RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>66312-540-16</NDCCode>
    <PackageDescription>50 CARTRIDGE in 1 CARTON (66312-540-16)  &gt; 1.7 mL in 1 CARTRIDGE</PackageDescription>
    <NDC11Code>66312-0540-16</NDC11Code>
    <ProductNDC>66312-540</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Citanest Forte</ProprietaryName>
    <NonProprietaryName>Prilocaine Hydrochloride And Epinephrine Bitartrate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBMUCOSAL</RouteName>
    <StartMarketingDate>19651118</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021383</ApplicationNumber>
    <LabelerName>Dentsply Pharmaceutical Inc.</LabelerName>
    <SubstanceName>PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE</SubstanceName>
    <StrengthNumber>40; .005</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>4% Citanest Plain Dental (prilocaine HCl) and 4% Citanest Forte Dental Injections are indicated for the production of local anesthesia in dentistry by nerve block or infiltration techniques. Only accepted procedures for these techniques as described in standard textbooks are recommended.</IndicationAndUsage>
    <Description>Citanest Dental (prilocaine HCl) Injection is a sterile, non pyrogenic isotonic solution that contains a local anesthetic agent with or without epinephrine (as bitartrate) and is administered parenterally by injection. See INDICATIONS AND USAGE for specific uses. The quantitative composition of each available injection is shown in Table 1. Citanest Dental injections contain prilocaine HCl, which is chemically designated as propanamide, N-(2-methyl-phenyl) -2- (propylamino)-, monohydrochloride and has the following structural formula. C 13H 20N 2o ∙ HCl molecular wt = 256.77. Epinephrine is (-) -3, 4-Dihydroxy-a-[(methylamino) methyl] benzyl alcohol and has the following structural formula. C 9H 13NO 3 molecular wt = 183.21. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. The specific quantitative composition of each available injection is shown in Table 1. Note: Sodium hydroxide and/or hydrochloric acid may be used to adjust the pH of Citanest Dental Injections. Filled under nitrogen.</Description>
  </NDC>
  <NDC>
    <NDCCode>66312-540-14</NDCCode>
    <PackageDescription>100 CARTRIDGE in 1 CARTON (66312-540-14)  &gt; 1.7 mL in 1 CARTRIDGE</PackageDescription>
    <NDC11Code>66312-0540-14</NDC11Code>
    <ProductNDC>66312-540</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Citanest Forte</ProprietaryName>
    <NonProprietaryName>Prilocaine Hydrochloride And Epinephrine Bitartrate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBMUCOSAL</RouteName>
    <StartMarketingDate>19651118</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021383</ApplicationNumber>
    <LabelerName>Dentsply Pharmaceutical Inc.</LabelerName>
    <SubstanceName>PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE</SubstanceName>
    <StrengthNumber>40; .005</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>4% Citanest Plain Dental (prilocaine HCl) and 4% Citanest Forte Dental Injections are indicated for the production of local anesthesia in dentistry by nerve block or infiltration techniques. Only accepted procedures for these techniques as described in standard textbooks are recommended.</IndicationAndUsage>
    <Description>Citanest Dental (prilocaine HCl) Injection is a sterile, non pyrogenic isotonic solution that contains a local anesthetic agent with or without epinephrine (as bitartrate) and is administered parenterally by injection. See INDICATIONS AND USAGE for specific uses. The quantitative composition of each available injection is shown in Table 1. Citanest Dental injections contain prilocaine HCl, which is chemically designated as propanamide, N-(2-methyl-phenyl) -2- (propylamino)-, monohydrochloride and has the following structural formula. C 13H 20N 2o ∙ HCl molecular wt = 256.77. Epinephrine is (-) -3, 4-Dihydroxy-a-[(methylamino) methyl] benzyl alcohol and has the following structural formula. C 9H 13NO 3 molecular wt = 183.21. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. The specific quantitative composition of each available injection is shown in Table 1. Note: Sodium hydroxide and/or hydrochloric acid may be used to adjust the pH of Citanest Dental Injections. Filled under nitrogen.</Description>
  </NDC>
  <NDC>
    <NDCCode>43333-540-16</NDCCode>
    <PackageDescription>473 mL in 1 BOTTLE, PUMP (43333-540-16) </PackageDescription>
    <NDC11Code>43333-0540-16</NDC11Code>
    <ProductNDC>43333-540</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200930</StartMarketingDate>
    <EndMarketingDate>20220930</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Tonic Bath &amp; Body Products Shenzhen Ltd</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>65</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-10-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20200930</StartMarketingDatePackage>
    <EndMarketingDatePackage>20220930</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>50991-540-16</NDCCode>
    <PackageDescription>473 mL in 1 BOTTLE (50991-540-16) </PackageDescription>
    <NDC11Code>50991-0540-16</NDC11Code>
    <ProductNDC>50991-540</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Duratuss Ac</ProprietaryName>
    <NonProprietaryName>Codeine Phosphate, Dexbrompheniramine Maleate</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250908</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>Poly Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>CODEINE PHOSPHATE; DEXBROMPHENIRAMINE MALEATE</SubstanceName>
    <StrengthNumber>10; 1</StrengthNumber>
    <StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-11-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250908</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses. temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itching of nose or throat, 4 itchy, watery eyes, 5 cough due to minor throat and bronchial irritation, 6 nasal congestion, 7 reduces swelling of nasal passages.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>67133-001-16</NDCCode>
    <PackageDescription>540 L in 1 DEWAR (67133-001-16) </PackageDescription>
    <NDC11Code>67133-0001-16</NDC11Code>
    <ProductNDC>67133-001</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxygen</ProprietaryName>
    <NonProprietaryName>Oxygen</NonProprietaryName>
    <DosageFormName>GAS</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20030501</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
    <LabelerName>Fairmeadows Home Health Center</LabelerName>
    <SubstanceName>OXYGEN</SubstanceName>
    <StrengthNumber>99</StrengthNumber>
    <StrengthUnit>L/100L</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110505</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>66312-176-16</NDCCode>
    <PackageDescription>50 CARTRIDGE in 1 CARTON (66312-176-16)  / 1.7 mL in 1 CARTRIDGE</PackageDescription>
    <NDC11Code>66312-0176-16</NDC11Code>
    <ProductNDC>66312-176</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Xylocaine</ProprietaryName>
    <NonProprietaryName>Lidocaine Hydrochloride And Epinephrine Bitartrate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBMUCOSAL</RouteName>
    <StartMarketingDate>19850122</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA088390</ApplicationNumber>
    <LabelerName>Dentsply Pharmaceutical</LabelerName>
    <SubstanceName>LIDOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE</SubstanceName>
    <StrengthNumber>20; 10</StrengthNumber>
    <StrengthUnit>mg/mL; ug/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090414</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>2% Xylocaine DENTAL Solutions are indicated for the production of local anesthesia for dental procedures by nerve block or infiltration techniques. Only accepted procedures for these techniques as described in standard textbooks are recommended.</IndicationAndUsage>
    <Description>2% Xylocaine DENTAL with Epinephrine 1:50,000 and 2% Xylocaine DENTAL with Epinephrine 1:100,000 are sterile isotonic solutions containing a local anesthetic agent, Lidocaine Hydrochloride, and a vasoconstrictor, Epinephrine (as bitartrate) and are administered parenterally by injection. Both solutions are available in single dose cartridges of 1.7 mL (See INDICATIONS AND USAGE for specific uses). 2% Xylocaine DENTAL solutions contain lidocaine hydrochloride which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-monohydrochloride, and has the following structural formula. C14H22N2O      HCI         H2O           M.W. 288.8. Epinephrine is (-)-3,4-Dihydroxy-α-[(Methylamino) methyl] benzyl alcohol and has the following structural formula. C9H13NO3           M.W. 183.21.  The pH of the 2% Xylocaine DENTAL solutions are adjusted to USP limits with sodium hydroxide. The pH of the 2% Xylocaine DENTAL solutions are adjusted to USP limits with Sodium Hydroxide or Hydrochloric Acid q.s.to adjust pH.</Description>
  </NDC>
  <NDC>
    <NDCCode>66312-181-16</NDCCode>
    <PackageDescription>50 CARTRIDGE in 1 CARTON (66312-181-16)  / 1.7 mL in 1 CARTRIDGE</PackageDescription>
    <NDC11Code>66312-0181-16</NDC11Code>
    <ProductNDC>66312-181</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Xylocaine</ProprietaryName>
    <NonProprietaryName>Lidocaine Hydrochloride And Epinephrine Bitartrate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBMUCOSAL</RouteName>
    <StartMarketingDate>19850122</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA088389</ApplicationNumber>
    <LabelerName>Dentsply Pharmaceutical</LabelerName>
    <SubstanceName>LIDOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE</SubstanceName>
    <StrengthNumber>20; 20</StrengthNumber>
    <StrengthUnit>mg/mL; ug/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090414</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>2% Xylocaine DENTAL Solutions are indicated for the production of local anesthesia for dental procedures by nerve block or infiltration techniques. Only accepted procedures for these techniques as described in standard textbooks are recommended.</IndicationAndUsage>
    <Description>2% Xylocaine DENTAL with Epinephrine 1:50,000 and 2% Xylocaine DENTAL with Epinephrine 1:100,000 are sterile isotonic solutions containing a local anesthetic agent, Lidocaine Hydrochloride, and a vasoconstrictor, Epinephrine (as bitartrate) and are administered parenterally by injection. Both solutions are available in single dose cartridges of 1.7 mL (See INDICATIONS AND USAGE for specific uses). 2% Xylocaine DENTAL solutions contain lidocaine hydrochloride which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-monohydrochloride, and has the following structural formula. C14H22N2O      HCI         H2O           M.W. 288.8. Epinephrine is (-)-3,4-Dihydroxy-α-[(Methylamino) methyl] benzyl alcohol and has the following structural formula. C9H13NO3           M.W. 183.21.  The pH of the 2% Xylocaine DENTAL solutions are adjusted to USP limits with sodium hydroxide. The pH of the 2% Xylocaine DENTAL solutions are adjusted to USP limits with Sodium Hydroxide or Hydrochloric Acid q.s.to adjust pH.</Description>
  </NDC>
  <NDC>
    <NDCCode>66312-441-16</NDCCode>
    <PackageDescription>50 CARTRIDGE in 1 CARTON (66312-441-16)  / 1.7 mL in 1 CARTRIDGE</PackageDescription>
    <NDC11Code>66312-0441-16</NDC11Code>
    <ProductNDC>66312-441</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Polocaine</ProprietaryName>
    <NonProprietaryName>Mepivacaine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBMUCOSAL</RouteName>
    <StartMarketingDate>19841010</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA088387</ApplicationNumber>
    <LabelerName>Dentsply Pharmaceutical</LabelerName>
    <SubstanceName>MEPIVACAINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-02-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19841010</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Mepivacaine is indicated for production of local anesthesia for dental procedures by infiltration or nerve block in adults and pediatric patients.</IndicationAndUsage>
    <Description>Mepivacaine Hydrochloride, a tertiary amine used as a local anesthetic, is 1-methyl-2,' 6' - pipecoloxylidide monohydrochloride with the following structural formula. It is a white, crystalline, odorless powder soluble in water, but very resistant to both acid and alkaline hydrolysis. Levonordefrin, a sympathomimetic amine used as a vasoconstrictor in local anesthetic solution, is (-)-α-(1-Aminoethyl)-3, 4-dihydroxybenzyl alcohol with the following structural formula. It is a white or buff-colored crystalline solid, freely soluble in aqueous solutions of mineral acids, but practically insoluble in water. DENTAL CARTRIDGES MAY NOT BE AUTOCLAVED. 3% (30 mg/mL) Polocaine® DENTAL (mepivacaine hydrochloride injection 3% (30 mg/mL)) and 2% (20 mg/mL) Polocaine® DENTAL with Levonordefrin 1:20,000 (mepivacaine hydrochloride 2% (20 mg/mL) with levonordefrin 1:20,000 injection) are sterile solutions for injection.</Description>
  </NDC>
  <NDC>
    <NDCCode>66312-461-16</NDCCode>
    <PackageDescription>50 CARTRIDGE in 1 CARTON (66312-461-16)  &gt; 1.7 mL in 1 CARTRIDGE</PackageDescription>
    <NDC11Code>66312-0461-16</NDC11Code>
    <ProductNDC>66312-461</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Polocaine</ProprietaryName>
    <NonProprietaryName>Mepivacaine Hydrochloride And Levonordefrin</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19841010</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA088388</ApplicationNumber>
    <LabelerName>Dentsply Pharmaceutical</LabelerName>
    <SubstanceName>LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>.05; 20</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2014-05-28</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>66312-580-16</NDCCode>
    <PackageDescription>50 CARTRIDGE in 1 CARTON (66312-580-16)  / 1.8 mL in 1 CARTRIDGE</PackageDescription>
    <NDC11Code>66312-0580-16</NDC11Code>
    <ProductNDC>66312-580</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Citanest Forte Dental</ProprietaryName>
    <NonProprietaryName>Prilocaine Hcl And Epinephrine</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBMUCOSAL</RouteName>
    <StartMarketingDate>20171204</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078959</ApplicationNumber>
    <LabelerName>Dentsply Pharmaceutical Inc.</LabelerName>
    <SubstanceName>PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE</SubstanceName>
    <StrengthNumber>40; .005</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-03-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171204</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Citanest Forte is indicated for the production of local anesthesia in dentistry by nerve block or infiltration techniques. Only accepted procedures for these techniques as described in standard textbooks are recommended.</IndicationAndUsage>
    <Description>4% Citanest® Forte DENTAL with Epinephrine 1:200,000 (Citanest Forte), Prilocaine HCl 4% (72 mg/1.8 mL) (40 mg/mL) with Epinephrine 1:200,000 Injection, is a sterile, non-pyrogenic isotonic solution that contains a local anesthetic agent with epinephrine (as bitartrate) and is administered parenterally by injection. See INDICATIONS AND USAGE for specific uses. The quantitative composition is shown in Table 1. Citanest Forte contains prilocaine HCl, which is chemically designated as propanamide, N-(2-methyl-phenyl) -2- (propylamino)-, monohydrochloride and has the following structural formula. and epinephrine, which is (-) -3, 4-Dihydroxy- ∝ -[(methylamino) methyl] benzyl alcohol and has the following structural formula. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. The specific quantitative composition is shown in Table 1.</Description>
  </NDC>
  <NDC>
    <NDCCode>66312-601-16</NDCCode>
    <PackageDescription>50 CARTRIDGE in 1 CARTON (66312-601-16)  / 1.7 mL in 1 CARTRIDGE</PackageDescription>
    <NDC11Code>66312-0601-16</NDC11Code>
    <ProductNDC>66312-601</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Articadent</ProprietaryName>
    <NonProprietaryName>Articaine Hydrochloride And Epinephrine Bitartrate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBMUCOSAL</RouteName>
    <StartMarketingDate>20090901</StartMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA020971</ApplicationNumber>
    <LabelerName>Dentsply Pharmaceutical</LabelerName>
    <SubstanceName>ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE</SubstanceName>
    <StrengthNumber>40; .01</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-03-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ARTICADENT is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older.</IndicationAndUsage>
    <Description>ARTICADENT (articaine hydrochloride and epinephrine injection), for intraoral submucosal infiltration use, is a sterile, aqueous solution that contains articaine HCl 4% (40 mg/mL) and epinephrine bitartrate in an epinephrine 1:200,000 or epinephrine 1:100,000 strength. Articaine HCl is an amino amide local anesthetic, chemically designated as 4-methyl-3-[2-(propylamino)-propionamido]-2-thiophene-carboxylic acid, methyl ester hydrochloride and is a racemic mixture. Articaine HCl has a molecular weight of 320.84 and the following structural formula. Articaine HCl has a partition coefficient in n-octanol/Soerensen buffer (pH 7.35) of 17 and a pKa of 7.8. Epinephrine bitartrate, (-)-1-(3,4-Dihydroxyphenyl)-2-methylamino-ethanol (+) tartrate (1:1) salt, is a vasoconstrictor with a concentration of 1:200,000 or 1:100,000 (expressed as free base). It has a molecular weight of 333.3 and the following structural formula. ARTICADENT contains the following inactive ingredients: sodium chloride (1.6 mg/mL), and sodium metabisulfite (0.5 mg/mL). The product is formulated with a 15% overage of epinephrine. The pH is adjusted with sodium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>66312-602-16</NDCCode>
    <PackageDescription>50 CARTRIDGE in 1 CARTON (66312-602-16)  / 1.7 mL in 1 CARTRIDGE</PackageDescription>
    <NDC11Code>66312-0602-16</NDC11Code>
    <ProductNDC>66312-602</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Articadent</ProprietaryName>
    <NonProprietaryName>Articaine Hydrochloride And Epinephrine Bitartrate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBMUCOSAL</RouteName>
    <StartMarketingDate>20090901</StartMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA020971</ApplicationNumber>
    <LabelerName>Dentsply Pharmaceutical</LabelerName>
    <SubstanceName>ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE</SubstanceName>
    <StrengthNumber>40; .005</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-03-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ARTICADENT is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older.</IndicationAndUsage>
    <Description>ARTICADENT (articaine hydrochloride and epinephrine injection), for intraoral submucosal infiltration use, is a sterile, aqueous solution that contains articaine HCl 4% (40 mg/mL) and epinephrine bitartrate in an epinephrine 1:200,000 or epinephrine 1:100,000 strength. Articaine HCl is an amino amide local anesthetic, chemically designated as 4-methyl-3-[2-(propylamino)-propionamido]-2-thiophene-carboxylic acid, methyl ester hydrochloride and is a racemic mixture. Articaine HCl has a molecular weight of 320.84 and the following structural formula. Articaine HCl has a partition coefficient in n-octanol/Soerensen buffer (pH 7.35) of 17 and a pKa of 7.8. Epinephrine bitartrate, (-)-1-(3,4-Dihydroxyphenyl)-2-methylamino-ethanol (+) tartrate (1:1) salt, is a vasoconstrictor with a concentration of 1:200,000 or 1:100,000 (expressed as free base). It has a molecular weight of 333.3 and the following structural formula. ARTICADENT contains the following inactive ingredients: sodium chloride (1.6 mg/mL), and sodium metabisulfite (0.5 mg/mL). The product is formulated with a 15% overage of epinephrine. The pH is adjusted with sodium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>66312-630-14</NDCCode>
    <PackageDescription>50 CARTRIDGE in 1 CARTON (66312-630-14)  &gt; 1.8 mL in 1 CARTRIDGE</PackageDescription>
    <NDC11Code>66312-0630-14</NDC11Code>
    <ProductNDC>66312-630</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Citanest Plain</ProprietaryName>
    <NonProprietaryName>Prilocaine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBMUCOSAL</RouteName>
    <StartMarketingDate>19651118</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA079235</ApplicationNumber>
    <LabelerName>Dentsply Pharmaceutical Inc.</LabelerName>
    <SubstanceName>PRILOCAINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2021-11-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19651118</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>4% Citanest Plain Dental Injection, Prilocaine Hydrochloride Injection, USP, 4% (72 mg/1.8 mL) (40 mg/mL), is indicated for the production of local anesthesia in dentistry by nerve block or infiltration techniques. Only accepted procedures for these techniques as described in standard textbooks are recommended.</IndicationAndUsage>
    <Description>4% Citanest Plain Dental, Prilocaine Hydrochloride Injection, USP, 4% (72 mg/1.8 mL) (40 mg/mL), (prilocaine HCl Injection, USP), is a sterile, non pyrogenic isotonic solution that contains a local anesthetic agent and is administered parenterally by injection. See INDICATIONS AND USAGE for specific uses. The quantitative composition is shown in Table 1. 4% Citanest Plain Dental, Prilocaine Hydrochloride Injection, USP, 4% (72 mg/1.8 mL) (40 mg/mL), contains prilocaine HCl, which is chemically designated as propanamide, N-(2-methyl-phenyl) -2- (propylamino)-, monohydrochloride and has the following structural formula. C13H20N2O ∙ HCl molecular wt = 256.77. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. The specific quantitative composition is shown in Table 1.</Description>
  </NDC>
  <NDC>
    <NDCCode>0143-9281-10</NDCCode>
    <PackageDescription>10 BAG in 1 BOX (0143-9281-10)  / 100 mL in 1 BAG (0143-9281-01) </PackageDescription>
    <NDC11Code>00143-9281-10</NDC11Code>
    <ProductNDC>0143-9281</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levetiracetam In Sodium Chloride</ProprietaryName>
    <NonProprietaryName>Levetiracetam In Sodium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20250208</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211356</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals USA 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>2025-03-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250208</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <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 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 bag with an aluminum over wrap. The container closure is not made with natural rubber latex. 500 mg/100 mL: One 100 mL bag 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 bag 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 bag 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.</Description>
  </NDC>
  <NDC>
    <NDCCode>0143-9282-10</NDCCode>
    <PackageDescription>10 BAG in 1 BOX (0143-9282-10)  / 100 mL in 1 BAG (0143-9282-01) </PackageDescription>
    <NDC11Code>00143-9282-10</NDC11Code>
    <ProductNDC>0143-9282</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levetiracetam In Sodium Chloride</ProprietaryName>
    <NonProprietaryName>Levetiracetam In Sodium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20250208</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211356</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals USA 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>2025-03-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250208</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <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 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 bag with an aluminum over wrap. The container closure is not made with natural rubber latex. 500 mg/100 mL: One 100 mL bag 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 bag 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 bag 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.</Description>
  </NDC>
  <NDC>
    <NDCCode>0143-9283-10</NDCCode>
    <PackageDescription>10 BAG in 1 BOX (0143-9283-10)  / 100 mL in 1 BAG (0143-9283-01) </PackageDescription>
    <NDC11Code>00143-9283-10</NDC11Code>
    <ProductNDC>0143-9283</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levetiracetam In Sodium Chloride</ProprietaryName>
    <NonProprietaryName>Levetiracetam In Sodium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20250208</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211356</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals USA 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>2025-03-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250208</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <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 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 bag with an aluminum over wrap. The container closure is not made with natural rubber latex. 500 mg/100 mL: One 100 mL bag 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 bag 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 bag 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.</Description>
  </NDC>
  <NDC>
    <NDCCode>0245-0070-11</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (0245-0070-11) </PackageDescription>
    <NDC11Code>00245-0070-11</NDC11Code>
    <ProductNDC>0245-0070</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Potassium Citrate</ProprietaryName>
    <NonProprietaryName>Potassium Citrate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20060901</StartMarketingDate>
    <EndMarketingDate>20270731</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019071</ApplicationNumber>
    <LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
    <SubstanceName>POTASSIUM CITRATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>meq/1</StrengthUnit>
    <Pharm_Classes>Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20060901</StartMarketingDatePackage>
    <EndMarketingDatePackage>20270731</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Potassium citrate is a citrate salt of potassium indicated for the management of: 1 Renal tubular acidosis (RTA) with calcium stones ( 1.1) , 2 Hypocitraturic calcium oxalate nephrolithiasis of any etiology ( 1.2) , 3 Uric acid lithiasis with or without calcium stones ( 1.3) .</IndicationAndUsage>
    <Description>Potassium citrate is a citrate salt of potassium. Its empirical formula is K 3C 6H 5O 7∙ H 2O, and it has the following chemical structure:. Potassium citrate extended-release tablets are yellowish to tan, oral wax-matrix tablets, containing either 5 mEq (540 mg) potassium citrate or 10 mEq (1080 mg) potassium citrate each. Inactive ingredients include carnauba wax and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>0245-0071-11</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (0245-0071-11) </PackageDescription>
    <NDC11Code>00245-0071-11</NDC11Code>
    <ProductNDC>0245-0071</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Potassium Citrate</ProprietaryName>
    <NonProprietaryName>Potassium Citrate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20060901</StartMarketingDate>
    <EndMarketingDate>20270731</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019071</ApplicationNumber>
    <LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
    <SubstanceName>POTASSIUM CITRATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>meq/1</StrengthUnit>
    <Pharm_Classes>Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20060901</StartMarketingDatePackage>
    <EndMarketingDatePackage>20270731</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Potassium citrate is a citrate salt of potassium indicated for the management of: 1 Renal tubular acidosis (RTA) with calcium stones ( 1.1) , 2 Hypocitraturic calcium oxalate nephrolithiasis of any etiology ( 1.2) , 3 Uric acid lithiasis with or without calcium stones ( 1.3) .</IndicationAndUsage>
    <Description>Potassium citrate is a citrate salt of potassium. Its empirical formula is K 3C 6H 5O 7∙ H 2O, and it has the following chemical structure:. Potassium citrate extended-release tablets are yellowish to tan, oral wax-matrix tablets, containing either 5 mEq (540 mg) potassium citrate or 10 mEq (1080 mg) potassium citrate each. Inactive ingredients include carnauba wax and magnesium stearate.</Description>
  </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>
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  <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>
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    <PackageDescription>10 BAG in 1 CARTON (14789-110-05)  / 100 mL in 1 BAG (14789-110-08) </PackageDescription>
    <NDC11Code>14789-0110-05</NDC11Code>
    <ProductNDC>14789-110</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levetiracetam In Sodium Chloride</ProprietaryName>
    <NonProprietaryName>Levetiracetam</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20200720</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213532</ApplicationNumber>
    <LabelerName>Nexus Pharmaceuticals LLC</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>2024-05-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200720</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Levetiracetam in Sodium Chloride Injection is indicated for adjunct therapy in adults (≥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 bag with an aluminum over wrap. The container closure is not made with natural rubber latex. 500 mg/100 mL: One 100 mL bag 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. 1000 mg/100 mL: One 100 mL bag contains 1000 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. 1500 mg/100 mL: One 100 mL bag contains 1500 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.</Description>
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  <NDC>
    <NDCCode>14789-220-10</NDCCode>
    <PackageDescription>10 BAG in 1 CARTON (14789-220-10)  / 100 mL in 1 BAG (14789-220-08) </PackageDescription>
    <NDC11Code>14789-0220-10</NDC11Code>
    <ProductNDC>14789-220</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levetiracetam In Sodium Chloride</ProprietaryName>
    <NonProprietaryName>Levetiracetam</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20200720</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213532</ApplicationNumber>
    <LabelerName>Nexus Pharmaceuticals LLC</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>2024-05-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200720</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Levetiracetam in Sodium Chloride Injection is indicated for adjunct therapy in adults (≥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 bag with an aluminum over wrap. The container closure is not made with natural rubber latex. 500 mg/100 mL: One 100 mL bag 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. 1000 mg/100 mL: One 100 mL bag contains 1000 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. 1500 mg/100 mL: One 100 mL bag contains 1500 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.</Description>
  </NDC>
  <NDC>
    <NDCCode>14789-330-15</NDCCode>
    <PackageDescription>10 BAG in 1 CARTON (14789-330-15)  / 100 mL in 1 BAG (14789-330-08) </PackageDescription>
    <NDC11Code>14789-0330-15</NDC11Code>
    <ProductNDC>14789-330</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levetiracetam In Sodium Chloride</ProprietaryName>
    <NonProprietaryName>Levetiracetam</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20200720</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213532</ApplicationNumber>
    <LabelerName>Nexus Pharmaceuticals LLC</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>2024-05-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200720</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Levetiracetam in Sodium Chloride Injection is indicated for adjunct therapy in adults (≥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 bag with an aluminum over wrap. The container closure is not made with natural rubber latex. 500 mg/100 mL: One 100 mL bag 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. 1000 mg/100 mL: One 100 mL bag contains 1000 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. 1500 mg/100 mL: One 100 mL bag contains 1500 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.</Description>
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  <NDC>
    <NDCCode>16252-540-01</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (16252-540-01) </PackageDescription>
    <NDC11Code>16252-0540-01</NDC11Code>
    <ProductNDC>16252-540</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Isradipine</ProprietaryName>
    <NonProprietaryName>Isradipine</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20060105</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077317</ApplicationNumber>
    <LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
    <SubstanceName>ISRADIPINE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20060105</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Isradipine is indicated in the management of hypertension. It may be used alone or concurrently with thiazide-type diuretics.</IndicationAndUsage>
    <Description>Isradipine is a calcium antagonist available for oral administration in capsules containing 2.5 mg or 5 mg. The structural formula of isradipine is. Chemically, isradipine is 3,5-Pyridinedicarboxylic acid, 4-(4-benzofurazanyl)-1,4-dihydro-2,6-dimethyl-, methyl 1-methylethyl ester. Isradipine is a yellow, fine crystalline powder which is odorless or has a faint characteristic odor. Isradipine is practically insoluble in water (&lt;10 mg/L at 37ºC), but is soluble in ethanol and freely soluble in acetone, chloroform and methylene chloride. Active Ingredient: isradipine. Inactive Ingredients: colloidal silicon dioxide, red iron oxide (2.5 mg capsule only), yellow iron oxide, gelatin, anhydrous lactose, magnesium stearate, sodium lauryl sulfate, starch (corn), titanium dioxide, black ink: black iron oxide, shellac, potassium hydroxide and propylene glycol.</Description>
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  <NDC>
    <NDCCode>16571-864-01</NDCCode>
    <PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (16571-864-01) </PackageDescription>
    <NDC11Code>16571-0864-01</NDC11Code>
    <ProductNDC>16571-864</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Potassium Citrate</ProprietaryName>
    <NonProprietaryName>Potassium Citrate</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241215</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077440</ApplicationNumber>
    <LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
    <SubstanceName>POTASSIUM CITRATE</SubstanceName>
    <StrengthNumber>540</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241215</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Potassium citrate is a citrate salt of potassium indicated for the management of:.</IndicationAndUsage>
    <Description>Potassium citrate USP (tripotassium citrate monohydrate) is a citrate salt of potassium. Its empirical formula is K3C6H5O7  H2O, and it has the following chemical structure. Potassium citrate extended-release tablets USP are pale yellow colored, oral wax-matrix tablets, contain 5 mEq (540 mg) potassium citrate, and 10 mEq (1080 mg) potassium citrate each. Inactive ingredients include carnauba wax, magnesium stearate and stearic acid. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>16571-865-01</NDCCode>
    <PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (16571-865-01) </PackageDescription>
    <NDC11Code>16571-0865-01</NDC11Code>
    <ProductNDC>16571-865</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Potassium Citrate</ProprietaryName>
    <NonProprietaryName>Potassium Citrate</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241215</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077440</ApplicationNumber>
    <LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
    <SubstanceName>POTASSIUM CITRATE</SubstanceName>
    <StrengthNumber>1080</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241215</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Potassium citrate is a citrate salt of potassium indicated for the management of:.</IndicationAndUsage>
    <Description>Potassium citrate USP (tripotassium citrate monohydrate) is a citrate salt of potassium. Its empirical formula is K3C6H5O7  H2O, and it has the following chemical structure. Potassium citrate extended-release tablets USP are pale yellow colored, oral wax-matrix tablets, contain 5 mEq (540 mg) potassium citrate, and 10 mEq (1080 mg) potassium citrate each. Inactive ingredients include carnauba wax, magnesium stearate and stearic acid. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>25021-793-82</NDCCode>
    <PackageDescription>10 BAG in 1 CARTON (25021-793-82)  / 100 mL in 1 BAG</PackageDescription>
    <NDC11Code>25021-0793-82</NDC11Code>
    <ProductNDC>25021-793</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levetiracetam</ProprietaryName>
    <NonProprietaryName>Levetiracetam</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20240915</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206880</ApplicationNumber>
    <LabelerName>Sagent Pharmaceuticals</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>2024-09-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Levetiracetam in Sodium Chloride Injection is indicated for adjunct therapy in adults (≥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 grams per 100 mL). It is freely soluble in chloroform (65.3 grams per 100 mL) and in methanol (53.6 grams per 100 mL), soluble in ethanol (16.5 grams per 100 mL), sparingly soluble in acetonitrile (5.7 grams per 100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as grams per 100 mL solvent.). Levetiracetam in Sodium Chloride Injection is a clear, colorless, sterile solution that is available in a single-dose dual port bag with an aluminum overwrap. The container closure is not made with natural rubber latex. 500 mg per 100 mL: One 100 mL bag contains 500 mg of levetiracetam (5 mg per 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 per 100 mL: One 100 mL bag contains 1,000 mg of levetiracetam (10 mg per 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 per 100 mL: One 100 mL bag contains 1,500 mg of levetiracetam (15 mg per 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.</Description>
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    <LabelerName>Sagent Pharmaceuticals</LabelerName>
    <SubstanceName>LEVETIRACETAM</SubstanceName>
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    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
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    <IndicationAndUsage>Levetiracetam in Sodium Chloride Injection is indicated for adjunct therapy in adults (≥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 grams per 100 mL). It is freely soluble in chloroform (65.3 grams per 100 mL) and in methanol (53.6 grams per 100 mL), soluble in ethanol (16.5 grams per 100 mL), sparingly soluble in acetonitrile (5.7 grams per 100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as grams per 100 mL solvent.). Levetiracetam in Sodium Chloride Injection is a clear, colorless, sterile solution that is available in a single-dose dual port bag with an aluminum overwrap. The container closure is not made with natural rubber latex. 500 mg per 100 mL: One 100 mL bag contains 500 mg of levetiracetam (5 mg per 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 per 100 mL: One 100 mL bag contains 1,000 mg of levetiracetam (10 mg per 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 per 100 mL: One 100 mL bag contains 1,500 mg of levetiracetam (15 mg per 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.</Description>
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    <PackageDescription>10 BAG in 1 CARTON (25021-795-82)  / 100 mL in 1 BAG</PackageDescription>
    <NDC11Code>25021-0795-82</NDC11Code>
    <ProductNDC>25021-795</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levetiracetam</ProprietaryName>
    <NonProprietaryName>Levetiracetam</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20240915</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206880</ApplicationNumber>
    <LabelerName>Sagent Pharmaceuticals</LabelerName>
    <SubstanceName>LEVETIRACETAM</SubstanceName>
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    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
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    <StartMarketingDatePackage>20240915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Levetiracetam in Sodium Chloride Injection is indicated for adjunct therapy in adults (≥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 grams per 100 mL). It is freely soluble in chloroform (65.3 grams per 100 mL) and in methanol (53.6 grams per 100 mL), soluble in ethanol (16.5 grams per 100 mL), sparingly soluble in acetonitrile (5.7 grams per 100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as grams per 100 mL solvent.). Levetiracetam in Sodium Chloride Injection is a clear, colorless, sterile solution that is available in a single-dose dual port bag with an aluminum overwrap. The container closure is not made with natural rubber latex. 500 mg per 100 mL: One 100 mL bag contains 500 mg of levetiracetam (5 mg per 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 per 100 mL: One 100 mL bag contains 1,000 mg of levetiracetam (10 mg per 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 per 100 mL: One 100 mL bag contains 1,500 mg of levetiracetam (15 mg per 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.</Description>
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