RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>60923-534-43</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (60923-534-43)  *  10 mL in 1 VIAL, SINGLE-USE (60923-562-01)  *  43 POUCH in 1 BOX / 1 SWAB in 1 POUCH</PackageDescription>
    <NDC11Code>60923-0534-43</NDC11Code>
    <ProductNDC>60923-534</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Elevidys</ProprietaryName>
    <NonProprietaryName>Delandistrogene Moxeparvovec-rokl</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20230622</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125781</ApplicationNumber>
    <LabelerName>Sarepta Therapeutics, Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-08-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230622</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ELEVIDYS is indicated for the treatment of patients 4 years of age and older with Duchenne muscular dystrophy (DMD), who are ambulatory and have a confirmed mutation in the DMD gene [see Clinical Pharmacology (12.2), Clinical Studies (14)].</IndicationAndUsage>
    <Description>ELEVIDYS (delandistrogene moxeparvovec-rokl) is a recombinant gene therapy designed to deliver the gene encoding the ELEVIDYS micro-dystrophin protein. ELEVIDYS is a non-replicating, recombinant, adeno-associated virus serotype rh74 (AAVrh74) based vector containing the ELEVIDYS micro-dystrophin transgene under the control of the MHCK7 promoter. The genome within the ELEVIDYS AAVrh74 vector contains no viral genes and consequently is incapable of replication or reversion to a replicating form. The micro-dystrophin protein expressed by ELEVIDYS is a shortened version (138 kDa, compared to 427 kDa size of dystrophin expressed in normal muscle cells) that contains selected domains of dystrophin expressed in normal muscle cells. ELEVIDYS is a preservative-free, sterile, clear, colorless liquid that may have some opalescence and may contain white to off-white particles. ELEVIDYS is a suspension for intravenous infusion with a nominal concentration of 1.33 ×1013 vg/mL and supplied in a single-dose 10 mL vial. Each vial contains an extractable volume of 10 mL and the following excipients: 200mM sodium chloride, 13 mM tromethamine HCl, 7 mM tromethamine, 1mM magnesium chloride, 0.001% poloxamer 188, with a pH of 8.0 ± 0.3.</Description>
  </NDC>
  <NDC>
    <NDCCode>0006-0461-02</NDCCode>
    <PackageDescription>2 CAPSULE in 1 DOSE PACK (0006-0461-02) </PackageDescription>
    <NDC11Code>00006-0461-02</NDC11Code>
    <ProductNDC>0006-0461</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Emend</ProprietaryName>
    <NonProprietaryName>Aprepitant</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20030326</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021549</ApplicationNumber>
    <LabelerName>Merck Sharp &amp; Dohme LLC</LabelerName>
    <SubstanceName>APREPITANT</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Neurokinin 1 Antagonists [MoA], Substance P/Neurokinin-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20030326</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>EMEND® for oral suspension, in combination with other antiemetic agents, is indicated in patients 6 months of age and older for the prevention of: 1 acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin., 2 nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).</IndicationAndUsage>
    <Description>EMEND capsules contain the active ingredient, aprepitant. Aprepitant is a substance P/neurokinin 1 (NK1) receptor antagonist, an antiemetic agent, chemically described as 5-[[(2R,3S)-2-[(1R)-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-1,2-dihydro-3H-1,2,4-triazol-3-one. Its empirical formula is C23H21F7N4O3, and its structural formula is. Aprepitant is a white to off-white crystalline solid, with a molecular weight of 534.43. It is practically insoluble in water. Aprepitant is sparingly soluble in ethanol and isopropyl acetate and slightly soluble in acetonitrile. Each capsule of EMEND for oral administration contains either 80 mg or 125 mg of aprepitant and the following inactive ingredients: sucrose, microcrystalline cellulose, hydroxypropyl cellulose and sodium lauryl sulfate. The capsule shell excipients are gelatin, titanium dioxide, and may contain sodium lauryl sulfate and silicon dioxide. The 125-mg capsule also contains red ferric oxide and yellow ferric oxide. Each pouch of EMEND for oral suspension 125 mg contains 125 mg of aprepitant and the following inactive ingredients: sucrose, lactose, hydroxypropyl cellulose, sodium lauryl sulfate, red iron oxide, and sodium stearyl fumarate.</Description>
  </NDC>
  <NDC>
    <NDCCode>0006-0461-12</NDCCode>
    <PackageDescription>2 CAPSULE in 1 DOSE PACK (0006-0461-12) </PackageDescription>
    <NDC11Code>00006-0461-12</NDC11Code>
    <ProductNDC>0006-0461</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Emend</ProprietaryName>
    <NonProprietaryName>Aprepitant</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20030326</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021549</ApplicationNumber>
    <LabelerName>Merck Sharp &amp; Dohme LLC</LabelerName>
    <SubstanceName>APREPITANT</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Neurokinin 1 Antagonists [MoA], Substance P/Neurokinin-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20030326</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>EMEND® for oral suspension, in combination with other antiemetic agents, is indicated in patients 6 months of age and older for the prevention of: 1 acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin., 2 nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).</IndicationAndUsage>
    <Description>EMEND capsules contain the active ingredient, aprepitant. Aprepitant is a substance P/neurokinin 1 (NK1) receptor antagonist, an antiemetic agent, chemically described as 5-[[(2R,3S)-2-[(1R)-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-1,2-dihydro-3H-1,2,4-triazol-3-one. Its empirical formula is C23H21F7N4O3, and its structural formula is. Aprepitant is a white to off-white crystalline solid, with a molecular weight of 534.43. It is practically insoluble in water. Aprepitant is sparingly soluble in ethanol and isopropyl acetate and slightly soluble in acetonitrile. Each capsule of EMEND for oral administration contains either 80 mg or 125 mg of aprepitant and the following inactive ingredients: sucrose, microcrystalline cellulose, hydroxypropyl cellulose and sodium lauryl sulfate. The capsule shell excipients are gelatin, titanium dioxide, and may contain sodium lauryl sulfate and silicon dioxide. The 125-mg capsule also contains red ferric oxide and yellow ferric oxide. Each pouch of EMEND for oral suspension 125 mg contains 125 mg of aprepitant and the following inactive ingredients: sucrose, lactose, hydroxypropyl cellulose, sodium lauryl sulfate, red iron oxide, and sodium stearyl fumarate.</Description>
  </NDC>
  <NDC>
    <NDCCode>0006-3066-03</NDCCode>
    <PackageDescription>1 POUCH in 1 CARTON (0006-3066-03)  / 1 POWDER, FOR SUSPENSION in 1 POUCH (0006-3066-01) </PackageDescription>
    <NDC11Code>00006-3066-03</NDC11Code>
    <ProductNDC>0006-3066</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Emend</ProprietaryName>
    <NonProprietaryName>Aprepitant</NonProprietaryName>
    <DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20151217</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA207865</ApplicationNumber>
    <LabelerName>Merck Sharp &amp; Dohme LLC</LabelerName>
    <SubstanceName>APREPITANT</SubstanceName>
    <StrengthNumber>125</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Neurokinin 1 Antagonists [MoA], Substance P/Neurokinin-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151217</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>EMEND® for oral suspension, in combination with other antiemetic agents, is indicated in patients 6 months of age and older for the prevention of: 1 acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin., 2 nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).</IndicationAndUsage>
    <Description>EMEND capsules contain the active ingredient, aprepitant. Aprepitant is a substance P/neurokinin 1 (NK1) receptor antagonist, an antiemetic agent, chemically described as 5-[[(2R,3S)-2-[(1R)-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-1,2-dihydro-3H-1,2,4-triazol-3-one. Its empirical formula is C23H21F7N4O3, and its structural formula is. Aprepitant is a white to off-white crystalline solid, with a molecular weight of 534.43. It is practically insoluble in water. Aprepitant is sparingly soluble in ethanol and isopropyl acetate and slightly soluble in acetonitrile. Each capsule of EMEND for oral administration contains either 80 mg or 125 mg of aprepitant and the following inactive ingredients: sucrose, microcrystalline cellulose, hydroxypropyl cellulose and sodium lauryl sulfate. The capsule shell excipients are gelatin, titanium dioxide, and may contain sodium lauryl sulfate and silicon dioxide. The 125-mg capsule also contains red ferric oxide and yellow ferric oxide. Each pouch of EMEND for oral suspension 125 mg contains 125 mg of aprepitant and the following inactive ingredients: sucrose, lactose, hydroxypropyl cellulose, sodium lauryl sulfate, red iron oxide, and sodium stearyl fumarate.</Description>
  </NDC>
  <NDC>
    <NDCCode>0006-3862-03</NDCCode>
    <PackageDescription>1 KIT in 1 DOSE PACK (0006-3862-03)  *  1 CAPSULE in 1 CAPSULE *  1 CAPSULE in 1 CAPSULE</PackageDescription>
    <NDC11Code>00006-3862-03</NDC11Code>
    <ProductNDC>0006-3862</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Emend</ProprietaryName>
    <NonProprietaryName>Aprepitant</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20030326</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021549</ApplicationNumber>
    <LabelerName>Merck Sharp &amp; Dohme LLC</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-10-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20030326</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>EMEND® for oral suspension, in combination with other antiemetic agents, is indicated in patients 6 months of age and older for the prevention of: 1 acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin., 2 nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).</IndicationAndUsage>
    <Description>EMEND capsules contain the active ingredient, aprepitant. Aprepitant is a substance P/neurokinin 1 (NK1) receptor antagonist, an antiemetic agent, chemically described as 5-[[(2R,3S)-2-[(1R)-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-1,2-dihydro-3H-1,2,4-triazol-3-one. Its empirical formula is C23H21F7N4O3, and its structural formula is. Aprepitant is a white to off-white crystalline solid, with a molecular weight of 534.43. It is practically insoluble in water. Aprepitant is sparingly soluble in ethanol and isopropyl acetate and slightly soluble in acetonitrile. Each capsule of EMEND for oral administration contains either 80 mg or 125 mg of aprepitant and the following inactive ingredients: sucrose, microcrystalline cellulose, hydroxypropyl cellulose and sodium lauryl sulfate. The capsule shell excipients are gelatin, titanium dioxide, and may contain sodium lauryl sulfate and silicon dioxide. The 125-mg capsule also contains red ferric oxide and yellow ferric oxide. Each pouch of EMEND for oral suspension 125 mg contains 125 mg of aprepitant and the following inactive ingredients: sucrose, lactose, hydroxypropyl cellulose, sodium lauryl sulfate, red iron oxide, and sodium stearyl fumarate.</Description>
  </NDC>
  <NDC>
    <NDCCode>0006-3862-13</NDCCode>
    <PackageDescription>1 KIT in 1 DOSE PACK (0006-3862-13)  *  1 CAPSULE in 1 CAPSULE *  1 CAPSULE in 1 CAPSULE</PackageDescription>
    <NDC11Code>00006-3862-13</NDC11Code>
    <ProductNDC>0006-3862</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Emend</ProprietaryName>
    <NonProprietaryName>Aprepitant</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20030326</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021549</ApplicationNumber>
    <LabelerName>Merck Sharp &amp; Dohme LLC</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-10-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20030326</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>EMEND® for oral suspension, in combination with other antiemetic agents, is indicated in patients 6 months of age and older for the prevention of: 1 acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin., 2 nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).</IndicationAndUsage>
    <Description>EMEND capsules contain the active ingredient, aprepitant. Aprepitant is a substance P/neurokinin 1 (NK1) receptor antagonist, an antiemetic agent, chemically described as 5-[[(2R,3S)-2-[(1R)-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-1,2-dihydro-3H-1,2,4-triazol-3-one. Its empirical formula is C23H21F7N4O3, and its structural formula is. Aprepitant is a white to off-white crystalline solid, with a molecular weight of 534.43. It is practically insoluble in water. Aprepitant is sparingly soluble in ethanol and isopropyl acetate and slightly soluble in acetonitrile. Each capsule of EMEND for oral administration contains either 80 mg or 125 mg of aprepitant and the following inactive ingredients: sucrose, microcrystalline cellulose, hydroxypropyl cellulose and sodium lauryl sulfate. The capsule shell excipients are gelatin, titanium dioxide, and may contain sodium lauryl sulfate and silicon dioxide. The 125-mg capsule also contains red ferric oxide and yellow ferric oxide. Each pouch of EMEND for oral suspension 125 mg contains 125 mg of aprepitant and the following inactive ingredients: sucrose, lactose, hydroxypropyl cellulose, sodium lauryl sulfate, red iron oxide, and sodium stearyl fumarate.</Description>
  </NDC>
  <NDC>
    <NDCCode>0781-2321-06</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (0781-2321-06)  / 1 CAPSULE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00781-2321-06</NDC11Code>
    <ProductNDC>0781-2321</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Aprepitant</ProprietaryName>
    <NonProprietaryName>Aprepitant</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20161227</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090999</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>APREPITANT</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Neurokinin 1 Antagonists [MoA], Substance P/Neurokinin-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-02-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161227</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Aprepitant is a substance P/neurokinin 1 (NK1) receptor antagonist. Aprepitant capsules is indicated: 1 in combination with other antiemetic agents, in patients 12 years of age and older for prevention of:acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin (1.1)nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) (1.1)for prevention of postoperative nausea and vomiting (PONV) in adults (1.2).</IndicationAndUsage>
    <Description>Aprepitant capsules, USP contain the active ingredient, aprepitant. Aprepitant is a substance P/neurokinin 1 (NK1) receptor antagonist, an antiemetic agent, chemically described as 5-[[(2R,3S)-2-[(1R)-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-1,2-dihydro-3H-1,2,4-triazol-3-one. Its empirical formula is C23H21F7N4O3, and its structural formula is. Aprepitant is a white to off-white crystalline solid, with a molecular weight of 534.43. It is practically insoluble in water. Aprepitant is sparingly soluble in ethanol and isopropyl acetate and slightly soluble in acetonitrile. Each aprepitant capsule, USP for oral administration contains either 40 mg, 80 mg or 125 mg of aprepitant and the following inactive ingredients: hydroxypropyl cellulose, microcrystalline cellulose, sodium lauryl sulfate and sucrose. The aprepitant capsule shell for 40 mg and 80 mg consists of gelatin and titanium dioxide. The aprepitant capsule shell for 125 mg consists of FD&amp;C Blue #1, gelatin and titanium dioxide. The capsule is printed with edible black pharmaceutical ink. The printing ink contains black iron oxide, propylene glycol and shellac. This product meets USP dissolution test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>0781-2321-51</NDCCode>
    <PackageDescription>5 BLISTER PACK in 1 CARTON (0781-2321-51)  / 1 CAPSULE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00781-2321-51</NDC11Code>
    <ProductNDC>0781-2321</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Aprepitant</ProprietaryName>
    <NonProprietaryName>Aprepitant</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20161227</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090999</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>APREPITANT</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Neurokinin 1 Antagonists [MoA], Substance P/Neurokinin-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-02-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161227</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Aprepitant is a substance P/neurokinin 1 (NK1) receptor antagonist. Aprepitant capsules is indicated: 1 in combination with other antiemetic agents, in patients 12 years of age and older for prevention of:acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin (1.1)nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) (1.1)for prevention of postoperative nausea and vomiting (PONV) in adults (1.2).</IndicationAndUsage>
    <Description>Aprepitant capsules, USP contain the active ingredient, aprepitant. Aprepitant is a substance P/neurokinin 1 (NK1) receptor antagonist, an antiemetic agent, chemically described as 5-[[(2R,3S)-2-[(1R)-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-1,2-dihydro-3H-1,2,4-triazol-3-one. Its empirical formula is C23H21F7N4O3, and its structural formula is. Aprepitant is a white to off-white crystalline solid, with a molecular weight of 534.43. It is practically insoluble in water. Aprepitant is sparingly soluble in ethanol and isopropyl acetate and slightly soluble in acetonitrile. Each aprepitant capsule, USP for oral administration contains either 40 mg, 80 mg or 125 mg of aprepitant and the following inactive ingredients: hydroxypropyl cellulose, microcrystalline cellulose, sodium lauryl sulfate and sucrose. The aprepitant capsule shell for 40 mg and 80 mg consists of gelatin and titanium dioxide. The aprepitant capsule shell for 125 mg consists of FD&amp;C Blue #1, gelatin and titanium dioxide. The capsule is printed with edible black pharmaceutical ink. The printing ink contains black iron oxide, propylene glycol and shellac. This product meets USP dissolution test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>0781-2322-46</NDCCode>
    <PackageDescription>2 CAPSULE in 1 DOSE PACK (0781-2322-46) </PackageDescription>
    <NDC11Code>00781-2322-46</NDC11Code>
    <ProductNDC>0781-2322</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Aprepitant</ProprietaryName>
    <NonProprietaryName>Aprepitant</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20161227</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090999</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>APREPITANT</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Neurokinin 1 Antagonists [MoA], Substance P/Neurokinin-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-02-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161227</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Aprepitant is a substance P/neurokinin 1 (NK1) receptor antagonist. Aprepitant capsules is indicated: 1 in combination with other antiemetic agents, in patients 12 years of age and older for prevention of:acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin (1.1)nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) (1.1)for prevention of postoperative nausea and vomiting (PONV) in adults (1.2).</IndicationAndUsage>
    <Description>Aprepitant capsules, USP contain the active ingredient, aprepitant. Aprepitant is a substance P/neurokinin 1 (NK1) receptor antagonist, an antiemetic agent, chemically described as 5-[[(2R,3S)-2-[(1R)-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-1,2-dihydro-3H-1,2,4-triazol-3-one. Its empirical formula is C23H21F7N4O3, and its structural formula is. Aprepitant is a white to off-white crystalline solid, with a molecular weight of 534.43. It is practically insoluble in water. Aprepitant is sparingly soluble in ethanol and isopropyl acetate and slightly soluble in acetonitrile. Each aprepitant capsule, USP for oral administration contains either 40 mg, 80 mg or 125 mg of aprepitant and the following inactive ingredients: hydroxypropyl cellulose, microcrystalline cellulose, sodium lauryl sulfate and sucrose. The aprepitant capsule shell for 40 mg and 80 mg consists of gelatin and titanium dioxide. The aprepitant capsule shell for 125 mg consists of FD&amp;C Blue #1, gelatin and titanium dioxide. The capsule is printed with edible black pharmaceutical ink. The printing ink contains black iron oxide, propylene glycol and shellac. This product meets USP dissolution test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>0781-2322-68</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (0781-2322-68)  / 6 CAPSULE in 1 BLISTER PACK (0781-2322-06) </PackageDescription>
    <NDC11Code>00781-2322-68</NDC11Code>
    <ProductNDC>0781-2322</ProductNDC>
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    <ProprietaryName>Aprepitant</ProprietaryName>
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    <DosageFormName>CAPSULE</DosageFormName>
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    <StartMarketingDate>20161227</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090999</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>APREPITANT</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Neurokinin 1 Antagonists [MoA], Substance P/Neurokinin-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-02-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161227</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Aprepitant is a substance P/neurokinin 1 (NK1) receptor antagonist. Aprepitant capsules is indicated: 1 in combination with other antiemetic agents, in patients 12 years of age and older for prevention of:acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin (1.1)nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) (1.1)for prevention of postoperative nausea and vomiting (PONV) in adults (1.2).</IndicationAndUsage>
    <Description>Aprepitant capsules, USP contain the active ingredient, aprepitant. Aprepitant is a substance P/neurokinin 1 (NK1) receptor antagonist, an antiemetic agent, chemically described as 5-[[(2R,3S)-2-[(1R)-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-1,2-dihydro-3H-1,2,4-triazol-3-one. Its empirical formula is C23H21F7N4O3, and its structural formula is. Aprepitant is a white to off-white crystalline solid, with a molecular weight of 534.43. It is practically insoluble in water. Aprepitant is sparingly soluble in ethanol and isopropyl acetate and slightly soluble in acetonitrile. Each aprepitant capsule, USP for oral administration contains either 40 mg, 80 mg or 125 mg of aprepitant and the following inactive ingredients: hydroxypropyl cellulose, microcrystalline cellulose, sodium lauryl sulfate and sucrose. The aprepitant capsule shell for 40 mg and 80 mg consists of gelatin and titanium dioxide. The aprepitant capsule shell for 125 mg consists of FD&amp;C Blue #1, gelatin and titanium dioxide. The capsule is printed with edible black pharmaceutical ink. The printing ink contains black iron oxide, propylene glycol and shellac. This product meets USP dissolution test 2.</Description>
  </NDC>
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    <PackageDescription>1 BLISTER PACK in 1 CARTON (0781-2323-68)  / 6 CAPSULE in 1 BLISTER PACK (0781-2323-06) </PackageDescription>
    <NDC11Code>00781-2323-68</NDC11Code>
    <ProductNDC>0781-2323</ProductNDC>
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    <ApplicationNumber>ANDA090999</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
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    <Pharm_Classes>Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Neurokinin 1 Antagonists [MoA], Substance P/Neurokinin-1 Receptor Antagonist [EPC]</Pharm_Classes>
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    <LastUpdate>2025-02-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161227</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Aprepitant is a substance P/neurokinin 1 (NK1) receptor antagonist. Aprepitant capsules is indicated: 1 in combination with other antiemetic agents, in patients 12 years of age and older for prevention of:acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin (1.1)nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) (1.1)for prevention of postoperative nausea and vomiting (PONV) in adults (1.2).</IndicationAndUsage>
    <Description>Aprepitant capsules, USP contain the active ingredient, aprepitant. Aprepitant is a substance P/neurokinin 1 (NK1) receptor antagonist, an antiemetic agent, chemically described as 5-[[(2R,3S)-2-[(1R)-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-1,2-dihydro-3H-1,2,4-triazol-3-one. Its empirical formula is C23H21F7N4O3, and its structural formula is. Aprepitant is a white to off-white crystalline solid, with a molecular weight of 534.43. It is practically insoluble in water. Aprepitant is sparingly soluble in ethanol and isopropyl acetate and slightly soluble in acetonitrile. Each aprepitant capsule, USP for oral administration contains either 40 mg, 80 mg or 125 mg of aprepitant and the following inactive ingredients: hydroxypropyl cellulose, microcrystalline cellulose, sodium lauryl sulfate and sucrose. The aprepitant capsule shell for 40 mg and 80 mg consists of gelatin and titanium dioxide. The aprepitant capsule shell for 125 mg consists of FD&amp;C Blue #1, gelatin and titanium dioxide. The capsule is printed with edible black pharmaceutical ink. The printing ink contains black iron oxide, propylene glycol and shellac. This product meets USP dissolution test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>0781-4063-36</NDCCode>
    <PackageDescription>1 KIT in 1 DOSE PACK (0781-4063-36)  *  1 CAPSULE in 1 BLISTER PACK *  2 CAPSULE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00781-4063-36</NDC11Code>
    <ProductNDC>0781-4063</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Aprepitant</ProprietaryName>
    <NonProprietaryName>Aprepitant</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20161227</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090999</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-02-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161227</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Aprepitant is a substance P/neurokinin 1 (NK1) receptor antagonist. Aprepitant capsules is indicated: 1 in combination with other antiemetic agents, in patients 12 years of age and older for prevention of:acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin (1.1)nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) (1.1)for prevention of postoperative nausea and vomiting (PONV) in adults (1.2).</IndicationAndUsage>
    <Description>Aprepitant capsules, USP contain the active ingredient, aprepitant. Aprepitant is a substance P/neurokinin 1 (NK1) receptor antagonist, an antiemetic agent, chemically described as 5-[[(2R,3S)-2-[(1R)-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-1,2-dihydro-3H-1,2,4-triazol-3-one. Its empirical formula is C23H21F7N4O3, and its structural formula is. Aprepitant is a white to off-white crystalline solid, with a molecular weight of 534.43. It is practically insoluble in water. Aprepitant is sparingly soluble in ethanol and isopropyl acetate and slightly soluble in acetonitrile. Each aprepitant capsule, USP for oral administration contains either 40 mg, 80 mg or 125 mg of aprepitant and the following inactive ingredients: hydroxypropyl cellulose, microcrystalline cellulose, sodium lauryl sulfate and sucrose. The aprepitant capsule shell for 40 mg and 80 mg consists of gelatin and titanium dioxide. The aprepitant capsule shell for 125 mg consists of FD&amp;C Blue #1, gelatin and titanium dioxide. The capsule is printed with edible black pharmaceutical ink. The printing ink contains black iron oxide, propylene glycol and shellac. This product meets USP dissolution test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>13668-591-81</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (13668-591-81)  / 1 CAPSULE in 1 BLISTER PACK (13668-591-80) </PackageDescription>
    <NDC11Code>13668-0591-81</NDC11Code>
    <ProductNDC>13668-591</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Aprepitant</ProprietaryName>
    <NonProprietaryName>Aprepitant</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201021</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211835</ApplicationNumber>
    <LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
    <SubstanceName>APREPITANT</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Neurokinin 1 Antagonists [MoA], Substance P/Neurokinin-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201021</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Aprepitant is a substance P/neurokinin 1 (NK1) receptor antagonist. Aprepitant capsules are indicated.  in combination with other antiemetic agents, in patients 12 years of age and older for prevention of. o acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin (1.1). o nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) (1.1).  for prevention of postoperative nausea and vomiting (PONV) in adults (1.2). Limitations of Use: (1.3).  Aprepitant has not been studied for treatment of established nausea and vomiting.  Chronic continuous administration of aprepitant is not recommended.</IndicationAndUsage>
    <Description>Aprepitant capsules, USP contain the active ingredient, aprepitant, USP. Aprepitant, USP is a substance P/neurokinin 1 (NK 1) receptor antagonist, an antiemetic agent, chemically described as 5-[[(2 R,3 S)-2-[(1 R)-1-[3,5bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-1,2-dihydro-3 H-1,2,4-triazol-3one. Its empirical formula is C23H21F7N4O3, and its structural formula is. Aprepitant, USP is a white to off-white powder, with a molecular weight of 534.43. It is practically insoluble in water. Aprepitant is sparingly soluble in alcohol and slightly soluble in acetonitrile. Each capsule of aprepitant for oral administration contains either 40 mg, 80 mg, or 125 mg of aprepitant, USP and the following inactive ingredients: hypromellose 2910, poloxamer 407, sucrose, microcrystalline cellulose and imprinting ink (shellac glaze, iron oxide black and propylene glycol). The capsule shell excipients are gelatin, titanium dioxide and sodium lauryl sulfate. The 40-mg capsule shell also contains yellow ferric oxide, sodium lauryl sulfate and titanium dioxide, 80-mg capsule shell contains sodium lauryl sulfate and titanium dioxide and the 125-mg capsule contains red ferric oxide, sodium lauryl sulfate and titanium dioxide. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>13668-591-82</NDCCode>
    <PackageDescription>5 BLISTER PACK in 1 CARTON (13668-591-82)  / 1 CAPSULE in 1 BLISTER PACK (13668-591-80) </PackageDescription>
    <NDC11Code>13668-0591-82</NDC11Code>
    <ProductNDC>13668-591</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Aprepitant</ProprietaryName>
    <NonProprietaryName>Aprepitant</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201021</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211835</ApplicationNumber>
    <LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
    <SubstanceName>APREPITANT</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Neurokinin 1 Antagonists [MoA], Substance P/Neurokinin-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201021</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Aprepitant is a substance P/neurokinin 1 (NK1) receptor antagonist. Aprepitant capsules are indicated.  in combination with other antiemetic agents, in patients 12 years of age and older for prevention of. o acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin (1.1). o nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) (1.1).  for prevention of postoperative nausea and vomiting (PONV) in adults (1.2). Limitations of Use: (1.3).  Aprepitant has not been studied for treatment of established nausea and vomiting.  Chronic continuous administration of aprepitant is not recommended.</IndicationAndUsage>
    <Description>Aprepitant capsules, USP contain the active ingredient, aprepitant, USP. Aprepitant, USP is a substance P/neurokinin 1 (NK 1) receptor antagonist, an antiemetic agent, chemically described as 5-[[(2 R,3 S)-2-[(1 R)-1-[3,5bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-1,2-dihydro-3 H-1,2,4-triazol-3one. Its empirical formula is C23H21F7N4O3, and its structural formula is. Aprepitant, USP is a white to off-white powder, with a molecular weight of 534.43. It is practically insoluble in water. Aprepitant is sparingly soluble in alcohol and slightly soluble in acetonitrile. Each capsule of aprepitant for oral administration contains either 40 mg, 80 mg, or 125 mg of aprepitant, USP and the following inactive ingredients: hypromellose 2910, poloxamer 407, sucrose, microcrystalline cellulose and imprinting ink (shellac glaze, iron oxide black and propylene glycol). The capsule shell excipients are gelatin, titanium dioxide and sodium lauryl sulfate. The 40-mg capsule shell also contains yellow ferric oxide, sodium lauryl sulfate and titanium dioxide, 80-mg capsule shell contains sodium lauryl sulfate and titanium dioxide and the 125-mg capsule contains red ferric oxide, sodium lauryl sulfate and titanium dioxide. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>13668-592-84</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 CARTON (13668-592-84)  / 1 CAPSULE in 1 BLISTER PACK (13668-592-85) </PackageDescription>
    <NDC11Code>13668-0592-84</NDC11Code>
    <ProductNDC>13668-592</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Aprepitant</ProprietaryName>
    <NonProprietaryName>Aprepitant</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201021</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211835</ApplicationNumber>
    <LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
    <SubstanceName>APREPITANT</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Neurokinin 1 Antagonists [MoA], Substance P/Neurokinin-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201021</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Aprepitant is a substance P/neurokinin 1 (NK1) receptor antagonist. Aprepitant capsules are indicated.  in combination with other antiemetic agents, in patients 12 years of age and older for prevention of. o acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin (1.1). o nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) (1.1).  for prevention of postoperative nausea and vomiting (PONV) in adults (1.2). Limitations of Use: (1.3).  Aprepitant has not been studied for treatment of established nausea and vomiting.  Chronic continuous administration of aprepitant is not recommended.</IndicationAndUsage>
    <Description>Aprepitant capsules, USP contain the active ingredient, aprepitant, USP. Aprepitant, USP is a substance P/neurokinin 1 (NK 1) receptor antagonist, an antiemetic agent, chemically described as 5-[[(2 R,3 S)-2-[(1 R)-1-[3,5bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-1,2-dihydro-3 H-1,2,4-triazol-3one. Its empirical formula is C23H21F7N4O3, and its structural formula is. Aprepitant, USP is a white to off-white powder, with a molecular weight of 534.43. It is practically insoluble in water. Aprepitant is sparingly soluble in alcohol and slightly soluble in acetonitrile. Each capsule of aprepitant for oral administration contains either 40 mg, 80 mg, or 125 mg of aprepitant, USP and the following inactive ingredients: hypromellose 2910, poloxamer 407, sucrose, microcrystalline cellulose and imprinting ink (shellac glaze, iron oxide black and propylene glycol). The capsule shell excipients are gelatin, titanium dioxide and sodium lauryl sulfate. The 40-mg capsule shell also contains yellow ferric oxide, sodium lauryl sulfate and titanium dioxide, 80-mg capsule shell contains sodium lauryl sulfate and titanium dioxide and the 125-mg capsule contains red ferric oxide, sodium lauryl sulfate and titanium dioxide. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>13668-592-86</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (13668-592-86)  / 2 CAPSULE in 1 BLISTER PACK (13668-592-83) </PackageDescription>
    <NDC11Code>13668-0592-86</NDC11Code>
    <ProductNDC>13668-592</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Aprepitant</ProprietaryName>
    <NonProprietaryName>Aprepitant</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201021</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211835</ApplicationNumber>
    <LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
    <SubstanceName>APREPITANT</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Neurokinin 1 Antagonists [MoA], Substance P/Neurokinin-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201021</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Aprepitant is a substance P/neurokinin 1 (NK1) receptor antagonist. Aprepitant capsules are indicated.  in combination with other antiemetic agents, in patients 12 years of age and older for prevention of. o acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin (1.1). o nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) (1.1).  for prevention of postoperative nausea and vomiting (PONV) in adults (1.2). Limitations of Use: (1.3).  Aprepitant has not been studied for treatment of established nausea and vomiting.  Chronic continuous administration of aprepitant is not recommended.</IndicationAndUsage>
    <Description>Aprepitant capsules, USP contain the active ingredient, aprepitant, USP. Aprepitant, USP is a substance P/neurokinin 1 (NK 1) receptor antagonist, an antiemetic agent, chemically described as 5-[[(2 R,3 S)-2-[(1 R)-1-[3,5bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-1,2-dihydro-3 H-1,2,4-triazol-3one. Its empirical formula is C23H21F7N4O3, and its structural formula is. Aprepitant, USP is a white to off-white powder, with a molecular weight of 534.43. It is practically insoluble in water. Aprepitant is sparingly soluble in alcohol and slightly soluble in acetonitrile. Each capsule of aprepitant for oral administration contains either 40 mg, 80 mg, or 125 mg of aprepitant, USP and the following inactive ingredients: hypromellose 2910, poloxamer 407, sucrose, microcrystalline cellulose and imprinting ink (shellac glaze, iron oxide black and propylene glycol). The capsule shell excipients are gelatin, titanium dioxide and sodium lauryl sulfate. The 40-mg capsule shell also contains yellow ferric oxide, sodium lauryl sulfate and titanium dioxide, 80-mg capsule shell contains sodium lauryl sulfate and titanium dioxide and the 125-mg capsule contains red ferric oxide, sodium lauryl sulfate and titanium dioxide. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>13668-593-86</NDCCode>
    <PackageDescription>6 BLISTER PACK in 1 CARTON (13668-593-86)  / 1 CAPSULE in 1 BLISTER PACK (13668-593-80) </PackageDescription>
    <NDC11Code>13668-0593-86</NDC11Code>
    <ProductNDC>13668-593</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Aprepitant</ProprietaryName>
    <NonProprietaryName>Aprepitant</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201021</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211835</ApplicationNumber>
    <LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
    <SubstanceName>APREPITANT</SubstanceName>
    <StrengthNumber>125</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Neurokinin 1 Antagonists [MoA], Substance P/Neurokinin-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201021</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Aprepitant is a substance P/neurokinin 1 (NK1) receptor antagonist. Aprepitant capsules are indicated.  in combination with other antiemetic agents, in patients 12 years of age and older for prevention of. o acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin (1.1). o nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) (1.1).  for prevention of postoperative nausea and vomiting (PONV) in adults (1.2). Limitations of Use: (1.3).  Aprepitant has not been studied for treatment of established nausea and vomiting.  Chronic continuous administration of aprepitant is not recommended.</IndicationAndUsage>
    <Description>Aprepitant capsules, USP contain the active ingredient, aprepitant, USP. Aprepitant, USP is a substance P/neurokinin 1 (NK 1) receptor antagonist, an antiemetic agent, chemically described as 5-[[(2 R,3 S)-2-[(1 R)-1-[3,5bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-1,2-dihydro-3 H-1,2,4-triazol-3one. Its empirical formula is C23H21F7N4O3, and its structural formula is. Aprepitant, USP is a white to off-white powder, with a molecular weight of 534.43. It is practically insoluble in water. Aprepitant is sparingly soluble in alcohol and slightly soluble in acetonitrile. Each capsule of aprepitant for oral administration contains either 40 mg, 80 mg, or 125 mg of aprepitant, USP and the following inactive ingredients: hypromellose 2910, poloxamer 407, sucrose, microcrystalline cellulose and imprinting ink (shellac glaze, iron oxide black and propylene glycol). The capsule shell excipients are gelatin, titanium dioxide and sodium lauryl sulfate. The 40-mg capsule shell also contains yellow ferric oxide, sodium lauryl sulfate and titanium dioxide, 80-mg capsule shell contains sodium lauryl sulfate and titanium dioxide and the 125-mg capsule contains red ferric oxide, sodium lauryl sulfate and titanium dioxide. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>13668-594-87</NDCCode>
    <PackageDescription>1 KIT in 1 DOSE PACK (13668-594-87)  *  2 CAPSULE in 1 BLISTER PACK *  1 CAPSULE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>13668-0594-87</NDC11Code>
    <ProductNDC>13668-594</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Aprepitant</ProprietaryName>
    <NonProprietaryName>Aprepitant</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20201021</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211835</ApplicationNumber>
    <LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-06-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201021</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Aprepitant is a substance P/neurokinin 1 (NK1) receptor antagonist. Aprepitant capsules are indicated.  in combination with other antiemetic agents, in patients 12 years of age and older for prevention of. o acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin (1.1). o nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) (1.1).  for prevention of postoperative nausea and vomiting (PONV) in adults (1.2). Limitations of Use: (1.3).  Aprepitant has not been studied for treatment of established nausea and vomiting.  Chronic continuous administration of aprepitant is not recommended.</IndicationAndUsage>
    <Description>Aprepitant capsules, USP contain the active ingredient, aprepitant, USP. Aprepitant, USP is a substance P/neurokinin 1 (NK 1) receptor antagonist, an antiemetic agent, chemically described as 5-[[(2 R,3 S)-2-[(1 R)-1-[3,5bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-1,2-dihydro-3 H-1,2,4-triazol-3one. Its empirical formula is C23H21F7N4O3, and its structural formula is. Aprepitant, USP is a white to off-white powder, with a molecular weight of 534.43. It is practically insoluble in water. Aprepitant is sparingly soluble in alcohol and slightly soluble in acetonitrile. Each capsule of aprepitant for oral administration contains either 40 mg, 80 mg, or 125 mg of aprepitant, USP and the following inactive ingredients: hypromellose 2910, poloxamer 407, sucrose, microcrystalline cellulose and imprinting ink (shellac glaze, iron oxide black and propylene glycol). The capsule shell excipients are gelatin, titanium dioxide and sodium lauryl sulfate. The 40-mg capsule shell also contains yellow ferric oxide, sodium lauryl sulfate and titanium dioxide, 80-mg capsule shell contains sodium lauryl sulfate and titanium dioxide and the 125-mg capsule contains red ferric oxide, sodium lauryl sulfate and titanium dioxide. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>16714-534-01</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (16714-534-01) </PackageDescription>
    <NDC11Code>16714-0534-01</NDC11Code>
    <ProductNDC>16714-534</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Emtricitabine And Tenofovir Disoproxil Fumarate</ProprietaryName>
    <NonProprietaryName>Emtricitabine And Tenofovir Disoproxil Fumarate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220309</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203442</ApplicationNumber>
    <LabelerName>NorthStar RxLLC</LabelerName>
    <SubstanceName>EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE</SubstanceName>
    <StrengthNumber>200; 300</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-08-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220309</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>HIV-1 Treatment (1.1) Emtricitabine and Tenofovir Disoproxil Fumarate Tablets is a two-drug combination of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), both HIV-1 nucleoside analog reverse transcriptase inhibitors, and is indicated:   in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg. HIV-1 PrEP (1.2):  Emtricitabine and Tenofovir Disoproxil Fumarate is indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test immediately prior to initiating emtricitabine and tenofovir disoproxil fumarate for HIV-1 PrEP.</IndicationAndUsage>
    <Description>Emtricitabine and tenofovir disoproxil fumarate tablets are fixed-dose combination tablets containing emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF). FTC is a synthetic nucleoside analog of cytidine. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Both FTC and tenofovir exhibit inhibitory activity against HIV-1 reverse transcriptase. Emtricitabine: The chemical name of FTC is 5-fluoro-1-(2R,5S)-[2- (hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine. FTC is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has a molecular formula of C8H10FN3O3S and a molecular weight of 247.24. It has the following structural formula. FTC is a white to off-white crystalline powder with a solubility of approximately 112 mg/mL in water at 25 °C. The partition coefficient (log p) for emtricitabine is ―0.43 and the pKa is 2.65. Tenofovir Disoproxil Fumarate: TDF is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of tenofovir DF is 9-[(R)-2[[bis[[(isopropoxycarbonyl)oxy]- methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10P. C4H4O4 and a molecular weight of 635.52. It has the following structural formula. Tenofovir disoproxil fumarate is a white to off-white crystalline powder with a solubility of 13.4 mg/mL in water at 25°C. The partition coefficient (log p) for tenofovir disoproxil is 1.25 and the pKa is 3.75. All dosages are expressed in terms of TDF except where otherwise noted. Emtricitabine and tenofovir disoproxil fumarate tablets are for oral administration, and are available in the following strengths.  Film-coated tablet containing 200 mg of FTC and 300 mg of TDF (which is equivalent to 245 mg of tenofovir disoproxil) as active ingredients. The tablets also include the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, colloidal silicon dioxide and pregelatinized starch. The tablets are coated with Instacoat Universal White A05G14934, which contains hydroxypropyl methylcellulose 2910, lactose monohydrate, titanium dioxide, and triacetin.</Description>
  </NDC>
  <NDC>
    <NDCCode>42254-160-01</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (42254-160-01)  &gt; 1 CAPSULE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>42254-0160-01</NDC11Code>
    <ProductNDC>42254-160</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Emend</ProprietaryName>
    <NonProprietaryName>Aprepitant</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20030326</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021549</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp</LabelerName>
    <SubstanceName>APREPITANT</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Neurokinin 1 Antagonists [MoA],Substance P/Neurokinin-1 Receptor Antagonist [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 3A4 Inducers [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>EMEND® is a substance P/neurokinin 1 (NK1) receptor antagonist, indicated: 1 in combination with other antiemetic agents for the: prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin (1.1)prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) (1.1) , 2 for the prevention of postoperative nausea and vomiting (PONV) (1.2) .</IndicationAndUsage>
    <Description>EMEND (aprepitant) is a substance P/neurokinin 1 (NK1) receptor antagonist, chemically described as 5-[[(2R,3S)-2-[(1R)-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-1,2-dihydro-3H-1,2,4-triazol-3-one. Its empirical formula is C23H21F7N4O3, and its structural formula is. Aprepitant is a white to off-white crystalline solid, with a molecular weight of 534.43. It is practically insoluble in water. Aprepitant is sparingly soluble in ethanol and isopropyl acetate and slightly soluble in acetonitrile. Each capsule of EMEND for oral administration contains either 40 mg, 80 mg, or 125 mg of aprepitant and the following inactive ingredients: sucrose, microcrystalline cellulose, hydroxypropyl cellulose and sodium lauryl sulfate. The capsule shell excipients are gelatin, titanium dioxide, and may contain sodium lauryl sulfate and silicon dioxide. The 40‑mg capsule shell also contains yellow ferric oxide, and the 125‑mg capsule also contains red ferric oxide and yellow ferric oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>47426-201-01</NDCCode>
    <PackageDescription>1 VIAL, GLASS in 1 CARTON (47426-201-01)  / 18 mL in 1 VIAL, GLASS</PackageDescription>
    <NDC11Code>47426-0201-01</NDC11Code>
    <ProductNDC>47426-201</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cinvanti</ProprietaryName>
    <NonProprietaryName>Aprepitant</NonProprietaryName>
    <DosageFormName>INJECTION, EMULSION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20180103</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA209296</ApplicationNumber>
    <LabelerName>Heron Therapeutics, Inc.</LabelerName>
    <SubstanceName>APREPITANT</SubstanceName>
    <StrengthNumber>130</StrengthNumber>
    <StrengthUnit>mg/18mL</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Neurokinin 1 Antagonists [MoA], Substance P/Neurokinin-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180103</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>CINVANTI, in combination with other antiemetic agents, is indicated in adults for the prevention of: 1 acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin as a single-dose regimen., 2 delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) as a single-dose regimen., 3 nausea and vomiting associated with initial and repeat courses of MEC as a 3-day regimen.</IndicationAndUsage>
    <Description>CINVANTI injectable emulsion contains the active ingredient, aprepitant. Aprepitant is a substance P/neurokinin 1 (NK1) receptor antagonist, an antiemetic agent, chemically described as 5-[[(2R,3S)-2-[(1R)-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-1,2-dihydro-3H-1,2,4-triazol-3-one. Its empirical formula is C23H21F7N4O3, and its structural formula is. Aprepitant is a white to off-white crystalline solid, with a molecular weight of 534.43. It is practically insoluble in water. Aprepitant is sparingly soluble in ethanol and isopropyl acetate and slightly soluble in acetonitrile. CINVANTI (aprepitant) injectable emulsion is a sterile, opaque, off-white to amber liquid in a single-dose vial for intravenous use. Each vial contains 130 mg aprepitant in 18 mL of emulsion. The emulsion also contains the following inactive ingredients: egg lecithin (2602 mg), dehydrated alcohol (513 mg), sodium oleate (87 mg), soybean oil (1734 mg), sucrose (973 mg), and water for injection (12142 mg).</Description>
  </NDC>
  <NDC>
    <NDCCode>47426-401-10</NDCCode>
    <PackageDescription>10 VIAL, GLASS in 1 CARTON (47426-401-10)  / 4.4 mL in 1 VIAL, GLASS (47426-401-01) </PackageDescription>
    <NDC11Code>47426-0401-10</NDC11Code>
    <ProductNDC>47426-401</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Aponvie</ProprietaryName>
    <NonProprietaryName>Aprepitant</NonProprietaryName>
    <DosageFormName>EMULSION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20230306</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA216457</ApplicationNumber>
    <LabelerName>Heron Therapeutics, Inc.</LabelerName>
    <SubstanceName>APREPITANT</SubstanceName>
    <StrengthNumber>32</StrengthNumber>
    <StrengthUnit>mg/4.4mL</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Neurokinin 1 Antagonists [MoA], Substance P/Neurokinin-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230306</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>APONVIE is indicated for the prevention of postoperative nausea and vomiting (PONV) in adults.</IndicationAndUsage>
    <Description>APONVIE injectable emulsion contains the active ingredient, aprepitant. Aprepitant is a substance P/neurokinin 1 (NK1) receptor antagonist, an antiemetic agent, and chemically described as 5-[[(2R,3S)-2-[(1R)-1-[3,5­-bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-1,2-dihydro-3H-1,2,4-triazol-3-one. Its empirical formula is C23H21F7N4O3, and its structural formula is. Aprepitant is a white to off-white crystalline solid, with a molecular weight of 534.43. It is practically insoluble in water. Aprepitant is sparingly soluble in ethanol and isopropyl acetate and slightly soluble in acetonitrile. APONVIE (aprepitant) injectable emulsion is a sterile, opaque, off-white to amber liquid in a single-dose vial for intravenous use. Each vial contains 32 mg aprepitant in 4.4 mL of emulsion. The emulsion also contains the following inactive ingredients: dehydrated alcohol (125 mg), egg lecithin (636 mg), sodium oleate (21 mg), soybean oil (424 mg), sucrose (238 mg), and water for injection (2968 mg).</Description>
  </NDC>
  <NDC>
    <NDCCode>51407-701-01</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (51407-701-01)  / 1 CAPSULE in 1 BLISTER PACK (51407-701-11) </PackageDescription>
    <NDC11Code>51407-0701-01</NDC11Code>
    <ProductNDC>51407-701</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Aprepitant</ProprietaryName>
    <NonProprietaryName>Aprepitant</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201021</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211835</ApplicationNumber>
    <LabelerName>Golden State Medical Supply, Inc.</LabelerName>
    <SubstanceName>APREPITANT</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Neurokinin 1 Antagonists [MoA], Substance P/Neurokinin-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250611</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Aprepitant is a substance P/neurokinin 1 (NK1) receptor antagonist. Aprepitant capsules are indicated.  in combination with other antiemetic agents, in patients 12 years of age and older for prevention of. o acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin ( 1.1). o nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) ( 1.1).  for prevention of postoperative nausea and vomiting (PONV) in adults ( 1.2). Limitations of Use: ( 1.3).  Aprepitant has not been studied for treatment of established nausea and vomiting.  Chronic continuous administration of aprepitant is not recommended.</IndicationAndUsage>
    <Description>Aprepitant capsules, USP contain the active ingredient, aprepitant, USP. Aprepitant, USP is a substance P/neurokinin 1 (NK 1) receptor antagonist, an antiemetic agent, chemically described as 5-[[(2 R,3 S)-2-[(1 R)-1-[3,5bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-1,2-dihydro-3 H-1,2,4-triazol-3one. Its empirical formula is C 23H 21F 7N 4O 3, and its structural formula is:. Aprepitant, USP is a white to off-white powder, with a molecular weight of 534.43. It is practically insoluble in water. Aprepitant is sparingly soluble in alcohol and slightly soluble in acetonitrile. Each capsule of aprepitant for oral administration contains either 40 mg, 80 mg, or 125 mg of aprepitant, USP and the following inactive ingredients: hypromellose 2910, poloxamer 407, sucrose, microcrystalline cellulose and imprinting ink (shellac glaze, iron oxide black and propylene glycol). The capsule shell excipients are gelatin, titanium dioxide and sodium lauryl sulfate. The 40-mg capsule shell also contains yellow ferric oxide, sodium lauryl sulfate and titanium dioxide, 80-mg capsule shell contains sodium lauryl sulfate and titanium dioxide and the 125-mg capsule contains red ferric oxide, sodium lauryl sulfate and titanium dioxide. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>51407-701-05</NDCCode>
    <PackageDescription>5 BLISTER PACK in 1 CARTON (51407-701-05)  / 1 CAPSULE in 1 BLISTER PACK (51407-701-11) </PackageDescription>
    <NDC11Code>51407-0701-05</NDC11Code>
    <ProductNDC>51407-701</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Aprepitant</ProprietaryName>
    <NonProprietaryName>Aprepitant</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201021</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211835</ApplicationNumber>
    <LabelerName>Golden State Medical Supply, Inc.</LabelerName>
    <SubstanceName>APREPITANT</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Neurokinin 1 Antagonists [MoA], Substance P/Neurokinin-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250611</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Aprepitant is a substance P/neurokinin 1 (NK1) receptor antagonist. Aprepitant capsules are indicated.  in combination with other antiemetic agents, in patients 12 years of age and older for prevention of. o acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin ( 1.1). o nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) ( 1.1).  for prevention of postoperative nausea and vomiting (PONV) in adults ( 1.2). Limitations of Use: ( 1.3).  Aprepitant has not been studied for treatment of established nausea and vomiting.  Chronic continuous administration of aprepitant is not recommended.</IndicationAndUsage>
    <Description>Aprepitant capsules, USP contain the active ingredient, aprepitant, USP. Aprepitant, USP is a substance P/neurokinin 1 (NK 1) receptor antagonist, an antiemetic agent, chemically described as 5-[[(2 R,3 S)-2-[(1 R)-1-[3,5bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-1,2-dihydro-3 H-1,2,4-triazol-3one. Its empirical formula is C 23H 21F 7N 4O 3, and its structural formula is:. Aprepitant, USP is a white to off-white powder, with a molecular weight of 534.43. It is practically insoluble in water. Aprepitant is sparingly soluble in alcohol and slightly soluble in acetonitrile. Each capsule of aprepitant for oral administration contains either 40 mg, 80 mg, or 125 mg of aprepitant, USP and the following inactive ingredients: hypromellose 2910, poloxamer 407, sucrose, microcrystalline cellulose and imprinting ink (shellac glaze, iron oxide black and propylene glycol). The capsule shell excipients are gelatin, titanium dioxide and sodium lauryl sulfate. The 40-mg capsule shell also contains yellow ferric oxide, sodium lauryl sulfate and titanium dioxide, 80-mg capsule shell contains sodium lauryl sulfate and titanium dioxide and the 125-mg capsule contains red ferric oxide, sodium lauryl sulfate and titanium dioxide. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>51407-702-02</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 CARTON (51407-702-02)  / 1 CAPSULE in 1 BLISTER PACK (51407-702-11) </PackageDescription>
    <NDC11Code>51407-0702-02</NDC11Code>
    <ProductNDC>51407-702</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Aprepitant</ProprietaryName>
    <NonProprietaryName>Aprepitant</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201021</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211835</ApplicationNumber>
    <LabelerName>Golden State Medical Supply, Inc.</LabelerName>
    <SubstanceName>APREPITANT</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Neurokinin 1 Antagonists [MoA], Substance P/Neurokinin-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250611</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Aprepitant is a substance P/neurokinin 1 (NK1) receptor antagonist. Aprepitant capsules are indicated.  in combination with other antiemetic agents, in patients 12 years of age and older for prevention of. o acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin ( 1.1). o nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) ( 1.1).  for prevention of postoperative nausea and vomiting (PONV) in adults ( 1.2). Limitations of Use: ( 1.3).  Aprepitant has not been studied for treatment of established nausea and vomiting.  Chronic continuous administration of aprepitant is not recommended.</IndicationAndUsage>
    <Description>Aprepitant capsules, USP contain the active ingredient, aprepitant, USP. Aprepitant, USP is a substance P/neurokinin 1 (NK 1) receptor antagonist, an antiemetic agent, chemically described as 5-[[(2 R,3 S)-2-[(1 R)-1-[3,5bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-1,2-dihydro-3 H-1,2,4-triazol-3one. Its empirical formula is C 23H 21F 7N 4O 3, and its structural formula is:. Aprepitant, USP is a white to off-white powder, with a molecular weight of 534.43. It is practically insoluble in water. Aprepitant is sparingly soluble in alcohol and slightly soluble in acetonitrile. Each capsule of aprepitant for oral administration contains either 40 mg, 80 mg, or 125 mg of aprepitant, USP and the following inactive ingredients: hypromellose 2910, poloxamer 407, sucrose, microcrystalline cellulose and imprinting ink (shellac glaze, iron oxide black and propylene glycol). The capsule shell excipients are gelatin, titanium dioxide and sodium lauryl sulfate. The 40-mg capsule shell also contains yellow ferric oxide, sodium lauryl sulfate and titanium dioxide, 80-mg capsule shell contains sodium lauryl sulfate and titanium dioxide and the 125-mg capsule contains red ferric oxide, sodium lauryl sulfate and titanium dioxide. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>51407-702-06</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (51407-702-06)  / 2 CAPSULE in 1 BLISTER PACK (51407-702-22) </PackageDescription>
    <NDC11Code>51407-0702-06</NDC11Code>
    <ProductNDC>51407-702</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Aprepitant</ProprietaryName>
    <NonProprietaryName>Aprepitant</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201021</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211835</ApplicationNumber>
    <LabelerName>Golden State Medical Supply, Inc.</LabelerName>
    <SubstanceName>APREPITANT</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Neurokinin 1 Antagonists [MoA], Substance P/Neurokinin-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250611</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Aprepitant is a substance P/neurokinin 1 (NK1) receptor antagonist. Aprepitant capsules are indicated.  in combination with other antiemetic agents, in patients 12 years of age and older for prevention of. o acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin ( 1.1). o nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) ( 1.1).  for prevention of postoperative nausea and vomiting (PONV) in adults ( 1.2). Limitations of Use: ( 1.3).  Aprepitant has not been studied for treatment of established nausea and vomiting.  Chronic continuous administration of aprepitant is not recommended.</IndicationAndUsage>
    <Description>Aprepitant capsules, USP contain the active ingredient, aprepitant, USP. Aprepitant, USP is a substance P/neurokinin 1 (NK 1) receptor antagonist, an antiemetic agent, chemically described as 5-[[(2 R,3 S)-2-[(1 R)-1-[3,5bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-1,2-dihydro-3 H-1,2,4-triazol-3one. Its empirical formula is C 23H 21F 7N 4O 3, and its structural formula is:. Aprepitant, USP is a white to off-white powder, with a molecular weight of 534.43. It is practically insoluble in water. Aprepitant is sparingly soluble in alcohol and slightly soluble in acetonitrile. Each capsule of aprepitant for oral administration contains either 40 mg, 80 mg, or 125 mg of aprepitant, USP and the following inactive ingredients: hypromellose 2910, poloxamer 407, sucrose, microcrystalline cellulose and imprinting ink (shellac glaze, iron oxide black and propylene glycol). The capsule shell excipients are gelatin, titanium dioxide and sodium lauryl sulfate. The 40-mg capsule shell also contains yellow ferric oxide, sodium lauryl sulfate and titanium dioxide, 80-mg capsule shell contains sodium lauryl sulfate and titanium dioxide and the 125-mg capsule contains red ferric oxide, sodium lauryl sulfate and titanium dioxide. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>51407-703-06</NDCCode>
    <PackageDescription>6 BLISTER PACK in 1 CARTON (51407-703-06)  / 1 CAPSULE in 1 BLISTER PACK (51407-703-66) </PackageDescription>
    <NDC11Code>51407-0703-06</NDC11Code>
    <ProductNDC>51407-703</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Aprepitant</ProprietaryName>
    <NonProprietaryName>Aprepitant</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201021</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211835</ApplicationNumber>
    <LabelerName>Golden State Medical Supply, Inc.</LabelerName>
    <SubstanceName>APREPITANT</SubstanceName>
    <StrengthNumber>125</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Neurokinin 1 Antagonists [MoA], Substance P/Neurokinin-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250611</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Aprepitant is a substance P/neurokinin 1 (NK1) receptor antagonist. Aprepitant capsules are indicated.  in combination with other antiemetic agents, in patients 12 years of age and older for prevention of. o acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin ( 1.1). o nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) ( 1.1).  for prevention of postoperative nausea and vomiting (PONV) in adults ( 1.2). Limitations of Use: ( 1.3).  Aprepitant has not been studied for treatment of established nausea and vomiting.  Chronic continuous administration of aprepitant is not recommended.</IndicationAndUsage>
    <Description>Aprepitant capsules, USP contain the active ingredient, aprepitant, USP. Aprepitant, USP is a substance P/neurokinin 1 (NK 1) receptor antagonist, an antiemetic agent, chemically described as 5-[[(2 R,3 S)-2-[(1 R)-1-[3,5bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-1,2-dihydro-3 H-1,2,4-triazol-3one. Its empirical formula is C 23H 21F 7N 4O 3, and its structural formula is:. Aprepitant, USP is a white to off-white powder, with a molecular weight of 534.43. It is practically insoluble in water. Aprepitant is sparingly soluble in alcohol and slightly soluble in acetonitrile. Each capsule of aprepitant for oral administration contains either 40 mg, 80 mg, or 125 mg of aprepitant, USP and the following inactive ingredients: hypromellose 2910, poloxamer 407, sucrose, microcrystalline cellulose and imprinting ink (shellac glaze, iron oxide black and propylene glycol). The capsule shell excipients are gelatin, titanium dioxide and sodium lauryl sulfate. The 40-mg capsule shell also contains yellow ferric oxide, sodium lauryl sulfate and titanium dioxide, 80-mg capsule shell contains sodium lauryl sulfate and titanium dioxide and the 125-mg capsule contains red ferric oxide, sodium lauryl sulfate and titanium dioxide. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>51407-704-03</NDCCode>
    <PackageDescription>1 KIT in 1 DOSE PACK (51407-704-03)  *  2 CAPSULE in 1 BLISTER PACK *  1 CAPSULE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>51407-0704-03</NDC11Code>
    <ProductNDC>51407-704</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Aprepitant</ProprietaryName>
    <NonProprietaryName>Aprepitant</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20201021</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211835</ApplicationNumber>
    <LabelerName>Golden State Medical Supply, Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-03-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250611</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Aprepitant is a substance P/neurokinin 1 (NK1) receptor antagonist. Aprepitant capsules are indicated.  in combination with other antiemetic agents, in patients 12 years of age and older for prevention of. o acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin ( 1.1). o nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) ( 1.1).  for prevention of postoperative nausea and vomiting (PONV) in adults ( 1.2). Limitations of Use: ( 1.3).  Aprepitant has not been studied for treatment of established nausea and vomiting.  Chronic continuous administration of aprepitant is not recommended.</IndicationAndUsage>
    <Description>Aprepitant capsules, USP contain the active ingredient, aprepitant, USP. Aprepitant, USP is a substance P/neurokinin 1 (NK 1) receptor antagonist, an antiemetic agent, chemically described as 5-[[(2 R,3 S)-2-[(1 R)-1-[3,5bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-1,2-dihydro-3 H-1,2,4-triazol-3one. Its empirical formula is C 23H 21F 7N 4O 3, and its structural formula is:. Aprepitant, USP is a white to off-white powder, with a molecular weight of 534.43. It is practically insoluble in water. Aprepitant is sparingly soluble in alcohol and slightly soluble in acetonitrile. Each capsule of aprepitant for oral administration contains either 40 mg, 80 mg, or 125 mg of aprepitant, USP and the following inactive ingredients: hypromellose 2910, poloxamer 407, sucrose, microcrystalline cellulose and imprinting ink (shellac glaze, iron oxide black and propylene glycol). The capsule shell excipients are gelatin, titanium dioxide and sodium lauryl sulfate. The 40-mg capsule shell also contains yellow ferric oxide, sodium lauryl sulfate and titanium dioxide, 80-mg capsule shell contains sodium lauryl sulfate and titanium dioxide and the 125-mg capsule contains red ferric oxide, sodium lauryl sulfate and titanium dioxide. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>54868-5231-1</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (54868-5231-1)  &gt; 6 CAPSULE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>54868-5231-01</NDC11Code>
    <ProductNDC>54868-5231</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Emend</ProprietaryName>
    <NonProprietaryName>Aprepitant</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20050629</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021549</ApplicationNumber>
    <LabelerName>Physicians Total Care, Inc.</LabelerName>
    <SubstanceName>APREPITANT</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Neurokinin 1 Antagonists [MoA],Substance P/Neurokinin-1 Receptor Antagonist [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 3A4 Inducers [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-07-24</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>EMEND® is a substance P/neurokinin 1 (NK1) receptor antagonist, indicated: 1 in combination with other antiemetic agents for the: prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin (1.1)prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) (1.1) , 2 for the prevention of postoperative nausea and vomiting (PONV) (1.2) .</IndicationAndUsage>
    <Description>EMEND (aprepitant) is a substance P/neurokinin 1 (NK1) receptor antagonist, chemically described as 5-[[(2R,3S)-2-[(1R)-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-1,2-dihydro-3H-1,2,4-triazol-3-one. Its empirical formula is C23H21F7N4O3, and its structural formula is. Aprepitant is a white to off-white crystalline solid, with a molecular weight of 534.43. It is practically insoluble in water. Aprepitant is sparingly soluble in ethanol and isopropyl acetate and slightly soluble in acetonitrile. Each capsule of EMEND for oral administration contains either 40 mg, 80 mg or 125 mg of aprepitant and the following inactive ingredients: sucrose, microcrystalline cellulose, hydroxypropyl cellulose and sodium lauryl sulfate. The capsule shell excipients are gelatin, titanium dioxide, and may contain sodium lauryl sulfate and silicon dioxide. The 40‑mg capsule shell also contains yellow ferric oxide, and the 125‑mg capsule also contains red ferric oxide and yellow ferric oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>54868-5231-2</NDCCode>
    <PackageDescription>2 CAPSULE in 1 DOSE PACK (54868-5231-2)</PackageDescription>
    <NDC11Code>54868-5231-02</NDC11Code>
    <ProductNDC>54868-5231</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Emend</ProprietaryName>
    <NonProprietaryName>Aprepitant</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20050629</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021549</ApplicationNumber>
    <LabelerName>Physicians Total Care, Inc.</LabelerName>
    <SubstanceName>APREPITANT</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Neurokinin 1 Antagonists [MoA],Substance P/Neurokinin-1 Receptor Antagonist [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 3A4 Inducers [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-07-24</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>EMEND® is a substance P/neurokinin 1 (NK1) receptor antagonist, indicated: 1 in combination with other antiemetic agents for the: prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin (1.1)prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) (1.1) , 2 for the prevention of postoperative nausea and vomiting (PONV) (1.2) .</IndicationAndUsage>
    <Description>EMEND (aprepitant) is a substance P/neurokinin 1 (NK1) receptor antagonist, chemically described as 5-[[(2R,3S)-2-[(1R)-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-1,2-dihydro-3H-1,2,4-triazol-3-one. Its empirical formula is C23H21F7N4O3, and its structural formula is. Aprepitant is a white to off-white crystalline solid, with a molecular weight of 534.43. It is practically insoluble in water. Aprepitant is sparingly soluble in ethanol and isopropyl acetate and slightly soluble in acetonitrile. Each capsule of EMEND for oral administration contains either 40 mg, 80 mg or 125 mg of aprepitant and the following inactive ingredients: sucrose, microcrystalline cellulose, hydroxypropyl cellulose and sodium lauryl sulfate. The capsule shell excipients are gelatin, titanium dioxide, and may contain sodium lauryl sulfate and silicon dioxide. The 40‑mg capsule shell also contains yellow ferric oxide, and the 125‑mg capsule also contains red ferric oxide and yellow ferric oxide.</Description>
  </NDC>
</NDCList>