RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>81968-045-14</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (81968-045-14)  / 14 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE</PackageDescription>
    <NDC11Code>81968-0045-14</NDC11Code>
    <ProductNDC>81968-045</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Auvelity</ProprietaryName>
    <NonProprietaryName>Dextromethorphan Hydrobromide, Bupropion Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, MULTILAYER, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220818</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA215430</ApplicationNumber>
    <LabelerName>Axsome Therapeutics, Inc.</LabelerName>
    <SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; BUPROPION HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>45; 105</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240918</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <Description>AUVELITY is a combination of dextromethorphan hydrobromide, an uncompetitive NMDA receptor antagonist and sigma-1 receptor agonist, and bupropion hydrochloride, an aminoketone and CYP450 2D6 inhibitor. The chemical name of dextromethorphan hydrobromide is morphinan, 3- methoxy-17-methyl-, (9α, 13α, 14α), hydrobromide monohydrate. Dextromethorphan hydrobromide has the empirical formula C18H25NOHBrH2O and a molecular weight of 370.33 (271.4 dextromethorphan base). The structural formula is. Dextromethorphan hydrobromide powder is white or almost white, crystalline, and sparingly soluble in water. The chemical name of bupropion hydrochloride is:(±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1­propanone hydrochloride. Bupropion hydrochloride has the empirical formula C13H18ClNOHCl and a molecular weight of 276.2 (239.74 bupropion base). The structural formula is. Bupropion hydrochloride powder is white and highly soluble in water. AUVELITY is for oral administration and is available as round bilayer tablets. Each tablet contains either 30 mg or 45 mg dextromethorphan hydrobromide (equivalent to 21.99 and 32.98 mg, respectively, dextromethorphan base) in an immediate-release formulation and 105 mg bupropion hydrochloride (equivalent to 91.14 mg bupropion base) in an extended-release formulation. Each tablet contains the following inactive ingredients: carbomer homopolymer, colloidal silicon dioxide, crospovidone, glyceryl monocaprylocaprate, l-cysteine hydrochloride monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, sodium lauryl sulfate, stearic acid, talc, and titanium dioxide. Beige tablets additionally contain red iron oxide and yellow iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>81968-045-30</NDCCode>
    <PackageDescription>30 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (81968-045-30) </PackageDescription>
    <NDC11Code>81968-0045-30</NDC11Code>
    <ProductNDC>81968-045</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Auvelity</ProprietaryName>
    <NonProprietaryName>Dextromethorphan Hydrobromide, Bupropion Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, MULTILAYER, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220818</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA215430</ApplicationNumber>
    <LabelerName>Axsome Therapeutics, Inc.</LabelerName>
    <SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; BUPROPION HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>45; 105</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220818</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>AUVELITY is a combination of dextromethorphan hydrobromide, an uncompetitive NMDA receptor antagonist and sigma-1 receptor agonist, and bupropion hydrochloride, an aminoketone and CYP450 2D6 inhibitor. The chemical name of dextromethorphan hydrobromide is morphinan, 3- methoxy-17-methyl-, (9α, 13α, 14α), hydrobromide monohydrate. Dextromethorphan hydrobromide has the empirical formula C18H25NOHBrH2O and a molecular weight of 370.33 (271.4 dextromethorphan base). The structural formula is. Dextromethorphan hydrobromide powder is white or almost white, crystalline, and sparingly soluble in water. The chemical name of bupropion hydrochloride is:(±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1­propanone hydrochloride. Bupropion hydrochloride has the empirical formula C13H18ClNOHCl and a molecular weight of 276.2 (239.74 bupropion base). The structural formula is. Bupropion hydrochloride powder is white and highly soluble in water. AUVELITY is for oral administration and is available as round bilayer tablets. Each tablet contains either 30 mg or 45 mg dextromethorphan hydrobromide (equivalent to 21.99 and 32.98 mg, respectively, dextromethorphan base) in an immediate-release formulation and 105 mg bupropion hydrochloride (equivalent to 91.14 mg bupropion base) in an extended-release formulation. Each tablet contains the following inactive ingredients: carbomer homopolymer, colloidal silicon dioxide, crospovidone, glyceryl monocaprylocaprate, l-cysteine hydrochloride monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, sodium lauryl sulfate, stearic acid, talc, and titanium dioxide. Beige tablets additionally contain red iron oxide and yellow iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>81968-045-31</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (81968-045-31)  / 30 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE</PackageDescription>
    <NDC11Code>81968-0045-31</NDC11Code>
    <ProductNDC>81968-045</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Auvelity</ProprietaryName>
    <NonProprietaryName>Dextromethorphan Hydrobromide, Bupropion Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, MULTILAYER, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220818</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA215430</ApplicationNumber>
    <LabelerName>Axsome Therapeutics, Inc.</LabelerName>
    <SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; BUPROPION HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>45; 105</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240510</StartMarketingDatePackage>
    <EndMarketingDatePackage>20270328</EndMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <Description>AUVELITY is a combination of dextromethorphan hydrobromide, an uncompetitive NMDA receptor antagonist and sigma-1 receptor agonist, and bupropion hydrochloride, an aminoketone and CYP450 2D6 inhibitor. The chemical name of dextromethorphan hydrobromide is morphinan, 3- methoxy-17-methyl-, (9α, 13α, 14α), hydrobromide monohydrate. Dextromethorphan hydrobromide has the empirical formula C18H25NOHBrH2O and a molecular weight of 370.33 (271.4 dextromethorphan base). The structural formula is. Dextromethorphan hydrobromide powder is white or almost white, crystalline, and sparingly soluble in water. The chemical name of bupropion hydrochloride is:(±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1­propanone hydrochloride. Bupropion hydrochloride has the empirical formula C13H18ClNOHCl and a molecular weight of 276.2 (239.74 bupropion base). The structural formula is. Bupropion hydrochloride powder is white and highly soluble in water. AUVELITY is for oral administration and is available as round bilayer tablets. Each tablet contains either 30 mg or 45 mg dextromethorphan hydrobromide (equivalent to 21.99 and 32.98 mg, respectively, dextromethorphan base) in an immediate-release formulation and 105 mg bupropion hydrochloride (equivalent to 91.14 mg bupropion base) in an extended-release formulation. Each tablet contains the following inactive ingredients: carbomer homopolymer, colloidal silicon dioxide, crospovidone, glyceryl monocaprylocaprate, l-cysteine hydrochloride monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, sodium lauryl sulfate, stearic acid, talc, and titanium dioxide. Beige tablets additionally contain red iron oxide and yellow iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>81968-045-60</NDCCode>
    <PackageDescription>60 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (81968-045-60) </PackageDescription>
    <NDC11Code>81968-0045-60</NDC11Code>
    <ProductNDC>81968-045</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Auvelity</ProprietaryName>
    <NonProprietaryName>Dextromethorphan Hydrobromide, Bupropion Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, MULTILAYER, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220818</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA215430</ApplicationNumber>
    <LabelerName>Axsome Therapeutics, Inc.</LabelerName>
    <SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; BUPROPION HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>45; 105</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240628</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>AUVELITY is a combination of dextromethorphan hydrobromide, an uncompetitive NMDA receptor antagonist and sigma-1 receptor agonist, and bupropion hydrochloride, an aminoketone and CYP450 2D6 inhibitor. The chemical name of dextromethorphan hydrobromide is morphinan, 3- methoxy-17-methyl-, (9α, 13α, 14α), hydrobromide monohydrate. Dextromethorphan hydrobromide has the empirical formula C18H25NOHBrH2O and a molecular weight of 370.33 (271.4 dextromethorphan base). The structural formula is. Dextromethorphan hydrobromide powder is white or almost white, crystalline, and sparingly soluble in water. The chemical name of bupropion hydrochloride is:(±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1­propanone hydrochloride. Bupropion hydrochloride has the empirical formula C13H18ClNOHCl and a molecular weight of 276.2 (239.74 bupropion base). The structural formula is. Bupropion hydrochloride powder is white and highly soluble in water. AUVELITY is for oral administration and is available as round bilayer tablets. Each tablet contains either 30 mg or 45 mg dextromethorphan hydrobromide (equivalent to 21.99 and 32.98 mg, respectively, dextromethorphan base) in an immediate-release formulation and 105 mg bupropion hydrochloride (equivalent to 91.14 mg bupropion base) in an extended-release formulation. Each tablet contains the following inactive ingredients: carbomer homopolymer, colloidal silicon dioxide, crospovidone, glyceryl monocaprylocaprate, l-cysteine hydrochloride monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, sodium lauryl sulfate, stearic acid, talc, and titanium dioxide. Beige tablets additionally contain red iron oxide and yellow iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>81968-345-01</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (81968-345-01)  *  30 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE *  1 BOTTLE in 1 CARTON / 14 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE *  1 BOTTLE in 1 CARTON / 21 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE</PackageDescription>
    <NDC11Code>81968-0345-01</NDC11Code>
    <ProductNDC>81968-345</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Auvelity</ProprietaryName>
    <NonProprietaryName>Dextromethorphan Hydrobromide, Bupropion Hydrochloride</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20260601</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA215430</ApplicationNumber>
    <LabelerName>Axsome Therapeutics, Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-08-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>AUVELITY is a combination of dextromethorphan hydrobromide, an uncompetitive NMDA receptor antagonist and sigma-1 receptor agonist, and bupropion hydrochloride, an aminoketone and CYP450 2D6 inhibitor. The chemical name of dextromethorphan hydrobromide is morphinan, 3- methoxy-17-methyl-, (9α, 13α, 14α), hydrobromide monohydrate. Dextromethorphan hydrobromide has the empirical formula C18H25NOHBrH2O and a molecular weight of 370.33 (271.4 dextromethorphan base). The structural formula is. Dextromethorphan hydrobromide powder is white or almost white, crystalline, and sparingly soluble in water. The chemical name of bupropion hydrochloride is:(±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1­propanone hydrochloride. Bupropion hydrochloride has the empirical formula C13H18ClNOHCl and a molecular weight of 276.2 (239.74 bupropion base). The structural formula is. Bupropion hydrochloride powder is white and highly soluble in water. AUVELITY is for oral administration and is available as round bilayer tablets. Each tablet contains either 30 mg or 45 mg dextromethorphan hydrobromide (equivalent to 21.99 and 32.98 mg, respectively, dextromethorphan base) in an immediate-release formulation and 105 mg bupropion hydrochloride (equivalent to 91.14 mg bupropion base) in an extended-release formulation. Each tablet contains the following inactive ingredients: carbomer homopolymer, colloidal silicon dioxide, crospovidone, glyceryl monocaprylocaprate, l-cysteine hydrochloride monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, sodium lauryl sulfate, stearic acid, talc, and titanium dioxide. Beige tablets additionally contain red iron oxide and yellow iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>81968-345-03</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (81968-345-03)  *  30 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE *  1 BOTTLE in 1 CARTON / 14 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE *  1 BOTTLE in 1 CARTON / 21 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE</PackageDescription>
    <NDC11Code>81968-0345-03</NDC11Code>
    <ProductNDC>81968-345</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Auvelity</ProprietaryName>
    <NonProprietaryName>Dextromethorphan Hydrobromide, Bupropion Hydrochloride</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20260601</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA215430</ApplicationNumber>
    <LabelerName>Axsome Therapeutics, Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-08-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260601</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <Description>AUVELITY is a combination of dextromethorphan hydrobromide, an uncompetitive NMDA receptor antagonist and sigma-1 receptor agonist, and bupropion hydrochloride, an aminoketone and CYP450 2D6 inhibitor. The chemical name of dextromethorphan hydrobromide is morphinan, 3- methoxy-17-methyl-, (9α, 13α, 14α), hydrobromide monohydrate. Dextromethorphan hydrobromide has the empirical formula C18H25NOHBrH2O and a molecular weight of 370.33 (271.4 dextromethorphan base). The structural formula is. Dextromethorphan hydrobromide powder is white or almost white, crystalline, and sparingly soluble in water. The chemical name of bupropion hydrochloride is:(±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1­propanone hydrochloride. Bupropion hydrochloride has the empirical formula C13H18ClNOHCl and a molecular weight of 276.2 (239.74 bupropion base). The structural formula is. Bupropion hydrochloride powder is white and highly soluble in water. AUVELITY is for oral administration and is available as round bilayer tablets. Each tablet contains either 30 mg or 45 mg dextromethorphan hydrobromide (equivalent to 21.99 and 32.98 mg, respectively, dextromethorphan base) in an immediate-release formulation and 105 mg bupropion hydrochloride (equivalent to 91.14 mg bupropion base) in an extended-release formulation. Each tablet contains the following inactive ingredients: carbomer homopolymer, colloidal silicon dioxide, crospovidone, glyceryl monocaprylocaprate, l-cysteine hydrochloride monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, sodium lauryl sulfate, stearic acid, talc, and titanium dioxide. Beige tablets additionally contain red iron oxide and yellow iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>81968-453-01</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (81968-453-01)  *  1 BOTTLE in 1 CARTON / 21 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE *  1 BOTTLE in 1 CARTON / 14 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE</PackageDescription>
    <NDC11Code>81968-0453-01</NDC11Code>
    <ProductNDC>81968-453</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Auvelity</ProprietaryName>
    <NonProprietaryName>Dextromethorphan Hydrobromide, Bupropion Hydrochloride</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20260730</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA215430</ApplicationNumber>
    <LabelerName>Axsome Therapeutics, Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-08-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260730</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <Description>AUVELITY is a combination of dextromethorphan hydrobromide, an uncompetitive NMDA receptor antagonist and sigma-1 receptor agonist, and bupropion hydrochloride, an aminoketone and CYP450 2D6 inhibitor. The chemical name of dextromethorphan hydrobromide is morphinan, 3- methoxy-17-methyl-, (9α, 13α, 14α), hydrobromide monohydrate. Dextromethorphan hydrobromide has the empirical formula C18H25NOHBrH2O and a molecular weight of 370.33 (271.4 dextromethorphan base). The structural formula is. Dextromethorphan hydrobromide powder is white or almost white, crystalline, and sparingly soluble in water. The chemical name of bupropion hydrochloride is:(±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1­propanone hydrochloride. Bupropion hydrochloride has the empirical formula C13H18ClNOHCl and a molecular weight of 276.2 (239.74 bupropion base). The structural formula is. Bupropion hydrochloride powder is white and highly soluble in water. AUVELITY is for oral administration and is available as round bilayer tablets. Each tablet contains either 30 mg or 45 mg dextromethorphan hydrobromide (equivalent to 21.99 and 32.98 mg, respectively, dextromethorphan base) in an immediate-release formulation and 105 mg bupropion hydrochloride (equivalent to 91.14 mg bupropion base) in an extended-release formulation. Each tablet contains the following inactive ingredients: carbomer homopolymer, colloidal silicon dioxide, crospovidone, glyceryl monocaprylocaprate, l-cysteine hydrochloride monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, sodium lauryl sulfate, stearic acid, talc, and titanium dioxide. Beige tablets additionally contain red iron oxide and yellow iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>11701-045-14</NDCCode>
    <PackageDescription>142 g in 1 TUBE (11701-045-14) </PackageDescription>
    <NDC11Code>11701-0045-14</NDC11Code>
    <ProductNDC>11701-045</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Baza Antifungal</ProprietaryName>
    <NonProprietaryName>Miconazole Nitrate</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20090615</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M005</ApplicationNumber>
    <LabelerName>Coloplast Corp</LabelerName>
    <SubstanceName>MICONAZOLE NITRATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090615</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses For effective treatment of jock itch. Relieves itching, scaling, irritation, redness and discomfort.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>20276-045-14</NDCCode>
    <PackageDescription>420 mL in 1 BOTTLE, PLASTIC (20276-045-14) </PackageDescription>
    <NDC11Code>20276-0045-14</NDC11Code>
    <ProductNDC>20276-045</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lucky</ProprietaryName>
    <ProprietaryNameSuffix>Classic</ProprietaryNameSuffix>
    <NonProprietaryName>Pyrithione Zinc</NonProprietaryName>
    <DosageFormName>SHAMPOO</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20120630</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>M032</ApplicationNumber>
    <LabelerName>Delta Brands Inc</LabelerName>
    <SubstanceName>PYRITHIONE ZINC</SubstanceName>
    <StrengthNumber>.3</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120630</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage> helps to treat flakes, itch, irritation, oilness or dryness caused by dandruff.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>65841-045-14</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (65841-045-14) </PackageDescription>
    <NDC11Code>65841-0045-14</NDC11Code>
    <ProductNDC>65841-045</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
    <NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171202</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077106</ApplicationNumber>
    <LabelerName>Zydus Lifesciences Limited</LabelerName>
    <SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-08-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171202</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>66267-045-14</NDCCode>
    <PackageDescription>14 CAPSULE in 1 BOTTLE (66267-045-14) </PackageDescription>
    <NDC11Code>66267-0045-14</NDC11Code>
    <ProductNDC>66267-045</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cefadroxil</ProprietaryName>
    <NonProprietaryName>Cefadroxil</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080423</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065392</ApplicationNumber>
    <LabelerName>NuCare Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>CEFADROXIL</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160928</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cefadroxil Capsules USP are indicated for the treatment of patients with infection caused by susceptible strains of the designated organisms in the following diseases. Urinary tract infections caused by E. coli, P. mirabilis, and Klebsiella species. Skin and skin structure infections caused by staphylococci and/or streptococci. Pharyngitis and/or tonsillitis caused by Streptococcus pyogenes (Group A beta-hemolytic streptococci). Note: Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Cefadroxil monohydrate is generally effective in the eradication of streptococci from the oropharynx. However, data establishing the efficacy of cefadroxil monohydrate for the prophylaxis of subsequent rheumatic fever are not available. Note: Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated. To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefadroxil capsules and other antibacterial drugs, cefadroxil capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
    <Description>Cefadroxil monohydrate is a semisynthetic cephalosporin antibiotic intended for oral administration. It is a white to yellowish-white crystalline powder. It is soluble in water and it is acid-stable. It is chemically designated as 5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[amino(4-hydroxyphenyl)acetyl]amino]-3-methyl-8-oxo-, monohydrate, [6R-[6α,7β(R*)]]-. It has the formula C 16H 17N 3O 5SH 2O and the molecular weight of 381.40. It has the following structural formula:. Each capsule contains cefadroxil monohydrate USP equivalent to 500 mg of cefadroxil. In addition, each capsule also contains the following inactive ingredients: crospovidone, D&amp;C Red No. 28, FD&amp;C Blue No. 1, FD&amp;C Red No. 40, ferric oxide black, gelatin, magnesium stearate, microcrystalline cellulose, potassium hydroxide, propylene glycol, shellac and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>68196-045-03</NDCCode>
    <PackageDescription>3 BOTTLE in 1 PACKAGE (68196-045-03)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68196-045-01) </PackageDescription>
    <NDC11Code>68196-0045-03</NDC11Code>
    <ProductNDC>68196-045</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lansoprazole</ProprietaryName>
    <NonProprietaryName>Lansoprazole</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190819</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202194</ApplicationNumber>
    <LabelerName>Sam's West Inc.</LabelerName>
    <SubstanceName>LANSOPRAZOLE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-08-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230502</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>treats frequent heartburn (occurs 2 or more days a week) . not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>68382-045-14</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (68382-045-14) </PackageDescription>
    <NDC11Code>68382-0045-14</NDC11Code>
    <ProductNDC>68382-045</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
    <NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171202</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077106</ApplicationNumber>
    <LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
    <SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-10-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171202</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>69555-045-14</NDCCode>
    <PackageDescription>75 mL in 1 TUBE (69555-045-14) </PackageDescription>
    <NDC11Code>69555-0045-14</NDC11Code>
    <ProductNDC>69555-045</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Every Day Mineral Sun Screen Spf 45</ProprietaryName>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20211111</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Stream2Sea, LLC</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>190</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-05-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231211</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses: 1 Helps prevent sunburn .</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>70377-045-14</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (70377-045-14) </PackageDescription>
    <NDC11Code>70377-0045-14</NDC11Code>
    <ProductNDC>70377-045</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pravastatin Sodium</ProprietaryName>
    <NonProprietaryName>Pravastatin Sodium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209869</ApplicationNumber>
    <LabelerName>Biocon Pharma Inc.</LabelerName>
    <SubstanceName>PRAVASTATIN SODIUM</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pravastatin sodium tablets are indicated: 1 To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD)., 2 To reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient ischemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident CHD., 3 As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia., 4 As an adjunct to diet to reduce LDL-C in pediatric patients ages 8 years and older with heterozygous familial hypercholesterolemia (HeFH)., 5 As an adjunct to diet for the treatment of adults with:Primary dysbetalipoproteinemia.o   Hypertriglyceridemia.</IndicationAndUsage>
    <Description>Pravastatin sodium, USP is a statin, an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Pravastatin sodium, USP is designated chemically as 1-Naphthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro-2-methyl-8-(2-methyl-1-oxobutoxy)-β,δ,6-trihydroxy-,monosodium salt, [1S- [1α(βS*,δS*),2α,6α,8β(R*),8aα]]-. Structural formula. Pravastatin sodium, USP is white to off-white powder. It is a relatively polar hydrophilic compound with a partition coefficient (n-octanol/water) of 0.59. It is soluble in water (676 mg/mL). Pravastatin sodium, USP is available for oral administration as 10 mg, 20 mg, 40 mg, and 80 mg tablets. Inactive ingredients include: Croscarmellose sodium, lactose Monohydrate, magnesium oxide, magnesium stearate, microcrystalline cellulose, and povidone.</Description>
  </NDC>
  <NDC>
    <NDCCode>70934-045-14</NDCCode>
    <PackageDescription>14 TABLET in 1 BOTTLE, PLASTIC (70934-045-14) </PackageDescription>
    <NDC11Code>70934-0045-14</NDC11Code>
    <ProductNDC>70934-045</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ciprofloxacin</ProprietaryName>
    <NonProprietaryName>Ciprofloxacin</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171121</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076639</ApplicationNumber>
    <LabelerName>Denton Pharma, Inc. DBA Northwind Pharmaceuticals</LabelerName>
    <SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Quinolone Antimicrobial [EPC],Quinolones [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180905</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ciprofloxacin is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the conditions and patient populations listed below.</IndicationAndUsage>
    <Description>Ciprofloxacin (ciprofloxacin hydrochloride) Tablets USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its empirical formula is C 17H 18FN 3O 3 HCl H 2O and its chemical structure is as follows:. Ciprofloxacin film-coated Tablets are available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths. Ciprofloxacin tablets USP are white to slightly yellowish. The inactive ingredients are pregelatinized starch, microcrystalline cellulose, colloidal silicon dioxide, crospovidone, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and purified water.</Description>
  </NDC>
  <NDC>
    <NDCCode>71220-045-01</NDCCode>
    <PackageDescription>1 CONTAINER in 1 CARTON (71220-045-01)  &gt; 14 g in 1 CONTAINER</PackageDescription>
    <NDC11Code>71220-0045-01</NDC11Code>
    <ProductNDC>71220-045</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Matte Full Cover Cushion W21</ProprietaryName>
    <NonProprietaryName>Octinoxate, Titanium Dioxide, And Zinc Oxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20170623</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Innisfree Corporation</LabelerName>
    <SubstanceName>OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>7; 3.32; 7.84</StrengthNumber>
    <StrengthUnit>g/14g; g/14g; g/14g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-10-17</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>76420-045-14</NDCCode>
    <PackageDescription>14 TABLET, FILM COATED in 1 BOTTLE (76420-045-14) </PackageDescription>
    <NDC11Code>76420-0045-14</NDC11Code>
    <ProductNDC>76420-045</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ciprofloxacin</ProprietaryName>
    <NonProprietaryName>Ciprofloxacin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070426</StartMarketingDate>
    <EndMarketingDate>20261031</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077859</ApplicationNumber>
    <LabelerName>Asclemed USA, Inc.</LabelerName>
    <SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20200904</StartMarketingDatePackage>
    <EndMarketingDatePackage>20261031</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ciprofloxacin tablet is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: : 1 Skin and Skin Structure Infections ( 1.1) , 2 Bone and Joint Infections ( 1.2) , 3 Complicated Intra-Abdominal Infections ( 1.3) , 4 Infectious Diarrhea ( 1.4) , 5 Typhoid Fever (Enteric Fever) ( 1.5) , 6 Uncomplicated Cervical and Urethral Gonorrhea ( 1.6) , 7 Inhalational Anthrax post-exposure in adult and pediatric patients ( 1.7) , 8 Plague in adult and pediatric patients ( 1.8) , 9 Chronic Bacterial Prostatitis ( 1.9) , 10 Lower Respiratory Tract Infections ( 1.10) Acute Exacerbation of Chronic Bronchitis, 11 Urinary Tract Infections ( 1.11) Urinary Tract Infections (UTI)Acute Uncomplicated CystitisComplicated UTI and Pyelonephritis in Pediatric Patients, 12 Acute Sinusitis ( 1.12) .</IndicationAndUsage>
    <Description>Ciprofloxacin tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3­-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C 17H 18FN 3O 3HClH 2O and its chemical structure is as follows:. Ciprofloxacin is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is C 17H 18FN 3O 3and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows:. Ciprofloxacin film-coated tablets are available in 500 mg (ciprofloxacin equivalent) strengths. Each ciprofloxacin film-coated tablet contains  500 mg (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets, USP are white to off-white. The inactive ingredients are colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>81968-030-22</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (81968-030-22)  / 21 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE</PackageDescription>
    <NDC11Code>81968-0030-22</NDC11Code>
    <ProductNDC>81968-030</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Auvelity</ProprietaryName>
    <NonProprietaryName>Dextromethorphan Hydrobromide, Bupropion Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, MULTILAYER, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260508</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA215430</ApplicationNumber>
    <LabelerName>Axsome Therapeutics, Inc.</LabelerName>
    <SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; BUPROPION HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>30; 105</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260508</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <Description>AUVELITY is a combination of dextromethorphan hydrobromide, an uncompetitive NMDA receptor antagonist and sigma-1 receptor agonist, and bupropion hydrochloride, an aminoketone and CYP450 2D6 inhibitor. The chemical name of dextromethorphan hydrobromide is morphinan, 3- methoxy-17-methyl-, (9α, 13α, 14α), hydrobromide monohydrate. Dextromethorphan hydrobromide has the empirical formula C18H25NOHBrH2O and a molecular weight of 370.33 (271.4 dextromethorphan base). The structural formula is. Dextromethorphan hydrobromide powder is white or almost white, crystalline, and sparingly soluble in water. The chemical name of bupropion hydrochloride is:(±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1­propanone hydrochloride. Bupropion hydrochloride has the empirical formula C13H18ClNOHCl and a molecular weight of 276.2 (239.74 bupropion base). The structural formula is. Bupropion hydrochloride powder is white and highly soluble in water. AUVELITY is for oral administration and is available as round bilayer tablets. Each tablet contains either 30 mg or 45 mg dextromethorphan hydrobromide (equivalent to 21.99 and 32.98 mg, respectively, dextromethorphan base) in an immediate-release formulation and 105 mg bupropion hydrochloride (equivalent to 91.14 mg bupropion base) in an extended-release formulation. Each tablet contains the following inactive ingredients: carbomer homopolymer, colloidal silicon dioxide, crospovidone, glyceryl monocaprylocaprate, l-cysteine hydrochloride monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, sodium lauryl sulfate, stearic acid, talc, and titanium dioxide. Beige tablets additionally contain red iron oxide and yellow iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>81968-350-01</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (81968-350-01) </PackageDescription>
    <NDC11Code>81968-0350-01</NDC11Code>
    <ProductNDC>81968-350</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sunosi</ProprietaryName>
    <NonProprietaryName>Solriamfetol</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190618</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA211230</ApplicationNumber>
    <LabelerName>Axsome Therapeutics, Inc.</LabelerName>
    <SubstanceName>SOLRIAMFETOL</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dopamine Uptake Inhibitors [MoA], Dopamine and Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-05-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220602</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>SUNOSI is indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) [see Clinical Studies (14)]. Limitations of Use. SUNOSI is not indicated to treat the underlying airway obstruction in OSA. Ensure that the underlying airway obstruction is treated (e.g., with continuous positive airway pressure (CPAP)) for at least one month prior to initiating SUNOSI for excessive daytime sleepiness. Modalities to treat the underlying airway obstruction should be continued during treatment with SUNOSI. SUNOSI is not a substitute for these modalities.</IndicationAndUsage>
    <Description>SUNOSI contains solriamfetol, a dopamine and norepinephrine reuptake inhibitor (DNRI). Solriamfetol is a phenylalanine derivative with the systematic name (R)-2-amino-3-phenylpropylcarbamate hydrochloride. The molecular formula is C10H15N2O2Cl, and the molecular weight is 230.69. The chemical structure is. Solriamfetol hydrochloride is a white to off-white solid that is freely soluble in water. SUNOSI tablets are intended for oral administration. Each 75 mg SUNOSI film-coated tablet contains 75 mg solriamfetol (equivalent to 89.3 mg solriamfetol hydrochloride). Each 150 mg SUNOSI film-coated tablet contains 150 mg solriamfetol (equivalent to 178.5 mg solriamfetol hydrochloride). The inactive ingredients are hydroxypropyl cellulose and magnesium stearate. In addition, the film coating contains: iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>81968-350-07</NDCCode>
    <PackageDescription>7 TABLET, FILM COATED in 1 BLISTER PACK (81968-350-07) </PackageDescription>
    <NDC11Code>81968-0350-07</NDC11Code>
    <ProductNDC>81968-350</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sunosi</ProprietaryName>
    <NonProprietaryName>Solriamfetol</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190618</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA211230</ApplicationNumber>
    <LabelerName>Axsome Therapeutics, Inc.</LabelerName>
    <SubstanceName>SOLRIAMFETOL</SubstanceName>
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    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dopamine Uptake Inhibitors [MoA], Dopamine and Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-05-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220602</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>SUNOSI is indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) [see Clinical Studies (14)]. Limitations of Use. SUNOSI is not indicated to treat the underlying airway obstruction in OSA. Ensure that the underlying airway obstruction is treated (e.g., with continuous positive airway pressure (CPAP)) for at least one month prior to initiating SUNOSI for excessive daytime sleepiness. Modalities to treat the underlying airway obstruction should be continued during treatment with SUNOSI. SUNOSI is not a substitute for these modalities.</IndicationAndUsage>
    <Description>SUNOSI contains solriamfetol, a dopamine and norepinephrine reuptake inhibitor (DNRI). Solriamfetol is a phenylalanine derivative with the systematic name (R)-2-amino-3-phenylpropylcarbamate hydrochloride. The molecular formula is C10H15N2O2Cl, and the molecular weight is 230.69. The chemical structure is. Solriamfetol hydrochloride is a white to off-white solid that is freely soluble in water. SUNOSI tablets are intended for oral administration. Each 75 mg SUNOSI film-coated tablet contains 75 mg solriamfetol (equivalent to 89.3 mg solriamfetol hydrochloride). Each 150 mg SUNOSI film-coated tablet contains 150 mg solriamfetol (equivalent to 178.5 mg solriamfetol hydrochloride). The inactive ingredients are hydroxypropyl cellulose and magnesium stearate. In addition, the film coating contains: iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>81968-350-10</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (81968-350-10)  / 7 TABLET, FILM COATED in 1 BLISTER PACK (81968-350-07) </PackageDescription>
    <NDC11Code>81968-0350-10</NDC11Code>
    <ProductNDC>81968-350</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sunosi</ProprietaryName>
    <NonProprietaryName>Solriamfetol</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190618</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA211230</ApplicationNumber>
    <LabelerName>Axsome Therapeutics, Inc.</LabelerName>
    <SubstanceName>SOLRIAMFETOL</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dopamine Uptake Inhibitors [MoA], Dopamine and Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-05-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220602</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>SUNOSI is indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) [see Clinical Studies (14)]. Limitations of Use. SUNOSI is not indicated to treat the underlying airway obstruction in OSA. Ensure that the underlying airway obstruction is treated (e.g., with continuous positive airway pressure (CPAP)) for at least one month prior to initiating SUNOSI for excessive daytime sleepiness. Modalities to treat the underlying airway obstruction should be continued during treatment with SUNOSI. SUNOSI is not a substitute for these modalities.</IndicationAndUsage>
    <Description>SUNOSI contains solriamfetol, a dopamine and norepinephrine reuptake inhibitor (DNRI). Solriamfetol is a phenylalanine derivative with the systematic name (R)-2-amino-3-phenylpropylcarbamate hydrochloride. The molecular formula is C10H15N2O2Cl, and the molecular weight is 230.69. The chemical structure is. Solriamfetol hydrochloride is a white to off-white solid that is freely soluble in water. SUNOSI tablets are intended for oral administration. Each 75 mg SUNOSI film-coated tablet contains 75 mg solriamfetol (equivalent to 89.3 mg solriamfetol hydrochloride). Each 150 mg SUNOSI film-coated tablet contains 150 mg solriamfetol (equivalent to 178.5 mg solriamfetol hydrochloride). The inactive ingredients are hydroxypropyl cellulose and magnesium stearate. In addition, the film coating contains: iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>81968-351-01</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (81968-351-01) </PackageDescription>
    <NDC11Code>81968-0351-01</NDC11Code>
    <ProductNDC>81968-351</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sunosi</ProprietaryName>
    <NonProprietaryName>Solriamfetol</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190618</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA211230</ApplicationNumber>
    <LabelerName>Axsome Therapeutics, Inc.</LabelerName>
    <SubstanceName>SOLRIAMFETOL</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dopamine Uptake Inhibitors [MoA], Dopamine and Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-05-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220602</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>SUNOSI is indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) [see Clinical Studies (14)]. Limitations of Use. SUNOSI is not indicated to treat the underlying airway obstruction in OSA. Ensure that the underlying airway obstruction is treated (e.g., with continuous positive airway pressure (CPAP)) for at least one month prior to initiating SUNOSI for excessive daytime sleepiness. Modalities to treat the underlying airway obstruction should be continued during treatment with SUNOSI. SUNOSI is not a substitute for these modalities.</IndicationAndUsage>
    <Description>SUNOSI contains solriamfetol, a dopamine and norepinephrine reuptake inhibitor (DNRI). Solriamfetol is a phenylalanine derivative with the systematic name (R)-2-amino-3-phenylpropylcarbamate hydrochloride. The molecular formula is C10H15N2O2Cl, and the molecular weight is 230.69. The chemical structure is. Solriamfetol hydrochloride is a white to off-white solid that is freely soluble in water. SUNOSI tablets are intended for oral administration. Each 75 mg SUNOSI film-coated tablet contains 75 mg solriamfetol (equivalent to 89.3 mg solriamfetol hydrochloride). Each 150 mg SUNOSI film-coated tablet contains 150 mg solriamfetol (equivalent to 178.5 mg solriamfetol hydrochloride). The inactive ingredients are hydroxypropyl cellulose and magnesium stearate. In addition, the film coating contains: iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>81968-351-07</NDCCode>
    <PackageDescription>7 TABLET, FILM COATED in 1 BLISTER PACK (81968-351-07) </PackageDescription>
    <NDC11Code>81968-0351-07</NDC11Code>
    <ProductNDC>81968-351</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sunosi</ProprietaryName>
    <NonProprietaryName>Solriamfetol</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190618</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA211230</ApplicationNumber>
    <LabelerName>Axsome Therapeutics, Inc.</LabelerName>
    <SubstanceName>SOLRIAMFETOL</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dopamine Uptake Inhibitors [MoA], Dopamine and Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-05-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220602</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>SUNOSI is indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) [see Clinical Studies (14)]. Limitations of Use. SUNOSI is not indicated to treat the underlying airway obstruction in OSA. Ensure that the underlying airway obstruction is treated (e.g., with continuous positive airway pressure (CPAP)) for at least one month prior to initiating SUNOSI for excessive daytime sleepiness. Modalities to treat the underlying airway obstruction should be continued during treatment with SUNOSI. SUNOSI is not a substitute for these modalities.</IndicationAndUsage>
    <Description>SUNOSI contains solriamfetol, a dopamine and norepinephrine reuptake inhibitor (DNRI). Solriamfetol is a phenylalanine derivative with the systematic name (R)-2-amino-3-phenylpropylcarbamate hydrochloride. The molecular formula is C10H15N2O2Cl, and the molecular weight is 230.69. The chemical structure is. Solriamfetol hydrochloride is a white to off-white solid that is freely soluble in water. SUNOSI tablets are intended for oral administration. Each 75 mg SUNOSI film-coated tablet contains 75 mg solriamfetol (equivalent to 89.3 mg solriamfetol hydrochloride). Each 150 mg SUNOSI film-coated tablet contains 150 mg solriamfetol (equivalent to 178.5 mg solriamfetol hydrochloride). The inactive ingredients are hydroxypropyl cellulose and magnesium stearate. In addition, the film coating contains: iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>81968-351-10</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (81968-351-10)  / 7 TABLET, FILM COATED in 1 BLISTER PACK (81968-351-07) </PackageDescription>
    <NDC11Code>81968-0351-10</NDC11Code>
    <ProductNDC>81968-351</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sunosi</ProprietaryName>
    <NonProprietaryName>Solriamfetol</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190618</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA211230</ApplicationNumber>
    <LabelerName>Axsome Therapeutics, Inc.</LabelerName>
    <SubstanceName>SOLRIAMFETOL</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dopamine Uptake Inhibitors [MoA], Dopamine and Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-05-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220602</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>SUNOSI is indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) [see Clinical Studies (14)]. Limitations of Use. SUNOSI is not indicated to treat the underlying airway obstruction in OSA. Ensure that the underlying airway obstruction is treated (e.g., with continuous positive airway pressure (CPAP)) for at least one month prior to initiating SUNOSI for excessive daytime sleepiness. Modalities to treat the underlying airway obstruction should be continued during treatment with SUNOSI. SUNOSI is not a substitute for these modalities.</IndicationAndUsage>
    <Description>SUNOSI contains solriamfetol, a dopamine and norepinephrine reuptake inhibitor (DNRI). Solriamfetol is a phenylalanine derivative with the systematic name (R)-2-amino-3-phenylpropylcarbamate hydrochloride. The molecular formula is C10H15N2O2Cl, and the molecular weight is 230.69. The chemical structure is. Solriamfetol hydrochloride is a white to off-white solid that is freely soluble in water. SUNOSI tablets are intended for oral administration. Each 75 mg SUNOSI film-coated tablet contains 75 mg solriamfetol (equivalent to 89.3 mg solriamfetol hydrochloride). Each 150 mg SUNOSI film-coated tablet contains 150 mg solriamfetol (equivalent to 178.5 mg solriamfetol hydrochloride). The inactive ingredients are hydroxypropyl cellulose and magnesium stearate. In addition, the film coating contains: iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0069-2522-02</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0069-2522-02)  / 1.1 mL in 1 VIAL, SINGLE-DOSE (0069-2522-01) </PackageDescription>
    <NDC11Code>00069-2522-02</NDC11Code>
    <ProductNDC>0069-2522</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Elrexfio</ProprietaryName>
    <NonProprietaryName>Elranatamab-bcmm</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20230815</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761345</ApplicationNumber>
    <LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
    <SubstanceName>ELRANATAMAB</SubstanceName>
    <StrengthNumber>44</StrengthNumber>
    <StrengthUnit>mg/1.1mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-09-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230815</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ELREXFIO is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).</IndicationAndUsage>
    <Description>Elranatamab-bcmm is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager. It is a bispecific, humanized immunoglobulin 2-alanine (IgG2Δa) kappa antibody derived from two monoclonal antibodies (mAbs), an anti-BCMA mAb and an anti-CD3 mAb. Each of these mAbs contributes one distinct heavy (H) chain and one distinct light (L) chain to the bispecific elranatamab-bcmm. The resulting 4-chain bispecific antibody is covalently linked via five inter-chain disulfide bonds. Elranatamab-bcmm is produced using two recombinant Chinese hamster ovary (CHO) cell lines, one that contains the DNA encoding the sequence for anti-BCMA monoclonal antibody (mAb) and one that contains the sequence for anti-CD3 mAb, which are grown separately in suspension culture using chemically-defined (CD), animal-derived component-free (ACF) media. The molecular weight of elranatamab-bcmm is approximately 148.5 kDa. ELREXFIO® (elranatamab-bcmm) injection is a sterile, preservative-free, clear to slightly opalescent, and colorless to pale brown liquid solution for subcutaneous administration. ELREXFIO (elranatamab-bcmm) is supplied at a concentration of 40 mg/mL in either 76 mg/1.9 mL or 44 mg/1.1 mL single-dose vials. Each mL of solution contains 40 mg elranatamab-bcmm, edetate disodium (0.045 mg), histidine (1.12 mg), L-histidine hydrochloride monohydrate (2.67 mg), polysorbate 80 (0.2 mg), sucrose (85 mg) and Water for Injection. The pH is 5.8.</Description>
  </NDC>
  <NDC>
    <NDCCode>0069-4494-02</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0069-4494-02)  / 1.9 mL in 1 VIAL, SINGLE-DOSE (0069-4494-01) </PackageDescription>
    <NDC11Code>00069-4494-02</NDC11Code>
    <ProductNDC>0069-4494</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Elrexfio</ProprietaryName>
    <NonProprietaryName>Elranatamab-bcmm</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20230815</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761345</ApplicationNumber>
    <LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
    <SubstanceName>ELRANATAMAB</SubstanceName>
    <StrengthNumber>76</StrengthNumber>
    <StrengthUnit>mg/1.9mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-09-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230815</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ELREXFIO is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).</IndicationAndUsage>
    <Description>Elranatamab-bcmm is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager. It is a bispecific, humanized immunoglobulin 2-alanine (IgG2Δa) kappa antibody derived from two monoclonal antibodies (mAbs), an anti-BCMA mAb and an anti-CD3 mAb. Each of these mAbs contributes one distinct heavy (H) chain and one distinct light (L) chain to the bispecific elranatamab-bcmm. The resulting 4-chain bispecific antibody is covalently linked via five inter-chain disulfide bonds. Elranatamab-bcmm is produced using two recombinant Chinese hamster ovary (CHO) cell lines, one that contains the DNA encoding the sequence for anti-BCMA monoclonal antibody (mAb) and one that contains the sequence for anti-CD3 mAb, which are grown separately in suspension culture using chemically-defined (CD), animal-derived component-free (ACF) media. The molecular weight of elranatamab-bcmm is approximately 148.5 kDa. ELREXFIO® (elranatamab-bcmm) injection is a sterile, preservative-free, clear to slightly opalescent, and colorless to pale brown liquid solution for subcutaneous administration. ELREXFIO (elranatamab-bcmm) is supplied at a concentration of 40 mg/mL in either 76 mg/1.9 mL or 44 mg/1.1 mL single-dose vials. Each mL of solution contains 40 mg elranatamab-bcmm, edetate disodium (0.045 mg), histidine (1.12 mg), L-histidine hydrochloride monohydrate (2.67 mg), polysorbate 80 (0.2 mg), sucrose (85 mg) and Water for Injection. The pH is 5.8.</Description>
  </NDC>
  <NDC>
    <NDCCode>13107-045-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (13107-045-01) </PackageDescription>
    <NDC11Code>13107-0045-01</NDC11Code>
    <ProductNDC>13107-045</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
    <NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130715</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA201972</ApplicationNumber>
    <LabelerName>Aurolife Pharma, LLC</LabelerName>
    <SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>7.5; 325</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-12-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130715</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of Use: Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
    <Description>Oxycodone hydrochloride and acetaminophen is available in tablets for oral administration. Each tablet, for oral administration, contains: Oxycodone Hydrochloride, USP……………...2.5 mg* (*2.5 mg oxycodone Hydrochloride is equivalent to 2.2409 mg of oxycodone) Acetaminophen, USP ……………..............    325 mg Oxycodone Hydrochloride, USP……………... 5 mg* (*5 mg oxycodone Hydrochloride is equivalent to 4.4815 mg of oxycodone) Acetaminophen, USP ……………..................325 mg Oxycodone Hydrochloride, USP……………...7.5 mg*  (*7.5 mg oxycodone Hydrochloride is equivalent to 6.7228 mg of oxycodone)  Acetaminophen, USP ……………..................325 mg Oxycodone Hydrochloride, USP……………...10 mg* (* 10 mg oxycodone Hydrochloride is equivalent to 8.9637 mg of oxycodone) Acetaminophen, USP  ……………..................325 mg All strengths of Oxycodone Hydrochloride and Acetaminophen Tablets also contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch, and stearic acid. Oxycodone Hydrochloride and Acetaminophen Tablets contain Oxycodone, 14-hydroxydihydrocodeinone, is a semisynthetic opioid analgesic which occurs as a white to off- white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4HCl and the molecular weight 351.82. It is derived from the opium alkaloid thebaine, and may be represented by the following structural formula. Oxycodone Hydrochloride and Acetaminophen Tablets contain acetaminophen, 4’-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.17. It may be represented by the following structural formula.</Description>
  </NDC>
  <NDC>
    <NDCCode>13107-045-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (13107-045-05) </PackageDescription>
    <NDC11Code>13107-0045-05</NDC11Code>
    <ProductNDC>13107-045</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
    <NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130715</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA201972</ApplicationNumber>
    <LabelerName>Aurolife Pharma, LLC</LabelerName>
    <SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>7.5; 325</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-12-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130715</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of Use: Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
    <Description>Oxycodone hydrochloride and acetaminophen is available in tablets for oral administration. Each tablet, for oral administration, contains: Oxycodone Hydrochloride, USP……………...2.5 mg* (*2.5 mg oxycodone Hydrochloride is equivalent to 2.2409 mg of oxycodone) Acetaminophen, USP ……………..............    325 mg Oxycodone Hydrochloride, USP……………... 5 mg* (*5 mg oxycodone Hydrochloride is equivalent to 4.4815 mg of oxycodone) Acetaminophen, USP ……………..................325 mg Oxycodone Hydrochloride, USP……………...7.5 mg*  (*7.5 mg oxycodone Hydrochloride is equivalent to 6.7228 mg of oxycodone)  Acetaminophen, USP ……………..................325 mg Oxycodone Hydrochloride, USP……………...10 mg* (* 10 mg oxycodone Hydrochloride is equivalent to 8.9637 mg of oxycodone) Acetaminophen, USP  ……………..................325 mg All strengths of Oxycodone Hydrochloride and Acetaminophen Tablets also contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch, and stearic acid. Oxycodone Hydrochloride and Acetaminophen Tablets contain Oxycodone, 14-hydroxydihydrocodeinone, is a semisynthetic opioid analgesic which occurs as a white to off- white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4HCl and the molecular weight 351.82. It is derived from the opium alkaloid thebaine, and may be represented by the following structural formula. Oxycodone Hydrochloride and Acetaminophen Tablets contain acetaminophen, 4’-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.17. It may be represented by the following structural formula.</Description>
  </NDC>
  <NDC>
    <NDCCode>13107-045-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (13107-045-30) </PackageDescription>
    <NDC11Code>13107-0045-30</NDC11Code>
    <ProductNDC>13107-045</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
    <NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130715</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA201972</ApplicationNumber>
    <LabelerName>Aurolife Pharma, LLC</LabelerName>
    <SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>7.5; 325</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-12-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130715</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of Use: Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
    <Description>Oxycodone hydrochloride and acetaminophen is available in tablets for oral administration. Each tablet, for oral administration, contains: Oxycodone Hydrochloride, USP……………...2.5 mg* (*2.5 mg oxycodone Hydrochloride is equivalent to 2.2409 mg of oxycodone) Acetaminophen, USP ……………..............    325 mg Oxycodone Hydrochloride, USP……………... 5 mg* (*5 mg oxycodone Hydrochloride is equivalent to 4.4815 mg of oxycodone) Acetaminophen, USP ……………..................325 mg Oxycodone Hydrochloride, USP……………...7.5 mg*  (*7.5 mg oxycodone Hydrochloride is equivalent to 6.7228 mg of oxycodone)  Acetaminophen, USP ……………..................325 mg Oxycodone Hydrochloride, USP……………...10 mg* (* 10 mg oxycodone Hydrochloride is equivalent to 8.9637 mg of oxycodone) Acetaminophen, USP  ……………..................325 mg All strengths of Oxycodone Hydrochloride and Acetaminophen Tablets also contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch, and stearic acid. Oxycodone Hydrochloride and Acetaminophen Tablets contain Oxycodone, 14-hydroxydihydrocodeinone, is a semisynthetic opioid analgesic which occurs as a white to off- white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4HCl and the molecular weight 351.82. It is derived from the opium alkaloid thebaine, and may be represented by the following structural formula. Oxycodone Hydrochloride and Acetaminophen Tablets contain acetaminophen, 4’-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.17. It may be represented by the following structural formula.</Description>
  </NDC>
</NDCList>