RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>62332-486-25</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (62332-486-25)  / 25 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>62332-0486-25</NDC11Code>
    <ProductNDC>62332-486</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clobetasol Propionate</ProprietaryName>
    <NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20191024</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212881</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-12-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191024</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Clobetasol Propionate Topical Solution USP, 0.05% is indicated for short-term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 mL/week because of the potential for the drug to suppress the HPA axis. This product is not recommended for use in pediatric patients under 12 years of age.</IndicationAndUsage>
    <Description>Clobetasol Propionate Topical Solution USP, 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11β,16β)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy) pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate has the molecular formula C25H32CIFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol Propionate Topical Solution USP, 0.05% contains clobetasol propionate 0.5 mg/g in a base of carbopol 974P, isopropyl alcohol (39.3% w/w), purified water, and sodium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-486-50</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (62332-486-50)  / 50 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>62332-0486-50</NDC11Code>
    <ProductNDC>62332-486</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clobetasol Propionate</ProprietaryName>
    <NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20191024</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212881</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-12-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191024</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Clobetasol Propionate Topical Solution USP, 0.05% is indicated for short-term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 mL/week because of the potential for the drug to suppress the HPA axis. This product is not recommended for use in pediatric patients under 12 years of age.</IndicationAndUsage>
    <Description>Clobetasol Propionate Topical Solution USP, 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11β,16β)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy) pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate has the molecular formula C25H32CIFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol Propionate Topical Solution USP, 0.05% contains clobetasol propionate 0.5 mg/g in a base of carbopol 974P, isopropyl alcohol (39.3% w/w), purified water, and sodium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>43744-486-25</NDCCode>
    <PackageDescription>25 g in 1 DRUM (43744-486-25)</PackageDescription>
    <NDC11Code>43744-0486-25</NDC11Code>
    <ProductNDC>43744-486</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Idoxuridine</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20120606</StartMarketingDate>
    <EndMarketingDate>20130624</EndMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>CBSCHEM LIMITED</LabelerName>
    <SubstanceName>IDOXURIDINE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20130624</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>46708-486-25</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (46708-486-25)  / 25 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>46708-0486-25</NDC11Code>
    <ProductNDC>46708-486</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clobetasol Propionate</ProprietaryName>
    <NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20250317</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212881</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
    <SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250317</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Clobetasol Propionate Topical Solution USP, 0.05% is indicated for short-term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 mL/week because of the potential for the drug to suppress the HPA axis. This product is not recommended for use in pediatric patients under 12 years of age.</IndicationAndUsage>
    <Description>Clobetasol Propionate Topical Solution USP, 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11β,16β)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy) pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate has the molecular formula C25H32CIFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol Propionate Topical Solution USP, 0.05% contains clobetasol propionate 0.5 mg/g in a base of carbopol 974P, isopropyl alcohol (39.3% w/w), purified water, and sodium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>50742-486-02</NDCCode>
    <PackageDescription>25 VIAL in 1 CARTON (50742-486-02)  &gt; 1 mL in 1 VIAL (50742-486-01) </PackageDescription>
    <NDC11Code>50742-0486-02</NDC11Code>
    <ProductNDC>50742-486</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Glycopyrrolate</ProprietaryName>
    <NonProprietaryName>Glycopyrrolate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20200220</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210083</ApplicationNumber>
    <LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>GLYCOPYRROLATE</SubstanceName>
    <StrengthNumber>.2</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Anticholinergic [EPC],Cholinergic Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-12-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200220</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>63323-486-17</NDCCode>
    <PackageDescription>25 VIAL, MULTI-DOSE in 1 TRAY (63323-486-17)  &gt; 10 mL in 1 VIAL, MULTI-DOSE (63323-486-01) </PackageDescription>
    <NDC11Code>63323-0486-17</NDC11Code>
    <ProductNDC>63323-486</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Xylocaine</ProprietaryName>
    <NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INFILTRATION; PERINEURAL</RouteName>
    <StartMarketingDate>20100812</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA006488</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>LIDOCAINE HYDROCHLORIDE ANHYDROUS</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2021-09-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100812</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Xylocaine (lidocaine HCl) Injections are indicated for production  of local or regional anesthesia by infiltration techniques such as  percutaneous injection and intravenous regional anesthesia by peripheral  nerve block techniques such as brachial plexus and intercostal and by  central neural techniques such as lumbar and caudal epidural blocks,  when the accepted procedures for these techniques as described in  standard textbooks are observed.</IndicationAndUsage>
    <Description>Xylocaine (lidocaine HCl) Injections are sterile, nonpyrogenic, aqueous solutions that contain a local anesthetic agent with or without epinephrine and are administered parenterally by injection.  See INDICATIONS AND USAGE section for specific uses. Xylocaine solutions contain lidocaine HCl, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the molecular wt. 270.8.  Lidocaine HCl (C14H22N2O  HCl) has the following structural formula:. Epinephrine is (-) -3, 4-Dihydroxy-α-[(methylamino) methyl] benzyl alcohol and has the molecular wt. 183.21.  Epinephrine (C9H13NO3) has the following structural formula:. Dosage forms listed as Xylocaine-MPF indicate single dose solutions that are Methyl Paraben Free (MPF). Xylocaine MPF is a sterile, nonpyrogenic, isotonic solution containing sodium chloride.  Xylocaine in multiple dose vials:  Each mL also contains 1 mg methyl­paraben as antiseptic preservative.  The pH of these solutions is adjusted to approximately 6.5 (5.0 to 7.0) with sodium hydroxide and/or hydrochloric acid. Xylocaine MPF with Epinephrine is a sterile, nonpyrogenic, isotonic solution containing sodium chloride.  Each mL contains lidocaine hydrochloride and epinephrine, with 0.5 mg sodium metabisulfite as an antioxidant and 0.2 mg citric acid as a stabilizer.   Xylocaine with Epinephrine in multiple dose vials:  Each mL also contains 1 mg methylparaben as antiseptic preservative.  The pH of these solutions is adjusted to approximately 4.5 (3.3 to 5.5) with sodium hydroxide and/or hydrochloric acid.  Filled under nitrogen.</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-486-26</NDCCode>
    <PackageDescription>25 VIAL, MULTI-DOSE in 1 TRAY (63323-486-26)  / 20 mL in 1 VIAL, MULTI-DOSE (63323-486-41) </PackageDescription>
    <NDC11Code>63323-0486-26</NDC11Code>
    <ProductNDC>63323-486</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Xylocaine</ProprietaryName>
    <NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INFILTRATION; PERINEURAL</RouteName>
    <StartMarketingDate>20100812</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA006488</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>LIDOCAINE HYDROCHLORIDE ANHYDROUS</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-05-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100812</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Xylocaine (lidocaine HCl) Injections are indicated for production  of local or regional anesthesia by infiltration techniques such as  percutaneous injection and intravenous regional anesthesia by peripheral  nerve block techniques such as brachial plexus and intercostal and by  central neural techniques such as lumbar and caudal epidural blocks,  when the accepted procedures for these techniques as described in  standard textbooks are observed.</IndicationAndUsage>
    <Description>Xylocaine (lidocaine HCl) Injections are sterile, nonpyrogenic, aqueous solutions that contain a local anesthetic agent with or without epinephrine and are administered parenterally by injection.  See INDICATIONS AND USAGE section for specific uses. Xylocaine solutions contain lidocaine HCl, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the molecular wt. 270.8.  Lidocaine HCl (C 14H 22N 2O  HCl) has the following structural formula:. Epinephrine is (-) -3, 4-Dihydroxy-α-[(methylamino) methyl] benzyl alcohol and has the molecular wt. 183.21.  Epinephrine (C 9H 13NO 3) has the following structural formula:. Dosage forms listed as Xylocaine-MPF indicate single dose solutions that are Methyl Paraben Free (MPF). Xylocaine MPF is a sterile, nonpyrogenic, isotonic solution containing sodium chloride.  Xylocaine in multiple dose vials:  Each mL also contains 1 mg methyl­paraben as antiseptic preservative.  The pH of these solutions is adjusted to approximately 6.5 (5.0 to 7.0) with sodium hydroxide and/or hydrochloric acid. Xylocaine MPF with Epinephrine is a sterile, nonpyrogenic, isotonic solution containing sodium chloride.  Each mL contains lidocaine hydrochloride and epinephrine, with 0.5 mg sodium metabisulfite as an antioxidant and 0.2 mg citric acid as a stabilizer.   Xylocaine with Epinephrine in multiple dose vials:  Each mL also contains 1 mg methylparaben as antiseptic preservative.  The pH of these solutions is adjusted to approximately 4.5 (3.3 to 5.5) with sodium hydroxide and/or hydrochloric acid.  Filled under nitrogen.</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-486-27</NDCCode>
    <PackageDescription>25 VIAL, MULTI-DOSE in 1 TRAY (63323-486-27)  &gt; 20 mL in 1 VIAL, MULTI-DOSE (63323-486-02) </PackageDescription>
    <NDC11Code>63323-0486-27</NDC11Code>
    <ProductNDC>63323-486</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Xylocaine</ProprietaryName>
    <NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INFILTRATION; PERINEURAL</RouteName>
    <StartMarketingDate>20100812</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA006488</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>LIDOCAINE HYDROCHLORIDE ANHYDROUS</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2021-09-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100812</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Xylocaine (lidocaine HCl) Injections are indicated for production  of local or regional anesthesia by infiltration techniques such as  percutaneous injection and intravenous regional anesthesia by peripheral  nerve block techniques such as brachial plexus and intercostal and by  central neural techniques such as lumbar and caudal epidural blocks,  when the accepted procedures for these techniques as described in  standard textbooks are observed.</IndicationAndUsage>
    <Description>Xylocaine (lidocaine HCl) Injections are sterile, nonpyrogenic, aqueous solutions that contain a local anesthetic agent with or without epinephrine and are administered parenterally by injection.  See INDICATIONS AND USAGE section for specific uses. Xylocaine solutions contain lidocaine HCl, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the molecular wt. 270.8.  Lidocaine HCl (C14H22N2O  HCl) has the following structural formula:. Epinephrine is (-) -3, 4-Dihydroxy-α-[(methylamino) methyl] benzyl alcohol and has the molecular wt. 183.21.  Epinephrine (C9H13NO3) has the following structural formula:. Dosage forms listed as Xylocaine-MPF indicate single dose solutions that are Methyl Paraben Free (MPF). Xylocaine MPF is a sterile, nonpyrogenic, isotonic solution containing sodium chloride.  Xylocaine in multiple dose vials:  Each mL also contains 1 mg methyl­paraben as antiseptic preservative.  The pH of these solutions is adjusted to approximately 6.5 (5.0 to 7.0) with sodium hydroxide and/or hydrochloric acid. Xylocaine MPF with Epinephrine is a sterile, nonpyrogenic, isotonic solution containing sodium chloride.  Each mL contains lidocaine hydrochloride and epinephrine, with 0.5 mg sodium metabisulfite as an antioxidant and 0.2 mg citric acid as a stabilizer.   Xylocaine with Epinephrine in multiple dose vials:  Each mL also contains 1 mg methylparaben as antiseptic preservative.  The pH of these solutions is adjusted to approximately 4.5 (3.3 to 5.5) with sodium hydroxide and/or hydrochloric acid.  Filled under nitrogen.</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-486-57</NDCCode>
    <PackageDescription>25 VIAL, MULTI-DOSE in 1 TRAY (63323-486-57)  &gt; 50 mL in 1 VIAL, MULTI-DOSE (63323-486-05) </PackageDescription>
    <NDC11Code>63323-0486-57</NDC11Code>
    <ProductNDC>63323-486</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Xylocaine</ProprietaryName>
    <NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INFILTRATION; PERINEURAL</RouteName>
    <StartMarketingDate>20100812</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA006488</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>LIDOCAINE HYDROCHLORIDE ANHYDROUS</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2021-09-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100812</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Xylocaine (lidocaine HCl) Injections are indicated for production  of local or regional anesthesia by infiltration techniques such as  percutaneous injection and intravenous regional anesthesia by peripheral  nerve block techniques such as brachial plexus and intercostal and by  central neural techniques such as lumbar and caudal epidural blocks,  when the accepted procedures for these techniques as described in  standard textbooks are observed.</IndicationAndUsage>
    <Description>Xylocaine (lidocaine HCl) Injections are sterile, nonpyrogenic, aqueous solutions that contain a local anesthetic agent with or without epinephrine and are administered parenterally by injection.  See INDICATIONS AND USAGE section for specific uses. Xylocaine solutions contain lidocaine HCl, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the molecular wt. 270.8.  Lidocaine HCl (C14H22N2O  HCl) has the following structural formula:. Epinephrine is (-) -3, 4-Dihydroxy-α-[(methylamino) methyl] benzyl alcohol and has the molecular wt. 183.21.  Epinephrine (C9H13NO3) has the following structural formula:. Dosage forms listed as Xylocaine-MPF indicate single dose solutions that are Methyl Paraben Free (MPF). Xylocaine MPF is a sterile, nonpyrogenic, isotonic solution containing sodium chloride.  Xylocaine in multiple dose vials:  Each mL also contains 1 mg methyl­paraben as antiseptic preservative.  The pH of these solutions is adjusted to approximately 6.5 (5.0 to 7.0) with sodium hydroxide and/or hydrochloric acid. Xylocaine MPF with Epinephrine is a sterile, nonpyrogenic, isotonic solution containing sodium chloride.  Each mL contains lidocaine hydrochloride and epinephrine, with 0.5 mg sodium metabisulfite as an antioxidant and 0.2 mg citric acid as a stabilizer.   Xylocaine with Epinephrine in multiple dose vials:  Each mL also contains 1 mg methylparaben as antiseptic preservative.  The pH of these solutions is adjusted to approximately 4.5 (3.3 to 5.5) with sodium hydroxide and/or hydrochloric acid.  Filled under nitrogen.</Description>
  </NDC>
  <NDC>
    <NDCCode>63868-486-25</NDCCode>
    <PackageDescription>25 TABLET, FILM COATED in 1 BOTTLE (63868-486-25) </PackageDescription>
    <NDC11Code>63868-0486-25</NDC11Code>
    <ProductNDC>63868-486</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Famotidine</ProprietaryName>
    <NonProprietaryName>Famotidine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100723</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090283</ApplicationNumber>
    <LabelerName>Chain Drug Marketing Association Inc.</LabelerName>
    <SubstanceName>FAMOTIDINE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100723</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>relieves heartburn associated with acid indigestion and sour stomach. prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>68462-486-19</NDCCode>
    <PackageDescription>1 JAR in 1 CARTON (68462-486-19)  / 25 g in 1 JAR</PackageDescription>
    <NDC11Code>68462-0486-19</NDC11Code>
    <ProductNDC>68462-486</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clindamycin And Benzoyl Peroxide</ProprietaryName>
    <NonProprietaryName>Clindamycin And Benzoyl Peroxide</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20190314</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209252</ApplicationNumber>
    <LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
    <SubstanceName>CLINDAMYCIN PHOSPHATE; BENZOYL PEROXIDE</SubstanceName>
    <StrengthNumber>10; 50</StrengthNumber>
    <StrengthUnit>mg/g; mg/g</StrengthUnit>
    <Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190314</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Clindamycin and Benzoyl Peroxide Gel is indicated for the topical treatment of acne vulgaris.</IndicationAndUsage>
    <Description>Clindamycin and Benzoyl Peroxide Gel, 1%/5% contains clindamycin phosphate, (7(S)-chloro-7-deoxylincomycin-2-phosphate). Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. Chemically, clindamycin phosphate is (C18H34ClN2O8PS). The structural formula for clindamycin is represented below. Clindamycin phosphate has a molecular weight of 504.96 g/mol and its chemical name is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido) -1-thio-L-threo-α-D- galacto-octopyranoside 2-(dihydrogen phosphate). Clindamycin and Benzoyl Peroxide Gel, 1%/5% also contains benzoyl peroxide, for topical use. Chemically, benzoyl peroxide is (C14H10O4). It has the following structural formula. Benzoyl peroxide has a molecular weight of 242.23 g/mol. Each gram of Clindamycin and Benzoyl Peroxide Gel, 1%/5% contains, as dispensed, 10 mg (1%) clindamycin as phosphate and 50 mg (5%) benzoyl peroxide in a base of carbomer homopolymer type C, docusate sodium, edetate disodium, sodium hydroxide and purified water.</Description>
  </NDC>
  <NDC>
    <NDCCode>75839-486-99</NDCCode>
    <PackageDescription>25 kg in 1 DRUM (75839-486-99)</PackageDescription>
    <NDC11Code>75839-0486-99</NDC11Code>
    <ProductNDC>75839-486</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Tiopronin</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20141012</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Attix Pharmaceuticals Inc</LabelerName>
    <SubstanceName>TIOPRONIN</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>80267-486-63</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (80267-486-63)  / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE</PackageDescription>
    <NDC11Code>80267-0486-63</NDC11Code>
    <ProductNDC>80267-486</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Betr Stool Softener</ProprietaryName>
    <NonProprietaryName>Docusate Sodium</NonProprietaryName>
    <DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20211005</StartMarketingDate>
    <EndMarketingDate>20241231</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M007</ApplicationNumber>
    <LabelerName>Live Betr LLC</LabelerName>
    <SubstanceName>DOCUSATE SODIUM</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20211005</StartMarketingDatePackage>
    <EndMarketingDatePackage>20241231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>relieves occasional constipation (irregularity). generally produces bowel movement in 12 to 72 hours.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>62332-071-25</NDCCode>
    <PackageDescription>25 VIAL in 1 CARTON (62332-071-25)  / 10 mL in 1 VIAL</PackageDescription>
    <NDC11Code>62332-0071-25</NDC11Code>
    <ProductNDC>62332-071</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pantoprazole Sodium</ProprietaryName>
    <NonProprietaryName>Pantoprazole Sodium Injection</NonProprietaryName>
    <DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20250331</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA219230</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/10mL</StrengthUnit>
    <Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250331</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pantoprazole sodium for injection is indicated for treatment of: 1 gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults., 2 pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome in adults.</IndicationAndUsage>
    <Description>The active ingredient in pantoprazole sodium for injection (pantoprazole sodium), a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S, with a molecular weight of 405.4. The structural formula is. Pantoprazole sodium is a white or almost white powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The reconstituted solution of pantoprazole sodium for injection is in the pH range of 9.0 to 10.5. Pantoprazole sodium for injection is supplied for intravenous administration as a sterile, freeze-dried powder in a single-dose clear glass vial fitted with a rubber stopper and crimp seal. Each vial contains 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium), edetate disodium (1 mg), and sodium hydroxide to adjust pH.</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-507-25</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (62332-507-25)  / 2.5 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>62332-0507-25</NDC11Code>
    <ProductNDC>62332-507</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bimatoprost</ProprietaryName>
    <NonProprietaryName>Bimatoprost</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20190412</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210263</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>BIMATOPROST</SubstanceName>
    <StrengthNumber>.3</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Prostaglandin Analog [EPC], Prostaglandins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190412</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Bimatoprost ophthalmic solution, 0.03% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.</IndicationAndUsage>
    <Description>Bimatoprost ophthalmic solution, 0.03% is a synthetic prostamide analog with ocular hypotensive activity. Its chemical name is (Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-[(1E,3S)-3-hydroxy-5-phenyl-1- pentenyl]cyclopentyl]-5-N-ethylheptenamide, and its molecular weight is 415.58. Its molecular formula is C25H37NO4. Its chemical structure is. Bimatoprost is a powder, soluble in methanol and alcohol. Bimatoprost ophthalmic solution, 0.03% is a clear, isotonic, colorless, sterile ophthalmic solution with an osmolality of approximately 290 mOsmol/kg. Bimatoprost ophthalmic solution, 0.03% contains Active: bimatoprost 0.3 mg/mL; Inactives: benzalkonium chloride 0.05 mg/mL; disodium hydrogen phosphate heptahydrate, citric acid monohydrate, sodium chloride and water for injection. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. The pH during its shelf life ranges from 6.8 to 7.8.</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-510-25</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (62332-510-25)  &gt; 2.5 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>62332-0510-25</NDC11Code>
    <ProductNDC>62332-510</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Travoprost Ophthalmic Solution Usp, 0.004%</ProprietaryName>
    <ProprietaryNameSuffix>Travoprost</ProprietaryNameSuffix>
    <NonProprietaryName>Travoprost Ophthalmic Solution Usp, 0.004%</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20191220</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210458</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>TRAVOPROST</SubstanceName>
    <StrengthNumber>.04</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Prostaglandin Analog [EPC], Prostaglandins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-07-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191220</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Travoprost Ophthalmic Solution USP, 0.004% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.</IndicationAndUsage>
    <Description>Travoprost is a synthetic prostaglandin F analogue. Its chemical name is [1R-[1α(Z),2β(1E,3R*),3α,5α]]-7-[3,5Dihydroxy-2-[3-hydroxy-4-[3(trifluoromethyl)phenoxy]-1-butenyl]cyclopentyl]-5heptenoic acid, 1-methylethylester. It has a molecular formula of C26H35F3O6 and a molecular weight of 500.55. The chemical structure of travoprost is. Travoprost is a clear, colorless and viscous oil that is very soluble in acetonitrile, methanol, octanol, and chloroform. It is practically insoluble in water. Travoprost Ophthalmic Solution 0.004% is supplied as sterile, buffered aqueous solution of travoprost with a pH of approximately 6.0 and an osmolality of approximately 290 mOsmol/kg. Travoprost ophthalmic solution contains Active: travoprost 0.04 mg/mL; Preservative: benzalkonium chloride 0.015% w/v; Inactives: polyoxyl 40 hydrogenated castor oil, tromethamine, boric acid, mannitol, edetate disodium, sodium hydroxide and/or hydrochloric acid (to adjust pH)and water for injection.</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-525-25</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (62332-525-25)  / 25 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>62332-0525-25</NDC11Code>
    <ProductNDC>62332-525</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxorubicin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Doxorubicin Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION, LIPOSOMAL</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20250627</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA219199</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>DOXORUBICIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Topoisomerase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250627</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Doxorubicin hydrochloride liposome injection is an anthracycline topoisomerase inhibitor indicated for: 1 Ovarian cancer: After failure of platinum-based chemotherapy (1.1), 2 AIDS-related Kaposi’s Sarcoma: After failure of prior systemic chemotherapy or intolerance to such therapy (1.2), 3  Multiple Myeloma: In combination with bortezomib in patients who have not previously received bortezomib and have received at least one prior therapy (1.3).</IndicationAndUsage>
    <Description>The active ingredient in Doxorubicin hydrochloride liposome injection is doxorubicin hydrochloride, an anthracycline topoisomerase inhibitor, that is encapsulated in pegylated liposomes for intravenous use. The chemical name of doxorubicin hydrochloride is (8S,10S)-10-[(3-amino-2,3,6-trideoxy-α-L-lyxo-hexopyranosyl)oxy]-8-glycolyl-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy-5,12-naphthacenedione hydrochloride. The molecular formula is C27H29NO11HCl and the molecular weight is 579.99. The structural formula is. Doxorubicin hydrochloride liposome injection is a sterile, translucent, red liposomal dispersion. Each single-dose vial contains 20 mg or 50 mg doxorubicin hydrochloride at a concentration of 2  mg/mL (equivalent to 1.87 mg/mL of doxorubicin). The pegylated liposome carriers are composed of cholesterol, 3.19 mg/mL; fully hydrogenated soy phosphatidylcholine (HSPC), 9.58 mg/mL; and N-(carbonyl-methoxypolyethylene glycol 2000)-1,2-distearoyl-sn-glycero-3-phosphoethanolamine sodium salt (MPEG-DSPE), 3.19 mg/mL. Each mL also contains ammonium sulfate, approximately 0.6 mg; histidine, 1.55 mg as a buffer; hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment (6.0 to 7.0); and sucrose, 94 mg to maintain isotonicity. Greater than 90% of the drug is encapsulated in the pegylated liposomes. MPEG-DSPE has the following structural formula. HSPC has the following structural formula. Representation of a pegylated liposome.</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-599-25</NDCCode>
    <PackageDescription>25 VIAL in 1 CARTON (62332-599-25)  / 1 mL in 1 VIAL (62332-599-01) </PackageDescription>
    <NDC11Code>62332-0599-25</NDC11Code>
    <ProductNDC>62332-599</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
    <NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20221102</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214456</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-08-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221102</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).Acute Pain in Adult PatientsKetorolac tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. The total combined duration of use of ketorolac tromethamine injection and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION, and ADVERSE REACTIONS). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.</IndicationAndUsage>
    <Description>Ketorolac Tromethamine Injection, USP is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (±)-5-benzoyl- 2,3- dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3- propanediol (1:1), and the structural formula is presented in Figure 1. Ketorolac tromethamine is a racemic mixture of [-]S and [+]R ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.40. Ketorolac Tromethamine Injection, USP is available for intravenous (IV) or intramuscular (IM) administration as: 15 mg in 1 mL (1.5%) and 30 mg in 1 mL (3%) in sterile solution; 60 mg in 2 mL (3%) of ketorolac tromethamine in sterile solution is available for intramuscular administration only. The solutions contain 10% (w/v) alcohol, USP, and 6.68 mg, 4.35 mg, and 8.70 mg, respectively, of sodium chloride in sterile water. The pH range is 6.9 to 7.9 and is adjusted with sodium hydroxide and/or hydrochloric acid. The sterile solutions are clear, colorless to slight yellow in color.</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-600-25</NDCCode>
    <PackageDescription>25 VIAL in 1 CARTON (62332-600-25)  / 1 mL in 1 VIAL (62332-600-01) </PackageDescription>
    <NDC11Code>62332-0600-25</NDC11Code>
    <ProductNDC>62332-600</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
    <NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20221102</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214456</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-08-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221102</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).Acute Pain in Adult PatientsKetorolac tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. The total combined duration of use of ketorolac tromethamine injection and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION, and ADVERSE REACTIONS). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.</IndicationAndUsage>
    <Description>Ketorolac Tromethamine Injection, USP is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (±)-5-benzoyl- 2,3- dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3- propanediol (1:1), and the structural formula is presented in Figure 1. Ketorolac tromethamine is a racemic mixture of [-]S and [+]R ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.40. Ketorolac Tromethamine Injection, USP is available for intravenous (IV) or intramuscular (IM) administration as: 15 mg in 1 mL (1.5%) and 30 mg in 1 mL (3%) in sterile solution; 60 mg in 2 mL (3%) of ketorolac tromethamine in sterile solution is available for intramuscular administration only. The solutions contain 10% (w/v) alcohol, USP, and 6.68 mg, 4.35 mg, and 8.70 mg, respectively, of sodium chloride in sterile water. The pH range is 6.9 to 7.9 and is adjusted with sodium hydroxide and/or hydrochloric acid. The sterile solutions are clear, colorless to slight yellow in color.</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-601-25</NDCCode>
    <PackageDescription>25 VIAL in 1 CARTON (62332-601-25)  / 2 mL in 1 VIAL (62332-601-02) </PackageDescription>
    <NDC11Code>62332-0601-25</NDC11Code>
    <ProductNDC>62332-601</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
    <NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20221102</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214456</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mg/2mL</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-08-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221102</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).Acute Pain in Adult PatientsKetorolac tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. The total combined duration of use of ketorolac tromethamine injection and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION, and ADVERSE REACTIONS). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.</IndicationAndUsage>
    <Description>Ketorolac Tromethamine Injection, USP is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (±)-5-benzoyl- 2,3- dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3- propanediol (1:1), and the structural formula is presented in Figure 1. Ketorolac tromethamine is a racemic mixture of [-]S and [+]R ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.40. Ketorolac Tromethamine Injection, USP is available for intravenous (IV) or intramuscular (IM) administration as: 15 mg in 1 mL (1.5%) and 30 mg in 1 mL (3%) in sterile solution; 60 mg in 2 mL (3%) of ketorolac tromethamine in sterile solution is available for intramuscular administration only. The solutions contain 10% (w/v) alcohol, USP, and 6.68 mg, 4.35 mg, and 8.70 mg, respectively, of sodium chloride in sterile water. The pH range is 6.9 to 7.9 and is adjusted with sodium hydroxide and/or hydrochloric acid. The sterile solutions are clear, colorless to slight yellow in color.</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-607-25</NDCCode>
    <PackageDescription>25 VIAL in 1 CARTON (62332-607-25)  / 1 mL in 1 VIAL (62332-607-01) </PackageDescription>
    <NDC11Code>62332-0607-25</NDC11Code>
    <ProductNDC>62332-607</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Glycopyrrolate</ProprietaryName>
    <NonProprietaryName>Glycopyrrolate</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20221026</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214635</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>GLYCOPYRROLATE</SubstanceName>
    <StrengthNumber>.2</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221026</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>In Anesthesia. Glycopyrrolate injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, glycopyrrolate injection may be used intraoperatively to counteract surgically or drug-induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants. In Peptic Ulcer. For use in adults to reduce symptoms of a peptic ulcer as an adjunctto treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated.  Glycopyrrolate injection is not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established.</IndicationAndUsage>
    <Description>Glycopyrrolate injection, USP is a synthetic anticholinergic agent. Each 1 mL contains: Glycopyrrolate, USP 0.2 mg Water for Injection, USP q.s. Benzyl Alcohol, NF 0.9% (preservative) pH adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide. For Intramuscular (IM) or Intravenous (IV) administration. Glycopyrrolate is a quaternary ammonium salt with the following chemical name: 3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide. The molecular formula is C19H28BrNO3 and the molecular weight is 398.33. Its structural formula is as follows. C19H28BrNO3                MW 398.33. Glycopyrrolate occurs as a white, odorless crystalline powder. It is soluble in water and alcohol, and practically insoluble in chloroform and ether. Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. Glycopyrrolate injection, USP, is a clear, colorless, sterile liquid; pH 2.0 to 3.0. The partition coefficient of glycopyrrolate in a n-octanol/water system is 0.304 (log10 P= -1.52) at ambient room temperature (24°C).</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-627-25</NDCCode>
    <PackageDescription>25 VIAL in 1 CARTON (62332-627-25)  / 2 mL in 1 VIAL (62332-627-02) </PackageDescription>
    <NDC11Code>62332-0627-25</NDC11Code>
    <ProductNDC>62332-627</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Glycopyrrolate</ProprietaryName>
    <NonProprietaryName>Glycopyrrolate</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20221026</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214635</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>GLYCOPYRROLATE</SubstanceName>
    <StrengthNumber>.2</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221026</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>In Anesthesia. Glycopyrrolate injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, glycopyrrolate injection may be used intraoperatively to counteract surgically or drug-induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants. In Peptic Ulcer. For use in adults to reduce symptoms of a peptic ulcer as an adjunctto treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated.  Glycopyrrolate injection is not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established.</IndicationAndUsage>
    <Description>Glycopyrrolate injection, USP is a synthetic anticholinergic agent. Each 1 mL contains: Glycopyrrolate, USP 0.2 mg Water for Injection, USP q.s. Benzyl Alcohol, NF 0.9% (preservative) pH adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide. For Intramuscular (IM) or Intravenous (IV) administration. Glycopyrrolate is a quaternary ammonium salt with the following chemical name: 3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide. The molecular formula is C19H28BrNO3 and the molecular weight is 398.33. Its structural formula is as follows. C19H28BrNO3                MW 398.33. Glycopyrrolate occurs as a white, odorless crystalline powder. It is soluble in water and alcohol, and practically insoluble in chloroform and ether. Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. Glycopyrrolate injection, USP, is a clear, colorless, sterile liquid; pH 2.0 to 3.0. The partition coefficient of glycopyrrolate in a n-octanol/water system is 0.304 (log10 P= -1.52) at ambient room temperature (24°C).</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-628-25</NDCCode>
    <PackageDescription>25 VIAL in 1 CARTON (62332-628-25)  / 5 mL in 1 VIAL (62332-628-05) </PackageDescription>
    <NDC11Code>62332-0628-25</NDC11Code>
    <ProductNDC>62332-628</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Glycopyrrolate</ProprietaryName>
    <NonProprietaryName>Glycopyrrolate</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20221026</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214635</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>GLYCOPYRROLATE</SubstanceName>
    <StrengthNumber>.2</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221026</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>In Anesthesia. Glycopyrrolate injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, glycopyrrolate injection may be used intraoperatively to counteract surgically or drug-induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants. In Peptic Ulcer. For use in adults to reduce symptoms of a peptic ulcer as an adjunctto treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated.  Glycopyrrolate injection is not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established.</IndicationAndUsage>
    <Description>Glycopyrrolate injection, USP is a synthetic anticholinergic agent. Each 1 mL contains: Glycopyrrolate, USP 0.2 mg Water for Injection, USP q.s. Benzyl Alcohol, NF 0.9% (preservative) pH adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide. For Intramuscular (IM) or Intravenous (IV) administration. Glycopyrrolate is a quaternary ammonium salt with the following chemical name: 3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide. The molecular formula is C19H28BrNO3 and the molecular weight is 398.33. Its structural formula is as follows. C19H28BrNO3                MW 398.33. Glycopyrrolate occurs as a white, odorless crystalline powder. It is soluble in water and alcohol, and practically insoluble in chloroform and ether. Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. Glycopyrrolate injection, USP, is a clear, colorless, sterile liquid; pH 2.0 to 3.0. The partition coefficient of glycopyrrolate in a n-octanol/water system is 0.304 (log10 P= -1.52) at ambient room temperature (24°C).</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-690-50</NDCCode>
    <PackageDescription>25 VIAL, MULTI-DOSE in 1 CARTON (62332-690-50)  / 2 mL in 1 VIAL, MULTI-DOSE (62332-690-02) </PackageDescription>
    <NDC11Code>62332-0690-50</NDC11Code>
    <ProductNDC>62332-690</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxercalciferol</ProprietaryName>
    <NonProprietaryName>Doxercalciferol</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20230615</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215810</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>DOXERCALCIFEROL</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>ug/2mL</StrengthUnit>
    <Pharm_Classes>Ergocalciferols [CS], Vitamin D2 Analog [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230615</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Doxercalciferol Injection is indicated for the treatment of secondary hyperparathyroidism in adult patients with CKD on dialysis.</IndicationAndUsage>
    <Description>Doxercalciferol injection contains doxercalciferol, which is a synthetic vitamin D2 analog. Doxercalciferol undergoes metabolic activation in vivo to form 1α,25-dihydroxyvitamin D2 (1α,25-(OH)2D2), a naturally occurring, biologically active form of vitamin D2.Doxercalciferol is a white to off-white crystallized powder with a calculated molecular weight of 412.66 and a molecular formula of C28H44O2. It is soluble in oils and organic solvents, but is relatively insoluble in water. Chemically, doxercalciferol is (1α,3β,5Z,7E,22E)-9,10-secoergosta-5,7,10(19),22-tetraene-1,3-diol. The structural formula is. Injection. Doxercalciferol Injection is a sterile, clear, and colorless solution. Doxercalciferol Injection 2 mL multiple-dose vials contain 4 mcg/2 mL (2 mcg/mL) of doxercalciferol. Each milliliter (mL) of solution contains 2 mcg doxercalciferol and the following inactive ingredients: butylated hydroxytoluene (0.02 mg); disodium edetate (1.1 mg); dehydrated alcohol (7.5% v/v); polysorbate 20 (10 mg); sodium chloride (1.5 mg); dibasic sodium phosphate, heptahydrate (14.4 mg); and monobasic sodium phosphate, monohydrate (1.8 mg).</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-812-25</NDCCode>
    <PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (62332-812-25)  / 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>62332-0812-25</NDC11Code>
    <ProductNDC>62332-812</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
    <NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRA-ARTICULAR; INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20251017</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218601</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251017</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Intramuscular  Where oral therapy is not feasible, injectable corticosteroid therapy, including triamcinolone acetonide injectable suspension is indicated for intramuscular use as follows:Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous system: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis.Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus. Intra-Articular The intra-articular or soft tissue administration of triamcinolone acetonide injectable suspension is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis.</IndicationAndUsage>
    <Description>Triamcinolone acetonide injectable suspension, USP is a synthetic glucocorticoid corticosteroid with anti-inflammatory action. THESE FORMULATION ARE SUITABLE FOR INTRAMUSCULAR AND INTRA-ARTICULAR USE ONLY. THESE FORMULATION ARE NOT FOR INTRADERMAL INJECTION.  Each mL of the sterile aqueous suspension provides 40 mg triamcinolone acetonide, USP with 0.66% sodium chloride for isotonicity, 0.94% (v/v) benzyl alcohol as a preservative, 0.63% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen.  The chemical name for triamcinolone acetonide is 9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. Its structural formula is. MW 434.50            Triamcinolone acetonide occurs as a white to almost-white, crystalline powder and is sparingly soluble in alcohol, methanol and chloroform; very slightly soluble in ether; practically insoluble in water.</Description>
  </NDC>
  <NDC>
    <NDCCode>43547-486-10</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (43547-486-10) </PackageDescription>
    <NDC11Code>43547-0486-10</NDC11Code>
    <ProductNDC>43547-486</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
    <NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200701</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212697</ApplicationNumber>
    <LabelerName>Solco Healthcare US,LLC</LabelerName>
    <SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</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>2025-09-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200701</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Methylphenidate hydrochloride tablets are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults, 2 Narcolepsy.</IndicationAndUsage>
    <Description>Methylphenidate hydrochloride tablets, USP contain methylphenidate hydrochloride, a CNS stimulant. It is available as tablets of 5 mg, 10 mg, and 20 mg strengths for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is. Methylphenidate hydrochloride, USP is a white to off-white 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 g/mol. Methylphenidate hydrochloride tablets, USP contain the following inactive ingredients: FD&amp;C Blue# 2 (10-mg tablets), ferric oxide yellow (5-mg and 20-mg tablets), hypromellose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol 8000, and stearic acid. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>47781-486-01</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (47781-486-01) </PackageDescription>
    <NDC11Code>47781-0486-01</NDC11Code>
    <ProductNDC>47781-486</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lenalidomide</ProprietaryName>
    <NonProprietaryName>Lenalidomide</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220903</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210480</ApplicationNumber>
    <LabelerName>Alvogen, Inc.</LabelerName>
    <SubstanceName>LENALIDOMIDE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Thalidomide Analog [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220903</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lenalidomide capsules are a thalidomide analogue indicated for the treatment of adult patients with: 1 Multiple myeloma (MM), in combination with dexamethasone (1.1)., 2 Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities (1.2).</IndicationAndUsage>
    <Description>Lenalidomide capsules, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name is 3-(4-amino-1-oxo 1,3-dihydro-2H-isoindol-2-yl) piperidine-2,6-dione and it has the following chemical structure:. 3-(4-amino-1-oxo 1,3-dihydro-2H-isoindol-2-yl) piperidine-2,6-dione. The empirical formula for lenalidomide is C13H13N3O3, and the gram molecular weight is 259.3. Lenalidomide is an off-white to pale-yellow solid powder. It is soluble in organic solvent/water mixtures, and buffered aqueous solvents. Lenalidomide is more soluble in organic solvents and low pH solutions. Solubility was significantly lower in less acidic buffers, ranging from about 0.4 to 0.5 mg/ml. Lenalidomide has an asymmetric carbon atom and can exist as the optically active forms S(-) and R(+), and is produced as a racemic mixture with a net optical rotation of zero. Lenalidomide capsules are available in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg capsules for oral administration. Each capsule contains lenalidomide as the active ingredient and the following inactive ingredients: croscarmellose sodium, lactose anhydrous, magnesium stearate and microcrystalline cellulose. The 2.5 mg capsule shell contains gelatin, red iron oxide, yellow iron oxide, titanium dioxide, FD&amp;C blue #1, FD&amp;C red #3, FD&amp;C red #40 and black ink. The 5 mg capsule shell contains gelatin, titanium dioxide, black iron oxide, red iron oxide, yellow iron oxide, FD&amp;C blue #1, FD&amp;C yellow #6 and black ink. The 10 mg capsule shell contains gelatin, titanium dioxide, FD&amp;C blue #1, FD&amp;C red #40, FD&amp;C yellow #6, FD&amp;C yellow #5 and black ink. The 15 mg capsule shell contains gelatin, titanium dioxide, FD&amp;C blue #1, FD&amp;C red #40, FD&amp;C yellow #5, black iron oxide, red iron oxide, yellow iron oxide and black ink. The 20 mg capsule shell contains gelatin, titanium dioxide, FD&amp;C blue #1, FD&amp;C red #40, red iron oxide, yellow iron oxide and black ink. The 25 mg capsule shell contains gelatin, titanium dioxide and black ink. The black imprinting ink contains shellac, strong ammonia solution, black iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>47781-486-77</NDCCode>
    <PackageDescription>21 CAPSULE in 1 BOTTLE (47781-486-77) </PackageDescription>
    <NDC11Code>47781-0486-77</NDC11Code>
    <ProductNDC>47781-486</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lenalidomide</ProprietaryName>
    <NonProprietaryName>Lenalidomide</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220903</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210480</ApplicationNumber>
    <LabelerName>Alvogen, Inc.</LabelerName>
    <SubstanceName>LENALIDOMIDE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Thalidomide Analog [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220903</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lenalidomide capsules are a thalidomide analogue indicated for the treatment of adult patients with: 1 Multiple myeloma (MM), in combination with dexamethasone (1.1)., 2 Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities (1.2).</IndicationAndUsage>
    <Description>Lenalidomide capsules, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name is 3-(4-amino-1-oxo 1,3-dihydro-2H-isoindol-2-yl) piperidine-2,6-dione and it has the following chemical structure:. 3-(4-amino-1-oxo 1,3-dihydro-2H-isoindol-2-yl) piperidine-2,6-dione. The empirical formula for lenalidomide is C13H13N3O3, and the gram molecular weight is 259.3. Lenalidomide is an off-white to pale-yellow solid powder. It is soluble in organic solvent/water mixtures, and buffered aqueous solvents. Lenalidomide is more soluble in organic solvents and low pH solutions. Solubility was significantly lower in less acidic buffers, ranging from about 0.4 to 0.5 mg/ml. Lenalidomide has an asymmetric carbon atom and can exist as the optically active forms S(-) and R(+), and is produced as a racemic mixture with a net optical rotation of zero. Lenalidomide capsules are available in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg capsules for oral administration. Each capsule contains lenalidomide as the active ingredient and the following inactive ingredients: croscarmellose sodium, lactose anhydrous, magnesium stearate and microcrystalline cellulose. The 2.5 mg capsule shell contains gelatin, red iron oxide, yellow iron oxide, titanium dioxide, FD&amp;C blue #1, FD&amp;C red #3, FD&amp;C red #40 and black ink. The 5 mg capsule shell contains gelatin, titanium dioxide, black iron oxide, red iron oxide, yellow iron oxide, FD&amp;C blue #1, FD&amp;C yellow #6 and black ink. The 10 mg capsule shell contains gelatin, titanium dioxide, FD&amp;C blue #1, FD&amp;C red #40, FD&amp;C yellow #6, FD&amp;C yellow #5 and black ink. The 15 mg capsule shell contains gelatin, titanium dioxide, FD&amp;C blue #1, FD&amp;C red #40, FD&amp;C yellow #5, black iron oxide, red iron oxide, yellow iron oxide and black ink. The 20 mg capsule shell contains gelatin, titanium dioxide, FD&amp;C blue #1, FD&amp;C red #40, red iron oxide, yellow iron oxide and black ink. The 25 mg capsule shell contains gelatin, titanium dioxide and black ink. The black imprinting ink contains shellac, strong ammonia solution, black iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>49884-486-11</NDCCode>
    <PackageDescription>30 TABLET, ORALLY DISINTEGRATING in 1 DOSE PACK (49884-486-11) </PackageDescription>
    <NDC11Code>49884-0486-11</NDC11Code>
    <ProductNDC>49884-486</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lamotrigine</ProprietaryName>
    <NonProprietaryName>Lamotrigine</NonProprietaryName>
    <DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20151216</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204158</ApplicationNumber>
    <LabelerName>Par Health USA, LLC</LabelerName>
    <SubstanceName>LAMOTRIGINE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151216</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lamotrigine orally disintegrating tablets are indicated for. Epilepsy—adjunctive therapy in patients aged 2 years and older: 1 partial-onset seizures., 2 primary generalized tonic-clonic (PGTC) seizures., 3 generalized seizures of Lennox-Gastaut syndrome. (1.1).</IndicationAndUsage>
    <Description>Lamotrigine, USP an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine, USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine, USP is slightly soluble in 0.1 N hydrochloric acid, in acetone, in methanol and in water. The structural formula is. Lamotrigine orally disintegrating tablets are supplied for oral administration. The tablets contain 25 mg (white), 50 mg (white), 100 mg (peach), 200 mg (white) of lamotrigine, USP and the following inactive ingredients. For lamotrigine orally disintegrating tablets 25 mg, 50 mg and 200 mg: Colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, mannitol, starch (maize),  microcrystalline cellulose, pregelatinized starch, peppermint flavor, sodium stearyl fumarate and sucralose. For lamotrigine orally disintegrating tablets 100 mg: Colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, mannitol, starch (maize), microcrystalline cellulose, pregelatinized starch, peppermint flavor, sodium stearyl fumarate, sucralose and idacol red oxide of iron. Lamotrigine orally disintegrating tablets are formulated using in-house technologies designed to mask the bitter taste of lamotrigine and achieve a rapid dissolution profile.</Description>
  </NDC>
  <NDC>
    <NDCCode>49884-486-41</NDCCode>
    <PackageDescription>14 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (49884-486-41) </PackageDescription>
    <NDC11Code>49884-0486-41</NDC11Code>
    <ProductNDC>49884-486</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lamotrigine</ProprietaryName>
    <NonProprietaryName>Lamotrigine</NonProprietaryName>
    <DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20151216</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204158</ApplicationNumber>
    <LabelerName>Endo USA, Inc.</LabelerName>
    <SubstanceName>LAMOTRIGINE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151216</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lamotrigine orally disintegrating tablets are indicated for. Epilepsy—adjunctive therapy in patients aged 2 years and older: 1 partial-onset seizures., 2 primary generalized tonic-clonic seizures., 3 generalized seizures of Lennox-Gastaut syndrome. (1.1).</IndicationAndUsage>
    <Description>Lamotrigine, USP an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine, USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine, USP is slightly soluble in 0.1 N hydrochloric acid, in acetone, in methanol and in water. The structural formula is. Lamotrigine orally disintegrating tablets are supplied for oral administration. The tablets contain 25 mg (white), 50 mg (white), 100 mg (peach), 200 mg (white) of lamotrigine, USP and the following inactive ingredients. For lamotrigine orally disintegrating tablets 25 mg, 50 mg and 200 mg: Colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, mannitol, starch (maize),  microcrystalline cellulose, pregelatinized starch, peppermint flavor, sodium stearyl fumarate and sucralose. For lamotrigine orally disintegrating tablets 100 mg: Colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, mannitol, starch (maize), microcrystalline cellulose, pregelatinized starch, peppermint flavor, sodium stearyl fumarate, sucralose and idacol red oxide of iron. Lamotrigine orally disintegrating tablets are formulated using in-house technologies designed to mask the bitter taste of lamotrigine and achieve a rapid dissolution profile.</Description>
  </NDC>
</NDCList>