RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>0228-2027-96</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (0228-2027-96) </PackageDescription>
    <NDC11Code>00228-2027-96</NDC11Code>
    <ProductNDC>0228-2027</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Alprazolam</ProprietaryName>
    <NonProprietaryName>Alprazolam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19931001</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074342</ApplicationNumber>
    <LabelerName>Actavis Pharma, Inc.</LabelerName>
    <SubstanceName>ALPRAZOLAM</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-09-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19931001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Alprazolam tablets are indicated for the: 1 acute treatment of generalized anxiety disorder (GAD) in adults., 2 treatment of panic disorder (PD), with or without agoraphobia in adults.</IndicationAndUsage>
    <Description>Alprazolam tablets, USP contain alprazolam, USP which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam, USP is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is. C17H13CIN4                 M.W. 308.76. Alprazolam, USP is a white to off-white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each tablet, for oral administration, contains 0.25 mg, 0.5 mg, 1 mg, or 2 mg of alprazolam, USP. The 2 mg tablets are multi-scored and may be divided in half to provide two 1 mg segments, or quarters to provide four 0.5 mg segments. Inactive ingredients: colloidal silicon dioxide, corn starch, docusate sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium benzoate. The 0.5 mg tablet also contains FD&amp;C Yellow #6 Aluminum Lake (Sunset Yellow Lake). The 1 mg tablet also contains FD&amp;C Blue #2 Aluminum Lake. The 2 mg tablet also contains D&amp;C Yellow #10 Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>0228-2027-00</NDCCode>
    <PackageDescription>77000 TABLET in 1 BAG (0228-2027-00) </PackageDescription>
    <NDC11Code>00228-2027-00</NDC11Code>
    <ProductNDC>0228-2027</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Alprazolam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <StartMarketingDate>20150730</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Actavis Pharma, Inc.</LabelerName>
    <SubstanceName>ALPRAZOLAM</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CIV</DEASchedule>
    <Status>Unfinished</Status>
    <LastUpdate>2026-09-01</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>30-JUL-15</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>0228-2027-10</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (0228-2027-10) </PackageDescription>
    <NDC11Code>00228-2027-10</NDC11Code>
    <ProductNDC>0228-2027</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Alprazolam</ProprietaryName>
    <NonProprietaryName>Alprazolam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19931001</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074342</ApplicationNumber>
    <LabelerName>Actavis Pharma, Inc.</LabelerName>
    <SubstanceName>ALPRAZOLAM</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-09-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19931001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Alprazolam tablets are indicated for the: 1 acute treatment of generalized anxiety disorder (GAD) in adults., 2 treatment of panic disorder (PD), with or without agoraphobia in adults.</IndicationAndUsage>
    <Description>Alprazolam tablets, USP contain alprazolam, USP which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam, USP is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is. C17H13CIN4                 M.W. 308.76. Alprazolam, USP is a white to off-white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each tablet, for oral administration, contains 0.25 mg, 0.5 mg, 1 mg, or 2 mg of alprazolam, USP. The 2 mg tablets are multi-scored and may be divided in half to provide two 1 mg segments, or quarters to provide four 0.5 mg segments. Inactive ingredients: colloidal silicon dioxide, corn starch, docusate sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium benzoate. The 0.5 mg tablet also contains FD&amp;C Yellow #6 Aluminum Lake (Sunset Yellow Lake). The 1 mg tablet also contains FD&amp;C Blue #2 Aluminum Lake. The 2 mg tablet also contains D&amp;C Yellow #10 Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>0228-2027-50</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (0228-2027-50) </PackageDescription>
    <NDC11Code>00228-2027-50</NDC11Code>
    <ProductNDC>0228-2027</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Alprazolam</ProprietaryName>
    <NonProprietaryName>Alprazolam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19931001</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074342</ApplicationNumber>
    <LabelerName>Actavis Pharma, Inc.</LabelerName>
    <SubstanceName>ALPRAZOLAM</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-09-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19931001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Alprazolam tablets are indicated for the: 1 acute treatment of generalized anxiety disorder (GAD) in adults., 2 treatment of panic disorder (PD), with or without agoraphobia in adults.</IndicationAndUsage>
    <Description>Alprazolam tablets, USP contain alprazolam, USP which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam, USP is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is. C17H13CIN4                 M.W. 308.76. Alprazolam, USP is a white to off-white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each tablet, for oral administration, contains 0.25 mg, 0.5 mg, 1 mg, or 2 mg of alprazolam, USP. The 2 mg tablets are multi-scored and may be divided in half to provide two 1 mg segments, or quarters to provide four 0.5 mg segments. Inactive ingredients: colloidal silicon dioxide, corn starch, docusate sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium benzoate. The 0.5 mg tablet also contains FD&amp;C Yellow #6 Aluminum Lake (Sunset Yellow Lake). The 1 mg tablet also contains FD&amp;C Blue #2 Aluminum Lake. The 2 mg tablet also contains D&amp;C Yellow #10 Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>0228-2027-77</NDCCode>
    <PackageDescription>92304 TABLET in 1 CONTAINER (0228-2027-77) </PackageDescription>
    <NDC11Code>00228-2027-77</NDC11Code>
    <ProductNDC>0228-2027</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Alprazolam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <StartMarketingDate>20150730</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Actavis Pharma, Inc.</LabelerName>
    <SubstanceName>ALPRAZOLAM</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CIV</DEASchedule>
    <Status>Unfinished</Status>
    <LastUpdate>2026-09-01</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>17-JAN-24</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>0228-2029-96</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (0228-2029-96) </PackageDescription>
    <NDC11Code>00228-2029-96</NDC11Code>
    <ProductNDC>0228-2029</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Alprazolam</ProprietaryName>
    <NonProprietaryName>Alprazolam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19931001</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074342</ApplicationNumber>
    <LabelerName>Actavis Pharma, Inc.</LabelerName>
    <SubstanceName>ALPRAZOLAM</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-09-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19931001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Alprazolam tablets are indicated for the: 1 acute treatment of generalized anxiety disorder (GAD) in adults., 2 treatment of panic disorder (PD), with or without agoraphobia in adults.</IndicationAndUsage>
    <Description>Alprazolam tablets, USP contain alprazolam, USP which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam, USP is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is. C17H13CIN4                 M.W. 308.76. Alprazolam, USP is a white to off-white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each tablet, for oral administration, contains 0.25 mg, 0.5 mg, 1 mg, or 2 mg of alprazolam, USP. The 2 mg tablets are multi-scored and may be divided in half to provide two 1 mg segments, or quarters to provide four 0.5 mg segments. Inactive ingredients: colloidal silicon dioxide, corn starch, docusate sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium benzoate. The 0.5 mg tablet also contains FD&amp;C Yellow #6 Aluminum Lake (Sunset Yellow Lake). The 1 mg tablet also contains FD&amp;C Blue #2 Aluminum Lake. The 2 mg tablet also contains D&amp;C Yellow #10 Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>0228-2031-96</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (0228-2031-96) </PackageDescription>
    <NDC11Code>00228-2031-96</NDC11Code>
    <ProductNDC>0228-2031</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Alprazolam</ProprietaryName>
    <NonProprietaryName>Alprazolam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19931001</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074342</ApplicationNumber>
    <LabelerName>Actavis Pharma, Inc.</LabelerName>
    <SubstanceName>ALPRAZOLAM</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-09-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19931001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Alprazolam tablets are indicated for the: 1 acute treatment of generalized anxiety disorder (GAD) in adults., 2 treatment of panic disorder (PD), with or without agoraphobia in adults.</IndicationAndUsage>
    <Description>Alprazolam tablets, USP contain alprazolam, USP which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam, USP is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is. C17H13CIN4                 M.W. 308.76. Alprazolam, USP is a white to off-white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each tablet, for oral administration, contains 0.25 mg, 0.5 mg, 1 mg, or 2 mg of alprazolam, USP. The 2 mg tablets are multi-scored and may be divided in half to provide two 1 mg segments, or quarters to provide four 0.5 mg segments. Inactive ingredients: colloidal silicon dioxide, corn starch, docusate sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium benzoate. The 0.5 mg tablet also contains FD&amp;C Yellow #6 Aluminum Lake (Sunset Yellow Lake). The 1 mg tablet also contains FD&amp;C Blue #2 Aluminum Lake. The 2 mg tablet also contains D&amp;C Yellow #10 Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>0228-2143-96</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (0228-2143-96)</PackageDescription>
    <NDC11Code>00228-2143-96</NDC11Code>
    <ProductNDC>0228-2143</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carbamazepine</ProprietaryName>
    <NonProprietaryName>Carbamazepine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19950103</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA071696</ApplicationNumber>
    <LabelerName>Actavis Elizabeth LLC</LabelerName>
    <SubstanceName>CARBAMAZEPINE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-06-08</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0228-2539-96</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (0228-2539-96) </PackageDescription>
    <NDC11Code>00228-2539-96</NDC11Code>
    <ProductNDC>0228-2539</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carbidopa And Levodopa</ProprietaryName>
    <NonProprietaryName>Carbidopa And Levodopa</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19930901</StartMarketingDate>
    <EndMarketingDate>20241130</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074260</ApplicationNumber>
    <LabelerName>Actavis Pharma, Inc.</LabelerName>
    <SubstanceName>CARBIDOPA; LEVODOPA</SubstanceName>
    <StrengthNumber>25; 100</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-11-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>19930901</StartMarketingDatePackage>
    <EndMarketingDatePackage>20241031</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carbidopa and levodopa tablets are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that  may follow carbon monoxide intoxication or manganese intoxication. Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on carbidopa and levodopa. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa. Carbidopa may also reduce nausea and vomiting and permit more rapid titration of  levodopa.</IndicationAndUsage>
    <Description>Carbidopa and levodopa tablets, USP are a combination product for the treatment of Parkinson's disease and syndrome. Carbidopa, USP an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.24. It is designated chemically as (-)-L-α-hydrazino-α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its molecular formula is        C10H14N2O4H2O, and its structural formula is. Tablet content is expressed in terms of anhydrous carbidopa which has a molecular weight of 226.23. Levodopa, USP an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.19. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its molecular formula is C9H11NO4, and its structural formula is. Carbidopa and Levodopa Tablets, USP for oral administration, are supplied in three strengths. 10 mg/100 mg, containing 10 mg of carbidopa, USP and 100 mg of levodopa, USP. 25 mg/100 mg, containing 25 mg of carbidopa, USP and 100 mg of levodopa, USP. 25 mg/250 mg, containing 25 mg of carbidopa, USP and 250 mg of levodopa, USP. In addition, each tablet contains the following inactive ingredients: corn starch, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize). In addition, the 25 mg/100 mg strength contain D&amp;C yellow #10 aluminum lake and FD&amp;C yellow #6 aluminum lake (sunset yellow lake). The 10 mg/100 mg and 25 mg/250 mg strengths contain FD&amp;C blue #2 aluminum lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>0228-2540-96</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (0228-2540-96) </PackageDescription>
    <NDC11Code>00228-2540-96</NDC11Code>
    <ProductNDC>0228-2540</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carbidopa And Levodopa</ProprietaryName>
    <NonProprietaryName>Carbidopa And Levodopa</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19930901</StartMarketingDate>
    <EndMarketingDate>20260531</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074260</ApplicationNumber>
    <LabelerName>Actavis Pharma, Inc.</LabelerName>
    <SubstanceName>CARBIDOPA; LEVODOPA</SubstanceName>
    <StrengthNumber>25; 250</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>19930901</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260531</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carbidopa and levodopa tablets are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that  may follow carbon monoxide intoxication or manganese intoxication. Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on carbidopa and levodopa. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa. Carbidopa may also reduce nausea and vomiting and permit more rapid titration of  levodopa.</IndicationAndUsage>
    <Description>Carbidopa and levodopa tablets, USP are a combination product for the treatment of Parkinson's disease and syndrome. Carbidopa, USP an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.24. It is designated chemically as (-)-L-α-hydrazino-α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its molecular formula is        C10H14N2O4H2O, and its structural formula is. Tablet content is expressed in terms of anhydrous carbidopa which has a molecular weight of 226.23. Levodopa, USP an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.19. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its molecular formula is C9H11NO4, and its structural formula is. Carbidopa and Levodopa Tablets, USP for oral administration, are supplied in three strengths. 10 mg/100 mg, containing 10 mg of carbidopa, USP and 100 mg of levodopa, USP. 25 mg/100 mg, containing 25 mg of carbidopa, USP and 100 mg of levodopa, USP. 25 mg/250 mg, containing 25 mg of carbidopa, USP and 250 mg of levodopa, USP. In addition, each tablet contains the following inactive ingredients: corn starch, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize). In addition, the 25 mg/100 mg strength contain D&amp;C yellow #10 aluminum lake and FD&amp;C yellow #6 aluminum lake (sunset yellow lake). The 10 mg/100 mg and 25 mg/250 mg strengths contain FD&amp;C blue #2 aluminum lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>0228-2550-96</NDCCode>
    <PackageDescription>1000 TABLET, DELAYED RELEASE in 1 BOTTLE (0228-2550-96) </PackageDescription>
    <NDC11Code>00228-2550-96</NDC11Code>
    <ProductNDC>0228-2550</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diclofenac Sodium</ProprietaryName>
    <NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
    <DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19960326</StartMarketingDate>
    <EndMarketingDate>20270331</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074514</ApplicationNumber>
    <LabelerName>Actavis Pharma, Inc.</LabelerName>
    <SubstanceName>DICLOFENAC SODIUM</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>19960326</StartMarketingDatePackage>
    <EndMarketingDatePackage>20270331</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation). Diclofenac sodium delayed-release tablets are indicated: 1 for relief of the signs and symptoms of osteoarthritis, 2 for relief of the signs and symptoms of rheumatoid arthritis, 3 for acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis.</IndicationAndUsage>
    <Description>Diclofenac sodium delayed-release tablets, USP are a benzene-acetic acid derivative. Diclofenac sodium, USP is a white to almost white crystalline powder and is sparingly soluble in water at 25°C. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.13 g/mol. Its molecular formula is C14H10Cl2NNaO2, and it has the following structural formula. Each enteric-coated tablet for oral administration contains 50 mg or 75 mg of diclofenac sodium, USP. In addition, each tablet contains the following inactive ingredients: aluminum hydrate, colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl acetate phthalate, propylene glycol, silica, sodium alginate, sodium starch glycolate (Type A), stearic acid, synthetic black iron oxide, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0228-2551-96</NDCCode>
    <PackageDescription>1000 TABLET, DELAYED RELEASE in 1 BOTTLE (0228-2551-96) </PackageDescription>
    <NDC11Code>00228-2551-96</NDC11Code>
    <ProductNDC>0228-2551</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diclofenac Sodium</ProprietaryName>
    <NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
    <DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19960326</StartMarketingDate>
    <EndMarketingDate>20270630</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074514</ApplicationNumber>
    <LabelerName>Actavis Pharma, Inc.</LabelerName>
    <SubstanceName>DICLOFENAC SODIUM</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>19960326</StartMarketingDatePackage>
    <EndMarketingDatePackage>20270630</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation). Diclofenac sodium delayed-release tablets are indicated: 1 for relief of the signs and symptoms of osteoarthritis, 2 for relief of the signs and symptoms of rheumatoid arthritis, 3 for acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis.</IndicationAndUsage>
    <Description>Diclofenac sodium delayed-release tablets, USP are a benzene-acetic acid derivative. Diclofenac sodium, USP is a white to almost white crystalline powder and is sparingly soluble in water at 25°C. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.13 g/mol. Its molecular formula is C14H10Cl2NNaO2, and it has the following structural formula. Each enteric-coated tablet for oral administration contains 50 mg or 75 mg of diclofenac sodium, USP. In addition, each tablet contains the following inactive ingredients: aluminum hydrate, colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl acetate phthalate, propylene glycol, silica, sodium alginate, sodium starch glycolate (Type A), stearic acid, synthetic black iron oxide, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0228-2571-96</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (0228-2571-96) </PackageDescription>
    <NDC11Code>00228-2571-96</NDC11Code>
    <ProductNDC>0228-2571</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Indapamide</ProprietaryName>
    <NonProprietaryName>Indapamide</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070102</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074722</ApplicationNumber>
    <LabelerName>Actavis Pharma, Inc.</LabelerName>
    <SubstanceName>INDAPAMIDE</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Diuresis [PE], Thiazide-like Diuretic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20070102</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Indapamide tablets are indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs. Indapamide tablets are also indicated for the treatment of salt and fluid retention associated with congestive heart failure. Usage in Pregnancy: The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard (see PRECAUTIONS). Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia. Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. Indapamide is indicated in pregnancy when edema is due to pathologic causes, just as it is in the absence of pregnancy (however, see PRECAUTIONS). Dependent edema in pregnancy, resulting from restriction of venous return by the expanded uterus, is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is not harmful to either the fetus or the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort which is not relieved by rest. In these cases, a short course of diuretics may provide relief and may be appropriate.</IndicationAndUsage>
    <Description>Indapamide is an oral antihypertensive/diuretic. Its molecule contains both a polar sulfamoyl chlorobenzamide moiety and a lipid-soluble methylindoline moiety. It differs chemically from the thiazides in that it does not possess the thiazide ring system and contains only one sulfonamide group. The chemical name of indapamide is 4-Chloro-N-(2-methyl-1-indolinyl)-3-Sulfamoylbenzamide, and its molecular weight is 365.84. The compound is a weak acid, pKa=8.8, and is soluble in aqueous solutions of strong bases. It is a white to yellow-white crystalline (tetragonal) powder, and has the following structural formula. Each tablet, for oral administration, contains 1.25 mg or 2.5 mg of indapamide, USP. In addition, each tablet contains the following inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, maltodextrin, microcrystalline cellulose, polydextrose, polyethylene glycol, talc, titanium dioxide, triacetin. The 1.25 mg tablet also contains FD&amp;C yellow #6 aluminum lake (sunset yellow lake).</Description>
  </NDC>
  <NDC>
    <NDCCode>0228-2597-96</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (0228-2597-96) </PackageDescription>
    <NDC11Code>00228-2597-96</NDC11Code>
    <ProductNDC>0228-2597</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Indapamide</ProprietaryName>
    <NonProprietaryName>Indapamide</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070102</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074722</ApplicationNumber>
    <LabelerName>Actavis Pharma, Inc.</LabelerName>
    <SubstanceName>INDAPAMIDE</SubstanceName>
    <StrengthNumber>1.25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Diuresis [PE], Thiazide-like Diuretic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20070102</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Indapamide tablets are indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs. Indapamide tablets are also indicated for the treatment of salt and fluid retention associated with congestive heart failure. Usage in Pregnancy: The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard (see PRECAUTIONS). Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia. Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. Indapamide is indicated in pregnancy when edema is due to pathologic causes, just as it is in the absence of pregnancy (however, see PRECAUTIONS). Dependent edema in pregnancy, resulting from restriction of venous return by the expanded uterus, is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is not harmful to either the fetus or the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort which is not relieved by rest. In these cases, a short course of diuretics may provide relief and may be appropriate.</IndicationAndUsage>
    <Description>Indapamide is an oral antihypertensive/diuretic. Its molecule contains both a polar sulfamoyl chlorobenzamide moiety and a lipid-soluble methylindoline moiety. It differs chemically from the thiazides in that it does not possess the thiazide ring system and contains only one sulfonamide group. The chemical name of indapamide is 4-Chloro-N-(2-methyl-1-indolinyl)-3-Sulfamoylbenzamide, and its molecular weight is 365.84. The compound is a weak acid, pKa=8.8, and is soluble in aqueous solutions of strong bases. It is a white to yellow-white crystalline (tetragonal) powder, and has the following structural formula. Each tablet, for oral administration, contains 1.25 mg or 2.5 mg of indapamide, USP. In addition, each tablet contains the following inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, maltodextrin, microcrystalline cellulose, polydextrose, polyethylene glycol, talc, titanium dioxide, triacetin. The 1.25 mg tablet also contains FD&amp;C yellow #6 aluminum lake (sunset yellow lake).</Description>
  </NDC>
  <NDC>
    <NDCCode>0228-2803-96</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (0228-2803-96) </PackageDescription>
    <NDC11Code>00228-2803-96</NDC11Code>
    <ProductNDC>0228-2803</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Spironolactone</ProprietaryName>
    <NonProprietaryName>Spironolactone</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070103</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040353</ApplicationNumber>
    <LabelerName>Actavis Pharma, Inc.</LabelerName>
    <SubstanceName>SPIRONOLACTONE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-10-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20070103</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0228-2820-96</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (0228-2820-96) </PackageDescription>
    <NDC11Code>00228-2820-96</NDC11Code>
    <ProductNDC>0228-2820</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydrochlorothiazide</ProprietaryName>
    <NonProprietaryName>Hydrochlorothiazide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070312</StartMarketingDate>
    <EndMarketingDate>20270630</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040707</ApplicationNumber>
    <LabelerName>Actavis Pharma, Inc.</LabelerName>
    <SubstanceName>HYDROCHLOROTHIAZIDE</SubstanceName>
    <StrengthNumber>12.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20231201</StartMarketingDatePackage>
    <EndMarketingDatePackage>20270630</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension. Use in Pregnancy. Routine use of diuretics during normal pregnancy is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy and there is no satisfactory evidence that they are useful in the treatment of toxemia. Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy (see PRECAUTIONS, Pregnancy). Dependent edema in pregnancy, resulting from restriction of venous return by the gravid uterus, is properly treated through elevation of the lower extremities and use of support stockings. Use of diuretics to lower intravascular volume in this instance is illogical and unnecessary. During normal pregnancy there is hypervolemia which is not harmful to the fetus or the mother in the absence of cardiovascular disease. However, it may be associated with edema, rarely generalized edema. If such edema causes discomfort, increased recumbency will often provide relief. Rarely this edema may cause extreme discomfort which is not relieved by rest. In these instances, a short course of diuretic therapy may provide relief and be appropriate.</IndicationAndUsage>
    <Description>Hydrochlorothiazide, USP is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. It is chemically designated as 6-chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide and has the following structural formula. C7H8ClN3O4S2              M.W. 297.74. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Each tablet for oral administration contains 12.5 mg of hydrochlorothiazide, USP. In addition, each tablet contains the following inactive ingredients: calcium stearate, corn starch, FD&amp;C Yellow #6 (Sunset Yellow), lactose monohydrate, pregelatinized starch, sodium lauryl sulfate, and stearic acid.</Description>
  </NDC>
  <NDC>
    <NDCCode>0228-2892-96</NDCCode>
    <PackageDescription>1000 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (0228-2892-96) </PackageDescription>
    <NDC11Code>00228-2892-96</NDC11Code>
    <ProductNDC>0228-2892</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Duloxetine</ProprietaryName>
    <NonProprietaryName>Duloxetine</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE PELLETS</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20131217</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090776</ApplicationNumber>
    <LabelerName>Actavis Pharma, Inc.</LabelerName>
    <SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140905</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major depressive disorder in adults, 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults and pediatric patients 13 years of age and older, 5 Chronic musculoskeletal pain in adults.</IndicationAndUsage>
    <Description>Duloxetine delayed-release capsules, USP are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The structural formula is. C18H19NOSHCl                   M.W. 333.88. Duloxetine hydrochloride, USP is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.4 mg, 33.7 mg, or 67.3 mg of duloxetine hydrochloride, USP equivalent to 20 mg, 30 mg, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include black iron oxide, hydroxypropyl cellulose, hypromellose, hypromellose phthalate, potassium hydroxide, propylene glycol, shellac, strong ammonia solution, sugar spheres (which contain sucrose and corn starch), talc, titanium dioxide, and triethyl citrate. The 20 mg and 30 mg capsules also contain FD&amp;C Blue #1 Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>0228-2899-96</NDCCode>
    <PackageDescription>1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (0228-2899-96)</PackageDescription>
    <NDC11Code>00228-2899-96</NDC11Code>
    <ProductNDC>0228-2899</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Glipizide</ProprietaryName>
    <ProprietaryNameSuffix>Er</ProprietaryNameSuffix>
    <NonProprietaryName>Glipizide</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20030908</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076467</ApplicationNumber>
    <LabelerName>Actavis Elizabeth LLC</LabelerName>
    <SubstanceName>GLIPIZIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-01-24</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>0228-2900-96</NDCCode>
    <PackageDescription>1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (0228-2900-96)</PackageDescription>
    <NDC11Code>00228-2900-96</NDC11Code>
    <ProductNDC>0228-2900</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Glipizide</ProprietaryName>
    <ProprietaryNameSuffix>Er</ProprietaryNameSuffix>
    <NonProprietaryName>Glipizide</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20030908</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076467</ApplicationNumber>
    <LabelerName>Actavis Elizabeth LLC</LabelerName>
    <SubstanceName>GLIPIZIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-01-24</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>67091-228-96</NDCCode>
    <PackageDescription>96 TABLET, CHEWABLE in 1 BOTTLE (67091-228-96) </PackageDescription>
    <NDC11Code>67091-0228-96</NDC11Code>
    <ProductNDC>67091-228</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Antacid Extra Strength Assorted Fruit</ProprietaryName>
    <NonProprietaryName>Calcium Antacid</NonProprietaryName>
    <DosageFormName>TABLET, CHEWABLE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20141212</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part331</ApplicationNumber>
    <LabelerName>WinCo Foods, LLC</LabelerName>
    <SubstanceName>CALCIUM CARBONATE</SubstanceName>
    <StrengthNumber>750</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20141212</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>relieves: 1 acid indigestion, 2 heartburn.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>49281-026-50</NDCCode>
    <PackageDescription>10 SYRINGE in 1 CARTON (49281-026-50)  / .5 mL in 1 SYRINGE (49281-026-88) </PackageDescription>
    <NDC11Code>49281-0026-50</NDC11Code>
    <ProductNDC>49281-026</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Nuvaxovid 2026-27</ProprietaryName>
    <NonProprietaryName>Nvx-cov2928</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20260827</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125817</ApplicationNumber>
    <LabelerName>Sanofi Vaccines US Inc.</LabelerName>
    <SubstanceName>NVX-COV2928</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>ug/.5mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-09-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260827</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>NUVAXOVID is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). NUVAXOVID is approved for use in individuals who are: 1 65 years of age and older, or, 2 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.</IndicationAndUsage>
    <Description>NUVAXOVID (COVID-19 Vaccine, Adjuvanted) is a colorless to slightly yellow, clear to mildly opalescent sterile suspension for intramuscular use that is free from visible particles. Each 0.5 mL dose of NUVAXOVID (2026-2027 Formula) contains 5 mcg of recombinant spike glycoprotein (rS) of the SARS-CoV-2 JN.1-descendent variant XFG and 50 mcg Matrix-M adjuvant. The Matrix-M adjuvant is composed of Fraction-A (42.5 mcg) and Fraction-C (7.5 mcg) of saponin extracts from the soapbark tree, Quillaja saponaria Molina. The rS protein is produced by recombinant DNA technology using a baculovirus expression system in the Sf9 insect cell line that is derived from the Spodoptera frugiperda species. Each 0.5 mL dose of NUVAXOVID also contains the following ingredients: cholesterol (30.5 mcg), phosphatidylcholine (23 mcg), potassium dihydrogen phosphate (3.85 mcg), potassium chloride (2.25 mcg), disodium hydrogen phosphate dihydrate (14.7 mcg), disodium hydrogen phosphate heptahydrate (2.465 mg), sodium dihydrogen phosphate monohydrate (0.445 mg), sodium chloride (8.766 mg), polysorbate 80 (0.050 mg), and Water for Injection. The pH is adjusted with sodium hydroxide or hydrochloric acid. Each 0.5 mL dose of NUVAXOVID may also contain residual amounts of baculovirus and Sf9 cell proteins (≤ 0.96 mcg), baculovirus and cellular DNA (≤ 0.00016 mcg), lentil lectin (&lt; 0.025 mcg), methyl-α-D-mannopyranoside (2 mcg), simethicone (&lt; 0.92 mcg), pluronic F-68 (&lt; 2.19 mcg), Triton X-100 (&lt; 0.025 mcg), Tergitol (NP9) (&lt; 0.05 mcg), and DL-α-tocopherol (≤ 0.05 mcg). NUVAXOVID does not contain a preservative. The syringe tip cap and plunger stopper are not made with natural rubber latex.</Description>
  </NDC>
  <NDC>
    <NDCCode>66019-113-10</NDCCode>
    <PackageDescription>10 APPLICATOR in 1 CARTON (66019-113-10)  / .2 mL in 1 APPLICATOR (66019-113-00) </PackageDescription>
    <NDC11Code>66019-0113-10</NDC11Code>
    <ProductNDC>66019-113</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Flumist</ProprietaryName>
    <NonProprietaryName>Influenza Vaccine Live Intranasal</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>NASAL</RouteName>
    <StartMarketingDate>20260722</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125020</ApplicationNumber>
    <LabelerName>MedImmune, LLC</LabelerName>
    <SubstanceName>INFLUENZA A VIRUS A/SWITZERLAND/6849/2025 (H1N1) LIVE (ATTENUATED) ANTIGEN; INFLUENZA A VIRUS A/DARWIN/1369/2025 (H3N2) LIVE (ATTENUATED) ANTIGEN; INFLUENZA B VIRUS B/PERTH/115/2025 LIVE (ATTENUATED) ANTIGEN</SubstanceName>
    <StrengthNumber>10000000; 10000000; 10000000</StrengthNumber>
    <StrengthUnit>[FFU]/.2mL; [FFU]/.2mL; [FFU]/.2mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-07-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260722</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>FluMist is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine [see Description (11)]. FluMist is approved for use in persons 2 through 49 years of age.</IndicationAndUsage>
    <Description>FluMist (Influenza Vaccine Live, Intranasal) is a nasal spray. FluMist contains three vaccine virus strains: an A/H1N1 strain, an A/H3N2 strain and a B strain from the B/Victoria lineage. The influenza virus strains in FluMist are (a) cold-adapted (ca) (i.e., they replicate efficiently at 25°C, a temperature that is restrictive for replication of many wild-type influenza viruses); (b) temperature-sensitive (ts) (i.e., they are restricted in replication at 37°C (Type B strain) or 39°C (Type A strains), temperatures at which many wild-type influenza viruses grow efficiently); and (c) attenuated (att) (i.e., they do not produce classic influenza-like illness in the ferret model of human influenza infection). No evidence of reversion has been observed in the recovered vaccine strains that have been tested (135 of possible 250 recovered isolates) using FluMist [see Clinical Pharmacology (12.2)]. For each of the three reassortant strains in FluMist, the six internal gene segments responsible for ca, ts, and att phenotypes are derived from a master donor virus (MDV), and the two segments that encode the two surface glycoproteins, hemagglutinin (HA) and neuraminidase (NA), are derived from the corresponding antigenically relevant wild-type influenza viruses. Thus, the three viruses contained in FluMist maintain the replication characteristics and phenotypic properties of the MDV and express the HA and NA of wild-type viruses expected to circulate during the 2026-2027 influenza season. For the Type A MDV, at least five genetic loci in three different internal gene segments contribute to the ts and att phenotypes. For the Type B MDV, at least three genetic loci in two different internal gene segments contribute to both the ts and att properties; five genetic loci in three gene segments control the ca property. Specific pathogen-free (SPF) eggs are inoculated with each of the reassortant strains and incubated to allow vaccine virus replication. The allantoic fluid of these eggs is harvested, pooled, and then clarified by filtration. The virus is concentrated by ultracentrifugation and diluted with stabilizing buffer to obtain the final sucrose and potassium phosphate concentrations. The viral harvests are then sterile filtered to produce the monovalent bulks. Each lot is tested for ca, ts, and att phenotypes and is also tested extensively by in vitro and in vivo methods to detect adventitious agents. Monovalent bulks from the three strains are subsequently blended and diluted as required to attain the desired potency with stabilizing buffers to produce the trivalent bulk vaccine. The bulk vaccine is then filled directly into individual sprayers for nasal administration. Each pre-filled refrigerated FluMist sprayer contains a single 0.2 mL dose. Each 0.2 mL dose contains 106.5-7.5 FFU (fluorescent focus units) of live attenuated influenza virus reassortants of each of the three strains: A/Switzerland/6849/2025 (H1N1) (an A/Missouri/11/2025 (H1N1)pdm09-like virus), A/Darwin/1369/2025 (H3N2) (an A/Darwin/1454/2025 (H3N2)-like virus), and B/Perth/115/2025 (B/Victoria lineage) (a B/Tokyo/EIS13-175/2025 (B/Victoria lineage)-like virus). These three influenza virus strains are recommended by FDA for the 2026-2027 influenza season. Each 0.2 mL dose also contains 0.188 mg/dose monosodium glutamate, 2.00 mg/dose hydrolyzed porcine gelatin, 2.42 mg/dose arginine, 13.68 mg/dose sucrose, 2.26 mg/dose dibasic potassium phosphate, and 0.96 mg/dose monobasic potassium phosphate. Each dose contains residual amounts of ovalbumin (&lt;0.024 mcg/dose), and may also contain residual amounts of gentamicin sulfate (&lt;0.015 mcg/mL), and ethylenediaminetetraacetic acid (EDTA) (&lt; 2.3 mcg/dose). FluMist contains no preservatives. The tip attached to the sprayer is equipped with a nozzle that produces a fine mist that is primarily deposited in the nose and nasopharynx. FluMist is a colorless to pale yellow suspension and is clear to slightly cloudy.</Description>
  </NDC>
  <NDC>
    <NDCCode>66019-113-51</NDCCode>
    <PackageDescription>1 APPLICATOR in 1 CARTON (66019-113-51)  / .2 mL in 1 APPLICATOR (66019-113-00) </PackageDescription>
    <NDC11Code>66019-0113-51</NDC11Code>
    <ProductNDC>66019-113</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Flumist</ProprietaryName>
    <NonProprietaryName>Influenza Vaccine Live Intranasal</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>NASAL</RouteName>
    <StartMarketingDate>20260722</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125020</ApplicationNumber>
    <LabelerName>MedImmune, LLC</LabelerName>
    <SubstanceName>INFLUENZA A VIRUS A/SWITZERLAND/6849/2025 (H1N1) LIVE (ATTENUATED) ANTIGEN; INFLUENZA A VIRUS A/DARWIN/1369/2025 (H3N2) LIVE (ATTENUATED) ANTIGEN; INFLUENZA B VIRUS B/PERTH/115/2025 LIVE (ATTENUATED) ANTIGEN</SubstanceName>
    <StrengthNumber>10000000; 10000000; 10000000</StrengthNumber>
    <StrengthUnit>[FFU]/.2mL; [FFU]/.2mL; [FFU]/.2mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-07-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260722</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>FluMist is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine [see Description (11)]. FluMist is approved for use in persons 2 through 49 years of age.</IndicationAndUsage>
    <Description>FluMist (Influenza Vaccine Live, Intranasal) is a nasal spray. FluMist contains three vaccine virus strains: an A/H1N1 strain, an A/H3N2 strain and a B strain from the B/Victoria lineage. The influenza virus strains in FluMist are (a) cold-adapted (ca) (i.e., they replicate efficiently at 25°C, a temperature that is restrictive for replication of many wild-type influenza viruses); (b) temperature-sensitive (ts) (i.e., they are restricted in replication at 37°C (Type B strain) or 39°C (Type A strains), temperatures at which many wild-type influenza viruses grow efficiently); and (c) attenuated (att) (i.e., they do not produce classic influenza-like illness in the ferret model of human influenza infection). No evidence of reversion has been observed in the recovered vaccine strains that have been tested (135 of possible 250 recovered isolates) using FluMist [see Clinical Pharmacology (12.2)]. For each of the three reassortant strains in FluMist, the six internal gene segments responsible for ca, ts, and att phenotypes are derived from a master donor virus (MDV), and the two segments that encode the two surface glycoproteins, hemagglutinin (HA) and neuraminidase (NA), are derived from the corresponding antigenically relevant wild-type influenza viruses. Thus, the three viruses contained in FluMist maintain the replication characteristics and phenotypic properties of the MDV and express the HA and NA of wild-type viruses expected to circulate during the 2026-2027 influenza season. For the Type A MDV, at least five genetic loci in three different internal gene segments contribute to the ts and att phenotypes. For the Type B MDV, at least three genetic loci in two different internal gene segments contribute to both the ts and att properties; five genetic loci in three gene segments control the ca property. Specific pathogen-free (SPF) eggs are inoculated with each of the reassortant strains and incubated to allow vaccine virus replication. The allantoic fluid of these eggs is harvested, pooled, and then clarified by filtration. The virus is concentrated by ultracentrifugation and diluted with stabilizing buffer to obtain the final sucrose and potassium phosphate concentrations. The viral harvests are then sterile filtered to produce the monovalent bulks. Each lot is tested for ca, ts, and att phenotypes and is also tested extensively by in vitro and in vivo methods to detect adventitious agents. Monovalent bulks from the three strains are subsequently blended and diluted as required to attain the desired potency with stabilizing buffers to produce the trivalent bulk vaccine. The bulk vaccine is then filled directly into individual sprayers for nasal administration. Each pre-filled refrigerated FluMist sprayer contains a single 0.2 mL dose. Each 0.2 mL dose contains 106.5-7.5 FFU (fluorescent focus units) of live attenuated influenza virus reassortants of each of the three strains: A/Switzerland/6849/2025 (H1N1) (an A/Missouri/11/2025 (H1N1)pdm09-like virus), A/Darwin/1369/2025 (H3N2) (an A/Darwin/1454/2025 (H3N2)-like virus), and B/Perth/115/2025 (B/Victoria lineage) (a B/Tokyo/EIS13-175/2025 (B/Victoria lineage)-like virus). These three influenza virus strains are recommended by FDA for the 2026-2027 influenza season. Each 0.2 mL dose also contains 0.188 mg/dose monosodium glutamate, 2.00 mg/dose hydrolyzed porcine gelatin, 2.42 mg/dose arginine, 13.68 mg/dose sucrose, 2.26 mg/dose dibasic potassium phosphate, and 0.96 mg/dose monobasic potassium phosphate. Each dose contains residual amounts of ovalbumin (&lt;0.024 mcg/dose), and may also contain residual amounts of gentamicin sulfate (&lt;0.015 mcg/mL), and ethylenediaminetetraacetic acid (EDTA) (&lt; 2.3 mcg/dose). FluMist contains no preservatives. The tip attached to the sprayer is equipped with a nozzle that produces a fine mist that is primarily deposited in the nose and nasopharynx. FluMist is a colorless to pale yellow suspension and is clear to slightly cloudy.</Description>
  </NDC>
  <NDC>
    <NDCCode>80777-114-96</NDCCode>
    <PackageDescription>10 SYRINGE, PLASTIC in 1 CARTON (80777-114-96)  / .5 mL in 1 SYRINGE, PLASTIC (80777-114-01) </PackageDescription>
    <NDC11Code>80777-0114-96</NDC11Code>
    <ProductNDC>80777-114</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Spikevax</ProprietaryName>
    <NonProprietaryName>Covid-19 Vaccine, Mrna</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20260817</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125752</ApplicationNumber>
    <LabelerName>Moderna US, Inc.</LabelerName>
    <SubstanceName>CX-055611</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>ug/.5mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-08-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260817</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>SPIKEVAX is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SPIKEVAX is approved for use in individuals who are: 1 65 years of age and older, or, 2 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.</IndicationAndUsage>
    <Description>SPIKEVAX (COVID-19 Vaccine, mRNA) is a sterile white to off-white injectable suspension for intramuscular use. Each 0.5 mL dose of SPIKEVAX (2026-2027 Formula) contains 50 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized spike glycoprotein (S) of the SARS-CoV-2 JN.1-descendent variant XFG. Each dose also contains the following ingredients: a total lipid content of 1.01 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.25 mg tromethamine, 1.2 mg tromethamine hydrochloride, 0.021 mg acetic acid, 0.10 mg sodium acetate trihydrate, and 43.5 mg sucrose. Each 0.25 mL dose of SPIKEVAX (2026-2027 Formula) contains 25 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized spike glycoprotein (S) of the SARS-CoV-2 JN.1-descendent variant XFG. Each dose also contains the following ingredients: a total lipid content of 0.50 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.13 mg tromethamine, 0.62 mg tromethamine hydrochloride, 0.011 mg acetic acid, 0.049 mg sodium acetate trihydrate, and 21.8 mg sucrose. SPIKEVAX does not contain a preservative. The rubber tip cap and plunger used for the single-dose syringes are not made with natural rubber latex.</Description>
  </NDC>
  <NDC>
    <NDCCode>0069-0228-02</NDCCode>
    <PackageDescription>10 SYRINGE in 1 CARTON (0069-0228-02)  / .72 mL in 1 SYRINGE (0069-0228-01) </PackageDescription>
    <NDC11Code>00069-0228-02</NDC11Code>
    <ProductNDC>0069-0228</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fragmin</ProprietaryName>
    <NonProprietaryName>Dalteparin Sodium</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20150401</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020287</ApplicationNumber>
    <LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
    <SubstanceName>DALTEPARIN SODIUM</SubstanceName>
    <StrengthNumber>18000</StrengthNumber>
    <StrengthUnit>[iU]/.72mL</StrengthUnit>
    <Pharm_Classes>Anti-coagulant [EPC], Heparin, Low-Molecular-Weight [CS], Low Molecular Weight Heparin [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>FRAGMIN is a low molecular weight heparin (LMWH) indicated for: 1 Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction (1.1), 2 Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery or medical patients with severely restricted mobility during acute illness (1.2), 3 Extended treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in adult patients with cancer. In these patients, the FRAGMIN therapy begins with the initial VTE treatment and continues for six months (1.3), 4 Treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in pediatric patients from birth (gestational age at least 35 weeks) (1.4), 5 Limitations of UseFRAGMIN is not indicated for the acute treatment of VTE (1.5).</IndicationAndUsage>
    <Description>FRAGMIN Injection (dalteparin sodium injection) is a sterile, low molecular weight heparin. It is available in single-dose, prefilled syringes preassembled with a needle guard device, and multiple-dose vials. With reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard, each syringe contains either 2,500 units, 5,000 units, 7,500 units, 10,000 units, 12,500 units, 15,000 units or 18,000 anti-Xa international units (units), equivalent to 16 mg, 32 mg, 48 mg, 64 mg, 80 mg, 96 mg or 115.2 mg dalteparin sodium, respectively. Each multiple-dose vial contains 25,000 anti-Xa units per 1 mL (equivalent to 160 mg dalteparin sodium), for a total of 95,000 anti-Xa units per vial. Each single-dose vial contains 2,500 anti-Xa units per 1 mL (equivalent to 16 mg dalteparin sodium) for a total of 10,000 anti-Xa units per vial. Each prefilled syringe also contains Water for Injection and sodium chloride, when required, to maintain physiologic ionic strength. The prefilled syringes are preservative-free. Each multiple-dose vial also contains Water for Injection and 14 mg of benzyl alcohol per mL as a preservative. The pH of both formulations is 5.0 to 7.5. When necessary, the pH of FRAGMIN is adjusted with hydrochloric acid and/or sodium hydroxide [see Dosage and Administration (2.7) and How Supplied/Storage and Handling (16)]. Dalteparin sodium is produced through controlled nitrous acid depolymerization of sodium heparin from porcine intestinal mucosa followed by a chromatographic purification process. It is composed of strongly acidic sulfated polysaccharide chains (oligosaccharide, containing 2,5-anhydro-D-mannitol residues as end groups) with an average molecular weight of 5,000 and about 90% of the material within the range 2,000–9,000. The molecular weight distribution is. Structural Formula.</Description>
  </NDC>
  <NDC>
    <NDCCode>0574-0228-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (0574-0228-01) </PackageDescription>
    <NDC11Code>00574-0228-01</NDC11Code>
    <ProductNDC>0574-0228</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Benazepril Hydrochloride And Hydrochlorothiazide</ProprietaryName>
    <NonProprietaryName>Benazepril Hydrochloride And Hydrochlorothiazide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190407</StartMarketingDate>
    <EndMarketingDate>20270331</EndMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA020033</ApplicationNumber>
    <LabelerName>Padagis US LLC</LabelerName>
    <SubstanceName>BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE</SubstanceName>
    <StrengthNumber>20; 25</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20190407</StartMarketingDatePackage>
    <EndMarketingDatePackage>20270331</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Benazepril HCl and Hydrochlorothiazide is indicated for the treatment of hypertension. This fixed combination drug is not indicated for the initial therapy of hypertension (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
    <Description>Benazepril hydrochloride USP is a white to off-white crystalline powder, soluble (&gt;100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride’s chemical name is 3-[[1-(ethoxycarbonyl)-3- phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine- 1-acetic acid monohydrochloride; its structural formula is. Its empirical formula is C24H28N2O5·HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin converting enzyme inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Hydrochlorothiazide USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide’s chemical name is 6-chloro-3,4-dihydro-2H-1,2,4- benzothiadiazine-7-sulfonamide 1,1-dioxide; its structural formula is. Its empirical formula is C7 H8 ClN3 O4 S2, and its molecular weight is 297.73. Hydrochlorothiazide is a thiazide diuretic. Benazepril HCl and Hydrochlorothiazide is a combination of benazepril and hydrochlorothiazide USP. The tablets are formulated for oral administration with a combination of 10 or 20 mg of benazepril and 12.5 or 25 mg of hydrochlorothiazide USP. The inactive ingredients of the tablets are cellulose compounds, crospovidone, hydrogenated castor oil, iron oxides (10/12.5 mg, 20/12.5 mg, and 20/25 mg tablets), lactose, polyethylene glycol, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>58284-228-01</NDCCode>
    <PackageDescription>1 SYRINGE, GLASS in 1 CARTON (58284-228-01)  / .36 mL in 1 SYRINGE, GLASS</PackageDescription>
    <NDC11Code>58284-0228-01</NDC11Code>
    <ProductNDC>58284-228</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Brixadi</ProprietaryName>
    <NonProprietaryName>Buprenorphine</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20230606</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA210136</ApplicationNumber>
    <LabelerName>Braeburn Inc.</LabelerName>
    <SubstanceName>BUPRENORPHINE</SubstanceName>
    <StrengthNumber>128</StrengthNumber>
    <StrengthUnit>mg/.36mL</StrengthUnit>
    <Pharm_Classes>Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
    <DEASchedule>CIII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-01-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230606</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>BRIXADI is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine. BRIXADI should be used as part of a complete treatment plan that includes counseling and psychosocial support.</IndicationAndUsage>
    <Description>BRIXADI (buprenorphine) extended-release injection is a sterile, yellowish to yellow clear liquid provided in a single-dose, pre-filled syringe intended for subcutaneous injection only. BRIXADI is designed to deliver buprenorphine at a controlled rate over either one week or one month. The active ingredient in BRIXADI is buprenorphine free base, a partial opioid agonist. BRIXADI is provided in multiple doses with two durations (weekly and monthly). : 1 BRIXADI (weekly; 8, 16, 24, 32 mg) consists of 50 mg/mL buprenorphine. The inactive ingredients include dehydrated alcohol (12% v/v), glycerol dioleate (43% v/v), and soybean phosphatidylcholine (41% w/v)., 2 BRIXADI (monthly; 64, 96, 128 mg) consists of 356 mg/mL buprenorphine. The inactive ingredients include glycerol dioleate (24% v/v), methylpyrrolidone (31% v/v), and soybean phosphatidylcholine (15% w/v).</Description>
  </NDC>
  <NDC>
    <NDCCode>0069-2501-10</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (0069-2501-10)  / .48 mL in 1 VIAL, SINGLE-DOSE (0069-2501-01) </PackageDescription>
    <NDC11Code>00069-2501-10</NDC11Code>
    <ProductNDC>0069-2501</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Comirnaty</ProprietaryName>
    <NonProprietaryName>Covid-19 Vaccine, Mrna</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20250827</StartMarketingDate>
    <EndMarketingDate>20261130</EndMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125742</ApplicationNumber>
    <LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
    <SubstanceName>BNT162B2 OMICRON (LP.8.1)</SubstanceName>
    <StrengthNumber>.0158</StrengthNumber>
    <StrengthUnit>mg/.48mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-09-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). COMIRNATY is approved for use in individuals who are: 1 65 years of age and older, or, 2 5 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.</IndicationAndUsage>
    <Description>COMIRNATY (COVID-19 Vaccine, mRNA) is a sterile injectable suspension for intramuscular use. Single-Dose Prefilled Syringe for Individuals 65 Years of Age and Older and Individuals 12 Years Through 64 Years of Age with at Least One Underlying Condition that Puts Them at High Risk for Severe Outcomes from COVID-19. Each 0.3 mL dose of COMIRNATY (2026-2027 Formula) is formulated to contain 30 mcg nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2 JN.1-descendent variant XFG. Each 0.3 mL dose of COMIRNATY also includes the following ingredients: lipids (0.43 mg ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.05 mg 2-(polyethylene glycol 2000)-N,N-ditetradecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.19 mg cholesterol), 0.06 mg tromethamine, 0.4 mg tromethamine hydrochloride, and 31 mg sucrose. Single-Dose Vial for Individuals 5 Years Through 11 Years of Age with at Least One Underlying Condition that Puts Them at High Risk for Severe Outcomes from COVID-19. Each 0.3 mL dose of COMIRNATY (2026-2027 Formula) is formulated to contain 10 mcg nucleoside-modified RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2 JN.1-descendent variant XFG. Each 0.3 mL dose of COMIRNATY also includes the following ingredients: lipids (0.14 mg ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.02 mg 2-(polyethylene glycol 2000)-N,N-ditetradecylacetamide, 0.03 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.06 mg cholesterol), 0.06 mg tromethamine, 0.4 mg tromethamine hydrochloride, and 31 mg sucrose. COMIRNATY does not contain preservatives. The vial stoppers are not made with natural rubber latex. The prefilled syringe tip cap and plunger stopper are not made with natural rubber latex.</Description>
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    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Comirnaty</ProprietaryName>
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    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
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    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125742</ApplicationNumber>
    <LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
    <SubstanceName>BNT162B2 OMICRON (LP.8.1)</SubstanceName>
    <StrengthNumber>.042</StrengthNumber>
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    <Status>Active</Status>
    <LastUpdate>2026-09-08</LastUpdate>
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    <IndicationAndUsage>COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). COMIRNATY is approved for use in individuals who are: 1 65 years of age and older, or, 2 5 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.</IndicationAndUsage>
    <Description>COMIRNATY (COVID-19 Vaccine, mRNA) is a sterile injectable suspension for intramuscular use. Single-Dose Prefilled Syringe for Individuals 65 Years of Age and Older and Individuals 12 Years Through 64 Years of Age with at Least One Underlying Condition that Puts Them at High Risk for Severe Outcomes from COVID-19. Each 0.3 mL dose of COMIRNATY (2026-2027 Formula) is formulated to contain 30 mcg nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2 JN.1-descendent variant XFG. Each 0.3 mL dose of COMIRNATY also includes the following ingredients: lipids (0.43 mg ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.05 mg 2-(polyethylene glycol 2000)-N,N-ditetradecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.19 mg cholesterol), 0.06 mg tromethamine, 0.4 mg tromethamine hydrochloride, and 31 mg sucrose. Single-Dose Vial for Individuals 5 Years Through 11 Years of Age with at Least One Underlying Condition that Puts Them at High Risk for Severe Outcomes from COVID-19. Each 0.3 mL dose of COMIRNATY (2026-2027 Formula) is formulated to contain 10 mcg nucleoside-modified RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2 JN.1-descendent variant XFG. Each 0.3 mL dose of COMIRNATY also includes the following ingredients: lipids (0.14 mg ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.02 mg 2-(polyethylene glycol 2000)-N,N-ditetradecylacetamide, 0.03 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.06 mg cholesterol), 0.06 mg tromethamine, 0.4 mg tromethamine hydrochloride, and 31 mg sucrose. COMIRNATY does not contain preservatives. The vial stoppers are not made with natural rubber latex. The prefilled syringe tip cap and plunger stopper are not made with natural rubber latex.</Description>
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    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (0069-2609-10)  / .48 mL in 1 VIAL, SINGLE-DOSE (0069-2609-01) </PackageDescription>
    <NDC11Code>00069-2609-10</NDC11Code>
    <ProductNDC>0069-2609</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Comirnaty</ProprietaryName>
    <NonProprietaryName>Covid-19 Vaccine, Mrna</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20260827</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125742</ApplicationNumber>
    <LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
    <SubstanceName>BNT-162B2 OMICRON (XFG) MRNA</SubstanceName>
    <StrengthNumber>.0158</StrengthNumber>
    <StrengthUnit>mg/.48mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-09-08</LastUpdate>
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    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260827</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). COMIRNATY is approved for use in individuals who are: 1 65 years of age and older, or, 2 5 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.</IndicationAndUsage>
    <Description>COMIRNATY (COVID-19 Vaccine, mRNA) is a sterile injectable suspension for intramuscular use. Single-Dose Prefilled Syringe for Individuals 65 Years of Age and Older and Individuals 12 Years Through 64 Years of Age with at Least One Underlying Condition that Puts Them at High Risk for Severe Outcomes from COVID-19. Each 0.3 mL dose of COMIRNATY (2026-2027 Formula) is formulated to contain 30 mcg nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2 JN.1-descendent variant XFG. Each 0.3 mL dose of COMIRNATY also includes the following ingredients: lipids (0.43 mg ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.05 mg 2-(polyethylene glycol 2000)-N,N-ditetradecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.19 mg cholesterol), 0.06 mg tromethamine, 0.4 mg tromethamine hydrochloride, and 31 mg sucrose. Single-Dose Vial for Individuals 5 Years Through 11 Years of Age with at Least One Underlying Condition that Puts Them at High Risk for Severe Outcomes from COVID-19. Each 0.3 mL dose of COMIRNATY (2026-2027 Formula) is formulated to contain 10 mcg nucleoside-modified RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2 JN.1-descendent variant XFG. Each 0.3 mL dose of COMIRNATY also includes the following ingredients: lipids (0.14 mg ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.02 mg 2-(polyethylene glycol 2000)-N,N-ditetradecylacetamide, 0.03 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.06 mg cholesterol), 0.06 mg tromethamine, 0.4 mg tromethamine hydrochloride, and 31 mg sucrose. COMIRNATY does not contain preservatives. The vial stoppers are not made with natural rubber latex. The prefilled syringe tip cap and plunger stopper are not made with natural rubber latex.</Description>
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