RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>69097-527-34</NDCCode>
    <PackageDescription>30 GRANULE, FOR SUSPENSION, EXTENDED RELEASE in 1 CARTON (69097-527-34) </PackageDescription>
    <NDC11Code>69097-0527-34</NDC11Code>
    <ProductNDC>69097-527</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Esomeprazole Magnesium</ProprietaryName>
    <NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
    <DosageFormName>GRANULE, FOR SUSPENSION, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200324</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211752</ApplicationNumber>
    <LabelerName>Cipla USA Inc.</LabelerName>
    <SubstanceName>ESOMEPRAZOLE MAGNESIUM</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>2024-05-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200324</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Esomeprazole magnesium for delayed release oral suspension is a proton pump inhibitor (PPI). Esomeprazole magnesium for delayed release oral suspension is indicated for the: 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 1 year to 17 years of age and of EE due to acid-mediated GERD in pediatric patients 1 month to less than 1 year 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 1 year 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 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 dihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S-and R-isomers. Its molecular formula is (C17H18N3O3S)2Mg x 2 H2O with molecular weight of 749.15 as a dihydrate and 690.80 on an anhydrous basis. The structural formula is. Figure 1. The magnesium salt is a white to slightly colored powder and is insoluble in water and freely soluble in dimethyl sulphoxide. Each packet of esomeprazole magnesium for delayed release oral suspension contains 10 mg of esomeprazole, in the form of the enteric-coated granules, and also inactive granules. The inactive granules are composed of the following ingredients: anhydrous citric acid, crospovidone, dextrose anhydrous, ferric oxide yellow, hydroxypropyl cellulose, hydroxypropyl methyl cellulose E-15, magnesium stearate, methyl acrylic acid and ethyl acrylate copolymer dispersion, plasACRYL® HTP-20, polysorbate 80, purified water, sugar sphere, talc and xanthan gum. The plasticizer plasACRYL® HTP-20 have the following inactive ingredients: glyceryl monostearate, polysorbate 80, triethyl Citrate. The esomeprazole granules and inactive granules are constituted with water to form a suspension and are given by oral, nasogastric, or gastric administration.</Description>
  </NDC>
  <NDC>
    <NDCCode>69097-528-34</NDCCode>
    <PackageDescription>30 FOR SUSPENSION in 1 CARTON (69097-528-34) </PackageDescription>
    <NDC11Code>69097-0528-34</NDC11Code>
    <ProductNDC>69097-528</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Esomeprazole Magnesium</ProprietaryName>
    <NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
    <DosageFormName>FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200324</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211751</ApplicationNumber>
    <LabelerName>Cipla USA Inc.</LabelerName>
    <SubstanceName>ESOMEPRAZOLE MAGNESIUM DIHYDRATE</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>2024-05-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200324</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Esomeprazole magnesium for delayed release oral suspension is a proton pump inhibitor (PPI). Esomeprazole magnesium for delayed release oral suspension is indicated for the: : 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 1 year 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 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 dihydrate. 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 2 H2O with molecular weight of 749.15 as a dihydrate and 690.80 on an anhydrous basis. The structural formula is. The magnesium salt is a white to slightly colored powder and is insoluble in water and freely soluble in dimethyl sulphoxide. Each packet of esomeprazole magnesium for delayed release oral suspension contains 20 mg and 40 mg of esomeprazole, in the form of the enteric-coated granules, and also inactive granules. The inactive granules are composed of the following ingredients: anhydrous citric acid, crospovidone, dextrose anhydrous, ferric oxide yellow, hydroxypropyl cellulose, hydroxypropyl methyl cellulose E-15, magnesium stearate, methyl acrylic acid and ethyl acrylate copolymer dispersion, plasACRYL® HTP-20, polysorbate 80, purified water, sugar sphere, talc and xanthan gum. The plasticizer plasACRYL® HTP-20 have the following inactive ingredients: glyceryl monostearate, polysorbate 80, triethyl Citrate. The esomeprazole granules and inactive granules are constituted with water to form a suspension and are given by oral, nasogastric, or gastric administration.</Description>
  </NDC>
  <NDC>
    <NDCCode>69097-529-34</NDCCode>
    <PackageDescription>30 FOR SUSPENSION in 1 CARTON (69097-529-34) </PackageDescription>
    <NDC11Code>69097-0529-34</NDC11Code>
    <ProductNDC>69097-529</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Esomeprazole Magnesium</ProprietaryName>
    <NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
    <DosageFormName>FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200324</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211751</ApplicationNumber>
    <LabelerName>Cipla USA Inc.</LabelerName>
    <SubstanceName>ESOMEPRAZOLE MAGNESIUM DIHYDRATE</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>2024-05-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200324</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Esomeprazole magnesium for delayed release oral suspension is a proton pump inhibitor (PPI). Esomeprazole magnesium for delayed release oral suspension is indicated for the: : 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 1 year 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 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 dihydrate. 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 2 H2O with molecular weight of 749.15 as a dihydrate and 690.80 on an anhydrous basis. The structural formula is. The magnesium salt is a white to slightly colored powder and is insoluble in water and freely soluble in dimethyl sulphoxide. Each packet of esomeprazole magnesium for delayed release oral suspension contains 20 mg and 40 mg of esomeprazole, in the form of the enteric-coated granules, and also inactive granules. The inactive granules are composed of the following ingredients: anhydrous citric acid, crospovidone, dextrose anhydrous, ferric oxide yellow, hydroxypropyl cellulose, hydroxypropyl methyl cellulose E-15, magnesium stearate, methyl acrylic acid and ethyl acrylate copolymer dispersion, plasACRYL® HTP-20, polysorbate 80, purified water, sugar sphere, talc and xanthan gum. The plasticizer plasACRYL® HTP-20 have the following inactive ingredients: glyceryl monostearate, polysorbate 80, triethyl Citrate. The esomeprazole granules and inactive granules are constituted with water to form a suspension and are given by oral, nasogastric, or gastric administration.</Description>
  </NDC>
  <NDC>
    <NDCCode>69097-664-34</NDCCode>
    <PackageDescription>1 SYRINGE, GLASS in 1 CARTON (69097-664-34)  / 3 mL in 1 SYRINGE, GLASS</PackageDescription>
    <NDC11Code>69097-0664-34</NDC11Code>
    <ProductNDC>69097-664</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Icatibant</ProprietaryName>
    <NonProprietaryName>Icatibant</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20200713</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212446</ApplicationNumber>
    <LabelerName>Cipla USA Inc.</LabelerName>
    <SubstanceName>ICATIBANT ACETATE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/3mL</StrengthUnit>
    <Pharm_Classes>Bradykinin B2 Receptor Antagonist [EPC], Bradykinin B2 Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-05-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200713</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Icatibant injection is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.</IndicationAndUsage>
    <Description>Icatibant is a synthetic decapeptide with five non-proteinogenic amino acids. The chemical structure of icatibant acetate is presented in Figure 1. Figure 1 Chemical Structure. Chemical name: D-Arginyl-L-arginyl-L-prolyl-L[(4R)-4-hydroxyprolyl]-glycyl-L[3-(2-thienyl)alanyl]-L-seryl-D-(1,2,3,4-tetrahydroisoquinolin-3-ylcarbonyl)-L[(3aS,7aS)-octahydroindol-2-ylcarbonyl]-L-arginine, acetate salt. Icatibant injection 30 mg/3ml (10 mg/mL) is provided as a sterile, isotonic, and buffered solution of icatibant acetate in a single-dose, prefilled syringe for subcutaneous administration. Each mL of the solution contains 10 mg of icatibant (free base) which is equilvalent to 11.38 mg of icatibant acetate. Each prefilled syringe delivers 3 mL of solution equivalent to a 30 mg icatibant dose. The solution is clear and colorless. The solution also contains sodium chloride (isotonicity reagent), glacial acetic acid (pH adjuster), sodium hydroxide (pH adjuster) and water for injection with a pH of approximately 5.5. The solution does not contain preservatives. Pharmacological class: Icatibant is a bradykinin B2 receptor antagonist.</Description>
  </NDC>
  <NDC>
    <NDCCode>69097-686-34</NDCCode>
    <PackageDescription>1 BOTTLE, WITH APPLICATOR in 1 CARTON (69097-686-34)  / 4 mL in 1 BOTTLE, WITH APPLICATOR</PackageDescription>
    <NDC11Code>69097-0686-34</NDC11Code>
    <ProductNDC>69097-686</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tavaborole</ProprietaryName>
    <NonProprietaryName>Tavaborole</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210218</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212224</ApplicationNumber>
    <LabelerName>Cipla USA Inc.</LabelerName>
    <SubstanceName>TAVABOROLE</SubstanceName>
    <StrengthNumber>43.5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Boron Compounds [CS], Oxaborole Antifungal [EPC], Protein Synthesis Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-12-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210218</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tavaborole topical solution, 5% is an oxaborole antifungal indicated for the treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes.</IndicationAndUsage>
    <Description>Tavaborole topical solution, 5% contains tavaborole, 5% (w/w) in a clear, colorless alcohol-based solution for topical use. The active ingredient, tavaborole, is an oxaborole antifungal with the chemical name of 5-fluoro-1,3-dihydro-1-hydroxy-2,1-benzoxaborole. The chemical formula is C7H6BFO2, the molecular weight is 151.93 and the structural formula is. Tavaborole is a white to off-white powder. It is slightly soluble in water and freely soluble in ethanol and propylene glycol. Each mL of tavaborole topical solution contains 43.5 mg of tavaborole. Inactive ingredients include alcohol 74.81 % (v/v), edetate calcium disodium, and propylene glycol.</Description>
  </NDC>
  <NDC>
    <NDCCode>69097-840-53</NDCCode>
    <PackageDescription>30 POUCH in 1 CARTON (69097-840-53)  / 1 VIAL in 1 POUCH (69097-840-34)  / 3 mL in 1 VIAL</PackageDescription>
    <NDC11Code>69097-0840-53</NDC11Code>
    <ProductNDC>69097-840</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ipratropium Bromide And Albuterol Sulfate</ProprietaryName>
    <NonProprietaryName>Ipratropium Bromide And Albuterol Sulfate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20200601</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202496</ApplicationNumber>
    <LabelerName>Cipla USA Inc.</LabelerName>
    <SubstanceName>IPRATROPIUM BROMIDE; ALBUTEROL SULFATE</SubstanceName>
    <StrengthNumber>.5; 2.5</StrengthNumber>
    <StrengthUnit>mg/3mL; mg/3mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-01-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is indicated for the treatment of bronchospasm associated with COPD in patients requiring more than one bronchodilator.</IndicationAndUsage>
    <Description>The active components in Ipratropium Bromide and Albuterol Sulfate Inhalation Solution are albuterol sulfate and ipratropium bromide. Albuterol sulfate, is a salt of racemic albuterol and a relatively selective β 2-adrenergic bronchodilator chemically described as α.  1-[(tert-butylamino)methyl]-4-hydroxy-m-xylene-α, α'-diol sulfate (2:1) (salt). It has a molecular weight of 576.7 and the empirical formula is (C13H 21NO3)2H2SO4. It is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization recommended name for albuterol base is salbutamol. Figure 3.1-1. Chemical structure of albuterol sulfate. Ipratropium bromide is an anticholinergic bronchodilator chemically described as 8-azoniabicyclo [3.2.1]-octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8methyl-8-(1-methylethyl)-, bromide, monohydrate (endo, syn)-, (±)-; a synthetic quaternary ammonium compound, chemically related to atropine. It has a molecular weight of 430.4 and the empirical formula is C20H30BrNO3H2O. It is a white crystalline substance, freely soluble in water and lower alcohols, and insoluble in lipophilic solvents such as ether, chloroform, and fluorocarbons. Figure 3.1-2. Chemical structure of ipratropium bromide. Each 3 mL Sterile Unit-dose Vial contains 0.5 mg of ipratropium bromide (0.017%) and 3 mg Equivalent to 2.5 mg albuterol base albuterol sulfate (0.083%) in an isotonic, sterile, aqueous solution containing sodium chloride and 1 N hydrochloric acid to adjust to pH 4. *Equivalent to 2.5 mg albuterol base. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is a clear, colorless solution. It does not require dilution prior to administration by nebulization. For Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari-LC-Plus® nebulizer (with face mask or mouthpiece) connected to a PRONEB® compressor system, under  in vitro conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 46% of albuterol and 42% of ipratropium bromide at a mean flow rate of 3.6 L/min. The mean nebulization time was 15 minutes or less. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces (see.    DOSAGE AND ADMINISTRATION).</Description>
  </NDC>
  <NDC>
    <NDCCode>69097-237-72</NDCCode>
    <PackageDescription>2 TABLET in 1 BOTTLE (69097-237-72) </PackageDescription>
    <NDC11Code>69097-0237-72</NDC11Code>
    <ProductNDC>69097-237</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Albendazole</ProprietaryName>
    <NonProprietaryName>Albendazole</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180924</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210434</ApplicationNumber>
    <LabelerName>Cipla USA Inc.</LabelerName>
    <SubstanceName>ALBENDAZOLE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anthelmintic [EPC], Cytochrome P450 1A Inducers [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180924</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Albendazole is an anthelmintic drug indicated for: 1   Treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium . (1.1), 2   Treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus . (1.2).</IndicationAndUsage>
    <Description>Albendazole tablet, USP is an orally administered anthelmintic drug. Chemically, it is methyl 5-(propylthio)-2-benzimidazolecarbamate. Its molecular formula is C12H15N3O2S. Its molecular weight is 265.34. It has the following chemical structure. Albendazole, USP is a white to faintly yellowish powder. It is freely soluble in anhydrous formic acid and very slightly soluble in ether and in methylene chloride. Albendazole, USP is practically insoluble in alcohol and in water. Albendazole tablets USP, 200 mg are available as white to off-white, circular, biconvex, bevel-edged, film coated tablet debossed with "C237" on one side and plain on other side. Inactive ingredients consist of: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate, saccharin sodium, sodium starch glycolate, and corn starch (maize). The film-coating material consists of polyvinyl alcohol-part hydrolyzed, titanium dioxide, macrogol and talc.</Description>
  </NDC>
  <NDC>
    <NDCCode>69097-237-73</NDCCode>
    <PackageDescription>28 TABLET in 1 BOTTLE (69097-237-73) </PackageDescription>
    <NDC11Code>69097-0237-73</NDC11Code>
    <ProductNDC>69097-237</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Albendazole</ProprietaryName>
    <NonProprietaryName>Albendazole</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180924</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210434</ApplicationNumber>
    <LabelerName>Cipla USA Inc.</LabelerName>
    <SubstanceName>ALBENDAZOLE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anthelmintic [EPC], Cytochrome P450 1A Inducers [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180924</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Albendazole is an anthelmintic drug indicated for: 1   Treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium . (1.1), 2   Treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus . (1.2).</IndicationAndUsage>
    <Description>Albendazole tablet, USP is an orally administered anthelmintic drug. Chemically, it is methyl 5-(propylthio)-2-benzimidazolecarbamate. Its molecular formula is C12H15N3O2S. Its molecular weight is 265.34. It has the following chemical structure. Albendazole, USP is a white to faintly yellowish powder. It is freely soluble in anhydrous formic acid and very slightly soluble in ether and in methylene chloride. Albendazole, USP is practically insoluble in alcohol and in water. Albendazole tablets USP, 200 mg are available as white to off-white, circular, biconvex, bevel-edged, film coated tablet debossed with "C237" on one side and plain on other side. Inactive ingredients consist of: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate, saccharin sodium, sodium starch glycolate, and corn starch (maize). The film-coating material consists of polyvinyl alcohol-part hydrolyzed, titanium dioxide, macrogol and talc.</Description>
  </NDC>
  <NDC>
    <NDCCode>69097-870-67</NDCCode>
    <PackageDescription>1 SYRINGE in 1 CARTON (69097-870-67)  / .5 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>69097-0870-67</NDC11Code>
    <ProductNDC>69097-870</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lanreotide Acetate</ProprietaryName>
    <NonProprietaryName>Lanreotide Acetate</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20211224</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA215395</ApplicationNumber>
    <LabelerName>Cipla USA Inc.</LabelerName>
    <SubstanceName>LANREOTIDE ACETATE</SubstanceName>
    <StrengthNumber>120</StrengthNumber>
    <StrengthUnit>mg/.5mL</StrengthUnit>
    <Pharm_Classes>Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-09-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211224</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lanreotide Injection is a somatostatin analog indicated for: 1 the long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy. (1.1), 2 the treatment of adult patients with unresectable, well- or moderately- differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival. (1.2), 3 the treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy. (1.3).</IndicationAndUsage>
    <Description>Lanreotide Injection 60 mg/0.2 mL, 90 mg/0.3 mL, and 120 mg/0.5 mL is a prolonged-release formulation for deep subcutaneous injection. It contains the drug substance lanreotide acetate, a synthetic octapeptide with a biological activity similar to naturally occurring somatostatin, water for injection and acetic acid (for pH adjustment). Lanreotide Injection is available as sterile, ready-to-use, single-dose prefilled syringes containing lanreotide acetate supersaturated bulk solution of 24.6% w/w lanreotide base. Lanreotide acetate is a synthetic cyclical octapeptide analog of the natural hormone, somatostatin. Lanreotide acetate is chemically known as [cyclo S-S]-3-(2-naphthyl)-D­ alanyl-L-cysteinyl-L-tyrosyl-D-tryptophyl-L-lysyl-L-valyl-L-cysteinyl-L-threoninamide, acetate salt. Its molecular weight is 1096.34 (base) and its amino acid sequence is. The Lanreotide Injection in the prefilled syringe is a white to pale yellow, semi-solid formulation.</Description>
  </NDC>
  <NDC>
    <NDCCode>69097-880-67</NDCCode>
    <PackageDescription>1 SYRINGE in 1 CARTON (69097-880-67)  / .2 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>69097-0880-67</NDC11Code>
    <ProductNDC>69097-880</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lanreotide Acetate</ProprietaryName>
    <NonProprietaryName>Lanreotide Acetate</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20211224</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA215395</ApplicationNumber>
    <LabelerName>Cipla USA Inc.</LabelerName>
    <SubstanceName>LANREOTIDE ACETATE</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mg/.2mL</StrengthUnit>
    <Pharm_Classes>Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-09-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211224</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lanreotide Injection is a somatostatin analog indicated for: 1 the long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy. (1.1), 2 the treatment of adult patients with unresectable, well- or moderately- differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival. (1.2), 3 the treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy. (1.3).</IndicationAndUsage>
    <Description>Lanreotide Injection 60 mg/0.2 mL, 90 mg/0.3 mL, and 120 mg/0.5 mL is a prolonged-release formulation for deep subcutaneous injection. It contains the drug substance lanreotide acetate, a synthetic octapeptide with a biological activity similar to naturally occurring somatostatin, water for injection and acetic acid (for pH adjustment). Lanreotide Injection is available as sterile, ready-to-use, single-dose prefilled syringes containing lanreotide acetate supersaturated bulk solution of 24.6% w/w lanreotide base. Lanreotide acetate is a synthetic cyclical octapeptide analog of the natural hormone, somatostatin. Lanreotide acetate is chemically known as [cyclo S-S]-3-(2-naphthyl)-D­ alanyl-L-cysteinyl-L-tyrosyl-D-tryptophyl-L-lysyl-L-valyl-L-cysteinyl-L-threoninamide, acetate salt. Its molecular weight is 1096.34 (base) and its amino acid sequence is. The Lanreotide Injection in the prefilled syringe is a white to pale yellow, semi-solid formulation.</Description>
  </NDC>
  <NDC>
    <NDCCode>69097-890-67</NDCCode>
    <PackageDescription>1 SYRINGE in 1 CARTON (69097-890-67)  / .3 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>69097-0890-67</NDC11Code>
    <ProductNDC>69097-890</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lanreotide Acetate</ProprietaryName>
    <NonProprietaryName>Lanreotide Acetate</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20211224</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA215395</ApplicationNumber>
    <LabelerName>Cipla USA Inc.</LabelerName>
    <SubstanceName>LANREOTIDE ACETATE</SubstanceName>
    <StrengthNumber>90</StrengthNumber>
    <StrengthUnit>mg/.3mL</StrengthUnit>
    <Pharm_Classes>Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-09-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211224</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lanreotide Injection is a somatostatin analog indicated for: 1 the long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy. (1.1), 2 the treatment of adult patients with unresectable, well- or moderately- differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival. (1.2), 3 the treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy. (1.3).</IndicationAndUsage>
    <Description>Lanreotide Injection 60 mg/0.2 mL, 90 mg/0.3 mL, and 120 mg/0.5 mL is a prolonged-release formulation for deep subcutaneous injection. It contains the drug substance lanreotide acetate, a synthetic octapeptide with a biological activity similar to naturally occurring somatostatin, water for injection and acetic acid (for pH adjustment). Lanreotide Injection is available as sterile, ready-to-use, single-dose prefilled syringes containing lanreotide acetate supersaturated bulk solution of 24.6% w/w lanreotide base. Lanreotide acetate is a synthetic cyclical octapeptide analog of the natural hormone, somatostatin. Lanreotide acetate is chemically known as [cyclo S-S]-3-(2-naphthyl)-D­ alanyl-L-cysteinyl-L-tyrosyl-D-tryptophyl-L-lysyl-L-valyl-L-cysteinyl-L-threoninamide, acetate salt. Its molecular weight is 1096.34 (base) and its amino acid sequence is. The Lanreotide Injection in the prefilled syringe is a white to pale yellow, semi-solid formulation.</Description>
  </NDC>
  <NDC>
    <NDCCode>69097-906-67</NDCCode>
    <PackageDescription>1 POUCH in 1 CARTON (69097-906-67)  / 1 SYRINGE in 1 POUCH / .5 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>69097-0906-67</NDC11Code>
    <ProductNDC>69097-906</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lanreotide Acetate</ProprietaryName>
    <NonProprietaryName>Lanreotide Acetate</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20250530</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217193</ApplicationNumber>
    <LabelerName>Cipla USA Inc.</LabelerName>
    <SubstanceName>LANREOTIDE ACETATE</SubstanceName>
    <StrengthNumber>120</StrengthNumber>
    <StrengthUnit>mg/.5mL</StrengthUnit>
    <Pharm_Classes>Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-05-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250530</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Lanreotide Injection 60 mg/0.2 mL, 90 mg/0.3 mL, and 120 mg/0.5 mL is a prolonged-release formulation for deep subcutaneous injection. It contains the drug substance lanreotide acetate, a synthetic octapeptide with a biological activity similar to naturally occurring somatostatin, water for injection and acetic acid (for pH adjustment). Lanreotide Injection is available as sterile, ready-to-use, single-dose prefilled syringes containing lanreotide acetate supersaturated bulk solution of 24.6% w/w lanreotide base. Lanreotide acetate is a synthetic cyclical octapeptide analog of the natural hormone, somatostatin. Lanreotide acetate is chemically known as [cyclo S-S]-3-(2-naphthyl)-D-alanyl-L-cysteinyl-L- tyrosyl-D-tryptophyl-L-lysyl-L-valyl-L-cysteinyl-L-threoninamide, acetate salt. Its molecular weight is 1096.34 (base) and its amino acid sequence is. The Lanreotide Injection in the prefilled syringe is a white to pale yellow, semi-solid formulation.</Description>
  </NDC>
  <NDC>
    <NDCCode>69097-907-67</NDCCode>
    <PackageDescription>1 POUCH in 1 CARTON (69097-907-67)  / 1 SYRINGE in 1 POUCH / .2 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>69097-0907-67</NDC11Code>
    <ProductNDC>69097-907</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lanreotide Acetate</ProprietaryName>
    <NonProprietaryName>Lanreotide Acetate</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20250530</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217193</ApplicationNumber>
    <LabelerName>Cipla USA Inc.</LabelerName>
    <SubstanceName>LANREOTIDE ACETATE</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mg/.2mL</StrengthUnit>
    <Pharm_Classes>Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-05-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250530</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Lanreotide Injection 60 mg/0.2 mL, 90 mg/0.3 mL, and 120 mg/0.5 mL is a prolonged-release formulation for deep subcutaneous injection. It contains the drug substance lanreotide acetate, a synthetic octapeptide with a biological activity similar to naturally occurring somatostatin, water for injection and acetic acid (for pH adjustment). Lanreotide Injection is available as sterile, ready-to-use, single-dose prefilled syringes containing lanreotide acetate supersaturated bulk solution of 24.6% w/w lanreotide base. Lanreotide acetate is a synthetic cyclical octapeptide analog of the natural hormone, somatostatin. Lanreotide acetate is chemically known as [cyclo S-S]-3-(2-naphthyl)-D-alanyl-L-cysteinyl-L- tyrosyl-D-tryptophyl-L-lysyl-L-valyl-L-cysteinyl-L-threoninamide, acetate salt. Its molecular weight is 1096.34 (base) and its amino acid sequence is. The Lanreotide Injection in the prefilled syringe is a white to pale yellow, semi-solid formulation.</Description>
  </NDC>
  <NDC>
    <NDCCode>69097-908-67</NDCCode>
    <PackageDescription>1 POUCH in 1 CARTON (69097-908-67)  / 1 SYRINGE in 1 POUCH / .3 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>69097-0908-67</NDC11Code>
    <ProductNDC>69097-908</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lanreotide Acetate</ProprietaryName>
    <NonProprietaryName>Lanreotide Acetate</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20250530</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217193</ApplicationNumber>
    <LabelerName>Cipla USA Inc.</LabelerName>
    <SubstanceName>LANREOTIDE ACETATE</SubstanceName>
    <StrengthNumber>90</StrengthNumber>
    <StrengthUnit>mg/.3mL</StrengthUnit>
    <Pharm_Classes>Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-05-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250530</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Lanreotide Injection 60 mg/0.2 mL, 90 mg/0.3 mL, and 120 mg/0.5 mL is a prolonged-release formulation for deep subcutaneous injection. It contains the drug substance lanreotide acetate, a synthetic octapeptide with a biological activity similar to naturally occurring somatostatin, water for injection and acetic acid (for pH adjustment). Lanreotide Injection is available as sterile, ready-to-use, single-dose prefilled syringes containing lanreotide acetate supersaturated bulk solution of 24.6% w/w lanreotide base. Lanreotide acetate is a synthetic cyclical octapeptide analog of the natural hormone, somatostatin. Lanreotide acetate is chemically known as [cyclo S-S]-3-(2-naphthyl)-D-alanyl-L-cysteinyl-L- tyrosyl-D-tryptophyl-L-lysyl-L-valyl-L-cysteinyl-L-threoninamide, acetate salt. Its molecular weight is 1096.34 (base) and its amino acid sequence is. The Lanreotide Injection in the prefilled syringe is a white to pale yellow, semi-solid formulation.</Description>
  </NDC>
  <NDC>
    <NDCCode>69097-910-55</NDCCode>
    <PackageDescription>5 SYRINGE, PLASTIC in 1 CARTON (69097-910-55)  / 3 mL in 1 SYRINGE, PLASTIC</PackageDescription>
    <NDC11Code>69097-0910-55</NDC11Code>
    <ProductNDC>69097-910</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Liraglutide</ProprietaryName>
    <NonProprietaryName>Liraglutide</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20260225</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217234</ApplicationNumber>
    <LabelerName>Cipla USA Inc.</LabelerName>
    <SubstanceName>LIRAGLUTIDE</SubstanceName>
    <StrengthNumber>6</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260225</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Liraglutide injection is indicated in combination with a reduced calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in: : 1 Adults and pediatric patients aged 12 years and older with body weight greater than 60 kg and obesity. , 2 Adults with overweight in the presence of at least one weight-related comorbid condition.</IndicationAndUsage>
    <Description>Liraglutide injection contains liraglutide, an analog of human GLP-1 and acts as a GLP-1 receptor agonist. Liraglutide is manufactured by synthetic process. The peptide precursor of liraglutide has been manufactured to be 97% homologous to native human GLP-1 by substituting arginine for lysine at position 34. Liraglutide is made by attaching a C-16 fatty acid (palmitic acid) with a glutamic acid spacer on the remaining lysine residue at position 26 of the peptide precursor. The molecular formula of liraglutide is C172H265N43O51 and the molecular weight is 3751.2 Daltons. The structural formula (Figure 1) is. Figure 1. Structural Formula of Liraglutide. Liraglutide injection is a sterile, aqueous, clear, colorless or almost colorless solution for subcutaneous use. Each 1 mL of liraglutide injection solution contains 6 mg of liraglutide and the following inactive ingredients: disodium   phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection. Liraglutide injection has a pH of approximately 8.15, hydrochloric acid or sodium hydroxide may be added to adjust pH. Each pre-filled pen contains a 3 mL solution of liraglutide injection equivalent to 18 mg liraglutide (free-base, anhydrous).</Description>
  </NDC>
  <NDC>
    <NDCCode>69097-910-68</NDCCode>
    <PackageDescription>3 SYRINGE, PLASTIC in 1 CARTON (69097-910-68)  / 3 mL in 1 SYRINGE, PLASTIC</PackageDescription>
    <NDC11Code>69097-0910-68</NDC11Code>
    <ProductNDC>69097-910</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Liraglutide</ProprietaryName>
    <NonProprietaryName>Liraglutide</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20260225</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217234</ApplicationNumber>
    <LabelerName>Cipla USA Inc.</LabelerName>
    <SubstanceName>LIRAGLUTIDE</SubstanceName>
    <StrengthNumber>6</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260225</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Liraglutide injection is indicated in combination with a reduced calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in: : 1 Adults and pediatric patients aged 12 years and older with body weight greater than 60 kg and obesity. , 2 Adults with overweight in the presence of at least one weight-related comorbid condition.</IndicationAndUsage>
    <Description>Liraglutide injection contains liraglutide, an analog of human GLP-1 and acts as a GLP-1 receptor agonist. Liraglutide is manufactured by synthetic process. The peptide precursor of liraglutide has been manufactured to be 97% homologous to native human GLP-1 by substituting arginine for lysine at position 34. Liraglutide is made by attaching a C-16 fatty acid (palmitic acid) with a glutamic acid spacer on the remaining lysine residue at position 26 of the peptide precursor. The molecular formula of liraglutide is C172H265N43O51 and the molecular weight is 3751.2 Daltons. The structural formula (Figure 1) is. Figure 1. Structural Formula of Liraglutide. Liraglutide injection is a sterile, aqueous, clear, colorless or almost colorless solution for subcutaneous use. Each 1 mL of liraglutide injection solution contains 6 mg of liraglutide and the following inactive ingredients: disodium   phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection. Liraglutide injection has a pH of approximately 8.15, hydrochloric acid or sodium hydroxide may be added to adjust pH. Each pre-filled pen contains a 3 mL solution of liraglutide injection equivalent to 18 mg liraglutide (free-base, anhydrous).</Description>
  </NDC>
  <NDC>
    <NDCCode>69097-920-67</NDCCode>
    <PackageDescription>2 SYRINGE, PLASTIC in 1 CARTON (69097-920-67)  / 3 mL in 1 SYRINGE, PLASTIC</PackageDescription>
    <NDC11Code>69097-0920-67</NDC11Code>
    <ProductNDC>69097-920</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Liraglutide</ProprietaryName>
    <NonProprietaryName>Liraglutide</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20260122</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217590</ApplicationNumber>
    <LabelerName>Cipla USA Inc.</LabelerName>
    <SubstanceName>LIRAGLUTIDE</SubstanceName>
    <StrengthNumber>6</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260122</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Liraglutide injection is indicated: 1 as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus., 2 to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease.</IndicationAndUsage>
    <Description>Liraglutide injection contains liraglutide, an analog of human GLP-1 and acts as a GLP-1 receptor agonist. Liraglutide is manufactured by synthetic process. The peptide precursor of liraglutide has been manufactured to be 97% homologous to native human GLP-1 by substituting arginine for lysine at position 34. Liraglutide is made by attaching a C-16 fatty acid (palmitic acid) with a glutamic acid spacer on the remaining lysine residue at position 26 of the peptide precursor. The molecular formula of liraglutide is C172H265N43O51 and the molecular weight is 3751.2 Daltons. The structural formula (Figure 1) is. Figure 1. Structural Formula of Liraglutide. Liraglutide injection is a sterile, aqueous, clear, colorless or almost colorless solution for subcutaneous use. Each 1 mL of liraglutide injection solution contains 6 mg of liraglutide and the following inactive ingredients: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection. Liraglutide injection has a pH of approximately 8.15, hydrochloric acid or sodium hydroxide may be added to adjust pH. Each prefilled pen contains a 3 mL solution of liraglutide injection equivalent to 18 mg liraglutide (free-base, anhydrous).</Description>
  </NDC>
  <NDC>
    <NDCCode>69097-920-68</NDCCode>
    <PackageDescription>3 SYRINGE, PLASTIC in 1 CARTON (69097-920-68)  / 3 mL in 1 SYRINGE, PLASTIC</PackageDescription>
    <NDC11Code>69097-0920-68</NDC11Code>
    <ProductNDC>69097-920</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Liraglutide</ProprietaryName>
    <NonProprietaryName>Liraglutide</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20260122</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217590</ApplicationNumber>
    <LabelerName>Cipla USA Inc.</LabelerName>
    <SubstanceName>LIRAGLUTIDE</SubstanceName>
    <StrengthNumber>6</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260122</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Liraglutide injection is indicated: 1 as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus., 2 to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease.</IndicationAndUsage>
    <Description>Liraglutide injection contains liraglutide, an analog of human GLP-1 and acts as a GLP-1 receptor agonist. Liraglutide is manufactured by synthetic process. The peptide precursor of liraglutide has been manufactured to be 97% homologous to native human GLP-1 by substituting arginine for lysine at position 34. Liraglutide is made by attaching a C-16 fatty acid (palmitic acid) with a glutamic acid spacer on the remaining lysine residue at position 26 of the peptide precursor. The molecular formula of liraglutide is C172H265N43O51 and the molecular weight is 3751.2 Daltons. The structural formula (Figure 1) is. Figure 1. Structural Formula of Liraglutide. Liraglutide injection is a sterile, aqueous, clear, colorless or almost colorless solution for subcutaneous use. Each 1 mL of liraglutide injection solution contains 6 mg of liraglutide and the following inactive ingredients: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection. Liraglutide injection has a pH of approximately 8.15, hydrochloric acid or sodium hydroxide may be added to adjust pH. Each prefilled pen contains a 3 mL solution of liraglutide injection equivalent to 18 mg liraglutide (free-base, anhydrous).</Description>
  </NDC>
  <NDC>
    <NDCCode>0069-0242-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0069-0242-30) </PackageDescription>
    <NDC11Code>00069-0242-30</NDC11Code>
    <ProductNDC>0069-0242</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Toviaz</ProprietaryName>
    <NonProprietaryName>Fesoterodine Fumarate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20081031</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022030</ApplicationNumber>
    <LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
    <SubstanceName>FESOTERODINE FUMARATE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-04-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20081031</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Toviaz is indicated for the treatment of: 1 Overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. (1.1), 2 Neurogenic detrusor overactivity (NDO) in pediatric patients 6 years of age and older and weighing greater than 25 kg. (1.2).</IndicationAndUsage>
    <Description>Toviaz contains fesoterodine fumarate and is an extended-release tablet. Fesoterodine is rapidly de-esterified to its active metabolite (R)-2-(3-diisopropylamino-1-phenylpropyl)-4-hydroxymethyl-phenol, or 5-hydroxymethyl tolterodine, which is a muscarinic receptor antagonist. Chemically, fesoterodine fumarate is designated as isobutyric acid 2-((R)-3-diisopropylammonium-1-phenylpropyl)-4-(hydroxymethyl) phenyl ester hydrogen fumarate. The empirical formula is C30H41NO7 and its molecular weight is 527.66. The structural formula is. The asterisk (*) indicates the chiral carbon. Fesoterodine fumarate is a white to off-white powder, which is freely soluble in water. Each Toviaz extended-release tablet contains either 4 mg or 8 mg of fesoterodine fumarate and the following inactive ingredients: glyceryl behenate, hypromellose, indigo carmine aluminum lake, lactose monohydrate, soya lecithin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and xylitol.</Description>
  </NDC>
  <NDC>
    <NDCCode>0069-0244-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0069-0244-30) </PackageDescription>
    <NDC11Code>00069-0244-30</NDC11Code>
    <ProductNDC>0069-0244</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Toviaz</ProprietaryName>
    <NonProprietaryName>Fesoterodine Fumarate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20081031</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022030</ApplicationNumber>
    <LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
    <SubstanceName>FESOTERODINE FUMARATE</SubstanceName>
    <StrengthNumber>8</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-04-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20081031</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Toviaz is indicated for the treatment of: 1 Overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. (1.1), 2 Neurogenic detrusor overactivity (NDO) in pediatric patients 6 years of age and older and weighing greater than 25 kg. (1.2).</IndicationAndUsage>
    <Description>Toviaz contains fesoterodine fumarate and is an extended-release tablet. Fesoterodine is rapidly de-esterified to its active metabolite (R)-2-(3-diisopropylamino-1-phenylpropyl)-4-hydroxymethyl-phenol, or 5-hydroxymethyl tolterodine, which is a muscarinic receptor antagonist. Chemically, fesoterodine fumarate is designated as isobutyric acid 2-((R)-3-diisopropylammonium-1-phenylpropyl)-4-(hydroxymethyl) phenyl ester hydrogen fumarate. The empirical formula is C30H41NO7 and its molecular weight is 527.66. The structural formula is. The asterisk (*) indicates the chiral carbon. Fesoterodine fumarate is a white to off-white powder, which is freely soluble in water. Each Toviaz extended-release tablet contains either 4 mg or 8 mg of fesoterodine fumarate and the following inactive ingredients: glyceryl behenate, hypromellose, indigo carmine aluminum lake, lactose monohydrate, soya lecithin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and xylitol.</Description>
  </NDC>
  <NDC>
    <NDCCode>0115-1248-01</NDCCode>
    <PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1248-01) </PackageDescription>
    <NDC11Code>00115-1248-01</NDC11Code>
    <ProductNDC>0115-1248</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carvedilol Phosphate</ProprietaryName>
    <NonProprietaryName>Carvedilol Phosphate</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204717</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
    <SubstanceName>CARVEDILOL PHOSPHATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).</IndicationAndUsage>
    <Description>Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO4 &amp;frac12; EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&amp;C Yellow No. 10, FD&amp;C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&amp;C Red No. 28, D&amp;C Yellow No. 10, FD&amp;C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&amp;C Red No. 28, D&amp;C Yellow No. 10, FD&amp;C Green No. 3, FD&amp;C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&amp;C Blue No. 1, FD&amp;C Blue No. 2, D&amp;C Yellow No. 10, FD&amp;C Red No. 40, iron oxide black and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>0115-1248-03</NDCCode>
    <PackageDescription>1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1248-03) </PackageDescription>
    <NDC11Code>00115-1248-03</NDC11Code>
    <ProductNDC>0115-1248</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carvedilol Phosphate</ProprietaryName>
    <NonProprietaryName>Carvedilol Phosphate</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204717</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
    <SubstanceName>CARVEDILOL PHOSPHATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).</IndicationAndUsage>
    <Description>Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO4 &amp;frac12; EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&amp;C Yellow No. 10, FD&amp;C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&amp;C Red No. 28, D&amp;C Yellow No. 10, FD&amp;C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&amp;C Red No. 28, D&amp;C Yellow No. 10, FD&amp;C Green No. 3, FD&amp;C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&amp;C Blue No. 1, FD&amp;C Blue No. 2, D&amp;C Yellow No. 10, FD&amp;C Red No. 40, iron oxide black and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>0115-1248-08</NDCCode>
    <PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1248-08) </PackageDescription>
    <NDC11Code>00115-1248-08</NDC11Code>
    <ProductNDC>0115-1248</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carvedilol Phosphate</ProprietaryName>
    <NonProprietaryName>Carvedilol Phosphate</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204717</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
    <SubstanceName>CARVEDILOL PHOSPHATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).</IndicationAndUsage>
    <Description>Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO4 &amp;frac12; EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&amp;C Yellow No. 10, FD&amp;C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&amp;C Red No. 28, D&amp;C Yellow No. 10, FD&amp;C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&amp;C Red No. 28, D&amp;C Yellow No. 10, FD&amp;C Green No. 3, FD&amp;C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&amp;C Blue No. 1, FD&amp;C Blue No. 2, D&amp;C Yellow No. 10, FD&amp;C Red No. 40, iron oxide black and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>0115-1248-10</NDCCode>
    <PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1248-10) </PackageDescription>
    <NDC11Code>00115-1248-10</NDC11Code>
    <ProductNDC>0115-1248</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carvedilol Phosphate</ProprietaryName>
    <NonProprietaryName>Carvedilol Phosphate</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204717</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
    <SubstanceName>CARVEDILOL PHOSPHATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).</IndicationAndUsage>
    <Description>Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO4 &amp;frac12; EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&amp;C Yellow No. 10, FD&amp;C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&amp;C Red No. 28, D&amp;C Yellow No. 10, FD&amp;C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&amp;C Red No. 28, D&amp;C Yellow No. 10, FD&amp;C Green No. 3, FD&amp;C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&amp;C Blue No. 1, FD&amp;C Blue No. 2, D&amp;C Yellow No. 10, FD&amp;C Red No. 40, iron oxide black and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>0115-1249-01</NDCCode>
    <PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1249-01) </PackageDescription>
    <NDC11Code>00115-1249-01</NDC11Code>
    <ProductNDC>0115-1249</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carvedilol Phosphate</ProprietaryName>
    <NonProprietaryName>Carvedilol Phosphate</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204717</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
    <SubstanceName>CARVEDILOL PHOSPHATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).</IndicationAndUsage>
    <Description>Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO4 &amp;frac12; EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&amp;C Yellow No. 10, FD&amp;C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&amp;C Red No. 28, D&amp;C Yellow No. 10, FD&amp;C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&amp;C Red No. 28, D&amp;C Yellow No. 10, FD&amp;C Green No. 3, FD&amp;C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&amp;C Blue No. 1, FD&amp;C Blue No. 2, D&amp;C Yellow No. 10, FD&amp;C Red No. 40, iron oxide black and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>0115-1249-03</NDCCode>
    <PackageDescription>1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1249-03) </PackageDescription>
    <NDC11Code>00115-1249-03</NDC11Code>
    <ProductNDC>0115-1249</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carvedilol Phosphate</ProprietaryName>
    <NonProprietaryName>Carvedilol Phosphate</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204717</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
    <SubstanceName>CARVEDILOL PHOSPHATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).</IndicationAndUsage>
    <Description>Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO4 &amp;frac12; EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&amp;C Yellow No. 10, FD&amp;C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&amp;C Red No. 28, D&amp;C Yellow No. 10, FD&amp;C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&amp;C Red No. 28, D&amp;C Yellow No. 10, FD&amp;C Green No. 3, FD&amp;C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&amp;C Blue No. 1, FD&amp;C Blue No. 2, D&amp;C Yellow No. 10, FD&amp;C Red No. 40, iron oxide black and shellac.</Description>
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    <NDCCode>0115-1249-08</NDCCode>
    <PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1249-08) </PackageDescription>
    <NDC11Code>00115-1249-08</NDC11Code>
    <ProductNDC>0115-1249</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carvedilol Phosphate</ProprietaryName>
    <NonProprietaryName>Carvedilol Phosphate</NonProprietaryName>
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    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204717</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
    <SubstanceName>CARVEDILOL PHOSPHATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).</IndicationAndUsage>
    <Description>Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO4 &amp;frac12; EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&amp;C Yellow No. 10, FD&amp;C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&amp;C Red No. 28, D&amp;C Yellow No. 10, FD&amp;C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&amp;C Red No. 28, D&amp;C Yellow No. 10, FD&amp;C Green No. 3, FD&amp;C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&amp;C Blue No. 1, FD&amp;C Blue No. 2, D&amp;C Yellow No. 10, FD&amp;C Red No. 40, iron oxide black and shellac.</Description>
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  <NDC>
    <NDCCode>0115-1249-10</NDCCode>
    <PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1249-10) </PackageDescription>
    <NDC11Code>00115-1249-10</NDC11Code>
    <ProductNDC>0115-1249</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carvedilol Phosphate</ProprietaryName>
    <NonProprietaryName>Carvedilol Phosphate</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204717</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
    <SubstanceName>CARVEDILOL PHOSPHATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).</IndicationAndUsage>
    <Description>Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO4 &amp;frac12; EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&amp;C Yellow No. 10, FD&amp;C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&amp;C Red No. 28, D&amp;C Yellow No. 10, FD&amp;C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&amp;C Red No. 28, D&amp;C Yellow No. 10, FD&amp;C Green No. 3, FD&amp;C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&amp;C Blue No. 1, FD&amp;C Blue No. 2, D&amp;C Yellow No. 10, FD&amp;C Red No. 40, iron oxide black and shellac.</Description>
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  <NDC>
    <NDCCode>0115-1250-01</NDCCode>
    <PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1250-01) </PackageDescription>
    <NDC11Code>00115-1250-01</NDC11Code>
    <ProductNDC>0115-1250</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carvedilol Phosphate</ProprietaryName>
    <NonProprietaryName>Carvedilol Phosphate</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204717</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
    <SubstanceName>CARVEDILOL PHOSPHATE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).</IndicationAndUsage>
    <Description>Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO4 &amp;frac12; EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&amp;C Yellow No. 10, FD&amp;C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&amp;C Red No. 28, D&amp;C Yellow No. 10, FD&amp;C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&amp;C Red No. 28, D&amp;C Yellow No. 10, FD&amp;C Green No. 3, FD&amp;C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&amp;C Blue No. 1, FD&amp;C Blue No. 2, D&amp;C Yellow No. 10, FD&amp;C Red No. 40, iron oxide black and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>0115-1250-03</NDCCode>
    <PackageDescription>1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1250-03) </PackageDescription>
    <NDC11Code>00115-1250-03</NDC11Code>
    <ProductNDC>0115-1250</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carvedilol Phosphate</ProprietaryName>
    <NonProprietaryName>Carvedilol Phosphate</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204717</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
    <SubstanceName>CARVEDILOL PHOSPHATE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).</IndicationAndUsage>
    <Description>Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO4 &amp;frac12; EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&amp;C Yellow No. 10, FD&amp;C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&amp;C Red No. 28, D&amp;C Yellow No. 10, FD&amp;C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&amp;C Red No. 28, D&amp;C Yellow No. 10, FD&amp;C Green No. 3, FD&amp;C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&amp;C Blue No. 1, FD&amp;C Blue No. 2, D&amp;C Yellow No. 10, FD&amp;C Red No. 40, iron oxide black and shellac.</Description>
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