain 10, 20, 40, or 80 mg atorvastatin and the following inactive ingredients: calcium carbonate, FCC; croscarmellose sodium; hydroxypropyl cellulose; hypromellose; lactose monohydrate; magnesium stearate; microcrystalline cellulose; polyethylene glycol; polysorbate 80; simethicone emulsion; talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>71335-0264-1</NDCCode>
    <PackageDescription>90 TABLET, COATED in 1 BOTTLE (71335-0264-1) </PackageDescription>
    <NDC11Code>71335-0264-01</NDC11Code>
    <ProductNDC>71335-0264</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluvoxamine Maleate</ProprietaryName>
    <NonProprietaryName>Fluvoxamine Maleate</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110809</StartMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA021519</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>FLUVOXAMINE MALEATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-02-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211227</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluvoxamine Maleate Tablets are indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD) (1).</IndicationAndUsage>
    <Description>Fluvoxamine maleate is a selective serotonin (5-HT) reuptake inhibitor (SSRI) belonging to the chemical series, the 2-aminoethyl oxime ethers of aralkylketones. It is chemically designated as 5-methoxy-4′-(trifluoromethyl)valerophenone-(E)-O-(2-aminoethyl)oxime maleate (1:1) and has the empirical formula C15H21O2N2F3∙C4H4O4. Its molecular weight is 434.41. The structural formula is. Fluvoxamine maleate is a white to off white, odorless, crystalline powder which is sparingly soluble in water, freely soluble in ethanol and chloroform and practically insoluble in diethyl ether. Fluvoxamine Maleate Tablets are available in 25 mg, 50 mg and 100 mg strengths for oral administration. In addition to the active ingredient, fluvoxamine maleate, each tablet contains the following inactive ingredients: mannitol, polyethylene glycol, polyvinyl alcohol, pregelatinized starch (potato), silicon dioxide, sodium stearyl fumarate, starch (corn), talc, and titanium dioxide. The 50 mg and 100 mg tablets also contain synthetic iron oxides.</Description>
  </NDC>
  <NDC>
    <NDCCode>72865-264-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (72865-264-90) </PackageDescription>
    <NDC11Code>72865-0264-90</NDC11Code>
    <ProductNDC>72865-264</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Quetiapine Fumarate</ProprietaryName>
    <NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240202</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204316</ApplicationNumber>
    <LabelerName>XLCare Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240722</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Quetiapine tablets are an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia ( 1.1) , 2 Bipolar I disorder manic episodes ( 1.2) , 3 Bipolar disorder, depressive episodes ( 1.2) .</IndicationAndUsage>
    <Description>Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-Dibenzo [ b,f] [1,4]thiazepin-11-yl-1-piperazinyl)-ethoxy] ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is (C 21H 25N 3O 2S) 2. C 4H 4O 4and it has a molecular weight of 883.1 (fumarate salt). The structural formula is:. Quetiapine fumarate USP is a white to off-white crystalline powder which is sparingly soluble in 0.1N hydrochloric acid, slightly soluble in water, in anhydrous ethanol and in methanol.  Quetiapine tablets USP are supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets.  Inactive ingredients are dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate and titanium dioxide. The 25 mg tablets contain red iron oxide and yellow iron oxide and the 100 mg and 400 mg tablets contain only yellow iron oxide.  Each 25 mg tablet contains 28.78 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.24 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.36 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.48 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine.</Description>
  </NDC>
  <NDC>
    <NDCCode>75834-264-90</NDCCode>
    <PackageDescription>90 TABLET, DELAYED RELEASE in 1 BOTTLE (75834-264-90) </PackageDescription>
    <NDC11Code>75834-0264-90</NDC11Code>
    <ProductNDC>75834-264</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diclofenac Sodium Misoprostol</ProprietaryName>
    <NonProprietaryName>Diclofenac Sodium And Misoprostol</NonProprietaryName>
    <DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210715</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205143</ApplicationNumber>
    <LabelerName>Nivagen Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>DICLOFENAC SODIUM; MISOPROSTOL</SubstanceName>
    <StrengthNumber>50; 200</StrengthNumber>
    <StrengthUnit>mg/1; ug/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210715</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>76420-264-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (76420-264-90) </PackageDescription>
    <NDC11Code>76420-0264-90</NDC11Code>
    <ProductNDC>76420-264</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Naproxen</ProprietaryName>
    <NonProprietaryName>Naproxen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200301</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212517</ApplicationNumber>
    <LabelerName>Asclemed USA, Inc.</LabelerName>
    <SubstanceName>NAPROXEN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220817</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Naproxen Tablets are indicated for: the relief of the signs and symptoms of: : 1 rheumatoid arthritis, 2 osteoarthritis, 3 ankylosing spondylitis, 4 polyarticular juvenile idiopathic arthritis, 5 tendonitis, 6 bursitis, 7 acute gout.</IndicationAndUsage>
    <Description>Naproxen tablets, USP are nonsteroidal anti-inflammatory drugs and available as follows: Naproxen tablets, USP are available as light yellow oblong shaped tablets containing 500 mg naproxen for oral administration. Naproxen is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has a molecular weight of 230.26 and a molecular formula of C 14H 14O 3. It has the following structural formula:. Naproxen is white or almost white crystalline powder. It is insoluble in water, soluble in chloroform, dehydrated ethanol and methanol. Sparingly soluble in ether. The octanol/water partition coefficient of Naproxen at pH &lt; 2.18 is 3.18. Each naproxen tablet, USP contains the following inactive ingredients: croscarmellose sodium, yellow iron oxide, povidone and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>0591-4050-94</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (0591-4050-94)  / 112 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>00591-4050-94</NDC11Code>
    <ProductNDC>0591-4050</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sildenafil</ProprietaryName>
    <NonProprietaryName>Sildenafil</NonProprietaryName>
    <DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200817</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211534</ApplicationNumber>
    <LabelerName>Actavis Pharma, Inc.</LabelerName>
    <SubstanceName>SILDENAFIL CITRATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200817</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Adults. Sildenafil for oral suspension is indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening [see Clinical Studies (14)]. Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) for oral suspension. However, due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
    <Description>Sildenafil for oral suspension, phosphodiesterase-5 (PDE-5) inhibitor, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE-5). Sildenafil is also marketed as VIAGRA® (sildenafil tablets USP) for erectile dysfunction. Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo [4,3-d] pyrimidin-5-yl)-4-ethoxyphenyl] sulfonyl]-4-methylpiperazine citrate and has the following structural formula. Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water. Sildenafil for oral suspension is supplied as white to off-white powder containing 1.57 g of sildenafil citrate, USP (equivalent to 1.12 g sildenafil) in an amber glass bottle intended for reconstitution. Following reconstitution with 90 mL water, the total volume of the oral suspension is 112 mL and the oral suspension contains 10 mg/mL sildenafil. The inactive ingredients include anhydrous citric acid, colloidal silicon dioxide, grape flavor, sodium benzoate, sodium citrate dihydrate, sorbitol, sucralose, titanium dioxide, and xanthan gum. In addition to the bottle, a press-in bottle adapter and an oral dosing syringe (with 0.5 mL and 2 mL dose markings) are provided.</Description>
  </NDC>
  <NDC>
    <NDCCode>42858-075-45</NDCCode>
    <PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42858-075-45) </PackageDescription>
    <NDC11Code>42858-0075-45</NDC11Code>
    <ProductNDC>42858-075</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
    <NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200401</StartMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA205831</ApplicationNumber>
    <LabelerName>Rhodes Pharmaceuticals LLC</LabelerName>
    <SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)].</IndicationAndUsage>
    <Description>Methylphenidate hydrochloride extended-release capsules contain methylphenidate hydrochloride, a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release capsules contain multi layered beads, which are composed of an immediate-release layer which contains approximately 40% of the methylphenidate dose, and a controlled release layer which contains approximately 60% of the methylphenidate dose. Methylphenidate hydrochloride extended-release capsules are available in seven capsule strengths. Each extended-release capsule for once-a-day oral administration contains 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 50 mg, or 60 mg of methylphenidate HCl USP, which is equivalent to 8.6 mg, 13.0 mg, 17.3 mg, 25.9 mg, 34.6 mg, 43.2 mg, or 51.9 mg of methylphenidate free base, respectively. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C14H19NO2∙HCl. Its structural formula is. Methylphenidate hydrochloride USP is a white to off-white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Inactive Ingredients: ammonio methacrylate copolymer, type B; colloidal silicon dioxide (added if necessary); gelatin; hypromelloses; methacrylic acid copolymer, type C; polyethylene glycol; sugar spheres; talc; titanium oxide; and triethyl citrate. Each strength capsule also contains colorant ingredients in the capsule shell as follows. 10 mg: FD&amp;C Blue No. 115 mg: D&amp;C Red No. 28, D&amp;C Yellow No. 10, FD&amp;C Red No. 4020 mg: D&amp;C Red No. 33, D&amp;C Yellow No. 1030 mg: FD&amp;C Blue No. 1, FD&amp;C Red No. 340 mg: D&amp;C Red No. 28, FD&amp;C Blue No. 1, FD&amp;C Red No. 4050 mg: D&amp;C Yellow No. 10, FD&amp;C Green No. 360 mg: Black Iron Oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>42858-076-45</NDCCode>
    <PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42858-076-45) </PackageDescription>
    <NDC11Code>42858-0076-45</NDC11Code>
    <ProductNDC>42858-076</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
    <NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200401</StartMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA205831</ApplicationNumber>
    <LabelerName>Rhodes Pharmaceuticals LLC</LabelerName>
    <SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)].</IndicationAndUsage>
    <Description>Methylphenidate hydrochloride extended-release capsules contain methylphenidate hydrochloride, a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release capsules contain multi layered beads, which are composed of an immediate-release layer which contains approximately 40% of the methylphenidate dose, and a controlled release layer which contains approximately 60% of the methylphenidate dose. Methylphenidate hydrochloride extended-release capsules are available in seven capsule strengths. Each extended-release capsule for once-a-day oral administration contains 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 50 mg, or 60 mg of methylphenidate HCl USP, which is equivalent to 8.6 mg, 13.0 mg, 17.3 mg, 25.9 mg, 34.6 mg, 43.2 mg, or 51.9 mg of methylphenidate free base, respectively. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C14H19NO2∙HCl. Its structural formula is. Methylphenidate hydrochloride USP is a white to off-white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Inactive Ingredients: ammonio methacrylate copolymer, type B; colloidal silicon dioxide (added if necessary); gelatin; hypromelloses; methacrylic acid copolymer, type C; polyethylene glycol; sugar spheres; talc; titanium oxide; and triethyl citrate. Each strength capsule also contains colorant ingredients in the capsule shell as follows. 10 mg: FD&amp;C Blue No. 115 mg: D&amp;C Red No. 28, D&amp;C Yellow No. 10, FD&amp;C Red No. 4020 mg: D&amp;C Red No. 33, D&amp;C Yellow No. 1030 mg: FD&amp;C Blue No. 1, FD&amp;C Red No. 340 mg: D&amp;C Red No. 28, FD&amp;C Blue No. 1, FD&amp;C Red No. 4050 mg: D&amp;C Yellow No. 10, FD&amp;C Green No. 360 mg: Black Iron Oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>42858-077-45</NDCCode>
    <PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42858-077-45) </PackageDescription>
    <NDC11Code>42858-0077-45</NDC11Code>
    <ProductNDC>42858-077</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
    <NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200401</StartMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA205831</ApplicationNumber>
    <LabelerName>Rhodes Pharmaceuticals LLC</LabelerName>
    <SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)].</IndicationAndUsage>
    <Description>Methylphenidate hydrochloride extended-release capsules contain methylphenidate hydrochloride, a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release capsules contain multi layered beads, which are composed of an immediate-release layer which contains approximately 40% of the methylphenidate dose, and a controlled release layer which contains approximately 60% of the methylphenidate dose. Methylphenidate hydrochloride extended-release capsules are available in seven capsule strengths. Each extended-release capsule for once-a-day oral administration contains 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 50 mg, or 60 mg of methylphenidate HCl USP, which is equivalent to 8.6 mg, 13.0 mg, 17.3 mg, 25.9 mg, 34.6 mg, 43.2 mg, or 51.9 mg of methylphenidate free base, respectively. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C14H19NO2∙HCl. Its structural formula is. Methylphenidate hydrochloride USP is a white to off-white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Inactive Ingredients: ammonio methacrylate copolymer, type B; colloidal silicon dioxide (added if necessary); gelatin; hypromelloses; methacrylic acid copolymer, type C; polyethylene glycol; sugar spheres; talc; titanium oxide; and triethyl citrate. Each strength capsule also contains colorant ingredients in the capsule shell as follows. 10 mg: FD&amp;C Blue No. 115 mg: D&amp;C Red No. 28, D&amp;C Yellow No. 10, FD&amp;C Red No. 4020 mg: D&amp;C Red No. 33, D&amp;C Yellow No. 1030 mg: FD&amp;C Blue No. 1, FD&amp;C Red No. 340 mg: D&amp;C Red No. 28, FD&amp;C Blue No. 1, FD&amp;C Red No. 4050 mg: D&amp;C Yellow No. 10, FD&amp;C Green No. 360 mg: Black Iron Oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>42858-078-45</NDCCode>
    <PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42858-078-45) </PackageDescription>
    <NDC11Code>42858-0078-45</NDC11Code>
    <ProductNDC>42858-078</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
    <NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200401</StartMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA205831</ApplicationNumber>
    <LabelerName>Rhodes Pharmaceuticals LLC</LabelerName>
    <SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)].</IndicationAndUsage>
    <Description>Methylphenidate hydrochloride extended-release capsules contain methylphenidate hydrochloride, a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release capsules contain multi layered beads, which are composed of an immediate-release layer which contains approximately 40% of the methylphenidate dose, and a controlled release layer which contains approximately 60% of the methylphenidate dose. Methylphenidate hydrochloride extended-release capsules are available in seven capsule strengths. Each extended-release capsule for once-a-day oral administration contains 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 50 mg, or 60 mg of methylphenidate HCl USP, which is equivalent to 8.6 mg, 13.0 mg, 17.3 mg, 25.9 mg, 34.6 mg, 43.2 mg, or 51.9 mg of methylphenidate free base, respectively. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C14H19NO2∙HCl. Its structural formula is. Methylphenidate hydrochloride USP is a white to off-white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Inactive Ingredients: ammonio methacrylate copolymer, type B; colloidal silicon dioxide (added if necessary); gelatin; hypromelloses; methacrylic acid copolymer, type C; polyethylene glycol; sugar spheres; talc; titanium oxide; and triethyl citrate. Each strength capsule also contains colorant ingredients in the capsule shell as follows. 10 mg: FD&amp;C Blue No. 115 mg: D&amp;C Red No. 28, D&amp;C Yellow No. 10, FD&amp;C Red No. 4020 mg: D&amp;C Red No. 33, D&amp;C Yellow No. 1030 mg: FD&amp;C Blue No. 1, FD&amp;C Red No. 340 mg: D&amp;C Red No. 28, FD&amp;C Blue No. 1, FD&amp;C Red No. 4050 mg: D&amp;C Yellow No. 10, FD&amp;C Green No. 360 mg: Black Iron Oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>42858-079-45</NDCCode>
    <PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42858-079-45) </PackageDescription>
    <NDC11Code>42858-0079-45</NDC11Code>
    <ProductNDC>42858-079</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
    <NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200401</StartMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA205831</ApplicationNumber>
    <LabelerName>Rhodes Pharmaceuticals LLC</LabelerName>
    <SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)].</IndicationAndUsage>
    <Description>Methylphenidate hydrochloride extended-release capsules contain methylphenidate hydrochloride, a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release capsules contain multi layered beads, which are composed of an immediate-release layer which contains approximately 40% of the methylphenidate dose, and a controlled release layer which contains approximately 60% of the methylphenidate dose. Methylphenidate hydrochloride extended-release capsules are available in seven capsule strengths. Each extended-release capsule for once-a-day oral administration contains 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 50 mg, or 60 mg of methylphenidate HCl USP, which is equivalent to 8.6 mg, 13.0 mg, 17.3 mg, 25.9 mg, 34.6 mg, 43.2 mg, or 51.9 mg of methylphenidate free base, respectively. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C14H19NO2∙HCl. Its structural formula is. Methylphenidate hydrochloride USP is a white to off-white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Inactive Ingredients: ammonio methacrylate copolymer, type B; colloidal silicon dioxide (added if necessary); gelatin; hypromelloses; methacrylic acid copolymer, type C; polyethylene glycol; sugar spheres; talc; titanium oxide; and triethyl citrate. Each strength capsule also contains colorant ingredients in the capsule shell as follows. 10 mg: FD&amp;C Blue No. 115 mg: D&amp;C Red No. 28, D&amp;C Yellow No. 10, FD&amp;C Red No. 4020 mg: D&amp;C Red No. 33, D&amp;C Yellow No. 1030 mg: FD&amp;C Blue No. 1, FD&amp;C Red No. 340 mg: D&amp;C Red No. 28, FD&amp;C Blue No. 1, FD&amp;C Red No. 4050 mg: D&amp;C Yellow No. 10, FD&amp;C Green No. 360 mg: Black Iron Oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>42858-080-45</NDCCode>
    <PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42858-080-45) </PackageDescription>
    <NDC11Code>42858-0080-45</NDC11Code>
    <ProductNDC>42858-080</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
    <NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200401</StartMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA205831</ApplicationNumber>
    <LabelerName>Rhodes Pharmaceuticals LLC</LabelerName>
    <SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)].</IndicationAndUsage>
    <Description>Methylphenidate hydrochloride extended-release capsules contain methylphenidate hydrochloride, a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release capsules contain multi layered beads, which are composed of an immediate-release layer which contains approximately 40% of the methylphenidate dose, and a controlled release layer which contains approximately 60% of the methylphenidate dose. Methylphenidate hydrochloride extended-release capsules are available in seven capsule strengths. Each extended-release capsule for once-a-day oral administration contains 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 50 mg, or 60 mg of methylphenidate HCl USP, which is equivalent to 8.6 mg, 13.0 mg, 17.3 mg, 25.9 mg, 34.6 mg, 43.2 mg, or 51.9 mg of methylphenidate free base, respectively. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C14H19NO2∙HCl. Its structural formula is. Methylphenidate hydrochloride USP is a white to off-white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Inactive Ingredients: ammonio methacrylate copolymer, type B; colloidal silicon dioxide (added if necessary); gelatin; hypromelloses; methacrylic acid copolymer, type C; polyethylene glycol; sugar spheres; talc; titanium oxide; and triethyl citrate. Each strength capsule also contains colorant ingredients in the capsule shell as follows. 10 mg: FD&amp;C Blue No. 115 mg: D&amp;C Red No. 28, D&amp;C Yellow No. 10, FD&amp;C Red No. 4020 mg: D&amp;C Red No. 33, D&amp;C Yellow No. 1030 mg: FD&amp;C Blue No. 1, FD&amp;C Red No. 340 mg: D&amp;C Red No. 28, FD&amp;C Blue No. 1, FD&amp;C Red No. 4050 mg: D&amp;C Yellow No. 10, FD&amp;C Green No. 360 mg: Black Iron Oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>42858-081-45</NDCCode>
    <PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42858-081-45) </PackageDescription>
    <NDC11Code>42858-0081-45</NDC11Code>
    <ProductNDC>42858-081</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
    <NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200401</StartMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA205831</ApplicationNumber>
    <LabelerName>Rhodes Pharmaceuticals LLC</LabelerName>
    <SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)].</IndicationAndUsage>
    <Description>Methylphenidate hydrochloride extended-release capsules contain methylphenidate hydrochloride, a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release capsules contain multi layered beads, which are composed of an immediate-release layer which contains approximately 40% of the methylphenidate dose, and a controlled release layer which contains approximately 60% of the methylphenidate dose. Methylphenidate hydrochloride extended-release capsules are available in seven capsule strengths. Each extended-release capsule for once-a-day oral administration contains 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 50 mg, or 60 mg of methylphenidate HCl USP, which is equivalent to 8.6 mg, 13.0 mg, 17.3 mg, 25.9 mg, 34.6 mg, 43.2 mg, or 51.9 mg of methylphenidate free base, respectively. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C14H19NO2∙HCl. Its structural formula is. Methylphenidate hydrochloride USP is a white to off-white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Inactive Ingredients: ammonio methacrylate copolymer, type B; colloidal silicon dioxide (added if necessary); gelatin; hypromelloses; methacrylic acid copolymer, type C; polyethylene glycol; sugar spheres; talc; titanium oxide; and triethyl citrate. Each strength capsule also contains colorant ingredients in the capsule shell as follows. 10 mg: FD&amp;C Blue No. 115 mg: D&amp;C Red No. 28, D&amp;C Yellow No. 10, FD&amp;C Red No. 4020 mg: D&amp;C Red No. 33, D&amp;C Yellow No. 1030 mg: FD&amp;C Blue No. 1, FD&amp;C Red No. 340 mg: D&amp;C Red No. 28, FD&amp;C Blue No. 1, FD&amp;C Red No. 4050 mg: D&amp;C Yellow No. 10, FD&amp;C Green No. 360 mg: Black Iron Oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0264-3193-11</NDCCode>
    <PackageDescription>24 CONTAINER in 1 CASE (0264-3193-11)  / 50 mL in 1 CONTAINER</PackageDescription>
    <NDC11Code>00264-3193-11</NDC11Code>
    <ProductNDC>0264-3193</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cefepime Hydrochloride And Dextrose</ProprietaryName>
    <NonProprietaryName>Cefepime Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20100506</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA050821</ApplicationNumber>
    <LabelerName>B. Braun Medical Inc.</LabelerName>
    <SubstanceName>CEFEPIME HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/50mL</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100506</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cefepime for Injection and Dextrose Injection is a cephalosporin antibacterial indicated in the treatment of the following infections caused by susceptible strains of the designated microorganisms: : 1 Pneumonia (1.1) , 2 Empiric therapy for febrile neutropenic patients (1.2) , 3 Uncomplicated and complicated urinary tract infections (1.3) , 4 Uncomplicated skin and skin structure infections (1.4), 5 Complicated intra-abdominal infections (used in combination with metronidazole) (1.5).</IndicationAndUsage>
    <Description>Cefepime hydrochloride, USP is a semi-synthetic, broad spectrum, cephalosporin antibacterial for parenteral administration. The chemical name is 1-[[(6R,7R)-7-[2-(2-amino-4-thiazolyl)-glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-1-methylpyrrolidinium chloride, 72-(Z)-(O-methyloxime), monohydrochloride, monohydrate, which corresponds to the following structural formula. Cefepime hydrochloride (monohydrate) has a molecular mass of 571.50 and a molecular formula of C19H25ClN6O5S2HClH2O. Cefepime hydrochloride is a white to pale yellow powder. Cefepime hydrochloride contains the equivalent of not less than 825 mcg and not more than 911 mcg of cefepime (C19H24N6O5S2) per mg, calculated on an anhydrous basis. It is highly soluble in water. Cefepime for Injection USP and Dextrose Injection USP in the DUPLEX® dual chamber container is supplied for intravenous administration in strengths equivalent to 1 g and 2 g of cefepime. Cefepime for Injection USP and Dextrose Injection USP is supplied as a sterile, nonpyrogenic, single-dose packaged combination of cefepime hydrochloride with L-arginine (drug chamber) and 50 mL of 5% dextrose injection (diluent) in the DUPLEX® sterile container. The powder chamber of the DUPLEX® container contains a sterile, dry mixture of cefepime hydrochloride and L-arginine. It contains the equivalent of not less than 90.0 percent and not more than 115.0 percent of the labeled amount of cefepime (C19H24N6O5S2). The L-arginine, at an approximate concentration of 725 mg/g of cefepime, is added to control the pH of the reconstituted solution at 4.0 - 6.0. The diluent chamber contains Dextrose Injection USP, an iso-osmotic diluent using Hydrous Dextrose USP in Water for Injection USP. Dextrose Injection USP is sterile, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents. Its empirical formula is C6H12O6H2O and its molecular weight is 198.17. Hydrous Dextrose USP has the following structural (molecular) formula. The DUPLEX® container is a flexible dual chamber container. After removing the peelable foil strip, activating the seals, and thoroughly mixing, the reconstituted drug product is hyperosmotic and is intended for single intravenous use. Each 50 mL contains cefepime hydrochloride equivalent to either 1 gram or 2 grams of cefepime. Reconstituted solutions of Cefepime for Injection USP and Dextrose Injection USP range in color from colorless to amber. The DUPLEX® dual chamber container is made from a specially formulated material. The product (diluent and drug) contact layer is a mixture of thermoplastic rubber and a polypropylene ethylene copolymer that contains no plasticizers. The safety of the container is supported by USP biological evaluation procedures.</Description>
  </NDC>
</NDCList>