RESTful Lookup — Test-Drive (2007 – 2026)

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    <NDCCode>43547-401-94</NDCCode>
    <PackageDescription>2000000 TABLET in 1 DRUM (43547-401-94) </PackageDescription>
    <NDC11Code>43547-0401-94</NDC11Code>
    <ProductNDC>43547-401</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Furosemide</ProprietaryName>
    <NonProprietaryName>Furosemide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20040326</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076796</ApplicationNumber>
    <LabelerName>Solco Healthcare LLC</LabelerName>
    <SubstanceName>FUROSEMIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Furosemide is a diuretic which is an anthranilic acid derivative. Furosemide Tablets, USP for oral administration contain furosemide, USP as the active ingredient and the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch, and talc. Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide is available as white-off white tablets for oral administration in dosage strengths of 20 mg, 40 mg and 80 mg. Furosemide is a white to off-white odorless crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The CAS Registry Number is 54-31-9. The structural formula is as follows. Tested by USP Dissolution Test 1.</Description>
  </NDC>
  <NDC>
    <NDCCode>42002-401-94</NDCCode>
    <PackageDescription>2 BOTTLE, PLASTIC in 1 PACKAGE (42002-401-94)  &gt; 1500 mL in 1 BOTTLE, PLASTIC (42002-401-70) </PackageDescription>
    <NDC11Code>42002-0401-94</NDC11Code>
    <ProductNDC>42002-401</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Listerine Antiseptic</ProprietaryName>
    <NonProprietaryName>Eucalyptol, Menthol, Methyl Salicylate, And Thymol</NonProprietaryName>
    <DosageFormName>MOUTHWASH</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120221</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part356</ApplicationNumber>
    <LabelerName>Johnson &amp; Johnson Consumer Inc.</LabelerName>
    <SubstanceName>EUCALYPTOL; MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE; THYMOL</SubstanceName>
    <StrengthNumber>.92; .42; .6; .64</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-08-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120221</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>43547-402-94</NDCCode>
    <PackageDescription>1000000 TABLET in 1 DRUM (43547-402-94) </PackageDescription>
    <NDC11Code>43547-0402-94</NDC11Code>
    <ProductNDC>43547-402</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Furosemide</ProprietaryName>
    <NonProprietaryName>Furosemide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20040326</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076796</ApplicationNumber>
    <LabelerName>Solco Healthcare LLC</LabelerName>
    <SubstanceName>FUROSEMIDE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Furosemide is a diuretic which is an anthranilic acid derivative. Furosemide Tablets, USP for oral administration contain furosemide, USP as the active ingredient and the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch, and talc. Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide is available as white-off white tablets for oral administration in dosage strengths of 20 mg, 40 mg and 80 mg. Furosemide is a white to off-white odorless crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The CAS Registry Number is 54-31-9. The structural formula is as follows. Tested by USP Dissolution Test 1.</Description>
  </NDC>
  <NDC>
    <NDCCode>43547-403-94</NDCCode>
    <PackageDescription>500000 TABLET in 1 DRUM (43547-403-94) </PackageDescription>
    <NDC11Code>43547-0403-94</NDC11Code>
    <ProductNDC>43547-403</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Furosemide</ProprietaryName>
    <NonProprietaryName>Furosemide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20040326</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076796</ApplicationNumber>
    <LabelerName>Solco Healthcare LLC</LabelerName>
    <SubstanceName>FUROSEMIDE</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Furosemide is a diuretic which is an anthranilic acid derivative. Furosemide Tablets, USP for oral administration contain furosemide, USP as the active ingredient and the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch, and talc. Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide is available as white-off white tablets for oral administration in dosage strengths of 20 mg, 40 mg and 80 mg. Furosemide is a white to off-white odorless crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The CAS Registry Number is 54-31-9. The structural formula is as follows. Tested by USP Dissolution Test 1.</Description>
  </NDC>
  <NDC>
    <NDCCode>43547-401-10</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (43547-401-10) </PackageDescription>
    <NDC11Code>43547-0401-10</NDC11Code>
    <ProductNDC>43547-401</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Furosemide</ProprietaryName>
    <NonProprietaryName>Furosemide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20040326</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076796</ApplicationNumber>
    <LabelerName>Solco Healthcare LLC</LabelerName>
    <SubstanceName>FUROSEMIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20040326</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Furosemide is a diuretic which is an anthranilic acid derivative. Furosemide Tablets, USP for oral administration contain furosemide, USP as the active ingredient and the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch, and talc. Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide is available as white-off white tablets for oral administration in dosage strengths of 20 mg, 40 mg and 80 mg. Furosemide is a white to off-white odorless crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The CAS Registry Number is 54-31-9. The structural formula is as follows. Tested by USP Dissolution Test 1.</Description>
  </NDC>
  <NDC>
    <NDCCode>43547-401-11</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE, PLASTIC (43547-401-11) </PackageDescription>
    <NDC11Code>43547-0401-11</NDC11Code>
    <ProductNDC>43547-401</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Furosemide</ProprietaryName>
    <NonProprietaryName>Furosemide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20040326</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076796</ApplicationNumber>
    <LabelerName>Solco Healthcare LLC</LabelerName>
    <SubstanceName>FUROSEMIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20040326</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Furosemide is a diuretic which is an anthranilic acid derivative. Furosemide Tablets, USP for oral administration contain furosemide, USP as the active ingredient and the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch, and talc. Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide is available as white-off white tablets for oral administration in dosage strengths of 20 mg, 40 mg and 80 mg. Furosemide is a white to off-white odorless crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The CAS Registry Number is 54-31-9. The structural formula is as follows. Tested by USP Dissolution Test 1.</Description>
  </NDC>
  <NDC>
    <NDCCode>43547-401-51</NDCCode>
    <PackageDescription>5000 TABLET in 1 BOTTLE, PLASTIC (43547-401-51) </PackageDescription>
    <NDC11Code>43547-0401-51</NDC11Code>
    <ProductNDC>43547-401</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Furosemide</ProprietaryName>
    <NonProprietaryName>Furosemide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20040326</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076796</ApplicationNumber>
    <LabelerName>Solco Healthcare LLC</LabelerName>
    <SubstanceName>FUROSEMIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20040326</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Furosemide is a diuretic which is an anthranilic acid derivative. Furosemide Tablets, USP for oral administration contain furosemide, USP as the active ingredient and the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch, and talc. Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide is available as white-off white tablets for oral administration in dosage strengths of 20 mg, 40 mg and 80 mg. Furosemide is a white to off-white odorless crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The CAS Registry Number is 54-31-9. The structural formula is as follows. Tested by USP Dissolution Test 1.</Description>
  </NDC>
  <NDC>
    <NDCCode>43547-001-03</NDCCode>
    <PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-001-03) </PackageDescription>
    <NDC11Code>43547-0001-03</NDC11Code>
    <ProductNDC>43547-001</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Esomeprazole Magnesium</ProprietaryName>
    <NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230328</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214920</ApplicationNumber>
    <LabelerName>Solco Healthcare US LLC</LabelerName>
    <SubstanceName>ESOMEPRAZOLE MAGNESIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230328</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1), 2 Maintenance of healing of EE in adults. (1.2), 3 Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. (1.3), 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4), 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5), 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6).</IndicationAndUsage>
    <Description>The active ingredient in esomeprazole magnesium delayed-release capsules for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydrate, a PPI. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2Mg x 3 H2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is. The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium delayed-release capsules, USP are supplied in delayed-release capsules. Each esomeprazole magnesium delayed-release capsules contains 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) or 40 mg of esomeprazole (equivalent to 44.5 mg esomeprazole magnesium trihydrate) in the form of enteric-coated pellets with the following inactive ingredients: hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, sugar spheres, talc, and triethyl citrate. The capsule shells have the following inactive ingredients: Black iron oxide, FD&amp;C Blue #1, FD&amp;C Red #3, gelatin, potassium hydroxide, propylene glycol, shellac, and titanium dioxide. Meets USP dissolution test 3.</Description>
  </NDC>
  <NDC>
    <NDCCode>43547-001-09</NDCCode>
    <PackageDescription>90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-001-09) </PackageDescription>
    <NDC11Code>43547-0001-09</NDC11Code>
    <ProductNDC>43547-001</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Esomeprazole Magnesium</ProprietaryName>
    <NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230328</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214920</ApplicationNumber>
    <LabelerName>Solco Healthcare US LLC</LabelerName>
    <SubstanceName>ESOMEPRAZOLE MAGNESIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230328</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1), 2 Maintenance of healing of EE in adults. (1.2), 3 Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. (1.3), 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4), 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5), 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6).</IndicationAndUsage>
    <Description>The active ingredient in esomeprazole magnesium delayed-release capsules for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydrate, a PPI. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2Mg x 3 H2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is. The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium delayed-release capsules, USP are supplied in delayed-release capsules. Each esomeprazole magnesium delayed-release capsules contains 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) or 40 mg of esomeprazole (equivalent to 44.5 mg esomeprazole magnesium trihydrate) in the form of enteric-coated pellets with the following inactive ingredients: hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, sugar spheres, talc, and triethyl citrate. The capsule shells have the following inactive ingredients: Black iron oxide, FD&amp;C Blue #1, FD&amp;C Red #3, gelatin, potassium hydroxide, propylene glycol, shellac, and titanium dioxide. Meets USP dissolution test 3.</Description>
  </NDC>
  <NDC>
    <NDCCode>43547-002-03</NDCCode>
    <PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-002-03) </PackageDescription>
    <NDC11Code>43547-0002-03</NDC11Code>
    <ProductNDC>43547-002</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Esomeprazole Magnesium</ProprietaryName>
    <NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230328</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214920</ApplicationNumber>
    <LabelerName>Solco Healthcare US LLC</LabelerName>
    <SubstanceName>ESOMEPRAZOLE MAGNESIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230328</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1), 2 Maintenance of healing of EE in adults. (1.2), 3 Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. (1.3), 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4), 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5), 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6).</IndicationAndUsage>
    <Description>The active ingredient in esomeprazole magnesium delayed-release capsules for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydrate, a PPI. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2Mg x 3 H2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is. The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium delayed-release capsules, USP are supplied in delayed-release capsules. Each esomeprazole magnesium delayed-release capsules contains 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) or 40 mg of esomeprazole (equivalent to 44.5 mg esomeprazole magnesium trihydrate) in the form of enteric-coated pellets with the following inactive ingredients: hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, sugar spheres, talc, and triethyl citrate. The capsule shells have the following inactive ingredients: Black iron oxide, FD&amp;C Blue #1, FD&amp;C Red #3, gelatin, potassium hydroxide, propylene glycol, shellac, and titanium dioxide. Meets USP dissolution test 3.</Description>
  </NDC>
  <NDC>
    <NDCCode>43547-002-09</NDCCode>
    <PackageDescription>90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-002-09) </PackageDescription>
    <NDC11Code>43547-0002-09</NDC11Code>
    <ProductNDC>43547-002</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Esomeprazole Magnesium</ProprietaryName>
    <NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230328</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214920</ApplicationNumber>
    <LabelerName>Solco Healthcare US LLC</LabelerName>
    <SubstanceName>ESOMEPRAZOLE MAGNESIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230328</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1), 2 Maintenance of healing of EE in adults. (1.2), 3 Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. (1.3), 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4), 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5), 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6).</IndicationAndUsage>
    <Description>The active ingredient in esomeprazole magnesium delayed-release capsules for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydrate, a PPI. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2Mg x 3 H2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is. The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium delayed-release capsules, USP are supplied in delayed-release capsules. Each esomeprazole magnesium delayed-release capsules contains 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) or 40 mg of esomeprazole (equivalent to 44.5 mg esomeprazole magnesium trihydrate) in the form of enteric-coated pellets with the following inactive ingredients: hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, sugar spheres, talc, and triethyl citrate. The capsule shells have the following inactive ingredients: Black iron oxide, FD&amp;C Blue #1, FD&amp;C Red #3, gelatin, potassium hydroxide, propylene glycol, shellac, and titanium dioxide. Meets USP dissolution test 3.</Description>
  </NDC>
  <NDC>
    <NDCCode>43547-002-11</NDCCode>
    <PackageDescription>1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-002-11) </PackageDescription>
    <NDC11Code>43547-0002-11</NDC11Code>
    <ProductNDC>43547-002</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Esomeprazole Magnesium</ProprietaryName>
    <NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230328</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214920</ApplicationNumber>
    <LabelerName>Solco Healthcare US LLC</LabelerName>
    <SubstanceName>ESOMEPRAZOLE MAGNESIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230328</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1), 2 Maintenance of healing of EE in adults. (1.2), 3 Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. (1.3), 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4), 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5), 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6).</IndicationAndUsage>
    <Description>The active ingredient in esomeprazole magnesium delayed-release capsules for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydrate, a PPI. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2Mg x 3 H2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is. The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium delayed-release capsules, USP are supplied in delayed-release capsules. Each esomeprazole magnesium delayed-release capsules contains 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) or 40 mg of esomeprazole (equivalent to 44.5 mg esomeprazole magnesium trihydrate) in the form of enteric-coated pellets with the following inactive ingredients: hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, sugar spheres, talc, and triethyl citrate. The capsule shells have the following inactive ingredients: Black iron oxide, FD&amp;C Blue #1, FD&amp;C Red #3, gelatin, potassium hydroxide, propylene glycol, shellac, and titanium dioxide. Meets USP dissolution test 3.</Description>
  </NDC>
  <NDC>
    <NDCCode>43547-003-03</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (43547-003-03) </PackageDescription>
    <NDC11Code>43547-0003-03</NDC11Code>
    <ProductNDC>43547-003</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fingolimod</ProprietaryName>
    <NonProprietaryName>Fingolimod</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200217</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208003</ApplicationNumber>
    <LabelerName>Solco Healthcare US, LLC</LabelerName>
    <SubstanceName>FINGOLIMOD</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Sphingosine 1-Phosphate Receptor Modulators [MoA], Sphingosine 1-phosphate Receptor Modulator [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-09-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211026</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fingolimod capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older.</IndicationAndUsage>
    <Description>Fingolimod is a sphingosine 1-phosphate receptor modulator. Chemically, fingolimod is 2-amino-2-[2-(4-octylphenyl)ethyl]propan-1,3-diol hydrochloride. Its structure is shown below. Fingolimod hydrochloride, USP is a white to practically white powder that is freely soluble in water and alcohol and soluble in propylene glycol. It has a molecular weight of 343.93 g/mol. Fingolimod capsules are provided as 0.5 mg hard gelatin capsules for oral use. Each 0.5 mg capsule contains 0.56 mg of fingolimod hydrochloride, equivalent to 0.5 mg of fingolimod. Each 0.5 mg fingolimod capsule contains the following inactive ingredients: black iron oxide, gelatin, magnesium stearate, potassium hydroxide, propylene glycol, silicified microcrystalline cellulose, shellac and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>43547-003-09</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (43547-003-09) </PackageDescription>
    <NDC11Code>43547-0003-09</NDC11Code>
    <ProductNDC>43547-003</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fingolimod</ProprietaryName>
    <NonProprietaryName>Fingolimod</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200217</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208003</ApplicationNumber>
    <LabelerName>Solco Healthcare US, LLC</LabelerName>
    <SubstanceName>FINGOLIMOD</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Sphingosine 1-Phosphate Receptor Modulators [MoA], Sphingosine 1-phosphate Receptor Modulator [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-09-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211026</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fingolimod capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older.</IndicationAndUsage>
    <Description>Fingolimod is a sphingosine 1-phosphate receptor modulator. Chemically, fingolimod is 2-amino-2-[2-(4-octylphenyl)ethyl]propan-1,3-diol hydrochloride. Its structure is shown below. Fingolimod hydrochloride, USP is a white to practically white powder that is freely soluble in water and alcohol and soluble in propylene glycol. It has a molecular weight of 343.93 g/mol. Fingolimod capsules are provided as 0.5 mg hard gelatin capsules for oral use. Each 0.5 mg capsule contains 0.56 mg of fingolimod hydrochloride, equivalent to 0.5 mg of fingolimod. Each 0.5 mg fingolimod capsule contains the following inactive ingredients: black iron oxide, gelatin, magnesium stearate, potassium hydroxide, propylene glycol, silicified microcrystalline cellulose, shellac and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>43547-005-03</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (43547-005-03) </PackageDescription>
    <NDC11Code>43547-0005-03</NDC11Code>
    <ProductNDC>43547-005</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Roflumilast</ProprietaryName>
    <NonProprietaryName>Roflumilast</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220510</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208299</ApplicationNumber>
    <LabelerName>Solco Healthcare US, LLC.</LabelerName>
    <SubstanceName>ROFLUMILAST</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>ug/1</StrengthUnit>
    <Pharm_Classes>Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-08-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220510</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Roflumilast is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. Limitations of Use. Roflumilast is not a bronchodilator and is not indicated for the relief of acute bronchospasm.</IndicationAndUsage>
    <Description>The active ingredient in roflumilast tablets is roflumilast. Roflumilast and its active metabolite (roflumilast N-oxide) are selective phosphodiesterase 4 (PDE4) inhibitors. The chemical name of roflumilast is N-(3,5-dichloropyridin-4-yl)-3-cyclopropylmethoxy-4-difluoromethoxy-benzamide. Its empirical formula is C17H14Cl2F2N2O3 and the molecular weight is 403.22. The chemical structure is. The drug substance is a white to off-white non-hygroscopic powder with a melting point of 160oC. It is practically insoluble in water and hexane, sparingly soluble in ethanol, and freely soluble in acetone. Roflumilast tablets are supplied as white to off-white, round tablets, debossed with “S” on one side and “500” on the other side. Each tablet contains 500 mcg of roflumilast. Each roflumilast tablet for oral administration contains the following inactive ingredients: lactose monohydrate, corn starch, copovidone, hydroxypropyl cellulose, and sodium stearyl fumarate.</Description>
  </NDC>
  <NDC>
    <NDCCode>43547-005-09</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (43547-005-09) </PackageDescription>
    <NDC11Code>43547-0005-09</NDC11Code>
    <ProductNDC>43547-005</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Roflumilast</ProprietaryName>
    <NonProprietaryName>Roflumilast</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220510</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208299</ApplicationNumber>
    <LabelerName>Solco Healthcare US, LLC.</LabelerName>
    <SubstanceName>ROFLUMILAST</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>ug/1</StrengthUnit>
    <Pharm_Classes>Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-08-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220510</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Roflumilast is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. Limitations of Use. Roflumilast is not a bronchodilator and is not indicated for the relief of acute bronchospasm.</IndicationAndUsage>
    <Description>The active ingredient in roflumilast tablets is roflumilast. Roflumilast and its active metabolite (roflumilast N-oxide) are selective phosphodiesterase 4 (PDE4) inhibitors. The chemical name of roflumilast is N-(3,5-dichloropyridin-4-yl)-3-cyclopropylmethoxy-4-difluoromethoxy-benzamide. Its empirical formula is C17H14Cl2F2N2O3 and the molecular weight is 403.22. The chemical structure is. The drug substance is a white to off-white non-hygroscopic powder with a melting point of 160oC. It is practically insoluble in water and hexane, sparingly soluble in ethanol, and freely soluble in acetone. Roflumilast tablets are supplied as white to off-white, round tablets, debossed with “S” on one side and “500” on the other side. Each tablet contains 500 mcg of roflumilast. Each roflumilast tablet for oral administration contains the following inactive ingredients: lactose monohydrate, corn starch, copovidone, hydroxypropyl cellulose, and sodium stearyl fumarate.</Description>
  </NDC>
  <NDC>
    <NDCCode>43547-019-06</NDCCode>
    <PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (43547-019-06) </PackageDescription>
    <NDC11Code>43547-0019-06</NDC11Code>
    <ProductNDC>43547-019</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Quetiapine</ProprietaryName>
    <NonProprietaryName>Quetiapine</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220401</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208781</ApplicationNumber>
    <LabelerName>Solco Healthcare U.S., LLC</LabelerName>
    <SubstanceName>QUETIAPINE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-06-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Quetiapine extended-release tablets are an atypical antipsychotic indicated for the treatment of: : 1 Schizophrenia (1.1), 2 Bipolar I disorder, manic, or mixed episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2), 4 Major depressive disorder, adjunctive therapy with antidepressants (1.3).</IndicationAndUsage>
    <Description>Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f ] [1,4] thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine extended-release tablets, USP, are supplied for oral administration as 50 mg (pink), 150 mg (white), 200 mg (yellow), 300 mg (yellow) and 400 mg (white). All tablets are capsule shaped and film coated. Inactive ingredients for quetiapine extended-release tablets are hypromellose,lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium citrate. Inactive ingredients of the film coats are slightly different among the 5 strengths of tablets and are tabulated below. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 150 mg tablet contains 172.69 mg of quetiapine fumarate equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.38 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.50 mg of quetiapine fumarate equivalent to 400 mg quetiapine. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>43547-019-50</NDCCode>
    <PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (43547-019-50) </PackageDescription>
    <NDC11Code>43547-0019-50</NDC11Code>
    <ProductNDC>43547-019</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Quetiapine</ProprietaryName>
    <NonProprietaryName>Quetiapine</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220401</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208781</ApplicationNumber>
    <LabelerName>Solco Healthcare U.S., LLC</LabelerName>
    <SubstanceName>QUETIAPINE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-06-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Quetiapine extended-release tablets are an atypical antipsychotic indicated for the treatment of: : 1 Schizophrenia (1.1), 2 Bipolar I disorder, manic, or mixed episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2), 4 Major depressive disorder, adjunctive therapy with antidepressants (1.3).</IndicationAndUsage>
    <Description>Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f ] [1,4] thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine extended-release tablets, USP, are supplied for oral administration as 50 mg (pink), 150 mg (white), 200 mg (yellow), 300 mg (yellow) and 400 mg (white). All tablets are capsule shaped and film coated. Inactive ingredients for quetiapine extended-release tablets are hypromellose,lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium citrate. Inactive ingredients of the film coats are slightly different among the 5 strengths of tablets and are tabulated below. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 150 mg tablet contains 172.69 mg of quetiapine fumarate equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.38 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.50 mg of quetiapine fumarate equivalent to 400 mg quetiapine. FDA approved dissolution test specifications differ from USP.</Description>
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    <Description>Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f ] [1,4] thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine extended-release tablets, USP, are supplied for oral administration as 50 mg (pink), 150 mg (white), 200 mg (yellow), 300 mg (yellow) and 400 mg (white). All tablets are capsule shaped and film coated. Inactive ingredients for quetiapine extended-release tablets are hypromellose,lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium citrate. Inactive ingredients of the film coats are slightly different among the 5 strengths of tablets and are tabulated below. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 150 mg tablet contains 172.69 mg of quetiapine fumarate equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.38 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.50 mg of quetiapine fumarate equivalent to 400 mg quetiapine. FDA approved dissolution test specifications differ from USP.</Description>
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    <Description>Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f ] [1,4] thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine extended-release tablets, USP, are supplied for oral administration as 50 mg (pink), 150 mg (white), 200 mg (yellow), 300 mg (yellow) and 400 mg (white). All tablets are capsule shaped and film coated. Inactive ingredients for quetiapine extended-release tablets are hypromellose,lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium citrate. Inactive ingredients of the film coats are slightly different among the 5 strengths of tablets and are tabulated below. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 150 mg tablet contains 172.69 mg of quetiapine fumarate equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.38 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.50 mg of quetiapine fumarate equivalent to 400 mg quetiapine. FDA approved dissolution test specifications differ from USP.</Description>
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    <IndicationAndUsage>Quetiapine extended-release tablets are an atypical antipsychotic indicated for the treatment of: : 1 Schizophrenia (1.1), 2 Bipolar I disorder, manic, or mixed episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2), 4 Major depressive disorder, adjunctive therapy with antidepressants (1.3).</IndicationAndUsage>
    <Description>Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f ] [1,4] thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine extended-release tablets, USP, are supplied for oral administration as 50 mg (pink), 150 mg (white), 200 mg (yellow), 300 mg (yellow) and 400 mg (white). All tablets are capsule shaped and film coated. Inactive ingredients for quetiapine extended-release tablets are hypromellose,lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium citrate. Inactive ingredients of the film coats are slightly different among the 5 strengths of tablets and are tabulated below. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 150 mg tablet contains 172.69 mg of quetiapine fumarate equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.38 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.50 mg of quetiapine fumarate equivalent to 400 mg quetiapine. FDA approved dissolution test specifications differ from USP.</Description>
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    <IndicationAndUsage>Quetiapine extended-release tablets are an atypical antipsychotic indicated for the treatment of: : 1 Schizophrenia (1.1), 2 Bipolar I disorder, manic, or mixed episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2), 4 Major depressive disorder, adjunctive therapy with antidepressants (1.3).</IndicationAndUsage>
    <Description>Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f ] [1,4] thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine extended-release tablets, USP, are supplied for oral administration as 50 mg (pink), 150 mg (white), 200 mg (yellow), 300 mg (yellow) and 400 mg (white). All tablets are capsule shaped and film coated. Inactive ingredients for quetiapine extended-release tablets are hypromellose,lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium citrate. Inactive ingredients of the film coats are slightly different among the 5 strengths of tablets and are tabulated below. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 150 mg tablet contains 172.69 mg of quetiapine fumarate equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.38 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.50 mg of quetiapine fumarate equivalent to 400 mg quetiapine. FDA approved dissolution test specifications differ from USP.</Description>
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    <IndicationAndUsage>Quetiapine extended-release tablets are an atypical antipsychotic indicated for the treatment of: : 1 Schizophrenia (1.1), 2 Bipolar I disorder, manic, or mixed episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2), 4 Major depressive disorder, adjunctive therapy with antidepressants (1.3).</IndicationAndUsage>
    <Description>Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f ] [1,4] thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine extended-release tablets, USP, are supplied for oral administration as 50 mg (pink), 150 mg (white), 200 mg (yellow), 300 mg (yellow) and 400 mg (white). All tablets are capsule shaped and film coated. Inactive ingredients for quetiapine extended-release tablets are hypromellose,lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium citrate. Inactive ingredients of the film coats are slightly different among the 5 strengths of tablets and are tabulated below. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 150 mg tablet contains 172.69 mg of quetiapine fumarate equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.38 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.50 mg of quetiapine fumarate equivalent to 400 mg quetiapine. FDA approved dissolution test specifications differ from USP.</Description>
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    <IndicationAndUsage>Quetiapine extended-release tablets are an atypical antipsychotic indicated for the treatment of: : 1 Schizophrenia (1.1), 2 Bipolar I disorder, manic, or mixed episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2), 4 Major depressive disorder, adjunctive therapy with antidepressants (1.3).</IndicationAndUsage>
    <Description>Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f ] [1,4] thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine extended-release tablets, USP, are supplied for oral administration as 50 mg (pink), 150 mg (white), 200 mg (yellow), 300 mg (yellow) and 400 mg (white). All tablets are capsule shaped and film coated. Inactive ingredients for quetiapine extended-release tablets are hypromellose,lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium citrate. Inactive ingredients of the film coats are slightly different among the 5 strengths of tablets and are tabulated below. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 150 mg tablet contains 172.69 mg of quetiapine fumarate equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.38 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.50 mg of quetiapine fumarate equivalent to 400 mg quetiapine. FDA approved dissolution test specifications differ from USP.</Description>
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    <IndicationAndUsage>Quetiapine extended-release tablets are an atypical antipsychotic indicated for the treatment of: : 1 Schizophrenia (1.1), 2 Bipolar I disorder, manic, or mixed episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2), 4 Major depressive disorder, adjunctive therapy with antidepressants (1.3).</IndicationAndUsage>
    <Description>Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f ] [1,4] thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine extended-release tablets, USP, are supplied for oral administration as 50 mg (pink), 150 mg (white), 200 mg (yellow), 300 mg (yellow) and 400 mg (white). All tablets are capsule shaped and film coated. Inactive ingredients for quetiapine extended-release tablets are hypromellose,lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium citrate. Inactive ingredients of the film coats are slightly different among the 5 strengths of tablets and are tabulated below. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 150 mg tablet contains 172.69 mg of quetiapine fumarate equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.38 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.50 mg of quetiapine fumarate equivalent to 400 mg quetiapine. FDA approved dissolution test specifications differ from USP.</Description>
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    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Quetiapine extended-release tablets are an atypical antipsychotic indicated for the treatment of: : 1 Schizophrenia (1.1), 2 Bipolar I disorder, manic, or mixed episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2), 4 Major depressive disorder, adjunctive therapy with antidepressants (1.3).</IndicationAndUsage>
    <Description>Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f ] [1,4] thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine extended-release tablets, USP, are supplied for oral administration as 50 mg (pink), 150 mg (white), 200 mg (yellow), 300 mg (yellow) and 400 mg (white). All tablets are capsule shaped and film coated. Inactive ingredients for quetiapine extended-release tablets are hypromellose,lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium citrate. Inactive ingredients of the film coats are slightly different among the 5 strengths of tablets and are tabulated below. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 150 mg tablet contains 172.69 mg of quetiapine fumarate equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.38 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.50 mg of quetiapine fumarate equivalent to 400 mg quetiapine. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>43547-024-14</NDCCode>
    <PackageDescription>14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43547-024-14) </PackageDescription>
    <NDC11Code>43547-0024-14</NDC11Code>
    <ProductNDC>43547-024</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dimethyl Fumarate</ProprietaryName>
    <NonProprietaryName>Dimethyl Fumarate</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20221018</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210414</ApplicationNumber>
    <LabelerName>Solco Healthcare US, LLC</LabelerName>
    <SubstanceName>DIMETHYL FUMARATE</SubstanceName>
    <StrengthNumber>120</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-09-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221018</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
    <Description>Dimethyl fumarate delayed-release capsules, USP contain dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C6H8O4). It has the following structure. Dimethyl fumarate, USP is a white to off-white powder that is slightly soluble in water with a molecular mass of 144.13. Dimethyl fumarate delayed-release capsules, USP are provided as hard gelatin delayed-release capsules for oral administration, containing 120 mg or 240 mg of dimethyl fumarate, USP consisting of the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, methacrylic acid and methyl methacrylate copolymer (methacrylic acid and methyl methacrylate copolymer, and sodium lauryl sulfate), methacrylic acid and ethyl acrylate copolymer dispersion (methacrylic acid and ethyl acrylate copolymer, sodium lauryl sulfate, and polysorbate 80), silicified microcrystalline cellulose, talc, and triethyl citrate. The capsule shell, printed with black ink, contains the following inactive ingredients: gelatin, red iron oxide, and titanium dioxide. The black edible ink BLACK SW9008 contains black iron oxide, potassium hydroxide, and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>43547-025-06</NDCCode>
    <PackageDescription>60 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43547-025-06) </PackageDescription>
    <NDC11Code>43547-0025-06</NDC11Code>
    <ProductNDC>43547-025</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dimethyl Fumarate</ProprietaryName>
    <NonProprietaryName>Dimethyl Fumarate</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20221018</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210414</ApplicationNumber>
    <LabelerName>Solco Healthcare US, LLC</LabelerName>
    <SubstanceName>DIMETHYL FUMARATE</SubstanceName>
    <StrengthNumber>240</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-09-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221018</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
    <Description>Dimethyl fumarate delayed-release capsules, USP contain dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C6H8O4). It has the following structure. Dimethyl fumarate, USP is a white to off-white powder that is slightly soluble in water with a molecular mass of 144.13. Dimethyl fumarate delayed-release capsules, USP are provided as hard gelatin delayed-release capsules for oral administration, containing 120 mg or 240 mg of dimethyl fumarate, USP consisting of the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, methacrylic acid and methyl methacrylate copolymer (methacrylic acid and methyl methacrylate copolymer, and sodium lauryl sulfate), methacrylic acid and ethyl acrylate copolymer dispersion (methacrylic acid and ethyl acrylate copolymer, sodium lauryl sulfate, and polysorbate 80), silicified microcrystalline cellulose, talc, and triethyl citrate. The capsule shell, printed with black ink, contains the following inactive ingredients: gelatin, red iron oxide, and titanium dioxide. The black edible ink BLACK SW9008 contains black iron oxide, potassium hydroxide, and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>43547-025-46</NDCCode>
    <PackageDescription>46 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43547-025-46) </PackageDescription>
    <NDC11Code>43547-0025-46</NDC11Code>
    <ProductNDC>43547-025</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dimethyl Fumarate</ProprietaryName>
    <NonProprietaryName>Dimethyl Fumarate</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20221018</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210414</ApplicationNumber>
    <LabelerName>Solco Healthcare US, LLC</LabelerName>
    <SubstanceName>DIMETHYL FUMARATE</SubstanceName>
    <StrengthNumber>240</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-09-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221018</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
    <Description>Dimethyl fumarate delayed-release capsules, USP contain dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C6H8O4). It has the following structure. Dimethyl fumarate, USP is a white to off-white powder that is slightly soluble in water with a molecular mass of 144.13. Dimethyl fumarate delayed-release capsules, USP are provided as hard gelatin delayed-release capsules for oral administration, containing 120 mg or 240 mg of dimethyl fumarate, USP consisting of the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, methacrylic acid and methyl methacrylate copolymer (methacrylic acid and methyl methacrylate copolymer, and sodium lauryl sulfate), methacrylic acid and ethyl acrylate copolymer dispersion (methacrylic acid and ethyl acrylate copolymer, sodium lauryl sulfate, and polysorbate 80), silicified microcrystalline cellulose, talc, and triethyl citrate. The capsule shell, printed with black ink, contains the following inactive ingredients: gelatin, red iron oxide, and titanium dioxide. The black edible ink BLACK SW9008 contains black iron oxide, potassium hydroxide, and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>43547-030-03</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (43547-030-03) </PackageDescription>
    <NDC11Code>43547-0030-03</NDC11Code>
    <ProductNDC>43547-030</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tadalafil</ProprietaryName>
    <NonProprietaryName>Tadalafil</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241127</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210609</ApplicationNumber>
    <LabelerName>Solco Healthcare US, LLC</LabelerName>
    <SubstanceName>TADALAFIL</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241127</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tadalafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 1  erectile dysfunction (ED) (1.1), 2  the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2), 3  ED and the signs and symptoms of BPH (ED/BPH) (1.3).</IndicationAndUsage>
    <Description>Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is. The chemical designation is pyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil tablets, USP are available as almond-shaped tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil, USP and the following inactive ingredients: croscarmellose sodium, ferrosoferric oxide, hydroxypropyl cellulose, iron oxide red, iron oxide yellow, lactose monohydrate, lecithin (soya), macrogol/PEG 3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol-partially hydrolyzed, sodium lauryl sulfate, talc, and titanium dioxide.</Description>
  </NDC>
</NDCList>