RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>67544-767-04</NDCCode>
    <PackageDescription>4 TABLET, CHEWABLE in 1 BOTTLE (67544-767-04) </PackageDescription>
    <NDC11Code>67544-0767-04</NDC11Code>
    <ProductNDC>67544-767</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Simethicone</ProprietaryName>
    <NonProprietaryName>Simethicone</NonProprietaryName>
    <DosageFormName>TABLET, CHEWABLE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19990312</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part332</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>DIMETHICONE</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-05-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130206</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>relieves: 1 bloating, 2 pressure, 3 discomfort of gas which can be caused by certain foods or air swallowing.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>60760-767-04</NDCCode>
    <PackageDescription>4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-767-04) </PackageDescription>
    <NDC11Code>60760-0767-04</NDC11Code>
    <ProductNDC>60760-767</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170531</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208170</ApplicationNumber>
    <LabelerName>ST. MARY'S MEDICAL PARK PHARMACY</LabelerName>
    <SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230620</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to 2 or 3 weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
    <Description>Cyclobenzaprine hydrochloride, USP is a tricyclic amine salt which is white to off white, odourless, crystalline powder with the molecular formula C 20H 21N  HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pKa of 8.47 at 25°C. It is freely soluble in water, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride, insoluble in n-hexane. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride is designated chemically as 3-(5H -dibenzo[a,d] cyclohepten-5-ylidene)- N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:. Cyclobenzaprine hydrochloride tablets, USP are available as 5 mg, 7.5 mg and 10 mg tablets for oral administration. Each 5 mg, 7.5 mg and 10 mg tablet contains cyclobenzaprine hydrochloride and the following inactive ingredients: crospovidone, hypromellose, lactose anhydrous, macrogol, magnesium stearate, polysorbate 80, pregelatinized starch, silicified microcrystalline cellulose, titanium dioxide. The tablets of 5 mg and 10 mg also contain D&amp;C Yellow #10 Aluminum Lake and FD&amp;C Yellow #6 Sunset Yellow FCF Aluminum Lake. In addition, the 5 mg tablets contain FD&amp;C Blue #2/INDIGO Carmine Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>66267-767-04</NDCCode>
    <PackageDescription>4 TABLET in 1 BOTTLE (66267-767-04)</PackageDescription>
    <NDC11Code>66267-0767-04</NDC11Code>
    <ProductNDC>66267-767</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carisoprodol</ProprietaryName>
    <NonProprietaryName>Carisoprodol</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070227</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040755</ApplicationNumber>
    <LabelerName>NuCare Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>CARISOPRODOL</SubstanceName>
    <StrengthNumber>350</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>73517-767-04</NDCCode>
    <PackageDescription>90 mL in 1 POUCH (73517-767-04) </PackageDescription>
    <NDC11Code>73517-0767-04</NDC11Code>
    <ProductNDC>73517-767</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200330</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Amyris, Inc</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>65</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>75682-767-04</NDCCode>
    <PackageDescription>118.294 mL in 1 BOTTLE, PLASTIC (75682-767-04) </PackageDescription>
    <NDC11Code>75682-0767-04</NDC11Code>
    <ProductNDC>75682-767</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Stalwart Medical Supply Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200330</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Froggy's Fog LLC</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-06-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200330</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>67544-355-04</NDCCode>
    <PackageDescription>4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-355-04) </PackageDescription>
    <NDC11Code>67544-0355-04</NDC11Code>
    <ProductNDC>67544-355</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Viagra</ProprietaryName>
    <NonProprietaryName>Sildenafil Citrate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19980327</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020895</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>SILDENAFIL CITRATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20050520</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>VIAGRA is indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
    <Description>VIAGRA (sildenafil citrate), an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula. Sildenafil citrate is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. VIAGRA is formulated as blue, film-coated rounded-diamond-shaped tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, lactose, triacetin, and FD &amp; C Blue #2 aluminum lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>67544-356-04</NDCCode>
    <PackageDescription>4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-356-04) </PackageDescription>
    <NDC11Code>67544-0356-04</NDC11Code>
    <ProductNDC>67544-356</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Viagra</ProprietaryName>
    <NonProprietaryName>Sildenafil Citrate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19980327</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020895</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>SILDENAFIL CITRATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20050304</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>VIAGRA is indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
    <Description>VIAGRA (sildenafil citrate), an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula. Sildenafil citrate is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. VIAGRA is formulated as blue, film-coated rounded-diamond-shaped tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, lactose, triacetin, and FD &amp; C Blue #2 aluminum lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>67544-507-04</NDCCode>
    <PackageDescription>4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-507-04)</PackageDescription>
    <NDC11Code>67544-0507-04</NDC11Code>
    <ProductNDC>67544-507</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levitra</ProprietaryName>
    <NonProprietaryName>Vardenafil Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080515</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021400</ApplicationNumber>
    <LabelerName>APHENA PHARMA SOLUTIONS - TENNESSEE, INC.</LabelerName>
    <SubstanceName>VARDENAFIL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>LEVITRA is indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
    <Description>LEVITRA® is an oral therapy for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil HCl is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1-f ][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula. Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water. LEVITRA is formulated as orange, round, film-coated tablets with “BAYER” cross debossed on one side and “2.5”, “5”, “10”, and “20” on the other side corresponding to 2.5 mg, 5 mg, 10 mg, and 20 mg of vardenafil, respectively. In addition to the active ingredient, vardenafil HCl, each tablet contains microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, yellow ferric oxide, and red ferric oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>67544-512-04</NDCCode>
    <PackageDescription>4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-512-04)</PackageDescription>
    <NDC11Code>67544-0512-04</NDC11Code>
    <ProductNDC>67544-512</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levitra</ProprietaryName>
    <NonProprietaryName>Vardenafil Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080515</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021400</ApplicationNumber>
    <LabelerName>APHENA PHARMA SOLUTIONS - TENNESSEE, INC.</LabelerName>
    <SubstanceName>VARDENAFIL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>LEVITRA is indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
    <Description>LEVITRA® is an oral therapy for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil HCl is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1-f ][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula. Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water. LEVITRA is formulated as orange, round, film-coated tablets with “BAYER” cross debossed on one side and “2.5”, “5”, “10”, and “20” on the other side corresponding to 2.5 mg, 5 mg, 10 mg, and 20 mg of vardenafil, respectively. In addition to the active ingredient, vardenafil HCl, each tablet contains microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, yellow ferric oxide, and red ferric oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>67544-655-04</NDCCode>
    <PackageDescription>4 TABLET, COATED in 1 BOTTLE, PLASTIC (67544-655-04) </PackageDescription>
    <NDC11Code>67544-0655-04</NDC11Code>
    <ProductNDC>67544-655</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Bisacodyl</ProprietaryName>
    <ProprietaryNameSuffix>Enteric Coated</ProprietaryNameSuffix>
    <NonProprietaryName>Bisacodyl</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20081024</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part334</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>BISACODYL</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100330</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>-relieves occasional constipation and irregularity.  -this product generally produces bowel movement in 6 to 12 hours.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0186-4010-01</NDCCode>
    <PackageDescription>30 GRANULE, DELAYED RELEASE in 1 CARTON (0186-4010-01) </PackageDescription>
    <NDC11Code>00186-4010-01</NDC11Code>
    <ProductNDC>0186-4010</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nexium</ProprietaryName>
    <NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
    <DosageFormName>GRANULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080707</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022101</ApplicationNumber>
    <LabelerName>AstraZeneca Pharmaceuticals LP</LabelerName>
    <SubstanceName>ESOMEPRAZOLE MAGNESIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>10</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>2026-04-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20080707</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>NEXIUM is a proton pump inhibitor (PPI). NEXIUM delayed-release capsules and NEXIUM for delayed-release oral. suspension 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 NEXIUM® (esomeprazole magnesium) delayed-release capsules for oral administration and NEXIUM (esomeprazole magnesium) for delayed-release oral suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-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. NEXIUM is supplied in delayed-release capsules and in packets for a delayed-release oral suspension. Each NEXIUM delayed-release capsule 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 granules with the following inactive ingredients: glyceryl monostearate 40-55, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer type C, polysorbate 80, sugar spheres, talc, and triethyl citrate. The capsule shells have the following inactive ingredients: D&amp;C Red #28, D&amp;C Yellow #10, ethyl alcohol, FD&amp;C Blue #1, FD&amp;C Red #40, gelatin, isopropyl alcohol, n-butyl alcohol, polyvinyl pyrrolidone, propylene glycol, shellac, sodium hydroxide, and titanium dioxide. Each packet of NEXIUM for delayed-release oral suspension contains esomeprazole, in the form of same enteric-coated granules used in NEXIUM delayed-release capsules, and also inactive granules: 1 2.5 mg esomeprazole (equivalent to 2.8 mg esomeprazole magnesium trihydrate), 2 5 mg esomeprazole (equivalent to 5.6 mg esomeprazole magnesium trihydrate), 3 10 mg esomeprazole (equivalent to 11.1 mg esomeprazole magnesium trihydrate), 4 20 mg esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate), 5 40 mg esomeprazole (equivalent to 44.5 mg esomeprazole magnesium trihydrate).</Description>
  </NDC>
  <NDC>
    <NDCCode>0186-4020-01</NDCCode>
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    <IndicationAndUsage>NEXIUM is a proton pump inhibitor (PPI). NEXIUM delayed-release capsules and NEXIUM for delayed-release oral. suspension 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 NEXIUM® (esomeprazole magnesium) delayed-release capsules for oral administration and NEXIUM (esomeprazole magnesium) for delayed-release oral suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-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. NEXIUM is supplied in delayed-release capsules and in packets for a delayed-release oral suspension. Each NEXIUM delayed-release capsule 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 granules with the following inactive ingredients: glyceryl monostearate 40-55, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer type C, polysorbate 80, sugar spheres, talc, and triethyl citrate. The capsule shells have the following inactive ingredients: D&amp;C Red #28, D&amp;C Yellow #10, ethyl alcohol, FD&amp;C Blue #1, FD&amp;C Red #40, gelatin, isopropyl alcohol, n-butyl alcohol, polyvinyl pyrrolidone, propylene glycol, shellac, sodium hydroxide, and titanium dioxide. Each packet of NEXIUM for delayed-release oral suspension contains esomeprazole, in the form of same enteric-coated granules used in NEXIUM delayed-release capsules, and also inactive granules: 1 2.5 mg esomeprazole (equivalent to 2.8 mg esomeprazole magnesium trihydrate), 2 5 mg esomeprazole (equivalent to 5.6 mg esomeprazole magnesium trihydrate), 3 10 mg esomeprazole (equivalent to 11.1 mg esomeprazole magnesium trihydrate), 4 20 mg esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate), 5 40 mg esomeprazole (equivalent to 44.5 mg esomeprazole magnesium trihydrate).</Description>
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    <IndicationAndUsage>NEXIUM is a proton pump inhibitor (PPI). NEXIUM delayed-release capsules and NEXIUM for delayed-release oral. suspension 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 NEXIUM® (esomeprazole magnesium) delayed-release capsules for oral administration and NEXIUM (esomeprazole magnesium) for delayed-release oral suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-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. NEXIUM is supplied in delayed-release capsules and in packets for a delayed-release oral suspension. Each NEXIUM delayed-release capsule 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 granules with the following inactive ingredients: glyceryl monostearate 40-55, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer type C, polysorbate 80, sugar spheres, talc, and triethyl citrate. The capsule shells have the following inactive ingredients: D&amp;C Red #28, D&amp;C Yellow #10, ethyl alcohol, FD&amp;C Blue #1, FD&amp;C Red #40, gelatin, isopropyl alcohol, n-butyl alcohol, polyvinyl pyrrolidone, propylene glycol, shellac, sodium hydroxide, and titanium dioxide. Each packet of NEXIUM for delayed-release oral suspension contains esomeprazole, in the form of same enteric-coated granules used in NEXIUM delayed-release capsules, and also inactive granules: 1 2.5 mg esomeprazole (equivalent to 2.8 mg esomeprazole magnesium trihydrate), 2 5 mg esomeprazole (equivalent to 5.6 mg esomeprazole magnesium trihydrate), 3 10 mg esomeprazole (equivalent to 11.1 mg esomeprazole magnesium trihydrate), 4 20 mg esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate), 5 40 mg esomeprazole (equivalent to 44.5 mg esomeprazole magnesium trihydrate).</Description>
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    <IndicationAndUsage>NEXIUM is a proton pump inhibitor (PPI). NEXIUM delayed-release capsules and NEXIUM for delayed-release oral. suspension 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 NEXIUM® (esomeprazole magnesium) delayed-release capsules for oral administration and NEXIUM (esomeprazole magnesium) for delayed-release oral suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-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. NEXIUM is supplied in delayed-release capsules and in packets for a delayed-release oral suspension. Each NEXIUM delayed-release capsule 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 granules with the following inactive ingredients: glyceryl monostearate 40-55, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer type C, polysorbate 80, sugar spheres, talc, and triethyl citrate. The capsule shells have the following inactive ingredients: D&amp;C Red #28, D&amp;C Yellow #10, ethyl alcohol, FD&amp;C Blue #1, FD&amp;C Red #40, gelatin, isopropyl alcohol, n-butyl alcohol, polyvinyl pyrrolidone, propylene glycol, shellac, sodium hydroxide, and titanium dioxide. Each packet of NEXIUM for delayed-release oral suspension contains esomeprazole, in the form of same enteric-coated granules used in NEXIUM delayed-release capsules, and also inactive granules: 1 2.5 mg esomeprazole (equivalent to 2.8 mg esomeprazole magnesium trihydrate), 2 5 mg esomeprazole (equivalent to 5.6 mg esomeprazole magnesium trihydrate), 3 10 mg esomeprazole (equivalent to 11.1 mg esomeprazole magnesium trihydrate), 4 20 mg esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate), 5 40 mg esomeprazole (equivalent to 44.5 mg esomeprazole magnesium trihydrate).</Description>
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    <IndicationAndUsage>NEXIUM is a proton pump inhibitor (PPI). NEXIUM delayed-release capsules and NEXIUM for delayed-release oral. suspension 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 NEXIUM® (esomeprazole magnesium) delayed-release capsules for oral administration and NEXIUM (esomeprazole magnesium) for delayed-release oral suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-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. NEXIUM is supplied in delayed-release capsules and in packets for a delayed-release oral suspension. Each NEXIUM delayed-release capsule 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 granules with the following inactive ingredients: glyceryl monostearate 40-55, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer type C, polysorbate 80, sugar spheres, talc, and triethyl citrate. The capsule shells have the following inactive ingredients: D&amp;C Red #28, D&amp;C Yellow #10, ethyl alcohol, FD&amp;C Blue #1, FD&amp;C Red #40, gelatin, isopropyl alcohol, n-butyl alcohol, polyvinyl pyrrolidone, propylene glycol, shellac, sodium hydroxide, and titanium dioxide. Each packet of NEXIUM for delayed-release oral suspension contains esomeprazole, in the form of same enteric-coated granules used in NEXIUM delayed-release capsules, and also inactive granules: 1 2.5 mg esomeprazole (equivalent to 2.8 mg esomeprazole magnesium trihydrate), 2 5 mg esomeprazole (equivalent to 5.6 mg esomeprazole magnesium trihydrate), 3 10 mg esomeprazole (equivalent to 11.1 mg esomeprazole magnesium trihydrate), 4 20 mg esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate), 5 40 mg esomeprazole (equivalent to 44.5 mg esomeprazole magnesium trihydrate).</Description>
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    <IndicationAndUsage>NEXIUM is a proton pump inhibitor (PPI). NEXIUM delayed-release capsules and NEXIUM for delayed-release oral. suspension 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 NEXIUM® (esomeprazole magnesium) delayed-release capsules for oral administration and NEXIUM (esomeprazole magnesium) for delayed-release oral suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-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. NEXIUM is supplied in delayed-release capsules and in packets for a delayed-release oral suspension. Each NEXIUM delayed-release capsule 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 granules with the following inactive ingredients: glyceryl monostearate 40-55, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer type C, polysorbate 80, sugar spheres, talc, and triethyl citrate. The capsule shells have the following inactive ingredients: D&amp;C Red #28, D&amp;C Yellow #10, ethyl alcohol, FD&amp;C Blue #1, FD&amp;C Red #40, gelatin, isopropyl alcohol, n-butyl alcohol, polyvinyl pyrrolidone, propylene glycol, shellac, sodium hydroxide, and titanium dioxide. Each packet of NEXIUM for delayed-release oral suspension contains esomeprazole, in the form of same enteric-coated granules used in NEXIUM delayed-release capsules, and also inactive granules: 1 2.5 mg esomeprazole (equivalent to 2.8 mg esomeprazole magnesium trihydrate), 2 5 mg esomeprazole (equivalent to 5.6 mg esomeprazole magnesium trihydrate), 3 10 mg esomeprazole (equivalent to 11.1 mg esomeprazole magnesium trihydrate), 4 20 mg esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate), 5 40 mg esomeprazole (equivalent to 44.5 mg esomeprazole magnesium trihydrate).</Description>
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    <IndicationAndUsage>NEXIUM is a proton pump inhibitor (PPI). NEXIUM delayed-release capsules and NEXIUM for delayed-release oral. suspension 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 NEXIUM® (esomeprazole magnesium) delayed-release capsules for oral administration and NEXIUM (esomeprazole magnesium) for delayed-release oral suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-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. NEXIUM is supplied in delayed-release capsules and in packets for a delayed-release oral suspension. Each NEXIUM delayed-release capsule 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 granules with the following inactive ingredients: glyceryl monostearate 40-55, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer type C, polysorbate 80, sugar spheres, talc, and triethyl citrate. The capsule shells have the following inactive ingredients: D&amp;C Red #28, D&amp;C Yellow #10, ethyl alcohol, FD&amp;C Blue #1, FD&amp;C Red #40, gelatin, isopropyl alcohol, n-butyl alcohol, polyvinyl pyrrolidone, propylene glycol, shellac, sodium hydroxide, and titanium dioxide. Each packet of NEXIUM for delayed-release oral suspension contains esomeprazole, in the form of same enteric-coated granules used in NEXIUM delayed-release capsules, and also inactive granules: 1 2.5 mg esomeprazole (equivalent to 2.8 mg esomeprazole magnesium trihydrate), 2 5 mg esomeprazole (equivalent to 5.6 mg esomeprazole magnesium trihydrate), 3 10 mg esomeprazole (equivalent to 11.1 mg esomeprazole magnesium trihydrate), 4 20 mg esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate), 5 40 mg esomeprazole (equivalent to 44.5 mg esomeprazole magnesium trihydrate).</Description>
  </NDC>
  <NDC>
    <NDCCode>0186-5040-31</NDCCode>
    <PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0186-5040-31) </PackageDescription>
    <NDC11Code>00186-5040-31</NDC11Code>
    <ProductNDC>0186-5040</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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    <ApplicationNumber>NDA021153</ApplicationNumber>
    <LabelerName>AstraZeneca Pharmaceuticals LP</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>
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    <IndicationAndUsage>NEXIUM is a proton pump inhibitor (PPI). NEXIUM delayed-release capsules and NEXIUM for delayed-release oral. suspension 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 NEXIUM® (esomeprazole magnesium) delayed-release capsules for oral administration and NEXIUM (esomeprazole magnesium) for delayed-release oral suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-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. NEXIUM is supplied in delayed-release capsules and in packets for a delayed-release oral suspension. Each NEXIUM delayed-release capsule 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 granules with the following inactive ingredients: glyceryl monostearate 40-55, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer type C, polysorbate 80, sugar spheres, talc, and triethyl citrate. The capsule shells have the following inactive ingredients: D&amp;C Red #28, D&amp;C Yellow #10, ethyl alcohol, FD&amp;C Blue #1, FD&amp;C Red #40, gelatin, isopropyl alcohol, n-butyl alcohol, polyvinyl pyrrolidone, propylene glycol, shellac, sodium hydroxide, and titanium dioxide. Each packet of NEXIUM for delayed-release oral suspension contains esomeprazole, in the form of same enteric-coated granules used in NEXIUM delayed-release capsules, and also inactive granules: 1 2.5 mg esomeprazole (equivalent to 2.8 mg esomeprazole magnesium trihydrate), 2 5 mg esomeprazole (equivalent to 5.6 mg esomeprazole magnesium trihydrate), 3 10 mg esomeprazole (equivalent to 11.1 mg esomeprazole magnesium trihydrate), 4 20 mg esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate), 5 40 mg esomeprazole (equivalent to 44.5 mg esomeprazole magnesium trihydrate).</Description>
  </NDC>
  <NDC>
    <NDCCode>0186-5040-54</NDCCode>
    <PackageDescription>90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0186-5040-54) </PackageDescription>
    <NDC11Code>00186-5040-54</NDC11Code>
    <ProductNDC>0186-5040</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nexium</ProprietaryName>
    <NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
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    <StartMarketingDate>20010319</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021153</ApplicationNumber>
    <LabelerName>AstraZeneca Pharmaceuticals LP</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>2026-04-10</LastUpdate>
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    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20010319</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>NEXIUM is a proton pump inhibitor (PPI). NEXIUM delayed-release capsules and NEXIUM for delayed-release oral. suspension 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 NEXIUM® (esomeprazole magnesium) delayed-release capsules for oral administration and NEXIUM (esomeprazole magnesium) for delayed-release oral suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-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. NEXIUM is supplied in delayed-release capsules and in packets for a delayed-release oral suspension. Each NEXIUM delayed-release capsule 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 granules with the following inactive ingredients: glyceryl monostearate 40-55, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer type C, polysorbate 80, sugar spheres, talc, and triethyl citrate. The capsule shells have the following inactive ingredients: D&amp;C Red #28, D&amp;C Yellow #10, ethyl alcohol, FD&amp;C Blue #1, FD&amp;C Red #40, gelatin, isopropyl alcohol, n-butyl alcohol, polyvinyl pyrrolidone, propylene glycol, shellac, sodium hydroxide, and titanium dioxide. Each packet of NEXIUM for delayed-release oral suspension contains esomeprazole, in the form of same enteric-coated granules used in NEXIUM delayed-release capsules, and also inactive granules: 1 2.5 mg esomeprazole (equivalent to 2.8 mg esomeprazole magnesium trihydrate), 2 5 mg esomeprazole (equivalent to 5.6 mg esomeprazole magnesium trihydrate), 3 10 mg esomeprazole (equivalent to 11.1 mg esomeprazole magnesium trihydrate), 4 20 mg esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate), 5 40 mg esomeprazole (equivalent to 44.5 mg esomeprazole magnesium trihydrate).</Description>
  </NDC>
  <NDC>
    <NDCCode>0615-8628-39</NDCCode>
    <PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8628-39) </PackageDescription>
    <NDC11Code>00615-8628-39</NDC11Code>
    <ProductNDC>0615-8628</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Esomeprazole Magnesium</ProprietaryName>
    <NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20231120</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205606</ApplicationNumber>
    <LabelerName>NCS HealthCare of KY, LLC dba Vangard Labs</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>2026-04-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260402</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 USP for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-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)2 Mg 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 powder. It contains 3 moles of water of solvation and is soluble in methanol, slightly soluble in water, practically insoluble in heptane. 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 is supplied in delayed-release capsules. Each esomeprazole magnesium delayed-release capsule contains 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate USP) or 40 mg of esomeprazole (equivalent to 44.5 mg esomeprazole magnesium trihydrate USP) in the form of enteric-coated granules with the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium carbonate, magnesium oxide, methacrylic acid and ethyl acrylate copolymer dispersion, mono and di glycerides, polysorbate 80, sugar spheres (which contains starch (maize) and sucrose), talc, titanium dioxide, and triethyl citrate. In addition, the empty hard gelatin capsule shells contain gelatin and sodium lauryl sulfate. The capsule shells are imprinted with edible ink containing butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, shellac, strong ammonia solution and yellow iron oxide. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>30142-767-01</NDCCode>
    <PackageDescription>1 BOTTLE, PUMP in 1 CARTON (30142-767-01)  &gt; 120 SPRAY, METERED in 1 BOTTLE, PUMP</PackageDescription>
    <NDC11Code>30142-0767-01</NDC11Code>
    <ProductNDC>30142-767</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Allergy Relief Nasal</ProprietaryName>
    <NonProprietaryName>Fluticasone Propionate</NonProprietaryName>
    <DosageFormName>SPRAY, METERED</DosageFormName>
    <RouteName>NASAL</RouteName>
    <StartMarketingDate>20200601</StartMarketingDate>
    <EndMarketingDate>20230401</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207957</ApplicationNumber>
    <LabelerName>Kroger Company</LabelerName>
    <SubstanceName>FLUTICASONE PROPIONATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>ug/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-04-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>30142-767-03</NDCCode>
    <PackageDescription>2 BOTTLE, PUMP in 1 CARTON (30142-767-03)  &gt; 120 SPRAY, METERED in 1 BOTTLE, PUMP</PackageDescription>
    <NDC11Code>30142-0767-03</NDC11Code>
    <ProductNDC>30142-767</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Allergy Relief Nasal</ProprietaryName>
    <NonProprietaryName>Fluticasone Propionate</NonProprietaryName>
    <DosageFormName>SPRAY, METERED</DosageFormName>
    <RouteName>NASAL</RouteName>
    <StartMarketingDate>20200601</StartMarketingDate>
    <EndMarketingDate>20230401</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207957</ApplicationNumber>
    <LabelerName>Kroger Company</LabelerName>
    <SubstanceName>FLUTICASONE PROPIONATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>ug/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-04-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20200601</StartMarketingDatePackage>
    <EndMarketingDatePackage>20230401</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>31722-767-01</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (31722-767-01) </PackageDescription>
    <NDC11Code>31722-0767-01</NDC11Code>
    <ProductNDC>31722-767</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Quetiapine Fumarate</ProprietaryName>
    <NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220616</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204316</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220616</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Quetiapine tablets are an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).</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 (C21H25N3O2S)2. C4H4O4 and it has a molecular weight of 883.1 (fumarate salt). The structural formula is. Quetiapine fumarate USP is a white to off-white crystalline powder which is sparingly soluble in 0.1N hydrochloric acid, slightly soluble in water, in anhydrous ethanol and in methanol.  Quetiapine tablets USP are supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets.  Inactive ingredients are dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate and titanium dioxide. The 25 mg tablets contain red iron oxide and yellow iron oxide and the 100 mg and 400 mg tablets contain only yellow iron oxide.  Each 25 mg tablet contains 28.78 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.24 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.36 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.48 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-767-05</NDCCode>
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    <ProductNDC>31722-767</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Quetiapine Fumarate</ProprietaryName>
    <NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
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    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220616</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204316</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220616</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Quetiapine tablets are an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).</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 (C21H25N3O2S)2. C4H4O4 and it has a molecular weight of 883.1 (fumarate salt). The structural formula is. Quetiapine fumarate USP is a white to off-white crystalline powder which is sparingly soluble in 0.1N hydrochloric acid, slightly soluble in water, in anhydrous ethanol and in methanol.  Quetiapine tablets USP are supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets.  Inactive ingredients are dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate and titanium dioxide. The 25 mg tablets contain red iron oxide and yellow iron oxide and the 100 mg and 400 mg tablets contain only yellow iron oxide.  Each 25 mg tablet contains 28.78 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.24 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.36 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.48 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-767-32</NDCCode>
    <PackageDescription>100 BLISTER PACK in 1 CARTON (31722-767-32)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-767-31) </PackageDescription>
    <NDC11Code>31722-0767-32</NDC11Code>
    <ProductNDC>31722-767</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Quetiapine Fumarate</ProprietaryName>
    <NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220616</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204316</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220616</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Quetiapine tablets are an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).</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 (C21H25N3O2S)2. C4H4O4 and it has a molecular weight of 883.1 (fumarate salt). The structural formula is. Quetiapine fumarate USP is a white to off-white crystalline powder which is sparingly soluble in 0.1N hydrochloric acid, slightly soluble in water, in anhydrous ethanol and in methanol.  Quetiapine tablets USP are supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets.  Inactive ingredients are dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate and titanium dioxide. The 25 mg tablets contain red iron oxide and yellow iron oxide and the 100 mg and 400 mg tablets contain only yellow iron oxide.  Each 25 mg tablet contains 28.78 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.24 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.36 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.48 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-767-34</NDCCode>
    <PackageDescription>100 BLISTER PACK in 1 CARTON (31722-767-34)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-767-33) </PackageDescription>
    <NDC11Code>31722-0767-34</NDC11Code>
    <ProductNDC>31722-767</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Quetiapine Fumarate</ProprietaryName>
    <NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220616</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204316</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220616</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Quetiapine tablets are an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).</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 (C21H25N3O2S)2. C4H4O4 and it has a molecular weight of 883.1 (fumarate salt). The structural formula is. Quetiapine fumarate USP is a white to off-white crystalline powder which is sparingly soluble in 0.1N hydrochloric acid, slightly soluble in water, in anhydrous ethanol and in methanol.  Quetiapine tablets USP are supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets.  Inactive ingredients are dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate and titanium dioxide. The 25 mg tablets contain red iron oxide and yellow iron oxide and the 100 mg and 400 mg tablets contain only yellow iron oxide.  Each 25 mg tablet contains 28.78 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.24 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.36 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.48 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine.</Description>
  </NDC>
  <NDC>
    <NDCCode>42291-767-50</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (42291-767-50) </PackageDescription>
    <NDC11Code>42291-0767-50</NDC11Code>
    <ProductNDC>42291-767</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ranitidine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Ranitidine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190819</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211893</ApplicationNumber>
    <LabelerName>AvKARE, Inc</LabelerName>
    <SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-04-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190819</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>43063-728-04</NDCCode>
    <PackageDescription>4 TABLET in 1 BOTTLE, PLASTIC (43063-728-04) </PackageDescription>
    <NDC11Code>43063-0728-04</NDC11Code>
    <ProductNDC>43063-728</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Azithromycin Monohydrate</ProprietaryName>
    <NonProprietaryName>Azithromycin Monohydrate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150818</StartMarketingDate>
    <EndMarketingDate>20240731</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065398</ApplicationNumber>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>AZITHROMYCIN MONOHYDRATE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20230731</StartMarketingDatePackage>
    <EndMarketingDatePackage>20240731</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Azithromycin tablets are a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: 1   Acute bacterial exacerbations of chronic bronchitis in adults ( 1.1) , 2   Acute bacterial sinusitis in adults ( 1.1) , 3   Uncomplicated skin and skin structure infections in adults ( 1.1) , 4   Urethritis and cervicitis in adults ( 1.1) , 5   Genital ulcer disease in men ( 1.1) , 6   Acute otitis media in pediatric patients (6 months of age and older) ( 1.2) , 7   Community-acquired pneumonia in adults and pediatric patients  (6 months of age and older) ( 1.1, 1.2) , 8   Pharyngitis/tonsillitis in adults and pediatric patients (2 years of age and older) ( 1.1, 1.2) .</IndicationAndUsage>
    <Description>Azithromycin tablets USP contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C 38H 72N 2O 12, and its molecular weight is 749.00. Azithromycin has the following structural formula:. Azithromycin, as the monohydrate, is a white to almost white crystalline powder with a molecular formula of C 38H 72N 2O 12H 2O and a molecular weight of 767.00. Azithromycin is supplied as tablets containing azithromycin monohydrate equivalent to either 250 mg or 500 mg azithromycin and the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate, hydroxypropyl methyl cellulose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, titanium dioxide, triacetin and D&amp;C Red #30. Organic Impurities Test Pending.</Description>
  </NDC>
  <NDC>
    <NDCCode>43063-767-20</NDCCode>
    <PackageDescription>28 TABLET in 1 BOTTLE, PLASTIC (43063-767-20) </PackageDescription>
    <NDC11Code>43063-0767-20</NDC11Code>
    <ProductNDC>43063-767</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ciprofloxacin</ProprietaryName>
    <NonProprietaryName>Ciprofloxacin</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20040910</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076639</ApplicationNumber>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>750</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Quinolone Antimicrobial [EPC], Quinolones [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-04-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170519</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>46708-767-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-767-30) </PackageDescription>
    <NDC11Code>46708-0767-30</NDC11Code>
    <ProductNDC>46708-767</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Paroxetine</ProprietaryName>
    <NonProprietaryName>Paroxetine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250930</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217280</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
    <SubstanceName>PAROXETINE HYDROCHLORIDE HEMIHYDRATE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250930</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Paroxetine extended-release tablets are indicated in adults for the treatment of:   Major depressive disorder (MDD)   Panic disorder (PD)   Social anxiety disorder (SAD)   Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
    <Description>Paroxetine extended-release tablets USP, contains paroxetine hydrochloride, USP an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4’-fluorophenyl)-3S-[(3’,4’­ methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the empirical formula of C19H20FNO3HCl1/2H2O. The molecular weight is 374.8 g/mol (329.4 g/mol as free base). The structural formula of paroxetine hydrochloride, USP is. Paroxetine hydrochloride, USP is white or almost white crystalline powder, having a melting point range of 120oC to 138oC and soluble in methanol and in alcohol, slightly soluble in water. Paroxetine extended-release tablets, USP are intended for oral administration. Each extended-release tablet contains 12.5 mg, 25 mg or 37.5 mg paroxetine equivalent to 14.22 mg, 28.51 mg or 42.76 mg of paroxetine hydrochloride USP, respectively. Each tablet consists of a hydrophilic matrix that contains the active material. Inactive ingredients consist of colloidal silicon dioxide, glyceryl dibehenate, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, povidone K-30, talc and triethyl citrate. The film-coating material contains hypromellose, polyethylene glycol 400, polyethylene glycol 6000 and titanium dioxide. Additionally, 12.5 mg tablets contain D&amp;C Yellow No. 10 Lake, FD&amp;C Yellow No. 6 Aluminium Lake and polysorbate 80, 25 mg tablets contain D&amp;C Red No. 30 Lake and polysorbate 80 and 37.5 mg tablets contain FD&amp;C Blue No. 2 Aluminium Lake and talc. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
</NDCList>